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VAERS ID: 1000473

AGE: 89| SEX: M|State: FR

Description

DIARRHEA; VOMITING; This is a spontaneous report from a contactable other healthcare professional downloaded from the Regulatory Authority with Regulatory authority report number NO-NOMAADVRE-FHI-2021-U4eqa, Sender's (Case) Safety Report Unique Identifier NO-NOMAADVRE-E2B_00014144. An 89-year-old male patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, lot number: EJ6795), intramuscularly on 06Jan2021 09:00 at single dose in Left arm for Covid-19 vaccination. Medical history included diabetes mellitus, angina pectoris, decreased appetite (Reduced food intake two weeks before vaccination) cognitive impairment, gastrointestinal spasm, nausea, hypertension, unrest, all from an unknown date and unknown if ongoing. The patient was Living in nursing home. Concomitant medication included hyoscine butylbromide (BUSCOPAN) from 12Jan2021 to 17Jan2021 for gastrointestinal spasm, metoclopramide hydrochloride (AFIPRAN) from 12Jan2021 to 17Jan2021 for nausea, paracetamol (PARACET) from an unknown date to 13Jan2021 for pain, paracetamol (PINEX) from an unknown date to 11Jan2021 for pain, metoprolol succinate (SELO-ZOK) from an unknown date to 12Jan2021 for hypertension, fentanyl (FENTANYL SANDOZ) from 11Jan2021 to 17Jan2021 for pain, insulin glargine (LANTUS) from an unknown date to 13Jan2021 for diabetes mellitus, morphine hydrochloride (MORPHINE ORION) from 12Jan2021 to 17Jan2021 for pain, oxazepam (SOBRIL) from an unknown date to 13Jan2021 for unrest, losartan potassium (COZAAR) from an unknown date to 12Jan2021 for hypertension, haloperidol (HALDOL) from 12Jan2021 to 17Jan2021 for unrest, midazolam from 12Jan2021 to 17Jan2021 for unrest. The patient experienced vomiting on 06Jan2021 and diarrhea on 08Jan2021, reported as serious with serious criteria death. The patient experienced vomiting once on the same day as vaccination on 06Jan2021. Two days after vaccination on 08Jan2021, he developed diarrhea, gradually continuous running stools, no food/fluid intake. Reporter states that it is not certain that the symptoms are due to a side effect of the vaccine as the man had reduced appetite a few weeks before vaccination, as well as comorbidity. In the time before vaccination, the man also did not want to take his medication, including long-acting insulin. The patient died on an unspecified date in Jan2021. It was not reported if an autopsy was performed. The outcome of events vomiting and diarrhea was fatal. Sender Comment: Nausea is reported as a side effect of the vaccine Comirnaty, while diarrhea is not listed as a known side effect. In some people, reactions such as short-term / transient nausea and loose stomach can be linked to being vaccinated, but then as a form of physiological stress response to the event / vaccination. In this case, there is a relatively close temporal relationship between vomiting, diarrhea and vaccination. It is stated that the patient had reduced food intake in the period before vaccination, and it can therefore not be ruled out that vomiting and diarrhea may have been symptoms of an underlying condition that was present in before vaccination. On the basis of the information in the report and in accordance with criteria, the causal link with vaccination is assessed as possible. A possible causal relationship is defined as a reaction, including pathological laboratory tests, which occurs in a temporal relationship to the use of a drug, but which may also be due to an underlying disease, other drugs or chemicals. Since the patient's death, the message is classified as serious, even though no causal link between the vaccine and the death has been established. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Vomiting; diarrhea

Symptoms

Death, Diarrhoea, Fluid intake reduced, Hypophagia, Vomiting

Vaccines

VAX DATE: 05 January 2021 | ONSET DATE: 05 January 2021 | DAYS TO ONSET: 0
Vaccine TypeManufacturerVaccine NameDoseRouteSiteLot
  • COVID19
  • PFIZERBIONTECH
  • COVID19 (COVID19 (PFIZER-BIONTECH))
  • 1
  • OT
  • LA
  • EJ6795

RECVDATE:
03 February 2021
CAGE_YR:
CAGE_MO:
RPT_DATE:
DIED:
Y
DATEDIED:
31 December 2020
L_THREAT:
ER_VISIT:
HOSPITAL:
HOSPDAYS:
X_STAY:
DISABLE:
RECOVD:
N
LAB_DATA:
V_ADMINBY:
OTH
OTHER_MEDS:
BUSCOPAN; AFIPRAN; PARACET [PARACETAMOL]; PINEX; SELO-ZOK; FENTANYL SANDOZ; LANTUS; MORPHINE ORION; SOBRIL; COZAAR; HALDOL; MIDAZOLAM
CUR_ILL:
HISTORY:
Medical History/Concurrent Conditions: Angina pectoris; Cognitive impairment; Decreased appetite; Diabetes mellitus; Gastrointestinal spasm; Hypertension; Living in nursing home; Nausea; Unrest
PRIOR_VAX:
SPLTTYPE:
NOPFIZER INC2021089362
FORM_VERS:
2
TODAYS_DATE:
01 February 2021
BIRTH_DEFECT:
OFC_VISIT:
ER_ED_VISIT:
ALLERGIES:
V_FUNDBY:
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