Age: 62.0
Sex: F
Vaccine: RSV
Symptoms: Chills, Fatigue, Pruritus, Pyrexia, Rash
Clinical narrative: severe itching all over body; rash appearing on her stomach and back, appearing red/rash covering her entire body, including hair and on the palms of her hands; rash appearing on her stomach and back, appearing blotchy/ blotchy rash had spread into her groin, arms and legs; low grade fever; chills; fatigue; This non-serious case was reported by a consumer via call center representative and described the occurrence of low grade fever in a 62-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 7357L, expiry date 26-MAR-2025) for prophylaxis.   On 04-DEC-2023, the patient received Arexvy (intramuscular). On 04-DEC-2023, 6 hrs after receiving Arexvy, the patient experienced low grade fever (Verbatim: low grade fever), chills (Verbatim: chills) and fatigue (Verbatim: fatigue). On 05-DEC-2023, the patient experienced red rash (Verbatim: rash appearing on her stomach and back, appearing red/rash covering her entire body, including hair and on the palms of her hands) and blotchy rash (Verbatim: rash appearing on her stomach and back, appearing blotchy/ blotchy rash had spread into her groin, arms and legs). On 06-DEC-2023, the patient experienced generalized pruritus (Verbatim: severe itching all over body). The patient was treated with methylprednisolone acetate and Dexamethasone sodium phosphate (Decadron). On 05-DEC-2023, the outcome of the low grade fever and chills were resolved (duration 1 day).  On 07-DEC-2023, the outcome of the fatigue was resolved (duration 3 days) and the outcome of the generalized pruritus was resolved (duration 1 day). The outcome of the red rash and blotchy rash were resolving.   It was unknown if the reporter considered the low grade fever, chills, fatigue, red rash, blotchy rash and generalized pruritus to be related to Arexvy.     It was unknown if the company considered the low grade fever, chills, fatigue, red rash, blotchy rash and generalized pruritus to be related to Arexvy.   Additional Information: GSK Receipt Date: 07-DEC-2023 It was reported that patient received Arexvy vaccination on 4th December 2023.   On that evening, she experienced a low grade fever, chills and fatigue.   On the next day the fever and chills were disappeared, but the fatigue remained.   After 32 hours of vaccination on the next day evening she noticed a rash appearing on her stomach and back, appearing red and blotchy.   3rd day after vaccination at 3:00 am she awoke and noticed that the blotchy rash had spread into her groin, arms and legs. She had a Teledoc appointment where she was told that it looked like a reaction to the Arexvy vaccine.   She was prescribed with Methylprednisolone 4mg dose pack and she picked up the medication  and immediately began taking it.   She had some relief from the rash but was still fatigued.   4th day after vaccination at 2:00 am she awoke with the rash covering her entire body, including in her hair and on the palms of her hands with severe itching all over.   She visited to urgent care facility where the nurse practitioner told her she needed a stronger dose of Methylprednisolone and a Decadron injection.   She was feeling better on the day of reporting. It was reported that the rash had cleared from her arms and legs but the rash on her chest remained and was much lighter. The itching was disappeared.  The patient stated that she had pictured of various stages of the rash that she was willing to share. The reporter consented to follow up via nurse practitioner