Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Feeling abnormal, Headache, Neck pain
Clinical narrative: apnea; weakness; feel crappy; achy on head and neck; achy on head and neck; This spontaneous case was reported by a consumer and describes the occurrence of APNOEA (apnea) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033R21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart attack (patient reports 4 previous heart attacks) and Bypass surgery. Concurrent medical conditions included Penicillin allergy and Drug allergy (Benadryl). Concomitant products included COLECALCIFEROL (VIT D [COLECALCIFEROL]), ASCORBIC ACID (VIT C) and SIMVASTATIN (STATINUM) for an unknown indication.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced APNOEA (apnea) (seriousness criterion medically significant), ASTHENIA (weakness), FEELING ABNORMAL (feel crappy), NECK PAIN (achy on head and neck) and HEADACHE (achy on head and neck). At the time of the report, APNOEA (apnea), ASTHENIA (weakness), FEELING ABNORMAL (feel crappy), NECK PAIN (achy on head and neck) and HEADACHE (achy on head and neck) outcome was unknown.            The patient was very concern with side effects and following his primary dose he was kept for 20 minutes observation in mental health facility.  No treatment information was provided.  Company comment: This case concerns a 60-year-old male patient with reported past medical history of heart attack and concurrent history of bypass surgery and drug allergy who experienced the unexpected event of apnea.  The events occurred on the same day after the third dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was unknown as the date of the event was not specified although most likely occurred after the third and last administered dose.  The reporter did not provide causality relationship with the product use. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event is assessed as serious (-medically significant) per regulatory reporting.; Sender's Comments: This case concerns a 60-year-old male patient with reported past medical history of heart attack and concurrent history of bypass surgery and drug allergy who experienced the unexpected event of apnea.  The events occurred on the same day after the third dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was unknown as the date of the event was not specified although most likely occurred after the third and last administered dose.  The reporter did not provide causality relationship with the product use. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event is assessed as serious (-medically significant) per regulatory reporting.