Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Tested positive for Covid19) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Drug allergy (Drug: Neosporin; Reaction: Allergy).   On 19-Jan-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021 at 1:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021 at 2:00 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2022 at 2:00 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Tested positive for Covid19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 18-May-2022 to 22-May-2022 for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (Tested positive for Covid19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-May-2022, SARS-CoV-2 test: positive (Positive) Tested positive for Covid19. On 29-May-2022, SARS-CoV-2 test: positive (Positive) tested positive again.         Patient was taking other medications/products within 2 weeks of starting COVID-19 treatment.  Patient took concomitant medications 'NOVADOZ PH' with active substance Atorvastatin 40 mg from 01May2022 to 24May2022 and 'ASCEND LAB' with active drug substance Amlodipine besylaye [sic] 2.5 mg from 01May2022 to 24May2022.  Patient previously received a COVID-19 vaccine.  Device date was reported as 31May2022.  Company Comment: This spontaneous case concerns a 74-year-old, male patient with past drug history of administration of three doses of the mRNA-1273 vaccine, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred approximately 1 month after receiving the fourth dose of the mRNA-1273 vaccine. The patient initially tested positive for SARS-CoV-2. He took and completed a 5-day course of Paxlovid (nirmatrelvir, ritonavir) from 18May2022 to 22May2022. It was reported that 7 days after the last dose of Paxlovid, the symptoms (sore throat) recurred and the patient again tested positive for SARS-CoV-2. No further details were provided The patient's advanced age (high risk for infections) remains a confounder. Of note, the patient's history of an underlying medical condition (not reported), which is probably being treated with the reported concomitant medication (amlodipine), also remains a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 74-year-old, male patient with past drug history of administration of three doses of the mRNA-1273 vaccine, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred approximately 1 month after receiving the fourth dose of the mRNA-1273 vaccine. The patient initially tested positive for SARS-CoV-2. He took and completed a 5-day course of Paxlovid (nirmatrelvir, ritonavir) from 18May2022 to 22May2022. It was reported that 7 days after the last dose of Paxlovid, the symptoms (sore throat) recurred and the patient again tested positive for SARS-CoV-2. No further details were provided The patient's advanced age (high risk for infections) remains a confounder. Of note, the patient's history of an underlying medical condition (not reported), which is probably being treated with the reported concomitant medication (amlodipine), also remains a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.