Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Scratch, Tardive dyskinesia, Vomiting
Clinical narrative: tardive dyskinesia; Cold; feeling strange/states she it was strange/felt surreal/did not know if she was dreaming or if this was real/she felt like she was floating; Scratch; She felt like she was in never never land; It scared her; Pins and Needles all over her body/like when the arm or foot falls asleep; Woke up and thought she was still sleep (Dream State)/did not know if she was dreaming or if this was real; felt like inside her body was cold; Nightmares; joint pain; Chills/had the weirdest chills she ever experienced/they were not normal chills; Fever; Nausea; Vomiting; Headache; Muscle pain; This spontaneous case was reported by a patient and describes the occurrence of TARDIVE DYSKINESIA (tardive dyskinesia) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 037A20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Atrial fibrillation. Concomitant products included RIVAROXABAN (XARELTO), METOPROLOL and LEVOTHYROXINE for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021 at 11:22 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced TARDIVE DYSKINESIA (tardive dyskinesia) (seriousness criterion medically significant), NASOPHARYNGITIS (Cold), FEELING ABNORMAL (feeling strange/states she it was strange/felt surreal/did not know if she was dreaming or if this was real/she felt like she was floating), SCRATCH (Scratch), EUPHORIC MOOD (She felt like she was in never never land), FEAR (It scared her), FEELING OF BODY TEMPERATURE CHANGE (felt like inside her body was cold), ARTHRALGIA (joint pain), VOMITING (Vomiting) and MYALGIA (Muscle pain). At the time of the report, TARDIVE DYSKINESIA (tardive dyskinesia), NASOPHARYNGITIS (Cold), FEELING ABNORMAL (feeling strange/states she it was strange/felt surreal/did not know if she was dreaming or if this was real/she felt like she was floating), SCRATCH (Scratch), EUPHORIC MOOD (She felt like she was in never never land), FEAR (It scared her), FEELING OF BODY TEMPERATURE CHANGE (felt like inside her body was cold), ARTHRALGIA (joint pain), VOMITING (Vomiting) and MYALGIA (Muscle pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Feb-2021, Body temperature: 101.5 (High) 101.5 F.         No treatment information was reported. 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.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Follow up received on 22-JUN-2021 : dose details, events and case seriousness was updated.; 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.