Received Nov 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | RA |
bump above her right posterior knee; a rash on her lower middle back that spreads to the back of her left leg; This non-serious case was reported by a consumer via call center representative and described the occurrence of local swelling in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included cerebrovascular accident (Patient stated, she had a stroke two years ago.). Concurrent medical conditions included menopause (Menopause), skin cancer (Stated the patient developed skin cancer six years ago) and cerebral palsy (Cerebral palsy- Diagnosed at birth. (right hemi aplasia)). Concomitant products included cabergoline, bisoprolol, famotidine, ciclosporin (Restasis), fluticasone furoate;umeclidinium bromide;vilanterol trifenatate (Trelegy Ellipta), acetylsalicylic acid (Aspirin), azelastine and fluoxetine hydrochloride (Prozac). On 10-NOV-2025, the patient received the 2nd dose of Shingrix (right deltoid). On 18-NOV-2025, 8 days after receiving Shingrix, the patient experienced local swelling (Verbatim: bump above her right posterior knee) and rash (Verbatim: a rash on her lower middle back that spreads to the back of her left leg). The outcome of the local swelling and rash were not resolved. It was unknown if the reporter considered the local swelling and rash to be related to Shingrix. It was unknown if the company considered the local swelling and rash to be related to Shingrix. Linked case(s) involving the same patient: US2025151331 Additional Information: GSK Receipt Date: 21-NOV-2025 The patient self-reported this case for herself. The patient stated that after the second dose she had developed a bump above her right posterior knee and a rash on her lower middle back that spreads to the back of her left leg. The patient's physician ordered an antiviral medication which she had not taken yet. The patient also had an MRI of her lumbar spine with no abnormal results. Since the tingling in her spine continues, she was scheduled for an MRI of complete spine next week. The batch number was not provided and a request for this information has been made.
Cerebral palsy (Cerebral palsy- Diagnosed at birth. (right hemi aplasia)); Menopause (Menopause); Skin cancer (Stated the patient developed skin cancer six years ago)
Medical History/Concurrent Conditions: Cerebrovascular accident (Patient stated, she had a stroke two years ago.)
CABERGOLINE; BISOPROLOL; FAMOTIDINE; RESTASIS; TRELEGY ELLIPTA; ASPIRIN; AZELASTINE; PROZAC