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Write-up: miscarriage; first pregnancy; Early miscarriage; Vaginal bleeding; Cramps; Low back ache; Maternal exposure during pregnancy; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-APPCOVID-20210605192632, Safety Report Unique Identifier GB-MHRA-ADR 25426369. A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: E003143)via an unspecified route of administration at single dose on 03Jun2021 at the age of 36 years old for COVID-19 immunisation. Medical history included miscarriage, lactation decreased, ongoing pregnancy. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Patient is not currently breastfeeding. Concomitant medications included estradiol (ELLESTE-SOLO) taken for IVF support from 19Apr2021; folic acid (Manufacturer unknown) taken for folic acid supplementation at 400 ug; ascorbic acid, betacarotene, biotin, calcium pantothenate, colecalciferol, copper, cyanocobalamin, folic acid, iodine, iron, magnesium, nicotinamide, phytomenadione, pyridoxine hydrochloride, riboflavin, selenium, thiamine mononitrate, tocopheryl acid succinate, zinc (PREGNACARE ORIGINAL) taken for pregnancy vitamins from 22May2021; progesterone (UTROGESTAN) taken for IVF support from 06May2021. The patient experienced miscarriage on an unspecified date, early miscarriage on 05Jun2021, first pregnancy on an unspecified date, maternal exposure during pregnancy on 03Jun2021, vaginal bleeding on 04Jun2021, cramps on 04Jun2021, low back ache on 04Jun2021. The events were serious as medically significant. The clinical course was reported as follows: The day after the first dose of vaccine was administered the patient started having cramps in her low abdomen, ache in the low back, and brown vaginal spotting. The day after the patient had a more intensive, red, bleeding. The patient was 7 weeks pregnant, and the patient was suspecting that the vaccine might have caused this bleeding/aches and potentially miscarriage(?). The patient was yet to confirm if she has had a miscarriage (it is Saturday evening and the patient was unable to get hold of anyone on the phone or via email). The patient was first pregnancy via IVF. Patient was exposed to the medicine first-trimester (1-12 weeks). The patient underwent lab test included COVID-19 virus test: Negative(No - Negative COVID-19 test) on 04Jun2021. The outcome of the events first pregnancy, miscarriage was recovering, of the event Maternal exposure during pregnancy was unknown, of the events Vaginal bleeding, Cramps, Low back ache, Early miscarriage was not recovered. No follow-up attempts are possible. No further information is expected.
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