Received Feb 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (ABRYSVO) | PFIZER\WYETH | 1 | KD0161 | LA |
Cellulitis of arm / where the vaccine was injected; This is a spontaneous report received from a Physician. A 35-year-old female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 12Nov2024 as dose 1, 0.5ml single (Lot number: KD0161) at the age of 35 years, in left deltoid for maternal immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP), (Lot number: 3RE73) for immunization and IRON. It was reported the Tdap vaccine was administered about four weeks before rsv vaccine prot.subunit pref 2v (ABRYSVO), date unspecified. The following information was reported: VACCINATION SITE CELLULITIS (medically significant), outcome "unknown", described as "Cellulitis of arm / where the vaccine was injected". Therapeutic measures were taken as a result of vaccination site cellulitis. The patient took clindamycin, antibiotics. Causality for "cellulitis of arm / where the vaccine was injected" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction). No follow-up attempts are possible.; Sender's Comments: Based on the temporal relationship and location, the association between the event vaccination site cellulitis with ABRYSVO can not be fully excluded. 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.
TDAP; IRON