Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid and symptoms returned; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Tested positive for Covid and symptoms returned) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergy to unknown drug), Arrhythmia (Irregular heart beat) and Chronic back pain (chronic back). Concomitant products included PREGABALIN (LYRICA), MAGNESIUM, MELATONIN, METOPROLOL, NALOXONE, TOPIRAMATE and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 14-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested positive for Covid and symptoms returned). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 23-May-2022 to 28-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Tested positive for Covid and symptoms returned) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         It was reported that the Device Date was 02-Jun-2022.  Patient tested positive for Covid on 31-May-2022 at 20:00, after treatment with Paxlovid, 3 days after completion and symptoms returned.    Company Comment: This spontaneous case concerns a 38-year-old, female patient with no relevant medical history who experienced the unexpected, non-serious adverse event of special interest of COVID-19 which occurred on unspecified interval after receiving the third dose of mRNA-1273 vaccine. There was no information regarding the first two doses of COVID-19 vaccination. Patient developed COVID-19 on unspecified date and was treated with 6-day course of Nirmatrelvir, Ritonavir (Paxlovid). Clinical presentation of COVID-19 was not specified however, patient developed recurrence of COVID-19 symptoms and positive SARS-CoV-2 test three days after completion of anti-viral treatment. The clinical course, diagnostic investigations, and treatment details after recurrence of symptoms were not reported. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 38-year-old, female patient with no relevant medical history who experienced the unexpected, non-serious adverse event of special interest of COVID-19 which occurred on unspecified interval after receiving the third dose of mRNA-1273 vaccine. There was no information regarding the first two doses of COVID-19 vaccination. Patient developed COVID-19 on unspecified date and was treated with 6-day course of Nirmatrelvir, Ritonavir (Paxlovid). Clinical presentation of COVID-19 was not specified however, patient developed recurrence of COVID-19 symptoms and positive SARS-CoV-2 test three days after completion of anti-viral treatment. The clinical course, diagnostic investigations, and treatment details after recurrence of symptoms were not reported. The benefit-risk relationship of mRNA-1273 is not affected by this report.