Received Oct 30, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | — |
Injection site swelling; Injection site pain; Injection site redness; Headache; Fatigue; patient was 59 years old; This non-serious case was reported by a consumer and described the occurrence of injection site swelling in a 59-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Concurrent medical conditions included type ii diabetes mellitus (has Type 2 Diabetes Mellitus), blood cholesterol increased (has High cholesterol), asthma (has Asthma), anxiety (has anxiety) and multiple allergies (has allergies). Concomitant products included tirzepatide (Mounjaro), ezetimibe (Zetia), duloxetine hydrochloride and azelastine hydrochloride, fluticasone propionate (Dymista). On 10-OCT-2025, the patient received Arexvy. On 10-OCT-2025, less than a day after receiving Arexvy, the patient experienced injection site swelling (Verbatim: Injection site swelling), injection site pain (Verbatim: Injection site pain), injection site erythema (Verbatim: Injection site redness), headache (Verbatim: Headache), fatigue (Verbatim: Fatigue) and inappropriate age at vaccine administration (Verbatim: patient was 59 years old). The patient was treated with hydrocortisone hydrogen succinate (Hydrocortisone) and ibuprofen sodium (Ibuprofen). On 12-OCT-2025, the outcome of the headache and fatigue were resolved (duration 2 days). The outcome of the injection site swelling, injection site pain and injection site erythema were not resolved and the outcome of the inappropriate age at vaccine administration was not applicable. It was unknown if the reporter considered the injection site swelling, injection site pain, injection site erythema, headache and fatigue to be related to Arexvy. It was unknown if the company considered the injection site swelling, injection site pain, injection site erythema, headache and fatigue to be related to Arexvy. Additional Information: GSK Receipt Date: 15-OCT-2025 The patient had received the Arexvy vaccine and experienced injection site swelling, pain, redness, fever, fatigue, and headache. The patient was treated for the reported symptoms. The patient was receiving Breo medication from 1 January 2025 for the condition of asthma. The batch number was not provided and a request for this information has been made.
Anxiety (has anxiety); Asthma (has Asthma); Blood cholesterol increased (has High cholesterol); Multiple allergies (has allergies); Type II diabetes mellitus (has Type 2 Diabetes Mellitus)
MOUNJARO; Zetia; Duloxetine hydrochloride; Dymista