Received Jan 6, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 37am2 | IM / LA |
short of breath; blurred vision; fatigue; headache; This non-serious case was reported by a consumer and described the occurrence of headache in a 51-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 37am2) for prophylaxis. Concurrent medical conditions included immunocompromised, asthma, spondyloarthropathy, gastroesophageal reflux disease, menopause and multiple allergies. Concomitant products included etanercept (Enbrel), lansoprazole, montelukast, fexofenadine and estradiol. On 31-DEC-2025, the patient received Arexvy (intramuscular, left arm) .5 ml. On 31-DEC-2025, less than a day after receiving Arexvy, the patient experienced headache (Verbatim: headache) and fatigue (Verbatim: fatigue). On 01-JAN-2026, the patient experienced blurred vision (Verbatim: blurred vision). On an unknown date, the patient experienced shortness of breath (Verbatim: short of breath). The outcome of the headache, blurred vision and fatigue were not resolved and the outcome of the shortness of breath was not reported. It was unknown if the reporter considered the headache, blurred vision, fatigue and shortness of breath to be related to Arexvy. It was unknown if the company considered the headache, blurred vision, fatigue and shortness of breath to be related to Arexvy. Additional Information: GSK Receipt Date: 02-JAN-2026 The patient was immunocompromised and had asthma. The patient had also felt short of breath since she received the vaccine.
Asthma; Gastroesophageal reflux disease; Immunocompromised; Menopause; Multiple allergies; Spondyloarthropathy
ENBREL; LANSOPRAZOLE; MONTELUKAST; FEXOFENADINE; ESTRADIOL