Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Migraine
Clinical narrative: This is a spontaneous report from a contactable nurse. A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration on 02Mar2021 (batch/lot number was not reported) as a single dose for COVID-19 immunization. Medical history included migraine (diagnosed about 30 years ago), low hypotension, allergic to strawberries, gastrooesophageal reflux disease (GERD). Concomitant medications included omeprazole taken for gastrooesophageal reflux disease, sumatriptan taken for migraine and naproxen taken for migraine; start and stop dates were not reported. Historical vaccine included BNT162B2 first dose on 09Feb2021 for COVID-19 immunization. The patient experienced four days after his second shot (06Mar2021), his migraines got more pronounced than normal which they expected, but then the migraines got so severe that it had occurred every single day. The reporter seriousness for migraine was medically significant. Migraine was reported as worsened. The caller stated that she was a registered nurse as well, she was calling about the Pfizer Covid vaccine. She spoke with the CDC on Saturday. Her fiance, he has a history of getting migraines for like the past 33 years. After the first dose on 09Feb2021, he then had the second on 02Mar2021. 4 days after the second dose, he got a migraine headache that was more severe than his usual and then it went away, then the next day after, he got another migraine headache, and he has been getting them everyday since then. He gets the headache once a day, for like a 12 hour duration then 8. Made attempt to clarify with the caller, she stated that for the 30 something years his migraines would occur once a week or twice a month, but now after the second dose it was daily. Currently the span of the migraine headache was shorter, it has gone from 12 hours to 8 hours. He was on sumatriptan and naproxen for his migraines, but now it takes the medication 1.5 hours to make the headache go away. They did a CAT scan and the result was normal. Both the first and second dose took place in the morning at 10AM or 10:30AM. After the second vaccine on 02Mar2021, his first migraine was on Saturday 06Mar2021. After stating his age, she stated that he's not old like the typical 73 year old. He sees a doctor at the VA for primary care and also has another primary care doctor outside of the VA. He has seen both for the migraines, caller stated that she would like to skip this section as her fiance was not there right now and doesn't know if he wanted to provide that. Migraine, it's usually on the right side of the head, in the temple, eye, cheek bone area, as well as a little bit around the hairline area. It was now every 8 hours a day, that he experiences the migraine for and it's getting worse and worse. Seriousness criteria: his medication before would take half hour, but now it's taking hour to hour and a half. His migraines were so severe that she recalls one time being in the car with him, and he actually has to hold the left side of his face, and put his head down. His primary doctor gave a shot called Aimovig and she guesses it takes a while to start working, it can take a couple weeks, it was suppose to be a preventative medication but it hasn't done anything yet, it hasn't kicked in yet. An as ER nurse for 30 years, she can tell his level of pain was more than 10 on a pain scale. Lot number was unknown, the vaccine card was physically with her fiance, she does not have it at this moment. When queried anatomical location of vaccine, sounding unsure she stated that he got one on the right arm and one on the left arm. Caller stated that she will try calling him on the other phone and see if he can answer, he carries the vaccine card with him. Causality was related, because this started 4 days after the second shot and has not stopped. It's not like a typical migraine. He takes a medication on and off for GERD called omeprazole. He was diagnosed with low hypotension, they put him on metoprolol but the doctor said that he might as well not take it since his blood pressure goes low. The CAT scan was normal and was done 2 weeks ago at the end Mar2021. He gets blood work every 6 month, the last one was a couple months ago and it was fine. Lot and expiry for sumatriptan, naproxen, and Aimovig were unknown, they were not physically with her at the moment. Facility of vaccine administration: it's not a military facility, it's a grocery store with pharmacy inside. He has not had to go to the ER. He did have a physician appointment however, he did not specifically see the doctors for the migraine, it was an appointment that was already annually schedule as he see's the doctor every 6 months. At the doctor's appoint he did tell (name) how bad the migraines were. He was really highly ranked in the military so his pain tolerance was pretty high, to see him double over with headache was unbelievable. He has had no other vaccines on the same day or in the 4 week period prior getting the Covid vaccine. He has had no issues with vaccines in the past. Treatment was Aimovig injection, it's a once a month injection, but she understood that it can take up to weeks for it to actually work. As an ER nurse, she has seen people with a headache and say their pain level was 10 but you know it's not, but in her fiance's case it was definitely 10+, they were also closer together in frequency and it worries her. At the end of the call, she asked that his doctor at VA mentioned the vaccines works with the immune system and can cause inflammation, caller asked if this was true. The outcome of the event was not recovered.    Information about lot/batch number has been requested.; Sender's Comments: Considering the plausible drug-event temporal association, a contributory role of the suspect product bnt162b2 to the reported migraine cannot be excluded. Case will be reassessed upon receipt of additional information. 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.