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Life Threatening? No
Write-up: Early miscarriage; Vaccination during pregnancy; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority e-WEB, regulatory authority number NL-LRB-00502812. A 32-year-old female patient received the second dose of bnt162b2 (COMIRNATY; Lot Number: EJ6795), via an unspecified route of administration on 10Feb2021 at 0.3 mL, single for covid-19 immunisation. Medical history included covid-19 from 08Dec2020 to an unknown date, disease risk factor from an unknown date and unknown if ongoing, maternal exposure timing unspecified from an unknown date and unknown if ongoing; COVID-19 vaccine exposure during pregnancy week: 5. The patient''s concomitant medications were not reported. The patient received first dose of COVID vaccine COMIRNATY on 19Jan2021 at 0.3ml for COVID-19 immunization and experienced painful arm. The patient experienced a miscarriage (other medically important condition), 5 days after administration. The miscarriage occurred at a pregnancy duration of about 9 weeks. This was the second Covid vaccination. The first vaccination took place at a pregnancy duration of about 5 weeks. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 08Dec2020. The outcome of the event was unknown. Sender''s comment: Since the nature of the reported reaction does imply seriousness according to one of the Regulatory Authority critera, the reaction (miscarriage) was considered as serious by the Regulatory Authority. No follow-up attempts are possible. No further information is expected. Lot/Batch number already obtained.
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