Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye pruritus, Fatigue, Hypersensitivity, Investigation, Pain in extremity
Clinical narrative: itching or rash that started over my face and eyes, then to the jaw, and is now on her hands and armpit and on her backside too; minor allergic reaction; itching or rash that started over my face and eyes, then to the jaw, and is now on her hands and armpit and on her backside too; itching or rash that started over my face and eyes, then to the jaw, and is now on her hands and armpit and on her backside too; her arm hurt bad; she was really tired; This is a spontaneous report from a contactable consumer or other non hcp. This consumer (patient) reported that a 74-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: EM9809), via an unspecified route of administration, administered in right arm on 04Feb2021 (age at vaccination 74-year-old) as single dose for COVID-19 immunisation. Medical history included fibromyalgia from 1990 to an unknown date, rheumatoid arthritis from 1993 to an unknown date and joint problems from 1990 to 1993 she was diagnosed with that after having joint problems from 1990 to 1993, she was really hurting a lot, then she finally got a rheumatologist up there, and they diagnosed her. Concomitant medications included methotrexate taken for rheumatoid arthritis. On 04Feb2021, patient experienced her arm hurt bad; she was really tired; On 09Feb2021 10:00, itching or rash that started over her face and eyes, then to the jaw, and was now on her hands and armpit and on her backside too; minor allergic reaction. The patient underwent lab tests and procedures which included investigation: unknown results on, investigation: unknown results on, weight: getting heavier on Caller said that she was getting heavier during this pandemic, it was making it harder to be exercising. Patient was received treatment for event itching or rash that started over her face and eyes, then to the jaw, and was now on her hands and armpit and on her backside too. It was reported that consumer received the first dose of Pfizer's COVID vaccine on 04Feb2021 and the second one scheduled 25Feb2021. She experienced a minor allergic reaction about 10 am this morning on 09Feb2021. It was an itching or rash that started over her face and eyes, then to the jaw, and was now on her hands and armpit and on her backside too. Caller asking for recommendations if she should take Benadryl or if she should still receive the second dose. She said her rash was not hurting, it was just a little itchy. She said she would like to ask about taking Benadryl. She said she was also not sure if she should get the second dose or not since she had this reaction. Caller said that she was itching, and on the first day her arm hurt bad. She said six hours later after getting the vaccine dose she was really tired, then went to bed that night and slept 12 hours straight on the night of the first day. She said she normally sleeps 8 hours or so, but she was pretty tired by evening. She said she went to bed at 08:30 PM and slept in to 09:00 AM, and then took a nap in the afternoon, which she never took a nap. She said she also had fibromyalgia which affected her muscles and joints anyway, so all that hurt, but it was not horrible, that all kind of faded away. She said that today the rash popped up on her face, and she was trying to keep her hands off while it is itching. Caller said for the rash she got in the shower, and when she got out her face felt really warm so she looked in the mirror and saw it was red over her eyebrows, so she put lotion on after her shower which made her feel better, she usually uses lotion because of the dry air in. Caller said she did not think she had Benadryl in her house to take it, and had not taken any yet, she said she would probably sleep all day if she took it. No further details provided about Benadryl. She said that her joints or muscles ache anyway due to her fibromyalgia, but she took probably three Advil, not all at one time, she took them over time. She said she took one at 10:00PM, which she always took one when she went to bed because it helped her sleep better, and then she took another one when she went to bed Advil UPC: 3 0573 0154 60 4, of which caller said that the first and last number were small. Documented as provided. LOT: X30241 EXP: Caller said she did not know why had to hide it and provides EXP May2021. Caller said they have not had any other recent vaccinations or started any new medications. Caller said she took Methotrexate, a low dose, for her rheumatoid arthritis. She said it came in an orange pharmacy bottle that said that the pills were yellow, round, and scored. NDC/LOT/EXP: Caller said that this information was not printed on pharmacy label. She said she took 4 a day, once a week, on Tuesdays. She said when she got down to 8 pills, they send her another bottle, it made her nervous, but she never runs out. Caller said she also would like to know, will the having the COVID vaccination and having a mild reaction to it affect the results of her blood tests in any way. There was a product complaint. The clinical outcome of all events was unknown.  Description of complaint: Consumer says she was starting to get a rash from the COVID-19 vaccine, later clarified to Pfizer BioNTech COVID-19 vaccine. She said that she got her first shot on 04Feb2021, and this was 09Feb2021, so 5 days later. She said she was getting a rash on her hands and face, and sometimes on her legs, unless she did not touch it. She said she wondered if she should leave the rash alone, though it was spreading a bit, or if it will go away if she did not touch it. She said it is on her face too around her eyes. Product strength and count size dispensed: first dose, one injection. Additional lot numbers: n/a. A sample of the product available to be returned was not provided. Packaging sealed and intact was not provided.  Follow-up attempts completed. No further information expected.