Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dyspnoea, Feeling abnormal, Malaise, Urticaria
Clinical narrative: sort of an anaphylactic reaction; felt crummy; had hives; trouble breathing; felt really bad; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (sort of an anaphylactic reaction) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Flu shot (A couple of weeks ago the patient got the flue shot (FluRX) and 15 minutes after the shot had a similar reaction to the first dose of the Moderna vaccine. Patient felt really bad. They took Benadryl and ibuprofen after that). Past adverse reactions to the above products included Hives with Flu shot. Concurrent medical conditions included Seasonal allergy. Concomitant products included ORAL CONTRACEPTIVE NOS for Birth control, MULTIVITAMIN [VITAMINS NOS] and FISH OIL for an unknown indication.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANAPHYLACTIC REACTION (sort of an anaphylactic reaction) (seriousness criterion medically significant), MALAISE (felt crummy), URTICARIA (had hives), DYSPNOEA (trouble breathing) and FEELING ABNORMAL (felt really bad). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency; FAMOTIDINE (PEPCID [FAMOTIDINE]) for Adverse event, at an unspecified dose and frequency; METHYLPREDNISOLONE SODIUM SUCCINATE (SOLUMEDROL) for Adverse event, at an unspecified dose and frequency and METHYLPREDNISOLONE for Adverse event, at an unspecified dose and frequency. At the time of the report, ANAPHYLACTIC REACTION (sort of an anaphylactic reaction), MALAISE (felt crummy), URTICARIA (had hives), DYSPNOEA (trouble breathing) and FEELING ABNORMAL (felt really bad) outcome was unknown.     Patient reported that after second dose she experienced sort of an anaphylactic reaction, the patient had hives and trouble breathing and couple of weeks ago Patient received flue shot 15 minutes after the shot had a similar reaction to the first dose of the Moderna vaccine. She took  Benadryl and ibuprofen as a treatment. Patient received steroids like solumedrol and Methylprednisolone and fluids as a treatment.  Company Comment - This is a spontaneous case concerning a 38 years old, female patient with clinical history of several allergies who experienced the unexpected events of MALAISE, URTICARIA, DYSPNOEA, FEELING ABNORMAL and the expected (AESI) event of  ANAPHYLACTIC REACTION The events occurred unknown days after the second dose of mRNA-1273 vaccine The rechallenge was not applicable since only information about the second dose was disclosed  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-382163 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 38 years old, female patient with clinical history of several allergies who experienced the unexpected events of MALAISE, URTICARIA, DYSPNOEA, FEELING ABNORMAL and the expected (AESI) event of  ANAPHYLACTIC REACTION The events occurred unknown days after the second dose of mRNA-1273 vaccine The rechallenge was not applicable since only information about the second dose was disclosed  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.