Adverse Event Reporting
| VAERS ID | 1189319 |
|---|---|
| Gender | Male |
| Age | |
| StateCode | FR |
| Pharmaceutical Company | PFIZER\BIONTECH |
| Lot Number | EL0725 |
| Number of vaccinations | 1 |
| Vaccinated | 2016-12-02 |
| Onset | 2021-02-06 |
| Condition | Hospitalized Life Threatening Permanent Disability |
Symptoms
- Nausea
- Vomiting
- Subarachnoid haemorrhage
- Cerebellar haemorrhage
Current Illness
Preexisting Conditions
Medical History/Concurrent Conditions: Atrial fibrillation; Hypertension; Orchidectomy; Osteopenia; Parkinson's disease; Prostate cancer
Other Medications
CANDESARTAN CILEXETIL; RASAGILINE; PRAMIPEXOLE; MIRTAZAPINE; MADOPARK QUICK; STALEVO [CARBIDOPA;ENTACAPONE;LEVODOPA]; KALCIPOS D; FURIX [CEFUROXIME]; ZERLINDA; METOPROLOL
Previous Vaccinations
Allergies
Laboratory Data
Write-up
Cerebellar haemorrhage; Vomiting; Nausea; Subarachnoid haemorrhage, unspecified; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority-WEB manufacturer report number SE-MPA-2021-023502.
Other Case number SE-MPA-1616742120869.
An 81-year-old male patient received the first dose of bnt162b2 (COMIRNATY, lot number: EL0725), intramuscular administered left arm on 03Feb2021 at 0.
3 mL, single for COVID-19 immunisation; apixaban (ELIQUIS; formulation: unknown), via an unspecified route of administration from 02Dec2016 at unspecified dose for an unspecified indication; and apixaban (ELIQUIS, formulation: film-coated tablet), oral from 02Dec2016 at 10 mg, daily (5mgx2) for atrial fibrillation.
Medical history included prostate cancer from 2009 to which cancer later metastasized and an orchidectomy were performed 2020, hypertension, osteopenia, atrial fibrillation, and parkinson's disease.
Concomitant medications included candesartan cilexetil; rasagiline; pramipexole; mirtazapine; benserazide hydrochloride, levodopa (MADOPARK QUICK); carbidopa, entacapone, levodopa (STALEVO [CARBIDOPA;ENTACAPONE;LEVODOPA]); calcium carbonate, colecalciferol (KALCIPOS D); cefuroxime (FURIX [CEFUROXIME]); zoledronic acid monohydrate (ZERLINDA) from 09Mar2020; and metoprolol.
On 06Feb2021, 3 days after the vaccination, the patient experienced nausea, subarachnoid haemorrhage, unspecified and vomiting.
On 17Feb2021, 14 days after the vaccination, the patient experienced cerebellar haemorrhage.
The reporter considered all events as serious due to hospitalization, life-threatening, and disability.
The action taken in response to the events for apixaban (ELIQUIS: unknown formulation) and apixaban (ELIQUIS; film-coated tablet) was unknown.
The patient recovered with sequel from all events.
No follow-up attempts are possible.
No further information is expected.