Age: 59.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Asthenia, Autoimmune disorder, Blood pressure measurement, Burning sensation, Cerebral disorder
Clinical narrative: Autoimmune response to the vaccine; obstruction in the brain or skull; Dry eye; Sleepy; no energy; debilitating pain; feels it burning in the background; was throwing up; dry mouth; inflammation in the vessels; blood pressure was very high; crying a lot in the office because she was in so much pain; retinal hemorrhage in right eye/ feels like something is in my right eye; large tearing-off in right eye in the shape of an "L"; couldn't sleep/ headaches and ear fluttering wake her up; had blurry vision/ blocked the center vision of her eye; really aching behind right eye; right ear started to flutter like a butterfly was in it/ ear fluttering it progressively got worse; severe headache, 10/10 on scale of 1-10/ headaches became intermittent/ e headache was behind her eyes; chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RETINAL HAEMORRHAGE (retinal hemorrhage in right eye/ feels like something is in my right eye) and AUTOIMMUNE DISORDER (Autoimmune response to the vaccine) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 013M20A,) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product AMITRIPTYLINE HYDROCHLORIDE for an unknown indication.    The patient's past medical history included GERD. Concurrent medical conditions included Hypoglycemia, Pancreatitis (Idiopathic reoccurring acute pancreatitis), Hashimoto's disease and Arteriosclerosis coronary artery. Concomitant products included OMEPRAZOLE SODIUM, ROSUVASTATIN, LEVOTHYROXINE SODIUM (UNITHROID), UBIDECARENONE (CO Q 10 [UBIDECARENONE]), ACETYLSALICYLIC ACID (ASPIRIN 81), COLECALCIFEROL (VITAMIN D 3), DOCUSATE SODIUM (COLACE), FISH OIL (OMEGA 3 COMPLETE) and GLUCOSAMINE & CHONDORITIN for an unknown indication.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient started AMITRIPTYLINE HYDROCHLORIDE (unknown route) 25 mg once a day. On 13-Feb-2021, the patient experienced EAR DISCOMFORT (right ear started to flutter like a butterfly was in it/ ear fluttering it progressively got worse), HEADACHE (severe headache, 10/10 on scale of 1-10/ headaches became intermittent/ e headache was behind her eyes) and CHILLS (chills). On 25-Feb-2021, the patient experienced INSOMNIA (couldn't sleep/ headaches and ear fluttering wake her up), VISION BLURRED (had blurry vision/ blocked the center vision of her eye) and EYE PAIN (really aching behind right eye). On 02-Mar-2021, the patient experienced RETINAL HAEMORRHAGE (retinal hemorrhage in right eye/ feels like something is in my right eye) (seriousness criterion medically significant) and EYE INJURY (large tearing-off in right eye in the shape of an "L"). On 03-Mar-2021, the patient experienced HYPERTENSION (blood pressure was very high) and CRYING (crying a lot in the office because she was in so much pain). On 26-Mar-2021, the patient experienced VASCULITIS (inflammation in the vessels). On an unknown date, the patient experienced AUTOIMMUNE DISORDER (Autoimmune response to the vaccine) (seriousness criterion medically significant), CEREBRAL DISORDER (obstruction in the brain or skull), BURNING SENSATION (feels it burning in the background), DRY EYE (Dry eye), DRY MOUTH (dry mouth), ASTHENIA (no energy), PAIN (debilitating pain), SOMNOLENCE (Sleepy) and VOMITING (was throwing up). The patient was treated with NAPROXEN ongoing since an unknown date at a dose of 500 mg; PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 500 mg and KETOROLAC TROMETHAMINE (TORADOL) ongoing from 03-Mar-2021 at a dose of vI. On 13-Feb-2021, CHILLS (chills) outcome was unknown. At the time of the report, RETINAL HAEMORRHAGE (retinal hemorrhage in right eye/ feels like something is in my right eye), AUTOIMMUNE DISORDER (Autoimmune response to the vaccine), EAR DISCOMFORT (right ear started to flutter like a butterfly was in it/ ear fluttering it progressively got worse), INSOMNIA (couldn't sleep/ headaches and ear fluttering wake her up), VISION BLURRED (had blurry vision/ blocked the center vision of her eye), EYE PAIN (really aching behind right eye), EYE INJURY (large tearing-off in right eye in the shape of an "L"), HYPERTENSION (blood pressure was very high), CEREBRAL DISORDER (obstruction in the brain or skull), CRYING (crying a lot in the office because she was in so much pain), VASCULITIS (inflammation in the vessels), BURNING SENSATION (feels it burning in the background), DRY EYE (Dry eye), DRY MOUTH (dry mouth), ASTHENIA (no energy), PAIN (debilitating pain), SOMNOLENCE (Sleepy), VOMITING (was throwing up) and HEADACHE (severe headache, 10/10 on scale of 1-10/ headaches became intermittent/ e headache was behind her eyes) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Blood pressure measurement: high (Inconclusive) high blood pressure.         Patient has sever headache but didn't have any migraines or headaches in past. patient experienced sever pain that she took Tylenol and Naproxen 500mg  as much as possible in a day (6times) even though in night time. patient consulted a Ophthalmologist on 1-Ma-r2021 and diagnosed  retinal hemorrhage in right eye. ophthalmologist  refered with Cardiologist  that patient previously consulted before second dose of vaccine . patient was crying because of pain.the results of EKG and CT was not provided. ON 04Mar2021 patient was refered to  neurologist  and doctor  stated that  it was an autoimmune response to the vaccine and scheduled two MRI's- with and without contrast for 26Mar2021 and prescribed with Amitriptyline 25mg.The Neurologist wanted to do two more MRIs to rule out bleeding/swelling of small vessels in head. patient had her last two MRI's (with and without contrast) on 6Apr2021 and was told they were clear, so patient was going forward with a follow up appointment with the neurologist on 14June2021. patient stated that the neurologist told her the headaches have to be 100% gone for four weeks before taking her of the Amitriptyline. patient stated the headaches are still painful, but tolerable .patient stated that  feels it burning in the background.  Company Comment: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded.  Assessment is confounded by the patient history and concurrent conditions and treatments.  Events of dry eye, dry mouth, lack of energy and somnolence reported as associated with amitriptyline, but an association cannot be excluded with Moderna vaccine   This case was linked to MOD-2021-162714 (Patient Link).; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded.  Assessment is confounded by the patient history and concurrent conditions and treatments.  Events of dry eye, dry mouth, lack of energy and somnolence reported as associated with amitriptyline, but an association cannot be excluded with Moderna vaccine