Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Asymptomatic COVID-19, SARS-CoV-2 test
Clinical narrative: Asymptomatic COVID-19; This spontaneous case was reported by a patient and describes the occurrence of ASYMPTOMATIC COVID-19 (Asymptomatic COVID-19) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003F214) for Prophylactic vaccination.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for Prophylactic vaccination.    Concurrent medical conditions included Drug allergy and ADHD. Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) from 23-May-2022 to an unknown date for an unknown indication.   On 16-Mar-2021 at 1:30 PM, the patient received first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) .5 milliliter. On 27-Oct-2021 at 6:30 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-May-2022, the patient experienced ASYMPTOMATIC COVID-19 (Asymptomatic COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 01-Jun-2022 to 06-Jun-2022 for COVID-19 treatment, at a dose of 3 tablets twice daily for 5 days. At the time of the report, ASYMPTOMATIC COVID-19 (Asymptomatic COVID-19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On 07-Jun-2022, SARS-CoV-2 test: positive (Positive) Positive.         The reporter's causality of co-suspect was reported as possible for the event asymptomatic COVID-19.  The patient took all the medication as prescribed for the event. The patient did not had any symptoms at this time of reporting.  It was reported that patient was not hospitalized.  Company comment: This spontaneous case concerns a 59-year-old female patient with history of interchange of vaccine products, who experienced the unexpected non-serious AESI of Asymptomatic Covid-19, 2months 15days after a dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) received as 1st dose and 4months 27days before receiving a dose of mRNA-1273 vaccine as 2nd dose. SARS-CoV-2 test was positive. The patient was treated with a course of Paxlovid (Nirmatrelvir + ritonavir) for 5 days. One day after the test the patient tested positive again. The outcome of the event was reported as not resolved. The current pandemic situation of covid-19 remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jun-2022: Follow up received contains, updated suspect's , concomitant medication was updated, treatment medication was added and event outcome was updated.; Sender's Comments: This spontaneous case concerns a 59-year-old female patient with history of interchange of vaccine products, who experienced the unexpected non-serious AESI of Asymptomatic Covid-19, 2months 15days after a dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) received as 1st dose and 4months 27days before receiving a dose of mRNA-1273 vaccine as 2nd dose. SARS-CoV-2 test was positive. The patient was treated with a course of Paxlovid (Nirmatrelvir + ritonavir) for 5 days. One day after the test the patient tested positive again. The outcome of the event was reported as not resolved. The current pandemic situation of covid-19 remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.