Received Oct 14, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | IM / LA |
Hot at injection site; red at injection site; swollen at injection site; overall did not feel well; Fever; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Additional patient notes included in the past prior to vaccination with Shingrix taken 2 injections of medication for osteoporosis prevention were taken. On an unknown date, the patient received the 1st dose of Shingrix (intramuscular, left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site warmth (Verbatim: Hot at injection site), injection site erythema (Verbatim: red at injection site), injection site swelling (Verbatim: swollen at injection site), feeling unwell (Verbatim: overall did not feel well) and fever (Verbatim: Fever). The outcome of the injection site warmth, injection site erythema, injection site swelling, feeling unwell and fever were resolved. It was unknown if the reporter considered the injection site warmth, injection site erythema, injection site swelling, feeling unwell and fever to be related to Shingrix. It was unknown if the company considered the injection site warmth, injection site erythema, injection site swelling, feeling unwell and fever to be related to Shingrix. Additional Information: GSK Receipt Date: 16-SEP-2025 The consumer was the reporter. The consumer reported that after receiving her first dose of Shingrix the injection site was hot, swollen and red. The consumer reported she may have had a bit of a fever that only lasted a couple of days. The consumer stated that overall she did not feel well. The consumer stated the dose was administered in her left arm and it took several weeks for the red, hot, swollen area to resolve. The consumer stated that her feeling of not feeling well overall resolved in a few days after the vaccination. Consumer stated she was healthy with no significant past history of health concerns. Consumer was unable to provide the date of the first Shingrix vaccination and stated if the lot number for the vaccine was provided to her that she would have discarded that information. The batch number was not provided, and we are unable to contact the reporter.
Comments: in the past prior to vaccination with Shingrix taken 2 injections of medication for osteoporosis prevention were taken