Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Blood pressure increased, Dysgeusia, Flushing, Histamine level
Clinical narrative: face turned flushed; taste of metal; elevated blood pressure; tachycardia; hypertension; Allergic reaction; vomiting; rash on face; itchy throat; This is a spontaneous report from a contactable physician (patient herself). A 41-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: EH9899), via intramuscular route, administered in left arm on 21Dec2020 16:33 (age at vaccination: 41-year-old) as 1st dose, single dose, for COVID-19 immunization. The vaccine was administered in a hospital. The patient's medical history included on an unknown date in 1979, anaphylactic reaction after general anaesthesia due to which the patient was in coma for 7-days; On an unknown date in 2016, tachycardia after Lidocaine inj. topical injection causing short of breath, hypotension; shortness of breath after Benzocaine topical during a dentist procedure causing short of breath, vomiting, wheezing; From 2012, the patient was allergic to yellow jacket, vispid, bee and seafood. Concomitant medication(s) included levothyroxine sodium taken for hypothyroidism from 07Aug2018 at a dose of 50mcg daily. On 21Dec2020 16:42, 9 minutes after the vaccine, the patient experienced vomiting, rash on face, tachycardia, hypertension, itchy throat, taste of metal. On an unknown date, the patient's face turned flushed and elevated blood pressure. The events of vomiting, rash, tachycardia, hypertension and throat irritation were considered to be medically significant. The patient reported that he got an allergic reaction to the first dose first dose of the vaccine and his allergist does not want him to get the 2nd dose. The patient was taken to the emergency room due to the event and was treated with Epinephrine SC was given, IV decadron and famotidine given oral loratadine (due to allergy to beta drugs), IV fluid was started. The patient was discharged from emergency room 4 hours later. Tachycardia lasted for 24 hours. The patient underwent antibody test on an unknown date for which the results were unknown; ON 21Dec2020, the patient's histamine level was normal and tryptase test (done 1 hour after event) was also normal. The patient was not deceased. The outcome of the event dysgeusia, flushing and blood pressure increase were unknown, and all the other events were recovered on 22Dec2020.   Reporter considerd the Pfizer product had a casual effect to the adverse event.  Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 in triggering the onset of rash,throat irritation,flushing,tachycardia.But also consider relevant medical history of anaphylaxis,allergic history and concomitant medications . The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.