Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Covid-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Covid-19) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066K21A, 025A21A, 026A21A and 039D21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Covid-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 22-Apr-2022 to 26-Apr-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Covid-19) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Apr-2022, SARS-CoV-2 test: positive (Positive) Positive. On 01-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medication information provided. It was reported that patient took treatment of COVID-19 from 22-Apr-2022 to 26-Apr-2022 with Paxlovid. Patient experienced Moderate gastric discomfort while taking Paxlovid.  Company comment: This spontaneous case concerns a 78-year-old elderly female patient with no relevant medical history who experienced the unexpected non serious AESI of COVID 19 which occurred approximately 23 days after the administration of fourth dose of mRNA-1273 vaccine. Initial Covid symptoms were mild, like a cold and intense sneezing. Patient received NIRMATRELVIR, RITONAVIR (Paxlovid) for 5 days as treatment for COVID 19 from 22-Apr to 26-Apr and the symptoms resolved. 3 days later the symptoms returned, and patient again tested positive for COVID 19 on 01-May. Patient received 3 doses of mRNA-1273 vaccine approximately 4, 12 and 13 months respectively, prior to the last dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 78-year-old elderly female patient with no relevant medical history who experienced the unexpected non serious AESI of COVID 19 which occurred approximately 23 days after the administration of fourth dose of mRNA-1273 vaccine. Initial Covid symptoms were mild, like a cold and intense sneezing. Patient received NIRMATRELVIR, RITONAVIR (Paxlovid) for 5 days as treatment for COVID 19 from 22-Apr to 26-Apr and the symptoms resolved. 3 days later the symptoms returned, and patient again tested positive for COVID 19 on 01-May. Patient received 3 doses of mRNA-1273 vaccine approximately 4, 12 and 13 months respectively, prior to the last dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.