Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Antibody test, Bedridden, Disease recurrence, Herpes zoster, Illness
Clinical narrative: Both doses in 2019, shingles twice in less than 6mo/suspected vaccination failure; Shingles twice in less than 6mo; Shingles twice in less than 6mo, in 2021 and today; Bedridden for 2-3mo after the 1st vaccine; Sick for 2-3mo, extremely ill, thought I was dying lol; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (from almost 18-19 years suffered from chronic shingles).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, disease recurrence, bedridden and sickness. On an unknown date, the outcome of the vaccination failure and disease recurrence were unknown and the outcome of the shingles was not recovered/not resolved and the outcome of the bedridden and sickness were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and disease recurrence to be related to Shingrix and Shingrix. It was unknown if the reporter considered the bedridden and sickness to be related to Shingrix.     Additional Information: GSK receipt date: 21-Apr-2022 Reporter's comment: The patient reported that she could not wait to turn 50 because for almost 18-19 years she suffered from chronic shingles, she was so disappointed. The patient had vaccine and booster in 2019 and had shingles twice in less than 6 months, first outbreak in 2021 and second outbreak on the date of reporting. The patient was bedridden and sick for 2-3mo after the first vaccine. The patient stated that first dose made her extremely ill. Thought the patient was dying lol. Covid had just hit her, could not get tested but  finally found a physician who tested her (negative) and 2 weeks later ran her antibodies (none). The patient had been seen to her dermatologist and her primary care physician to confirm also. The medical representative stated that individual medical guidance for patients should be provided by medical professionals and was  not something GlaxoSmithKline provided to patients. The Food and Drug Administration (FDA) approved dosing schedule for Shingrix was the first dose at month 0, followed by a second dose 2-6 months after the first dose. The Centers for Disease Control and Prevention (CDC) had provided guidance that if it had been more than 6 months since a patient received the first dose, they should get the second dose as soon as possible, patients did not need to restart the vaccine series. However, the efficacy of alternative dosing regimens had not been evaluated. Data regarding the safety of alternative regimens were limited. Individuals might remain at risk for herpes zoster during a longer than recommended interval between doses 1 and 2. They advised that patients should consult with their healthcare provider about this guidance and their individual situation. Because patient care was individualized, a healthcare provider should always be consulted to evaluate their health and provide guidance to them based on their medical history. The medical representative stated that wanted to make sure that the patient understand that there was no  Food and Drug Administration (FDA) approval for a third dose or a repeat of the series. The medical representative wanted to make the patient aware of an opportunity to participate in an initiative to share her personal experience, which might be used in an education and awareness campaign that GlaxoSmithKline was creating. This campaign will help healthcare professionals to understand how shingles impact patients and their lives and will stress the importance to talk to their patients about how they can prevent shingles. Consented to follow-up. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding laboratory test confirming shingles were unknown at the time of reporting. Note: Query was raised regarding the lab details, patient's details, vaccination details and onset date of events.