Received Oct 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | 2 | — | IM |
She was given 2 doses of MNEXSPIKE as a med error - she was meant to get 1 COVID, 1 flu/ erroneous second dose; She was given 2 doses of MNEXSPIKE as a med error - she was meant to get 1 COVID, 1 flu; extra pain for the fractured vertebrae; painful injection site; This spontaneous case was reported by a nurse and describes the occurrence of SPINAL PAIN (extra pain for the fractured vertebrae), VACCINATION SITE PAIN (painful injection site), EXTRA DOSE ADMINISTERED (She was given 2 doses of MNEXSPIKE as a med error - she was meant to get 1 COVID, 1 flu/ erroneous second dose) and WRONG PRODUCT ADMINISTERED (She was given 2 doses of MNEXSPIKE as a med error - she was meant to get 1 COVID, 1 flu) in a 69-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) (batch no. 3052034) for COVID-19 prophylaxis. Concurrent medical conditions included Vertebral hyperplasia (hypoplasty of three vertebrae) and Vertebral fracture (fractured vertebrae right now). On 07-Oct-2025, the patient received first dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) 1 dosage form. On 10-Oct-2025, received second dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) dosage was changed to .2 milliliter. On 08-Oct-2025, the patient experienced SPINAL PAIN (extra pain for the fractured vertebrae). On 10-Oct-2025, the patient experienced EXTRA DOSE ADMINISTERED (She was given 2 doses of MNEXSPIKE as a med error - she was meant to get 1 COVID, 1 flu/ erroneous second dose). 10-Oct-2025, the patient experienced WRONG PRODUCT ADMINISTERED (She was given 2 doses of MNEXSPIKE as a med error - she was meant to get 1 COVID, 1 flu). In October 2025, the patient experienced VACCINATION SITE PAIN (painful injection site). In October 2025, SPINAL PAIN (extra pain for the fractured vertebrae) and VACCINATION SITE PAIN (painful injection site) had resolved. At the time of the report, EXTRA DOSE ADMINISTERED (She was given 2 doses of MNEXSPIKE as a med error - she was meant to get 1 COVID, 1 flu/ erroneous second dose) and WRONG PRODUCT ADMINISTERED (She was given 2 doses of MNEXSPIKE as a med error - she was meant to get 1 COVID, 1 flu) outcome was unknown. For mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use), the reporter considered SPINAL PAIN (extra pain for the fractured vertebrae) to be related. No further causality assessments were provided for VACCINATION SITE PAIN (painful injection site), EXTRA DOSE ADMINISTERED (She was given 2 doses of MNEXSPIKE as a med error - she was meant to get 1 COVID, 1 flu/ erroneous second dose) and WRONG PRODUCT ADMINISTERED (She was given 2 doses of MNEXSPIKE as a med error - she was meant to get 1 COVID, 1 flu). No concomitant medication was reported. The patient had received two doses of mNEXSPIKE 2025-2026 formula both on 07-Oct-2025 (assumed as 0.2 ml) and on 10-Oct-2025 respectively. The patient was supposed to receive the flu shot on 10-Oct-2025 but the pharmacist that gave her the shot had administered the mNEXSPIKE instead of the flu shot. The patient termed the second dose administered to her as "erroneous second dose." The patient also confirmed she had no reactions on the day of reporting but confirmed she had a very painful injection site but had no redness or any problem as such and then added she had a hypoplasty of three vertebrae adding she had a fractured vertebra right now. And so that ached quite a bit the following day pertaining to the shot she had received on 07-Oct-2025. She was assuming that extra pain for the fractured vertebrae was caused by the first COVID vaccine which she referred to was the dose she got on 07-Oct-2025 at 3 o'clockish in the afternoon. The patient did not experience any additional symptoms/events. No treatment medication was reported. Most recent FOLLOW-UP information incorporated above includes: On 10-Oct-2025: Significant live follow-up received. Reporter's mail ID was added, additional reporter was added, medical history was added, suspect details updated, additional events were added, and narrative was updated. On 13-Oct-2025: Live follow-up received that contains non-significant information (reference ids were added).
Vertebral fracture (fractured vertebrae right now); Vertebral hyperplasia (hypoplasty of three vertebrae)