Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Blood pressure measurement, Heart rate, Heart rate irregular, Peripheral coldness
Clinical narrative: 2 months after the last vaccine a FIRSTOCCURRENCE THYROGLOSSAL DUCT CYST; Within 12 hours after the first dose: Upon retiring to bed, I experienced the sudden onset of very unpleasant ice cold feet and knees, which could not be remedied with blankets. This lasted all night; same pattern appearred again about 6 weeks later, along with pulse and blood pressure irregularities; same pattern appearred again about 6 weeks later, along with pulse and blood pressure irregularities; This is a spontaneous report from a contactable physician reported about himself (patient). A 69-year-old male patient received second dose of bnt162b2 (BNT162B2; Solution for injection; Lot number: 59267-1000-01), via an unspecified route of administration, administered in left arm as dose 2, single on 13May2021 12:45 (at the age of 69-year-old) for covid-19 immunisation. Medical history included attention deficit hyperactivity disorder (ADHD), autism spectrum disorder, asperger's syndrome and known allergies: Cashews. Concomitant medications included methylphenidate hydrochloride (RITALINE), allopurinol (ELAVIL [ALLOPURINOL]) and acetylsalicylic acid (ASPIRIN) all taken for an unspecified indication, start and stop date were not reported. Historical vaccine included patient previously took first dose of bnt162b2 (BNT162B2; Solution for injection; Lot number: UNKNOWN), via an unspecified route of administration, administered in left arm as dose 1, single on 22Apr2021 12:45 for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and received other medications ritalin, elavil, aspirin and multivitamin. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Lab tests and procedures which included blood pressure measurement: same pattern appeared again about 6 weeks later, along with pulse and blood pressure irregularities and heart rate: same pattern appeared again about 6 weeks later, along with pulse and blood pressure irregularities both on unspecified date in 2021. On unspecified date in 2021, the patient experienced sudden onset of very unpleasant ice-cold feet and knees, which could not be remedied with blankets and lasted all night and reoccurred only at bedtime for days, same pattern appeared again about 6 weeks later, along with pulse and blood pressure irregularities and thyroglossal duct cyst. Within 12 hours after the first dose: Upon retiring to bed, patient experienced the sudden onset of very unpleasant ice-cold feet and knees, which could not be remedied with blankets and lasted all night and reoccurred only at bedtime for days. The same pattern appeared again about 6 weeks later, along with pulse and blood pressure irregularities. About 2 months after the last vaccine dose, a first occurrence thyroglossal duct cyst (a 'birth defect' which appears in early life, almost never in the elderly) arose on the left side between the hyoid bone and the thyroid cartilage. Adverse events resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage and Congenital anomaly or birth defect. No treatment was received for adverse events. At the time of this report, outcome of the events was not recovered, except thyroglossal duct cyst was unknown .; Sender's Comments: Based on current information available, the event cold feet, pulse irregular, blood pressure abnormal were considered related and thyroglossal duct cyst represented intercurrent condition in this patient with advanced age and with congenital anamoly. unrelated to Bnt162b2. More information is needed to better assess the case.  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 RAs, Ethics Committees, and Investigators, as appropriate