Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Pyrexia, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Feverish Feeling; took the Covid-19 home test kit and tested positive; felt increasingly worst everyday; felt shivering in bed; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt increasingly worst everyday), PYREXIA (Feverish Feeling), CHILLS (felt shivering in bed) and SARS-COV-2 TEST POSITIVE (took the Covid-19 home test kit and tested positive) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination.     Concurrent medical conditions included Back disorder NOS. Concomitant products included VITAMIN B3 and CALCIUM for Back disorder NOS, ATENOLOL, CITALOPRAM, OMEPRAZOLE and AMLODIPINE for an unknown indication.    On 19-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Dec-2021, the patient experienced FEELING ABNORMAL (felt increasingly worst everyday) and CHILLS (felt shivering in bed). On 21-Dec-2021, the patient experienced PYREXIA (Feverish Feeling) and SARS-COV-2 TEST POSITIVE (took the Covid-19 home test kit and tested positive). The patient was treated with GUAIFENESIN (MUCINEX) for Adverse event, at a dose of 3 tablet, q12h. At the time of the report, FEELING ABNORMAL (felt increasingly worst everyday), PYREXIA (Feverish Feeling), CHILLS (felt shivering in bed) and SARS-COV-2 TEST POSITIVE (took the Covid-19 home test kit and tested positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive.         Patient received the booster dose of the Moderna Covid-19 Vaccine and felt shivering in bed on Monday and feverish feeling on Tuesday. Patient felt increasingly worst everyday. Patient took the Covid-19 home test kit and tested positive.  Company Comment: This case concerns a 62-year-old female patient with no previous relevant medical history reported, who experienced the non-serious events of Feeling abnormal, Pyrexia, Chills and SARS-CoV-2 test positive. The events occurred on the following two days after the third dose of COVID-19 Vaccine Moderna (mRNA-1273). Based on the mechanism of action of mRNA-1273 causal association between the event of SARS-CoV-2 test positive and mRNA-1273 product is assessed as not applicable. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report.; Sender's Comments: This case concerns a 62-year-old female patient with no previous relevant medical history reported, who experienced the non-serious events of Feeling abnormal, Pyrexia, Chills and SARS-CoV-2 test positive. The events occurred on the following two days after the third dose of COVID-19 Vaccine Moderna (mRNA-1273). Based on the mechanism of action of mRNA-1273 causal association between the event of SARS-CoV-2 test positive and mRNA-1273 product is assessed as not applicable. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report.