Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Dysphonia, Feeling hot, Flushing, Nausea
Clinical narrative: anaphylactic reaction; anaphylactic reaction; This is a spontaneous report from a contactable nurse (patient). A 65-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8733; Expiration Date: 31Jul2021), via an unspecified route of administration, administered in Arm Right on 29Mar2021 08:00 (at age of 65 years old) as single dose for COVID-19 immunisation. Medical history included She has had idiopathic anaphylaxis in the past Started around 2015. No Prior Vaccinations (within 4 weeks), She is immune suppressed. Concomitant drug included: a monochromial injection that wipes out all of her eosinophils. She takes it every 8 weeks. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6189, Expiration Date: 30Jun2021) on 04Mar2021 (at 64 years old) at left arm as single dose for COVID-19 immunization. Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer-BioNTech COVID-19 Vaccine. Antibody testing is not recommended to assess for immunity to SARS-CoV-2 following COVID-19 vaccination because the clinical utility of post-vaccination testing has not been established. Experts are currently evaluating how COVID-19 vaccination may affect antibody testing results. If an immune response develops the goal of vaccination is a possibility of on antibody tests. Antibody tests indicate a previous infection and there may be some level of protection against the virus. Caller states she received the second dose of the vaccine, had an anaphylactic reaction, and was treated with steroids, and Benadryl. She is calling about the Pfizer COVID 19 vaccine. After the second dose of the COVID vaccine, she had an anaphylactic reaction. Her question is, since she had to get IV steroids and stuff, is the dose still effective. If she needs a booster, she doesn't think she can get it. She thinks that a report has already been done by the physicians at the facility, but she is not sure. Anaphylactic reaction: She was sent to the hospital by ambulance. On the way to the hospital she received IV Benadryl, and Epi. She cannot remember if they gave her steroids there or at the hospital. She knows she received steroids in the ambulance. Confirms she was not admitted to the hospital. Adverse Event was Anaphylactic reaction. Time of Onset: Provides time as started 30 minutes after she received the second dose of the COVID vaccine. Reporter seriousness for Anaphylactic reaction: Life threatening. AE requires a visit to Emergency Room. The outcome of the events was recovered on 29Mar2021.; Sender's Comments: Based on the available information in the case, the causal association between the events anaphylactic reaction, disease recurrence and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is 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.