Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Urinary tract infection, Urine analysis, Urine protein/creatinine ratio
Clinical narrative: legs felt like it weighed 100-200 pounds; Legs were purple; she did not feel well; Legs barely pick them up; The quality of her life is going down the drain quickly.; Walking difficulty; Decreased appetite; I was freezing; Slept most of the wat home; Discomfort was very high over entire body/upper leg discomfort/my upper legs feel like they weiht over hundred lds each/ she did not feel weel/she was a mess all night; Rash was red; Symptoms got worsen; Dry mouth; Dry eyes; Rash was burning/Burning; Rash was itching; Flare up that caused a lot of pain/Rash became more painful/Pain was inmanagble/pain out 91/2 out of 10/throbbing; Diffuse connective tissue disease; Retinal hemorrhage; UTI; chills; itching; Redness; Eyes red; Itchy eyes; Felt like her skin was prickly; flushing; Rash was hot/Skin hot; very very slight rash on her upper back/upper chest/face/torso/arm/legs/covered her body/Rash was throbbing/Meltdown whereby the rash exploded; This spontaneous case was reported by a consumer and describes the occurrence of RETINAL HAEMORRHAGE (Retinal hemorrhage) and CONNECTIVE TISSUE DISORDER (Diffuse connective tissue disease) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 029K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lumbar laminectomy on 16-Dec-2020 and Surgery (Cataract surgery). Concurrent medical conditions included Hay fever, Back pain aggravated since 01-Mar-1996, Osteopenia since 01-Jun-1998, Blood pressure abnormal, Cholesterol, Thyroid disorder NOS and Acid reflux (esophageal). Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) from 01-Jun-2021 to an unknown date for Acid reflux (esophageal), LOSARTAN from 12-Jul-2018 to 31-Aug-2021 for Blood pressure abnormal, HYDROCHLOROTHIAZID from 20-Jun-2016 to 01-May-2021 for Blood pressure abnormal and Water retention, PRAVASTATIN from 20-Jun-2021 to 31-Aug-2021 for Cholesterol, LEVOTHYROXINE SODIUM (SYNTHROID) from 2008 to an unknown date for Thyroid disorder NOS, VERAPAMIL, VITAMIN D3 from an unknown date to 12-May-2021, VITAMIN B12 NOS from an unknown date to 12-May-2021, CALCIUM CITRATE, COLECALCIFEROL (CITRACAL + D3) from 12-May-2021 to an unknown date, XYLITOL (XYLIMELTS), PROBIOTICS NOS from 09-Aug-2021 to an unknown date, BETAMETHASONE and HYDROXYZINE for an unknown indication, FEXOFENADINE from 09-Aug-2021 to an unknown date.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021 at 8:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (very very slight rash on her upper back/upper chest/face/torso/arm/legs/covered her body/Rash was throbbing/Meltdown whereby the rash exploded). On 10-Feb-2021, the patient experienced PRURITUS (itching), ERYTHEMA (Redness), OCULAR HYPERAEMIA (Eyes red), EYE PRURITUS (Itchy eyes), PARAESTHESIA (Felt like her skin was prickly), FLUSHING (flushing), FEELING HOT (Rash was hot/Skin hot) and CHILLS (chills). In June 2021, the patient experienced URINARY TRACT INFECTION (UTI). On 16-Aug-2021, the patient experienced RETINAL HAEMORRHAGE (Retinal hemorrhage) (seriousness criterion medically significant). On 31-Aug-2021, the patient experienced CONNECTIVE TISSUE DISORDER (Diffuse connective tissue disease) (seriousness criterion medically significant). On 10-Sep-2021, the patient experienced DISCOMFORT (Discomfort was very high over entire body/upper leg discomfort/my upper legs feel like they weiht over hundred lds each/ she did not feel weel/she was a mess all night). On 12-Sep-2021, the patient experienced DECREASED APPETITE (Decreased appetite), FEELING COLD (I was freezing) and SOMNOLENCE (Slept most of the wat home). On 13-Sep-2021, the patient experienced GAIT DISTURBANCE (Walking difficulty). In September 2021, the patient experienced BURNING SENSATION (Rash was burning/Burning), RASH PRURITIC (Rash was itching), PAIN (Flare up that caused a lot of pain/Rash became more painful/Pain was inmanagble/pain out 91/2 out of 10/throbbing), DRY MOUTH (Dry mouth), DRY EYE (Dry eyes), RASH ERYTHEMATOUS (Rash was red) and CONDITION AGGRAVATED (Symptoms got worsen). On an unknown date, the patient experienced LIMB DISCOMFORT (legs felt like it weighed 100-200 pounds), SKIN DISCOLOURATION (Legs were purple), MALAISE (she did not feel well), MOBILITY DECREASED (Legs barely pick them up) and QUALITY OF LIFE DECREASED (The quality of her life is going down the drain quickly.). The patient was treated with TRIAMCINOLONE ACETONIDE (topical) on 16-Mar-2021 for Adverse event, at a dose of 0.01 UNK; FAMOTIDINE (PEPCID AC) for Adverse event, at a dose of 20 milligram; CLOBETASOL from 30-Apr-2021 to 15-May-2021 for Adverse event, at an unspecified dose and frequency; METHYLPREDNISOLONE SODIUM SUCCINATE (SOLU MEDROL) for Adverse event, at a dose of 125 milligram; CORTISONE (topical) for Rash, at an unspecified dose and frequency; HYDROXYZINE on 13-Sep-2021 for Adverse event, at a dose of 25 milligram three times a day; HYDROXYZINE from 02-Jul-2021 to 31-Aug-2021 for Adverse event, at a dose of 25 milligram once a day; HYDROXYCHLOROQUINE from 31-Aug-2021 to 24-Sep-2021 for Adverse event, at a dose of 200 milligram once a day; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) from 12-Sep-2021 to 13-Sep-2021 for Discomfort, at a dose of 2-25 mg for 7 and 1/2 hours; METHYLPREDNISOLONE SODIUM SUCCINATE (METHYLPREDNISOLONE [METHYLPREDNISOLONE SODIUM SUCCINATE]) on 13-Sep-2021 for Adverse event, at a dose of 4 milligram; METHYLPREDNISOLONE SODIUM SUCCINATE (SOLUMEDROL) on 17-Sep-2021 for Adverse event, at a dose of 125 milligram; FAMOTIDINE (PEPCID [FAMOTIDINE]) on 17-Sep-2021 for Adverse event, at a dose of 20 milligram; PREDNISONE on 17-Sep-2021 for Adverse event, at a dose of 20 milligram; PREDNISONE on 24-Sep-2021 for Adverse event, at a dose of 20 milligram three times a day and BETAMETHASONE for Adverse event, at a dose of UNK, bid, 0.05 CRM. On 12-Jul-2021, URINARY TRACT INFECTION (UTI) had resolved. At the time of the report, RETINAL HAEMORRHAGE (Retinal hemorrhage), CONNECTIVE TISSUE DISORDER (Diffuse connective tissue disease), BURNING SENSATION (Rash was burning/Burning), RASH PRURITIC (Rash was itching), PAIN (Flare up that caused a lot of pain/Rash became more painful/Pain was inmanagble/pain out 91/2 out of 10/throbbing), LIMB DISCOMFORT (legs felt like it weighed 100-200 pounds), DRY MOUTH (Dry mouth), DRY EYE (Dry eyes), SKIN DISCOLOURATION (Legs were purple), MALAISE (she did not feel well), MOBILITY DECREASED (Legs barely pick them up), RASH ERYTHEMATOUS (Rash was red), CONDITION AGGRAVATED (Symptoms got worsen), DISCOMFORT (Discomfort was very high over entire body/upper leg discomfort/my upper legs feel like they weiht over hundred lds each/ she did not feel weel/she was a mess all night), DECREASED APPETITE (Decreased appetite), FEELING COLD (I was freezing), GAIT DISTURBANCE (Walking difficulty), SOMNOLENCE (Slept most of the wat home) and QUALITY OF LIFE DECREASED (The quality of her life is going down the drain quickly.) outcome was unknown and PRURITUS (itching), ERYTHEMA (Redness), OCULAR HYPERAEMIA (Eyes red), EYE PRURITUS (Itchy eyes), PARAESTHESIA (Felt like her skin was prickly), FLUSHING (flushing), FEELING HOT (Rash was hot/Skin hot), CHILLS (chills) and RASH (very very slight rash on her upper back/upper chest/face/torso/arm/legs/covered her body/Rash was throbbing/Meltdown whereby the rash exploded) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Apr-2021, Biopsy skin: negative (Negative) Lichenoid and vascular interface 0.03  punch biopsy of skin on back. Dermatitis with epidermal necrosis.. On 12-May-2021, Double stranded DNA antibody: positive (Positive) Positive (Abnormal). On 02-Jul-2021, Angiotensin converting enzyme (14-82): 35 (normal) ACE 35 {^U/L}, Normal, Range: 14-82. On 02-Jul-2021, Anti-cyclic citrullinated peptide antibody: negative (Negative) Anti CCP negative, Normal, Range: neg Comments: 3RD generation method detects IGG and IGA antibodies. On 02-Jul-2021, Antibody test: <20.0 (normal) Mitochondrial (M2) antibody <20.0 {^Units}, Normal. On 02-Jul-2021, Antineutrophil cytoplasmic antibody: normal (normal) Antimyeloperoxidase (MPO) Abs<9.0 {^U/L}, Normal, Range: 0.0-9.0 Antiproteinase 3 (PR-3) Abs <3.5 {^U/L}, Normal, Range: 0.0-3.5 Cytoplasmic (C-ANCA) <1:20 {^titer} Normal, Range: < 1:20 Perinuclear (P-ANCA) <1:20 {^titer} Normal, Range: < 1:20 Atypical pANCA <1:20 {^titer} Normal, Range: < 1:20. On 02-Jul-2021, Antinuclear antibody: negative (Negative) negative. On 02-Jul-2021, Blood pressure measurement: 120/80 (normal) mmHg. On 02-Jul-2021, Blood test: high (High) C3 170 {^MG/DL}, above high threshold, Range:  79-152 C4 45 {^MG/DL}, above high threshold, Range: 16-38 and negative (Negative) HLA-B27 antigen negative, Normal  Comments: HLA-B*27, negative. On 02-Jul-2021, Electrophoresis protein: (High) Protein, total, serum 7.3 {^g/dl}, Normal, Range: 6.0-8.5 Albumin 4.2 {^g/dl}, Normal, Range: 2.9-4.4 Alpha-1-Globulin 0.2 {^g/dl}, Normal, Range: 0.0-0.4 Alpha-2-Globulin 0.8 {^g/dl}, Normal, Range: 0.4-1.0 Beta Globulin 1.4 {^g/dl}, above high threshold, Range: 0.7-1.8 Gamma Globulin 0.8 {^g/dl}, Normal, Range: 0.4-1.8. On 02-Jul-2021, Full blood count: normal (normal) WBC 6.1 {^TH/MM3}, Normal, Range: 3.8-10.5 RBC 4.01 {^MIL/MM3}, Normal, Range: 3.80-5.10 HGB 13.2 {^G/DL}, Normal, Range: 12.0-16.0 HCT 39.3 {^%}, Normal, Range: 37.0-47.0 MCV 98 {^FL}, Normal, Range: 81.0-99.0 MCH 33, {^PG/MM3}, Normal, Range: 27.0-33.0 MCHC 33.7 {^G/DL}, Normal, Range: 32.0-36.0 RDW 13.1 {^%}, Normal, Range: 11.5- 14.5 PLT 328 {^TH/MM3}, Normal, Range: 130-400 MPV 9.2 {^FL}, Normal, Range: 7.4 10.4. On 02-Jul-2021, Heart rate: 80 (normal) Beats per minute. On 02-Jul-2021, Hepatitis viral test: negative (Negative) HEP A Ig M antibody nonreactive, Normal HEP B Core Ig M Antibody nonreactive, Normal. On 02-Jul-2021, Metabolic function test: high (High) Potassium 4.4 {^Mmol/L}, Normal, Range: 3.5-5.3 Chloride 102 {^Mmol/L}, Normal, Range: 97-111 CO2 27 {^Mmol/L}, Normal, Range: 22-32 Glucose 86 {^MG/DL}, Normal, Range: 65-100 Urea nitrogen 14 {^MG/DL}, Normal, Range: 7- 25 Creatinine 0.71 {^MG/DL}, Normal, Range: 0.44-1.03 Calcium 9.8 {^MG/DL}, Normal, Range:  8.5-10.6 Total protein 7.4 {^G/DL}, Normal, Range: 6.0-8.0 Albumin 4.4 {^G/DL}, Normal, Range: 3.0-130 ALK phos 68 {^IU/L}, Normal, Range: 33-130. On 02-Jul-2021, Red blood cell sedimentation rate increased: high (High) Sed rate 44 {^MM/HR} above high threshold. On 02-Jul-2021, Respiratory rate: 16 (normal) Breaths per minute. On 02-Jul-2021, Rheumatoid factor: high (High) RF<14 {^IU/L}, Normal, Range: 0-14 Calcium 9.8 {^MG/DL}, Normal, Range: 8.5-10.6 Total protein 7.4 {^G/DL}, Normal, Range: 6.0-8.0 Albumin 4.4 {^G/DL}, Normal, Range: 3.0-5.0 ALK Phos 68 {{^IU/L}, Normal, Range: 33-130 Total Bilirubin 0.4 {^MG/DL}, Normal, Range: 0.2-1.2 ALT 71 {^U/L}, above high threshold, Range: 8-54 and 14 (normal) RF<14 {^IU/ML} Normal. On 02-Jul-2021, Smooth muscle antibody: normal (normal) Actin (Smooth muscle) Antibody 5 {^Units}, Normal. Comments: Negative 0-19, Weak positive 20-30, Moderate to strong positive >30. On 02-Jul-2021, Urine analysis: normal (normal) Color yellow: Normal Appearance clear: Normal~ Specific gravity: <=1.005, Normal, Range: 1.005-1.03~ pH 7: Normal, Range: 5.0-8.0~ Leukocyte esterase trace, Normal, Range: Negative Nitrate negative, Normal, Range: Negative Protein negative, Normal, Range: Negative. On 02-Jul-2021, Urine protein/creatinine ratio: high (High) Comment: No normal values established for random urines  UR total PROT 7 {^MG/DL} Normal, Range: 5-24. On 31-Aug-2021, Blood pressure measurement: 136/70 (abnormal) mmHg. On 31-Aug-2021, Heart rate: 68 (normal) Beats per minute. On 31-Aug-2021, Respiratory rate: 16 (normal) Breaths per minute.         Patient had multiple visits to dermatologist, ophthalmologist, hematologist and rheumatologist. Patient underwent blood and urine test, chest X- ray and CT scan of abdomen whose results were not provided. Patient also received labs on unknown date of protein in urine, body temperature of 97.1, and antinuclear antibodies test which was positive with lower level titer 1:80.  This case concerns a 70-year-old female patient with past medical history of Lumbar laminectomy on 16-Dec-2020 and Cataract surgery, who experienced the serious unexpected event of Retinal Hemorrhage. The event occurred 193 days after receiving the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.   This case was linked to MOD-2021-322557 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Sep-2021: Non-significant follow-up appended No new information was added in dose two already events were captured On 26-Sep-2021: Upon significant follow-up received on 26 Sep 2021 case was upgraded to serious, had updated patient's information, current conditions, laboratory details, additional concomitant and treatment medication, new events, start date of events and outcome of few events.; Sender's Comments: This case concerns a 70-year-old female patient with past medical history of Lumbar laminectomy on 16-Dec-2020 and Cataract surgery, who experienced the serious unexpected event of Retinal Hemorrhage. The event occurred 193 days after receiving the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.