Age: 1.67
Sex: F
Vaccine: DTPPVHBHPB, HEPA, MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE; PRODUCT STORAGE ERROR; This case was retrieved during the VAERS-ICSR monitoring in FDA on 12-JAN-2022 with the following reference number: 1827116-1. The original narrative from the sender is as below:  "No additional AE was reported; temperature excursion for VARIVAX; This spontaneous report was received from a vaccine coordinator referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided. On 19-OCT-2021, the patient was vaccinated with improper stored varicella virus vaccine live (oka/merck)(VARIVAX) (lot # T024287,expiration date 15-JUL-2022, 0.5 milliliter, route and strength were not provided) for prophylaxis (product storage error). The vaccine administered experienced temperature excursion of 8 Degree Celsius for 1 hour 47 minutes. There was no previous temperature excursion. No additional adverse event was reported. Follow up information has been received from vaccine coordinator on 26-OCT-2021. Information has been received regarding a 20-month-old female patient who weights 6lb 12Oz at the time of birth. She had 2 sisters. On 19-OCT-2021, she was vaccinated with an improperly stored first dose of varicella virus vaccine live (oka/merck) (VARIVAX) administered subcutaneously (SQ) through right arm; with the first dose of diphtheria vaccine toxoid (+) hepatitis B vaccine rhbsag (yeast) (+) hib vaccine conj (menigococcal protein) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (vero) (+) tetanus vaccine toxoid (VAXELIS) (dosage regimen not provided), lot# U7124AA, expiration date 13-JUL-2024 administered intramuscularly (IM) through left thigh; with the first dose of hepatitis A vaccine (dosage regimen not provided), lot# 2JD3Y, expiration date 04-DEC-2022, IM through left thigh; and with the first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live recombinant human albumin (rHA) (M-M-R II) (dosage regimen not provided), lot# S039316, expiration date 04-DEC-2021, SQ through left arm. All vaccines were storage in clinical practice administered as prophylaxis. On that day, second dose of pneumococcal vaccine conj 13v (CRM197) (PREVENAR 13) (dosage regimen was not provided) lot# DL2971, expiration date 30-NOV-2022, IM through right thigh for prophylaxis. It was reported that the operator was trained, and the vaccine was used according to the instruction's leaflet; however, the vaccine was not available for return because was used. On that day, the clinic lost power and the vaccine was administered to the patient before being cleared by manufacturer for use. On 20-OCT-2021, the manufacturer was contacted and were cleared all affected vaccines for use. The patient involved had not reported any adverse reactions to immunization. All staff clinic was aware to have vaccines cleared by manufacturer after a temperature excursion. The temperature excursion occurred as a result of a reading from the digital data logger."  Notes: Based on the available information, the events were not related to Vaxelis but to Varivax vaccine. Vaxelis should have been considered a concomitant, however the case was retrieved from VAERS and information was kept as reported in the form.