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VAERS Report 2157381

Case Report Section

Vaer Report Details

Age: 22 years old

Gender: Female

State: Outside US

Patient Died?
No
Vaccine information

Name: COVID19 (COVID19 (PFIZER-BIONTECH))

Type: Coronavirus 2019 vaccine

Manufacturer: PFIZER

Lot: ew6327


Date report was received
2022-03-04
Date form completed
Date Vaccinated
2021-05-03
Date of Onset
0
Number of days (onset date – vaccination date)
0
Adverse Event Description

loss of sphincters; fever 39 centigrade; vomiting; weakness; diarrhea; this is a non-interventional study report from the agency regulatory authority-web. regulatory number: it-minisal02-843983. a 22 year-old female patient received bnt162b2 (comirnaty), intramuscular, administered in arm right, administration date 03may2021 12:17 (lot number: ew6327) at the age of 22 years as dose 2, 0.3 ml single for covid-19 immunisation. relevant medical history included: "multiple sclerosis" (unknown if ongoing). the patient's concomitant medications were not reported. vaccination history included: covid-19 vaccine (dose 1; manufacturer unknown), for covid-19 immunisation. on 03may2021, the patient experienced fever 39 centigrade, vomiting, weakness, diarrhea. the events was reported as serious for being medical significant. in the 20 days following the vaccine the patient has a clinical relapse with loss of sphincters on 23may2021. the patient underwent the following laboratory tests and procedures: body temperature: (03may2021) 39 centigrade. the outcome of the events was resolving. the reporter's assessment of the causal relationship of the "fever", "vomiting", "weakness", "diarrhea" and "loss of sphincters" with the suspect product(s) bnt162b2 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.; sender's comments: based on the close temporal association the possibility of causal association between the reported events and the suspect drug bnt162b2 cannot be ruled out. the impact of this report on the benefit/risk profile of the pfizer product 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
test date: 20210503; test name: body temperature; result unstructured data: test result:39 centigrade
List of symptoms
diarrhoea vomiting asthenia pyrexia incontinence body temperature
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