Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Angioedema; flu; Redness local; hot around the injection site; Chills; Swollen itchy arm; Left arm got hot; Hypersensititivy reaction; Became a raised oval around the shot site/swollen and hot around the injection site; Dry cough; Nasal drainage; Nausea; Fever; Sore arm; Fatigue; This spontaneous case was reported by a physician and describes the occurrence of ANGIOEDEMA (Angioedema), COUGH (Dry cough), RHINORRHOEA (Nasal drainage), HYPERSENSITIVITY (Hypersensititivy reaction) and INFLUENZA (flu) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hay fever, Dermatographia in 1958, Peripheral neuropathy in 2003, Osteoporosis in 2018 and Thyroiditis. Concurrent medical conditions included Hypothyroidism since 1983, Migraine headache since 2007, Drug allergy (Meloxicam, Bisphosphonates bb), Drug eruption (Mobic) since 2000, Drug allergy (Actonel (flu-like symptoms)) since 2018, Asthma, Hives and Urticaria. Concomitant products included FISH OIL (OMEGA-3 FISH OIL) for Antiinflammatory therapy, CURCUMA LONGA (TURMERIC) for Antioxidant therapy, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, SUMATRIPTAN (IMITREX) for Migraine headache, CALCIUM and COLECALCIFEROL (VIT D) for Osteoporosis, DOXYLAMINE SUCCINATE for Sleep disorder.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced MYALGIA (Sore arm) and FATIGUE (Fatigue). On 26-Feb-2021, the patient experienced COUGH (Dry cough), RHINORRHOEA (Nasal drainage), NAUSEA (Nausea) and PYREXIA (Fever). On 27-Feb-2021, the patient experienced VACCINATION SITE SWELLING (Became a raised oval around the shot site/swollen and hot around the injection site). On 28-Feb-2021, the patient experienced HYPERSENSITIVITY (Hypersensititivy reaction), SKIN WARM (Left arm got hot) and PRURITUS (Swollen itchy arm). On an unknown date, the patient experienced ANGIOEDEMA (Angioedema), INFLUENZA (flu), ERYTHEMA (Redness local), VACCINATION SITE WARMTH (hot around the injection site) and CHILLS (Chills). The patient was treated with NAPROXEN SODIUM (ALEVE) (oral) 25-Feb-2021 for Adverse event, at an unspecified dose and frequency. On 28-Feb-2021, MYALGIA (Sore arm), FATIGUE (Fatigue), NAUSEA (Nausea) and PYREXIA (Fever) had resolved. On 01-Mar-2021, COUGH (Dry cough) and RHINORRHOEA (Nasal drainage) had resolved. On 04-Mar-2021, HYPERSENSITIVITY (Hypersensititivy reaction), SKIN WARM (Left arm got hot), PRURITUS (Swollen itchy arm) and VACCINATION SITE SWELLING (Became a raised oval around the shot site/swollen and hot around the injection site) had resolved. At the time of the report, ANGIOEDEMA (Angioedema), INFLUENZA (flu), ERYTHEMA (Redness local), VACCINATION SITE WARMTH (hot around the injection site) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Feb-2021, Body temperature: 101 (High) 101°F. On 26-Feb-2021, Body temperature: 100 (High) 100°F. On 28-Feb-2021, Body temperature: 99 (High) 99°F. On 01-Mar-2021, Body temperature: 98.6 (normal) 98.6°F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Four days after the shot, the patient's left arm got hot and within a matter of hours it became a raised oval around the shot site about 4 inches in length and 3 inches in diameter. The symptoms peaked by day five and then over the next 3 days they resolved completely.  The patient had low grade fever with the first shot but did not measure it.  The patient developed a cough with both shots, which left as soon as the fever broke in both cases. Both shots made felt had the flu and was extremely tired with both shots. The arm hurt with both shots, but only became swollen and hot around the injection site with the second shot. The first shot site did not itch at all but the second shot site did. The patient experienced very low grade nausea on day 2 and 3 after both shots. The nose ran profusely while had the cough and stopped when the cough stopped. The drainage was clear had no sneezing.  The patient ticked angioedema on the follow-up form in the section "Please indicate all signs and symptoms experienced by the patient".   Although this is listed as an important medical event, the event was downgraded as it was not reported spontaneously.  Also, the patient did not receive medical attention or treatment for that event.   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 29-Apr-2021: Follow-up information received on 29-Apr-2021 will be processed with initial report. Follow-up information updated patient demographics, patient history, concomitant medications and events. On 22-Jun-2021: Medical history, treatment medication, labs, concomitant medication, and new events (angioedema, flu, hot around the injection site, became a raised oval around the shot site/swollen and hot around the injection site, and chills) were added.