Adverse Event Reporting
| VAERS ID | 1333063 |
|---|---|
| Gender | Female |
| Age | 87 |
| StateCode | FR |
| Pharmaceutical Company | MODERNA |
| Lot Number | |
| Number of vaccinations | 1 |
| Vaccinated | 2021-01-29 |
| Onset | 2021-03-09 |
| Condition | Died |
Symptoms
- Seizure
- Death
- Hypokinesia
- General physical health deterioration
- Apraxia
Current Illness
Preexisting Conditions
Medical History/Concurrent Conditions: COVID-19 (Reported no significant symptoms, no complications and with favorable progress.); Dementia
Other Medications
Previous Vaccinations
Allergies
Laboratory Data
Write-up
Inability to swallow; Inability to move spontaneously; Gradual decline in her general conditions; Death; multiple epileptic Seizure; This regulatory authority case was reported by a consumer and describes the occurrence of DEATH (Death), SEIZURE (multiple epileptic Seizure), APRAXIA (Inability to swallow), HYPOKINESIA (Inability to move spontaneously) and GENERAL PHYSICAL HEALTH DETERIORATION (Gradual decline in her general conditions) in an 87-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 vaccination.
The patient's past medical history included Dementia in 2020 and COVID-19 (Reported no significant symptoms, no complications and with favorable progress.
) in 2020.
On 29-Jan-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form.
On 05-Mar-2021, received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form.
On 09-Mar-2021, the patient experienced SEIZURE (multiple epileptic Seizure) (seriousness criterion medically significant).
On an unknown date, the patient experienced APRAXIA (Inability to swallow) (seriousness criterion medically significant), HYPOKINESIA (Inability to move spontaneously) (seriousness criterion medically significant) and GENERAL PHYSICAL HEALTH DETERIORATION (Gradual decline in her general conditions) (seriousness criterion medically significant).
The patient died on 10-Apr-2021.
The cause of death was not reported.
An autopsy was not performed.
At the time of death, SEIZURE (multiple epileptic Seizure) had not resolved and APRAXIA (Inability to swallow), HYPOKINESIA (Inability to move spontaneously) and GENERAL PHYSICAL HEALTH DETERIORATION (Gradual decline in her general conditions) outcome was unknown.
Patient experienced multiple epileptic seizures within a 24-hour period an event that to a gradual decline in her general conditions, including inability to swallow and inability to move spontaneously (from that moment, she could only move in a wheelchair).
Swallowing was compromised to the point that would not eat anything other than blended food.
Following the gradual decline, palliative care was set up.
No investigations of any kind were carried out by the medical staff.
Concomitant product use was not provided by the reporter.
This case concerns an 87-year-old woman, residing in a care home for elderly people, known to have dementia and previous COVID-19 disease in 2020, with no significant symptoms, no complications and with favourable progress.
Usual pharmacotherapy unknown.
No known allergies.
On 29-Jan-2021, the woman was vaccinated with the first dose of the Moderna Covid-19 vaccine.
No adverse reactions were reported.
Approximately one month later, on 05-Mar-2021, the woman was vaccinated with the second dose of the Moderna Covid-19 vaccine.
On 09-Mar-2021, the woman experienced multiple epileptic seizures within a 24-hour period, an event that to a gradual decline in here general conditions, including inability to swallow and inability to move spontaneously (from that moment, she could only move in a wheelchair).
Swallowing was compromised to the point that would not eat anything other than blended food.
Following the gradual decline, palliative care was set up.
The patient was confirmed deceased on 10-Apr-2021.
No investigations of any kind were carried out by the medical staff.
Action taken with m-RNA-1273 in response to the event was not applicable.
Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded.
Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Translation received.
Narrative updated.
; Sender's Comments: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded.
; Reported Cause(s) of Death: Unknown cause of death