Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Feeling abnormal, Herpes zoster, Neck pain, Pain in extremity
Clinical narrative: Suspected vaccination failure; diagnosed me with shingles; This serious case was reported by a consumer and described the occurrence of vaccination failure in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included polycythemia vera. Additional patient notes included patient was in fairly good health. Concomitant products included hydroxycarbamide (Hydroxyurea).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. In AUG-2024, 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: diagnosed me with shingles). The patient was treated with gabapentin. The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 25-NOV-2024 The patient self-reported this case. The patient had a fairly good health and had both Shingrix shots about five years ago and took hydroxyurea for polycythemia vera (PV). The patient around 1st August, noticed some spots on his forearm that appeared to be a spider bite.  The patient went to his family doctor and she immediately diagnosed him with shingles and put him on gabapentin, which did not helped much.  The next month was complete misery and the patient never really had itching or an extensive rash, but intense pain and burning developed from the top of his neck down to his left thumb and forefinger.  The patient's wife read that hydroxyurea lowered his immune system, which was probably why he had such a bad case of shingles despite the Shingrix shots. The patient's cousin was a retired anesthesiologist and he recommended an epidural steroid injection (ESI) that would help him immediately.  The patient had the injection and within 24 hours he had an 80 percent improvement in his pain level.  Over the next month, the pain decreased another 10 percent to 15 percent and the patient went from being almost incapacitated to being able to live again in 24 hours nd the outcome was life-changing. This case was considered as suspected vaccination failure since the details regarding the laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation regarding shingles) is considered unrelated to GSK vaccine Shingrix (Dose 1 and Dose 2).