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Life Threatening? No
Write-up: miscarriage; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202103290116140840, Safety Report Unique Identifier GB-MHRA-ADR 25042453. A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 15Jan2021 (Lot number was not reported) as single dose for COVID-19 immunisation. Patient had not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Medical history included miscarriage, pregnancy, gastritis. Concomitant medications included folic acid taken for folic acid supplementation; lansoprazole taken for gastritis from Sep2020 to 13Feb2021. The patient experienced the loss, miscarriage, foetal exposure during pregnancy on an unspecified date, pregnancy unexpected on 20Feb2021. It was also reported as unexpected pregnancy resulting in pregnancy of unknown location and miscarriage. The patient believed the vaccine enabled the pregnancy. The loss, given her age, was likely to be a natural occurrence. The patient believed she couldn''t conceive after having her only child 24 years before 2021. The child and the patient was exposure to the medicine before pregnancy. The pregnancy occurred the following month 20Feb2021 resulting in loss. Details of scans or investigations was pregnancy of unknown location resulting in miscarriage. The investigations included internal scans 1 x, private 2 x NHS and blood work. Patient had not tested positive for COVID-19 since having the vaccine. The patient lab test included negative COVID-19 test on 25Mar2021. The case was reported as serious with seriousness criteria other medically important condition. The events outcome was unknown. No follow up attempts are possible, information about lot/batch number cannot be obtained.
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