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VAERS Report 2156958

Case Report Section

Vaer Report Details

Age: 17 years old

Gender: Female

State: Outside US

Patient Died?
No
Vaccine information

Name: COVID19 (COVID19 (PFIZER-BIONTECH))

Type: Coronavirus 2019 vaccine

Manufacturer: PFIZER

Lot: ff331g


Date report was received
2022-03-04
Date form completed
Date Vaccinated
2021-08-19
Date of Onset
0
Number of days (onset date – vaccination date)
0
Adverse Event Description

drug ineffective; sars-cov-2 infection; muscle pain; this is a solicited report from the uk-mhra yellow card vaccine monitor program from a contactable consumer. this is a report received from the regulatory authority. regulatory authority report number gb-mhra-ycvm-202108151403440960-yder6, safety report unique identifier gb-mhra-adr 25828053. a 17-year-old female patient received bnt162b2 (pfizer-biontech covid-19 vaccine,, solution for injection, lot number: ff331g), via an unspecified route of administration on 19aug2021 (at the age of 17-years-old) as dose 1, single for covid-19 immunization. the patient's medical history and concomitant medications were not reported. on 19aug2021 the patient experienced muscle pain (myalgia). the patient underwent lab tests and procedures which included sars-cov-2 test was negative on 03jul2021 no - negative covid-19 test. patient lmp date: 19jun2021. patient has not had symptoms associated with covid-19 patient was not pregnant, patient was not currently breastfeeding. patient has not tested positive for covid-19 since having the vaccine. patient was not enrolled in clinical trial. on 11feb2022, patient experienced sars-cov-2 infection (suspected -covid-19) and drug ineffective. events sars-cov-2 infection and drug ineffective considered medically significant. no causality was provided for muscle pain, sars-cov-2 infection and drug ineffective. the outcome of event muscle pain was recovered with sequelae. the outcome of event sars-cov-2 infection was recovered on 19feb2022 and outcome of event drug ineffective was unknown. the reporter's assessment of the causal relationship of the events with the suspect product 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 (25feb2022): this is a solicited follow-up report received from the contactable consumer via regulatory authority card vaccine monitor program. updated information: study information; event sars-cov-2 infection and drug ineffective added.; sender's comments: based on the information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug bnt162b2 cannot be excluded

Lab Data
test date: 20210703; test name: covid-19 virus test; test result: negative ; comments: no - negative covid-19 test
List of symptoms
drug ineffective myalgia sars-cov-2 test suspected covid-19
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