Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Delayed Type IV hypersensitivity; Urticaria; Headache; Extreme fatigue; Painful to touch; rash occuured with pustules getting worse; Severe chills; Burning eyeballs; Tingling lip sensation; Eyeball pain; Rash, pustules worsened; This case was reported by a consumer and described the occurrence of chills in a 50-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received first dose on 6th November 2022). Concurrent medical conditions included hemiplegic migraine and small intestinal bacterial overgrowth. Concomitant products included valproic acid (Depakote), memantine hydrochloride (Namenda), botulinum toxin type a (Botox) and rifaximin (Xifaxan).   On 10th February 2023, the patient received the 2nd dose of Shingles vaccine. On 11th February 2023, 1 days after receiving Shingles vaccine, the patient experienced type iv hypersensitivity reaction, urticaria, headache and fatigue. In February 2023, the patient experienced chills, burning in eyes, tingling lips, eye pain, rash, tenderness and pustular rash. On an unknown date, the outcome of the chills, burning in eyes, tingling lips, type iv hypersensitivity reaction, urticaria, headache, eye pain and rash were not recovered/not resolved and the outcome of the fatigue was recovered/resolved and the outcome of the tenderness and pustular rash were unknown.   It was unknown if the reporter considered the chills, burning in eyes, tingling lips, type iv hypersensitivity reaction, urticaria, headache, eye pain, rash, fatigue, tenderness and pustular rash to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 16-Feb-2023 Reporter's Comments: The patient received a dose of Shingles vaccine and one day after vaccination, 16 hours post vaccination, the patient had severe chills.  The patient had extreme fatigue for 2.5 days. Approximately less than 72 hours post vaccination, the rash occurred with pustules getting worse.   Approximately 96 hours post vaccination the patient started experiencing burning eyeballs and tingling lip sensation. In February 2023, less than a week after the vaccination ,the patient had experienced pain to touch. The patient had no fever. The Fluocinonide ointment was prescribed (twice/day) with 50mg Benadryl (night) 2 times Zyrtec (day).  The severe chills, headache, fatigue, delayed type IV hypersensitivity (urticaria), tingling sensation on lip, burning eyeballs all symptoms were treated. The reporter consented to follow-up. As pustule was getting worse was reported but it was auto coded as pustular rash, so kept both rash and pustular rash as separate event. As it was reported that approximately less than 72 hours post vaccination the rash occurred with pustules getting worse, time to onset was captured as less than  a week as a closest LOV to described the verbatim. As duration was reported for fatigue therefore outcome was captured as recovered and clarification request was raise for the same and also the Fluocinonide ointment, Benadryl and Zyrtec was prescribed but it was unknown whether the patient started or not therefore this information was captured in narrative only.