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VAERS Report 2157434

Case Report Section

Vaer Report Details

Age: NA

Gender: Female

State: Outside US

Patient Died?
No
Vaccine information

Name: COVID19 (COVID19 (PFIZER-BIONTECH))

Type: Coronavirus 2019 vaccine

Manufacturer: PFIZER

Lot: fk6304


Date report was received
2022-03-04
Date form completed
Date Vaccinated
2021-12-16
Date of Onset
16
Number of days (onset date – vaccination date)
16
Adverse Event Description

calcification; gasesous distension; coxarthrosis; faro this is a non-interventional study report from the regulatory authority. a 84 year-old female patient received bnt162b2 (comirnaty), intramuscular, administration date 16dec2021 17:04 (lot number: fk6304, expiration date: 31jan2022) as dose 3 (booster), 0.3 ml single for covid-19 immunisation. relevant medical history included: "senile dementia" (unknown if ongoing); "polyposis gastric" (unknown if ongoing); "hyperthyroidism" (unknown if ongoing); "chronic obstructive bronchopneumopathy" (unknown if ongoing); "depression" (unknown if ongoing); "hypertension arterial" (unknown if ongoing). concomitant medication(s) included: deursil; olanzapine; citalopram taken for depression; tenormin taken for hypertension; folina [folic acid]. vaccination history included: comirnaty (1st dose, lot number: ep2166, vaccination time: 9:51), administration date: 01mar2021, for covid-19 immunisation, reaction(s): "vaccination failure", "covid-19"; comirnaty (2nd dose, lot number: ed3620, vaccination time: 9:14), administration date: 22mar2021, for covid-19 immunisation, reaction(s): "vaccination failure", "covid-19". the following information was reported: aortic arteriosclerosis with onset jan2022, outcome "unknown", described as "calcification"; abdominal distension with onset jan2022, outcome "unknown", described as "gasesous distension"; osteoarthritis with onset jan2022, outcome "unknown", described as "coxarthrosis". the patient underwent the following laboratory tests and procedures: abdominal x-ray: (22jan2022) discrete gaseous distension of ileocolic loops, notes: loops in mesogastrium, left flank and pelvic excavation, with associated hydroaerial levels in tangential projection. there is gaseous overdistension of intestinal loops in the hypochondrium with marked associated hydroaerial levels. collaterally there are calcified parietal plaques of the abdominal aorta, arthrosis of the rachis included in the investigation and evolved bilateral coxarthrosis; chest x-ray: (22jan2022) marked over-elevation of right hemidiaphragm;, notes: subdiaphragmatically two hydroaerial levels of probable intestinal relevance. in the seated a-p view, minimal obliteration of the right lateral costophrenic sinus seems to be present, doubtful due to modest pleural effusion. no pleural effusion on the left. slightly thicker in the left retrocardiac region. accentuation of the bronchovascular pattern in the lower third of the left lung. heart and mediastinum not evaluated; sars-cov-2 test: (22jan2022) positive. therapeutic measures were taken as a result of aortic arteriosclerosis, abdominal distension, osteoarthritis (infusion of urbason 20mg, pantoprazole 40mg and fluimicil 300mg). the reporter's assessment of the causal relationship of the "calcification", "gasesous distension" and "coxarthrosis" with the suspect product(s) bnt162b2 was not provided at the time of this report. since no determination has been received, the case is managed based on the company causality assessment. no follow-up attempts are possible. no further information is expected.; sender's comments: based on the information in the case report, a possible causal relationship between the events and suspect drug bnt162b2 cannot be excluded. 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.,linked report(s) : it-pfizer inc-202200302374 same reporter/patient/drug, different dose

Lab Data
test date: 20220122; test name: abdominal x-ray; result unstructured data: test result:discrete gaseous distension of ileocolic loops; comments: loops in mesogastrium, left flank and pelvic excavation, with associated hydroaerial levels in tangential projection. there is gaseous overdistension of intestinal loops in the hypochondrium with marked associated hydroaerial levels. collaterally there are calcified parietal plaques of the abdominal aorta, arthrosis of the rachis included in the investigation and evolved bilateral coxarthrosis.; test date: 20220122; test name: chest x-ray; result unstructured data: test result:marked over-elevation of right hemidiaphragm;; comments: subdiaphragmatically two hydroaerial levels of probable intestinal relevance. in the seated a-p view, minimal obliteration of the right lateral costophrenic sinus seems to be present, doubtful due to modest pleural effusion. no pleural effusion on the left. slightly thicker in the left retrocardiac region. accentuation of the bronchovascular pattern in the lower third of the left lung. heart and mediastinum not evaluated; test date: 20220122; test name: covid-19 test; result unstructured data: test result:positive
List of symptoms
osteoarthritis abdominal distension chest x-ray sars-cov-2 test abdominal x-ray aortic arteriosclerosis
Patient Died?
No
Date Died
NA
Birth defect
false
Vaccine Administered By:
Other
Vaccine Purchased By:
Unknown
Patient visit ER?
No
Patient Hospitalized?
No
Stay in hospital
No
Days in hospital
Unspecified
Permanent disability?
No
Allergies:
na
Current Illness
na