Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Haemorrhage, Herpes zoster, Pain in extremity, Pruritus, Scab
Clinical narrative: had a mosquito bite and scratched the area and he bled; fourth outbreak November 2024; third outbreak October 2024; second outbreak July 2024; Suspected Vaccination failure; first outbreak was in April 2024; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In JAN-2024, the patient received the 2nd dose of Shingrix. On 24-OCT-2023, the patient received the 1st dose of Shingrix. In APR-2024, between 2 and 4 months after receiving Shingrix and between 5 and 7 months after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: first outbreak was in April 2024). In JUL-2024, the patient experienced shingles (Verbatim: second outbreak July 2024). In OCT-2024, the patient experienced shingles (Verbatim: third outbreak October 2024). In NOV-2024, the patient experienced shingles (Verbatim: fourth outbreak November 2024). On an unknown date, the patient experienced hemorrhage (Verbatim: had a mosquito bite and scratched the area and he bled). The outcome of the vaccination failure, shingles, shingles, shingles and hemorrhage were not reported and the outcome of the shingles was unknown.   It was unknown if the reporter considered the vaccination failure, shingles, shingles, shingles, shingles and hemorrhage to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles, shingles, shingles, shingles and hemorrhage to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 14-NOV-2024 The patient self-reported this case. He had the completed series of Shingrix administered in the recommended time per the PI as the first dose and second dose of Shingrix was administered.   The reporter stated there was first outbreak, second outbreak, third outbreak and fourth outbreak.   The first outbreak was itchy and painful and occurred on his left shin right above the ankle. He described the pain a feeling like a ton of paper cuts in the affected area and stated the outbreak was bad and the lesion as being a straight line. The reporter described his third outbreak as occurring on his back and stated he thought he had a mosquito bite and scratched the area and he bled everywhere and stated that was shingles that had already crusted over The fourth outbreak was on his upper right thigh that was itchy and painful, again, describing the pain as similar to lots of paper cuts. The pharmacist that administered both did not liked him and he wondered if the pharmacist added something to vaccine to cause him to have these outbreaks. This case was considered as suspected vaccination failure since the details regarding the laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 and Dose 2).