Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Oropharyngeal discomfort, Pain, Pain in extremity, Pruritus
Clinical narrative: Angioedema; thirsty; tongue was swelling up; couldn't talk; couldn't swallow; flaming hives around rectal area; felt like a poker was on my hand; a hive showed up between my middle and index finger and on my palm which was itchy and sore; no stamina; totally wiped out; lethargic; left arm reacted immediately after vaccine; puffy, itchy and warm arm; puffy, itchy and warm arm; feels like it is in my lymps, like an infection; general body aches; fever of 100.7; i developed a rash travelled down my arm; puffy, itchy and warm arm; This spontaneous case was reported by a nurse and describes the occurrence of ANGIOEDEMA (Angioedema) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to chemicals (allergic to sulphur medications) and Hypothyroidism since 2003. Concomitant products included LEVOTHYROXINE SODIUM (THYROXINE) from 03-Oct-2011 to an unknown date and MAGNESIUM CITRATE, THYROID (THYTROPHIN PMG) from 20-Mar-2021 to an unknown date for Hypothyroidism, VITAMIN D NOS from 20-Mar-2020 to an unknown date for an unknown indication.    On 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced VACCINATION SITE REACTION (left arm reacted immediately after vaccine), SKIN SWELLING (puffy, itchy and warm arm), SKIN WARM (puffy, itchy and warm arm), PRURITUS (puffy, itchy and warm arm), INFECTION (feels like it is in my lymps, like an infection), PAIN (general body aches), RASH (i developed a rash travelled down my arm) and PYREXIA (fever of 100.7). On 07-Apr-2021, the patient experienced LETHARGY (lethargic), FATIGUE (no stamina) and FATIGUE (totally wiped out). On 08-Apr-2021, the patient experienced PAIN IN EXTREMITY (felt like a poker was on my hand) and URTICARIA (a hive showed up between my middle and index finger and on my palm which was itchy and sore). On 09-Apr-2021, the patient experienced THIRST (thirsty), SWOLLEN TONGUE (tongue was swelling up), DYSPHAGIA (couldn't swallow), OROPHARYNGEAL DISCOMFORT (couldn't talk) and URTICARIA (flaming hives around rectal area). On an unknown date, the patient experienced ANGIOEDEMA (Angioedema) (seriousness criterion medically significant). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of high dose; METHYLPREDNISOLONE SODIUM SUCCINATE (SOLUMEDROL) for Adverse event, at a dose of high dose; FAMOTIDINE (PEPCID [FAMOTIDINE]) (intravenous) for Adverse event, at a dose of high dose and IBUPROFEN for Pain, at an unspecified dose and frequency. On 06-Apr-2021, PYREXIA (fever of 100.7) had resolved. On 07-Apr-2021, PAIN (general body aches) had resolved. On 08-Apr-2021, LETHARGY (lethargic), FATIGUE (no stamina) and FATIGUE (totally wiped out) had resolved. On 09-Apr-2021, THIRST (thirsty), SWOLLEN TONGUE (tongue was swelling up), DYSPHAGIA (couldn't swallow), OROPHARYNGEAL DISCOMFORT (couldn't talk), PAIN IN EXTREMITY (felt like a poker was on my hand), URTICARIA (a hive showed up between my middle and index finger and on my palm which was itchy and sore) and URTICARIA (flaming hives around rectal area) had resolved. At the time of the report, ANGIOEDEMA (Angioedema), VACCINATION SITE REACTION (left arm reacted immediately after vaccine), SKIN SWELLING (puffy, itchy and warm arm), SKIN WARM (puffy, itchy and warm arm), PRURITUS (puffy, itchy and warm arm), INFECTION (feels like it is in my lymps, like an infection) and RASH (i developed a rash travelled down my arm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Apr-2021, Body temperature: 100.7 (High) Fever of 100.7.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   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.   This case was linked to MOD-2021-073779 (Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Follow-up received on 09-JUL-2021 and contains significant information updated patient demographics, past medical history, vaccine start date, route of administration, concomitant and treatment medications, updated events and event outcomes; 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.