Received Jun 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | — | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | — | — |
Diverticulitis daignosed in 2024; Feels like bad sunburn; Scar; Sleep concerns; Shingles/shingles was located from the center of his back to his belly button around his left side, waist height.; Suspected vaccination failure; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. In JUL-2020, the patient received the 1st dose of Shingrix. In SEP-2020, the patient received the 2nd dose of Shingrix. On 09-APR-2025, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles/shingles was located from the center of his back to his belly button around his left side, waist height.). On an unknown date, the patient experienced diverticulitis (Verbatim: Diverticulitis daignosed in 2024) (serious criteria GSK medically significant), burning sensation (Verbatim: Feels like bad sunburn), scar (Verbatim: Scar) and sleep disorder (Verbatim: Sleep concerns). The patient was treated with valaciclovir hydrochloride (Valaciclovir Hcl), prednisone and lidocaine. The outcome of the vaccination failure was not reported and the outcome of the diverticulitis was unknown and the outcome of the shingles was resolved and the outcome of the burning sensation, scar and sleep disorder were not resolved. It was unknown if the reporter considered the vaccination failure, diverticulitis, shingles, burning sensation, scar and sleep disorder to be related to Shingrix and Shingrix. The company considered the vaccination failure and diverticulitis to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles, burning sensation, scar and sleep disorder to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 03-JUN-2025 The patient reported that he was woke up with Shingles on, Wednesday, 9-APR- 2025, after receiving both doses of Shingrix, the first in July 2020, and the second September 2020 (no specific dates were provided). Patient was only provided the name of the pharmacy of the grocery store where he got Shingrix on 2020. The patient reported that the shingles was located from the center of his back to his belly button around his left side, waist height. The patient reported that he went to the emergency room on Friday, 11-APR-2025, and was diagnosed with shingles; and prescribed an antiviral, Valacyclovir HCL 1GM unknown product information, to take 1 tablet by mouth three times a day he believes for either 21 tablets or to take for two weeks it was unclear about duration. The patient reported the Valacyclovir did not do anything, so he went to urgent care and was prescribed a steroid, Prednisone 20mg the unknown product information to take 2 tablets by mouth in the morning for 7 days. The patient reported that the shingles was healed up, except maybe for a scar. The patient reported that he was still having aftereffects from shingles that was worse at night, and feels like a bad sunburn, and he could feel it when his clothes touch it . The patient was using an ice gel pack at night to help him sleep (AE Filed), and Lidocaine roll. The patient also reported that he was diagnosed with diverticulitis in 2024 no specific date was provided, at the emergency room where a CAT Scan was performed, after experiencing pain in his left lower back, after receiving both doses of Shingrix. The patient was given medication unknown product Information and later a pain killer (unknown product information) for the diverticulitis. The patient did not have a Lot Expiry ot route of Administration or Location of Administration for either the first or second dose of Shingrix. The reporter reported all that was provided about these adverse events. The patient was going to a new physician in July 2025 and was willing to provide the HCP information on the follow up from safety. This case was considered as suspected vaccination failure as details regarding laboratory test confirming shingles were unknown at the time of reporting. The case US2025069644 was found as duplicate of this case. All the information from the case US2025069644 was merged into this case. The case US2025069644 was deleted and this case stand as case of record for this patient.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about laboratory confirmation regarding shingles) is considered unrelated to GSK vaccine Shingrix (Dose 1 & 2). Diverticulitis is an unlisted event which is considered unrelated to GSK vaccine Shingrix (Dose 1 & 2).
Test Date: 202504; Test Name: CAT Scan; Result Unstructured Data: (Test Result:Not reported,Unit:unknown,Normal Low:,Normal High:)