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Write-up: blood pressure 168/75; Vomiting; Cardiac hypertrophy; Intestinal obstruction (vascular mesenteric occlusion); Intestinal obstruction (vascular mesenteric occlusion); This is a spontaneous report from a contactable internist (physician) received via a Pfizer sale representative. The patient was 94 years old female with ongoing dementia. The patient concomitant medications were not provided. On 23Apr2021, the patient received BNT162b2 (COMIRNATY, Lot# and Expiration date unknown) via intramuscular as a single dose for COVID-19 immunization. The dose number was not provided. On 24Apr2021 (1 day after the vaccination), the patient experienced intestinal obstruction (vascular mesenteric occlusion). On 24Apr2021 at 18:27 (1 day after the vaccination), the patient died. The outcome was fatal. The course of the event was as follows: On 20Apr2021 at 22:45, the patient made nurse call continuously many times saying "Help! Help!" The patient lay on the bed and stated, she could not move because her body ached. Sign of intestinal obstruction was considered, or lumbar part and sacral region. At the same time, urinary incontinence was noted. No abnormality was found with vitals. (Urinary retention was considered). The patient was told, "please relax herself and sleep well. A nursing home worker will return next morning" on the timing when the patient calmed down. On 21Apr2021 in the morning, the patient came down to the office at the first floor with a nursing home worker to say thank you. When the internist went to see the patient in the hospital room at the 5th floor, the patient was found measuring body temperature in front of an office. At 8:45, body temperature 36.5 degrees Centigrade, blood pressure 121/59, pulse rate 49 and no abnormality was found. The patient seemed a little concerned. The physician went to see the patient in the hospital room at a little past 09:00. Body temperature 36.0 degrees Centigrade, blood pressure 121/67, pulse rate 67, and SpO2 98% at 9:08. By the time the nursing home worker visited her room, the patient had washed the towel used under her body, and she was hanging the laundry up with help of the nursing home worker. Her gait was unsteady, and the patient complained of feeling tired because she had insufficient sleep, for which the patient was instructed to rest in her room. At 10:20, the patient was lying on her bed. The patient complained of being unable to get herself up from the bed because she had low back pain. Blood pressure 139/48, pulse rated 61. Her body was slightly feverish. The patient tended to get lie down even the physician tried to get her up. The patient insisted that she felt better lying down turning her body to the wall side. Bathing was not performed. At 11:50, the patient made a nurse call. The patient was found lying with her arm and body fell between the wall and bed. The patient told her body was sucked into it. A nursing home worker got her body up and put a pillow into the space to prevent the patient from fall into it again. Body temperature 37.0 degrees Centigrade, blood pressure 124/64, pulse rate 64, and SpO2 96%. From 14:00 to 15:00, the patient was seen at the outpatient clinic in reclining wheelchair. Chief complaint included whole body aching, but no headache was noted when the patient moved both hip joints. No pain due to hitting or falling was noted. Because patients cared in a nursing home tended to complain whole body aching, the primary physician considered it was a kind of behavioral and psychological symptom of dementia (BPSD) accompanying dementia. Follow-up after that was unspecified. On 22Apr2021, the patient''s course of the day was unspecified. On 23Apr2021, the patient came down to the first floor in while chair for receiving COVID-19 vaccine. At history taking, no complain of body was heard in specific from the patient. The patient received intramuscular injection of BNT162b2 (COMIRNATY, Lot# and Expiration date unknown) vaccine. The patient was followed up for about 1 hour, but no abnormality was noted. The patient ate dinner as usual. On 24Apr2021 at 5:00, the patient vomited. Thereafter, 4 times of vomiting were noted. The patient could not eat breakfast. At 10:30, nursing home recoded that vomiting with brownish vomit and saliva, body temperature 36.4 degrees Centigrade, pulse rate 65, SpO2 93%, blood pressure 168/75. At 13:30, the patient was seen at the outpatient clinic in reclining wheelchair. The patient responded with smile to the questions, but her speech was not clear. Body temperature 36.5 degrees Centigrade, blood pressure 152/82, pulse rate 87, SpO2 99%. No murmur was hear at auscultation, regular. No tenderness in abdominal region, and bowel sound normal. Cause for vomiting was unspecified. Treatment was provided with glucose, potassium chloride, sodium chloride, sodium lactate (SOLDEM) 3A 1000 mL at 1 dose and metoclopramide hydrochloride (PRIMPERAN) at 1 ample. At 17:50, on room visit, the patient in her room. No respiratory abnormal was found, but the patient eyes were closed when her name was called. At 18:00, on room visit, respiratory arrest was noted. Monitor showed flat. One mouth of vomit mark was seen. At 18:27, the patient family came over. Her death was confirmed with two nieces as witnesses. Systemic CT (AI) was performed to find death cause. Head CT showed no acute cerebral haemorrhage or cerebral infarction. Chest CT showed no obvious pneumonia or pleural effusion. No vomit that induce asphyxia in bronchus was noted. Although cardiac hypertrophy was found, no sign of cardiac failure was noted. Abdominal CT showed niveau was found in small intestine and large intestine, but occluded site was unspecified. Anaphylaxis known with BNT162b2 vaccine was not found. At 19:56, after details were told to the patient''s family, pathologic autopsy was asked for further investigation for death cause. However, the family declined it because they considered that the patient made a lot of effort and died a peaceful death. The internist classified the event as serious (Death) and the causality between the event and BNT162b2 as unassessable. The internist considered the intestinal obstruction (vascular mesenteric occlusion) was the most like death cause based on the AI result although pathologic autopsy was not performed and the death cause was not identified. Information on the lot/batch number has been requested.; Sender''s Comments: Based on the available information, the company considered that the events intestinal obstruction (vascular mesenteric occlusion) were unrelated to the vaccination with BNT162B2. Of note, sign of intestinal obstruction was suspected prior to the vaccination. The events were most likely related to the patient''s advanced age and underlying medical conditions. 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: Intestinal obstruction (vascular mesenteric occlusion); Intestinal obstruction (vascular mesenteric occlusion)
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