Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Breast pain, Cough, Dizziness, Drug hypersensitivity
Clinical narrative: anaphylactic; reactions are allergic; Terrible airway swelling, it felt like breathing through a straw, narrowing airway; Sensation of throat closure/narrowing of airway; significant shortness of breath/difficult to breath like through a straw; Pain in both lymph nodes, under both the armpit; Pain in both breasts; Dry cough; Itching, airway/trachea itchy; Hoarseness; Dizziness; This is a spontaneous report from a contactable nurse (patient). A 65-years-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL3248), via an unspecified route of administration, administered in the left deltoid on 15Feb2021 at 15:30 as a single dose for protection against Covid.  Medical history included ongoing obesity as she gains and loses it, ongoing hypertension, ongoing asthma (at 59 she was bumped up to moderate degree asthma), ongoing significant food allergies, was born with and had ongoing eczema so she was allergic to milk (was given soy milk since she could not tolerate milk, when she drank milk, it produced phlegm/caused increase in mucus, ongoing significant environmental allergies wherein she would have allergies in the fall, from August through September and would have sneezing, congestion and itchy watery eyes. The patient also had a history of getting bronchitis but has not had it for a long time. The patient got stung by a bee when she was 40ish and her upper thigh got red, itchy and it lasted for 10 days and she and no other symptoms and was now careful around bees. The patient reacts to the smoky matches that blow out and make smoke, from the sulfa in the matches, fireplaces, wood burning and firepits. Concomitant medications included cetirizine hydrochloride (ZYRTEC) taken for an unspecified indication, start and stop date were not reported; montelukast sodium (SINGULAIR) taken for an unspecified indication, start and stop date were not reported; fluticasone propionate, salmeterol xinafoate (ADVAIR) taken for asthma, start and stop date were not reported and fluticasone (manufacturer unknown) taken for asthma and allergies, start and stop date were not reported.  The patient was on significant medications for her asthma, allergies and blood pressure. The patient previously got a flu shot at the end of Oct2020. The patient also previously took Aleve in her early 40's and was taking them for a neck injury for 2-3 months and at the end of the treatment she broke out in a rash. The patient also previously took aspirin 3 years ago and broke out in a rash. The patient also has an albuterol inhaler but has not taken it for years. The patient was careful, handwashing normally, wipes the shopping carts as they are germy. The patient stated that after receiving the vaccine, one main event was terrible airway swelling, itching and it was difficult to breathe. The terrible airway swelling felt like breathing through a straw and narrowing airway. She stated that it started 18.5 hours after the vaccine, on 16Feb2021 at 10 am and lasted for 4 hours between 10 to 2 pm. The patient also had itching wherein her airway and trachea were itchy which also started on 16Feb2021 at 10 am to 2 pm. The patient experienced narrowing of airway and sensation of throat closure also between 10 am to 2 pm. The patient also experienced that it was difficult to breathe but she did not feel like she needed to go to the hospital. If it got any worse she would gave went to the emergency department. She stated that she was sitting up, walking around and she would have had a significant shortness of breath and she was trying to wait it out. It was difficult to breath like through a straw which also started from 10 am to 2pm. She did not feel like she wanted to walk or do daily activities. She was on the phone with her mother and her mother could hear her difficulty in talking and her heavy breathing. The patient also experienced pain in both lymph nodes, under both armpits and pain in both breasts which started also on 16Feb2021 at 10 am and lasted for 24 hours the 10 am the next day. The patient had dizziness which started about noon and when she woke up the next day it as gone which she considered as medically significant since she is never dizzy and it was not due to her blood pressure and she has been on pills for a long time. The patient had dry cough and hoarseness also on 16Feb2021 from 10 am to 2 pm. The patient was afraid to take the second vaccine and she spoke to her pulmonologist who knows her history and was told that she would benefit. She thought that if she felt bad, she would go to the emergency room if it got worse but it did not. The patient stated that she thinks these reactions are allergic, the itching and narrowing of throat can be anaphylactic. The patient did not require any medical intervention and was not seen in the emergency department and was not hospitalized. The events lasted for 4 hours and stayed at that level. The patient did not get any treatment and it went away. The outcome of the events terrible airway swelling, it felt like breathing through a straw, narrowing airway, Dry cough, Itching, airway/trachea itchy, Hoarseness, Sensation of throat closure/narrowing of airway, reactions are allergic and anaphylactic was recovered on 16Feb2021 at 14:00. The outcome of dizziness was recovered on 17Feb2021 and the outcome of pain in both lymph nodes, under both the armpit and pain in both breasts on 17Feb2021 at 10:00. The patient reported that the events were considered as medically significant. The relatedness of the drug to the reactions from primary source reporter (method of assessment: Global Introspection) for the events was related.; Sender's Comments: A contributory role of vaccine BNT162B2 to reported events cannot be fully excluded since it is part of the product safety profile. Potential contributors include patient's advanced age, as well as underlying obesity, hypertension, asthma, eczema, multiple allergies and other co-morbidities.  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.