Adverse Event Reporting
| VAERS ID | 2354632 |
|---|---|
| Gender | Male |
| Age | 79 |
| StateCode | FR |
| Pharmaceutical Company | MODERNA |
| Lot Number | 000088A |
| Number of vaccinations | 5 |
| Vaccinated | 2020-06-24 |
| Onset | 2022-06-24 |
| Condition | Permanent Disability |
Symptoms
- Arthralgia
- Fatigue
- Dizziness
- Dyspnoea
- SARS-CoV-2 test
- Wound complication
Current Illness
Preexisting Conditions
Medical History/Concurrent Conditions: CLL; Suspected COVID-19
Other Medications
BETAHISTINE; RIBAVIRIN MILPHARM
Previous Vaccinations
Allergies
Laboratory Data
Test Date: 20220421; Test Name: COVID-19 virus test; Result Unstructured Data: test result = Yes - Positive COVID-19 test;
Write-up
Shortness of breath; Felt faint; Joint pain; Tired all the time; Wound itching; This case was received via Regulatory Authority.
This regulatory authority case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath), DIZZINESS (Felt faint), ARTHRALGIA (Joint pain), FATIGUE (Tired all the time) and WOUND COMPLICATION (Wound itching) in a 79-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no.
000088A) for COVID-19 vaccination.
The patient's past medical history included CLL and Suspected COVID-19 from 20-Apr-2022 to 27-Apr-2022.
Concomitant products included RIBAVIRIN (RIBAVIRIN MILPHARM) for Blood pressure high, BETAHISTINE from 16-Apr-2022 to an unknown date for Labyrinthitis.
On 24-Jun-2020, the patient received fifth dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form.
On 24-Jun-2022, the patient experienced DYSPNOEA (Shortness of breath) (seriousness criteria disability and medically significant), DIZZINESS (Felt faint) (seriousness criteria disability and medically significant), ARTHRALGIA (Joint pain) (seriousness criteria disability and medically significant), FATIGUE (Tired all the time) (seriousness criteria disability and medically significant) and WOUND COMPLICATION (Wound itching) (seriousness criteria disability and medically significant).
On 26-Jun-2022, WOUND COMPLICATION (Wound itching) had resolved.
At the time of the report, DYSPNOEA (Shortness of breath), DIZZINESS (Felt faint), ARTHRALGIA (Joint pain) and FATIGUE (Tired all the time) was resolving.
DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Apr-2022, SARS-CoV-2 test: positive test result = Yes - Positive COVID-19 test;.
The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown.
Patient has not tested positive for COVID-19 since having the vaccine.
Patient was not enrolled in clinical trial.
No treatment drugs were reported.
The report did not relate to possible myocarditis or pericarditis.
Company comment: This regulatory case concerns a 79-year-old, male patient with medical history of Chronic lymphocytic leukemia, High blood pressure and Labyrinthitis, who experienced the unexpected, serious (Medically significant, Disability) events of Dyspnoea, Dizziness, Arthralgia, Fatigue and Wound complication.
The events occurred on the same day of administration of fifth dose of mRNA-1273, there was no information provided regarding the initial doses.
The patient's medical condition of Chronic lymphocytic leukemia could be a confounder to the events Dyspnoea, Dizziness, Fatigue and Wound complication, the patient's medical condition of Labyrinthitis could be a confounder to the event Dizziness.
On April 21, 2022, patient took a SARS-CoV-2 which revealed a positive result.
The events were resolving at the time of report.
The benefit-risk relationship of mRNA-1273 is not affected by this report.
Events' seriousness retained as per Regulatory Authority's report.
; Sender's Comments: This regulatory case concerns a 79-year-old, male patient with medical history of Chronic lymphocytic leukemia, High blood pressure and Labyrinthitis, who experienced the unexpected, serious (Medically significant, Disability) events of Dyspnoea, Dizziness, Arthralgia, Fatigue and Wound complication.
The events occurred on the same day of administration of fifth dose of mRNA-1273, there was no information provided regarding the initial doses.
The patient's medical condition of Chronic lymphocytic leukemia could be a confounder to the events Dyspnoea, Dizziness, Fatigue and Wound complication, the patient's medical condition of Labyrinthitis could be a confounder to the event Dizziness.
On April 21, 2022, patient took a SARS-CoV-2 which revealed a positive result.
The events were resolving at the time of report.
The benefit-risk relationship of mRNA-1273 is not affected by this report.
Events' seriousness retained as per Regulatory Authority's report.