Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Vaccination failure
Clinical narrative: shooting pains/ pain; post herpetic neuralgia; 3 dots; she could not wear clothes; last month she experienced another bout of Shingles; Suspected vaccination failure/ lack of effect; diagnosed with shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. In OCT-2023, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure/ lack of effect) (serious criteria GSK medically significant) and shingles (Verbatim: diagnosed with shingles). In AUG-2024, the patient experienced shingles (Verbatim: last month she experienced another bout of Shingles). On an unknown date, the patient experienced shooting pain (Verbatim: shooting pains/ pain), post herpetic neuralgia (Verbatim: post herpetic neuralgia), rash (Verbatim: 3 dots) and activities of daily living impaired (Verbatim: she could not wear clothes). The outcome of the vaccination failure, shooting pain, post herpetic neuralgia and shingles were unknown and the outcome of the shingles was resolved (duration 4 months) and the outcome of the rash was not resolved and the outcome of the activities of daily living impaired was not reported.   It was unknown if the reporter considered the vaccination failure, shingles, shooting pain, post herpetic neuralgia, shingles, rash and activities of daily living impaired to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be related to Shingrix and Shingrix. It was unknown if the company considered the shingles, shooting pain, post herpetic neuralgia, shingles, rash and activities of daily living impaired to be related to Shingrix and Shingrix.   Additional Information: GSK receipt date: 05-SEP-2024 The patient had the complete series of Shingrix administered in 2018 with the second dose administered within 6 months after receiving the first dose.   Consumer stated was diagnosed with shingles (lack of effect.)   The patient stated that the outbreak lasted approximately 4 months.   The outbreak occurred on her right hip and right torso and she found the pain to be unbearable and she could not wear clothes comfortably due to that pain.   The patient suffered many months of continuous pain and shooting pains in that region.   Consumer was treated by a healthcare provider during that outbreak but was uncertain what medications she was prescribed.   The patient stated last month she experienced another bout of Shingles and did was treated by a healthcare provider with medication, although, she could not remember the names of the medication except the medication used to treat the post herpetic neuralgia (PHN) Gabapentin (unknown dose/frequency.)   Consumer stated that the Gabapentin did not help in treating the pain/PHN.  The patient stated she was now experiencing 3 dots that she suspected was another outbreak of shingles but she had not received treatment or diagnosis for these 3 dots. The consumer stated she did speak with her HCP about having another series or booster of Shingrix and the HCP did not advise to have another series/booster of Shingrix. No further information was available including dates Shingrix was administered in 2018 or dates of shingles outbreaks Did not consent to follow-up.; Sender's Comments: Vaccination failure  is a listed event which is considered related to GSK vaccine  Shingrix (1st dose)and Shingrix(2nd dose)