Received Oct 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (ABRYSVO) | PFIZER\WYETH | 1 | — | — |
The vaccine was administered to a pregnant patient who delivered the baby earlier than expected.; This is a spontaneous report received from a Nurse from medical information team. A female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 08Oct2025 as dose 1, single (Batch/Lot number: unknown) for maternal immunisation. The patient was 32 weeks pregnant at the time of exposure to rsv vaccine prot.subunit pref 2v. The patient was 33 weeks pregnant at the event onset. The patient is expected to deliver one baby(s). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PREMATURE DELIVERY (medically significant), outcome "unknown", described as "The vaccine was administered to a pregnant patient who delivered the baby earlier than expected.". The baby was delivered. Nurse has some questions about Abrysvo. The vaccine was administered to a pregnant patient who delivered the baby earlier than expected. The nurse reviewed information from the CDC, which states that for antibodies to form in the baby, the vaccine should be administered at least two weeks before delivery. She is wondering if the baby now needs Beyfortus (Nirsevimab) to be fully protected. When asked if the vaccine was administered between 32-36 weeks of gestation, the nurse confirmed that it was given on October 8th, 2025, at 32 weeks and 3 days of gestational age. The baby was born, so maybe the full immune protection did not have time to develop. Nurse ruled out any adverse event from the patients. The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.; Sender's Comments: There is not a reasonable possibility that the reported event was related to the suspect product event premature delivery most likely due to patient underlying contributory factors. 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.