Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Pyrexia, Vaccination site pain
Clinical narrative: Diagnosed with COVID-19; lack of drug effect; Dry cough; 24 to 36 hours later I started to feel cruddy; Sore left arm; feels like a case of pneumonia; Headache; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Diagnosed with COVID-19), ILLNESS (feels like a case of pneumonia), COUGH (Dry cough), FEELING ABNORMAL (24 to 36 hours later I started to feel cruddy) and HEADACHE (Headache) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma and Bronchitis. Concomitant products included IBUPROFEN (ADVIL [IBUPROFEN]), FINASTERIDE, ROSUVASTATIN CALCIUM (CRESTOR), NIFEDIPINE, RABEPRAZOLE SODIUM (ACIPHEX), HYOSCYAMINE SULFATE (LEVSINEX) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced ILLNESS (feels like a case of pneumonia), HEADACHE (Headache) and PYREXIA (Low grade fever). On 13-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Sore left arm). On 14-Oct-2021, the patient experienced FEELING ABNORMAL (24 to 36 hours later I started to feel cruddy). On 11-Dec-2021, the patient experienced COUGH (Dry cough). On 12-Dec-2021, the patient experienced COVID-19 (Diagnosed with COVID-19). 12-Dec-2021, the patient experienced DRUG INEFFECTIVE (lack of drug effect). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. On 15-Oct-2021, VACCINATION SITE PAIN (Sore left arm) had resolved. On 12-Dec-2021, DRUG INEFFECTIVE (lack of drug effect) had resolved. At the time of the report, COVID-19 (Diagnosed with COVID-19) and FEELING ABNORMAL (24 to 36 hours later I started to feel cruddy) outcome was unknown and ILLNESS (feels like a case of pneumonia), COUGH (Dry cough), HEADACHE (Headache) and PYREXIA (Low grade fever) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the patient feels like this is a case of Pneumonia. The patient was scheduled for Monoclonal antibodies on 13DEC2021.  Company comment: This is a case of lack of efficacy concerning a 63-year-old male patient, with medical history of asthma and bronchitis, who experienced the non-serious, unexpected AESI event of Covid-19, 2 months after the third dose of mRNA-1273 (Moderna COVID-19 Vaccine). Patient was diagnosed with Covid-19, 2 months after the third dose and is scheduled for monoclonal antibiodies. At the time of report patient had a headache, dry cough, and a low grade fever.  The patient's history of asthma and bronchitis remain as confounders to the events and may have increased his risk of getting infected with Covid-19. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This is a case of lack of efficacy concerning a 63-year-old male patient, with medical history of asthma and bronchitis, who experienced the non-serious, unexpected AESI event of Covid-19, 2 months after the third dose of mRNA-1273 (Moderna COVID-19 Vaccine). Patient was diagnosed with Covid-19, 2 months after the third dose and is scheduled for monoclonal antibiodies. At the time of report patient had a headache, dry cough, and a low grade fever.  The patient's history of asthma and bronchitis remain as confounders to the events and may have increased his risk of getting infected with Covid-19. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.