Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chest discomfort, Dysphagia, Dyspnoea, Erythema
Clinical narrative: Mild facial erythema flushing; chest tightness; SOB; sore throat; heart rate went up to 127 and blood pressure up to 170 within a few minutes after getting vaccine; severe allergic reaction within 2 minutes; heart rate went up to 127 and blood pressure up to 170 within a few minutes after getting vaccine; it was difficult to swallow/trouble swallowing; I started to get hot; my heart started racing; inflamed tonsils; fever; This is a spontaneous report from a Pfizer sponsored Program. A contactable consumer (patient) reported for a 34-year-old non-pregnant female patient received BNT162B2 (Solution for injection), dose 1 via an unspecified route of administration, administration in left arm on 18Mar2021 11:45 (at the age of 34-year-old) (Lot Number: ER2613) as SINGLE DOSE for covid-19 immunisation. The patient had allergies to Sulfa antibiotics, Lumbar disc herniation, keratosis pilaris, acne. Occasionally the patient drinks alcohol.  Concomitant medication included ethinylestradiol/ ferrous fumarate/ norethisterone acetate (JUNEL FE) spironolactone, ethinylestradiol, norethisterone acetate (AUROVELA), acetominophen and ibuprofen.. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had a reaction a severe allergic reaction to the COVID 19 vaccine on 18Mar2021 at 11:45 . It was reported within 2 minutes of receiving vaccine the patient started to get hot, heart started racing, a facial redness, face got bright red and swollen, throat started to swell, and it was difficult to swallow. The patient heart rate went up to 127 and blood pressure up to 170 within a few minutes after getting vaccine. The patient heart rate and blood pressure were high. The patient also experienced inflamed tonsils.  On 18Mar2021 at 11:52 the patient experienced also: sore throat, shortness of breath and chest tightness, at 12:00 the patient had mild facial erythema flushing and at an unknown time fever up to 99.5°F. All these with outcome of unknown. The patient was not in anaphylactic shock, but she was initially given diphenhydramine (BENADRYL) to treat the symptoms, but it had no effect. She was admitted to emergency room and was given epinephrine and prednisone and things started to get better. The next day symptoms returned, and patient went to urgent care the next morning. There the patient received another prescription for prednisone for 5 days. After that finished her symptoms returned and was given another round of prednisone for 6 days. The patient was still having slight symptoms that she was treating with fexofenadine (ALLEGRA) twice per day per advice of allergist. The patient was met with an allergist and was slightly concerned and thought it was unusual that this would continue past symptoms of 2 weeks. It was reported that the patient was experiencing slight symptoms, nothing crazy, but was wondering what communication from Pfizer was if someone did have an allergic reaction that most people were treated in emergency room. On an unknown date, the patient had allergy tests and no information found on allergy tests. It was reported that the patient antibody testing was not currently recommended to assess for immunity. The patient was discharged with instructions to get an epi pen in case anything got crazy, and her husband drove her home. It was stated as soon as it was her turn the system disconnected. The patient stated the only reason she waited after 4 hours was because she was 5th in line, and it took 2 hours 50 minutes to get to be her turn. The patient was on hold for four hours and she got hung up on, but she was not sure if the system was down, but she got an email and, in the case, it had her interactions. Among the Vaccine recipients, mild-to-moderate pain at the injection site within 7 days after an injection was the most reported local reaction, with less than 1% of participants. In general, local side effects; the ones you get on the arm where you got the shot (such as injection site redness and injection site swelling) were mostly mild-to-moderate in severity and resolved within 1 to 2 days. Side effects that you may experience throughout the rest of your body; (systemic side effects) including fever and chills were observed with the first 1 to 2 days after vaccination and resolved shortly thereafter. Swollen lymph nodes (lymphadenopathy), which generally resolved within 10 days, is likely to have resulted from a robust vaccine-elicited immune response. A cross all age groups reporting severe pain. Since the vaccination the patient was not tested for COVID-19. The outcome of the events was recovering. The patient was suggested  not to get the second dose of COVID-19 vaccination of any type.  No follow-up attempts are needed. No further information is expected.  Follow-up (27Apr2021): This is a follow-up spontaneous report from a contactable Pharmacist. New information included: patient medical history, concomitant medications, new non serious adverse event (sore throat, shortness of breath and chest tightness, mild facial erythema flushing and fever up to 99.5°F.); Sender's Comments: A contributory role of BNT162B2 to the reported events cannot be excluded based on the temporal relationship 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.