Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dry mouth, Eructation, Fatigue, Gait disturbance
Clinical narrative: belching; diarrhoea; blurred vision; experienced a headache describing that " an explosion happened in my head; lightheadedness; drying of the mouth and throat; vertigo; nausea; Dehydration; Tingling all the way to fingertips; general fatigue; trouble walking; inability to lift right leg; hypoaesthesia; lethargy; lethargy; dizziness; anaphylactic reaction; vaccination site bruising; blood pressure increase; paraesthesia left arm; dehydration; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (lightheadedness), DIZZINESS (dizziness), DRY MOUTH (drying of the mouth and throat), VERTIGO (vertigo), ERUCTATION (belching), DEHYDRATION (Dehydration), PARAESTHESIA (Tingling all the way to fingertips), FATIGUE (general fatigue), GAIT DISTURBANCE (trouble walking), MOVEMENT DISORDER (inability to lift right leg), HYPOAESTHESIA (hypoaesthesia), the second episode of LETHARGY (lethargy), HEADACHE (experienced a headache describing that " an explosion happened in my head), VISION BLURRED (blurred vision), DIARRHOEA (diarrhoea), NAUSEA (nausea), the first episode of LETHARGY (lethargy) and ANAPHYLACTIC REACTION (anaphylactic reaction) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Fusion cervical spine. Concurrent medical conditions included Anaphylaxis, Coronary artery disease, Asthma, Gastroesophageal reflux disease, Osteoarthritis, Hypoglycemia, Hypothyroidism, Hypertension, Allergy to antibiotic (levaquin), Drug allergy (vioxx), Shellfish allergy, Arrhythmia, Epilepsy and Allergy (steroids). Concomitant products included EPINEPHRINE (EPIPEN), TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA), ASPIRIN [ACETYLSALICYLIC ACID], ATENOLOL (TENORMIN), UBIDECARENONE (COQ10 [UBIDECARENONE]), LEVETIRACETAM (KEPPRA [LEVETIRACETAM]), GABAPENTIN (NEURONTIN), VITAMIN B12 [VITAMIN B12 NOS], CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), NITROGLYCERIN, ALBUTEROL [SALBUTAMOL], BUTALBITAL, CAFFEINE, PARACETAMOL (FIORICET), MONTELUKAST SODIUM (SINGULAIR), LEVOTHYROXINE SODIUM (SYNTHROID), ROSUVASTATIN CALCIUM (CRESTOR) and DONEPEZIL HYDROCHLORIDE (ARICEPT) for an unknown indication, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR).    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 DIZZINESS (dizziness) (seriousness criterion hospitalization prolonged), the first episode of LETHARGY (lethargy) (seriousness criterion hospitalization), VACCINATION SITE BRUISING (vaccination site bruising), BLOOD PRESSURE INCREASED (blood pressure increase), PARAESTHESIA (paraesthesia left arm), DEHYDRATION (dehydration) and FATIGUE (fatigue). On 18-Jun-2021, the patient experienced DIZZINESS (lightheadedness) (seriousness criterion hospitalization prolonged), DRY MOUTH (drying of the mouth and throat) (seriousness criterion hospitalization prolonged), VERTIGO (vertigo) (seriousness criterion hospitalization prolonged), DEHYDRATION (Dehydration) (seriousness criterion hospitalization prolonged), PARAESTHESIA (Tingling all the way to fingertips) (seriousness criterion hospitalization prolonged), FATIGUE (general fatigue) (seriousness criterion hospitalization prolonged), GAIT DISTURBANCE (trouble walking) (seriousness criterion hospitalization prolonged), MOVEMENT DISORDER (inability to lift right leg) (seriousness criterion hospitalization prolonged), HYPOAESTHESIA (hypoaesthesia) (seriousness criterion hospitalization prolonged), the second episode of LETHARGY (lethargy) (seriousness criterion hospitalization prolonged) and NAUSEA (nausea) (seriousness criterion hospitalization prolonged). On 19-Jun-2021, the patient experienced HEADACHE (experienced a headache describing that " an explosion happened in my head) (seriousness criterion hospitalization prolonged). On 20-Jun-2021, the patient experienced VISION BLURRED (blurred vision) (seriousness criterion hospitalization prolonged). On 21-Jun-2021, the patient experienced ERUCTATION (belching) (seriousness criterion hospitalization prolonged) and DIARRHOEA (diarrhoea) (seriousness criterion hospitalization prolonged). On an unknown date, the patient experienced ANAPHYLACTIC REACTION (anaphylactic reaction) (seriousness criterion medically significant). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, DIZZINESS (lightheadedness), DIZZINESS (dizziness), DRY MOUTH (drying of the mouth and throat), VERTIGO (vertigo), ERUCTATION (belching), DEHYDRATION (Dehydration), PARAESTHESIA (Tingling all the way to fingertips), FATIGUE (general fatigue), GAIT DISTURBANCE (trouble walking), MOVEMENT DISORDER (inability to lift right leg), HYPOAESTHESIA (hypoaesthesia), the last episode of LETHARGY (lethargy), HEADACHE (experienced a headache describing that " an explosion happened in my head), VISION BLURRED (blurred vision), DIARRHOEA (diarrhoea), NAUSEA (nausea), ANAPHYLACTIC REACTION (anaphylactic reaction), VACCINATION SITE BRUISING (vaccination site bruising), BLOOD PRESSURE INCREASED (blood pressure increase), PARAESTHESIA (paraesthesia left arm), DEHYDRATION (dehydration) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jul-2021, Blood pressure measurement: high (High) 172/95-98.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient has Coronary Artery Disease for which they Artery Disease for which they have three cardiac stents. The patient is RH negative.  Company Comment: Based on the currently available information and temporal association between the use of the product and the start date of the immediate events following vaccination with a start date of 21May2021, a causal relationship cannot be excluded.   Very limited information regarding the events with an onset date of 18Jun2021 and 19Jun2021 has been provided at this time.  Further information has been requested and is necessary for assessing a causal relationship.   This case was linked to MOD-2021-264136 (Patient Link).; Sender's Comments: Based on the currently available information and temporal association between the use of the product and the start date of the immediate events following vaccination with a start date of 21May2021, a causal relationship cannot be excluded.   Very limited information regarding the events with an onset date of 18Jun2021 and 19Jun2021 has been provided at this time.  Further information has been requested and is necessary for assessing a causal relationship.