Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Palatal swelling, Paraesthesia oral, Pharyngeal paraesthesia, Pharyngeal swelling
Clinical narrative: went into anaphylaxis/recurrent anaphylaxis/she ended up in the ER with anaphylaxis; recurrent angioedema of tongue; recurrent hives/Hives on the hands and feet are constant/Hives on face are less persistent; her tongue swells; her throat swells; her palate swells; she will have tachycardia; high blood pressure; magnesium injection to reduce inflammation of throat lungs and tongue; 7 minutes and 36 seconds later, her tongue palate and throat was itching; 7 minutes and 36 seconds later, her tongue palate and throat was tingling.; 7 minutes and 36 seconds later, her tongue palate and throat was tingling.; 7 minutes and 36 seconds later, her tongue palate and throat was itching; eczema of hands and feet; makes her very nauseous,; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (went into anaphylaxis/recurrent anaphylaxis/she ended up in the ER with anaphylaxis) and ANGIOEDEMA (recurrent angioedema of tongue) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Migraine (Shots for Migraines) and Thyroid disorder (c3c4 compound for thyroid). Concomitant products included LISDEXAMFETAMINE MESILATE (VYVANSE), LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL), FORMOTEROL FUMARATE, MOMETASONE FUROATE (DULERA), SALBUTAMOL SULFATE (VENTOLIN HFA), BUDESONIDE (NASOCORT), CLONIDINE, CALCIUM, MAGNESIUM and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced ANAPHYLACTIC REACTION (went into anaphylaxis/recurrent anaphylaxis/she ended up in the ER with anaphylaxis) (seriousness criteria hospitalization, medically significant and life threatening), ANGIOEDEMA (recurrent angioedema of tongue) (seriousness criterion medically significant), URTICARIA (recurrent hives/Hives on the hands and feet are constant/Hives on face are less persistent), SWOLLEN TONGUE (her tongue swells), PHARYNGEAL SWELLING (her throat swells), PALATAL SWELLING (her palate swells), TACHYCARDIA (she will have tachycardia), HYPERTENSION (high blood pressure), PNEUMONITIS (magnesium injection to reduce inflammation of throat lungs and tongue), TONGUE PRURITUS (7 minutes and 36 seconds later, her tongue palate and throat was itching), PHARYNGEAL PARAESTHESIA (7 minutes and 36 seconds later, her tongue palate and throat was tingling.), ECZEMA (eczema of hands and feet) and NAUSEA (makes her very nauseous,). 16-Mar-2021, the patient experienced PARAESTHESIA ORAL (7 minutes and 36 seconds later, her tongue palate and throat was tingling.) and THROAT IRRITATION (7 minutes and 36 seconds later, her tongue palate and throat was itching). The patient was hospitalized on 19-Mar-2021 due to ANAPHYLACTIC REACTION. The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of UNK, qd; HYDROXYZINE for Adverse event, at an unspecified dose and frequency; LEVOCETIRIZINE DIHYDROCHLORIDE (ALLEGRA [LEVOCETIRIZINE DIHYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency; LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) for Adverse event, at an unspecified dose and frequency; PREDNISONE for Adverse event, at a dose of intermittently prednisone dose packs; DEXAMETHASONE ACETATE (DECADRON [DEXAMETHASONE ACETATE]) for Adverse event, at an unspecified dose and frequency; MAGNESIUM for Inflammation, at an unspecified dose and frequency; ONDANSETRON (ZOFRAN [ONDANSETRON]) for Nausea, at an unspecified dose and frequency; ALBUTEROL [SALBUTAMOL] for Adverse event, at an unspecified dose and frequency; CLOBETASOL for Eczema, at an unspecified dose and frequency; LEVOSALBUTAMOL HYDROCHLORIDE (XOPENEX) for Adverse event, at an unspecified dose and frequency; EPINEPHRINE (EPIPEN) for Adverse event, at a dose of Oncne or two a month; ZAFIRLUKAST (ACCOLATE) for Adverse event, at a dose of 20 milligram twice a day; FAMOTIDINE for Adverse event, at a dose of UNK, bid; FAMOTIDINE for Adverse event, at a dose of UNK UNK, qd and OMALIZUMAB (XOLAIR) for Hives, at an unspecified dose and frequency. At the time of the report, ANAPHYLACTIC REACTION (went into anaphylaxis/recurrent anaphylaxis/she ended up in the ER with anaphylaxis), ANGIOEDEMA (recurrent angioedema of tongue), URTICARIA (recurrent hives/Hives on the hands and feet are constant/Hives on face are less persistent), SWOLLEN TONGUE (her tongue swells), PHARYNGEAL SWELLING (her throat swells), PALATAL SWELLING (her palate swells), TACHYCARDIA (she will have tachycardia), HYPERTENSION (high blood pressure) and NAUSEA (makes her very nauseous,) had not resolved and PNEUMONITIS (magnesium injection to reduce inflammation of throat lungs and tongue), TONGUE PRURITUS (7 minutes and 36 seconds later, her tongue palate and throat was itching), PARAESTHESIA ORAL (7 minutes and 36 seconds later, her tongue palate and throat was tingling.), PHARYNGEAL PARAESTHESIA (7 minutes and 36 seconds later, her tongue palate and throat was tingling.), THROAT IRRITATION (7 minutes and 36 seconds later, her tongue palate and throat was itching) and ECZEMA (eczema of hands and feet) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, Blood pressure measurement: high (High) high blood pressure.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications also include Birth control, shots for migraine and c3c4 compound for thyroid.  The patient went into anaphylaxis. The next day patient ended up in the ER with anaphylaxis again. 2 days later, on 19-Mar-2021 patient was in the ER and hospitalized for 5 days again. Since seeing the allergist, patient ended up in the ER multiple times, last time in the ER for anaphylaxis was Friday 3-Dec-2021. Patient was not recovered from ER visits on Friday. Patient had severe anaphylaxis reactions.  Patient would not receive second shot.  Received Xolair injection to try to stop the hives (does not work).; Sender's Comments: This case concerns a 47-year-old, female patient with no relevant medical history, who experienced the unexpected events of Anaphylactic Reaction and Angioedema. The events occurred approximately 1 day after the first dose of mRNA-1273 (Moderna covid-19 vaccine). The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.