Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dizziness, Flushing, Headache, Migraine
Clinical narrative: 2 week migraine; headache; flushed/Got flushed; persistent extreme dizziness; This is a spontaneous report from a contactable nurse (patient). A 37-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Batch/lot number: EK5730, Intramuscular at single dose on 17Dec2020 19:00 on right arm for precaution as front line health care worker. Medical history included Hemiplegic migraine. Her mother also had migraines. Concomitant medication included ranitidine hydrochloride (ZANTAC) and H1 and H2 blocker. The patient called to report AE of flushed, persistent extreme dizziness, and a headache that has evolved into a 2 week migraine.  She has a history of hemiplegic migraines and was taking and h1 and h2 blocker when she received the vaccine.  She was calling on guidance whether or not to receive the second vaccine. She was scheduled for second dose on Thursday, but wanted to speak with someone before she got it to see if it was OK. About 15 minutes after receiving the first dose, she got flushed and extremely dizzy. She had a mild headache when she woke up on 18Dec2020 06:00, which then developed into a severe migraine on 22Dec2020 08:00 that she has had for 2 weeks and dizziness continues. She received it at work and there was no prescriber. She called and left a message with Pfizer but has not heard back from anyone yet about this. She would say the flushed and dizziness would be medically serious because she had allergies and had medication on board. She takes daily allergy medication and Zantac and not sure she would not have had a worse reaction if she hadn't had that on board. She took it every night. She had an H1 and H2 blocker on board. Flushed has improved but the dizziness has stayed constant. She had been treated twice for headache and now they have put her on a Prednisone taper. She got it on her right arm so she could work her arm out. On 22Dec2020, she saw a Neurologist for the Migraine. They gave her Toradol 30 mg and Zofran 4mg injection in office. They were given IM. Then, she had another office visit for urgent care on 02Jan2021, and that was for the exacerbation of the migraine. They prescribed 1 liter of fluids and then another Toradol injection, Zofran injection and Decadron injection. The dose of the Toradol was 30 mg, Decadron was 6 mg, and Zofran was 4mg. These were given IV in urgent care. The patient had no prior vaccinations within 4 weeks. The outcome of flushed/Got flushed was resolving. The outcome of other events was not resolved.; Sender's Comments: Based on the compatible temporal association, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the events flushing, dizziness, headache and migraine. 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.