Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Gait disturbance, Herpes zoster, Hypoaesthesia, Pain, Pain in extremity
Clinical narrative: suffering from pain/ constant pain; cannot walk very far/ I limp; numbness in in parts of my leg; lesions on his legs; pain in his legs; hives; Suspected vaccination failure; Shingles in my left hip/leg/ shingles are on the patient's left side from his hip to his ankles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and gabapentin for pain in extremity and pain.   On an unknown date, the patient received the 2nd dose of Shingrix, the 1st dose of Shingrix and gabapentin. 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: Shingles in my left hip/leg/ shingles are on the patient's left side from his hip to his ankles). On an unknown date, the patient experienced pain (Verbatim: suffering from pain/ constant pain), walking difficulty (Verbatim: cannot walk very far/ I limp), numbness in leg (Verbatim: numbness in in parts of my leg), skin lesion (Verbatim: lesions on his legs), leg pain (Verbatim: pain in his legs) and hives (Verbatim: hives). The patient was treated with pregabalin and paracetamol (Tylenol). Gabapentin was discontinued. The outcome of the vaccination failure and hives were not reported and the outcome of the shingles, pain, walking difficulty, numbness in leg and leg pain were not resolved and the outcome of the skin lesion was resolving.   It was unknown if the reporter considered the vaccination failure, shingles, pain, walking difficulty, numbness in leg, skin lesion, leg pain and hives 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, pain, walking difficulty, numbness in leg, skin lesion, leg pain and hives to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 25-SEP-2024 and 27-SEP-2024 The patient self-reported this case for himself. The patient had the Shingrix 2 dose vaccine 6 years ago, in 2018 and got Shingles in his left hip/leg about 6 weeks ago (from the date of reporting) and was suffering from pain.  The patient guessed the vaccine did not work for him for some reason.  The patient was told by the medical clinic that he should get a booster in 6 months after recovering from this bout.  The patient asked the pharmacy about it today (on the day of reporting) when he was picked up pain meds and they told him that was not recommended to get a booster after the two doses. The patient wanted to know which was correct, get a booster or not. Also, he wanted to know what the percentage chance were of getting shingles again after having the vaccine and shingles both. Also, when the patient received the vaccine six years ago the pharmacy/manufacturer advertised to get the vaccine and only about 1 percent of people would get the shingles and it would be so mild that would get over it quickly but that did not happen to the patient.  The patient would start week 7 tomorrow (the day after reporting) and could not walk very far with the hip.  The patient was in constant pain, was limp. There was numbness in parts of the leg.  The patient was thoroughly disappointed in what he was told and what actually has occurred.  The patient wanted to know why GlaxoSmithKline advertised one thing and the opposite happens. The patient had never been diagnosed with shingles prior to receiving Shingrix. This was the patient's first bout with Shingles.  The shingles were on the patient's left side from his hip to his ankles.  The lesions on his legs were disappearing, however was experiencing, numbness and pain in his legs and could not walk very far.  The patient was prescribed Gabapentin (unknown manufacturer) for the which he took for a few weeks but developed hives from the Gabapentin. Gabapentin was subsequently discontinued.  The patient was also prescribed an antiviral (not specified) for 7 days. The patient was recently prescribed Pregabalin.  The patient also took Tylenol. In 2024, more than 2 years after, the patient experienced pain, walking difficulty, numbness in leg, skin lesion, leg pain and hives. It was unknown if the reporter considered the reported events to be related to Gabapentin. This case was considered as suspected vaccination failure as details regarding laboratory test confirming 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 the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix and Shingrix(1 and 2)