Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash erythematous, Scratch, Swelling, Vaccination failure, Wound secretion
Clinical narrative: Suspected vaccination failure; Mild shingles; these vesicles she has described are on both sides of her body; red bumps; she had itching/ itchy spots that look like pimples; the first red bumps under her left breast/have slowly cropped up in different parts of the body, bilaterally/spot look-like pimple; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In MAR-2021, the patient received the 2nd dose of Shingrix. In JAN-2021, the patient received the 1st dose of Shingrix. On 25-JUL-2023, more than 2 years after receiving Shingrix and Shingrix, the patient experienced pruritus (Verbatim: she had itching/ itchy spots that look like pimples) and swelling (Verbatim: the first red bumps under her left breast/have slowly cropped up in different parts of the body, bilaterally/spot look-like pimple). On an unknown date, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Mild shingles), vesicles (Verbatim: these vesicles she has described are on both sides of her body) and erythema (Verbatim: red bumps). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved and the outcome of the pruritus, swelling, vesicles and erythema were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, pruritus, swelling, vesicles and erythema to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure, shingles, pruritus, swelling, vesicles and erythema to be related to Shingrix and Shingrix.   Additional Information: GSK receipt date: 8-Aug-2023 The patient received both Shingrix doses and had an outbreak of shingles which had not been diagnosed by a physician.   On 25th July 2023, the patient had beginning itching and the first red bumps under her left breast.   The bumps had slowly cropped up in different parts of the body, bilaterally and described them as beginning with red bumps, itching and advancing to raised, itchy spots that look like pimples and if scratched, ooze a watery white liquid.   They had appeared in several spots: side, back, mid back, under her left breast, at the top of her tail bone, on her upper right side and on her big toe. The patient urged her to see her physician for a definitive diagnosis, as these vesicles she had described were on both sides of her body and did not appear to be connected. The patient had photos she would be willing to provide if needed.  The patient gave consent to contact her for the photos and had not contacted her physician, and therefore did not give consent to contact him.  The patient planned to contact him on the day of reporting and will call back with an update and consent to contact him.  Did not consent to follow-up. This case was considered as suspected vaccination failure since the details regarding the laboratory confirmation of shingles were unknown at the time of reporting.