Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Acne, Burning sensation, Dermatitis contact, Herpes zoster, Pruritus
Clinical narrative: rashes which were itchy; rash on the leg; did crust; he had red blotchy spots; pimples which were itchy; Patient reports burning usually at night; there was some itchy patches on his arms at this time; he has poison ivy on his hand; Suspected vaccination failure; Shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Varicella zoster vaccine (another Shingles vaccination previously before Shingrix vaccination.).   On 16-JUL-2018, the patient received the 2nd dose of Shingrix. On 09-MAY-2018, the patient received the 1st dose of Shingrix. In AUG-2021, 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). On an unknown date, the patient experienced itchy rash (Verbatim: rashes which were itchy), rash (Verbatim: rash on the leg), crust (Verbatim: did crust), red rash (Verbatim: he had red blotchy spots), pimples (Verbatim: pimples which were itchy), burning sensation (Verbatim: Patient reports burning usually at night), itchy upper limbs (Verbatim: there was some itchy patches on his arms at this time) and poison ivy rash (Verbatim: he has poison ivy on his hand). The patient was treated with triamcinolone and valacyclovir. (Dechallenge was negative). The outcome of the vaccination failure was unknown and the outcome of the shingles, rash, red rash, pimples, burning sensation, itchy upper limbs and poison ivy rash were not resolved and the outcome of the itchy rash and crust were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, itchy rash, rash, crust, red rash, pimples, burning sensation, itchy upper limbs and poison ivy rash to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure, shingles, itchy rash, rash, crust, red rash, pimples, burning sensation, itchy upper limbs and poison ivy rash to be related to Shingrix and Shingrix.   Additional Information: RA Receipt Date: 05-DEC-2023 The reporter was the patient that reported that he had 2 doses of Shingrix, and had mild case of shingles (no further information provided on this case).  He currently reported that he was experiencing shingles on his leg which clustered and was treated with Valacyclovir for 7 days and Triamcinolone Cream(unknown product information) and it went away.  He also experienced rashes which were itchy and he saw his primary clinical practitioner (PCP).  The rash on the leg initially did crust and seem to went away but then he indicated that he had red blotchy spots and pimples which were itchy and went by his knee and on his leg extending down to his foot and he also stated there was some itchy patches on his arms at that time.  Patient reported burning usually at night.  Patient also had another Shingles vaccination previously before Shingrix vaccination (unknown product information). This case was considered as suspected vaccination failure as details regarding laboratory test confirming shingles were unknown at the time of reporting. The reporter consented to follow up