Document text
Listing 7.7.6 Page 3of 4
BNT162b2 Protocol C4591008
Participant Reported Unplanned Hospitalization
PFIZER CONFIDENTIAL SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021 Source Data: ADSL, ADHOSP, HO, CE
Generated from /dcri/ct/hero_together/lists/l_hosp.sas on 24MAY2021 12:45 Page 1614 of 1689 Subject ID Age/Sex/Race Vaccination Date Admission DateDays
Hospitalized Condition(s) Causing hospitalization
C4591008 -1306785856 35/F/NOT
REPORTED2020 -12-23 2021 -01-25 4 COVID -19 infection
C4591008 -1418206784 63/M/WHITE 2020 -12-24 2021 -04-23 3 Brain or spinal cord inflammation (e.g., meningitis, encephalitis,
Guillain -Barre syndrome)
C4591008 -1853039680 44/F/WHITE 2020 -12-30 2021 -02-07 2 Heart inflammation (e.g., myocarditis, pericarditis)
44/F/WHITE 2020 -12-30 2021 -02-07 2 Joint stiffness or pain (e.g., arthralgia, arthritis)
44/F/WHITE 2020 -12-30 2021 -02-07 2 Nerve inflammation or autoimmune disease (e.g., multiple
sclerosis, rheumatoid arthritis)
C4591008 -1897854528 41/M/WHITE 2021 -01-14 2021 -01-21 Other
C4591008 -2064350784 35/F/WHITE 2020 -12-24 2021 -03-19 1 Severe allergic reaction (anaphylaxis)
35/F/WHITE 2020 -12-24 2021 -03-20 1 Severe allergic reaction (anaphylaxis)
C4591008 -2245633600 45/F/WHITE 2021 -01-03 2021 -01-08 1 Multisystem inflammation
45/F/WHITE 2021 -01-03 2021 -01-08 1 Other
C4591008 -2568285760 61/F/WHITE 2021 -01-12 2021 -04-23 1 Other
C4591008 -3063080000 24/F/WHITE 2020 -12-30 2021 -01-26 1 Severe allergic reaction (anaphylaxis)
C4591008 -3121647168 35/F/WHITE 2021 -01-26 2021 -02-26 2 Pregnancy -related issue (including labor and delivery)
C4591008 -3184466496 55/F/WHITE 2021 -01-14 2021 -04-12 4 Brain or spinal cord inflammation (e.g., meningitis, encephalitis,
Guillain -Barre syndrome)
C4591008 -3190858304 56/F/WHITE 2020 -12-18 2021 -02-28 1 Other
C4591008 -3451674688 44/F/WHITE 2020 -12-17 2021 -03-12 5 Other
C4591008 -3581352512 32/F/WHITE 2020 -12-28 2021 -01-31 2 Pregnancy -related issue (including labor and delivery)
C4591008 -3639740992 39/F/WHITE 2021 -03-15 2021 -04-13 4 Liver injury
39/F/WHITE 2021 -03-15 2021 -04-13 4 Other
C4591008 -3735742528 43// 2020 -12-23 2021 -01-22 2 Other
C4591008 -4025179200 56/M/WHITE 2020 -12-29 2021 -01-29 3 Other
C4591008 -4035549248 24/F/WHITE 2021 -01-11 2021 -01-27 2 Stroke or possible stroke
C4591008 -4046079552 45/F/WHITE 2021 -01-13 2021 -02-15 7 Blood clot inside a vein in the body (thromboembolism)
45/F/WHITE 2021 -01-13 2021 -02-15 7 Heart attack (myocardial infarction)
090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT)
Page 1
FDA-CBER-2021-5683-1075877
Listing 7.7.6 Page 4of 4
BNT162b2 Protocol C4591008
Participant Reported Unplanned Hospitalization
PFIZER CONFIDENTIAL SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021 Source Data: ADSL, ADHOSP, HO, CE
Generated from /dcri/ct/hero_together/lists/l_hosp.sas on 24MAY2021 12:45 Page 1615 of 1689 Subject ID Age/Sex/Race Vaccination Date Admission DateDays
Hospitalized Condition(s) Causing hospitalization
45/F/WHITE 2021 -01-13 2021 -02-15 7 Heart failure/cardiogenic shock
C4591008 -4256380992 39/F/WHITE 2021 -01-02 2021 -03-18 7 Joint stiffness or pain (e.g., arthralgia, arthritis)
39/F/WHITE 2021 -01-02 2021 -03-18 7 Liver injury
39/F/WHITE 2021 -01-02 2021 -03-18 7 Nerve inflammation or autoimmune disease (e.g., multiple
sclerosis, rheumatoid arthritis)
39/F/WHITE 2021 -01-02 2021 -03-18 7 Other
39/F/WHITE 2021 -01-02 2021 -03-18 7 Severe allergic reaction (anaphylaxis)
C4591008 -4286986816 43/F/BLACK OR
AFRICAN
AMERICAN2021 -03-03 2021 -04-20 2 Other
C4591008 -4421321280 34/F/WHITE 2020 -12-29 2021 -01-18 2 Other
C4591008 -4570781760 34/F/MULTIPLE 2020 -12-23 2020 -12-31 1 Severe allergic reaction (anaphylaxis)
C4591008 -4791751744 43/F/WHITE 2020 -12-22 2021 -01-17 Blood clot inside a vein in the body (thromboembolism)
C4591008 -4809344576 30/F/WHITE 2020 -12-26 2021 -04-18 1 Pregnancy -related issue (including labor and delivery)
C4591008 -4858039872 41/F/WHITE 2021 -01-05 2021 -03-23 1 Pregnancy -related issue (including labor and delivery)
C4591008 -5101264448 46/F/WHITE 2020 -12-18 2020 -12-26 1 Other
C4591008 -5119733312 47/F/WHITE 2020 -12-24 2021 -02-24 1 Other
C4591008 -5237998144 42/F/BLACK OR
AFRICAN
AMERICAN2021 -01-04 2021 -01-30 2 Other
C4591008 -5490974784 34/F/WHITE 2020 -12-26 2021 -04-09 1 Pregnancy -related issue (including labor and delivery)
C4591008 -5561580608 56/M/WHITE 2020 -12-19 2021 -04-09 1 Other
C4591008 -5611444800 37/M/WHITE 2021 -01-06 2021 -01-09 1 Other
C4591008 -5837968960 32/F/WHITE 2020 -12-31 2021 -02-16 1 Pregnancy -related issue (including labor and delivery)
C4591008 -5941260352 42/M/WHITE 2020 -12-23 2021 -02-10 3 Abnormal heart rhythm (arrhythmia)
42/M/WHITE 2020 -12-23 2021 -02-10 3 Stress cardiomyopathy
42/M/WHITE 2020 -12-23 2021 -02-02 5 Other
C4591008 -6078125120 36/F/WHITE 2020 -12-18 2021 -03-29 1 Other
C4591008 -6180086336 43/F/WHITE 2020 -12-24 2021 -01-20 Other
090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT)
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FDA-CBER-2021-5683-1075878
Listing 7.7.6 Page 5of 4
BNT162b2 Protocol C4591008
Participant Reported Unplanned Hospitalization
PFIZER CONFIDENTIAL SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021 Source Data: ADSL, ADHOSP, HO, CE
Generated from /dcri/ct/hero_together/lists/l_hosp.sas on 24MAY2021 12:45 Page 1616 of 1689 Subject ID Age/Sex/Race Vaccination Date Admission DateDays
Hospitalized Condition(s) Causing hospitalization
C4591008 -6185487936 49// 2021 -01-29 2021 -02-27 2 Other
C4591008 -6465883200 54/M/WHITE 2020 -12-17 2021 -03-16 5 Other
54/M/WHITE 2020 -12-17 2021 -03-25 3 Other
C4591008 -6538561088 47/F/WHITE 2020 -12-16 2021 -04-10 1 Severe allergic reaction (anaphylaxis)
C4591008 -6778689600 53/F/WHITE 2021 -01-08 2021 -03-27 3 Other
C4591008 -6849839680 34/F/WHITE 2020 -12-28 2021 -01-19 8 Pregnancy -related issue (including labor and delivery)
C4591008 -6872706624 73/M/WHITE 2020 -12-16 2021 -02-05 1 Other
C4591008 -6966642752 58/F/WHITE 2020 -12-21 2021 -02-10 1 Joint stiffness or pain (e.g., arthralgia, arthritis)
C4591008 -6967400000 43/F/WHITE 2020 -12-23 2020 -12-23 1 Other
C4591008 -7447300160 30/F/WHITE 2021 -01-14 2021 -03-26 1 Pregnancy -related issue (including labor and delivery)
C4591008 -7472225856 39/F/WHITE 2020 -12-18 2021 -01-15 2 Pregnancy -related issue (including labor and delivery)
39/F/WHITE 2020 -12-18 2021 -02-02 1 Pregnancy -related issue (including labor and delivery)
C4591008 -7523525696 35/F/WHITE 2020 -12-17 2021 -01-12 2 Pregnancy -related issue (including labor and delivery)
C4591008 -7672349760 48/M/ASIAN 2020 -12-29 2021 -01-15 4 Joint stiffness or pain (e.g., arthralgia, arthritis)
48/M/ASIAN 2020 -12-29 2021 -01-15 4 Other
C4591008 -7843681344 37/F/WHITE 2020 -12-17 2021 -01-20 1 Heart inflammation (e.g., myocarditis, pericarditis)
C4591008 -7897823808 34/F/WHITE 2021 -01-09 2021 -01-11 1 Pregnancy -related issue (including labor and delivery)
C4591008 -8163889728 34/F/WHITE 2020 -12-17 2021 -02-13 2 Pregnancy -related issue (including labor and delivery)
C4591008 -8304289344 32/F/WHITE 2021 -01-09 2021 -03-03 2 Pregnancy -related issue (including labor and delivery)
C4591008 -8317815360 43/F/BLACK OR
AFRICAN
AMERICAN2021 -01-09 2021 -03-23 1 Other
C4591008 -8503588416 47/F/WHITE 2021 -01-07 2021 -02-11 5 Other
C4591008 -8517725248 56/M/WHITE 2021 -01-17 2021 -02-15 2 Other
C4591008 -8993653312 35/F/WHITE 2020 -12-28 2021 -02-16 2 Pregnancy -related issue (including labor and delivery)
C4591008 -9371438656 34/F/WHITE 2021 -02-13 2021 -03-27 4 Other
C4591008 -9373166656 50/M/ASIAN 2021 -02-18 2021 -03-10 1 Other
C4591008 -9381119040 32/F/WHITE 2021 -01-27 2021 -03-06 5 Other
090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT)
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FDA-CBER-2021-5683-1075879
Listing 7.7.6 Page 6of 4
BNT162b2 Protocol C4591008
Participant Reported Unplanned Hospitalization
PFIZER CONFIDENTIAL SDTM Creation: 11MAY2021:07:31:19 Data Cutoff: 29APR2021 Source Data: ADSL, ADHOSP, HO, CE
Generated from /dcri/ct/hero_together/lists/l_hosp.sas on 24MAY2021 12:45 Page 1617 of 1689 Subject ID Age/Sex/Race Vaccination Date Admission DateDays
Hospitalized Condition(s) Causing hospitalization
C4591008 -9510783040 35/F/WHITE 2020 -12-19 2021 -02-05 1 Pregnancy -related issue (including labor and delivery)
C4591008 -9571370048 27/F/WHITE 2020 -12-17 2021 -02-27 10 Other
27/F/WHITE 2020 -12-17 2021 -02-26 10 Other
C4591008 -9647940160 53/M/NOT
REPORTED2021 -01-13 2021 -04-03 1 Other
C4591008 -9810170432 54/F/WHITE 2021 -01-04 2021 -03-24 2 Other
C4591008 -9818355776 29/F/WHITE 2020 -12-18 2021 -03-26 4 Pregnancy -related issue (including labor and delivery)
090177e1972e4eaa\Approved\Approved On: 22-Jun-2021 15:08 (GMT)
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FDA-CBER-2021-5683-1075880