Received Jun 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | 3AF9E | — |
uncomfortable sensation in the groin area, which they first attributed to a tick bite, appearing as a cluster lesion; drug dose interval too short; fatigue; pain in injection arm; This non-serious case was reported by a physician via call center representative and described the occurrence of fatigue in a 58-year-old male patient who received Herpes zoster (Shingrix) (batch number 3AF9E) for prophylaxis. Previously administered products included Shingrix (received first dose on 07-MAY-2018 with batch number LT533 For tolerance of first dose refer case US2025AMR068322). On 07-JUN-2018, the patient received the 2nd dose of Shingrix. On 07-JUN-2018, less than a day after receiving Shingrix, the patient experienced fatigue (Verbatim: fatigue), pain in arm (Verbatim: pain in injection arm) and drug dose administration interval too short (Verbatim: drug dose interval too short). On an unknown date, the patient experienced skin lesion (Verbatim: uncomfortable sensation in the groin area, which they first attributed to a tick bite, appearing as a cluster lesion). The patient was treated with valaciclovir hydrochloride (Valacyclovir) and pheniramine aminosalicylate (Avil). Rechallenge with Shingrix was positive. The outcome of the fatigue and pain in arm were unknown and the outcome of the skin lesion was not reported and the outcome of the drug dose administration interval too short was not applicable. It was unknown if the reporter considered the fatigue, pain in arm and skin lesion to be related to Shingrix. It was unknown if the company considered the fatigue, pain in arm and skin lesion to be related to Shingrix. Linked case(s) involving the same patient: US2025AMR068322 Additional Information: GSK Receipt Date: 30-MAY-2025 Physician called in to request data about the recommendation of booster doses of Shingrix after the initial series, then inquiring about the incidence of postherpetic neuralgia after Shingrix, how many doses are needed to reduce the incidence of postherpetic neuralgia and how many cases of shingles were present after vaccination with Shingrix. This stemmed after the physician stated that whilst hiking, they started to feel an uncomfortable sensation in the groin area, which they first attributed to a tick bite, appearing as a cluster lesion but after this, they went to a physician's office and a PCR swab test was done (identified as Diasorin Molecular Symplexa VZ direct assay) which came back as abnormal and the patient started with valacyclovir, 1000 mg every 8 hours and Aliv. They stated that the after the second doses, they had pain, with an accentuated fatigue.; Sender's Comments: US-GSK-US2025AMR068322:For 1st dose shingrix
Test Date: 20250530; Test Name: PCR test; Result Unstructured Data: (Test Result:abnormal,Unit:unknown,Normal Low:,Normal High:)