Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Condition aggravated, Herpes zoster, Neuralgia, Rash
Clinical narrative: rash; Blister; Nerve pain has gotten worse; Nerve pain was better with vaccine series; an episode of Shingles/Suspected vaccination failure; an episode of Shingles; 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.   Concurrent medical conditions included nerve pain. Concomitant products included medication unknown (Other Medications) and gabapentin.   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular) and the 1st dose of Shingrix (intramuscular). In JAN-2022, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: an episode of Shingles/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: an episode of Shingles). On an unknown date, the patient experienced rash (Verbatim: rash), blister (Verbatim: Blister), condition aggravated (Verbatim: Nerve pain has gotten worse) and unexpected therapeutic effect (Verbatim: Nerve pain was better with vaccine series). The outcome of the vaccination failure and unexpected therapeutic effect were unknown and the outcome of the shingles was not reported and the outcome of the rash and blister were recovered/resolved and the outcome of the condition aggravated was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, rash, blister and condition aggravated to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure, shingles, rash, blister and condition aggravated to be related to Shingrix and Shingrix.   Linked case(s) involving the same patient:  US2023AMR041942   Additional Information: GSK Receipt Date: 16-MAR-2023 The reporter stated that she had an episode of Shingles. The patient reported that the rash and blisters had resolved. Patient reports that the nerve pain was better when she got her Shingrix vaccine series (dose 1 and dose 2). The patient reported that she was prescribed Gabapentin for the nerve pain, but it did not helped with the pain.  The patient reported that she took other medications in addition to Gabapentin for other medical conditions.  The patient did not recall the dates of the vaccination.  The patient did not recall in which arm she was administered the vaccines.  The patient stated that she could obtain this information from the pharmacy where she got vaccinated. The patient stated that she did not had rash or blisters, but the nerve pain had gotten worse.  The patient reported the nerve pain was worse than when she got the vaccines. Not all information is available.  The patient provided consent to follow up with health care professional (HCP). This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.