Received Mar 9, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 7HZ93 | RA |
| TDAP | TDAP (BOOSTRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | PF44A | LA |
decrease in her activities of daily living; rash was located on the left side of her back; broke out in itchy bumps rash; tingling sensation in feet and legs; flu-like symptoms (chills); blurred vison; loud ringing in her ears; Brain fog; Confusion; oral yeast infection; the ringing in her ears was so loud that she could not sleep (Insomnia); This non-serious case was reported by a consumer via call center representative and described the occurrence of headache in a 67-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 7HZ93, expiry date 12-DEC-2026) for prophylaxis. Co-suspect products included DTPa (Reduced antigen) (Boostrix) (batch number PF44A, expiry date 12-JUN-2028) for prophylaxis. Previously administered products included Flu (patient received flu vaccine on 11-OCT-2025) and pneumonia vaccine (patient received pneumonia vaccine on 11-OCT-2025). Concurrent medical conditions included candidiasis and keratosis. Concomitant products included fluorouracil, nystatin and fluconazole (Diflucan). On 24-OCT-2025, the patient received Arexvy (right arm) and Boostrix (left arm). On 24-OCT-2025, 2 hrs after receiving Arexvy and Boostrix, the patient experienced headache (Verbatim: headache), blurred vision (Verbatim: blurred vison), ringing in ears (Verbatim: loud ringing in her ears), influenza-like symptoms (Verbatim: flu-like symptoms (chills)), muscle weakness (Verbatim: Weakness muscle), muscle spasm (Verbatim: Muscle spasms), fatigue (Verbatim: fatigue), brain fog (Verbatim: Brain fog), confusion (Verbatim: Confusion), yeast infection of the mouth (Verbatim: oral yeast infection), insomnia (Verbatim: the ringing in her ears was so loud that she could not sleep (Insomnia)) and tingling sensation (Verbatim: tingling sensation in feet and legs). On an unknown date, the patient experienced activities of daily living decreased (Verbatim: decrease in her activities of daily living), rash (Verbatim: rash was located on the left side of her back) and itchy rash (Verbatim: broke out in itchy bumps rash). The outcome of the headache, blurred vision, influenza-like symptoms, muscle weakness, muscle spasm, confusion, insomnia, activities of daily living decreased, tingling sensation and rash were resolving and the outcome of the ringing in ears and brain fog were not resolved and the outcome of the fatigue and itchy rash were not reported and the outcome of the yeast infection of the mouth was resolved. It was unknown if the reporter considered the headache, blurred vision, ringing in ears, influenza-like symptoms, muscle weakness, muscle spasm, fatigue, brain fog, confusion, yeast infection of the mouth, insomnia, activities of daily living decreased, tingling sensation, rash and itchy rash to be related to Arexvy and Boostrix. It was unknown if the company considered the headache, blurred vision, ringing in ears, influenza-like symptoms, muscle weakness, muscle spasm, fatigue, brain fog, confusion, yeast infection of the mouth, insomnia, activities of daily living decreased, tingling sensation, rash and itchy rash to be related to Arexvy and Boostrix. Additional Information: GSK Receipt Date: 27-JAN-2026 Patient described the events 2 hours after vaccination on 24-Oct-2025, developed multiple symptoms; symptoms described as ongoing. The tingling sensation (began in feet/legs, progressed up body over 4 months, described as vibrating), and decreased ability to perform daily activities. The bloodwork was normal. Chiropractic care for muscle spasms was done.
Candidiasis; Keratosis
FLUOROURACIL; NYSTATIN; DIFLUCAN
Test Name: activities of daily living; Result Unstructured Data: (Test Result:decreased,Unit:unknown,Normal Low:,Normal High:); Test Name: Blood test; Result Unstructured Data: (Test Result:normal,Unit:unknown,Normal Low:,Normal High:)