Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Blister, Exfoliative rash, Rash
Clinical narrative: This solicited report has been received from a nurse via company (Manufacturer number UNT-2016-018279) and refers to a 1 year old female patient who was enrolled in a Patient Support Program. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date in November 2016, the patient was vaccinated with M-M-R II (dose and route of administration were not reported) for prophylaxis. Other suspect therapy included REMODULIN injection, subcutaneously (strength, dose and frequency were not reported) for an unknown indication received for the first time on an unknown date in November 2016. It was reported that shortly after the administration of REMODULIN injection, the patient experienced blisters on her body (on an unknown date in November 2016). The patient got hospitalized for the event and was not sure whether the blisters were due to REMODULIN injection or M-M-R II or combination of both. Action taken with M-M-R II and REMODULIN was not reported. Outcome of event was unknown at the time of this report. The relationship between the event blisters with the suspect therapies was not reported. All telephone attempts on 20-MAR-2017 and 30-MAR-2017 to obtain follow-up information have been unsuccessful. Follow up information has been received from the registered nurse on 31-MAR-2017. The nurse shared that the patient had history of Congenital Diaphragmatic Hernia and Pulmonary arterial hypertension (PAH). Prior to receiving M-M-R II vaccination, the patient was hospitalized for rash (31-OCT-2016 to 07-NOV-2016). During hospitalization, the route of REMODULIN therapy was changed from intravenous to subcutaneous. The rash had resolved. The patient was seen in the cardiology office for follow up visit on 28-NOV-2016. The nurse reported that the patient presented with a severe scaly rash involving patient's arms, chest and her back. The nurse clarified that the injection of REMODULIN was not being given in these sites. The nurse further reported that this office took pictures of this rash and sent them to child's pediatrician (pictures were available upon request). The nurse was informed by the father of the patient that on unknown date in November 2016 (after discharged from hospital) the patient received her M-M-R II vaccination (lot # unknown) and the pediatrician told the father that this rash was related to M-M-R II vaccination. The patient was referred back to her treating pediatrician for unspecified treatment. The patient was seen in cardiology office for a routine follow up on 30-JAN-2017. On unspecified date, REMODULIN was weaned and discontinued due to improve PAH status. The rash had completed resolved. The reporter did not provided the causality assessment. Additional information has been requested. Company Causality Assessment: Based on the limited information currently available for this case, a reasonable possibility to suggest a relationship between the therapy and the reported serious event cannot be established. The date of administration of vaccine, as well as the date of onset of reported event are unknown. Additionally, there is no information for the reported event such as location, severity, body surface area affected. The following non serious event of Severe scaly rash involving patient's arms chest and her back was also reported.