Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Allergy test, Anaphylactic reaction
Clinical narrative: Anaphylactic reaction clarified as facial swelling, difficulty breathing and eye swelling; Anaphylactic reaction; Anaphylactic reaction; Anaphylactic reaction; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic reaction clarified as facial swelling, difficulty breathing and eye swelling), the first episode of ANAPHYLACTIC REACTION (Anaphylactic reaction), the second episode of ANAPHYLACTIC REACTION (Anaphylactic reaction) and the third episode of ANAPHYLACTIC REACTION (Anaphylactic reaction) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction clarified as facial swelling, difficulty breathing and eye swelling) (seriousness criterion medically significant), the first episode of ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criterion medically significant), the second episode of ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criterion medically significant) and the third episode of ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criterion medically significant). The patient was treated with EPINEPHRINE for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, ANAPHYLACTIC REACTION (Anaphylactic reaction clarified as facial swelling, difficulty breathing and eye swelling) and the last episode of ANAPHYLACTIC REACTION (Anaphylactic reaction) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Allergy test: negative (Negative) Negative.  Three days after second shot on an unknown date, the patient was drinking coffee and went into anaphylaxis, clarified as facial swelling, difficulty breathing and eye swelling.The same thing happened the following week, eyes swollen, anaphylaxis and went to ER. He had two more episodes since then. The patient was sent home with an epinephrine pen. All allergy testing to coffee or other things he was exposed to were negative. Reporter stated it was poisoning him and was sure that one day he will be a causality. Both the specialist and his primary care doctor have said that it was a reaction to the Moderna vaccine.  No concomitant details were reporter.  Company Comment - This case concerns a 35 year-old male patient with no reported medical history, who experienced the expected serious events of Anaphylactic reaction (x4). The event occurred on multiple occasions at an unknown number of days after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 35 year-old male patient with no reported medical history, who experienced the expected serious events of Anaphylactic reaction (x4). The event occurred on multiple occasions at an unknown number of days after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.