Age: 68.0
Sex: F
Vaccine: COVID19, FLU3, VARZOS, VARZOS
Symptoms: Blood urea, Herpes zoster, Illness, Influenza like illness, Vaccination failure
Clinical narrative: flu like symptoms; Sick; Suspected vaccination failure; shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis, Influenza vaccine (Fluzone) for prophylaxis and COVID-19 vaccine for prophylaxis.   Previously administered products included Zostavax (received on 30-OCT-2015). Concurrent medical conditions included eczema. Concomitant products included amoxicillin;clavulanic acid.   On 02-JUN-2023, the patient received the 2nd dose of Shingrix. On 07-MAR-2023, the patient received the 1st dose of Shingrix. On 19-SEP-2024, the patient received Fluzone and COVID-19 vaccine. On 18-NOV-2024, 535 days after receiving Shingrix and 622 days after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). On an unknown date, the patient experienced influenza-like symptoms (Verbatim: flu like symptoms) and sickness (Verbatim: Sick). The patient was treated with aciclovir (Acyclovir). The outcome of the vaccination failure, influenza-like symptoms and sickness were not reported and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and sickness to be related to Shingrix and Shingrix. It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles and sickness to be related to Shingrix and Shingrix. It was unknown if the company considered the influenza-like symptoms to be related to Shingrix.   Additional Information: GSK Receipt Date: 19-NOV-2024 and 20-NOV-2024 The case was self reported by patient. The reporter was ask was there any information or data concerning herpes zoster infections after a healthy person has been fully vaccinated for at least 12 months, were symptoms any less severe. The patient was possibly developed shingles yesterday and was fully vaccinated with Shingrix last year.  The patient was not immunocompromised.  The patient states she became sick after the first and second dose of Shingrix vaccine, especially with the first dose in which she experienced flu like symptoms. On 18-NOV-2024 the patient developed tenderness and a raised area on her forehead near the temple area above her eye brow.  It was warm to the touch.  It was not blistering and it was not impacting her vision.  It was about a 2 inch round area above her eye brow which was swollen and tender.  The mild tenderness goes down along the left side of her face from her ear to the jaw.  The patient used an icepack to the area for awhile. A slit lamp was used to check the patient eye and her vision was okay. The patient had a history of cellulitis on various parts of her body.  The patient has eczema and develops cellulitis easily.  The last time she had cellulitis was earlier this year, it was on her face.  The patient was prescribed Augmentin to treat the cellulitis. The physician thinks she currently had Shingles and not cellulitis but the patient was being treated for both.  The patient was taking Acyclovir for Shingles and Augmentin for Cellulitis. The patient received the Pfizer COVID vaccine on September 19th, 2024. The patient received Fluzone Trivalent flu vaccine on September 19, 2024. This case was considered as suspected vaccination failure since the details regarding laboratory confirmation of shingles were unknown at the time of reporting. It was unknown if the company considered the vaccination failure, shingles and sickness to be related to Fluzone and Covid 19 vaccine.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about laboratory confirmation regarding shingles) is considered unrelated to GSK vaccine Shingrix (Dose 1) and Shingrix (Dose 2).