Adverse Event Reporting

VAERS ID 2309439
Gender Female
Age 60
StateCode GA
Pharmaceutical Company MODERNA
Lot Number 006B21A
Number of vaccinations 1
Vaccinated 2021-03-22
Onset
Condition
Symptoms
  • COVID-19

Current Illness

Allergy (Name of Drug was not Reported); Asthma

Preexisting Conditions

Other Medications

PAXLOVID

Previous Vaccinations

Allergies

Laboratory Data

Write-up

COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos.
036B21A and 006B21A) for COVID-19 vaccination.
Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.
Concurrent medical conditions included Asthma and Allergy (Name of Drug was not Reported).
On 22-Mar-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.
On 19-Apr-2021 at 2:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.
On 04-Jan-2022 at 4:45 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.
On 21-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose.
On an unknown date, the patient experienced COVID-19 (COVID-19).
At the time of the report, COVID-19 (COVID-19) outcome was unknown.
No concomitant medication was reported.
The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment.
The patient had previously received a COVID-19 Vaccine.
The patient had sore throat returning 9 days later.
Device date mentioned as 30-May-2022 No treatment medication was reported.
Company comment: This spontaneous case concerns a 60-year-old female patient, with concurrent asthma, who experienced the unexpected non-serious adverse event of special interest COVID-19, which occurred at an unspecified date after receiving a dose of mRNA1273.
The patient was initially diagnosed with COVID-19 and was started with Nirmatrelvir/Ritonavir (Paxlovid) for 5 days.
Patient reported sore throat returning 9 days later.
Further details regarding the diagnostic test done and clinical course of the patient were not provided.
The patient's elderly age and concurrent asthma may be considered as risk factors for the event COVID-19.
The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
; Sender's Comments: This spontaneous case concerns a 60-year-old female patient, with concurrent asthma, who experienced the unexpected non-serious adverse event of special interest COVID-19, which occurred at an unspecified date after receiving a dose of mRNA1273.
The patient was initially diagnosed with COVID-19 and was started with Nirmatrelvir/Ritonavir (Paxlovid) for 5 days.
Patient reported sore throat returning 9 days later.
Further details regarding the diagnostic test done and clinical course of the patient were not provided.
The patient's elderly age and concurrent asthma may be considered as risk factors for the event COVID-19.
The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.