Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Weight
Clinical narrative: Throat swelling; severe allergic reaction to the Pfizer vaccine; chills; sweats; nausea; This is a spontaneous report from two contactable physicians. A 46-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9267), via an unspecified route of administration on 13Feb2021 at a single dose in left arm for COVID-19 immunization. Medical history included herpes Simplex I, back pain, SI joint dysfunction, difficulty sleeping and allergy to raw tomatoes. The patient's concomitant medications were not reported. On 13Feb2021, the patient experienced throat swelling, severe allergic reaction to the Pfizer vaccine, chills, sweats, nausea, the seriousness of throat swelling, severe allergic reaction was reported as hospitalization, seriousness of the other events was reported as medically significant.  Under anaphylaxis that the patient has EpiPen at home for raw tomatoes Clinical course: she had a severe reaction to the first shot presenting the following side effects: chills, sweats  and nausea within 5 minutes and then developed throat swelling within 10 minutes, the patient was administered with an EpiPen, Benadryl and was sent to the ER where she received Benadryl IV monitored, eventually her symptoms diminished from 10 of 10 to a 6 in a scale of 10, the patient also received Prednisone 40 mg everyday for 4 days. She did have nausea and sweats. It was six out of ten in the ER. Then it went to four or five out of ten. It took four to five days to get back to normal. By five days after the vaccination she was back to normal. She had a virtual visit with a patient who apparently had a severe reaction after the first vaccine. It was set up in physical therapy office.  HCP wants to know if it is safe for the patient to receive the second dose of the vaccine. HCP mentioned that this is her first patient who has a severe allergic reaction to the Pfizer vaccine. She was feeling better. She was told to call her doctor about getting the second shot. The bottom line is if they acted as severely as they did she would think the answer would be not to get the second. She was better. She felt fine. She has an allergy to raw tomatoes. She knows she is not supposed to have raw tomatoes. A couple of days ago she had a dressing that must have had raw tomatoes in it because she had throat swelling. The patient said what happened with Pfizer was more. She knew it when it was happening because it has happened before. She had no hypoxia. The patient reported that her pulse ox was checked and was in the high 90's. The patient was able to swallow. No drooling. She did have nausea and sweats. It was six out of ten in the ER. Then it went to four or five out of ten. It took four to five days to get back to normal. By five days after the vaccination she was back to normal. On 23Nov2020, the patient weighed 150 pounds and her height was 66 inches. The outcome of events was recovering.  There is a causality, because it happened with 5 to 10 minutes after receiving the vaccination. She had to wait for 15 minutes. The patient had chills, sweats, and nausea within 5 minutes. She felt fine upon immediately receiving and then within 5 minutes she had chills, sweat, nausea, headache. Then within 5 to 10 minutes throat swelling.  There is a causality, because it happened with 5 to 10 minutes after receiving the vaccination. She had to wait for 15 minutes. The patient had chills, sweats, and nausea within 5 minutes. She felt fine upon immediately receiving and then within 5 minutes she had chills, sweat, nausea, headache. Then within 5 to 10 minutes throat swelling.; Sender's Comments: Based on known safety profile and temporal association, the contribution of the suspect drug to the onset of events cannot be 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.