Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Back pain, Blister, Herpes zoster, Neck pain
Clinical narrative: pain; Received first and second Shingrix, shingles/ Suspected vaccination failure; shingles; severe nerve pain on back, neck, and shoulder; shingles blisters, already dried up; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In March 2022, the patient received the 2nd dose of Shingrix (intramuscular). In December 2021, the patient received the 1st dose of Shingrix (intramuscular). In June 2022, between 3 and 4 months after receiving Shingrix and Shingrix, the patient experienced blister. On 17th June 2022, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and nerve pain. On an unknown date, the patient experienced pain. The patient was treated with valaciclovir hydrochloride (Valtrex) and pregabalin (Lyrica). On an unknown date, the outcome of the vaccination failure and blister were unknown and the outcome of the shingles, nerve pain and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, nerve pain, blister and pain to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 28-Jun-2022 Reporters Comments: The case was self-reported by the patient. The patient received first and second dose of Shingrix vaccine into the left arm.  The patient reported that she began to feel severe nerve pain on the left side of back, left neck, and upper left shoulder.  The HCP (health care professional) confirmed a case of shingles when she saw patient yesterday (the day before reporting). The patient reported that the HCP said the shingles blisters were already dried up.  The HCP started patient on Valtrex and Lyrica. The patient reported that the pain was better but had not resolved.  The patient reported that the customer service representative did a very good job, but it seems to me there was a lot of questions GlaxoSmithKline could not answer as an organization related to the Shingrix shot.  The patient was hoping to increase her knowledge of her situation, and patient was not sure that patient knew that much more than when patient first called. So again, nothing against my representative, patient thought she was very good, but patient kind of was hoping that GlaxoSmithKline would have a lot more information about shingles, and especially in her situation that she got vaccinated, and still got the shot, and can not get any sense of what the impact patient mean still got shingles, and patient did not have any sense of what the impact was going to be, because patient was in a lot of pain right now, and if patient would have a shorter duration, or less likelihood to get PHN (post herpetic neuralgia) from this, because patient got the shot. The reporter did not give permission to contact HCP (health care professional), but GlaxoSmithKline could contact the reporter. The reporter did not consent to follow up.  Additional Supportive Information: This case was considered as suspected vaccination failure as detail regarding the laboratory test confirming shingles were unknown at the time of reporting.