Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for Covid and my symptoms appeared/fever, headache, achiness, cold symptoms/still fatigued/became ill again with a low-grade fever, headache, cold symptoms and a cough.; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (tested positive for Covid and my symptoms appeared/fever, headache, achiness, cold symptoms/still fatigued/became ill again with a low-grade fever, headache, cold symptoms and a cough.) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 057M21A, 030H21B, 048B21A and 006B21A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Latex allergy. Concomitant products included ALENDRONATE SODIUM, ESTRADIOL (VAGIFEM) and CETIRIZINE HYDROCHLORIDE (ALLER TEC) for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-May-2022 at 8:00 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 14-May-2022, the patient experienced COVID-19 (tested positive for Covid and my symptoms appeared/fever, headache, achiness, cold symptoms/still fatigued/became ill again with a low-grade fever, headache, cold symptoms and a cough.). At the time of the report, COVID-19 (tested positive for Covid and my symptoms appeared/fever, headache, achiness, cold symptoms/still fatigued/became ill again with a low-grade fever, headache, cold symptoms and a cough.) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         It was reported that within three days, the symptoms (fever, headache, achiness, cold symptoms) had largely disappeared, but the patient was still fatigued. Then one week later, patient became ill again with a low-grade fever, headache, cold symptoms, and a cough. It was reported that the patient had been isolating during that time, so it was unlikely contracted a different illness) Company comment: This spontaneous case concerns a 60-year-old, female patient with no relevant medical history, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred 13 days after administration of fourth dose of mRNA-1273, the initial two doses of mRNA-1273 were given approximately 13 months prior, the interval between the two doses 29 days, the third dose of mRNA-1273 was given 6 months prior. It has been reported that within three days fever, headache, achiness, cold symptoms had resolved but fatigued persisted. After one week, the symptoms recurred. On May 14, 2022, SARS-CoV-2 test was done which revealed a positive result. Details of concomitant medications, clinical course, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 60-year-old, female patient with no relevant medical history, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred 13 days after administration of fourth dose of mRNA-1273, the initial two doses of mRNA-1273 were given approximately 13 months prior, the interval between the two doses 29 days, the third dose of mRNA-1273 was given 6 months prior. It has been reported that within three days fever, headache, achiness, cold symptoms had resolved but fatigued persisted. After one week, the symptoms recurred. On May 14, 2022, SARS-CoV-2 test was done which revealed a positive result. Details of concomitant medications, clinical course, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.