Age: 78.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Headache, Insomnia
Clinical narrative: headache; hard to sleep; This is a spontaneous report from a contactable consumer (patient herself). A 78-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL9262), via an unspecified route of administration in left arm on 26Jan2021 (at the age of 78-years-old) as single dose for covid-19 immunisation. On an unspecified date, the patient started receiving lisinopril (LISINOPRIL) Dosage text: 20mg, 1 tablet, oral for blood pressure measurement, cardiac disorder and was Ongoing. No lot number was provided for Lisinopril due to Product dispensed in pharmacy vial. The patient was taken Covid vaccine due to her age and heart issues. Relevant medical history and concurrent conditions included pacemaker inserted on Oct2011 and ongoing, had it replaced Jan2020. No further details provided. Pertinent Details include surgical procedures and dates were Pacemaker inserted Oct2011 and Jan2020. No other AE following prior vaccinations. No family Medical history relevant to AEs. Relevant Tests were none. History of all previous immunization with the Pfizer vaccine considered as suspect was None. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. No other Prior Vaccinations were taken within 4 weeks prior to the first administration date of the suspect vaccine. No Other Products were reported. No Investigation Assessment. On an unspecified date in Jan2021, the patient experienced headache and felt hard to sleep. It was reported that patient getting a bit of a headache almost every day for almost 2 weeks. Patient reported about 2 weeks ago she got the first dose of the Pfizer Covid vaccine. She wants to know if this was expected and if it will be worse on the second dose. She had a question about the side effects. It's not serious, but she just had like a headache every day and wondered how long side effects supposing to last. Patient got the vaccine on Tuesday, 26Jan2021 and the headaches started like the next day. It was still there sometimes worse than others and at night it had bothered her more. She doesn't have them nightly and it's hard to sleep. No further details provided. Patient Mentioned she did see the cardiologist and her medication Lisinopril was increased to 20mg once daily. Does not know if that had anything to do with the headaches. Patient clarified the headaches were before she had the medication increase. Not visited Emergency Room due to events. Event headache caused Physician Office to visit. Outcome of the events was not recovered.  Follow-up (08Feb2021): This is a follow-up Spontaneous report from a contactable consumer. New information included patient details, RMH, Outcome of the events.  Description of Product Complaint: Did see the cardiologist and her medication, Lisinopril was increased to 20mg once daily. Clarifies the headaches were before she had the medication increase. Unable to provide NDC, Lot or expiry from pharmacy bottles. Product strength and count size dispensed: 20mg  Follow-up attempts are completed. No further information is expected.