Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Anti-platelet factor 4 antibody test, Drug hypersensitivity, Investigation, Urticaria chronic
Clinical narrative: break out with hives/chronic hives; allergies; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) from medical information team, Program ID: The reporter is the patient.  A 63-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 as dose 5 (booster), single (Lot number: GH9072) at the age of 63 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LIPITOR, stop date: Dec2022; INFLUENZA VACCINE, on 14Sep2022 as dose number unknown, 0.5ml single. Vaccination history included: BNT162b2 (Dose 1, Time: late in afternoon, probably 1600 or 1700, lot: EN6205, NDC: Unknown, does not see on vaccine card, expiration: NDC: Unknown, does not see on vaccine card, route of administration: left arm), administration date: 25Feb2021, when the patient was 62-year-old, for COVID-19 immunization; BNT162b2 (Dose 2, Time: 1600 or 1700,, lot: EN6205, NDC: NDC: Unknown, does not see on vaccine card, expiration: NDC: Unknown, does not see on vaccine card, route of administration: left arm), administration date: 18Mar2021, when the patient was 62-year-old, for COVID-19 immunization; BNT162b2 (Dose 3, Time: 1600 or 1700, lot: 30155BA, NDC: NDC: Unknown, does not see on vaccine card, expiration: NDC: Unknown, does not see on vaccine card, route of adminstration: left arm), administration date: 29Sep2021, when the patient was 62-year-old, for COVID-19 immunization; BNT162b2 (Dose 4, Time: later in afternoon, lot: FK9894, NDC: NDC: Unknown, does not see on vaccine card, expiration: NDC: Unknown, does not see on vaccine card, route of adminstration: left arm), administration date: 29May2022, when the patient was 63-year-old, for COVID-19 immunization. The following information was reported: DRUG HYPERSENSITIVITY (non-serious) with onset 16Sep2022, outcome "recovered" (25Dec2022), described as "allergies"; URTICARIA CHRONIC (non-serious) with onset 16Sep2022, outcome "recovered" (25Dec2022), described as "break out with hives/chronic hives". The events "break out with hives/chronic hives" and "allergies" required emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of urticaria chronic, drug hypersensitivity. Additional information: Caller states "I received my booster of the Pfizer COVID-19 Vaccine Bivalent Grey Cap Adult dose 14Sep2022, the one for the original and omicron (confirmed adult dose). Two days later, I began to break out with hives and went to the emergency room. The doctor put me on Prednisone and continue to have them every day. My dermatologist had me go off Lipitor for six weeks and now I am back on Lipitor and now also on Zyrtec. Thinking this might have been caused by Pfizer COVID-19 Vaccine Bivalent Grey Cap Adult Dose. For two months I have no hives." She mentioned her doctor wants to know if any particular preservative in the vaccine is present which may have caused the hives. She wants to know if Pfizer was able to point out what caused people to have hives or react to the vaccine like this. Caller clarified she received the Pfizer booster in Sep2022 and she ended up with chronic hives for weeks and ended up going to a dermatologist, the doctors cannot figure out, they did some tests, they stopped Lipitor, and now she is back on Lipitor but she is fine, it must be the booster, asking if there are some preservatives in the booster that could have triggered the allergies. Clarified had last break out of hives on Christmas day, 25Dec2022. Throughout the month of Dec and Nov would have sporadic like day here or two where wouldn't break out. For most part was having everyday. Patient was in between physicians right now and is going to see new doctor next Tuesday. She received Flu shot the same day as the Pfizer COVID-19 Vaccine Bivalent Grey Cap Adult Dose: Also got flu shot. Clarifies received Flu shot the same day as the Pfizer COVID-19 Vaccine Bivalent Grey Cap Adult Dose, 14Sep2022. Flu vaccine: Is looking at withheld app to provide product information for Flu Vaccine. States regarding the Flu Vaccine, the withheld app only says: Sluarix quad .5ml injection Glax. Sluarix quad .5ml injection Glax. confirmed and documented as provided by the caller. NDC/lot/expiration: unknown, not see on app, route of administration: right arm. Patient was off Lipitor, because is number 3 on list for people to break out. Clarifies was taken off Lipitor after receiving the booster dose of the Pfizer COVID 19 Vaccine Bivalent Grey Cap Adult Dose. Went to see dermatologist in December and find reason for ongoing hives. Clarifies was off Lipitor from Dec2022 until 07Feb2023. No follow-up attempts are possible. No further information is expected.