Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: symptoms returned on day 9 with positive at home test that has remained positive for three days. Severe congestion, stuffy and runny nose and sneezing; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (symptoms returned on day 9 with positive at home test that has remained positive for three days. Severe congestion, stuffy and runny nose and sneezing) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067H21A, 02B21A and 026A21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (From an unspecified drug.).   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (symptoms returned on day 9 with positive at home test that has remained positive for three days. Severe congestion, stuffy and runny nose and sneezing). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 10-May-2022 to 14-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (symptoms returned on day 9 with positive at home test that has remained positive for three days. Severe congestion, stuffy and runny nose and sneezing) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-May-2022, SARS-CoV-2 test: negative (Negative) at home negative test for 3 days. On 18-May-2022, SARS-CoV-2 test: positive (Positive) symptoms returned on day 9 with positive at home test that has remained positive for three days. On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.         No relevant medical history and concurrent conditions. No concomitant medications were reported. It was reported that the patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. Device date was mentioned as 21-May-2022.  Company comment: This spontaneous case concerns a 55-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI Covid-19, on an unspecified date after receiving the third dose of mRNA-1273 vaccine. The patient had mild symptoms (Severe congestion, stuffy and runny nose, sneezing), was tested positive for SARS-CoV-2, was started on Paxlovid (Nirmatrelvir + Ritonavir) and had full recovery after two days of the course. The patient finished the full course (five days) at home and tested negative for three days. From day nine, the symptoms recurred, and he was tested positive again. The outcome was reported as not resolved. Details of further clinical course, investigation reports and treatment were not reported. The patient had taken two primary doses of mRNA-1273 (appropriate schedule) and the third dose five months prior to the events. The current pandemic of Covid-19 could be a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 55-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI Covid-19, on an unspecified date after receiving the third dose of mRNA-1273 vaccine. The patient had mild symptoms (Severe congestion, stuffy and runny nose, sneezing), was tested positive for SARS-CoV-2, was started on Paxlovid (Nirmatrelvir + Ritonavir) and had full recovery after two days of the course. The patient finished the full course (five days) at home and tested negative for three days. From day nine, the symptoms recurred, and he was tested positive again. The outcome was reported as not resolved. Details of further clinical course, investigation reports and treatment were not reported. The patient had taken two primary doses of mRNA-1273 (appropriate schedule) and the third dose five months prior to the events. The current pandemic of Covid-19 could be a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.