Received Nov 14, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | — |
inflammation on her back legs; burning; she cannot sleep; shoulders were sore; itching; pain; scars that do not heal/scratch/scars everywhere; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching), PAIN (pain), SCAR (scars that do not heal/scratch/scars everywhere), INFLAMMATION (inflammation on her back legs) and BURNING SENSATION (burning) in a 54-year-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. Co-suspect product included non-company product Metformin hydrochloride (Metformin) for an unknown indication. Concurrent medical conditions included Type 2 diabetes mellitus. In December 2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started Metformin hydrochloride (Metformin) (unknown route) at an unspecified dose. In 2021, the patient experienced PRURITUS (itching), PAIN (pain) and SCAR (scars that do not heal/scratch/scars everywhere). On an unknown date, the patient experienced INFLAMMATION (inflammation on her back legs), BURNING SENSATION (burning), INSOMNIA (she cannot sleep) and ARTHRALGIA (shoulders were sore). The patient was treated with Cefalexin (Cephalexin) at a dose of 500 milligram and Diclofenac sodium (topical) at a dose of 1 % percent. At the time of the report, PRURITUS (itching), PAIN (pain), SCAR (scars that do not heal/scratch/scars everywhere), INFLAMMATION (inflammation on her back legs), BURNING SENSATION (burning), INSOMNIA (she cannot sleep) and ARTHRALGIA (shoulders were sore) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided. It was reported that the patient received the Moderna COVID-19 vaccine back in Dec-2020 while living at a homeless shelter as it was mandatory that she had to get it. The reporter stated that it looked like a slave master tied to a tree and whipped back and legs up really bad. The reporter stated that people with type 2 diabetes should not get the vaccine because the side effect was bad. The patient reported that it was cool for 5 weeks and then it started itching and every time she ate something it got itch, so she started to scratch, and all of a sudden it blew out. The reporter stated that she went to the emergency room and the doctor clinic and had given antibiotics and creams, but it did not help, and the pain was that much worse. The reporter stated that she had scars that do not heal. The reporter was given cephalexin 500mg capsule and Diclofenac sodium topical gel 1% but stated that it did not help. The reporter stated that she had bad inflammation on her back legs, and her shoulders were sore. She stated that she had scars everywhere and that she looks like a spotted-up leopard with scars that she did not scratch, and they busted and went down to the scar tissue. The reporter continued to experience pain. When she took Metformin, she stated that it really kicks it off and made the pain and the itching, burning and everything worse. The reporter stated that some days she could not sleep because the pain was too bad. No other details provided. It was unknown if the patient experienced any additional symptoms/events.
Type 2 diabetes mellitus
Metformin