Received Jun 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 7+ | — | IM |
Patient had a bad experience getting the vaccine/a minor side effects after getting vaccinated; plunger did not move; The vaccination did not go well as the nurse noticed that the plunger of the syringe did not move and when the nurse took out the syringe/Patient believed that some of the content went in as she experienced a minor side effect; The vaccination did not go well as the nurse noticed that the plunger of the syringe did not move and when the nurse took out the syringe/Patient believed that some of the content went in as she experienced a minor side effect; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Patient had a bad experience getting the vaccine/a minor side effects after getting vaccinated), DEVICE ISSUE (plunger did not move), INCORRECT DOSE ADMINISTERED (The vaccination did not go well as the nurse noticed that the plunger of the syringe did not move and when the nurse took out the syringe/Patient believed that some of the content went in as she experienced a minor side effect) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (The vaccination did not go well as the nurse noticed that the plunger of the syringe did not move and when the nurse took out the syringe/Patient believed that some of the content went in as she experienced a minor side effect) in a 75-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. Co-suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Patient was getting the Moderna shot since March 2021.) in March 2021, SPIKEVAX 2024-2025 PFS (Dose: 9 and lot number: 3043030) on 17-Oct-2024. Past adverse reactions to the above products included No adverse effect with Moderna COVID-19 Vaccine and SPIKEVAX 2024-2025 PFS. On 24-Apr-2025, the patient received tenth dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 24-Apr-2025, the patient experienced DEVICE ISSUE (plunger did not move), INCORRECT DOSE ADMINISTERED (The vaccination did not go well as the nurse noticed that the plunger of the syringe did not move and when the nurse took out the syringe/Patient believed that some of the content went in as she experienced a minor side effect) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (The vaccination did not go well as the nurse noticed that the plunger of the syringe did not move and when the nurse took out the syringe/Patient believed that some of the content went in as she experienced a minor side effect). On an unknown date, the patient experienced IMMUNISATION REACTION (Patient had a bad experience getting the vaccine/a minor side effects after getting vaccinated). At the time of the report, IMMUNISATION REACTION (Patient had a bad experience getting the vaccine/a minor side effects after getting vaccinated), DEVICE ISSUE (plunger did not move), INCORRECT DOSE ADMINISTERED (The vaccination did not go well as the nurse noticed that the plunger of the syringe did not move and when the nurse took out the syringe/Patient believed that some of the content went in as she experienced a minor side effect) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (The vaccination did not go well as the nurse noticed that the plunger of the syringe did not move and when the nurse took out the syringe/Patient believed that some of the content went in as she experienced a minor side effect) outcome was unknown. No concomitant medication was reported. Patient was a senior citizen and was getting the Moderna shot since March 2021 and from then getting the covid shot every other 6 months. It was reported that she recently had a Moderna covid shot at a Clinic last 24-Apr-2025 which she had a bad experience getting the vaccine. It was mentioned that the vaccination did not go well as the nurse noticed that the plunger of the syringe did not move and when the nurse took out the syringe, she immediately placed it on the used needles without investigating further and advising the patient if how much vaccines were left on the syringe. They thought that the nurse had not let the vaccine thaw long enough because of the plunger did not move. Patient believed that some of the content went in as she experienced a minor side effect after getting vaccinated. It was reported that the Clinic nor the nurse did not provide her a vaccination record as they believed no vaccine was used/administered to the patient. Patient tried to look the data of her recent vaccination on her online vaccination record, and it stated that on 24-Apr-2025, did not receive vaccine. It was reported that that she already tried to ask multiple healthcare provider including her personal doctor and was not able to get a valid response. No treatment medication was reported. The device problem code for SPIKEVAX 2024-2025 PFS syringe included FDA code 1670, IMDRF code A23 which included use of device problem. The evaluation /investigation code information for SPIKEVAX 2024-2025 PFS syringe included FDA code 4114, IMDRF Code B17 which included device not returned, FDA code 3221, IMDRF code C20 which included no findings available and FDA code 19, IMDRF Code D11 which concluded cause traced to user. Investigation Summary & Conclusion with Root Cause Details: A patient reported a suspected maladministration during administration of the Moderna Spikevax (2024-2025 Formula) COVID-19 vaccine on at a clinic. The patient reported that the syringe plunger did not move during injection, raised concern that the vaccine was not delivered. The patient reported that the nurse discarded the syringe without confirming whether any volume had been administered, and no vaccination documentation was provided. The patient's electronic immunization record for that date indicated "did not receive vaccine." Following the incident, the patient reported experiencing minor side effects, suggesting the possibility of partial administration. An Adverse Event case was submitted to document this experience. The patient was referred by the call center agent to consult her healthcare provider for medical guidance. However, she indicated that she had already contacted multiple HCPs, including her personal physician, but was unable to obtain a clear or valid response. Providers reportedly stated that "they did not know," leaving the patient uncertain about her immunization status and whether she must wait the full six-month interval for revaccination. This complaint was based primarily on the patient's perception and inability to confirm whether the dose was properly administered, rather than on an identifiable product quality defect. No product sample or photographic evidence was available, and no further information could be retrieved from the administering clinic or providers to support or clarify the event. No trending analysis for the reported defect could be performed since no batch number could be retrieved. Based on the available information, no product quality issue has been confirmed, and the event was assessed as operational and non-systemic in nature. No additional investigation or CAPA was required. The patient was advised to consult regarding any revaccination needs. Most recent FOLLOW-UP information incorporated above includes: On 23-May-2025: Live follow up received which contains non-significant information, reference number was added. On 27-May-2025: Live significant follow-up received which contains PQC closed investigation report: Reporter's email address, QC comment, QC result date in product tab and narrative was updated.