Received Jul 7, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | 2 | A3052859 | IM |
given two doses of the COVID-19 vaccine; the clinic later disclosed that the first dose was expired when administered; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills) and EXPIRED PRODUCT ADMINISTERED (given two doses of the COVID-19 vaccine; the clinic later disclosed that the first dose was expired when administered) in a 20-month-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) (batch nos. A3052859 and A3053849) for COVID-19 prophylaxis. Co-suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. No Medical History information was reported. On 05-May-2026, the patient received first dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) .25 milliliter. On 04-Jun-2026, received second dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (unknown route) dosage was changed to .25 milliliter. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 05-May-2026, the patient experienced EXPIRED PRODUCT ADMINISTERED (given two doses of the COVID-19 vaccine; the clinic later disclosed that the first dose was expired when administered). In 2026, the patient experienced PYREXIA (Fever) and CHILLS (Chills). At the time of the report, PYREXIA (Fever) and CHILLS (Chills) had resolved and EXPIRED PRODUCT ADMINISTERED (given two doses of the COVID-19 vaccine; the clinic later disclosed that the first dose was expired when administered) outcome was unknown. Concomitant medications were not reported. It was reported that the patient was given two doses of the COVID-19 vaccine, the clinic later disclosed that the first dose was expired when administered. The caller also noted that the patient experienced fever and chills after vaccination, which their healthcare provider indicated were common side effects. Since these symptoms had subsided, and the child was healthy. It was unknown if the patient experienced any additional symptoms/events. Treatment information was not reported. Initial and follow-up 1 received on 25-Jun-2026 has been processed together in the same case cycle. Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2026: Live follow up received contains significant information. Patient age was added, suspect start date of dose 1 was updated and event onset date of expired vaccine used was updated.