Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Therapeutic response unexpected, Vomiting
Clinical narrative: has not felt this good in years; nose bleed when sneezed and coughed; feet were red; awake hallucinations; shaking chills,teeth were chattering; myalgia; arthralgia; sever nausea; violent vomiting; headache; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of HALLUCINATION (awake hallucinations) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 031A20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in January 2021. Concurrent medical conditions included Pituitary apoplexy, Myelosuppression since January 2021, Thrombocytopenia since January 2021 and Leukopenia since January 2021. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), LIOTHYRONINE and CORTISONE for an unknown indication.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced HALLUCINATION (awake hallucinations) (seriousness criterion medically significant), ERYTHEMA (feet were red), CHILLS (shaking chills,teeth were chattering), MYALGIA (myalgia), ARTHRALGIA (arthralgia), NAUSEA (sever nausea), VOMITING (violent vomiting) and HEADACHE (headache). On 20-Mar-2021, the patient experienced EPISTAXIS (nose bleed when sneezed and coughed). On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (has not felt this good in years). On 20-Mar-2021, HALLUCINATION (awake hallucinations), ERYTHEMA (feet were red), CHILLS (shaking chills,teeth were chattering), MYALGIA (myalgia), ARTHRALGIA (arthralgia) and HEADACHE (headache) had resolved, NAUSEA (sever nausea) and VOMITING (violent vomiting) outcome was unknown. At the time of the report, EPISTAXIS (nose bleed when sneezed and coughed) and THERAPEUTIC RESPONSE UNEXPECTED (has not felt this good in years) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitants medications also included Fludroscortisone, Cabergoline, Pantoprazole, Aspirin 81mg, Testosterone Gel and Vitamin E.  No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  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. This report also refers to a case of positive therapeutic effect.   This case was linked; 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. This report also refers to a case of positive therapeutic effect.