Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Eye paraesthesia, Herpes zoster, Loss of personal independence in daily activities, Oral mucosal eruption, Oral mucosal erythema
Clinical narrative: experiencing heart palpitations; having Shingles 4 times within the same year; Rash on the top of their head; Felt like a second degree burn; having Shingles 4 times / Suspected vaccination failure; experiencing hair loss; Rash was very itchy; changes in their blood pressure, with it varying between normal and high; Remain almost fully bedridden; Reported decreased vision; tingling sensation in both eyes; Red spot on roof of the mouth; Now experience significant reading issues; Redness on their legs and stomach; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   Concomitant products included prednisone and valaciclovir (Valacyclovir).   On an unknown date, the patient received Shingrix and Shingles vaccine. On an unknown date, an unknown time after receiving Shingrix and Shingles vaccine, the patient experienced vaccination failure (Verbatim: having Shingles 4 times / Suspected vaccination failure) (serious criteria GSK medically significant), palpitation (Verbatim: experiencing heart palpitations) (serious criteria hospitalization), shingles (Verbatim: having Shingles 4 times within the same year), scalp rash (Verbatim: Rash on the top of their head), burning sensation (Verbatim: Felt like a second degree burn), erythema (Verbatim: Redness on their legs and stomach), hair loss (Verbatim: experiencing hair loss), itchy rash (Verbatim: Rash was very itchy), blood pressure fluctuation (Verbatim: changes in their blood pressure, with it varying between normal and high), bedridden (Verbatim: Remain almost fully bedridden), vision decreased (Verbatim: Reported decreased vision), eye paresthesia (Verbatim: tingling sensation in both eyes), rash mouth (Verbatim: Red spot on roof of the mouth) and activities of daily living impaired (Verbatim: Now experience significant reading issues). The outcome of the vaccination failure and shingles were unknown and the outcome of the palpitation, scalp rash, burning sensation, hair loss, itchy rash, blood pressure fluctuation, vision decreased, eye paresthesia, rash mouth and activities of daily living impaired were not resolved and the outcome of the erythema was resolved (duration 1 year) and the outcome of the bedridden was resolved.   It was unknown if the reporter considered the vaccination failure, palpitation, shingles, scalp rash, burning sensation, erythema, hair loss, itchy rash, blood pressure fluctuation, bedridden, vision decreased, eye paresthesia, rash mouth and activities of daily living impaired to be related to Shingrix. It was unknown if the reporter considered the vaccination failure, palpitation, shingles, scalp rash, burning sensation, erythema, hair loss, itchy rash, blood pressure fluctuation, bedridden, vision decreased, eye paresthesia and rash mouth to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, palpitation, shingles, scalp rash, burning sensation, erythema, hair loss, itchy rash, blood pressure fluctuation, bedridden, vision decreased, eye paresthesia, rash mouth and activities of daily living impaired to be related to Shingrix. It was unknown if the company considered the vaccination failure, palpitation, shingles, scalp rash, burning sensation, erythema, hair loss, itchy rash, blood pressure fluctuation, bedridden, vision decreased, eye paresthesia and rash mouth to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 30-MAY-2023 The reporter was the patient.  The reporter being certain that she received one dose of Shingrix approximately one year ago from reporting (did not know the date of receipt) but was uncertain if Shingrix received was the first or second dose. Prior to that Shingrix dose and reported receiving another unknown vaccination. Confirm reported dose was simply listed as non-active zoster and they were unsuccessful with trying to obtain name of vaccine or a lot number. The patient reported having Shingles 4 times within the same year, after receipt of Shingrix.  Reported had a rash on the top of their head, which felt like a second-degree burn, redness on their legs and stomach for a year (did not stated there was an accompanying rash), experiencing hair loss due to rash on top of head.  The patient had Shingles rash on their back, in the L4/L5 region, rash was very itchy.  The patient experienced heart palpitations, resulting in hospitalization.  The patient experiencing changes in their blood pressure, with it varying between normal and high.  Reported that each Shingles episode caused them to remain almost fully bedridden for a month.  Reported decreased vision, went from 225 to 350 and now experience significant reading issues.  The patient had tingling sensation in both eyes that felt like pins and needles.  The patient recently developing red spot-on roof of the mouth.  All symptoms were still ongoing, to varying degrees at various times.  The reporter did not consent to follow-up.