Received Dec 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
inflammed under the skin; old acne-like bacterial infection; pimple that went bad and it was inflamed under the skin; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): US-MO-MOC20251120000002 (Moderna Therapeutics), MOD-2025-791587 (Moderna Therapeutics). A patient (age and gender not provided) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 19May2025 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; COVID-19 vaccine mrna omicron (kp.2) moderna (SPIKEVAX 2024-2025 FORMULA [COVID-19 VACCINE MRNA OMICRON (KP.2) MODERNA]), in Sep2024 as dose 7 (booster), single intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Varicella zoster vaccine (DOSE NUMBER UNKNOWN; MANUFACTURER UNKNOWN), for Immunization; Rsv vaccine (DOSE NUMBER UNKNOWN; MANUFACTURER UNKNOWN), for Immunization; Tdap vaccine (DOSE NUMBER UNKNOWN; MANUFACTURER UNKNOWN), for Immunization; Fluzone [influenza vaccine] (DOSE NUMBER UNKNOWN), for Immunization; Moderna (DOSE 1), for Covid-19 Immunization; Moderna (DOSE 2), for Covid-19 Immunization; Moderna (DOSE 3 (BOOSTER)), for Covid-19 Immunization; Spikevax (DOSE 4 (BOOSTER)), administration date: Jun2022, for Covid-19 Immunization; Bnt162b2 (DOSE 5 (BOOSTER)), administration date: Sep2023, for Covid-19 Immunization; Bnt162b2 (DOSE 6 (BOOSTER)), administration date: Oct2023, for Covid-19 Immunization. The following information was reported: INFLAMMATION (medically significant), outcome "recovering", described as "inflammed under the skin"; SKIN BACTERIAL INFECTION (medically significant), outcome "recovering", described as "old acne-like bacterial infection"; SKIN MASS (medically significant), outcome "recovering", described as "pimple that went bad and it was inflamed under the skin". Therapeutic measures were taken as a result of inflammation, skin bacterial infection, skin mass. Non-health care professional causality assessment for suspect product SPIKEVAX KP.2 and the events was not related. Clinical course: The reporter states that received a steroid shot for inflammation and has received COVID vaccines in the past. 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 and received a single steroid shot and an antibiotic. 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 definitely way down in size. The reporter states that has received both Pfizer and Moderna COVID vaccines, last booster dose being Pfizer on 19MAY2025.