Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Product use issue
Clinical narrative: grade 2 allergic reaction; short of breathe; flushed; she was an oncology patient with large granular lymphocytic leukemia and received BNT162B2; she was an oncology patient with large granular lymphocytic leukemia and received BNT162B2; This is a spontaneous report from a contactable other healthcare professional. A 79-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL9262, NDC number of COVID Vaccine: 59267-1000-1; Expiry Date of COVID Vaccine: 31May2021), intramuscularly at Left Deltoid on 08Feb2021 10:30 (either 10:30AM or within that hour or prior) at single dose for COVID-19 immunization. Medical history included anxiety, panic disorder, asthma, obstructive sleep apnea, additional Information for Other Conditions: She was oxygen Dependent, coeliac disease, allergy, Additional Information for Other Conditions: She had Medication, Environmental, and Food Allergies, central neuro hearing loss, vertigo, Allergic rhinitis, gastrooesophageal reflux disease (GERD), Additional Information for Other Conditions: Esophageal Reflux, osteopenia, impaired glucose tolerance, hypothyroidism, claustrophobia, rheumatoid arthritis (she had arthritis for which she took Orencia for), history of coronary heart disease, diabetes, she would be a targeting patient, as she was an oncology patient with large granular lymphocytic leukemia she met criteria for the pandemic, as well as they put down that she was due for immunization. She had anaphylaxis to bees. With adhesive tapes she got dermatitis. With shellfish she got hives. She had a gluten sensitivity and with mango her mouth gets fuzzy. Family Medical History Relevant to AE(s): her sisters had a few cancer. There were no concomitant medications. The patient previously received levofloxacin she had hives, with quinolones drug class she had hives, with thiopental she had hives and needed IV Decadron for it, with sertraline she has syncope, with Revatio she had an adverse event of joint and muscle pain, with ciprofloxacin she had tachycardia, with Enbrel it caused a drug induced pulmonary fibrosis granulomatosis, with Montelukast she had a headache and muscle pain, nitrofurantoin she had headache, with Symbicort it gave her hoarseness, she took Orencia for arthritis, she got the flu Vaccine in Sep2020. That was most recent. The patient had a grade 2 allergic reaction on 08Feb2021. The patient was watched after administering the vaccine on 08Feb2021 as she had background of multiple allergies and asthma. She was watched for 30 minutes in the oncology unit infusion suite. The reaction happened within 5 minutes of administration. Seriousness Criteria: Caller explained that this reaction was mild to moderate, there was a grade to intervene but at no point was she unstable, she did have a significant anxiety disorder, and so she was nervous about getting the vaccine. She was short of breathe, odd and flushed. She was physically stable, her vitals were stable and there was no angioedema. Reporter seriousness for grade 2 allergic reaction: Medically significant. The patient recovered, as a treatment they gave her IV Benadryl 50mg and IV fluids, she also had her own albuterol inhaler. In the pandemic, they are not doing nebulizers. The outcome of events allergic reaction, shortness of breath and flushed was recovered on 08Feb2021. Relatedness of drug to reaction(s)/event(s). Reaction assessed: Grade 2 allergic reaction; Source of assessment: Primary Source Reporter. Method of assessment: Global Introspection. Drug result: Related. Causality: reporter stated that she did think the patient's base line anxiety played into the reaction she experienced, the reaction was aggravated by it.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of grade 2 allergic reaction, short of breathe and flushed due to temporal relationship and current known drug safety profile. The patient's underlying allergic physique also predisposed the patient to developing the event. 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.