Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Erythema, Feeling abnormal, Head discomfort, Headache
Clinical narrative: Headache; head felt like it was going to explode/head seemed full; blood pressure was higher; feel like I am racing and I can't relax, like I drank a bunch of caffeine drinks; a red area the size of the band aid/impression of the bandaid was all reddish; still black and blue from vaccine shot/arm was still bruised; This is a spontaneous report from a contactable Consumer or other non health professional (patient). A 69-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was EL3247 and expiration date were not reported), via an unspecified route of administration, administered in arm left on 28Jan2021 at 09:25 as 1st dose, single for COVID-19 immunisation. The patient medical history included prostate cancer from 02Dec2020 to an unknown date, diabetes from an unknown date and unknown if ongoing , blood pressure from an unknown date and unknown if ongoing (blood pressure was higher), blood thinner (anticoagulant therapy) from an unknown date and unknown if ongoing , neuropathy from an unknown date and unknown if ongoing, cholesterol from an unknown date and unknown if ongoing, allergy: trees grass and pollen mold, from an unknown date and unknown if ongoing. Family history included stroke from an unknown date and unknown if ongoing (dad had a stroke 20 years ago). Concomitant medications included insulin aspart (FIASP) at an unknown dose, daily (sliding scale dose; take with meals by injection daily) for diabetes (taking 8 years) from an unspecified start date and ongoing; insulin glargine (LANTUS, injection) at 14 mL once daily by injection for diabetes (taking 8 years) from an unspecified start date and ongoing; hydrochlorothiazide, losartan potassium (LOSARTAN HCTZ) at 100mg/12.5mg once daily by mouth (orally) for blood pressure (taking for 8 years; added the HCTZ 3 years ago; no product to provide information for the old product, added the HCTZ to his Losartan product about three years ago. He has none of his old Losartan product to provide NDC, lot or expiration date) from an unspecified start date and ongoing; pentoxifylline at 400mg three times daily by mouth (orally) as blood thinner (taking 4 or 5 years) from an unspecified start date and ongoing; gabapentin at 400mg three times daily by mouth for neuropathy (taking for 5 years) from an unspecified start date and ongoing; atorvastatin at 10mg once daily by mouth for cholesterol (taking for 5 years) from an unspecified start date and ongoing; Align Daily Probiotic Supplement at an unknown dose once daily by mouth for an unspecified indication from an unspecified start date and ongoing; calcium at 500mg twice daily by mouth for an unspecified indication from an unspecified start date and ongoing; aspirin (acetylsalicylic acid) at 81mg once daily by mouth for an unspecified indication from an unspecified start date and ongoing; fish oil at an unknown dose for an unspecified indication from an unspecified start date and ongoing; vitamin D3 at an unknown dose for an unspecified indication from an unspecified start date and ongoing, multivitamins at an unknown dose once daily by mouth for an unspecified indication from an unspecified start date and ongoing, and products allergy shots at an unknown dose by injection monthly for allergy: trees grass, pollen mold from 1994 and ongoing. On an unspecified date in Jan2021, the patient experienced headache, head felt like it was going to explode, blood pressure was higher, feel like I am racing and I can not relax, like I drank a bunch of caffeine drinks, a red area the size of the band aid/impression of the bandaid was all reddish, and still black and blue from vaccine shot/arm was still bruised. The clinical course of the event was reported as follow: the patient received 1st dose of the COVID vaccine last Thursday, 8 days ago (as reported), he got headaches, and he inquired how long do they last. Headache started a couple days after, his head felt like it was going to explode, his blood pressure was higher, base line was 120/70 - 130/75, it went to 150/. The doctor turned off the light and it went to 130/. He had not had it that high in a long time, his dad had a stroke 20 years ago and inquired if all of this related to the vaccine. He felt like he was racing and he could not relax, like he drank a bunch of caffeine drinks. This started just after getting the vaccine, could be a coincidence, but could be something else. He got an allergy shot today at 10:00 am eastern time, in the arm where they did the vaccine. It was still black and blue from vaccine shot, the band aid the person put over it, he asked if he was allergic to latex. He reported that where the band aid was, it was a red area the size of the band aid. He questioned that there was latex in his vaccine or was this due to the band aid, making a red mark after he had taken off the band aid for 7 days. Going to healthcare professional on Monday (as reported), he talked with his medical assistant and set up an appointment. He also inquired if increased blood pressure was side effect and how long did it last. The patient mentioned he asked his son who was a pharmacist and he did not know the answer to his question about his headache. Patient stated his head seemed full and now after a week he still had a headache. He added it felt like his head was going to explode. It was still there but better now but it came and went. His blood pressure was up too. Usually, it was only 130 at the top but now it was 130 to 150 on the top. Added he felt like he was racing all the time and could not relax. He was unsure how long after the vaccine he noticed these effects but stated it had been going on for several days. He was scheduled to get the second dose 18Feb2021. Patient went to get his allergy shot today (as reported) and when the nurse went to do the shot, his arm was still bruised and where they put the bandaid over there was an impression of the bandaid was all reddish. No events required a visit to physician or ER (emergency room). No prior vaccinations (within 4 weeks) were reported. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none.The outcome of the event headache was recovering, outcome of the event head felt like it was going to explode was unknown, and outcome of the other events was not recovered.  Follow-up attempts are completed. No further information is expected.