Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: arm is a little bit swollen and red/ arm was bright red swollen, discomfort; arm is a little bit swollen and red/ arm was bright red swollen, discomfort; arm was bright red swollen, discomfort; chills; felt very hot; felt draggy; If she touches it, it feels itchy; She had a little tenderness on the arm, but  it wasn't swollen and red and just angry; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 80-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 05Oct2023 as dose 1, single (Lot number: HG4680, Expiration Date: 31Dec2023) at the age of 80 years, in left arm for covid-19 immunisation; for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Blood pressure" (unspecified if ongoing), notes: Takes small dose blood pressure pill; "Bronchiectasis" (unspecified if ongoing); "allergic to a lot of things/ allergic to feathers, like a feather pillow, but maybe its just dust" (unspecified if ongoing). Concomitant medication(s) included: AZITHROMYCIN taken for bronchiectasis (ongoing). Vaccination history included: bnt162b2 (Dose 1, single, Lot: EL3248, Anatomical Site of injection: Got all in upper arm, probably left arm, is right handed, usually gets shot in left arm), administration date: 16Jan2021, when the patient was 77-year-old, for Covid-19 immunization; bnt162b2 (Dose 2, single, Lot: EN9581, Anatomical Site of injection: Got all in upper arm, probably left arm, is right handed, usually gets shot in left arm), administration date: 06Feb2021, when the patient was 77-year-old, for Covid-19 immunization; bnt162b2 (Dose 3 (Booster), single, Lot: FE3592, Anatomical Site of injection: Got all in upper arm, probably left arm, is right handed, usually gets shot in left arm.), administration date: 24Sep2021, when the patient was 78-year-old, for Covid-19 immunization; bnt162b2 (Dose 4 (Booster), single, Lot: FM9992, Anatomical Site of injection: Got all in upper arm, probably left arm, is right handed, usually gets shot in left arm), administration date: 14Apr2022, when the patient was 79-year-old, for Covid-19 immunization; bnt162b2 (Dose 6 (Booster), single, Lot: GH9694, Anatomical Site of injection: Got all in upper arm, probably left arm, is right handed, usually gets shot in left arm), administration date: 23Sep2022, when the patient was 79-year-old, for Covid-19 immunization, reaction(s): "Felt pretty bad a couple days"; Bnt162b2 (Dose 5 (Booster), single, Lot: Unknown, Anatomical Site of injection: Got all in upper arm, probably left arm, is right handed, usually gets shot in left arm), for Covid-19 immunization. The following information was reported: CHILLS (non-serious) with onset 05Oct2023, outcome "unknown"; FATIGUE (non-serious) with onset 05Oct2023, outcome "unknown", described as "felt draggy"; FEELING HOT (non-serious) with onset 05Oct2023, outcome "unknown", described as "felt very hot"; VACCINATION SITE SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset 06Oct2023, outcome "recovering" and all described as "arm is a little bit swollen and red/ arm was bright red swollen, discomfort"; VACCINATION SITE DISCOMFORT (non-serious) with onset 06Oct2023, outcome "unknown", described as "arm was bright red swollen, discomfort"; PRURITUS (non-serious) with onset Oct2023, outcome "unknown", described as "If she touches it, it feels itchy"; VACCINATION SITE PAIN (non-serious) with onset Oct2023, outcome "unknown", described as "She had a little tenderness on the arm, but  it wasn't swollen and red and just angry". Therapeutic measures were taken as a result of vaccination site swelling, vaccination site erythema, vaccination site discomfort, vaccination site pain, chills, feeling hot, pruritus.  Additional information: The patient concomitantly took Azithromycin to keep lungs from getting inflamed, has been taking more than a year, maybe year and a half. The patient had no prior vaccination within 4 weeks. The patient recently received the Comirnaty 12+ 2023-2024  vaccine and she a reaction to it.  She wants to know, because she had a reaction, how long does she have to wait to receive and RSV and/or flu vaccine?  She had chosen to get the vaccines separately incase she got a reaction, and she did. Caller states her arm is still arm is a little bit swollen and red, so she will probably wait until next week to get the other vaccines. She took Benadryl, she thinks it helped because after that it began to get better.  Its just like treating an allergic reaction which she guesses this was. Is there something in that [new Comirnaty] vaccine that she should know about so she knows for the future?  She's had all of them, 7 all Pfizer, except for one she isn't sure, because they didn't write down the number of it and what it was. It was at the health department. All the others were Pfizer and she provided the numbers to the previous agent. She started off with Pfizer and that seemed to work so she stuck with it. She had no reaction like this to any of the others. She was really surprised because the day of she hardly felt injection go in, it was amazing. And it wasn't red, she had no reaction the fist 24 hours. It was the next day that it came up, which she thought was odd because they usually happen in the beginning. She had a little tenderness on the arm, but  it wasn't swollen and red and just angry. Anyway she thought it was an odd reaction, and if there was something different from the others that she needs to know about, to avoid a vaccines that has whatever she's allergic to. She is allergic to a lot of things, although she's never had a reaction like this to any vaccine. She can eat eggs, but she is allergic to feathers, like a feather pillow, but maybe its just dust. By Friday, arm was bright red, swollen, had some discomfort in it. Swelling began to go down yesterday (09Oct2023), today, still a little swollen, redness is reducing. The size of, from injection site, almost to elbow, was covered. Got vaccine 05Oct2023. It didn't hurt at all. That evening, had chills, felt very hot but, did not run fever, just felt draggy, by Friday arm, later in day, about 24 hours after she got it, arm began to swell, get very red. If she touches it, it feels itchy, it' not like she is scratching it. If she puts hand on it, feels it. Arm does not feel hot but still red in patches, not the entire upper arm. This all occurred in left arm. Treatment: Sunday evening, took Benadryl because, it was extremely uncomfortable. Took Benadryl before she went to bed. Initially tried some Cortisone, hydrocortisone, that didn't make any difference, didn't help at all. The hydrocortisone had no effect. Sunday, took Benadryl, she thinks 25mg. Had other reaction to last booster she got. Felt pretty bad a couple days, not her arm. That was the first time, other that allergy shots, this is first time having reaction. There may be something in there, she is allergic to.    The information on the batch/lot number for bnt162b2 omi xbb.1.5  has been requested and will be submitted if and when received.