Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Computerised tomogram, Echocardiogram, Hallucination, Hypoaesthesia
Clinical narrative: Neuroligical hallucination; Heart palpitations; Panic attacks; Myocarditis; Arm felt numb; Vomiting; Heart fluttering; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION (Neuroligical hallucination), PALPITATIONS (Heart palpitations), PANIC ATTACK (Panic attacks), CARDIAC FLUTTER (Heart fluttering) and MYOCARDITIS (Myocarditis) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007C21A, 036B21A and 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    The patient's past medical history included Non-tobacco user and Abstains from alcohol. Concurrent medical conditions included Sarcoidosis and Rheumatoid arthritis.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Sep-2021, the patient experienced HALLUCINATION (Neuroligical hallucination) (seriousness criteria hospitalization and medically significant), PALPITATIONS (Heart palpitations) (seriousness criterion hospitalization) and PANIC ATTACK (Panic attacks) (seriousness criterion hospitalization). On 12-Sep-2021, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criterion medically significant). In September 2021, the patient experienced CARDIAC FLUTTER (Heart fluttering) (seriousness criterion medically significant), HYPOAESTHESIA (Arm felt numb) and VOMITING (Vomiting). The patient was hospitalized on 11-Sep-2021 due to HALLUCINATION, PALPITATIONS and PANIC ATTACK. In September 2021, CARDIAC FLUTTER (Heart fluttering), HYPOAESTHESIA (Arm felt numb) and VOMITING (Vomiting) had resolved. At the time of the report, HALLUCINATION (Neuroligical hallucination), PALPITATIONS (Heart palpitations), PANIC ATTACK (Panic attacks) and MYOCARDITIS (Myocarditis) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Sep-2021, Computerised tomogram: Results were normal. On 11-Sep-2021, Echocardiogram: Results were normal. On 11-Sep-2021, Magnetic resonance imaging: Results were normal.         It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Patient was taking concomitant medications mainly for sarcoidosis but list was not provided because she mentioned that it was too many to go through.  On 07 Sep 2021, the patient took the third covid 19 vaccination and her arm felt numb, heart started fluttering, vomiting and had hallucinations. On 11 Sep 2021, she was hospitalized because of heart palpitations, panic attacks and neurological hallucination. She stayed in the hospital for four days but unable to recall the treatments given aside from unspecified intravenous fluids.  the reporter's causality for the event(s) of heart fluttering, myocarditis, neuroligical hallucination, heart palpitations, arm felt numb, panic attacks and vomiting with humira 40mg/0.4ml(adalimumab) was no reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment  This is a spontaneous case reported by a consumer, concerning a 70-year-old female patient with no relevant medical history reported, who experienced the unexpected, serious (Hospitalization, medically significant) event of HALLUCINATION (Neuroligical hallucination), the serious events PALPITATIONS and PANIC ATTACK (Hospitalization)   01 day after vaccination,  CARDIAC FLUTTER (medically significant) on an unknown date and the expected serious(medically significant) AESI of Myocarditis about 4 days after receiving the 3 dose of mRNA-1273 Vaccine in the covid 19 vaccination series, along with non serious events Hypoaesthesia and Vomiting.  Patient previously received the 2 primary doses with mRNA1273 vaccine about 5 months prior to 3 dose, with no adverse events reported.  Concurrent medical conditions included Sarcoidosis and Rheumatoid arthritis. The patient was started on ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose for Rheumatoid Arthritis.  Details of clinical course, concomitant medications and treatment details were not reported. Radiological imaging was normal. Concurrent illness with sarcoidosis could be considered as confounder to the event Hallucination. Rheumatoid Arthritis is a risk factor for the cardiac events.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case reported by a consumer, concerning a 70-year-old female patient with no relevant medical history reported, who experienced the unexpected, serious (Hospitalization, medically significant) event of HALLUCINATION (Neuroligical hallucination), the serious events PALPITATIONS and PANIC ATTACK (Hospitalization)   01 day after vaccination,  CARDIAC FLUTTER (medically significant) on an unknown date and the expected serious(medically significant) AESI of Myocarditis about 4 days after receiving the 3 dose of mRNA-1273 Vaccine in the covid 19 vaccination series, along with non serious events Hypoaesthesia and Vomiting.  Patient previously received the 2 primary doses with mRNA1273 vaccine about 5 months prior to 3 dose, with no adverse events reported.  Concurrent medical conditions included Sarcoidosis and Rheumatoid arthritis. The patient was started on ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose for Rheumatoid Arthritis.  Details of clinical course, concomitant medications and treatment details were not reported. Radiological imaging was normal. Concurrent illness with sarcoidosis could be considered as confounder to the event Hallucination. Rheumatoid Arthritis is a risk factor for the cardiac events.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.