Age: 1.3
Sex: F
Vaccine: UNK
Symptoms: Malaise, Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal, Mean cell volume normal, Mean platelet volume decreased
Clinical narrative: This is a spontaneous report from a contactable pharmacist communicated to a Pfizer Sales representative. This registered pharmacist reported for a female patient (Pharmacists great granddaughter). This Pfizer sales representative was contacted by a former Wyeth colleague (Pharmacist) on Sunday 23Feb2014 at approximately 7:00 PM ET. After some general conversation, he shared that his great granddaughter has experienced health concerns following vaccine administration. On 19Feb2014 the patient saw her pediatrician for a routine 15 month check, including three vaccination at 11am. He was not sure if the vaccines administered included PREVNAR 13. That evening about 8 pm, during normal activities, the patient became ill, she vomited and went limp and had a seizure. She kept seizing for almost a whole hour off and on. ATIVAN, phenobarbital, VERSED and other drugs were administered until she finally stopped seizing. The patient was taken to the hospital. The patient was intubated and sedated with propofol. CT scan of brain, spinal tap and EEG were performed. EEG monitor shows increased activity when her belongings talk to her. The patient had temp so it was probably a spike in temp from the vaccines but other tests were performed and flu, brain tumor, blood cancers (from cell study), stroke and meningitis were ruled out. Neurologist examined her and in his opinion the patient had a febrile seizure that went into status epilepticus, that she just kept seizing. The neurologist said that the patient EEG showed normal sedated brain waves but he wanted to see it as she woke up. Ultrasound of the abdomen to check liver and spleen were performed just to be extra cautious because the white blood cell count numbers were low. Propofol was changed to midazolam hydrochloride, fentanyl and PRECEDEX. Temp 100.4. Test results on 18Nov2013 were: WBC 8.4, Hgb 12.3, Hct 37.9, Rbc 4.15, LY 58.9, Mo 2.8, Gr 38.3, LY #4.9, Mo # 0.2, Gr # 3.2, Mcv 91.3, Mch 29.7, Mchc 32.5, Rdw 11.7, Platelets 240, Mpv 7.0. On 20Feb2014: WBC 1.5, Hgb 7.7, Platelets 128. MRI completely normal. All these low red and white cell and platelet counts sound like she had a generalized depression of bone marrow function. On 21Feb2014: Hgb 7.7 and white count 1.4. One of the doctors were equating the seizure with a fever caused by the vaccine, but the others said the patient had a viral process that caused a spike in fever, then the seizure. The patient had a couple of breathing problems with mucus clogging the airtube and having to reintubate her, and when they do that, they basically start the process all over again of having her on a lot of oxygen and sedation, then weaning her off. On 22Feb2014 at 01:00 propofol and dexmedetomidine hydrochloride were discontinued and the patient woke up in 20 - 30 minutes. Then the ventilation was took out and just oxygen nasal cannula was maintained. The patient was agitated so a mild sedation was administered. The MRI showed some swelling in the mastoid bone behind the ear and in the ethmoid sinuses. The doctors told that the overall consensus was that she was starting a viral illness, the she got the vaccines and had a reaction to that, which caused a spike in fever, which caused the seizure, and all these things caused bone marrow suppression (the white and red cell count and platelets dropping). The physician was concerned about the red blood cell count (Hgb) specifically and this needed to be followed up on since her Hgb was 12.3 in November. No pneumonia was detected. In the night between 22feb2014 and 23Feb2014 the patient had just periods of discomfort and lots of sleep. The patient remained at the hospital through Sunday 23Feb2014. The patient is reported to have low hemoglobin counts and was given a transfusion on 23Feb2014 and was treated with albuterol because she was wheezing. The patient may be transferred to another hospital.