Your Health. Your Family. Your Choice.
Administered by: Other Purchased by: ?
Life Threatening? No
Write-up: Spontaneous abortion; This is a spontaneous report from a contactable other healthcare professional, downloaded from the WEB, Regulatory Authority Report Number: NO-NOMAADVRE-FHI-2021-Un88aa, Safety Report Unique Identifier: NO-NOMAADVRE-E2B_00023000. This other healthcare professional reported information for both mother and fetus/baby. This is a maternal report. A 37-years-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in the left arm on 10Feb2021 at 13:00 (Batch/Lot Number: EJ6789) as 2ND DOSE, SINGLE for COVID-19 immunization. Medical history included one previous spontaneous abortion. The patient''s concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (COMIRNATY) (Batch/lot number: EJ 6789) in Jan2021 for COVID-19 immunization. The patient was 1 week pregnant at the time of the second dose of the vaccine. It was not known at the time of vaccination. The mother became pregnant while taking bnt162b2 and was 10 weeks pregnant at the onset of the event. The patient had a spontaneous abortion in 2021, in week 10. The event spontaneous abortion resolved in 2021 while the outcome of the rest of the events was unknown. Relatedness of drug to reaction/event was reported as Possible. Sender Comment: Since the vaccine is new, it will be subject to special monitoring to identify any new safety information as soon as possible. It is especially important that serious and/or unusual side effects be reported. Your message is therefore important to expand knowledge about adverse reactions that were not discovered in the studies, and it is an important contribution to international cooperation to maintain safe vaccination worldwide. No follow-up attempts are possible. No further information is expected.
Copyright © 2021 National Vaccine Information Center. All rights reserved.
21525 Ridgetop Circle, Suite 100, Sterling, VA 20166