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PFIZER GENERAL BUSINESS
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Page 1of 5Pfizer -BioNTech COVID -19VaccineAnaphylactic Reaction Data C apture Aid
Instructions for use:
This Da ta Capture Aid ( DCA )is intended to enable the retrieval of clinical details about potential anaphylactic reaction sexperienced by an
individual following administration of Pfizer- BioNTech COVID -19 Vaccin e.
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 fo llow-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 Add ress:
1. Product information (Pfizer -BioNT ech COVID -19 Vaccine )
DoseDate
(dd-Mmm -yyyy)Time
(24 hr)Anatomical Site of
injectio nRoute Batch /Lot number
1stdose
2nd
dose
Only Valid on 18-May-2021 (GMT)\090177e195de31a4\Effective\Effective On:23-Dec-2020 (GMT)
FDA-CBER-2021-5683-0779727
PFIZER GENERAL BUSINESS
Theofficial ve rsion of this form is located in the electronic do cument ma nagement system.
Page 2of 5Pfizer -BioNTech COVID -19VaccineAnaphylactic Reaction 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. Please describe all the signs and symptoms of the
anaphylactic reactio n [please also seeSection 7] :
(Please include information on vital signs, e.g. blood pressure ,
oximetry)
Details:2. Please describe the time course of the anaphyl actic
reaction:
(Please specify time of onset fo llowing vaccination , speed of progression
and duration of signs and sy mptoms )
Details:
3. Did the patient require medical intervention ?
Unknow n No Yes If Yes, please provide details
(including dates and times of intervent ion)
Adrenal ine Corticosteroids Antihistamine IV fluids
Oxygen Bron chodilators Other (please specify)
Details :4. Was/Is the patient seen in the Emergency Department?
Unknown No YesIf Yes ,please provid e details
Detai ls:
5. Was/ Is the patient hospitalized ?
Unknown No Yes If Yes ,please prov ide details
(e.g., date of hospitalization and duration of stay )
Detai ls:6. Was/Is the patient admitted to an Intensive Care Unit ?
Unknown No Yes If Yes , please provide deta ils
(e.g., date of admission to ICU and duration of stay)
Detai ls:
7. Please pro videinformation on organ involvement
Multiorgan involvement Unknown No Yes If Yes, pleas e indica te which o rgan system s wereaffected and provide
information onthe ap plicabl esystems below
Respir atory Cardiovascular Dermatological /Mucosal Gastrointestinal Other
Respiratory Unknown No Yes If Yes, please provid e details
Bilateral wheeze/broncho spasm Unknown No Yes If Yes,please provide d etails
Stridor Unknown No YesIf Yes, please provide deta ils
Upper airway swelling Unknown No Yes If Yes,please provide d etails
Respiratory distress Unknown No Yes If Yes,please pr ovide detai ls– specifically on the followi ng:
Tachy pnoea Unknown No Yes If Yes, p lease pr ovide details
Increased use of accessory respiratory muscles Unknown No Yes IfYes, please provide details
Recess ion Unknown No Yes IfYes, please provide details
Cyanosis Unknown No Yes IfYes, please provide details
Grunting Unknown No Yes IfYes, please provide d etails
Dry cough Unknown No Yes If Yes, p lease pr ovide details
Only Valid on 18-May-2021 (GMT)\090177e195de31a4\Effective\Effective On:23-Dec-2020 (GMT)
FDA-CBER-2021-5683-0779728
PFIZER GENERAL BUSINESS
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Page 3of 5Pfizer -BioNTech COVID -19VaccineAnaphylactic Reaction Data C apture Aid
Hoarse voice Unknown No Yes IfYes, please provide details
Difficulty bre athing (without wheeze o r stridor) Unknown No Yes IfYes, please p rovide details
Se nsation of throat clos ure Unknown No Yes IfYes, please provi de details
Sneezing Unknown No Yes IfYes, please provide d etails
Rhinorrh ea Unknown No Yes IfYes, please provide details
Other Unknown No Yes IfYes, please pro vide detai ls
Details:
Cardiovascular Unknown No Yes IfYes, pleas e provide details
Measured hypotension Unknown No Yes If Yes, please p rovide de tails
Shoc k Unknown No Yes If Yes, please provide details – specifically on the following :
Tachycardia Unknown No Yes If Yes, p lease p rovide de tails
Capillary refill time > 3 s ec Unknown No Yes If Yes, p lease p rovide de tails
Reduced cent ralpulse volume Unknown No Yes If Yes, p lease p rovide de tails
Decreased level of consciousness Unknown No YesIf Yes, p lease p rovide de tails
Loss of consciousness Unknown No Yes If Yes, p lease provide de tails
Other Unknown No Yes If Yes, please pro vide details
Details:
Dermatol ogical/Mucosal Unknown No Yes If Yes, p lease prov ide det ails
Generalized urticaria (hives) Unknown No Yes If Yes, please provide details
Generalized eryt hema Unknown No Yes IfYes, p lease provide details
Angioedema (not heredi tary) Unknown No Yes If Yes, please provide det ails (e.g. loc al or generalized)
Generalized pruritus with skin rash Unknown No YesIf Yes, pleaseprovide det ails
Generalized pruritu s withoutskin rash Unknown No YesIf Yes, pleaseprovide det ails
Generalized prick le sensation Unknown No YesIf Yes, pleaseprovide det ails
Localized i njection site urticaria Unknown No YesIf Yes,pleaseprovide det ails
Red and itchy eyes Unknown No Yes If Yes, please p rovide detail s
Other Unknown No Yes If Yes, please pro vide details
Details:
Gastrointestinal Unknown No Yes If Yes, please provide details
Diarrhea Unknown No Yes IfYes, please provide det ails
Abdominal pain Unknown No Yes If Yes, please provide details
Nausea Unknown No Yes IfYes, please provide d etails
Vomiting Unknown No Yes If Yes , please provide d etails
Other Unknown No Yes If Yes, pleas eprovide detai ls
Details:
ANY OTHER SYMPTOM S/SIGNS Unknown No Yes If Yes, please pr ovide details
Details
Only Valid on 18-May-2021 (GMT)\090177e195de31a4\Effective\Effective On:23-Dec-2020 (GMT)
FDA-CBER-2021-5683-0779729
PFIZER GENERAL BUSINESS
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Page 4of 5Pfizer -BioNTech COVID -19VaccineAnaphylactic Reaction Data C apture Aid
8. Didthe ev entrequire the initiation of new medic ation or other treatment or procedure?
Unknown No Yes IfYes, please provide details
Details:
9. Patient ’s outcome following the potential anaphylactic reaction :
Recovering Recover ed Not recovered Unknow n Fatal,Date (dd-Mmm -yyyy): …………… ……….
Ifoutcomeisfatal,was an autops y performed? Unknown No YesIf Yes ,pleas eprovide a utopsy findings
Details:
10. Were an y of the fol lowing labora tory test s or diagno stic studies performed? Please s pecify labor atory data with units, date
of test , and refer enceranges; and pleas e provide p rintouts and ph otogra phs if available:
Laborato ry TestDate Perfo rmed
(dd-M mm- yyyy)Results with u nits,if
appli cableReference Ranges, if applicable
(orplease stat e if abnormal or
elevated/reduced)
Mast cell try ptase
Immune mark ers (e.g. total IgE leve ls)
Complement activation test
Hematology
Clinical chem istry
Other relevant tes ts
(please specify) :________ ____ __
Past Medical H istoryQuestions
Please provide additional detailson a s epara te page if needed andrefere nce the qu estio nnumber.
11. Does t he patient have a hist oryof any pre vious allergi es
to specific products or any conditions indicative of an
allergy?
Medic ation (please sp ecify) Asthma
Vaccine (please sp ecify) Arrythmia
Foods (please sp ecify) Urticaria
Environ mental (please sp ecify) Pruritus
Insect bite/sting (please specif y) Mastocytosis
Latex (please sp ecify) Other (please specif y)
Chemica l(please sp ecify)
Other (please sp ecify)
Details:12. If there is a previous history of an yallergies, does the
patient take (or ha ve readily available) any specif ic
medication relat ed to this
Adrenalin e (Epipen) Corticos teroid Antihista mine Other
Details:
Only Valid on 18-May-2021 (GMT)\090177e195de31a4\Effective\Effective On:23-Dec-2020 (GMT)
FDA-CBER-2021-5683-0779730
PFIZER GENERAL BUSINESS
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Page 5of 5Pfizer -BioNTech COVID -19VaccineAnaphylactic Reaction Data C apture Aid
13. Was the patient taking any medications prior to the ev ent being report ed?
Unknown No Yes IfYes, please provi de details
Details:
14. Did the patient receive any recent vaccines for any other conditions prior to the ev ent being report ed?
Unknown No Yes If Yes, ple ase pro vide details
Details:
15. Did the patient receive any recent vaccines for SARS -CoV2 other than Pfizer -BioNTech COVID -19 Vaccin e prior to the ev ent
being report ed?
Unknown No Yes If Yes, ple ase pro vide details
Details:
16. Has thepatient receiv ed any othervacci nesaround the time ofPfizer -BioNTe ch COVID -19 Vaccine vaccinatio n?
Unkn own No Yes If Yes, please provid e details
Details:
Revision Histor y
Revision E ffective Date Summary of Revision s
1.0 23-Dec- 2020 New DCA
Only Valid on 18-May-2021 (GMT)\090177e195de31a4\Effective\Effective On:23-Dec-2020 (GMT)
FDA-CBER-2021-5683-0779731
Document Approval Record
Document Name:
Document Title:
Signed By: Date(GMT) Signing Capacity
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Only Valid on 18-May-2021 (GMT)\090177e195de31a4\Effective\Effective On:23-Dec-2020 (GMT)
FDA-CBER-2021-5683-0779732