Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Herpes zoster, Pain, Vaccination failure
Clinical narrative: Abdominal cramps; Head hurts; the pain started in the lower left side of the abdomen, spread around the chest; Diverticulosis ruled out; 2 doses of Shingrix years ago, developed Shingles/ Suspected vaccination failure; developed Shingles/Really bad shingles rash (midline left side all the way to the back); Extreme pain all around body/ also pain around chest; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included renal disease and diverticulosis. Concurrent medical conditions included eosinophilic asthma.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On 18th November 2022, several years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and generalized aching. On an unknown date, the patient experienced abdominal cramp, headache, lower abdominal pain and diverticulosis. The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)), analgesic, nos (Pain Medication) and gabapentin. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, generalized aching and headache were not recovered/not resolved and the outcome of the abdominal cramp, lower abdominal pain and diverticulosis were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, generalized aching, abdominal cramp, headache, lower abdominal pain and diverticulosis to be related to Shingrix and Shingrix.     Linked case(s) involving the same patient:  US2022116945, US2022AMR178500   Additional Information: GSK receipt date: 28-Nov-2022 Reporter's comment: The patient's wife reported that the patient received full vaccination with Shingrix (2 doses administered to patient within the recommended schedule window) several years ago and developed shingles. The patient also experienced extreme pain all around his body, the pain started in the lower left side of the abdomen, spread around the abdomen all the way to the back, and also around the chest. On 20th November 2022, the patient developed a really bad shingles rash (midline left side all the way to the back), and as such, patient was started on antivirals, pain medications and gabapentin.  The patient also experienced abdominal cramps (diverticulosis was ruled out).  The patient's symptoms continue to get worse, they are not getting better at all and his head also hurts. The reporter could not provide the exact vaccination date or the product details when asked (no formulation, dose, route/site of administration, lot number or expiration date provided). The reporter gave consented for safety follow-up with patient's primary care physician and pulmonologist. The case was linked with case US2022116945 and US2022AMR178500, reported by same reporter for different products.  Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the laboratory confirmation of shingles were unknown at the time of reporting. The abdominal cramps and lower abdominal pain were sign and symptom of diverticulosis therefore, the outcome was captured as recovered as reported.; Sender's Comments:  US-GSK-US2022AMR178500:Same reporter US-GSK-US2022116945:Same reporter