Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Breakthrough COVID-19, Feeling abnormal, SARS-CoV-2 test, Sinusitis
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of BREAKTHROUGH COVID-19 (He got a breakthrough infection of Covid 19 after receiving 4 doses of the Moderna Covid 19 vaccine/Covid19 symptoms lasted for 5 weeks), SINUSITIS (also had a Sinus Infection) and FEELING ABNORMAL (He also states he felt rotten) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066k21A, 032L20A, 14M20A and 013F21A) for COVID-19 vaccination. Concurrent medical conditions included Allergic asthma (Minor Asthma). On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jul-2022, the patient experienced BREAKTHROUGH COVID-19 (He got a breakthrough infection of Covid 19 after receiving 4 doses of the Moderna Covid 19 vaccine/Covid19 symptoms lasted for 5 weeks) and SINUSITIS (also had a Sinus Infection). On an unknown date, the patient experienced FEELING ABNORMAL (He also states he felt rotten). The patient was treated with FAVIPIRAVIR at an unspecified dose and frequency and PARACETAMOL at an unspecified dose and frequency. At the time of the report, BREAKTHROUGH COVID-19 (He got a breakthrough infection of Covid 19 after receiving 4 doses of the Moderna Covid 19 vaccine/Covid19 symptoms lasted for 5 weeks), SINUSITIS (also had a Sinus Infection) and FEELING ABNORMAL (He also states he felt rotten) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jul-2022, SARS-CoV-2 test: (Positive) Positive. On an unknown date, Body temperature: 101 had fever over 101 Fahrenheit degrees. Concomitant medication details were not reported by the reporter. It was reported that patient had fever over 101 Fahrenheit degrees as well as headache. Since symptoms lasted 5 weeks patient thought it would not go away. Patient felt functional but not normal and then after 3 days everything cleared and patient felt normal again. The patient contracted the infection in a trip. Treatment also included broad spectrum antibiotics. Company Comment: This is a regulatory case concerning a 78-year-old male patient with no relevant medical history reported, vaccinated with 4 doses of COVID-19 vaccine mRNA-1273, who experienced the unexpected non-serious events of Breakthrough COVID-19 (AESI), Sinusitis, and Feeling abnormal which occurred approximately 2 months 18 days after receiving the 2nd booster dose of COVID-19 vaccine mRNA-1273, dose 4 in COVID-19 vaccine series, given 5 months 19 days after the 1st booster dose (dose 3).  The primary series was given with 27 days interval, with the dose 2 administered 8 months 21 days before the dose 3. Patient tested positive for Covid-19 and the symptoms lasted around 5 weeks. He had fever (over 101 degrees Fahrenheit), a sinus infection, as well as headache. He also felt rotten. As treatment, he took Favipiravir, broad-spectrum antibiotics, and Paracetamol. There is no available information regarding the clinical course. The patient's elderly age remains a predisposition risk factor for all the events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Sender's Comments: This is a regulatory case concerning a 78-year-old male patient with no relevant medical history reported, vaccinated with 4 doses of COVID-19 vaccine mRNA-1273, who experienced the unexpected non-serious events of Breakthrough COVID-19 (AESI), Sinusitis, and Feeling abnormal which occurred approximately 2 months 18 days after receiving the 2nd booster dose of COVID-19 vaccine mRNA-1273, dose 4 in COVID-19 vaccine series, given 5 months 19 days after the 1st booster dose (dose 3). The primary series was given with 27 days interval, with the dose 2 administered 8 months 21 days before the dose 3. Patient tested positive for Covid-19 and the symptoms lasted around 5 weeks. He had fever (over 101 degrees Fahrenheit), a sinus infection, as well as headache. He also felt rotten. As treatment, he took Favipiravir, broad-spectrum antibiotics, and Paracetamol. There is no available information regarding the clinical course. The patient's elderly age remains a predisposition risk factor for all the events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.