Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Arthralgia, Chills, Epistaxis, Erythema
Clinical narrative: abdominal pain; lymphadenopathy; Nose bleed again for 1 to 2 days when he sneezed or coughed; Awake hallucination; Shaking chills; Feet were red; Myalgia; Arthralgia; Chills,Teeth were chattering; Headache; Nausea; Violent vomiting, vomit was coming out of his nose; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of HALLUCINATION (Awake hallucination) 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 (The patient received monoclonal antibodies.) in January 2021, Myelosuppression (As a result his platelets and white blood cells count were dropped.) in January 2021 and Nose bleed in January 2021. Concurrent medical conditions included Asthenia, Walking difficulty, Pituitary apoplexy (makes him high risk patient) and Panhypopituitarism (makes him high risk patient). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), LIOTHYRONINE, CORTISONE, FLUDROCORTISONE, CABERGOLINE, PANTOPRAZOLE, ACETYLSALICYLIC ACID (ASPIRIN 81), TESTOSTERONE and VITAMIN E NOS 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 hallucination) (seriousness criterion medically significant), TREMOR (Shaking chills), ERYTHEMA (Feet were red), MYALGIA (Myalgia), ARTHRALGIA (Arthralgia), CHILLS (Chills,Teeth were chattering), HEADACHE (Headache), NAUSEA (Nausea) and VOMITING (Violent vomiting, vomit was coming out of his nose). On 20-Mar-2021, the patient experienced EPISTAXIS (Nose bleed again for 1 to 2 days when he sneezed or coughed). On an unknown date, the patient experienced ABDOMINAL PAIN (abdominal pain) and LYMPHADENOPATHY (lymphadenopathy). On 20-Mar-2021, HALLUCINATION (Awake hallucination), TREMOR (Shaking chills), ERYTHEMA (Feet were red), MYALGIA (Myalgia), ARTHRALGIA (Arthralgia), CHILLS (Chills,Teeth were chattering), HEADACHE (Headache), NAUSEA (Nausea) and VOMITING (Violent vomiting, vomit was coming out of his nose) had resolved. At the time of the report, EPISTAXIS (Nose bleed again for 1 to 2 days when he sneezed or coughed), ABDOMINAL PAIN (abdominal pain) and LYMPHADENOPATHY (lymphadenopathy) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to events was not applicable.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   This case was linked to MOD-2021-076797 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. MOD-2021-076797:first dose