Received Nov 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (ABRYSVO) | PFIZER\WYETH | 1 | MN0315 | OT / LA |
| RSV | RSV (ABRYSVO) | PFIZER\WYETH | 1 | MN0315 | OT |
| RSV | RSV (ABRYSVO) | PFIZER\WYETH | 1 | MN0315 | OT |
Premature live birth/ 36 5/7 wks; This is a spontaneous report received from a Physician. A male patient born to a mother who, while pregnant, received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose 1, single (Lot number: MN0315) via subcutaneous for maternal immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: DICYCLOMINE [DICYCLOVERINE] transplacental taken for gastrointestinal disorder not provided; ZOFRAN [ONDANSETRON] transplacental taken for gastrointestinal disorder not provided; PANTOPRAZOLE transplacental taken for gastrointestinal disorder not provided. The mother's relevant medical history included: "2 previous pregnant" (unspecified if ongoing), notes: live birth; "Saethre-Chotzen syndrome" (unspecified if ongoing); "not smoke during this pregnancy" (unspecified if ongoing); "not drink alcohol during this pregnancy" (unspecified if ongoing); "GI" (ongoing). Date of last menstrual period of the mother: 09Feb2025. The mother was 36 weeks pregnant at the event onset. The mother is expected to deliver two baby(s) on 16Nov2025. The following information was reported: PREMATURE BABY (non-serious) with onset date, outcome "unknown", described as "Premature live birth/ 36 5/7 wks". The first baby was delivered via cesarean route, delivery date. The baby weighed 2355 grams. APGAR Score was 8, 9. The second baby was delivered via cesarean route, delivery date. The baby weighed 2250 grams. APGAR Score was 7, 9. Additional information: The patient did not receive any other vaccines on the same date as the Pfizer vaccine. The patient did not receive any other vaccines within 4 weeks prior to the first administration of the suspect vaccine. The mother previous did not experience pregnancy complications, fetal/neonatal abnormalities. The mother did not have history of sub-fertility. The mother did not treat for infertility. The mother did not use illicit drugs during pregnancy, did not experience any problems before delivery and during delivery. Outcome of this pregnancy is premature liver birth. Healthy newborn. The father was adult (18-64 years).; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500228528 Same reporter/ SD/ AE, different patients;US-PFIZER INC-202500196194 Mother-baby case;
DICYCLOMINE [DICYCLOVERINE]; ZOFRAN [ONDANSETRON]; PANTOPRAZOLE