Received Jan 20, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (ABRYSVO) | PFIZER\WYETH | 1 | — | — |
sent to LDR for PTL contracting every 5-7 minutes; started having irregular contractions that weekend; This is a spontaneous report received from an Other HCP from a sales representative. A female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 13Dec2025 as dose 1, single (Batch/Lot number: unknown) for maternal immunisation. The patient was 35 weeks pregnant at the event onset. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: UTERINE CONTRACTIONS DURING PREGNANCY (non-serious) with onset Dec2025, outcome "unknown", described as "started having irregular contractions that weekend"; PREMATURE LABOUR (hospitalization) with onset 16Dec2025, outcome "unknown", described as "sent to LDR for PTL contracting every 5-7 minutes". Clinical course: The patient was vaccinated on 12Dec2025 and started having irregular contractions that weekend. On 16Dec2025, the patient was sent to LDR for PTL contracting every 5-7 minutes.; Sender's Comments: The event premature labour is conservatively assessed as related to the suspect drug RSV VACCINE PROT.SUBUNIT PREF 2V based on plausible temporal association but consider also possible contributory effects from medical history of the patient and/or concomitant medications. 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.