Received Apr 9, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 1 | — | — |
severe reaction affecting left shoulder; Heart palpitations; Swelling; Pain; Numbness on her left side; Tingling in her extremities; Chest pressure; Elevated blood pressure; Significant discomfort; Mast Cell Activation Syndrome (MCAS)/hives, itching, swelling, flushing, hot flashes, sinus drainage, nasal congestion, headaches, tinnitus, blurred vision, gastrointestinal distress, shortness of breath, wheezing, rapid heart rate, muscle twitching; Idiopathic angioedema-urticaria; Idiopathic angioedema-urticaria; Gastroesophageal Reflux Disease (GERD); Patient received dose 1 on 02-Feb-2022 and dose 2 on 24-Mar-2022; health had progressively declined-physically, mentally, and emotionally/quality of life had been profoundly diminished; health has progressively and severely declined-physically, mentally, and emotionally-to the point that I am no longer able to work and am often unable to get out of bed; health had progressively declined-physically, mentally, and emotionally; health had progressively declined-physically, mentally, and emotionally; This spontaneous case was reported by a consumer and describes the occurrence of ARTHROPATHY (severe reaction affecting left shoulder), PALPITATIONS (Heart palpitations), SWELLING (Swelling), PAIN (Pain), HYPOAESTHESIA (Numbness on her left side), PARAESTHESIA (Tingling in her extremities), CHEST DISCOMFORT (Chest pressure), BLOOD PRESSURE INCREASED (Elevated blood pressure), DISCOMFORT (Significant discomfort), MAST CELL ACTIVATION SYNDROME (Mast Cell Activation Syndrome (MCAS)/hives, itching, swelling, flushing, hot flashes, sinus drainage, nasal congestion, headaches, tinnitus, blurred vision, gastrointestinal distress, shortness of breath, wheezing, rapid heart rate, muscle twitching), IDIOPATHIC ANGIOEDEMA (Idiopathic angioedema-urticaria) and MENTAL IMPAIRMENT (health had progressively declined-physically, mentally, and emotionally) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 02-Feb-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 24-Mar-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 02-Feb-2022, the patient experienced MENTAL IMPAIRMENT (health had progressively declined-physically, mentally, and emotionally) (seriousness criterion medically significant), GENERAL PHYSICAL HEALTH DETERIORATION (health had progressively declined-physically, mentally, and emotionally/quality of life had been profoundly diminished), BEDRIDDEN (health has progressively and severely declined-physically, mentally, and emotionally-to the point that I am no longer able to work and am often unable to get out of bed) and EMOTIONAL DISORDER (health had progressively declined-physically, mentally, and emotionally). In February 2022, the patient experienced ARTHROPATHY (severe reaction affecting left shoulder) (seriousness criterion hospitalization), PALPITATIONS (Heart palpitations) (seriousness criterion hospitalization), SWELLING (Swelling) (seriousness criterion hospitalization), PAIN (Pain) (seriousness criterion hospitalization), HYPOAESTHESIA (Numbness on her left side) (seriousness criteria hospitalization and medically significant), PARAESTHESIA (Tingling in her extremities) (seriousness criterion hospitalization), CHEST DISCOMFORT (Chest pressure) (seriousness criterion hospitalization), BLOOD PRESSURE INCREASED (Elevated blood pressure) (seriousness criterion hospitalization) and DISCOMFORT (Significant discomfort) (seriousness criterion hospitalization). On 24-Mar-2022, after starting mRNA-1273 (Spikevax), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received dose 1 on 02-Feb-2022 and dose 2 on 24-Mar-2022). In September 2025, the patient experienced MAST CELL ACTIVATION SYNDROME (Mast Cell Activation Syndrome (MCAS)/hives, itching, swelling, flushing, hot flashes, sinus drainage, nasal congestion, headaches, tinnitus, blurred vision, gastrointestinal distress, shortness of breath, wheezing, rapid heart rate, muscle twitching) (seriousness criterion medically significant), IDIOPATHIC ANGIOEDEMA (Idiopathic angioedema-urticaria) (seriousness criterion medically significant), IDIOPATHIC URTICARIA (Idiopathic angioedema-urticaria) and GASTROOESOPHAGEAL REFLUX DISEASE (Gastroesophageal Reflux Disease (GERD)). The patient was hospitalized on 18-Feb-2022 due to ARTHROPATHY, BLOOD PRESSURE INCREASED, CHEST DISCOMFORT, DISCOMFORT, HYPOAESTHESIA, PAIN, PALPITATIONS, PARAESTHESIA and SWELLING. At the time of the report, ARTHROPATHY (severe reaction affecting left shoulder), PALPITATIONS (Heart palpitations), SWELLING (Swelling), PAIN (Pain), HYPOAESTHESIA (Numbness on her left side), PARAESTHESIA (Tingling in her extremities), CHEST DISCOMFORT (Chest pressure), BLOOD PRESSURE INCREASED (Elevated blood pressure), DISCOMFORT (Significant discomfort), MAST CELL ACTIVATION SYNDROME (Mast Cell Activation Syndrome (MCAS)/hives, itching, swelling, flushing, hot flashes, sinus drainage, nasal congestion, headaches, tinnitus, blurred vision, gastrointestinal distress, shortness of breath, wheezing, rapid heart rate, muscle twitching), IDIOPATHIC ANGIOEDEMA (Idiopathic angioedema-urticaria), IDIOPATHIC URTICARIA (Idiopathic angioedema-urticaria), GASTROOESOPHAGEAL REFLUX DISEASE (Gastroesophageal Reflux Disease (GERD)), GENERAL PHYSICAL HEALTH DETERIORATION (health had progressively declined-physically, mentally, and emotionally/quality of life had been profoundly diminished) and BEDRIDDEN (health has progressively and severely declined-physically, mentally, and emotionally-to the point that I am no longer able to work and am often unable to get out of bed) had not resolved and MENTAL IMPAIRMENT (health had progressively declined-physically, mentally, and emotionally), EMOTIONAL DISORDER (health had progressively declined-physically, mentally, and emotionally) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received dose 1 on 02-Feb-2022 and dose 2 on 24-Mar-2022) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2022, Blood pressure measurement: elevated. In September 2025, Blood pressure measurement: high. No concomitant medications were reported. Patient had serious, life altering adverse reactions that the patient was experiencing following vaccination and respectfully requested for assistance regarding the patient's ongoing health and financial challenges. On 18-Feb-2022, patient was hospitalized with a severe adverse reaction involving the left shoulder and systemic symptoms, including heart palpitations, swelling, pain, numbness on the left side, tingling in the extremities, chest pressure, elevated blood pressure, and significant pain. Patient returned to the emergency room again on 01-Mar-2022. On 24-Mar-2022, patient received Moderna booster vaccination. Since 02-Feb-2022, patient's health had progressively and severely declined physically, mentally, and emotionally to the point that patient would no longer be able to work and often unable to get out of bed. Over the course of the past 4 years, patient have had more than 100 documented emergency room visits, hospitalizations, and physician appointments with numerous specialists. In September 2025, patient was finally diagnosed with Mast Cell Activation Syndrome (MCAS), Gastroesophageal Reflux Disease (GERD), and Idiopathic Angioedema Urticaria and High blood pressure. None of these diseases existed prior to receiving the Moderna SARS-CoV-2 vaccination. Despite extensive treatment, patient continued to experience constant and severe reactions-approximately 15 to 30 episodes per day. Patient was currently prescribed AYVAKIT, Xolair, Cromolyn Sodium, Loratadine, Famotidine, Montelukast, Benadryl, Xanax, Omeprazole, Tyrvaya, Ubrelvy, Hydroxychloroquine Sulfate, and additional medications and antihistamines. Patient must carry an EpiPen at all times due to the ongoing risk of anaphylaxis. Patient's mast cells were now triggered by a wide range of factors, including chemical and drug exposures, environmental factors, foods, physical stimuli, biological agents, emotional and neurological stressors, and electromagnetic fields. These triggers were not present prior to vaccination. Before receiving the first Moderna vaccination, patient was a healthy marathon runner, a mother of four children, and a successful international project manager. Patient was socially active, fully employed, and had no chronic medical conditions or daily prescription medications. Since Feb-2022, the patient's quality of life had been profoundly diminished. Patient was now largely homebound, often confined to a dark, cold bedroom in isolation in an effort to prevent mast cell activation episodes. Patient's daily symptoms included hives, itching, swelling, flushing, hot flashes, sinus drainage, nasal congestion, headaches, tinnitus, blurred vision, gastrointestinal distress, shortness of breath, wheezing, rapid heart rate, muscle twitching, joint and bone pain, night sweats, extreme fatigue, brain fog, diarrhea, anxiety, panic attacks, and, at times, anaphylaxis. The financial burden of the patient's medical care and prescription medications was overwhelming and ongoing, with no foreseeable resolution.; Reporter's Comments: Causality for Mast cell activation syndrome, Idiopathic angioedema, Idiopathic urticaria and Gastroesophageal reflux disease was assessed as not related, due to long latency. The benefit-risk relationship of product is not affected by this report.
Test Date: 202202; Test Name: Blood pressure; Result Unstructured Data: elevated; Test Date: 202509; Test Name: Blood pressure; Result Unstructured Data: high