Adverse Event Reporting
| VAERS ID | 994675 |
|---|---|
| Gender | Female |
| Age | 31 |
| StateCode | IL |
| Pharmaceutical Company | PFIZER\BIONTECH |
| Lot Number | EL3247 |
| Number of vaccinations | 1 |
| Vaccinated | 2021-01-16 |
| Onset | 2021-01-16 |
| Condition | Permanent Disability |
Symptoms
- Hypoaesthesia
- Asthenia
- Vomiting
- Injection site pain
- Mobility decreased
- Influenza like illness
- Neck pain
- Paralysis
Current Illness
Preexisting Conditions
Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Other Medications
Previous Vaccinations
Allergies
Laboratory Data
Write-up
numbness has moved up her neck; she touches her neck, it hurts a little; maintains numbness and "no control of her arm"/can barely move her right arm; paralyzed at the shoulder from the elbow up;it's numb; can barely move her right arm; paralyzed at the shoulder from the elbow up; flu like symptoms; Threw up a couple times; mild pain at the injection site; This is a spontaneous report from a contactable nurse reporting for herself.
A 31-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Batch/lot number: EL3247, Expiry date 31May2021, via an unspecified route of administration in right arm on 16Jan2021 at 07:30 at single dose for COVID-19 immunization as frontline worker.
The patient had no relevant medical history.
There were no concomitant medications.
The patient received BNT162B2 Pfizer-BioNTech COVID-19 Vaccine in Hospital.
The patient reported that she was fine all day Saturday (16Jan2021), she just had some very mild pain at the injection site started a couple hours after getting injection.
She developed flu like symptoms on the following day (17Jan2021) at 18:00PM and threw up a couple times.
On 18Jan2021 at noon she noticed that she could barely move her arm: anything above her elbow on her right arm was not moving; it was paralyzed at the shoulder from the elbow up.
If someone were to pick it up and let go, she couldn't control it at all.
She also stated that she had no pain at all in that arm; she couldn't feel anything at all; it was numb.
When she woke up on 19Jan2021 the numbness had moved up her neck, instead of being localized to her arm.
She stated that when she touched her neck, it hurt a little, but it was not super significant.
She stated that it was debilitating at that point as she was maintaining numbness and "no control of her arm".
The nurse reported that this event had not required yet a visit to physician, but she has a feeling it will.
She will probably have to go somewhere due to her paralyzed arm, but she had not yet.
At the time of the report the event "No control of her arm"/can barely move her right arm; paralyzed at the shoulder from the elbow up; it's numb" had not resolved yet; the event "mild pain at the injection site" resolved on 17Jan2021, the events "Flu like symptoms" and "Threw up a couple times" were recovering and outcome of the events "Numbness has moved up her neck" and "She touches her neck, it hurts a little" was unknown.
The reporter assessed the events "Pain injection site" and "Flu like symptoms" as non-serious and assessed the event "Can barely move her right arm; paralyzed at the shoulder from the elbow up; it's numb" as disabling.
She assessed all the reported events as related to BNT162B2 Pfizer-BioNTech COVID-19 Vaccine (method of assessment: Global Introspection).
; Sender's Comments: Based on the temporal relationship, the association between the events numbness of upper extremity and arm paralysis with BNT162b2 use can not be fully excluded.
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.