Sex: F
Vaccine: COVID19
Symptoms: Headache, Inappropriate schedule of product administration, Loss of consciousness, Myalgia, Syncope
Clinical narrative: fainted; unconsciousness; Side effects; I had intestinal problems and have constipation; I had intestinal problems and have constipation; lack of strength; difficulty breathing; Had a lot of pain throughout my body; vomiting; Headaches; Very tired; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (fainted) and LOSS OF CONSCIOUSNESS (unconsciousness) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 300194 and 3002916) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced SYNCOPE (fainted) (seriousness criterion medically significant), LOSS OF CONSCIOUSNESS (unconsciousness) (seriousness criterion medically significant), VACCINATION COMPLICATION (Side effects), ABDOMINAL DISCOMFORT (I had intestinal problems and have constipation), CONSTIPATION (I had intestinal problems and have constipation), ASTHENIA (lack of strength), DYSPNOEA (difficulty breathing), MYALGIA (Had a lot of pain throughout my body), VOMITING (vomiting), HEADACHE (Headaches) and FATIGUE (Very tired). At the time of the report, SYNCOPE (fainted), LOSS OF CONSCIOUSNESS (unconsciousness), VACCINATION COMPLICATION (Side effects), ABDOMINAL DISCOMFORT (I had intestinal problems and have constipation), CONSTIPATION (I had intestinal problems and have constipation), ASTHENIA (lack of strength), DYSPNOEA (difficulty breathing), MYALGIA (Had a lot of pain throughout my body), VOMITING (vomiting), HEADACHE (Headaches) and FATIGUE (Very tired) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.            No relevant concomitant medications were reported.  No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  All events are captured in one case because of the lack of clear onset date to a specific dose.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Translation received contains significant information, address, events information, product information added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  All events are captured in one case because of the lack of clear onset date to a specific dose.