Received Mar 30, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | 3052995 | IM / LL |
| DTPPVHBHPB | DTAP+IPV+HIB+HEPB (VAXELIS) | MSP VACCINE COMPANY | UNK | U7969AA | IM / LL |
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | UNK | MM0534 | IM / RL |
| RV5 | ROTAVIRUS (ROTATEQ) | MERCK & CO. INC. | UNK | Z006001 | PO / MO |
Beyond use date was not prominently displayed. Typically, it was displayed on the top of the Moderna Spikevax packaging, but in this case, it was written small on the side, and they failed to notice it.; Infantile atopic dermatitis; A patient was administered Spikevax that was already beyond use date (11-Jan-2026); This spontaneous case was reported by a nurse and describes the occurrence of DERMATITIS ATOPIC (Infantile atopic dermatitis), EXPIRED PRODUCT ADMINISTERED (A patient was administered Spikevax that was already beyond use date (11-Jan-2026)) and PHYSICAL PRODUCT LABEL ISSUE (Beyond use date was not prominently displayed. Typically, it was displayed on the top of the Moderna Spikevax packaging, but in this case, it was written small on the side, and they failed to notice it.) in a 6-month-old male patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) (batch no. 3052995) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection (batch no. 3052995) for COVID-19 prophylaxis. The non-company co-suspect products included Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20) for an unknown indication, Vaxelis for an unknown indication and Rotavirus vaccine live reassort oral 5v (Rotateq) for an unknown indication. Concurrent medical conditions included Plagiocephaly (Congenital Plagiocephaly) since 16-Sep-2025, Torticollis since 16-Sep-2025 and Umbilical hernia without mention of obstruction or gangrene (Umbilical hernia without obstruction and without gangrene) since 16-Sep-2025. On 21-Jan-2026, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form, dose of Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20) (Intramuscular use) 1 dosage form, dose of Vaxelis (Intramuscular use) 1 dosage form and dose of Rotavirus vaccine live reassort oral 5v (Rotateq) (Oral use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 21-Jan-2026, the patient experienced DERMATITIS ATOPIC (Infantile atopic dermatitis) and EXPIRED PRODUCT ADMINISTERED (A patient was administered Spikevax that was already beyond use date (11-Jan-2026)). On an unknown date, the patient experienced PHYSICAL PRODUCT LABEL ISSUE (Beyond use date was not prominently displayed. Typically, it was displayed on the top of the Moderna Spikevax packaging, but in this case, it was written small on the side, and they failed to notice it.). At the time of the report, DERMATITIS ATOPIC (Infantile atopic dermatitis), EXPIRED PRODUCT ADMINISTERED (A patient was administered Spikevax that was already beyond use date (11-Jan-2026)) and PHYSICAL PRODUCT LABEL ISSUE (Beyond use date was not prominently displayed. Typically, it was displayed on the top of the Moderna Spikevax packaging, but in this case, it was written small on the side, and they failed to notice it.) 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. The race was reported as Multi. Allergies to medication, food and other products were reported as none. It was unknown that patient had relevant medical history (vaccines within the past 4 weeks, medical conditions). No Concomitant medication was reported. The health care professional (HCP) wanted to determine patient safety, efficacy of the vaccine, and just saw how to go about this recommendation. The reporter also inquired about the BUD (Beyond use date) extension or if the vaccine would be still viable. On unknown date of 2026 (Friday), one of the health care professional's nurses pull the vaccine out of the fridge and realized that the beyond use date had passed. Then, one of the health care professional's medical assistants recalled that she had administered the vaccine. It was unknown if the patient experienced any additional symptoms/events. No treatment information was reported. Most recent FOLLOW-UP information incorporated above includes: On 24-Mar-2026: Significant follow-up information received: Reporter details (address, institute, phone number and fax number) added, occupation and report media updated, patient date of birth added, age and race updated, current condition added, suspect anatomical location, co-suspects, new event atopic dermatitis added, event no adverse effect removed and narrative updated.
Plagiocephaly (Congenital Plagiocephaly); Torticollis; Umbilical hernia without mention of obstruction or gangrene (Umbilical hernia without obstruction and without gangrene)