Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Tension headache
Clinical narrative: Passed out; Pressure in her head; Major headache; Fatigue/ tiredness; Stress/fatigue headache; This is a spontaneous report from a contactable consumer (patient herself) via a medical information team. A 59-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8730, NDC number: Unknown, Expiration date: Unknown), via an unspecified route of administration in left arm on 12Apr2021 at 09:30 (at the age of 59-year-old) as a single dose for COVID-19 immunisation and asthmatic. The patient's medical history included rheumatoid arthritis (diagnosed three months ago), sleep disorder, blood pressure, blood pressure increased, PTSD (post-traumatic stress disorder). Patient's medical history (including any illness at time of vaccination) was none. Concomitant medications included trazodone (Strength: 25 mg) orally taking for years at 25 mg, once a day for sleep disorder, losartan (Strength: 25 mg) orally taking for 4 years at 25 mg, once a day for blood pressure, acetylsalicylic acid (ASPIRIN) orally taking for 4 years 81 mg, once a day for blood pressure increased, hydroxychloroquine (Strength: 200mg) orally taking for two months at 200 mg, once a day for rheumatoid arthritis, leflunomide (Strength: 10 mg) orally taking for two months at 10 mg, once a day, sertraline orally taking for 4 years at 50 mg, once a day for PTSD (post-traumatic stress disorder); All ongoing. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6206, NDC number: Unknown, Expiration date: Unknown), on 22Mar2021 at 15:30 as a single dose in left arm for COVID-19 Immunization and asthmatic. Family history was none. Prior vaccinations (within 4 weeks) was none. No additional vaccines administered on same date of the Pfizer suspect. On 14Apr2021 she reports developing a headache that has been ongoing since then, 14-16 days total. She also reports fatigue. She has been seen by doctors and had CT scans and bloodwork, the doctors think it was a stress/fatigue headache. Caller indicated she didn't think the symptoms were vaccine related but wants to rule everything out. Enquired what information do we have for duration of headache after vaccination. Caller indicated she had already spoken to a nurse with safety. Caller was a 59-year-old female reporting a headache that started 2 days after her second dose of the Pfizer COVID-19 vaccine, with symptoms that have been ongoing for 14-16 days. Response: Provided information from fact sheet that 55.1% of patients reported headache in the clinical trials, and that data was coming from the 7 days after either dose. Enquired how long side effects last. Which states adverse events typically start 1-2 days after vaccination and resolve shortly thereafter; Also spoke from CDC data which indicates adverse events might be more intense after the second dose. Referred back to healthcare professional for additional assessment and treatment. Consumer calling regarding the Pfizer COVID-19 vaccine. Reports she got the second shot 12Apr2021 and a couple of days later she got pressure in her head that has turned into a major headache. States and it has been a major headache. Reports she has been to the emergency room and her primary care doctor. Adds she had a CT scan, and bloodwork till she looks like a pin cushion, and everything was coming back fine. Adds she was tired all the time and could not get rid of the headache. Her question; Mentions she was looking at the side effects and saw tiredness and headaches a couple of days after; but enquired have we had any complaints about them lasting so long. Clarified she received the second dose of the Pfizer COVID-19 vaccine on 12Apr2021 at 09:30 AM in the left arm. A couple of day later the headache started; and the tiredness started at the same time. Tiredness was reported as worsened. She got the shot at PRIVACY. Adds she has missed two weeks of work and she could sleep 24 hours a day if the headache would let her. Adds she was 60 years old and takes a lot of medication; she tries not. Primary/prescriber: States the rank was major; she thinks her doctor was on maternity leave; Product: Pfizer COVID-19 vaccine; treatment first dose of the vaccine 22Mar2021 at 15:30 PM in the left arm. Lot EN6206; provides lot number for both doses from vaccination card but does not see NDC, expiration date or dose. This past Sunday the headache got so bad that she passed out in her living room and her 72-year-old husband called 911. She was taken to the (PRIVACY) Hospital and they did the CT scan and the blood work that was normal. She went home and tried to go to work on Monday and that only lasted 3 hours. No investigation assessment. No relevant test. The adverse events require a visit to emergency room but not admitted to the hospital and visit to physician office as she saw a doctor at the base on Monday, she had doctor's excuse to be off on Monday and Tuesday, so she called and got a walk-in appointment for Thursday. They did more blood work, and it came out great. The patient underwent lab test and procedure which included blood work: Normal, CT scan: Normal on an unspecified date. The outcome of the event passed out was recovered on an unspecified date in 2021, unknown for the event pressure in her head and not recovered for the other events.   No follow-up attempts are needed. No further information is expected. Lot number obtained.