Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration, Product storage error
Clinical narrative: Vaccine was puncutured on 28-Apr2-022 at 12:00pm and administered on 29-Apr-2022 at 10:57am; Booster dose administered 23 hours post puncture; 3rd dose administered on 23-Dec-2022 and booster dose was administered on 29-Apr-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Booster dose administered 23 hours post puncture), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (3rd dose administered on 23-Dec-2022 and booster dose was administered on 29-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine was puncutured on 28-Apr2-022 at 12:00pm and administered on 29-Apr-2022 at 10:57am) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 057M21A, 030H21B, 022C21A and 039B21A) for COVID-19 vaccination.     The patient's past medical history included Memory loss. Concurrent medical conditions included Immunocompromised, Hypertension, Opioid type dependence and Chronic hepatitis C genotype 1a. Concomitant products included SALBUTAMOL SULFATE (ALBUTEROL SULFATE HFA), ASPIRIN [ACETYLSALICYLIC ACID], BACLOFEN, CLOPIDOGREL BISULFATE, DULOXETINE HCL, GABAPENTIN, IBUPROFEN, LISINOPRIL, GLECAPREVIR, PIBRENTASVIR (MAVYRET), METHADONE, NALOXONE HYDROCHLORIDE (NARCAN), OMEPRAZOLE, PRAVASTATIN SODIUM and TOPIRAMATE for an unknown indication.   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2022 at 10:57 AM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2022 at 10:57 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Booster dose administered 23 hours post puncture) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (3rd dose administered on 23-Dec-2022 and booster dose was administered on 29-Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was puncutured on 28-Apr2-022 at 12:00pm and administered on 29-Apr-2022 at 10:57am). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Booster dose administered 23 hours post puncture), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (3rd dose administered on 23-Dec-2022 and booster dose was administered on 29-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine was puncutured on 28-Apr2-022 at 12:00pm and administered on 29-Apr-2022 at 10:57am) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had no allergies. Other vaccines given within 1 month prior to Moderna COVID-19 vaccine  was reported as no. It was unknow if the patient experienced any symptoms after any of the vaccines.  The vial was stored in refrigerator on 27-Apr-2022. The vial was first punctured on 28-Apr-2022 at 12:00 pm. The vial stored was stored at room temperature (RT) post puncture for about 16 to 18 hours and it did not undergo any temperature excursions.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2022: Follow up received include medical history and concomitant medications.