Symptomtext
Nausea; Injection site soreness; Uncomfortable; Back Pain/body, neck and back aches; Neck Pain/body, neck and back aches; Body aches/body, neck and back aches; Chills; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 64-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 929PN, expiry date 29-MAR-2025) for prophylaxis. On 20-DEC-2023 10:40, the patient received Arexvy (left arm). In DEC-2023, an unknown time after receiving Arexvy, the patient experienced discomfort (Verbatim: Uncomfortable), back pain (Verbatim: Back Pain/body, neck and back aches), neck pain (Verbatim: Neck Pain/body, neck and back aches), general body pain (Verbatim: Body aches/body, neck and back aches) and chills (Verbatim: Chills). On 20-DEC-2023, the patient experienced injection site pain (Verbatim: Injection site soreness). On 21-DEC-2023 02:00, the patient experienced nausea (Verbatim: Nausea). The patient was treated with paracetamol (Tylenol). The outcome of the injection site pain, discomfort, back pain, neck pain, general body pain and chills were not resolved and the outcome of the nausea was resolved. It was unknown if the reporter considered the injection site pain, nausea, discomfort, back pain, neck pain, general body pain and chills to be related to Arexvy. It was unknown if the company considered the injection site pain, nausea, discomfort, back pain, neck pain, general body pain and chills to be related to Arexvy. Additional Information: GSK Receipt Date: 21-DEC-2023 The patient self-reported this case. The patient reported that the injection site got sore as the evening progressed and was still sore today (on reporting day). The patient also reported that she had chills last night from reporting starting around midnight, where she was so cold, she had to drink a warm drink to warm up, and was still cold on reporting day. The patient also reported she had body, neck and back aches that started around midnight last night from reporting, and she still had these aches on reporting day. The patient was very uncomfortable and having to use heat on her back. The patient also reported that she had nausea that started around 2:30 to 2 AM (15 hours 20 minutes after vaccination) on reporting day morning, but it was now gone. The patient reported that she took 1-Tylenol Rapid Release 500 mg tablet around 1 to 2 AM reporting day morning; and the patient took 2 more Tylenol Rapid Release 500 mg tablets reporting day morning (no specific time provided). The reporter consented to follow up.