Received Mar 13, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | LA |
patient mentioned he is hard of hearing; little discomfort in his arm at the injection site; blood test performed by his allergist, that he contracted Alpha-Gal; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site discomfort in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included depression and insomnia (sleep). Concomitant products included citric acid, potassium citrate (Potassium Citrate), zolpidem tartrate (Ambien) and bupropion hydrochloride (Bupropion). In SEP-2025, the patient received the 1st dose of Shingrix (left deltoid). In SEP-2025, an unknown time after receiving Shingrix, the patient experienced injection site discomfort (Verbatim: little discomfort in his arm at the injection site) and alpha-gal allergy (Verbatim: blood test performed by his allergist, that he contracted Alpha-Gal). On an unknown date, the patient experienced hard of hearing (Verbatim: patient mentioned he is hard of hearing). The outcome of the injection site discomfort was unknown and the outcome of the alpha-gal allergy and hard of hearing were not resolved. It was unknown if the reporter considered the injection site discomfort, alpha-gal allergy and hard of hearing to be related to Shingrix. It was unknown if the company considered the injection site discomfort, alpha-gal allergy and hard of hearing to be related to Shingrix. Additional Information: GSK receipt date 05-MAR-2026 The reporter reported that in SEP-2025 (no specific date provided) an testing performed by his allergist confirmed that he had contracted Alpha Gal syndrome. He had not yet received his second dose of Shingrix, and it was unknown whether the dose was considered late, as it had been approximately six months since early September 2025. The patient mentioned that he has EpiPens. The batch number was not provided and a request for this information has been made.
Depression; Insomnia (sleep)
POTASSIUM CITRATE; AMBIEN; BUPROPION