Received May 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (ABRYSVO) | PFIZER\WYETH | 1 | — | OT |
Provider mentioned 2 full term babies were hospitalized last year with severe RSV with moms who had received the RSV maternal vaccine at 35-36 weeks gestation.; Provider mentioned 2 full term babies were hospitalized last year with severe RSV with moms who had received the RSV maternal vaccine at 35-36 weeks gestation.; This is a spontaneous report received from a Physician from a sales representative. An infant patient born to a mother who, while pregnant received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose 1, single (Batch/Lot number: unknown) for maternal immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), RESPIRATORY SYNCYTIAL VIRUS INFECTION (hospitalization, medically significant), outcome "unknown" and all described as "Provider mentioned 2 full term babies were hospitalized last year with severe RSV with moms who had received the RSV maternal vaccine at 35-36 weeks gestation.". The patient was hospitalized for drug ineffective, respiratory syncytial virus infection (start date: 2024). It was unknown if therapeutic measures were taken as a result of drug ineffective, respiratory syncytial virus infection. Clinical course: It was reported that 2 full term babies were hospitalized last year with severe RSV with moms who had received the RSV maternal vaccine at 35-36 weeks gestation. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event lack of effect/drug ineffective (respiratory syncytial virus infection) with the suspect product RSV VACCINE PROT.SUBUNIT PREF 2V cannot be fully excluded.,Linked Report(s) : US-PFIZER INC-202500094055 same product/event, different patient;