Vaer Report Details
Age: 78 years old
Gender: Female
State: Outside US
- Patient Died?
- No
- Vaccine information
-
Name: COVID19 (COVID19 (MODERNA))
Type: Coronavirus 2019 vaccine
Manufacturer: MODERNA
Lot: 094f21a
- Date report was received
- 2022-02-24
- Date form completed
- Date Vaccinated
- 2021-12-16
- Date of Onset
- 5
- Number of days (onset date – vaccination date)
- 5
- Adverse Event Description
-
herseninfarct; this regulatory authority case was reported by a consumer and describes the occurrence of ischaemic cerebral infarction (herseninfarct) in a 78-year-old female patient who received mrna-1273 (spikevax) (batch no. 094f21a) for covid-19 vaccination. previously administered products included for product used for unknown indication: biontech/pfizer vaccin (comirnaty) covid-19 vaccin pfizer injvlst 0,3ml on 19-mar-2021, biontech/pfizer vaccin (comirnaty) covid-19 vaccin pfizer injvlst 0 and3ml on 19-apr-2021. past adverse reactions to the above products included no adverse reaction with biontech/pfizer vaccin (comirnaty) covid-19 vaccin pfizer injvlst 0,3ml, biontech/pfizer vaccin (comirnaty) covid-19 vaccin pfizer injvlst 0 and3ml. on 16-dec-2021, the patient received dose of mrna-1273 (spikevax) (unknown route) 1 dosage form. on 21-dec-2021, the patient experienced ischaemic cerebral infarction (herseninfarct) (seriousness criterion hospitalization). at the time of the report, ischaemic cerebral infarction (herseninfarct) was resolving. no concomitant medication was provided. no treatment medication was provided. company comment: this regulatory case concerns a 78-year-old female patient no reported medical history, who experienced the unexpected serious aesi event of ischaemic cerebral infarction 6 days following the receipt of mrna-1273 vaccine. the patient had previously received 2 doses of comirnaty (interchange of vaccine products). elderly age of the patient can be a risk factors for the event. the benefit-risk relationship of mrna-1273 is not affected by this report. seriousness of the event retained as per regulatory authority reporting.; sender's comments: this regulatory case concerns a 78-year-old female patient no reported medical history, who experienced the unexpected serious aesi event of ischaemic cerebral infarction 6 days following the receipt of mrna-1273 vaccine. the patient had previously received 2 doses of comirnaty (interchange of vaccine products). elderly age of the patient can be a risk factors for the event. the benefit-risk relationship of mrna-1273 is not affected by this report. seriousness of the event retained as per regulatory authority reporting
- Lab Data
-
na
- List of symptoms
-
ischaemic cerebral infarction
- Patient Died?
- No
- Date Died
- NA
- Birth defect
- false
- Vaccine Administered By:
- Unknown
- Vaccine Purchased By:
- Unknown
- Patient visit ER?
- No
- Patient Hospitalized?
- Yes
- Stay in hospital
- No
- Days in hospital
- Unspecified
- Permanent disability?
- No
- Allergies:
-
na
- Current Illness
-
na