Received Dec 2, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | — |
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 6 | — | — |
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | UNK | — | — |
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
| TDAP | TDAP (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
pimple that went bad and it was inflamed under the skin; plain old acne-like bacterial infection; inflamed under the skin; This spontaneous case was reported by a consumer and describes the occurrence of SKIN MASS (pimple that went bad and it was inflamed under the skin), SKIN INFECTION (plain old acne-like bacterial infection) and DERMATITIS (inflamed under the skin) in a 68-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Co-suspect products included non-company products Tozinameran (Pfizer BioNTech COVID-19 vaccine) for an unknown indication, RSV vaccine for an unknown indication, Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (Tdap) for an unknown indication and Influenza vaccine (Fluzone) for an unknown indication. No Medical History information was reported. In June 2022, the patient received fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. In September 2023, the patient received fifth dose of Tozinameran (Pfizer BioNTech COVID-19 vaccine) (unknown route) 1 dosage form. In October 2023, received sixth dose of Tozinameran (Pfizer BioNTech COVID-19 vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2024, received seventh dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form On an unknown date, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form and third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form., dose of RSV vaccine (unknown route) 1 dosage form, dose of Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (Tdap) (unknown route) 1 dosage form and dose of Influenza vaccine (Fluzone) (unknown route) 1 dosage form. On an unknown date, the patient experienced SKIN MASS (pimple that went bad and it was inflamed under the skin), SKIN INFECTION (plain old acne-like bacterial infection) and DERMATITIS (inflamed under the skin). At the time of the report, SKIN MASS (pimple that went bad and it was inflamed under the skin) was resolving and SKIN INFECTION (plain old acne-like bacterial infection) and DERMATITIS (inflamed under the skin) had resolved. No concomitant medication was reported. The patient received the shingles, RSV, Tdap, and Fluzone vaccines. He received a steroid shot for inflammation and had received COVID vaccines in the past. There was an infection under the skin, like a pimple that went bad, and it was inflamed under the skin. It had nothing to do with COVID or Moderna. The patient continued to describe that it was a plain old acne-like bacterial infection that got carried away and did not resolve on its own. The steroid shot was to try and take the inflammation down, which was somewhat effective that day (Thursday), but the antibiotic was kicking in, and the mass was definitely way down in size. He had received both Pfizer and Moderna COVID vaccines, his last booster dose being Pfizer on 19-May-2025. The patient had caught COVID in late August, Friday 22-Aug-2025, and was given Paxlovid. The steroid shot had nothing to do with COVID. No other details were provided. It was unknown if the patient experienced any additional symptoms/events. The patient went to the dermatologist last Thursday and received a single steroid shot and an antibiotic. This case was linked to MOD-2025-791591 (Patient Link).