Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Nausea, Somnolence
Clinical narrative: coughing more; heaviness in chest; had eye surgery; difficulty getting words out; feel dizzy; had fatigue/ tired; headache; feeling hot/ hot; sleepy/ feels groggy; brain fog; felt ill; decreased appetite; nausea; chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (feeling hot/ hot), SOMNOLENCE (sleepy/ feels groggy), FEELING ABNORMAL (brain fog), MALAISE (felt ill) and DECREASED APPETITE (decreased appetite) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prophylactic vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) injection for Asthma.    Concurrent medical conditions included Drug allergy (Lamotrigine allergy), Drug allergy (Amitriptyline allergy), Drug allergy (Bupropion allergy), Allergy to antibiotic (Clarithromycin allergy) and Drug allergy (Mirteburine allergy). Concomitant products included PREDNISONE, FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), ASPIRIN [ACETYLSALICYLIC ACID], FORMOTEROL FUMARATE, MOMETASONE FUROATE (DULERA), TIOTROPIUM BROMIDE (SPIRIVA [TIOTROPIUM BROMIDE]), MONTELUKAST, MIRTAZAPINE and FORMOTEROL FUMARATE for an unknown indication.   On 23-Apr-2020, the patient DUPILUMAB (DUPIXENT) (Subcutaneous) dosage was changed to 600 milligram once a day. On 08-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) 300 milligram. On 08-Dec-2021, the patient experienced NAUSEA (nausea). 08-Dec-2021, the patient experienced CHILLS (chills). On 09-Dec-2021, the patient experienced FEELING HOT (feeling hot/ hot), SOMNOLENCE (sleepy/ feels groggy), FEELING ABNORMAL (brain fog), MALAISE (felt ill), DECREASED APPETITE (decreased appetite), FATIGUE (had fatigue/ tired) and HEADACHE (headache). On 10-Dec-2021, the patient experienced APHASIA (difficulty getting words out) and DIZZINESS (feel dizzy). On an unknown date, the patient experienced COUGH (coughing more), CHEST DISCOMFORT (heaviness in chest) and EYE OPERATION (had eye surgery). The patient was treated with ALBUTEROL [SALBUTAMOL] for Cough, at a dose of UNK, inhaler; PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency; BUDESONIDE for Chest discomfort, at a dose of UNK, nebulizer and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Cough, at an unspecified dose and frequency. On 10-Dec-2021, HEADACHE (headache) had resolved. On 04-Jan-2022, NAUSEA (nausea) outcome was unknown. At the time of the report, FEELING HOT (feeling hot/ hot), SOMNOLENCE (sleepy/ feels groggy), COUGH (coughing more), CHEST DISCOMFORT (heaviness in chest) and FATIGUE (had fatigue/ tired) had not resolved, FEELING ABNORMAL (brain fog), MALAISE (felt ill), DECREASED APPETITE (decreased appetite), APHASIA (difficulty getting words out), CHILLS (chills) and DIZZINESS (feel dizzy) outcome was unknown and EYE OPERATION (had eye surgery) was resolving.            This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.