Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Vaccination failure
Clinical narrative: open heart surgery (AE)(Double Bypass); End stage renal disease; pain in arm after second dose; Suspected vaccination failure; At the end of January 2025, the patient developed Shingles; pain left arm after first dose; This serious case was reported by a consumer via call center representative and described the occurrence of double vessel bypass graft in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included diabetes. Concomitant products included ulinastatin (Statin) and insulin nos.   On 29-NOV-2018, the patient received the 2nd dose of Shingrix. On 20-AUG-2018, the patient received the 1st dose of Shingrix (intramuscular, left arm). On 13-DEC-2024, 2206 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced double vessel bypass graft (Verbatim: open heart surgery (AE)(Double Bypass)) (serious criteria hospitalization). In JAN-2025, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: At the end of January 2025, the patient developed Shingles). On an unknown date, the patient experienced end stage renal disease (Verbatim: End stage renal disease) (serious criteria GSK medically significant), pain in arm (Verbatim: pain left arm after first dose) and pain in arm (Verbatim: pain in arm after second dose). The patient was treated with hydrocodone, lidocaine and gabapentin. Rechallenge with Shingrix was positive. The outcome of the double vessel bypass graft, end stage renal disease, vaccination failure and shingles were unknown and the outcome of the pain in arm was resolved (duration 3 days) and the outcome of the pain in arm was not reported.   It was unknown if the reporter considered the double vessel bypass graft, end stage renal disease, vaccination failure, shingles and pain in arm to be related to Shingrix. It was unknown if the reporter considered the vaccination failure, shingles and pain in arm to be related to Shingrix.     The company considered the double vessel bypass graft, end stage renal disease and vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles and pain in arm to be related to Shingrix. The company considered the shingles to be unrelated to Shingrix. It was unknown if the company considered the pain in arm to be related to Shingrix.   Linked case(s) involving the same patient:  US2018GSK223654   Additional Information: Follow up information received on 18-JUL-2025. Upon follow up reporter mentioned that the reporter was the patient.  The patient was received the first dose of of SHINGRIX on 20 August 2018 and the second dose on 29 November 2018.  At the end of January 2025, the patient developed Shingles. The doctor believes that the Shingles were triggered by trauma of the patient having open heart surgery(Double Bypass) on 13 December 2024.  The patient did not developed blisters from the Shingles but has pain which she has not had any relief since.  The patient uses hydrocodone, compounded topical creams. lidocaine patches, and gabapentin to treat the pain.  The patient was currently on Dialysis due to End Stage Renal Disease.  The patient was in need of a kidney transplant. This case was considered as suspected vaccination failure as details regarding, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The case US2025082454 was found as duplicate of this case. All the information from the case US2018218442 was merged into this case. The case US2025082454 was deleted, and this case stand as case of record for this patient.; Sender's Comments: A case of Coronary artery bypass and End stage renal disease, 2,206 days after receiving Shingrix in a 61-year-old female patient.  Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset, absence of biological plausibility and alternative risk factors (concurrent diabetes). Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding exact time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 and Dose 2) US-GLAXOSMITHKLINE-US2018GSK223654:same patient