125742 S1 M5 5351 bnt162 01 interim3 adverse events
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Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Fina l 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.1-1: Lis ting of solicited local reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of col lection Loc al reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 1 µg You nger 10015 29APR20 20 23:00 Pain Mil d 0 29APR20 20 9:23 29APR20 20 23:00 Ten derness Mod erate 0 29APR20 20 9:23 20M AY2020 23:00 Pain Mil d 21 0 29APR20 20 9:23 10018 29APR20 20 Pain Mil d 0 29APR20 20 9:53 29APR20 20 Ten derness Mod erate 0 29APR20 20 9:53 20M AY2020 23:00 Pain Mil d 21 0 29APR20 20 9:53 20M AY2020 23:00 Ten derness Mil d 21 0 29APR20 20 9:53 10025 26M AY2020 22:00 Pain Mil d 21 0 05M AY2020 9:06 26M AY2020 22:00 Ten derness Mil d 21 0 05M AY2020 9:06 10033 05M AY2020 20:00 Ten derness Mil d 0 05M AY2020 10:03 28M AY2020 20:00 Ten derness Mil d 23 2 05M AY2020 10:03 10040 08M AY2020 20:31 Pain Mil d 0 08M AY2020 8:51 08M AY2020 20:31 Ten derness Mil d 0 08M AY2020 8:51 09M AY2020 21:20 Pain Mil d 1 08M AY2020 8:51 09M AY2020 21:20 Ten derness Mil d 1 08M AY2020 8:51 30M AY2020 21:18 Pain Mod erate 22 1 08M AY2020 8:51 30M AY2020 21:18 Ten derness Seve re 22 1 08M AY2020 8:51 30M AY2020 21:18 Indu ration/Swelling Mod erate 22 1 08M AY2020 8:51 Progra m: Lsa f_locR_1.sas (Page 1 of 56) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 1 FDA-CBER-2021-5683-0049996 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data rece ived on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.1-1: Lis ting of solicited local reacti ons - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Loc al reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 1 µg You nger 10040 31M AY2020 21:04 Pain Seve re 23 2 08M AY2020 8:51 31M AY2020 21:04 Ten derness Seve re 23 2 08M AY2020 8:51 01J UN2020 21:10 Pain Mod erate 24 3 08M AY2020 8:51 01J UN2020 21:10 Ten derness Mod erate 24 3 08M AY2020 8:51 02J UN2020 21:00 Pain Seve re 25 4 08M AY2020 8:51 02J UN2020 21:00 Ten derness Seve re 25 4 08M AY2020 8:51 03J UN2020 21:15 Pain Mod erate 26 5 08M AY2020 8:51 03J UN2020 21:15 Ten derness Mod erate 26 5 08M AY2020 8:51 10041 08M AY2020 20:25 Pain Mil d 0 08M AY2020 9:06 08M AY2020 20:2 5 Ten derness Mil d 0 08M AY2020 9:06 09M AY2020 21:20 Pain Mil d 1 08M AY2020 9:06 09M AY2020 21:20 Ten derness Mil d 1 08M AY2020 9:06 29M AY2020 22:10 Pain Mil d 21 0 08M AY2020 9:06 29M AY2020 22:10 Ten derness Seve re 21 0 08M AY2020 9:06 30M AY2020 21:18 Pain Mod erate 22 1 08M AY2020 9:06 30M AY2020 21:18 Ten derness Seve re 22 1 08M AY2020 9:06 30M AY2020 21:18 Indu ration/Swelling Mod erate 22 1 08M AY2020 9:06 31M AY2020 21:04 Pain Mod erate 23 2 08M AY2020 9:06 Progra m: Lsa f_locR_1.sas (Page 2 of 56) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 2 FDA-CBER-2021-5683-0049997 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV 2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.1-1: Lis ting of solicited local reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Loc al reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 1 µg You nger 10041 31M AY2020 21:04 Ten derness Mod erate 23 2 08M AY2020 9:06 01J UN2020 21:13 Pain Mil d 24 3 08M AY2020 9:06 10052 08M AY2020 23:00 Ten derness Mil d 0 08M AY2020 9:51 09M AY2020 23:10 Ten derness Mil d 1 08M AY2020 9:51 02J UN2020 Pain Mod erate 25 4 08M AY2020 9:51 02J UN2020 Ten derness Mod erate 25 4 08M AY2020 9:51 3 µg You nger 10170 31J UL2020 20:00 Pain Mil d 0 31J UL2020 8:00 31J UL2020 20:00 Ten derness Mil d 0 31J UL2020 8:00 01AUG 2020 20:05 Ten derness Mil d 1 31J UL2020 8:00 21AUG 2020 20:04 Ten derness Mil d 21 0 31J UL2020 8:00 10194 22J UL2020 21:15 Pain Mil d 0 22J UL2020 8:00 22J UL2020 21:15 Ten derness Mil d 0 22J UL2020 8:00 23J UL2020 21:45 Pain Mil d 1 22J UL2020 8:00 23J UL2020 21:45 Ten derness Mil d 1 22J UL2020 8:00 12AUG 2020 22:15 Ten derness Mil d 21 0 22J UL2020 8:00 13AUG 2020 21:45 Ten derness Mil d 22 1 22J UL2020 8:00 14AUG 2020 22:00 Ten derness Mil d 23 2 22J UL2020 8:00 17AUG 2020 22:00 Pain Mil d 26 5 22J UL2020 8:00 Progra m: Lsa f_locR_1.sas (Page 3 of 56) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 3 FDA-CBER-2021-5683-0049998 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.1-1: Lis ting of solicited local reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Loc al reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 3 µg You nger 10194 17AUG 2020 22:00 Ten derness Mil d 26 5 22J UL2020 8:00 17AUG 2020 22:00 Erythe ma/Redness Mil d 26 5 22J UL2020 8:00 17AUG 2020 22:00 Indu ration/Swelling Mil d 26 5 22J UL2020 8:00 10204 12AUG 2020 21:45 Pain Mil d 21 0 22J UL2020 8:45 12AUG 2020 21:45 Ten derness Mil d 21 0 22J UL2020 8:45 13AUG 2020 22:00 Ten derness Mil d 22 1 22J UL2020 8:45 17AUG 2020 21:40 Pain Mil d 26 5 22J UL2020 8:45 17AUG 2020 21:40 Ten derness Mil d 26 5 22J UL2020 8:45 10212 22J UL2020 20:30 Ten derness Mil d 0 22J UL2020 9:15 23J UL2020 21:30 Ten derness Mil d 1 22J UL2020 9:15 24J UL2020 20:30 Ten derness Mil d 2 22J UL2020 9:15 25J UL2020 20:45 Ten derness Mil d 3 22J UL2020 9:15 26J UL2020 20:40 Ten derness Mil d 4 22J UL2020 9:15 27J UL2020 20:45 Ten derness Mil d 5 22J UL2020 9:15 12AUG 2020 21:30 Ten derness Mil d 21 0 22J UL2020 9:15 13AUG 2020 20:00 Ten derness Mil d 22 1 22J UL2020 9:15 14AUG 2020 20:00 Ten derness Mil d 23 2 22J UL2020 9:15 15AUG 2020 22:30 Ten derness Mil d 24 3 22J UL2020 9:15 Progra m: Lsa f_locR_1.sas (Page 4 of 56) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 4 FDA-CBER-2021-5683-0049999 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.1-1: Lis ting of solicited local reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Loc al reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 3 µg You nger 10212 16AUG 2020 21:00 Ten derness Mil d 25 4 22J UL2020 9:15 17AUG 2020 Ten derness Mil d 26 5 22J UL2020 9:15 10226 31J UL2020 20:00 Pain Mil d 0 31J UL2020 8:45 31J UL2020 20:00 Ten derness Mil d 0 31J UL2020 8:45 01AUG 2020 20:00 Pain Mod erate 1 31J UL2020 8:45 01AUG 2020 20:00 Ten derness Mod erate 1 31J UL2020 8:45 02AUG 2020 20:00 Pain Mil d 2 31J UL2020 8:45 02AUG 2020 20:00 Ten derness Mil d 2 31J UL2020 8:45 03AUG 2020 20:00 Ten derness Mil d 3 31J UL2020 8:45 21AUG 2020 20:00 Pain Mod erate 21 0 31J UL2020 8:45 21AUG 2020 20:00 Ten derness Mod erate 21 0 31J UL2020 8:45 22AUG 2020 20:00 Pain Mod erate 22 1 31J UL2020 8:45 22AUG 2020 20:00 Ten derness Mil d 22 1 31J UL2020 8:45 23AUG 2020 20:00 Pain Mil d 23 2 31J UL2020 8:45 23AUG 2020 20:00 Ten derness Mil d 23 2 31J UL2020 8:45 24AUG 2020 20:00 Ten derness Mil d 24 3 31J UL2020 8:45 10227 31J UL2020 18:00 Ten derness Mil d 0 31J UL2020 9:15 01AUG 2020 18:00 Ten derness Mil d 1 31J UL2020 9:15 Progra m: Lsa f_locR_1.sas (Page 5 of 56) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 5 FDA-CBER-2021-5683-0050000 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.1-1: Lis ting of solicited local reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Loc al reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 10 µg You nger 10001 15M AY2020 20:00 Ten derness Mil d 21 0 24APR20 20 10:15 10003 29APR20 20 19:10 Pain Mil d 1 28APR20 20 8:30 29APR20 20 19:10 Ten derness Mil d 1 28APR20 20 8:30 19M AY2020 20:35 Pain Mil d 21 0 28APR20 20 8:30 19M AY2020 20:35 Ten derness Mil d 21 0 28APR20 20 8:30 20M AY2020 20:25 Pain Mil d 22 1 28APR20 20 8:30 20M AY2020 20:25 Ten derness Mil d 22 1 28APR20 20 8:30 21M AY2020 20:30 Ten derness Mil d 23 2 28APR20 20 8:30 22M AY2020 20:15 Ten derness Mil d 24 3 28APR20 20 8:30 23M AY2020 20:20 Ten derness Mil d 25 4 28APR20 20 8:30 24M AY2020 20:25 Ten derness Mil d 26 5 28APR20 20 8:30 25M AY2020 20:10 Ten derness Mil d 27 6 28APR20 20 8:30 26M AY2020 20:15 Ten derness Mil d 28 7 28APR20 20 8:30 10004 24APR20 20 22:15 Ten derness Mil d 0 24APR20 20 9:15 25APR20 20 21:00 Ten derness Mil d 1 24APR20 20 9:15 15M AY2020 21:30 Pain Mil d 21 0 24APR20 20 9:15 15M AY2020 21:30 Ten derness Mil d 21 0 24APR20 20 9:15 16M AY2020 22:15 Pain Mil d 22 1 24APR20 20 9:15 Progra m: Lsa f_locR_1.sas (Page 6 of 56) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 6 FDA-CBER-2021-5683-0050001 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.1-1: Lis ting of solicited local reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Loc al reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 10 µg You nger 10004 16M AY2020 22:15 Ten derness Mil d 22 1 24APR20 20 9:15 17M AY2020 23:15 Pain Mil d 23 2 24APR20 20 9:15 17M AY2020 23:15 Ten derness Mil d 23 2 24APR20 20 9:15 18M AY2020 23:00 Pain Mil d 24 3 24APR20 20 9:15 18M AY2020 23:00 Ten derness Mil d 24 3 24APR20 20 9:15 10005 24APR20 20 21:00 Ten derness Mod erate 0 24APR20 20 11:15 25APR20 20 19:30 Ten derness Mod erate 1 24APR20 20 11:15 15M AY2020 19:00 Pain Mil d 21 0 24APR20 20 11:15 15M AY2020 19:00 Ten derness Mil d 21 0 24APR20 20 11:15 16M AY2020 19:00 Pain Mil d 22 1 24APR20 20 11:15 16M AY2020 19:00 Ten derness Mil d 22 1 24APR20 20 11:15 10006 29APR20 20 22:00 Pain Mil d 1 28APR20 20 9:00 29APR20 20 22:00 Ten derness Mil d 1 28APR20 20 9:00 19M AY2020 22:00 Ten derness Mil d 21 0 28APR20 20 9:00 20M AY2020 22:00 Ten derness Mil d 22 1 28APR20 20 9:00 10007 23APR20 20 20:00 Pain Mil d 0 23APR20 20 11:08 24APR20 20 9:10 Pain Mil d 1 23APR20 20 11:08 24APR20 20 9:10 Ten derness Mil d 1 23APR20 20 11:08 Progra m: Lsa f_locR_1.sas (Page 7 of 56) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 7 FDA-CBER-2021-5683-0050002 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data rece ived on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3-1.1-1: Lis ting of solicited local reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Loc al reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prim e imm unization 10 µg You nger 10007 25APR20 20 9:00 Pain Mil d 2 23APR20 20 11:08 26APR20 20 20:00 Pain Mil d 3 23APR20 20 11:08 27APR20 20 20:00 Pain Mil d 4 23APR20 20 11:08 28APR20 20 20:00 Pain Mil d 5 23APR20 20 11:08 14M AY2020 Pain Mil d 21 0 23APR20 20 11:08 14M AY2020 Ten derness Mod erate 21 0 23APR20 20 11:08 15M AY2020 20:00 Pain Mod erate 22 1 23APR20 20 11:08 15M AY2020 20:00 Ten derness Mil d 22 1 23APR20 20 11:08 15M AY2020 20:00 Indu ration/Swelling Mil d 22 1 23APR20 20 11:08 16M AY2020 20:00 Pain Mil d 23 2 23APR20 20 11:08 16M AY2020 20:00 Ten derness Mil d 23 2 23APR20 20 11:08 17M AY2020 20:00 Pain Mil d 24 3 23APR20 20 11:08 17M AY2020 20:00 Ten derness Mil d 24 3 23APR20 20 11:08 18M AY2020 20:00 Pain Mil d 25 4 23APR20 20 11: 08 18M AY2020 20:00 Ten derness Mil d 25 4 23APR20 20 11:08 10008 28APR20 20 22:00 Ten derness Mod erate 0 28APR20 20 9:30 29APR20 20 22:00 Ten derness Mil d 1 28APR20 20 9:30 19M AY2020 22:00 Ten derness Mil d 21 0 28APR20 20 9:30 Progra m: Lsa f_locR_1.sas (Page 8 of 56) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 8 FDA-CBER-2021-5683-0050003 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.1-1: Lis ting of solicited local reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Loc al reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 10 µg You nger 10008 20M AY2020 22:00 Ten derness Mil d 22 1 28APR20 20 9:30 21M AY2020 22:00 Ten derness Mil d 23 2 28APR20 20 9:30 10009 28APR20 20 21:00 Pain Mil d 0 28APR20 20 10:00 28APR20 20 21:00 Ten derness Mil d 0 28APR20 20 10:00 29APR20 20 20:30 Ten derness Mil d 1 28APR20 20 10:00 30APR20 20 20:00 Ten derness Mil d 2 28APR20 20 10:00 19M AY2020 22:00 Pain Mil d 21 0 28APR20 20 10:00 19M AY2020 22:00 Ten derness Mil d 21 0 28APR20 20 10:00 20M AY2020 19:00 Pain Mil d 22 1 28APR20 20 10:00 20M AY2020 19:00 Ten derness Mil d 22 1 28APR20 20 10:00 21M AY2020 19:00 Ten derness Mil d 23 2 28APR20 20 10:00 10010 25APR20 20 18:15 Pain Seve re 1 24APR20 20 12:15 25APR20 20 18:15 Ten derness Seve re 1 24APR20 20 12:15 26APR20 20 18:15 Pain Mod erate 2 24APR20 20 12:15 26APR20 20 18:15 Ten derness Mod erate 2 24APR20 20 12:15 27APR20 20 18:15 Pain Mod erate 3 24APR20 20 12:15 27APR20 20 18:15 Ten derness Mod erate 3 24APR20 20 12:15 28APR20 20 18:30 Pain Mod erate 4 24APR20 20 12:15 Progra m: Lsa f_locR_1.sas (Page 9 of 56) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 9 FDA-CBER-2021-5683-0050004 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Snap shot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.1-1: Lis ting of solicited local reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Loc al reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 10 µg You nger 10010 28APR20 20 18:30 Ten derness Mod erate 4 24APR20 20 12:15 29APR20 20 18:30 Pain Mod erate 5 24APR20 20 12:15 29APR20 20 18:30 Ten derness Mod erate 5 24APR20 20 12:15 30APR20 20 18:15 Pain Mil d 6 24APR20 20 12:15 30APR20 20 18:15 Ten derness Mil d 6 24APR20 20 12:15 01M AY2020 18:45 Pain Mil d 7 24APR20 20 12:15 01M AY2020 18:45 Ten derness Mil d 7 24APR20 20 12:15 02M AY2020 19:00 Pain Mil d 8 24APR20 20 12:15 02M AY2020 19:00 Ten derness Mil d 8 24APR20 20 12:15 10011 25APR20 20 6:30 Pain Mil d 1 24APR20 20 13:15 25APR20 20 6:30 Ten derness Mil d 1 24APR20 20 13:15 26APR20 20 6:15 Ten derness Mil d 2 24APR20 20 13:15 15M AY2020 22:00 Pain Mil d 21 0 24APR20 20 13:15 15M AY2020 22:00 Ten derness Mil d 21 0 24APR20 20 13:15 16M AY2020 22:00 Pain Mil d 22 1 24APR20 20 13:15 16M AY2020 22:00 Ten derness Mil d 22 1 24APR20 20 13:15 10017 28APR20 20 22:00 Ten derness Mod erate 0 28APR20 20 10:30 29APR20 20 20:43 Ten derness Mod erate 1 28APR20 20 10:30 Progra m: Lsa f_locR_1.sas (Page 10 of 56) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 10 FDA-CBER-2021-5683-0050005 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data rece ived on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.1-1: Lis ting of soli cited local reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Loc al reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 10 µg You nger 10017 19M AY2020 22:00 Pain Mil d 21 0 28APR20 20 10:30 20 µg You nger 10151 16J UL2020 18:00 Pain Mil d 0 16J UL2020 8:00 16J UL2020 18:00 Ten derness Mil d 0 16J UL2020 8:00 17J UL2020 20:00 Pain Mil d 1 16J UL2020 8:00 17J UL2020 20:00 Ten derness Mil d 1 16J UL2020 8:00 18J UL2020 20:00 Ten derness Mil d 2 16J UL2020 8:00 19J UL2020 20:00 Ten derness Mil d 3 16J UL2020 8:00 06AUG 2020 22:00 Pain Mil d 21 0 16J UL2020 8:00 06AUG 2020 22:00 Ten derness Mil d 21 0 16J UL2020 8:00 07AUG 2020 22:00 Pain Mil d 22 1 16J UL2020 8:00 07AUG 2020 22:00 Ten derness Mil d 22 1 16J UL2020 8:00 08AUG 2020 22:00 Pain Mil d 23 2 16J UL2020 8:00 08AUG 2020 22:00 Ten derness Mil d 23 2 16J UL2020 8:00 09AUG 2020 22:00 Pain Mil d 24 3 16J UL2020 8:00 09AUG 2020 22:00 Ten derness Mil d 24 3 16J UL2020 8:00 10AUG 2020 22:00 Pain Mil d 25 4 16J UL2020 8:00 10AUG 2020 22:00 Ten derness Mil d 25 4 16J UL2020 8:00 11AUG 2020 22:00 Pain Mil d 26 5 16J UL2020 8:00 Progra m: Lsa f_locR_1.sas (Page 11 of 56) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 11 FDA-CBER-2021-5683-0050006 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.1-1: Lis ting of solicited local reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Loc al reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 20 µg You nger 10151 11AUG 2020 22:00 Ten derness Mil d 26 5 16J UL2020 8:00 12AUG 2020 22:00 Ten derness Mil d 27 6 16J UL2020 8:00 10171 16J UL2020 17:40 Ten derness Mil d 0 16J UL2020 8:15 17J UL2020 20:28 Ten derness Mil d 1 16J UL2020 8:15 18J UL2020 20:10 Ten derness Mil d 2 16J UL2020 8:15 19J UL2020 21:07 Ten derness Mil d 3 16J UL2020 8:15 06AUG 2020 20:22 Pain Mod erate 21 0 16J UL2020 8:15 06AUG 2020 20:22 Ten derness Mod erate 21 0 16J UL2020 8:15 07AUG 2020 20:10 Pain Mil d 22 1 16J UL2020 8:15 07AUG 2020 20:10 Ten derness Mil d 22 1 16J UL2020 8:15 08AUG 2020 20:06 Pain Mil d 23 2 16J UL2020 8:15 08AUG 2020 20:06 Ten derness Mil d 23 2 16J UL2020 8:15 09AUG 2020 19:40 Pain Mil d 24 3 16J UL2020 8:15 09AUG 2020 19:40 Ten derness Mil d 24 3 16J UL2020 8:15 10AUG 2020 20:13 Pain Mil d 25 4 16J UL2020 8:15 10AUG 2020 20:13 Ten derness Mil d 25 4 16J UL2020 8:15 10172 16J UL2020 20:15 Pain Mod erate 0 16J UL2020 8:30 16J UL2020 20:15 Ten derness Mil d 0 16J UL2020 8:30 Progra m: Lsa f_locR_1.sas (Page 12 of 56) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 12 FDA-CBER-2021-5683-0050007 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.1-1: Lis ting of solicited local reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Loc al reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 20 µg You nger 10172 17J UL2020 20:22 Pain Mil d 1 16J UL2020 8:30 17J UL2020 20:22 Ten derness Mil d 1 16J UL2020 8:30 06AUG 2020 19:50 Pain Mod erate 21 0 16J UL2020 8:30 06AUG 2020 19:50 Ten derness Mod erate 21 0 16J UL2020 8:30 10173 17J UL2020 16:00 Pain Mil d 1 16J UL2020 8:45 17J UL2020 16:00 Ten derness Mil d 1 16J UL2020 8:45 06AUG 2020 22:00 Pain Mil d 21 0 16J UL2020 8:45 06AUG 2020 22:00 Ten derness Mod erate 21 0 16J UL2020 8:45 08AUG 2020 22:00 Pain Mil d 23 2 16J UL2020 8:45 08AUG 2020 22:00 Ten derness Mil d 23 2 16J UL2020 8:45 09AUG 2020 13:00 Ten derness Mil d 24 3 16J UL2020 8:45 10175 17J UL2020 17:54 Pain Mil d 1 16J UL2020 9:00 17J UL2020 17:54 Ten derness Mil d 1 16J UL2020 9:00 06AUG 2020 21:00 Ten derness Mil d 21 0 16J UL2020 9:00 07AUG 2020 21:08 Ten derness Mil d 22 1 16J UL2020 9:00 08AUG 2020 21:01 Ten derness Mil d 23 2 16J UL2020 9:00 10176 16J UL2020 21:00 Pain Mil d 0 16J UL2020 9:15 16J UL2020 21:00 Ten derness Mil d 0 16J UL2020 9:15 Progra m: Lsa f_locR_1.sas (Page 13 of 56) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 13 FDA-CBER-2021-5683-0050008 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on cl ean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3-1.1-1: Lis ting of solicited local reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Loc al reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prim e imm unization 20 µg You nger 10176 17J UL2020 20:30 Pain Mil d 1 16J UL2020 9:15 17J UL2020 20:30 Ten derness Mil d 1 16J UL2020 9:15 17J UL2020 20:30 Indu ration/Swelling Mil d 1 16J UL2020 9:15 06AUG 2020 22:00 Ten derness Mil d 21 0 16J UL2020 9:15 07AUG 2020 22:00 Ten derness Mil d 22 1 16J UL2020 9:15 08AUG 2020 21:00 Ten derness Mil d 23 2 16J UL2020 9:15 08AUG 2020 21:00 Erythe ma/Redness Mil d 23 2 16J UL2020 9:15 09AUG 2020 22:00 Erythe ma/Redness Mil d 24 3 16J UL2020 9:15 10178 16J UL2020 20:15 Pain Mil d 0 16J UL2020 9:30 16J UL2020 20:15 Ten derness Mil d 0 16J UL2020 9:30 17J UL2020 20:00 Pain Mil d 1 16J UL2020 9:30 17J UL2020 20:00 Ten derness Mil d 1 16J UL2020 9:30 18J UL2020 20:20 Pain Mil d 2 16J UL2020 9:30 18J UL2020 20:20 Ten derness Mil d 2 16J UL2020 9:30 19J UL2020 19:40 Ten derness Mil d 3 16J UL2020 9:30 20J UL2020 20:00 Ten derness Mil d 4 16J UL2020 9:30 06AUG 2020 19:40 Ten derness Mil d 21 0 16J UL2020 9:30 07AUG 2020 19:00 Ten derness Mil d 22 1 16J UL2020 9:30 Progra m: Lsa f_locR_1.sas (Page 14 of 56) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 14 FDA-CBER-2021-5683-0050009 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.1-1: Lis ting of solicited local reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Loc al reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 20 µg You nger 10178 08AUG 2020 19:30 Ten derness Mil d 23 2 16J UL2020 9:30 10179 16J UL2020 21:00 Pain Mil d 0 16J UL2020 9:45 06AUG 2020 21:0 0 Pain Mil d 21 0 16J UL2020 9:45 06AUG 2020 21:00 Ten derness Mil d 21 0 16J UL2020 9:45 10181 16J UL2020 20:15 Pain Mod erate 0 16J UL2020 10:00 16J UL2020 20:15 Ten derness Mod erate 0 16J UL2020 10:00 17J UL2020 20:45 Pain Mod erate 1 16J UL2020 10: 00 17J UL2020 20:45 Ten derness Mod erate 1 16J UL2020 10:00 18J UL2020 20:45 Pain Mil d 2 16J UL2020 10:00 18J UL2020 20:45 Ten derness Mil d 2 16J UL2020 10:00 06AUG 2020 20:30 Pain Mil d 21 0 16J UL2020 10:00 06AUG 2020 20:30 Ten derness Mil d 21 0 16J UL2020 10:00 07AUG 2020 21:10 Pain Mil d 22 1 16J UL2020 10:00 07AUG 2020 21:10 Ten derness Mil d 22 1 16J UL2020 10:00 08AUG 2020 20:40 Pain Mil d 23 2 16J UL2020 10:00 08AUG 2020 20:40 Ten derness Mil d 23 2 16J UL2020 10:00 10182 16J UL2020 19:31 Pain Mil d 0 16J UL2020 10:15 16J UL2020 19:31 Ten derness Mil d 0 16J UL2020 10:15 Progra m: Lsa f_locR_1.sas (Page 15 of 56) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 15 FDA-CBER-2021-5683-0050010 Bio NTech RNA Phar maceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.1-1: Lis ting of solicited local reactions - BNT 162b1 Safety set Dose grou p Subj ect num ber Date/t ime of collection Loc al reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 20 µg You nger 10183 16J UL2020 20:30 Pain Seve re 0 16J UL2020 10:30 16J UL2020 20:30 Ten derness Seve re 0 16J UL2020 10:30 17J UL2020 0:00 Pain Mod erate 1 16J UL2020 10:30 17J UL2020 0:00 Ten derness Mod erate 1 16J UL2020 10:30 18J UL2020 7:15 Pain Mil d 2 16J UL2020 10:30 18J UL2020 7:15 Ten derness Mil d 2 16J UL2020 10:30 06AUG 2020 18:30 Pain Mil d 21 0 16J UL2020 10:30 06AUG 2020 18:30 Ten derness Mil d 21 0 16J UL2020 10:30 06AUG 2020 18:30 Indu ration/Swelling Mil d 21 0 16J UL2020 10:30 07AUG 2020 20:10 Pain Mil d 22 1 16J UL2020 10:30 07AUG 2020 20:10 Ten derness Mil d 22 1 16J UL2020 10:30 07AUG 2020 20:10 Indu ration/Swelling Mil d 22 1 16J UL2020 10:30 08AUG 2020 20:45 Pain Mil d 23 2 16J UL2020 10:30 08AUG 2020 20:45 Ten derness Mil d 23 2 16J UL2020 10:30 09AUG 2020 21:00 Ten derness Mil d 24 3 16J UL2020 10:30 10197 16J UL2020 20:30 Pain Mod erate 0 16J UL2020 10:45 16J UL2020 20:30 Ten derness Mod erate 0 16J UL2020 10:45 17J UL2020 20:30 Pain Seve re 1 16J UL2020 10:45 Progra m: Lsa f_locR_1.sas (Page 16 of 56) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 16 FDA-CBER-2021-5683-0050011 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM d ata received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.1-1: Lis ting of solicited local reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Loc al reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 20 µg You nger 10197 17J UL2020 20:30 Ten derness Mod erate 1 16J UL2020 10:45 18J UL2020 18:30 Pain Mil d 2 16J UL2020 10:45 18J UL2020 18:30 Ten derness Mod erate 2 16J UL2020 10:45 19J UL2020 18:20 Pain Mil d 3 16J UL2020 10:45 19J UL2020 18:20 Ten derness Mil d 3 16J UL2020 10:45 20J UL2020 18:00 Ten derness Mil d 4 16J UL2020 10:45 06AUG 2020 22:00 Pain Mil d 21 0 16J UL2020 10:45 06AUG 2020 22:00 Ten derness Mil d 21 0 16J UL2020 10:45 07AUG 2020 18:30 Pain Mod erate 22 1 16J UL2020 10:45 07AUG 2020 18:30 Ten derness Mil d 22 1 16J UL2020 10:45 08AUG 2020 18:30 Pain Mil d 23 2 16J UL2020 10:45 08AUG 2020 18:30 Ten derness Mil d 23 2 16J UL2020 10:45 09AUG 2020 18:00 Pain Mil d 24 3 16J UL2020 10:45 09AUG 2020 18:00 Ten derness Mil d 24 3 16J UL2020 10:45 10AUG 2020 17:15 Ten derness Mil d 25 4 16J UL2020 10:45 30 µg You nger 10016 29APR20 20 Pain Seve re 0 29APR20 20 9:03 29APR20 20 Ten derness Seve re 0 29APR20 20 9:03 30APR20 20 Pain Mil d 1 29APR20 20 9:03 Progra m: Lsa f_locR_1.sas (Page 17 of 56) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 17 FDA-CBER-2021-5683-0050012 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.1-1: Lis ting of solicited local reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Loc al reaction Seve rity/ Inten sity Num be r of d ays afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 30 µg You nger 10016 30APR20 20 Ten derness Mil d 1 29APR20 20 9:03 20M AY2020 Pain Mil d 21 0 29APR20 20 9:03 20M AY2020 Ten derness Mil d 21 0 29APR20 20 9:03 21M AY2020 Pain Mod erate 22 1 29APR20 20 9:03 21M AY2020 Ten derness Mod erate 22 1 29APR20 20 9:03 24M AY2020 Ten derness Mil d 25 4 29APR20 20 9:03 10020 20M AY2020 19:00 Pain Mil d 21 0 29APR20 20 10:06 10021 05M AY2020 20:00 Pain Mil d 0 05M AY2020 8:30 05M AY2020 20:00 Ten derness Mil d 0 05M AY2020 8:30 06M AY2020 20:00 Pain Mil d 1 05M AY2020 8:30 06M AY2020 20:00 Ten derness Mil d 1 05M AY2020 8:30 10M AY2020 20:01 Ten derness Mil d 5 05M AY2020 8:30 26M AY2020 20:00 Pain Seve re 21 0 05M AY2020 8:30 26M AY2020 20:00 Ten derness Seve re 21 0 05M AY2020 8:30 27M AY2020 20:00 Pain Mod erate 22 1 05M AY2020 8:30 27M AY2020 20:00 Ten derness Mod erate 22 1 05M AY2020 8:30 28M AY2020 20:00 Pain Mod erate 23 2 05M AY2020 8:30 28M AY2020 20:00 Ten derness Mod erate 23 2 05M AY2020 8:30 Progra m: Lsa f_locR_1.sas (Page 18 of 56) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 18 FDA-CBER-2021-5683-0050013 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.1-1: Lis ting of solicited local reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of col lection Loc al reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 30 µg You nger 10028 07M AY2020 21:27 Pain Mil d 0 07M AY2020 8:30 07M AY2020 21:27 Ten derness Mil d 0 07M AY2020 8:30 08M AY2020 21:40 Pain Mil d 1 07M AY2020 8:30 08M AY2020 21:40 Ten derness Mil d 1 07M AY2020 8:30 09M AY2020 22:00 Pain Mil d 2 07M AY2020 8:30 09M AY2020 22:00 Ten derness Mil d 2 07M AY2020 8:30 09M AY2020 22:00 Erythe ma/Redness Mil d 2 07M AY2020 8:30 10M AY2020 22:00 Pain Mil d 3 07M AY2020 8:30 10M AY2020 22:00 Ten derness Mil d 3 07M AY2020 8:30 10M AY2020 22:00 Erythe ma/Redness Mil d 3 07M AY2020 8:30 28M AY2020 22:00 Pain Mil d 21 0 07M AY2020 8:30 28M AY2020 22:00 Ten derness Mil d 21 0 07M AY2020 8:30 29M AY2020 22:00 Pain Mod erate 22 1 07M AY2020 8:30 29M AY2020 22:00 Ten derness Mod erate 22 1 07M AY2020 8:30 10031 07M AY2020 22:00 Pain Seve re 0 07M AY2020 9:00 07M AY2020 22:00 Ten derness Seve re 0 07M AY2020 9:00 08M AY2020 22:00 Pain Mil d 1 07M AY2020 9:00 08M AY2020 22:00 Ten derness Mil d 1 07M AY2020 9:00 Progra m: Lsa f_locR_1.sas (Page 19 of 56) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 19 FDA-CBER-2021-5683-0050014 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data rece ived on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.1-1: Lis ting of solicited local reacti ons - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Loc al reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 30 µg You nger 10031 09M AY2020 22:00 Ten derness Mil d 2 07M AY2020 9:00 28M AY2020 22:00 Pain Mod erate 21 0 07M AY2020 9:00 28M AY2020 22:00 Ten derness Mod erate 21 0 07M AY2020 9:00 29M AY2020 22:00 Pain Mil d 22 1 07M AY2020 9:00 29M AY2020 22:00 Ten derness Mod erate 22 1 07M AY2020 9:00 30M AY2020 22:00 Pain Mil d 23 2 07M AY2020 9:00 30M AY2020 22:00 Ten derness Mil d 23 2 07M AY2020 9:00 31M AY2020 22:00 Pain Mil d 24 3 07M AY2020 9:00 31M AY2020 22:00 Ten derness Mil d 24 3 07M AY2020 9:00 01J UN2020 22:00 Ten derness Mil d 25 4 07M AY2020 9:00 03J UN2020 22:00 Ten derness Mil d 27 6 07M AY2020 9:00 10032 05M AY2020 19:00 Ten derness Mil d 0 05M AY2020 9:00 06M AY2020 18:33 Ten derness Mil d 1 05M AY2020 9:00 26M AY2020 19:20 Pain Mil d 21 0 05M AY2020 9:00 26M AY2020 19:20 Ten derness Mil d 21 0 05M AY2020 9:00 27M AY2020 18:35 Pain Mil d 22 1 05M AY2020 9:00 27M AY2020 18:35 Ten derness Mod erate 22 1 05M AY2020 9:00 10034 05M AY2020 22:05 Pain Mil d 0 05M AY2020 9:30 Progra m: Lsa f_locR_1.sas (Page 20 of 56) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 20 FDA-CBER-2021-5683-0050015 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.1-1: Lis ting of solicited local reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Loc al reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 30 µg You nger 10034 05M AY2020 22:05 Ten derness Mil d 0 05M AY2020 9:30 05M AY2020 22:05 Indu ration/Swelling Mil d 0 05M AY2020 9:30 06M AY2020 20:10 Ten derness Mod erate 1 05M AY2020 9:30 06M AY2020 20:10 Erythe ma/Redness Mil d 1 05M AY2020 9:30 07M AY2020 20:10 Pain Mil d 2 05M AY2020 9:30 07M AY2020 20:10 Ten derness Mil d 2 05M AY2020 9:30 07M AY2020 20:10 Erythe ma/Redness Mil d 2 05M AY2020 9:30 08M AY2020 12:15 Pain Mil d 3 05M AY2020 9:30 08M AY2020 12:15 Ten derness Mil d 3 05M AY2020 9:30 08M AY2020 12:15 Erythe ma/Redness Mil d 3 05M AY2020 9:30 08M AY2020 12:15 Indu ration/Swelling Mil d 3 05M AY2020 9:30 09M AY2020 20:00 Pain Mil d 4 05M AY2020 9:30 09M AY2020 20:00 Ten derness Mod erate 4 05M AY2020 9:30 09M AY2020 20:00 Erythe ma/Redness Mil d 4 05M AY2020 9:30 09M AY2020 20:00 Indu ration/Swelling Mil d 4 05M AY2020 9:30 10M AY2020 20:00 Pain Mil d 5 05M AY2020 9:30 10M AY2020 20:00 Ten derness Mod erate 5 05M AY2020 9:30 10M AY2020 20:00 Erythe ma/Redness Mil d 5 05M AY2020 9:30 Progra m: Lsa f_locR_1.sas (Page 21 of 56) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 21 FDA-CBER-2021-5683-0050016 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data rece ived on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.1-1: Lis ting of solicited local reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Loc al reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 30 µg You nger 10034 10M AY2020 20:00 Indu ration/Swelling Mil d 5 05M AY2020 9:30 11M AY2020 20:10 Erythe ma/Redness Mil d 6 05M AY2020 9:30 11M AY2020 20:10 Indu ration/Swelling Mil d 6 05M AY2020 9:30 26M AY2020 23:00 Pain Mod erate 21 0 05M AY2020 9:30 26M AY2020 23:00 Ten derness Mod erate 21 0 05M AY2020 9:30 27M AY2020 21:00 Pain Mil d 22 1 05M AY2020 9:30 27M AY2020 21:00 Ten derness Mod erate 22 1 05M AY2020 9:30 28M AY2020 21:00 Ten derness Mil d 23 2 05M AY2020 9:30 10037 05M AY2020 21:00 Ten derness Mil d 0 05M AY2020 10:00 06M AY2020 21:00 Ten derness Mil d 1 05M AY2020 10:00 07M AY2020 21:00 Pain Mil d 2 05M AY2020 10:00 07M AY2020 21:00 Ten derness Mil d 2 05M AY2020 10:00 26M AY2020 21:00 Pain Mod erate 21 0 05M AY2020 10:00 26M AY2020 21:00 Ten derness Mod erate 21 0 05M AY2020 10:00 27M AY2020 21:00 Pain Mod erate 22 1 05M AY2020 10:00 27M AY2020 21:00 Ten derness Mod erate 22 1 05M AY2020 10:00 28M AY2020 21:00 Pain Mil d 23 2 05M AY2020 10:00 28M AY2020 21:00 Ten derness Mod erate 23 2 05M AY2020 10:00 Progra m: Lsa f_locR_1.sas (Page 22 of 56) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 22 FDA-CBER-2021-5683-0050017 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.1-1: Lis ting of solicited local reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Loc al reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 30 µg You nger 10037 29M AY2020 21:00 Pain Mil d 24 3 05M AY2020 10:00 29M AY2020 21:00 Ten derness Mil d 24 3 05M AY2020 10:00 10038 07M AY2020 21:00 Pain Mil d 0 07M AY2020 9:30 07M AY2020 21:00 Ten derness Mod erate 0 07M AY2020 9:30 10039 07M AY2020 22:00 Pain Seve re 0 07M AY2020 10:00 07M AY2020 22:00 Ten derness Mod erate 0 07M AY2020 10:00 08M AY2020 22:00 Pain Seve re 1 07M AY2020 10:00 08M AY2020 22:0 0 Ten derness Mod erate 1 07M AY2020 10:00 09M AY2020 22:00 Pain Mil d 2 07M AY2020 10:00 09M AY2020 22:00 Ten derness Mil d 2 07M AY2020 10:00 28M AY2020 22:00 Pain Seve re 21 0 07M AY2020 10:00 28M AY2020 22:00 Ten derness Mod erate 21 0 07M AY2020 10:0 0 29M AY2020 22:00 Pain Mod erate 22 1 07M AY2020 10:00 29M AY2020 22:00 Ten derness Mil d 22 1 07M AY2020 10:00 30M AY2020 22:00 Ten derness Mil d 23 2 07M AY2020 10:00 10043 07M AY2020 20:00 Pain Mil d 0 07M AY2020 10:30 07M AY2020 20:00 Ten derness Mod erate 0 07M AY2020 10:30 08M AY2020 20:00 Pain Mil d 1 07M AY2020 10:30 Progra m: Lsa f_locR_1.sas (Page 23 of 56) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 23 FDA-CBER-2021-5683-0050018 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data rece ived on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.1-1: Lis ting of solicited local reactions - BNT 162b1 Safety set Dose grou p Subj ect num ber Date/t ime of collection Loc al reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 30 µg You nger 10043 08M AY2020 20:00 Ten derness Seve re 1 07M AY2020 10:30 08M AY2020 20:00 Erythe ma/Redness Mil d 1 07M AY2020 10:30 08M AY2020 20:00 Indu ration/Swelling Mil d 1 07M AY2020 10:30 09M AY2020 20:00 Pain Mil d 2 07M AY2020 10:30 09M AY2020 20:00 Ten derness Mod erate 2 07M AY2020 10:30 09M AY2020 20:00 Erythe ma/Redness Mil d 2 07M AY2020 10:30 09M AY2020 20:00 Indu ration/Swelling Mil d 2 07M AY2020 10:30 10M AY2020 20:00 Pain Mil d 3 07M AY2020 10:30 10M AY2020 20:00 Ten derness Mil d 3 07M AY2020 10:30 10M AY2020 20:00 Erythe ma/Redness Mil d 3 07M AY2020 10:30 10M AY2020 20:00 Indu ration/Swelling Mil d 3 07M AY2020 10:30 11M AY2020 20:00 Pain Mil d 4 07M AY2020 10:30 11M AY2020 20:00 Ten derness Mil d 4 07M AY2020 10:30 11M AY2020 20:00 Erythe ma/Redness Mil d 4 07M AY2020 10:30 11M AY2020 20:0 0 Indu ration/Swelling Mil d 4 07M AY2020 10:30 12M AY2020 20:00 Pain Mil d 5 07M AY2020 10:30 12M AY2020 20:00 Ten derness Mil d 5 07M AY2020 10:30 12M AY2020 20:00 Erythe ma/Redness Mil d 5 07M AY2020 10:30 Progra m: Lsa f_locR_1.sas (Page 24 of 56) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 24 FDA-CBER-2021-5683-0050019 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV 2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.1-1: Lis ting of solicited local reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Loc al reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 30 µg You nger 10043 12M AY2020 20:00 Indu ration/Swelling Mil d 5 07M AY2020 10:30 28M AY2020 20:00 Pain Mil d 21 0 07M AY2020 10:30 28M AY2020 20:00 Ten derness Mil d 21 0 07M AY2020 10:30 29M AY2020 20:00 Pain Mod erate 22 1 07M AY2020 10:30 29M AY2020 20:00 Ten derness Mod erate 22 1 07M AY2020 10:30 30M AY2020 20:00 Pain Mil d 23 2 07M AY2020 10:30 31M AY2020 20:00 Pain Mil d 24 3 07M AY2020 10:30 10047 07M AY2020 23:00 Pain Mil d 0 07M AY2020 11:00 07M AY2020 23:00 Ten derness Mod erate 0 07M AY2020 11:00 08M AY2020 23:45 Pain Mil d 1 07M AY2020 11:00 08M AY2020 23:45 Ten derness Mil d 1 07M AY2020 11:00 09M AY2020 23:45 Ten derness Mil d 2 07M AY2020 11:00 10M AY2020 23:40 Ten derness Mil d 3 07M AY2020 11:00 28M AY2020 23:55 Pain Mil d 21 0 07M AY2020 11:00 28M AY2020 23:55 Ten derness Mod erate 21 0 07M AY2020 11:00 29M AY2020 21:00 Pain Mod erate 22 1 07M AY2020 11:00 29M AY2020 21:00 Ten derness Mod erate 22 1 07M AY2020 11:00 30M AY2020 23:55 Pain Mil d 23 2 07M AY2020 11:00 Progra m: Lsa f_locR_1.sas (Page 25 of 56) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 25 FDA-CBER-2021-5683-0050020 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data rece ived on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.1-1: Lis ting of solicited local reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Loc al reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 30 µg You nger 10047 30M AY2020 23:55 Ten derness Mil d 23 2 07M AY2020 11:00 31M AY2020 22:00 Ten derness Mil d 24 3 07M AY2020 11:00 50 µg You nger 10049 12M AY2020 19:30 Pain Mil d 0 12M AY2020 9:10 12M AY2020 19:30 Ten derness Mod erate 0 12M AY2020 9:10 13M AY2020 13:00 Pain Mil d 1 12M AY2020 9:10 13M AY2020 13:0 0 Ten derness Mil d 1 12M AY2020 9:10 02J UN2020 23:00 Pain Mil d 21 0 12M AY2020 9:10 02J UN2020 23:00 Ten derness Mil d 21 0 12M AY2020 9:10 02J UN2020 23:00 Indu ration/Swelling Mil d 21 0 12M AY2020 9:10 03J UN2020 7:15 Pain Mil d 22 1 12M AY2020 9:10 03J UN2020 7:15 Ten derness Mil d 22 1 12M AY2020 9:10 03J UN2020 7:15 Indu ration/Swelling Mil d 22 1 12M AY2020 9:10 10050 15M AY2020 19:15 Pain Mod erate 0 15M AY2020 8:45 15M AY2020 19:15 Ten derness Mod erate 0 15M AY2020 8:45 15M AY2020 19:1 5 Erythe ma/Redness Mil d 0 15M AY2020 8:45 15M AY2020 19:15 Indu ration/Swelling Mil d 0 15M AY2020 8:45 16M AY2020 19:43 Pain Mod erate 1 15M AY2020 8:45 16M AY2020 19:43 Ten derness Mod erate 1 15M AY2020 8:45 Progra m: Lsa f_locR_1.sas (Page 26 of 56) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 26 FDA-CBER-2021-5683-0050021 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.1-1: Lis ting of solicited local reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Loc al reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 50 µg You nger 10050 17M AY2020 20:17 Pain Mil d 2 15M AY2020 8:45 17M AY2020 20:17 Ten derness Mod erate 2 15M AY2020 8:45 17M AY2020 20:17 Erythe ma/Redness Mod erate 2 15M AY2020 8:45 17M AY2020 20:17 Indu ration/Swelling Mil d 2 15M AY2020 8:45 18M AY2020 20:00 Pain Mil d 3 15M AY2020 8:45 18M AY2020 20:00 Ten derness Mil d 3 15M AY2020 8:45 18M AY2020 20:00 Erythe ma/Redness Mil d 3 15M AY2020 8:45 18M AY2020 20:00 Indu ration/Swelling Mil d 3 15M AY2020 8:45 19M AY2020 21:20 Pain Mil d 4 15M AY2020 8:45 19M AY2020 21:20 Ten derness Mil d 4 15M AY2020 8:45 19M AY2020 21:20 Erythe ma/Redness Mil d 4 15M AY2020 8:45 20M AY2020 19:25 Pain Mil d 5 15M AY2020 8:45 20M AY2020 19:25 Ten derness Mil d 5 15M AY2020 8:45 21M AY2020 20:13 Pain Mil d 6 15M AY2020 8:45 21M AY2020 20:13 Ten derness Mil d 6 15M AY2020 8:45 10053 12M AY2020 20:00 Pain Mil d 0 12M AY2020 10:13 12M AY2020 20:00 Ten derness Mil d 0 12M AY2020 10:13 13M AY2020 20:00 Pain Mil d 1 12M AY2020 10:13 Progra m: Lsa f_locR_1.sas (Page 27 of 56) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 27 FDA-CBER-2021-5683-0050022 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Fin al 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.1-1: Lis ting of solicited local reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Loc al reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 50 µg You nger 10053 13M AY2020 20:00 Ten derness Mod erate 1 12M AY2020 10:13 14M AY2020 20:00 Ten derness Mil d 2 12M AY2020 10:13 15M AY2020 20:00 Ten derness Mil d 3 12M AY2020 10:13 02J UN2020 20:00 Pain Mil d 21 0 12M AY2020 10:13 02J UN2020 20:00 Ten derness Mil d 21 0 12M AY2020 10:13 03J UN2020 20:00 Pain Mil d 22 1 12M AY2020 10:1 3 03J UN2020 20:00 Ten derness Mil d 22 1 12M AY2020 10:13 10055 14M AY2020 21:30 Pain Mil d 1 13M AY2020 9:13 14M AY2020 21:30 Ten derness Mil d 1 13M AY2020 9:13 15M AY2020 22:00 Pain Mil d 2 13M AY2020 9:13 15M AY2020 22:00 Ten derness Mil d 2 13M AY2020 9:13 03J UN2020 8:30 Pain Mil d 21 0 13M AY2020 9:13 03J UN2020 8:30 Ten derness Mil d 21 0 13M AY2020 9:13 04J UN2020 22:48 Ten derness Mil d 22 1 13M AY2020 9:13 10056 13M AY2020 20:30 Pain Mil d 0 13M AY2020 10:16 13M AY2020 20:30 Ten derness Mil d 0 13M AY2020 10:16 14M AY2020 20:30 Pain Mil d 1 13M AY2020 10:16 14M AY2020 20:30 Ten derness Mil d 1 13M AY2020 10:16 Progra m: Lsa f_locR_1.sas (Page 28 of 56) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 28 FDA-CBER-2021-5683-0050023 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data rece ived on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.1-1: Lis ting of solicited local reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Loc al reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 50 µg You nger 10056 03J UN2020 21:30 Pain Mil d 21 0 13M AY2020 10:16 03J UN2020 21:30 Ten derness Mil d 21 0 13M AY2020 10:16 04J UN2020 21:30 Pain Mod erate 22 1 13M AY2020 10:16 04J UN2020 21:30 Ten derness Mod erate 22 1 13M AY2020 10:16 05J UN2020 21:30 Pain Mil d 23 2 13M AY2020 10:16 05J UN2020 21:30 Ten derness Mil d 23 2 13M AY2020 10:16 06J UN2020 21:30 Pain Mil d 24 3 13M AY2020 10:16 06J UN2020 21:30 Ten derness Mil d 24 3 13M AY2020 10:16 10057 15M AY2020 20:00 Pain Mil d 0 15M AY2020 9:15 16M AY2020 20:00 Pain Mod erate 1 15M AY2020 9:15 16M AY2020 20:00 Ten derness Mod erate 1 15M AY2020 9:15 05J UN2020 20:38 Pain Mod erate 21 0 15M AY2020 9:15 05J UN2020 20:38 Ten derness Seve re 21 0 15M AY2020 9:15 06J UN2020 17:30 Pain Mil d 22 1 15M AY2020 9:15 06J UN2020 17:30 Ten derness Mil d 22 1 15M AY2020 9:15 07J UN2020 14:00 Pain Mil d 23 2 15M AY2020 9:15 07J UN2020 14:00 Ten derness Mil d 23 2 15M AY2020 9:15 08J UN2020 14:00 Pain Mil d 24 3 15M AY2020 9:15 Progra m: Lsa f_locR_1.sas (Page 29 of 56) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 29 FDA-CBER-2021-5683-0050024 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.1-1: Lis ting of solicited local reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Loc al reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 50 µg You nger 10057 08J UN2020 14:00 Ten derness Mil d 24 3 15M AY2020 9:15 10059 13M AY2020 16:50 Pain Mil d 0 13M AY2020 10:46 13M AY2020 16:50 Ten derness Mod erate 0 13M AY2020 10:46 14M AY2020 17:00 Pain Mod erate 1 13M AY2020 10:46 14M AY2020 17:00 Ten derness Mod erate 1 13M AY2020 10:46 15M AY2020 17:50 Pain Mod erate 2 13M AY2020 10:46 15M AY2020 17:50 Ten derness Mod erate 2 13M AY2020 10:46 16M AY2020 17:30 Pain Mod erate 3 13M AY2020 10:46 16M AY2020 17:30 Ten derness Mod erate 3 13M AY2020 10:46 17M AY2020 17:15 Pain Mod erate 4 13M AY2020 10:46 17M AY2020 17:15 Ten derness Mod erate 4 13M AY2020 10:46 03J UN2020 11:50 Pain Mod erate 21 0 13M AY2020 10:46 03J UN2020 11:50 Ten derness Mod erate 21 0 13M AY2020 10:46 04J UN2020 10:00 Pain Mod erate 22 1 13M AY2020 10:46 04J UN2020 10:00 Ten derness Mod erate 22 1 13M AY2020 10:46 05J UN2020 18:00 Pain Mod erate 23 2 13M AY2020 10:46 05J UN2020 18:0 0 Ten derness Mod erate 23 2 13M AY2020 10:46 06J UN2020 17:00 Pain Mod erate 24 3 13M AY2020 10:46 Progra m: Lsa f_locR_1.sas (Page 30 of 56) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 30 FDA-CBER-2021-5683-0050025 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.1-1: Lis ting of solicited local reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Loc al reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 50 µg You nger 10059 06J UN2020 17:00 Ten derness Mod erate 24 3 13M AY2020 10:46 07J UN2020 20:00 Pain Mod erate 25 4 13M AY2020 10:46 07J UN2020 20:00 Ten derness Mod erate 25 4 13M AY2020 10:46 08J UN2020 14:20 Pain Mil d 26 5 13M AY2020 10:46 08J UN2020 14:20 Ten derness Mil d 26 5 13M AY2020 10:46 10060 14M AY2020 18:00 Pain Seve re 1 13M AY2020 11:16 14M AY2020 18:00 Ten derness Mil d 1 13M AY2020 11:16 04J UN2020 6:00 Pain Mil d 22 1 13M AY2020 11:16 04J UN2020 6:00 Ten derness Mil d 22 1 13M AY2020 11:16 10067 15M AY2020 22:00 Ten derness Mil d 0 15M AY2020 9:45 05J UN2020 22:00 Pain Mil d 21 0 15M AY2020 9:45 05J UN2020 22:00 Ten derness Mil d 21 0 15M AY2020 9:45 06J UN2020 22:00 Pain Mod erate 22 1 15M AY2020 9:45 06J UN2020 22:00 Ten derness Mod erate 22 1 15M AY2020 9:45 10068 15M AY2020 22:3 0 Pain Mil d 0 15M AY2020 10:15 15M AY2020 22:30 Ten derness Mod erate 0 15M AY2020 10:15 16M AY2020 23:00 Pain Mil d 1 15M AY2020 10:15 16M AY2020 23:00 Ten derness Mod erate 1 15M AY2020 10:15 Progra m: Lsa f_locR_1.sas (Page 31 of 56) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 31 FDA-CBER-2021-5683-0050026 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV 2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.1-1: Lis ting of solicited local reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Loc al reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 50 µg You nger 10068 16M AY2020 23:00 Erythe ma/Redness Mil d 1 15M AY2020 10:15 16M AY2020 23:00 Indu ration/Swelling Mil d 1 15M AY2020 10:15 17M AY2020 22:30 Pain Mil d 2 15M AY2020 10:15 17M AY2020 22:30 Ten derness Mil d 2 15M AY2020 10:15 17M AY2020 22:30 Erythe ma/Redness Mod erate 2 15M AY2020 10:15 17M AY2020 22:30 Indu ration/Swelling Mil d 2 15M AY2020 10:15 18M AY2020 23:00 Pain Mil d 3 15M AY2020 10:15 18M AY2020 23:00 Ten derness Mil d 3 15M AY2020 10:15 18M AY2020 23:00 Erythe ma/Redness Mod erate 3 15M AY2020 10:15 18M AY2020 23:00 Indu ration/Swelling Mil d 3 15M AY2020 10:15 19M AY2020 23:00 Pain Mil d 4 15M AY2020 10:15 19M AY2020 23:00 Ten derness Mil d 4 15M AY2020 10:15 19M AY2020 23:00 Erythe ma/Redness Mod erate 4 15M AY2020 10:15 19M AY2020 23:00 Indu ration/Swelling Mil d 4 15M AY2020 10:15 20M AY2020 23:30 Pain Mil d 5 15M AY2020 10:15 20M AY2020 23:30 Ten derness Mil d 5 15M AY2020 10:15 20M AY2020 23:30 Erythe ma/Redness Mil d 5 15M AY2020 10:15 05J UN2020 22:30 Pain Mod erate 21 0 15M AY2020 10:15 Progra m: Lsa f_locR_1.sas (Page 32 of 56) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 32 FDA-CBER-2021-5683-0050027 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.1-1: Lis ting of solicited local reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Loc al reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 50 µg You nger 10068 05J UN2020 22:30 Ten derness Mod erate 21 0 15M AY2020 10:15 06J UN2020 22:00 Pain Mod erate 22 1 15M AY2020 10:15 06J UN2020 22:00 Ten derness Mod erate 22 1 15M AY2020 10:15 07J UN2020 22:30 Pain Mil d 23 2 15M AY2020 10:15 07J UN2020 22:30 Ten derness Mod erate 23 2 15M AY2020 10:15 07J UN2020 22:3 0 Erythe ma/Redness Mil d 23 2 15M AY2020 10:15 08J UN2020 23:00 Pain Mil d 24 3 15M AY2020 10:15 08J UN2020 23:00 Ten derness Mod erate 24 3 15M AY2020 10:15 08J UN2020 23:00 Erythe ma/Redness Mil d 24 3 15M AY2020 10:15 09J UN2020 23:00 Pain Mil d 25 4 15M AY2020 10:15 09J UN2020 23:00 Ten derness Mil d 25 4 15M AY2020 10:15 09J UN2020 23:00 Erythe ma/Redness Mil d 25 4 15M AY2020 10:15 10J UN2020 23:30 Pain Mil d 26 5 15M AY2020 10:15 10J UN2020 23:30 Ten derness Mil d 26 5 15M AY2020 10:15 11J UN2020 23:0 0 Pain Mil d 27 6 15M AY2020 10:15 11J UN2020 23:00 Ten derness Mil d 27 6 15M AY2020 10:15 10070 16M AY2020 19:00 Pain Seve re 1 15M AY2020 10:45 16M AY2020 19:00 Ten derness Seve re 1 15M AY2020 10:45 Progra m: Lsa f_locR_1.sas (Page 33 of 56) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 33 FDA-CBER-2021-5683-0050028 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20 NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.1-1: Lis ting of solicited local reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Loc al reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 50 µg You nger 10070 16M AY2020 19:00 Indu ration/Swelling Mod erate 1 15M AY2020 10:45 17M AY2020 19:00 Pain Mod erate 2 15M AY2020 10:45 17M AY2020 19:00 Ten derness Mod erate 2 15M AY2020 10:45 17M AY2020 19:0 0 Erythe ma/Redness Mil d 2 15M AY2020 10:45 17M AY2020 19:00 Indu ration/Swelling Mod erate 2 15M AY2020 10:45 18M AY2020 19:15 Ten derness Mil d 3 15M AY2020 10:45 18M AY2020 19:15 Erythe ma/Redness Mod erate 3 15M AY2020 10:45 18M AY2020 19:15 Indu ration/Swelling Mod erate 3 15M AY2020 10:45 19M AY2020 19:00 Erythe ma/Redness Mod erate 4 15M AY2020 10:45 05J UN2020 19:00 Pain Seve re 21 0 15M AY2020 10:45 05J UN2020 19:00 Ten derness Mod erate 21 0 15M AY2020 10:45 06J UN2020 19:00 Ten derness Mil d 22 1 15M AY2020 10:45 07J UN2020 19:00 Ten derness Mil d 23 2 15M AY2020 10:45 10073 16M AY2020 22:00 Pain Mil d 1 15M AY2020 11:15 16M AY2020 22:00 Ten derness Mil d 1 15M AY2020 11:15 05J UN2020 22:23 Pain Seve re 21 0 15M AY2020 11:15 05J UN2020 22:2 3 Ten derness Seve re 21 0 15M AY2020 11:15 06J UN2020 16:10 Pain Seve re 22 1 15M AY2020 11:15 Progra m: Lsa f_locR_1.sas (Page 34 of 56) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 34 FDA-CBER-2021-5683-0050029 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data rece ived on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.1-1: Lis ting of solicited local reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Loc al reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 50 µg You nger 10073 06J UN2020 16:10 Ten derness Seve re 22 1 15M AY2020 11:15 07J UN2020 22:46 Pain Seve re 23 2 15M AY2020 11:15 07J UN2020 22:46 Ten derness Seve re 23 2 15M AY2020 11:15 08J UN2020 23:20 Pain Mod erate 24 3 15M AY2020 11:15 08J UN2020 23:20 Ten derness Mod erate 24 3 15M AY2020 11:15 09J UN2020 1:04 Pain Mil d 25 4 15M AY2020 11:15 60 µg You nger 10066 19M AY2020 21:55 Pain Mod erate 0 19M AY2020 8:36 19M AY2020 21:55 Ten derness Mod erate 0 19M AY2020 8:36 19M AY2020 21:55 Indu ration/Swelling Mod erate 0 19M AY2020 8:36 20M AY2020 21:54 Pain Mil d 1 19M AY2020 8:36 20M AY2020 21:54 Ten derness Mod erate 1 19M AY2020 8:36 20M AY2020 21:54 Indu ration/Swelling Mod erate 1 19M AY2020 8:36 21M AY2020 21:55 Pain Mil d 2 19M AY2020 8:36 21M AY2020 21:55 Ten derness Mil d 2 19M AY2020 8:36 21M AY2020 21:55 Indu ration/Swelling Mil d 2 19M AY2020 8:36 22M AY2020 21:55 Pain Mil d 3 19M AY2020 8:36 22M AY2020 21:55 Ten derness Mil d 3 19M AY2020 8:36 22M AY2020 21:55 Indu ration/Swelling Mil d 3 19M AY2020 8:36 Progra m: Lsa f_locR_1.sas (Page 35 of 56) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 35 FDA-CBER-2021-5683-0050030 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.1-1: Lis ting of solicited local reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Loc al reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 60 µg You nger 10075 22M AY2020 22:05 Pain Seve re 0 22M AY2020 8:50 22M AY2020 22:05 Ten derness Mod erate 0 22M AY2020 8:50 23M AY2020 22:00 Pain Seve re 1 22M AY2020 8:50 23M AY2020 22:00 Ten derness Mod erate 1 22M AY2020 8:50 24M AY2020 22:00 Pain Mil d 2 22M AY2020 8:50 24M AY2020 22:00 Ten derness Mod erate 2 22M AY2020 8:50 25M AY2020 22:00 Pain Mil d 3 22M AY2020 8:50 25M AY2020 22:00 Ten derness Mil d 3 22M AY2020 8:50 26M AY2020 22:00 Pain Mil d 4 22M AY2020 8:50 26M AY2020 22:00 Ten derness Mil d 4 22M AY2020 8:50 27M AY2020 22:30 Pain Mil d 5 22M AY2020 8:50 27M AY2020 22:30 Ten derness Mil d 5 22M AY2020 8:50 10076 22M AY2020 22:0 0 Pain Mil d 0 22M AY2020 9:20 23M AY2020 22:00 Pain Mil d 1 22M AY2020 9:20 10078 22M AY2020 23:15 Pain Mil d 0 22M AY2020 9:50 22M AY2020 23:15 Ten derness Mil d 0 22M AY2020 9:50 23M AY2020 22:45 Pain Mil d 1 22M AY2020 9:50 23M AY2020 22:4 5 Ten derness Mod erate 1 22M AY2020 9:50 Progra m: Lsa f_locR_1.sas (Page 36 of 56) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 36 FDA-CBER-2021-5683-0050031 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV 2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.1-1: Lis ting of solicited local reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Loc al reac tion Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 60 µg You nger 10083 20M AY2020 19:21 Pain Mil d 0 20M AY2020 9:15 20M AY2020 19:21 Ten derness Mil d 0 20M AY2020 9:15 21M AY2020 18:45 Pain Mil d 1 20M AY2020 9:15 21M AY2020 18:45 Ten derness Mil d 1 20M AY2020 9:15 22M AY2020 20:00 Pain Mil d 2 20M AY2020 9:15 22M AY2020 20:00 Ten derness Mil d 2 20M AY2020 9:15 10084 22M AY2020 20:30 Pain Mil d 0 22M AY2020 10:2 0 22M AY2020 20:30 Ten derness Mil d 0 22M AY2020 10:20 23M AY2020 20:30 Ten derness Mil d 1 22M AY2020 10:20 10085 22M AY2020 23:00 Pain Mil d 0 22M AY2020 10:50 22M AY2020 23:00 Ten derness Mod erate 0 22M AY2020 10:50 23M AY2020 21:50 Pain Mil d 1 22M AY2020 10:50 23M AY2020 21:50 Ten derness Mod erate 1 22M AY2020 10:50 24M AY2020 22:15 Pain Mil d 2 22M AY2020 10:50 24M AY2020 22:15 Ten derness Mil d 2 22M AY2020 10:50 10089 20M AY2020 22:00 Pain Mil d 0 20M AY2020 9:45 20M AY2020 22:00 Ten derness Mod erate 0 20M AY2020 9:45 21M AY2020 22:00 Pain Mil d 1 20M AY2020 9:45 Progra m: Lsa f_locR_1.sas (Page 37 of 56) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 37 FDA-CBER-2021-5683-0050032 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.1-1: Lis ting of solicited local reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Loc al reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 60 µg You nger 10089 21M AY2020 22:00 Ten derness Mod erate 1 20M AY2020 9:45 22M AY2020 22:00 Pain Mil d 2 20M AY2020 9:45 22M AY2020 22:00 Ten derness Mil d 2 20M AY2020 9:45 23M AY2020 22:00 Ten derness Mil d 3 20M AY2020 9:45 10093 20M AY2020 19:00 Pain Mil d 0 20M AY2020 10:15 21M AY2020 18:45 Pain Mil d 1 20M AY2020 10:15 21M AY2020 18:45 Ten derness Mil d 1 20M AY2020 10:15 10096 19M AY2020 22:49 Pain Mil d 0 19M AY2020 9:08 19M AY2020 22:49 Ten derness Mil d 0 19M AY2020 9:08 20M AY2020 19:30 Pain Mil d 1 19M AY2020 9:08 20M AY2020 19:30 Ten derness Mil d 1 19M AY2020 9:08 10103 22M AY2020 20:48 Pain Mil d 0 22M AY2020 11:32 22M AY2020 20:48 Ten derness Mod erate 0 22M AY2020 11:32 23M AY2020 15:18 Pain Mil d 1 22M AY2020 11:32 23M AY2020 15:18 Ten derness Mil d 1 22M AY2020 11:32 10104 20M AY2020 22:0 0 Pain Mil d 0 20M AY2020 10:45 20M AY2020 22:00 Ten derness Mod erate 0 20M AY2020 10:45 21M AY2020 22:00 Pain Mod erate 1 20M AY2020 10:45 Progra m: Lsa f_locR_1.sas (Page 38 of 56) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 38 FDA-CBER-2021-5683-0050033 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.1-1: Lis ting of soli cited local reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Loc al reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 60 µg You nger 10104 21M AY2020 22:00 Ten derness Mod erate 1 20M AY2020 10:45 22M AY2020 22:00 Pain Mil d 2 20M AY2020 10:45 22M AY2020 22:00 Ten derness Mil d 2 20M AY2020 10:45 23M AY2020 23:00 Pain Mil d 3 20M AY2020 10:45 23M AY2020 23:00 Ten derness Mil d 3 20M AY2020 10:45 24M AY2020 22:00 Ten derness Mil d 4 20M AY2020 10:45 10 µg Old er 10274 18SEP2 020 20:00 Ten derness Mil d 22 1 27AUG 2020 9:00 18SEP2 020 20:00 Erythe ma/Redness Mil d 22 1 27AUG 2020 9:00 18SEP2 020 20:00 Indu ration/Swelling Mil d 22 1 27AUG 2020 9:00 19SEP2 020 21:00 Ten derness Mil d 23 2 27AUG 2020 9:00 19SEP2 020 21:00 Erythe ma/Redness Mil d 23 2 27AUG 2020 9:00 20SEP2 020 19:45 Erythe ma/Redness Mil d 24 3 27AUG 2020 9:00 21SEP2 020 20:15 Erythe ma/Redness Mil d 25 4 27AUG 2020 9:0 0 22SEP2 020 20:00 Erythe ma/Redness Mil d 26 5 27AUG 2020 9:00 10282 20AUG 2020 18:50 Pain Mil d 0 20AUG 2020 9:33 20AUG 2020 18:50 Ten derness Mil d 0 20AUG 2020 9:33 21AUG 2020 19:00 Pain Mil d 1 20AUG 2020 9:33 21AUG 2020 19:00 Ten derness Mil d 1 20AUG 2020 9:33 Progra m: Lsa f_locR_1.sas (Page 39 of 56) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 39 FDA-CBER-2021-5683-0050034 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV 2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.1-1: Lis ting of solicited local reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Loc al reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 10 µg Old er 10282 10SEP2 020 16:00 Ten derness Mil d 21 0 20AUG 2020 9:33 11SEP2 020 18:00 Pain Mil d 22 1 20AUG 2020 9:33 10283 27AUG 2020 21:00 Pain Mil d 0 27AUG 2020 9:30 27AUG 2020 21:00 Ten derness Mil d 0 27AUG 2020 9:30 28AUG 2020 21:30 Pain Mil d 1 27AUG 2020 9:30 28AUG 2020 21:30 Ten derness Mil d 1 27AUG 2020 9:30 17SEP2 020 21:00 Pain Mil d 21 0 27AUG 2020 9:30 17SEP2 020 21:00 Ten derness Mil d 21 0 27AUG 2020 9:30 18SEP2 020 21:00 Pain Mil d 22 1 27AUG 2020 9:30 18SEP2 020 21:00 Ten derness Mil d 22 1 27AUG 2020 9:30 10286 25AUG 2020 18:30 Ten derness Mil d 0 25AUG 2020 8:30 26AUG 2020 18:30 Pain Mil d 1 25AUG 2020 8:30 26AUG 2020 18:30 Ten derness Mil d 1 25AUG 2020 8:30 15SEP2 020 20:00 Ten derness Mil d 21 0 25AUG 2020 8:30 10287 25AUG 2020 21:00 Pain Mil d 0 25AUG 2020 9:00 25AUG 2020 21:00 Ten derness Mil d 0 25AUG 2020 9:00 26AUG 2020 0:00 Ten derness Mil d 1 25AUG 2020 9:00 15SEP2 020 23:10 Pain Mod erate 21 0 25AUG 2020 9:00 Progra m: Lsa f_locR_1.sas (Page 40 of 56) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 40 FDA-CBER-2021-5683-0050035 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.1-1: Lis ting of solicited local reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Loc al reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 10 µg Old er 10287 15SEP2 020 23:10 Ten derness Mil d 21 0 25AUG 2020 9:00 16SEP2 020 23:00 Pain Mil d 22 1 25AUG 2020 9:00 16SEP2 020 23:00 Ten derness Mil d 22 1 25AUG 2020 9:00 17SEP2 020 0:00 Pain Mil d 23 2 25AUG 2020 9:00 17SEP2 020 0:00 Ten derness Mil d 23 2 25AUG 2020 9:00 18SEP2 020 1:20 Pain Mil d 24 3 25AUG 2020 9:00 18SEP2 020 1:20 Ten derness Mil d 24 3 25AUG 2020 9:00 19SEP2 020 1:15 Pain Mil d 25 4 25AUG 2020 9:00 19SEP2 020 1:15 Ten derness Mil d 25 4 25AUG 2020 9:00 20SEP2 020 1:05 Pain Mil d 26 5 25AUG 2020 9:00 20SEP2 020 1:05 Ten derness Mil d 26 5 25AUG 2020 9:00 10288 25AUG 2020 21:00 Ten derness Mil d 0 25AUG 2020 9:30 26AUG 2020 21:00 Pain Mil d 1 25AUG 2020 9:30 26AUG 2020 21:00 Ten derness Mil d 1 25AUG 2020 9:30 15SEP2 020 23:00 Pain Mil d 21 0 25AUG 2020 9:30 15SEP2 020 23:00 Ten derness Mil d 21 0 25AUG 2020 9:30 15SEP2 020 23:00 Indu ration/Swelling Mil d 21 0 25AUG 2020 9:30 16SEP2 020 23:00 Pain Mil d 22 1 25AUG 2020 9:30 Progra m: Lsa f_locR_1.sas (Page 41 of 56) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 41 FDA-CBER-2021-5683-0050036 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3-1.1-1: Lis ting of solicited local reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Loc al reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prim e imm unization 10 µg Old er 10288 16SEP2 020 23:00 Indu ration/Swelling Mil d 22 1 25AUG 2020 9:30 17SEP2 020 23:00 Indu ration/Swelling Mil d 23 2 25AUG 2020 9:30 18SEP2 020 23:00 Indu ration/Swelling Mil d 24 3 25AUG 2020 9:30 19SEP2 020 23:00 Erythe ma/Redness Mil d 25 4 25AUG 2020 9:30 19SEP2 020 23:00 Indu ration/Swelling Mil d 25 4 25AUG 2020 9:30 20SEP2 020 23:00 Erythe ma/Redness Mil d 26 5 25AUG 2020 9:30 20SEP2 020 23:00 Indu ration/Swelling Mil d 26 5 25AUG 2020 9:30 21SEP2 020 23:00 Erythe ma/Redness Mil d 27 6 25AUG 2020 9:30 21SEP2 020 23:00 Indu ration/Swelling Mil d 27 6 25AUG 2020 9:30 10298 27AUG 2020 20:15 Pain Mil d 0 27AUG 2020 10:30 27AUG 2020 20:15 Ten derness Mil d 0 27AUG 2020 10:30 28AUG 2020 20:08 Pain Mil d 1 27AUG 2020 10:3 0 28AUG 2020 20:08 Ten derness Mil d 1 27AUG 2020 10:30 29AUG 2020 20:10 Pain Mil d 2 27AUG 2020 10:30 29AUG 2020 20:10 Ten derness Mil d 2 27AUG 2020 10:30 17SEP2 020 1:00 Pain Mil d 21 0 27AUG 2020 10:30 17SEP2 020 1:00 Ten derness Mod erate 21 0 27AUG 2020 10:30 18SEP2 020 10:00 Pain Mil d 22 1 27AUG 2020 10:30 Progra m: Lsa f_locR_1.sas (Page 42 of 56) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 42 FDA-CBER-2021-5683-0050037 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.1-1: Lis ting of solicited local reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Loc al reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 10 µg Old er 10298 18SEP2 020 10:00 Ten derness Mod erate 22 1 27AUG 2020 10:30 19SEP2 020 16:00 Pain Mil d 23 2 27AUG 2020 10:30 19SEP2 020 16:00 Ten derness Mil d 23 2 27AUG 2020 10:30 20SEP2 020 20:00 Pain Mil d 24 3 27AUG 2020 10:30 20SEP2 020 20:00 Ten derness Mil d 24 3 27AUG 2020 10:30 21SEP2 020 20:10 Pain Mil d 25 4 27AUG 2020 10:3 0 21SEP2 020 20:10 Ten derness Mil d 25 4 27AUG 2020 10:30 22SEP2 020 20:05 Pain Mil d 26 5 27AUG 2020 10:30 22SEP2 020 20:05 Ten derness Mil d 26 5 27AUG 2020 10:30 23SEP2 020 20:10 Ten derness Mil d 27 6 27AUG 2020 10:30 10320 27AUG 2020 19:00 Ten derness Mil d 0 27AUG 2020 11:00 28AUG 2020 19:00 Ten derness Mil d 1 27AUG 2020 11:00 17SEP2 020 Pain Mod erate 21 0 27AUG 2020 11:00 18SEP2 020 10:00 Pain Mod erate 22 1 27AUG 2020 11:00 18SEP2 020 10:00 Ten derness Mod erate 22 1 27AUG 2020 11:00 19SEP2 020 10:00 Pain Mod erate 23 2 27AUG 2020 11:00 19SEP2 020 10:00 Ten derness Mil d 23 2 27AUG 2020 11:00 20SEP2 020 10:00 Pain Mil d 24 3 27AUG 2020 11:00 Progra m: Lsa f_locR_1.sas (Page 43 of 56) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 43 FDA-CBER-2021-5683-0050038 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data rece ived on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.1-1: Listi ng of solicited local reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Loc al reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 10 µg Old er 10320 20SEP2 020 10:00 Ten derness Mil d 24 3 27AUG 2020 11:00 21SEP2 020 10:00 Pain Mil d 25 4 27AUG 2020 11:00 21SEP2 020 10:00 Ten derness Mil d 25 4 27AUG 2020 11:00 22SEP2 020 10:30 Pain Mil d 26 5 27AUG 2020 11:00 22SEP2 020 10:3 0 Ten derness Mil d 26 5 27AUG 2020 11:00 23SEP2 020 10:00 Ten derness Mil d 27 6 27AUG 2020 11:00 20 µg Old er 20207 09SEP2 020 20:30 Pain Mil d 0 09SEP2 020 9:00 09SEP2 020 20:30 Ten derness Mil d 0 09SEP2 020 9:00 10SEP2 020 20:00 Pain Mil d 1 09SEP2 020 9:00 10SEP2 020 20:00 Ten derness Mil d 1 09SEP2 020 9:00 30SEP2 020 19:00 Ten derness Mil d 21 0 09SEP2 020 9:00 01O CT2020 20:00 Pain Mil d 22 1 09SEP2 020 9:00 01O CT2020 20:00 Ten derness Mil d 22 1 09SEP2 020 9:00 02O CT2020 20:30 Pain Mil d 23 2 09SEP2 020 9:00 02O CT2020 20:30 Ten derness Mil d 23 2 09SEP2 020 9:00 20211 08SEP2 020 20:30 Ten derness Mil d 0 08SEP2 020 8:00 09SEP2 020 20:30 Pain Mil d 1 08SEP2 020 8:00 09SEP2 020 20:30 Ten derness Mil d 1 08SEP2 020 8:00 Progra m: Lsa f_locR_1.sas (Page 44 of 56) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 44 FDA-CBER-2021-5683-0050039 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV 2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.1-1: Lis ting of solicited local reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Loc al reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 20 µg Old er 20211 10SEP2 020 20:30 Pain Mil d 2 08SEP2 020 8:00 10SEP2 020 20:30 Ten derness Mil d 2 08SEP2 020 8:00 30SEP2 020 19:30 Pain Mil d 22 0 08SEP2 020 8:00 30SEP2 020 19:30 Ten derness Mil d 22 0 08SEP2 020 8:00 20220 08SEP2 020 21:00 Ten derness Mil d 0 08SEP2 020 9:00 08SEP2 020 21:00 Indu ration/Swelling Mil d 0 08SEP2 020 9:00 09SEP2 020 21:00 Ten derness Mil d 1 08SEP2 020 9:00 09SEP2 020 21:00 Indu ration/Swelling Mil d 1 08SEP2 020 9:00 30SEP2 020 20:00 Pain Mil d 22 0 08SEP2 020 9:00 30SEP2 020 20:00 Ten derness Mil d 22 0 08SEP2 020 9:00 01O CT2020 21:00 Pain Mil d 23 1 08SEP2 020 9:00 01O CT2020 21:00 Ten derness Mil d 23 1 08SEP2 020 9:00 01O CT2020 21:00 Indu ration/Swelling Mil d 23 1 08SEP2 020 9:00 02O CT2020 21:00 Pain Mil d 24 2 08SEP2 020 9:00 02O CT2020 21:00 Ten derness Mil d 24 2 08SEP2 020 9:00 03O CT2020 20:00 Pain Mil d 25 3 08SEP2 020 9:00 03O CT2020 20:00 Ten derness Mil d 25 3 08SEP2 020 9:00 04O CT2020 20:00 Ten derness Mil d 26 4 08SEP2 020 9:00 Progra m: Lsa f_locR_1.sas (Page 45 of 56) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 45 FDA-CBER-2021-5683-0050040 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.1-1: Lis ting of solicited local reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Loc al reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 20 µg Old er 20220 05O CT2020 21:00 Ten derness Mil d 27 5 08SEP2 020 9:00 20227 12SEP2 020 22:10 Ten derness Mod erate 1 11SEP2 020 11:30 02O CT2020 22:15 Pain Mil d 21 0 11SEP2 020 11:30 02O CT2020 22:15 Ten derness Mil d 21 0 11SEP2 020 11:30 03O CT2020 20:00 Pain Mod erate 22 1 11SEP2 020 11:30 03O CT2020 20: 00 Ten derness Mod erate 22 1 11SEP2 020 11:30 03O CT2020 20:00 Indu ration/Swelling Mil d 22 1 11SEP2 020 11:30 04O CT2020 21:50 Pain Mod erate 23 2 11SEP2 020 11:30 04O CT2020 21:50 Ten derness Mod erate 23 2 11SEP2 020 11:30 04O CT2020 21:50 Indu ration/Swelling Mil d 23 2 11SEP2 020 11:30 05O CT2020 22:00 Pain Mil d 24 3 11SEP2 020 11:30 05O CT2020 22:00 Ten derness Mil d 24 3 11SEP2 020 11:30 20234 10SEP2 020 21:00 Pain Mil d 1 09SEP2 020 9:30 11SEP2 020 21:15 Pain Mil d 2 09SEP2 020 9:30 12SEP2 020 21:00 Pain Mil d 3 09SEP2 020 9:30 30SEP2 020 21:30 Pain Mil d 21 0 09SEP2 020 9:30 01O CT2020 21:00 Pain Mil d 22 1 09SEP2 020 9:30 20236 11SEP2 020 21:46 Ten derness Mil d 0 11SEP2 020 10:30 Progra m: Lsa f_locR_1.sas (Page 46 of 56) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 46 FDA-CBER-2021-5683-0050041 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.1-1: Lis ting of solicited local reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Loc al reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 20 µg Old er 20236 12SEP2 020 21:46 Ten derness Mil d 1 11SEP2 020 10:30 20237 11SEP2 020 22:00 Pain Mod erate 0 11SEP2 020 9:00 11SEP2 020 22:00 Ten derness Mod erate 0 11SEP2 020 9:00 12SEP2 020 22:15 Pain Mil d 1 11SEP2 020 9:00 12SEP2 020 22:15 Ten derness Mil d 1 11SEP2 020 9:00 02O CT2020 22:30 Pain Mil d 21 0 11SEP2 020 9:00 02O CT2020 22:30 Ten derness Mil d 21 0 11SEP2 020 9:00 03O CT2020 23:00 Pain Mil d 22 1 11SEP2 020 9:00 03O CT2020 23:00 Ten derness Mil d 22 1 11SEP2 020 9:00 04O CT2020 22:30 Pain Mil d 23 2 11SEP2 020 9:00 04O CT2020 22:30 Ten derness Mil d 23 2 11SEP2 020 9:00 20238 11SEP2 020 19:45 Ten derness Mod erate 0 11SEP2 020 10:00 11SEP2 020 19:45 Indu ration/Swelling Mil d 0 11SEP2 020 10:00 12SEP2 020 19:30 Ten derness Mil d 1 11SEP2 020 10:00 02O CT2020 21:12 Pain Mil d 21 0 11SEP2 020 10:00 02O CT2020 21:12 Ten derness Mil d 21 0 11SEP2 020 10:00 02O CT2020 21:12 Indu ration/Swelling Mil d 21 0 11SEP2 020 10:00 20239 11SEP2 020 22:00 Pain Mil d 0 11SEP2 020 11:00 Progra m: Lsa f_locR_1.sas (Page 47 of 56) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 47 FDA-CBER-2021-5683-0050042 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.1-1: Lis ting of solicited local reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Loc al reac tion Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 20 µg Old er 20239 11SEP2 020 22:00 Ten derness Mod erate 0 11SEP2 020 11:00 12SEP2 020 22:00 Pain Mil d 1 11SEP2 020 11:0 0 12SEP2 020 22:00 Ten derness Mod erate 1 11SEP2 020 11:00 02O CT2020 19:30 Ten derness Mil d 21 0 11SEP2 020 11:00 03O CT2020 20:00 Ten derness Mod erate 22 1 11SEP2 020 11:00 04O CT2020 20:00 Ten derness Mod erate 23 2 11SEP2 020 11:00 20241 09SEP2 020 21:45 Pain Mil d 0 09SEP2 020 10:30 09SEP2 020 21:45 Ten derness Mil d 0 09SEP2 020 10:30 10SEP2 020 21:45 Pain Mil d 1 09SEP2 020 10:30 10SEP2 020 21:45 Ten derness Mil d 1 09SEP2 020 10:30 11SEP2 020 21:45 Pain Mil d 2 09SEP2 020 10:30 11SEP2 020 21:45 Ten derness Mil d 2 09SEP2 020 10:30 12SEP2 020 21:45 Ten derness Mil d 3 09SEP2 020 10:30 30SEP2 020 20:00 Pain Mil d 21 0 09SEP2 020 10:30 01O CT2020 9:30 Pain Mil d 22 1 09SEP2 020 10:30 02O CT2020 9:30 Pain Mil d 23 2 09SEP2 020 10:30 03O CT2020 9:30 Pain Mil d 24 3 09SEP2 020 10:30 03O CT2020 9:30 Ten derness Mil d 24 3 09SEP2 020 10:30 Progra m: Lsa f_locR_1.sas (Page 48 of 56) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 48 FDA-CBER-2021-5683-0050043 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.1-1: Lis ting of solicited local reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Loc al reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 20 µg Old er 20241 04O CT2020 9:30 Pain Mil d 25 4 09SEP2 020 10:30 04O CT2020 9:30 Ten derness Mod erate 25 4 09SEP2 020 10:30 05O CT2020 9:30 Pain Mil d 26 5 09SEP2 020 10:30 05O CT2020 9:30 Ten derness Mod erate 26 5 09SEP2 020 10:30 06O CT2020 9:30 Pain Mil d 27 6 09SEP2 020 10:30 06O CT2020 9:30 Ten derness Mil d 27 6 09SEP2 020 10:30 07O CT2020 9:07 Pain Mil d 28 7 09SEP2 020 10:30 07O CT2020 9:07 Ten derness Mil d 28 7 09SEP2 020 10:30 20242 09SEP2 020 22:00 Pain Mil d 0 09SEP2 020 10:00 10SEP2 020 23:00 Pain Mil d 1 09SEP2 020 10:00 10SEP2 020 23:0 0 Ten derness Mil d 1 09SEP2 020 10:00 11SEP2 020 22:30 Pain Mil d 2 09SEP2 020 10:00 11SEP2 020 22:30 Ten derness Mil d 2 09SEP2 020 10:00 12SEP2 020 23:00 Pain Mil d 3 09SEP2 020 10:00 12SEP2 020 23:00 Ten derness Mil d 3 09SEP2 020 10:00 13SEP2 020 22:30 Pain Mil d 4 09SEP2 020 10:00 13SEP2 020 22:30 Ten derness Mil d 4 09SEP2 020 10:00 30 µg Old er 10350 25SEP2 020 20:00 Pain Mil d 0 25SEP2 020 8:20 Progra m: Lsa f_locR_1.sas (Page 49 of 56) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 49 FDA-CBER-2021-5683-0050044 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM d ata received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3-1.1-1: Lis ting of solicited local reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Loc al reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prim e imm unization 30 µg Old er 10350 25SEP2 020 20:00 Ten derness Mil d 0 25SEP2 020 8:20 26SEP2 020 20:00 Pain Mil d 1 25SEP2 020 8:20 26SEP2 020 20:00 Ten derness Mil d 1 25SEP2 020 8:20 16O CT2020 20:00 Pain Mod erate 21 0 25SEP2 020 8:20 16O CT2020 20:00 Ten derness Mod erate 21 0 25SEP2 020 8:20 17O CT2020 20:00 Pain Mil d 22 1 25SEP2 020 8:20 17O CT2020 20:00 Ten derness Mil d 22 1 25SEP2 020 8:20 18O CT2020 20:00 Pain Mil d 23 2 25SEP2 020 8:20 18O CT2020 20:00 Ten derness Mil d 23 2 25SEP2 020 8:20 10351 25SEP2 020 20:45 Pain Mil d 0 25SEP2 020 8:50 25SEP2 020 20:45 Ten derness Mod erate 0 25SEP2 020 8:50 26SEP2 020 21:40 Pain Mil d 1 25SEP2 020 8:50 26SEP2 020 21:40 Ten derness Mil d 1 25SEP2 020 8:50 16O CT2020 8:50 Pain Mod erate 21 0 25SEP2 020 8:50 16O CT2020 8:50 Ten derness Mod erate 21 0 25SEP2 020 8:50 16O CT2020 21:00 Pain Mod erate 21 0 25SEP2 020 8:50 16O CT2020 21:00 Ten derness Mod erate 21 0 25SEP2 020 8:50 17O CT2020 21:00 Pain Mod erate 22 1 25SEP2 020 8:50 Progra m: Lsa f_locR_1.sas (Page 50 of 56) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 50 FDA-CBER-2021-5683-0050045 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV 2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.1-1: Lis ting of solicited local reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Loc al reaction Seve rity/ Inten sity Num be r of d ays afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 30 µg Old er 10351 17O CT2020 21:00 Ten derness Mod erate 22 1 25SEP2 020 8:50 18O CT2020 21:00 Pain Mil d 23 2 25SEP2 020 8:50 18O CT2020 21:00 Ten derness Mil d 23 2 25SEP2 020 8:50 10353 22SEP2 020 19:00 Pain Mil d 0 22SEP2 020 8:50 22SEP2 020 19:00 Ten derness Mil d 0 22SEP2 020 8:50 22SEP2 020 19:00 Indu ration/Swelling Mil d 0 22SEP2 020 8:50 23SEP2 020 19:00 Pain Mil d 1 22SEP2 020 8:50 23SEP2 020 19:00 Ten derness Mil d 1 22SEP2 020 8:50 23SEP2 020 19:00 Indu ration/Swelling Mil d 1 22SEP2 020 8:50 24SEP2 020 20:00 Pain Mil d 2 22SEP2 020 8:50 24SEP2 020 20:00 Ten derness Mil d 2 22SEP2 020 8:50 24SEP2 020 20:00 Indu ration/Swelling Mil d 2 22SEP2 020 8:50 25SEP2 020 20:00 Pain Mil d 3 22SEP2 020 8:50 25SEP2 020 20:00 Ten derness Mil d 3 22SEP2 020 8:50 26SEP2 020 20:00 Ten derness Mil d 4 22SEP2 020 8:50 13O CT2020 20:00 Pain Mod erate 21 0 22SEP2 020 8:50 13O CT2020 20:00 Ten derness Mod erate 21 0 22SEP2 020 8:50 14O CT2020 22:00 Pain Mod erate 22 1 22SEP2 020 8:50 Progra m: Lsa f_locR_1.sas (Page 51 of 56) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 51 FDA-CBER-2021-5683-0050046 Bio NTech RNA Phar maceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.1-1: Lis ting of solicited local reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Loc al reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 30 µg Old er 10353 14O CT2020 22:00 Ten derness Mod erate 22 1 22SEP2 020 8:50 10358 23SEP2 020 19:30 Pain Mil d 0 23SEP2 020 8:31 23SEP2 020 19:30 Ten derness Mil d 0 23SEP2 020 8:31 24SEP2 020 19:30 Pain Mod erate 1 23SEP2 020 8:31 24SEP2 020 19:30 Ten derness Mod erate 1 23SEP2 020 8:31 14O CT2020 Pain Mil d 21 0 23SEP2 020 8:31 14O CT2020 Ten derness Mil d 21 0 23SEP2 020 8:31 15O CT2020 19:00 Pain Mil d 22 1 23SEP2 020 8:31 15O CT2020 19:00 Ten derness Mil d 22 1 23SEP2 020 8:31 16O CT2020 18:30 Pain Mil d 23 2 23SEP2 020 8:31 16O CT2020 18:30 Ten derness Mil d 23 2 23SEP2 020 8:31 16O CT2020 18:30 Erythe ma/Redness Mil d 23 2 23SEP2 020 8:31 17O CT2020 18:30 Pain Mil d 24 3 23SEP2 020 8:31 17O CT2020 18:30 Ten derness Mil d 24 3 23SEP2 020 8:31 17O CT2020 18:30 Indu ration/Swelling Mil d 24 3 23SEP2 020 8:31 18O CT2020 19:30 Pain Mil d 25 4 23SEP2 020 8:31 18O CT2020 19:30 Ten derness Mil d 25 4 23SEP2 020 8:31 18O CT2020 19:30 Indu ration/Swelling Mil d 25 4 23SEP2 020 8:31 Progra m: Lsa f_locR_1.sas (Page 52 of 56) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 52 FDA-CBER-2021-5683-0050047 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on cl ean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.1-1: Lis ting of solicited local reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Loc al reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 30 µg Old er 10358 19O CT2020 19:00 Pain Mil d 26 5 23SEP2 020 8:31 19O CT2020 19:00 Ten derness Mil d 26 5 23SEP2 020 8:31 19O CT2020 19:00 Indu ration/Swelling Mil d 26 5 23SEP2 020 8:31 20O CT2020 18:30 Pain Mil d 27 6 23SEP2 020 8:31 20O CT2020 18:30 Ten derness Mil d 27 6 23SEP2 020 8:31 20O CT2020 18:30 Indu ration/Swelling Mil d 27 6 23SEP2 020 8:31 10360 23SEP2 020 21:00 Pain Mil d 0 23SEP2 020 9:00 23SEP2 020 21:00 Ten derness Mil d 0 23SEP2 020 9:00 24SEP2 020 21:15 Pain Mil d 1 23SEP2 020 9:00 24SEP2 020 21:15 Ten derness Mil d 1 23SEP2 020 9:00 25SEP2 020 22:00 Pain Mil d 2 23SEP2 020 9:00 25SEP2 020 22:00 Ten derness Mil d 2 23SEP2 020 9:00 14O CT2020 22:00 Pain Mil d 21 0 23SEP2 020 9:00 14O CT2020 22:00 Ten derness Mil d 21 0 23SEP2 020 9:00 15O CT2020 21:30 Pain Mil d 22 1 23SEP2 020 9:00 15O CT2020 21:30 Ten derness Mil d 22 1 23SEP2 020 9:00 10361 25SEP2 020 22:30 Pain Mil d 0 25SEP2 020 9:20 25SEP2 020 22:30 Ten derness Mil d 0 25SEP2 020 9:20 Progra m: Lsa f_locR_1.sas (Page 53 of 56) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 53 FDA-CBER-2021-5683-0050048 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.1-1: Lis ting of solicited local reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Loc al reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 30 µg Old er 10361 26SEP2 020 22:15 Pain Mil d 1 25SEP2 020 9:20 26SEP2 020 22:15 Ten derness Mil d 1 25SEP2 020 9:20 27SEP2 020 23:00 Ten derness Mil d 2 25SEP2 020 9:20 16O CT2020 22:30 Pain Mod erate 21 0 25SEP2 020 9:20 16O CT2020 22:30 Ten derness Mod erate 21 0 25SEP2 020 9:20 17O CT2020 23:00 Pain Mil d 22 1 25SEP2 020 9:20 17O CT2020 23:00 Ten derness Mod erate 22 1 25SEP2 020 9:20 18O CT2020 23:30 Ten derness Mil d 23 2 25SEP2 020 9:20 10362 26SEP2 020 20:45 Pain Mil d 1 25SEP2 020 9:50 26SEP2 020 20:45 Ten derness Mil d 1 25SEP2 020 9:50 27SEP2 020 20:45 Ten derness Mil d 2 25SEP2 020 9:50 10363 25SEP2 020 21:30 Ten derness Mod erate 0 25SEP2 020 10:20 26SEP2 020 21:30 Ten derness Mod erate 1 25SEP2 020 10:20 16O CT2020 21:45 Pain Mil d 21 0 25SEP2 020 10:20 16O CT2020 21:45 Ten derness Mil d 21 0 25SEP2 020 10:20 17O CT2020 21:45 Pain Mil d 22 1 25SEP2 020 10:20 17O CT2020 21: 45 Ten derness Mod erate 22 1 25SEP2 020 10:20 10364 25SEP2 020 22:00 Ten derness Mil d 0 25SEP2 020 10:50 Progra m: Lsa f_locR_1.sas (Page 54 of 56) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 54 FDA-CBER-2021-5683-0050049 Bio NTech RNA Phar maceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.1-1: Lis ting of solicited local reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Loc al reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 30 µg Old er 10364 26SEP2 020 22:00 Ten derness Mil d 1 25SEP2 020 10:50 16O CT2020 21:30 Ten derness Mil d 21 0 25SEP2 020 10:50 17O CT2020 21:00 Ten derness Mod erate 22 1 25SEP2 020 10:50 18O CT2020 20:30 Ten derness Mil d 23 2 25SEP2 020 10:50 10365 23SEP2 020 20:00 Pain Mil d 0 23SEP2 020 9:43 23SEP2 020 20:0 0 Ten derness Mil d 0 23SEP2 020 9:43 24SEP2 020 20:00 Pain Mil d 1 23SEP2 020 9:43 24SEP2 020 20:00 Ten derness Mil d 1 23SEP2 020 9:43 25SEP2 020 20:00 Pain Mil d 2 23SEP2 020 9:43 25SEP2 020 20:00 Ten derness Mil d 2 23SEP2 020 9:43 14O CT2020 21:00 Pain Mil d 21 0 23SEP2 020 9:43 14O CT2020 21:00 Ten derness Mil d 21 0 23SEP2 020 9:43 15O CT2020 21:00 Pain Mil d 22 1 23SEP2 020 9:43 15O CT2020 21:00 Ten derness Mil d 22 1 23SEP2 020 9:43 16O CT2020 21:00 Pain Mil d 23 2 23SEP2 020 9:43 16O CT2020 21:00 Ten derness Mil d 23 2 23SEP2 020 9:43 16O CT2020 21:00 Erythe ma/Redness Mil d 23 2 23SEP2 020 9:43 16O CT2020 21:00 Indu ration/Swelling Mil d 23 2 23SEP2 020 9:43 Progra m: Lsa f_locR_1.sas (Page 55 of 56) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 55 FDA-CBER-2021-5683-0050050 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20 NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.1-1: Lis ting of solicited local reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Loc al reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 30 µg Old er 10365 17O CT2020 21:30 Pain Mil d 24 3 23SEP2 020 9:43 17O CT2020 21:30 Ten derness Mil d 24 3 23SEP2 020 9:43 17O CT2020 21:30 Erythe ma/Redness Mil d 24 3 23SEP2 020 9:43 18O CT2020 21:00 Erythe ma/Redness Mil d 25 4 23SEP2 020 9:43 10366 23SEP2 020 21:00 Pain Mil d 0 23SEP2 020 10:13 Progra m: Lsa f_locR_1.sas (Page 56 of 56) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 56 FDA-CBER-2021-5683-0050051 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clea n SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.3-1: Lis ting of solicited systemic reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Syste mic reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boo st imm unization Date/t ime of prime imm unization 1 µg You nger 10015 29APR20 20 23:00 Heada che Mil d 0 29APR20 20 9:23 29APR20 20 23:00 Fatig ue Mil d 0 29APR20 20 9:23 20M AY2020 23:00 Heada che Mod erate 21 0 29APR20 20 9:23 10018 29APR20 20 Heada che Mil d 0 29APR20 20 9:53 29APR20 20 Fatig ue Mil d 0 29APR20 20 9:53 10025 05M AY2020 20:45 Fatig ue Mil d 0 05M AY2020 9:06 05M AY2020 20:45 Chill s Mil d 0 05M AY2020 9:06 26M AY2020 22:00 Heada che Mil d 21 0 05M AY2020 9:06 26M AY2020 22:00 Fatig ue Mil d 21 0 05M AY2020 9:06 26M AY2020 22:00 Mya lgia Mil d 21 0 05M AY2020 9:06 26M AY2020 22:00 Chill s Mil d 21 0 05M AY2020 9:06 27M AY2020 22:00 Heada che Mil d 22 1 05M AY2020 9:06 27M AY2020 22:00 Fatig ue Mod erate 22 1 05M AY2020 9:06 28M AY2020 21:0 0 Fatig ue Mod erate 23 2 05M AY2020 9:06 29M AY2020 22:00 Fatig ue Mil d 24 3 05M AY2020 9:06 30M AY2020 22:00 Fatig ue Mil d 25 4 05M AY2020 9:06 10033 27M AY2020 20:00 Heada che Mil d 22 1 05M AY2020 10:03 27M AY2020 20:00 Fatig ue Mod erate 22 1 05M AY2020 10:03 Progra m: Lsa f_sysR_1.sas (Page 1 of 92) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 57 FDA-CBER-2021-5683-0050052 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.3-1: Lis ting of solicited systemic reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Syste mic reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 1 µg You nger 10033 27M AY2020 20:00 Mya lgia Mil d 22 1 05M AY2020 10:03 27M AY2020 20:00 Arthral gia Mil d 22 1 05M AY2020 10:03 27M AY2020 20:00 Chill s Mil d 22 1 05M AY2020 10:03 10036 29M AY2020 18:00 Heada che Mod erate 21 0 08M AY2020 8:30 29M AY2020 18:00 Mya lgia Mod erate 21 0 08M AY2020 8:30 29M AY2020 18:00 Chill s Mod erate 21 0 08M AY2020 8:30 29M AY2020 18:00 Feve r Seve re 21 0 08M AY2020 8:30 30M AY2020 18:00 Heada che Mod erate 22 1 08M AY2020 8:30 10040 08M AY2020 20:32 Fatig ue Mil d 0 08M AY2020 8:51 09M AY2020 21:23 Fatig ue Mil d 1 08M AY2020 8:51 13M AY2020 21:49 Heada che Mil d 5 08M AY2020 8:51 13M AY2020 21:4 9 Fatig ue Mil d 5 08M AY2020 8:51 13M AY2020 21:49 Mya lgia Mil d 5 08M AY2020 8:51 13M AY2020 21:49 Mal aise Mod erate 5 08M AY2020 8:51 29M AY2020 22:12 Heada che Mod erate 21 0 08M AY2020 8:51 29M AY2020 22:12 Fatig ue Mod erate 21 0 08M AY2020 8:51 29M AY2020 22:12 Los s of Appetite Mil d 21 0 08M AY2020 8:51 29M AY2020 22:12 Mal aise Mil d 21 0 08M AY2020 8:51 Progra m: Lsa f_sysR_1.sas (Page 2 of 92) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 58 FDA-CBER-2021-5683-0050053 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM d ata received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.3-1: Lis ting of solicited systemic reacti ons - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Syste mic reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 1 µg You nger 10040 30M AY2020 21:19 Nause a Mil d 22 1 08M AY2020 8:51 30M AY2020 21:19 Heada che Mod erate 22 1 08M AY2020 8:51 30M AY2020 21:19 Fatig ue Mod erate 22 1 08M AY2020 8:51 30M AY2020 21:19 Mya lgia Mod erate 22 1 08M AY2020 8:51 30M AY2020 21:19 Arthral gia Mod erate 22 1 08M AY2020 8:51 30M AY2020 21:19 Los s of Appetite Mil d 22 1 08M AY2020 8:51 30M AY2020 21:19 Mal aise Mod erate 22 1 08M AY2020 8:51 31M AY2020 21:05 Heada che Mod erate 23 2 08M AY2020 8:51 31M AY2020 21:05 Fatig ue Seve re 23 2 08M AY2020 8:51 31M AY2020 21:05 Mya lgia Mod erate 23 2 08M AY2020 8:51 31M AY2020 21:05 Los s of Appetite Mil d 23 2 08M AY2020 8:51 31M AY2020 21:05 Mal aise Mod erate 23 2 08M AY2020 8:51 01J UN2020 21:10 Nause a Mil d 24 3 08M AY2020 8:51 01J UN2020 21:10 Heada che Mil d 24 3 08M AY2020 8:51 01J UN2020 21:10 Fatig ue Mod erate 24 3 08M AY2020 8:51 01J UN2020 21:10 Mya lgia Mil d 24 3 08M AY2020 8:51 01J UN2020 21:10 Arthral gia Mil d 24 3 08M AY2020 8:51 01J UN2020 21:10 Los s of Appetite Mil d 24 3 08M AY2020 8:51 Progra m: Lsa f_sysR_1.sas (Page 3 of 92) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 59 FDA-CBER-2021-5683-0050054 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20 NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.3-1: Lis ting of solicited systemic reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Syste mic reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 1 µg You nger 10040 01J UN2020 21:10 Mal aise Mil d 24 3 08M AY2020 8:51 02J UN2020 21:00 Nause a Mil d 25 4 08M AY2020 8:51 02J UN2020 21:00 Heada che Mod erate 25 4 08M AY2020 8:51 02J UN2020 21:00 Fatig ue Mil d 25 4 08M AY2020 8:51 02J UN2020 21:00 Mya lgia Mod erate 25 4 08M AY2020 8:51 02J UN2020 21:00 Arthral gia Mod erate 25 4 08M AY2020 8:51 02J UN2020 21:00 Los s of Appetite Mil d 25 4 08M AY2020 8:51 02J UN2020 21:00 Mal aise Mil d 25 4 08M AY2020 8:51 03J UN2020 21:15 Heada che Mil d 26 5 08M AY2020 8:51 03J UN2020 21:15 Fatig ue Mil d 26 5 08M AY2020 8:51 03J UN2020 21:15 Mya lgia Mil d 26 5 08M AY2020 8:51 03J UN2020 21:15 Arthral gia Mil d 26 5 08M AY2020 8:51 10041 08M AY2020 20:31 Diarrhe a Mil d 0 08M AY2020 9:06 09M AY2020 21:23 Fatig ue Mil d 1 08M AY2020 9:06 10M AY2020 21:28 Fatig ue Mil d 2 08M AY2020 9:06 11M AY2020 21:17 Fatig ue Mil d 3 08M AY2020 9:06 13M AY2020 21:50 Fatig ue Mil d 5 08M AY2020 9:06 13M AY2020 21:50 Chill s Mil d 5 08M AY2020 9:06 Progra m: Lsa f_sysR_1.sas (Page 4 of 92) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 60 FDA-CBER-2021-5683-0050055 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data rece ived on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.3-1: Lis ting of solicited systemic reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Syste mic reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 1 µg You nger 10041 13M AY2020 21:50 Mal aise Mil d 5 08M AY2020 9:06 14M AY2020 21:40 Nause a Mil d 6 08M AY2020 9:06 14M AY2020 21:40 Diarrhe a Mil d 6 08M AY2020 9:06 14M AY2020 21:40 Heada che Mod erate 6 08M AY2020 9:06 14M AY2020 21:40 Fatig ue Mil d 6 08M AY2020 9:06 29M AY2020 22:12 Nause a Mod erate 21 0 08M AY2020 9:06 29M AY2020 22:12 Heada che Mod erate 21 0 08M AY2020 9:06 29M AY2020 22:12 Fatig ue Mod erate 21 0 08M AY2020 9:06 29M AY2020 22:12 Mya lgia Mod erate 21 0 08M AY2020 9:06 29M AY2020 22:12 Los s of Appetite Mod erate 21 0 08M AY2020 9:06 29M AY2020 22:12 Mal aise Mil d 21 0 08M AY2020 9:06 30M AY2020 21:19 Nause a Mod erate 22 1 08M AY2020 9:06 30M AY2020 21:19 Heada che Mod erate 22 1 08M AY2020 9:06 30M AY2020 21:19 Mya lgia Mod erate 22 1 08M AY2020 9:06 30M AY2020 21:1 9 Chill s Mil d 22 1 08M AY2020 9:06 30M AY2020 21:19 Los s of Appetite Mod erate 22 1 08M AY2020 9:06 30M AY2020 21:19 Mal aise Mod erate 22 1 08M AY2020 9:06 31M AY2020 21:05 Heada che Mil d 23 2 08M AY2020 9:06 Progra m: Lsa f_sysR_1.sas (Page 5 of 92) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 61 FDA-CBER-2021-5683-0050056 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.3-1: Lis ting of solicited systemic reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Syste mic reaction Seve rity/ Inten sity Num be r of day s afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 1 µg You nger 10041 31M AY2020 21:05 Fatig ue Mil d 23 2 08M AY2020 9:06 31M AY2020 21:05 Los s of Appetite Seve re 23 2 08M AY2020 9:06 31M AY2020 21:05 Mal aise Mod erate 23 2 08M AY2020 9:06 01J UN2020 21:14 Los s of Appetite Seve re 24 3 08M AY2020 9:06 01J UN2020 21:14 Mal aise Mod erate 24 3 08M AY2020 9:06 02J UN2020 21:32 Nause a Mod erate 25 4 08M AY2020 9:06 02J UN2020 21:32 Los s of Appetite Mod erate 25 4 08M AY2020 9:06 02J UN2020 21:32 Mal aise Mod erate 25 4 08M AY2020 9:06 03J UN2020 21:36 Los s of Appetite Mod erate 26 5 08M AY2020 9:06 03J UN2020 21:36 Mal aise Mod erate 26 5 08M AY2020 9:06 10042 08M AY2020 22:00 Fatig ue Mil d 0 08M AY2020 9:22 10045 05M AY2020 20:30 Fatig ue Mil d 0 05M AY2020 10:33 10048 08M AY2020 20:06 Fatig ue Mil d 0 08M AY2020 9:36 10052 08M AY2020 23:00 Heada che Mil d 0 08M AY2020 9:51 13M AY2020 23:40 Heada che Mod erate 5 08M AY2020 9:51 30M AY2020 23:4 4 Fatig ue Mod erate 22 1 08M AY2020 9:51 02J UN2020 Heada che Mod erate 25 4 08M AY2020 9:51 3 µg You nger 10170 31J UL2020 20:00 Fatig ue Mod erate 0 31J UL2020 8:00 Progra m: Lsa f_sysR_1.sas (Page 6 of 92) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 62 FDA-CBER-2021-5683-0050057 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data rece ived on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3-1.3-1: Lis ting of solicited systemic reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Syste mic reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of p rime imm unization 3 µg You nger 10170 01AUG 2020 20:05 Fatig ue Mil d 1 31J UL2020 8:00 21AUG 2020 20:04 Heada che Mil d 21 0 31J UL2020 8:00 21AUG 2020 20:04 Fatig ue Mil d 21 0 31J UL2020 8:00 10194 22J UL2020 21:15 Heada che Mil d 0 22J UL2020 8:00 22J UL2020 21:15 Fatig ue Mil d 0 22J UL2020 8:00 12AUG 2020 22:15 Heada che Mod erate 21 0 22J UL2020 8:00 12AUG 2020 22:15 Fatig ue Mil d 21 0 22J UL2020 8:00 12AUG 2020 22:15 Mal aise Mod erate 21 0 22J UL2020 8:00 13AUG 2020 21:45 Heada che Mil d 22 1 22J UL2020 8:00 13AUG 2020 21:45 Fatig ue Mil d 22 1 22J UL2020 8:00 13AUG 2020 21:45 Mya lgia Mil d 22 1 22J UL2020 8:00 13AUG 2020 21:45 Mal aise Mil d 22 1 22J UL2020 8:00 17AUG 2020 22:00 Heada che Mil d 26 5 22J UL2020 8:00 17AUG 2020 22:00 Mal aise Mil d 26 5 22J UL2020 8:00 10204 25J UL2020 23:15 Heada che Mil d 3 22J UL2020 8:45 10212 23J UL2020 21:30 Fatig ue Mil d 1 22J UL2020 9:15 24J UL2020 20:30 Diarrhe a Mil d 2 22J UL2020 9:15 24J UL2020 20:30 Fatig ue Mil d 2 22J UL2020 9:15 Progra m: Lsa f_sysR_1.sas (Page 7 of 92) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 63 FDA-CBER-2021-5683-0050058 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.3-1: Lis ting of solicited systemic reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Syste mic reaction Seve rity/ Inten sity Num be r of day s afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 3 µg You nger 10212 12AUG 2020 21:30 Fatig ue Mil d 21 0 22J UL2020 9:15 13AUG 2020 20:00 Nause a Mil d 22 1 22J UL2020 9:15 13AUG 2020 20:00 Heada che Mod erate 22 1 22J UL2020 9:15 13AUG 2020 20:00 Fatig ue Mod erate 22 1 22J UL2020 9:15 13AUG 2020 20:00 Arthral gia Mod erate 22 1 22J UL2020 9:15 13AUG 2020 20:00 Los s of Appetite Mil d 22 1 22J UL2020 9:15 13AUG 2020 20:00 Mal aise Mod erate 22 1 22J UL2020 9:15 13AUG 2020 20:00 Feve r Mod erate 22 1 22J UL2020 9:15 14AUG 2020 20:00 Fatig ue Mil d 23 2 22J UL2020 9:15 14AUG 2020 20:00 Mal aise Mil d 23 2 22J UL2020 9:15 10221 31J UL2020 20:00 Heada che Mil d 0 31J UL2020 9:00 31J UL2020 20:00 Fatig ue Mod erate 0 31J UL2020 9:00 02AUG 2020 20:00 Fatig ue Mil d 2 31J UL2020 9:00 21AUG 2020 20:00 Fatig ue Mil d 21 0 31J UL2020 9:00 10224 23AUG 2020 20:00 Heada che Mod erate 23 2 31J UL2020 8:15 23AUG 2020 20:00 Fatig ue Mod erate 23 2 31J UL2020 8:15 25AUG 2020 19:00 Heada che Mil d 25 4 31J UL2020 8:15 25AUG 2020 19:00 Fatig ue Mil d 25 4 31J UL2020 8:15 Progra m: Lsa f_sysR_1.sas (Page 8 of 92) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 64 FDA-CBER-2021-5683-0050059 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.3-1: Lis ting of solicited systemic reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Syste mic reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 3 µg You nger 10224 26AUG 2020 20:0 0 Fatig ue Mil d 26 5 31J UL2020 8:15 10225 31J UL2020 20:15 Heada che Mil d 0 31J UL2020 8:30 31J UL2020 20:15 Fatig ue Mod erate 0 31J UL2020 8:30 10226 31J UL2020 20:00 Heada che Mil d 0 31J UL2020 8:45 31J UL2020 20:00 Fatig ue Mod erate 0 31J UL2020 8:45 01AUG 2020 20:00 Heada che Mil d 1 31J UL2020 8:45 01AUG 2020 20:00 Fatig ue Mil d 1 31J UL2020 8:45 01AUG 2020 20:00 Chill s Mil d 1 31J UL2020 8:45 02AUG 2020 20:00 Heada che Mil d 2 31J UL2020 8:45 02AUG 2020 20:00 Fatig ue Mil d 2 31J UL2020 8:45 02AUG 2020 20:00 Chill s Mil d 2 31J UL2020 8:45 03AUG 2020 20:00 Heada che Mil d 3 31J UL2020 8:45 03AUG 2020 20:00 Fatig ue Mil d 3 31J UL2020 8:45 03AUG 2020 20:00 Chill s Mil d 3 31J UL2020 8:45 04AUG 2020 20:00 Chill s Mil d 4 31J UL2020 8:45 05AUG 2020 20:00 Chill s Mil d 5 31J UL2020 8:45 06AUG 2020 20:00 Chill s Mil d 6 31J UL2020 8:45 07AUG 2020 8:11 Chill s Mil d 7 31J UL2020 8:45 Progra m: Lsa f_sysR_1.sas (Page 9 of 92) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 65 FDA-CBER-2021-5683-0050060 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data rece ived on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3-1.3-1: Lis ting of solicited systemic reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Syste mic reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of p rime imm unization 3 µg You nger 10226 21AUG 2020 20:00 Heada che Mil d 21 0 31J UL2020 8:45 21AUG 2020 20:00 Fatig ue Seve re 21 0 31J UL2020 8:45 21AUG 2020 20:00 Mya lgia Mil d 21 0 31J UL2020 8:45 22AUG 2020 20:00 Heada che Mod erate 22 1 31J UL2020 8:45 22AUG 2020 20:00 Fatig ue Mod erate 22 1 31J UL2020 8:45 22AUG 2020 20:00 Mya lgia Mil d 22 1 31J UL2020 8:45 23AUG 2020 20:00 Heada che Mod erate 23 2 31J UL2020 8:45 23AUG 2020 20:00 Fatig ue Mod erate 23 2 31J UL2020 8:45 23AUG 2020 20:00 Mya lgia Mil d 23 2 31J UL2020 8:45 23AUG 2020 20:00 Chill s Mil d 23 2 31J UL2020 8:45 24AUG 2020 20:00 Heada che Mil d 24 3 31J UL2020 8:45 24AUG 2020 20:00 Fatig ue Mil d 24 3 31J UL2020 8:45 24AUG 2020 20:00 Mya lgia Mil d 24 3 31J UL2020 8:45 24AUG 2020 20:0 0 Chill s Mil d 24 3 31J UL2020 8:45 25AUG 2020 20:00 Fatig ue Mil d 25 4 31J UL2020 8:45 25AUG 2020 20:00 Mya lgia Mil d 25 4 31J UL2020 8:45 26AUG 2020 20:00 Fatig ue Mil d 26 5 31J UL2020 8:45 10227 06AUG 2020 18:00 Heada che Mil d 6 31J UL2020 9:15 Progra m: Lsa f_sysR_1.sas (Page 10 of 92) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 66 FDA-CBER-2021-5683-0050061 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.3-1: Lis ting of solicited systemic reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Syste mic reaction Seve rity/ Inten sity Num be r of day s afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 3 µg You nger 10227 21AUG 2020 Heada che Mod erate 21 0 31J UL2020 9:15 10 µg You nger 10003 19M AY2020 20:35 Heada che Mil d 21 0 28APR20 20 8:30 10004 25APR20 20 21:00 Diarrhe a Mil d 1 24APR20 20 9:15 26APR20 20 21:30 Diarrhe a Mil d 2 24APR20 20 9:15 15M AY2020 21:30 Nause a Mod erate 21 0 24APR20 20 9:15 15M AY2020 21:30 Heada che Mod erate 21 0 24APR20 20 9:15 15M AY2020 21:30 Fatig ue Mil d 21 0 24APR20 20 9:15 15M AY2020 21:30 Arthral gia Mil d 21 0 24APR20 20 9:15 15M AY2020 21:30 Chill s Seve re 21 0 24APR20 20 9:15 16M AY2020 22:15 Heada che Mil d 22 1 24APR20 20 9:15 16M AY2020 22:15 Fatig ue Mil d 22 1 24APR20 20 9:15 16M AY2020 22:15 Mya lgia Mil d 22 1 24APR20 20 9:15 16M AY2020 22:15 Arthral gia Mil d 22 1 24APR20 20 9:15 16M AY2020 22:15 Chill s Mil d 22 1 24APR20 20 9:15 16M AY2020 22:15 Los s of Appetite Mil d 22 1 24APR20 20 9:15 16M AY2020 22:15 Mal aise Mil d 22 1 24APR20 20 9:15 17M AY2020 23:15 Fatig ue Mil d 23 2 24APR20 20 9:15 17M AY2020 23:15 Mya lgia Mil d 23 2 24APR20 20 9:15 Progra m: Lsa f_sysR_1.sas (Page 11 of 92) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 67 FDA-CBER-2021-5683-0050062 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data rece ived on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.3-1: Lis ting of solicited systemic reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Syste mic reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 10 µg You nger 10004 17M AY2020 23:1 5 Arthral gia Mil d 23 2 24APR20 20 9:15 10005 24APR20 20 13:00 Heada che Mod erate 0 24APR20 20 11:15 24APR20 20 13:00 Fatig ue Mod erate 0 24APR20 20 11:15 25APR20 20 19:30 Heada che Mil d 1 24APR20 20 11:15 25APR20 20 19:30 Fatig ue Mil d 1 24APR20 20 11: 15 28APR20 20 19:45 Fatig ue Mil d 4 24APR20 20 11:15 15M AY2020 19:00 Heada che Mil d 21 0 24APR20 20 11:15 15M AY2020 19:00 Fatig ue Mod erate 21 0 24APR20 20 11:15 15M AY2020 19:00 Mya lgia Mil d 21 0 24APR20 20 11:15 15M AY2020 19:00 Chill s Mod erate 21 0 24APR20 20 11:15 16M AY2020 19:00 Fatig ue Mod erate 22 1 24APR20 20 11:15 16M AY2020 19:00 Mya lgia Mod erate 22 1 24APR20 20 11:15 16M AY2020 19:00 Arthral gia Mod erate 22 1 24APR20 20 11:15 16M AY2020 19:00 Chill s Mod erate 22 1 24APR20 20 11:15 16M AY2020 19:00 Los s of Appetite Mod erate 22 1 24APR20 20 11:15 16M AY2020 19:00 Mal aise Mod erate 22 1 24APR20 20 11:15 17M AY2020 19:00 Heada che Mod erate 23 2 24APR20 20 11:15 17M AY2020 19:00 Fatig ue Mod erate 23 2 24APR20 20 11:15 Progra m: Lsa f_sysR_1.sas (Page 12 of 92) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 68 FDA-CBER-2021-5683-0050063 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.3-1: Lis ting of solicited systemic reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Syste mic reaction Seve rity/ Inten sity Num be r of day s afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 10 µg You nger 10005 18M AY2020 19:00 Fatig ue Mil d 24 3 24APR20 20 11:15 19M AY2020 19:00 Fatig ue Mod erate 25 4 24APR20 20 11:15 19M AY2020 19:00 Mal aise Mil d 25 4 24APR20 20 11:15 20M AY2020 19:00 Fatig ue Mod erate 26 5 24APR20 20 11:15 21M AY2020 19:00 Fatig ue Mod erate 27 6 24APR20 20 11:15 21M AY2020 19:00 Mal aise Mil d 27 6 24APR20 20 11:15 22M AY2020 19:00 Fatig ue Mod erate 28 7 24APR20 20 11:15 10006 29APR20 20 22:00 Heada che Mil d 1 28APR20 20 9:00 29APR20 20 22:00 Fatig ue Mil d 1 28APR20 20 9:00 19M AY2020 22:00 Fatig ue Mil d 21 0 28APR20 20 9:00 19M AY2020 22:00 Chill s Mil d 21 0 28APR20 20 9:00 19M AY2020 22:00 Feve r Seve re 21 0 28APR20 20 9:00 20M AY2020 22:00 Nause a Mil d 22 1 28APR20 20 9:00 20M AY2020 22:00 Fatig ue Mod erate 22 1 28APR20 20 9:00 20M AY2020 22:00 Mya lgia Mil d 22 1 28APR20 20 9:00 20M AY2020 22:00 Chill s Mil d 22 1 28APR20 20 9:00 20M AY2020 22:00 Mal aise Mil d 22 1 28APR20 20 9:00 20M AY2020 22:00 Feve r Mil d 22 1 28APR20 20 9:00 Progra m: Lsa f_sysR_1.sas (Page 13 of 92) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 69 FDA-CBER-2021-5683-0050064 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.3-1: Lis ting of solicited systemic reactions - BNT 162b1 Safety set Dose grou p Subj ect num ber Date/t ime of collection Syste mic reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 10 µg You nger 10007 Heada che Mod erate 23APR20 20 11:08 Los s of App etite Mil d 23APR20 20 11:08 Mal aise Mil d 23APR20 20 11:08 23APR20 20 20:00 Heada che Mod erate 0 23APR20 20 11:08 24APR20 20 9:00 Heada che Mil d 1 23APR20 20 11:08 24APR20 20 9:00 Mya lgia Mil d 1 23APR20 20 11:08 25APR20 20 9:00 Heada che Mil d 2 23APR20 20 11:08 25APR20 20 9:00 Fatig ue Mil d 2 23APR20 20 11:08 26APR20 20 8:00 Heada che Mod erate 3 23APR20 20 11:08 26APR20 20 8:00 Fatig ue Mil d 3 23APR20 20 11:08 27APR20 20 9:00 Heada che Mod erate 4 23APR20 20 11:08 27APR20 20 9:00 Fatig ue Mil d 4 23APR20 20 11:08 28APR20 20 9:00 Heada che Mil d 5 23APR20 20 11:08 14M AY2020 Heada che Mil d 21 0 23APR20 20 11:08 14M AY2020 Fatig ue Mil d 21 0 23APR20 20 11:08 14M AY2020 Mya lgia Mod erate 21 0 23APR20 20 11:08 14M AY2020 Mal aise Mil d 21 0 23APR20 20 11:08 15M AY2020 20:00 Heada che Mod erate 22 1 23APR20 20 11:08 Progra m: Lsa f_sysR_1.sas (Page 14 of 92) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 70 FDA-CBER-2021-5683-0050065 Bio NTech RNA Phar maceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.3-1: Lis ting of solicited systemic reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Syste mic reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 10 µg You nger 10007 15M AY2020 20:00 Fatig ue Mod erate 22 1 23APR20 20 11:08 15M AY2020 20:00 Mya lgia Mil d 22 1 23APR20 20 11:08 15M AY2020 20:00 Mal aise Mil d 22 1 23APR20 20 11:08 16M AY2020 20:00 Heada che Mil d 23 2 23APR20 20 11:08 16M AY2020 20:00 Fatig ue Mil d 23 2 23APR20 20 11:08 16M AY2020 20:00 Mya lgia Mil d 23 2 23APR20 20 11:08 16M AY2020 20:00 Mal aise Mil d 23 2 23APR20 20 11:08 17M AY2020 20:00 Heada che Mil d 24 3 23APR20 20 11:08 17M AY2020 20:00 Mya lgia Mil d 24 3 23APR20 20 11:08 18M AY2020 20:00 Heada che Mil d 25 4 23APR20 20 11:08 18M AY2020 20:0 0 Mya lgia Mil d 25 4 23APR20 20 11:08 10008 28APR20 20 22:00 Fatig ue Mil d 0 28APR20 20 9:30 19M AY2020 22:00 Nause a Seve re 21 0 28APR20 20 9:30 19M AY2020 22:00 Heada che Mil d 21 0 28APR20 20 9:30 19M AY2020 22:00 Fatig ue Mod erate 21 0 28APR20 20 9:30 19M AY2020 22:00 Chill s Seve re 21 0 28APR20 20 9:30 19M AY2020 22:00 Los s of Appetite Seve re 21 0 28APR20 20 9:30 19M AY2020 22:00 Mal aise Seve re 21 0 28APR20 20 9:30 Progra m: Lsa f_sysR_1.sas (Page 15 of 92) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 71 FDA-CBER-2021-5683-0050066 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo GmbH. B ased on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.3-1: Lis ting of solicited systemic reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Syste mic reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boo st imm unization Date/t ime of prime imm unization 10 µg You nger 10008 19M AY2020 22:00 Feve r Mil d 21 0 28APR20 20 9:30 20M AY2020 22:00 Nause a Mil d 22 1 28APR20 20 9:30 20M AY2020 22:00 Fatig ue Mil d 22 1 28APR20 20 9:30 20M AY2020 22:00 Chill s Mil d 22 1 28APR20 20 9:30 20M AY2020 22:00 Los s of Appetite Mil d 22 1 28APR20 20 9:30 20M AY2020 22:00 Mal aise Mil d 22 1 28APR20 20 9:30 10009 28APR20 20 21:00 Fatig ue Mil d 0 28APR20 20 10:00 19M AY2020 22:00 Heada che Mil d 21 0 28APR20 20 10:00 19M AY2020 22:00 Fatig ue Mil d 21 0 28APR20 20 10:00 19M AY2020 22:00 Mya lgia Mil d 21 0 28APR20 20 10:00 20M AY2020 19:00 Heada che Mil d 22 1 28APR20 20 10:00 20M AY2020 19:00 Fatig ue Mil d 22 1 28APR20 20 10:00 20M AY2020 19:00 Mya lgia Mil d 22 1 28APR20 20 10: 00 20M AY2020 19:00 Chill s Mil d 22 1 28APR20 20 10:00 20M AY2020 19:00 Los s of Appetite Mil d 22 1 28APR20 20 10:00 10010 24APR20 20 18:15 Fatig ue Mil d 0 24APR20 20 12:15 25APR20 20 18:15 Nause a Seve re 1 24APR20 20 12:15 25APR20 20 18:15 Heada che Seve re 1 24APR20 20 12:15 Progra m: Lsa f_sysR_1.sas (Page 16 of 92) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 72 FDA-CBER-2021-5683-0050067 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.3-1: Lis ting of solicited systemic reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Syste mic reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 10 µg You nger 10010 25APR20 20 18:15 Fatig ue Seve re 1 24APR20 20 12:15 25APR20 20 18:15 Mya lgia Mod erate 1 24APR20 20 12: 15 25APR20 20 18:15 Arthral gia Mod erate 1 24APR20 20 12:15 25APR20 20 18:15 Chill s Seve re 1 24APR20 20 12:15 25APR20 20 18:15 Los s of Appetite Mil d 1 24APR20 20 12:15 25APR20 20 18:15 Mal aise Mod erate 1 24APR20 20 12:15 26APR20 20 18:15 Nause a Mod erate 2 24APR20 20 12:15 26APR20 20 18:15 Diarrhe a Mod erate 2 24APR20 20 12:15 26APR20 20 18:15 Heada che Seve re 2 24APR20 20 12:15 26APR20 20 18:15 Fatig ue Mod erate 2 24APR20 20 12:15 26APR20 20 18:15 Mya lgia Mod erate 2 24APR20 20 12:15 26APR20 20 18:15 Arthral gia Mod erate 2 24APR20 20 12:15 26APR20 20 18:15 Chill s Mil d 2 24APR20 20 12:15 26APR20 20 18:15 Los s of Appetite Mil d 2 24APR20 20 12:15 26APR20 20 18:15 Mal aise Mil d 2 24APR20 20 12:15 27APR20 20 18:15 Nause a Mod erate 3 24APR20 20 12:15 27APR20 20 18:15 Diarrhe a Mil d 3 24APR20 20 12:15 27APR20 20 18:15 Heada che Mod erate 3 24APR20 20 12:15 Progra m: Lsa f_sysR_1.sas (Page 17 of 92) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 73 FDA-CBER-2021-5683-0050068 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data rece ived on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.3-1: Lis ting of solicited systemic reacti ons - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Syste mic reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 10 µg You nger 10010 27APR20 20 18:15 Fatig ue Mod erate 3 24APR20 20 12:15 27APR20 20 18:15 Mya lgia Mod erate 3 24APR20 20 12:15 27APR20 20 18:15 Arthral gia Mil d 3 24APR20 20 12:15 27APR20 20 18:15 Los s of Appetite Mil d 3 24APR20 20 12:15 27APR20 20 18:15 Mal aise Mil d 3 24APR20 20 12:15 28APR20 20 18:30 Nause a Mil d 4 24APR20 20 12:15 28APR20 20 18:30 Heada che Mod erate 4 24APR20 20 12:15 28APR20 20 18:30 Fatig ue Mod erate 4 24APR20 20 12:15 28APR20 20 18:30 Mya lgia Mod erate 4 24APR20 20 12:15 28APR20 20 18:30 Arthral gia Mil d 4 24APR20 20 12:15 28APR20 20 18:30 Mal aise Mil d 4 24APR20 20 12:15 29APR20 20 18:30 Heada che Mod erate 5 24APR20 20 12:15 29APR20 20 18:30 Fatig ue Mod erate 5 24APR20 20 12:15 29APR20 20 18:30 Mya lgia Mod erate 5 24APR20 20 12:15 29APR20 20 18:30 Arthral gia Mil d 5 24APR20 20 12:15 29APR20 20 18:30 Mal aise Mil d 5 24APR20 20 12:15 30APR20 20 18:15 Heada che Mil d 6 24APR20 20 12:15 30APR20 20 18:15 Fatig ue Mod erate 6 24APR20 20 12:15 Progra m: Lsa f_sysR_1.sas (Page 18 of 92) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 74 FDA-CBER-2021-5683-0050069 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.3-1: Lis ting of solicited systemic reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Syste mic reaction Seve rity/ Inten sity Num be r of day s afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 10 µg You nger 10010 30APR20 20 18:15 Mya lgia Mil d 6 24APR20 20 12:15 30APR20 20 18:15 Mal aise Mil d 6 24APR20 20 12:15 01M AY2020 18:45 Nause a Mil d 7 24APR20 20 12:15 01M AY2020 18:45 Diarrhe a Mil d 7 24APR20 20 12:15 01M AY2020 18:45 Heada che Mod erate 7 24APR20 20 12:15 01M AY2020 18:45 Fatig ue Mod erate 7 24APR20 20 12:15 01M AY2020 18:45 Mya lgia Mod erate 7 24APR20 20 12:15 01M AY2020 18:45 Chill s Mil d 7 24APR20 20 12:15 01M AY2020 18:45 Los s of Appetite Mil d 7 24APR20 20 12:15 01M AY2020 18:45 Mal aise Mil d 7 24APR20 20 12:15 02M AY2020 19:00 Heada che Mil d 8 24APR20 20 12:15 02M AY2020 19:00 Fatig ue Mod erate 8 24APR20 20 12:15 02M AY2020 19:00 Mya lgia Mod erate 8 24APR20 20 12:15 02M AY2020 19:00 Mal aise Mil d 8 24APR20 20 12:15 10017 28APR20 20 22:00 Heada che Mil d 0 28APR20 20 10:30 19M AY2020 22:00 Heada che Mil d 21 0 28APR20 20 10:30 19M AY2020 22:00 Feve r Mod erate 21 0 28APR20 20 10:30 20M AY2020 21:47 Heada che Mil d 22 1 28APR20 20 10:30 Progra m: Lsa f_sysR_1.sas (Page 19 of 92) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 75 FDA-CBER-2021-5683-0050070 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.3-1: Lis ting of solicited systemic reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Syste mic reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 10 µg You nger 10017 20M AY2020 21:47 Mya lgia Seve re 22 1 28APR20 20 10:30 21M AY2020 21:39 Mya lgia Mil d 23 2 28APR20 20 10:30 10019 20M AY2020 18:10 Heada che Seve re 22 1 28APR20 20 11:00 20M AY2020 18:10 Arthral gia Mil d 22 1 28APR20 20 11:00 20M AY2020 18:10 Los s of Appetite Mil d 22 1 28APR20 20 11:00 20M AY2020 18:10 Mal aise Mil d 22 1 28APR20 20 11:00 20M AY2020 18:10 Feve r Mil d 22 1 28APR20 20 11:00 21M AY2020 20:00 Heada che Mil d 23 2 28APR20 20 11:00 24M AY2020 19:20 Heada che Mil d 26 5 28APR20 20 11:00 25M AY2020 19:55 Heada che Mil d 27 6 28APR20 20 11:00 26M AY2020 18:4 5 Heada che Mil d 28 7 28APR20 20 11:00 27M AY2020 7:10 Heada che Mil d 29 8 28APR20 20 11:00 20 µg You nger 10151 16J UL2020 18:00 Fatig ue Mil d 0 16J UL2020 8:00 17J UL2020 20:00 Nause a Mil d 1 16J UL2020 8:00 17J UL2020 20:00 Fatig ue Mil d 1 16J UL2020 8:00 18J UL2020 20:00 Fatig ue Mil d 2 16J UL2020 8:00 06AUG 2020 22:00 Fatig ue Mil d 21 0 16J UL2020 8:00 07AUG 2020 22:00 Heada che Mil d 22 1 16J UL2020 8:00 Progra m: Lsa f_sysR_1.sas (Page 20 of 92) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 76 FDA-CBER-2021-5683-0050071 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data rece ived on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3-1.3-1: Lis ting of solicited systemic reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Syste mic reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of p rime imm unization 20 µg You nger 10151 07AUG 2020 22:00 Fatig ue Mod erate 22 1 16J UL2020 8:00 08AUG 2020 22:00 Heada che Mil d 23 2 16J UL2020 8:00 08AUG 2020 22:00 Fatig ue Mil d 23 2 16J UL2020 8:00 09AUG 2020 22:00 Fatig ue Mil d 24 3 16J UL2020 8:00 10AUG 2020 22:00 Fatig ue Mil d 25 4 16J UL2020 8:00 11AUG 2020 22:00 Fatig ue Mil d 26 5 16J UL2020 8:00 10171 16J UL2020 17:40 Fatig ue Mil d 0 16J UL2020 8:15 16J UL2020 17:40 Chill s Mil d 0 16J UL2020 8:15 16J UL2020 17:40 Mal aise Mil d 0 16J UL2020 8:15 17J UL2020 20:28 Fatig ue Mil d 1 16J UL2020 8:15 17J UL2020 20:28 Chill s Mil d 1 16J UL2020 8:15 17J UL2020 20:28 Mal aise Mil d 1 16J UL2020 8:15 18J UL2020 20:10 Fatig ue Mil d 2 16J UL2020 8:15 06AUG 2020 20:22 Heada che Mod erate 21 0 16J UL2020 8:15 06AUG 2020 20:22 Fatig ue Mil d 21 0 16J UL2020 8:15 06AUG 2020 20:22 Mya lgia Mil d 21 0 16J UL2020 8:15 06AUG 2020 20:22 Chill s Seve re 21 0 16J UL2020 8:15 06AUG 2020 20:22 Los s of Appetite Mod erate 21 0 16J UL2020 8:15 Progra m: Lsa f_sysR_1.sas (Page 21 of 92) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 77 FDA-CBER-2021-5683-0050072 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.3-1: Lis ting of solicited systemic reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Syste mic reaction Seve rity/ Inten sity Num be r of day s afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 20 µg You nger 10171 06AUG 2020 20:22 Mal aise Mod erate 21 0 16J UL2020 8:15 06AUG 2020 20:22 Feve r Seve re 21 0 16J UL2020 8:15 07AUG 2020 20:10 Heada che Mod erate 22 1 16J UL2020 8:15 07AUG 2020 20:10 Fatig ue Mil d 22 1 16J UL2020 8:15 07AUG 2020 20:10 Mya lgia Mil d 22 1 16J UL2020 8:15 07AUG 2020 20:10 Chill s Mod erate 22 1 16J UL2020 8:15 07AUG 2020 20:10 Los s of Appetite Mod erate 22 1 16J UL2020 8:15 07AUG 2020 20:10 Mal aise Mod erate 22 1 16J UL2020 8:15 07AUG 2020 20:10 Feve r Mod erate 22 1 16J UL2020 8:15 08AUG 2020 20:06 Heada che Mod erate 23 2 16J UL2020 8:15 08AUG 2020 20:06 Fatig ue Mil d 23 2 16J UL2020 8:15 08AUG 2020 20:0 6 Mya lgia Mil d 23 2 16J UL2020 8:15 08AUG 2020 20:06 Chill s Mod erate 23 2 16J UL2020 8:15 08AUG 2020 20:06 Los s of Appetite Mod erate 23 2 16J UL2020 8:15 08AUG 2020 20:06 Mal aise Mod erate 23 2 16J UL2020 8:15 09AUG 2020 19:40 Heada che Mil d 24 3 16J UL2020 8:15 09AUG 2020 19:40 Fatig ue Mil d 24 3 16J UL2020 8:15 09AUG 2020 19:40 Chill s Mil d 24 3 16J UL2020 8:15 Progra m: Lsa f_sysR_1.sas (Page 22 of 92) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 78 FDA-CBER-2021-5683-0050073 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data rece ived on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.3-1: Lis ting of solicited systemic reacti ons - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Syste mic reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 20 µg You nger 10171 09AUG 2020 19:40 Los s of Appetite Mil d 24 3 16J UL2020 8:15 09AUG 2020 19:40 Mal aise Mil d 24 3 16J UL2020 8:15 10AUG 2020 20:13 Heada che Mil d 25 4 16J UL2020 8:15 10AUG 2020 20:13 Fatig ue Mil d 25 4 16J UL2020 8:15 10AUG 2020 20:13 Chill s Mil d 25 4 16J UL2020 8:15 10AUG 2020 20:13 Los s of Appetite Mil d 25 4 16J UL2020 8:15 10AUG 2020 20:13 Mal aise Mil d 25 4 16J UL2020 8:15 10172 16J UL2020 20:16 Fatig ue Mil d 0 16J UL2020 8:30 17J UL2020 20:23 Fatig ue Mil d 1 16J UL2020 8:30 18J UL2020 20:41 Fatig ue Mil d 2 16J UL2020 8:30 19J UL2020 20:16 Fatig ue Mil d 3 16J UL2020 8:30 20J UL2020 20:20 Fatig ue Mil d 4 16J UL2020 8:30 21J UL2020 20:15 Fatig ue Mil d 5 16J UL2020 8:30 06AUG 2020 19:50 Heada che Mod erate 21 0 16J UL2020 8:30 07AUG 2020 22:0 0 Heada che Mod erate 22 1 16J UL2020 8:30 10173 17J UL2020 16:00 Heada che Seve re 1 16J UL2020 8:45 17J UL2020 16:00 Fatig ue Mod erate 1 16J UL2020 8:45 17J UL2020 16:00 Mya lgia Mil d 1 16J UL2020 8:45 Progra m: Lsa f_sysR_1.sas (Page 23 of 92) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 79 FDA-CBER-2021-5683-0050074 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.3-1: Lis ting of solicited systemic reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Syste mic reaction Seve rity/ Inten sity Num be r of day s afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 20 µg You nger 10173 17J UL2020 16:00 Arthral gia Mil d 1 16J UL2020 8:45 06AUG 2020 22:00 Heada che Mod erate 21 0 16J UL2020 8:45 07AUG 2020 4:38 Heada che Seve re 22 1 16J UL2020 8:45 07AUG 2020 4:38 Mya lgia Mil d 22 1 16J UL2020 8:45 07AUG 2020 4:38 Chill s Seve re 22 1 16J UL2020 8:45 07AUG 2020 4:38 Los s of Appetite Mod erate 22 1 16J UL2020 8:45 07AUG 2020 4:38 Mal aise Mod erate 22 1 16J UL2020 8:45 07AUG 2020 4:38 Feve r Seve re 22 1 16J UL2020 8:45 08AUG 2020 11:00 Heada che Mod erate 23 2 16J UL2020 8:45 08AUG 2020 11:00 Fatig ue Mil d 23 2 16J UL2020 8:45 08AUG 2020 11:00 Los s of Appetite Mil d 23 2 16J UL2020 8:45 08AUG 2020 11:0 0 Mal aise Mil d 23 2 16J UL2020 8:45 09AUG 2020 13:00 Heada che Mil d 24 3 16J UL2020 8:45 10175 16J UL2020 18:00 Fatig ue Mil d 0 16J UL2020 9:00 16J UL2020 18:00 Mya lgia Mil d 0 16J UL2020 9:00 17J UL2020 18:04 Fatig ue Mil d 1 16J UL2020 9:00 07AUG 2020 21:08 Mal aise Mil d 22 1 16J UL2020 9:00 08AUG 2020 21:01 Mal aise Mil d 23 2 16J UL2020 9:00 Progra m: Lsa f_sysR_1.sas (Page 24 of 92) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 80 FDA-CBER-2021-5683-0050075 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.3-1: Lis ting of solicited systemic reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Syste mic reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 20 µg You nger 10176 16J UL2020 21:00 Heada che Mil d 0 16J UL2020 9:15 16J UL2020 21:00 Mya lgia Mil d 0 16J UL2020 9:15 16J UL2020 21:00 Mal aise Mil d 0 16J UL2020 9:15 17J UL2020 20:30 Heada che Mil d 1 16J UL2020 9:15 17J UL2020 20:30 Mya lgia Mil d 1 16J UL2020 9:15 17J UL2020 20:30 Arthral gia Mil d 1 16J UL2020 9:15 22J UL2020 21:00 Fatig ue Mil d 6 16J UL2020 9:15 06AUG 2020 22:00 Heada che Mod erate 21 0 16J UL2020 9:15 06AUG 2020 22:00 Mya lgia Mil d 21 0 16J UL2020 9:15 06AUG 2020 22:00 Chill s Mil d 21 0 16J UL2020 9:15 06AUG 2020 22:00 Feve r Mod erate 21 0 16J UL2020 9:15 07AUG 2020 17:00 Heada che Mil d 22 1 16J UL2020 9:15 07AUG 2020 17:00 Mya lgia Mod erate 22 1 16J UL2020 9:15 08AUG 2020 21:00 Mya lgia Mil d 23 2 16J UL2020 9:15 10178 16J UL2020 20:15 Nause a Mil d 0 16J UL2020 9:30 16J UL2020 20:15 Heada che Mod erate 0 16J UL2020 9:30 16J UL2020 20:15 Fatig ue Mil d 0 16J UL2020 9:30 16J UL2020 20:15 Chill s Mil d 0 16J UL2020 9:30 Progra m: Lsa f_sysR_1.sas (Page 25 of 92) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 81 FDA-CBER-2021-5683-0050076 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data rece ived on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3-1.3-1: Lis ting of solicited systemic reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Syste mic reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of p rime imm unization 20 µg You nger 10178 16J UL2020 20:15 Los s of Appetite Mil d 0 16J UL2020 9:30 16J UL2020 20:15 Mal aise Mil d 0 16J UL2020 9:30 17J UL2020 20:00 Heada che Mil d 1 16J UL2020 9:30 17J UL2020 20:00 Fatig ue Mil d 1 16J UL2020 9:30 17J UL2020 20:00 Mal aise Mil d 1 16J UL2020 9:30 21J UL2020 19:50 Heada che Mil d 5 16J UL2020 9:30 21J UL2020 19:50 Fatig ue Mil d 5 16J UL2020 9:30 06AUG 2020 19:40 Heada che Mil d 21 0 16J UL2020 9:30 07AUG 2020 19:00 Heada che Mil d 22 1 16J UL2020 9:30 11AUG 2020 19:45 Heada che Mil d 26 5 16J UL2020 9:30 10179 16J UL2020 21:00 Heada che Mil d 0 16J UL2020 9:45 16J UL2020 21:00 Fatig ue Mil d 0 16J UL2020 9:45 16J UL2020 21:00 Mya lgia Mil d 0 16J UL2020 9:45 06AUG 2020 21:00 Nause a Mil d 21 0 16J UL2020 9:45 06AUG 2020 21:00 Heada che Seve re 21 0 16J UL2020 9:45 06AUG 2020 21:00 Fatig ue Mil d 21 0 16J UL2020 9:45 07AUG 2020 21:00 Heada che Mod erate 22 1 16J UL2020 9:45 08AUG 2020 21:00 Heada che Mod erate 23 2 16J UL2020 9:45 Progra m: Lsa f_sysR_1.sas (Page 26 of 92) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 82 FDA-CBER-2021-5683-0050077 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV 2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.3-1: Lis ting of solicited systemic reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Syste mic reaction Seve rity/ Inten sity Num be r of day s afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 20 µg You nger 10181 16J UL2020 20:15 Fatig ue Mil d 0 16J UL2020 10:00 16J UL2020 20:15 Mal aise Mil d 0 16J UL2020 10:00 10183 16J UL2020 21:00 Nause a Mod erate 0 16J UL2020 10:30 16J UL2020 21:00 Heada che Seve re 0 16J UL2020 10:30 16J UL2020 21:00 Mya lgia Seve re 0 16J UL2020 10:30 16J UL2020 21:00 Chill s Mod erate 0 16J UL2020 10:30 16J UL2020 21:00 Los s of Appetite Mil d 0 16J UL2020 10:30 16J UL2020 21:00 Mal aise Mod erate 0 16J UL2020 10:30 17J UL2020 21:10 Heada che Seve re 1 16J UL2020 10:30 17J UL2020 21:10 Fatig ue Mod erate 1 16J UL2020 10:30 17J UL2020 21:10 Mya lgia Seve re 1 16J UL2020 10:30 17J UL2020 21:10 Chill s Mil d 1 16J UL2020 10:30 17J UL2020 21:10 Los s of Appetite Mil d 1 16J UL2020 10:30 17J UL2020 21:10 Mal aise Mil d 1 16J UL2020 10:30 18J UL2020 21:50 Nause a Mil d 2 16J UL2020 10:30 18J UL2020 21:50 Heada che Mod erate 2 16J UL2020 10:30 18J UL2020 21:50 Fatig ue Mil d 2 16J UL2020 10:30 18J UL2020 21:50 Mya lgia Mod erate 2 16J UL2020 10:30 Progra m: Lsa f_sysR_1.sas (Page 27 of 92) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 83 FDA-CBER-2021-5683-0050078 Bio NTech RNA Phar maceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.3-1: Lis ting of solicited systemic reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Syste mic reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 20 µg You nger 10183 18J UL2020 21:50 Los s of Appetite Mil d 2 16J UL2020 10:30 18J UL2020 21:50 Mal aise Mil d 2 16J UL2020 10:30 19J UL2020 21:36 Heada che Mil d 3 16J UL2020 10:30 19J UL2020 21:36 Mya lgia Mil d 3 16J UL2020 10:30 06AUG 2020 18:30 Nause a Mil d 21 0 16J UL2020 10:30 06AUG 2020 18:30 Heada che Mil d 21 0 16J UL2020 10:30 06AUG 2020 18:30 Fatig ue Mod erate 21 0 16J UL2020 10:30 06AUG 2020 18:30 Mya lgia Mod erate 21 0 16J UL2020 10:30 06AUG 2020 18:30 Chill s Mil d 21 0 16J UL2020 10:30 06AUG 2020 18:30 Los s of Appetite Mil d 21 0 16J UL2020 10:30 06AUG 2020 18:30 Mal aise Mil d 21 0 16J UL2020 10:30 07AUG 2020 20:10 Heada che Mod erate 22 1 16J UL2020 10:30 07AUG 2020 20:10 Fatig ue Mil d 22 1 16J UL2020 10:30 07AUG 2020 20:10 Mya lgia Seve re 22 1 16J UL2020 10:30 07AUG 2020 20:10 Los s of Appetite Mil d 22 1 16J UL2020 10:30 08AUG 2020 20:30 Heada che Mil d 23 2 16J UL2020 10:30 08AUG 2020 20:30 Mya lgia Mod erate 23 2 16J UL2020 10:30 09AUG 2020 21:00 Mya lgia Mil d 24 3 16J UL2020 10:30 Progra m: Lsa f_sysR_1.sas (Page 28 of 92) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 84 FDA-CBER-2021-5683-0050079 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on cl ean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.3-1: Lis ting of solicited systemic reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Syste mic reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boo st imm unization Date/t ime of prime imm unization 20 µg You nger 10197 16J UL2020 20:30 Heada che Mod erate 0 16J UL2020 10:45 16J UL2020 20:30 Fatig ue Mod erate 0 16J UL2020 10:45 16J UL2020 20:30 Mal aise Mil d 0 16J UL2020 10:45 17J UL2020 2:30 Nause a Mil d 1 16J UL2020 10:45 17J UL2020 2:30 Heada che Mil d 1 16J UL2020 10:45 17J UL2020 2:30 Fatig ue Mod erate 1 16J UL2020 10:45 17J UL2020 2:30 Mya lgia Mil d 1 16J UL2020 10:45 17J UL2020 2:30 Chill s Mod erate 1 16J UL2020 10:45 17J UL2020 2:30 Mal aise Mod erate 1 16J UL2020 10:45 17J UL2020 20:30 Nause a Mil d 1 16J UL2020 10:45 17J UL2020 20:30 Heada che Mod erate 1 16J UL2020 10:45 17J UL2020 20:30 Fatig ue Mod erate 1 16J UL2020 10:45 17J UL2020 20:30 Mya lgia Mil d 1 16J UL2020 10:45 17J UL2020 20:30 Arthral gia Mil d 1 16J UL2020 10:45 17J UL2020 20:30 Chill s Mil d 1 16J UL2020 10:45 17J UL2020 20:30 Los s of Appetite Mod erate 1 16J UL2020 10:45 17J UL2020 20:30 Mal aise Mod erate 1 16J UL2020 10:45 18J UL2020 18:30 Nause a Mil d 2 16J UL2020 10:45 Progra m: Lsa f_sysR_1.sas (Page 29 of 92) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 85 FDA-CBER-2021-5683-0050080 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.3-1: Lis ting of solicited systemic reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Syste mic reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 20 µg You nger 10197 18J UL2020 18:30 Heada che Mil d 2 16J UL2020 10:45 18J UL2020 18:30 Fatig ue Mil d 2 16J UL2020 10:45 18J UL2020 18: 30 Mya lgia Mil d 2 16J UL2020 10:45 18J UL2020 18:30 Arthral gia Mil d 2 16J UL2020 10:45 18J UL2020 18:30 Los s of Appetite Mil d 2 16J UL2020 10:45 18J UL2020 18:30 Mal aise Mil d 2 16J UL2020 10:45 19J UL2020 18:20 Arthral gia Mil d 3 16J UL2020 10:45 20J UL2020 18:00 Mya lgia Mil d 4 16J UL2020 10:45 21J UL2020 16:00 Arthral gia Mil d 5 16J UL2020 10:45 06AUG 2020 22:00 Nause a Mod erate 21 0 16J UL2020 10:45 06AUG 2020 22:00 Vomi ting Mod erate 21 0 16J UL2020 10:45 06AUG 2020 22:00 Diarrhe a Seve re 21 0 16J UL2020 10:45 06AUG 2020 22:00 Heada che Mil d 21 0 16J UL2020 10:45 06AUG 2020 22:00 Fatig ue Mod erate 21 0 16J UL2020 10:45 06AUG 2020 22:00 Mya lgia Mil d 21 0 16J UL2020 10:45 06AUG 2020 22:00 Arthral gia Mil d 21 0 16J UL2020 10:45 06AUG 2020 22:0 0 Chill s Seve re 21 0 16J UL2020 10:45 06AUG 2020 22:00 Los s of Appetite Seve re 21 0 16J UL2020 10:45 Progra m: Lsa f_sysR_1.sas (Page 30 of 92) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 86 FDA-CBER-2021-5683-0050081 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data rece ived on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.3-1: Lis ting of solicited systemic reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Syste mic reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 20 µg You nger 10197 06AUG 2020 22:00 Mal aise Seve re 21 0 16J UL2020 10:45 06AUG 2020 22:00 Feve r Mod erate 21 0 16J UL2020 10:45 07AUG 2020 18:30 Nause a Mod erate 22 1 16J UL2020 10:45 07AUG 2020 18:30 Vomi ting Mil d 22 1 16J UL2020 10:45 07AUG 2020 18:30 Diarrhe a Seve re 22 1 16J UL2020 10:45 07AUG 2020 18:30 Heada che Seve re 22 1 16J UL2020 10:45 07AUG 2020 18:30 Fatig ue Seve re 22 1 16J UL2020 10:45 07AUG 2020 18:30 Mya lgia Mod erate 22 1 16J UL2020 10:45 07AUG 2020 18:30 Arthral gia Mil d 22 1 16J UL2020 10:45 07AUG 2020 18:30 Chill s Seve re 22 1 16J UL2020 10:45 07AUG 2020 18:30 Los s of Appetite Seve re 22 1 16J UL2020 10:45 07AUG 2020 18:30 Mal aise Seve re 22 1 16J UL2020 10:45 07AUG 2020 18:30 Feve r Mod erate 22 1 16J UL2020 10:45 08AUG 2020 18:30 Nause a Mod erate 23 2 16J UL2020 10:45 08AUG 2020 18:30 Vomi ting Mil d 23 2 16J UL2020 10:45 08AUG 2020 18:30 Diarrhe a Seve re 23 2 16J UL2020 10:45 08AUG 2020 18:30 Heada che Mod erate 23 2 16J UL2020 10:45 08AUG 2020 18:30 Fatig ue Mod erate 23 2 16J UL2020 10:45 Progra m: Lsa f_sysR_1.sas (Page 31 of 92) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 87 FDA-CBER-2021-5683-0050082 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV 2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.3-1: Lis ting of solicited systemic reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Syste mic reaction Seve rity/ Inten sity Num be r of day s afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 20 µg You nger 10197 08AUG 2020 18:30 Mya lgia Mil d 23 2 16J UL2020 10:45 08AUG 2020 18:30 Arthral gia Mil d 23 2 16J UL2020 10:45 08AUG 2020 18:30 Chill s Mil d 23 2 16J UL2020 10:45 08AUG 2020 18:30 Los s of Appetite Mod erate 23 2 16J UL2020 10:45 08AUG 2020 18:30 Mal aise Seve re 23 2 16J UL2020 10:45 09AUG 2020 18:00 Nause a Mil d 24 3 16J UL2020 10:45 09AUG 2020 18:00 Diarrhe a Mil d 24 3 16J UL2020 10:45 09AUG 2020 18:00 Heada che Mil d 24 3 16J UL2020 10:45 09AUG 2020 18:00 Fatig ue Mil d 24 3 16J UL2020 10:45 09AUG 2020 18:00 Arthral gia Mil d 24 3 16J UL2020 10:45 09AUG 2020 18:00 Mal aise Mil d 24 3 16J UL2020 10:45 10AUG 2020 17:15 Fatig ue Mil d 25 4 16J UL2020 10:45 10AUG 2020 17:15 Mya lgia Mil d 25 4 16J UL2020 10:45 10AUG 2020 17:15 Arthral gia Mil d 25 4 16J UL2020 10:45 11AUG 2020 18:00 Mya lgia Mil d 26 5 16J UL2020 10:45 12AUG 2020 16:00 Mya lgia Mil d 27 6 16J UL2020 10:45 30 µg You nger 10016 29APR20 20 Nause a Mod erate 0 29APR20 20 9:03 29APR20 20 Heada che Mod erate 0 29APR20 20 9:03 Progra m: Lsa f_sysR_1.sas (Page 32 of 92) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 88 FDA-CBER-2021-5683-0050083 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Snap shot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.3-1: Lis ting of solicited systemic reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Syste mic reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 30 µg You nger 10016 29APR20 20 Fatig ue Mil d 0 29APR20 20 9:03 29APR20 20 Mya lgia Mil d 0 29APR20 20 9:03 29APR20 20 Arthral gia Mod erate 0 29APR20 20 9:03 29APR20 20 Mal aise Mil d 0 29APR20 20 9:03 30APR20 20 20:50 Heada che Mil d 1 29APR20 20 9:03 30APR20 20 20:50 Fatig ue Mil d 1 29APR20 20 9:03 30APR20 20 20:50 Mya lgia Mod erate 1 29APR20 20 9:03 30APR20 20 20:50 Arthral gia Mod erate 1 29APR20 20 9:03 30APR20 20 20:50 Mal aise Mil d 1 29APR20 20 9:03 01M AY2020 21:00 Heada che Mil d 2 29APR20 20 9:03 02M AY2020 20:30 Heada che Mil d 3 29APR20 20 9:03 20M AY2020 20:13 Heada che Seve re 21 0 29APR20 20 9:03 20M AY2020 20:13 Fatig ue Mod erate 21 0 29APR20 20 9:03 20M AY2020 20:13 Mya lgia Mod erate 21 0 29APR20 20 9:03 20M AY2020 20:13 Arthral gia Seve re 21 0 29APR20 20 9:03 20M AY2020 20:1 3 Chill s Seve re 21 0 29APR20 20 9:03 20M AY2020 20:13 Mal aise Seve re 21 0 29APR20 20 9:03 21M AY2020 21:30 Heada che Seve re 22 1 29APR20 20 9:03 Progra m: Lsa f_sysR_1.sas (Page 33 of 92) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 89 FDA-CBER-2021-5683-0050084 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data rece ived on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.3-1: Lis ting of soli cited systemic reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Syste mic reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 30 µg You nger 10016 21M AY2020 21:30 Mya lgia Mil d 22 1 29APR20 20 9:03 21M AY2020 21:30 Arthral gia Mil d 22 1 29APR20 20 9:03 21M AY2020 21:30 Chill s Mod erate 22 1 29APR20 20 9:03 21M AY2020 21:30 Mal aise Mod erate 22 1 29APR20 20 9:03 10020 20M AY2020 19:0 1 Arthral gia Mil d 21 0 29APR20 20 10:06 21M AY2020 19:06 Arthral gia Mil d 22 1 29APR20 20 10:06 10021 05M AY2020 20:01 Heada che Mil d 0 05M AY2020 8:30 05M AY2020 20:01 Fatig ue Mil d 0 05M AY2020 8:30 06M AY2020 20:01 Heada che Mil d 1 05M AY2020 8:30 06M AY2020 20:01 Chill s Mil d 1 05M AY2020 8:30 06M AY2020 20:01 Mal aise Mil d 1 05M AY2020 8:30 10M AY2020 20:00 Mal aise Mil d 5 05M AY2020 8:30 26M AY2020 20:00 Heada che Seve re 21 0 05M AY2020 8:30 26M AY2020 20:00 Fatig ue Mil d 21 0 05M AY2020 8:30 26M AY2020 20:00 Mya lgia Seve re 21 0 05M AY2020 8:30 26M AY2020 20:00 Chill s Mil d 21 0 05M AY2020 8:30 26M AY2020 20:00 Mal aise Seve re 21 0 05M AY2020 8:30 27M AY2020 20:00 Heada che Mod erate 22 1 05M AY2020 8:30 Progra m: Lsa f_sysR_1.sas (Page 34 of 92) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 90 FDA-CBER-2021-5683-0050085 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.3-1: Lis ting of solicited systemic reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Syste mic reaction Seve rity/ Inten sity Num be r of day s afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 30 µg You nger 10021 27M AY2020 20:00 Mya lgia Mod erate 22 1 05M AY2020 8:30 27M AY2020 20:00 Chill s Mil d 22 1 05M AY2020 8:30 27M AY2020 20:00 Mal aise Mod erate 22 1 05M AY2020 8:30 28M AY2020 20:00 Heada che Mod erate 23 2 05M AY2020 8:30 28M AY2020 20:00 Mya lgia Mod erate 23 2 05M AY2020 8:30 28M AY2020 20:00 Mal aise Mod erate 23 2 05M AY2020 8:30 29M AY2020 20:00 Heada che Mil d 24 3 05M AY2020 8:30 29M AY2020 20:00 Mya lgia Mil d 24 3 05M AY2020 8:30 29M AY2020 20:00 Mal aise Mil d 24 3 05M AY2020 8:30 10028 07M AY2020 21:27 Heada che Mil d 0 07M AY2020 8:30 08M AY2020 21:40 Heada che Mil d 1 07M AY2020 8:30 28M AY2020 22:00 Heada che Mod erate 21 0 07M AY2020 8:30 28M AY2020 22:00 Fatig ue Mod erate 21 0 07M AY2020 8:30 28M AY2020 22:00 Mya lgia Mod erate 21 0 07M AY2020 8:30 28M AY2020 22:00 Arthral gia Mod erate 21 0 07M AY2020 8:30 28M AY2020 22:00 Chill s Mod erate 21 0 07M AY2020 8:30 28M AY2020 22:00 Mal aise Mod erate 21 0 07M AY2020 8:30 29M AY2020 22:00 Nause a Mod erate 22 1 07M AY2020 8:30 Progra m: Lsa f_sysR_1.sas (Page 35 of 92) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 91 FDA-CBER-2021-5683-0050086 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data rece ived on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.3-1: Lis ting of solicited systemic reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Syste mic reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 30 µg You nger 10028 29M AY2020 22:0 0 Heada che Mod erate 22 1 07M AY2020 8:30 29M AY2020 22:00 Fatig ue Mod erate 22 1 07M AY2020 8:30 29M AY2020 22:00 Mya lgia Mod erate 22 1 07M AY2020 8:30 29M AY2020 22:00 Arthral gia Mod erate 22 1 07M AY2020 8:30 29M AY2020 22:00 Chill s Mod erate 22 1 07M AY2020 8:30 29M AY2020 22:00 Los s of Appetite Mod erate 22 1 07M AY2020 8:30 29M AY2020 22:00 Mal aise Mod erate 22 1 07M AY2020 8:30 10031 07M AY2020 22:00 Heada che Mod erate 0 07M AY2020 9:00 07M AY2020 22:00 Fatig ue Mod erate 0 07M AY2020 9:00 07M AY2020 22:00 Mya lgia Seve re 0 07M AY2020 9:00 07M AY2020 22:00 Arthral gia Seve re 0 07M AY2020 9:00 07M AY2020 22:00 Chill s Mod erate 0 07M AY2020 9:00 07M AY2020 22:00 Los s of Appetite Mil d 0 07M AY2020 9:00 07M AY2020 22:00 Mal aise Seve re 0 07M AY2020 9:00 07M AY2020 22:00 Feve r Mod erate 0 07M AY2020 9:00 08M AY2020 21:00 Fatig ue Mil d 1 07M AY2020 9:00 08M AY2020 21:00 Mya lgia Mod erate 1 07M AY2020 9:00 08M AY2020 21:00 Arthral gia Mil d 1 07M AY2020 9:00 Progra m: Lsa f_sysR_1.sas (Page 36 of 92) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 92 FDA-CBER-2021-5683-0050087 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV 2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.3-1: Lis ting of solicited systemic reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Syste mic reaction Seve rity/ Inten sity Num be r of day s afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 30 µg You nger 10031 08M AY2020 21:00 Mal aise Mil d 1 07M AY2020 9:00 09M AY2020 22:00 Fatig ue Mil d 2 07M AY2020 9:00 28M AY2020 22:00 Heada che Seve re 21 0 07M AY2020 9:00 28M AY2020 22:00 Fatig ue Mil d 21 0 07M AY2020 9:00 28M AY2020 22:00 Mya lgia Seve re 21 0 07M AY2020 9:00 28M AY2020 22:00 Arthral gia Seve re 21 0 07M AY2020 9:00 28M AY2020 22:00 Chill s Seve re 21 0 07M AY2020 9:00 28M AY2020 22:0 0 Mal aise Seve re 21 0 07M AY2020 9:00 28M AY2020 22:00 Feve r Mil d 21 0 07M AY2020 9:00 29M AY2020 22:00 Heada che Seve re 22 1 07M AY2020 9:00 29M AY2020 22:00 Fatig ue Mod erate 22 1 07M AY2020 9:00 29M AY2020 22:00 Mya lgia Mod erate 22 1 07M AY2020 9:00 29M AY2020 22:00 Arthral gia Mod erate 22 1 07M AY2020 9:00 29M AY2020 22:00 Chill s Mod erate 22 1 07M AY2020 9:00 29M AY2020 22:00 Los s of Appetite Mod erate 22 1 07M AY2020 9:00 29M AY2020 22:00 Mal aise Seve re 22 1 07M AY2020 9:00 30M AY2020 22:0 0 Heada che Mil d 23 2 07M AY2020 9:00 30M AY2020 22:00 Mya lgia Mil d 23 2 07M AY2020 9:00 Progra m: Lsa f_sysR_1.sas (Page 37 of 92) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 93 FDA-CBER-2021-5683-0050088 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.3-1: Lis ting of solicited systemic reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Syste mic reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 30 µg You nger 10031 30M AY2020 22:00 Arthral gia Mil d 23 2 07M AY2020 9:00 30M AY2020 22:00 Chill s Mil d 23 2 07M AY2020 9:00 30M AY2020 22:00 Mal aise Mil d 23 2 07M AY2020 9:00 31M AY2020 22:00 Mya lgia Mil d 24 3 07M AY2020 9:00 31M AY2020 22:00 Mal aise Mil d 24 3 07M AY2020 9:00 10032 05M AY2020 19:00 Heada che Mil d 0 05M AY2020 9:00 05M AY2020 19:00 Fatig ue Mil d 0 05M AY2020 9:00 06M AY2020 18:34 Los s of Appetite Mil d 1 05M AY2020 9:00 06M AY2020 18:34 Mal aise Mil d 1 05M AY2020 9:00 26M AY2020 19:20 Heada che Mil d 21 0 05M AY2020 9:00 27M AY2020 18:35 Heada che Mil d 22 1 05M AY2020 9:00 27M AY2020 18:35 Fatig ue Mod erate 22 1 05M AY2020 9:00 27M AY2020 18:35 Mya lgia Mod erate 22 1 05M AY2020 9:00 27M AY2020 18:35 Arthral gia Mod erate 22 1 05M AY2020 9:00 27M AY2020 18:35 Los s of App etite Mil d 22 1 05M AY2020 9:00 27M AY2020 18:35 Mal aise Mod erate 22 1 05M AY2020 9:00 27M AY2020 18:35 Feve r Mil d 22 1 05M AY2020 9:00 10034 05M AY2020 22:05 Heada che Mod erate 0 05M AY2020 9:30 Progra m: Lsa f_sysR_1.sas (Page 38 of 92) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 94 FDA-CBER-2021-5683-0050089 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.3-1: Lis ting of solicited systemic reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Syste mic reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boo st imm unization Date/t ime of prime imm unization 30 µg You nger 10034 05M AY2020 22:05 Fatig ue Mod erate 0 05M AY2020 9:30 05M AY2020 22:05 Mya lgia Mod erate 0 05M AY2020 9:30 05M AY2020 22:05 Chill s Seve re 0 05M AY2020 9:30 05M AY2020 22:05 Mal aise Mil d 0 05M AY2020 9:30 06M AY2020 20:10 Heada che Mil d 1 05M AY2020 9:30 06M AY2020 20:10 Fatig ue Mod erate 1 05M AY2020 9:30 06M AY2020 20:10 Los s of Appetite Mil d 1 05M AY2020 9:30 06M AY2020 20:10 Mal aise Mil d 1 05M AY2020 9:30 08M AY2020 12:15 Fatig ue Mil d 3 05M AY2020 9:30 26M AY2020 23:00 Nause a Mil d 21 0 05M AY2020 9:30 26M AY2020 23:00 Heada che Seve re 21 0 05M AY2020 9:30 26M AY2020 23:00 Fatig ue Seve re 21 0 05M AY2020 9:30 26M AY2020 23:00 Mya lgia Mod erate 21 0 05M AY2020 9:30 26M AY2020 23:00 Arthral gia Mil d 21 0 05M AY2020 9:30 26M AY2020 23:00 Chill s Seve re 21 0 05M AY2020 9:30 26M AY2020 23:00 Mal aise Seve re 21 0 05M AY2020 9:30 26M AY2020 23:00 Feve r Mil d 21 0 05M AY2020 9:30 27M AY2020 21:00 Heada che Mil d 22 1 05M AY2020 9:30 Progra m: Lsa f_sysR_1.sas (Page 39 of 92) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 95 FDA-CBER-2021-5683-0050090 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.3-1: Lis ting of solicited systemic reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Syste mic reac tion Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 30 µg You nger 10034 27M AY2020 21:00 Fatig ue Mil d 22 1 05M AY2020 9:30 27M AY2020 21:00 Mal aise Mil d 22 1 05M AY2020 9:30 10037 06M AY2020 20:00 Heada che Mil d 1 05M AY2020 10:00 07M AY2020 21:00 Heada che Mil d 2 05M AY2020 10:00 07M AY2020 21:00 Fatig ue Mil d 2 05M AY2020 10:00 07M AY2020 21:00 Mal aise Mil d 2 05M AY2020 10:00 10M AY2020 21:00 Fatig ue Mil d 5 05M AY2020 10:00 26M AY2020 21:00 Nause a Mil d 21 0 05M AY2020 10:00 26M AY2020 21:00 Heada che Mod erate 21 0 05M AY2020 10:00 26M AY2020 21:00 Fatig ue Seve re 21 0 05M AY2020 10:00 26M AY2020 21:00 Mya lgia Mil d 21 0 05M AY2020 10:00 26M AY2020 21:0 0 Chill s Mil d 21 0 05M AY2020 10:00 26M AY2020 21:00 Mal aise Mil d 21 0 05M AY2020 10:00 27M AY2020 21:00 Nause a Mil d 22 1 05M AY2020 10:00 27M AY2020 21:00 Heada che Mod erate 22 1 05M AY2020 10:00 27M AY2020 21:00 Fatig ue Mod erate 22 1 05M AY2020 10:0 0 27M AY2020 21:00 Mya lgia Mil d 22 1 05M AY2020 10:00 27M AY2020 21:00 Chill s Mil d 22 1 05M AY2020 10:00 Progra m: Lsa f_sysR_1.sas (Page 40 of 92) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 96 FDA-CBER-2021-5683-0050091 Bio NTech RNA Phar maceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.3-1: Lis ting of solicited systemic reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Syste mic reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 30 µg You nger 10037 27M AY2020 21:0 0 Mal aise Mil d 22 1 05M AY2020 10:00 28M AY2020 21:00 Nause a Mil d 23 2 05M AY2020 10:00 28M AY2020 21:00 Heada che Mil d 23 2 05M AY2020 10:00 28M AY2020 21:00 Fatig ue Mil d 23 2 05M AY2020 10:00 28M AY2020 21:00 Mal aise Mil d 23 2 05M AY2020 10:00 29M AY2020 21:00 Heada che Mil d 24 3 05M AY2020 10:00 29M AY2020 21:00 Fatig ue Mil d 24 3 05M AY2020 10:00 29M AY2020 21:00 Mal aise Mil d 24 3 05M AY2020 10:00 30M AY2020 21:00 Fatig ue Mil d 25 4 05M AY2020 10:00 30M AY2020 21:00 Mal aise Mil d 25 4 05M AY2020 10:0 0 31M AY2020 21:00 Mal aise Mil d 26 5 05M AY2020 10:00 01J UN2020 21:00 Heada che Mil d 27 6 05M AY2020 10:00 01J UN2020 21:00 Mal aise Mil d 27 6 05M AY2020 10:00 10038 07M AY2020 21:00 Mya lgia Mil d 0 07M AY2020 9:30 10039 07M AY2020 22:00 Heada che Seve re 0 07M AY2020 10:00 07M AY2020 22:00 Fatig ue Seve re 0 07M AY2020 10:00 07M AY2020 22:00 Mya lgia Seve re 0 07M AY2020 10:00 07M AY2020 22:00 Arthral gia Seve re 0 07M AY2020 10:00 Progra m: Lsa f_sysR_1.sas (Page 41 of 92) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 97 FDA-CBER-2021-5683-0050092 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.3-1: Lis ting of solicited systemic reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Syste mic reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boo st imm unization Date/t ime of prime imm unization 30 µg You nger 10039 07M AY2020 22:00 Chill s Seve re 0 07M AY2020 10:00 07M AY2020 22:00 Mal aise Seve re 0 07M AY2020 10:00 08M AY2020 22:00 Heada che Mod erate 1 07M AY2020 10:00 08M AY2020 22:00 Fatig ue Mod erate 1 07M AY2020 10:00 08M AY2020 22:00 Mya lgia Mod erate 1 07M AY2020 10:00 08M AY2020 22:00 Arthral gia Mod erate 1 07M AY2020 10:00 08M AY2020 22:00 Mal aise Mil d 1 07M AY2020 10:00 28M AY2020 22:00 Heada che Seve re 21 0 07M AY2020 10:00 28M AY2020 22:00 Fatig ue Seve re 21 0 07M AY2020 10:00 28M AY2020 22:00 Mya lgia Seve re 21 0 07M AY2020 10:00 28M AY2020 22:00 Arthral gia Seve re 21 0 07M AY2020 10:00 28M AY2020 22:00 Chill s Seve re 21 0 07M AY2020 10:00 28M AY2020 22:00 Los s of App etite Seve re 21 0 07M AY2020 10:00 28M AY2020 22:00 Mal aise Seve re 21 0 07M AY2020 10:00 28M AY2020 22:00 Feve r Seve re 21 0 07M AY2020 10:00 29M AY2020 22:00 Heada che Mod erate 22 1 07M AY2020 10:00 29M AY2020 22:00 Fatig ue Mil d 22 1 07M AY2020 10:00 29M AY2020 22:00 Mya lgia Mil d 22 1 07M AY2020 10:00 Progra m: Lsa f_sysR_1.sas (Page 42 of 92) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 98 FDA-CBER-2021-5683-0050093 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.3-1: Lis ting of solicited systemic reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of col lection Syste mic reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 30 µg You nger 10039 29M AY2020 22:00 Arthral gia Mil d 22 1 07M AY2020 10:00 29M AY2020 22:00 Mal aise Mil d 22 1 07M AY2020 10:00 10043 07M AY2020 20:00 Heada che Mod erate 0 07M AY2020 10:30 08M AY2020 20:00 Heada che Mod erate 1 07M AY2020 10:30 09M AY2020 20:00 Heada che Mod erate 2 07M AY2020 10:30 10M AY2020 20:00 Heada che Mod erate 3 07M AY2020 10:3 0 11M AY2020 20:00 Heada che Mod erate 4 07M AY2020 10:30 12M AY2020 20:00 Heada che Mod erate 5 07M AY2020 10:30 13M AY2020 20:00 Heada che Mil d 6 07M AY2020 10:30 28M AY2020 20:00 Heada che Mil d 21 0 07M AY2020 10:30 29M AY2020 20:00 Heada che Mil d 22 1 07M AY2020 10:30 29M AY2020 20:00 Fatig ue Mil d 22 1 07M AY2020 10:30 29M AY2020 20:00 Chill s Mil d 22 1 07M AY2020 10:30 29M AY2020 20:00 Mal aise Mil d 22 1 07M AY2020 10:30 30M AY2020 20:00 Heada che Mil d 23 2 07M AY2020 10:30 31M AY2020 20:00 Heada che Mil d 24 3 07M AY2020 10:30 10047 07M AY2020 23:00 Diarrhe a Mil d 0 07M AY2020 11:00 07M AY2020 23:00 Heada che Mil d 0 07M AY2020 11:00 Progra m: Lsa f_sysR_1.sas (Page 43 of 92) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 99 FDA-CBER-2021-5683-0050094 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data rece ived on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.3-1: Lis ting of soli cited systemic reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Syste mic reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 30 µg You nger 10047 07M AY2020 23:00 Fatig ue Mil d 0 07M AY2020 11:00 07M AY2020 23:00 Mya lgia Mil d 0 07M AY2020 11:00 07M AY2020 23:00 Arthral gia Mil d 0 07M AY2020 11:00 07M AY2020 23:00 Mal aise Mil d 0 07M AY2020 11:00 08M AY2020 23:45 Fatig ue Mil d 1 07M AY2020 11:00 08M AY2020 23:45 Mya lgia Mil d 1 07M AY2020 11:00 08M AY2020 23:45 Arthral gia Mil d 1 07M AY2020 11:00 10M AY2020 23:40 Heada che Mil d 3 07M AY2020 11:00 10M AY2020 23:40 Fatig ue Mil d 3 07M AY2020 11:00 11M AY2020 0:30 Fatig ue Mil d 4 07M AY2020 11:00 28M AY2020 23:55 Heada che Mil d 21 0 07M AY2020 11:00 28M AY2020 23:55 Fatig ue Mil d 21 0 07M AY2020 11:00 28M AY2020 23:55 Mya lgia Mil d 21 0 07M AY2020 11:00 28M AY2020 23:55 Arthral gia Mil d 21 0 07M AY2020 11:00 28M AY2020 23:5 5 Mal aise Mil d 21 0 07M AY2020 11:00 29M AY2020 21:00 Heada che Mod erate 22 1 07M AY2020 11:00 29M AY2020 21:00 Fatig ue Mod erate 22 1 07M AY2020 11:00 29M AY2020 21:00 Mya lgia Mod erate 22 1 07M AY2020 11:00 Progra m: Lsa f_sysR_1.sas (Page 44 of 92) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 100 FDA-CBER-2021-5683-0050095 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.3-1: Lis ting of solicited systemic reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Syste mic reaction Seve rity/ Inten sity Num be r of day s afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 30 µg You nger 10047 29M AY2020 21:00 Arthral gia Mod erate 22 1 07M AY2020 11:00 29M AY2020 21:00 Chill s Mil d 22 1 07M AY2020 11:00 29M AY2020 21:00 Los s of A ppetite Mil d 22 1 07M AY2020 11:00 29M AY2020 21:00 Mal aise Mod erate 22 1 07M AY2020 11:00 29M AY2020 21:00 Feve r Mil d 22 1 07M AY2020 11:00 30M AY2020 23:55 Fatig ue Mil d 23 2 07M AY2020 11:00 30M AY2020 23:55 Mya lgia Mil d 23 2 07M AY2020 11:00 30M AY2020 23:55 Arthral gia Mil d 23 2 07M AY2020 11:00 31M AY2020 22:00 Fatig ue Mil d 24 3 07M AY2020 11:00 50 µg You nger 10049 12M AY2020 19:30 Heada che Mil d 0 12M AY2020 9:10 12M AY2020 19:30 Fatig ue Mil d 0 12M AY2020 9:10 12M AY2020 19:30 Mal aise Mil d 0 12M AY2020 9:10 13M AY2020 13:00 Heada che Mil d 1 12M AY2020 9:10 13M AY2020 13:00 Chill s Mil d 1 12M AY2020 9:10 13M AY2020 13:00 Los s of Appetite Mil d 1 12M AY2020 9:10 13M AY2020 13:00 Mal aise Mil d 1 12M AY2020 9:10 13M AY2020 13:00 Feve r Mil d 1 12M AY2020 9:10 15M AY2020 13:40 Mya lgia Mil d 3 12M AY2020 9:10 Progra m: Lsa f_sysR_1.sas (Page 45 of 92) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 101 FDA-CBER-2021-5683-0050096 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data rece ived on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.3-1: Lis ting of solicited systemic reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Syste mic reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 50 µg You nger 10049 02J UN2020 23:00 Heada che Seve re 21 0 12M AY2020 9:10 02J UN2020 23:00 Fatig ue Mod erate 21 0 12M AY2020 9:10 02J UN2020 23:00 Arthral gia Mil d 21 0 12M AY2020 9:10 02J UN2020 23:00 Los s of Appetite Seve re 21 0 12M AY2020 9:10 02J UN2020 23:00 Mal aise Seve re 21 0 12M AY2020 9:10 02J UN2020 23:0 0 Feve r Seve re 21 0 12M AY2020 9:10 03J UN2020 7:15 Heada che Seve re 22 1 12M AY2020 9:10 03J UN2020 7:15 Fatig ue Mod erate 22 1 12M AY2020 9:10 03J UN2020 7:15 Arthral gia Mil d 22 1 12M AY2020 9:10 03J UN2020 7:15 Los s of Appetite Seve re 22 1 12M AY2020 9:10 03J UN2020 7:15 Mal aise Seve re 22 1 12M AY2020 9:10 03J UN2020 7:15 Feve r Mil d 22 1 12M AY2020 9:10 04J UN2020 9:00 Heada che Mod erate 23 2 12M AY2020 9:10 04J UN2020 9:00 Fatig ue Mil d 23 2 12M AY2020 9:10 04J UN2020 9:00 Los s of Appetite Mod erate 23 2 12M AY2020 9:10 04J UN2020 9:00 Mal aise Mil d 23 2 12M AY2020 9:10 05J UN2020 9:00 Los s of Appetite Mil d 24 3 12M AY2020 9:10 10050 15M AY2020 19:18 Heada che Mod erate 0 15M AY2020 8:45 Progra m: Lsa f_sysR_1.sas (Page 46 of 92) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 102 FDA-CBER-2021-5683-0050097 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.3-1: Lis ting of solicited systemic reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Syste mic reaction Seve rity/ Inten sity Num be r of day s afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 50 µg You nger 10050 15M AY2020 19:18 Fatig ue Mod erate 0 15M AY2020 8:45 15M AY2020 19:18 Mya lgia Mil d 0 15M AY2020 8:45 15M AY2020 19:18 Los s of App etite Mil d 0 15M AY2020 8:45 15M AY2020 19:18 Mal aise Mod erate 0 15M AY2020 8:45 16M AY2020 19:45 Heada che Mil d 1 15M AY2020 8:45 16M AY2020 19:45 Fatig ue Mod erate 1 15M AY2020 8:45 16M AY2020 19:45 Chill s Mil d 1 15M AY2020 8:45 16M AY2020 19:45 Los s of Appetite Mil d 1 15M AY2020 8:45 16M AY2020 19:45 Mal aise Mod erate 1 15M AY2020 8:45 17M AY2020 20:19 Fatig ue Mod erate 2 15M AY2020 8:45 17M AY2020 20:19 Los s of Appetite Mil d 2 15M AY2020 8:45 17M AY2020 20:19 Mal aise Mod erate 2 15M AY2020 8:45 18M AY2020 20:03 Heada che Mil d 3 15M AY2020 8:45 18M AY2020 20:03 Fatig ue Mil d 3 15M AY2020 8:45 18M AY2020 20:03 Mal aise Mil d 3 15M AY2020 8:45 19M AY2020 21:22 Fatig ue Mil d 4 15M AY2020 8:45 19M AY2020 21:22 Mal aise Mil d 4 15M AY2020 8:45 20M AY2020 19:24 Heada che Mil d 5 15M AY2020 8:45 Progra m: Lsa f_sysR_1.sas (Page 47 of 92) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 103 FDA-CBER-2021-5683-0050098 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.3-1: Lis ting of solicited systemic reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Syste mic reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 50 µg You nger 10050 20M AY2020 19:24 Mal aise Mil d 5 15M AY2020 8:45 21M AY2020 20:14 Fatig ue Mil d 6 15M AY2020 8:45 21M AY2020 20:14 Mal aise Mil d 6 15M AY2020 8:45 10053 12M AY2020 20:00 Fatig ue Mil d 0 12M AY2020 10:13 12M AY2020 20:00 Chill s Mil d 0 12M AY2020 10:13 13M AY2020 20:00 Chill s Mil d 1 12M AY2020 10:1 3 13M AY2020 20:00 Feve r Mod erate 1 12M AY2020 10:13 02J UN2020 20:00 Heada che Mil d 21 0 12M AY2020 10:13 02J UN2020 20:00 Fatig ue Mil d 21 0 12M AY2020 10:13 02J UN2020 20:00 Chill s Mil d 21 0 12M AY2020 10:13 02J UN2020 20:00 Los s of Appetite Mil d 21 0 12M AY2020 10:13 02J UN2020 20:00 Mal aise Mod erate 21 0 12M AY2020 10:13 03J UN2020 20:00 Heada che Mil d 22 1 12M AY2020 10:13 03J UN2020 20:00 Fatig ue Mil d 22 1 12M AY2020 10:13 03J UN2020 20:00 Chill s Mil d 22 1 12M AY2020 10:13 03J UN2020 20:0 0 Los s of Appetite Mil d 22 1 12M AY2020 10:13 03J UN2020 20:00 Mal aise Mil d 22 1 12M AY2020 10:13 03J UN2020 20:00 Feve r Mod erate 22 1 12M AY2020 10:13 Progra m: Lsa f_sysR_1.sas (Page 48 of 92) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 104 FDA-CBER-2021-5683-0050099 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data rece ived on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.3-1: Listi ng of solicited systemic reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Syste mic reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 50 µg You nger 10055 13M AY2020 17:30 Heada che Mil d 0 13M AY2020 9:13 13M AY2020 17:30 Fatig ue Mil d 0 13M AY2020 9:13 14M AY2020 21:30 Heada che Mil d 1 13M AY2020 9:13 14M AY2020 21:30 Arthral gia Mod erate 1 13M AY2020 9:13 15M AY2020 22:0 0 Arthral gia Mod erate 2 13M AY2020 9:13 03J UN2020 21:40 Mya lgia Mil d 21 0 13M AY2020 9:13 03J UN2020 21:40 Arthral gia Mod erate 21 0 13M AY2020 9:13 03J UN2020 21:40 Los s of Appetite Mod erate 21 0 13M AY2020 9:13 03J UN2020 21:40 Mal aise Mil d 21 0 13M AY2020 9:13 10056 13M AY2020 20:30 Nause a Mil d 0 13M AY2020 10:16 13M AY2020 20:30 Heada che Mil d 0 13M AY2020 10:16 13M AY2020 20:30 Fatig ue Mil d 0 13M AY2020 10:16 13M AY2020 20:30 Mal aise Mil d 0 13M AY2020 10:16 14M AY2020 20:30 Nause a Mil d 1 13M AY2020 10:16 14M AY2020 20:30 Heada che Mod erate 1 13M AY2020 10:16 14M AY2020 20:30 Fatig ue Mod erate 1 13M AY2020 10:16 14M AY2020 20:30 Mya lgia Mod erate 1 13M AY2020 10:16 14M AY2020 20:30 Arthral gia Mil d 1 13M AY2020 10:16 Progra m: Lsa f_sysR_1.sas (Page 49 of 92) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 105 FDA-CBER-2021-5683-0050100 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV 2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.3-1: Lis ting of solicited systemic reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Syste mic reaction Seve rity/ Inten sity Num be r of day s afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 50 µg You nger 10056 14M AY2020 20:30 Chill s Mod erate 1 13M AY2020 10:16 14M AY2020 20:30 Los s of Appetite Mil d 1 13M AY2020 10:16 14M AY2020 20:30 Mal aise Mod erate 1 13M AY2020 10:16 15M AY2020 20:30 Heada che Mil d 2 13M AY2020 10:16 15M AY2020 20:30 Fatig ue Mil d 2 13M AY2020 10:16 15M AY2020 20:30 Mya lgia Mil d 2 13M AY2020 10:16 15M AY2020 20:30 Mal aise Mil d 2 13M AY2020 10:16 16M AY2020 20:3 0 Fatig ue Mil d 3 13M AY2020 10:16 17M AY2020 20:30 Fatig ue Mil d 4 13M AY2020 10:16 03J UN2020 21:30 Nause a Mil d 21 0 13M AY2020 10:16 03J UN2020 21:30 Heada che Seve re 21 0 13M AY2020 10:16 03J UN2020 21:30 Fatig ue Seve re 21 0 13M AY2020 10:16 03J UN2020 21:30 Mya lgia Mod erate 21 0 13M AY2020 10:16 03J UN2020 21:30 Arthral gia Mod erate 21 0 13M AY2020 10:16 03J UN2020 21:30 Chill s Seve re 21 0 13M AY2020 10:16 03J UN2020 21:30 Los s of Appetite Seve re 21 0 13M AY2020 10:16 03J UN2020 21:30 Mal aise Seve re 21 0 13M AY2020 10:16 03J UN2020 21:30 Feve r Seve re 21 0 13M AY2020 10:16 Progra m: Lsa f_sysR_1.sas (Page 50 of 92) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 106 FDA-CBER-2021-5683-0050101 Bio NTech RNA Phar maceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.3-1: Lis ting of solicited systemic reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Syste mic reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 50 µg You nger 10056 04J UN2020 21:30 Heada che Seve re 22 1 13M AY2020 10:16 04J UN2020 21:30 Fatig ue Seve re 22 1 13M AY2020 10:16 04J UN2020 21:30 Mya lgia Mod erate 22 1 13M AY2020 10:16 04J UN2020 21:30 Arthral gia Mod erate 22 1 13M AY2020 10:16 04J UN2020 21:30 Chill s Seve re 22 1 13M AY2020 10:16 04J UN2020 21:3 0 Los s of Appetite Mod erate 22 1 13M AY2020 10:16 04J UN2020 21:30 Mal aise Seve re 22 1 13M AY2020 10:16 04J UN2020 21:30 Feve r Mod erate 22 1 13M AY2020 10:16 05J UN2020 21:30 Heada che Mil d 23 2 13M AY2020 10:16 05J UN2020 21:30 Fatig ue Mil d 23 2 13M AY2020 10:16 05J UN2020 21:30 Mya lgia Mil d 23 2 13M AY2020 10:16 05J UN2020 21:30 Arthral gia Mil d 23 2 13M AY2020 10:16 06J UN2020 21:30 Fatig ue Mil d 24 3 13M AY2020 10:16 06J UN2020 21:30 Mya lgia Mil d 24 3 13M AY2020 10:16 10057 15M AY2020 20:00 Mya lgia Mil d 0 15M AY2020 9:15 15M AY2020 20:00 Arthral gia Mil d 0 15M AY2020 9:15 15M AY2020 20:00 Chill s Mod erate 0 15M AY2020 9:15 15M AY2020 20:00 Mal aise Mil d 0 15M AY2020 9:15 Progra m: Lsa f_sysR_1.sas (Page 51 of 92) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 107 FDA-CBER-2021-5683-0050102 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.3-1: Lis ting of solicited systemic reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Syste mic reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boo st imm unization Date/t ime of prime imm unization 50 µg You nger 10057 16M AY2020 20:00 Fatig ue Mod erate 1 15M AY2020 9:15 16M AY2020 20:00 Mya lgia Seve re 1 15M AY2020 9:15 16M AY2020 20:00 Arthral gia Seve re 1 15M AY2020 9:15 16M AY2020 20:00 Chill s Seve re 1 15M AY2020 9:15 16M AY2020 20:00 Mal aise Mod erate 1 15M AY2020 9:15 05J UN2020 20:37 Fatig ue Mod erate 21 0 15M AY2020 9:15 05J UN2020 20:37 Mya lgia Mod erate 21 0 15M AY2020 9:15 05J UN2020 20:37 Arthral gia Mil d 21 0 15M AY2020 9:15 05J UN2020 20:37 Chill s Mod erate 21 0 15M AY2020 9:15 05J UN2020 20:37 Mal aise Mil d 21 0 15M AY2020 9:15 06J UN2020 18:30 Diarrhe a Mil d 22 1 15M AY2020 9:15 06J UN2020 18:30 Heada che Mil d 22 1 15M AY2020 9:15 06J UN2020 18:30 Fatig ue Mil d 22 1 15M AY2020 9:15 06J UN2020 18:30 Mya lgia Mil d 22 1 15M AY2020 9:15 06J UN2020 18:30 Arthral gia Mil d 22 1 15M AY2020 9:15 06J UN2020 18:30 Chill s Mil d 22 1 15M AY2020 9:15 06J UN2020 18:30 Mal aise Mil d 22 1 15M AY2020 9:15 07J UN2020 14:00 Heada che Mil d 23 2 15M AY2020 9:15 Progra m: Lsa f_sysR_1.sas (Page 52 of 92) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 108 FDA-CBER-2021-5683-0050103 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Fina l 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.3-1: Lis ting of solicited systemic reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Syste mic reac tion Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 50 µg You nger 10057 07J UN2020 14:00 Mya lgia Mil d 23 2 15M AY2020 9:15 10059 13M AY2020 16:50 Heada che Mil d 0 13M AY2020 10:46 14M AY2020 17:00 Nause a Mod erate 1 13M AY2020 10:46 14M AY2020 17:00 Heada che Mod erate 1 13M AY2020 10:46 14M AY2020 17:00 Fatig ue Seve re 1 13M AY2020 10:46 14M AY2020 17:00 Mya lgia Mil d 1 13M AY2020 10:46 14M AY2020 17:00 Arthral gia Mil d 1 13M AY2020 10:46 14M AY2020 17:00 Chill s Mod erate 1 13M AY2020 10:46 14M AY2020 17:00 Los s of Appetite Seve re 1 13M AY2020 10:46 14M AY2020 17:00 Mal aise Seve re 1 13M AY2020 10:46 14M AY2020 17:00 Feve r Mod erate 1 13M AY2020 10:46 15M AY2020 17:50 Nause a Mod erate 2 13M AY2020 10:46 15M AY2020 17:50 Heada che Mod erate 2 13M AY2020 10:46 15M AY2020 17:50 Fatig ue Mod erate 2 13M AY2020 10:46 15M AY2020 17:50 Mya lgia Mil d 2 13M AY2020 10:46 15M AY2020 17:50 Arthral gia Mil d 2 13M AY2020 10:46 15M AY2020 17:50 Los s of Appetite Seve re 2 13M AY2020 10:46 15M AY2020 17:50 Mal aise Mod erate 2 13M AY2020 10:46 Progra m: Lsa f_sysR_1.sas (Page 53 of 92) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 109 FDA-CBER-2021-5683-0050104 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM d ata received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.3-1: Lis ting of solicited systemi c r eactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Syste mic reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 50 µg You nger 10059 16M AY2020 17:30 Nause a Mil d 3 13M AY2020 10:46 16M AY2020 17:30 Heada che Mil d 3 13M AY2020 10:46 16M AY2020 17:30 Fatig ue Mod erate 3 13M AY2020 10:46 16M AY2020 17:30 Los s of Appetite Mod erate 3 13M AY2020 10:46 16M AY2020 17:30 Mal aise Mod erate 3 13M AY2020 10:46 17M AY2020 17:15 Heada che Mil d 4 13M AY2020 10:46 17M AY2020 17:15 Fatig ue Mil d 4 13M AY2020 10:46 17M AY2020 17:15 Los s of Appetite Mil d 4 13M AY2020 10:46 17M AY2020 17:15 Mal aise Mil d 4 13M AY2020 10:46 18M AY2020 19:00 Heada che Mil d 5 13M AY2020 10:46 18M AY2020 19:00 Los s of Appetite Mil d 5 13M AY2020 10:46 03J UN2020 17:30 Nause a Mod erate 21 0 13M AY2020 10:46 03J UN2020 17:30 Heada che Seve re 21 0 13M AY2020 10:46 03J UN2020 17:30 Fatig ue Seve re 21 0 13M AY2020 10:46 03J UN2020 17:30 Mya lgia Mod erate 21 0 13M AY2020 10:46 03J UN2020 17:30 Arthral gia Mod erate 21 0 13M AY2020 10:46 03J UN2020 17:30 Chill s Seve re 21 0 13M AY2020 10:46 03J UN2020 17:30 Los s of Appetite Mod erate 21 0 13M AY2020 10:4 6 Progra m: Lsa f_sysR_1.sas (Page 54 of 92) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 110 FDA-CBER-2021-5683-0050105 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Fina l 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data received on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.3-1: Lis ting of solicited systemic reactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Syste mic reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 50 µg You nger 10059 03J UN2020 17:30 Mal aise Seve re 21 0 13M AY2020 10:46 03J UN2020 17:30 Feve r Mod erate 21 0 13M AY2020 10:46 04J UN2020 10:0 0 Nause a Seve re 22 1 13M AY2020 10:46 04J UN2020 10:00 Heada che Seve re 22 1 13M AY2020 10:46 04J UN2020 10:00 Fatig ue Seve re 22 1 13M AY2020 10:46 04J UN2020 10:00 Mya lgia Mod erate 22 1 13M AY2020 10:46 04J UN2020 10:00 Arthral gia Mod erate 22 1 13M AY2020 10:46 04J UN2020 10:00 Chill s Seve re 22 1 13M AY2020 10:46 04J UN2020 10:00 Los s of Appetite Seve re 22 1 13M AY2020 10:46 04J UN2020 10:00 Mal aise Seve re 22 1 13M AY2020 10:46 04J UN2020 10:00 Feve r Mil d 22 1 13M AY2020 10:46 05J UN2020 18:0 0 Nause a Seve re 23 2 13M AY2020 10:46 05J UN2020 18:00 Heada che Seve re 23 2 13M AY2020 10:46 05J UN2020 18:00 Fatig ue Mod erate 23 2 13M AY2020 10:46 05J UN2020 18:00 Mya lgia Mod erate 23 2 13M AY2020 10:46 05J UN2020 18:00 Arthral gia Mod erate 23 2 13M AY2020 10:46 05J UN2020 18:00 Chill s Mil d 23 2 13M AY2020 10:46 05J UN2020 18:00 Los s of Appetite Seve re 23 2 13M AY2020 10:46 Progra m: Lsa f_sysR_1.sas (Page 55 of 92) 090177e1959f7374\Approved\Approved On: 27-Nov-2020 03:38 (GMT) Page 111 FDA-CBER-2021-5683-0050106 Bio NTech RNA Pharmaceuticals GmbH / Listi ngs - 6. Sn apshot All TLFs Final 1.0 BNT16 2b1 BNT16 2-01 Created on 20NOV2020 Staburo G mbH. Based on clean SDTM data rece ived on 03NOV2020. Data cut -off: 23O CT2020. Listing 16.2.3 -1.3-1: Lis ting of solicited systemi c r eactions - BNT 162b1 Safety set Dose grou p Subj ect number Date/t ime of collection Syste mic reaction Seve rity/ Inten sity Num be r of days afte r prime imm unization Num be r of days afte r boost imm unization Date/t ime of prime imm unization 50 µg You nger 10059 05J UN2020 18:00 Mal aise Mod erate 23 2 13M AY2020 10:46 06J UN2020 17:00 Nause a Mil d 24 3 13M AY2020 10:46 06J UN2020 17:00 Heada che Mil d 24 3 13M AY2020 10:46 06J UN2020 17:00 Fatig ue Mil d 24 3 13M AY2020 10:46 06J UN2020 17:00 Mya lgia Mil d 24 3 13M AY2020 10:46 06J UN2020 17:00 Arthral gia Mil d 24 3 13M AY2020 10:46 06J UN2020 17:00 Los s of Appetite Mil d 24 3 13M AY2020 10:46 …[truncated]