Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Eyelid pain, Ocular hyperaemia, Pain in extremity
Clinical narrative: Sore arm; Upset stomach; Diarrhea; Red  burning eyes; Red painful swollen eye lid; Painful swollen eye lid; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sore arm), ABDOMINAL DISCOMFORT (Upset stomach), DIARRHOEA (Diarrhea), OCULAR HYPERAEMIA (Red  burning eyes) and SWELLING OF EYELID (Red painful swollen eye lid) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products TASIMELTEON (HETLIOZ) capsule for Circadian rhythm sleep disorder and BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for Asthma.    The patient's past medical history included Victim of child abuse and Developmental disturbance (Patient missed social steps). Previously administered products included for Product used for unknown indication: Depakote, Biaxin, Dynapen, Codeine, Erythromycin, Abilify and Keflex. Past adverse reactions to the above products included Drug allergy with Abilify, Biaxin, Codeine, Depakote, Dynapen, Erythromycin and Keflex. Concurrent medical conditions included Attention deficit hyperactivity disorder (Patient stated the condition as predominantly inattentive type), Major depressive disorder (Patient stated the condition as recurrent, moderate), Post-traumatic stress disorder, Anxiety and Asthma. Concomitant products included RANITIDINE HYDROCHLORIDE (ZANTAC), BECLOMETASONE DIPROPIONATE (QNASL), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), ALPRAZOLAM (XANAX), AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) and ESZOPICLONE (LUNESTA) for an unknown indication.   In 2015, the patient started TASIMELTEON (HETLIOZ) (Oral) 20 milligram once a day. On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) (unknown route) at an unspecified dose. On 14-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). 14-Apr-2021, the patient experienced ABDOMINAL DISCOMFORT (Upset stomach), DIARRHOEA (Diarrhea), OCULAR HYPERAEMIA (Red  burning eyes), SWELLING OF EYELID (Red painful swollen eye lid) and EYELID PAIN (Painful swollen eye lid). At the time of the report, PAIN IN EXTREMITY (Sore arm), ABDOMINAL DISCOMFORT (Upset stomach), OCULAR HYPERAEMIA (Red  burning eyes), SWELLING OF EYELID (Red painful swollen eye lid) and EYELID PAIN (Painful swollen eye lid) had not resolved and DIARRHOEA (Diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient reported that she took treatment medication along with Hetlioz. Patient also reported that episodes of not sleeping well after taking Hetlioz resulted in waking with burning eyes.