Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I received the positive results; took a rapid test and am positive; Lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I received the positive results), COVID-19 (took a rapid test and am positive) and VACCINATION FAILURE (Lack of drug effect) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001M21A, 076C21A, 012M20A and 012L20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE and SPIRONOLACTONE for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-May-2022, the patient experienced COVID-19 (took a rapid test and am positive) and VACCINATION FAILURE (Lack of drug effect). On an unknown date, the patient experienced COVID-19 (I received the positive results). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 04-May-2022 to 09-May-2022 for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (I received the positive results) had resolved, COVID-19 (took a rapid test and am positive) had not resolved and VACCINATION FAILURE (Lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: negative (Negative) Negative a week ago. In 2022, SARS-CoV-2 test: positive (Positive) Positive.         Concomitant medication include Low dose HRT. Patient was bit congested, so took a rapid test and positive but she was negative a week ago and coughing again and Device date was 14-MAY-2022.  Company Comment: This spontaneous case concerns a 61-year-old female patient with no relevant medical history, who experienced the unexpected non-serious AESI of COVID-19 unspecified days after receiving the fourth dose of mRNA-1273 vaccine and unexpected non serious AESI of COVID-19, 16 days after receiving the fourth dose of mRNA-1273 vaccine in the COVID-19 vaccination series. Additionally, Vaccination failure is also reported.  Its reported that Patient was treated with Nirmatrelvir and Ritonavir for covid-19 as she received the positive results. As she was coughing again and was bit congested, so she took a rapid test which resulted positive though she was negative a week ago. COVID-19 pandemic could be confounding for the events. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 61-year-old female patient with no relevant medical history, who experienced the unexpected non-serious AESI of COVID-19 unspecified days after receiving the fourth dose of mRNA-1273 vaccine and unexpected non serious AESI of COVID-19, 16 days after receiving the fourth dose of mRNA-1273 vaccine in the COVID-19 vaccination series. Additionally, Vaccination failure is also reported.  Its reported that Patient was treated with Nirmatrelvir and Ritonavir for covid-19 as she received the positive results. As she was coughing again and was bit congested, so she took a rapid test which resulted positive though she was negative a week ago. COVID-19 pandemic could be confounding for the events. The benefit-risk relationship of mRNA-1273 is not affected by this report.