Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Mammogram, Migraine, Ophthalmological examination normal, Smear cervix
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (severe adverse reactions/only conclusion is it is a side effect of the vaccine), DIZZINESS (When she stands up she gets very dizzy), HYPOAESTHESIA (has numbness on the side of body from the fingers, hands, and to the feet/tingling/Jaw numb), STENOSIS (Foraminal narrowing) and SPINAL OSTEOARTHRITIS (Spondylosis) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 429L21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Vitamin D deficiency on 11-Aug-2010, Hemorrhoids (w/o complications) on 31-Mar-2010, Apnea (obstructive sleep apnea syndrome) on 09-Oct-2009, Dermatophilosis on 30-Dec-2008, Hypertension (Benign) on 04-Dec-2008, Cervicalgia (Cervicalgia Pre evaluation by Dr. h/o ESI) on 11-Apr-2008, Hypertrophy on 11-Apr-2021, Graves' disease (s/p sub total thyroidectomy) on 11-Apr-2008, Depression (anxiety with depression) on 04-Mar-2008, Hypercholesterolaemia (mild) on 04-Mar-2008, Allergic rhinitis, Hypertrophic cardiomyopathy, Numbness, Body mass index (adult), Knee pain, Female circumcision, Diarrhoea predominant irritable bowel syndrome, Night sweats, Lumbar pain (s/p lumbar surgery at L4-5, Dr. ON 5/16), Paresthesia lower limb, Depression (Medicare patients- negative), Peripheral neuropathy, Neuropathy NOS, Reflux gastritis, Hemorrhoids, Hearing loss, Joint pain, Obesity, Shortness of breath, Screening test, Body mass index (32.0-32.9 adult), Body mass index (greater than 25), Anemia (colonoscopy negative) in 2003, Eye exam on 03-Oct-2017 and HYPER CHOLESTER0LEMIA. Previously administered products included for an unreported indication: DIPHTHERIA AND TETANUS VACCINE on 11-Apr-2008, TD VACCINE on 11-Mar-2012, PNEUMOCOCCAL VACCINE on 28-Aug-2015, PNEUMOVAX on 13-Oct-2017, IMUNIXX since 28-Jan-2021 and IMUNIXX since 25-Feb-2021. Concurrent medical conditions included Immunocompromised, erythromycin (macrolides * anaphylaxis) on 31-Dec-2008, Drug allergy GI agents -MISC * drug allergy; anxiety, hallucination, bad dreams), Drug allergy (gabapentin Anti convulsant agents drug allergy; worsening, depression), Drug allergy (TOLERATES LEVAQUIN) on 31-Dec-2008, Drug allergy (KEFLAX* CEHALOSPORINS) on 31-Dec-2008, Drug allergy (PAXIL) on 31-Dec-2008, Drug allergy (PENCILLIN) on 31-Dec-2008, Drug allergy (anti-infective agents misc.* ( all sulfa drugs ).) on 31-Dec-2021, Osteoarthritis (Osteoarthritis of the thumb) on 04-Mar-2008, Osteopenia, Prediabetes, Alcohol addiction (moderate alcohol use), Tobacco user (former smoker), Substance use (no history of drug abuse) and Health care provider instructions for product use lacking (10: 38 pm) since 10-Dec-2021. Concomitant products included LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) from 15-Oct-2018 to an unknown date for Allergy, ROSUVASTATIN, DULOXETINE HYDROCHLORIDE (CYMBALTA) from 15-Oct-2018 to an unknown date, LOSARTAN, METOPROLOL from 20-Nov-2018 to an unknown date, HYDROCHLOROTHIAZIDE, LEVOTHYROXINE SODIUM (SYNTHROID), BUPROPION HYDROCHLORIDE (WELLBUTRIN) from 17-Sep-2018 to an unknown date, PRAMIPEXOLE, ASPIRIN [ACETYLSALICYLIC ACID], MOMETASONE FUROATE (MOMENTASONE), FLUTICASONE PROPIONATE from 30-May-2017 to an unknown date and LORAZEPAM from 12-May-2016 to an unknown date for an unknown indication. On 30-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Aug-2021, the patient experienced VACCINATION COMPLICATION (severe adverse reactions/only conclusion is it is a side effect of the vaccine), DIZZINESS (When she stands up she gets very dizzy) and HYPOAESTHESIA (has numbness on the side of body from the fingers, hands, and to the feet/tingling/Jaw numb). On an unknown date, the patient experienced STENOSIS (Foraminal narrowing), SPINAL OSTEOARTHRITIS (Spondylosis), HYPOAESTHESIA ORAL (Tongue numb), ASTHENIA (No energy), MIGRAINE (Migraines) and BLOOD PRESSURE INCREASED (BP remains elevated). At the time of the report, VACCINATION COMPLICATION (severe adverse reactions/only conclusion is it is a side effect of the vaccine), DIZZINESS (When she stands up she gets very dizzy), HYPOAESTHESIA (has numbness on the side of body from the fingers, hands, and to the feet/tingling/Jaw numb), STENOSIS (Foraminal narrowing), SPINAL OSTEOARTHRITIS (Spondylosis), HYPOAESTHESIA ORAL (Tongue numb), ASTHENIA (No energy), MIGRAINE (Migraines) and BLOOD PRESSURE INCREASED (BP remains elevated) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-May-2013, Blood test: inflammatory polyp only inflammatory polyp only. On 28-May-2015, Blood test: normal (normal) normal. On 03-Oct-2017, Blood test: normal (normal) normal. On 20-Aug-2022, Blood test: phq-9 depression CPTZ code documented for 2021. On an unknown date, Anti B antibody: < 0.2 < 0.2 and < 0.2 < 0.2. On an unknown date, Antibody test normal: <0.2 <0.2 and 0.9 0.9. On an unknown date, Blood test: abnormal (abnormal) side effect of the vaccine. On an unknown date, Bone density abnormal: normal (normal) normal. On an unknown date, Drug specific antibody: < 0.2 < 0.2, 0.9 0.9, 0.9 0.9, <0.2 <0.2 and <0.2 < 0.2. On an unknown date, Magnetic resonance imaging: abnormal (abnormal) side effect of the vaccine. On an unknown date, Mammogram: gynecology gynecology. On an unknown date, Ophthalmological examination normal: normal (normal) normal. On an unknown date, Smear cervix: normal TAH with BSO (normal) TAH with BSO. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment medication were reported. Patient got the first shot on 28Jan2021 and second shot on 25Feb2021 (lot: 011A21A). Fall risk assessment 08-20-2021, CPTZ code documented for 2021. Review of systems: respiratory not present dyspnea, cardiovascular not present -edema and palpitations , musculoskeletal present-knee pain (right knee), neurological present, numbness right foot, psychiatric present, insomnia, endocrine present, sweating increase. SJOGREN'S ANTI-SS-A <0.2 SJOGREN'S ANTI-SS-B <0.2 ANTI CHROMATIN ANTIBODIES<0.2 ANTIRIBOSOMAL ANTIBODIES<0.2 ANTI-JO-1 < 0.2 ANTI-CENTROSOME B ANTIBODI ES<0.2 HYPERCHOLESTEROLEMIA 03/04/2008 IMMUNOGLOBIN G ON SERUM: 1204mg/dl immunoglobin A 146 mg/dl immunoglobin m, 151 mg/dl protein , total, 7.1 g/dl albumin , 3.6 g/dl alpha-1-globulin 0.3g/dl alpha-2-globulin 0.9 g/dl beta globulin 1.1g/dl gamma globulin 1.3 g/dl m-spike not observed  globulin, total: 3.5 g/dl kappa and Lambda free light chains 8.3883 free kappa IT chains36.3MG/DL kappa / Lambda ratios 2.06 HIV ANTIGEN/ ANTIBODY  RHEUMATOID FACTOR  CREATININE KINASE 67 IU/DL LYME IgG/ IgM < 0.91   This case was linked to MOD-2021-406488 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Jan-2022: Significant follow-up-event, event outcome, medical history, patient height and lab data, concomitants updated