Sex: F
Vaccine: VARCEL
Symptoms: Rash, Secondary transmission, Skin lesion, Varicella, Varicella virus test positive
Clinical narrative: Infant developed chickenpox 30 days post maternal vaccination/ Diffuse distribution of vesicles; a mom who just delivered her newborn baby is positive for varicella and transmitted virus to newborn baby/ The baby was delivered and the mother was vaccinated on 12-DEC-2020; The baby was delivered and the mother was vaccinated on 12-DEC-2020/ had been breastfeeding until the infant developed the rash.; This spontaneous report was received from a physician and refers to a 5-week-old female patient. The concurrent conditions included meningomyelocele and hydrocephalus. The patient's concomitant medications included vancomycin and acyclovir.  On 12-DEC-2020, the patient's mother was vaccinated post-partum with varicella virus vaccine live (oka/merck)(VARIVAX) in her left upper right arm (lot number 279202867, dose and expiration date were not reported) since it was determined, that she was seronegative for varicella virus vaccine (for prophylaxis). The physician reported that the mother was not sure if she had chicken pox in the past and there were no available medical records for the mother. The physician also stated that there was no known recent exposure to VZV and confirmed that the mother did not develop an injection site reaction or rash post-vaccination. An immunological work-up was not performed for the mother. It was reported that on 12-JAN-2021, the patient developed diffuse distribution of vesicles. The physician reported that the baby's rash specimen was collected on 14-JAN-2021, which was approximately 8 hours after acyclovir treatment began. The polymerase chain reaction (PCR) sample was tested on 15-JAN-2021 and revealed the vaccine strain (it was also reported that the infant developed chickenpox 30 days post maternal vaccination). The physician reported that the baby had been breastfeeding until the infant developed the rash (vaccine exposure via breast milk). The infant had more than 20 diffuse lesions on her trunk, legs, arms, and face (secondary transmission). She reported that the baby was treated with acyclovir for a total of seven days and reported that the baby was currently "doing well". The physician also stated that an immunological work-up for the baby was performed and the results were pending. The outcome of varicella and secondary transmission was not reported.  The causal relationship between varicella, secondary transmission and varicella virus vaccine live (oka/merck) (VARIVAX) was not provided.  This is one of the two linked reports of mother and child (the mother's case # 2101USA008318).  Follow up information has been received from the reporting physician on 10-FEB-2021. The patient was a premature baby (the time of delivery was 35 weeks and 6 days) (current condition). On 03-JAN- 2021, the patient underwent polymerase chain reaction (PCR) testing which result was reported as: vaccine strain VZV.  The event of varicella has been updated to disseminated varicella zoster vaccine virus infection because the strain was identified as Oka/Merck vaccine strain in the PCR result.  The physician provided different lot numbers: Lot number 137376 was invalid for varicella virus vaccine live (oka/merck) (VARIVAX), lot number 137376 is a valid lot number for rocuronium bromide (ESMERON) and lot number 0006482700 was invalid for varicella virus vaccine live (oka/merck)(VARIVAX), lot number 0006482700 did not match any Company product as confirmed by lot Verification team. These lot numbers were found in the patient's chart, but the reporter was unsure if the numbers were lot numbers for the dose of varicella virus vaccine live (oka/merck)(VARIVAX) administered, therefore, she stated that she would look further when she had the chance and contact us again if she found the correct lot number. The outcome of disseminated varicella zoster vaccine virus infection was reported as recovered.   The causal relationship between disseminated varicella zoster vaccine virus infection and varicella virus vaccine live (oka/merck) (VARIVAX) was not provided.  Follow-up information has been received from  a physician on 23-JUN-2021. On an unspecified date, the patient was performed a lumbar puncture at the hospital, and the cerebrospinal fluid (CSF) was VZV negative.