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VAERS ID: 1000472

AGE: UNK| SEX: F|State: FR

Description

ISCHEMIC STROKE; This is a spontaneous report from a contactable healthcare professional downloaded from the Regulatory Authority-WEB (NO-NOMAADVRE-FHI-2021-U3xw4 and NO-NOMAADVRE-E2B_00014128). An 88-year-old female patient received the first dose of BNT162B2 (COMIRNATY; Lot number: EM0477), intramuscularly in the left arm, on 13Jan2021 at 12:20 at a single dose for COVID-19 vaccination. Medical history included palliative care, stroke on 12Dec2019, living in nursing home, ongoing hypertension, ongoing gastric ulcer, and ongoing pain. Concomitant medications included enalapril maleate, hydrochlorothiazide (RENITEC COMP) taken for hypertension from 10Sep2020 to 16Jan2021; cyanocobalamin, folic acid, pyridoxine hydrochloride (TRIOBE) taken from an unspecified date to 16Jan2021; felodipine (FELODIPIN; MANUFACTURED BY: HEXAL) taken for hypertension from an unspecified date to 16Jan2021; esomeprazole magnesium (ESOMERAZOL; MANUFACTURED BY: KRKA) taken for gastric ulcer from 14Aug2020 to 16Jan2021, atorvastatin calcium (MANUFACTURED BY: MYLAN) from 08Jan2021 to 16Jan2021; paracetamol (PARACET) taken for pain from 23Jun2020 to 16Jan2021; buprenorphine hydrochloride (BUGNANTO) taken for pain from 08Jan2021 to 16Jan2021; and acetylsalicylic acid, magnesium oxide (ALBYL-E) from 23Jun2020 to 16Jan2021. The patient experienced ischemic stroke on 15Jan2021, which caused hospitalization and was reported as life-threatening. The clinical course was reported as follows: The patient was reported to have had several other predisposing factors for stroke. The patient was hospitalized with ischemic stroke, three days after vaccination (as reported) and received only palliative care. All of the patient's medications were discontinued on 16Jan2021. The clinical outcome of ischemic stroke was not recovered. Sender's Comments: The patient has previously suffered a stroke. This in itself, in addition to other comorbidities, will increase the risk of a new stroke. We consider it more likely that these conditions are behind the event in question. On the basis of the information in the report and in accordance with international 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 died, the report is classified as serious, even though no causal link between the vaccine and the death has been established. No follow-up attempts possible. No further information expected.

Symptoms

Ischaemic stroke

Vaccines

VAX DATE: 12 January 2021 | ONSET DATE: 14 January 2021 | DAYS TO ONSET: 2
Vaccine TypeManufacturerVaccine NameDoseRouteSiteLot
  • COVID19
  • PFIZERBIONTECH
  • COVID19 (COVID19 (PFIZER-BIONTECH))
  • 1
  • OT
  • LA
  • EM0477

RECVDATE:
03 February 2021
CAGE_YR:
CAGE_MO:
RPT_DATE:
DIED:
Y
DATEDIED:
L_THREAT:
Y
ER_VISIT:
HOSPITAL:
Y
HOSPDAYS:
X_STAY:
DISABLE:
RECOVD:
N
LAB_DATA:
V_ADMINBY:
OTH
OTHER_MEDS:
RENITEC COMP; TRIOBE [CYANOCOBALAMIN;FOLIC ACID;PYRIDOXINE HYDROCHLORIDE]; FELODIPIN HEXAL; ESOMEPRAZOL KRKA; ATORVASTATIN MYLAN; PARACET [PARACETAMOL]; BUGNANTO; ALBYL-E
CUR_ILL:
Gastric ulcer; Hypertension; Pain
HISTORY:
Medical History/Concurrent Conditions: Living in nursing home; Palliative care; Stroke
PRIOR_VAX:
SPLTTYPE:
NOPFIZER INC2021089321
FORM_VERS:
2
TODAYS_DATE:
01 February 2021
BIRTH_DEFECT:
OFC_VISIT:
ER_ED_VISIT:
ALLERGIES:
V_FUNDBY:
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OpenVAERS is a private organization that posts publicly available CDC/FDA data of injuries reported post-vaccination. Reports are not proof of causality.