Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: On 27-May-2022, developed a runny nose, some body aches and slight fever/COVID positive on 28-May-2022; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (On 27-May-2022, developed a runny nose, some body aches and slight fever/COVID positive on 28-May-2022) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002m21a, 026d21a, 028a21a and 036a21a) for COVID-19 vaccination.     Concurrent medical conditions included Latent autoimmune diabetes in adults and Drug allergy. Concomitant products included INSULIN GLARGINE, LIXISENATIDE (SOLIQUA) from 09-May-2022 to 23-May-2022 for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-May-2022 at 5:00 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (On 27-May-2022, developed a runny nose, some body aches and slight fever/COVID positive on 28-May-2022). 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. At the time of the report, COVID-19 (On 27-May-2022, developed a runny nose, some body aches and slight fever/COVID positive on 28-May-2022) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-May-2022, SARS-CoV-2 test: positive (Positive) COVID antigen test taken on May 28 was strongly positive.         Concomitant medication also included an unknown drug from 09-May-2022 to 23-May-2022 for headache relief. It was reported that The 5-day Paxlovid course of treatment (May 18 pm -May 23 am) reduced the patient's symptoms except for some fatigue. Then on 27-May-2022, patient developed a runny nose, some body aches and slight fever. A COVID antigen test taken on 28-May-2022 was strongly positive. The patient stated that the patient continue to have these symptoms on 29-May-2022. No treatment was received. COMPANY COMMENT: This is an spontaneous case concerning a 66-years-old female patient with medical history of Latent autoimmune diabetes in adults and Drug allergy, Moderna COVID-19 Vaccine on3/4, 4/1, 11/17 of 2021 and 4/15, 2022, Concomitant products included INSULIN GLARGINE, LIXISENATIDE and PAXLOVID from 18-May-2022 to 23-May-2022 for COVID-19 treatment who experienced the unexpected event of COVID-19 (AESI) 13 days after 4th  dose of  mRNA-1273 vaccine. On 28-May-2022, SARS-CoV-2 test: positive The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event´s seriousness assessed as reporting.; Sender's Comments: COMPANY COMMENT: This is an spontaneous case concerning a 66-years-old female patient with medical history of Latent autoimmune diabetes in adults and Drug allergy, Moderna COVID-19 Vaccine on3/4, 4/1, 11/17 of 2021 and 4/15, 2022, Concomitant products included INSULIN GLARGINE, LIXISENATIDE and PAXLOVID from 18-May-2022 to 23-May-2022 for COVID-19 treatment who experienced the unexpected event of COVID-19 (AESI) 13 days after 4th  dose of  mRNA-1273 vaccine. On 28-May-2022, SARS-CoV-2 test: positive The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event´s seriousness assessed as reporting.