Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chest X-ray, Computerised tomogram head, Dry mouth, Fatigue
Clinical narrative: vertigo; Off & on migraine; Anxiety; spasticity on right side in her arm; Feeling extremely tired; Mouth dry; spasticity on right side in her chest; spasticity on right side in her lower extremities; rigidity on right side in neck,; rigidity on right side in her arm; rigidity on right side in her chest; rigidity on right side in her lower extremities; spasticity on right side in neck,; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MUSCLE RIGIDITY (rigidity on right side in neck,), MUSCLE RIGIDITY (rigidity on right side in her arm), MUSCLE RIGIDITY (rigidity on right side in her chest), MUSCLE RIGIDITY (rigidity on right side in her lower extremities) and MUSCLE SPASTICITY (spasticity on right side in neck,) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030620A and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stroke in 2018. Concurrent medical conditions included Allergy to intravenous contrast media (Ivp dye), Drug allergy (Allergic to dermerol) and Drug allergy (Allergic to percocet). Concomitant products included DILTIAZEM HYDROCHLORIDE (DILTIAZEM CD) for Blood pressure management, ATORVASTATIN from 20-Dec-2018 to an unknown date for Hypocholesterolaemia, ASA, LORAZEPAM (ATIVAN) and BACLOFEN for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced MUSCLE RIGIDITY (rigidity on right side in neck,), MUSCLE RIGIDITY (rigidity on right side in her arm), MUSCLE RIGIDITY (rigidity on right side in her chest), MUSCLE RIGIDITY (rigidity on right side in her lower extremities), MUSCLE SPASTICITY (spasticity on right side in neck,), MUSCLE SPASTICITY (spasticity on right side in her chest) and MUSCLE SPASTICITY (spasticity on right side in her lower extremities). On 11-Mar-2021, the patient experienced MUSCLE SPASTICITY (spasticity on right side in her arm), DRY MOUTH (Mouth dry) and FATIGUE (Feeling extremely tired). On 29-Mar-2021, the patient experienced ANXIETY (Anxiety). On 06-Apr-2021, the patient experienced VERTIGO (Symptoms of vertigo) and MIGRAINE (Off & on migraine). The patient was treated with BACLOFEN at a dose of 1 dosage form. At the time of the report, MUSCLE RIGIDITY (rigidity on right side in neck,), MUSCLE RIGIDITY (rigidity on right side in her arm), MUSCLE RIGIDITY (rigidity on right side in her chest), MUSCLE RIGIDITY (rigidity on right side in her lower extremities), MUSCLE SPASTICITY (spasticity on right side in neck,), MUSCLE SPASTICITY (spasticity on right side in her arm), MUSCLE SPASTICITY (spasticity on right side in her chest) and MUSCLE SPASTICITY (spasticity on right side in her lower extremities) had not resolved and DRY MOUTH (Mouth dry), VERTIGO (Symptoms of vertigo), ANXIETY (Anxiety), MIGRAINE (Off & on migraine) and FATIGUE (Feeling extremely tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Chest X-ray: unknown (normal) Normal. In March 2021, Computerised tomogram head: unknown (normal) Normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 05-Apr-2021: No new information was provided. On 14-Apr-2021: No new information was provided. On 18-Apr-2021: Follow up information received on 18-APR-2021 added dosage information, events,concomitant medication such as diltiazem CD,Atorvastatin,Ativan,ASP,Baclofen and treatment medications such as vitamin C, Vitamin B complex, Vitamin D3,Zinc Gluconate. On 16- Jul-2021: Non Significant Follow up information received on 16-JUL-2021 included neurologic history with meningioma at the base of brain and had brain surgery.; Reporter'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.  The subject's underlying history of rigidity and spasticity on right side in her neck, arm, chest, and lower extremities can also be confounding factors.