Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, COVID-19, Haemoptysis, Hallucination, Illness
Clinical narrative: Hallucinations; Coughing blood clots during 6 hours; 3 weeks ago she got COVID-19; She felt so sick and her brain was scrambled; Real pain in the abdomen/it was an excruciating pain; Experienced vomit; This spontaneous case was reported by a patient and describes the occurrence of HALLUCINATION (Hallucinations) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In July 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HALLUCINATION (Hallucinations) (seriousness criterion medically significant), HAEMOPTYSIS (Coughing blood clots during 6 hours), COVID-19 (3 weeks ago she got COVID-19), ILLNESS (She felt so sick and her brain was scrambled), ABDOMINAL PAIN (Real pain in the abdomen/it was an excruciating pain) and VOMITING (Experienced vomit). At the time of the report, HALLUCINATION (Hallucinations), HAEMOPTYSIS (Coughing blood clots during 6 hours), COVID-19 (3 weeks ago she got COVID-19), ILLNESS (She felt so sick and her brain was scrambled), ABDOMINAL PAIN (Real pain in the abdomen/it was an excruciating pain) and VOMITING (Experienced vomit) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant Medication use information was not provided by reporter.  Patient got COVID-19 3 weeks ago, patient had to go to ER because of coughing blood and was on an excruciating pain.   Patient needed to visit ER because she felt so sick, and her brain was scrambled.   It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Treatment Medication use information was not provided by reporter.  Company comment-This spontaneous case concerns a female patient aged 79 years with no medical history reported, who experienced the unexpected, serious (medically significant) event of Hallucination in the context of unspecified booster dose of mRNA-1273 vaccination. Latency cannot be assessed since exact vaccination date and event onset date were not disclosed. Patient also experienced multiple non-serious events of Haemoptysis, COVID-19, Illness, Abdominal pain, Vomiting on unknown dates. It was reported that 3 weeks ago patient got COVID-19 and experienced vomit, hallucinations, was coughing blood clots during 6 hours, had real excruciating pain in the abdomen. Patient visited emergency as she was so sick. No further information on risk factors, clinical course, investigations, treatment of the events, details of previous doses was available in the report. Outcome of the events was not known at the time of report. Current pandemic situation of COVID 19 may remain as confounder to the event Covid -19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact. Sender's Comments: This spontaneous case concerns a female patient aged 79 years with no medical history reported, who experienced the unexpected, serious (medically significant) event of Hallucination in the context of unspecified booster dose of mRNA-1273 vaccination. Latency cannot be assessed since exact vaccination date and event onset date were not disclosed. Patient also experienced multiple non-serious events of Haemoptysis, COVID-19, Illness, Abdominal pain, Vomiting on unknown dates. It was reported that 3 weeks ago patient got COVID-19 and experienced vomit, hallucinations, was coughing blood clots during 6 hours, had real excruciating pain in the abdomen. Patient visited emergency as she was so sick. No further information on risk factors, clinical course, investigations, treatment of the events, details of previous doses was available in the report. Outcome of the events was not known at the time of report. Current pandemic situation of COVID 19 may remain as confounder to the event Covid -19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.