Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Genital herpes zoster, Herpes simplex test, Herpes zoster reactivation, Influenza like illness, Pain in extremity
Clinical narrative: sore arm; Confirmed vaccination failure; shingles became reactivated in the same location as first outbreak in 2022/herpes zoster labia; Rotator cuff repair surgery; fever; flu like symptoms; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On 20-SEP-2024, the patient received the 2nd dose of Shingrix (left arm). On 29-JUN-2024, the patient received the 1st dose of Shingrix (left arm). On 21-SEP-2024, 1 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced fever (Verbatim: fever) and influenza-like symptoms (Verbatim: flu like symptoms). On 15-OCT-2024, the patient experienced rotator cuff repair (Verbatim: Rotator cuff repair surgery) (serious criteria clinically significant/intervention required). On 31-OCT-2024, the patient experienced vaccination failure (Verbatim: Confirmed vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles became reactivated in the same location as first outbreak in 2022/herpes zoster labia). On an unknown date, the patient experienced pain in arm (Verbatim: sore arm). The patient was treated with valaciclovir hydrochloride (Valtrex). The outcome of the vaccination failure, rotator cuff repair and pain in arm were not reported and the outcome of the shingles was resolving and the outcome of the fever and influenza-like symptoms were resolved (duration 24 hrs).   It was unknown if the reporter considered the vaccination failure, rotator cuff repair, shingles, pain in arm, fever and influenza-like symptoms to be related to Shingrix. It was unknown if the reporter considered the vaccination failure, rotator cuff repair, shingles and pain in arm to be related to Shingrix.     The company considered the vaccination failure and rotator cuff repair to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles, pain in arm, fever and influenza-like symptoms to be related to Shingrix. It was unknown if the company considered the shingles and pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 05-NOV-2024 and 07-NOV-2024 The patient wanted to report an adverse event for the Shingrix vaccine. The patient had shingles in January 2022. The patient received two Shingrix vaccines this year (June 29 and Sept 20) The patient had no adverse events from the first injection, other than a sore arm. With the second injection, in addition to the sore arm, the patient also had a fever and flu like symptoms. The fever and flu-like symptoms lasted about 24 hours. Beginning 31st October 2024, shingles became reactivated in the same location as patient's first outbreak in 2022. The patient got a blood test this weekend and tested positive for both varicella zoster IgG and IgM. The patient believed that she received both doses of the Shingrix vaccine in the left arm. The fever and flu like symptoms experienced after the second dose did not start immediately, the patient believed they began the next day. The patient experienced Shingles in January 2022, was the first time she ever had Shingles. The Shingles developed on her labia which traveled and stopped exactly at midline. The patient was tested for STD's, HSV-1 and HSV-2. The current Shingles episode was at the same location (labia). The patient was currently taking Valtrex three times daily to treat the Shingles, and was in the process of healing. The patient had Rotator Cuff Repair surgery on October 15, 2024.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description) is considered unrelated to GSK vaccine Shingrix (Dose 1 and Dose 2). Rotator cuff repair is an unlisted event which is considered unrelated to GSK vaccine Shingrix (Dose 1 and Dose 2).