Received Sep 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | — |
that made him feel unwell for a few days; the patient developed ringing in the ears or tinnitus; This non-serious case was reported by a other health professional via sales rep and described the occurrence of feeling unwell in a 55-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of malaise (received 1st dose in SEP-2020 and dose made him felt unwell, refer case US2025AMR107961). Concurrent medical conditions included prostatic disorder (pre-existing prostate problems). In FEB-2021, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced feeling unwell (Verbatim: that made him feel unwell for a few days) and tinnitus (Verbatim: the patient developed ringing in the ears or tinnitus). Rechallenge with Shingrix was positive. The outcome of the feeling unwell was resolved and the outcome of the tinnitus was not resolved. It was unknown if the reporter considered the feeling unwell to be related to Shingrix. The reporter considered the tinnitus to be possibly related to Shingrix. It was unknown if the company considered the feeling unwell to be related to Shingrix. The company considered the tinnitus to be possibly related to Shingrix. Linked case(s) involving the same patient: US2025AMR107961 Additional Information: GSK Receipt Date: 20-AUG-2025 The patient took dose 2 of Shingrix and also had side effects that made him feel unwell for a few days. Within a month of taking the 2nd dose of the Shingrix vaccine the patient developed ringing in the ears or tinnitus. He saw an ENT physician who ordered a magnetic resonance imaging and the findings did not identify the cause or reason for the tinnitus. The patient still experienced almost daily episodes of ringing in the ears as this form of tinnitus was not debilitating, but annoying and still persisted from 2020 through 2025. The patient's ENT physician was suspicious that the tinnitus was somehow related to the Shingrix vaccine since it developed within a few weeks of taking dose 2 of Shingrix.; Sender's Comments: US-GSK-US2025AMR107961:same patient
Prostatic disorder (pre-existing prostate problems)
Test Name: MRI; Result Unstructured Data: (Test Result:Not reported,Unit:unknown,Normal Low:,Normal High:)