Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Dyspnoea exertional, Flushing, Influenza A virus test negative
Clinical narrative: Around 10:30pm I felt like my throat was closing and I was choking; Around 10:30pm I felt like my throat was closing and I was choking; I had chest pain, chest tightness; I had chest pain, chest tightness; Very SOB at rest; Throughout the day I was cough and my face started flushing so I tool Benadryl/severe facial flushing; On 23Dec I got nerve blocks for my migraines.; Throughout the day I was cough and my face started flushing so I tool Benadryl.; This is a spontaneous report from a contactable nurse who reported for herself. A 36-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EK5730) dose number 1, via an unspecified route of administration on 19Dec2020 11:30 at single dose for COVID-19 immunization. Medical history included von willebrand's disease, narcolepsy with cataplexy, IIH (Idiopathic intracranial hypertension), HTN (hypertension), GERD (gastrooesophageal reflux disease), migraines. Patient also had known allergies: PCN (penicillin), shellfish, IV contrast, cefdinir and bees. On 23Dec2020, patient got nerve blocks for her migraines. Throughout the day patient was cough and her face started flushing so she tooled diphenhydramine hydrochloride (BENADRYL). Around 22:30, patient felt like her throat was closing and she was choking. She had chest pain, chest tightness. EMS (emergency medical services) was called and patient was brought to the hospital. On 25Dec2020, patient felt like her throat was closing, like someone was sitting on her chest and chest tightness still with chest pain. Very SOB (shortness of breath) at rest. Patient went to the ER (emergency room) and received IV dexamethasone (DECADRON) and diphenhydramine hydrochloride. On 26Dec2020, patient had the same symptoms but with severe facial flushing and patient went back to the ER and was given IV dexamethasone. Patient was sent home on a maximum amount of medications. I had seen her primary care, ENT (ear nose throat centre), Allergy, ID (infectious disease), and pulmonology. Her CT (computerised tomogram) of chest on 25Dec2020 was negative along with her COVID test. Patient SOB on rest and exertion still. Onset date of the adverse events was reported as 23Dec2020, 22:30. Patient received treatment for the events included multiple medications and high dose prednisone. Lab data on 25Dec2020 included CT of chest: negative, influenza type A/B combo: negative, Covid 19: negative and nasal swab: negative. Action taken in response to the events for bnt162b2 was not applicable. Outcome of the events was not resolved.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events due to temporal relationship.  The clinical presentation of the events is suggestive of possible allergic reactions. There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is available.  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.