Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Vaccination failure
Clinical narrative: suspected vaccination failure; shingles; pain in left arm from shoulder to elbow; left breast sore; bumps on the left side of her back; pain left shoulder, down arm to elbow; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (got 1 shot for shingles before Shingrix came out). Concomitant products included valaciclovir hydrochloride (Valacyclovir Hydrochloride).   In AUG-2021, the patient received the 2nd dose of Shingrix. In JUN-2021, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles), pain in arm (Verbatim: pain in left arm from shoulder to elbow), soreness breast (Verbatim: left breast sore), local swelling (Verbatim: bumps on the left side of her back) and shoulder pain (Verbatim: pain left shoulder, down arm to elbow). The patient was treated with prednisone and valaciclovir hydrochloride (Valtrex). The outcome of the vaccination failure was unknown and the outcome of the shingles, pain in arm, soreness breast and shoulder pain were not resolved and the outcome of the local swelling was resolving.   It was unknown if the reporter considered the vaccination failure, shingles, pain in arm, soreness breast, local swelling and shoulder pain 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, pain in arm, soreness breast, local swelling and shoulder pain to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt date: 09-JUL-2024 The patient received Shingrix dose 1 in June 2021 and dose 2 August 2021 and she stated she had shingles for several weeks now (at the time of reporting).  She experienced pain in left arm from shoulder to elbow and also her left breast was sore.  She stated she had to cancel mammogram because of this, she had bumps on the left side of her back that are getting better.  She was put on prednisone and had a steroid shot for the pain, she went to urgent care, and they diagnosed her with shingles and gave her generic Valtrex for 7 days.  She stated she was not fully recovered yet, referred her to health care professional. This case was considered as suspected vaccination failure since the details regarding the time to onset and 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 completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (dose 1) and Shingrix (dose 2).