Received Dec 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | — | OT |
| COVID19 | COVID19 (COVID19 (UNKNOWN)) | UNKNOWN MANUFACTURER | UNK | — | OT |
| DTAP | DTAP (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | OT |
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | UNK | — | OT |
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | OT |
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | OT |
inflamed under the skin; old acne-like bacterial infection; pimple that went bad and it was inflamed under the skin; covid; Initial information received on 03-Dec-2025 regarding an unsolicited valid non-serious courtesy case received from a consumer/non-healthcare professional via Moderna. This case involves an unknown age and unknown gender patient who experienced inflamed under the skin, old acne-like bacterial infection, pimple that went bad and it was inflamed under the skin and covid after receiving Varicella Zoster Vaccine, Rsv Vaccine, Spikevax 2024-2025 Formula [Covid-19 Vaccine Mrna Omicron (Kp.2) Moderna], Pfizer Biontech Covid-19 Vaccine, Diphtheria, Tetanus And Acellular Pertussis Vaccine And Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone]. The patient's past vaccination(s) included Spikevax [Covid-19 Vaccine Mrna Omicron (Jn.1) Moderna] with 3 doses administered on an unknown date and 1 on an unknown date in Jun-2022 and Pfizer Biontech Covid-19 Vaccine with 1 dose on an unknown date in SEP-2023 and 1 dose on an unknown date in OCT-2023. The patient's past medical history, medical treatment(s) and family history were not provided. On an unknown date, the patient received a dose of suspect Varicella Zoster Vaccine not produced by Sanofi Pasteur, RSV vaccine not produced by Sanofi Pasteur, Diphtheria, Tetanus And Acellular Pertussis Vaccine produced by unknown manufacturer (unknown form) and Influenza Usp Trival A-B Subvirion No Preservative Vaccine Suspension for injection (lot number, strength, dose and expiry not reported) via unknown route in unknown administration site as prophylactic vaccination. On an unknown date in Sep-2024, the patient received a dose of suspect Spikevax 2024-2025 Formula [Covid-19 Vaccine Mrna Omicron (Kp.2) Moderna] not produced by Sanofi Pasteur (lot number, strength, dose and expiry not reported) via intramuscular in unknown administration site as Covid-19 immunization. On 19-May-2025, the patient received a booster dose of suspect Pfizer BioNTech COVID-19 vaccine not produced by Sanofi Pasteur (lot number, strength, dose and expiry not reported) via unknown route in unknown administration site as Covid-19 immunization. There will be no information on batch number and expiration date corresponding to the one at time of event occurrence. On an unknown date the patient developed inflamed under the skin (dermatitis), old acne-like bacterial infection (skin bacterial infection) and pimple that went bad and it was inflamed under the skin (skin mass) (unknown latency). On 22-AUG-2025 the patient developed covid (covid-19) (Latency: 3 months 3 days) following the administration of Pfizer BioNTech COVID-19 vaccine, (latency: 11 months approximately) following the administration of Spikevax 2024-2025 Formula [Covid-19 Vaccine Mrna Omicron (Kp.2) Moderna] and (unknown latency) following other suspects. It was reported, "The reporter states that there was an infection under the skin, like a pimple that went bad and it was inflamed under the skin, so the reporter went to the dermatologist last Thursday (13-Nov-2025) and received treatment. The reporter states that it had nothing to do with COVID or Moderna. The reporter 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 is kicking in and the reporter states that the mass is going way down in size. The reporter stated that the shared event had nothing to do with COVID, No other details were provided." Action taken: not applicable. Treatment: The patient was treated with Nirmatrelvir, Ritonavir (Paxlovid) for COVID-19 and single steroid shot and an antibiotic for other events. At time of reporting, the outcome was Recovering / Resolving for the event pimple that went bad and it was inflamed under the skin and was unknown for the other events.