Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus, Pyrexia, Urticaria
Clinical narrative: Anaphylactic shock; full blown hives to the chest, shoulders, and arms, thighs, and ultimately having hives on face/ hives progressing and getting worse; Itchy hives; red marks; Flu like symptoms; aches; Fever/ low grade fever; Fatigue; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC SHOCK (Anaphylactic shock) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) for Atopic dermatitis.    Concurrent medical conditions included Eczema. Concomitant products included FLUTICASONE FUROATE (ARNUITY ELLIPTA), UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (ANORO) and MONTELUKAST for an unknown indication.   In 2019, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) 300 mg once a day. In September 2019, DUPILUMAB (DUPIXENT) (Subcutaneous) dosage was changed to 300 mg. On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (aches), PYREXIA (Fever/ low grade fever), FATIGUE (Fatigue) and NAUSEA (Nausea). On 19-Mar-2021, the patient experienced PRURITUS (Itchy hives) and ERYTHEMA (red marks). On 19-Mar-2021 at 9:00 PM, the patient experienced URTICARIA (full blown hives to the chest, shoulders, and arms, thighs, and ultimately having hives on face/ hives progressing and getting worse). On 21-Mar-2021, the patient experienced ANAPHYLACTIC SHOCK (Anaphylactic shock) (seriousness criterion medically significant). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) on 21-Mar-2021 for Urticaria, at a dose of 1 dosage form; PREDNISONE on 21-Mar-2021 for Urticaria, at a dose of 50 mg and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Fever, Fatigue, Nausea, Flu like symptoms and Ache, at an unspecified dose and frequency. On 15-Mar-2021, INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (aches), PYREXIA (Fever/ low grade fever), FATIGUE (Fatigue) and NAUSEA (Nausea) had resolved. At the time of the report, ANAPHYLACTIC SHOCK (Anaphylactic shock), PRURITUS (Itchy hives) and URTICARIA (full blown hives to the chest, shoulders, and arms, thighs, and ultimately having hives on face/ hives progressing and getting worse) outcome was unknown and ERYTHEMA (red marks) had resolved.            Patient experienced anaphylactic shock, got itchy hives described noticing red marks, hives progressing and getting worse, full blown hives to the chest, shoulders, and arms, thighs, and ultimately having hives on face, flu like symptoms, fatigue, low grade fever and aches and pains, while she was treated with dupilumab [Dupixent] delivered via dupilumab prefilled syringe.  Action taken with mRNA-1273 in response to the event was not applicable .  Company Comment: Based on the current available information which shows a strong temporal association between the use of mRNA-1273 and the onset of the reported events, a causal relationship cannot be excluded. Anaphylaxis, fever, fatigue and nausea are consistent with the product known safety profile.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Added new historical condition, treatment and events. Added new serious event anaphylactic shock.; Sender's Comments: Based on the current available information which shows a strong temporal association between the use of mRNA-1273 and the onset of the reported events, a causal relationship cannot be excluded. Anaphylaxis, fever, fatigue and nausea are consistent with the product known safety profile.