Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Feeling cold, Nausea, Throat irritation, Tongue oedema
Clinical narrative: big rash over her body; Peripheral neuropathy returned; Severe Fatigue; Blood vessels burst in left third fingers; anaphylaxis reaction; This is a spontaneous report from a contactable nurse (patient). This 41-year-old female patient received the first dose of bnt162b2 (COMIRNATY), via intramuscular in the deltoid left on 22Dec2020 at 08:00 (at the age of 41-year-old; lot number: EK5730) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included she had breast cancer less than 2 years prior. Family medical history relevant to events and relevant tests were none. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) were none. Additional vaccines administered on same date of the Pfizer suspect were none. Prior vaccinations (within 4 weeks) were none. There were no concomitant medications. The patient previously received pertussis vaccine when she was an infant for immunization. The patient experienced anaphylactic reaction (life threatening) on 22Dec2020 at 08:20, blood vessels burst in left third fingers (medically significant) on 23Dec2020, peripheral neuropathy returned (medically significant) on 24Dec2020, severe fatigue (medically significant) on 24Dec2020. The patient stated she was one of the first ones to have an anaphylaxis reaction after receiving the first dose of the Pfizer COVID vaccine. She was trying to find the clinical trial information about someone receiving the first dose of the Pfizer COVID vaccine only. Patient had an RN calling on behalf of self. She had an anaphylactic reaction after 1st dose of Pfizer BioNtech COVID 19 vaccine. She was calling to see about efficacy of first dose and did not want to get second dose. She just wished someone could tell her about the efficacy of just one dose instead of recommending she get two, without knowing what reaction she will have with the second dose. She is 42 years now, but was 41 years at the time it occurred, not 24 years old. She was sure it is documented and reported through VAERS. In Dec2020, she was reaching out to VAERS and no one ever called her back. As a result, she went to the ER and required Epinephrine. She had breast cancer less than 2 years prior. She developed big rash over her body and developed peripheral neuropathy after it had resolved after chemotherapy. The chemo that caused it was Taxotere and Cytoxan. Spontaneously on 24Dec2020, she had peripheral neuropathy back in hands and feet. She had some blood vessels blow in fingertips. She later stated it was just the left third finger. Illness/event reported as severe anaphylaxis. Clam chowder, tuna fish, nuts that walnuts or pecans, kiwi, delayed allergic reaction 5-7 days post last dose of chemotherapy. It was not anaphylactic, but full body rash and she needed to go back on steroids for (unspecified). All other treated with Epi and steroids for (unspecified). Events required a visit to emergency room that she was given Epinephrine IM, Solumedrol, Benadryl, Albuterol Inhaler and Prednisone taper. She developed a big rash and developed peripheral neuropathy a few days after getting it. She followed up with her primary care. Events also required a visit to physician office. Primary care office and she saw someone else. No medical treatment was offered. Everyone told her it was experimental and no one could answer any questions. Someone was supposed to call her back from VAERS and they never did. She was just repeatedly told it was experimental and no one had information. Treatment received for events. Outcome of the event anaphylactic reaction was resolved with sequel on unspecified date, outcome of the event big rash over her body was unknown, while of the other events was recovering.; Sender's Comments: Based on available information and the close drug event temporal association, a possible contributory role of suspect product BNT162B2 to the development of events anaphylactic reaction, vascular rupture, neuropathy peripheral, fatigue and rash cannot be totally excluded.  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.