Age: 2.0
Sex: F
Vaccine: FLUN(H1N1), FLUX(H1N1), FLU3
Symptoms: No reaction on previous exposure to drug, Speech disorder developmental, Urticaria
Clinical narrative: Initial report received on 11 May 2010 from a health care professional. Follow-up information was received via a follow-up telephone call made by the manufacturer to the reporter on 12 May 2010. A 3-year-old female patient had received a third intramuscular left thigh injection of FLUZONE No Preservative 2009-2010 (lot number U3263DA) on 27 October 2009. One week post-vaccination on 03 November 2009, the mother called the physician's office and reported the patient had hives on her legs and torso. The mother was instructed to administer BENADRYL and if symptoms did not improve the patient was to be seen for evaluation. The physician's office did not hear back from the mother until the patient was seen for another reason in December 2009. At that visit, the mother reported that the previously reported event of hives had only lasted 2 weeks. The mother also reported the patient had developed speech and language comprehension issues after receiving an H1N1 vaccine (date not reported) and had seen a specialist several times for this. The reporter was unsure if the mother was referring to the FLUZONE received on 27 October 2009, or if the patient had received a separate vaccination with H1N1 as they had not administered a H1N1 vaccine to the patient. The reporter was following up with the mother for clarification. The serious adverse event associated with the possible administration of H1N1 vaccine is reported in case number 2010-02731. At the time of this report, the patient had recovered from hives. Follow-up information was received 04 June 2010 from a health care professional. The reporter confirmed the patient received H1N1 vaccine (manufacturer and lot number not reported) on 30 October 2009 (year reported as 2010) via nasal route (not a sanofi pasteur formulation), three days after the patient had received FLUZONE on 27 October 2009. Due to the timing of vaccines administered, the H1N1 vaccine and the serious adverse event of speech and language comprehension issues following H1N1 vaccination (previously captured in case number 2010-02731) will be combined with and captured in this case, and this case will be upgraded from non-serious to serious. Case 2010-02731 will now become a duplicate report and will be deleted from our database. According to the reporter, the event of hives were reported to their office on 03 November 2009; however, the patient had not been seen at their facility. The patient's mother informed the reporter that the patient had been seen by an allergist for hives but the reporter had not received any notes from that evaluation. The reporter further clarified that during an office visit in May 2010 (previously reported as December 2009), the mother reported the events of speech and comprehension problems which began two weeks after the patient had received H1N1 vaccine. It was unknown if the patient had any diagnostic tests or laboratory data completed. Patient medical history includes no concurrent illnesses, no known allergies and no use of other medications at time of vaccination with H1N1 vaccine. It was also reported the patient had no adverse events associated with any vaccinations received prior to 27 October 2009. At the time of this report, the patient had not recovered. Documents held by sender: None.