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Life Threatening? No
Write-up: I am pregnant for 8 weeks; Premature live birth; This is a spontaneous report from a contactable consumer (patient). This consumer or other non hcp reported information for both mother and fetus/baby. This is a mother report. A 29-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8734) via an unspecified route of administration, administered in Arm Left on 08Apr2021 at 16:00 (at the age of 29-year-old) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6204) via an unspecified route of administration, administered in Arm Left on 11Mar2021 at 16:30 (at the age of 29-year-old) as dose 1, single for COVID-19 immunisation. It was reported that patient did not smoke and drink alcohol during pregnancy. It was reported that patient did not use illicit drugs during pregnancy. It was reported that patient had no previous Pregnancy. It was reported that patient had no problems before delivery, during delivery and after delivery. Gestational age at birth in weeks reported as 34 weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the patient''s husband did not smoke and drink alcohol during pregnancy. It was reported that the patient''s husband did use illicit drugs during pregnancy. The patient reported she was pregnant for 8 weeks (maternal exposure during pregnancy) and she has not had any symptoms so far, she was feeling well. She sent this message making myself available for any follow-up or research that you want to do with pregnant women, she will be happy if she can help or contribute with something in some study. Thank you very much and congratulations on your work. On 01Nov2021 it was reported that premature live birth on unknown date in 2021. The mother reported she became pregnant while taking bnt162b2. The mother was 9 Weeks pregnant at the onset of the event. The mother was due to deliver on 06Nov2021. The patient underwent lab tests and procedures which included urine analysis: positive on 03Mar2021 Pregnancy. Outcome of the events was unknown. Information on the lot/batch number has been requested. Follow up (01Nov2021): This is a follow-up spontaneous report received from a contactable consumer. This consumer reported in response to EDP letter which included that: dose 1 and dose 2 information, patient age, height, weight and clinical course information.
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