Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Respiratory tract congestion, Rhinorrhoea, Vomiting
Clinical narrative: Mental impairment; Photophobia; Respiratory tract congestion; Nasal congestion; Feeling abnormal; Asthenia; Insomnia; Rhinorrhoea; Irritability; Cough; Feeling hot; Pain; Arthralgia; Chills; Headache; Nausea; Pyrexia; Vomiting; This case was received via FDA VAERS on 18-May-2021 and was forwarded to Moderna on 18-May-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of MENTAL IMPAIRMENT (Mental impairment) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: Shingrix. Concurrent medical conditions included ADHD and Anxiety disorder. Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL), CELECOXIB (CELEXA [CELECOXIB]), TRAZODONE, MELOXICAM (MOBIC), LAMOTRIGINE (LAMICTAL) and MULTI VIT for an unknown indication.   On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced MENTAL IMPAIRMENT (Mental impairment) (seriousness criterion medically significant), PHOTOPHOBIA (Photophobia), RESPIRATORY TRACT CONGESTION (Respiratory tract congestion), NASAL CONGESTION (Nasal congestion), FEELING ABNORMAL (Feeling abnormal), ASTHENIA (Asthenia), INSOMNIA (Insomnia), RHINORRHOEA (Rhinorrhoea), IRRITABILITY (Irritability), COUGH (Cough), FEELING HOT (Feeling hot), PAIN (Pain), ARTHRALGIA (Arthralgia), CHILLS (Chills), HEADACHE (Headache), NAUSEA (Nausea), PYREXIA (Pyrexia) and VOMITING (Vomiting). At the time of the report, MENTAL IMPAIRMENT (Mental impairment), PHOTOPHOBIA (Photophobia), RESPIRATORY TRACT CONGESTION (Respiratory tract congestion), NASAL CONGESTION (Nasal congestion), FEELING ABNORMAL (Feeling abnormal), ASTHENIA (Asthenia), INSOMNIA (Insomnia), RHINORRHOEA (Rhinorrhoea), IRRITABILITY (Irritability), COUGH (Cough), FEELING HOT (Feeling hot), PAIN (Pain), ARTHRALGIA (Arthralgia), CHILLS (Chills), HEADACHE (Headache), NAUSEA (Nausea), PYREXIA (Pyrexia) and VOMITING (Vomiting) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Feb-2021, Body temperature: 100.5 (Inconclusive) 100.5 F. and 102.5 (Inconclusive) 102.5 F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient had fever which was between 100.5 to 102.5 F , chills, feeling hot, runny nose congestion, slightly productive cough, extreme head ache, was feeling weak and awful all over, light sensitivity, nausea and vomiting, hard to focus, joints and body ache inability to sleep and Irritability.  Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not Applicable.  Company Comment : 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.; 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.