Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Pain, SARS-CoV-2 test negative
Clinical narrative: Headache; Body aches; This is a spontaneous report from a contactable nurse (patient).  A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EH9899), intramuscular (hope it was IM, but did not know for sure because she was not watching) at right arm deltoid on 29Dec2020 08:40 at single dose for COVID-19 immunization, at the hospital where she works.  The vaccine was not administered at military facility. The patient's second dose was scheduled to be 19Jan2021. The patient's medical history included potassium low, hypertension, pericarditis, asthma, herniated disc in back, pain, gastrointestinal infection (GI), Vitamin D low, wheezing, exposed to someone who was positive with COVID at a wedding on 28Dec2020, "diuretic", "cardiac/heart" and "Cholesterol". Concomitant medication included ranolazine (RANEXA) for heart, isosorbide for cardiac, potassium chloride for potassium Low, furosemide for diuretic, atorvastatin (LIPITOR) for cholesterol, acetylsalicylic acid (ASPIRIN) for cardiac, montelukast sodium (SINGULAIR) for asthma, pregabalin (LYRICA) for herniated disc in back take for pain, nebivolol hydrochloride (BYSTOLIC) for blood pressure, pantoprazole sodium sesquihydrate (PROTONIX) for GI, celecoxib (CELEBREX) for pain, spironolactone for diuretic, vitamin D for Vitamin D low, nitroglycerin for angina, salbutamol (ALBUTEROL) for wheezing, and oxycodone for pain; all ongoing. History of all previous immunizations with the Pfizer vaccine considered as suspect was reported as none. No additional vaccines administered on same date of the Pfizer Suspect. No prior vaccinations within 4 weeks. The patient reported events on the Pfizer COVID Vaccine. She reported after getting the vaccine she had body ache and headaches. On 30Dec2020 16:00, the patient experienced headache and body aches. The event headache was reported as serious medically significant. She received the COVID vaccine on 29Dec2020 and had significant body aches, but she still had a headache that had not gone away since she got the vaccine. The patient explained the body aches were mild to non-existent/resolved, later confirmed as still ongoing, but better. Her main issue was the headaches that had not gone away. The events headache and body aches started around 16:00. She worked nightshift and she woke up with it. The events did not require a visit to the emergency room or physician office. The day after she received the COVID Vaccine she was tested for COVID. She found out she was exposed the day before she received the COVID vaccine, 28Dec2020 to someone who was positive with COVID at a wedding. She later found out her COVID test on 30Dec2020 was negative. The reporter assessed both events headache and body aches as related to the suspect vaccine. She believed the body ache and headache were related to the COVID Vaccine itself. She added, she felt it's related because these events are not part of her typical health problems. She added they're not going away even with medications (oxycodone, Celebrex, and ibuprofen). Oxycodone was located in an orange pharmacy filled bottle and she was unable to provide a lot/exp/NDC. Celebrex was located in an orange pharmacy filled bottle and unable to provide a lot/exp/NDC. She saw a use by date of 10Mar2021. Ibuprofen (Lot number: OCE2824A and expiration date: Dec2021).  The outcome of the event headache was not recovered, for the event body aches was recovering.; Sender's Comments: There is a reasonable possibility that the event headache was related to BNT162b2 based on known drug safety profile and close temporal relationship.  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.