Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: diarrhea; abdominal pain; Migraines; anorexia; mild edema of extremities; Night sweats; presyncope; POTS; Fatigue; pain at injection site; Severe mid-back pain; Fever; Worse case of headaches radiating from the base of her head; Muscle aches; 5hours later she had stiff neck and pain; 5hours later she had stiff neck and pain; Profound somnolence; Loss of appetite; Mental confusion; Left and right eye pain; having symptoms similar to meningitis; This spontaneous case was reported by a physician and describes the occurrence of MUSCULOSKELETAL STIFFNESS (5hours later she had stiff neck and pain), NECK PAIN (5hours later she had stiff neck and pain), SOMNOLENCE (Profound somnolence), DECREASED APPETITE (Loss of appetite) and CONFUSIONAL STATE (Mental confusion) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lymphopenia (CD4 count 119), Autonomic neuropathy, Raynaud's disease, Fever (Episodic fever of unknown origin) and Vasculitis. Concurrent medical conditions included Drug allergy (many adverse drug reactions), Food allergy (Allergic to Ocean Perch), Allergy to topical drugs, Immunodeficiency, Antiphospholipid syndrome since 2007, GERD, Hypertension, Sjogren's syndrome since 1986, Protein S deficiency, Migraine, Hiatus hernia, Diverticulum, Candidiasis of mouth, Rhinitis, Factor VIII inhibitor increased, Antiphospholipid antibodies, Methylenetetrahydrofolate reductase deficiency, Chronic pulmonary embolism, DVT and Tricuspid regurgitation (Moderate). Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Allergy, PARACETAMOL (TYLENOL) for Chronic pain, FAMOTIDINE for GERD, NEBIVOLOL HYDROCHLORIDE (BYSTOLIC) for Migraine, DICLOFENAC SODIUM (DICLOFENAC HIKMA) for Neuropathy, Pain and Phlebitis, OXYMETAZOLINE for Sinus arrest, FONDAPARINUX, TRAMADOL, CALCIUM CARBONATE, CHLORHEXIDINE and FLUCONAZOLE for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced BACK PAIN (Severe mid-back pain). On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (5hours later she had stiff neck and pain), NECK PAIN (5hours later she had stiff neck and pain), SOMNOLENCE (Profound somnolence), DECREASED APPETITE (Loss of appetite), CONFUSIONAL STATE (Mental confusion), EYE PAIN (Left and right eye pain), MENINGISM (having symptoms similar to meningitis), DIARRHOEA (diarrhea), ABDOMINAL PAIN (abdominal pain), MIGRAINE (Migraines), DECREASED APPETITE (anorexia), OEDEMA (mild edema of extremities), NIGHT SWEATS (Night sweats), PRESYNCOPE (presyncope), POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (POTS), FATIGUE (Fatigue), HEADACHE (Worse case of headaches radiating from the base of her head), MYALGIA (Muscle aches), INJECTION SITE PAIN (pain at injection site) and PYREXIA (Fever). On 14-Mar-2021, BACK PAIN (Severe mid-back pain) had resolved. At the time of the report, MUSCULOSKELETAL STIFFNESS (5hours later she had stiff neck and pain), NECK PAIN (5hours later she had stiff neck and pain), SOMNOLENCE (Profound somnolence), DECREASED APPETITE (Loss of appetite), CONFUSIONAL STATE (Mental confusion), EYE PAIN (Left and right eye pain), MENINGISM (having symptoms similar to meningitis), HEADACHE (Worse case of headaches radiating from the base of her head), MYALGIA (Muscle aches) and PYREXIA (Fever) had resolved, DIARRHOEA (diarrhea), ABDOMINAL PAIN (abdominal pain), DECREASED APPETITE (anorexia), OEDEMA (mild edema of extremities), NIGHT SWEATS (Night sweats), PRESYNCOPE (presyncope), POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (POTS), FATIGUE (Fatigue) and INJECTION SITE PAIN (pain at injection site) outcome was unknown and MIGRAINE (Migraines) was resolving. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99-100f (Low) Low grade fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Follow-up received and does not contain significant information. On 23-Jul-2021: Follow-up received contains Significant information Medical history and concomitant Details updated.