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VAERS Report 2156792

Case Report Section

Vaer Report Details

Age: NA

Gender: Female

State: Outside US

Patient Died?
No
Vaccine information

Name: COVID19 (COVID19 (PFIZER-BIONTECH))

Type: Coronavirus 2019 vaccine

Manufacturer: PFIZER

Lot: fm3092


Date report was received
2022-03-04
Date form completed
Date Vaccinated
2021-12-16
Date of Onset
0
Number of days (onset date – vaccination date)
0
Adverse Event Description

cough; allergic edema/swelling of soft palate and tongue approx 10 minutes post dose 3 until approx. 30 minutes post dose; this is a spontaneous report received from contactable reporter(s) (physician) from the regulatory authority. regulatory number: gb-mhra-webcovid-202202171006408340-z0agw. other case identifier(s): gb-mhra-adr 26612419. a female patient received bnt162b2 (comirnaty), administration date 16dec2021 (lot number: fm3092) as dose 3, (booster), single for covid-19 immunisation. relevant medical history included: "hypertension" (unknown if ongoing); "migraine prophylaxis" (unspecified if ongoing). concomitant medication(s) included: influenza virus taken for prophylaxis, administration date: sep2021; topiramate taken for migraine prophylaxis, start date: 2014; perindopril taken for hypertension, start date: 2019. patient took no immunosuppressants. patient had nil other past medical history or surgical history patient has not had symptoms associated with covid-19. patient had not tested positive for covid-19 since having the vaccine. patient was not enrolled in clinical trial. vaccination history included: bnt162b2 (dose 1), administration date: 07jan2021, for covid-19 immunisation; bnt162b2 (dose 2), administration date: 18mar2021, for covid-19 immunisation, reaction(s): "periorbital oedema", "inappropriate schedule of vaccine administered". patient experienced marked periorbital oedema from day 2 (post dose 2 of comirnaty vaccine) until approx day 4. the following information was reported: allergic oedema (medically significant) with onset 16dec2021, outcome "recovered" (16dec2021), described as "allergic edema/swelling of soft palate and tongue approx 10 minutes post dose 3 until approx. 30 minutes post dose"; cough (medically significant), outcome "not recovered", described as "cough". the patient underwent the following laboratory tests and procedures: sars-cov-2 test: (14dec2021) no - negative covid-19 test. therapeutic measures were taken as a result of allergic oedema, cough. the clinical course report includes: prior to dose 3 of comirnaty patient took antihistamine loratidine 1 hour pre-dose and continued on antihistamine for 3 days post dose. patient experienced swelling of soft palate and tongue approx 10 minutes post dose 3 until approx. 30 minutes post dose. patient remained in observation area in vaccination centre but did not experience dyspnoea, wheeze. cough etc. the patient report was not related to possible blood clots or low platelet counts and possible myocarditis or pericarditis. no follow-up attempts are possible. no further information is expected.; sender's comments: linked report(s) : gb-pfizer inc-202200328734 same patient, different dose/event

Lab Data
test date: 20211214; test name: covid-19 virus test; result unstructured data: test result:no - negative covid-19 test
List of symptoms
allergic oedema cough sars-cov-2 test
Patient Died?
No
Date Died
NA
Birth defect
false
Vaccine Administered By:
Other
Vaccine Purchased By:
Unknown
Patient visit ER?
No
Patient Hospitalized?
No
Stay in hospital
No
Days in hospital
Unspecified
Permanent disability?
No
Allergies:
na
Current Illness
na