Age: 0.75
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Angioedema, Device malfunction, Needle issue
Clinical narrative: automatic retracting needle and some of the vaccines leaked and got into the patient's legs; There was a mechanical error that occurred while she was being injected; anaphylaxis; This spontaneous case was reported by a physician and describes the occurrence of ANAPHYLACTIC REACTION (anaphylaxis) in a 9-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Jul-2022 at 9:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jul-2022, the patient experienced ANAPHYLACTIC REACTION (anaphylaxis) (seriousness criterion medically significant) and NEEDLE ISSUE (There was a mechanical error that occurred while she was being injected). On 05-Jul-2022 at 9:45 AM, the patient experienced ACCIDENTAL UNDERDOSE (automatic retracting needle and some of the vaccines leaked and got into the patient's legs). The patient was treated with EPINEPHRINE in 2022 for Anaphylaxis, at a dose of 1 dosage form; FAMOTIDINE in 2022 for Anaphylaxis, at a dose of 1 dosage form and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) in 2022 for Anaphylaxis, at a dose of 1 dosage form. At the time of the report, ANAPHYLACTIC REACTION (anaphylaxis), ACCIDENTAL UNDERDOSE (automatic retracting needle and some of the vaccines leaked and got into the patient's legs) and NEEDLE ISSUE (There was a mechanical error that occurred while she was being injected) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Reported that there was a mechanical error occurred, the vaccine provider used an automatic retracting needle and some of the vaccines leaked and got into the patient's legs. They were not sure how much of the original dose got in. On 05 Jul 2022, around 5:45pm, patient had dinner which consisted of salmon, shrimp, potatoes and dairy and asparagus, the patient had angioedema and hives. Also reported that patient had taken these food items before and did not have any allergies. It was not sure if the anaphylaxis was due to the vaccine or the food that the patient had for dinner. The patient was treated for anaphylaxis. Treatment medication includes steroid.  Company Comment: This spontaneous case concerns a 9-month-old female patient with no medical history reported, who experienced the expected serious (medically significant) event of Anaphylactic reaction which occurred on the same day after receiving the first dose of mRNA-1273 vaccine. Additionally, Accidental underdose and Needle issue are noted in the case as there was a mechanical error occurred, the vaccine provider used an automatic retracting needle and some of the vaccines leaked and got into the patient's legs. They were not sure how much of the original dose got in. After the dinner patient had angioedema and hives. Patient did not have any allergies. The patient was treated for anaphylaxis with steroids. No further details on clinical course, other lab test results were reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 9-month-old female patient with no medical history reported, who experienced the expected serious (medically significant) event of Anaphylactic reaction which occurred on the same day after receiving the first dose of mRNA-1273 vaccine. Additionally, Accidental underdose and Needle issue are noted in the case as there was a mechanical error occurred, the vaccine provider used an automatic retracting needle and some of the vaccines leaked and got into the patient's legs. They were not sure how much of the original dose got in. After the dinner patient had angioedema and hives. Patient did not have any allergies. The patient was treated for anaphylaxis with steroids. No further details on clinical course, other lab test results were reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.