Received Jul 16, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19-2 | COVID19 (COVID19 (MODERNA BIVALENT)) | MODERNA | UNK | 055F22B | IM |
I think I am dying from this vaccine; experiencing "hives" since June 2024 / Chronic spontaneous hives; This spontaneous case was reported by a consumer and describes the occurrence of NEAR DEATH EXPERIENCE (I think I am dying from this vaccine) in a 66-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 055F22B) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Previously administered products included for Drug use for unknown indication: Tylenol (Patient took a couple of Tylenol and felt better). Past adverse reactions to the above products included No adverse effect with Tylenol. On 09-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular use) 1 dosage form. In June 2024, the patient experienced URTICARIA CHRONIC (experiencing "hives" since June 2024 / Chronic spontaneous hives). On an unknown date, the patient experienced NEAR DEATH EXPERIENCE (I think I am dying from this vaccine) (seriousness criterion medically significant). The patient was treated with Prednisone at an unspecified dose and frequency. At the time of the report, NEAR DEATH EXPERIENCE (I think I am dying from this vaccine) and URTICARIA CHRONIC (experiencing "hives" since June 2024 / Chronic spontaneous hives) outcome was unknown. No concomitant medications were reported. The reporter received her first Moderna COVID-19 vaccine in Dec-2020. After the first injection, her injection site arm was very sore. She received her second Moderna COVID-19 vaccine in Jan-2021, and she experienced a sore injection site arm, fatigue, headache, muscle pain, and joint pain. These effects lasted for 24 hours. In Nov-2021, she received her booster dose of the Moderna COVID-19 vaccine in her right arm shoulder deltoid muscle as an intramuscular injection. After the booster, she had a sore right arm, chills, a fever of 101 degrees Fahrenheit, teeth chattering from feeling extremely cold, and a swollen right arm. It was reported that the reporter had experienced hives since Jun-2024, which she associated from her Moderna Covid-19 vaccine doses. She mentioned that she received vaccine shots except in 2025 and reported that the vaccination information she had was old. However, she was not able to provide the complete information regarding her doses. She reported that she reached out to multiple specialists, including an oncologist, rheumatologist, and allergist. She also mentioned that antihistamines and prednisone did not help her to treat the hives. She reported that she was not properly informed of the side-effects she may experience after receiving the vaccine. She was experienced awful symptoms and stated that she thought that it was killing her and she thought she was dying from that vaccine. She also added that her dermatologist, allergist, rheumatologist, and family doctor said that she had Chronic spontaneous hives. It was unknown if the patient experienced any additional symptoms or events. This case was linked to MOD-2022-516527 (Patient Link).; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.