Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abnormal behaviour, Amnesia, Decreased appetite, Delusional disorder, unspecified type
Clinical narrative: Migraine; Sick to her stomach; She had slept for 4 days / slept for 3-5 days; Affected her more in her brain/when she was awake she was doing off the wall stuff; loss of memory; didn't feel like herself / it was weird, not like the typical side effects you would get; Felt delusional / disillusionment; No appetite; Unable to figure things out/ couldn't think; Unable to eat; Couldn't  walk; Hallucinations; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION (Hallucinations) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sulfonamide allergy (sulfa allergy) and Multiple sclerosis (patient gets infusions for MS, every six months.).   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced MIGRAINE (Migraine) and ABDOMINAL DISCOMFORT (Sick to her stomach). In April 2021, the patient experienced HALLUCINATION (Hallucinations) (seriousness criterion medically significant), HYPERSOMNIA (She had slept for 4 days / slept for 3-5 days), ABNORMAL BEHAVIOUR (Affected her more in her brain/when she was awake she was doing off the wall stuff), AMNESIA (loss of memory), FEELING ABNORMAL (didn't feel like herself / it was weird, not like the typical side effects you would get), DELUSIONAL DISORDER, UNSPECIFIED TYPE (Felt delusional / disillusionment), DECREASED APPETITE (No appetite), THINKING ABNORMAL (Unable to figure things out/ couldn't think ), FEEDING DISORDER (Unable to eat) and GAIT DISTURBANCE (Couldn't  walk). On 04-Apr-2021, MIGRAINE (Migraine) had resolved. At the time of the report, HALLUCINATION (Hallucinations), ABDOMINAL DISCOMFORT (Sick to her stomach), HYPERSOMNIA (She had slept for 4 days / slept for 3-5 days), ABNORMAL BEHAVIOUR (Affected her more in her brain/when she was awake she was doing off the wall stuff), AMNESIA (loss of memory), FEELING ABNORMAL (didn't feel like herself / it was weird, not like the typical side effects you would get), DELUSIONAL DISORDER, UNSPECIFIED TYPE (Felt delusional / disillusionment), THINKING ABNORMAL (Unable to figure things out/ couldn't think ), FEEDING DISORDER (Unable to eat) and GAIT DISTURBANCE (Couldn't  walk) outcome was unknown and DECREASED APPETITE (No appetite) was resolving.            The treatment history was not reported. The concomitant medication was not provided.  The patients gets infusion for MS every 6 months. Patient felt like her body was rejecting the vaccine because of the side effects.  Company Comment :Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded.    Events seriousness per IME list.   This case was linked to MOD-2021-294611 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Aug-2021: Follow-up received on 23-AUG-2021 with significant information of additional events.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded.    Events seriousness per IME list