Age: 36.0
Sex: U
Vaccine: COVID19
Symptoms: Injection site swelling, Malaise, Pain, Poor quality sleep, Pyrexia
Clinical narrative: Hallucination; Abnormal dreams; Poor quality sleep; Malaise; Pain; Injection site pain; Injection site swelling; Headache; Chills; Pyrexia; This case was received via FDA VAERS on 25-May-2021 and was forwarded to Moderna on 25-May-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of HALLUCINATION (Hallucination) in a 36-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Reactive airways disease. Concomitant products included OMEPRAZOLE for an unknown indication.   On 28-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 28-Apr-2021, the patient experienced HALLUCINATION (Hallucination) (seriousness criterion medically significant), ABNORMAL DREAMS (Abnormal dreams), POOR QUALITY SLEEP (Poor quality sleep), MALAISE (Malaise), PAIN (Pain), INJECTION SITE PAIN (Injection site pain), INJECTION SITE SWELLING (Injection site swelling), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Pyrexia). The patient was treated with SUMATRIPTAN (IMITREX [SUMATRIPTAN]) ongoing since an unknown date for Headache, at a dose of 50 mg twice a day; IBUPROFEN ongoing since an unknown date for Swelling, at a dose of 400 mg and PARACETAMOL (TYLENOL) ongoing since an unknown date for Fever, at a dose of 1000 mg. At the time of the report, HALLUCINATION (Hallucination), ABNORMAL DREAMS (Abnormal dreams), POOR QUALITY SLEEP (Poor quality sleep), MALAISE (Malaise), PAIN (Pain), INJECTION SITE PAIN (Injection site pain), INJECTION SITE SWELLING (Injection site swelling), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Pyrexia) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Prior Vaccine: Same symptoms for dose 1. Patient was experienced headache, chills, body aches, Injection site pain and swelling, general malaise, fever, poor sleep, waking dreams (hallucinations). Patient was used Imitrex for the headache (2x doses 6 hours apart, 50mg) Used Ibuprofen 400mg/Tylenol 1000mg alternating for fever/swelling. Symptoms were resolved approx. 26 hours after they began.  Company Comment: This case concerns a 36-year-old patient of unknown gender with a serious unexpected event of hallucination, and nonserious unexpected abnormal dreams, poor quality sleep, malaise, pain, and nonserious expected injection site pain, injection site swelling, headache, chills and pyrexia. Event latency with 24 hours after mRNA-1273. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 36-year-old patient of unknown gender with a serious unexpected event of hallucination, and nonserious unexpected abnormal dreams, poor quality sleep, malaise, pain, and nonserious expected injection site pain, injection site swelling, headache, chills and pyrexia. Event latency with 24 hours after mRNA-1273. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.