Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: diagnosed with covid/COVID-19 infection; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (diagnosed with covid/COVID-19 infection) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007J212A, 036B21A and 001A21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (diagnosed with covid/COVID-19 infection). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 06-Jul-2022 to 11-Jul-2022 at an unspecified dose and frequency. At the time of the report, COVID-19 (diagnosed with covid/COVID-19 infection) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jul-2022, SARS-CoV-2 test: (Positive) Positive. On an unknown date, SARS-CoV-2 test: (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The ethinicity of the patient was reported. The patient was fully vaccinated and took the 1st booster shot, was diagnosed with covid. She had three doses of the Moderna Covid-19 Vaccine and then got Covid-19 infection. She just completed Paxlovid and was negative now. The patient started Paxlovid on 06-Jul-2022 with the evening dose then took the last dose 11-Jul-2022 and that was a morning dose. She was asking if she should get a fourth dose of the Moderna Covid-19 Vaccine.  Company Comment:  This spontaneous case concerns a 77-year-old female patient with no reported medical history, who experienced the unexpected, non-serious  adverse event of special interest COVID-19 (reported as diagnosed with COVID-19 infection)  5 months  and 3 days after receiving the booster dose of mRNA-1273 vaccine given as third in the COVID-19 vaccination series. The event was documented by a positive SARS-CoV-2 test. Patient treated with Nirmatrelvir, Ritonavir (Paxlovid) for 6 days and subsequently tested negative.  Patient previously received a 2-dose primary series of mRNA-1273 vaccine given 33 days apart, with the last dose administered 9 months and 26 days prior to current vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 77-year-old female patient with no reported medical history, who experienced the unexpected, non-serious  adverse event of special interest COVID-19 (reported as diagnosed with COVID-19 infection)  5 months  and 3 days after receiving the booster dose of mRNA-1273 vaccine given as third in the COVID-19 vaccination series. The event was documented by a positive SARS-CoV-2 test. Patient treated with Nirmatrelvir, Ritonavir (Paxlovid) for 6 days and subsequently tested negative.  Patient previously received a 2-dose primary series of mRNA-1273 vaccine given 33 days apart, with the last dose administered 9 months and 26 days prior to current vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.