Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for covid May 12, 2022 and was symptomatic; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (tested positive for covid May 12, 2022 and was symptomatic) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076c21a, 012m20a and 026L20a) for COVID-19 vaccination.     Patient previously had received a COVID-19 Vaccine.  Concurrent medical conditions included Anxiety, Seasonal allergy, GERD and Allergy (unknown drug). Concomitant products included ESCITALOPRAM, LEVOCETIRIZINE and OMEPRAZOLE for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (tested positive for covid May 12, 2022 and was symptomatic). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 13-May-2022 to 18-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (tested positive for covid May 12, 2022 and was symptomatic) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On 18-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 26-May-2022, SARS-CoV-2 test: negative, despite worsening symptoms (Negative) Negative, despite worsening symptoms. On 27-May-2022, SARS-CoV-2 test: negative, despite worsening symptoms (Negative) Negative, despite worsening symptoms. On 28-May-2022, 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 the patient took any other medications/products within 2 weeks of starting COVID-19 treatment. 26-May-2022, patient had symptoms of covid again. Rapid test of 26-May-2022 and 27-May-2022 was negative despite worsening symptoms. Tested positive on rapid antigen test the morning of 28-May-2022. It was reported that suspect rebound covid due to Paxlovid treatment. The device date reported as 28-May-2022.   Company comment: This spontaneous case concerns a 39 year old female patient with no relevant medical history, who experienced the unexpected non serious AESI of COVID-19, about 6 months and 13 days after receiving the third dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient received the previous two doses with mRNA-1273 vaccine in accordance with the recommended schedule, with no reported adverse events. The patient tested positive for COVID-19 and was started on Paxlovid for 6 days. She tested negative for COVID-19 after the treatment despite worsening of symptoms. However, the following day, she tested positive for COVID-19 again. 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.; Sender's Comments: This spontaneous case concerns a 39 year old female patient with no relevant medical history, who experienced the unexpected non serious AESI of COVID-19, about 6 months and 13 days after receiving the third dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient received the previous two doses with mRNA-1273 vaccine in accordance with the recommended schedule, with no reported adverse events. The patient tested positive for COVID-19 and was started on Paxlovid for 6 days. She tested negative for COVID-19 after the treatment despite worsening of symptoms. However, the following day, she tested positive for COVID-19 again. 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.