Age: 48.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Product administered to patient of inappropriate age, Schirmer's test abnormal
Clinical narrative: Pain in the area of previous shingles; Inappropriate age at vaccine administration; Inappropriate age at vaccine administration; This non-serious case was reported by a consumer and described the occurrence of pain in a 48-year-old female patient who received Herpes zoster (Shingrix) for varicella zoster.   Co-suspect products included Herpes zoster (Shingrix) for varicella zoster, Ocrelizumab (Ocrevus) for prophylaxis and Ocrelizumab (Ocrevus) for prophylaxis.   The patient's past medical history included shingles (Shingles on 9th July 2020 lasting for 4 months), corneal erosion (7/01-10/01), iritis (7/01), myopia, astigmatism, presbyopia, cataract (2022), sjogren's, hypertension, tachycardia and chest tightness. Previously administered products included Valtrex (tarted Valtrex within hours of Shingles). Additional patient notes included Low grade squamous epithelial lesion on Pap, squamous metaplasia, koilocytotic atypia on colpo, high risk HPV+ (not 16 & 1Heme Iron deficiency, Endocrine: Metabolic syndrome, Hgb A1c 6.1, Metformin side effect Hyperlipidemia, started Atorvastatin, Hashimoto's thyroiditis /Hypothyroid-on and off Synthroid (see lab list)Febrile seizures, Arachnoid cyst T4 (Windsock type) Multiple sclerosis, C4 & C6 lesions, multi small brain lesions Musculoskeletal: lumbar T score -1.35, hip T score -0.02 NSAID's, Ice R hip pain stiff mid 20's, pain early 30's, inject, R knee effusion, L Biceps tendinitis, Melanonychia.   On 28-JAN-2021, the patient received the 1st dose of Shingrix. On 27-APR-2021, the patient received the 2nd dose of Shingrix. On 20-OCT-2022, the patient received the 1st dose of Ocrevus. On 24-OCT-2024, the patient received the 2nd dose of Ocrevus. On 28-JAN-2021, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration). On 27-APR-2021, the patient experienced inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration). On 21-OCT-2024, the patient experienced pain (Verbatim: Pain in the area of previous shingles). The patient was treated with valaciclovir hydrochloride (Valtrex) and aciclovir sodium (Acyclovir). (Dechallenge was negative). (Dechallenge was negative). On 22-JAN-2025, the outcome of the pain was resolved with sequelae (duration 3 months 1 day). The outcome of the inappropriate age at vaccine administration and inappropriate age at vaccine administration were not applicable.   It was unknown if the reporter considered the pain to be related to Shingrix and Shingrix.     It was unknown if the company considered the pain to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 11-APR-2025 The patient had shingles starting on 9th July 2020 and lasting 4 months. The patient started Valtrex within hours. The patient was only 48 at the time she took Shingrix and had quite the ordeal getting it before age 50, but did finally manage to get it in early 2021 as noted which led to inappropriate age at vaccine administration. The patient started Ocrevus on 20th October 2022. The doe of 21st October 2024 dose was delayed because of pain in the area of previous shingles. The Valtrex  was again started within hours, 1g TID for 7 days, and pain lasted for 3 months. Ocrevus was given on 24th October 2024 and early in the morning on 10th April 2025, she awoke with pain in the same dermatome. The next Ocrevus dose was in 2 weeks. The patient started 800mg acyclovir 5 times a day in liquid suspension this afternoon.