Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Headache, Investigation, Maternal exposure during pregnancy, Pain in extremity
Clinical narrative: Gestational period at time of initial exposure: 4 (15 weeks, 5 days) months; 2nd Trimester; arm soreness; Headache; This is a spontaneous report from a contactable consumer in response to Non-HCP letter. This female consumer reported information for both mother and fetus. This is a maternal report.  A 38-year-old female patient received BNT162B2 (Pfizer/BioNTech Covid-19 vaccine, Age at the of vaccination: 38 years), dose 1 intramuscular, administered in arm left (left arm) on 28Apr2021 13:30 (Batch/Lot Number: EWC175, expiration date not reported) as dose 1, single for COVID-19 immunisation. Concomitant medication included prenatal vitamin via oral, gummy, daily, 2 per day starting from 12months (>2years (01Jan2018)) and ongoing as supplement. Medical history included mild covid infection week of 17Mar2020. Historical Vaccine included MMR vaccine booster received prior to pregnancy (positive Ab to measles, rubella, NOT mumps though- did not take). Family history included sporadic migraine for mother/ niece/ sister. The mother did not smoke during this pregnancy and did not drink alcohol during this pregnancy (a few drinks early- prior + pregnancy test (average<1 drink/day). No illicit drugs during this pregnancy. The father smoked (recreational (<1 per week)) and drank alcohol recreational (10 beers per week) during the mother pregnancy. No illicit drugs during the mother pregnancy. On 29Apr2021, the patient experienced headache next day and recovered with no treatment. On 29Apr2021 at, 1800, the patient experienced arm soreness and recovered with no treatment. The patient also received BNT162B2 (Pfizer/BioNTech Covid-19 vaccine), dose 2 intramuscular, administered in arm left (left arm) on 19May2021 0930 (Batch/Lot Number: EW0185, expiration date not reported) as dose 2, single for COVID-19 immunisation. The patient reported that she was in her first trimester of pregnancy and was considering enrolling in trial. However, it looked like no study sites within town, based on  website. The mother reported she became pregnant while taking BNT162B2. The mother was 16 weeks pregnant at the onset of the event. The mother was due to deliver on 15Oct2021. First day of last menstrual period was on 08Jan2021, estimated date of conception was 20Jan2021 and estimated delivery date was on 15Oct2021. Gestational period at time of initial exposure: 4 (15 weeks, 5 days) months; 2nd Trimester. The patient underwent lab tests and procedures which included Covid tests, many in 2020: Negative; on 19May2020: Positive (repeatedly positive over course of 5 months); on 27May2020: positive, on 01Sep2020: Negative, tested for antigen many times on an unspecified date and once available (summer 2020); all negative, no antigen test available at time of active infection; re-tested for antibody (Ab) several times to track possible loss of immunity over years (loss at 6months post- infection). The patient did not received treatment for the events. The outcome of the events arm soreness and headache was recovered on an unspecified date in 2021, whereas for another event it was unknown.  No follow-up attempts are needed. No further information is expected.