Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Eructation, Fatigue, Gait disturbance, Headache, Hypoaesthesia
Clinical narrative: Trouble walking; inability to lift right leg; experienced a headache describing that " an explosion happened in my head; High BP 172/95-98; left arm felt heavy with numbness all the way to fingertips; lethargy; vertigo; Lightheadedness; dehydration; Tingling all the way to fingertips; general fatigue; diarrhea; belching; blurred vision; Mouth dry; nausea; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Jun-2021 and was forwarded to Moderna on 21-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo), DIZZINESS (Lightheadedness), DEHYDRATION (dehydration), PARAESTHESIA (Tingling all the way to fingertips), FATIGUE (general fatigue), GAIT DISTURBANCE (Trouble walking), HYPOKINESIA (inability to lift right leg), BLOOD PRESSURE INCREASED (High BP 172/95-98), HYPOAESTHESIA (left arm felt heavy with numbness all the way to fingertips), LETHARGY (lethargy) and HEADACHE (experienced a headache describing that " an explosion happened in my head) 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.     Concurrent medical conditions included Anaphylaxis, Coronary artery disease, Asthma, Gastroesophageal reflux disease, Osteoarthritis, Hypoglycemia, Hypothyroidism, Hypertension, Allergy to antibiotic (The patient is allergic to Levaquin.), Drug allergy (The patient is allergic to Vioxx.), Shellfish allergy and Arrhythmia. Concomitant products included TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), 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]), LEVOSALBUTAMOL TARTRATE (XOPENEX HFA), EPINEPHRINE (EPIPEN), NITROGLYCERIN, ALBUTEROL [SALBUTAMOL], BUTALBITAL, CAFFEINE, PARACETAMOL (FIORICET), MONTELUKAST SODIUM (SINGULAIR), LEVOTHYROXINE SODIUM (SYNTHYROID), ROSUVASTATIN CALCIUM (CRESTOR) and DONEPEZIL HYDROCHLORIDE (ARICEPT) 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 18-Jun-2021, the patient experienced VERTIGO (vertigo) (seriousness criterion hospitalization), DIZZINESS (Lightheadedness) (seriousness criterion hospitalization), DEHYDRATION (dehydration) (seriousness criterion hospitalization), PARAESTHESIA (Tingling all the way to fingertips) (seriousness criterion hospitalization), FATIGUE (general fatigue) (seriousness criterion hospitalization), BLOOD PRESSURE INCREASED (High BP 172/95-98) (seriousness criterion hospitalization), HYPOAESTHESIA (left arm felt heavy with numbness all the way to fingertips) (seriousness criterion hospitalization), LETHARGY (lethargy) (seriousness criterion hospitalization), DRY MOUTH (Mouth dry) and NAUSEA (nausea). On 19-Jun-2021, the patient experienced HYPOKINESIA (inability to lift right leg) (seriousness criterion hospitalization) and HEADACHE (experienced a headache describing that " an explosion happened in my head) (seriousness criterion hospitalization). On 20-Jun-2021, the patient experienced VISION BLURRED (blurred vision). On 21-Jun-2021, the patient experienced DIARRHOEA (diarrhea) and ERUCTATION (belching). On an unknown date, the patient experienced GAIT DISTURBANCE (Trouble walking) (seriousness criterion hospitalization). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL) ongoing from 21-May-2021 at an unspecified dose and frequency. At the time of the report, VERTIGO (vertigo), DIZZINESS (Lightheadedness), DEHYDRATION (dehydration), PARAESTHESIA (Tingling all the way to fingertips), FATIGUE (general fatigue), GAIT DISTURBANCE (Trouble walking), HYPOKINESIA (inability to lift right leg), BLOOD PRESSURE INCREASED (High BP 172/95-98), HYPOAESTHESIA (left arm felt heavy with numbness all the way to fingertips), LETHARGY (lethargy), HEADACHE (experienced a headache describing that " an explosion happened in my head), VISION BLURRED (blurred vision), DIARRHOEA (diarrhea), DRY MOUTH (Mouth dry), ERUCTATION (belching) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   After the patient received the first dose of the Moderna COVID-19 vaccine on 21 May 2021, the patient reports having a black and blue arm as a side effect from receiving that dose. The patient experienced high BP 172/95-98, which resolved to systolic BP of 155 by the time of discharge from the vaccine facility. The patient's left arm felt heavy with numbness and tingling down the entire arm to the finger tips. At the vaccine facility, the patient was treated with Benadryl and rest until they felt good enough to go home. After arriving home the patient experienced generalized fatigue, continued numbness and tingling of left arm, lightheadedness, increased blood pressure, and lethargy and presented to their local ER where they were treated for dehydration and given meclizine. The decision was made to keep the patient overnight where they were observed and discharged 19 Jun 2021. During their observation period, the patient experienced a headache describing that " an explosion happened in my head" as well as the inability to lift their right leg and trouble walking, which required the use of a wheelchair. There was no report of any additional treatment given for these symptoms. The patient is currently experiencing the above mentioned symptoms intermittently with the addition of: belching, the inability to lift the right leg, and blurred vision (onset 20 Jun 2021) and diarrhea ( onset 21 Jun 2021).  The patient has Coronary Artery Disease for which they have three cardiac stents. The patient is Rh NEG. The patient is epileptic and has a cervical spine fusion. The patient is also allergic to steroids.       Reporter did not allow further contact; 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.