Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Maternal exposure during pregnancy, Off label use, Product use issue, Vaccination site pain
Clinical narrative: soreness in arm at injection site; received the first dose of your Covid vaccine at 30 weeks 5 days; received the first dose of your Covid vaccine at 30 weeks 5 days; received the first dose of your Covid vaccine at 30 weeks 5 days; This is a spontaneous report from a contactable consumer or other non hcp. This consumer or other non hcp reported information for both mother and fetus/baby.     A 36-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 intramuscular, administered in Arm on 20Feb2021 13:50 (Batch/Lot Number: EN6201) as 1st dose, single dose, dose 2 intramuscular on 13Mar2021 13:50 (Batch/Lot Number: EN6208) as 2nd dose, single dose for covid-19 immunisation. Medical history included gestational diabetes from 11Jul2020 to 19Apr2021, pregnancy from an unknown date and unknown if ongoing, high risk pregnancy from an unknown date and unknown if ongoing, morning sickness from an unknown date and unknown if ongoing. Concomitant medications included Prenatal vitamins for pregnancy, from Jan2020, 1 tablet at bedtime, aspirin [acetylsalicylic acid]) taken for high risk pregnancy from Oct2020 to 11Apr2021 (tablet, 81 mg at bedtime); insulin human injection, isophane (NOVOLIN N) taken for gestational diabetes from 05Feb2021 to 18Apr2021 (subcutaneous suspension pen, 23 units at bedtime); dexamethasone (UNISONE [DEXAMETHASONE]) taken for morning sickness, start and stop date were not reported (tablet, 12.5 mg at bedtime); pyridoxine hydrochloride (B6) taken for morning sickness, start and stop date were not reported (tablet, 25mg at bedtime). The patient took Tdap (boostrix) on 05Feb2021 at upper arm within 4 weeks. The mother did not smoke during this pregnancy. The mother did not drink alcohol during this pregnancy. The mother did not use illicit drugs during this pregnancy. Mother's information -obstetrical history: Number of previous pregnancies was 2, Number of other children was 2. Outcome of previous pregnancies. History of sub-fertility: 2 previous live births; gestational diabetes during 2nd and 3rd pregnancy, placental abruption with 2nd pregnancy at 35 weeks 4 days. The patient had soreness in arm at injection site on 20Feb2021 at 08:00 and on 13Mar2021. The patient reported that she was 31 weeks pregnant and received the first dose of Covid vaccine at 30 weeks 5 days. She wanted to see if there was any information she could offer to help with clinical trials for the Covid vaccine in pregnant women and babies. She had a question about forms to be filled (scheduled delivery is 19Apr21). Also, was there any interest in testing the baby's cord blood for antibodies or breast milk. She was ready to provide. The patient delivered on 19Apr2021 via cesarean delivery.  The baby was delivered full-term. The fetal outcome was normal.  The patient underwent lab tests and procedures which included blood glucose: 220 mg/dl on 11Jun2020 Results indicated gestational diabetes. The outcome of the events was reported as unknown for maternal exposure during pregnancy and was reported as recovered for off label use, product use issue and vaccination site pain.  No follow-up attempts are possible. No further information is expected.