Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Ear discomfort, Head discomfort, Hypoaesthesia
Clinical narrative: chest pressure; I experienced dizziness, with feeling of fullness in inner ear and head; I experienced dizziness, with feeling of fullness in inner ear and head; I experienced dizziness, with feeling of fullness in inner ear and head; numbness of lip (throat ,tongue  and facial swelling) and it kept spreading to the back of my neck; numbness of lip (throat ,tongue  and facial swelling) and it kept spreading to the back of my neck; numbness of lip (throat ,tongue  and facial swelling) and it kept spreading to the back of my neck; numbness of lip (throat ,tongue  and facial swelling) and it kept spreading to the back of my neck; numbness of lip (throat ,tongue  and facial swelling) and it kept spreading to the back of my neck; This is a spontaneous report from a contactable consumer (patient, self-reported). A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0186 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 06Jul2021 at 10:00 AM (age at vaccination: 56 years), as a single dose for COVID-19 immunization at doctor's office/urgent care. The patient was not pregnant at the time of vaccination. The patient's medical history included sarcoidosis with lung involvement, allergic rhinitis, asthma (environmental), sleep apnea, cardiomyopathy, and known allergies: Shellfish, Sulfa, Bee/wash venom, and penicillin. Concomitant medications included ciclesonide (ALVESCO), azelastin, fluticasone propionate (FLONASE), and paracetamol (TYLENOL). The patient did not receive any other vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient reported that on 06Jul2021 at 10:00 AM, shortly after vaccine administered in left deltoid, she experienced dizziness, with feeling of fullness in inner ear and head, minutes later, numbness of lip (throat, tongue and facial swelling) and it kept spreading to the back of her neck. She also felt chest pressure. She alerted nurse immediately of symptoms and received Epi-pen, and Benadryl. Adverse events resulted in doctor or other healthcare professional office/clinic visit emergency room/department or urgent care. The patient received treatment for the events. Outcome of the events was not recovered.; Sender's Comments: Based on the information provided and considering close temporal relationship, the causal association between the reported event Chest discomfort and the suspect drug cannot be completely excluded. The case will be reassessed further upon receipt of additional information. 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 RAs, Ethics Committees, and Investigators, as appropriate.