Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: tired; he felt like he had the flu for about 60 hours; muscle aching/tenderness and soreness like muscle aching in the entire upper arm and shoulder area; shortness of breath; left arm was increasingly itchy; the soreness at the shoulder that was injected in; the site was a little swollen; itching and hives were in the upper arm; his voice being hoarse; This is a spontaneous report received from a Consumer or other non HCP.  A 67-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 05Dec2024 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (ongoing), notes: Asthma, approximately since age 14 years old; "Chronic lymphocytic leukemia", start date: 2022 (unspecified if ongoing), notes: Chronic lymphocytic leukemia; "pollen allergy" (unspecified if ongoing); "hives" (unspecified if ongoing); "itching" (unspecified if ongoing); "having a reaction to some deodorant" (unspecified if ongoing); "slight food reactions" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Tylenol for back problems. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation, reaction(s): "a little tired"; Moderna (Dose number unknown), for COVID-19 immunisation; Comirnaty (2023-2024 formula) (DOSE 1, SINGLE), administration date: Apr2024, for COVID-19 immunisation, reaction(s): "swelling of the lymph nodes", "swelling under his arms". The following information was reported: INFLUENZA (non-serious) with onset Dec2024, outcome "unknown", described as "he felt like he had the flu for about 60 hours"; DYSPHONIA (non-serious) with onset Dec2024, outcome "unknown", described as "his voice being hoarse"; URTICARIA (non-serious) with onset Dec2024, outcome "unknown", described as "itching and hives were in the upper arm"; VACCINATION SITE PRURITUS (non-serious) with onset Dec2024, outcome "unknown", described as "left arm was increasingly itchy"; MYALGIA (non-serious) with onset Dec2024, outcome "unknown", described as "muscle aching/tenderness and soreness like muscle aching in the entire upper arm and shoulder area"; DYSPNOEA (non-serious) with onset Dec2024, outcome "unknown", described as "shortness of breath"; VACCINATION SITE SWELLING (non-serious) with onset Dec2024, outcome "unknown", described as "the site was a little swollen"; VACCINATION SITE PAIN (non-serious) with onset Dec2024, outcome "unknown", described as "the soreness at the shoulder that was injected in"; FATIGUE (non-serious) with onset Dec2024, outcome "unknown", described as "tired". Additional information: patient received all the vaccines and boosters when they were released except for the fourth one which he probably waited 6 months to get and to his memory all were Pfizer except for maybe his fourth or fifth dose of the covid vaccines that he had which were Moderna. Patient stated with the Pfizer covid vaccine he had in Apr2024, he had swelling of the lymph nodes and swelling under his arms about two weeks which was not very much but received it with the RSV vaccine, influenza vaccine and a pneumonia vaccine; he has no manufacturer names or lot numbers to provide for the RSV vaccine, influenza vaccine and a pneumonia vaccine and there is no way to tell which he reacted to; he did not have any noticeable reaction to any other covid vaccines he had. He thinks the 2nd one he had he was a little tired with but that's it and that one was definitely Pfizer and the first two he had were Pfizer. The negative reaction one he had in Apr2024 was the one he had with a group of four other vaccines and he can't say whether or not it had to do with the covid vaccine and could not really single that out and does not have an opinion on whether it was the covid or not and he suspected it was not as he was reading up on other vaccines when he had them. Patient confirmed the other vaccines he had were the RSV vaccine, influenza vaccine and a pneumonia vaccine despite having said previously it was four. This one vaccine he had just about 5 weeks ago, he just stopped reacting to. Patient clarified he had no swelling with the most recent vaccine and no did not get any and did not experience any swelling and this dose was definitely Pfizer. With that vaccine, he got tired, had no fever that he could measure and he felt like he had the flu for about 60 hours and like he was getting flu about 60 hours and was tired and had some fatigue, muscle aching and a little bit of shortness of breath and generally overall feeling like oncoming influenza and he did not experience anything more than normal pain.  States pain is the wrong word, but it was soreness at the injection site for that period of time of like 60 hours and was sore where the injection site was and the site was a little swollen for like 60 hours.  States these symptoms of being tired, muscle aching, and shortness of breath began and he had received the vaccine on 05Dec2024 in the afternoon and had the negative reaction on 06Dec2024, 07Dec2024 and through 08Dec2024. It seemed very unusual and he is certain it was different for him than other vaccines he had had. He did not have any reactions before not that he noticed anyways.Clarified that his Moderna vaccine was three vaccines back and was not the 4th or 5th one but probably was the 4th one but he is not sure. The most recent vaccine was on 05Dec2024 and he does not know the dosage but it was administered to his left shoulder. After the initial reaction subsided underneath his armpit of the left arm where the injection was, states he has slight food reactions and allergies and pollen allergy and has asthma and that is ongoing. He took Tylenol and states it was Acetaminophen and he takes that steadily as he has some back problems and has some substantial pollen allergies and asthma and has only had what he calls hives and itching two to three times in his entire life and his left arm was increasingly itchy until about three days ago for the entire period of time and he thought he might be having a reaction to some deodorant he used and used the deodorant one to two times during that time period.Towards the end he realized he had tenderness and soreness like muscle aching in the entire upper arm and shoulder area until about 3 days ago. The itching and hives were in the upper arm the entire time and the soreness at the shoulder that was injected in, he did not get any lymph node swelling as he did previously with other injections and never had reactions like this after 3.5 to 4.5 weeks. There was no other cause other than this dosage of the vaccine.Other medical conditions included he does not think this affects this but he has chronic lymphocytic leukemia and it is inactive because it is monitored. He did not realize what this was and it not occur to him it was cause by the vaccine and he experienced itchy underarm the whole month and after he realized it was the vaccine. States he is having trouble with his voice being hoarse.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500007905 Same patient/suspect vaccine; different dose/events;US-PFIZER INC-202500007906 Same patient/suspect vaccine; different dose/events;