Adverse Event Reporting
| VAERS ID | 2128042 |
|---|---|
| Gender | Male |
| Age | 53 |
| StateCode | |
| Pharmaceutical Company | PFIZER\BIONTECH |
| Lot Number | |
| Number of vaccinations | 1 |
| Vaccinated | 2021-04-09 |
| Onset | 2021-10-08 |
| Condition | Permanent Disability |
Symptoms
- Fatigue
- Pain in extremity
- Dizziness
- Seizure
- Transient ischaemic attack
Current Illness
Preexisting Conditions
Other Medications
HUMIRA
Previous Vaccinations
Allergies
Laboratory Data
Write-up
dizzy; transient ischaemic attack; seizures; fatigued; sore arm; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program.
The reporter is the patient.
Other Case identifier(s): 21K-163-4022144-00 (AbbVie).
A 53 year-old male patient received bnt162b2 (Pfizer biontech covid-19 vaccine), intramuscular, administration date 09Apr2021 (Batch/Lot number: unknown) at the age of 53 years as dose 1, single and intramuscular, administration date 30Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA) (Batch/Lot number: unknown) for colitis ulcerative, crohn's disease.
The patient's relevant medical history and concomitant medications were not reported.
The following information was reported: SEIZURE (disability, medically significant) with onset 2021, outcome "unknown", described as "seizures"; TRANSIENT ISCHAEMIC ATTACK (medically significant) with onset 08Oct2021, outcome "unknown", described as "transient ischaemic attack"; DIZZINESS (non-serious), outcome "not recovered", described as "dizzy"; FATIGUE (non-serious) with onset 2021, outcome "recovered" (2021), described as "fatigued"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "sore arm".
The action taken for adalimumab was unknown.
Causality for Humira (Adalimumab): The reporter's causality for the event(s) of seizures, dizzy, fatigued and sore arm was not provided.
The reporter's causality for the event(s) of transient ischaemic attack with humira(adalimumab) was no reasonable possibility.
Abbvie's opinion is that there is no reasonable possibility that the events of seizures, fatigued and sore arm are related to humira(adalimumab).
Abbvie's opinion is that the events of transient ischaemic attack and dizzy are not assessable.
Causality of Pfizer biontech covid-19 vaccine: The reporter's causality for the event(s) of Seizures, Transient ischaemic attack, Dizzy was not provided.
The reporter's causality for the event(s) of Fatigue, Pain in extremity was not related.
Clinical course: Age years: 52.
On 24Jul2021, the patient had a mini stroke but it was getting better.
It was caught on time.
There was an update regarding seizures caused by stroke.
He had fatigue and sore arm with covid vaccinations.
He was filing for permanent disability because of the seizures.
He felt numb and tingly and then he had it, then he did not remember anything.
On 08Oct2021, had a mini stroke (tia) which then turned into a seizure.
It was unknown if patient was enrolled in a covid-19 vaccine trial.
No follow-up attempts are possible; information about lot/batch number cannot be obtained.
No further information is expected; Sender's Comments: Based on possible temporal association the causal role of BNT162B2 Vaccine cannot be excluded for reported events .
Case will be reviewed further on receipt of FU information The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.
Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate