Age: 66.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Urticaria
Clinical narrative: hair is falling out / Also states her hair has thinned out; Fever; chills; Headache; The hives are gone but when I had them at night. I have at throat, the inside of my arm; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 66-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 10Sep2024 as dose 1, single (Batch/Lot number: unknown) at the age of 66 years, in right arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 10Sep2024 as dose number unknown, single) for immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: PYREXIA (medically significant) with onset 10Sep2024, outcome "not recovered", described as "Fever"; HEADACHE (medically significant) with onset 10Sep2024, outcome "not recovered"; URTICARIA (medically significant) with onset 10Sep2024, outcome "recovered" (11Dec2024), described as "The hives are gone but when I had them at night. I have at throat, the inside of my arm"; CHILLS (medically significant) with onset 10Sep2024, outcome "not recovered"; ALOPECIA (non-serious), outcome "unknown", described as "hair is falling out / Also states her hair has thinned out". The events "fever", "chills", "headache", "the hives are gone but when i had them at night. i have at throat, the inside of my arm" and "hair is falling out / also states her hair has thinned out" required physician office visit. The patient underwent the following laboratory tests and procedures: Body temperature: (09Jan2025) 98.8 Fahrenheit. Therapeutic measures were taken as a result of pyrexia, chills, headache, urticaria.  Clinical course: The caller had the Pfizer COVID vaccine on 10Sep2024. She was still having side effects from the shot. She had been to her primary care provider and back to the pharmacist several times. She needed to know what to do. The caller stated, "I went to an allergist, and he said I was not allergic to anything because I had a clear nose, mouth, eyes, and throat everything was perfect but I was still having side effects from the COVID shot. I can't get an allergist to help me because they don't know what's in the COVID vaccine, so they can't run tests on me, and the pharmacist said they don't get told. I am trying to figure out who I should talk to, where I should go, and what I should do. The doctor tried everything she knew to try to stop it, but it was still happening. I was wondering what to do." The caller stated, "Every day I got a fever and chills. If I rested a little bit, the fever would go away, and I needed to take Tylenol every single day. I also got a headache." The caller stated, "The doctor put me on prednisone for 29 days, but that didn't help. He put me on antibiotics twice to see if that would help, but the antibiotics did not help. I would still run a fever while taking the amoxicillin. I wasn't sick; I felt great. I went to an allergist, and he said I wasn't allergic to anything. It's just that I was having the side effects day after day. I hadn't taken Advil orally yet, but I took it before I went to bed because I had a fever of 99.8 degree Fahrenheit last night." The caller stated, "They sent me to a cardiologist, they put me on stress medications, and I was still getting the fever. My hair was falling out; there were a lot of problems that I had. The hives were gone, but when I had them, they were at night. I had them in my throat and the inside of my arm. I took care of some of the side effects, but I couldn't shake the fever or the headache. I would take Advil and Tylenol every day to keep the fever down because the fever was trying to fight off the COVID." The patient other conditions and investigations was reported as no. She received the Comirnaty vaccine on 10Sep2024. She was experiencing fever, headache, and chills every day. She contacted her primary care about this. She asked about figuring out what to do and was referred to an allergist after contacting her primary care. The agent referred the caller back to her doctor. She confirmed contact details upon transfer. The fever, headache, and chills started the same day as receiving the Comirnaty vaccine. Treatment: antibiotics. Outcome of fever, headache, and chills: It stayed the same. She got hives that day and then went to the doctor on 13Sep2024 since she was itching so badly. Treatment: steroids. Outcome of hives: The hives recovered around 11Dec2024. Height/Weight was declined. The pharmacy also made a report regarding the caller's side effects since the side effects were not going away. Indication: Because her husband was diabetic and trying to keep all infections and diseases away from him. When querying about other medications, she stated no, since she had been on the same medications for years and did not have a list; her primary care provider prescribed them for her. No further details. Her hives started on the COVID side; she clarified that the hives started on the right side, which was the side she received the Comirnaty injection. Family medical history relevant to adverse events was reported as no. AE required visit to Emergency Room was reported as no. Physician Office: She went to the doctor on 13Sep2024 and was given steroids. She finished the first round of steroids, and two days afterward, she stated the hives came back. She had to go to urgent care at Patients First, which was on a Saturday. She clarified that it was on 21Sep2024 when she went to urgent care, and that was when she was started on another round of steroids. Autopsy Information: N/A. Was she followed up? She wanted to know if someone from Pfizer could reach out to her doctor to tell her what to do, as it was getting old now and she felt like she was taking too much Advil and too much Aleve. The hives were in her throat, and she could not swallow, so she went to the doctor and got Nystatin, which is a liquid antibiotic; she wasn't sure of the spelling of Nystatin. She was also given a medication for yeast in case the infection had spread throughout her body, as the infection had started in her mouth and, as she stated, went all the way through. She also mentioned that her hair had thinned out, and she didn't know if it was from the antibiotic or the Comirnaty COVID vaccine. She would have her doctor call.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.