Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy, Blood test, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Unusual lip reaction; This is a spontaneous report received from contactable reporter(s) (Physician). A 71-year-old female patient received BNT162b2 (BNT162B2), on 28Oct2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 70 years for covid-19 immunization, time for her to have the shot. The patient's relevant medical history included: "Cholesterol" (ongoing); "Antilipid" (ongoing); "Blood pressure" (ongoing). Concomitant medication(s) included: ROSUVASTATIN CALCIUM oral taken as cholesterol medication, antilipid (ongoing); AMLODIPINE oral taken for blood pressure (ongoing). Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: EL3302), administration date: 22Jan2021, when the patient was 70-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, Lot number: EM9809), administration date: 12Feb2021, when the patient was 70-year-old, for COVID-19 immunization. The following information was reported: LIP DISORDER (non-serious) with onset Mar2022, outcome "recovering", described as "Unusual lip reaction". The event "unusual lip reaction" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient took a low dose blood pressure medicine and cholesterol medicine that were taken prior to any of the COVID-19 Vaccines. It was noted under concomitant medications that Crestor was clarified to Generic Crestor, lowest dosage; taken for quite some time and hasn't changed. Amlodipine: low dose as blood pressure medicine; started 2 years ago maybe. The patient had no other conditions, healthy as a bear. A retired physician reported that his wife previously had all the Pfizer shots but she didn't have the third booster. About 4 or 5 months after her last Pfizer vaccine dose she got COVID-19 and developed the same thing in her upper and lower lips but hers was worse. Slept next to his wife when she had COVID-19 every day and never got COVID-19. Dates of her vaccinations were the same as his. He clarified his wife only had three doses and then had COVID-19. Was advised to not have 4th dose, booster, due to this. The patient had COVID-19 after vaccines with start date: 02Feb2022; acute illness about a week, then lingering weakness following it. It was not serious, like having a virus with a low grade fever. Outcome noted to have recovered from that completely then had the unusual lip reaction. Unusual lip reaction start date was maybe a month after having COVID-19. Clarified approximately a month after 02Feb2022. It was not as bad but still present, ongoing. It was not serious. Very aware of it, cosmetically. The outcome has improved slowly and continued to improve. Product: COVID-19 Vaccine Booster was the most recent dose that preceded her symptoms. Causality-Lip reaction: No. It was 6 months after the COVID-19 Vaccine booster before she got COVID-19 and then had the lip reaction. Suspected the COVID-19 infection itself caused her lip reaction, not the COVID-19 Vaccine Booster. Because of the concern with the lip, she went to several different physicians. First the primary care provider who recommended an ENT. Had an ENT consult who found no explanation. All providers are pointing their fingers at COVID-19 infection. Went to dermatologist who didn't know anything either, recommended a biopsy and blood work. Nothing turned up on any blood work. Decided to do a biopsy. Declined to provide any test results.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201287280 same reporter/patient/product, different dose/event;