Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Cough, Tracheomalacia, Wheezing
Clinical narrative: wheezing; coughing; this reaction seems to be a clear exacerbation of the patient's tracheomalacia; this reaction seems to be a clear exacerbation of the patient's tracheomalacia; This is a spontaneous report from a contactable pharmacist. A 60-year-old female patient received the first dose of BNT162B2 (lot number: EK5730), intramuscular at the left arm on 16Dec2020 19:00 at single dose for immunisation. Medical history included asthma, diverticulosis, tracheomalacia, migraines, sciatica, sleep apnea, hiatal hernia, GERD, T2DM, extensive history of reactive airway disease, esophageal spasms, and tracheomalacia; Anaphylaxis to amide, halogenated and ester anesthetics, and zofran; history of swelling with bee venom; Hives, shortness of breath and rash with peaches and sulfamethoxazole trimethoprim; SVT with rizatriptan and sumatriptan. Concomitant medication (within 2 weeks of vaccination) includes Acetaminophen, hydrocortisone acetate, pramocaine hydrochloride (ANALPRAM-HC, reported as Analpram-HC rectal cream), Albuterol Sulfate, vitamin b complex (B COMPLEX (B50), reported as B complex vitamins), Cholecalciferol, Cyclobenzaprine, duloxetine hydrochloride (DULOXETINE DR), ipratropium bromide, salbutamol sulfate (DUONEB), Esomeprazole, acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN MIGRAINE), hydroxyzine hydrochloride, ipratropium nasal spray, levothyroxine, loratidine, Metformin, hydrocodone bitartrate, paracetamol (NORCO), mepolizumab (NUCALA), Prednisone, Sodium chloride nasal spray. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. This patient had an extensive history of reactive airway disease, esophageal spasms, and tracheomalacia. Patient historically had to reactions to other vaccines (not including influenza vaccine). Given history and high risk of ADE, patient was immunized in the Emergency Department of hospital. Approximately 10 minutes after vaccine administration (about 16Dec2020 19:15), patient reported wheezing and coughing. Patient received epinephrine IM, IV Benadryl, IV solumedrol and racemic epinephrine SVN. Patient never developed a rash, hypotension, swelling of the lips, mouth or tongue, other GI side effects. Per ER attending and admitting physician, this reaction seems to be a clear exacerbation of the patient's tracheomalacia. These events considered serious due to caused hospitalization for 1 day. The patient was more responsive to racemic epinephrine as opposed to IM epi. Patient admits that psychological stress may be a component to her symptoms. The admitting physician does not consider this to be an anaphylactic reaction to the vaccination. The outcome of events was recovering.; Sender's Comments: Based on the close temporal relationship and the description of the events, wheezing, coughing, exacerbation of tracheomalacia, there is a reasonable possibility that the events are related to BNT162 vaccine. 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.