Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Blood pressure increased, Chest X-ray, Dyspnoea, Fatigue
Clinical narrative: allergy; Short of breath; Tachycardia/my heartrate was like 140 - 150; Blood pressure was like 165 over 114/my blood pressure just like skyrocketed; Upset stomach; Tired; Started to feel not very good/not feeling like wonderful/overall sickness; Muscle ache; This is a spontaneous report from a contactable consumer (patient). A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL014 (can't really tell), via an unspecified route of administration on 31Dec2020 at single dose for COVID-19 immunization. Medical history included allergy and heartburn. Concomitant medication included omeprazole for heartburn, cetirizine hydrochloride (off-brand for Zyrtec) as allergy medicine and a birth control medicine. Consumer stated, she just was calling this number because she didn't necessarily know if she had an adverse reaction or a symptom. She just wanted to report it and see if maybe you had any insight if this has happened to anybody else. Consumer further stated, she had an adverse reaction where she had to go to the emergency room. So, she didn't know if it was from the Vaccine or not because her reaction was very delayed. She got her vaccine on 31Dec2020, New Year's Eve and then starting on Monday after the vaccine on 04Jan2021. She started to feel not very good, it was mostly just like overall sickness, just as muscle aches, tired, having upset stomach so that was after 4 days. Patient had allergy from an unspecified date. And then on 07Jan2021, a week after she got the vaccine, she had signs of tachycardia and her blood pressure just like skyrocketed, her blood pressure was like 165 over a 114 and her heartrate was like 140 - 150. And she worked in healthcare, which was why she was one of the first ones to get the vaccine and she went to the ER and got worked up and they couldn't find, nothing was abnormal with her labs or blood work. She even had a chest X-ray and they couldn't find anything and they just gave her fluids and sent her home. And she was home now and still not feeling like wonderful, she felt better though but she just wanted to report that and see if there was any correlation. She didn't really know because it was so delayed, a week later. So she just wanted to report it. Consumer further stated, she forget to tell one thing, she was also short of breath on 07Jan2021. So that was why they had sent her to ER because of Tachycardia, shortness of breath and her blood pressure was really high. They didn't give her any medicine they just gave two big bags of fluid and then they discharged her. Consumer stated, she was scheduled to have her second one, she thought it was 14Jan2021. She wanted to know if she should get the second one. Consumer stated, when she went into the ER she had a lot of lab work. She didn't even know what all they did but a lot like, blood panels, she checked everything was there, that was on Thursday, last week, 07Jan2021. Consumer stated no treatment was received for the events. Outcome of the events was unknown.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. 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.