Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Throat tightness
Clinical narrative: The patient had an ongoing medical history of Crohn's disease/Concomitant medication included vedolizumab (ENTYVIO) for Crohn's disease; shortness of breath; difficulty swallowing; fever; headache; nausea; she was feeling as if her throat was closing; Chest tightness; This is a spontaneous report from a contactable physician reporting for a patient.  A 34-year-old female patient received the first dose of BNT162B2 (COIVD-19 Vaccine) , via an unspecified route of administration on 03Jan2021 at single dose for covid-19 immunisation.  Medical history included Crohn's disease from an unknown date and unknown if ongoing, COVID-19 in 2020 to an unknown date and unknown if ongoing.  Concomitant medication included vedolizumab (ENTYVIO) for Crohn's disease.  The reporter is a physician who is reporting and AE for a patient who received the vaccine and subsequently developed symptoms including short of breath, fever, headache, nausea, difficulty swallowing with seriousness criteria of Medically significant on 03Jan2021. The patient self-medicated with benadryl and symptoms resolved briefly but then went to urgent care with re-occurring symptoms and was prescribed prednisone. Caller states the patient's symptoms have resolved. She is calling to get more information to determine if the patient should receive the second dose. The reporter further stated that she has a patient who received her first shot, clarified as the COVID-19 Vaccine. About an hour and 45 minutes later, the patient had shortness of breath and then later had a fever, headache and nausea. It was later that night when the patient had a fever. The patient had difficulty swallowing which worsen; she was feeling as if her throat was closing. The patient is a nurse, so she self medicated with Benadryl. After taking the Benadryl, the patient was better in the early morning. When the doctor's office opened, the patient called and was having similar symptoms, clarified as all the symptoms mentioned above. The patient went to the urgent care where she received more Benadryl and was started on prednisone. Caller did not know the dose of prednisone the patient had received. After that, the patient started feeling better. The patient's second dose of the COVID19 Vaccine is due around 24 to 26Jan2021. The patient has not called the doctor/caller back. The caller assumes that the patient has recovered but could not be certain. Caller added that the patient also experienced chest tightness when she was having shortness of breath. The patient's fever was 101 on 03Jan2021. The patient was not drooling with her difficulty swallowing. Caller stated that the patient had a positive COVID test earlier, she thinks it was maybe 3 to 4 months ago (in 2020). The patient has not received another COVID test since she received the first dose of the COVID-19 vaccine to the caller's knowledge. Reporting physician is an internal medicine physician. Therapeutic measures were taken as a result of the events. The outcome of the events was unknown.   Information on the Batch/Lot number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported short of breath, fever, headache, nausea, difficulty swallowing, throat closing, chest tightness, and the administration of COVID 19 vaccine, BNT162B2, based on the plausible temporal association.   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 RA, IEC, as appropriate.