Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RVX
Symptoms: Activities of daily living impaired, Anal incontinence, Arnold-Chiari malformation, Back pain, Brain injury
Clinical narrative: Initial unsolicited report received from a consumer (patient's mother) on 26-Apr-2016. This case involves a six-month-old female patient, who was vaccinated with a dose of DTAP-HIB-IPV (batch number, expiry date, route and site of administration: not reported), a dose of HEPATITIS B VACCINE (other manufacturer, batch number, expiry date, route and site of administration: not reported), a dose of ROTAVIRUS VACCINE (other manufacturer, batch number, expiry date, route and site of administration: not reported) and a dose of PREVNAR 13 Vaccine (other manufacturer, batch number, expiry date, route and site of administration: not reported) on 05-Nov-2012. The patient had also received a dose of DTaP-Hep B-IPV and a dose of Hib vaccine (manufacturer: unknown, batch number, expiry date, route and site of administration: not reported for both the vaccines) on 22-Oct-2015. It was reported that the patient was healthy with no health or development issues, patient was crawling and sitting on her own prior to vaccination. Concomitant medications were not reported. On an unspecified date, after the vaccination the patient was fussy and was sleeping more. On an unspecified date, one month after vaccination, the patient was unresponsive in her arms, her head went back and forth for a moment, was not responding to anything and was stuck, like if she had a stroke or something. On the same day patient was taken to emergency room, where the patient had fever, the patient was paralyzed and was sent home. On an unspecified date, after vaccination, the patient was not able to sit down on her own any more, was not able to move. The patient was admitted to hospital and was placed in ICU on 06-Dec-2016. It was reported that at first, they blamed shaken baby syndrome, which was shocking, because she was not ever shaken, then they came back and apologized, stating the bleeding was from birth, that it was old blood and that the patient may never walk or crawl. It was reported that on an unspecified date, after vaccination the patient had bleeding in her brain, ended up paralyzed and was diagnosed with transverse myelitis spinal cord disease. Patient was in ICU for 8 days, was discharged on 14-Dec-2012. About a year after vaccination the patient still continued the complications with her walking, not being able to feel her feet, she was falling often, had a lot of headaches and constant back pain, also got ill and started to have episodes where she stayed stuck for 30 to 45 minutes, the patient was not able to communicate. On an unspecified date in 2015, the patient was diagnosed with Chiari malformation and had hypertonic dystonia. On an unspecified date, after vaccination the patient became more irritable and had horrible headaches, could not play like normal kids without feeling frustrated, if she played like a normal child her age, she used to cry and hold the back of her head and back that hurt, the patient's vision had gone bad and she had to wear glasses. The patient stutters, walks on her tiptoes and falls all the time, wakes up every morning with back pain and cries every morning, cannot hold her bowel movements some days. She had problems in understanding and had communication problems and squint her eyes. Laboratory investigations included CT scan and MRI (date and result not provided). Patient received corrective treatment with steroids. At the time of the report the patient could walk, was recovered from the event difficulty in walking but it was reported that the patient still presented many complications. The outcome of all other events was reported as not recovered. Documents held by sender: none. Sender's Comments: This is a social media case from consumer where manufacturer of the DTAP-HIB-IPV was not reported. Cerebral haemorrhage, Chiari malformation, myelitis transverse and stroke reported after the following immunization. The most widely accepted pathophysiological mechanism by which Chiari type I malformations occur is by a reduction or lack of development of the posterior fossa as a result of congenital or acquired disorders but no particular diagnosis was provided after CT and MRI. However examination which confirmed diagnosis, family history and other etiological information would be needed to further assess this case.