Your Health. Your Family. Your Choice.
Life Threatening? No
Write-up: Light-headed; YELLOW CARD VACCINE MONITOR This is received from a contactable consumer via the Regulatory Authority. The Regulatory Authority report number is GB-MHRA-YCVM-202106041720241730-4LW0Q, Safety Report Unique Identifier GB-MHRA-ADR 25422441. A male patient of an unspecified age received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 04Jun2021 (Batch/Lot Number: Et8885), as single dose, for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. The patient experienced light-headed (dizziness) (medically significant) on 04Jun2021 with outcome of recovering. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on unknown date. No follow-up attempts are possible. No further information is expected. The reporter''s assessment of the causal relationship of the event 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.; Sender''s Comments: Based on the current available information and the plausible drug-event temporal association, there is a reasonable possibility that event Light-headed was related to suspect drug.
Copyright © 2021 National Vaccine Information Center. All rights reserved.
21525 Ridgetop Circle, Suite 100, Sterling, VA 20166