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VAERS ID: 1000378

AGE: UNK| SEX: F|State: FR

Description

lethargy; abdominal pain; vomiting; hyponatraemic; very confused; mobility issues; memory problems; urea and creatinine increasing; urea and creatinine increasing; hypotensive and unresponsive; abdominal tenderness; Intestinal perforation; This is a spontaneous report received from a contactable physician by Pfizer from the products Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202101272230124630. Safety Report Unique Identifier GB-MHRA-ADR 24657446. An 86-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration on 13Jan2021 at single dose for COVID-19 Immunization. The relevant medical history included brain tumour (acoustic neuroma, 20 years ago) and breast cancer (mastectomy, 20 years ago). Concomitant medications were not reported. The patient experienced Intestinal perforation on 21Jan2021. It was also reported as admitted on 21Jan2021, GP admit with abdominal pain, off food, vomiting and lethargy, previous brain tumour (acoustic neuroma) and breast cancer (mastectomy) 20 years ago, also noted to be very confused, mild lower abdominal pain, also mobility issues and memory problems, CRP=18; 1/7 right in brief MMT, sodium 117 (previously hyponatraemic) very dry AKI plan is to rehydrate, consultant review replace electrolytes, slight RIF tenderness, AXR reported as NAD, 23Jan2021. 23Jan2021 (12.43) asked to see sodium increasing but urea and creatinine increasing, became unresponsive later that day (16.35) hypotensive and unresponsive, diffuse abdominal tenderness, plan is for CTTAP, hydrocortisone, pip/taz, also sees later in the day, CT abdomen showed intestinal perforation, spoke to surgical team at CIC accepted patient, tube, 22.10, further deterioration 23.57 decision to keep comfortable, family updated on a regular basis. Following day palliative care involved and dies early hours of 25Jan2021 at 00:25. Haemoglobin remains normal throughout, CT scan reported as unclear as to source of perforation, lactate was slightly elevated on admission but lactate elevated 3.5; NEWS = zero on admission, acute collapse probably reflects perforation but there was a delay in identifying cause of intra-abdominal pathology. Patient died on 25Jan2021. It was not reported if an autopsy was performed. The patient had COVID-19 virus test on 21Jan2021 showed No - Negative COVID-19 test. Patient had not tested positive for COVID-19 since having the vaccine. The outcome of the event intestinal perforation was fatal, while other events were unknown. No follow-up attempts are possible; information about batch number cannot be obtained.; Reported Cause(s) of Death: intestinal perforation

Symptoms

Abdominal pain, Blood urea increased, Intestinal perforation, Scan abdomen abnormal, Abdominal tenderness, Confusional state, Lethargy, Unresponsive to stimuli, Blood creatinine increased, Haemoglobin normal, Memory impairment, Vomiting, Blood lactic acid increased, Hyponatraemia, Mobility decreased, Blood sodium decreased, Hypotension, SARS-CoV-2 test negative

Vaccines

VAX DATE: 12 January 2021 | ONSET DATE: 20 January 2021 | DAYS TO ONSET: 8
Vaccine TypeManufacturerVaccine NameDoseRouteSiteLot
  • COVID19
  • PFIZERBIONTECH
  • COVID19 (COVID19 (PFIZER-BIONTECH))
  • UNK
  • Not known

RECVDATE:
03 February 2021
CAGE_YR:
CAGE_MO:
RPT_DATE:
DIED:
Y
DATEDIED:
24 January 2021
L_THREAT:
ER_VISIT:
HOSPITAL:
Y
HOSPDAYS:
X_STAY:
DISABLE:
RECOVD:
N
LAB_DATA:
Test Date: 20210123; Test Name: creatinine; Result Unstructured Data: Test Result:increasing; Test Date: 20210121; Test Name: lactate; Result Unstructured Data: Test Result:slightly elevated on admission but lactate elevate; Comments: slightly elevated on admission but lactate elevated 3.5; Test Date: 20210123; Test Name: BP; Result Unstructured Data: Test Result:hypotensive; Test Name: sodium; Result Unstructured Data: Test Result:hyponatraemic; Comments: previously hyponatraemic; Test Date: 20210121; Test Name: sodium; Result Unstructured Data: Test Result:117; Test Date: 20210123; Test Name: urea; Result Unstructured Data: Test Result:increasing; Test Name: CT scan; Result Unstructured Data: Test Result:reported as unclear as to source of perforation; Test Date: 20210123; Test Name: CT scan; Result Unstructured Data: Test Result:showed intestinal perforation; Test Date: 20210121; Test Name: CRP; Result Unstructured Data: Test Result:18; Test Name: Haemoglobin; Result Unstructured Data: Test Result:remains normal throughout; Test Date: 20210121; Test Name: NEWS; Result Unstructured Data: Test Result:zero on admission; Test Date: 20210121; Test Name: MMT; Result Unstructured Data: Test Result:1/7 right; Test Date: 20210121; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
V_ADMINBY:
OTH
OTHER_MEDS:
CUR_ILL:
HISTORY:
Medical History/Concurrent Conditions: Brain tumour (acoustic neuroma, 20 years ago); Breast cancer (mastectomy, 20 years ago); Mastectomy
PRIOR_VAX:
SPLTTYPE:
GBPFIZER INC2021095661
FORM_VERS:
2
TODAYS_DATE:
01 February 2021
BIRTH_DEFECT:
OFC_VISIT:
ER_ED_VISIT:
ALLERGIES:
V_FUNDBY:
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