Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19 treated with Paxlovid; Lack of drug effect; Recurrence of covid symptoms; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Recurrence of covid symptoms), COVID-19 (COVID-19 treated with Paxlovid) and DRUG INEFFECTIVE (Lack of drug effect) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A, 013A21A and 007M20A) for COVID-19 vaccination.  The patient's past medical history included Atrial flutter. Concurrent medical conditions included Drug allergy (unspecified drug).  On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Recurrence of covid symptoms). On an unknown date, the patient experienced COVID-19 (COVID-19 treated with Paxlovid) and DRUG INEFFECTIVE (Lack of drug effect). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 04-May-2022 to 08-May-2022 for COVID-19 treatment, at a dose of 1 dosage form and ACETAMINOPHEN from 01-May-2022 to 05-May-2022 at a dose of 1 dosage form. At the time of the report, COVID-19 (Recurrence of covid symptoms) was resolving and COVID-19 (COVID-19 treated with Paxlovid) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  It was reported that patient received unspecified medications within 2 weeks of starting of COVID-19 treatment. The device date was 18-May-2022.  Company comment: This is a spontaneous case concerning a 63-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19 (reported as COVID-19 and COVID-19 recurrent), which occurred approximately 6 months after receiving third dose of mRNA-1273 vaccine. Patient previously received a 2-dose primary series of mRNA-1273 vaccine given at an interval of 28 days, which falls within the recommended vaccine dosing schedule. The second dose of mRNA-1273 vaccine was given approximately 7 months prior to the third dose. Additionally, Drug ineffective was also included as an event. The patient had initial infection of COVID-19 and was treated with 5-day-course of Paxlovid and acetaminophen. Five days after completion of Paxlovid treatment, patient noted recurrence of COVID-19 symptoms. No further details about the diagnostic procedures were provided. Patient reported that the event COVID-19 recurrent was resolving. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 63-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19 (reported as COVID-19 and COVID-19 recurrent), which occurred approximately 6 months after receiving third dose of mRNA-1273 vaccine. Patient previously received a 2-dose primary series of mRNA-1273 vaccine given at an interval of 28 days, which falls within the recommended vaccine dosing schedule. The second dose of mRNA-1273 vaccine was given approximately 7 months prior to the third dose. Additionally, Drug ineffective was also included as an event. The patient had initial infection of COVID-19 and was treated with 5-day-course of Paxlovid and acetaminophen. Five days after completion of Paxlovid treatment, patient noted recurrence of COVID-19 symptoms. No further details about the diagnostic procedures were provided. Patient reported that the event COVID-19 recurrent was resolving. The benefit-risk relationship of mRNA-1273 is not affected by this report.