Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypertension, Loss of consciousness, Nervousness, Rash
Clinical narrative: rash; dizziness and weakness almost like a flash of seeing white for a brief second and she thought she was going to pass out; dizziness and weakness almost like a flash of seeing white for a brief second and she thought she was going to pass out; dizziness and weakness almost like a flash of seeing white for a brief second and she thought she was going to pass out; bouts of chest pain; getting anxious because she had a severe reaction to the vaccine; she is nervous; blood pressure started going up every time she has the chest pain; This is a spontaneous report from a contactable physician (patient herself).   This 34-year-old female patient received the first dose of BNT162B2 (COMIRNATY, solution for injection, Lot number EN5318 and Expiration date 29Jan2021), via an unknown route administered in the left arm, on 29Jan2021 (at the age of 34-year-old) at 0.3 ml single for COVID-19 immunization. Relevant medical history included thyroid cancer and thyroidectomy. Relevant concomitant medications included levothyroxine. On 29Jan2021, after receiving the vaccine, she had dizziness and weakness, almost like a flash of seeing white for a brief second and she thought she was going to pass out (medically significant). She notified the medical personnel, and they had her sit for a longer period of time. Shortly after that, 2 days later, on 31Jan2021 the patient had a rash (non-serious) that she noticed. The patient had also had bouts of chest pain (serious for disability) and has been to the emergency room a few times. She was getting anxious because she had a severe reaction to the vaccine. The patient wanted to know if these severe allergic reactions are common enough to get the vaccine. The patient was getting a cardiac work up because of the frequency of her chest pains. Her troponin was checked when she went to the emergency room and it was fine. The patient was never admitted as a patient to the hospital. The patient was anxious for the second dose. The patient needs the vaccine for her work, but she is nervous and doesn't know how serious she should take this, especially the dizziness. The patient has never had this reaction to other vaccines.  Patient's rash happened 2 days after the vaccine, but she is better. The bouts of chest pain were a couple of times after and it was 2-3 weeks after the patient received the vaccine. Patient's blood pressure started going up every time she has the chest pain, she doesn't know if it's her body reacting. The patient has had to miss work and had to stop driving because of the chest pain. The patient knows these can be signs of severe allergies. The patient had recovered from 'dizziness almost like a flash of seeing white for a brief second and she thought she was going to pass out' on 29Jan2021; the patient had recovered from 'weakness' on unknown date in 2021; the patient was recovering from 'rash' while she had not recovered from' bouts of chest pain'. The outcome of the remaining events was unknown.; Sender's Comments: Based on the close temporal relation, the association between the events of dizziness, asthenia, loss of consciousness and chest pain and the suspect product of BNT162B2 cannot be completely ruled out. 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.