Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Inappropriate schedule of product administration, Insomnia, Rash, Skin discolouration, Weight decreased
Clinical narrative: COVID; unable to sleep; weight loss; hair loss; toes and feet are turning black; hearing loss; vision loss; white circles on her head/rash on face and neck; shingles since June 2023; dose 2 in July or August of 2023; This serious case was reported by a consumer via call center representative and described the occurrence of shingles in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included hydroxyzine embonate (Hydroxyzine Pamoate).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. In JUN-2023, not applicable after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: shingles since June 2023) (serious criteria hospitalization). On an unknown date, the patient experienced covid-19 (Verbatim: COVID) (serious criteria hospitalization), sleeplessness (Verbatim: unable to sleep) (serious criteria hospitalization), weight loss (Verbatim: weight loss) (serious criteria hospitalization), hair loss (Verbatim: hair loss) (serious criteria hospitalization), skin discoloration (Verbatim: toes and feet are turning black) (serious criteria hospitalization), hearing loss (Verbatim: hearing loss) (serious criteria hospitalization and GSK medically significant), loss of vision (Verbatim: vision loss) (serious criteria hospitalization and GSK medically significant), rash (Verbatim: white circles on her head/rash on face and neck) (serious criteria hospitalization) and drug dose administration interval too long (Verbatim: dose 2 in July or August of 2023). The outcome of the shingles was resolved and the outcome of the covid-19 and drug dose administration interval too long were unknown and the outcome of the sleeplessness, weight loss, hair loss, skin discoloration, hearing loss, loss of vision and rash were not resolved.   It was unknown if the reporter considered the covid-19, sleeplessness, weight loss, hair loss, skin discoloration, hearing loss, loss of vision and rash to be related to Shingrix and Shingrix. It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the covid-19, sleeplessness, weight loss, hair loss, skin discoloration, hearing loss, loss of vision and rash to be related to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 18-OCT-2023 The reporter stated that she got her first Shingrix vaccine in 2022 and 2nd dose in July or August of 2023.  The patient had shingles since June 2023 and was hospitalized. The patient reported having Covid, was unable to sleep, had weight loss. hair loss, toes and feet were turning black, hearing and vision loss, white circles on her head and rash on face and neck. Concomitant products included unspecified ointment for rash. The patient was given ointment for the rash and hydroxyzine pamoate  pills to take. The patient stated that none of these symptoms have been resolved and unsure if she still had Covid. The patient had gone to several healthcare professionals who were giving her different information. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule. The reporter consented to follow up.