019736 S387 M5 c4591008 interim non hospitalization

Document text

Listing 7.7.7 Page 3of 72
BNT162b2 Protocol C4591008
Participant Reported Non -Hospitalization Safety Events of Interest
1: Duplicative events that occur on the same date or that appear as a hospitalized events on the same date are not analyzed.
PFIZER CONFIDENTIAL    SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021    Source Data: ADSL, ADEVENT, FA
Generated from /dcri/ct/hero_together/lists/l_event.sas on 24MAY2021 12:45 Page 1618 of 1689   Subject ID Age/Sex/RaceVaccination 
Date Reported Condition Onset Date Analyzed1What caused you to seek medical care 
for this condition
C4591008 -1000222784 28/F/WHITE 2020 -12-30 Other . Y
C4591008 -1006879296 45/M/WHITE 2020 -12-30 Other . Y
45/M/WHITE 2020 -12-30 Other .
C4591008 -1015169600 31/F/WHITE 2020 -12-30 Other . Y
C4591008 -1018784832 40/F/WHITE 2020 -12-26 Other . Y
C4591008 -1031008320 28/F/WHITE 2021 -01-04 Pregnancy -related issue . Y
C4591008 -1059175488 35/F/WHITE 2020 -12-18 COVID -19 infection 2020 -12-30 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
35/F/WHITE 2020 -12-18 COVID -19 infection 2020 -12-30 I experienced new symptoms and was 
diagnosed with this condition for the first 
time
35/F/WHITE 2020 -12-18 COVID -19 infection 2020 -12-30 I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -1060278336 50/F/WHITE 2020 -12-24 COVID -19 infection . Y I have been diagnosed with this condition, 
and I had a routine visit to manage my 
condition
50/F/WHITE 2020 -12-24 COVID -19infection . I have been diagnosed with this condition, 
and I had a routine visit to manage my 
condition
C4591008 -1062537280 61/F/WHITE 2020 -12-28 Other . Y
C4591008 -1066244672 55/M/WHITE 2020 -12-23 Other . Y
C4591008 -1069432384 44/F/WHITE 2020 -12-20 Other . Y
C4591008 -1087542848 32/F/WHITE 2021 -01-06 Other . Y
C4591008 -1097108544 32/F/WHITE 2020 -12-05 Other . Y
C4591008 -1109784128 35/F/WHITE 2021 -01-05 Other . Y
090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT) 
Page 1
FDA-CBER-2021-5683-1075348
Listing 7.7.7 Page 4of 72
BNT162b2 Protocol C4591008
Participant Reported Non -Hospitalization Safety Events of Interest
1: Duplicative events that occur on the same date or that appear as a hospitalized events on the same date are not analyzed.
PFIZER CONFIDENTIAL    SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021    Source Data: ADSL, ADEVENT, FA
Generated from /dcri/ct/hero_together/lists/l_event.sas on 24MAY2021 12:45 Page 1619 of 1689   Subject ID Age/Sex/RaceVaccination 
Date Reported Condition Onset Date Analyzed1What caused you to seek medical care 
for this condition
C4591008 -1113876032 58/F/WHITE 2021 -01-06 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -01-13 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
58/F/WHITE 2021 -01-06 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -02-11 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -1129966656 50/M/WHITE 2020 -12-31 Other . Y
C4591008 -1147386432 67/F/WHITE 2020 -12-23 Other . Y
C4591008 -1164365888 61/M/WHITE 2021 -01-22 Other . Y
C4591008 -1170239040 51/F/WHITE 2020 -12-11 Other . Y
C4591008 -1175978048 36/F/WHITE 2021 -01-14 Abnormal blood clotting (e.g., 
disseminated intravascular 
coagulation, thrombocytopenia)2021 -01-15 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
36/F/WHITE 2021 -01-14 Other . Y
36/F/WHITE 2021 -01-14 Other .
C4591008 -1178097728 35/F/WHITE 2021 -02-20 Other . Y
C4591008 -1182010944 49/F/WHITE 2020 -12-23 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -03-11 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
49/F/WHITE 2020 -12-23 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -03-30 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
C4591008 -1202857536 41/F/WHITE 2020 -12-17 Other . Y
C4591008 -1242637376 40// 2021 -01-04 Other . Y
40// 2021 -01-04 Other .
C4591008 -1262859840 40/F/WHITE 2020 -12-21 Other . Y
C4591008 -1265702976 32/F/WHITE 2020 -12-28 Other . Y
32/F/WHITE 2020 -12-28 Other .
090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT) 
Page 2
FDA-CBER-2021-5683-1075349
Listing 7.7.7 Page 5of 72
BNT162b2 Protocol C4591008
Participant Reported Non -Hospitalization Safety Events of Interest
1: Duplicative events that occur on the same date or that appear as a hospitalized events on the same date are not analyzed.
PFIZER CONFIDENTIAL    SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021    Source Data: ADSL, ADEVENT, FA
Generated from /dcri/ct/hero_together/lists/l_event.sas on 24MAY2021 12:45 Page 1620 of 1689   Subject ID Age/Sex/RaceVaccination 
Date Reported Condition Onset Date Analyzed1What caused you to seek medical care 
for this condition
C4591008 -1272851520 39/F/WHITE 2020 -12-19 Nerve inflammation or autoimmune 
disease (e.g., multiple sclerosis, 
rheumatoid arthritis)2021 -04-21 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
C4591008 -1288888896 67/F/WHITE 2021 -01-06 Other . Y
C4591008 -1289153600 36/M/WHITE 2021 -01-08 Other . Y
C4591008 -1297006656 34/F/WHITE 2020 -12-29 Other . Y
34/F/WHITE 2020 -12-29 Other .
C4591008 -1301644352 52/F/WHITE 2020 -12-28 Other . Y
C4591008 -1306785856 35/F/NOT 
REPORTED2020 -12-23 COVID -19 infection 2021 -01-05 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -1321333824 46/F/WHITE 2021 -01-07 Other . Y
C4591008 -1332813888 48/F/WHITE 2021 -01-22 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -01-31 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
48/F/WHITE 2021 -01-22 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -04-05 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -1340720192 37/F/WHITE 2020 -12-22 Other . Y
37/F/WHITE 2020 -12-22 Other .
37/F/WHITE 2020 -12-22 Other .
C4591008 -1342499904 40/F/WHITE 2020 -12-27 Other . Y
C4591008 -1343416384 47/F/WHITE 2021 -01-04 Other . Y
C4591008 -1351402560 50/F/WHITE 2020 -12-23 COVID -19 infection 2020 -12-28 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -1351866432 39/F/WHITE 2021 -02-04 Other . Y
090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT) 
Page 3
FDA-CBER-2021-5683-1075350
Listing 7.7.7 Page 6of 72
BNT162b2 Protocol C4591008
Participant Reported Non -Hospitalization Safety Events of Interest
1: Duplicative events that occur on the same date or that appear as a hospitalized events on the same date are not analyzed.
PFIZER CONFIDENTIAL    SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021    Source Data: ADSL, ADEVENT, FA
Generated from /dcri/ct/hero_together/lists/l_event.sas on 24MAY2021 12:45 Page 1621 of 1689   Subject ID Age/Sex/RaceVaccination 
Date Reported Condition Onset Date Analyzed1What caused you to seek medical care 
for this condition
C4591008 -1369829952 43/F/BLACK OR 
AFRICAN 
AMERICAN2020 -12-24 Other . Y
C4591008 -1412825664 51/F/WHITE 2021 -01-07 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -02-06 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -1415271488 50/F/WHITE 2021 -01-07 Other . Y
C4591008 -1418206784 63/M/WHITE 2020 -12-24 Brain or spinal cord inflammation 
(e.g., meningitis, encephalitis, 
Guillain -Barre syndrome)2021 -03-23 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
C4591008 -1442282560 35/F/WHITE 2020 -12-28 Other . Y
C4591008 -1466026560 55/F/WHITE 2020 -12-29 Other . Y
C4591008 -1471406656 52/M/WHITE 2020 -12-28 Other . Y
C4591008 -1475905088 58/F/WHITE 2021 -02-05 Other . Y
C4591008 -1516435520 64/F/WHITE 2020 -12-29 Other . Y
64/F/WHITE 2020 -12-29 Other .
C4591008 -1520302656 30/F/WHITE 2020 -12-22 Other . Y
30/F/WHITE 2020 -12-22 Other .
C4591008 -1549053504 34/F/WHITE 2020 -12-16 Non-severe allergic reaction 2021 -01-15 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -1551990336 41/F/WHITE 2021 -01-12 Other . Y
C4591008 -1562167360 36/M/WHITE 2020 -12-29 Other . Y
36/M/WHITE 2020 -12-29 Other .
C4591008 -1578391104 49/F/WHITE 2020 -12-16 Other . Y
C4591008 -1595292224 36/M/WHITE 2020 -12-19 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2020 -12-31 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT) 
Page 4
FDA-CBER-2021-5683-1075351
Listing 7.7.7 Page 7of 72
BNT162b2 Protocol C4591008
Participant Reported Non -Hospitalization Safety Events of Interest
1: Duplicative events that occur on the same date or that appear as a hospitalized events on the same date are not analyzed.
PFIZER CONFIDENTIAL    SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021    Source Data: ADSL, ADEVENT, FA
Generated from /dcri/ct/hero_together/lists/l_event.sas on 24MAY2021 12:45 Page 1622 of 1689   Subject ID Age/Sex/RaceVaccination 
Date Reported Condition Onset Date Analyzed1What caused you to seek medical care 
for this condition
C4591008 -1603343936 37/F/WHITE 2020 -12-29 Other . Y
C4591008 -1606053952 31/F/WHITE 2020 -12-30 Other . Y
C4591008 -1645515328 56/M/WHITE 2020 -12-19 Other . Y
C4591008 -1649581120 37/M/UNKNOWN 2020 -12-31 Other . Y
C4591008 -1655812672 65/F/WHITE 2020 -12-20 Other . Y
C4591008 -1662150720 48/F/NOT 
REPORTED2020 -12-22 Multisystem inflammation 2021 -01-20 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -1686278720 39/F/WHITE 2020 -12-21 Other . Y
C4591008 -1688550464 29/F/WHITE 2021 -01-12 Other . Y
C4591008 -1703325760 39/M/WHITE 2021 -02-12 Other . Y
39/M/WHITE 2021 -02-12 Other .
C4591008 -1724875840 46/F/WHITE 2020 -12-29 Other . Y
46/F/WHITE 2020 -12-29 Other .
C4591008 -1733539904 42/F/WHITE 2020 -12-23 Non-severe allergic reaction 2021 -04-14 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -1737778240 45/F/WHITE 2020 -12-18 Other . Y
C4591008 -1738082880 38/F/WHITE 2020 -12-29 COVID -19 infection 2021 -04-06 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
38/F/WHITE 2020 -12-29 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -01-25 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
C4591008 -1746240576 38/F/AMERICAN 
INDIAN OR 
ALASKA2020 -12-21 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -04-10 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
C4591008 -1746347584 42/F/WHITE 2021 -01-20 Other . Y
090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT) 
Page 5
FDA-CBER-2021-5683-1075352
Listing 7.7.7 Page 8of 72
BNT162b2 Protocol C4591008
Participant Reported Non -Hospitalization Safety Events of Interest
1: Duplicative events that occur on the same date or that appear as a hospitalized events on the same date are not analyzed.
PFIZER CONFIDENTIAL    SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021    Source Data: ADSL, ADEVENT, FA
Generated from /dcri/ct/hero_together/lists/l_event.sas on 24MAY2021 12:45 Page 1623 of 1689   Subject ID Age/Sex/RaceVaccination 
Date Reported Condition Onset Date Analyzed1What caused you to seek medical care 
for this condition
C4591008 -1748127296 38/F/WHITE 2020 -12-24 Other . Y
C4591008 -1750359616 30/F/ASIAN 2021 -01-07 Other . Y
C4591008 -1751077952 52/F/ASIAN 2020 -12-22 COVID -19 infection 2021 -01-05 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -1768017472 31/M/WHITE 2020 -12-21 Other . Y
C4591008 -1776946752 28/F/WHITE 2020 -12-24 Joint stiffness or pain (e.g., arthralgia, 
arthritis). Y I have been diagnosed with this condition, 
and I had a routine visit to manage my 
condition
C4591008 -1781503552 50/F/WHITE 2021 -01-03 Other . Y
C4591008 -1794697280 30/F/WHITE 2020 -12-22 Other . Y
C4591008 -1796637760 33/F/WHITE 2020 -12-23 Severe allergic reaction (anaphylaxis) 2020 -12-23 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -1813418560 45/F/WHITE 2021 -01-16 Other . Y
C4591008 -1819796032 37/F/WHITE 2020 -12-27 Other . Y
37/F/WHITE 2020 -12-27 Other .
C4591008 -1836610624 46/F/WHITE 2021 -02-05 Nerve inflammation or autoimmune 
disease (e.g., multiple sclerosis, 
rheumatoid arthritis)2021 -04-29 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -1838317632 49/F/WHITE 2020 -12-19 Other . Y
C4591008 -1853039680 44/F/WHITE 2020 -12-30 Heart inflammation (e.g., myocarditis, 
pericarditis). Y I have been diagnosed with this condition, 
and I had a routine visit to manage my 
condition
44/F/WHITE 2020 -12-30 Nerve inflammation or autoimmune 
disease (e.g., multiple sclerosis, 
rheumatoid arthritis)2021 -02-15 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
C4591008 -1862008384 32/F/WHITE 2020 -12-16 Other . Y
C4591008 -1862964800 71/F/WHITE 2020 -12-31 Other . Y
090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT) 
Page 6
FDA-CBER-2021-5683-1075353
Listing 7.7.7 Page 9of 72
BNT162b2 Protocol C4591008
Participant Reported Non -Hospitalization Safety Events of Interest
1: Duplicative events that occur on the same date or that appear as a hospitalized events on the same date are not analyzed.
PFIZER CONFIDENTIAL    SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021    Source Data: ADSL, ADEVENT, FA
Generated from /dcri/ct/hero_together/lists/l_event.sas on 24MAY2021 12:45 Page 1624 of 1689   Subject ID Age/Sex/RaceVaccination 
Date Reported Condition Onset Date Analyzed1What caused you to seek medical care 
for this condition
71/F/WHITE 2020 -12-31 Other .
C4591008 -1875952704 22/F/BLACK OR 
AFRICAN 
AMERICAN2021 -03-31 Other . Y
C4591008 -1894320192 34/F/NOT 
REPORTED2020 -12-22 Other . Y
C4591008 -1898240064 28/F/WHITE 2021 -01-06 Other . Y
C4591008 -1899130432 41/F/WHITE 2020 -12-23 Other . Y
41/F/WHITE 2020 -12-23 Other .
C4591008 -1910079552 54/F/WHITE 2020 -12-16 Nerve inflammation or autoimmune 
disease (e.g., multiple sclerosis, 
rheumatoid arthritis)2021 -01-13 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
C4591008 -1914742336 57/F/WHITE 2021 -02-26 Other . Y
57/F/WHITE 2021 -02-26 Other .
C4591008 -1915672128 30/F/WHITE 2020 -12-27 Other . Y
C4591008 -1922475584 33/F/WHITE 2021 -01-11 Pregnancy -related issue 2021 -04-02 Y
C4591008 -1929304128 60/F/WHITE 2021 -01-13 Non-severe allergic reaction 2021 -03-08 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
60/F/WHITE 2021 -01-13 Non-severe allergic reaction 2021 -03-08 I experienced new symptoms and was 
diagnosed with this condition for the first 
time
60/F/WHITE 2021 -01-13 Other . Y
C4591008 -1931337792 37/F/WHITE 2020 -12-16 Other . Y
C4591008 -1942126656 61/F/WHITE 2020 -12-15 Other . Y
C4591008 -1942511680 52/F/WHITE 2020 -12-23 Other . Y
C4591008 -1946709568 48/F/WHITE 2020 -12-28 Other . Y
C4591008 -1958209088 65/F/WHITE 2021 -01-11 Other . Y
090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT) 
Page 7
FDA-CBER-2021-5683-1075354
Listing 7.7.7 Page 10of 72
BNT162b2 Protocol C4591008
Participant Reported Non -Hospitalization Safety Events of Interest
1: Duplicative events that occur on the same date or that appear as a hospitalized events on the same date are not analyzed.
PFIZER CONFIDENTIAL    SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021    Source Data: ADSL, ADEVENT, FA
Generated from /dcri/ct/hero_together/lists/l_event.sas on 24MAY2021 12:45 Page 1625 of 1689   Subject ID Age/Sex/RaceVaccination 
Date Reported Condition Onset Date Analyzed1What caused you to seek medical care 
for this condition
65/F/WHITE 2021 -01-11 Other .
C4591008 -1958868032 48/F/WHITE 2020 -12-17 Other . Y
C4591008 -1965883456 46/F/ASIAN 2020 -12-16 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -04-04 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
46/F/ASIAN 2020 -12-16 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -04-07 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
46/F/ASIAN 2020 -12-16 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -04-07 I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -1976976448 35/F/WHITE 2020 -12-23 Pregnancy -related issue 2021 -02-09 Y
C4591008 -1981933120 43/F/WHITE 2020 -12-27 Non-severe allergic reaction 2021 -01-18 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -1985454144 55/F/WHITE 2020 -12-16 Other . Y
C4591008 -1992356928 33/F/WHITE 2021 -02-16 Non-severe allergic reaction . Y I have been diagnosed with this condition, 
and I had a routine visit to manage my 
condition
C4591008 -2011017792 50/F/WHITE 2021 -01-10 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -03-25 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
50/F/WHITE 2021 -01-10 Nerve inflammation or autoimmune 
disease (e.g., multiple sclerosis, 
rheumatoid arthritis)2021 -03-25 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
C4591008 -2022616128 42/F/WHITE 2021 -01-04 Pregnancy -related issue 2021 -01-06 Y
42/F/WHITE 2021 -01-04 Pregnancy -related issue 2021 -01-19 Y
090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT) 
Page 8
FDA-CBER-2021-5683-1075355
Listing 7.7.7 Page 11of 72
BNT162b2 Protocol C4591008
Participant Reported Non -Hospitalization Safety Events of Interest
1: Duplicative events that occur on the same date or that appear as a hospitalized events on the same date are not analyzed.
PFIZER CONFIDENTIAL    SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021    Source Data: ADSL, ADEVENT, FA
Generated from /dcri/ct/hero_together/lists/l_event.sas on 24MAY2021 12:45 Page 1626 of 1689   Subject ID Age/Sex/RaceVaccination 
Date Reported Condition Onset Date Analyzed1What caused you to seek medical care 
for this condition
C4591008 -2030509120 34/F/WHITE 2020 -12-17 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -03-30 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
C4591008 -2031013952 35/F/WHITE 2020 -12-30 Other . Y
C4591008 -2033271872 40/F/WHITE 2020 -12-16 Autoimmune thyroiditis 2021 -03-08 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
C4591008 -2041523264 55/F/WHITE 2021 -01-09 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -04-04 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -2041629248 56/F/WHITE 2020 -12-29 Other . Y
C4591008 -2064350784 35/F/WHITE 2020 -12-24 Other . Y
35/F/WHITE 2020 -12-24 Other .
C4591008 -2076813376 29/F/WHITE 2021 -01-11 Other . Y
C4591008 -2079005248 61/F/WHITE 2020 -12-30 Nerve inflammation or autoimmune 
disease (e.g., multiple sclerosis, 
rheumatoid arthritis)2021 -01-19 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
61/F/WHITE 2020 -12-30 Nerve inflammation or autoimmune 
disease (e.g., multiple scleros is, 
rheumatoid arthritis)2021 -01-20 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
C4591008 -2086419008 31/F/WHITE 2020 -12-28 Other . Y
31/F/WHITE 2020 -12-28 Other .
C4591008 -2089276480 45/F/WHITE 2021 -01-20 Abnormal blood clotting (e.g., 
disseminated intravascular 
coagulation, thrombocytopenia)2021 -02-16 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -2104063552 45/F/WHITE 2020 -12-28 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -01-20 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
45/F/WHITE 2020 -12-28 Other . Y
090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT) 
Page 9
FDA-CBER-2021-5683-1075356
Listing 7.7.7 Page 12of 72
BNT162b2 Protocol C4591008
Participant Reported Non -Hospitalization Safety Events of Interest
1: Duplicative events that occur on the same date or that appear as a hospitalized events on the same date are not analyzed.
PFIZER CONFIDENTIAL    SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021    Source Data: ADSL, ADEVENT, FA
Generated from /dcri/ct/hero_together/lists/l_event.sas on 24MAY2021 12:45 Page 1627 of 1689   Subject ID Age/Sex/RaceVaccination 
Date Reported Condition Onset Date Analyzed1What caused you to seek medical care 
for this condition
C4591008 -2111304256 36/F/WHITE 2021 -01-11 Other . Y
C4591008 -2115264064 53/F/WHITE 2021 -01-06 Severe allergic reaction (anaphylaxis) 2021 -01-06 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -2132829248 21/F/WHITE 2021 -01-03 Other . Y
C4591008 -2143697984 49/F/WHITE 2021 -01-13 COVID -19 infection 2021 -01-19 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
49/F/WHITE 2021 -01-13 COVID -19 infection 2021 -02-01 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
C4591008 -2147671104 47/F/WHITE 2020 -12-30 Other . Y
C4591008 -2153489472 32/M/WHITE 2021 -01-29 Other . Y
32/M/WHITE 2021 -01-29 Other .
C4591008 -2157144128 56/F/WHITE 2021 -01-22 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -03-16 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -2182441536 41/F/ASIAN 2020 -12-21 Other . Y
C4591008 -2188101696 35/M/WHITE 2021 -01-11 Other . Y
C4591008 -2188938304 35/M/WHITE 2020 -12-23 Other . Y
C4591008 -2191702592 40/F/WHITE 2020 -12-21 COVID -19 infection 2020 -12-31 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
40/F/WHITE 2020 -12-21 Other . Y
C4591008 -2194745920 34/F/WHITE 2020 -12-20 Pregnancy -related issue 2021 -01-27 Y
C4591008 -2197416000 35/F/WHITE 2020 -12-29 COVID -19 infection 2021 -01-13 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT) 
Page 10
FDA-CBER-2021-5683-1075357
Listing 7.7.7 Page 13of 72
BNT162b2 Protocol C4591008
Participant Reported Non -Hospitalization Safety Events of Interest
1: Duplicative events that occur on the same date or that appear as a hospitalized events on the same date are not analyzed.
PFIZER CONFIDENTIAL    SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021    Source Data: ADSL, ADEVENT, FA
Generated from /dcri/ct/hero_together/lists/l_event.sas on 24MAY2021 12:45 Page 1628 of 1689   Subject ID Age/Sex/RaceVaccination 
Date Reported Condition Onset Date Analyzed1What caused you to seek medical care 
for this condition
C4591008 -2200564800 23/F/NOT 
REPORTED2020 -12-28 Other . Y
C4591008 -2209134144 34/F/WHITE 2021 -01-27 Other . Y
C4591008 -2210848320 38/M/WHITE 2020 -12-27 Brain or spinal cord inflammation 
(e.g., meningitis, encephalitis, 
Guillain -Barre syndrome)2020 -12-27 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -2215312448 33/F/WHITE 2020 -12-18 Pregnancy -related issue 2021 -04-02 Y
C4591008 -2219444800 28/F/WHITE 2020 -12-19 Other . Y
C4591008 -2245633600 45/F/WHITE 2021 -01-03 Multisystem inflammation 2021 -01-08 I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -2263410752 26/F/WHITE 2020 -12-24 Other . Y
C4591008 -2270638656 32/F/WHITE 2020 -12-18 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -03-23 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -2274637376 26/F/WHITE 2020 -12-29 Other . Y
C4591008 -2284058176 28/F/WHITE 2021 -01-22 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -02-08 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
C4591008 -2333776960 45/F/WHITE 2020 -12-27 Other . Y
45/F/WHITE 2020 -12-27 Other .
45/F/WHITE 2020 -12-27 Other .
C4591008 -2347687488 32/F/ASIAN 2020 -12-22 Other . Y
C4591008 -2350026816 52/M/WHITE 2021 -01-19 Other . Y
C4591008 -2364216896 56/F/WHITE 2020 -12-16 Other . Y
C4591008 -2364454976 28/F/WHITE 2020 -12-18 Other . Y
C4591008 -2372852288 30/M/WHITE 2020 -12-19 Other . Y
C4591008 -2375762496 28/F/WHITE 2020 -12-22 Other . Y
090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT) 
Page 11
FDA-CBER-2021-5683-1075358
Listing 7.7.7 Page 14of 72
BNT162b2 Protocol C4591008
Participant Reported Non -Hospitalization Safety Events of Interest
1: Duplicative events that occur on the same date or that appear as a hospitalized events on the same date are not analyzed.
PFIZER CONFIDENTIAL    SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021    Source Data: ADSL, ADEVENT, FA
Generated from /dcri/ct/hero_together/lists/l_event.sas on 24MAY2021 12:45 Page 1629 of 1689   Subject ID Age/Sex/RaceVaccination 
Date Reported Condition Onset Date Analyzed1What caused you to seek medical care 
for this condition
C4591008 -2379296320 61/M/ASIAN 2020 -12-19 Other . Y
C4591008 -2379337280 71/M/WHITE 2020 -12-22 Other . Y
C4591008 -2384319040 31/F/BLACK OR 
AFRICAN 
AMERICAN2021 -01-20 Other . Y
C4591008 -2384730688 65/F/WHITE 2020 -12-17 Stroke or possible stroke 2021 -04-13 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -2391426624 46/M/NOT 
REPORTED2020 -12-15 Other . Y
C4591008 -2413390912 57/F/WHITE 2020 -12-21 Other . Y
C4591008 -2425680960 41/F/WHITE 2020 -12-25 Other . Y
41/F/WHITE 2020 -12-25 Other .
C4591008 -2435924032 39/F/WHITE 2020 -12-23 Other . Y
C4591008 -2440907328 35/M/ASIAN 2020 -12-17 Other . Y
C4591008 -2461275712 61/F/WHITE 2021 -01-04 Other . Y
C4591008 -2473631808 52/F/WHITE 2021 -01-16 COVID -19 infection 2021 -01-27 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -2475358784 28/F/WHITE 2020 -12-17 Other . Y
C4591008 -2484208704 60/M/WHITE 2021 -02-18 Other . Y
60/M/WHITE 2021 -02-18 Other .
60/M/WHITE 2021 -02-18 Other .
C4591008 -2507008064 51/F/WHITE 2020 -12-21 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -03-27 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
51/F/WHITE 2020 -12-21 Other . Y
090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT) 
Page 12
FDA-CBER-2021-5683-1075359
Listing 7.7.7 Page 15of 72
BNT162b2 Protocol C4591008
Participant Reported Non -Hospitalization Safety Events of Interest
1: Duplicative events that occur on the same date or that appear as a hospitalized events on the same date are not analyzed.
PFIZER CONFIDENTIAL    SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021    Source Data: ADSL, ADEVENT, FA
Generated from /dcri/ct/hero_together/lists/l_event.sas on 24MAY2021 12:45 Page 1630 of 1689   Subject ID Age/Sex/RaceVaccination 
Date Reported Condition Onset Date Analyzed1What caused you to seek medical care 
for this condition
C4591008 -2507485760 52/F/WHITE 2020 -12-28 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -01-21 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
C4591008 -2509093440 32/F/WHITE 2020 -12-18 Severe allergic reaction (anaphylaxis) 2021 -01-08 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
C4591008 -2522327104 28/M/MULTIPLE 2020 -12-17 Other . Y
C4591008 -2547692096 27/F/WHITE 2021 -01-15 Other . Y
C4591008 -2560977472 38/F/WHITE 2021 -01-14 Other . Y
38/F/WHITE 2021 -01-14 Pregnancy -related issue 2021 -01-26 Y
C4591008 -2568285760 61/F/WHITE 2021 -01-12 Other . Y
C4591008 -2578543680 50/F/WHITE 2020 -12-21 Other . Y
C4591008 -2579699776 63/F/WHITE 2020 -12-28 Other . Y
C4591008 -2610591296 61/F/WHITE 2020 -12-17 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2020 -12-25 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
61/F/WHITE 2020 -12-17 Other . Y
C4591008 -2612198464 44/F/ASIAN 2020 -12-21 Other . Y
C4591008 -2631848512 40/F/WHITE 2021 -01-05 Nerve inflammation or autoimmune 
disease (e.g., multiple sclerosis, 
rheumatoid arthritis)2021 -03-26 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -2659419712 31/F/WHITE 2020 -12-18 Other . Y
C4591008 -2669941824 43/F/WHITE 2020 -12-18 Other . Y
43/F/WHITE 2020 -12-18 Other .
C4591008 -2671761984 52/M/WHITE 2020 -12-24 Other . Y
C4591008 -2718225472 43/F/WHITE 2020 -12-19 Other . Y
C4591008 -2732375104 24/F/WHITE 2021 -01-18 Other . Y
24/F/WHITE 2021 -01-18 Other .
090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT) 
Page 13
FDA-CBER-2021-5683-1075360
Listing 7.7.7 Page 16of 72
BNT162b2 Protocol C4591008
Participant Reported Non -Hospitalization Safety Events of Interest
1: Duplicative events that occur on the same date or that appear as a hospitalized events on the same date are not analyzed.
PFIZER CONFIDENTIAL    SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021    Source Data: ADSL, ADEVENT, FA
Generated from /dcri/ct/hero_together/lists/l_event.sas on 24MAY2021 12:45 Page 1631 of 1689   Subject ID Age/Sex/RaceVaccination 
Date Reported Condition Onset Date Analyzed1What caused you to seek medical care 
for this condition
24/F/WHITE 2021 -01-18 Other .
C4591008 -2746778176 31/F/WHITE 2021 -01-22 Other . Y
C4591008 -2747336768 28/F/WHITE 2021 -01-08 Pregnancy -related issue . Y
C4591008 -2759971904 58/F/WHITE 2021 -01-08 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -01-21 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
58/F/WHITE 2021 -01-08 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -03-19 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
C4591008 -2777284672 36/F/WHITE 2020 -12-30 Pregnancy -related issue 2021 -04-14 Y
C4591008 -2777749568 47/F/ASIAN 2020 -12-21 Generalized convulsions/seizures 2021 -02-07 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
C4591008 -2789468736 27/F/WHITE 2020 -12-30 Other . Y
C4591008 -2796962368 41/F/WHITE 2020 -12-30 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -02-08 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
41/F/WHITE 2020 -12-30 Other . Y
C4591008 -2800934464 38/F/WHITE 2020 -12-31 Other . Y
C4591008 -2804549696 61/F/UNKNOWN 2021 -01-13 Other . Y
61/F/UNKNOWN 2021 -01-13 Other .
C4591008 -2809013312 45/F/WHITE 2021 -01-06 Other . Y
C4591008 -2824705088 30/F/WHITE 2020 -12-18 Other . Y
C4591008 -2835227200 53/F/WHITE 2020 -12-23 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -04-28 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -2862784576 31/F/WHITE 2020 -12-17 Other . Y
090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT) 
Page 14
FDA-CBER-2021-5683-1075361
Listing 7.7.7 Page 17of 72
BNT162b2 Protocol C4591008
Participant Reported Non -Hospitalization Safety Events of Interest
1: Duplicative events that occur on the same date or that appear as a hospitalized events on the same date are not analyzed.
PFIZER CONFIDENTIAL    SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021    Source Data: ADSL, ADEVENT, FA
Generated from /dcri/ct/hero_together/lists/l_event.sas on 24MAY2021 12:45 Page 1632 of 1689   Subject ID Age/Sex/RaceVaccination 
Date Reported Condition Onset Date Analyzed1What caused you to seek medical care 
for this condition
C4591008 -2863329344 50/F/WHITE 2020 -12-28 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -01-25 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
C4591008 -2892559936 32/F/WHITE 2020 -12-24 Other . Y
C4591008 -2894498880 45/F/BLACK OR 
AFRICAN 
AMERICAN2020 -12-27 Other . Y
C4591008 -2896346688 60/F/WHITE 2020 -12-29 Other . Y
60/F/WHITE 2020 -12-29 Other .
C4591008 -2897037376 46/F/WHITE 2020 -12-28 Other . Y
C4591008 -2905939520 40/F/WHITE 2020 -12-23 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -03-03 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
C4591008 -2906257472 50/F/WHITE 2020 -12-16 Other . Y
50/F/WHITE 2020 -12-16 Other .
C4591008 -2908476480 61/F/WHITE 2020 -12-30 Other . Y
61/F/WHITE 2020 -12-30 Other .
C4591008 -2911732288 32// 2020 -12-11 Other . Y
C4591008 -2956826688 53/F/WHITE 2020 -12-28 Other . Y
53/F/WHITE 2020 -12-28 Other .
53/F/WHITE 2020 -12-28 Other .
C4591008 -2957756992 47/M/WHITE 2020 -12-19 Other . Y
47/M/WHITE 2020 -12-19 Other .
C4591008 -2964134464 44/F/WHITE 2020 -12-20 Other . Y
44/F/WHITE 2020 -12-20 Other .
44/F/WHITE 2020 -12-20 Other .
090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT) 
Page 15
FDA-CBER-2021-5683-1075362
Listing 7.7.7 Page 18of 72
BNT162b2 Protocol C4591008
Participant Reported Non -Hospitalization Safety Events of Interest
1: Duplicative events that occur on the same date or that appear as a hospitalized events on the same date are not analyzed.
PFIZER CONFIDENTIAL    SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021    Source Data: ADSL, ADEVENT, FA
Generated from /dcri/ct/hero_together/lists/l_event.sas on 24MAY2021 12:45 Page 1633 of 1689   Subject ID Age/Sex/RaceVaccination 
Date Reported Condition Onset Date Analyzed1What caused you to seek medical care 
for this condition
C4591008 -2981155392 31/F/WHITE 2020 -12-23 Non-severe allergic reaction 2021 -04-03 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -2987094592 52/F/WHITE 2020 -12-19 Other . Y
C4591008 -2996926016 34/F/WHITE 2020 -12-22 Other . Y
C4591008 -3011009600 50/F/WHITE 2021 -01-19 COVID -19 infection 2021 -02-03 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
50/F/WHITE 2021 -01-19 Other . Y
50/F/WHITE 2021 -01-19 Other .
C4591008 -3014384704 39/F/WHITE 2020 -12-29 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -04-16 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -3016589888 70/M/WHITE 2020 -12-22 Other . Y
C4591008 -3031816768 55/F/WHITE 2021 -01-03 Other . Y
C4591008 -3047070784 55/F/WHITE 2021 -01-04 Other . Y
C4591008 -3051295296 61/M/WHITE 2020 -12-18 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2020 -12-30 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
61/M/WHITE 2020 -12-18 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -02-09 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
61/M/WHITE 2020 -12-18 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -02-15 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
61/M/WHITE 2020 -12-18 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -03-04 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
61/M/WHITE 2020 -12-18 Other . Y
090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT) 
Page 16
FDA-CBER-2021-5683-1075363
Listing 7.7.7 Page 19of 72
BNT162b2 Protocol C4591008
Participant Reported Non -Hospitalization Safety Events of Interest
1: Duplicative events that occur on the same date or that appear as a hospitalized events on the same date are not analyzed.
PFIZER CONFIDENTIAL    SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021    Source Data: ADSL, ADEVENT, FA
Generated from /dcri/ct/hero_together/lists/l_event.sas on 24MAY2021 12:45 Page 1634 of 1689   Subject ID Age/Sex/RaceVaccination 
Date Reported Condition Onset Date Analyzed1What caused you to seek medical care 
for this condition
C4591008 -3057220672 40/F/WHITE 2020 -12-29 Other . Y
C4591008 -3059186752 25/F/WHITE 2020 -12-30 Non-severe allergic reaction 2021 -01-06 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -3059824704 42/F/BLACK OR 
AFRICAN 
AMERICAN2020 -12-24 Other . Y
C4591008 -3063080000 24/F/WHITE 2020 -12-30 COVID -19 infection 2021 -01-11 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -3071836224 50/M/ASIAN 2020 -12-21 Other . Y
C4591008 -3074546240 38/M/WHITE 2020 -12-22 Other . Y
C4591008 -3079821376 57/F/MULTIPLE 2021 -01-04 Other . Y
C4591008 -3081946688 40/F/WHITE 2020 -12-30 Other . Y
C4591008 -3093055040 40/F/WHITE 2021 -01-08 Pregnancy -related issue 2021 -01-15 Y
C4591008 -3095525952 34/F/WHITE 2021 -01-20 Fibromyalgia 2021 -04-06 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
34/F/WHITE 2021 -01-20 Other . Y
C4591008 -3122564672 34/M/NOT 
REPORTED2020 -12-22 Other . Y
34/M/NOT 
REPORTED2020 -12-22 Other .
C4591008 -3127480896 39/F/WHITE 2021 -01-04 Pregnancy -related issue 2021 -03-08 Y
39/F/WHITE 2021 -01-04 Pregnancy -related issue 2021 -05-02 Y
C4591008 -3134954560 50/F/WHITE 2021 -03-16 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -03-24 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT) 
Page 17
FDA-CBER-2021-5683-1075364
Listing 7.7.7 Page 20of 72
BNT162b2 Protocol C4591008
Participant Reported Non -Hospitalization Safety Events of Interest
1: Duplicative events that occur on the same date or that appear as a hospitalized events on the same date are not analyzed.
PFIZER CONFIDENTIAL    SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021    Source Data: ADSL, ADEVENT, FA
Generated from /dcri/ct/hero_together/lists/l_event.sas on 24MAY2021 12:45 Page 1635 of 1689   Subject ID Age/Sex/RaceVaccination 
Date Reported Condition Onset Date Analyzed1What caused you to seek medical care 
for this condition
C4591008 -3150917696 51/F/WHITE 2021 -01-03 Generalized convulsions/seizures 2021 -01-11 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
51/F/WHITE 2021 -01-03 Generalized convulsions/seizures 2021 -01-11 I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
51/F/WHITE 2021 -01-03 Generalized convulsions/seizures 2021 -01-11 I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
C4591008 -3153043520 34/F/WHITE 2020 -12-30 Other . Y
C4591008 -3156392000 24/F/WHITE 2020 -12-27 Other . Y
C4591008 -3162278976 35/F/WHITE 2021 -01-05 Other . Y
C4591008 -3168868928 59/F/WHITE 2020 -12-23 Other . Y
59/F/WHITE 2020 -12-23 Other .
C4591008 -3174303296 38/F/WHITE 2020 -12-27 Pregnancy -related issue 2021 -04-17 Y
C4591008 -3176920640 32/F/WHITE 2020 -12-18 Other . Y
32/F/WHITE 2020 -12-18 Other .
C4591008 -3190858304 56/F/WHITE 2020 -12-18 Other . Y
C4591008 -3202696256 24/F/WHITE 2021 -01-05 Other . Y
C4591008 -3217232448 36/F/WHITE 2021 -01-11 Pregnancy -related issue 2021 -02-01 Y
C4591008 -3265993280 51/F/WHITE 2020 -12-19 Other . Y
C4591008 -3267933248 53/F/WHITE 2020 -12-30 COVID -19 infection 2021 -01-14 Y I experienced new symptoms and was 
diagnosed with this condition for the first
time
C4591008 -3267960896 65/F/WHITE 2020 -12-24 Other . Y
65/F/WHITE 2020 -12-24 Other .
C4591008 -3280502336 24/F/WHITE 2021 -01-26 Other . Y
C4591008 -3291849792 37/F/WHITE 2021 -01-12 Other . Y
090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT) 
Page 18
FDA-CBER-2021-5683-1075365
Listing 7.7.7 Page 21of 72
BNT162b2 Protocol C4591008
Participant Reported Non -Hospitalization Safety Events of Interest
1: Duplicative events that occur on the same date or that appear as a hospitalized events on the same date are not analyzed.
PFIZER CONFIDENTIAL    SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021    Source Data: ADSL, ADEVENT, FA
Generated from /dcri/ct/hero_together/lists/l_event.sas on 24MAY2021 12:45 Page 1636 of 1689   Subject ID Age/Sex/RaceVaccination 
Date Reported Condition Onset Date Analyzed1What caused you to seek medical care 
for this condition
C4591008 -3298041408 34/F/BLACK OR 
AFRICAN 
AMERICAN2021 -02-25 Other . Y
C4591008 -3333224512 48/F/BLACK OR 
AFRICAN 
AMERICAN2020 -12-18 Other . Y
48/F/BLACK OR 
AFRICAN 
AMERICAN2020 -12-18 Other .
C4591008 -3354031168 26/F/WHITE 2021 -01-15 Other . Y
C4591008 -3355201088 29/F/WHITE 2020 -12-28 Other . Y
C4591008 -3362202688 34/M/WHITE 2020 -12-23 Other . Y
34/M/WHITE 2020 -12-23 Other .
C4591008 -3367344192 48/F/WHITE 2021 -01-05 Other . Y
C4591008 -3382531136 50/M/WHITE 2020 -12-26 Other . Y
C4591008 -3394409024 59/F/WHITE 2020 -12-20 Other . Y
C4591008 -3400986176 62/F/WHITE 2021 -01-04 Other . Y
62/F/WHITE 2021 -01-04 Other .
C4591008 -3407258176 31/F/ASIAN 2020 -12-22 Pregnancy -related issue 2021 -03-02 Y
C4591008 -3420198976 66/F/WHITE 2021 -01-17 Other . Y
C4591008 -3436368960 30/F/WHITE 2020 -12-31 Other . Y
C4591008 -3446372928 37/F/AMERICAN 
INDIAN OR 
ALASKA2020 -12-30 Other . Y
C4591008 -3455249472 39/F/WHITE 2020 -12-29 Other . Y
C4591008 -3468734528 51/F/WHITE 2020 -12-24 Other . Y
C4591008 -3475497536 38/F/WHITE 2020 -12-22 Other . Y
090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT) 
Page 19
FDA-CBER-2021-5683-1075366
Listing 7.7.7 Page 22of 72
BNT162b2 Protocol C4591008
Participant Reported Non -Hospitalization Safety Events of Interest
1: Duplicative events that occur on the same date or that appear as a hospitalized events on the same date are not analyzed.
PFIZER CONFIDENTIAL    SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021    Source Data: ADSL, ADEVENT, FA
Generated from /dcri/ct/hero_together/lists/l_event.sas on 24MAY2021 12:45 Page 1637 of 1689   Subject ID Age/Sex/RaceVaccination 
Date Reported Condition Onset Date Analyzed1What caused you to seek medical care 
for this condition
C4591008 -3479815744 41/F/WHITE 2020 -12-27 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -03-08 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -3483695680 44/M/WHITE 2020 -12-16 COVID -19 infection 2020 -12-23 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -3497354304 35/F/WHITE 2020 -12-22 Other . Y
C4591008 -3501168192 22/F/WHITE 2021 -01-09 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -02-12 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
C4591008 -3510733376 77/F/WHITE 2021 -01-20 Other . Y
C4591008 -3521409088 42/F/WHITE 2021 -02-04 Non-severe allergic reaction . Y I have been diagnosed with this condition, 
and I had a routine visit to manage my 
condition
C4591008 -3535619136 55/M/ASIAN 2020 -12-16 Nerve inflammation or autoimmune 
disease (e.g., multiple sclerosis, 
rheumatoid arthritis)2021 -04-28 Y I experienced new symptom s and was 
diagnosed with this condition for the first 
time
C4591008 -3564930112 32/F/WHITE 2020 -12-23 Other . Y
C4591008 -3569580608 42/M/MULTIPLE 2020 -12-17 Other . Y
C4591008 -3573233728 29/F/WHITE 2021 -01-05 Pregnancy -related issue 2021 -02-26 Y
29/F/WHITE 2021 -01-05 Pregnancy -related issue 2021 -03-08 Y
C4591008 -3574031936 42/F/WHITE 2020 -12-22 COVID -19 infection 2021 -01-13 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
42/F/WHITE 2020 -12-22 COVID -19 infection 2021 -01-21 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
42/F/WHITE 2020 -12-22 Other . Y
090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT) 
Page 20
FDA-CBER-2021-5683-1075367
Listing 7.7.7 Page 23of 72
BNT162b2 Protocol C4591008
Participant Reported Non -Hospitalization Safety Events of Interest
1: Duplicative events that occur on the same date or that appear as a hospitalized events on the same date are not analyzed.
PFIZER CONFIDENTIAL    SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021    Source Data: ADSL, ADEVENT, FA
Generated from /dcri/ct/hero_together/lists/l_event.sas on 24MAY2021 12:45 Page 1638 of 1689   Subject ID Age/Sex/RaceVaccination 
Date Reported Condition Onset Date Analyzed1What caused you to seek medical care 
for this condition
C4591008 -3577845312 36/F/WHITE 2021 -01-04 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -01-20 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
C4591008 -3580594752 56/F/WHITE 2020 -12-31 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -02-26 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -3601547840 49/F/WHITE 2021 -01-04 Other . Y
C4591008 -3605189184 39/F/WHITE 2020 -12-17 Severe allergic reaction (anaphylaxis) 2020 -12-17 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
39/F/WHITE 2020 -12-17 Severe allergic reaction (anaphylaxis) 2020 -12-17 I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -3615273024 48/F/BLACK OR 
AFRICAN 
AMERICAN2021 -01-28 Pregnancy -related issue 2021 -05-05 Y
C4591008 -3630380608 39/F/WHITE 2020 -12-17 Other . Y
C4591008 -3635974208 61/F/WHITE 2020 -12-31 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -02-23 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
61/F/WHITE 2020 -12-31 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -02-24 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -3639740992 39/F/WHITE 2021 -03-15 Other . Y
C4591008 -3686729280 44/F/WHITE 2020 -12-23 Other . Y
C4591008 -3692203072 36/M/WHITE 2020 -12-21 Other . Y
C4591008 -3710139456 43/F/BLACK OR 
AFRICAN 
AMERICAN2020 -12-24 Other . Y
090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT) 
Page 21
FDA-CBER-2021-5683-1075368
Listing 7.7.7 Page 24of 72
BNT162b2 Protocol C4591008
Participant Reported Non -Hospitalization Safety Events of Interest
1: Duplicative events that occur on the same date or that appear as a hospitalized events on the same date are not analyzed.
PFIZER CONFIDENTIAL    SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021    Source Data: ADSL, ADEVENT, FA
Generated from /dcri/ct/hero_together/lists/l_event.sas on 24MAY2021 12:45 Page 1639 of 1689   Subject ID Age/Sex/RaceVaccination 
Date Reported Condition Onset Date Analyzed1What caused you to seek medical care 
for this condition
C4591008 -3716823104 50/F/MULTIPLE 2021 -01-04 Other . Y
C4591008 -3723653184 42/F/WHITE 2021 -01-20 Other . Y
C4591008 -3725007936 35/F/WHITE 2020 -12-21 Other . Y
35/F/WHITE 2020 -12-21 Other .
C4591008 -3728036416 40/F/WHITE 2020 -12-22 Other . Y
C4591008 -3729419328 28/F/WHITE 2020 -12-29 Other . Y
C4591008 -3730242112 49/F/WHITE 2020 -12-17 Non-severe allergic reaction 2020 -12-17 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
49/F/WHITE 2020 -12-17 Non-severe allergic reaction 2020 -12-17 I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -3732766784 43/F/BLACK OR 
AFRICAN 
AMERICAN2020 -12-23 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -04-08 Y I experienced new symptoms and was 
diagnosed with this condi tion for the first 
time
C4591008 -3732792896 51/F/WHITE 2020 -12-27 Non-severe allergic reaction 2021 -03-27 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -3743528512 62/M/WHITE 2020 -12-19 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -02-25 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -3749780032 34/F/WHITE 2021 -03-10 Nerve inflammation or autoimmune 
disease (e.g., multiple sclerosis, 
rheumatoid arthritis)2021 -04-20 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
C4591008 -3757786176 46/F/WHITE 2020 -12-22 Other . Y
46/F/WHITE 2020 -12-22 Other .
C4591008 -3759154752 56/F/WHITE 2020 -12-22 Other . Y
C4591008 -3767956032 44/M/WHITE 2021 -03-17 Other . Y
C4591008 -3783455808 40/F/WHITE 2021 -01-14 Other . Y
090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT) 
Page 22
FDA-CBER-2021-5683-1075369
Listing 7.7.7 Page 25of 72
BNT162b2 Protocol C4591008
Participant Reported Non -Hospitalization Safety Events of Interest
1: Duplicative events that occur on the same date or that appear as a hospitalized events on the same date are not analyzed.
PFIZER CONFIDENTIAL    SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021    Source Data: ADSL, ADEVENT, FA
Generated from /dcri/ct/hero_together/lists/l_event.sas on 24MAY2021 12:45 Page 1640 of 1689   Subject ID Age/Sex/RaceVaccination 
Date Reported Condition Onset Date Analyzed1What caused you to seek medical care 
for this condition
C4591008 -3788418112 45/F/WHITE 2021 -01-20 Other . Y
45/F/WHITE 2021 -01-20 Other .
C4591008 -3790471232 60/F/WHITE 2020 -12-31 Other . Y
60/F/WHITE 2020 -12-31 Other .
C4591008 -3842806848 44/F/WHITE 2020 -12-16 COVID -19 infection 2020 -12-23 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -3876582464 36/F/MULTIPLE 2020 -12-23 Multisystem inflammation 2021 -04-26 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
C4591008 -3877485120 39/F/WHITE 2020 -12-21 Non-severe allergic reaction 2021 -02-10 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
39/F/WHITE 2020 -12-21 Non-severe allergic reaction 2021 -03-01 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
C4591008 -3888114240 36/F/WHITE 2020 -12-30 Other . Y
C4591008 -3897953856 52/M/WHITE 2021 -02-18 COVID -19 infection 2021 -04-15 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -3915550784 61/F/WHITE 2021 -01-28 Other . Y
C4591008 -3935747648 59/M/WHITE 2020 -12-22 Other . Y
C4591008 -3940079168 60/F/WHITE 2020 -12-09 Non-severe allergic reaction 2020 -12-09 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
60/F/WHITE 2020 -12-09 Other . Y
C4591008 -3953843776 77/M/WHITE 2020 -12-21 Other . Y
C4591008 -3954056768 37/F/WHITE 2020 -12-21 Other . Y
090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT) 
Page 23
FDA-CBER-2021-5683-1075370
Listing 7.7.7 Page 26of 72
BNT162b2 Protocol C4591008
Participant Reported Non -Hospitalization Safety Events of Interest
1: Duplicative events that occur on the same date or that appear as a hospitalized events on the same date are not analyzed.
PFIZER CONFIDENTIAL    SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021    Source Data: ADSL, ADEVENT, FA
Generated from /dcri/ct/hero_together/lists/l_event.sas on 24MAY2021 12:45 Page 1641 of 1689   Subject ID Age/Sex/RaceVaccination 
Date Reported Condition Onset Date Analyzed1What caused you to seek medical care 
for this condition
C4591008 -3963768384 27/F/WHITE 2020 -12-18 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -03-17 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -3965961280 52/F/WHITE 2020 -12-18 Nerve inflammation or autoimmune 
disease (e.g., multiple sclerosis, 
rheumatoid arthritis)2021 -02-01 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
C4591008 -3980071488 35/F/WHITE 2021 -01-20 Other . Y
C4591008 -3983246400 35/F/WHITE 2020 -12-30 Other . Y
C4591008 -3988402752 44/M/WHITE 2020 -12-28 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -04-14 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -4001335872 42/F/BLACK OR 
AFRICAN 
AMERICAN2021 -04-12 Non-severe allergic reaction 2021 -04-12 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
42/F/BLACK OR 
AFRICAN 
AMERICAN2021 -04-12 Non-severe allergic reaction 2021 -04-12 I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -4035549248 24/F/WHITE 2021 -01-11 Generalized convulsions/seizures 2021 -01-31 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
24/F/WHITE 2021 -01-11 Generalized convulsions/seizures 2021 -01-31 I experienced new symptoms and was 
diagnosed with this condition for the first 
time
24/F/WHITE 2021 -01-11 Other . Y
24/F/WHITE 2021 -01-11 Stroke or possible stroke 2021 -03-05 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
C4591008 -4046079552 45/F/WHITE 2021 -01-13 Heart attack (myocardial infarction) . Y I have been diagnosed with this condition, 
and I had a routine visit to manage my 
condition
090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT) 
Page 24
FDA-CBER-2021-5683-1075371
Listing 7.7.7 Page 27of 72
BNT162b2 Protocol C4591008
Participant Reported Non -Hospitalization Safety Events of Interest
1: Duplicative events that occur on the same date or that appear as a hospitalized events on the same date are not analyzed.
PFIZER CONFIDENTIAL    SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021    Source Data: ADSL, ADEVENT, FA
Generated from /dcri/ct/hero_together/lists/l_event.sas on 24MAY2021 12:45 Page 1642 of 1689   Subject ID Age/Sex/RaceVaccination 
Date Reported Condition Onset Date Analyzed1What caused you to seek medical care 
for this condition
C4591008 -4085878848 59/F/WHITE 2021 -02-19 COVID -19 infection 2021 -03-13 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
59/F/WHITE 2021 -02-19 Other . Y
C4591008 -4115927104 44/F/WHITE 2020 -12-22 Other . Y
C4591008 -4124789824 33/F/WHITE 2020 -12-31 Other . Y
C4591008 -4129811520 38/M/WHITE 2020 -12-30 Other . Y
C4591008 -4147402816 62/F/WHITE 2020 -12-30 Other . Y
C4591008 -4151323200 71/M/BLACK OR 
AFRICAN 
AMERICAN2020 -12-16 Other . Y
71/M/BLACK OR 
AFRICAN 
AMERICAN2020 -12-16 Other .
C4591008 -4156809792 42/F/WHITE 2021 -01-13 Other . Y
42/F/WHITE 2021 -01-13 Other .
C4591008 -4156864064 32/F/WHITE 2020 -12-20 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -03-16 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
C4591008 -4159892032 35/F/ASIAN 2021 -01-08 Pregnancy -related issue 2021 -02-16 Y
C4591008 -4167266880 39/F/WHITE 2020 -12-18 Pregnancy -related issue 2021 -04-02 Y
C4591008 -4169578560 48/F/WHITE 2020 -12-28 Other . Y
C4591008 -4173537856 42/F/WHITE 2020 -12-21 Other . Y
C4591008 -4174427712 27/F/WHITE 2020 -12-28 Pregnancy -related issue 2021 -01-16 Y
C4591008 -4197640768 46/F/WHITE 2020 -12-23 Other . Y
C4591008 -4202436672 42/F/WHITE 2021 -01-27 Non-severe allergic reaction 2021 -01-31 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT) 
Page 25
FDA-CBER-2021-5683-1075372
Listing 7.7.7 Page 28of 72
BNT162b2 Protocol C4591008
Participant Reported Non -Hospitalization Safety Events of Interest
1: Duplicative events that occur on the same date or that appear as a hospitalized events on the same date are not analyzed.
PFIZER CONFIDENTIAL    SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021    Source Data: ADSL, ADEVENT, FA
Generated from /dcri/ct/hero_together/lists/l_event.sas on 24MAY2021 12:45 Page 1643 of 1689   Subject ID Age/Sex/RaceVaccination 
Date Reported Condition Onset Date Analyzed1What caused you to seek medical care 
for this condition
C4591008 -4210263104 50/F/WHITE 2020 -12-16 Other . Y
C4591008 -4210342976 41/F/WHITE 2020 -12-23 Nerve inflammation or autoimmune 
disease (e.g., multiple sclerosis, 
rheumatoid arthritis)2021 -03-11 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -4217184832 30/F/WHITE 2020 -12-22 Other . Y
C4591008 -4221264448 54/F/WHITE 2020 -12-16 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -03-03 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -4228703808 52/F/WHITE 2020 -12-18 Other . Y
C4591008 -4253164608 38/M/WHITE 2021 -01-10 Other . Y
C4591008 -4256380992 39/F/WHITE 2021 -01-02 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -04-28 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
C4591008 -4272842304 47/F/BLACK OR 
AFRICAN 
AMERICAN2020 -12-29 Other . Y
47/F/BLACK OR 
AFRICAN 
AMERICAN2020 -12-29 Other .
C4591008 -4286986816 43/F/BLACK OR 
AFRICAN 
AMERICAN2021 -03-03 Non-severe allergic reaction 2021 -04-20 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
43/F/BLACK OR 
AFRICAN 
AMERICAN2021 -03-03 Other . Y
C4591008 -4308742720 62/F/WHITE 2020 -12-19 Other . Y
C4591008 -4320236096 36/F/WHITE 2020 -12-22 Other . Y
36/F/WHITE 2020 -12-22 Other .
C4591008 -4336126528 28/F/ASIAN 2021 -01-11 Other . Y
090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT) 
Page 26
FDA-CBER-2021-5683-1075373
Listing 7.7.7 Page 29of 72
BNT162b2 Protocol C4591008
Participant Reported Non -Hospitalization Safety Events of Interest
1: Duplicative events that occur on the same date or that appear as a hospitalized events on the same date are not analyzed.
PFIZER CONFIDENTIAL    SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021    Source Data: ADSL, ADEVENT, FA
Generated from /dcri/ct/hero_together/lists/l_event.sas on 24MAY2021 12:45 Page 1644 of 1689   Subject ID Age/Sex/RaceVaccination 
Date Reported Condition Onset Date Analyzed1What caused you to seek medical care 
for this condition
28/F/ASIAN 2021 -01-11 Other .
C4591008 -4338452032 38/F/WHITE 2020 -12-16 Other . Y
C4591008 -4394096192 53/F/WHITE 2020 -12-28 Other . Y
C4591008 -4397098560 60/F/WHITE 2020 -12-30 Other . Y
C4591008 -4408950848 37/M/WHITE 2020 -12-24 Other . Y
C4591008 -4409137216 43/F/WHITE 2020 -12-18 Other . Y
43/F/WHITE 2020 -12-18 Other .
C4591008 -4416803904 28/F/WHITE 2021 -01-23 Other . Y
C4591008 -4437597248 46/F/WHITE 2020 -12-24 Other . Y
C4591008 -4440653376 41/M/AMERICAN 
INDIAN OR 
ALASKA2020 -12-18 Other . Y
C4591008 -4444147776 51/F/WHITE 2021 -02-06 Other . Y
51/F/WHITE 2021 -02-06 Other .
C4591008 -4454205504 26/F/WHITE 2020 -12-31 Other . Y
C4591008 -4461247552 41/F/WHITE 2020 -12-28 Other . Y
C4591008 -4468236352 44/F/ASIAN 2020 -12-18 Other . Y
44/F/ASIAN 2020 -12-18 Other .
C4591008 -4491845696 47/F/WHITE 2021 -01-07 Other . Y
47/F/WHITE 2021 -01-07 Other .
C4591008 -4519694912 31/F/BLACK OR 
AFRICAN 
AMERICAN2021 -01-11 Other . Y
31/F/BLACK OR 
AFRICAN 
AMERICAN2021 -01-11 Other .
C4591008 -4522326592 51/F/WHITE 2020 -12-29 Other . Y
090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT) 
Page 27
FDA-CBER-2021-5683-1075374
Listing 7.7.7 Page 30of 72
BNT162b2 Protocol C4591008
Participant Reported Non -Hospitalization Safety Events of Interest
1: Duplicative events that occur on the same date or that appear as a hospitalized events on the same date are not analyzed.
PFIZER CONFIDENTIAL    SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021    Source Data: ADSL, ADEVENT, FA
Generated from /dcri/ct/hero_together/lists/l_event.sas on 24MAY2021 12:45 Page 1645 of 1689   Subject ID Age/Sex/RaceVaccination 
Date Reported Condition Onset Date Analyzed1What caused you to seek medical care 
for this condition
C4591008 -4530098752 68/F/WHITE 2020 -12-23 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -03-31 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
68/F/WHITE 2020 -12-23 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -03-31 I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
C4591008 -4544208960 50/F/WHITE 2020 -12-28 Other . Y
C4591008 -4547597376 33/F/WHITE 2020 -12-15 Pregnancy -related issue . Y
33/F/WHITE 2020 -12-15 Pregnancy -related issue 2021 -03-16 Y
C4591008 -4549152320 54/F/WHITE 2020 -12-28 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -02-09 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
54/F/WHITE 2020 -12-28 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -02-09 I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
C4591008 -4566011968 44/F/WHITE 2020 -12-28 Other . Y
C4591008 -4579830336 68/F/WHITE 2021 -01-27 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -01-28 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
68/F/WHITE 2021 -01-27 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -04-21 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
68/F/WHITE 2021 -01-27 Other . Y
68/F/WHITE 2021 -01-27 Other .
C4591008 -4603241024 29/F/WHITE 2021 -01-13 Pregnancy -related issue 2021 -03-30 Y
C4591008 -4615505472 35/F/WHITE 2020 -12-18 Other . Y
C4591008 -4635036736 36/F/WHITE 2020 -12-28 Other . Y
090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT) 
Page 28
FDA-CBER-2021-5683-1075375
Listing 7.7.7 Page 31of 72
BNT162b2 Protocol C4591008
Participant Reported Non -Hospitalization Safety Events of Interest
1: Duplicative events that occur on the same date or that appear as a hospitalized events on the same date are not analyzed.
PFIZER CONFIDENTIAL    SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021    Source Data: ADSL, ADEVENT, FA
Generated from /dcri/ct/hero_together/lists/l_event.sas on 24MAY2021 12:45 Page 1646 of 1689   Subject ID Age/Sex/RaceVaccination 
Date Reported Condition Onset Date Analyzed1What caused you to seek medical care 
for this condition
C4591008 -4636883008 55/F/BLACK OR 
AFRICAN 
AMERICAN2020 -12-22 Joint stiffness or pain (e.g., arthralgia, 
arthritis). Y I have been diagnosed with this condition, 
and I had a routine visit to manage my 
condition
C4591008 -4657902656 62/F/WHITE 2020 -12-30 Other . Y
C4591008 -4665197632 33/F/WHITE 2020 -12-21 Non-severe allergic reaction 2021 -01-12 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -4668551232 29/F/WHITE 2021 -02-04 Multisystem inflammation 2021 -03-19 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
29/F/WHITE 2021 -02-04 Other . Y
29/F/WHITE 2021 -02-04 Other .
C4591008 -4672066112 39/F/WHITE 2020 -12-16 Other . Y
C4591008 -4681141824 41/F/WHITE 2020 -12-26 Other . Y
C4591008 -4685220416 39/F/WHITE 2020 -12-22 Blood vessel inflammation (e.g., 
Kawasaki disease, vasculitides)2021 -04-27 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
39/F/WHITE 2020 -12-22 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -04-27 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
39/F/WHITE 2020 -12-22 Other . Y
C4591008 -4687823936 40/F/WHITE 2021 -01-07 COVID -19 infection 2021 -01-11 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
40/F/WHITE 2021 -01-07 Other . Y
C4591008 -4703236672 41/F/WHITE 2021 -01-05 Other . Y
C4591008 -4711500352 29/F/WHITE 2020 -12-23 Other . Y
C4591008 -4715235392 58/F/WHITE 2020 -12-19 Other . Y
090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT) 
Page 29
FDA-CBER-2021-5683-1075376
Listing 7.7.7 Page 32of 72
BNT162b2 Protocol C4591008
Participant Reported Non -Hospitalization Safety Events of Interest
1: Duplicative events that occur on the same date or that appear as a hospitalized events on the same date are not analyzed.
PFIZER CONFIDENTIAL    SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021    Source Data: ADSL, ADEVENT, FA
Generated from /dcri/ct/hero_together/lists/l_event.sas on 24MAY2021 12:45 Page 1647 of 1689   Subject ID Age/Sex/RaceVaccination 
Date Reported Condition Onset Date Analyzed1What caused you to seek medical care 
for this condition
C4591008 -4728135744 41/F/NOT 
REPORTED2020 -12-24 Other . Y
41/F/NOT 
REPORTED2020 -12-24 Other .
C4591008 -4759784512 34/F/MULTIPLE 2020 -12-21 Other . Y
C4591008 -4766434880 35/F/MULTIPLE 2021 -04-08 Other . Y
C4591008 -4774067776 34/F/WHITE 2021 -01-02 Other . Y
C4591008 -4780551232 54/F/WHITE 2020 -12-23 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2020 -12-31 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -4789280320 58/F/MULTIPLE 2021 -01-22 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -03-16 Y I have been diagnosed with this condition 
in the past, but my symptoms change d or 
got worse
C4591008 -4791751744 43/F/WHITE 2020 -12-22 Blood clot inside a vein in the body 
(thromboembolism)2021 -01-17 I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -4793160256 64/F/WHITE 2020 -12-18 Other . Y
64/F/WHITE 2020 -12-18 Other .
64/F/WHITE 2020 -12-18 Other .
64/F/WHITE 2020 -12-18 Other .
C4591008 -4793559104 37/M/WHITE 2020 -12-30 Other . Y
C4591008 -4809861696 50/F/WHITE 2020 -12-22 Other . Y
C4591008 -4814857792 58/F/WHITE 2020 -12-15 Other . Y
58/F/WHITE 2020 -12-15 Other .
58/F/WHITE 2020 -12-15 Other .
C4591008 -4821700672 65/F/WHITE 2021 -02-04 Joint stiffness or pain (e.g., arthralgia, 
arthritis). Y I have been diagnosed with this condition, 
and I had a routine visit to manage my 
condition
090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT) 
Page 30
FDA-CBER-2021-5683-1075377
Listing 7.7.7 Page 33of 72
BNT162b2 Protocol C4591008
Participant Reported Non -Hospitalization Safety Events of Interest
1: Duplicative events that occur on the same date or that appear as a hospitalized events on the same date are not analyzed.
PFIZER CONFIDENTIAL    SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021    Source Data: ADSL, ADEVENT, FA
Generated from /dcri/ct/hero_together/lists/l_event.sas on 24MAY2021 12:45 Page 1648 of 1689   Subject ID Age/Sex/RaceVaccination 
Date Reported Condition Onset Date Analyzed1What caused you to seek medical care 
for this condition
C4591008 -4822072384 34/F/WHITE 2021 -01-04 Pregnancy -related issue . Y
C4591008 -4835518016 48/F/WHITE 2020 -12-22 Other . Y
C4591008 -4836608576 60/M/WHITE 2021 -01-06 Other . Y
C4591008 -4841390656 27/F/WHITE 2020 -12-30 Other . Y
C4591008 -4843610176 35/F/WHITE 2020 -12-23 Other . Y
C4591008 -4843862080 56/F/WHITE 2020 -12-21 Severe allergic reaction (anaphylaxis) 2021 -02-02 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -4851197504 50/F/WHITE 2021 -01-13 Multisystem inflammation 2021 -01-21 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
C4591008 -4853056576 56/F/WHITE 2020 -12-28 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -03-08 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
56/F/WHITE 2020 -12-28 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -03-09 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -4858039872 41/F/WHITE 2021 -01-05 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -01-14 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -4858875968 50/F/WHITE 2021 -01-14 Other . Y
50/F/WHITE 2021 -01-14 Other .
C4591008 -4875059776 24/F/WHITE 2021 -01-13 Other . Y
24/F/WHITE 2021 -01-13 Other .
C4591008 -4885622848 32/F/WHITE 2020 -12-20 Other . Y
32/F/WHITE 2020 -12-20 Other .
C4591008 -4894166080 47/F/WHITE 2020 -12-26 Other . Y
47/F/WHITE 2020 -12-26 Other .
090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT) 
Page 31
FDA-CBER-2021-5683-1075378
Listing 7.7.7 Page 34of 72
BNT162b2 Protocol C4591008
Participant Reported Non -Hospitalization Safety Events of Interest
1: Duplicative events that occur on the same date or that appear as a hospitalized events on the same date are not analyzed.
PFIZER CONFIDENTIAL    SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021    Source Data: ADSL, ADEVENT, FA
Generated from /dcri/ct/hero_together/lists/l_event.sas on 24MAY2021 12:45 Page 1649 of 1689   Subject ID Age/Sex/RaceVaccination 
Date Reported Condition Onset Date Analyzed1What caused you to seek medical care 
for this condition
C4591008 -4896783936 46/F/WHITE 2020 -12-24 Other . Y
C4591008 -4905805376 31/M/WHITE 2021 -01-14 Other . Y
C4591008 -4908648512 41/F/WHITE 2021 -01-05 Other . Y
41/F/WHITE 2021 -01-05 Other .
C4591008 -4918799424 45/F/WHITE 2021 -01-21 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -02-12 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -4928259136 42/F/MULTIPLE 2021 -01-21 Other . Y
42/F/MULTIPLE 2021 -01-21 Other .
C4591008 -4932338240 51/F/WHITE 2020 -12-23 Nerve inflammation or autoimmune 
disease (e.g., multiple sclerosis, 
rheumatoid arthritis)2021 -02-01 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
51/F/WHITE 2020 -12-23 Other . Y
C4591008 -4935088192 40/F/WHITE 2021 -01-04 Other . Y
C4591008 -4944734272 38/F/WHITE 2021 -01-13 Other . Y
C4591008 -4945478720 41/F/WHITE 2021 -01-05 Other . Y
C4591008 -4950566976 30/F/WHITE 2020 -12-29 Pregnancy -related issue 2021 -04-11 Y
C4591008 -4962325568 62/F/WHITE 2021 -01-22 Other . Y
C4591008 -4963946560 32/F/WHITE 2020 -12-19 Other . Y
C4591008 -4965236288 64/F/WHITE 2020 -12-27 Non-severe allergic reaction 2021 -03-02 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -4983664704 52/F/WHITE 2021 -01-01 COVID -19 infection 2021 -01-17 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
52/F/WHITE 2021 -01-01 COVID -19 infection 2021 -01-17 I experienced new symptoms and was 
diagnosed with this condition for the first 
time
090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT) 
Page 32
FDA-CBER-2021-5683-1075379
Listing 7.7.7 Page 35of 72
BNT162b2 Protocol C4591008
Participant Reported Non -Hospitalization Safety Events of Interest
1: Duplicative events that occur on the same date or that appear as a hospitalized events on the same date are not analyzed.
PFIZER CONFIDENTIAL    SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021    Source Data: ADSL, ADEVENT, FA
Generated from /dcri/ct/hero_together/lists/l_event.sas on 24MAY2021 12:45 Page 1650 of 1689   Subject ID Age/Sex/RaceVaccination 
Date Reported Condition Onset Date Analyzed1What caused you to seek medical care 
for this condition
C4591008 -4994241088 51/F/WHITE 2021 -01-21 Other . Y
C4591008 -4997350464 29/F/BLACK OR 
AFRICAN 
AMERICAN2021 -02-12 Other . Y
29/F/BLACK OR 
AFRICAN 
AMERICAN2021 -02-12 Other .
C4591008 -5004126784 52/M/WHITE 2020 -12-21 Other . Y
C4591008 -5032930880 31/F/WHITE 2020 -12-23 Other . Y
C4591008 -5046350912 27/F/WHITE 2021 -01-20 Other . Y
C4591008 -5046390848 28/F/WHITE 2020 -12-28 Other . Y
28/F/WHITE 2020 -12-28 Other .
C4591008 -5058999872 64/F/WHITE 2021 -01-06 Other . Y
64/F/WHITE 2021 -01-06 Other .
C4591008 -5059691072 20/F/WHITE 2021 -01-14 Other . Y
20/F/WHITE 2021 -01-14 Other .
C4591008 -5064700480 38/F/WHITE 2020 -12-17 Other . Y
38/F/WHITE 2020 -12-17 Other .
C4591008 -5075409472 54/F/WHITE 2020 -12-28 Other . Y
54/F/WHITE 2020 -12-28 Other .
C4591008 -5084974656 30/F/MULTIPLE 2021 -01-05 Other . Y
C4591008 -5088987200 28/F/WHITE 2020 -12-22 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -02-09 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
28/F/WHITE 2020 -12-22 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -04-21 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT) 
Page 33
FDA-CBER-2021-5683-1075380
Listing 7.7.7 Page 36of 72
BNT162b2 Protocol C4591008
Participant Reported Non -Hospitalization Safety Events of Interest
1: Duplicative events that occur on the same date or that appear as a hospitalized events on the same date are not analyzed.
PFIZER CONFIDENTIAL    SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021    Source Data: ADSL, ADEVENT, FA
Generated from /dcri/ct/hero_together/lists/l_event.sas on 24MAY2021 12:45 Page 1651 of 1689   Subject ID Age/Sex/RaceVaccination 
Date Reported Condition Onset Date Analyzed1What caused you to seek medical care 
for this condition
C4591008 -5091260480 67/F/WHITE 2020 -12-28 COVID -19 infection . Y I have been diagnosed with this condition, 
and I had a routine visit to manage my 
condition
67/F/WHITE 2020 -12-28 COVID -19 infection 2021 -01-15 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
67/F/WHITE 2020 -12-28 COVID -19 infection 2021 -01-23 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
C4591008 -5101264448 46/F/WHITE 2020 -12-18 Other . Y
C4591008 -5119733312 47/F/WHITE 2020 -12-24 Other . Y
C4591008 -5143170112 29/F/WHITE 2021 -01-08 Other . Y
C4591008 -5151209024 61/F/WHITE 2020 -12-18 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -01-28 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
C4591008 -5154982464 50/F/WHITE 2020 -12-31 Other . Y
C4591008 -5192863296 38/F/WHITE 2020 -12-23 Other . Y
C4591008 -5207770688 45/F/WHITE 2020 -12-17 Other . Y
C4591008 -5233852480 53/M/WHITE 2021 -01-22 Other . Y
C4591008 -5234609728 31/F/WHITE 2020 -12-18 Other . Y
C4591008 -5235273280 61/F/BLACK OR 
AFRICAN 
AMERICAN2021 -01-04 Severe allergic reaction (anaphylaxis) 2021 -01-11 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
61/F/BLACK OR 
AFRICAN 
AMERICAN2021 -01-04 Severe allergic reaction (anaphylaxis) 2021 -01-26 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
C4591008 -5237998144 42/F/BLACK OR 
AFRICAN 
AMERICAN2021 -01-04 Blood clot inside a vein in the body 
(thromboembolism)2021 -02-18 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT) 
Page 34
FDA-CBER-2021-5683-1075381
Listing 7.7.7 Page 37of 72
BNT162b2 Protocol C4591008
Participant Reported Non -Hospitalization Safety Events of Interest
1: Duplicative events that occur on the same date or that appear as a hospitalized events on the same date are not analyzed.
PFIZER CONFIDENTIAL    SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021    Source Data: ADSL, ADEVENT, FA
Generated from /dcri/ct/hero_together/lists/l_event.sas on 24MAY2021 12:45 Page 1652 of 1689   Subject ID Age/Sex/RaceVaccination 
Date Reported Condition Onset Date Analyzed1What caused you to seek medical care 
for this condition
C4591008 -5245597760 46/F/WHITE 2020 -12-24 Other . Y
C4591008 -5248878656 43/F/WHITE 2020 -12-30 Non-severe allergic reaction 2021 -02-02 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -5253822528 63/M/WHITE 2020 -12-24 Other . Y
63/M/WHITE 2020 -12-24 Other .
63/M/WHITE 2020 -12-24 Other .
C4591008 -5268557376 64/F/WHITE 2021 -01-07 Other . Y
64/F/WHITE 2021 -01-07 Other .
64/F/WHITE 2021 -01-07 Other .
C4591008 -5272875072 56/F/WHITE 2020 -12-23 Other . Y
C4591008 -5273817664 49/F/WHITE 2020 -12-31 Other . Y
49/F/WHITE 2020 -12-31 Other .
49/F/WHITE 2020 -12-31 Other .
C4591008 -5287650368 40/F/WHITE 2020 -12-18 Other . Y
C4591008 -5294305856 43/F/WHITE 2020 -12-26 Other . Y
43/F/WHITE 2020 -12-26 Other .
C4591008 -5315060800 38/F/WHITE 2020 -12-18 Other . Y
38/F/WHITE 2020 -12-18 Other .
C4591008 -5320853056 45/F/WHITE 2020 -12-18 Other . Y
C4591008 -5331893824 41/F/WHITE 2020 -12-23 Other . Y
C4591008 -5426149440 31// 2020 -12-18 Other . Y
C4591008 -5433782848 39/M/WHITE 2021 -01-24 Multisystem inflammation 2021 -03-22 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
C4591008 -5438984256 53/F/WHITE 2020 -12-29 Other . Y
090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT) 
Page 35
FDA-CBER-2021-5683-1075382
Listing 7.7.7 Page 38of 72
BNT162b2 Protocol C4591008
Participant Reported Non -Hospitalization Safety Events of Interest
1: Duplicative events that occur on the same date or that appear as a hospitalized events on the same date are not analyzed.
PFIZER CONFIDENTIAL    SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021    Source Data: ADSL, ADEVENT, FA
Generated from /dcri/ct/hero_together/lists/l_event.sas on 24MAY2021 12:45 Page 1653 of 1689   Subject ID Age/Sex/RaceVaccination 
Date Reported Condition Onset Date Analyzed1What caused you to seek medical care 
for this condition
C4591008 -5441203264 42/F/WHITE 2021 -01-05 Non-severe allergic reaction 2021 -04-08 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -5452112448 41/F/WHITE 2020 -12-24 Other . Y
C4591008 -5453626944 50/F/WHITE 2020 -12-20 Non-severe allergic reaction 2020 -12-23 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
50/F/WHITE 2020 -12-20 Other . Y
C4591008 -5459286592 63/M/WHITE 2020 -12-24 COVID -19 infection . Y I have been diagnosed with this condition, 
and I had a routine visit to manage my 
condition
63/M/WHITE 2020 -12-24 COVID -19 infection . I have been diagnosed with this condition, 
and I had a routine visit to manage my 
condition
63/M/WHITE 2020 -12-24 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -02-12 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
C4591008 -5464880704 51/F/WHITE 2020 -12-27 Other . Y
C4591008 -5473237056 36/F/WHITE 2020 -12-18 Other . Y
C4591008 -5490974784 34/F/WHITE 2020 -12-26 Pregnancy -related issue . Y
C4591008 -5512260160 50/F/WHITE 2021 -01-14 Other . Y
C4591008 -5514359872 25/F/ASIAN 2021 -01-04 Blood vessel inflammation (e.g., 
Kawasaki disease, vasculitides)2021 -01-27 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -5519899712 27/F/WHITE 2020 -12-18 Other . Y
C4591008 -5523380800 51/F/WHITE 2020 -12-26 Other . Y
C4591008 -5532017728 64/F/WHITE 2020 -12-17 Other . Y
64/F/WHITE 2020 -12-17 Other .
64/F/WHITE 2020 -12-17 Other .
090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT) 
Page 36
FDA-CBER-2021-5683-1075383
Listing 7.7.7 Page 39of 72
BNT162b2 Protocol C4591008
Participant Reported Non -Hospitalization Safety Events of Interest
1: Duplicative events that occur on the same date or that appear as a hospitalized events on the same date are not analyzed.
PFIZER CONFIDENTIAL    SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021    Source Data: ADSL, ADEVENT, FA
Generated from /dcri/ct/hero_together/lists/l_event.sas on 24MAY2021 12:45 Page 1654 of 1689   Subject ID Age/Sex/RaceVaccination 
Date Reported Condition Onset Date Analyzed1What caused you to seek medical care 
for this condition
64/F/WHITE 2020 -12-17 Other .
C4591008 -5547084352 42/F/WHITE 2020 -12-28 Severe allergic reaction (anaphylaxis) 2020 -12-31 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -5567611968 63/F/WHITE 2020 -12-28 Other . Y
C4591008 -5574270016 60/F/WHITE 2020 -12-27 Other . Y
C4591008 -5578626624 37/F/WHITE 2020 -12-20 Other . Y
37/F/WHITE 2020 -12-20 Other .
C4591008 -5578880064 57/F/WHITE 2020 -12-23 Other . Y
C4591008 -5593987136 59/M/WHITE 2020 -12-16 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -02-25 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -5600589376 38/F/WHITE 2021 -01-09 Other . Y
C4591008 -5622779456 57/F/NOT 
REPORTED2021 -01-16 Other . Y
C4591008 -5650852928 40/F/WHITE 2020 -12-17 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -01-08 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -5652487744 65/F/WHITE 2020 -12-30 Other . Y
C4591008 -5654586432 75/M/WHITE 2021 -01-05 Abnormal blood clotting (e.g., 
disseminated intravascular 
coagulation, thrombocytopenia)2021 -03-01 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
75/M/WHITE 2021 -01-05 Other . Y
C4591008 -5659369536 58/F/WHITE 2020 -12-30 Other . Y
C4591008 -5662187072 63/F/WHITE 2021 -01-07 Other . Y
C4591008 -5665880128 47/M/WHITE 2021 -01-04 Other . Y
C4591008 -5690048576 49/F/WHITE 2020 -12-26 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -03-10 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT) 
Page 37
FDA-CBER-2021-5683-1075384
Listing 7.7.7 Page 40of 72
BNT162b2 Protocol C4591008
Participant Reported Non -Hospitalization Safety Events of Interest
1: Duplicative events that occur on the same date or that appear as a hospitalized events on the same date are not analyzed.
PFIZER CONFIDENTIAL    SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021    Source Data: ADSL, ADEVENT, FA
Generated from /dcri/ct/hero_together/lists/l_event.sas on 24MAY2021 12:45 Page 1655 of 1689   Subject ID Age/Sex/RaceVaccination 
Date Reported Condition Onset Date Analyzed1What caused you to seek medical care 
for this condition
C4591008 -5702245440 42/F/WHITE 2020 -12-27 Non-severe allergic reaction 2021 -01-06 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -5706817600 32/F/WHITE 2020 -12-21 Other . Y
C4591008 -5733682752 42/F/WHITE 2020 -12-30 Other . Y
C4591008 -5735502400 43/F/BLACK OR 
AFRICAN 
AMERICAN2020 -12-18 Fibromyalgia 2021 -01-08 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
C4591008 -5737442880 52/M/WHITE 2020 -12-22 Other . Y
C4591008 -5752309824 52/F/BLACK OR 
AFRICAN
AMERICAN2020 -12-23 Other . Y
C4591008 -5752709184 24/F/WHITE 2020 -12-28 Other . Y
C4591008 -5761822784 24/F/WHITE 2020 -12-21 Other . Y
24/F/WHITE 2020 -12-21 Other .
24/F/WHITE 2020 -12-21 Other .
C4591008 -5785341504 37/M/WHITE 2020 -12-24 Other . Y
C4591008 -5793790528 43/F/WHITE 2021 -01-02 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -02-26 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
C4591008 -5803158592 35/F/WHITE 2021 -02-08 Pregnancy -related issue . Y
C4591008 -5814797888 63/F/WHITE 2021 -01-20 Other . Y
63/F/WHITE 2021 -01-20 Other .
C4591008 -5824895552 61/F/WHITE 2020 -12-19 Other . Y
61/F/WHITE 2020 -12-19 Other .
C4591008 -5836613696 35/F/WHITE 2021 -01-05 Other . Y
35/F/WHITE 2021 -01-05 Other .
C4591008 -5841051200 33/F/WHITE 2021 -01-03 Pregnancy -related issue 2021 -04-19 Y
090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT) 
Page 38
FDA-CBER-2021-5683-1075385
Listing 7.7.7 Page 41of 72
BNT162b2 Protocol C4591008
Participant Reported Non -Hospitalization Safety Events of Interest
1: Duplicative events that occur on the same date or that appear as a hospitalized events on the same date are not analyzed.
PFIZER CONFIDENTIAL    SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021    Source Data: ADSL, ADEVENT, FA
Generated from /dcri/ct/hero_together/lists/l_event.sas on 24MAY2021 12:45 Page 1656 of 1689   Subject ID Age/Sex/RaceVaccination 
Date Reported Condition Onset Date Analyzed1What caused you to seek medical care 
for this condition
C4591008 -5849541184 53/F/WHITE 2020 -12-30 Other . Y
C4591008 -5868328512 46/F/WHITE 2020 -12-21 Other . Y
C4591008 -5906754112 56/M/WHITE 2020 -12-18 Nerve inflammation or autoimmune 
disease (e.g., multiple sclerosis, 
rheumatoid arthritis)2020 -12-29 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
56/M/WHITE 2020 -12-18 Nerve inflammation or autoimmune 
disease (e.g., multiple sclerosis, 
rheumatoid arthritis)2021 -01-22 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
C4591008 -5911669824 56/F/WHITE 2020 -12-28 Other . Y
C4591008 -5913503296 65/F/WHITE 2020 -12-22 Other . Y
C4591008 -5914985536 34/M/WHITE 2021 -04-16 Joint stiffness or pain (e.g., arthralgia, 
arthritis). Y I have been diagnosed with this condition, 
and I had a routine visit to manage my 
condition
C4591008 -5922166336 32/F/WHITE 2020 -12-18 Other . Y
C4591008 -5941260352 42/M/WHITE 2020 -12-23 Multisystem inflammation 2021 -01-22 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
42/M/WHITE 2020 -12-23 Other . Y
C4591008 -5962743360 55/F/WHITE 2021 -01-01 Other . Y
55/F/WHITE 2021 -01-01 Other .
55/F/WHITE 2021 -01-01 Other .
C4591008 -5973625408 37/M/WHITE 2020 -12-24 Other . Y
37/M/WHITE 2020 -12-24 Other .
C4591008 -5973639232 30/F/WHITE 2020 -12-17 Other . Y
C4591008 -5995097664 48/F/WHITE 2021 -01-04 Other . Y
C4591008 -6000983616 31/F/WHITE 2020 -12-21 Other . Y
C4591008 -6014043200 32/F/WHITE 2021 -01-19 Other . Y
32/F/WHITE 2021 -01-19 Other .
090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT) 
Page 39
FDA-CBER-2021-5683-1075386
Listing 7.7.7 Page 42of 72
BNT162b2 Protocol C4591008
Participant Reported Non -Hospitalization Safety Events of Interest
1: Duplicative events that occur on the same date or that appear as a hospitalized events on the same date are not analyzed.
PFIZER CONFIDENTIAL    SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021    Source Data: ADSL, ADEVENT, FA
Generated from /dcri/ct/hero_together/lists/l_event.sas on 24MAY2021 12:45 Page 1657 of 1689   Subject ID Age/Sex/RaceVaccination 
Date Reported Condition Onset Date Analyzed1What caused you to seek medical care 
for this condition
C4591008 -6024049216 41/F/WHITE 2020 -12-23 Other . Y
C4591008 -6027862080 41/F/WHITE 2021 -01-19 Multisystem inflammation 2021 -04-23 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -6039368768 40/F/WHITE 2020 -12-29 Other . Y
40/F/WHITE 2020 -12-29 Other .
C4591008 -6047944256 58/F/WHITE 2021 -03-07 Other . Y
C4591008 -6071229504 44/F/WHITE 2020 -12-29 Other . Y
C4591008 -6078125120 36/F/WHITE 2020 -12-18 Other . Y
C4591008 -6079693888 42/F/WHITE 2020 -12-18 Other . Y
C4591008 -6087187520 44/F/WHITE 2020 -12-20 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -03-28 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
44/F/WHITE 2020 -12-20 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -04-19 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -6091717184 32/F/WHITE 2021 -01-15 COVID -19 infection 2021 -03-14 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -6097616960 36/F/WHITE 2020 -12-18 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -01-26 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
36/F/WHITE 2020 -12-18 Other . Y
C4591008 -6100293696 64/M/WHITE 2021 -01-28 Other . Y
64/M/WHITE 2021 -01-28 Other .
C4591008 -6108896832 51/F/WHITE 2021 -01-02 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -01-06 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT) 
Page 40
FDA-CBER-2021-5683-1075387
Listing 7.7.7 Page 43of 72
BNT162b2 Protocol C4591008
Participant Reported Non -Hospitalization Safety Events of Interest
1: Duplicative events that occur on the same date or that appear as a hospitalized events on the same date are not analyzed.
PFIZER CONFIDENTIAL    SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021    Source Data: ADSL, ADEVENT, FA
Generated from /dcri/ct/hero_together/lists/l_event.sas on 24MAY2021 12:45 Page 1658 of 1689   Subject ID Age/Sex/RaceVaccination 
Date Reported Condition Onset Date Analyzed1What caused you to seek medical care 
for this condition
51/F/WHITE 2021 -01-02 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -03-21 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
C4591008 -6109469248 30/F/WHITE 2020 -12-21 Other . Y
C4591008 -6120217664 42/M/WHITE 2020 -12-16 Other . Y
C4591008 -6126316608 33/F/WHITE 2021 -01-08 Other . Y
C4591008 -6132958784 49/F/WHITE 2020 -12-22 Other . Y
C4591008 -6134619712 51/F/WHITE 2020 -12-29 Other . Y
C4591008 -6150590016 35/F/WHITE 2020 -12-17 Other . Y
C4591008 -6173064256 31/F/WHITE 2021 -03-12 Other . Y
C4591008 -6174307392 49/M/WHITE 2020 -12-18 Other . Y
C4591008 -6233963584 52/F/WHITE 2021 -01-18 Other . Y
C4591008 -6238388288 31/M/ASIAN 2020 -12-22 Other . Y
C4591008 -6245517888 34/F/WHITE 2021 -02-23 Other . Y
C4591008 -6251702336 50/F/WHITE 2020 -12-31 Other . Y
C4591008 -6312687168 40/M/WHITE 2020 -12-27 Other . Y
C4591008 -6315371584 60/F/WHITE 2020 -12-26 Other . Y
C4591008 -6329136704 27/F/WHITE 2020 -12-22 Other . Y
C4591008 -6330424896 45/F/WHITE 2021 -01-07 Blood clot inside a vein in the body 
(thromboembolism)2021 -01-27 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -6363044416 51/F/WHITE 2020 -12-24 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -02-05 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
C4591008 -6368072768 29/F/MULTIPLE 2021 -03-11 Other . Y
C4591008 -6385153600 38/M/WHITE 2020 -12-28 Other . Y
090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT) 
Page 41
FDA-CBER-2021-5683-1075388
Listing 7.7.7 Page 44of 72
BNT162b2 Protocol C4591008
Participant Reported Non -Hospitalization Safety Events of Interest
1: Duplicative events that occur on the same date or that appear as a hospitalized events on the same date are not analyzed.
PFIZER CONFIDENTIAL    SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021    Source Data: ADSL, ADEVENT, FA
Generated from /dcri/ct/hero_together/lists/l_event.sas on 24MAY2021 12:45 Page 1659 of 1689   Subject ID Age/Sex/RaceVaccination 
Date Reported Condition Onset Date Analyzed1What caused you to seek medical care 
for this condition
C4591008 -6407886912 38/F/WHITE 2020 -12-29 Autoimmune thyroiditis 2021 -03-26 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
C4591008 -6420509248 22/F/WHITE 2020 -12-28 Other . Y
22/F/WHITE 2020 -12-28 Other .
22/F/WHITE 2020 -12-28 Other .
C4591008 -6420868160 40/F/WHITE 2020 -12-31 Other . Y
C4591008 -6436705856 43/F/WHITE 2021 -01-03 Other . Y
C4591008 -6436957248 43/F/WHITE 2020 -12-26 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -03-11 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
C4591008 -6442125888 44/M/WHITE 2020 -12-21 Other . Y
C4591008 -6444464704 60/M/WHITE 2020 -12-24 Other . Y
C4591008 -6445487168 41/F/WHITE 2021 -01-12 Other . Y
C4591008 -6467635776 55/M/WHITE 2020 -12-18 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -01-07 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -6470638656 37/F/WHITE 2020 -12-17 Other . Y
C4591008 -6479421504 54/M/WHITE 2020 -12-30 Other . Y
54/M/WHITE 2020 -12-30 Other .
54/M/WHITE 2020 -12-30 Other .
C4591008 -6479714368 38/F/WHITE 2020 -12-23 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -04-21 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
C4591008 -6490289728 37/F/WHITE 2021 -01-19 Other . Y
C4591008 -6506326592 41/F/WHITE 2020 -12-17 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -01-12 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT) 
Page 42
FDA-CBER-2021-5683-1075389
Listing 7.7.7 Page 45of 72
BNT162b2 Protocol C4591008
Participant Reported Non -Hospitalization Safety Events of Interest
1: Duplicative events that occur on the same date or that appear as a hospitalized events on the same date are not analyzed.
PFIZER CONFIDENTIAL    SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021    Source Data: ADSL, ADEVENT, FA
Generated from /dcri/ct/hero_together/lists/l_event.sas on 24MAY2021 12:45 Page 1660 of 1689   Subject ID Age/Sex/RaceVaccination 
Date Reported Condition Onset Date Analyzed1What caused you to seek medical care 
for this condition
41/F/WHITE 2020 -12-17 Non-severe allergic reaction 2021 -01-21 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
gotworse
41/F/WHITE 2020 -12-17 Other . Y
41/F/WHITE 2020 -12-17 Other .
C4591008 -6508732480 47/M/WHITE 2020 -12-28 Other . Y
C4591008 -6515228736 63/M/WHITE 2020 -12-21 Other . Y
63/M/WHITE 2020 -12-21 Other .
C4591008 -6520291392 50/F/WHITE 2021 -01-08 Other . Y
50/F/WHITE 2021 -01-08 Other .
C4591008 -6537112640 44/F/WHITE 2021 -01-05 Other . Y
C4591008 -6544553024 50/F/WHITE 2021 -02-01 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -02-06 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
50/F/WHITE 2021 -02-01 Nerve inflammation or autoimmune 
disease (e.g., multiple sclerosis, 
rheumatoid arthritis)2021 -02-26 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
50/F/WHITE 2021 -02-01 Other . Y
50/F/WHITE 2021 -02-01 Other .
50/F/WHITE 2021 -02-01 Other .
C4591008 -6547448896 36/F/WHITE 2021 -01-07 Other . Y
C4591008 -6556483648 52/F/WHITE 2021 -01-05 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -03-18 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
C4591008 -6562157120 36/F/WHITE 2020 -12-21 Other . Y
C4591008 -6569997376 54/F/WHITE 2020 -12-24 Other . Y
C4591008 -6581755968 57/F/WHITE 2021 -01-20 Other . Y
C4591008 -6581862464 54/F/WHITE 2020 -12-30 Other . Y
090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT) 
Page 43
FDA-CBER-2021-5683-1075390
Listing 7.7.7 Page 46of 72
BNT162b2 Protocol C4591008
Participant Reported Non -Hospitalization Safety Events of Interest
1: Duplicative events that occur on the same date or that appear as a hospitalized events on the same date are not analyzed.
PFIZER CONFIDENTIAL    SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021    Source Data: ADSL, ADEVENT, FA
Generated from /dcri/ct/hero_together/lists/l_event.sas on 24MAY2021 12:45 Page 1661 of 1689   Subject ID Age/Sex/RaceVaccination 
Date Reported Condition Onset Date Analyzed1What caused you to seek medical care 
for this condition
C4591008 -6599347776 23/F/WHITE 2020 -12-30 Other . Y
C4591008 -6602017344 50/F/WHITE 2020 -12-17 Other . Y
C4591008 -6602868288 56/F/WHITE 2020 -12-18 Other . Y
C4591008 -6608195648 38/F/WHITE 2021 -01-12 Other . Y
C4591008 -6641094208 66/M/WHITE 2020 -12-16 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -01-28 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -6644494400 40/M/WHITE 2020 -12-22 COVID -19 infection 2021 -04-30 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
40/M/WHITE 2020 -12-22 COVID -19 infection 2021 -05-06 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
40/M/WHITE 2020 -12-22 Other . Y
C4591008 -6654341184 43/F/WHITE 2020 -12-22 COVID -19 infection 2020 -12-30 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
43/F/WHITE 2020 -12-22 COVID -19 infection 2021 -01-07 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
43/F/WHITE 2020 -12-22 COVID -19 infection 2021 -01-21 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
43/F/WHITE 2020 -12-22 Other . Y
43/F/WHITE 2020 -12-22 Other .
C4591008 -6689058880 43/F/WHITE 2021 -01-21 Other . Y
43/F/WHITE 2021 -01-21 Other .
C4591008 -6702239296 63/F/WHITE 2021 -01-07 Other . Y
090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT) 
Page 44
FDA-CBER-2021-5683-1075391
Listing 7.7.7 Page 47of 72
BNT162b2 Protocol C4591008
Participant Reported Non -Hospitalization Safety Events of Interest
1: Duplicative events that occur on the same date or that appear as a hospitalized events on the same date are not analyzed.
PFIZER CONFIDENTIAL    SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021    Source Data: ADSL, ADEVENT, FA
Generated from /dcri/ct/hero_together/lists/l_event.sas on 24MAY2021 12:45 Page 1662 of 1689   Subject ID Age/Sex/RaceVaccination 
Date Reported Condition Onset Date Analyzed1What caused you to seek medical care 
for this condition
C4591008 -6723204672 45/F/WHITE 2020 -12-30 Non-severe allergic reaction 2021 -02-17 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
45/F/WHITE 2020 -12-30 Other . Y
C4591008 -6724626496 50/M/WHITE 2020 -12-20 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -01-22 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -6749883968 40/F/WHITE 2021 -01-21 Other . Y
C4591008 -6763981376 37/F/WHITE 2020 -12-30 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -03-04 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
C4591008 -6767635520 40/M/WHITE 2020 -12-18 Non-severe allergic reaction 2021 -01-13 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
C4591008 -6768711744 40/F/WHITE 2020 -12-22 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -02-15 Y I experienced new symptoms and was 
diagnosed with this condition f or the first 
time
40/F/WHITE 2020 -12-22 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -03-05 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
C4591008 -6778689600 53/F/WHITE 2021 -01-08 Other . Y
C4591008 -6783446592 31/F/WHITE 2020 -12-22 Pregnancy -related issue 2021 -04-12 Y
C4591008 -6793876032 47/F/WHITE 2020 -12-20 COVID -19 infection 2021 -05-06 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
47/F/WHITE 2020 -12-20 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -04-05 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -6812345920 39/F/WHITE 2021 -01-06 Other . Y
090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT) 
Page 45
FDA-CBER-2021-5683-1075392
Listing 7.7.7 Page 48of 72
BNT162b2 Protocol C4591008
Participant Reported Non -Hospitalization Safety Events of Interest
1: Duplicative events that occur on the same date or that appear as a hospitalized events on the same date are not analyzed.
PFIZER CONFIDENTIAL    SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021    Source Data: ADSL, ADEVENT, FA
Generated from /dcri/ct/hero_together/lists/l_event.sas on 24MAY2021 12:45 Page 1663 of 1689   Subject ID Age/Sex/RaceVaccination 
Date Reported Condition Onset Date Analyzed1What caused you to seek medical care 
for this condition
C4591008 -6821393472 40/M/WHITE 2021 -02-11 COVID -19 infection 2021 -02-15 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -6830880320 65/F/WHITE 2021 -01-15 Other . Y
C4591008 -6849839680 34/F/WHITE 2020 -12-28 Pregnancy -related issue . Y
C4591008 -6859857984 39/F/WHITE 2020 -12-28 Other . Y
C4591008 -6863326272 64/M/WHITE 2020 -12-23 Heart attack (myocardial infarction) 2020 -12-30 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
64/M/WHITE 2020 -12-23 Other . Y
C4591008 -6870235200 39/F/WHITE 2020 -12-22 Other . Y
C4591008 -6877741632 52/F/WHITE 2020 -12-31 Other . Y
C4591008 -6884012608 59/F/WHITE 2020 -12-27 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -02-23 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
59/F/WHITE 2020 -12-27 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -03-17 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
gotworse
C4591008 -6899451968 74/M/WHITE 2020 -12-31 Other . Y
C4591008 -6906308160 33/F/WHITE 2021 -01-08 Other . Y
C4591008 -6920378944 55/F/WHITE 2020 -12-28 Non-severe allergic reaction 2021 -03-19 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -6943417920 39/F/WHITE 2021 -01-06 Other . Y
C4591008 -6947576384 53/F/WHITE 2020 -12-21 Other . Y
C4591008 -6956386368 48/F/WHITE 2021 -02-26 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -03-27 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
48/F/WHITE 2021 -02-26 Other . Y
090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT) 
Page 46
FDA-CBER-2021-5683-1075393
Listing 7.7.7 Page 49of 72
BNT162b2 Protocol C4591008
Participant Reported Non -Hospitalization Safety Events of Interest
1: Duplicative events that occur on the same date or that appear as a hospitalized events on the same date are not analyzed.
PFIZER CONFIDENTIAL    SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021    Source Data: ADSL, ADEVENT, FA
Generated from /dcri/ct/hero_together/lists/l_event.sas on 24MAY2021 12:45 Page 1664 of 1689   Subject ID Age/Sex/RaceVaccination 
Date Reported Condition Onset Date Analyzed1What caused you to seek medical care 
for this condition
C4591008 -6962232384 24/M/WHITE 2021 -02-26 Other . Y
C4591008 -6966642752 58/F/WHITE 2020 -12-21 Joint stiffness or pain (e.g., arthralgia,
arthritis)2021 -01-20 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
58/F/WHITE 2020 -12-21 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -01-20 I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
58/F/WHITE 2020 -12-21 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -01-29 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
58/F/WHITE 2020 -12-21 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -02-03 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
C4591008 -6967400000 43/F/WHITE 2020 -12-23 Other . Y
C4591008 -6981576768 51/F/BLACK OR 
AFRICAN 
AMERICAN2021 -01-08 Fibromyalgia 2021 -04-26 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
51/F/BLACK OR 
AFRICAN 
AMERICAN2021 -01-08 Nerve inflammation or autoimmune 
disease (e.g., multiple sclerosis, 
rheumatoid arthritis)2021 -03-12 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
C4591008 -6989828672 68/F/WHITE 2020 -12-22 Other . Y
C4591008 -7016773184 59/M/WHITE 2020 -12-17 Other . Y
59/M/WHITE 2020 -12-17 Other .
C4591008 -7029847104 28/F/ASIAN 2020 -12-19 Other . Y
C4591008 -7050521152 34/F/WHITE 2020 -12-18 Pregnancy -related issue 2021 -01-07 Y
34/F/WHITE 2020 -12-18 Pregnancy -related issue 2021 -01-15 Y
C4591008 -7050574400 33/F/WHITE 2020 -12-17 Other . Y
C4591008 -7059185216 32/F/WHITE 2020 -12-17 Pregnancy -related issue 2021 -02-03 Y
32/F/WHITE 2020 -12-17 Pregnancy -related issue 2021 -02-03
090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT) 
Page 47
FDA-CBER-2021-5683-1075394
Listing 7.7.7 Page 50of 72
BNT162b2 Protocol C4591008
Participant Reported Non -Hospitalization Safety Events of Interest
1: Duplicative events that occur on the same date or that appear as a hospitalized events on the same date are not analyzed.
PFIZER CONFIDENTIAL    SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021    Source Data: ADSL, ADEVENT, FA
Generated from /dcri/ct/hero_together/lists/l_event.sas on 24MAY2021 12:45 Page 1665 of 1689   Subject ID Age/Sex/RaceVaccination 
Date Reported Condition Onset Date Analyzed1What caused you to seek medical care 
for this condition
C4591008 -7082316864 34/F/WHITE 2021 -01-14 Other . Y
C4591008 -7096240192 63/F/WHITE 2020 -12-21 Other . Y
C4591008 -7096852032 36/F/WHITE 2021 -01-15 Other . Y
C4591008 -7111109184 33/F/WHITE 2020 -12-26 Other . Y
C4591008 -7119080512 28/F/WHITE 2020 -12-21 Other . Y
28/F/WHITE 2020 -12-21 Other .
C4591008 -7123491392 37/F/WHITE 2020 -12-18 Other . Y
C4591008 -7125882944 50// 2020 -12-16 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -01-10 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -7138227264 31/F/WHITE 2020 -12-19 Pregnancy -related issue 2021 -04-22 Y
C4591008 -7148504640 34/F/WHITE 2021 -01-11 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -04-07 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
C4591008 -7160681024 50/F/WHITE 2020 -12-28 Other . Y
C4591008 -7166381120 29/M/NOT 
REPORTED2020 -12-17 Other . Y
C4591008 -7170925120 40/F/WHITE 2020 -12-30 Fibromyalgia 2021 -01-01 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
C4591008 -7179522112 40/F/WHITE 2020 -12-21 Other . Y
C4591008 -7191518784 45/F/WHITE 2020 -12-19 Other . Y
C4591008 -7199265344 34/F/WHITE 2020 -12-27 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -01-29 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
34/F/WHITE 2020 -12-27 Nerve inflammation or autoimmune 
disease (e.g., multiple sclerosis, 
rheumatoid arthritis)2021 -02-04 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -7210851904 32/M/WHITE 2020 -12-30 Other . Y
090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT) 
Page 48
FDA-CBER-2021-5683-1075395
Listing 7.7.7 Page 51of 72
BNT162b2 Protocol C4591008
Participant Reported Non -Hospitalization Safety Events of Interest
1: Duplicative events that occur on the same date or that appear as a hospitalized events on the same date are not analyzed.
PFIZER CONFIDENTIAL    SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021    Source Data: ADSL, ADEVENT, FA
Generated from /dcri/ct/hero_together/lists/l_event.sas on 24MAY2021 12:45 Page 1666 of 1689   Subject ID Age/Sex/RaceVaccination 
Date Reported Condition Onset Date Analyzed1What caused you to seek medical care 
for this condition
C4591008 -7211583040 57/F/WHITE 2020 -12-23 Other . Y
C4591008 -7212247104 53/F/WHITE 2020 -12-22 Other . Y
C4591008 -7233133632 36/F/WHITE 2020 -12-16 Other . Y
C4591008 -7235258432 31/F/WHITE 2020 -12-18 Other . Y
C4591008 -7249900608 32/F/WHITE 2020 -12-20 Other . Y
C4591008 -7271517760 54/M/WHITE 2021 -01-14 Death 2021 -03-04 Y
C4591008 -7305239104 36/F/WHITE 2021 -01-06 Non-severe allergic reaction . Y I have been diagnosed with this condition, 
and I had a routine visit to manage my 
condition
36/F/WHITE 2021 -01-06 Non-severe allergic reaction . I have been diagnosed with this condition, 
and I had a routine visit to manage my 
condition
36/F/WHITE 2021 -01-06 Other . Y
C4591008 -7312175680 49/F/WHITE 2020 -12-29 Non-severe allergic reaction . Y I have been diagnosed with this condition, 
and I had a routine visit to manage my 
condition
C4591008 -7340097600 59/F/WHITE 2021 -02-18 Non-severe allergic reaction 2021 -03-08 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
59/F/WHITE 2021 -02-18 Other . Y
59/F/WHITE 2021 -02-18 Other .
C4591008 -7361257024 38/F/WHITE 2021 -01-21 Non-severe allergic reaction 2021 -02-12 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -7369560128 40/F/WHITE 2020 -12-21 Other . Y
C4591008 -7405075008 39/F/WHITE 2021 -01-14 Other . Y
39/F/WHITE 2021 -01-14 Other .
090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT) 
Page 49
FDA-CBER-2021-5683-1075396
Listing 7.7.7 Page 52of 72
BNT162b2 Protocol C4591008
Participant Reported Non -Hospitalization Safety Events of Interest
1: Duplicative events that occur on the same date or that appear as a hospitalized events on the same date are not analyzed.
PFIZER CONFIDENTIAL    SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021    Source Data: ADSL, ADEVENT, FA
Generated from /dcri/ct/hero_together/lists/l_event.sas on 24MAY2021 12:45 Page 1667 of 1689   Subject ID Age/Sex/RaceVaccination 
Date Reported Condition Onset Date Analyzed1What caused you to seek medical care 
for this condition
C4591008 -7407718976 59/F/WHITE 2020 -12-24 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -02-17 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
59/F/WHITE 2020 -12-24 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -02-18 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
59/F/WHITE 2020 -12-24 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -03-11 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
C4591008 -7412795968 30/F/WHITE 2020 -12-23 Other . Y
C4591008 -7418149952 33/F/WHITE 2020 -12-22 Pregnancy -related issue 2021 -01-28 Y
C4591008 -7430785600 39/F/WHITE 2020 -12-20 Multisystem inflammation 2020 -12-28 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -7447300160 30/F/WHITE 2021 -01-14 Pregnancy -related issue 2021 -04-11 Y
C4591008 -7450674752 50/F/WHITE 2020 -12-22 Other . Y
C4591008 -7472225856 39/F/WHITE 2020 -12-18 Pregnancy -related issue 2021 -02-03 Y
39/F/WHITE 2020 -12-18 Pregnancy -related issue 2021 -02-03
C4591008 -7484037696 35/F/WHITE 2020 -12-17 Other . Y
C4591008 -7488501824 38/F/WHITE 2020 -12-20 Other . Y
C4591008 -7496101952 49/F/WHITE 2020 -12-19 Other . Y
C4591008 -7503171136 53/F/WHITE 2020 -12-29 Non-severe allergic reaction . Y I have been diagnosed with this condition, 
and I had a routine visit to manage my 
condition
53/F/WHITE 2020 -12-29 Other . Y
C4591008 -7506425920 37/F/WHITE 2021 -01-20 Other . Y
C4591008 -7509681216 43/F/WHITE 2020 -12-23 Other . Y
43/F/WHITE 2020 -12-23 Other .
090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT) 
Page 50
FDA-CBER-2021-5683-1075397
Listing 7.7.7 Page 53of 72
BNT162b2 Protocol C4591008
Participant Reported Non -Hospitalization Safety Events of Interest
1: Duplicative events that occur on the same date or that appear as a hospitalized events on the same date are not analyzed.
PFIZER CONFIDENTIAL    SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021    Source Data: ADSL, ADEVENT, FA
Generated from /dcri/ct/hero_together/lists/l_event.sas on 24MAY2021 12:45 Page 1668 of 1689   Subject ID Age/Sex/RaceVaccination 
Date Reported Condition Onset Date Analyzed1What caused you to seek medical care 
for this condition
43/F/WHITE 2020 -12-23 Other .
43/F/WHITE 2020 -12-23 Other .
43/F/WHITE 2020 -12-23 Other .
C4591008 -7523327552 29/F/WHITE 2020 -12-28 Other . Y
29/F/WHITE 2020 -12-28 Pregnancy -related issue 2021 -04-19 Y
C4591008 -7528043072 59/F/WHITE 2020 -12-17 COVID -19 infection 2020 -12-30 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
59/F/WHITE 2020 -12-17 COVID -19 infection 2021 -01-02 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -7553766976 42/F/WHITE 2020 -12-19 Other . Y
C4591008 -7556908096 45/F/WHITE 2021 -04-03 Non-severe allergic reaction 2021 -04-08 Y Iexperienced new symptoms and was 
diagnosed with this condition for the first 
time
45/F/WHITE 2021 -04-03 Non-severe allergic reaction 2021 -04-15 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
C4591008 -7609504320 60/M/WHITE 2020 -12-18 Other . Y
C4591008 -7609676352 33/M/WHITE 2020 -12-18 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -01-08 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -7610406976 32/F/BLACK OR 
AFRICAN 
AMERICAN2020 -12-29 Other . Y
C4591008 -7610792000 43/M/WHITE 2020 -12-17 Other . Y
C4591008 -7615668288 45/F/WHITE 2021 -01-05 Other . Y
C4591008 -7620147264 37/F/WHITE 2020 -12-14 Pregnancy -related issue . Y
C4591008 -7652499008 34/F/WHITE 2020 -12-16 Other . Y
090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT) 
Page 51
FDA-CBER-2021-5683-1075398
Listing 7.7.7 Page 54of 72
BNT162b2 Protocol C4591008
Participant Reported Non -Hospitalization Safety Events of Interest
1: Duplicative events that occur on the same date or that appear as a hospitalized events on the same date are not analyzed.
PFIZER CONFIDENTIAL    SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021    Source Data: ADSL, ADEVENT, FA
Generated from /dcri/ct/hero_together/lists/l_event.sas on 24MAY2021 12:45 Page 1669 of 1689   Subject ID Age/Sex/RaceVaccination 
Date Reported Condition Onset Date Analyzed1What caused you to seek medical care 
for this condition
C4591008 -7654200896 40/F/WHITE 2021 -01-28 Non-severe allergic reaction . Y I have been diagnosed with this condition, 
and I had a routine visit to manage my 
condition
40/F/WHITE 2021 -01-28 Non-severe allergic reaction 2021 -02-26 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
40/F/WHITE 2021 -01-28 Other . Y
40/F/WHITE 2021 -01-28 Other .
C4591008 -7667925568 45/F/WHITE 2020 -12-18 Other . Y
C4591008 -7674169920 43/F/WHITE 2020 -12-22 Other . Y
C4591008 -7683603520 45/F/WHITE 2020 -12-18 Nerve inflammation or autoimmune 
disease (e.g., multiple sclerosis, 
rheumatoid arthritis)2021 -03-03 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
C4591008 -7690752064 50/F/WHITE 2020 -12-29 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -03-28 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -7711963200 42/F/WHITE 2021 -02-02 Other . Y
C4591008 -7752734272 36/F/WHITE 2021 -02-12 Multisystem inflammation 2021 -04-09 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -7776111680 51/F/WHITE 2021 -01-12 Other . Y
51/F/WHITE 2021 -01-12 Other .
C4591008 -7783013440 31/F/WHITE 2020 -11-28 Pregnancy -related issue 2021 -03-08 Y
C4591008 -7807302208 30/M/WHITE 2020 -12-29 Other . Y
C4591008 -7832606272 59/M/WHITE 2021 -01-28 Other . Y
C4591008 -7840305728 73/M/WHITE 2020 -12-16 COVID -19 infection 2020 -12-30 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT) 
Page 52
FDA-CBER-2021-5683-1075399
Listing 7.7.7 Page 55of 72
BNT162b2 Protocol C4591008
Participant Reported Non -Hospitalization Safety Events of Interest
1: Duplicative events that occur on the same date or that appear as a hospitalized events on the same date are not analyzed.
PFIZER CONFIDENTIAL    SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021    Source Data: ADSL, ADEVENT, FA
Generated from /dcri/ct/hero_together/lists/l_event.sas on 24MAY2021 12:45 Page 1670 of 1689   Subject ID Age/Sex/RaceVaccination 
Date Reported Condition Onset Date Analyzed1What caused you to seek medical care 
for this condition
73/M/WHITE 2020 -12-16 COVID -19 infection 2020 -12-30 I experienced new symptoms and was 
diagnosed with this condition for the first 
time
73/M/WHITE 2020 -12-16 COVID -19 infection 2020 -12-31 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -7841236032 37/F/WHITE 2020 -12-15 Other . Y
C4591008 -7843681344 37/F/WHITE 2020 -12-17 Blood vessel inflammation (e.g., 
Kawasaki disease, vasculitides)2021 -01-27 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
37/F/WHITE 2020 -12-17 Other . Y
37/F/WHITE 2020 -12-17 Other .
C4591008 -7852729408 34/F/WHITE 2020 -12-24 Pregnancy -related issue 2021 -01-27 Y
34/F/WHITE 2020 -12-24 Pregnancy -related issue 2021 -01-27
C4591008 -7856742464 62/F/MULTIPLE 2021 -01-16 Other . Y
C4591008 -7857512512 50/F/WHITE 2021 -01-06 Other . Y
C4591008 -7862827584 38/M/WHITE 2021 -01-12 Other . Y
38/M/WHITE 2021 -01-12 Other .
C4591008 -7872181312 63/F/WHITE 2020 -12-28 Other . Y
C4591008 -7882570816 59/F/WHITE 2021 -01-14 Other . Y
C4591008 -7883946560 53/M/WHITE 2021 -01-14 Generalized convulsions/seizures 2021 -01-28 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
53/M/WHITE 2021 -01-14 Generalized convulsions/seizures 2021 -02-15 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -7884271168 24/F/WHITE 2021 -01-22 Other . Y
090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT) 
Page 53
FDA-CBER-2021-5683-1075400
Listing 7.7.7 Page 56of 72
BNT162b2 Protocol C4591008
Participant Reported Non -Hospitalization Safety Events of Interest
1: Duplicative events that occur on the same date or that appear as a hospitalized events on the same date are not analyzed.
PFIZER CONFIDENTIAL    SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021    Source Data: ADSL, ADEVENT, FA
Generated from /dcri/ct/hero_together/lists/l_event.sas on 24MAY2021 12:45 Page 1671 of 1689   Subject ID Age/Sex/RaceVaccination 
Date Reported Condition Onset Date Analyzed1What caused you to seek medical care 
for this condition
C4591008 -7896946752 42/F/WHITE 2021 -01-08 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -01-12 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
42/F/WHITE 2021 -01-08 Nerve inflammation or autoimmune 
disease (e.g., multiple sclerosis, 
rheumatoid arthritis)2021 -01-12 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -7915190336 58/M/WHITE 2020 -12-24 Other . Y
C4591008 -7934880832 43/F/WHITE 2020 -12-18 Autoimmune thyroiditis 2021 -04-29 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
43/F/WHITE 2020 -12-18 Other . Y
C4591008 -7973810752 57/M/WHITE 2020 -12-23 Other . Y
C4591008 -7993713216 32/F/WHITE 2020 -12-17 Other . Y
C4591008 -8009949760 26/F/WHITE 2021 -01-04 Other . Y
C4591008 -8011411520 55/M/WHITE 2020 -12-22 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2020 -12-22 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
55/M/WHITE 2020 -12-22 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2020 -12-22 I experienced new symptoms and was 
diagnosed with this condition for the first 
time
55/M/WHITE 2020 -12-22 Other . Y
C4591008 -8024738368 34/F/WHITE 2020 -12-29 Other . Y
C4591008 -8036403264 28/F/WHITE 2021 -01-04 Other . Y
C4591008 -8041705536 42/F/WHITE 2020 -12-17 Other . Y
C4591008 -8051737152 28/F/WHITE 2020 -12-23 Nerve inflammation or autoimmune 
disease (e.g., multiple sclerosis, 
rheumatoid arthritis)2021 -02-01 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT) 
Page 54
FDA-CBER-2021-5683-1075401
Listing 7.7.7 Page 57of 72
BNT162b2 Protocol C4591008
Participant Reported Non -Hospitalization Safety Events of Interest
1: Duplicative events that occur on the same date or that appear as a hospitalized events on the same date are not analyzed.
PFIZER CONFIDENTIAL    SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021    Source Data: ADSL, ADEVENT, FA
Generated from /dcri/ct/hero_together/lists/l_event.sas on 24MAY2021 12:45 Page 1672 of 1689   Subject ID Age/Sex/RaceVaccination 
Date Reported Condition Onset Date Analyzed1What caused you to seek medical care 
for this condition
28/F/WHITE 2020 -12-23 Nerve inflammation or autoimmune 
disease (e.g., multiple sclerosis, 
rheumatoid arthritis)2021 -02-02 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
C4591008 -8090028608 57/F/WHITE 2021 -01-08 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -02-24 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
C4591008 -8097602112 53/F/WHITE 2021 -02-17 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -04-11 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
53/F/WHITE 2021 -02-17 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -04-11 I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -8100366400 35/F/WHITE 2020 -12-22 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -02-21 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
C4591008 -8104630848 36/F/WHITE 2020 -12-29 Non-severe allergic reaction 2021 -02-07 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
36/F/WHITE 2020 -12-29 Non-severe allergic reaction 2021 -03-30 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
36/F/WHITE 2020 -12-29 Other . Y
C4591008 -8106995264 63/F/WHITE 2020 -12-28 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -03-18 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
63/F/WHITE 2020 -12-28 Other . Y
C4591008 -8109055552 31/F/WHITE 2021 -01-13 Other . Y
C4591008 -8111646272 43/F/WHITE 2020 -12-24 Other . Y
C4591008 -8113387072 55/F/WHITE 2021 -01-27 Other . Y
090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT) 
Page 55
FDA-CBER-2021-5683-1075402
Listing 7.7.7 Page 58of 72
BNT162b2 Protocol C4591008
Participant Reported Non -Hospitalization Safety Events of Interest
1: Duplicative events that occur on the same date or that appear as a hospitalized events on the same date are not analyzed.
PFIZER CONFIDENTIAL    SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021    Source Data: ADSL, ADEVENT, FA
Generated from /dcri/ct/hero_together/lists/l_event.sas on 24MAY2021 12:45 Page 1673 of 1689   Subject ID Age/Sex/RaceVaccination 
Date Reported Condition Onset Date Analyzed1What caused you to seek medical care 
for this condition
55/F/WHITE 2021 -01-27 Other .
C4591008 -8119432256 47/M/WHITE 2021 -01-02 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -03-12 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -8119685184 56/F/WHITE 2021 -01-14 Other . Y
C4591008 -8124559936 38/F/WHITE 2020 -12-15 Other . Y
C4591008 -8127304768 32/F/WHITE 2021 -02-12 Other . Y
C4591008 -8128944704 40/F/WHITE 2020 -12-26 Other . Y
40/F/WHITE 2020 -12-26 Other .
C4591008 -8138325568 37/F/WHITE 2020 -12-21 Other . Y
C4591008 -8151001664 36/F/WHITE 2021 -02-09 Non-severe allergic reaction 2021 -04-01 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -8161908800 28/F/WHITE 2020 -12-21 Other . Y
C4591008 -8163131456 60/F/WHITE 2021 -01-15 Other . Y
C4591008 -8163889728 34/F/WHITE 2020 -12-17 Pregnancy -related issue 2021 -01-12 Y
C4591008 -8184675392 41/F/WHITE 2021 -04-09 Other . Y
C4591008 -8198182464 63/F/WHITE 2021 -01-10 Other . Y
C4591008 -8205556288 52/F/WHITE 2020 -12-16 COVID -19 infection 2021 -01-02 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
52/F/WHITE 2020 -12-16 COVID -19 infection 2021 -01-02 I experienced new symptoms and was 
diagnosed with this condition for the first 
time
52/F/WHITE 2020 -12-16 COVID -19 infection 2021 -01-03 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
52/F/WHITE 2020 -12-16 Other . Y
090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT) 
Page 56
FDA-CBER-2021-5683-1075403
Listing 7.7.7 Page 59of 72
BNT162b2 Protocol C4591008
Participant Reported Non -Hospitalization Safety Events of Interest
1: Duplicative events that occur on the same date or that appear as a hospitalized events on the same date are not analyzed.
PFIZER CONFIDENTIAL    SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021    Source Data: ADSL, ADEVENT, FA
Generated from /dcri/ct/hero_together/lists/l_event.sas on 24MAY2021 12:45 Page 1674 of 1689   Subject ID Age/Sex/RaceVaccination 
Date Reported Condition Onset Date Analyzed1What caused you to seek medical care 
for this condition
52/F/WHITE 2020 -12-16 Other .
C4591008 -8210286656 43/F/WHITE 2020 -12-16 Other . Y
C4591008 -8233510976 39/M/WHITE 2020 -12-17 Non-severe allergic reaction 2021 -01-06 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
39/M/WHITE 2020 -12-17 Severe allergic reaction (anaphylaxis) 2021 -01-06 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -8233870400 31/F/WHITE 2021 -01-21 Other . Y
C4591008 -8238640192 32/F/WHITE 2020 -12-22 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -02-09 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -8241947712 59/F/WHITE 2020 -12-27 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -02-01 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
C4591008 -8243808832 29/F/WHITE 2021 -01-07 Other . Y
C4591008 -8244101184 32/M/WHITE 2020 -12-16 Other . Y
C4591008 -8262302784 46/F/WHITE 2021 -01-02 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -02-01 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -8266780736 30/F/WHITE 2020 -12-23 Non-severe allergic reaction 2021 -02-20 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
30/F/WHITE 2020 -12-23 Non-severe allergic reaction 2021 -02-20 I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -8286113344 64/F/ASIAN 2021 -01-25 Other . Y
090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT) 
Page 57
FDA-CBER-2021-5683-1075404
Listing 7.7.7 Page 60of 72
BNT162b2 Protocol C4591008
Participant Reported Non -Hospitalization Safety Events of Interest
1: Duplicative events that occur on the same date or that appear as a hospitalized events on the same date are not analyzed.
PFIZER CONFIDENTIAL    SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021    Source Data: ADSL, ADEVENT, FA
Generated from /dcri/ct/hero_together/lists/l_event.sas on 24MAY2021 12:45 Page 1675 of 1689   Subject ID Age/Sex/RaceVaccination 
Date Reported Condition Onset Date Analyzed1What caused you to seek medical care 
for this condition
C4591008 -8288624704 54/F/WHITE 2020 -12-21 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -02-05 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
54/F/WHITE 2020 -12-21 Other . Y
C4591008 -8289367616 31/M/WHITE 2020 -12-24 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -01-03 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -8295094848 36/F/WHITE 2021 -02-18 Pregnancy -related issue 2021 -03-01 Y
C4591008 -8296010816 58/M/WHITE 2020 -12-27 Other . Y
C4591008 -8298084416 39/F/WHITE 2020 -12-17 Nerve inflammation or autoimmune 
disease (e.g., multiple sclerosis, 
rheumatoid arthritis)2021 -02-26 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -8309936704 54/F/WHITE 2020 -12-17 Other . Y
C4591008 -8313271360 52/F/ASIAN 2020 -12-22 Heart inflammation (e.g., myocarditis, 
pericarditis)2021 -03-02 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
52/F/ASIAN 2020 -12-22 Other . Y
C4591008 -8317815360 43/F/BLACK OR 
AFRICAN 
AMERICAN2021 -01-09 Other . Y
43/F/BLACK OR 
AFRICAN 
AMERICAN2021 -01-09 Other .
43/F/BLACK OR 
AFRICAN 
AMERICAN2021 -01-09 Other .
C4591008 -8324963392 34/F/WHITE 2021 -01-21 Other . Y
34/F/WHITE 2021 -01-21 Other .
34/F/WHITE 2021 -01-21 Other .
090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT) 
Page 58
FDA-CBER-2021-5683-1075405
Listing 7.7.7 Page 61of 72
BNT162b2 Protocol C4591008
Participant Reported Non -Hospitalization Safety Events of Interest
1: Duplicative events that occur on the same date or that appear as a hospitalized events on the same date are not analyzed.
PFIZER CONFIDENTIAL    SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021    Source Data: ADSL, ADEVENT, FA
Generated from /dcri/ct/hero_together/lists/l_event.sas on 24MAY2021 12:45 Page 1676 of 1689   Subject ID Age/Sex/RaceVaccination 
Date Reported Condition Onset Date Analyzed1What caused you to seek medical care 
for this condition
34/F/WHITE 2021 -01-21 Other .
C4591008 -8325701184 52/F/WHITE 2021 -02-13 Other . Y
C4591008 -8327965760 48/F/MULTIPLE 2021 -01-06 Other . Y
C4591008 -8339445312 42/F/WHITE 2021 -01-05 Non-severe allergic reaction 2021 -01-30 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
42/F/WHITE 2021 -01-05 Other . Y
C4591008 -8347909696 38/F/WHITE 2020 -12-31 Other . Y
C4591008 -8361315392 35/F/WHITE 2021 -01-23 Other . Y
C4591008 -8377989696 64/F/WHITE 2020 -12-22 COVID -19 infection 2021 -04-09 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -8378202176 73/F/WHITE 2020 -12-23 Other . Y
C4591008 -8387091520 53/F/WHITE 2021 -01-15 Non-severe allergic reaction 2021 -03-12 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -8391622720 55/F/WHITE 2020 -12-15 Other . Y
C4591008 -8393057856 42/F/BLACK OR 
AFRICAN 
AMERICAN2020 -12-18 Other . Y
C4591008 -8397773376 40/F/WHITE 2021 -01-19 Other . Y
C4591008 -8408084544 23/F/WHITE 2020 -12-31 Other . Y
C4591008 -8419537984 28/F/WHITE 2021 -01-14 Non-severe allergic reaction 2021 -03-11 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -8423071296 30/F/WHITE 2021 -01-17 Other . Y
30/F/WHITE 2021 -01-17 Other .
090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT) 
Page 59
FDA-CBER-2021-5683-1075406
Listing 7.7.7 Page 62of 72
BNT162b2 Protocol C4591008
Participant Reported Non -Hospitalization Safety Events of Interest
1: Duplicative events that occur on the same date or that appear as a hospitalized events on the same date are not analyzed.
PFIZER CONFIDENTIAL    SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021    Source Data: ADSL, ADEVENT, FA
Generated from /dcri/ct/hero_together/lists/l_event.sas on 24MAY2021 12:45 Page 1677 of 1689   Subject ID Age/Sex/RaceVaccination 
Date Reported Condition Onset Date Analyzed1What caused you to seek medical care 
for this condition
C4591008 -8452992576 68/F/WHITE 2020 -12-31 Blood clot inside a vein in the body 
(thromboembolism)2021 -02-20 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -8462041664 54/F/WHITE 2020 -12-20 Other . Y
54/F/WHITE 2020 -12-20 Other .
C4591008 -8474264640 63/F/WHITE 2020 -12-22 Other . Y
63/F/WHITE 2020 -12-22 Other .
C4591008 -8474517568 33/M/WHITE 2021 -01-07 Other . Y
C4591008 -8482595904 29/F/ASIAN 2021 -01-07 Other . Y
C4591008 -8483498560 42/M/WHITE 2020 -12-22 Other . Y
C4591008 -8488069696 28/F/WHITE 2020 -12-28 Pregnancy -related issue 2021 -03-09 Y
C4591008 -8492134976 67/F/WHITE 2020 -12-19 Other . Y
C4591008 -8493531200 28/F/WHITE 2020 -12-20 Other . Y
28/F/WHITE 2020 -12-20 Other .
C4591008 -8495629888 57/F/WHITE 2020 -12-17 Other . Y
C4591008 -8503588416 47/F/WHITE 2021 -01-07 Other . Y
47/F/WHITE 2021 -01-07 Other .
C4591008 -8509315136 42/F/MULTIPLE 2020 -12-28 Other . Y
C4591008 -8517725248 56/M/WHITE 2021 -01-17 Other . Y
56/M/WHITE 2021 -01-17 Other .
C4591008 -8538491968 42/F/WHITE 2020 -12-18 Other . Y
C4591008 -8539795520 46/F/WHITE 2020 -12-18 Other . Y
46/F/WHITE 2020 -12-18 Other .
C4591008 -8548496960 49/F/MULTIPLE 2021 -01-07 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -03-01 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT) 
Page 60
FDA-CBER-2021-5683-1075407
Listing 7.7.7 Page 63of 72
BNT162b2 Protocol C4591008
Participant Reported Non -Hospitalization Safety Events of Interest
1: Duplicative events that occur on the same date or that appear as a hospitalized events on the same date are not analyzed.
PFIZER CONFIDENTIAL    SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021    Source Data: ADSL, ADEVENT, FA
Generated from /dcri/ct/hero_together/lists/l_event.sas on 24MAY2021 12:45 Page 1678 of 1689   Subject ID Age/Sex/RaceVaccination 
Date Reported Condition Onset Date Analyzed1What caused you to seek medical care 
for this condition
49/F/MULTIPLE 2021 -01-07 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -03-31 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
C4591008 -8572173888 32/F/WHITE 2020 -12-27 Other . Y
C4591008 -8577456192 61/M/WHITE 2021 -01-10 Other . Y
C4591008 -8578060352 63/F/WHITE 2020 -12-17 Other . Y
C4591008 -8585792576 65/F/WHITE 2021 -01-11 Other . Y
C4591008 -8597592128 68/M/WHITE 2020 -12-30 COVID -19 infection 2021 -01-07 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -8613648960 45/F/WHITE 2021 -01-28 Other . Y
C4591008 -8616166976 25/F/WHITE 2020 -12-18 Other . Y
C4591008 -8623195200 41/F/WHITE 2020 -12-23 Other . Y
C4591008 -8652066368 67/F/WHITE 2020 -12-23 Other . Y
C4591008 -8668050496 36/M/WHITE 2020 -12-30 COVID -19 infection 2021 -01-10 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -8684844608 40/F/WHITE 2020 -12-18 Other . Y
C4591008 -8685947968 62/F/WHITE 2021 -01-08 Other . Y
C4591008 -8687860800 42/F/WHITE 2020 -12-17 Nerve inflammation or autoimmune 
disease (e.g., multiple sclerosis, 
rheumatoid arthritis)2021 -02-14 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -8701719616 62/F/WHITE 2021 -01-04 Other . Y
62/F/WHITE 2021 -01-04 Other .
C4591008 -8709916736 41/F/WHITE 2020 -12-24 Other . Y
C4591008 -8718487616 30/F/ASIAN 2021 -01-12 Other . Y
090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT) 
Page 61
FDA-CBER-2021-5683-1075408
Listing 7.7.7 Page 64of 72
BNT162b2 Protocol C4591008
Participant Reported Non -Hospitalization Safety Events of Interest
1: Duplicative events that occur on the same date or that appear as a hospitalized events on the same date are not analyzed.
PFIZER CONFIDENTIAL    SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021    Source Data: ADSL, ADEVENT, FA
Generated from /dcri/ct/hero_together/lists/l_event.sas on 24MAY2021 12:45 Page 1679 of 1689   Subject ID Age/Sex/RaceVaccination 
Date Reported Condition Onset Date Analyzed1What caused you to seek medical care 
for this condition
C4591008 -8718605888 44/F/WHITE 2020 -12-23 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -01-30 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -8737527360 33/F/WHITE 2020 -12-29 COVID -19 infection 2021 -04-26 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -8741219904 63/F/WHITE 2020 -12-19 Other . Y
C4591008 -8752633920 28/F/WHITE 2020 -12-29 Blood clot inside a vein in the body 
(thromboembolism)2021 -04-16 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
28/F/WHITE 2020 -12-29 Blood clot inside a vein in the body 
(thromboembolism)2021 -04-16 I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
C4591008 -8753537088 52/M/WHITE 2020 -12-31 Other . Y
52/M/WHITE 2020 -12-31 Other .
52/M/WHITE 2020 -12-31 Other .
C4591008 -8762878016 30/F/WHITE 2020 -12-18 Other . Y
C4591008 -8763734080 33/F/BLACK OR 
AFRICAN 
AMERICAN2021 -01-20 Other . Y
33/F/BLACK OR 
AFRICAN 
AMERICAN2021 -01-20 Other .
C4591008 -8767873088 43/F/WHITE 2021 -01-25 Other . Y
C4591008 -8772284992 48/F/WHITE 2020 -12-28 Other . Y
C4591008 -8781864512 48/F/WHITE 2021 -01-05 Other . Y
C4591008 -8785751104 39/F/NOT 
REPORTED2021 -02-26 Other . Y
C4591008 -8786182208 48/F/WHITE 2020 -12-17 Other . Y
090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT) 
Page 62
FDA-CBER-2021-5683-1075409
Listing 7.7.7 Page 65of 72
BNT162b2 Protocol C4591008
Participant Reported Non -Hospitalization Safety Events of Interest
1: Duplicative events that occur on the same date or that appear as a hospitalized events on the same date are not analyzed.
PFIZER CONFIDENTIAL    SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021    Source Data: ADSL, ADEVENT, FA
Generated from /dcri/ct/hero_together/lists/l_event.sas on 24MAY2021 12:45 Page 1680 of 1689   Subject ID Age/Sex/RaceVaccination 
Date Reported Condition Onset Date Analyzed1What caused you to seek medical care 
for this condition
C4591008 -8822189120 38/F/WHITE 2020 -12-29 Other . Y
C4591008 -8834306112 39/F/WHITE 2021 -01-06 Non-severe allergic reaction 2021 -01-20 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
39/F/WHITE 2021 -01-06 Non-severe allergic reaction 2021 -01-20 I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
C4591008 -8851565632 64/F/WHITE 2021 -01-20 Other . Y
C4591008 -8853532736 44/M/WHITE 2021 -01-13 Other . Y
C4591008 -8853758016 33/F/WHITE 2020 -12-17 Other . Y
C4591008 -8854409792 54/F/WHITE 2021 -01-08 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -01-30 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
54/F/WHITE 2021 -01-08 Multisystem inflammation 2021 -02-11 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
54/F/WHITE 2021 -01-08 Other . Y
54/F/WHITE 2021 -01-08 Other .
C4591008 -8856740416 51/F/WHITE 2021 -03-02 Other . Y
51/F/WHITE 2021 -03-02 Other .
C4591008 -8864586816 60/F/WHITE 2020 -12-22 Other . Y
C4591008 -8864959040 45/F/WHITE 2021 -01-13 COVID -19 infection . Y I have been diagnosed with this condition, 
and I had a routine visit to manage my 
condition
C4591008 -8878046784 36/F/WHITE 2020 -12-23 Non-severe allergic reaction 2020 -12-23 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT) 
Page 63
FDA-CBER-2021-5683-1075410
Listing 7.7.7 Page 66of 72
BNT162b2 Protocol C4591008
Participant Reported Non -Hospitalization Safety Events of Interest
1: Duplicative events that occur on the same date or that appear as a hospitalized events on the same date are not analyzed.
PFIZER CONFIDENTIAL    SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021    Source Data: ADSL, ADEVENT, FA
Generated from /dcri/ct/hero_together/lists/l_event.sas on 24MAY2021 12:45 Page 1681 of 1689   Subject ID Age/Sex/RaceVaccination 
Date Reported Condition Onset Date Analyzed1What caused you to seek medical care 
for this condition
C4591008 -8900274240 68/F/WHITE 2021 -01-18 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -03-11 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -8904207936 56/F/WHITE 2021 -01-04 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -04-02 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -8908299840 35/F/WHITE 2021 -01-08 Other . Y
35/F/WHITE 2021 -01-08 Other .
C4591008 -8928587840 33/F/WHITE 2020 -12-29 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -04-02 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -8930435648 35/F/WHITE 2020 -12-22 Pregnancy -related issue . Y
35/F/WHITE 2020 -12-22 Pregnancy -related issue 2021 -03-13 Y
C4591008 -8933131840 35/F/WHITE 2020 -12-16 Other . Y
C4591008 -8934368832 27/F/WHITE 2020 -12-29 Other . Y
C4591008 -8952969280 53/F/WHITE 2021 -01-13 Other . Y
53/F/WHITE 2021 -01-13 Other .
C4591008 -8961326144 48/F/WHITE 2020 -12-28 Other . Y
C4591008 -8971969600 30/F/WHITE 2021 -01-05 Non-severe allergic reaction 2021 -04-30 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
C4591008 -8986637376 66/F/WHITE 2021 -01-22 Other . Y
C4591008 -9001147456 46/F/WHITE 2021 -01-12 Other . Y
C4591008 -9001399360 29/F/WHITE 2021 -01-15 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -04-30 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
29/F/WHITE 2021 -01-15 Other . Y
C4591008 -9010633280 69/F/WHITE 2021 -01-13 Other . Y
090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT) 
Page 64
FDA-CBER-2021-5683-1075411
Listing 7.7.7 Page 67of 72
BNT162b2 Protocol C4591008
Participant Reported Non -Hospitalization Safety Events of Interest
1: Duplicative events that occur on the same date or that appear as a hospitalized events on the same date are not analyzed.
PFIZER CONFIDENTIAL    SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021    Source Data: ADSL, ADEVENT, FA
Generated from /dcri/ct/hero_together/lists/l_event.sas on 24MAY2021 12:45 Page 1682 of 1689   Subject ID Age/Sex/RaceVaccination 
Date Reported Condition Onset Date Analyzed1What caused you to seek medical care 
for this condition
C4591008 -9041258560 36/F/WHITE 2021 -01-04 Other . Y
C4591008 -9049643072 32/F/WHITE 2020 -12-29 Other . Y
C4591008 -9057482304 24/F/WHITE 2020 -12-30 Other . Y
24/F/WHITE 2020 -12-30 Other .
C4591008 -9065613376 26/F/WHITE 2021 -02-01 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -03-01 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -9067313728 47/F/WHITE 2020 -12-30 Non-severe allergic reaction 2021 -03-16 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
C4591008 -9087590464 42/F/WHITE 2020 -12-21 Other . Y
42/F/WHITE 2020 -12-21 Other .
42/F/WHITE 2020 -12-21 Other .
42/F/WHITE 2020 -12-21 Other .
C4591008 -9116807232 31/F/WHITE 2020 -12-31 Other . Y
31/F/WHITE 2020 -12-31 Other .
C4591008 -9136550976 28/F/WHITE 2020 -12-29 Other . Y
C4591008 -9139765824 49/F/WHITE 2021 -01-14 Non-severe allergic reaction 2021 -01-19 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -9146063936 51/F/WHITE 2020 -12-24 Non-severe allergic reaction 2021 -02-20 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -9150541888 65/F/WHITE 2021 -01-06 Other . Y
65/F/WHITE 2021 -01-06 Other .
C4591008 -9153146944 63/M/WHITE 2021 -01-05 Other . Y
090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT) 
Page 65
FDA-CBER-2021-5683-1075412
Listing 7.7.7 Page 68of 72
BNT162b2 Protocol C4591008
Participant Reported Non -Hospitalization Safety Events of Interest
1: Duplicative events that occur on the same date or that appear as a hospitalized events on the same date are not analyzed.
PFIZER CONFIDENTIAL    SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021    Source Data: ADSL, ADEVENT, FA
Generated from /dcri/ct/hero_together/lists/l_event.sas on 24MAY2021 12:45 Page 1683 of 1689   Subject ID Age/Sex/RaceVaccination 
Date Reported Condition Onset Date Analyzed1What caused you to seek medical care 
for this condition
C4591008 -9168001088 43/F/WHITE 2020 -12-23 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -01-16 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
43/F/WHITE 2020 -12-23 Non-severe allergic reaction 2021 -04-02 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
43/F/WHITE 2020 -12-23 Other . Y
C4591008 -9171880000 34/F/WHITE 2021 -01-04 Other . Y
C4591008 -9173792832 31/F/WHITE 2020 -12-18 Other . Y
C4591008 -9178032192 29/F/WHITE 2020 -12-21 Nerve inflammation or autoimmune 
disease (e.g., multiple sclerosis, 
rheumatoid arthritis)2021 -02-15 Y I experienced new symptoms and was
diagnosed with this condition for the first 
time
29/F/WHITE 2020 -12-21 Other . Y
C4591008 -9207501376 27/M/WHITE 2020 -12-30 Non-severe allergic reaction 2021 -02-01 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -9213254208 31/F/WHITE 2020 -12-24 Pregnancy -related issue 2021 -03-25 Y
C4591008 -9225133632 45/F/WHITE 2020 -12-28 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -02-17 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
C4591008 -9245248576 44/F/WHITE 2020 -12-16 Other . Y
C4591008 -9247468096 45/F/WHITE 2020 -12-28 Other . Y
45/F/WHITE 2020 -12-28 Other .
C4591008 -9260182592 35/F/WHITE 2021 -02-15 Pregnancy -related issue 2021 -04-23 Y
C4591008 -9262295616 32/F/WHITE 2020 -12-28 Other . Y
C4591008 -9264820288 44/F/WHITE 2020 -12-20 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -03-10 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
44/F/WHITE 2020 -12-20 Other . Y
090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT) 
Page 66
FDA-CBER-2021-5683-1075413
Listing 7.7.7 Page 69of 72
BNT162b2 Protocol C4591008
Participant Reported Non -Hospitalization Safety Events of Interest
1: Duplicative events that occur on the same date or that appear as a hospitalized events on the same date are not analyzed.
PFIZER CONFIDENTIAL    SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021    Source Data: ADSL, ADEVENT, FA
Generated from /dcri/ct/hero_together/lists/l_event.sas on 24MAY2021 12:45 Page 1684 of 1689   Subject ID Age/Sex/RaceVaccination 
Date Reported Condition Onset Date Analyzed1What caused you to seek medical care 
for this condition
44/F/WHITE 2020 -12-20 Severe allergic reaction (anaphylaxis) 2020 -12-20 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -9276513344 38/F/WHITE 2020 -12-26 Other . Y
C4591008 -9283255872 45/M/WHITE 2021 -03-26 Other . Y
C4591008 -9305796672 35/F/WHITE 2020 -12-22 Other . Y
C4591008 -9321540672 39/M/WHITE 2020 -12-20 Other . Y
C4591008 -9322584640 45/F/WHITE 2021 -03-23 Other . Y
C4591008 -9325367872 34/F/ASIAN 2021 -01-16 Narcolepsy or cataplexy 2021 -04-06 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
34/F/ASIAN 2021 -01-16 Narcolepsy or cataplexy 2021 -04-06 I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
C4591008 -9326270528 33/F/WHITE 2020 -12-18 Other . Y
C4591008 -9348433984 60/F/WHITE 2021 -01-13 Other . Y
60/F/WHITE 2021 -01-13 Other .
C4591008 -9355302976 30/F/WHITE 2021 -01-03 Other . Y
30/F/WHITE 2021 -01-03 Other .
C4591008 -9358345280 60/F/WHITE 2020 -12-21 Other . Y
C4591008 -9377955392 41/F/WHITE 2021 -01-14 Fibromyalgia 2021 -04-01 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
41/F/WHITE 2021 -01-14 Multisystem inflammation 2021 -03-23 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -9402589760 48/F/WHITE 2020 -12-29 Other . Y
C4591008 -9438329920 51/F/WHITE 2021 -01-07 Other . Y
090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT) 
Page 67
FDA-CBER-2021-5683-1075414
Listing 7.7.7 Page 70of 72
BNT162b2 Protocol C4591008
Participant Reported Non -Hospitalization Safety Events of Interest
1: Duplicative events that occur on the same date or that appear as a hospitalized events on the same date are not analyzed.
PFIZER CONFIDENTIAL    SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021    Source Data: ADSL, ADEVENT, FA
Generated from /dcri/ct/hero_together/lists/l_event.sas on 24MAY2021 12:45 Page 1685 of 1689   Subject ID Age/Sex/RaceVaccination 
Date Reported Condition Onset Date Analyzed1What caused you to seek medical care 
for this condition
51/F/WHITE 2021 -01-07 Other .
C4591008 -9440616000 45/F/WHITE 2021 -02-19 Other . Y
C4591008 -9443432512 64/F/WHITE 2021 -01-28 Other . Y
C4591008 -9443737664 62/F/WHITE 2020 -12-09 Other . Y
C4591008 -9452308032 29/F/MULTIPLE 2021 -01-14 Multisystem inflammation 2021 -02-25 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
29/F/MULTIPLE 2021 -01-14 Multisystem inflammation 2021 -03-29 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
29/F/MULTIPLE 2021 -01-14 Multisystem inflammation 2021 -03-29 I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
C4591008 -9465369152 34/M/WHITE 2020 -12-16 Other . Y
C4591008 -9476662336 52/F/WHITE 2020 -12-17 Other . Y
52/F/WHITE 2020 -12-17 Other .
C4591008 -9493389888 29/F/UNKNOWN 2020 -12-19 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -02-01 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
C4591008 -9496167488 29/F/WHITE 2020 -12-23 Other . Y
C4591008 -9502012992 41/F/WHITE 2020 -12-19 Other . Y
C4591008 -9510783040 35/F/WHITE 2020 -12-19 Pregnancy -related issue 2021 -02-05
C4591008 -9512576064 27/F/WHITE 2020 -12-22 Non-severe allergic reaction 2021 -01-29 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -9518768192 43/F/WHITE 2020 -12-18 Other . Y
C4591008 -9520388672 40/F/WHITE 2021 -01-12 Other . Y
C4591008 -9540319296 40/F/WHITE 2020 -12-19 Other . Y
090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT) 
Page 68
FDA-CBER-2021-5683-1075415
Listing 7.7.7 Page 71of 72
BNT162b2 Protocol C4591008
Participant Reported Non -Hospitalization Safety Events of Interest
1: Duplicative events that occur on the same date or that appear as a hospitalized events on the same date are not analyzed.
PFIZER CONFIDENTIAL    SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021    Source Data: ADSL, ADEVENT, FA
Generated from /dcri/ct/hero_together/lists/l_event.sas on 24MAY2021 12:45 Page 1686 of 1689   Subject ID Age/Sex/RaceVaccination 
Date Reported Condition Onset Date Analyzed1What caused you to seek medical care 
for this condition
C4591008 -9543865920 65/M/WHITE 2020 -12-15 Multisystem inflammation 2021 -02-12 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
C4591008 -9544144960 52/F/WHITE 2020 -12-27 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -03-01 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
52/F/WHITE 2020 -12-27 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -03-03 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
C4591008 -9544849984 45/F/WHITE 2020 -12-17 Other . Y
C4591008 -9549075008 62/F/WHITE 2020 -12-31 COVID -19 infection . Y I have been diagnosed with this condition, 
and I had a routine visit to manage my 
condition
62/F/WHITE 2020 -12-31 COVID -19 infection 2021 -01-04 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
62/F/WHITE 2020 -12-31 COVID -19 infection 2021 -01-05 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
62/F/WHITE 2020 -12-31 COVID -19 infection 2021 -01-11 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
C4591008 -9571370048 27/F/WHITE 2020 -12-17 Other . Y
C4591008 -9573023296 54/F/WHITE 2021 -03-16 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -04-23 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
54/F/WHITE 2021 -03-16 Other . Y
54/F/WHITE 2021 -03-16 Other .
090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT) 
Page 69
FDA-CBER-2021-5683-1075416
Listing 7.7.7 Page 72of 72
BNT162b2 Protocol C4591008
Participant Reported Non -Hospitalization Safety Events of Interest
1: Duplicative events that occur on the same date or that appear as a hospitalized events on the same date are not analyzed.
PFIZER CONFIDENTIAL    SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021    Source Data: ADSL, ADEVENT, FA
Generated from /dcri/ct/hero_together/lists/l_event.sas on 24MAY2021 12:45 Page 1687 of 1689   Subject ID Age/Sex/RaceVaccination 
Date Reported Condition Onset Date Analyzed1What caused you to seek medical care 
for this condition
C4591008 -9604892224 41/F/BLACK OR 
AFRICAN 
AMERICAN2020 -12-21 Other . Y
C4591008 -9610047552 30/F/WHITE 2020 -12-21 Other . Y
C4591008 -9615188544 65/F/WHITE 2020 -12-23 Other . Y
C4591008 -9638048832 25/F/WHITE 2021 -01-22 Other . Y
25/F/WHITE 2021 -01-22 Other .
C4591008 -9647940160 53/M/NOT 
REPORTED2021 -01-13 Other . Y
53/M/NOT 
REPORTED2021 -01-13 Other .
C4591008 -9699173952 43/F/WHITE 2020 -12-22 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -03-01 Y I have been diagnosed with this condition 
in the past, but my symptoms changed or 
got worse
C4591008 -9714706496 49/F/WHITE 2020 -12-27 Other . Y
49/F/WHITE 2020 -12-27 Other .
C4591008 -9728299072 55/F/WHITE 2021 -01-06 Other . Y
C4591008 -9750605888 47/F/WHITE 2020 -12-18 Other . Y
C4591008 -9766683200 59/M/NOT 
REPORTED2020 -12-15 Other . Y
C4591008 -9768756288 45/M/WHITE 2020 -12-18 Other . Y
C4591008 -9771413568 34/F/WHITE 2020 -12-16 Other . Y
C4591008 -9781776960 34/F/WHITE 2020 -12-21 Autoimmune thyroiditis 2021 -01-19 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -9800550464 44/F/ASIAN 2021 -01-08 Other . Y
C4591008 -9806476352 58/F/WHITE 2020 -12-23 Other . Y
58/F/WHITE 2020 -12-23 Other .
090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT) 
Page 70
FDA-CBER-2021-5683-1075417
Listing 7.7.7 Page 73of 72
BNT162b2 Protocol C4591008
Participant Reported Non -Hospitalization Safety Events of Interest
1: Duplicative events that occur on the same date or that appear as a hospitalized events on the same date are not analyzed.
PFIZER CONFIDENTIAL    SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021    Source Data: ADSL, ADEVENT, FA
Generated from /dcri/ct/hero_together/lists/l_event.sas on 24MAY2021 12:45 Page 1688 of 1689   Subject ID Age/Sex/RaceVaccination 
Date Reported Condition Onset Date Analyzed1What caused you to seek medical care 
for this condition
C4591008 -9807659584 53/F/WHITE 2020 -12-24 Other . Y
C4591008 -9808429632 37/M/WHITE 2020 -12-31 Other . Y
C4591008 -9810170432 54/F/WHITE 2021 -01-04 Other . Y
54/F/WHITE 2021 -01-04 Other .
C4591008 -9825303616 28/F/WHITE 2020 -12-16 Other . Y
C4591008 -9840131648 49/F/WHITE 2020 -12-16 COVID -19 infection 2020 -12-21 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
49/F/WHITE 2020 -12-16 Joint stiffness or pain (e.g., arthralgia, 
arthritis). Y I have been diagnosed with this condition, 
and I had a routine visit to manage my 
condition
49/F/WHITE 2020 -12-16 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -01-04 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
49/F/WHITE 2020 -12-16 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -01-10 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
49/F/WHITE 2020 -12-16 Other . Y
49/F/WHITE 2020 -12-16 Other .
C4591008 -9840463424 48/M/WHITE 2020 -12-20 Other . Y
C4591008 -9843254336 26/F/WHITE 2021 -01-15 Other . Y
C4591008 -9845898304 35/F/NOT 
REPORTED2021 -01-06 Other . Y
C4591008 -9868353600 45/F/WHITE 2020 -12-22 Other . Y
45/F/WHITE 2020 -12-22 Other .
C4591008 -9891326016 45/F/WHITE 2021 -01-11 Joint stiffness or pain (e.g., arthralgia, 
arthritis)2021 -04-22 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -9897609280 32/F/WHITE 2020 -12-30 Other . Y
090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT) 
Page 71
FDA-CBER-2021-5683-1075418
Listing 7.7.7 Page 74of 72
BNT162b2 Protocol C4591008
Participant Reported Non -Hospitalization Safety Events of Interest
1: Duplicative events that occur on the same date or that appear as a hospitalized events on the same date are not analyzed.
PFIZER CONFIDENTIAL    SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021    Source Data: ADSL, ADEVENT, FA
Generated from /dcri/ct/hero_together/lists/l_event.sas on 24MAY2021 12:45 Page 1689 of 1689   Subject ID Age/Sex/RaceVaccination 
Date Reported Condition Onset Date Analyzed1What caused you to seek medical care 
for this condition
32/F/WHITE 2020 -12-30 Other .
C4591008 -9905647680 49/F/WHITE 2021 -01-06 Other . Y
49/F/WHITE 2021 -01-06 Other .
C4591008 -9927053376 50/F/WHITE 2020 -12-28 COVID -19 infection 2021 -04-03 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
50/F/WHITE 2020 -12-28 COVID -19 infection 2021 -04-03 I experienced new symptoms and was 
diagnosed with this condition for the first 
time
50/F/WHITE 2020 -12-28 Other . Y
C4591008 -9933457984 28/F/WHITE 2020 -12-17 Other . Y
C4591008 -9952045120 25/F/WHITE 2021 -01-22 Other . Y
C4591008 -9952178752 31/F/WHITE 2021 -01-21 Pregnancy -related issue . Y
C4591008 -9960720960 43/F/WHITE 2020 -12-22 Blood vessel inflammation (e.g., 
Kawasaki disease, vasculitides)2021 -02-16 Y I experienced new symptoms and was 
diagnosed with this condition for the first 
time
C4591008 -9972387904 30/F/ASIAN 2020 -12-23 Other . Y
090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT) 
Page 72
FDA-CBER-2021-5683-1075419