Adverse Event Reporting
| VAERS ID | 996740 |
|---|---|
| Gender | Female |
| Age | 37 |
| StateCode | IL |
| Pharmaceutical Company | PFIZER\BIONTECH |
| Lot Number | EK5730 |
| Number of vaccinations | 1 |
| Vaccinated | 2020-12-18 |
| Onset | 2020-12-18 |
| Condition | Hospitalized Permanent Disability |
Symptoms
- SARS-CoV-2 test negative
- Muscular weakness
- Exposure during pregnancy
- Facial paresis
- Adverse event
- Immunoglobulin therapy
- Guillain-Barre syndrome
Current Illness
Preexisting Conditions
Other Medications
Previous Vaccinations
Allergies
Laboratory Data
Test Date: 20210110; Test Name: COVID-19 PCR test (Nasal Swab); Test Result: Negative
Write-up
Patient developed GBS with 4 extremity weakness and facial weakness; Patient developed GBS with 4 extremity weakness and facial weakness; Patient developed GBS with 4 extremity weakness and facial weakness; This is a spontaneous report from a contactable pharmacist (patient).
A 37-year-old non-pregnant female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot.
Ek5730) at single dose, in the right arm, on 18Dec2020, at 03:30 PM, for COVID-19 immunisation.
Relevant medical history and concomitant medications were unknown.
The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine.
The patient had not experienced Covid-19 prior vaccination.
On 18Dec2020, at 07:00 PM, the patient developed Guillain-Barre syndrome (GBS) with 4 extremity weakness and facial weakness.
Emergency Room Visit required.
Hospitalization required (7 days admission in hospital).
Treatment required: IVIG.
The adverse events were assessed as serious (hospitalization and disability).
Clinical outcome of the adverse events was recovering at time of this report.
Post the vaccination, on 10Jan2021, the patient has been tested for COVID-19 and resulted negative.
COVID-19 test type post vaccination: COVID-19 PCR test (Nasal Swab).
; Sender's Comments: Based on the close temporal relationship, the association between the events Guillain-Barre syndrome (GBS) with 4 extremity weakness and facial weakness with BNT162b2 can not be completely 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.