Adverse Event Reporting
| VAERS ID | 2023458 |
|---|---|
| Gender | Female |
| Age | 48 |
| StateCode | FR |
| Pharmaceutical Company | PFIZER\BIONTECH |
| Lot Number | |
| Number of vaccinations | 3 |
| Vaccinated | 2020-03-24 |
| Onset | 2021-12-01 |
| Condition | Permanent Disability |
Symptoms
- Hypoaesthesia
- SARS-CoV-2 test
- Vision blurred
Current Illness
Preexisting Conditions
Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped)
Other Medications
Previous Vaccinations
Allergies
Laboratory Data
Test Date: 20201113; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Positive
Write-up
Blurred vision; Numbness in hand; Numbness in feet; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26418477) on 31-Dec-2021 and was forwarded to Moderna on 31-Dec-2021.
This regulatory authority case was reported by an other health care professional and describes the occurrence of VISION BLURRED (Blurred vision), HYPOAESTHESIA (Numbness in hand) and HYPOAESTHESIA (Numbness in feet) in a 48-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication.
Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.
The patient's past medical history included Suspected COVID-19 (Unsure when symptoms stopped) on 11-Nov-2020.
On 24-Mar-2020, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form.
On 14-Jan-2021, the patient received third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form.
On 22-Dec-2021, received third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form.
In December 2021, the patient experienced HYPOAESTHESIA (Numbness in feet) (seriousness criterion disability).
On 22-Dec-2021, the patient experienced HYPOAESTHESIA (Numbness in hand) (seriousness criterion disability).
On 23-Dec-2021, the patient experienced VISION BLURRED (Blurred vision) (seriousness criterion disability).
At the time of the report, VISION BLURRED (Blurred vision), HYPOAESTHESIA (Numbness in hand) and HYPOAESTHESIA (Numbness in feet) had not resolved.
DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Nov-2020, SARS-CoV-2 test: positive (Positive) Positive.
The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown.
For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Concomitant product use was not provided by the reporter.
The patient had numbness in hands commenced few hours following booster vaccine.
Numbness in feet shortly afterwards.
Blurred vision commenced the following day.
Struggling to use left forefinger and middle finger.
Also pain in fingers to left hand.
Patient has not tested positive for COVID-19 since having the vaccine.
Patient was not enrolled in clinical trial.
Treatment information was not provided.
Company comment: This regulatory authority case concerns a 48 year old female patient with no relevant medical history, who experienced the serious (disability) unexpected events of blurred vision, hypoaesthesia in hand and hypoaesthesia in feet.
The event of hypoaesthesia in feet occurred on an unspecified date in December after the third dose of Covid-19 vaccine, the event on hypoaesthesia in hand occurred on the same day after the third dose, while the event of blurred vision occurred 1 day after the third dose.
Clinical course was as follows: The patient had numbness in hands which commenced few hours following booster vaccine.
Numbness in feet followed shortly afterwards.
Blurred vision commenced the following day.
Struggling to use left forefinger and middle finger.
Also experienced pain in fingers to left hand.
The rechallenge was not applicable as there are no plans for future dosing.
The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
; Sender's Comments: This regulatory authority case concerns a 48 year old female patient with no relevant medical history, who experienced the serious (disability) unexpected events of blurred vision, hypoaesthesia in hand and hypoaesthesia in feet.
The event of hypoaesthesia in feet occurred on an unspecified date in December after the third dose of Covid-19 vaccine, the event on hypoaesthesia in hand occurred on the same day after the third dose, while the event of blurred vision occurred 1 day after the third dose.
Clinical course was as follows: The patient had numbness in hands which commenced few hours following booster vaccine.
Numbness in feet followed shortly afterwards.
Blurred vision commenced the following day.
Struggling to use left forefinger and middle finger.
Also experienced pain in fingers to left hand.
The rechallenge was not applicable as there are no plans for future dosing.
The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.