Your Health. Your Family. Your Choice.
Administered by: Other Purchased by: ?
Life Threatening? No
Write-up: Respiratory difficulty; Cough; Respiratory difficulty; Lung embolism; Anaemia; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB. This is a report received from the regulatory authority. The regulatory authority report number is DK-DKMA-WBS-0032205; Safety Report Unique Identifier: DK-DKMA-ADR 24698262. An 85-year-old male patient received the second dose of the bnt162b2 (COMIRNATY; Lot Number: EJ6134 and Expiration Date: 30Apr2021), via an unspecified route of administration on 22Jan2021 at a single dose for COVID-19 immunization. Medical history included ongoing renal insufficiency (increasing renal insufficiency the past year) from an unknown date, ongoing atrial fibrillation from an unknown date, ongoing artificial cardiac pacemaker user from an unknown date, ongoing general physical health deterioration from an unknown date, alcoholic from an unknown date and unknown if ongoing (previous alcoholic), arthritis gouty from an unknown date and unknown if ongoing, vitamin B12 deficiency from an unknown date and unknown if ongoing, sleeplessness from an unknown date and unknown if ongoing, heart rate irregular from an unknown date and unknown if ongoing, difficulty sleeping from an unknown date and unknown if ongoing, mood altered from an unknown date and unknown if ongoing, pain from an unknown date and unknown if ongoing, Type 2 diabetes mellitus from an unknown date and unknown if ongoing. Concomitant medications included mirtazapine (MIRTAZAPIN ACTAVIS; 15 mg) taken for difficulty sleeping from 21Jan2021 to an unknown date, cyanocobalamin zinc tannate (BETOLVEX [CYANOCOBALAMIN ZINC TANNATE]; 1 mg) taken for Vitamin B12 deficiency from 06Jul2017 to an unknown date, metoprolol succinate (METOPROLOL SUCCINATE, "HEXAL"; 50mg) taken for Heart rate irregular from 07Jul2016 to an unknown date, paracetamol (PANODIL; 1000 mg) taken for pain from 31Jan2019 to an unknown date, allopurinol (ALLOPURINOL, "DAK"; 100 mg) taken for arthritis gouty from 24Feb2013 to an unknown date, linagliptin (TRAJENTA; 5 mg) taken for Type 2 diabetes mellitus from 20Aug2020 to an unknown date, acetylsalicylic acid (HJERTEMAGNYL [ACETYLSALICYLIC ACID]; 75 mg) taken for Anticoagulant therapy from 25Feb2013 to an unknown date, melatonin (MANUFACTURER UNKNOWN; 3 mg) taken for Sleeplessness from 03Oct2019 to an unknown date, citalopram hydrobromide (TRIMOPAN [CITALOPRAM HYDROBROMIDE]; 100 mg) taken for prophylaxis urinary tract infection from 02Nov2017 to an unknown date, cefuroxime (FURIX [CEFUROXIME]; 40 mg) taken for diuretic therapy from an unknown date to an unknown date, vitamin D [vitamin d nos] (MANUFACTURER UNKNOWN; 25 ug) taken for Vitamin supplementation from 16Nov2017 to an unknown date, potassium chloride (KALEORID; 750 mg) taken for Potassium supplementation from 21Mar2019 to an unknown date. The patient previously received the first dose of the bnt162b2 (COMIRNATY; Lot Number: EJ6797) for COVID-19 immunization on 30Dec2020. On 22Jan2021, the patient experienced cough (death, hospitalization), and respiratory difficulty (hospitalization). On 01Feb2021, the patient experienced respiratory difficulty (death, hospitalization). On an unspecified date, the patient experienced anaemia (death) and lung embolism (death, medically significant). The patient was hospitalized for respiratory difficulty and cough from 22Jan2021 to 24Jan2021. The patient was also hospitalized again for respiratory difficulty (for the 01Feb2021 onset) on unknown dates. The clinical course was reported as follows: On 22Jan2021, the same date as the second COMIRNATY vaccine was administered, the patient developed difficulty breathing and cough. The difficulty breathing was recovered on 24Jan2021 (as reported); however, the difficulty breathing restarted on 01Feb2021. The physician reported that the difficulty breathing caused hospitalisation from 22Jan2021-24Jan2021 (22-24Feb2021 as reported) and as being fatal (the patient died on 01Feb2021). The patient during the hospitalization was treated with an unknown penicillin and clarithromycin due to a suspicion of pneumonia; which was disproved by x-ray. The treatment with an unknown penicillin and clarithromycin was continued. From 28Jan2021, the patient was treated with codeine phosphate hemihydrate in an attempt to reduce his cough. the patient was treated with furosemide (FURIX) on 01Feb2021 for difficulty breathing. The patient underwent lab tests and procedures which included body temperature: no fever on 01Feb2021, X-Ray: suspicion of pneumonia which was disproved in Jan2021. Therapeutic measures were taken as a result of cough, and respiratory difficulty. The clinical outcome of the event, respiratory difficulty (for the 22Jan2021 onset), was recovered on 24Jan2021. The clinical outcome of the events: cough (outcome also reported as unknown), respiratory difficulty (for the 01Feb2021 onset), anaemia, lung embolism was fatal. The patient died on 01Feb2021 due to anaemia, lung embolism, and difficulty breathing (as reported). An autopsy was not performed. Causality: The reporting physician had reported the case because of the temporal correlation between the patient''s death and COMIRNATY. The physician had a small suspicion that it can be caused by COMIRNATY, but other factors may also have contributed. The physician mentioned lung embolism and anaemia as contributing factors to the patient''s death. If the Agency receives supplemental significant information regarding this case the case will be re-submitted. No follow-up attempts are possible. No further information is expected. ; Reported Cause(s) of Death: Anaemia; Lung embolism; Difficulty breathing
Copyright © 2021 National Vaccine Information Center. All rights reserved.
21525 Ridgetop Circle, Suite 100, Sterling, VA 20166