Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID on April 29, 2022; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID on April 29, 2022) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017f21a, 012m20a and 011a21a) for COVID-19 vaccination.     Concurrent medical conditions included Shellfish allergy. Concomitant products included VITAMIN D [VITAMIN D NOS] for Vitamin D supplementation.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2022, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Tested positive for COVID on April 29, 2022). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 29-Apr-2022 to 04-May-2022 for COVID-19, at a dose of 1 dosage form. At the time of the report, COVID-19 (Tested positive for COVID on April 29, 2022) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Apr-2022, SARS-CoV-2 test: positive (Positive) Positive. On 10-May-2022, SARS-CoV-2 test: positive (Positive) Positive (Rapid was immediately positive).         It was reported that patient felt better by the following day, and the symptoms again started on 08-May-2022.  Company Comment:  This is a spontaneous case concerning a 40-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19 supported by a positive SARS-CoV-2 test, which occurred 6 months and 8 days after receiving the third dose of mRNA-1273 vaccine. Patient also received 2 doses of mRNA-1273 vaccine with 28 days interval, approximately 7 months prior to the third dose. Patient immediately started taking Paxlovid for 6 days and patient felt better by the following day. However, symptoms started again 4 days post-treatment of Paxlovid and patient was again tested positive for COVID-19. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 40-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19 supported by a positive SARS-CoV-2 test, which occurred 6 months and 8 days after receiving the third dose of mRNA-1273 vaccine. Patient also received 2 doses of mRNA-1273 vaccine with 28 days interval, approximately 7 months prior to the third dose. Patient immediately started taking Paxlovid for 6 days and patient felt better by the following day. However, symptoms started again 4 days post-treatment of Paxlovid and patient was again tested positive for COVID-19. The benefit-risk relationship of mRNA-1273 is not affected by this report.