Pyrexia

INFLUENZA (FLUMIST) Side Effects Report # 337162
INFLUENZA (FLUMIST) side effect was reported on 01/13/2009. Female patient, child 6.0 years of age, was vaccinated with INFLUENZA (FLUMIST). After vaccination, patient experienced the following side effects: cough, oropharyngeal pain, pyrexia, streptococcal identification test, streptococcal identification test negative"PT PRESENTED TO OFFICE ON 12-24-08 WITH C/O SORE THROAT, COUGH AND FEVER. STREP SCREEN PERFORMED, RESULTS NEGATIVE. DR. DX'D PT WITH POSSIBLE FLUMIST SIDE EFFECT.". NONE. PT SEEN FOR ROUTINE PHYSICAL.ECZEMA . During the same period patient was treated with NONE. Patient recovered.


INFLUENZA (FLUMIST) Side Effects Report # 337347
INFLUENZA (FLUMIST) side effect was reported on 01/14/2009. Female patient, child 6.0 years of age, was vaccinated with INFLUENZA (FLUMIST). After vaccination, patient experienced the following side effects: aphonia, asthenia, asthenia, barium swallow, blood albumin normal"SHE RECEIVED THE FLU SHOT IN MID-OCTOBER AND DISPLAYED A FEVER DURING VETERAN'S DAY WEEKEND WITH NO OTHER SYMPTOMS. SHE FELL OFF THE MONKEY BARS AT SCHOOL ON NOV 13 AND STARTED TO COMPLAIN OF TINGLING AND LOSS OF 'CONTROL' OF LIMBS ON RIGHT SIDE ON NOV 14. SHE STARTED LOSING HER VOICE NOV 30. SHE COMPLAINED OF HER HEAD TINGLING ON DEC 9 AND SUBSEQUENTLY WENT TO DOCTOR ON DEC 10 AND HAS HAD MRI'S, NERVE CONDUCTION TESTS, ETC AND WAS FINALLY DIAGNOSED WITH GBS ON/ABOUT DEC 12. 1/16/09-records received for DOS 12/10-12/13/08-DC DX: Guillain-Barre syndrome. Presented with C/O tingling all four extremities for about 4 weeks, back pain and leg pain. Day prior to hospitalization fell from monkey bar approximately 6 feet high. Subsequently C/O tingling in all 4 extremities. Seen by chiropractor. Few days later lost voice, whispery and hypophonic. DX: sciatica and recommended bedrest for 1 month. PE: reflexes absent ankle and knee jerk bilaerally.12/29/08-follow-up visit with neurology, after 12/25/08 developed left facial palsy and at time of visit nearly resolved. Voice remains with whisper and occasionally chokes on liquids. Jerky gait. Mild weaknesses throughout. 1/9/09-admitted with multiple cranial nerve palsy. Began IVIG. Discharged 1/13/09.". NONENONE"NERVE CONDUCTION, MRI, BARIUM SWALLOW TEST, 1/16/09-records received-CSF: protein 77, glucose 52.NCV abnormal, F-wave. MRI normal. Nerve conduction studies and electromyelography:general acquired sensorimotor polyneuropathy, mixed. CBC, BM" . Patient was hospitalized Patient recovered.

INFLUENZA (FLUMIST) Side Effects Report # 338532
INFLUENZA (FLUMIST) side effect was reported on 12/19/2008. Male patient, child 4.0 years of age, was vaccinated with INFLUENZA (FLUMIST). After vaccination, patient experienced the following side effects: abdominal pain upper, fatigue, influenza, influenza serology positive, oropharyngeal pain"A non serious spontaneous report of influenza A, fatigue, fever, sore throat, and stomach ache has been received from a physician concerning a four-year-old male subsequent to FLUMIST. This case is submitted in accordance to a post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The patient's past medical history included an enterovirus on the 04-Nov (year unreported). The patient received FLUMIST 0.2ml intranasally for influenza vaccine on 22-Oct-2008. On 14-Dec-2008, the patient experienced fatigue, fever, a=sore throat, stomach ache, and was positive for Influenza A on 150Dec-2008, when tested with BIONEX rapid Influenza A&B test. On 15-Dec-2008, she had a negative rapid streptococcal test and a urinalysis revealed large ketones. The patient was treated with oseltamivir phosphate and was sent home to be followed up in one week. The events resolved on an unreported date in 2008.". "Enterovirus, 11/04, (unreported year)""Influenza A, B, 12/15/08, influenza A, positive; Rapid Strep test, 12/15/08, negative; Urinalysis,12/15/08, Large Ketones" . Patient recovered.

INFLUENZA (FLUMIST) Side Effects Report # 338640
INFLUENZA (FLUMIST) side effect was reported on 01/28/2009. Female patient, child 8.0 years of age, was vaccinated with INFLUENZA (FLUMIST). After vaccination, patient experienced the following side effects: abasia, acute disseminated encephalomyelitis, anion gap increased, antibody test negative, aphasia"Pt has received FLUMIST in previous years. Received FLUMIST 1/15/09. Seen in ER 1/17/09 for presumed viral illness. Admitted to PICU 1/19/09 with encephalomyelitis. 3/25/09 Received hospital medical records of 1/19-2/9/2009. FINAL DX: viral meningeal encephalitis Records reveal patient experienced pharyngitis before Christmas, tx w/oral antibiotics, improved then relapsed & tx w/second round of oral antibiotics. Improved & given flu shot. Developed sore throat, cough, fever, runny nose& URI s/s again. Seen in ER 1/17 & dx w/viral syndrome. D/C to home then developed dizziness, falls, HA, emesis, eye deviation to right, sudden onset of inability to walk or talk. Episodes of unresponsiveness thought to be seizures. Neuro & ID consults done. Admitted PICU. Tx w/IV antibiotics, antivirals, steroids, antiseizure meds w/limited improvement. Feeding tube inserted. Labs & clinical status improved slowly but remained nonverbal w/very limited movement & unable to walk unassisted w/unsteady gait. Transferred to rehab.". None PMH: hypocalcemia resolved; fever requiring hospitalization; developmental delays & in special ed class. Had received flu shot prior years w/o reaction. Family hx: congenital heart defect."Bact'l cultures (-). Viral panel (-). DFA (-). MRI c/w acute disseminated encephalomyelitis LABS:WBC 7.9(N), lymphs 27.7(L). Creatinine 0.42(L), anion gap 17(H). CSF: RBC 130(H), WBC 520(H), lymphs 92(H), monos 5(L), glucose 51(N) & pr" . Patient was hospitalized Patient recovered.

INFLUENZA (FLUMIST) Side Effects Report # 339297
INFLUENZA (FLUMIST) side effect was reported on 02/09/2009. Female patient, child 2.0 years of age, was vaccinated with INFLUENZA (FLUMIST). After vaccination, patient experienced the following side effects: febrile convulsion, full blood count normal, laboratory test normal, lethargy, pyrexiaVaccine on 25-09 2-6-09 fever (elevated to 104.7 rectally - ER notes) lethargy > febrile seizure. NoneHistory of GE reflux"CBC, CMP, CT Brain Scan all normal" . Patient recovered.

INFLUENZA (FLUMIST) Side Effects Report # 341154
INFLUENZA (FLUMIST) side effect was reported on 02/01/2009. Female patient, 41.0 years of age, was vaccinated with INFLUENZA (FLUMIST). After vaccination, patient experienced the following side effects: chest x-ray normal, influenza like illness, pyrexia, wheezing, 3 days post immunization pt. c/o wheezing with exhalation. The Monday following 11/10 she came down with flu-like symptoms + fever 101 degrees. She saw her personal physician given Z Pack. 2 additional episodes in December + January treated with Z-Pack + OTC cold med CXR-negative in February.. None reportedNone reported . Patient recovered.


INFLUENZA (FLUMIST) Side Effects Report # 345407
INFLUENZA (FLUMIST) side effect was reported on 05/01/2009. Female patient, child 11.0 years of age, was vaccinated with INFLUENZA (FLUMIST). After vaccination, patient experienced the following side effects: abdominal pain, abdominal pain upper, anorexia, biopsy intestine normal, biopsy oesophagus abnormal"Vomiting, indegestion, lack of appetite, weightloss, dizziness, abdominal pain, fever, fainting, listlessness and nausea. This lasted from date of vaccine in January until end of March.She went to the Pediatrician three times, the Pediatric Gastroenteroligist, a Chiropractor and a surgeon. She underwent two blood tests, had a stool sample, an ultrasound and a Endosopy with no results found. She took several anti nausea vmiting medicines, took over the counter medications for her nausea and indigestion. 5/5/05 Records received DOS 1/7/09 to 3/7/09. Includes immunization records. FINAL DIAGNOSIS: Post vaccination: Flu-like symptoms, fever, chills, nausea and vomiting. Diarrhea. Later developed epigastric pain. Foul smelling flatus. LABS: MCV low, Abdominal Ultrasound WNL 5/11/09 Gastroenterology records received DOS 2/9/09 to 2/19/09. FINAL DIAGNOSIS: Abdominal pain, nausea, vomiting Post vaccination: Flu-like symptoms, fever, chills, nausea and vomiting which subsided, followed one week later with recurrence of nausea, and development of epigastric abdominal pain, diarrhea. Progressed to persistant vomiting, epigastric pain, and severe nausea. Frequent foul smelling flatus.". None"Lactose intolerance, nocternal enuresis, hypothyroidism""Ultrasound, Endoscopy, Blood tests and stool sample 5/5/05 Records received DOS 1/7/09 to 3/7/09. LABS: MCV low, Abdominal Ultrasound WNL 5/11/09 Gastroenterology records received DOS 2/9/09 to 2/19/09. LABS and DIAGNOSTICS: Endoscopy" . During the same period patient was treated with None. Patient recovered.