Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Condition aggravated, Inappropriate schedule of product administration, Mechanical urticaria, Pain in extremity
Clinical narrative: inappropriate schedule of product administration; facial angioedema/angioedema worse than ever; covered in hives/autoimmune condition came out of remission-dermatographism worse than ever; autoimmune condition came out of remission-chronic hives, angioedema and dermatographism worse than ever; sore arm; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of ANGIOEDEMA (facial angioedema/angioedema worse than ever) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Angioedema from 2013 to November 2020, Nissen fundoplication in 2004, Nissen fundoplication (re-do), Hernia repair and Intestinal operation (removal of part of stomach due to scar tissue from Nissen fundoplication in 2004). Family history included Osteopenia (diagnosed at age 51 due to undiagnosed hyperparathyroidism with adenoma) since an unknown date. Concurrent medical conditions included Hives (idiopathic chronic) since 2013, Dermatographism since 2013, Hypertension (controlled with medications), Chronic depression, Herniated disc, Gastroparesis, Kidney stones (from abnl urine calcium oxalate levels; primarily L. kidney (MD suspects medullary sponge kidney) with ureter stricture issues), Migraine (since early 20's), Chilaiditi's syndrome, Hyperparathyroidism secondary, Osteoarthritis (cervical spine, lumbar spine, bilat. hips, shoulders, wrists, hands, great toes & L. ankle. ), Enlarged thyroid (with nodules & isthmus), Fibromyalgia, Chronic fatigue syndrome, Insomnia (severe since age 13), Restless leg syndrome, Adenomyosis, Otitis media with effusion, Rhinitis (non-allergic), Asthma, Eczema, Food allergy (yeast, sugar, corn, and artificial sweeteners), Environmental allergy (strong odors- perfumes, cleaning products, cigarette smoke), Anxiety, Panic attacks (causes tachycardia), Mood disorder (extreme irritability-not bipolar), Lumbar disc herniation, Spinal hemangioma, Bone spur, Spinal stenosis (moderate), Degenerative disc disease (significant), Pinched nerve, Chronic gastritis, Constipation chronic (with intermittent bouts of diarrhea), Vagus nerve disorder, Gluten intolerance, Dairy intolerance, Premature ventricular contractions (occasional due to stress- causes palpitations), Calcium low, Potassium low, Vitamin D deficiency, Vitamin B12 deficiency, Blood pressure high, Drug allergy (amlodipine- swollen feet and ankles), Allergy to antibiotic (amoxicillin/clavulanate potassium- severe pain, burning, and cramping in stomach), Allergy to antibiotic (sulfamethoxazole/trimethoprim- elevated heart rate, low oxygen levels, nausea & chest tightness ), Allergy to antibiotic (ciprofloxacin- elevated heart rate, low oxygen levels, nausea, tightness in chest, Achilles pain & photosensitivity), Drug allergy (diclofenac topical gel- vertigo), Drug allergy (dilaudid- severe nausea/vomiting, dizzy & slow heart rate), Allergy to antibiotic (doxycycline- severe nausea & eyesight issues), Drug hypersensitivity (general anesthesia- nausea), Drug allergy (hydrochlorothiazide- sudden drops in blood pressure, nausea, extreme fatigue & yeast infections), Drug allergy (all narcotics- nausea/vomiting), Drug allergy (pyridium- rash), Drug allergy (temazepam- asthma, tachycardia, anxiety, panic attacks & excessive urination) and Allergy to vaccine (MMR and shingles vaccine (Shingrix) but not hives, angioedema, or dermatographism). Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) from 01-Feb-2021 to an unknown date for Allergy, ALPRAZOLAM (XANAX) for Anxiety and Panic attacks, ALBUTEROL SULFATE for Asthma, BENZONATATE for Chronic cough and Asthma, HYDROXYZINE HCL from 01-Feb-2021 to an unknown date and PREDNISONE for Chronic idiopathic urticaria, Angioedema and Dermatographism, IBUPROFEN for Chronic pain, MAGNESIUM OXIDE for Constipation, TRIAMCINOLONE ACETONIDE for Eczema and Urticaria, CALCIUM CITRATE for Hyperparathyroidism secondary and Osteopenia, VITAMIN D3 for Hyperparathyroidism, Osteopenia and Kidney stones, OLMESARTAN for Hypertension, CLONAZEPAM (KLONOPIN) for Insomnia, LAMOTRIGINE (LAMICTAL) for Irritability, TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]) for Kidney stones, VENLAFAXINE HYDROCHLORIDE (EFFEXOR SR) for Major depression, DIHYDROERGOTAMINE MESILATE and ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN MIGRAINE) for Migraine, ZOLMITRIPTAN (ZOMIG) for Migraine headache, PROMETHAZINE HYDROCHLORIDE (PHENERGAN [PROMETHAZINE HYDROCHLORIDE]) for Nausea and Gastroparesis, ZOLEDRONIC ACID (RECLAST) for Osteopenia, AZELASTINE HCL and FLUTICASONE PROPIONATE for Rhinitis.    On 19-Mar-2021 at 2:40 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 24-Mar-2021 at 6:30 AM, the patient experienced MECHANICAL URTICARIA (covered in hives/autoimmune condition came out of remission-dermatographism worse than ever) and CONDITION AGGRAVATED (autoimmune condition came out of remission-chronic hives, angioedema and dermatographism worse than ever). On 20-Apr-2021, the patient experienced ANGIOEDEMA (facial angioedema/angioedema worse than ever) (seriousness criterion medically significant). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of product administration). On 21-Mar-2021, PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, ANGIOEDEMA (facial angioedema/angioedema worse than ever), MECHANICAL URTICARIA (covered in hives/autoimmune condition came out of remission-dermatographism worse than ever) and CONDITION AGGRAVATED (autoimmune condition came out of remission-chronic hives, angioedema and dermatographism worse than ever) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of product administration) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was temporarily withheld on an unknown date.       The patient's autoimmune conditions of idiopathic chronic hives, angioedema, and dermatographism were diagnosed in approximately 2013 and took about a year to get under control.  During 2018, it came back so she was treated with omalizumab, but it lost effectiveness, so she was switched to ciclosporin for a month in January 2019.  Then the patient was taken off cyclosporin and "doubled up" on cetirizine hydrochloride, and hydroxyzine per her immunologist.  This "surprisingly" kept her under control from 01 Feb 2021 until she got the first vaccination.  She noted she hadn't had an episode of angioedema since November 2020.  Treatment included prednisone 60 mg on 20 Apr 2021 but the angioedema (which involved her eyes and lips) did not respond, although she said it had gone down somewhat.  The patient was supposed to get her second dose of the vaccine on 22 Apr 2021 but that was cancelled per a nurse practitioner (NP) at the pharmacy because she took one dose of prednisone on 22 Apr 2021.  The NP said that would make the vaccine less effective so she should wait until at least 27 Apr 2021 so that one dose of prednisone was out of her system.  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.   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Major updates to multiple fields (medical history, concomitant medications, narrative); 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.