Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue, Vaccination site pruritus
Clinical narrative: not feeling well; upset stomach/sour stomach/not feeling well; did not realize her throat was closing up; cold sweats; very bad aches; left side of face is swollen; Lips puffy; two big itchy welts in the left arm; tongue was swelling/tongue puffy; Her vaccine was given as a half dose in the right arm and the other half dose was given in the left arm, both given in the upper arm.; allergic reaction; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INCORRECT DOSE ADMINISTERED (Her vaccine was given as a half dose in the right arm and the other half dose was given in the left arm, both given in the upper arm.), SWOLLEN TONGUE (tongue was swelling/tongue puffy), FEELING ABNORMAL (not feeling well), ABDOMINAL DISCOMFORT (upset stomach/sour stomach/not feeling well) and SENSATION OF FOREIGN BODY (did not realize her throat was closing up) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0041991) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Immunodeficiency, Migraine and Thyroid disorder. Concomitant products included ERENUMAB AOOE (AIMOVIG [ERENUMAB AOOE]) for Migraine, NIMESULIDE, PARACETAMOL (NP [NIMESULIDE;PARACETAMOL]), PANTOPRAZOLE, BUPROPION, ESTRADIOL, IMMUNOGLOBULIN HUMAN NORMAL (GAMUNEX) and EPINEPHRINE (EPIPEN) for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced INCORRECT DOSE ADMINISTERED (Her vaccine was given as a half dose in the right arm and the other half dose was given in the left arm, both given in the upper arm.) and HYPERSENSITIVITY (allergic reaction). On 08-Apr-2021, the patient experienced SWOLLEN TONGUE (tongue was swelling/tongue puffy) and VACCINATION SITE PRURITUS (two big itchy welts in the left arm). On 09-Apr-2021, the patient experienced LIP SWELLING (Lips puffy). On an unknown date, the patient experienced FEELING ABNORMAL (not feeling well), ABDOMINAL DISCOMFORT (upset stomach/sour stomach/not feeling well), SENSATION OF FOREIGN BODY (did not realize her throat was closing up), COLD SWEAT (cold sweats), PAIN (very bad aches) and SWELLING FACE (left side of face is swollen). At the time of the report, INCORRECT DOSE ADMINISTERED (Her vaccine was given as a half dose in the right arm and the other half dose was given in the left arm, both given in the upper arm.) had resolved and SWOLLEN TONGUE (tongue was swelling/tongue puffy), FEELING ABNORMAL (not feeling well), ABDOMINAL DISCOMFORT (upset stomach/sour stomach/not feeling well), SENSATION OF FOREIGN BODY (did not realize her throat was closing up), COLD SWEAT (cold sweats), LIP SWELLING (Lips puffy), HYPERSENSITIVITY (allergic reaction), PAIN (very bad aches), SWELLING FACE (left side of face is swollen) and VACCINATION SITE PRURITUS (two big itchy welts in the left arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Mar-2021, Skin test: negative (Negative) The allergy skin test had no reaction to the Moderna COVID-19 Vaccine..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessment. Treatment information was not provided.