Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected, Tremor
Clinical narrative: secondary infections, like staphylococcus; back pain went away and breathing better/skin tone was better\  I realized my muscles were relaxed and less achy than they had been since; attempting to get bronchitis; Shaking; chest discomfort; feeling abnormal; My skin has been becoming spotted like vitiligo appears. Very white spots; My skin had become pale with bleach spots.; lifelong issues around medical facility; my joints don't hurt; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of STAPHYLOCOCCAL INFECTION (secondary infections, like staphylococcus) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021C21A and 001C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Post-traumatic stress disorder on 01-Jan-2010. Previously administered products included for an unreported indication: FLU VACCINE VII since an unknown date. Concurrent medical conditions included Autoimmune disorder NOS, Anaphylaxis, Hypersensitivity reaction, Hives, Asthma, Hay fever, Drug allergy (patient is allergic to aspartame) since 01-Jan-1996, Drug allergy (patient is allergic to compazine) since 01-Jan-1997, Penicillin allergy on 21-Mar-1973, COPD since 21-Mar-1973, Migraine since 06-Jan-1996, Depression since 24-Dec-1983 and Bipolar disorder since 01-Feb-2017. Concomitant products included LAMOTRIGINE (LAMICTAL) and BUPROPION HYDROCHLORIDE (WELLBUTRIN) from 03-Jan-2017 to an unknown date for Bipolar disorder, MONTELUKAST SODIUM (SINGULAIR) for COPD, OMALIZUMAB (XOLAIR) and DIAZEPAM for an unknown indication.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced STAPHYLOCOCCAL INFECTION (secondary infections, like staphylococcus) (seriousness criterion medically significant), THERAPEUTIC RESPONSE UNEXPECTED (back pain went away and breathing better/skin tone was better\  I realized my muscles were relaxed and less achy than they had been since), BRONCHITIS (attempting to get bronchitis), TREMOR (Shaking), CHEST DISCOMFORT (chest discomfort), FEELING ABNORMAL (feeling abnormal), SKIN DEPIGMENTATION (My skin has been becoming spotted like vitiligo appears. Very white spots), PALLOR (My skin had become pale with bleach spots.), IMPAIRED QUALITY OF LIFE (lifelong issues around medical facility), ARTHRALGIA (my joints don't hurt), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, STAPHYLOCOCCAL INFECTION (secondary infections, like staphylococcus), THERAPEUTIC RESPONSE UNEXPECTED (back pain went away and breathing better/skin tone was better\  I realized my muscles were relaxed and less achy than they had been since), BRONCHITIS (attempting to get bronchitis), TREMOR (Shaking), CHEST DISCOMFORT (chest discomfort), FEELING ABNORMAL (feeling abnormal), SKIN DEPIGMENTATION (My skin has been becoming spotted like vitiligo appears. Very white spots), PALLOR (My skin had become pale with bleach spots.), IMPAIRED QUALITY OF LIFE (lifelong issues around medical facility), ARTHRALGIA (my joints don't hurt), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.  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 27-Jul-2021: Follow-up information was received on 28-Jul-2021  contains new event.; 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.