Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate increased, Immediate post-injection reaction, Throat tightness
Clinical narrative: believed the heart rate might be a result of being nervous; Tightness of throat/throat tightness; Laboured breathing; Fast HR/high heart rate; This is a spontaneous report from a contactable nurse, reporting for herself. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 03Jan2021 at a single dose for COVID-19 immunization. Medical history included sensitivity to pollen, sensitivity to narcotics and allergic reactions to perfume, all from unknown dates and unknown if ongoing. There were no concomitant medications. The patient previously received pneumonia vaccine and flu vaccine, both for immunization and experienced pain on the side. The patient also previously took cortisone to lower her immune system. It was reported that on 03Jan2021, the patient developed a slight reaction immediately after first dose of Pfizer Covid vaccine which included tightness of throat along with laboured breathing with fast HR/heart rate was high (she believed it was greater than 80 BPM; her heart rate is usually in the 60's) which resolved after a few minutes. The nurse was going to give her Benadryl but did not as her signs and symptoms were resolving. She was asking for recommendations/clarifications on whether she should get the second dose given her reactions. She never had that type of reaction before. She had had sensitivity to pollen and narcotics. She read that she should not receive the second dose given her reactions but was asking for clarification. She would like to get the second dose and bought an Epi pen. Throat tightness and high heart rate didn't last for more than two minutes maximum. She visited websites and was directed not to get the second dose. She wanted to be 100% certain in regards to whether or not she should receive the second dose. Stated tightness in throat wasn't really that bad. She felt throat tightness previously when smelling perfume. Stated it wasn't anything to be frightened about. She also stated some websites said it does not matter and some websites said not to get the second dose. Also wanted to know if having the Epi Pen would help. She added that she explained reaction to the physician who advised her to get an Epi Pen for the second COVID Vaccine dose. She only had allergic reactions to pollen and perfume. Got the vaccine for Pneumonia and Flu. Did not get adverse reactions, but stated she only had pain on the side. Confirmed she has no NDC/Lot/Exp for the Pneumonia vaccine and Flu vaccine. She also got Coronavirus three months prior to receiving the COVID vaccine. She clarified that she diagnosed herself and it was the weirdest thing. She took cortisone to lower her immune system. Received first dose of COVID Vaccine on 03Jan2021. She wa due for second COVID Vaccine on 26Jan2021. She stated she is a psychologist with specialty in mental health. She believed the heart rate might be a result of being nervous. When she is nervous her heart rate goes up. Tightness of throat made her concerned. When asked about the indication, she stated that her husband works and the right thing to do was to be protected. She read she should have stopped taking Ibuprofen 10 days prior to the COVID Vaccine. She was not taking Ibuprofen any longer. Has no NDC/Lot/Exp for Ibuprofen at time of call. Confirmed she did not use the Epi Pen after the first dose of COVID Vaccine. She bought it for the second dose. The nurse who administered COVID Vaccine to the patient suggested she take Benadryl. By that time, she was feeling better. She stated it was questionable for half an hour. The outcome of the event Tightness of throat/throat tightness and fast HR/high heart rate was recovered on 03Jan2021 while the outcome of all other events was unknown.  Information on the batch/lot number has been requested.; Sender's Comments: The patient had medical history included sensitivity to pollen, sensitivity to narcotics and allergic reactions to perfume.  The reported events were likely related to first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to plausible temporal relationship and clinical course.  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.