Received Apr 17, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | — | LA |
redness at the injection site; warmth at the site of injection; Fatigue; Drug dose administration interval too long; This non-serious case was reported by a physician via sales rep and described the occurrence of injection site erythema in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of injection site erythema (for tolerance of first dose refer case US2025AMR088873). On 04-APR-2026, the patient received the 2nd dose of Shingrix (left deltoid). On 04-APR-2026, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Drug dose administration interval too long). On 05-APR-2026, the patient experienced injection site erythema (Verbatim: redness at the injection site), injection site warmth (Verbatim: warmth at the site of injection) and fatigue (Verbatim: Fatigue). Rechallenge with Shingrix was positive. The outcome of the injection site erythema, injection site warmth and fatigue were resolving and the outcome of the drug dose administration interval too long was not applicable. The reporter considered the injection site erythema, injection site warmth and fatigue to be related to Shingrix. The company considered the injection site erythema, injection site warmth and fatigue to be related to Shingrix. Linked case(s) involving the same patient: US2025AMR088873 Additional Information: GSK Receipt Date: 06-APR-2026 Patient felt fatigue 24 hours after the injection and then had redness and warmth at the injection site, she said that she napped a couple of times the other day after she was vaccinated and felt better. There were no other signs or symptoms. The batch number was not provided upon follow- up with the reporter.; Sender's Comments: US-GSK-US2025AMR088873:first dose