Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test
Clinical narrative: symptoms of Covid recurred within days/continued testing positive.; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (symptoms of Covid recurred within days/continued testing positive.) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066194A, 004F21A, 039B21A and 030A21A) for COVID-19 vaccination.     Allergic reaction was reported for Medications.  Concurrent medical conditions included Inclusion body myositis, Rheumatoid arthritis, Irritable bowel syndrome and Sleep apnea.   On 22-Mar-2021 at 1:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021 at 2:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Aug-2021 at 3:30 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2022 at 11:00 AM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (symptoms of Covid recurred within days/continued testing positive.). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 20-May-2022 to 24-May-2022 for COVID-19, at an unspecified dose and frequency and KETOROLAC TROMETHAMINE (TORADOL) for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (symptoms of Covid recurred within days/continued testing positive.) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-May-2022, SARS-CoV-2 antibody test: positive (Positive) Positive. In 2022, SARS-CoV-2 antibody test: positive (Positive) positive.         Patient was not taking other medications/products within 2 weeks of starting COVID-19 treatment. Patient previously received a COVID-19 Vaccine. 26-MAY-2022 at 8 AM, patient's symptoms of COVID recurred within days of completing her 5-day prescribed treatment( treatment with Paxlovid,). She continued testing positive. Her symptoms had continued through the present and included one trip to the ER .Treatment received for the adverse event was reported as IV fluids. Device date was reported as 02-Jun-2022.  Company comment: This spontaneous case concerns a 60 year old female patient with no relevant medical history, who experienced the unexpected non serious AESI of COVID-19, about 1 month and 25 days after receiving the fourth dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient received the primary series of mRNA-1273 vaccine in accordance with the recommended schedule and the third dose with mRNA-1273 vaccine about 7 months ago, with no reported adverse events. The patient was started on Paxlovid for COVID-19 infection for 5 days. Her symptoms returned within a few days of completing the treatment. She tested positive for COVID-19 and had to visit the ER where she was treated with ketorolac and IV fluids. The ongoing COVID-19 pandemic could be a confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-583742 (Patient Link).; Sender's Comments: This spontaneous case concerns a 60 year old female patient with no relevant medical history, who experienced the unexpected non serious AESI of COVID-19, about 1 month and 25 days after receiving the fourth dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient received the primary series of mRNA-1273 vaccine in accordance with the recommended schedule and the third dose with mRNA-1273 vaccine about 7 months ago, with no reported adverse events. The patient was started on Paxlovid for COVID-19 infection for 5 days. Her symptoms returned within a few days of completing the treatment. She tested positive for COVID-19 and had to visit the ER where she was treated with ketorolac and IV fluids. The ongoing COVID-19 pandemic could be a confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.