Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Chest pain, Condition aggravated, Drug ineffective, Headache
Clinical narrative: received the Shingirx two-dose series/ was diagnosed with shingles; neuropathy\neuralgia; mild case of shingles; it hurt like heck/ painful injection; it hurt like heck/ painful injection; she couldn't raise her arm; she couldn't raise her arm; burning on her chest; red rash eruptions; headache; neuropathy\neuralgia; burning; valacyclovir pills and acyclovir cream, rash/eruptions come(s) and go.; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis, acyclovir cream for shingles and valaciclovir hydrochloride (Valaciclovir) tablet for prophylaxis.   The patient's past medical history included shingles (outbreak many years ago (when she was stressed taking care of her mother who had dementia) over a decade ago) and dementia (Family History). Concurrent medical conditions included benign paroxysmal positional vertigo and intervertebral disc bulging.   On an unknown date, the patient received the 2nd dose of Shingrix, the 1st dose of Shingrix, acyclovir at an unknown dose and frequency and Valaciclovir at an unknown dose and frequency. On an unknown date, more than a year after receiving Shingrix and Shingrix and not applicable after starting acyclovir and Valaciclovir, the patient experienced vaccination failure (serious criteria GSK medically significant), neuropathy (serious criteria GSK medically significant), shingles, injection site pain, injection site pain, mobility decreased, mobility decreased, chest burning, red rash, headache, neuralgia, burning sensation and lack of drug effect. The action taken with acyclovir was unknown. The action taken with Valaciclovir was unknown. On an unknown date, the outcome of the vaccination failure, chest burning, headache, burning sensation and lack of drug effect were unknown and the outcome of the neuropathy, shingles, red rash and neuralgia were not recovered/not resolved and the outcome of the injection site pain, injection site pain, mobility decreased and mobility decreased were recovered/resolved.   The reporter considered the vaccination failure, neuropathy, shingles, injection site pain, mobility decreased, red rash and neuralgia to be related to Shingrix. It was unknown if the reporter considered the chest burning, headache and burning sensation to be related to Shingrix and Shingrix. The reporter considered the vaccination failure, neuropathy, shingles, injection site pain, mobility decreased, red rash and neuralgia to be related to Shingrix. It was unknown if the reporter considered the neuropathy, red rash, headache, neuralgia and burning sensation to be related to acyclovir and Valaciclovir.  Additional details were reported as follows: This case was reported by the patient. The age at vaccination was not reported. The patient was healthy with good cholesterol numbers, good blood pressure and good A1c, no major health conditions, not stressed, no autoimmune disease. About 2 years before the date of reporting, the patient received the Shingirx two dose series. She said, vaccine hurt like heck and she couldn't raise her arm but that didn't last long. One week before the date of reporting, the patient felt burning on her chest and saw red rash eruptions (on her chest). The patient went to urgent care and was diagnosed with shingles. The patient was prescribed with valacyclovir pills and acyclovir cream. The patient states that she has an extremely mild case of shingles. She said it was only might be 6 eruptions. For example, on Thursday (30-Sep-2021) she only had 1 eruption. She said that the rash/eruptions come(s) and go. She would wake up one day and it would be gone and then the next day it was back. The patient said that she has 2 more valacyclovir pills to take. Day of reporting would be her last day of valacyclovir pills. The patient also mentioned that she has neuropathy or neuralgia, burning and headache. The patient indicated that she was not sure why Shingrix failed to protect her from shingles and that she could not understand why she got a case of shingles when she was healthy and not under stress. The patient was reluctant to share her personal information. She did provide her first and last name, her email address, and her phone number. She stated she was age 68 and would turn 69 in December. No any other medication was received by the patient, but she did state that she had her Covid shots. The reporter was fine with safety contacting her via email.