Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: severe allergic reaction (anaphylaxis) after the 2nd dose; her lips felt like they were on fire; lips started swell; bronchospasm; wheezing; stridor; respiratory failure; Both arms were completely numb; respiratory distress; tachypnea; hoarse voice; difficulty breathing; sensation of throat closure; a little bit of hives, mostly on chest and abdomen; This is a spontaneous report from a contactable nurse (patient). This 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration administered in right arm on 13Jan2021 (at the age of 39 years) (Batch/Lot Number: EL3247; Expiration Date: May2021) as a single dose for COVID-19 immunization. Medical history included immunodeficiency common variable diagnosed about 4 years ago or a little longer and allergy to sulfa antibiotics as a child. Concomitant medications included famotidine (PEPCID), diphenhydramine hydrochloride (BENADRYL), and montelukast sodium (SINGULAIR) all taken a week prior to getting both doses of the COVID vaccine. With her immunodeficiency, she gets weekly IGg infusions and has been getting these infusions for at least 4 years or more. The patient previously received the first dose of bnt162b2 administered in right arm on 23Dec2020 (lot number: EL1284) for COVID-19 immunization. Patient also previously took Demerol and experienced anaphylactic reaction. Patient is a part of the immunocompromised population but experienced a severe allergic reaction (anaphylaxis) on 13Jan2021, after the second dose of the Pfizer BioNTech Covid-19 Vaccine. The signs and symptoms of the anaphylactic reaction were reported as follows: First thing she noticed was that her lips felt like they were on fire, then lips started swell, she went into a bronchospasm with wheezing and stridor, then started to go into respiratory failure. Code team was called. Both arms were completely numb. They thought she was going to need a breathing tube put in but they did not "bronc" her. Patient was not hospitalized and was not admitted to an Intensive Care Unit. Information on organ involvement/multiorgan involvement were reported as follows: Respiratory: wheezing/bronchospasm; stridor; respiratory distress (details: tachypnea; hoarse voice; difficulty breathing, sensation of throat closure), Cardiovascular: tachycardia due to Epi, no shock or blood pressure issues, and Dermatological: she thought she got a little bit of hives, mostly on chest and abdomen, no gastrointestinal symptoms, no any other symptoms/signs. AEs did not require visit to the physician office (also reported as "she called her doctors"). No relevant tests were performed. These started within 7 minutes of receiving the second dose. Treatment received included epinephrine (Recemic Epi, may have received an epinephrine nebulizer), steroids, Benadryl, and was in the ER for 6 hours. Patient did not receive any recent vaccines for any other conditions or for SARS-CoV2 other than Pfizer- BioNTech COVID-19 Vaccine prior to the event being reported. Patient did not receive any other vaccines around the time of Pfizer-BioNTech COVID-19 Vaccine vaccination and within 4 weeks prior to the COVID vaccine. Outcome of the events was recovered on 13Jan2021. Reporter's seriousness assessment for anaphylactic reaction was life threatening. The patient wanted to know if we have information on tests being done involving alteration of doses of the Pfizer BioNTech COVID-19 Vaccine for people who experienced severe allergic reaction after the dose of the vaccine. The patient to know the Pfizer BioNTech Covid-19 Vaccine booster dose recommendations for a patient who is part of the immunocompromised population who is exposed to COVID-19 patients, but had an anaphylactic reaction after the second dose of the vaccine. She is interested in getting the booster dose of the vaccine. She might be potentially contraindicated to get the booster dose since she had a severe reaction to the second dose of the COVID vaccine, she had an anaphylactic reaction.; Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported events Anaphylactic reaction, oral discomfort, lip swelling, bronchospasm, wheezing, stridor, Respiratory failure, Hypoesthesia, respiratory distress, tachypnoea, Dysphonia, dyspnea, Throat tightness and urticaria which cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available. 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.