Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Depressed level of consciousness, Dyspepsia, Erythema, Fatigue, Headache
Clinical narrative: Rash that was itchy; Red; Burns (Red Bumps area on the neck); Depressed level of consciousness; Abdominal cramping; Chills; Mild Headache; Red Bumps Right Side of the Neck \ front on my neck was red with a rash/Red bumpy rash covering the front of my neck; Burning sensation; Lethargic; No energy\ low energy; Sore left upper arm shot site; Felt Tired; Throwing up/Vomiting; Stomach burning; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSED LEVEL OF CONSCIOUSNESS (Depressed level of consciousness) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMIN C [ASCORBIC ACID] and CURCUMA LONGA (TURMERIC CURCUMIN [CURCUMA LONGA]) for Immune disorder (NOS), MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 19-Mar-2021 at 3:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Mar-2021 at 8:30 AM, the patient experienced DYSPEPSIA (Stomach burning). On 19-Mar-2021 at 8:45 AM, the patient experienced VOMITING (Throwing up/Vomiting). On 20-Mar-2021, the patient experienced LETHARGY (Lethargic), ASTHENIA (No energy\ low energy), VACCINATION SITE PAIN (Sore left upper arm shot site) and FATIGUE (Felt Tired). On 21-Mar-2021, the patient experienced RASH MACULAR (Red Bumps Right Side of the Neck \ front on my neck was red with a rash/Red bumpy rash covering the front of my neck). 21-Mar-2021, the patient experienced BURNING SENSATION (Burning sensation) and HEADACHE (Mild Headache). On 22-Mar-2021, the patient experienced DEPRESSED LEVEL OF CONSCIOUSNESS (Depressed level of consciousness) (seriousness criterion medically significant), ABDOMINAL PAIN (Abdominal cramping) and CHILLS (Chills). On 26-Mar-2021, the patient experienced SKIN BURNING SENSATION (Burns (Red Bumps area on the neck)). On an unknown date, the patient experienced RASH PRURITIC (Rash that was itchy) and ERYTHEMA (Red). The patient was treated with HYDROCORTISONE at a dose of UNK dosage form and LEVOCETIRIZINE DIHYDROCHLORIDE (LEVOCETRIZINE HYDROCHLORIDE) from 23-Mar-2021 to 27-Mar-2021 for Rash, at a dose of 1 DF. On 22-Mar-2021, VOMITING (Throwing up/Vomiting) had resolved. On 23-Mar-2021, HEADACHE (Mild Headache) had resolved. On 27-Mar-2021, RASH MACULAR (Red Bumps Right Side of the Neck \ front on my neck was red with a rash/Red bumpy rash covering the front of my neck), LETHARGY (Lethargic), ASTHENIA (No energy\ low energy), FATIGUE (Felt Tired) and CHILLS (Chills) had resolved. At the time of the report, DEPRESSED LEVEL OF CONSCIOUSNESS (Depressed level of consciousness), DYSPEPSIA (Stomach burning), RASH PRURITIC (Rash that was itchy), ERYTHEMA (Red), SKIN BURNING SENSATION (Burns (Red Bumps area on the neck)), BURNING SENSATION (Burning sensation), ABDOMINAL PAIN (Abdominal cramping) and VACCINATION SITE PAIN (Sore left upper arm shot site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Mar-2021, Body temperature: 97.5 (normal) 97.5.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-255837 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: New events depressed level of consciousness, dyspepsia, rash pruritic, erythema, lethargy, asthenia, burning sensation, abdominal pain, vaccination site pain, fatigue and chills were added. Treatment medication and concomitant medications were added. Action taken was updated.; 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.