Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Initial COVID-19 infection prior to COVID-19 treatment; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Initial COVID-19 infection prior to COVID-19 treatment) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939903, 044A21A and 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypercholesterolemia, Vertigo, Obesity, Prediabetes, Blood pressure increased and Drug allergy (Hydrocodone). Concomitant products included POTASSIUM CITRATE, VITAMIN C [ASCORBIC ACID] from 17-May-2022 to an unknown date, VITAMIN D3, PRAVASTATIN SODIUM (PRAVACHOL) and ALLOPURINOL (ZYLOPRIM) for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2022, the patient experienced COVID-19 (Initial COVID-19 infection prior to COVID-19 treatment). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) (oral) from 17-May-2022 to 22-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Initial COVID-19 infection prior to COVID-19 treatment) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 28-May-2022, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was taking other unspecified medications/products within 2 weeks of starting COVID-19 treatment.  The patient had recurring cold/flu symptoms, but much milder.  Company Comment:  This is a spontaneous case concerning a 64-year-old male patient with no relevant medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19, described as initial COVID-19 infection prior to COVID-19 treatment, which occurred approximately 5 months after receiving the third dose of mRNA-1273 vaccine. Patient had received 2-dose primary series of mRNA-1273 vaccine with no reported adverse event, given at an interval of 28 days which falls within the recommended vaccine dosing schedule, approximately 9 months prior to third mRNA-1273 vaccination. Patient was given a five-day-course of Paxlovid treatment for the initial COVID-19 infection and was tested negative for COVID-19 on the next day. However, six days after the completion of Paxlovid treatment, patient noted recurrence of cold and flu symptoms and was tested positive for COVID-19. Outcome of the event for the initial COVID-19 infection had resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 64-year-old male patient with no relevant medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19, described as initial COVID-19 infection prior to COVID-19 treatment, which occurred approximately 5 months after receiving the third dose of mRNA-1273 vaccine. Patient had received 2-dose primary series of mRNA-1273 vaccine with no reported adverse event, given at an interval of 28 days which falls within the recommended vaccine dosing schedule, approximately 9 months prior to third mRNA-1273 vaccination. Patient was given a five-day-course of Paxlovid treatment for the initial COVID-19 infection and was tested negative for COVID-19 on the next day. However, six days after the completion of Paxlovid treatment, patient noted recurrence of cold and flu symptoms and was tested positive for COVID-19. Outcome of the event for the initial COVID-19 infection had resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.