Sex: U
Vaccine: PNC20, RSV
Symptoms: Body temperature increased, Chills, Erythema, Feeling of body temperature change, Hypersensitivity
Clinical narrative: Injection site hot; Hypersentivity reaction; Chills/Shivering; cold and hot; temperature was 100.5; redness expanded and completely circled the entire am/Injection site redness; all around arm and very itchy/ itchy in the size for the golf ball; area of hardness was probably like the size of an orange or avocado; was a good sized lump/the lump in arm about the size of a golf ball now; Hives; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of injection site warmth in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20) (expiry date 30-NOV-2024) for prophylaxis.   Concurrent medical conditions included autoimmune disorder (Autoimmune disorder diagnosed in August 7 years ago) and immunosuppression. Concomitant products included azathioprine (Imuran).   On 01-DEC-2023, the patient received Arexvy (right arm) and Prevnar 20 (right arm). On 01-DEC-2023, less than a day after receiving Arexvy, the patient experienced injection site warmth (Verbatim: Injection site hot), hypersensitivity reaction (Verbatim: Hypersentivity reaction), chills (Verbatim: Chills/Shivering), feeling hot and cold (Verbatim: cold and hot), fever (Verbatim: temperature was 100.5) and erythema of extremities (Verbatim: redness expanded and completely circled the entire am/Injection site redness). In DEC-2023, the patient experienced hives (Verbatim: Hives), itchy upper limbs (Verbatim: all around arm and very itchy/ itchy in the size for the golf ball), induration (Verbatim: area of hardness was probably like the size of an orange or avocado) and swelling arm (Verbatim: was a good sized lump/the lump in arm about the size of a golf ball now). The outcome of the injection site warmth, hypersensitivity reaction, chills, feeling hot and cold, fever, hives, erythema of extremities and induration were not reported and the outcome of the itchy upper limbs and swelling arm were not resolved.   It was unknown if the reporter considered the injection site warmth, hypersensitivity reaction, chills, feeling hot and cold, fever, hives, erythema of extremities, itchy upper limbs, induration and swelling arm to be related to Arexvy.     It was unknown if the company considered the injection site warmth, hypersensitivity reaction, chills, feeling hot and cold, fever, hives, erythema of extremities, itchy upper limbs, induration and swelling arm to be related to Arexvy.   Additional Information: GSK receipt date: 20-DEC-2023 The patient self-reported this case. The patient was doing the math in head and this agent may be able to do the math faster. The reporter got the Prevnar 20 shot so and it was the first time had the pneumonia shot and also got the Arexvy RSV shot the same time in the same arm; had never had very little in the way of any kind of reaction to any kind of vaccine and thought did had a somewhat severe reaction for these and did not know which one it could be.  The patient was also on Imuran as was immunosuppressed and was surprised had any reaction at all because immune system was suppressed.  The patient did went on and do clinical research for 25 years so and was familiar with the process and was less concerned about the reaction and looked up both drugs for what happened and was already aware and the pharmacist mentioned these were one and done and never had to get a pneumonia vaccine again but if that was to change in the future was more concerned if was allergic to one ingredient and there was no way of knowing what ingredients might be sensitive to.  The patient showed to the pharmacist his/her arm and they said definitely had a hypersensitive reaction for one of the vaccines and that if had the vaccine again it would be way worse and was trying to figure out what could possibly be sensitive to for one of these ingredients that might be more likely causing the adverse events.  Reporter details were declined email.  The health care professional (HCP) information, declined to provide information and stated did not see a physician and did call them and told them how was treating and they said fine and to keep doing that. The patient got the Prevnar 20 and the reaction started that evening, the reaction was in right arm.  The patient did not get up to take temperature and woke up that night with chills, shivering and cold and hot and when finally, did get up in the morning took temperature and at that time was not shivering any longer and temperature was 100.5 and was making the assumption that temperature was higher than that to had the chills or any of that by the time took temperature.  It had started out just as redness probably like a 2 inch by 2 inch area where the injection had gone in and it was hot.  On Monday went back to the pharmacy by Monday and had hives and the area of redness expanded and completely circled the entire am and was about 2 hand widths for 6 to 8 inches wide all around arm and very itchy and red and the area of hardness was probably like the size of an orange or avocado and was a good sized lump and went to the pharmacist. The concern was not having this reaction but if needed the shot again what was going to happen and still had the lump in arm about the size of a golf ball now and itchy. The Arexvy vaccine and stated the manufacturer of that was GSK and it was given in the same arm and same location and did not think it was the Pfizer vaccine that bothered. The pharmacy gave the vaccine.  The caller was asked for the dosage and dosage units and stated the app on phone lists the quantity of 0.5 but did not know what that was and did not had any other information on phone for the lot number.  The reporter did not consent to follow up.