Received Apr 8, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
Deaf in one ear; Diarrhea; Hemorrhoids; weight loss; increases skin; This serious case was reported by a consumer and described the occurrence of deafness unilateral in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included arthritis (Arthritis pain) and cholesterol. Concomitant products included hydrocodone and rosuvastatin. On 07-MAR-2023, the patient received Shingrix. On 11-APR-2023, 35 days after receiving Shingrix, the patient experienced deafness unilateral (Verbatim: Deaf in one ear) (serious criteria GSK medically significant), diarrhea (Verbatim: Diarrhea), hemorrhoids (Verbatim: Hemorrhoids), weight loss (Verbatim: weight loss) and skin disorder (Verbatim: increases skin). The patient was treated with prednisone. The outcome of the deafness unilateral, diarrhea, hemorrhoids and skin disorder were not resolved and the outcome of the weight loss was resolved. It was unknown if the reporter considered the deafness unilateral, diarrhea, hemorrhoids, weight loss and skin disorder to be related to Shingrix. The company considered the deafness unilateral to be unrelated to Shingrix. It was unknown if the company considered the diarrhea, hemorrhoids, weight loss and skin disorder to be related to Shingrix. Additional Information: GSK Receipt Date: 26-MAR-2026 The patient was severely deaf in the left ear, and other maladies followed and continue, except that the weight loss ceased. The batch number was not provided upon follow- up with the reporter.; Sender's Comments: A case of Deafness unilateral, 35 days after receiving Shingrix, in a 72-year-old male patient. Based on the available information, a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received.
Arthritis (Arthritis pain); Cholesterol
HYDROCODONE; ROSUVASTATIN
Test Date: 20230411; Test Name: weight loss; Result Unstructured Data: (Test Result:25 to 30,Unit:%,Normal Low:,Normal High:)