Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm, Swelling face, Vomiting
Clinical narrative: feeling off; left injection site arm is very painful; Seizure; vomited 4 times; body aches; head ache/massive headache; Hallucinations; patients eyes went back in her head; face started swelling; left side of my body went stiff.; hot flashes; skin was red; skin was hot; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Seizure) and HALLUCINATION (Hallucinations) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007J21-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Autoimmune disorder, Autoimmune hepatitis, Lupus syndrome, Rheumatoid arthritis, Irritable bowel syndrome, Chronic kidney disease stage 3 and Colitis. Concomitant products included AZATHIOPRINE (IMURAN [AZATHIOPRINE]), PREDNISONE, HYDROXYCHLOROQUINE, ESCITALOPRAM OXALATE (LEXAPRO), OMEPRAZOLE, GABAPENTIN, ALPRAZOLAM (XANAX), AMLODIPINE BESILATE (NORVASC), ZOLPIDEM TARTRATE (AMBIEN), LEVOTHYROXINE, TRAZODONE, CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) and TIZANIDINE for an unknown indication.    On 24-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2022, the patient experienced HALLUCINATION (Hallucinations) (seriousness criterion medically significant), EYE MOVEMENT DISORDER (patients eyes went back in her head), SWELLING FACE (face started swelling), MUSCULOSKELETAL STIFFNESS (left side of my body went stiff.), HOT FLUSH (hot flashes), ERYTHEMA (skin was red), SKIN WARM (skin was hot), MYALGIA (body aches) and HEADACHE (head ache/massive headache). On 24-Jan-2022 at 1:00 PM, the patient experienced VOMITING (vomited 4 times). On 24-Jan-2022 at 3:30 PM, the patient experienced SEIZURE (Seizure) (seriousness criterion medically significant). On 25-Jan-2022, the patient experienced FEELING ABNORMAL (feeling off) and INJECTION SITE PAIN (left injection site arm is very painful). At the time of the report, SEIZURE (Seizure), HALLUCINATION (Hallucinations), EYE MOVEMENT DISORDER (patients eyes went back in her head), SWELLING FACE (face started swelling), MUSCULOSKELETAL STIFFNESS (left side of my body went stiff.), FEELING ABNORMAL (feeling off), HOT FLUSH (hot flashes), ERYTHEMA (skin was red), SKIN WARM (skin was hot), INJECTION SITE PAIN (left injection site arm is very painful), VOMITING (vomited 4 times), MYALGIA (body aches) and HEADACHE (head ache/massive headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient was on immunosuppressants.  The patients mother told her daughter that she had 3 seizures and that it was looked like the patient was looking through her Mom and not at her. The patients eyes went back in her head, face started swelling , and the left side of my body went stiff. The patients Mother also reports that her daughter was having hallucinations. No Treatment medications were provided.  Company comment: This spontaneous case concerns a 51-year-old female patient with a relevant medical history of Systemic lupus erythematous and concomitant use of Hydroxychloroquine, Escitalopram, Alprazolam, Zolpidem, Trazodone and Tizanidine who experienced the unexpected serious events of Seizure (AESI) and Hallucination after mRNA- 1273 vaccine. The onset of the events occurred on the day after the first dose of mRNA- 1273 vaccine. It was reported that the patient experienced three seizures, clinical manifestations included eye rolling, swelling face and musculoskeletal stiffness. No information is available regarding medical assessment and diagnostic work-up. Previous history of Systemic lupus erythematous and polypharmacy remain a confounder. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.   On 24JAN2022 at 3:30 the patient suffered a seizure. The patient vomited 4 times on 24JAN2022. The vomiting started at 1PM on 24JAN2022. The patient reports feeling off on 25JAN2022. The patient had headaches, body aches, and hot flashes that started 24JAN2022 and continue through today. The patient has a massive headache. The patients mother is a nurse. The patients mother told her daughter that she had 3 seizures and that it looked like the patient was looking through her Mom and not at her. The patients eyes went back in her head, face started swelling , and the left side of my body went stiff. The patients Mother also reports that her daughter was having hallucinations. Patient also feels like her skin was red and hot.; Sender's Comments: This spontaneous case concerns a 51-year-old female patient with a relevant medical history of Systemic lupus erythematous and concomitant use of Hydroxychloroquine, Escitalopram, Alprazolam, Zolpidem, Trazodone and Tizanidine who experienced the unexpected serious events of Seizure (AESI) and Hallucination after mRNA- 1273 vaccine. The onset of the events occurred on the day after the first dose of mRNA- 1273 vaccine. It was reported that the patient experienced three seizures, clinical manifestations included eye rolling, swelling face and musculoskeletal stiffness. No information is available regarding medical assessment and diagnostic work-up. Previous history of Systemic lupus erythematous and polypharmacy remains a confounder. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.