Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Ear swelling, Erythema, Headache, Hypersensitivity
Clinical narrative: Mild allergic reaction; Swelling in tongue throat and ear area; Swelling in tongue throat and ear area; Sore arm; Swelling in tongue throat and ear area/Swelling of upper airway; Redness/erythema; Headache; Little chills; get the one-shot Johnson & Johnson vaccine, which I was finally allowed to receive (without incident); This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Mild allergic reaction), SWOLLEN TONGUE (Swelling in tongue throat and ear area), EAR SWELLING (Swelling in tongue throat and ear area), PAIN IN EXTREMITY (Sore arm) and PHARYNGEAL SWELLING (Swelling in tongue throat and ear area/Swelling of upper airway) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Environmental allergy, Hypertension since 2013, Vasculitis since 2003, Osteoporosis since 2005, High cholesterol since 2020, Allergy to plants (hives from contact), Allergy to moulds (throat, tongue swelling), Dust allergy (throat, tongue swelling), Fruit allergy (throat, tongue swelling), Pollen allergy (throat, tongue swelling) and Autoimmune disorder since 2013. Concomitant products included FAMOTIDINE and AZELASTINE;FLUTICASONE for Allergy, HYDROXYCHLOROQUINE and HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]) for Autoimmune disorder, ROSUVASTATIN for High cholesterol, LISINOPRIL for Hypertension, XYLOMETAZOLINE HYDROCHLORIDE (NASAL SPRAY II) and DENOSUMAB (PROLIA) for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (get the one-shot Johnson & Johnson vaccine, which I was finally allowed to receive (without incident)). On 23-Mar-2021, the patient experienced HYPERSENSITIVITY (Mild allergic reaction). 23-Mar-2021, the patient experienced SWOLLEN TONGUE (Swelling in tongue throat and ear area), EAR SWELLING (Swelling in tongue throat and ear area), PAIN IN EXTREMITY (Sore arm), PHARYNGEAL SWELLING (Swelling in tongue throat and ear area/Swelling of upper airway), ERYTHEMA (Redness/erythema), HEADACHE (Headache) and CHILLS (Little chills). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) (oral) from 23-Mar-2021 to 24-Mar-2021 at a dose of 50 milligram four times per day. On 24-Mar-2021, HYPERSENSITIVITY (Mild allergic reaction), SWOLLEN TONGUE (Swelling in tongue throat and ear area), EAR SWELLING (Swelling in tongue throat and ear area), PHARYNGEAL SWELLING (Swelling in tongue throat and ear area/Swelling of upper airway) and ERYTHEMA (Redness/erythema) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache) and CHILLS (Little chills) outcome was unknown and INTERCHANGE OF VACCINE PRODUCTS (get the one-shot Johnson & Johnson vaccine, which I was finally allowed to receive (without incident)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Significant Follow up added on 19-may-2021 added health care professional details, past medical history, event outcome On 27-Jul-2021: Follow up received with significant information: Allergic information, Medical History, Indications and  Events were added. The Action taken, Concomitant drug  and treatment drug  details were updated