VAERS ID: 1773196

Description

Interstitial pneumonia; pulmonary edema; late-onset allergy due to side reaction of vaccination; infectious enteritis; Abdominal pain; Queasy; pyrexia of 38.0 to 38.9 degrees centigrade; This is a spontaneous report from a contactable physician via Regulatory authority. Regulatory authority number is v21129077. A 70-year and 0-month-old female patient received BNT162b2 (COMIRNATY, Solution for injection; Lot number FE8162, Expiration date 30Nov2021) via an unspecified route of administration on 05Aug2021 at 15:10, dose 2, single for COVID-19 immunization. The patient had no family history. Medical history included hypertension, hypercholesterolemia, and bronchial asthma which was under control with an inhaled drug. Concomitant medications were not reported. Patient previously received BNT162b2 (COMIRNATY, Solution for injection; Lot number EY0573, Expiration date 30Sep2021) via an unspecified route of administration on 15Jul2021 at 14:10, dose 1, single for COVID-19 immunization. Body temperature before vaccination was 36.9 degrees centigrade. The patient experienced pyrexia of 38.0 to 38.9 degrees centigrade on 06Aug2021, abdominal pain, queasy on 08Aug2021, infectious enteritis on 10Aug2021, late-onset allergy due to side reaction of vaccination on 11Aug2021, pulmonary edema, and interstitial pneumonia on 11Aug2021 at 17:00 (6 days after the vaccination). The course of the event was as follows: The initial administration of BNT162b2 was performed on 15Jul2021, there was no change thereafter. The second administration of BNT162B2 was performed on 05Aug2021, and the patient experienced pyrexia of 38.0 to 38.9 degrees centigrade between 06Aug2021 to 07Aug2021. The pyrexia resolved spontaneously on 08Aug2021, but abdominal pain and queasy started. The patient visited the reporting clinic again on 10Aug2021, and the consciousness was clear. The patient blood pressure was 127/84 mmHg, pulse rate 116, and blood test revealed increased inflammation reaction with WBC 26800 and CRP 3.2. The ultrasound abdomen and abdomen CT were performed, but there were no significant findings of cholecystitis, intestinal obstruction, acute pancreatitis, or appendicitis. Fluid replacement was performed with a diagnosis of infectious enteritis, and oral administration of an antibacterial drug and an intestinal drug was started. The patient visited the reporting clinic on 11Aug2021 around 16:30 without improvement of abdominal pain. WBC was 23500, indicating poor improvement. When suggesting to perform upper gastrointestinal endoscopy for close investigation of the cause, the patient's respiratory status worsened suddenly (anguish-like breathing accompanied by cyanosis, with supraduction of the eye; the clock time was 17:00). Suffocation due to vomiting was suspected, but there was no vomitus. The consciousness was recovered immediately after the airway was cleared by jaw-lift. Oxygen administration was started, and epinephrine (EPINEPHRINE; subcutaneous injection) was administered with a suspicion of late-onset allergy due to side reaction of vaccination. The patient was in a shock state with the systolic blood pressure decreased to 70 mmHg, SpO2 90% to 95%, pulse rate 110, and respiratory rate 22. The patient was referred to hospital A for close investigation of the cause/treatment and was raced to the hospital (around 17:25). The patient was examined closely at the hospital A, and CT image with suspected interstitial pneumonia was observed on bilateral lung fields. By the time that all the examination results came out, the patient's respiratory status worsened gradually and it became impossible to maintain SpO2 90% with administration of oxygen 8L/min through oxygen mask. It was determined difficult to manage respiration at the hospital A, and the patient was referred to hospital B. The patient's respiratory status worsened in the ambulance as well, the spontaneous breathing gradually weakened, and the patient suffered cardiopulmonary arrest immediately after arriving at hospital B. Cardiopulmonary resuscitation was performed, and the patient's spontaneous breathing/heart rate returned once. Before long, the patient however died on 11Aug2021, 23:19. CT was performed again at the hospital B, which revealed pulmonary edema. The possibility of interstitial pneumonia which was resulted in pulmonary edema and then death was suggested. The side reaction to BNT162b2 was suspected as a factor of leading to interstitial pneumonia, and this report was submitted. On 11Aug2021 (6 days after the vaccination), the outcome of pulmonary edema, interstitial pneumonia was fatal, pyrexia recovered on 08Aug2021, and infectious enteritis, late-onset allergy due to side reaction of vaccination, abdominal pain, and queasy was unknown. The reporting physician classified the event as serious (death) and assessed that the event was related to BNT162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: Since the patient received vaccination, the symptoms shifted from pyrexia, abdominal pain/queasy, shock by dyspnoea, and to death; however, these symptoms are considered to be a series of clinical condition. As a factor of dyspnoea, the shadow suspected of interstitial pneumonia was confirmed on the CT test, and as a factor resulting in the onset of interstitial pneumonia, allergic reaction with increased WBC (significant increase in eosinophils [2800/uL] on differential leukocyte count) was suggested. There was no other external factor than the vaccine, and the side reaction was suspected.; Reported Cause(s) of Death: pulmonary edema; Interstitial pneumonia

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