Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cardiac flutter, Heart rate irregular, Pruritus, Throat tightness
Clinical narrative: throat closing; heart flutters; Itching; fluctuation in heart; weak; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 31Oct2022 at 14:30 as dose 5 (booster), 0.3 ml single (Lot number: GJ6665) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "She has Hashimoto's" (unspecified if ongoing); "She has many allergies to medicine" (unspecified if ongoing). Concomitant medication(s) included: DIPHTHERIA VACCINE taken for immunisation, on 28Sep2022 as dose number unknown, single; TETANUS VACCINE taken for immunisation, on 28Sep2022 as dose number unknown, single. Vaccination history included: BNT162b2 (Dose: 4 (2nd booster), Lot provided as both numbers on card: BNT162, FJ6369, expiration is unknown. Injected in left arm.), administration date: 08Apr2022, when the patient was 69-year-old, for COVID-19 immunization; BNT162b2 (Dose: 3 (1st booster), Lot is unknown, expiration is unknown.  Injected in left arm.), administration date: 12Nov2021, when the patient was 68-year-old, for COVID-19 immunization; BNT162b2 (Dose: 2, Lot is unknown, expiration is unknown.  Injected in left arm.), administration date: 06Mar2021, when the patient was 68-year-old, for COVID-19 immunization; BNT162b2 (Dose: 1, Lot is unknown, expiration is unknown. Injected in left arm.), administration date: 13Feb2021, when the patient was 68-year-old, for COVID-19 immunization, reaction(s): "Headache". The following information was reported: HEART RATE IRREGULAR (non-serious) with onset 2022, 1 month 4 days after the suspect product(s) administration, outcome "unknown", described as "fluctuation in heart"; ASTHENIA (non-serious) with onset 2022, 1 month 4 days after the suspect product(s) administration, outcome "unknown", described as "weak"; PRURITUS (non-serious) with onset 31Oct2022, outcome "recovering", described as "Itching"; CARDIAC FLUTTER (medically significant) with onset 31Oct2022, outcome "not recovered", described as "heart flutters"; THROAT TIGHTNESS (non-serious), outcome "unknown", described as "throat closing". Therapeutic measures were taken as a result of pruritus, throat tightness. Additional information: Received call from consumer regarding the Pfizer Bivalent vaccine. She had first 2 and then the 2 boosters because she is 69 years old. They were all with the Pfizer and she had no problems. Had Bivalent and is on 3rd day of Benadryl and heart flutters. She dug into it and saw that the ingredients changed. She just said they should let people know because her doctor said there were no changes other than the MRNA should target the Omicron. It was just a few days ago. Trying not to go out because there is COVID everywhere. Had shot on Halloween and started 2 hours after is when it started. Itching has improved, but the fluctuation in heart has not. It is not enough for her not to be able to move, but she gets weak easily. She has not been to the doctor for any treatment. She tries to handle things at home first because when she goes in, something else usually happens. She has Hashimoto's which was diagnosed many years ago and prior to receiving any of the Pfizer COVID vaccines. She has many allergies to medicine and needs to know when they change something. She has a lot of medicines she is allergic to. The event itching and heart flutters started about 2 hours after receiving it. She stated with the first Pfizer COVID vaccine, she only had a headache. She did not have the lot or expiration for that one. It could cause someone a death. She breaks open a Benadryl as soon as she feels her throat closing. Other people might not know this. Is a sample of the product available to be returned, if requested (Y/N): no Packaging sealed and intact? not provided.