Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pre-eclampsia, Protein urine present, Urine analysis, Weight, Weight increased
Clinical narrative: pre-eclampsia; blood pressure remains somewhat elevated; heart rate is severe, intermittently/heart rate remained very elevated; the end of January for the first shot and three weeks later for second shot and at the time, she was pregnant; protein in the urine; weighed a little more; This is a spontaneous report received from a contactable healthcare professional (HCP) (patient) via the medical information team. This healthcare professional reported information for both mother and fetus/baby. This is a mother (patient) report.  A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), first dose (batch: EL9262) on 22Jan2021 (at the age of 29-years-old) then second dose (lot: EN6201) on 18Feb2021 (at the age of 29-years-old); both via an unspecified route of administration as single dose for covid-19 immunisation. The patient was pregnant at the time of vaccination. Medical history included blood clot (during her previous pregnancy); pulmonary embolism (during her previous pregnancy) and pregnancies (previous pregnancies were kind of close together). Concomitant medication included enoxaparin sodium (LOVENOX) for blood clot prophylaxis/pulmonary embolism prophylaxis (patient had a blood clot, a pulmonary embolism, during her previous pregnancy and so they make her prophylactically take it, always has been on it. The patient had a blood clot and was breastfeeding so she did enoxaparin sodium and she got pregnant again and was still on enoxaparin sodium). The patient received first dose of bnt162b2 on 22Jan2021, and the second dose on 18Feb2021. She was pregnant at the time, subsequently developed pre-eclampsia on 22Mar2021, and delivered on 25Mar2021, 7 weeks before her due date. The patient's seriousness for preeclampsia was hospitalization from 22Mar2021 to 28Mar2021 and life threatening. The patient stated that they delivered the baby and the overall preeclampsia has resolved. The patient's blood pressure remains somewhat elevated and heart rate was severe, intermittently in Mar2021 with seriousness of medically significant and hospitalization from 22Mar2021 to 28Mar2021. The patient had a doctor appointment at a maternal fetal medicine on 22Mar2021 then from there she was delivered because her blood pressure and heart rates continued to worsen. The patient still has increased blood pressure, but she never had any blood pressure issues, just mild. The patient's blood pressure remained somewhat elevated and heart rate remained very elevated, but she couldn't say there was still protein in the urine (in 2021). The patient stated that her heart rate and blood pressure improved, and were medically significant. The patient remained on the dose and then her heart rate went up, not her blood pressure, just her heart rate went up really high starting in February, beginning of March and they increased her dose to, maybe in March, beginning of March, her heart rate went up, had her on enoxaparin sodium at 100mg once daily as her prophylactic dose and changed and went up from that to 100mg twice daily by injection. The patient stated that she may have weighed a little more (in 2021). The last weight was with pregnancy and pre-eclampsia. The patient weighed 205 (unspecified date). The patient was pregnant so she was seeing more of her maternal/fetal medicine and OB, but had seen her primary care throughout, maybe once. The patient stated that they didn't have enough data on pregnancy and neonatal and she wanted to contribute and advance knowledge in her area by providing information. The patient got the vaccination just on her own, just wanted to protect herself and her baby, the benefits outweighed the risks so she proceeded to get the vaccine. The outcome of the events blood pressure increased and heart rate abnormal was recovered in 2021; for pre-eclampsia was recovered with sequel on 25Mar2021 while for the remaining events was unknown. The patient did not believe the pre eclampsia had anything to do with the vaccine. The patient was not indicating that the vaccination led to the pre-eclampsia, that's for Pfizer to determine.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the current available information, the events Pre-eclampsia, Blood pressure increased, and Heart rate increased are most likely related to an intercurrent or underlying condition which is not related to the suspected drug. The patient was pregnant at the time of vaccination may provide a plausible explanation for the events. The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021374536 Same reporter/drug/event for different patients (for baby)