Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Migraine, Nausea, Thyroid function test, Urticaria chronic
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 45 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Feb2022 08:30 (Lot number: FK9895) at the age of 45 years as dose 3 (booster), single for Covid-19 immunisation. Relevant medical history included: "Hashimoto's disease" (ongoing), notes: Diagnosed about 2018; "Fibromyalgia" (ongoing), notes: Diagnosed about 2018; "Chronic urticaria", start date: 2016 (ongoing); "Angioedema", start date: 2016 (ongoing); "Alopecia", start date: 2018 (ongoing); "Eczema", start date: 2016 (ongoing); "Covid", start date: Oct2020 (unspecified if ongoing), notes: tested positive 21Oct2020, this was prior to vaccination.; "allergy to eggs" (ongoing), notes: allergy to eggs; "immune compromised" (unspecified if ongoing). Family history included: "Asthma", start date: 2016 (unspecified if ongoing), notes: Grandmother; "COPD" (unspecified if ongoing), notes: Grandmother; "heart disease" (unspecified if ongoing), notes: Grandmother. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, Lot: 30130BA, Expiration: unknown, Dosage: 0.3ml, Time: 08:30 , Injection into left arm), administration date: 20Dec2021, when the patient was 45 years old, for Covid-19 immunization, reaction(s): "Migraine", "Nauseous", "Dizzy", "Light headed"; Bnt162b2 (Dose: 2, Lot: FL3198, Expiration: unknown, Dosage: unknown, Time: 08:30 , Injection into left arm), administration date: 10Jan2022, when the patient was 45 years old, for Covid-19 immunization, reaction(s): "Migraine", "Nauseous", "Dizzy", "Light headed"; Influenza quadrivalent injection (She now has an allergy to eggs, so it didn't go very well when she got her flu shot), administration date: 10Dec2021, when the patient was 45 years old, for Immunization, reaction(s): "hives", "angioedema", "swelling". The following information was reported: ANGIOEDEMA (medically significant) with onset 18Feb2022, outcome "not recovered", described as "Angioedema/had been having flare ups of the angioedema and urticaria"; URTICARIA CHRONIC (non-serious), CONDITION AGGRAVATED (non-serious) all with onset 18Feb2022, outcome "not recovered" and all described as "Chronic urticaria/had been having flare ups of the angioedema and urticaria"; MIGRAINE (non-serious) with onset 07Feb2022, outcome "recovered" (2022), described as "Migraine"; NAUSEA (non-serious) with onset 07Feb2022, outcome "not recovered", described as "Nauseous/having a hard time keeping foods down"; DIZZINESS (non-serious) with onset 07Feb2022, outcome "not recovered", described as "Dizzy/Light headed"; FATIGUE (non-serious) with onset 2022, outcome "unknown", described as "Fatigue". The patient's symptoms started on the same after the last dose, on 07Feb2022 within 15 to 20 minutes. The patient had migraine but she didn't think anything of it, and she was really nauseous, dizzy and light headed. She had that with other doses as well, she had some warm herbal tea in her car and thought the migraine would wear off. She made an appointment to see her primary care on 14Feb2022, and all those initial symptoms were still there. She had fatigue, light headedness, migraine, and was very nauseous and was having a hard time keeping foods down. Since the patient has Hashimoto's disease which is a thyroid disease, she thought her thyroid was off; she had labs drawn, and was checked for vitamin deficiency, but everything was good, the doctor didn't need to change anything. The patient was hoping the labs would say something to let them know what was going on. On 18Feb2022, she had an appointment with the immunologist, by this time she started breaking out in hives and had a diagnosis of Chronic urticaria, which is not the same as regular hives, and had a diagnosis of Angioedema. On 18Feb2022, the patient's doctor, the immunologist, reviewed the labs from and said her thyroid looked good, her vitamins looked good, looked at her A1C and that was good. The doctor addressed her migraines and prescribed Atenolol. There was some miscommunication, he thought she was still getting injections of Xolair, for the Angioedema and Urticaria. On 14March2022, she went back for follow up for the Atenolol and migraines, which were fine by that point, but she had been having flare ups of the angioedema and urticaria. Every day for last two weeks of Feb2022, and from 01Mar2022 to 14Mar2022, she broke out every day with no breaks in between. She tracks the information for her appointments. The Chronic Urticaria and Angioedema are still on going, the doctor doesn't know what to do. On the week of 21Feb2022 symptoms started with the chronic Urticaria and Angioedema. The immunologist didn't realize she was no longer getting the Xolair injections; he started her on a new medication on 14Mar2022, but it hasn't helped, called Doxepin. Her doctor did tell her she would need to titrate the Doxepin, she has an appointment next month, and he is going to make sure she is not having and side effects and then he would gradually increase the dose. The events did not require a visit to the ER. She is afraid to go to the Emergency Room, the reaction got so bad one night she almost used her EpiPen but didn't because she didn't want to go the ER. She was told if she ever uses her EpiPen she should go to the ER, but going to the ER would be a waste of time, it would take 24 hours or longer to wait, until you either die or leave. The patient added that when she had Covid she went to the ER and she sat there for 11 hours and she wasn't seen or tested. She fell asleep in the waiting room and woke up 11am the next morning, she left the ER and went to urgent care. The ER doesn't know anything about rare diseases, she spends more time explaining her diseases to them, so it is pointless for her to go to the ER. She has been so stressed out, she tried to report through the nurse line, she first thought it was her thyroid. She thought it was the weather changes, every time the weather changes, its awful, but when having angioedema and urticaria flare ups everyday, she called the FDA. The patient underwent the following laboratory tests and procedures: haemoglobin: (Feb2022) good; investigation: (Feb2022) good; thyroid function test: (Feb2022) good. Therapeutic measures were taken as a result of angioedema, urticaria chronic, condition aggravated, migraine.