Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death, Foaming at mouth
Clinical narrative: unspecified event: Death; This is a spontaneous report from a contactable pharmacist through VAERS system. A 81-year-old male patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number: EN6200, Expiration date: 31Jun2021) via unspecified route on 19Mar2021 between 10:30 to 11:30 Am, in the right arm, deltoid at a single dose for COVID-19 immunization. The patient' 's relevant medical history included Chronic Obstructive Pulmonary Disease acute exacerbation (end date: 20Mar2021), Anemia, unspecified (from 18Mar2021 to 20Mar2021), Acquired Coagulation Factor Deficiency, Thrombocytopenia, unspecified, Hypothyroidism, unspecified, Hyperlipidemia, Sleep apnea, unspecified, Polyneuropathy, unspecified, Hemiplegia with hemiparesis, Esophagitis unspecified without bleeding, Gastroesophageal reflux disease without esophagitis, Unspecified Cirrhosis of the liver, Non-alcoholic steato hepatitis, Other Ascites, Dependence on Supplemental Oxygen all from 18Mar2021 to 20Mar2021, History of Falling on 30Nov2017 to 20Mar2021, Acute and Chronic Respiratory Failure with hypoxia from 18Mar2021 to Unspecified. Concomitant medications, Apixaban (5mg, one tab by mouth two times a day) from 18Mar2021 to 20Mar20201 for DVT prevention, Carvedilol (3.125 mg, one tab by mouth once a day) for hypertension from 19Mar2021 to 20Mar2021, Ezetimibe (10mg tablets one tab by mouth once a day) for hyperlipidemia from 19Mar2021 to 20Mar2021, ferrous Sulfate (325 mg tab, one tab by mouth one time a day for supplement) from 19Mar2021 to 20Mar2021, folic Acid (1mg tablet, one my by mouth one time a day for supplement) from 19Mar2021 to 20Mar2021, Gabapentin (300 mg , capsule one cap by mouth three times a day) for neuropathy from 19Mar2021 to 20Mar2021, levothyroxine (25 mcq, one tab by mouth once a day) for hypothyroidism from 19Mar2021 to 20Mar2021, oxycodone (5 mg tablet; one tab by mouth every four hours as needed) for pain from 19Mar2021 to 20Mar2021 and Ergocalciferol on unspecified dates (order date of 18Mar2021 and to be started on 24Mar2021, so it was probably never started) as supplement. The patient had not taken any previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent and no additional vaccines were administered within 2 weeks. Prior to vaccinations (within 4 weeks) the patient had not taken any vaccinations given for two weeks before. On 20Mar2021 the patient died due to unspecified reason. It was unknown if autopsy was done. It was reported that the patient did not have a severe reaction with anaphylaxis treated with an EpiPen or hospitalization and anaphylaxis not related to a drug. Investigation assessment was unknown. The patient was discharged on 20Mar2021. It was further stated by reporter that she has no idea if any of this is related to the Covid vaccine or not, however her Medical Director wanted her to call and report the event. Reporter's causality was not known.; Sender's Comments: The event of death is assessed as possibly related to the suspect drug BNT162B2 based on strong temporal association, but possible contributory effects from patient's multiple medical history of acute and chronic respiratory failure, chronic obstructive pulmonary disease, hepatic cirrhosis and ascites cannot be completely ruled out.  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.; Reported Cause(s) of Death: unspecified event: Death