Adverse Event Reporting
| VAERS ID | 2401562 |
|---|---|
| Gender | Female |
| Age | 51 |
| StateCode | FR |
| Pharmaceutical Company | NOVAVAX |
| Lot Number | |
| Number of vaccinations | |
| Vaccinated | |
| Onset | 2021-10-12 |
| Condition |
Symptoms
- Hypoaesthesia
- Dizziness
- Paraesthesia
- Chest discomfort
- Chest pain
- Pain
- Palpitations
- Neck pain
- Angina pectoris
- Insomnia
- Pericarditis
Current Illness
Preexisting Conditions
Other Medications
Colchicine
Previous Vaccinations
Allergies
Laboratory Data
Write-up
This regulatory authority case was reported by an other health care professional and describes the occurrence of ANGINA PECTORIS (Angina pectoris) and PERICARDITIS (Pericarditis) in a 51-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.
The occurrence of additional non-serious events is detailed below.
Co-suspect product included non-company product COVID-19 VACCINE PROT.
SUBUNIT (NVX COV 2373) (NUVAXOVID) for an unknown indication.
Concomitant products included COLCHICINE for an unknown indication.
On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form and dose of COVID-19 VACCINE PROT.
SUBUNIT (NVX COV 2373) (NUVAXOVID) (unknown route) 1 dosage form.
On 12-Oct-2021, the patient experienced ANGINA PECTORIS (Angina pectoris) (seriousness criterion medically significant), PERICARDITIS (Pericarditis) (seriousness criterion medically significant), CHEST DISCOMFORT (Chest discomfort), CHEST PAIN (Chest pain), INSOMNIA (Insomnia), NECK PAIN (Neck pain), PAIN (Pain), PALPITATIONS (Palpitations), DIZZINESS (Dizziness), HYPOAESTHESIA (Hypoaesthesia) and PARAESTHESIA (Paraesthesia).
At the time of the report, ANGINA PECTORIS (Angina pectoris), PERICARDITIS (Pericarditis), CHEST DISCOMFORT (Chest discomfort), CHEST PAIN (Chest pain), INSOMNIA (Insomnia), NECK PAIN (Neck pain), PAIN (Pain), PALPITATIONS (Palpitations), DIZZINESS (Dizziness), HYPOAESTHESIA (Hypoaesthesia) and PARAESTHESIA (Paraesthesia) had not resolved.
The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.
For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.
No relevant concomitant medications were reported.
No treatment information was provided.
The reference number was reported as AU-TGA-728377.
Company comment: This regulatory authority case reported by other health care professional, concerns a 51 year old female patient with no reported medical history, who experienced the unexpected, serious (medically significant) event of Angina pectoris and expected, serious (medically significant) event of Pericarditis, unknown days after receiving a dose of mRNA-1273 vaccine in the COVID-19 vaccination series.
The patient experienced chest pain, chest discomfort, dizziness and palpitations along with the events.
The patient also received a dose of NUVAXOVID COVID 19 vaccine on an unknown date.
Interchange of vaccine products was noted.
No information on risk factors, co morbidities, detailed clinical course, relevant investigations, treatment of the events and details pertaining to the dose schedule was available in the report.
The events had not resolved.
The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sender's Comments: This regulatory authority case reported by other health care professional, concerns a 51 year old female patient with no reported medical history, who experienced the unexpected, serious (medically significant) event of Angina pectoris and expected, serious (medically significant) event of Pericarditis, unknown days after receiving a dose of mRNA-1273 vaccine in the COVID-19 vaccination series.
The patient experienced chest pain, chest discomfort, dizziness and palpitations along with the events.
The patient also received a dose of NUVAXOVID COVID 19 vaccine on an unknown date.
Interchange of vaccine products was noted.
No information on risk factors, co morbidities, detailed clinical course, relevant investigations, treatment of the events and details pertaining to the dose schedule was available in the report.
The events had not resolved.
The benefit-risk relationship of mRNA-1273 is not affected by this report.