Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram, Electrocardiogram, Headache, Hypertension, Magnetic resonance imaging
Clinical narrative: vomiting; headache; woke up disoriented; unable to complete or understand tasks; confused; Cellulitis; high blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of DISORIENTATION (woke up disoriented), COGNITIVE DISORDER (unable to complete or understand tasks), CONFUSIONAL STATE (confused), CELLULITIS (Cellulitis), VOMITING (vomiting), HEADACHE (headache) and HYPERTENSION (high blood pressure) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 031620A) for COVID-19 vaccination.     Concurrent medical conditions included Hives since 2020 and Acid reflux (esophageal) since 2020. Concomitant products included OMALIZUMAB (XOLAIR) from 03-Mar-2021 to an unknown date for Hives.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced VOMITING (vomiting) (seriousness criterion hospitalization) and HEADACHE (headache) (seriousness criterion hospitalization). On 08-Mar-2021, the patient experienced HYPERTENSION (high blood pressure) (seriousness criterion hospitalization prolonged). On 11-Mar-2021, the patient experienced DISORIENTATION (woke up disoriented) (seriousness criterion hospitalization), COGNITIVE DISORDER (unable to complete or understand tasks) (seriousness criterion hospitalization) and CONFUSIONAL STATE (confused) (seriousness criterion hospitalization). On an unknown date, the patient experienced CELLULITIS (Cellulitis) (seriousness criterion medically significant). The patient was hospitalized from 11-Mar-2021 to 12-Mar-2021 due to COGNITIVE DISORDER, CONFUSIONAL STATE and DISORIENTATION. At the time of the report, DISORIENTATION (woke up disoriented), COGNITIVE DISORDER (unable to complete or understand tasks) and CONFUSIONAL STATE (confused) was resolving and CELLULITIS (Cellulitis), VOMITING (vomiting), HEADACHE (headache) and HYPERTENSION (high blood pressure) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Computerised tomogram: negative Negative. On 11-Mar-2021, Echocardiogram: negative Negative. On 11-Mar-2021, Electrocardiogram: negative Negative. On 11-Mar-2021, Magnetic resonance imaging: negative Negative.         Plavix was prescribed on 12Mar2021 in case it was a "vascular event." The patient discontinued Carvedilol 6.25mg (Oct 2020). Feb 22nd: Patient experienced trouble finding words, and lost bladder control. March 6th: Went ER for vomiting, headache. March 8th:  In the ER, the patient high blood pressure and was started on Carvedilol at a higher dose 12.5mg 2x/day. Family noticed that she had trouble finding words, highly emotional, blurry vision. An unspecified diagnostic test revealed Carotid arteries smaller on both sides with no blockage, and Cortical atrophy.  Based on the current available information and temporal association between the use of the product and the start date of the event (cellulitis, vomiting, high BP, and headache), a causal relationship cannot be excluded. Very limited information regarding the events (Disorientation, cognitive disorder, confusional state) has been provided at this time.  Further information has been requested.   This case was linked to MOD-2021-040734 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event (cellulitis, vomiting, high BP, and headache), a causal relationship cannot be excluded. Very limited information regarding the events (Disorientation, cognitive disorder, confusional state) has been provided at this time.  Further information has been requested.