Sex: F
Vaccine: VARZOS
Symptoms: Autoimmune disorder, Chills, Eye pain, Facial pain, Malaise
Clinical narrative: suspected autoimmune disorder; achiness under the eyes; one inch itchy area; fever of 101.7 / The 2nd day / she had a 107 fever; chills; Didn't feel well; This case was reported by a consumer via call center representative and described the occurrence of suspected autoimmune disorder in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included conjunctivitis. Previously administered products included tdap vaccine with an associated reaction of pain (received number of years ago from the reporting date, reference case US2021AMR060204), Shingrix with an associated reaction of pruritus genital (1st dose received on 17th July 2020, reference case US2021059714) and hydrocortisone ointment. Concurrent medical conditions included pre-diabetic, house dust mite allergy and allergy to animal dander. Concomitant products included cetirizine hydrochloride (Zyrtec) and famotidine (Pepcid).   On 16th December 2020, the patient received the 2nd dose of Shingrix. On 18th December 2020, 2 days after receiving Shingrix, the patient experienced fever, chills and feeling unwell. On an unknown date, the patient experienced autoimmune disorder (serious criteria GSK medically significant), eye pain and localized itching. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the autoimmune disorder and feeling unwell were unknown and the outcome of the fever, chills and eye pain were recovered/resolved and the outcome of the localized itching was not recovered/not resolved.   It was unknown if the reporter considered the autoimmune disorder, feeling unwell and localized itching to be related to Shingrix. The reporter considered the fever, chills and eye pain to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for herself. The age at vaccination was not reported, however it could be 61 or 62 years. In November 2020, the patient was prescribed with Zyrtec and Pepcid and ointment for genital itching and asked to use it for 2 weeks but still the itching was not over, she used them for 2 more weeks prior to getting 2nd dose of Shingrix. The patient experienced a fever of 101.7 and 107, chills, did not feel well and achiness under the eyes, 2nd day after receiving the second dose of Shingrix. The patient took Tylenol and was better. The patient was still getting genital itching sometimes but only on one side, it was slowly going away. The patient had a one inch itchy area on one side of her stomach and she had pictures to share. The patient asked her doctor if her itchy symptoms could be autoimmune, doctor replied that they could be.  The patient asked doctor if her itchy symptoms could be cancer and doctor replied that he did not think so. The patient was not sure if itching symptoms were related to Shingrix or not which was why she was calling. The consent to follow-up was requested.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021059714:Same reporter, Shingrix 1st dose US-GLAXOSMITHKLINE-US2021AMR060204:Same reporter, Tdap vaccine US-GLAXOSMITHKLINE-US2021AMR061311:Same reporter. Invalid Hearsay case.