Received Oct 1, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | — |
she had atrial fibrillation; she had a TIA and was admitted to the hospital; developed back pain/ had back surgery for the back pain and was hospitalized overnight; A little over a year ago, she developed shingles under her breast; Suspected vaccination failure; had frequent UTIs this year; About five weeks ago she developed shingles; This serious case was reported by a consumer via call center representative and described the occurrence of atrial fibrillation in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (shingles twice, pre-vaccination). On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. In DEC-2024, more than 2 years after receiving Shingrix and Shingrix, the patient experienced back pain (Verbatim: developed back pain/ had back surgery for the back pain and was hospitalized overnight) (serious criteria hospitalization). On 27-MAR-2025, the patient experienced atrial fibrillation (Verbatim: she had atrial fibrillation) (serious criteria hospitalization and GSK medically significant). On 30-APR-2025, the patient experienced transient ischemic attack (Verbatim: she had a TIA and was admitted to the hospital) (serious criteria hospitalization and GSK medically significant). In AUG-2025, the patient experienced shingles (Verbatim: About five weeks ago she developed shingles). On an unknown date, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: A little over a year ago, she developed shingles under her breast) and recurrent urinary tract infection (Verbatim: had frequent UTIs this year). The patient was treated with gabapentin and prednisone. In MAR-2025, the outcome of the atrial fibrillation was resolved. On 30-APR-2025, the outcome of the transient ischemic attack was resolved. The outcome of the vaccination failure and shingles were not reported and the outcome of the back pain was unknown and the outcome of the shingles was resolving and the outcome of the recurrent urinary tract infection was not resolved. It was unknown if the reporter considered the atrial fibrillation, transient ischemic attack, vaccination failure, back pain, shingles, shingles and recurrent urinary tract infection to be related to Shingrix and Shingrix. The company considered the atrial fibrillation, transient ischemic attack, vaccination failure and back pain to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles, shingles and recurrent urinary tract infection to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 16-SEP-2025 The patient self-reported this case for herself. The patient received the two Shingrix doses as soon as they were available. The first was in 2017 and the second two months later. A little over a year ago (from the date of reporting), she developed shingles under her breast that she describes as mild adverse event. She self-treated with an unknown ointment. She developed back pain and on 19-DEC-2024 received injections in her back to treat the pain. She had frequented urinary tract infections this year in 2025 On 27-MAR-2025, she had atrial fibrillation and had her heart shocked back into rhythm and was hospitalized. On 28-APR-2025, she had back surgery for the back pain and was hospitalized overnight until 29-APR-2025. Two days later, on 30-APR-2025, she had a TIA (transient ischemic attack) and was admitted to the hospital for three days until 03-MAY-2025. About five weeks ago (from the date of reporting), she developed shingles that she describes as severe. The lesions were on her left from middle of abdomen to her back. She saw the physician that day and was treated with an unknown antiviral pill, gabapentin 100mg and prednisone 10mg. The shingles case was improving. Nothing else was reported. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting. The batch number was not provided, and a request for this information has been made.; Sender's Comments: A case of Back pain, Atrial fibrillation, Transient ischaemic attack and Vaccination failure, an unknown time after receiving Shingrix, in a 78-year-old female patient. Based on the available information a possible causality that the events were caused by the GSK product cannot be ascertained. Further follow up information has been sought.
Medical History/Concurrent Conditions: Shingles (shingles twice, pre-vaccination)