Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: CNS toxicity; skin rash; itching; vertigo; dizziness; vomiting all weekend; This serious case was reported by a physician via call center representative and described the occurrence of central nervous system toxicity in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included methotrexate sodium (Methotrexate) for rheumatoid arthritis.   The patient's past medical history included chickenpox. Previously administered products included covid vaccine. Concurrent medical conditions included rheumatoid arthritis (moderate to severe rheumatoid arthritis). Concomitant products included adalimumab (Humira).   On 08-SEP-2023, the patient received the 1st dose of Shingrix. In SEP-2023, the patient started Methotrexate. On an unknown date, an unknown time after receiving Shingrix, the patient experienced central nervous system toxicity (Verbatim: CNS toxicity) (serious criteria GSK medically significant), rash (Verbatim: skin rash), pruritus (Verbatim: itching), vertigo (Verbatim: vertigo), dizziness (Verbatim: dizziness) and vomiting (Verbatim: vomiting all weekend). The action taken with Methotrexate was unknown. The outcome of the central nervous system toxicity, vertigo, dizziness and vomiting were resolving and the outcome of the rash and pruritus were unknown.   It was unknown if the reporter considered the central nervous system toxicity, rash, pruritus, vertigo, dizziness and vomiting to be related to Shingrix.     It was unknown if the company considered the central nervous system toxicity, rash, pruritus, vertigo, dizziness and vomiting to be related to Shingrix.   Additional Information: GSK Receipt date: 06-MAR-2024 The reporter was a patient. Patient called regarding Shingrix 2nd dose. Patient got her shingrix first dose and it was remarkable and did not have side effects from it. The reason she dint have her 2nd shingrix was that she was planning to have on reporting day week, before she started her first dose of Shingrix she was diagnosed with rheumatoid arthritis (RA) and Humira and was just on boarding on that just had covid vaccine , patient was not upto having the 2nd dose of Shingrix which was scheduled on November 8th because of just getting acclimated with RA even though doctor said there was no adjustment needed. Patient want to get 2nd dose of Shingrix and patient was on Humira for moderate to severe RA and take it sunday evenings at 5.30 post meridiem, had a routine check-up with the rheumatologist day after of reporting day and patient wanted to be informed and she want to tell her that her RA was feeling really great at this point and patient was upto having the 2nd dose of Shingrix as patient better get it in next couple of days to be in the 6 months (which was March 8th). Patient had a child chicken pox, she asked question that did she had to hold the Humira to allow to sink in because it was every 2 weeks injection and with the coivd vaccine she did make hold the humira for a week to let it sink in. So, with the shingrix did she need to hold Humira or just give did not adjust the humira. Reporter asked if there was no adjustment then patient would get the Shingrix at pharmacy but if there was adjustment, then if she had it a few days later longer than the 6 months, if she had 6 months and 3 days , however it works out was there a window period. A week before patient was started on Humira she had on Methotrexate and some steroids taper and patient had central nervus system toxicity from methotrexate- patient had vomiting all weekend, dizziness and vertigo and she stopped it and it resolved right away. Rheumatologist was positive it was temporally related to Methotrexate and since she stopped it went away. Also had a itching and a skin rash in October 2023 which seems to related the covid vaccine and biologic Humira so was not comfortable taking the 2nd dose of Shingrix then. The reporter did not consent to follow-up.