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Life Threatening? No
Write-up: Headache; Nausea; Dizziness; The patient received the first dose of BNT162B2 on 26Feb2021 and the second dose on 03Jun2021; This is a non-interventional study report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-YCVM-202106041001148320-ZQQ37, Safety Report Unique Identifier GB-MHRA-ADR 25419086. A 49-years-old female patient received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, on 03Jun2021 (Lot Number: EW3143), at the age of 49 years, for COVID-19 immunisation. Medical history included type 2 diabetic. The first dose of BNT162B2 vaccine was administered on 26Feb2021 (Batch/lot number: EL8713). Unsure if patient has had symptoms associated with COVID-19. Patient was not enrolled in clinical trial, was not pregnant and was not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced headache on 04Jun2021 with outcome of not recovered, nausea on 03Jun2021 with outcome of not recovered, dizziness on 03Jun2021 with outcome of not recovered. The events were reported as serious as medically significant. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on unspecified date. Additional information included: Type 2 diabetic. The reporter''s assessment of the causal relationship of the events headache, nausea and dizziness 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.; Sender''s Comments: Based on the current available information and the plausible drug-event temporal association, there is a reasonable possibility that events Headache, Nausea, and Dizziness were related to suspect drug.
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