Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: COVID-19 infection; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19 infection) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L21B, 065D21A, 010A21A and 010M20A) for COVID-19 vaccination.     The patient's past medical history included Kidney stones. Concurrent medical conditions included Blood pressure high and Drug allergy (The patient had allergy to unknown drug). Concomitant products included LOSARTAN and AMOXICILLIN TRIHYDRATE, CLAVULANATE POTASSIUM (AMOXICLAV) from 19-May-2022 to 22-May-2022 for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19 infection). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 18-May-2022 to 23-May-2022 for COVID-19 treatment, at an unspecified dose and frequency and NIRMATRELVIR, RITONAVIR (PAXLOVID) on 01-Jun-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19 infection) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jun-2022, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.         The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. It was reported that patient had reoccurring Covid symptoms in 6 days after treatment with paxlovid. Tested positive again in 9 days after treatment. Device Date was reported as 02-Jun-2022.  Company  Comment: This Spontaneous case concerns a 58-year-old female patient, with no relevant medical history, who experienced the unexpected, non-serious RA of COVID-19, which occurred approximately 1 months after the fourth dose of mRNA-1273 vaccine. Patient completed treatment for COVID-19 with Nirmatrelvir, Ritonavir (Paxlovid) for 5 days. It was reported that 6 days after completing this treatment, symptoms of COVID-19 reoccurred, and patient tested positive again 9 days after treatment. At the time of the report, the event was resolving. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-582888 (Patient Link). Sender's Comments: This Spontaneous case concerns a 58-year-old female patient, with no relevant medical history, who experienced the unexpected, non-serious RA of COVID-19, which occurred approximately 1 months after the fourth dose of mRNA-1273 vaccine. Patient completed treatment for COVID-19 with Nirmatrelvir, Ritonavir (Paxlovid) for 5 days. It was reported that 6 days after completing this treatment, symptoms of COVID-19 reoccurred, and patient tested positive again 9 days after treatment. At the time of the report, the event was resolving. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.