Adverse Event Reporting
|Number of vaccinations|
- Blood pressure increased
Test Date: 202012; Test Name: blood pressure; Result Unstructured Data: Test Result:It was 160's over 105; Test Date: 202012; Test Name: blood pressure; Result Unstructured Data: Test Result:not come down/ still really high; Test Date: 20201218; Test Name: blood pressure; Result Unstructured Data: Test Result:Her blood pressure was high; Test Date: 20201219; Test Name: blood pressure; Result Unstructured Data: Test Result:138/90; Test Date: 20201220; Test Name: blood pressure; Result Unstructured Data: Test Result:156/100; Test Date: 20201220; Test Name: blood pressure; Result Unstructured Data: Test Result:her blood pressure was up; Test Date: 20201220; Test Name: blood pressure; Result Unstructured Data: Test Result:had been high all day; Test Date: 20201218; Test Name: Body temperature; Result Unstructured Data: Test Result:low grade fever; Comments: night; Test Date: 202012; Test Name: heart rate; Result Unstructured Data: Test Result:in the low 100's, around 105; Test Date: 20201218; Test Name: heart rate; Result Unstructured Data: Test Result:in the 100's
low grade fever; Her blood pressure was high/ still really high/ blood pressure was up; headache; Fifteen to twenty minutes after she received the vaccine she became light headed and dizzy/ light headedness and dizziness; This is a spontaneous report from a contactable nurse (patient).
A 36-year-old female patient received BNT162B2 (Lot#: EK5730) via an unspecified route of administration on 17Dec2020 afternoon at single dose in the left arm for COVID-19 immunization.
Caller was unable to confirm the manufacturer of the vaccine that she received.
It is not written on the card, and she didn't see the vial.
The patient medical history was not reported.
Concomitant medications included oral contraception pill, but the name was unknown.
Fifteen to twenty minutes after she received the vaccine on 17Dec2020 she became light headed and dizzy.
She had to catch her breath.
She couldn't shake it off.
The light headedness and dizziness lasted at that intensity for 10 minutes, but it never went away.
They encouraged her to be admitted in the emergency room (ER).
She would say that the seriousness of being light headed and dizzy was disabling.
Caller didn't remember the exact numbers for her blood pressure.
It was 160's over 105.
Her heart rate was in the low 100's, around 105.
She stayed at the first monitoring station in the vaccine area for 2 hours.
They were taking her blood pressure every five minutes.
She was given diphenhydramine hydrochloride (BENADRYL) there and lots of water.
After 3 hours and she was not improving they called a "code medic" that got the medical director and nursing supervisor to come.
They encouraged her to go to the ER for continual monitoring.
She stayed in the ER for4 hours and was given meds to help with the blood pressure.
She was discharged from the ER home.
She was nervous because of all this stemming from the vaccine.
She had a low grade fever on 18Dec2020 (Friday) night.
Caller stated her work had already reported her reaction.
Occupational safety and the medical director are aware.
Caller does not have reference number to provide.
On 18Dec2020 (Friday) she was not overly concerned because it was the next day.
Her blood pressure was high and her heart rate was in the 100's.
They monitored her for a couple of hours and she was given a diphenhydramine hydrochloride (BENADRYL).
She went to the emergency room (ER) for a few more hours and received additional treatment.
They sent her home to be monitored at home.
She has been taking her blood pressure every day since and it had not come down.
It was still really high.
She called her primary care doctor.
He was wanting her to start blood pressure for medication it.
She was concerned about starting it with the assumption that it was related to the vaccine.
She would like to know the right thing to do.
It seems safe to take the medicine, but it was unknown that whether it was going to mask the blood pressure and something else be going on.
On 18Dec2020 she still had a headache and didn't feel well, but she thought she needed to give it some time.
She had been anticipating not to feel well on 18Dec2020 (Friday).
On 19Dec2020 she felt better considering she didn't have a headache.
On 19Dec2020 (Saturday) her blood pressure was 138/90 and she felt good.
Then on 20Dec2020 she had the bad headache and her blood pressure was up.
On 20Dec2020 (Sunday) she had a bad headache and her blood pressure was 156/100.
She came to work today and her blood pressure had been high all day.
She still had a headache and the light headedness continued.
The outcome of the event low grade fever was unknown, of other remain events was not recovered.
; Sender's Comments: A causal association between BNT162B2 and the event dizziness cannot be excluded based on a compatible temporal relation.
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.