Age: 62.0
Sex: F
Vaccine: PNC20, RSV, PNC20, RSV
Symptoms: Injection site induration, Injection site mass, Injection site pruritus, Injection site warmth, Urticaria
Clinical narrative: her temperature was 100.5; Is there one ingredients that might cause sensitivity more than the others? Caller states she did have a reaction to it; chills, shivering; cold and hot; redness probably like a 2 inch by 2 inch area where the injection had gone in and it was hot; redness probably like a 2 inch by 2 inch area where the injection had gone in and it was hot; hives; area of redness expanded and completely circled the entire am and was about 2 hand widths for 6-8 inches wide all around her 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 l; area of redness expanded and completely circled the entire am and was about 2 hand widths for 6-8 inches wide all around her 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 l; lump in her arm about the size of a golf ball; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 62-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 01Dec2023 as dose 1, single (Batch/Lot number: unknown, Expiration Date: 30Nov2024) at the age of 62 years intramuscular, in right arm for immunisation; rsv vaccine prot. subunit pref3 (AREXVY), on 01Dec2023 as dose number unknown, single), in right arm. The patient's relevant medical history included: "Autoimmune disorder", start date: Aug2016 (ongoing), notes: Autoimmune disorder diagnosed.She only has autoimmune disease that was diagnosed in Aug 7 years ago; "immunosuppressed", start date: Aug2016 (ongoing), notes: She is also on Imuran as she is immunosuppressed. Concomitant medication(s) included: IMURAN [AZATHIOPRINE] taken for immunosuppression, autoimmune disorder, start date: Aug2016. The following information was reported: HYPERSENSITIVITY (non-serious) with onset 01Dec2023, outcome "unknown", described as "Is there one ingredients that might cause sensitivity more than the others? Caller states she did have a reaction to it"; CHILLS (non-serious) with onset 01Dec2023, outcome "recovered" (02Dec2023), described as "chills, shivering"; FEELING OF BODY TEMPERATURE CHANGE (non-serious) with onset 01Dec2023, outcome "unknown", described as "cold and hot"; PYREXIA (non-serious) with onset 02Dec2023, outcome "unknown", described as "her temperature was 100.5"; VACCINATION SITE PRURITUS (non-serious), VACCINATION SITE INDURATION (non-serious) all with onset Dec2023, outcome "unknown" and all described as "area of redness expanded and completely circled the entire am and was about 2 hand widths for 6-8 inches wide all around her 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 l"; URTICARIA (non-serious) with onset Dec2023, outcome "unknown", described as "hives"; VACCINATION SITE MASS (non-serious) with onset Dec2023, outcome "unknown", described as "lump in her arm about the size of a golf ball"; VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE WARMTH (non-serious) all with onset Dec2023, outcome "unknown" and all described as "redness probably like a 2 inch by 2 inch area where the injection had gone in and it was hot". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: On 01Dec2023 patient received the Prevnar 20 shot so it was the first time she had the pneumonia shot and also got the Arexvy RSV shot the same time in the same arm; she has never had very little in the way of any kind of reaction to any kind of vaccine and thinks she did have a somewhat severe reaction for these and does not know which one it could be. She was also on Imuran as she was immunosuppressed and was surprised she had any reaction at all because her immune system is suppressed. She did go on and do clinical research for 25 years so she 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 she never had to get a pneumonia vaccine again but if that was to change in the future she was more concerned if she was allergic to one ingredient and there is no way of knowing what ingredients she might be sensitive to. She showed the pharmacist her arm and they said she definitely had a hypersensitive reaction for one of the vaccines and that if she had the vaccine again it would be way worse and she was trying to figure out what she could possibly be sensitive to for one of these ingredients that might be more likely causing the adverse events. She got the Prevnar 20 on 01Dec2023 and the reaction started that evening 01Dec2023; the reaction was in her right arm. She did not get up to take her temperature and woke up that night with chills, shivering and cold and hot and when she finally did get up in the morning she took her temperature and at that time she was not shivering any longer and her temperature was 100.5 and she was making the assumption that her temperature was higher than that for her to have the chills. She did not have the chills or any of that by the time she took her 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 she 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 6-8 inches wide all around her 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 she went to the pharmacist. The concern was not having this reaction but if she needed the shot again what was going to happen and she still has the lump in her arm about the size of a golf ball now and itchy in the size for the golf ball. The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein), pneumococcal 20-val conj vac (dipht CRM197 protein)  will be requested and submitted if and when received.