Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test, Sinusitis, Vaccination site pain
Clinical narrative: sinuses are now acting up; COVID-19 virus test positive; Lack of efficacy; sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (sinuses are now acting up), VACCINATION SITE PAIN (sore left arm), COVID-19 (COVID-19 virus test positive) and DRUG INEFFECTIVE (Lack of efficacy) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A and 040A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced VACCINATION SITE PAIN (sore left arm). On 27-Dec-2021, the patient experienced COVID-19 (COVID-19 virus test positive) and DRUG INEFFECTIVE (Lack of efficacy). On 25-Feb-2022, the patient experienced SINUSITIS (sinuses are now acting up). At the time of the report, SINUSITIS (sinuses are now acting up), VACCINATION SITE PAIN (sore left arm), COVID-19 (COVID-19 virus test positive) and DRUG INEFFECTIVE (Lack of efficacy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Dec-2021, SARS-CoV-2 test: positive (Positive) positive.         No concomitant medications were reported.  No treatment information was provided.  It was reported that there might be delay in getting his Moderna Covid-19 booster dose on 26-Feb-2022.  Company Comment: This spontaneous case concerns a 24 year old male with no medical history reported, who experienced the non-serious, unexpected, AESI event of Covid 19 which occurred 8 months, 15 days post vaccination with an the 2nd dose of mRNA-1273 vaccine. This case was also accompanied by other non-serious unexpected event of sinusitis and non-serious expected event of vaccination site pain . Event of drug ineffective was also reported for this case. At the time of this report the events ' outcome was reported as unknown. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.   This case was linked to MOD-2022-496034 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Feb-2022: Follow-up Received: No new information. On 25-Feb-2022: Follow-up received: No new information.; Sender's Comments: This spontaneous case concerns a 24 year old male with no medical history reported, who experienced the non-serious, unexpected, AESI event of Covid 19 which occurred 8 months, 15 days post vaccination with an the 2nd dose of mRNA-1273 vaccine. This case was also accompanied by other non-serious unexpected event of sinusitis and non-serious expected event of vaccination site pain . Event of drug ineffective was also reported for this case. At the time of this report the events ' outcome was reported as unknown. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.