Received Jan 6, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (ABRYSVO) | PFIZER\WYETH | 1 | KD424 | — |
RSV; RSV; COPD; This is a spontaneous report received from a Physician from a sales representative. A 75-year-old female patient (not pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 18Oct2023 as dose 1, single (Lot number: KD424) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHRONIC OBSTRUCTIVE PULMONARY DISEASE (hospitalization) with onset 15Dec2025, outcome "recovered" (18Dec2025), described as "COPD"; DRUG INEFFECTIVE (hospitalization, medically significant), RESPIRATORY SYNCYTIAL VIRUS INFECTION (hospitalization, medically significant) all with onset 15Dec2025, outcome "recovered" (18Dec2025) and all described as "RSV". The patient was hospitalized for drug ineffective, respiratory syncytial virus infection, chronic obstructive pulmonary disease (start date: 15Dec2025, discharge date: 18Dec2025, hospitalization duration: 4 day(s)). It was unknown if therapeutic measures were taken as a result of drug ineffective, respiratory syncytial virus infection, chronic obstructive pulmonary disease. No follow-up attempts are possible.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event drug ineffective (respiratory syncytial virus infection) with the suspect product RSV VACCINE PROT.SUBUNIT PREF 2V cannot be fully excluded. The event chronic obstructive pulmonary disease is conservatively assessed as related to the suspect drug 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.