Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Oropharyngeal pain, SARS-CoV-2 test, Sepsis, Tinnitus
Clinical narrative: Blood infection; Shortness of breath; lack of drug effect; Tested positive for covid; Ears were ringing; ear Stuff up; stuffy nose; Headaches/head hurt a lot; Sore throat; This spontaneous case was reported by a consumer and describes the occurrence of SEPSIS (Blood infection) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Autoimmune disorder and Diabetes.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced OROPHARYNGEAL PAIN (Sore throat). On 21-Jul-2021, the patient experienced NASAL CONGESTION (stuffy nose) and HEADACHE (Headaches/head hurt a lot). On 24-Jul-2021, the patient experienced TINNITUS (Ears were ringing), EAR CONGESTION (ear Stuff up), DRUG INEFFECTIVE (lack of drug effect) and COVID-19 (Tested positive for covid). On 25-Jul-2021, the patient experienced SEPSIS (Blood infection) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced DYSPNOEA (Shortness of breath). The patient was hospitalized from 25-Jul-2021 to 06-Aug-2021 due to SEPSIS. On 06-Aug-2021, SEPSIS (Blood infection) had resolved. At the time of the report, OROPHARYNGEAL PAIN (Sore throat), NASAL CONGESTION (stuffy nose), TINNITUS (Ears were ringing), EAR CONGESTION (ear Stuff up), DYSPNOEA (Shortness of breath), DRUG INEFFECTIVE (lack of drug effect), HEADACHE (Headaches/head hurt a lot) and COVID-19 (Tested positive for covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jul-2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered SEPSIS (Blood infection), OROPHARYNGEAL PAIN (Sore throat), NASAL CONGESTION (stuffy nose), TINNITUS (Ears were ringing), EAR CONGESTION (ear Stuff up), DYSPNOEA (Shortness of breath), DRUG INEFFECTIVE (lack of drug effect), HEADACHE (Headaches/head hurt a lot) and COVID-19 (Tested positive for covid) to be possibly related.    No relevant concomitant medications were reported. Treatment information was provided i.e., IV antibiotics. Unknown Infusion  On 24 Jul 2021 consumer also went to the ER, they did covid-19 test and blood cultures.  Company comment: This case concerns a 56-year-old, female subject with medical history of diabetes, who experienced the unexpected serious event of sepsis and non-serious event of COVID-19, lack of drug effect was considered as an additional event. The events occurred approximately 4 months after administration of the second dose of the Moderna COVID-19 Vaccine. The rechallenge was unknown since no information/no events reported following administration of the first dose was provided. The medical history of diabetes, which may cause complications including infections, remains a confounder. The benefit-risk relationship of the Moderna COVID-19 Vaccine is not affected by this report.; Sender's Comments: This case concerns a 56-year-old, female subject with medical history of diabetes, who experienced the unexpected serious event of sepsis and non-serious event of COVID-19, lack of drug effect was considered as an additional event. The events occurred approximately 4 months after administration of the second dose of the Moderna COVID-19 Vaccine. The rechallenge was unknown since no information/no events reported following administration of the first dose was provided. The medical history of diabetes, which may cause complications including infections, remains a confounder. The benefit-risk relationship of the Moderna COVID-19 Vaccine is not affected by this report.