Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Expiration date was 13JUL2022 and administered on 3NOV2022 and 15DEC2022; Dose 1 administered on 11/3/2022 and  dose 2 administered on 12/15/2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expiration date was 13JUL2022 and administered on 3NOV2022 and 15DEC2022), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 administered on 11/3/2022 and  dose 2 administered on 12/15/2022) and NO ADVERSE EVENT (No adverse event) in a 65-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 004M21A and 004M21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 03-Nov-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 15-Dec-2022, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to .5 milliliter. On 15-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expiration date was 13JUL2022 and administered on 3NOV2022 and 15DEC2022) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 administered on 11/3/2022 and  dose 2 administered on 12/15/2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expiration date was 13JUL2022 and administered on 3NOV2022 and 15DEC2022), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 administered on 11/3/2022 and  dose 2 administered on 12/15/2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Expiration date was 13JUL2022 and administered on 3NOV2022 and 15DEC2022) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 administered on 11/3/2022 and  dose 2 administered on 12/15/2022).    Concomitant Medication use information was not provided by reporter.  It was unknown that the patient ever been diagnosed with/tested positive for COVID-19  It was unknown that the patient had acute illness at the time of vaccination and up to one month before.  It was unknown that the patient had any chronic or long-standing health conditions.  It was unknown that the patient was prescribed OTC medications, dietary supplements or herbal remedies being taken at the time of vaccination and/or at the time of adverse event.  Treatment Medication use information was not provided by reporter.   This case was linked to MODERNATX, INC.-MOD-2023-703832, MODERNATX, INC.-MOD-2023-704260 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jan-2023: The IRD of deletion case is 23-Jan-2023. On 24-Jan-2023: Live Significant FU : Reporter qualification updated and Narrative updated On 24-Jan-2023: Live Significant FU : Patient identifier details added. Upon the receipt of the follow-up information on 23-Jan-2023, it was identified that the information in cases MOD-2023-703832 and MOD-2023-703265 are pertaining to the same patient and same product. Hence the case MOD-2023-703265 will be retained for further follow-up and all the information from the case MOD-2023-703832 has been incorporated into the retained case MOD-2023-703265. The case MOD-2023-703832 will be deleted from the safety database. On 24-Jan-2023: Reporter qualification updated and Narrative updated On 24-Jan-2023: Patient identifier details added. On 02-Feb-2023: Follow up received that contains significant information includes added suspect product dose details, route of administration and location of vaccination and updated I narrative information. Sender's Comments:  MODERNATX, INC.-MOD-2023-703832:Patient 1 MODERNATX, INC.-MOD-2023-704260:Master case