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Write-up: Respiratory failure due to acute aggravation of COPD; Respiratory failure due to acute aggravation of COPD; Oedema of the bilateral feet, back, and face; Malaise was intensified; Hot flushes facial; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution. The patient was an 82-year-old male (reported as 81-year-old, pending clarification). The most recent COVID-19 vaccine administered was received at the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination included prescribed drugs. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient had no known allergies. Other medical history included chronic obstructive pulmonary disease (COPD), prostate cancer, and left lung cancer. On 16Jun2021 at 13:30 (the day of vaccination), at age of 82-year-old, the patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA4597, Expiration date 31Aug2021) intramuscularly in the left arm for COVID-19 immunization. On 16Jun2021 (the day of vaccination), the patient experienced hot flushes facial at 13:30 and malaise was intensified at 19:00. On 17Jun2021 at 05:00 (1 day after the vaccination), the patient experienced oedema of the bilateral feet, back, and face. On 18Jun2021 at 16:26 (2 days after the vaccination), the patient experienced death. The events resulted in death. The death cause was reported as respiratory failure due to acute aggravation of COPD. Autopsy was not performed. Treatment for AEs included oxygen administration at increased doses and fluid replacement. The reporting physician assessed the event as serious (death). The causality of the events was not reported. The course of the events was as follows: On 16Jun2021 at 13:30 (the day of vaccination), the patient was vaccinated. Right after this, hot flushes facial was present (+); the body temperature (BT) was 36.6 degrees centigrade, the pulse (P) 95, the blood pressure (BP) 129/66, the SpO2 99% (oxygen (02): 3L) (first measurement after vaccination). At 19:00, malaise was intensified, and the SpO2 was 88-89% (O2: increased from 3L to 4L) (second measurement after vaccination). On 17Jun2021 at 05:00 (1 day after the vaccination), oedema of the bilateral feet, back, and face was (+). The patient could not eat because of distressing condition; the BT was 37.3 degrees centigrade, the P 109, the BP 155/67, and X-ray photography (X-P) negative (-) to pneumonia findings. Blood collection was performed, and ''WPC'' and C-reactive protein (CRP) were both normal. On 18Jun2021 at 06:00 (2 days after the vaccination), the coma scale was III-200, the BT 36.9 degrees centigrade, the P 92, the BP 139/72, and the SpO2 90% (02: 8L). On 19Jun2021 at 15:15 (3 days after the vaccination), the HR was in 30 to 50s, the SpO2 70% (O2: 10L), and the ''BT'' 68/39 (as reported). At 16:26, death was confirmed. The outcome of the events was fatal.; Sender''s Comments: The events were considered intercurrent conditions and unrelated to BNT162b2 (COMIRNATY, Solution for injection, Lot number FA4597, Expiration date 31Aug2021).; Reported Cause(s) of Death: Respiratory failure due to acute aggravation of COPD; Hot flushes facial; Malaise was intensified; Oedema of the bilateral feet, back, and face; Respiratory failure due to acute aggravation of COPD
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