Sex: F
Vaccine: COVID19
Symptoms: Fall, Feeling abnormal, Headache, Loss of consciousness, Vomiting
Clinical narrative: she passed out three times after recieving second dose of moderna vaccine; she reports that a "hell night" for her following her 2nd dose.; she fell two times after the second dose.; vomiting; she also experienced a "very strong headache; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (she passed out three times after recieving second dose of moderna vaccine), FEELING ABNORMAL (she reports that a "hell night" for her following her 2nd dose.), FALL (she fell two times after the second dose.), VOMITING (vomiting) and HEADACHE (she also experienced a "very strong headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Kidney disorder. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and ESTRADIOL, NORETHISTERONE ACETATE (COMBIPATCH) for an unknown indication.    In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (she passed out three times after recieving second dose of moderna vaccine), FEELING ABNORMAL (she reports that a "hell night" for her following her 2nd dose.), FALL (she fell two times after the second dose.), VOMITING (vomiting) and HEADACHE (she also experienced a "very strong headache). At the time of the report, LOSS OF CONSCIOUSNESS (she passed out three times after recieving second dose of moderna vaccine), FEELING ABNORMAL (she reports that a "hell night" for her following her 2nd dose.), FALL (she fell two times after the second dose.), VOMITING (vomiting) and HEADACHE (she also experienced a "very strong headache) outcome was unknown. Not Provided          Concomitant medication was not provided. Treatment medication  was not provided .   Most recent FOLLOW-UP information incorporated above includes: On 13-Sep-2021: Follow-up information included no new information.; Sender's Comments: This case concerns a female patient of unknown age, with relevant medical history of kidney disorder, who experienced the expected events of vomiting and headache and the unexpected events of Feeling abnormal, fall and Loss of consciousness. The events occurred on an unknown date after the second dose of Moderna COVID-19 vaccine. The rechallenge was not applicable, as the events were reported exclusively after the second dose. The events were considered related to the vaccine per the reporter's assessment. The events vomiting and headache are consistent with the current understanding of the mechanism of action of the study medication. The medical history, of kidney disorder, use of concomitant medication levothyroxine and estradiol/norethindrone acetate, remain a confounder. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report. Event Loss of consciousness was automatically upgraded as serious as per IME list. However, based on reporter´s assesment, information available and due to the lack of evidence of seriousness from a regulatory or clinical standpoint, it was assessed as non-serious.