Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Symptoms returned 5/11 and posttive test result, symptoms 10x worse; Positive for covid with mild symptoms; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Positive for covid with mild symptoms) and COVID-19 (Symptoms returned 5/11 and posttive test result, symptoms 10x worse) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041521a) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2022 at 9:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Positive for covid with mild symptoms). On 11-May-2022, the patient experienced COVID-19 (Symptoms returned 5/11 and posttive test result, symptoms 10x worse). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 02-May-2022 to 06-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. On 06-May-2022, COVID-19 (Positive for covid with mild symptoms) had resolved. At the time of the report, COVID-19 (Symptoms returned 5/11 and posttive test result, symptoms 10x worse) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On 06-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 11-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medication information was provided.  Company comment: This spontaneous case concerns a 44 year old female patient with no reported medical history, who experienced the unexpected non serious AESI of COVID-19, about 3 months and 24 days;  the unexpected non serious AESI of COVID-19, about 4 months and 3 days after receiving the third dose with mRNA-1273 vaccine in the COVID-19 vaccination series. The patient was positive initially with mild symptoms which lasted for 5 days when she was treated with Paxlovid. Symptoms worsened the second time. She tested positive for COVID-19 during the first time followed by negative test result and tested positive again for the second time. No further information on risk factors, co morbidities and details pertaining to the previous doses was available in the report. The event which occurred for the second time was resolving. COVID-19 pandemia could be confounding for the events. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 44 year old female patient with no reported medical history, who experienced the unexpected non serious AESI of COVID-19, about 3 months and 24 days;  the unexpected non serious AESI of COVID-19, about 4 months and 3 days after receiving the third dose with mRNA-1273 vaccine in the COVID-19 vaccination series. The patient was positive initially with mild symptoms which lasted for 5 days when she was treated with Paxlovid. Symptoms worsened the second time. She tested positive for COVID-19 during the first time followed by negative test result and tested positive again for the second time. No further information on risk factors, co morbidities and details pertaining to the previous doses was available in the report. The event which occurred for the second time was resolving. COVID-19 pandemia could be confounding for the events. The benefit-risk relationship of mRNA-1273 is not affected by this report.