Adverse Event Reporting
| VAERS ID | 994081 |
|---|---|
| Gender | Male |
| Age | 87 |
| StateCode | NC |
| Pharmaceutical Company | PFIZER\BIONTECH |
| Lot Number | EL3249 |
| Number of vaccinations | 1 |
| Vaccinated | 2021-01-13 |
| Onset | 2021-01-01 |
| Condition | Permanent Disability |
Symptoms
- Asthenia
- Malaise
- Fall
- Gait inability
- Dysstasia
- Muscular weakness
Current Illness
Preexisting Conditions
Medical History/Concurrent Conditions: COVID-19; Forgetfulness
Other Medications
Previous Vaccinations
Allergies
Laboratory Data
Write-up
Fell; Weakness in legs; got so weak; His legs just continued to get worse/He could not get up without help; He could not walk; This is a spontaneous report from a contactable nurse reported for her father.
An 87-years-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL3249, intramuscular on left arm on 13Jan2021 (Time the vaccination was given: 13:00-13:15) at the age of 87-years-old at single dose for prevention because of age group.
Medical history included covid-19 in Jun2020, forgetful from an unknown date, he got a little forgetful sometimes, so he may have forgotten to tell her.
This occurred prior to getting the vaccine.
The patient's concomitant medications were not reported.
Prior Vaccinations (within 4 weeks) was none.
Family medical history was none.
The patient got the Pfizer COVID vaccine last week on 13Jan2021, he was really sick in Jan2021.
The patient had weak legs anyway, but he got so weak.
Weakness in legs started at night on 13Jan2021, around 20:00.
No emergency room (ER) or physician's office required.
He never complained of any symptoms and did not know if there were other symptoms, because he did not complain.
He fell on Thursday night on 14Jan2021.
He got the vaccine around 1:00-1:15pm, and got so weak, that he went to the bathroom and he fell in the floor.
His legs just continued to get worse.
It started on Wednesday night on 13Jan2021.
He could not walk in Jan2021.
Thursday was the worst.
By Friday, it started to get better.
He did not get hospitalized.
He could not get up without help.
The patient had Covid 19 in Jun2020.
He had a lot of symptoms after receiving the first dose of the vaccine.
The reporter reported her father fell in the bathroom while brushing his teeth and her brother had to come over to get him up.
The reporter was starting to wonder if he should take the second dose.
The outcome of the events Weakness in legs and fell was resolving and of the other events was unknown.
The reporter considered event Weakness in legs was serious due to medically significant and disabling; considered event fall was serious due to medically significant.
; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect BNT162B2 in triggering the onset of the events muscular weakness, fall and gait disturbance cannot be excluded.
The events are confounded by the elderly patient's underlying conditions.
The impacts of this report on the benefit/risk profile of the 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.