Received Jun 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | RA |
fatigue; headache; drug dose administration interval too long; This non-serious case was reported by a consumer via call center representative and described the occurrence of fatigue in a male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of fatigue (received first dose on 23 or 24 October 2024). On 11-JUN-2025, the patient received the 2nd dose of Shingrix (right arm). On 11-JUN-2025, less than a day after receiving Shingrix, the patient experienced fatigue (Verbatim: fatigue), headache (Verbatim: headache) and drug dose administration interval too long (Verbatim: drug dose administration interval too long). Rechallenge with Shingrix was positive. The outcome of the fatigue and headache were not resolved and the outcome of the drug dose administration interval too long was not applicable. It was unknown if the reporter considered the fatigue and headache to be related to Shingrix. It was unknown if the company considered the fatigue and headache to be related to Shingrix. Additional Information: GSK Receipt Date: 12-JUN-2025 Patient received his second dose on 11 JUN 2025. Patient had the same reaction with both dose one and dose 2. Patient had fatigue and a headache, these symptoms after the second dose have been persisting for two days. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccinations schedule.