Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain in extremity, Pyrexia, SARS-CoV-2 test
Clinical narrative: A little bit of nausea; Headaches; Extreme fatigue; Sore throat; Cough; She had really high fever that night, around 104; COVID-19; Patient tested Positive for Covid 19 after two doses of vaccine; Almost felt like she had the flu; Had congestion; No energy; Was coughing; Had a sore arm but not as much as the first dose.; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), DRUG INEFFECTIVE (Patient tested Positive for Covid 19 after two doses of vaccine), INFLUENZA LIKE ILLNESS (Almost felt like she had the flu), NASAL CONGESTION (Had congestion) and ASTHENIA (No energy) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Almost felt like she had the flu), NASAL CONGESTION (Had congestion), ASTHENIA (No energy), COUGH (Was coughing), PAIN IN EXTREMITY (Had a sore arm but not as much as the first dose.) and FATIGUE (Fatigue). In August 2021, the patient experienced COVID-19 (COVID-19) and DRUG INEFFECTIVE (Patient tested Positive for Covid 19 after two doses of vaccine). On 28-Aug-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), COUGH (Cough), PYREXIA (She had really high fever that night, around 104) and FATIGUE (Extreme fatigue). On an unknown date, the patient experienced NAUSEA (A little bit of nausea) and HEADACHE (Headaches). On 10-Feb-2021, INFLUENZA LIKE ILLNESS (Almost felt like she had the flu), NASAL CONGESTION (Had congestion), ASTHENIA (No energy), COUGH (Was coughing), PAIN IN EXTREMITY (Had a sore arm but not as much as the first dose.) and FATIGUE (Fatigue) had resolved. At the time of the report, COVID-19 (COVID-19), OROPHARYNGEAL PAIN (Sore throat), COUGH (Cough), PYREXIA (She had really high fever that night, around 104), NAUSEA (A little bit of nausea), FATIGUE (Extreme fatigue) and HEADACHE (Headaches) was resolving and DRUG INEFFECTIVE (Patient tested Positive for Covid 19 after two doses of vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Aug-2021, Body temperature: 104 (High) High. On 29-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient concomitant medication was reported as Antidepressants.  It was reported that patient didn't go to the hospital, she called her doctor and she was given some medicines (steroids, antibiotics, inhaler. Did not remember the name of the medications). Stated that that day was the first day she felt better.  Company Comment: This report refers to a case of Drug ineffective for mRNA-1273, lot # 028L20A with adverse events.   Based on the current available information and temporal association between the use of the product and the start date of event Drug ineffective, a causal relationship cannot be excluded.   For the event COVID-19, based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable.   This case was linked to MOD-2021-306622 (Patient Link).; Sender's Comments: This report refers to a case of Drug ineffective for mRNA-1273, lot # 028L20A with adverse events.   Based on the current available information and temporal association between the use of the product and the start date of event Drug ineffective, a causal relationship cannot be excluded.   For the event COVID-19, based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable.