Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Pyrexia, Vaccination site erythema, Vaccination site scab, Vaccination site swelling
Clinical narrative: Cellulitis in arm; Arm has a bruise that is getting larger over time; Swollen arm bright red in color, hot to the touch; Swollen arm bright red in color, hot to the touch; Swollen arm bright red in color, hot to the touch; Fever of 103.8 degrees Fahrenheit; Vomiting; words slurring; Sweating profusely; Became truly delirious; Scab at the site of injection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DELIRIUM (Became truly delirious) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Guillain Barre syndrome and Cutaneous lupus erythematosus. Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN), TOPIRAMATE (TOPAMAX), HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]), IMMUNOGLOBULINS NOS and LISDEXAMFETAMINE MESILATE (VYVANSE) for an unknown indication.    On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, the patient experienced VACCINATION SITE SCAB (Scab at the site of injection). On 22-May-2021, the patient experienced DELIRIUM (Became truly delirious) (seriousness criterion medically significant), DYSARTHRIA (words slurring), HYPERHIDROSIS (Sweating profusely), PYREXIA (Fever of 103.8 degrees Fahrenheit) and VOMITING (Vomiting). On 23-May-2021, the patient experienced CELLULITIS (Cellulitis in arm), INJECTION SITE BRUISING (Arm has a bruise that is getting larger over time), VACCINATION SITE WARMTH (Swollen arm bright red in color, hot to the touch), VACCINATION SITE SWELLING (Swollen arm bright red in color, hot to the touch) and VACCINATION SITE ERYTHEMA (Swollen arm bright red in color, hot to the touch). The patient was treated with CEFTRIAXONE (CEFTIN [CEFTRIAXONE]) ongoing since an unknown date for Cellulitis, at an unspecified dose and frequency; ACETAMINOPHEN ongoing since an unknown date at an unspecified dose and frequency and IBUPROFEN ongoing since an unknown date for Fever, at a dose of UNK dosage form. On 22-May-2021, DELIRIUM (Became truly delirious), DYSARTHRIA (words slurring), HYPERHIDROSIS (Sweating profusely) and VOMITING (Vomiting) had resolved. On 23-May-2021, PYREXIA (Fever of 103.8 degrees Fahrenheit) had resolved. On 24-May-2021, CELLULITIS (Cellulitis in arm), VACCINATION SITE WARMTH (Swollen arm bright red in color, hot to the touch), VACCINATION SITE SWELLING (Swollen arm bright red in color, hot to the touch) and VACCINATION SITE ERYTHEMA (Swollen arm bright red in color, hot to the touch) had resolved. At the time of the report, INJECTION SITE BRUISING (Arm has a bruise that is getting larger over time) and VACCINATION SITE SCAB (Scab at the site of injection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-May-2021, Body temperature: 103.8 (High) 103.8 degrees Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the event included intravenous fluids in Emergency Room.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: contained significant information: lot number updated. On 08-Jun-2021: non-significant information: contact details updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.