Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Blood immunoglobulin G, Skin test
Clinical narrative: Anaphylactic reaction; This literature-non-study case was reported in a literature article and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic reaction) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE:(privacy) The patient's past medical history included Anaphylaxis. Concurrent medical conditions included Allergic rhinitis (Atopic History: Allergic rhinitis), Food allergy (Atopic History: tree nut allergy), Asthma (Atopic History: Asthma), Allergy to venom (Atopic History: Venom allergy), Hay fever and Hypersensitivity reaction. Concomitant products included BUDESONIDE for Asthma, ETHINYLESTRADIOL, FERROUS FUMARATE, NORETHISTERONE ACETATE (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE) for Oral contraceptive, CETIRIZINE HYDROCHLORIDE (CETRIZINE) for Rhinitis.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criterion medically significant). The patient was treated with DIPHENHYDRAMINE for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Nausea, at a dose of 25 milligram. On 15-Jan-2021, ANAPHYLACTIC REACTION (Anaphylactic reaction) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood immunoglobulin G: 16.85 16.85. On an unknown date, Skin test: positive (Positive) Positive Skin Test Component : Vaccine (Intradermal).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ANAPHYLACTIC REACTION (Anaphylactic reaction) to be related.    The weight of the patient was provided to be 155 (unit not provided).  The route for budesonide was provided as inhalational.  Patient experienced symptoms of generalized itching/pruritus, generalized hives/urticaria and nausea.  Within 15 minutes of Moderna vaccine, patient had hives on neck, chest, back, associated itching and took celritin 10mg without initial improvement.  The symptoms resolved within 1 hour.  Patient had convincing objective and subjective histories of immediate hypersensitivity reactions and received dose 2 through a graded administration protocol.  mRNA COVID-19 Vaccine Given Every 15 Minutes was as follows: Step 1- 0.05 mL of 1:10 dilution, Step 2-0.05 mL of full strength, Step 3-0.1 mL of full strength, Step 4-0.15 mL of full strength and Step 5-0.2 mL of full strength. Company comment This case concerns a 32-year-old female patient, with medical history of Anaphylaxis, Allergic rhinitis, Food allergy, Asthma, Allergy to venom, Hay fever and Hypersensitivity reaction, who experienced the expected serious event of ANAPHYLACTIC REACTION.  The event occurred 15 minutes after the administration of the first dose of mRNA-1273 vaccine. The patient was treated with DIPHENHYDRAMINE. Event resolved within 1 hour. Patient´s medical history of Anaphylaxis, Allergic rhinitis, Food allergy, Asthma, Allergy to venom, Hay fever and Hypersensitivity reaction, remains as contributing factors for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-409797, MOD-2021-409799, MOD-2021-409803, MOD-2021-409801, MOD-2021-409802, MOD-2021-409800, MOD-2021-409798 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jan-2022: Follow-up received by safety on 14-Jan-2022 includes Vaccine Hypersensitivity/Anaphylaxis Follow-up Form which contains significant information- Case seriousness was upgraded to serious,patient details were updated final diagnosis was reported, event was updated.; Sender's Comments: This case concerns a 32-year-old female patient, with medical history of Anaphylaxis, Allergic rhinitis, Food allergy, Asthma, Allergy to venom, Hay fever and Hypersensitivity reaction, who experienced the expected serious event of ANAPHYLACTIC REACTION.  The event occurred 15 minutes after the administration of the first dose of mRNA-1273 vaccine. The patient was treated with DIPHENHYDRAMINE. Event resolved within 1 hour. Patient´s medical history of Anaphylaxis, Allergic rhinitis, Food allergy, Asthma, Allergy to venom, Hay fever and Hypersensitivity reaction, remains as contributing factors for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.