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16.2.7.2.3 Listing of Severe and Grade 4 Local Reacti ons – Subjects With Indeterminate Vaccine –
All Subjects ≥16 Years of Age
Rel Daya
Age Group (Years) Subject Dose No. Dose Date Local Reactionb 1 2 3 4 5 6 7 Stop Datec Dur (Days)d
No subject meets the reporting criteria.
Abbreviation: Dur = duration.
a. Relative day (Rel Day) = date of reaction - date of last vaccination + 1.
b. The maximum measurable size for redness and swelling in the electronic diary (e-diary) wa s 21 caliper units. Redness and swelling exceeding 21
caliper units are reported as >21. Study sites recorded injecti on site redness or swelling in cen timeters. These were converted to caliper units (1 caliper
unit = 0.5 centimeters).
c. Stop date is the date the reaction was last reported.
d. Duration (days) was calculated as the difference from the start of the first reported reaction to resolution of the last reported reaction, inclusive. If the
reaction continued beyond Day 7, the calculation includes all days from the last e-diary day until the date of resolution colle cted on the case report form. If
the reaction was ongoing at the time of the subsequent vaccination, the end date/day for the reaction is the date/day that the next vaccine was administered,
which was used for the duration calculation.
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (19:22) Source Data: adfacevd Table Generation: 27MAR2021 (01:47)
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File: ./nda2 unblinded/C4591001 BLA/adce l004 sevlr ivall
090177e196af7323\Final\Final On: 01-Apr-2021 13:56 (GMT)
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16.2.7.3.3 Listing of Severe and Grade 4 Systemic Ev ents – Subjects With Indeterminate Vaccine –
All Subjects ≥16 Years of Age
Rel Daya
Age Group (Years) Subject Dose No. Dose Date Systemic Event 1 2 3 4 5 6 7 Stop Dateb Dur (Days)c
No subject meets the reporting criteria.
Abbreviation: Dur = duration.
a. Relative day (Rel Day) = date of event - date of last vaccination + 1.
b. Stop date is the date the event was last reported.
c. Duration (days) was calculated as the difference from th e start of the first reported event to resolution of the last re ported event, inclusive. If the event
continued beyond Day 7, the calculation includes all days from the last electronic diary (e-diary) day until the date of resolu tion collected on the case
report form. If the event is ongoing at the time of the subseque nt vaccination, the end date/day for the event is the date/day that the next vaccine was
administered, which was used for the duration calculation.
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (19:22) Source Data: adfacevd Table Generation: 27MAR2021 (01:53)
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File: ./nda2 _unblinded/C4591001 _BLA/adce _l004_sevse _iv_all
090177e196af7324\Final\Final On: 01-Apr-2021 13:56 (GMT)
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16.2.7.4.3 Listing of Adverse Events – Subjects Wi th Indeterminate Vaccine – All Subjects ≥ 16 Years of Age
Age Group
(Years)/
Subject System
Organ
Class Preferred Term/
AE Investigator
Text Dose
No. Onset
Date Rel
Daya/
Dur
(Days)b Toxicity
Grade Vax
Relc Cause
of
AE Action:
Investigational
Vaccine Dose/
Subject Outcome
(End Date) SAE/Imm
AE
(Yes/No)
>55/
C4591001 1163
11631008 PSYCH Anxiety/
ANXIETY 1 03NOV2020 96/C 1 No O NA/TC N N/N
Abbreviations: C = continuing; Dur = duration; Imm = immediate. Re fer to the AE legend page (Listing 16.2.7.1) for additional d efinitions.
Note: MedDRA (v23.1) coding dictionary applied.
a. Relative day (Rel Day) = date of AE - date of last vaccination + 1. For an AE that occurred before the date of the first study vaccination, + 1 was not
added to compute relative day.
b. Duration (days) was calculated as the difference from the start of the first reported event to resolution of the last re ported event, inclusive.
c. Vaccine related (Vax Rel): relationship to in vestigational vaccine as assessed by the investigator.
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (20:15) Source Data: adae Table Generation: 27MAR2021 (01:53)
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Output File: ./nda2 unblinded/C4591001 BLA/adae l002 ivall
090177e196af7325\Final\Final On: 01-Apr-2021 13:56 (GMT)
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