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VAERS Report 2156950

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: fg6431


Date report was received
2022-03-04
Date form completed
Date Vaccinated
2021-10-29
Date of Onset
9
Number of days (onset date – vaccination date)
9
Adverse Event Description

diarrhoea; diarrhoea; card vaccine monitor this is a solicited report received from a contactable reporter(s) (consumer or other non hcp) from the regulatory authority for a sponsored program. regulatory number: gb-mhra-ycvm-202101301448555150. other case identifier(s): gb-mhra-adr 25267350. a 80 year-old female patient received bnt162b2 (comirnaty), administration date 29oct2021 (lot number: fg6431) as dose 3 (booster) single for covid-19 immunisation. relevant medical history included: "systolic hypertension" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "generalised osteoarthritis" (unspecified if ongoing); "blood cholesterol" (unspecified if ongoing); "muscle cramp" (unspecified if ongoing). concomitant medication(s) included: candesartan taken for systolic hypertension; felodipine taken for hypertension; ibuprofen taken for osteoarthritis, osteoarthritis; omeprazole; paracetamol taken for osteoarthritis, osteoarthritis; rosuvastatin taken for blood cholesterol; quinine sulphate taken for muscle spasms. vaccination history included: bnt162b2 (dose 1, single, start date: 27apr2021, stop date: 29apr2021, outcome: recovered/resolved, lot: el0739), administration date: 29jan2021, for covid-19 immunization, reaction(s): "diarrhoea"; bnt162b2 (dose 2, single), for covid-19 immunization. the following information was reported: diarrhoea (medically significant) with onset 07nov2021, outcome "recovering", diarrhoea (medically significant), outcome "not recovered" and all described as "diarrhoea". additional information: patient has not had symptoms associated with covid-19. not had a covid-19 test. patient has not tested positive for covid-19 since having the vaccine. patient was not enrolled in clinical trial. the reporters assessment of the causal relationship of the events with the suspect products was not provided at the time of this report. since no determination has been received, the case is managed based on the company causality assessment. no follow-up attempts are possible. no further information is expected. follow-up#2 (21feb2022): this is a solicited report from the regulatory authority card vaccine monitor program from a contactable consumer. this is a report received from the regulatory authority. updated information: dose description captured for 3rd dose and 2nd dose and also concomitant drug captured quinine sulphate, and event captured diarrhoea outcome not recovered /not resolved. no follow-up attempts are possible. no further information is expected.; sender's comments: based on temporal association, there is reasonable possibility of causal association between the reported events and the suspect drug bnt162b2. the impact of this report on the benefit/risk profile of the pfizer drug is evaluated as part of pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees, and investigators, as appropriate

Lab Data
na
List of symptoms
diarrhoea
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