Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Hypokalaemia, Insomnia, Intentional dose omission, Iron binding capacity total
Clinical narrative: diagnosed as anemic; Unable to sleep; Loss my appetite; No tastebuds; snezzing; Abdominal cramping; I had use walker; coughing; runny nose; Suffering from severe fatigue- Somnolence; Did not get the second vaccine; Woke up dizzy and nauseous; Hypokalemia; Woke up dizzy and nauseous; Suffered with Vertigo/Spinning sensation that is worse with head movement; Vomiting; Runny nose/Sinus drainage/sneezing/coughing- prior to shot allergies controlled with medications and allergy shots, now not  working; Foot pain; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKALAEMIA (Hypokalemia) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Postoperative nausea, Thyroiditis NOS, Vertigo, Anesthesia (Prolonged emergence), Joint replacement (R total hip x 2, L total hip x 1), Blood transfusion, Cesarean section, Tonsillectomy (age 8), Tooth extraction, Cataract operation, Colonoscopy, Endoscopy (colon, diagnostic) on 01-Sep-2013, Lesion excision (growth of right hand, age 10), Hysterectomy (secondary to fibroids - TAH/BSO), Fusion lumbar spine, Oophorectomy, Rotator cuff repair (Bilateral), Lobectomy (thyroid) (Thyroid lobectomy total without isthmusectomy) on 12-Oct-2016, Postoperative vomiting, Wisdom teeth removal and Hip replacement (Bilateral). Family history included Heart disorder (Father and paternal side - 9 aunts/uncles and sister) since an unknown date, Diabetes (Mother and sister) since an unknown date, Cancer (Maternal Grandmother) since an unknown date, Prostate cancer (Paternal Grandfather and sister) since an unknown date, Breast cancer (Maternal Aunt) since an unknown date and Thyroid disorder (Sister) since an unknown date. Concurrent medical conditions included Multiple allergies (controlled with medications a day and weekly allergy shots.), Food allergy (allergies to eggs, cow's milk, gluten, canola oil, shrimp, soy, barley, beer, red wine, cheese, MSG white potato, egg plant.), Hypertension since 2002, Arthritis in 2009, Arthropathy (unspecified, site unspecified), Esophageal reflux, Uterine disorder, Hoarseness, Hypercholesteremia since 2015, Hyperlipemia, Multinodular goiter, Dry cough (patient states unknown cause), Rotator cuff injury, Drug allergy (Tramadol, Codeine Sulfate, Cozaar [Losartan], Crestor [Rosuvastatin], Darvocet A500, Darvon, Morphine, Percocet, Opioids - Morphine Analogues, Opioids-Methadone And Related), Asthma (intermittent symptoms) and Divorced. Concomitant products included IRBESARTAN (AVAPRO), ROSUVASTATIN CALCIUM (CRESTOR), HYDROCHLOROTHIAZIDE and DILTIAZEM (CARDIZEM [DILTIAZEM]) for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced PAIN IN EXTREMITY (Foot pain) and HYPERSENSITIVITY (Runny nose/Sinus drainage/sneezing/coughing- prior to shot allergies controlled with medications and allergy shots, now not  working). On 15-Feb-2021, the patient experienced HYPOKALAEMIA (Hypokalemia) (seriousness criterion medically significant), DIZZINESS (Woke up dizzy and nauseous), VERTIGO (Suffered with Vertigo/Spinning sensation that is worse with head movement), VOMITING (Vomiting) and NAUSEA (Woke up dizzy and nauseous). On an unknown date, the patient experienced ANAEMIA (diagnosed as anemic), INSOMNIA (Unable to sleep), DECREASED APPETITE (Loss my appetite), AGEUSIA (No tastebuds), SNEEZING (snezzing), ABDOMINAL PAIN (Abdominal cramping), WALKING AID USER (I had use walker), COUGH (coughing), RHINORRHOEA (runny nose), FATIGUE (Suffering from severe fatigue- Somnolence) and INTENTIONAL DOSE OMISSION (Did not get the second vaccine). The patient was treated with IRON for Anemia, at an unspecified dose and frequency; ONDANSETRON (ZOFRAN [ONDANSETRON]) (intravenous) 15-Feb-2021 for Nausea and Vomiting, at a dose of UNK UNK, tid; MECLOZINE HYDROCHLORIDE (ANTIVERT [MECLOZINE HYDROCHLORIDE]) (oral) 15-Feb-2021 for Vertigo, at a dose of 25 milligram three times a day; NORMAL SALINE (intravenous) 15-Feb-2021 for Adverse event, at an unspecified dose and frequency; POTASSIUM CHLORIDE (oral) from 15-Feb-2021 to 17-Feb-2021 for Adverse event, at an unspecified dose and frequency; DIAZEPAM (VALIUM) (oral) 15-Feb-2021 for Adverse event, at a dose of 2 milligram; DIAZEPAM (VALIUM) (intravenous) from 15-Feb-2021 to 17-Feb-2021 for Adverse event, at an unspecified dose and frequency; OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) (oral) 15-Feb-2021 for Adverse event, at a dose of 40 milligram and Physical therapy for Vertigo. On 15-Feb-2021, VOMITING (Vomiting) and NAUSEA (Woke up dizzy and nauseous) had resolved. On 26-Feb-2021, HYPOKALAEMIA (Hypokalemia) had resolved. On 02-Jul-2021, VERTIGO (Suffered with Vertigo/Spinning sensation that is worse with head movement) had resolved. At the time of the report, DIZZINESS (Woke up dizzy and nauseous), PAIN IN EXTREMITY (Foot pain), ANAEMIA (diagnosed as anemic), INSOMNIA (Unable to sleep), DECREASED APPETITE (Loss my appetite), AGEUSIA (No tastebuds), HYPERSENSITIVITY (Runny nose/Sinus drainage/sneezing/coughing- prior to shot allergies controlled with medications and allergy shots, now not  working) and FATIGUE (Suffering from severe fatigue- Somnolence) had not resolved, SNEEZING (snezzing), ABDOMINAL PAIN (Abdominal cramping), WALKING AID USER (I had use walker), COUGH (coughing) and RHINORRHOEA (runny nose) outcome was unknown and INTENTIONAL DOSE OMISSION (Did not get the second vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2021, Alanine aminotransferase: 12 (normal) 12 U/L Norm low: 5 Norm high: 40. On 21-Jan-2021, Albumin globulin ratio: 1.9 (normal) 1.9 ratio Norm low: 1.1 Norm high: 2.6. On 21-Jan-2021, Anion gap: 11.0 (normal) 11.0 mmol/L Norm low: 3 Norm high: 15. On 21-Jan-2021, Aspartate aminotransferase: 24 (normal) 24 U/L Norm low: 10 Norm high: 37. On 21-Jan-2021, Blood albumin: 4.3 (normal) 4.3 g/dL Norm low: 3.5 Norm high: 5. On 21-Jan-2021, Blood alkaline phosphatase: 96 (normal) 96 U/L Norm low: 40 Norm high: 120. On 21-Jan-2021, Blood bilirubin: 0.7 (normal) 0.2 - 1.2 mg/dL Norm low: 0.1 Norm high: 1.2. On 21-Jan-2021, Blood calcium: 10.5 (normal) 10.5 mg/dL Norm low: 8.4 Norm high: 10.5. On 21-Jan-2021, Blood chloride: 100 (normal) 100 mmol/L Norm low: 98 Norm high: 110. On 21-Jan-2021, Blood creatinine: 0.7 (normal) 0.7 mg/dL Norm low: 0.8 Norm high: 1.4. On 21-Jan-2021, Blood glucose: 100 (High) 100 mg/dL Norm low: 70 Norm high: 99. On 21-Jan-2021, Blood potassium: 4.5 (normal) 4.5 mmol/L Norm low: 3.5 Norm high: 5.5. On 21-Jan-2021, Blood sodium: 143 (normal) 143 mmol/L Norm low: 133 Norm high: 145. On 21-Jan-2021, Blood urea: 11 (normal) 11 mg/dL Norm low: 6 Norm high: 22. On 21-Jan-2021, Carbon dioxide: 32 (normal) 32 mmol/L Norm low: 20 Norm high: 32. On 21-Jan-2021, Globulin: 2.3 (normal) 2.3 g/dL Norm low: 2 Norm high: 4. On 21-Jan-2021, Protein total: 6.6 (normal) 6.6 g/dL Norm low: 6.2 Norm high: 8.1. On 21-Jan-2021, Thyroxine free: 1.2 (normal) 1.2 ng/dL Norm low: 0.9 Norm high: 1.8. On 15-Feb-2021, Anion gap: 11.0 (normal) 11.0 mmol/L Norm low: 3 Norm high: 15. On 15-Feb-2021, Basophil count: 0.1 (Inconclusive) 0.1 K/uL and 1 (Inconclusive) 1 Percent. On 15-Feb-2021, Blood calcium: 9.4 (normal) 9.4 mg/dL Norm low: 8.4 Norm high: 10.5. On 15-Feb-2021, Blood chloride: 100 (normal) 100 mmol/L Norm low: 98 Norm high: 110. On 15-Feb-2021, Blood creatinine: 0.8 (normal) 0.8 mg/dL Norm low: 0.8 Norm high: 1.4. On 15-Feb-2021, Blood glucose: 168 (High) 168 mg/dL Norm low: 70 Norm high: 99. On 15-Feb-2021, Blood potassium: 2.7 (Low) 2.7 mmol/L Norm low: 3.5 Norm high: 5.5. On 15-Feb-2021, Blood sodium: 137 (normal) 137 mmol/L Norm low: 133 Norm high: 145. On 15-Feb-2021, Blood urea: 21 (normal) 21 mg/dL Norm low: 6 Norm high: 22. On 15-Feb-2021, Body mass index: 34.74 (abnormal) 34.74. On 15-Feb-2021, Carbon dioxide: 26 (normal) 26 mmol/L Norm low: 20 Norm high: 32. On 15-Feb-2021, Electrocardiogram: abnormal (abnormal) Abnormal SR-Sinus rhythm-normal P axis, V-rate 50-99; LVHPRE-Probable LVH with secondary repol abnrm-multiple LVH criteria; IMIO-Inferior infarct, old-Q Greater than 35mS, II III aVF. Please REMOVE form Lab Data: 1. Electrocardiogram PR Interval; 15-FEB-2021;186 ms;186 ms. On 15-Feb-2021, Electrocardiogram PR interval: 186 (abnormal) 186 ms. On 15-Feb-2021, Electrocardiogram QT interval: 411 (abnormal) 411 ms. On 15-Feb-2021, Electrocardiogram RR interval: 848 (abnormal) 848ms. On 15-Feb-2021, Eosinophil count: 0.1 (abnormal) 0.1 K/uL and 1 (abnormal) 1 %. On 15-Feb-2021, Haematocrit: 34.5 (Inconclusive) 34.5 percent. On 15-Feb-2021, Haemoglobin: 11.2 (Inconclusive) 11.2 g/dL. On 15-Feb-2021, Heart rate: 71 (normal) 71bpm. On 15-Feb-2021, Lymphocyte count: 2.0 (Inconclusive) 2.0 K/uL and 23 (Inconclusive) 23 Percent. On 15-Feb-2021, Magnetic resonance imaging head: normal (normal) normal sagittal T1, axial T1IR, coronal and axial T2 IR, axial T2,  axial GRE, axial diffusion and ADC, No acute abnormality. Small vessel ischemic changes. On 15-Feb-2021, Mean cell haemoglobin: 28 (Inconclusive) 28 pg. On 15-Feb-2021, Mean cell haemoglobin concentration: 33 (Inconclusive) 33 g/dL. On 15-Feb-2021, Mean cell volume: 87 (Inconclusive) 87 fL. On 15-Feb-2021, Mean platelet volume: 9.8 (Inconclusive) 9.8 fL. On 15-Feb-2021, Monocyte count: 0.7 (Inconclusive) 0.7 K/uL and 8 (Inconclusive) 8 Percent. On 15-Feb-2021, Neutrophil count: 5.8 (Inconclusive) 5.8 K/uL and 68 (Inconclusive) 68 percent. On 15-Feb-2021, Platelet count: 261 (Inconclusive) 261 K/uL. On 15-Feb-2021, QRS axis: minus 2 (Inconclusive) -2 deg. On 15-Feb-2021, Red blood cell count: 3.98 (Inconclusive) 3.98 M/uL x 10e6. On 15-Feb-2021, Red cell distribution width: 13.2 (Inconclusive) 13.2 percent. On 15-Feb-2021, Sinus rhythm: normal p axis (normal) normal P axis V-rate 50-99. On 15-Feb-2021, Troponin T: 8 (Inconclusive) 8 ng/L. On 15-Feb-2021, White blood cell count: 8.5 (Inconclusive) 8.5 K/uL x 10e3. On 17-Feb-2021, Blood iron: 28 (Low) 28 mcg/dL Norm low: 30 Norm high: 160. On 17-Feb-2021, Iron binding capacity total: 360 (normal) 360 mcg/dL Norm low: 228 Norm high: 428. On 17-Feb-2021, Iron binding capacity unsaturated: 332 (normal) 332 mcg/dL Norm low: 110 Norm high: 370. On 17-Feb-2021, Serum ferritin: 79 (normal) 79 ng/mL Norm low: 10 Norm high: 291. On 17-Feb-2021, Transferrin saturation: 360 (normal) 360 mcg/dL Norm low: 20 Norm high: 50. On 26-Feb-2021, Alanine aminotransferase: 10 (normal) 10 U/L Norm low: 5 Norm high: 40. On 26-Feb-2021, Albumin globulin ratio: 1.8 (normal) 1.8 ratio Norm low: 1.1 Norm high: 2.6. On 26-Feb-2021, Anion gap: 13.0 (normal) 13.0 mmol/L Norm low: 3 Norm high: 15. On 26-Feb-2021, Aspartate aminotransferase: 18 (normal) 18 U/L Norm low: 10 Norm high: 37. On 26-Feb-2021, Blood albumin: 4.2 (normal) 4.2 g/dL Norm low: 3.5 Norm high: 5. On 26-Feb-2021, Blood alkaline phosphatase: 106 (normal) 106 U/L Norm low: 40 Norm high: 120. On 26-Feb-2021, Blood bilirubin: 1.1 (normal) 1.1 mg/dL Norm low: 0.1 Norm high: 1.2. On 26-Feb-2021, Blood calcium: 9.9 (normal) 9.9 mg/dL Norm low: 8.4 Norm high: 10.5. On 26-Feb-2021, Blood chloride: 99 (normal) 99 mmol/L Norm low: 98 Norm high: 110. On 26-Feb-2021, Blood creatinine: 0.8 (normal) 0.8 mg/dL Norm low: 0.8 Norm high: 1.4. On 26-Feb-2021, Blood glucose: 92 (normal) 92 mg/dL Norm low: 70 Norm high: 99. On 26-Feb-2021, Blood potassium: 4.1 (normal) 4.1 mmol/L Norm low: 3.5 Norm high: 5.5. On 26-Feb-2021, Blood sodium: 142 (normal) 142 mmol/L Norm low: 133 Norm high: 145. On 26-Feb-2021, Blood urea: 14 (normal) 14 mg/dL Norm low: 6 Norm high: 22. On 26-Feb-2021, Carbon dioxide: 30 (normal) 30 mmol/L Norm low: 20 Norm high: 32. On 26-Feb-2021, Globulin: 2.4 (normal) 2.4 g/dL Norm low: 2 Norm high: 4. On 26-Feb-2021, Protein total: 6.6 (normal) 6.6 g/dL Norm low: 6.2 Norm high: 8.1. On an unknown date, Blood potassium: decreased (Low) Decreased. On an unknown date, Magnetic resonance imaging head: normal (normal) normal It was ok..     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.   She also went for physical therapy for vertigo (suffered for 137 days). Patient had an MRI on head because they thought patient had a stroke, but it was ok. Patient was having severe allergies and taking 6 medications a day for sneezing, coughing, runny nose and sinus drainage and weekly allergy shots. Prior to the vaccine patient was having allergies but was in control, not medications and allergy shots are not working. Patient reports a history of vertigo, states that this resolves after hearing aids in 2015. Today's episode feels similar to prior. No concomitant medication information was provided. This case concerns Intentional dose omission in a patient of unknown age and gender with relevant history of multiple allergies, who experienced the unexpected non-serious event of Ageusia (AESI). The event occurred an unknown number of days after the first dose of mRNA-1273 vaccine. The concurrent worsening of allergies that prior to vaccine were controlled with medications but were not controlled after vaccination, may have contributed to the event of ageusia.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Following tests were performed on 15-Feb-21: Atrial Rate (71 ms), P Duration (130 ms), P Horizontal Axis (-15 deg), P Front Axis (47 deg) ,Q Onset( 499 ms), QRSD Interval (98 ms), QTcB (446 ms),QTcF (435 ms) QRS Horizontal Axis (-4 deg),  I-40 Front Axis (-24 deg), t-40 Horizontal Axis( -13 deg), T-40 Front Axis (7 deg), T Wave Axis (-38 deg), S-T Horizontal Axis (152 deg) S-T Front Axis (-81 deg),  LVHPRE-Probable LVH with secondary repol abnrm-multiple LVH criteria, IMIO-Inferior infarct, old-Q >35mS, II III Avf   Most recent FOLLOW-UP information incorporated above includes: On 26-Oct-2021: significant follow-up received on 26-Oct-2021,Events added, Medical records provided, Lab data updated, Patient history updated On 27-Oct-2021: significant follow-up was received on 27-Oct-2021, Pregnancy related information updated. On 31-Oct-2021: Follow up received on 01-Nov-2021 contains no new information.; Sender's Comments: This is a spontaneous case concerning a 75-year-old female patient with medical history of Vertigo and  multiple allergies, who experienced the serious  unexpected event Hypokalemia and non serious event Vertigo . The events occurred approximately 2 days after the first dose  of mRNA-1273 Moderna vaccine. Patient go to the Emergency room for Vertigo and hypokalemia was diagnosed; she received a Potassium infusion and other medications for nausea and was discharged. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.