Received Jun 29, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | 3052786 | IM |
Spikevax was administered after the expiry date; did wake up with a pimple on her face; bacterial infection; This spontaneous case was reported by a pharmacist and describes the occurrence of ACNE (did wake up with a pimple on her face), BACTERIAL INFECTION (bacterial infection) and EXPIRED PRODUCT ADMINISTERED (Spikevax was administered after the expiry date) in an 80-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) (batch no. 3052786) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection (batch no. 3052786) for COVID-19 prophylaxis. The patient's past medical history included Urinary frequency. Previously administered products included for COVID-19 prophylaxis: mNEXSPIKE in October 2025. Past adverse reactions to the above products included No adverse effect with mNEXSPIKE. Concurrent medical conditions included Osteoporosis, Hypertension and Asthma (generic asthma). On 20-Jun-2026, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) .5 milliliter. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. In June 2026, the patient experienced ACNE (did wake up with a pimple on her face) and BACTERIAL INFECTION (bacterial infection). On 20-Jun-2026, after starting mRNA-1273.251 (Spikevax LP.8.1 PFS), the patient experienced EXPIRED PRODUCT ADMINISTERED (Spikevax was administered after the expiry date). At the time of the report, ACNE (did wake up with a pimple on her face), BACTERIAL INFECTION (bacterial infection) and EXPIRED PRODUCT ADMINISTERED (Spikevax was administered after the expiry date) outcome was unknown. For mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use), the reporter did not provide any causality assessments. For Pre-filled Syringe, the reporter did not provide any causality assessments. No concomitant medication was reported. The reporter stated that the doses were appropriately stored, however they did not check the expiry date before administration. The reporter stated that they did not expect the product to have such a short expiry date as they were ordered 26-Feb-2026 and had an expiration date of 3 months time. The reporter stated that the patient did wake up with a pimple on her face and she put Benedryl on it and took an antibiotic that she had laying around. The reporter stated that her concern was bacterial infection but stated that the patient lives in a farmhouse, so she was unsure what that spot was. The reporter stated that patient would be having oral surgery in July 2026, so she wanted another dose for extra coverage. No other side effects reported for patient. This case was linked to US-MODERNATX, INC.-MOD-2026-798120 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2026-798120:Same reporter different patient
Asthma (generic asthma); Hypertension; Osteoporosis
Medical History/Concurrent Conditions: Urinary frequency