Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia oral, Swollen tongue, Tongue discomfort, Tongue disorder
Clinical narrative: anaphylactic reaction; anaphylactic shock; my tongue first tingling; burning all over my tongue; massive and dangerous swelling of my tongue; an intense burning on the roof of my mouth; there were bumps forming all over the back of my tongue; blisters forming on the back of my throat; She has been very very sick; This is a spontaneous report from a contactable consumer (patient), other healthcare professional, and a physician. A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6208), dose 1 via an unspecified route of administration, administered in Arm Left on 23Mar2021 16:00 (at the age of 48years) as single dose for Covid-19 immunization. Medical history included known allergies: mild allergy to sulfa as a child that resulted in a rash; mild allergy to Crestor that resulted in extreme gas and bloating; other medical history: type 2 diabetic that has been controlled for 8 years with no A1C higher than 7.0. The patient is not pregnant at the time of vaccination. Concomitant medications included metformin, glipizide, bupropion hydrochloride (WELLBUTRIN), lovastatin, and other unspecified medication; all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that on 23Mar2021, she received her vaccine at 4 p.m. and experienced an anaphylactic reaction within 5 minutes, by 4:10 she was taken to the ER (emergency room) attached to the clinic due to her tongue first tingling, then burning all over her tongue, and then massive and dangerous swelling of her tongue and an intense burning on the roof of her mouth. The attending physician noted there were bumps forming all over the back of her tongue and blisters forming on the back of her throat. She was admitted for anaphylactic shock and kept at the ER for 2 hours before being transferred via ambulance to other hospital and she was admitted to the ICU (intensive case unit). She spent the next day in the ICU then 2 days in Cardiac Care, another day back in the ICU, with a 5th and final day back in the Cardiac care. All 5 days were spend trying to get her anaphylactic shock under control. She had numerous doses of EpiPen, steroids, Benadryl, and Pepcid. Her tongue never did completely stop swelling and the burning sensation has never stopped. The patient was hospitalized for 5 days. It was reported further reported that the patient was hospitalized for 6 days (also initially reported as 5 days-pending clarification) and was sent home with medications but was back in the hospital yesterday (unspecified date) because of another big blow up. She has had 2 stays in the ICU, 4 days in cardiac care and is now back in cardiac care again because of yesterday. It has been 2 weeks since she received the vaccine and it is now day 12 but it keeps coming back and she just cannot stop it. She has been very very sick, in a very severe, very rare, extreme, constant state of anaphylactic shock. She has had many Epi (Epinephrine) and is on strong steroids but it has not subsided. She mentioned that their lead pharmacist called last week but never heard any response back. Her doctor told her that they accessed a website from Pfizer which allowed them to search for adverse reactions and they mentioned to her that most of these reactions subside within 24-48 hours. She mentioned that she has no food allergies, no allergies to vaccines, and has only had minor drug reactions. This is the 1st time that this has happened to her and it is getting serious. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). The patient has not been tested for COVID-19 since the vaccination. The outcome of events was not recovered. The reporter (consumer) assessed the events as non-serious.   Information on lot/batch number was available. Additional information has been requested.