VAERS ID: 1404926

Description

cardio-respiratory arrest; Acute respiratory failure (interstitial pneumonia); Acute respiratory failure (interstitial pneumonia); acute respiratory distress syndrome; This is a spontaneous report from a contactable physician. An 88-year and 9-month-old female patient received the first dose of BNT162B2 (COMIRNATY; Lot Number: EY0779; Expiration Date: 31Aug2021), via an unspecified route of administration, on 20May2021 at 14:00 (at the age of 88-years-old) as a single dose for COVID-19 immunisation. Medical history included adult still's disease, cardiac failure chronic, and diverticulitis (required hospital treatment from Apr2021). Concomitant medications included prednisolone (PREDONINE) from 2018 and tocilizumab (ACTEMRA) from 2019. The patient experienced acute respiratory failure (interstitial pneumonia) on 03Jun2021 at 14:30 (14 days after the vaccination), which was reported as fatal. The patient also experienced acute respiratory distress syndrome on 03Jun2021 at 14:30 and cardio-respiratory arrest on 04Jun2021 at 18:00. The clinical course was reported as follows: The body temperature before vaccination was 36.5 degrees Centigrade on 20May2021. The patient required hospitalization treatment from Apr2021 for diverticulitis and at the time of discharge on 08May2021, the general condition was good and respiratory status was also good without generalized swelling. At the time of the vaccination, the patient stayed in a good condition, which was seen at the time of discharge from the hospital. On 20May2021, shortly after the vaccination, no abnormalities were noted soon after the vaccination. As the patient was admitted to an elder care facility with home-care services, she was observed by nurses, caregivers, and care managers every day. From 25May2021, the patient started to be aware of slight change of her physical condition. On 03Jun2021, in the morning, severe malaise and inappetence appeared and she could not eat meals. Afterwards, according to the nurse who observed the patient, no pyrexia was noted, oxygen saturation percutaneous (SpO2) was within the normal range on 03Jun2021, and a sign of respiratory failure was not seen. Thereafter, the patient was sleeping in her room. At 14:30, the physician in charge examined her. Afterwards, significant cyanosis and wheezing were noted. Swelling of the whole body acutely worsened. On 03Jun2021, the body temperature was 36.7 degrees Centigrade, SpO2 was 56%, blood pressure was 140/80 mmHg, and heart rate (HR) was 80. Oxygen administration was started. The patient visited the hospital where her attending physician was working. Blood test results on 03Jun2021 showed: white blood cell (WBC): 40000, C-reactive protein (CRP): 3, creatinine (Cr): 1.8 (estimated glomerular filtration rate (eGFR): 20), lactate dehydrogenase (LDH): 700, and N-terminal prohormone brain natriuretic peptide (Nt-proBNP): 800. Chest CT scan on 03Jun2021 showed bilateral pleural effusion. Acute aggravation of cardiac failure chronic and renal failure chronic (Cr was around 1.2-1.3 at normal level) and recurrence of adult still's disease were suspected. However, her symptoms acutely progressed and cardiac failure chronic could have been controlled for several years, a marked sign of aggravation could not have been seen until the previous day. Since marked inflammatory reaction and increased LDH were concurrently occurred even though the patient was receiving prednisolone plus tocilizumab. Given those facts, progression of respiratory failure was considered, also, because of presence of pleural effusion, acute respiratory distress syndrome (ARDS) was suspected. Although continuous oxygen administration, administration of unspecified diuretic, nitrous acid medicine, and additional administration of betamethasone sodium phosphate (RINDERON) 6 mg were performed, her respiratory status was aggravated. On 04Jun2021 at 18:00, the patient was in cardio-respiratory arrest. The patient had Do Not Attempt Resuscitation (DNAR) order and artificial respiratory therapy management or transfer to a high level emergency medical service agency was not conducted. Therapeutic measures were taken as a result of acute respiratory failure (interstitial pneumonia) and acute respiratory distress syndrome as aforementioned and no treatment was given for cardio-respiratory arrest. The clinical outcome of all of the events was assessed as fatal. The patient died on 04Jun2021 at 18:00 (15 days after the vaccination). The cause of death was reported as acute respiratory failure and additionally assessed as interstitial pneumonia, acute respiratory distress syndrome, and cardio-respiratory arrest. It was not reported if an autopsy was performed. The reporting physician assessed the causality between the event and BNT162B2 as unassessable. Other possible cause of the event was reported as follows: There was a possibility that adult still's disease accidentally recurred which resulted in ARDS or cardiac failure chronic acutely aggravated. The reporting physician commented as follows: If aggravated respiratory status was due to ARDS, it was assumed that her underlying disease, adult still's disease triggered systemic inflammatory response syndrome (SIRS) to occur. Recurrence of adult still's disease was considered to be triggered with following factors: accidental recurrence, diverticulitis which was treated from Apr2021 to the beginning of May2021, or BNT162B2 which the patient received on 20May2021. Considering that the patient had noticed her poor condition from 25May2021, it was possible that from around the time adult still's disease had already recurred. The reporter's hospital mainly conducted facility management and home visit medical treatment, therefore, compared to a group of persons who could receive the vaccination at a public vaccination site, many patients who received at this hospital tended to have severe underlying diseases or have weakened physical conditions. In several cases of patients here, even though an adverse reaction seemed to be mild shortly after the vaccination, there was a complaint of vomiting or inappetence from 5 to 7 days after vaccination and hospital treatment was given. There were also other fatal case(s) which had been already reported. The reporter's hospital had not allowed to give vaccination to the patients with terminal cancer or the patients who might expect to have serious outcome due to pyrexia as much as possible. In this case the patient's condition became aggravated. The patient might have up to a year to live but it was not expected that she die within several days. The causal relationship with BNT162b2 was uncertain, but it could be considered.; Reported Cause(s) of Death: interstitial pneumonia; acute respiratory distress syndrome; cardio-respiratory arrest; Acute respiratory failure

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