Received Dec 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 5N79Z | — |
severe headache; This non-serious case was reported by a consumer and described the occurrence of headache in a 50-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 5N79Z) for prophylaxis. Concurrent medical conditions included anxiety, post-traumatic stress disorder, epilepsy, migraine, menopausal symptoms, menopause, asthma and eczema. Concomitant products included buspirone, escitalopram oxalate (Lexapro), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (Adderall), gabapentin, prazosin, topiramate (Topamax), sumatriptan succinate, estradiol, progesterone, fluticasone propionate, salmeterol xinafoate (Wixela Inhub), albuterol and clobetasol. On 09-DEC-2025, the patient received Arexvy .5 ml. On 09-DEC-2025, 8 hrs after receiving Arexvy, the patient experienced headache (Verbatim: severe headache). The patient was treated with acetaminophen, ibuprofen and sumatriptan. The outcome of the headache was not resolved. It was unknown if the reporter considered the headache to be related to Arexvy. It was unknown if the company considered the headache to be related to Arexvy. Additional Information: GSK Receipt Date: 11-DEC-2025 The patient self-reported this case for herself. Approximately 8 hours after the administration of the vaccine, the patient began experiencing a migraine-like headache, as if her head was being crushed on concrete. The patient took 1000 mg of acetaminophen and 500 mg of ibuprofen, but these did not alleviate the headache. She then took a 50 mg dose of sumatriptan. Despite this, neither the acetaminophen and ibuprofen combination nor the sumatriptan (200 mg total over 8 hours) alleviated the headache. As of Today (till the day of reporting), the headache persisted, although it was not as severe as during the previous two days. The batch number was not provided and a request for this information had been made.
Anxiety; Asthma; Eczema; Epilepsy; Menopausal symptoms; Menopause; Migraine; Post-traumatic stress disorder
BUSPIRONE; LEXAPRO; ADDERALL; GABAPENTIN; PRAZOSIN; TOPAMAX; SUMATRIPTAN SUCCINATE; ESTRADIOL; PROGESTERONE; WIXELA INHUB; ALBUTEROL; CLOBETASOL