Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Vaccination failure
Clinical narrative: Pain on his side and abdomen/pain in his shoulder and arm; Pain on his side and abdomen/pain in his shoulder and arm; Developed a painful rash on his back and side extending to middle of his abdomen; Pain on his side and abdomen/pain in his shoulder and arm; Pain on his side and abdomen/pain in his shoulder and arm; Suspected Vaccination failure; he was diagnosed with shingles; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 65-year-old 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 shingles (history of shingles rash about 20 years prior to the reporting). Concurrent medical conditions included rheumatoid arthritis. Concomitant products included gabapentin (Gralise), infliximab (Inflectra), baclofen, methotrexate and leflunomide.   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular) and the 1st dose of Shingrix. On 27th March 2022, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain localized and abdominal pain. On 31st March 2022, the patient experienced painful rash. On an unknown date, the patient experienced pain in arm and shoulder pain. The patient was treated with lidocaine (Lidocain Topical). On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the pain in arm, pain localized, abdominal pain and shoulder pain were not recovered/not resolved and the outcome of the painful rash was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain in arm, pain localized, abdominal pain, shoulder pain and painful rash to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 20-APR-2022 Reporter's comment: The reporter was the patient. He received both doses of Shingrix, two months apart, in 2018 or 2019. On 27th March 2022, he developed pain on his side and abdomen.  He saw his physician on 31st March 2022 for a routine physical. During abdominal palpation, he experienced severe pain and his physician sent him to the emergency department for evaluation.  He was not admitted to the hospital. The next day, on 1st April 2022 he developed a painful rash on his back and side extending to middle of his abdomen. He also developed pain in his shoulder and arm that he describes as feeling like he was hit with a sledge hammer.  His physician again referred him to the emergency department where he was diagnosed with shingles. He was prescribed Lidocaine patches and also used roll-on lidocaine with no relief of pain. He states this shingles episode was twenty times worse. The rash had resolved. He still had pain, but it had lessened. The reporter consented to follow up. Additional supportive information: This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting.