Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Hypersensitivity, Injection site pruritus, Pruritus, Rash
Clinical narrative: States that the rash is itchy; she developed a rash on both arms, both legs, chest, stomach, neck, and back; she developed a sore left arm from the injection which; day after receiving her vaccine she had fatigue; Intramuscular formulation administered by other route; This non-serious case was reported by a consumer via call center representative and described the occurrence of fatigue in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number 9S252, expiry date 18-JUN-2024) for prophylaxis.   Concurrent medical conditions included allergy to plants (had allergy testing in the past that showed allergies to trees), pollen allergy (allergies to pollen), grass allergy (allergies to grass) and allergy (allergy to airborne). Concomitant products included fexofenadine hydrochloride (Allegra) and montelukast sodium (Montelukast).   On 21-MAR-2023, the patient received the 1st dose of Shingrix (intercostal, left deltoid). On 21-MAR-2023, an unknown time after receiving Shingrix, the patient experienced intramuscular formulation administered by other route (Verbatim: Intramuscular formulation administered by other route). On 22-MAR-2023, the patient experienced fatigue (Verbatim: day after receiving her vaccine she had fatigue). On 23-MAR-2023, the patient experienced pain in arm (Verbatim: she developed a sore left arm from the injection which). On 24-MAR-2023, the patient experienced rash (Verbatim: she developed a rash on both arms, both legs, chest, stomach, neck, and back). On an unknown date, the patient experienced itchy rash (Verbatim: States that the rash is itchy). The outcome of the fatigue and pain in arm were resolved and the outcome of the rash was not resolved and the outcome of the itchy rash was not reported and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the fatigue, pain in arm, rash and itchy rash to be related to Shingrix.     It was unknown if the company considered the fatigue, pain in arm, rash and itchy rash to be related to Shingrix.   Additional Information: RA receipt date: 05-DEC-2023 The patient received her first Shingrix vaccine and had fatigue that resolved. Two days after received her vaccine she developed a sore left arm from the injection which had resolved.   Three days after received her vaccine she developed a rash on both arms, both legs, chest, stomach, neck, and back.  She stated that the rash was itchy and was not on all locations at one time.  She reported that over the summer of 2023 she went to a couple of Dermatologists and was ordered a steroid cream for the rash.   She also had seen an Allergist and had food allergy testing.   The reporter took antihistamines 3 times a day.   The reporter stated that she took Allegra in the morning and afternoon then Montelukast at night.   The reporter did not get her second Shingrix vaccine due to the adverse reaction stated in this report. The patient received Shingrix vaccine by intercostal route which led to intramuscular formulation by other route. The reporter consented to follow up.