Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Pyrexia, Wrong technique in product usage process
Clinical narrative: Really sick; she could not do anything; stay in bed due to a major headache; she could not do anything but stay in bed due to a major headache and full body aches; she could not do anything but stay in bed due to a major headache and full body aches; Patient also reports her arm was sore starting about 3 to 4 hours; she felt like she had a fever all night; Arexvy and Fluzone at the same time, both in her left arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 72-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 27-SEP-2023, the patient received Arexvy (left arm). In SEP-2023, an unknown time after receiving Arexvy, the patient experienced sickness (Verbatim: Really sick). On 27-SEP-2023, the patient experienced pain in arm (Verbatim: Patient also reports her arm was sore starting about 3 to 4 hours), fever (Verbatim: she felt like she had a fever all night) and wrong technique in drug usage process (Verbatim: Arexvy and Fluzone at the same time, both in her left arm). On 28-SEP-2023, the patient experienced headache (Verbatim: she could not do anything but stay in bed due to a major headache and full body aches), general body pain (Verbatim: she could not do anything but stay in bed due to a major headache and full body aches), activities of daily living impaired (Verbatim: she could not do anything) and bedridden (Verbatim: stay in bed due to a major headache).The patient was treated with ibuprofen and paracetamol (Tylenol). In SEP-2023, the outcome of the sickness was resolved. The outcome of the pain in arm was not resolved and the outcome of the fever, headache and general body pain were resolved and the outcome of the activities of daily living impaired and bedridden were not reported and the outcome of the wrong technique in drug usage process was unknown.   It was unknown if the reporter considered the pain in arm, fever, headache, general body pain, sickness, activities of daily living impaired and bedridden to be related to Arexvy.  It was unknown if the company considered the pain in arm, fever, headache, general body pain, sickness, activities of daily living impaired and bedridden to be related to Arexvy.   Additional Information: GSK Receipt Date: 29-SEP-2023 The case was reported by the patient. The reporter reported that she received both Arexvy and Fluzone (2023-2024) at the same time both in her left arm at 4PM MDT, which led to wrong technique in drug usage process. The patient started about 3 to 4 hours later, she felt like she had a fever all night (patient did not take her temperature). The patient also reported that all day the day after receiving the 2 vaccines, she could not do anything but stay in bed due to a major headache and full body aches. The patient also reported that her arm was sore starting about 3 to 4 hours after receiving the 2 vaccines and was still sore at the time of reporting. The patient reported that she took 800mg Ibuprofen (unknown product information) the morning of 28-SEP-2023, Tylenol 500mg (unknown product information) 6 hours after the Ibuprofen and Tylenol 500mg again 6 hours after the first Tylenol dose. It was unknown if the reporter considered the pain in arm, fever, headache, general body pain, sickness, activities of daily living impaired and bedridden to be related to Fluzone. The reporter consented to follow up.