Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Hypoaesthesia, Lymphadenopathy, Migraine, Night sweats
Clinical narrative: left kidney atrophy; renal artery stenosis; chronic kidney disease; more episodes of migraines; hot flashes; tightness in the skin; swollen neck glands; night sweats; cough; headache; prickly feeling forehead, temple and face; episodes of numbness and tingling/subsequent tingling and numbness of scalp/tingling in hands; felt hyper; electric jolt to my head at crown; shaky; episodes of numbness and tingling/subsequent tingling and numbness of scalp/ intermittent numbness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RENAL ATROPHY (left kidney atrophy), RENAL ARTERY STENOSIS (renal artery stenosis), CHRONIC KIDNEY DISEASE (chronic kidney disease), MIGRAINE (more episodes of migraines) and HYPOAESTHESIA (episodes of numbness and tingling/subsequent tingling and numbness of scalp/ intermittent numbness) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Tingling in 2014, Numbness in 2014, Itchy scalp in 2014 and Cardiac catheterization (Patient had a similar reaction in 2014 following a cardiac cath when surgeon implanted a St. Jude Angio Seal to prevent bleed. The polymer 'sponge' plug remained until her body absorbed it, about two months and over that two months, the patient had scalp, face and body tingling and numbness intermittently and feeling of prickly itchiness scalp, face, trunk.) in 2014. Previously administered products included for an unreported indication: PNEUMOCOCCAL VACCINE (PPSV23 Injection left arm) on 05-Jan-2021. Concurrent medical conditions included Drug allergy (sulfa allergy), Drug allergy (chlorthalidone allergy), Drug allergy (dobutamine allergy), Contrast media allergy (ionic contrast- hives), Hypertension (resistant hypertension) since 2014, Ophthalmic migraine (Recent changes: Unbalance, vertigo, double vision, headaches) since 1976, Balance difficulty (unbalance), Vertigo, Double vision, Headache, Disease coronary artery (cad) since 2014, Fibromyalgia since 1985, Mixed connective tissue disease since 1985, Hashimoto's disease (Hashimoto's disease) since 1990, Metabolic syndrome since 1985 and Lichen sclerosis atrophicus. Concomitant products included METOPROLOL for Arrhythmia, APIXABAN (ELIQUIS) for Atrial fibrillation, ACETYLSALICYLIC ACID (ASPIRIN 81) for Disease coronary artery, AMLODIPINE BESILATE (NORVASC) and LOSARTAN POTASSIUM (COZAAR) for Hypertension, HYDROCHLOROTHIAZIDE, LEVOTHYROXINE SODIUM (SYNTHROID) and GABAPENTIN from an unknown date to 16-Apr-2021 for an unknown indication.   On 29-Jan-2021 at 1:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021 at 1:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced HYPOAESTHESIA (episodes of numbness and tingling/subsequent tingling and numbness of scalp/ intermittent numbness), PARAESTHESIA (episodes of numbness and tingling/subsequent tingling and numbness of scalp/tingling in hands), PSYCHOMOTOR HYPERACTIVITY (felt hyper), ELECTRIC SHOCK SENSATION (electric jolt to my head at crown), TREMOR (shaky) and PRURITUS (prickly feeling forehead, temple and face). On an unknown date, the patient experienced RENAL ATROPHY (left kidney atrophy), RENAL ARTERY STENOSIS (renal artery stenosis), CHRONIC KIDNEY DISEASE (chronic kidney disease), MIGRAINE (more episodes of migraines), SKIN TIGHTNESS (tightness in the skin), HOT FLUSH (hot flashes), LYMPHADENOPATHY (swollen neck glands), NIGHT SWEATS (night sweats), COUGH (cough) and HEADACHE (headache). At the time of the report, RENAL ATROPHY (left kidney atrophy), RENAL ARTERY STENOSIS (renal artery stenosis), CHRONIC KIDNEY DISEASE (chronic kidney disease), MIGRAINE (more episodes of migraines), SKIN TIGHTNESS (tightness in the skin), HOT FLUSH (hot flashes), PSYCHOMOTOR HYPERACTIVITY (felt hyper), ELECTRIC SHOCK SENSATION (electric jolt to my head at crown), LYMPHADENOPATHY (swollen neck glands) and COUGH (cough) outcome was unknown, HYPOAESTHESIA (episodes of numbness and tingling/subsequent tingling and numbness of scalp/ intermittent numbness), PARAESTHESIA (episodes of numbness and tingling/subsequent tingling and numbness of scalp/tingling in hands), PRURITUS (prickly feeling forehead, temple and face), NIGHT SWEATS (night sweats) and HEADACHE (headache) had not resolved and TREMOR (shaky) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Blood pressure measurement: 168 (High) elevated. In March 2021, SARS-CoV-2 test: negative Negative. In April 2021, SARS-CoV-2 test: negative Negative.         The patient reported, MD opinion was that she was reacting to the PEG and/ or preservative additives in the vaccine. The patient saw her PCP and specialists who follow her various chronic health conditions. She underwent scans and labs (unspecified) during the process. A new development is CDK and L kidney atrophy with renal artery stenosis.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-127019 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: case upgraded to serious, updated patient medical history, suspect product details, added concomitant medications, added new serious events, updated outcome.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.