Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Panic disorder, Sleep disorder due to general medical condition, insomnia type, Vaccination site pain, X-ray
Clinical narrative: had an infection in her bronchitis; feel weak/very weak from the pain; get a little panicky; still had the pain in her arm/ Patient tries to go to sleep, when she move her arm, it wakes her up; could not lift up her arm; tired; the pain in her arm, in her bone; it felt like she was pulling a muscle from her shot left side and that connects her to her left side every time she pulls her arm up; felt throbbing on the injection site; the injection site in her left arm starting pain that radiates from left arm to her chest to her breast; the injection site in her left arm starting pain that radiates from left arm to her chest to her breast; the injection site in her left arm starting pain that radiates from left arm to her chest to her breast; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 71-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 21Oct2024 at 08:00 as dose 1, 0.3 ml single (Batch/Lot number: unknown) at the age of 71 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COPD" (ongoing). Concomitant medication(s) included: TRELEGY ELLIPTA. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: 2022, for Covid-19 Immunization, reaction(s): "No adverse effect"; Bnt162b2 (DOSE 2, SINGLE), administration date: 2022, for Covid-19 Immunization, reaction(s): "No adverse effect". No other vaccine was received on the same date on the vaccination with Comirnaty vaccine. The following information was reported: PAIN IN EXTREMITY (non-serious), CHEST PAIN (non-serious), BREAST PAIN (non-serious) all with onset 2024, outcome "not recovered" and all described as "the injection site in her left arm starting pain that radiates from left arm to her chest to her breast"; VACCINATION SITE PAIN (non-serious) with onset Oct2024, outcome "not recovered", described as "felt throbbing on the injection site"; MUSCLE STRAIN (non-serious) with onset Nov2024, outcome "not recovered", described as "it felt like she was pulling a muscle from her shot left side and that connects her to her left side every time she pulls her arm up"; BRONCHITIS (hospitalization) with onset Dec2024, outcome "unknown", described as "had an infection in her bronchitis"; ASTHENIA (non-serious), outcome "unknown", described as "feel weak/very weak from the pain"; PANIC DISORDER (non-serious), outcome "unknown", described as "get a little panicky"; SLEEP DISORDER DUE TO GENERAL MEDICAL CONDITION, INSOMNIA TYPE (non-serious), outcome "unknown", described as "still had the pain in her arm/ Patient tries to go to sleep, when she move her arm, it wakes her up"; JOINT RANGE OF MOTION DECREASED (non-serious), outcome "unknown", described as "could not lift up her arm"; FATIGUE (non-serious), outcome "unknown", described as "tired"; BONE PAIN (non-serious), outcome "unknown", described as "the pain in her arm, in her bone". The patient was hospitalized for bronchitis (start date: 19Dec2024, discharge date: 21Dec2024, hospitalization duration: 3 day(s)). The events "felt throbbing on the injection site", "the injection site in her left arm starting pain that radiates from left arm to her chest to her breast" and "it felt like she was pulling a muscle from her shot left side and that connects her to her left side every time she pulls her arm up" required physician office visit. Therapeutic measures were taken as a result of bronchitis, vaccination site pain, pain in extremity, chest pain, breast pain, muscle strain.   Clinical details: Patient stated when first COVID came out, she got the two COVID shots. She got no adverse reactions on the first two. Two years later her doctor says go get the booster shot and that is when she got it, adverse reaction from it and she is suffering from it. This is her third COVID shot. She got adverse reaction from this one. The patient stated she got her shot on 21Oct2024 at 8 am. For the first week she felt throbbing on the injection site, into Nov2024 she is having problems lifting up her arm because it started hurting so she gave that a week and it was still hurting then she realized it felt like she was pulling a muscle from her shot left side and that connects her to her left side every time she pulls her arm up. She feels it in her left breast a pull, a pain, it was painful and every time she went to bed she puts a heating pad. She lifts her breast up and she had to sleep that way for many days and something is not right, that's when she called medical center to explain to them she has pain in her arm when she lift them up and they did an x-ray. Patient was trying to tell them that it feels like it's in the bone because she got inoculated they brushed it off and said she slept on her shoulder or something they just ignored what she was saying and they kept her in there because she has COPD and a low oxygen rate and they wanted to give her the right antibiotics. To this day she feels weak, she got things to do, she lives by herself and she gets a little panicky. She is 71, and she doesn't feel like no 80 or 90 or 100 years old except for this constant pain she has in her arm and her left breast. It is very annoying and very painful and it's holding her back she can't get things done. Patient confirmed the pain is related to the vaccine. Patient stated she feels it in her bone when pharmacist inoculated her, that's the first part of this, patient feels where he inoculated her whatever he did the first week a little throbbing no biggie but when it stretched on and on to a pain and then it went to a pull on her upper left breast down to the side of her breast. She is trying sleep and she is using heating pad and every time she turns the wrong way she is up. She can't get back to sleep. She hasn't sleep all night. Upon hearing the response, patient stated so that means it's a pet scan or she got to do a scan because x-ray doesn't work, they said patient has nothing pulled, patient has no spasm. But she just did an x-ray it's in the bone and when it goes in the bone she got to do a special pet scan or something. It was also reported that for the first week, patient did feel what's in the needle, it was something nasty. But in Nov2024, then she started feeling pressure as she lifts up her arm on the inoculation site, on the left side. She started feeling pain, she could not lift up her arm, and then she kind of suffered with it a while. Well, sometime in Dec2024, patient got to get this checked up, and she went to the hospital, and they took an X-ray and she had been inoculated. They keep her there for other reason, she had an infection in her bronchitis, they gave her some antibiotics (clarified as Zithromax) that was for three days but she still had the pain in her arm. Now, it's going to the level that she feels it on her left side of chest going into her left breast. It make her feel weak, she is very weak from the pain. She tries to go to sleep, when she moves her arm, it wakes her up. Patient stated she live on herself, she is awake, she is tired, she is in pain, she does not know what's going on. Patient stated she was complaining about the pain in her arm, in her bone, it felt like, it was in the bone, and all they did was take an X-ray and they said everything looks like patient probably slept on her shoulder. Because she has COPD and her oxygen levels was eight, they were concerned, they wanted to get some antibiotics in her or steroids (prednisone) that's what they had her for three days, given her all these injections. They never bothered and all they did is, they took and X-ray and said everything looks fine. It's in the bone. When patient was discharged, she was given Azithromycin to take home: 500mg tablet commonly known Zithromax (Hence, captured as Suspect), take 1 tablet in the morning for 5 days. Patient is taking Zithromax and Prednisone and still experiencing the arm pain. NDC number of Comirnaty was reported as 00069243210. DM number was reported as FF11F403MD13CPR.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.