Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Inappropriate schedule of product administration, Influenza, Loss of consciousness, Mobility decreased
Clinical narrative: knocked him out; pretty bad adverse reaction, worse reaction he ever had; super sick, extremely sick, got so ill; like he had a major case of the flu; was cold; dizzy; could not function; slept a lot; wiped out, exhausted; chills; Headache; got second dose more than 35 days since the first; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (knocked him out), VACCINATION COMPLICATION (pretty bad adverse reaction, worse reaction he ever had), ILLNESS (super sick, extremely sick, got so ill), INFLUENZA (like he had a major case of the flu) and NASOPHARYNGITIS (was cold) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced LOSS OF CONSCIOUSNESS (knocked him out), VACCINATION COMPLICATION (pretty bad adverse reaction, worse reaction he ever had), ILLNESS (super sick, extremely sick, got so ill), INFLUENZA (like he had a major case of the flu), NASOPHARYNGITIS (was cold), DIZZINESS (dizzy), MOBILITY DECREASED (could not function), HYPERSOMNIA (slept a lot), FATIGUE (wiped out, exhausted), CHILLS (chills), HEADACHE (Headache) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got second dose more than 35 days since the first). On 03-Mar-2021, HYPERSOMNIA (slept a lot) and FATIGUE (wiped out, exhausted) was resolving. At the time of the report, LOSS OF CONSCIOUSNESS (knocked him out), VACCINATION COMPLICATION (pretty bad adverse reaction, worse reaction he ever had), ILLNESS (super sick, extremely sick, got so ill), INFLUENZA (like he had a major case of the flu), NASOPHARYNGITIS (was cold), DIZZINESS (dizzy), MOBILITY DECREASED (could not function), CHILLS (chills) and HEADACHE (Headache) was resolving and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got second dose more than 35 days since the first) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information not provided. Concomitant medication not provided.  Company Comment: This case concerns a 54-year-old, male patient with no previous relevant medical history reported, who experienced the unexpected event of loss of consciousness. The event occurred the same day after the second dose of mRNA-1273 Moderna vaccine. The rechallenge was not applicable since the event happened after the second dose. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report. The event was downgrade to non-serious since there is no evidence in the source document of any medical intervention or any information supporting that the event meets the criteria to be medically significant.   This case was linked to MOD-2021-374945 (Patient Link).; Sender's Comments: This case concerns a 54-year-old, male patient with no previous relevant medical history reported, who experienced the unexpected event of loss of consciousness. The event occurred the same day after the second dose of mRNA-1273 Moderna vaccine. The rechallenge was not applicable since the event happened after the second dose. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report. The event was downgrade to non-serious since there is no evidence in the source document of any medical intervention or any information supporting that the event meets the criteria to be medically significant.