Adverse Event Reporting
| VAERS ID | 985933 |
|---|---|
| Gender | Female |
| Age | |
| StateCode | |
| Pharmaceutical Company | MODERNA |
| Lot Number | |
| Number of vaccinations | 1 |
| Vaccinated | 2020-12-29 |
| Onset | 2020-12-30 |
| Condition | Died |
Symptoms
- Pyrexia
- Erythema
- Dyspnoea
- Chest X-ray abnormal
- Respiratory rate increased
- Blood urea increased
- Blood creatinine increased
- White blood cell count increased
- Influenza virus test negative
- Pulmonary congestion
- Death
- Leukocytosis
- Lung infiltration
Current Illness
Preexisting Conditions
Medical History/Concurrent Conditions: Dementia; Walking disability
Other Medications
Previous Vaccinations
Allergies
Laboratory Data
Test Date: 20201231; Test Name: creatinine; Test Result: Inconclusive ; Test Date: 20201231; Test Name: BUN; Test Date: 20201231; Test Name: Temperature; Result Unstructured Data: °F; Test Date: 20201231; Test Name: CXR; Test Result: Inconclusive ; Result Unstructured Data: mild left lower lung infiltrate; Test Date: 20201231; Test Name: Pulse; Test Result: Inconclusive ; Result Unstructured Data: Heart beats per minute; Test Date: 20201231; Test Name: Flu swab; Test Result: Negative ; Result Unstructured Data: negative; Test Date: 20201231; Test Name: O2; Test Result: Inconclusive ; Result Unstructured Data: Percent Room air; Test Date: 20201231; Test Name: WBC
Write-up
Died; Increased respirations (22 and labored at times); Pulse 105; 94% O2 on RA; Labored breathing at times; leukocytosis; elevated BUN; left lower lung congestion; elevated creatinine; Temperature of 102.
0F; Redness on face; A spontaneous report was received from a nurse concerning a 92-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced redness on face, increased respirations, labored breathing at times, temperature of 102F, pulse of 105, 94 percent O2, leukocytosis, elevated BUN, left lower lung congestion, elevated creatinine, and death.
The patient's medical history, as provided by the reporter, included dementia and reduced mobility.
No relevant concomitant medications were reported.
On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.
On 30 Dec 2020, the patient began to experience redness on her face, increased respirations (reported as 22 and labored at times), pulse of 105, and 94 percent oxygen saturation on room air.
The patient had a fever of 102 degrees Fahrenheit.
Laboratory tests revealed a negative influenza swab, elevated white blood cell count of 14.
1, elevated BUN at 113, and creatinine 2.
7.
Chest x-ray showed mild, left lower lung infiltrate.
On 31 Dec 2020, the patient went under hospice care per her family request.
.
Action taken with mRNA-1273 in response to the events was not applicable.
The patient died on 01 Jan 2021, the cause of death was unknown.
; Reporter's Comments: This case concerns a 92-year-old, female subject with medical history of dementia and reduced mobility, who experienced the serious unexpected events of death, respiratory rate increased, heart rate increased, oxygen saturation decreased, elevated BUN, elevated creatinine, left lung congestion and dyspnoea and the non-serious events of erythema and pyrexia.
The events of respiratory rate increased, heart rate increased, oxygen saturation decreased, dyspnoea, erythema and pyrexia occurred 2 days after the first dose of the study medication administration, and the event of death occurred 4 days after the first dose of the study medication administration.
Very limited information regarding the events is available at this time and no definite diagnosis or autopsy report have been provided.
Additional information has been requested.
; Reported Cause(s) of Death: Died