Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactoid reaction, Blood pressure measurement, Body temperature, Dysphonia, Ear, nose and throat examination
Clinical narrative: acute allergic reaction; Acute anaphylactoid type reaction; Throat swelling; Redness around neck; HIves/Urticaria; Swelling of upper airway; Sensation of throat closing; Hoarseness; This spontaneous case was reported by a nurse and describes the occurrence of HYPERSENSITIVITY (acute allergic reaction) and ANAPHYLACTOID REACTION (Acute anaphylactoid type reaction) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Acute conjunctivitis, Cough and Dysphagia. Concurrent medical conditions included Hypothyroidism, Drug allergy (Allergy to Amoxicillin - Diarrhea), Drug allergy (Allergy to Codeine - nausea and vomiting), Sulfonamide allergy (Hives), Drug allergy (Tetracycline), Drug allergy (Zithromax), Latex allergy, Alcohol use (occasional) and Caffeine consumption (moderate). Concomitant products included LEVOTHYROXINE for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced HYPERSENSITIVITY (acute allergic reaction) (seriousness criterion intervention required), ANAPHYLACTOID REACTION (Acute anaphylactoid type reaction) (seriousness criterion medically significant), PHARYNGEAL SWELLING (Throat swelling), ERYTHEMA (Redness around neck), URTICARIA (HIves/Urticaria), SWELLING (Swelling of upper airway), THROAT TIGHTNESS (Sensation of throat closing) and DYSPHONIA (Hoarseness). The patient was treated with LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) (oral) on 17-Mar-2021 at a dose of 5 mg once a day; FAMOTIDINE (intravenous) on 17-Mar-2021 at a dose of 20 mg; SODIUM CHLORIDE (SODIUM CHLORIDE IV) (intravenous) on 17-Mar-2021 at a dose of 1 LNS; METHYLPREDNISOLONE SODIUM SUCCINATE (SOLUMEDROL) (intravenous) on 17-Mar-2021 at a dose of 125 mg; FAMOTIDINE (PEPCID [FAMOTIDINE]) (oral) on 17-Mar-2021 at a dose of 20 mg once a day and PREDNISONE (oral) on 17-Mar-2021 at a dose of 20 mg once a day. On 17-Mar-2021, HYPERSENSITIVITY (acute allergic reaction), ANAPHYLACTOID REACTION (Acute anaphylactoid type reaction), URTICARIA (HIves/Urticaria), SWELLING (Swelling of upper airway), THROAT TIGHTNESS (Sensation of throat closing) and DYSPHONIA (Hoarseness) had resolved. At the time of the report, PHARYNGEAL SWELLING (Throat swelling) and ERYTHEMA (Redness around neck) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, Blood pressure measurement: 193/100 (Inconclusive) sitting L arm. On 17-Mar-2021, Body temperature: 98.2 °F (Inconclusive) Temporal artery (36.78 degree Celsius). On 17-Mar-2021, Ear, nose and throat examination: inconclusive (Inconclusive) Right Ear & Left Ear: TM, Clear Nasopharynx: Clear Pharynx: Airway clear Tonsil: No Trismus or abscess and normal Neck: Supple and Trachea Midline.. On 17-Mar-2021, Heart rate: > 100 (High) Increased and 82 (normal) bpm regular. On 17-Mar-2021, Neurological examination: normal (normal) Intact and non-focal. On 17-Mar-2021, Oxygen saturation: 99 % (Inconclusive) room air at rest. On 17-Mar-2021, Respiratory rate: 18 (Inconclusive) 18.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient visited the clinic 1 hour after receiving the vaccine with throat swelling and redness around her neck. The patient was observed for an hour.   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. Concomitant Drug allergies conditions could be potentially co-suspects for the events.   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Lab data, treatment, outcome of event, patient identifiers, events and medical history were updated.; 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. Concomitant Drug allergies conditions could be potentially co-suspects for the events.