Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (COVID-19) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001M21A and 035C21A) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: COVID 19 vaccine (Dose 1) on 11-Feb-2021 and COVID 19 vaccine (Dose 2) on 11-Mar-2021. Past adverse reactions to the above products included No adverse event with COVID 19 vaccine and COVID 19 vaccine. Concurrent medical conditions included Arthritis, Cataract, Fibrocystic breast (lifelong), GERD, Hyperlipidemia, Sinusitis and Sulfonamide allergy (Sulfa (sulfonamide antibiotics)). Concomitant products included SIMVASTATIN from 12-Aug-2020 to an unknown date for an unknown indication.   On 24-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2022, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) (oral) from 13-May-2022 to 18-May-2022 for COVID-19 treatment, at an unspecified dose and frequency and ONDANSETRON (ZOFRAN [ONDANSETRON]) for Nausea, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that Patient had been traveling and tested positive for COVID. Patient started on Paxlovid, and tolerated COVID well initially, but her symptoms remained mild and while on Paxlovid. Patient remained in isolation at home despite feeling quite well initially. Patient experienced COVID rebound and was much more profound than they initially ever were. Patient tested positive for COVID again, despite not being in contact with any other people since her initial diagnosis of COVID. Patient experienced headache, fatigue, nasal congestion, sore throat, heaviness in her chest, low grade fevers, general weakness, and profound sinus pressure. Patient also had nausea and had been managing this with Zofran. Rebound Covid-19 onset date was reported as 23-May-2022. Device date was reported as 25-May-2022  Company Comment This is a spontaneous case concerning a 68-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19, which occurred on the same month after receiving the second mRNA-1273 vaccine as fourth COVID-19 vaccination. Patient had received 2-dose primary series of unspecified COVID-19 vaccine with no reported adverse event, approximately 7 months prior to the first mRNA-1273 vaccination and 14 months prior to the second mRNA-1273 vaccination. Initially, patient reported that she had been traveling and tested positive for COVID-19. Patient sought consultation through telemedicine and was given a six-day-course of Paxlovid treatment which was well-tolerated. Patient reported that her symptoms remained mild while on Paxlovid and remained in isolation at home despite feeling quite well initially. However, COVID-19 symptoms have recurred which were more profound and tested positive again for COVID-19, despite not being in contact with any other people since her initial diagnosis of COVID-19. Patient experienced nausea, headache, fatigue, nasal congestion, sore throat, chest heaviness, low grade fever, general weakness, and profound sinus pressure. Patient took Zofran for nausea. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This is a spontaneous case concerning a 68-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19, which occurred on the same month after receiving the second mRNA-1273 vaccine as fourth COVID-19 vaccination. Patient had received 2-dose primary series of unspecified COVID-19 vaccine with no reported adverse event, approximately 7 months prior to the first mRNA-1273 vaccination and 14 months prior to the second mRNA-1273 vaccination. Initially, patient reported that she had been traveling and tested positive for COVID-19. Patient sought consultation through telemedicine and was given a six-day-course of Paxlovid treatment which was well-tolerated. Patient reported that her symptoms remained mild while on Paxlovid and remained in isolation at home despite feeling quite well initially. However, COVID-19 symptoms have recurred which were more profound and tested positive again for COVID-19, despite not being in contact with any other people since her initial diagnosis of COVID-19. Patient experienced nausea, headache, fatigue, nasal congestion, sore throat, chest heaviness, low grade fever, general weakness, and profound sinus pressure. Patient took Zofran for nausea. The benefit-risk relationship of mRNA-1273 is not affected by this report.