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|History of Changes from the VAERS Wayback Machine|
|Vaccination / Manufacturer||Lot / Dose||Site / Route|
|COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH||ET8885 / 1||- / -|
Administered by: Other Purchased by: ??
Symptoms: Threatened labour, Off label use, Maternal exposure during pregnancy, Product use issue, Maternal exposure during breast feeding
Life Threatening? No
Birth Defect? No
Permanent Disability? Yes
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? Yes, days:
Write-up: Threatened premature labor; Maternal exposure during pregnancy; Maternal exposure during breast feeding; maternal exposure during breast feeding; maternal exposure during breast feeding; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107061633449950-2LEYR,Safety Report Unique Identifier GB-MHRA-ADR 25605360. This consumer reported information for both mother and baby. This is a maternal report. A 30-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration at the age of 30-year-old on 03Jun2021 (Lot Number: ET8885) as single dose for COVID-19 immunisation. Medical history included ongoing pregnancy, ongoing breast feeding, suspected covid-19 from 02Mar2020 to 20Mar2020, deep vein thrombosis, Folic acid supplementation, hypothyroidism, polycystic ovaries, pregnancy (First pregnancy through IVF with donor sperm). Not had a COVID-19 test Patient is not enrolled in clinical trial. Concomitant medications included enoxaparin taken for deep vein thrombosis from 01May2021 to an unspecified stop date; folic acid taken for Folic acid supplementation, start and stop date were not reported; levothyroxine taken for hypothyroidism, start and stop date were not reported; metformin taken for polycystic ovaries, start and stop date were not reported. The patient experienced maternal exposure during pregnancy (hospitalization, disability, medically significant) on 03Jun2021, maternal exposure during breast feeding (hospitalization, disability, medically significant) on 03Jun2021, threatened premature labor (hospitalization, disability, medically significant) on 06Jun2021. The outcome of event threatened premature labor was recovering. The outcome of other events was unknown. The clinical course was reported as follows: On Sunday 06Jun2021 (3 days after patient had the vaccine), patient''s waters broke prematurely at 30 weeks 2 days pregnant. This is also known as PPROM (preterm prelabour rupture of membranes). PPROM has not resulted in premature labour so far - patient was now 34 weeks and 4 days pregnant. Patient had no evidence to suggest this was a direct result of the vaccine but felt compelled to report it incase there is a pattern and other women have experienced similar. Patient has not tested positive for COVID-19 since having the vaccine. Details of previous pregnancies: First pregnancy through IVF with donor sperm. Patient was exposed to the medicine Third-trimester (29-40 weeks). No follow up attempts are possible. No further information is expected.
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