Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypersensitivity, Lip swelling, Swollen tongue, Throat tightness
Clinical narrative: Allergic/Anaphylaxis reaction; Allergic/Anaphylaxis reaction; Tongue swelling, lip swelling, chest and throat tightness, shortness of breath and cough; Tongue swelling, lip swelling, chest and throat tightness, shortness of breath and cough; Tongue swelling, lip swelling, chest and throat tightness, shortness of breath and cough; Tongue swelling, lip swelling, chest and throat tightness, shortness of breath and cough; Tongue swelling, lip swelling, chest and throat tightness, shortness of breath and cough; Tongue swelling, lip swelling, chest and throat tightness, shortness of breath and cough; This is a spontaneous report from a contactable Nurse (patient).  A 53-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL1284), intramuscular in the right arm on 06Jan2021 17:15 at single dose for COVID-19 immunisation. Medical history included allergy induced asthma, environmental allergies and seasonal allergies. Family history included hypertension and high cholesterol. The patient previously took hydrocodone and experienced drug hypersensitivity. Concomitant medication included cetirizine hydrochloride (ZYRTEC), montelukast sodium (SINGULAIR), fluticasone propionate, salmeterol xinafoate (ADVAIR), omalizumab (XOLAIR), pregabalin (LYRICA), ascorbic acid (VIT C), cyanocobalamin (VIT B12), fluticasone propionate (FLONASE) and allergic shot once a month. On 06Jan2021 at 18:00 the patient experienced allergic/anaphylaxis reaction, tongue swelling, lip swelling, chest and throat tightness, shortness of breath and cough with outcome of recovered on 07Jan2021 at 05:00. Due to AE the patient visited Emergency room/department or urgent care. She was administered IV Benadryl Solumedrol IV and Pepcid IV. Also, Epinephrine IM and a nebulizing treatment. ER visit overnight, the patient recovered on 07Jan2021 around 05:00 am she was discharged from Hospital. She was prescribed a '3-day medication' after she was discharged: Oral Steroid (prednisone - 40 mg daily) for 3 days, Benadryl and Pepcid for 5 days. Relevant Tests included physical Exam at ER and exam for allergic reactions. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient had not been tested for COVID-19. The reporter considered that there was a reasonable possibility that the event was related to suspect vaccine.; Sender's Comments: Based on a close chronological association, a causal relationship between events allergic/anaphylaxis reaction, tongue swelling, lip swelling, chest and throat tightness, shortness of breath and cough and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. 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.