Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Influenza, Nausea, Presyncope, Sensory disturbance
Clinical narrative: does bike for heart problems/Saturday was "knocked out, did not know what day it was", says have no idea what I did that day"; memory loss; uncontrollable anxiety issues; After eating popcorn she had food poisoning ended up in the ER; she has digestive issues that started with onions, butter, milk, half and half, fruit, can only eat blackberries, teas; Flu symptoms; Felt very dizzy/really dizzy couldn't even go to the bathroom; Felt like fingers were numb, pinky was numb, could not type.; Was sitting in a chair, felt like she was going to throw up; Hallucinations/she had hallucination thought she was a gorilla/Caller started making gorilla sounds during call/she has hallucinations that she knows are not real; on subway felt like she was going to faint; she started to feel very off; Felt something growing in nose to brain/woke up feeling weird; lost 35 pounds and is skin and bones now; Felt starving very hungry; felt an alien substance in skin covered in it like jelly; breathing was affected: taking very big breaths/ays there was a hurricane and she was unable to breath; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION (Hallucinations/she had hallucination thought she was a gorilla/Caller started making gorilla sounds during call/she has hallucinations that she knows are not real) and PRESYNCOPE (on subway felt like she was going to faint) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Heart disorder.    On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, the patient experienced HALLUCINATION (Hallucinations/she had hallucination thought she was a gorilla/Caller started making gorilla sounds during call/she has hallucinations that she knows are not real) (seriousness criterion medically significant), PRESYNCOPE (on subway felt like she was going to faint) (seriousness criterion medically significant), AFFECTIVE DISORDER (she started to feel very off), FEELING ABNORMAL (Felt something growing in nose to brain/woke up feeling weird), WEIGHT DECREASED (lost 35 pounds and is skin and bones now), HUNGER (Felt starving very hungry), SENSORY DISTURBANCE (felt an alien substance in skin covered in it like jelly), DYSPNOEA (breathing was affected: taking very big breaths/ays there was a hurricane and she was unable to breath), AMNESIA (memory loss), ANXIETY (uncontrollable anxiety issues), FOOD POISONING (After eating popcorn she had food poisoning ended up in the ER), DYSPEPSIA (she has digestive issues that started with onions, butter, milk, half and half, fruit, can only eat blackberries, teas), INFLUENZA (Flu symptoms), DIZZINESS (Felt very dizzy/really dizzy couldn't even go to the bathroom), HYPOAESTHESIA (Felt like fingers were numb, pinky was numb, could not type.) and NAUSEA (Was sitting in a chair, felt like she was going to throw up). On an unknown date, the patient experienced VACCINATION COMPLICATION (does bike for heart problems/Saturday was "knocked out, did not know what day it was", says have no idea what I did that day"). The patient was treated with FAMOTIDINE for Adverse event, at an unspecified dose and frequency and PREDNISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, HALLUCINATION (Hallucinations/she had hallucination thought she was a gorilla/Caller started making gorilla sounds during call/she has hallucinations that she knows are not real), PRESYNCOPE (on subway felt like she was going to faint), AFFECTIVE DISORDER (she started to feel very off), FEELING ABNORMAL (Felt something growing in nose to brain/woke up feeling weird), WEIGHT DECREASED (lost 35 pounds and is skin and bones now), HUNGER (Felt starving very hungry), SENSORY DISTURBANCE (felt an alien substance in skin covered in it like jelly), DYSPNOEA (breathing was affected: taking very big breaths/ays there was a hurricane and she was unable to breath), VACCINATION COMPLICATION (does bike for heart problems/Saturday was "knocked out, did not know what day it was", says have no idea what I did that day"), AMNESIA (memory loss), ANXIETY (uncontrollable anxiety issues), FOOD POISONING (After eating popcorn she had food poisoning ended up in the ER), DYSPEPSIA (she has digestive issues that started with onions, butter, milk, half and half, fruit, can only eat blackberries, teas), INFLUENZA (Flu symptoms), DIZZINESS (Felt very dizzy/really dizzy couldn't even go to the bathroom), HYPOAESTHESIA (Felt like fingers were numb, pinky was numb, could not type.) and NAUSEA (Was sitting in a chair, felt like she was going to throw up) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing was interrupted on an unknown date.       Concomitant medications were not reported.  Treatment also included psychological medications and allergy medications. And also reported that patient had reaction to allergy medication.  It was reported that the patient did not get second dose but she visited ER 10 times in last 6 months. Doctors think this is all psychological issue as per patient. Patient also reported that she was experiencing the side effects ongoing greater than 6 months after receiving the 1st Moderna dose.  Company comment: This is a spontaneous case concerning a 48-year-old female patient with medical history of heart problems, who experienced the unexpected serious events of Hallucination and Presyncope, the unexpected non-serious events of Affective disorder, Feeling abnormal, Weight decreased, Hunger, Sensory disturbance, Dyspnoea, Vaccination complication, Amnesia, Anxiety, Food poisoning, Dyspepsia and Influenza, and expected non-serious events of Dizziness, Hypoaesthesia and Nausea on an unknown dates after the first dose of mRNA-1273 vaccine. It was reported that the patient had not received any further doses as per discretion of healthcare provider, however, the events were ongoing greater than 6 months, making dechallenge negative. As reported, the doctors thought this was all psychological issue. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 48-year-old female patient with medical history of heart problems, who experienced the unexpected serious events of Hallucination and Presyncope, the unexpected non-serious events of Affective disorder, Feeling abnormal, Weight decreased, Hunger, Sensory disturbance, Dyspnoea, Vaccination complication, Amnesia, Anxiety, Food poisoning, Dyspepsia and Influenza, and expected non-serious events of Dizziness, Hypoaesthesia and Nausea on an unknown dates after the first dose of mRNA-1273 vaccine. It was reported that the patient had not received any further doses as per discretion of healthcare provider, however, the events were ongoing greater than 6 months, making dechallenge negative. As reported, the doctors thought this was all psychological issue. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.