Sex: U
Vaccine: COVID19, DTAPIPVHIB, PNC15, RV5
Symptoms: Cough, Expired product administered, Irritability, Product storage error
Clinical narrative: Patient fussy that night after vaccines; cough; expired vaccnie used; improper storage of product in use; This spontaneous report was received from a nurse via other company, concerning a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions included plagiocephaly, cough, and teething. Concomitant medications included multivitamins (VITAMINS NOS) and ibuprofen (MOTRIN INFANTS).   On an unknown date, the patient was vaccinated with the third dose of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) syringe, 1 dosage form, lot #W039033, expiration date: 01-OCT-2024 intramuscularly as prophylaxis (strength was not provided); and with diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (PENTACEL), 1 dosage form, administered intramuscularly (strength, formulation, lot #, expiry date, and indication were not provided).  On 09-JUN-2023 at 15:48, the patient was vaccinated with the first dose of elasomeran (COVID-19 VACCINE MODERNA), 1 dosage form, batch no. AS7185B, administered for covid-19 prophylaxis (strength, formulation, expiry date, and route of administration were not provided); and with the third dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, administered as prophylaxis (strength, lot #, expiry date, and route of administration were not provided).   On 09-JUN-2023, the patient experienced cough at the time of vaccination and, that night after the vaccines were given, the patient was fussy (irritability). The nurse stated that the doses were given in their facility more than 12 hours post puncture (expired vaccine used). The vial was initially stored in the refrigerator on 01-JUN-2023, first punctured on 08-JUN-2023 and was administered on 09-JUN-2023 (Product storage error). At the time of reporting, the event of irritability had resolved, and cough was ongoing.   Unspecified vial size was reported as 2.5 ml. The date on which vial was moved to refrigeration was reported as 01-JUN-2023. The date/time vial was moved to room temperature was reported as 08-JUN-2023 12:25pm. The Date/time of first vial puncture was 08-JUN-2023 at 1:44 PM. The date of administration was reported as 09-JUN-2023 3:48PM. Total time at room temperature was reported as 27 hours and 23 minutes. Total time past first puncture was reported as 26 hrs and 4 minutes. Total amount of time the vial was exposed to room temperature range (8 to 25 C equal 46 to 77 F): 26hs and 30 minutes.  For elasomeran (COVID-19 VACCINE MODERNA), the reporter considered the event of expired product administered to be related. No further causality assessments were provided for the events. The causal relationship between the events and pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was not reported.  Follow up information was received from a consumer via other company on 05-APR-2024.  This case involved an adult and unknown gender patient. It was not reported if the patient received a corrective treatment for the events fussy that night after the vaccines (irritability). At the reporting time, the outcome was unknown for the event.