Received Apr 22, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (ABRYSVO) | PFIZER\WYETH | 1 | — | — |
Injection site reaction redness; Injection site reaction: swelling; Injection site reaction: warm; Injection site reaction: itching; Injection site reaction: mild pain; gestational_period: 37; gestational_period: 37; This is a spontaneous report received from a Pharmacist. A 33-year-old female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 10Apr2025 at 10:00 as dose 1, single (Batch/Lot number: unknown) at the age of 33 years for maternal immunisation. The patient's relevant medical history included: "Allergy: Sulfa drugs" (unspecified if ongoing). The patient was 37 weeks pregnant at the time of exposure to rsv vaccine prot.subunit pref 2v. The patient was 37 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 05May2025. Concomitant medication(s) included: TDAP taken for immunisation, on 25Mar2025 as dose number unknown, single. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 10Apr2025 at 10:00, outcome "unknown" and all described as "gestational_period: 37"; VACCINATION SITE ERYTHEMA (non-serious) with onset 11Apr2025, outcome "recovering", described as "Injection site reaction redness"; VACCINATION SITE PRURITUS (non-serious) with onset 11Apr2025, outcome "recovering", described as "Injection site reaction: itching"; VACCINATION SITE PAIN (non-serious) with onset 11Apr2025, outcome "recovering", described as "Injection site reaction: mild pain"; VACCINATION SITE SWELLING (non-serious) with onset 11Apr2025, outcome "recovering", described as "Injection site reaction: swelling"; VACCINATION SITE WARMTH (non-serious) with onset 11Apr2025, outcome "recovering", described as "Injection site reaction: warm". Therapeutic measures were not taken as a result of vaccination site erythema, vaccination site swelling, vaccination site warmth, vaccination site pruritus, vaccination site pain. The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Medical History/Concurrent Conditions: Sulfonamide allergy