Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrospinal fluid circulation disorder, Cough, Ear discomfort, Fatigue, Headache
Clinical narrative: pressure in her ears is occasional and is noticeable when she coughs or is lying down or sneezes; pressure in her ears is occasional and is noticeable when she coughs or is lying down or sneezes; pressure in her ears is occasional and is noticeable when she coughs or is lying down or sneezes; MRI revealed spinal fluid on the brain; queasy stomach; sore head/headaches; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROSPINAL FLUID CIRCULATION DISORDER (MRI revealed spinal fluid on the brain) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Medical history was not reported.  Concomitant products included LEVOTHYROXINE SODIUM (LEVOTHROID), LEVOTHYROXINE SODIUM (SYNTHROID), RAMIPRIL, SIMVASTATIN, TRAZODONE, FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), ASPIRIN [ACETYLSALICYLIC ACID], COLECALCIFEROL (VITAMIN D3), MULTIVITAMIN [VITAMINS NOS], CALCIUM CITRATE, DOCUSATE SODIUM (STOOL SOFTENER) and CYAMOPSIS TETRAGONOLOBA GUM (BENEFIBER FIBER SUPPLEMENT) for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced NAUSEA (queasy stomach), HEADACHE (sore head/headaches) and FATIGUE (fatigue). On 12-May-2021, the patient experienced CEREBROSPINAL FLUID CIRCULATION DISORDER (MRI revealed spinal fluid on the brain) (seriousness criterion medically significant). On an unknown date, the patient experienced EAR DISCOMFORT (pressure in her ears is occasional and is noticeable when she coughs or is lying down or sneezes), COUGH (pressure in her ears is occasional and is noticeable when she coughs or is lying down or sneezes) and SNEEZING (pressure in her ears is occasional and is noticeable when she coughs or is lying down or sneezes). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] in 2021 for Adverse event, at an unspecified dose and frequency and FAMOTIDINE in April 2021 for Queasy, at a dose of 20 mg. At the time of the report, CEREBROSPINAL FLUID CIRCULATION DISORDER (MRI revealed spinal fluid on the brain) outcome was unknown and EAR DISCOMFORT (pressure in her ears is occasional and is noticeable when she coughs or is lying down or sneezes), COUGH (pressure in her ears is occasional and is noticeable when she coughs or is lying down or sneezes), SNEEZING (pressure in her ears is occasional and is noticeable when she coughs or is lying down or sneezes), NAUSEA (queasy stomach), HEADACHE (sore head/headaches) and FATIGUE (fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-May-2021, Magnetic resonance imaging: abnormal (abnormal) Spinal fluid on the brain.         Company Comment: This case concerns a 80 year-old, female with no relevant medical history, who experienced the added unexpected events of Cerebrospinal fluid circulation disorder, Ear discomfort, Cough, Sneezing and expected reported events of Nausea, headache and fatigue. The added unexpected events of Cerebrospinal fluid circulation disorder, Ear discomfort, Cough, Sneezing occurred after the second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (event onset date unknown) and the expected events of Nausea, headache and fatigue occurred on the same day after the second dose. The rechallenge is not applicable. The concomitant medications, LEVOTHYROXINE SODIUM (LEVOTHROID), LEVOTHYROXINE SODIUM (SYNTHROID), TRAZODONE, FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) remains a confounder. The benefit-risk relationship of mRNA-1273 Moderna vaccine in not affected by this report.   This case was linked to MOD-2021-336420 (Patient Link).; Sender's Comments: This case concerns a 80 year-old, female with no relevant medical history, who experienced the added serious unexpected event of Cerebrospinal fluid circulation disorder. The event occurred approximately 60 days after the second dose of mRNA-1273 (COVID-19 Vaccine Moderna). The rechallenge is not applicable. The benefit-risk relationship of mRNA-1273 Moderna vaccine in not affected by this report.