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PFIZER GENERAL BUSINESS
The official version o f this form is located in the electronic document management system.
Page 1of 6Pfizer -BioNTech COVID- 19Vaccine VAED Data C apture Aid
Instructions for use:
This Da ta Capture Aid ( DCA )is intended to capture the available clinical details about the nature and severity of COVID -19 illness
experienced ,particularly in relation to potential cases of vaccine lack of effect o rvaccine associ ated enhanced disease (VAED) .
Select qu estions as needed to obtain any DCA -defined information described below that was not included in the initial report .
AER/Manufacturer Report #: ____________________
Suspect product: ____________________
Reported even tterm pr ompting special follow -up activities :____________________
AE onset date (dd-Mmm -yyyy): ____________________
Patient Age (e.g., 65 years) : _________________
Patient Gender : Male Female Not Stated
Race: White Black or African America n Native American Alaska Native Native Hawaiian Asian Other
Refused or Don ’t Know
Ethnic Group : Hispanic/LatinX Non-Hispanic /Non -Latin X
Reporter Information
Name of reporter completi ng this form (If other than address ee, provide contac tinformation below):
Phone Nu mber: Fax Number: Email Address:
1. Product information (Pfizer -BioNTech COVID -19 Vaccine )
DoseDate
(dd-Mmm -yyyy)Site of injectio n Route Batch /Lot number
1stdose
2nddose
Only Valid on 18-May-2021 (GMT)\090177e195e5e283\Effective\Effective On:05-Jan-2021 (GMT)
FDA-CBER-2021-5683-0779733
PFIZER GENERAL BUSINESS
The official version o f this form is located in the electronic document management system.
Page 2of 6Pfizer -BioNTech COVID- 19Vaccine VAED Data C apture Aid
Follow -up Qu estions
Please provide additional details on a se parate page if need ed and referen ce the question number.
1. Does the patient have a positive t est for SAR S-CoV2?
Unknown No Yes If Yes, p lease prov ide details
(and indica te ifthis is a new infection or a recurrence )
Details: (Please spe cify date of te st and type of test –e.g., nasal
swab reverse transcription– polymerase chain reaction (RT -PCR) test
or nucleic ac id amplification –based test (NAAT) or antigen test)2. Does the patien t haveSARS -CoV2 an tibodies at diagn osis?
Unknown No Yes IfYes, please provide det ails
Detai ls:(Please specify date of test, whether IgM /IgG or bo thand thetiterif
available )
3. Was/Isthe pat ient hospitalized ?
Unknow n No Yes If Yes, please provide details
(e.g., duration of hospitaliz ation)
Detai ls:4. Was/Is the patient admitted to an In tensive Care Unit?
Unknown No Yes IfYes, please provid e details (e.g.,
duration of hospitali zation)
Detai ls:
5. Is the patient still hospitalized ?
Unknown No Yes If Yes ,please provid e details
(e.g.,duration of hospitali zation)
Detai ls:6. If discharged, didthe p atient have SARS -CoV2 antibodies
at hospi tal discharge?
Unknown No Yes If Yes , please provide deta ils
Details:(Please specify dateof test, whether IgM /IgG or both and thetiterif
available )
7. Did the patient display c linical signs at rest indicative
of sever e systemic illness ?
Unkno wn No Yes If Yes , please provide de tails
(e.g.,Fever ,RR≥30 breaths per minute, HR ≥125 beats per minute,
use of vasopress ors to maintain BP, SpO2 ≤93% o n room air ,
PaO2/FiO2 <300 mm Hg) ?)
Detai ls:8. Did t he patient require supplemental oxygen (including
high flow or ECMO) or receive mechanic al ventilation?
Unkn own No Yes If Yes, ple ase pr ovide details (e.g.,
oxygen requirements, pulse oximetry results)
Detai ls:
9. Please provide information on any new or worsened symptom s/signs during the COVID-19illness experie nced(including
date of onset/worse ning)
Multiorgan failure Unknown No Yes If Yes, pleas e indica te which o rgan syst ems wereaffected and provide
information onthe applicabl esystems below
Respiratory Cardiovascular Gastr ointestinal /Hepatic Vascular Renal Neur ological Hematologic al Dermatologic al
Other
Only Valid on 18-May-2021 (GMT)\090177e195e5e283\Effective\Effective On:05-Jan-2021 (GMT)
FDA-CBER-2021-5683-0779734
PFIZER GENERAL BUSINESS
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Page 3of 6Pfizer -BioNTech COVID- 19Vaccine VAED Data C apture Aid
Respiratory Unknown No Yes If Yes, please provid e details
Dyspn ea Unknown No Yes If Yes,please provide d etails
Tachypnea Unknown No Yes If Yes, please provide details
Hypoxemia Unknown No Yes If Yes,please provide d etails
COVID- pneumo nia Unknown No Yes If Yes,please pr ovide detai ls
Respiratory failure Unknown No Yes If Yes, p lease pr ovide details
Acute Respiratory Distress Syndrome (ARDS) Unknown No Yes IfYes, please provide details
Other Unkn own No Yes If Yes, please pro vide detai ls
Details:
Cardiovascular Unknown No Yes If Yes, ple ase provide details
Heart failure Unknown No Yes If Yes, p lease provide de tails
Cardiogeni c shock Unknown No Yes If Yes , please provide details
Acute m yocardial infarction Unknown No Yes If Yes, please provide details
Arrhythmia Unknown No YesIf Yes, please pr ovide det ails
Myocarditis Unknown No Yes If Yes, please pr ovide details
Other Unknown No Yes If Yes, please pro vide details
Details:
Gastrointestinal /Hepatic Unknown No Yes If Yes, please provide details
Vomiting Unknown No Yes If Yes, ple aseprovide de tails
Diarrhea Unknown No Yes IfYes, please provide details
Ab dominal pain Unknown No Yes If Yes, please provid e details
Jaundice Unknown No Yes IfYes, please provide details
Acute l iver f ailure Unknown No Yes IfYes, pleas e provide detai ls
Other Unknown No Yes If Yes, pleas eprovide detai ls
Detail s:
Vascular Unknown No YesIf Yes, p lease provi de det ails
Deep v ein thrombosis Unknown No Yes If Yes, please provide details
Pulmon ary embolism Unknown No Yes IfYes, p lease provide details
Limb ischemia Unknown No YesIf Yes,pleaseprovide det ails
Vasculiti s Unknown No Yes If Yes, please provide detail s
Other (in particular any o therthromboembolic even ts) Unknown No Yes If Yes, plea se pro vide details
Details:
Renal Unknown No Yes If Yes, please prov ide details
Acute kidney inju ry Unkn own No Yes If Yes, please provide detai ls
Renal failure Unknown No Yes If Yes,please provide detail s
Other Unknown No Yes If Yes, please pro vide de tails
Details:
Only Valid on 18-May-2021 (GMT)\090177e195e5e283\Effective\Effective On:05-Jan-2021 (GMT)
FDA-CBER-2021-5683-0779735
PFIZER GENERAL BUSINESS
The official version o f this form is located in the electronic document management system.
Page 4of 6Pfizer -BioNTech COVID- 19Vaccine VAED Data C apture Aid
Neurological Unknown No Yes If Yes, please provide details
Altered co nscious ness Unknown No Yes If Yes, please provide d etails
Convulsions/seizures Unknown No Yes If Yes, please provide det ails
Encepha lopath y Unknown No Yes If Yes, pleaseprovide details
Meningitis Unknown No Yes If Yes, please provi de deta ils
Cer ebrova scular accide nt Unknown No YesIf Yes, please provide details and indicateifischemic or h emorrh agic
Other Unknown No Yes If Yes, please provide details
Details:
Hematological Unknown No Yes If Yes, please provide details
Throm bocytopenia Unknown No Yes If Yes, please provide details (see also Q14 )
Disseminated intravascular coag ulation Unknown No Yes If Yes, please provide de tails (see also Q14)
Other Unknown No Yes If Yes, please provide details
Details :
Dermatological Unknown No Yes If Yes, please provide details
Chillblains Unknown No Yes IfYes, please provide deta ils
Erythema multiforme Unknown No Yes If Yes, please provide details
Other Unknown No YesIf Yes, please providedetails
Details:
OTHER (e.g. multisystem inflammatory syndrome [MIS]) Unknown No Yes If Yes, please pr ovide details
Details :
10. Did the patient recei ve an y add itionaltherapies forCOVID-19?
TherapyDate Started
(dd-Mmm -yyyy)Date Stopped
(dd-Mmm -yyyy)Dose/Any additional information
Remdesivir
Hydroxychloroquine/ chloroquine
Azithromycin
Corticosteroids
Other (Please S pecify)
11. Didthe eventrequire the initiation of ne w medic ation or other treatment or procedure?
Unknown No Yes If Yes, please provide details
Details:
Only Valid on 18-May-2021 (GMT)\090177e195e5e283\Effective\Effective On:05-Jan-2021 (GMT)
FDA-CBER-2021-5683-0779736
PFIZER GENERAL BUSINESS
The official version o f this form is located in the electronic document management system.
Page 5of 6Pfizer -BioNTech COVID- 19Vaccine VAED Data C apture Aid
12. Patient ’s outcome with COVID -19:
Recovering Recover ed Not recovered Unknow n Fatal,Date (dd-Mmm -yyyy): …………………….
Ifoutcome isfatal,was an autops y performed? Unknown No YesIf Yes ,please provide a utopsy findings
Details:
13. How ma ny days f rom the SARS -CoV2 diagnosis did it take before the SAR S-Co V2antigen testbecame neg ative?
14. Were an y of the fol lowing labora tory test s or d iagnostic stud iesperformed? Ple ase specify labor atory data with units, date
of test , and refer enceranges; and pleas e provide p rintouts and photogra phs if available:
Laborato ry Test or Diagnostic StudiesDate Perfo rmed
(dd-M mm- yyyy)Results with u nits,if
appli cableReferenc eRanges,ifapplicable (or
please state if abnormal or
elevated/reduced)
TestforSARS-CoV-2 by PCR, or other
commer cial or pu blichealthassay
Imaging for COVID -Pneumonia
(e.g.CXR, CT)
Other r adiological investigation s (e.g.
MRI, angi ogram ,V/Q scan )
Imagin g for thrombo- embolic events (e.g.
doppler or CT)
Hematology (e.g. leu cocyte count
[including neutrophil and lymphocyte
counts], h emoglobin , platele t count ,
coagulation paramet ers [PT, P TT, D-
Dimer , INR], fibrinogen , Band T cell
function assays)
Clinical chem istry (e.g. serum creatini ne,
glomerular filtration rate [ GFR ],liver
enzymes, bilirubin ,albumin , B-type
natriuretic peptide [ BNP],troponin )
Inflammatory markers (e.g. CRP , ESR,
procalcitonin , ferritin , LDH , cytokines
[including IL -6])
Urinalysis
Evidence of hypoxemia (e.g. PaO 2/FiO 2
[P/F ratio], Sp O2/FiO2[S/F ratio] ),
hypercapn ia (PaCO 2) or acidosis (p H)
Other relevant test s (please
specify) :____________ __
Only Valid on 18-May-2021 (GMT)\090177e195e5e283\Effective\Effective On:05-Jan-2021 (GMT)
FDA-CBER-2021-5683-0779737
PFIZER GENERAL BUSINESS
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Page 6of 6Pfizer -BioNTech COVID- 19Vaccine VAED Data C apture Aid
Past Medical H istory Questions
Please provide additional detailson a s epara te page if needed and referencethe qu estion number.
15. Does thepatient have a hist oryof anyof the following ?
Hypertension
Diabete s
Hea rtDisease (please sp ecify)
Lung Disease (please specify)
Liver disea se(plea se spec ify)
Kidney disease (please specif y)
Cancer (plea se speci fy)
Immunosuppressiv edisorder(please sp ecify)
Obesity
Other (please s pecify)
Details:16. Is the pat ient asmoker /former smoker ?
Current Smo ker Former smoker No
Details:
17. Was the patient taking any medications r outinely prior to the event being report ed?
Unknown No Yes If Yes, ple ase provide det ails
Details:
18. Have any pre-existi ng diseases worsen edduring the SARS -CoV2 infe ction (please sp ecify)
Unknown No Yes If Yes, ple ase provide details
Details:
19. Has t hepatient be en treated with immunomodulating orimmun osuppressin gmedications or received a ny other vaccin es
around the time of COVID -19 vaccinatio n?
Unknown No Yes If Yes, ple ase provide details
Details:
Revis ionHistory
Revision E ffective Date Summary of Revision s
2.0 05-Jan-2021 Title updated to Pfizer -BioNTech COVID -19 Vaccine VAED
1.0 07-Dec- 2020 New DCA
Only Valid on 18-May-2021 (GMT)\090177e195e5e283\Effective\Effective On:05-Jan-2021 (GMT)
FDA-CBER-2021-5683-0779738
Document Approval Record
Document Name:
Document Title:
Signed By: Date(GMT) Signing Capacity
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Only Valid on 18-May-2021 (GMT)\090177e195e5e283\Effective\Effective On:05-Jan-2021 (GMT)
FDA-CBER-2021-5683-0779739