Age: 72.0
Sex: M
Vaccine: RSV, FLUX, RSV
Symptoms: Pain, Vomiting
Clinical narrative: black stools; stomach was "on fire."; bumps on his body around his waist, on his face, and on his beard/had a total of 10-15 bumps; felt wiped out; aching; stomach pain; He also threw up and it smelled like chemicals; bumps were localized to his upper body and only had one bump on his knee; This non-serious case was reported by a consumer via call center representative and described the occurrence of worn out in a 72-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included Influenza vaccine inact split 4v (Quadrivalent influenza vaccine) (batch number ll942, expiry date 23-MAR-2025) for prophylaxis.   Concurrent medical conditions included intervertebral disc protrusion.   On 21-NOV-2023, the patient received Arexvy (unknown arm) and Quadrivalent influenza vaccine (unknown arm). In NOV-2023, an unknown time after receiving Arexvy, the patient experienced worn out (Verbatim: felt wiped out), pain (Verbatim: aching), generalized rash (Verbatim: bumps on his body around his waist, on his face, and on his beard/had a total of 10-15 bumps), stomach pain (Verbatim: stomach pain), vomiting (Verbatim: He also threw up and it smelled like chemicals) and local swelling (Verbatim: bumps were localized to his upper body and only had one bump on his knee). On 22-NOV-2023, the patient experienced stomach burning sensation of (Verbatim: stomach was "on fire."). On 24-NOV-2023, the patient experienced black stools (Verbatim: black stools). The patient was treated with calcium carbonate (Antacid) and sucralfate. The outcome of the worn out, pain, stomach burning sensation of, generalized rash, black stools, stomach pain, vomiting and local swelling were resolving.   It was unknown if the reporter considered the worn out, pain, stomach burning sensation of, generalized rash, black stools, stomach pain, vomiting and local swelling to be related to Arexvy.     It was unknown if the company considered the worn out, pain, stomach burning sensation of, generalized rash, black stools, stomach pain, vomiting and local swelling to be related to Arexvy.   Additional Information: GSK Receipt date: 29-NOV-2023 The patient was self-reported. He received a dose of Arexvy and flu vaccine (Influenza high dose quadrivalent Sanofi Pasteur) last Tuesday (21 November 2023).  The patient received Arexvy in one arm and the flu vaccine in another. The patient states that after receiving the vaccines, he felt wiped out and was aching.  The next morning, he woke up and felt like his stomach was on fire and he also noticed something on top of his head.  He had bumps on his body, around his waist, on his face, and on his beard and he also threw up and it smelled like chemicals.  On Thursday, he noticed that he had a total of 10-15 bumps and the bumps were localized to his upper body and only had one bump on his knee.  He bought some over the counter antacid for his stomach and he was also prescribed sucralfate.  He thought the bumps may had been fleas so he put his bedding in the washer.  On Friday, he had black stools, when asked about the symptoms today, he stated that all symptoms had pretty much resolved and he had some pain injections this morning for his herniated disks in his back which was present before the vaccinations. It was unknown if the company considered the worn out, pain, stomach burning sensation of, rash, black stools, stomach pain, vomiting and local swelling to be related to Flu vaccine.  The reporter consent to follow up.