Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Nerve conduction studies, Pain in extremity, Peripheral swelling, Product dose omission issue
Clinical narrative: Pain in arm for days; Left arm swelled; The vaccination site is swollen, red, and heat; Vaccination site is swollen; Redness of left arm vaccination site; Carrying a low grade fever had 100.7 at ear, 99 is a fever for me"; Patient advised by her doctor to not get the second vaccine as my allergic reaction would be worse; Feeling hot; The patient noticed her face, lips, eyes and tongue were selling up fast; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Jul-2021. The most recent information was received on 31-Aug-2021 and was forwarded to Moderna on 31-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm for days), PERIPHERAL SWELLING (Left arm swelled), VACCINATION SITE WARMTH (The vaccination site is swollen, red, and heat), FEELING HOT (Feeling hot) and SWELLING (The patient noticed her face, lips, eyes and tongue were selling up fast) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (sulfa allergy.), Drug allergy (Levaquin allergy.), Allergy to antibiotic (antibiotics allergy.), Allergy to antibiotic (tetracycline allergy.), Drug allergy (codeine allergy.), Chiari malformation, Mast cell activation syndrome, Dysautonomia since 12-Oct-2018, Syncope vasovagal since 12-Oct-2018, Mast cell activation syndrome (On 6-30-2021 the mast cell activation syndrome got worsen with vaccine.) since October 2018, Hypertension (Improved with meds.), Hypotension (Improved with meds), High cholesterol (Improved with treatment.), Mitral valve prolapse, Drug allergy, Allergy to antibiotic, Allergy to antibiotic, Drug allergy, Drug allergy, Allergy to chemicals and Allergy to vaccine. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for Blood cholesterol increased, ROSUVASTATIN CALCIUM (ROSUVASTATIN +PHARMA) for Cholesterol, LISINOPRIL for Hypertension, FISH OIL (FISH OIL OMEGA 3) for Triglycerides, VITAMIN B12 NOS and COLECALCIFEROL (VITAMIN D3) for an unknown indication.    On 30-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jun-2021, the patient experienced FEELING HOT (Feeling hot) and SWELLING (The patient noticed her face, lips, eyes and tongue were selling up fast). On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in arm for days), PERIPHERAL SWELLING (Left arm swelled), VACCINATION SITE WARMTH (The vaccination site is swollen, red, and heat), VACCINATION SITE SWELLING (Vaccination site is swollen), VACCINATION SITE ERYTHEMA (Redness of left arm vaccination site), PYREXIA (Carrying a low grade fever had 100.7 at ear, 99 is a fever for me") and PRODUCT DOSE OMISSION ISSUE (Patient advised by her doctor to not get the second vaccine as my allergic reaction would be worse). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at a dose of 1 dosage form; LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for Swelling, at a dose of 50 mg and PREDNISONE for Fever, at an unspecified dose and frequency. On 15-Jul-2021, FEELING HOT (Feeling hot) and SWELLING (The patient noticed her face, lips, eyes and tongue were selling up fast) had resolved. At the time of the report, PAIN IN EXTREMITY (Pain in arm for days), PERIPHERAL SWELLING (Left arm swelled), VACCINATION SITE WARMTH (The vaccination site is swollen, red, and heat), VACCINATION SITE SWELLING (Vaccination site is swollen), VACCINATION SITE ERYTHEMA (Redness of left arm vaccination site) and PYREXIA (Carrying a low grade fever had 100.7 at ear, 99 is a fever for me") outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Patient advised by her doctor to not get the second vaccine as my allergic reaction would be worse) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Nerve conduction studies: abnormal (abnormal) unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications include ice.  The concomitant medication included omega 3 ethyl esters. The patient stayed well hydrated for a few days with no improvement.  Patient was treated with prednisone for 6 days for fever which helped.   Most recent FOLLOW-UP information incorporated above includes: On 31-Aug-2021: significant follow up : included patient details and medical history. New events and concomitant medications were added.