Pyrexia

INFLUENZA (FLUZONE) Side Effects Report # 336385
INFLUENZA (FLUZONE) side effect was reported on 01/02/2009. Female patient, child 0.5 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: diarrhoea, pyrexia, vomiting, , Approximately 8 hours after receiving vaccines child spiked fever of 104 degrees(rectal) with vomiting and diarrhea. Twin sister had fever spike as well without the vomiting and diarrhea. Mother took both children to urgent care and was told by the attending physician that is was likely caused by the flu vaccine. Child was treated with alternating tylenol and motrin with resolution three days later.. None. Information in #14 entered in error. No vaccinations given within 4 weeks of the date listed in #10 but unable to deletnone . During the same period patient was treated with none. Patient recovered.


INFLUENZA (FLUZONE) Side Effects Report # 336386
INFLUENZA (FLUZONE) side effect was reported on 01/02/2009. Female patient, child 0.5 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: pyrexia, , , , Received vaccines along with twin sister and spiked a fever of 103 degrees (rectal) within 8 hours after administration. She wasn't having the vomitting and diarrhea that her sister was experiencing but she was also seen by physician at urgent care. Attending physician told parents that it was from the flu vaccine. Continued with what mother describes as low grade fever for approximately three days.. NoneNOne . During the same period patient was treated with None. Patient recovered.

INFLUENZA (FLUZONE) Side Effects Report # 336626
INFLUENZA (FLUZONE) side effect was reported . Male patient, child 0.6 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: bacteraemia, blood culture positive, csf glucose normal, csf pressure increased, csf protein increased"This is a previously health 8-month-old boy with a 2-week history of runny nose and cough without fever. Three days prior to admission he developed a fever which has been a T-max of 103. He was seen in the emergency department at his referring hospital two days prior to this admission at which point he was diagnosed with bilateral otitis media. Labs were not drawn at that time. He was started on azithromycin orally for which he had received two doses when he returned to the emergency department last night due to persistent fever and irritability. At that point his bulging fontanelle was noticed and he was empirically given a dose of IM ceftriaxone 100 mg hg. Note that a lumbar puncture was attempted and yielded only a few drops of apparently bloody CSF. It is unclear to me in talking with the lab whether this was actually received by the lab. A blood culture was obtained and that is pending. Finally a urine culture was obtained, but the lab also does not have this specimen. The patient was then transported by a team originating from that hospital. He had an 10 in place as both peripheral and central access were unsuccessful. 1/6/09-records received for DOS 11/22/08-12/29/08-DC DX: Streptococcus meningitis. Streptococcus Bacteremia.admitted with C/O two week history of rhinorrhea and cough and 3 day histoy of fever to 103. Bilateral otitis media 2 days prior to admission. Irritability. Bulging fontanelles.". None 1/6/09-records received-two week history of rhinorrhea and cough and 3 day histoy of fever to 103. Bilateral otitis mediaCrytorehism (rt)"1/9/09-records received-Urine culture negative. Lumbar puncture increased protein of 317, increased opening pressure, WBC 741 with 71 polys and normal glucose. CSF gram positive cocci in pair. Blood culture streptococcus pneumoniae. WBC 20." . During the same period patient was treated with None. Patient was hospitalized Patient recovered.

INFLUENZA (FLUZONE) Side Effects Report # 336785
INFLUENZA (FLUZONE) side effect was reported on 01/07/2009. Male patient, child 1.0 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: bacterial sepsis, death, pyrexia, , "Patient seen on 12/18/08, received immunizations, had low grade fever next day and then was brought to ER lifeless. 2/17/09-records received COB bacterial sepsis. Other significant conditions contributing to death but not related to terminal conditions:sickle cell anemia trait. krk". "None, healthy""Extra digit both hands at birth - tied; H/O drugs use in, child was in D 2/17/09-records received-sickle cell anemia trait" . During the same period patient was treated with None. Patient died on 9//08/12/1.

INFLUENZA (FLUZONE) Side Effects Report # 336973
INFLUENZA (FLUZONE) side effect was reported on 01/09/2009. Female patient, child 1.1 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: pyrexia, rash generalised, , , "Rash over body started 1/8/09, worsened 1/9/09. Fever.". OtitisNoneNone . During the same period patient was treated with AMOXIL. Patient recovered.

INFLUENZA (FLUZONE) Side Effects Report # 337071
INFLUENZA (FLUZONE) side effect was reported on 01/12/2009. Male patient, 14.0 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: muscular weakness, pain in extremity, pyrexia, vision blurred, "Four hours after vaccination, patient complained of sore arm, then started to complain of wobbly legs, blurred vision, and had high fever, and lasted 24 hours. (as reported by mother)". none . Patient recovered.


INFLUENZA (FLUZONE) Side Effects Report # 337094
INFLUENZA (FLUZONE) side effect was reported on 01/12/2009. Male patient, child 1.4 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: injection site warmth, pyrexia, vomiting, , "Vomiting, fever, Heat @ site.". NoNo . Patient recovered.

INFLUENZA (FLUZONE) Side Effects Report # 337132
INFLUENZA (FLUZONE) side effect was reported on 01/08/2009. Female patient, child 1.8 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: alanine aminotransferase increased, aspartate aminotransferase increased, blood creatinine decreased, chest x-ray abnormal, computerised tomogram abnormal"Developed cold, cough, vomiting after Influenza vaccination, requiring hospitalization for Pneumonia. 1/26/2009 MR received for DOS 12/15/2008-1/xx/2009. No D/C Summary sent since pt still hospitalized. DX: Pneumonia. S/P Respiratory Failure with intubation. Pt presented with worsening fever, SOB and cough x 2 days. PE (+) for dry mucous membranes,nasal flaring, retractions and grunting. O2 sat 88% on RA. Started on O2 NC then later intubated for further respiratory decline. May require tracheostomy. TX abx. Still hospitalized.". NoneCutis Laxa; congenital disorder of Glycosylation. PMH: Autosomal recessive cutis lax due to congenital defect of glycosylation. Pneumonia. G-tube. Hypotonia"Labs and Diagnostics: CXR (+) for likely atelectasis. CT chest (+) for marked volume loss L lung. pH probe (+) for mild reflux. Resp cx (+) Psuedomonas aeruginosa. Brain MRI (+) for ventriculomegaly. Echo WNL. CBC with normal WBCs. RBC, Hc" . Patient was hospitalized Patient recovered.

INFLUENZA (FLUZONE) Side Effects Report # 337421
INFLUENZA (FLUZONE) side effect was reported on 01/12/2009. Female patient, 53.0 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: injection site cellulitis, pyrexia, vomiting, , "Pt developed cellulitis on the site of Pneumococcal vaccine with fever, vomiting 01/9/09. 11 1/2 hours after the shot treated with Abx augmentin.". NoDiabeticNone . During the same period patient was treated with None. Patient recovered.

INFLUENZA (FLUZONE) Side Effects Report # 337496
INFLUENZA (FLUZONE) side effect was reported on 01/15/2009. Male patient, child 0.9 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: bacteria urine, blood creatinine increased, blood creatinine normal, chest x-ray normal, convulsion"On 1-14-09 per mother at 10:30 pm she felt infant & he was hot. She gave Tylenol and child had seizure. Child taken to ER by ambulance with temp of 102.3 F, pulse 157, R 28, 99% O2 RA. Tylenol given in ER. Seizure lasted approximately 3 minutes. Child delivered to home at 01:39 AM. Temp 99.9 F. Mom called me on 1-15-09. This sibling's fraternal twin was vaccinated at same time with same vaccines and had no difficulties. Mom said no redness at sites and no other s/s.". NoneNoneBMP creatinine 0.3 mg/dl; Hgb 12.1 g/dl; Hct 36.7%; CXR = WNL; UA-bacteria moderate; CBC - WBC 12.7 x/cmm; RBC 4.34 mb/cmm; temp 102.3 on adm to ER final dx: febrile seizure. . Patient recovered.

INFLUENZA (FLUZONE) Side Effects Report # 337541
INFLUENZA (FLUZONE) side effect was reported on 01/12/2009. Female patient, child 4.0 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: headache, pyrexia, rash erythematous, rash macular, "1/5/09 received DTAP, IPV, MMR,Volvox and flu 1/6/09 T100.3 1/7/09 0 fever 1/8/09 fever to 104 lasting 3 day associated with headache 1/11/09 blotchy pink rash on trunk last < 2 yo 1/12/09 Barely visible residual rash and febrile.". NoneKeratosis plans . During the same period patient was treated with "Tylenol, Motrin". Patient recovered.

INFLUENZA (FLUZONE) Side Effects Report # 337602
INFLUENZA (FLUZONE) side effect was reported on 01/16/2009. Male patient, 67.0 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: cellulitis, chills, lymphadenopathy, oedema peripheral, pyrexia"Patient presented with cellulitis of right arm associated with swelling and axillary lymphadeopathy. Patient reported fever, chills at home.". n/a . Patient recovered.

INFLUENZA (FLUZONE) Side Effects Report # 337669
INFLUENZA (FLUZONE) side effect was reported on 01/19/2009. Male patient, child 1.0 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: brain oedema, cardiac arrest, chest x-ray abnormal, corneal reflex decreased, croup infectious"Pt given HIB #4; PREVNAR #4; Hepatitis A #1; MMR #1; Varicella #1 and Influenza #1 on 11-17-08. Pt presented one week later "barely breathing"; flacid and unresponsive to verbal-painful stimuli at 1755-transferred-died at local hospital a couple of hours later. 2/12/09 PCP and hospital records received from FDA. Pt with mild fever 11/24/08 put down to nap. Ptfound to be diaphoretic, limp, minimally breathing and non-interactive in crib. Upon arrival of EMS pt noted to be unresponsive to stim, satring with no blink response, pulse 160, RR 32 with rhonchi bilaterally R>L. Dx with severe croup at local hospital with transport planned to higher level of care. In ER unresponsive in severe respiratory distress, skin mottled, O2 sats 80s-90s on pale toes. Arrived to transfer hospital unresposive to pain, lethargic, initially flaccid then posturing, (+) cervical lymphadenopathy, resp distress with stridor and rhonchi- intubated. Impression- Respiratory Failure. Cardiac arrest. CPR unsuccesful. 3/25/09 Autopsy report received with COD: Community Acquired Pneumonia. Manner of Death: natural. Final DX: 1) Acute hemorrhage pneumonia, multifocal, community acquired- a) Diffusely firm, edematous and hemorrhagic lungs, bilaterally. b) Histologic exam confirms purulent multifocal pneumonia. 2) Moderate Cerebral Edema. 3) Serous Pleural and Peritoneal Effusions.". None - normal"? slight allergy 6-10-08; Hx otitis media . PMH: PCP records reveal normal childhood illnesses (OM, URI, bronchits) in 1st yr of life. Excessive wt gain noted at 3 months.""Labs and Diagnostics: CXR (+) for R pneumpthorax, pneumomediastinum, and probable L pneumothorax." . During the same period patient was treated with None. Patient died on 4//08/11/2.

INFLUENZA (FLUZONE) Side Effects Report # 337681
INFLUENZA (FLUZONE) side effect was reported on 01/19/2009. Male patient, child 0.9 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: injection site erythema, injection site mass, injection site pain, irritability, pyrexia"Localized redness, lump, tenderness at right thigh. Fever 99-102.6. Vomiting x 1 on 1/14/09. Irritable and cranky. Treated with TYLENOL-MOTRIN. Symptoms started 1/14/09.". NoneNoneNone . During the same period patient was treated with None. Patient recovered.


INFLUENZA (FLUZONE) Side Effects Report # 337759
INFLUENZA (FLUZONE) side effect was reported on 01/05/2009. Male patient, child 1.3 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: irritability, pyrexia, rash maculo-papular, viral skin infection, "Patient developed fever, irritability and rash on 12-31-08. Parent took child to ER. ER MD noted fever and maculopapular rash diagnosed viral exanthem or possible chicken pox.". NoneNone . Patient recovered.

INFLUENZA (FLUZONE) Side Effects Report # 337780
INFLUENZA (FLUZONE) side effect was reported on 01/21/2009. Male patient, 29.0 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: arthralgia, asthenia, dyspnoea, fatigue, pain in extremity"16 Jan 09 arms were sore. 17 Jan 09 felt conjested. 18 Jan 09 more conjested 19 Jan 09 felt conjested and run down. 20 Jan had conjestion fever weakness fatigue dyspnea and joint pain, and went to the ER that night.". NOPCN . During the same period patient was treated with NO. Patient recovered.

INFLUENZA (FLUZONE) Side Effects Report # 337800
INFLUENZA (FLUZONE) side effect was reported on 01/10/2009. Female patient, 50.0 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: erythema, full blood count, oedema peripheral, pyrexia, skin warm"Fever developed; Right arm red, swollen, hot from upper deltoid to mid humerus- started KEFLUX & ROCEPLIN 2gm 1mx 3 days -> improvement is WBC, SXS, arm redness & fever". UR1Allergic rhinitis.CBC; WBC 19.7 . During the same period patient was treated with Allergy ZITHROMAX - given 1/7 FORURX. Patient recovered.

INFLUENZA (FLUZONE) Side Effects Report # 338110
INFLUENZA (FLUZONE) side effect was reported on 01/23/2009. Male patient, child 1.0 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: condition aggravated, febrile convulsion, grand mal convulsion, laboratory test normal, otitis media"On 1/21/09 at the time of immunization, baby was seen and diagnosed with URI/(L)otitis media. Afebrile. During night of 1/22 developed fever of 102. On 1/23/08 about 7:30am had grand mal seizure. taken by ambulance to ACMH ER. temp 103.9 in ER. treated with antipyretics. dishcarged. Dx: acute febrile seizure/(L) otitis media. f/u PCP 2-3 days.". URI/left otitis mediapreemieRIFA-neg. pulse ox 98% . During the same period patient was treated with none. Patient recovered.

INFLUENZA (FLUZONE) Side Effects Report # 338282
INFLUENZA (FLUZONE) side effect was reported on 11/10/2008. Male patient, 52.0 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: chills, erythema, malaise, oedema peripheral, pyrexia"Pt received ADACEL RA upper deltoid, PNEUMOVAX RA lower deltoid. On 11/4/08 since vaccinations febrile, chilling. Has not felt well since. Negative cough, negative vomiting or diarrhea. RA lower redened size of tennis ball, red streak going inward around arm.". Recovering from left rotator cuff surg.NKDANone . During the same period patient was treated with Advil 800 TID; LISINOPRIL 10 mg QD; Simvastatin 40 mg QD; METFORMIN 500 mg QD; FEXOFENADINE 180 mg QD; FLONASE QD.. Patient recovered.


INFLUENZA (FLUZONE) Side Effects Report # 338296
INFLUENZA (FLUZONE) side effect was reported on 10/24/2008. Female patient, 58.0 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: asthenia, chills, disturbance in attention, dysgraphia, eye pain"Headache, weakness, decreased concentration, writing illegible, chills, stiffness lower extremities, muscle aching, fever 101 (although this was taken after client took hot bath for chills), eyes aching, nausea.". "None; BP, 109/66; P, 56" . Patient recovered.

INFLUENZA (FLUZONE) Side Effects Report # 338715
INFLUENZA (FLUZONE) side effect was reported on 01/30/2009. Female patient, 67.0 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: chills, fatigue, injection site pain, pyrexia, "Patient experienced soreness at the site where the Pneumovax was given (left deltoid). Client reports chills, fatigue, and fever of 103 degrees for about 6 hours immediately after immunization was given. Soreness remains at the site (left arm) over 3 months later. Client describes it as a "dull" sensation. Client reports soreness increases when affected arm is used (gardening, chores, etc). The soreness subsides but never has been completely alleviated since the vaccine was given". None"Allergy to Codeine (reaction: rash), Hypertension, Type II DM, Hypercholesterolemia."None . During the same period patient was treated with "Diovan 320 mg 1 PO daily; Zetia 10 mg 1 PO daily, Simvastatin 20 mg PO daily, Metformin 500 mg PO 2 tablets 2 x daily, glyburide 5 mg 1/2 tablet in morning and 1 tablet in evening, ASA 81 mg 1 PO daily, Multivitamin 1 PO daily, Fish oil 100". Patient recovered.

INFLUENZA (FLUZONE) Side Effects Report # 338716
INFLUENZA (FLUZONE) side effect was reported on 01/30/2009. Male patient, child 11.0 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: pyrexia, , , , Father reports fever of 100-103 for 3 days fllowing immmunization. afebrile today in clinic. URIAsthmaNone . Patient recovered.

INFLUENZA (FLUZONE) Side Effects Report # 338901
INFLUENZA (FLUZONE) side effect was reported on 02/03/2009. Female patient, 20.0 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: asthenia, chills, dehydration, diarrhoea, injection site swelling"48 hours after administration - Fever, Chills, Swelling at Injection site, Aches, Diahreah for 6 days. DR. visit then sent to ER for fluids for dehydration. Weakness and weight loss continues for about 2 weeks after.". noneCeliac Disease . During the same period patient was treated with none. Patient recovered.

INFLUENZA (FLUZONE) Side Effects Report # 339015
INFLUENZA (FLUZONE) side effect was reported on 02/04/2009. Male patient, child 2.0 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: full blood count normal, pain in extremity, pruritus, pyrexia, rash"Right leg pain, fever, vomiting, perioral- rash, Itching (scalp) > -acetaminophen (rectal) - warm compresses - ZYRTEC". "Food allergies, apples, peas, milk; mild asthma""CBC, normal, 2-4-09" . During the same period patient was treated with FLOVENT. Patient recovered.

INFLUENZA (FLUZONE) Side Effects Report # 339033
INFLUENZA (FLUZONE) side effect was reported on 02/04/2009. Male patient, child 1.3 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: diarrhoea, pyrexia, vomiting, , "Developed vomitting, diarrhea, and low grade temp withiin 12 hours of vaccine". . Patient recovered.

INFLUENZA (FLUZONE) Side Effects Report # 339108
INFLUENZA (FLUZONE) side effect was reported on 02/05/2009. Male patient, child 1.6 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: pyrexia, rash generalised, , , "Patient began febrile episode on 1/31 with fever up to 102.4 F lasting 3 days. Patient was taken to physician and upon examination no signs of infections noted. On 2/4 after fever subsided, rash appeared over entire body per parents. Rash remains on body as of today,2/5/09 with no other symptoms of reactions reported.". noneNone known . During the same period patient was treated with none known. Patient recovered.

INFLUENZA (FLUZONE) Side Effects Report # 339205
INFLUENZA (FLUZONE) side effect was reported on 02/05/2009. Male patient, 13.0 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: crying, injection site erythema, injection site swelling, irritability, pyrexia"Hep A site, fever 104, red, swollen injection site- less than 24 hrs. Patient irritable + crying frequently. Influenza site: Normal.". . Patient recovered.

INFLUENZA (FLUZONE) Side Effects Report # 339258
INFLUENZA (FLUZONE) side effect was reported on 02/02/2009. Male patient, 51.0 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: chills, pain, pyrexia, , "Body aches, fever (>100 degrees), chills-onset 8 hrs. After administration of FLUZONE. Lasted over night, until next A.M. Took Tylenol po.". None . During the same period patient was treated with ZOCOR qd. Patient recovered.

INFLUENZA (FLUZONE) Side Effects Report # 339263
INFLUENZA (FLUZONE) side effect was reported on 02/04/2009. Female patient, child 1.1 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: condition aggravated, pyrexia, rash erythematous, , "Morn after imm. child had fever 101, rash very red and much more prominent than usual. No vom or diarrhea. Took to doctors office at 11 AM. Doctor called and reported reaction was to one of the vaccines. Benadryl and Tylenol prn. 2/4 called mom to check on child and she is much better. Still has dry skin and rash as before imm. with derm. Will make appt.". Very dry skin and rash.Had seen derm for skin rash and to see again after 1 year of age.None . During the same period patient was treated with None. Patient recovered.


INFLUENZA (FLUZONE) Side Effects Report # 339282
INFLUENZA (FLUZONE) side effect was reported on 02/09/2009. Male patient, child 0.5 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: cyanosis, irritability, oedema peripheral, pyrexia, swelling face"Diffuse upper and lower extremity swelling and erythema when extemities are warm. Cyanosis of the swollen extremities when they are cool. Also facial swelling. Also, acting very cranky. Possible slight fever, but none now.". conjunctivitisnoneNone yet.. will obtain in 48 hours if not improved . During the same period patient was treated with occuflox eye drops. Patient recovered.

INFLUENZA (FLUZONE) Side Effects Report # 339464
INFLUENZA (FLUZONE) side effect was reported on 02/11/2009. Male patient, child 0.6 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: diarrhoea, irritability, pyrexia, vomiting, "Initial flu vaccine given 1-6-2009. Had fever for 48 hours and fussiness after that vaccine. Had 2nd dose of flu vaccine 2-9-2009. Within an hour or two developed vomiting, diarrhea and fever which persists through today. In addition to vaccines below had flu shot 2-9-2009, sanofi, lot U2764AA in left thigh". cold symptoms at time of 2nd flu shotnone . Patient recovered.

INFLUENZA (FLUZONE) Side Effects Report # 339579
INFLUENZA (FLUZONE) side effect was reported on 02/13/2009. Male patient, child 3.0 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: pain, pyrexia, vaccination complication, , Mother states he started a fever@ 1PM Fri. 1/30/09& by 8PM it was 104 degrees. Dr's office suggested alternating Motrin&Tylenol-it would go down then 4 hrs later up. Sat.1/31/09PM it was 105.8 degrees-went to ER-they got it down in a few hrs. Took him to Dr's office 2/2/09-No other signs of infection-He concludes it is a reaction to Flu shot. Fever continued till Wed.2/4/09. Today has some aches but NO fever.. NoneNone . During the same period patient was treated with None. Patient recovered.

INFLUENZA (FLUZONE) Side Effects Report # 339620
INFLUENZA (FLUZONE) side effect was reported on 02/11/2009. Female patient, child 1.1 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: culture throat, grand mal convulsion, pyrexia, , "Brief 1 minute seizure - tonic clonic associated with fever. No treatment except TYLENOL, MOTRIN for fever". URI-coldFEBRILE SEIZURE 1/14/09Neg - Throat Culture . During the same period patient was treated with IBUPROFEN. Patient recovered.

INFLUENZA (FLUZONE) Side Effects Report # 339928
INFLUENZA (FLUZONE) side effect was reported on 01/22/2009. Male patient, 28.0 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: chest discomfort, headache, injection site swelling, pain, pyrexia"Rash on (R) deltoid, fever, swelling at injection site, body aches, chest tightness, headache. Pt seen by PA at Medical Clinic on 1/22/09. Recommended Ibuprofen and Benadryl prn.". NonePCN allergyNone . During the same period patient was treated with None. Patient recovered.


INFLUENZA (FLUZONE) Side Effects Report # 339972
INFLUENZA (FLUZONE) side effect was reported on 02/11/2009. Male patient, child 1.1 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: decreased appetite, pyrexia, rash generalised, , "high fever x 3 nights (night only) (highest 104.5) slight rash all over body, not much appetite, no breathing difficulty". Unknownnone known . Patient recovered.

INFLUENZA (FLUZONE) Side Effects Report # 339982
INFLUENZA (FLUZONE) side effect was reported on 02/11/2009. Female patient, 33.0 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: pyrexia, vomiting, , , "Had Td and influenza vaccine on 2/9/08-started with vomiting, high fever approx. 2 hours after vaccine". NoneNoneNone . Patient recovered.

INFLUENZA (FLUZONE) Side Effects Report # 340019
INFLUENZA (FLUZONE) side effect was reported on 01/29/2009. Female patient, child 0.6 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: convulsion, pyrexia, , , "fever, seizure like activity". . Patient recovered.

INFLUENZA (FLUZONE) Side Effects Report # 340022
INFLUENZA (FLUZONE) side effect was reported on 01/28/2009. Male patient, child 1.1 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: measles, pyrexia, rash, , "patient received vaccines on 1-16-09- Hepatitis A, PREVNAR, influenza, and MMR. On 1-24-09 patient started with symptoms of rash, fever-rash started on face moving downward. (+) Koplik spots.". NoneNoneNone done . During the same period patient was treated with None. Patient recovered.

INFLUENZA (FLUZONE) Side Effects Report # 340170
INFLUENZA (FLUZONE) side effect was reported on 02/20/2009. Male patient, child 1.3 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: anorexia, asthenia, dermatitis acneiform, diarrhoea, ocular hyperaemia"Thursday Feb. 5, 2009 fever 102- C was the highest the fever and slight rash on face, no energy, red eyes not eating. Fr. Feb 6, 2009 fever and rash not on face moving to neck and chest. Saturday Feb 7, 2009 no fever but rash moved to chest and back. Urgent care in afternoon for vomiting and diarrhea. Monday Feb 9, 2009 rash still covering body, still not eating, no energy. Tuesday Feb 10, 2009 rash still covering body.". developmental delay . Patient recovered.


INFLUENZA (FLUZONE) Side Effects Report # 340577
INFLUENZA (FLUZONE) side effect was reported on 02/24/2009. Male patient, child 0.7 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: bacterial infection, blood culture positive, chest x-ray abnormal, cough, culture stool negative"Reported from mother: Pt was admitted to hospital 2-18-09 due to fever 104.6. Stated blood culture done in ER was (+) for bacterial infection. Repeat blood cultures on Friday were negative. Stool cultures done were negative. Pt was released home 2-21-09 in a.m. with Rx AZITHROMAX. Spoke with mother 2-24-09 states pt doing well with no fever and has been Tx with antbx. 2/25/09 MR received for DOS 2/19-21/2009 with DX: Fever w/o source. Leukocytosis. Pt presented with 2 day hx of fever. Received vax today and fever up to 104.6. PE (+) for cough and rhinorrhea, mild tachycardia. Admitted for observation and tx with abx.". 12-30-08 DX with RSV; 7-20-08 DX with GERD; 1/10/09 Acute Bronchitis PMH: RSV"1/10/09 WBC's increased 23.5 k/ul per PCP. Labs: WBC 17.9, 26% lymphs, 59.9% neutros. Flu (-). Strep (-). CXR (+) mild perihilar and peribronchial inflammatory changes c/w bronchitis early pneumonia." . During the same period patient was treated with Albuterol Nebulizer; Hx taking ZANTAC. Patient was hospitalized Patient recovered.

INFLUENZA (FLUZONE) Side Effects Report # 341150
INFLUENZA (FLUZONE) side effect was reported on 03/02/2009. Male patient, child 1.1 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: fall, muscular weakness, neurological examination normal, pyrexia, urticariaSee attached. Neurologist's assessment 2/20/09 - normal with coincidental viral infection with fever to 102 on day of visit 2/20/09.. NoneNoneSee attached . Patient recovered.

INFLUENZA (FLUZONE) Side Effects Report # 341569
INFLUENZA (FLUZONE) side effect was reported on 03/11/2009. Female patient, child 0.5 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: abdominal x-ray, abdominal pain upper, barium enema, constipation, gastroenteritis"10m 3 wk old had INTUSSUSCEPTION, had previously had 3 doses of Rotateq at correct schedule, last dose on 10/20/08 10/20/08-office visit-well baby exam. C/O constipation. 4/2/09-records received for DOS 3/9-3/9/09-DC DX:Febrile illness began on 3/6/09, seen in office normal physical exam, thought to have a viral infection. Fever broke and appeared fine. On day of admission woke up very irritable and acting like her stomach hurt, started vomiting, nonbilious. Seen in ED thought to have gastroenteritis. Returned later that afternoon after patient had a stool with bright red color and a second stool deeper red. Stool positive heme.". nono"4/2/09-records received-Unremarkable CMP, normal white count, low hemoglobin 10.5, unremarkable differential. Barium enema releived intussuception. Abdominal x-ray series demonstrates fairly prominent soft tissue density in upper midabdomen" . During the same period patient was treated with no. Patient was hospitalized Patient recovered.

INFLUENZA (FLUZONE) Side Effects Report # 341730
INFLUENZA (FLUZONE) side effect was reported on 03/13/2009. Male patient, child 1.3 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: allergy to vaccine, chills, lethargy, pyrexia, "Mother reports the following: Child had normal behavior throughout day until approximately 7 hours post vaccination, (7 PM) the child became lethargic and spiked a fever and started shivering. Acetaminophen was administered at 8:15 PM. Parents became worried and took child to the local ER for evaluation. There he was observed and given Prednisilone 4ml (15mg/5ml) po. In addition the child was encouraged to take fluids po. He was later D/C from ER with diagnosis of probable allergic reaction to influenza vaccine. Mother of child contacted via phone this date (03/13/09) and she reports that child exhibited no further symptoms and has returned to normal behavior.". NoCongenital cleft lip and palateNone . During the same period patient was treated with None. Patient recovered.

INFLUENZA (FLUZONE) Side Effects Report # 341731
INFLUENZA (FLUZONE) side effect was reported on 03/13/2009. Female patient, 55.0 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: axillary pain, chills, injection site swelling, pyrexia, "10/31/08 5pm c/o sore right armpit, took ibuprofen 800mg,11/1/08 3pm injection site size of a quarter, fever & chills, temp 101 degree: 11/2/08 injection site size of palm of hand taking ibuprofen q 4 hr; 11/3/08 injection site measured by PHN 18.5cm wide, 15 cm long, temp 98.7; resolved by 11/10/08". NONONE . During the same period patient was treated with NONE. Patient recovered.

INFLUENZA (FLUZONE) Side Effects Report # 341889
INFLUENZA (FLUZONE) side effect was reported on 03/01/2009. Male patient, child 5.0 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: abdominal discomfort, abdominal distension, arthralgia, blood pressure decreased, c-reactive protein normal"By 11/28 evening upper left arm was red, swollen, itchy. Following day, more swelling, hot to touch, very itchy. 4 a.m. 12/14, severe swelling in knees, wrists, entire left arm huge and hot, hives over whole body, fever, itchy pain. ER, vomiting, dropping blood pressure, swelling and rash whole body. Dx serum sickness. Symptoms lasted 3-4 weeks. 2 days in hospital. Wheezing, swollen lips, trouble walking. A lot of joint pain. 3/20/09 Received PCP medical records of 12/3/08-3/2/2009. FINAL DX: serum sickness, amoxicillin vs vaccines Records reveal patient w/persistent cough & postnasal drip x 3-4 wks when seen 12/3 w/poor sleep secondary to cough. Initially had URI w/croup, phlegm now dx w/sinusitis & tx w/oral antibiotics. Exam on 12/12 was well child, had been seen in OT but stopped some time prior, being watched for social lag. RTC 12/16 s/p hospital admit visit for swelling of lips, knees & wrists. Tx w/nebs & antihistamines. Now had tongue tickling, sleepiness, urticarial rash all over, left arm very swollen, purplish, hot, swollen joints. Followup w/allergist. Allergy consult 1/9/09. FINAL DX: serum sickness like reaction likely penicillin allergy Suggested patient have FluMist in future. Continued to have wheezing & tx w/nebs. Abdominal distension/discomfort was likely due to constipation. Had trace proteinuria in hospital & UA repeated but not included. Was to return in 2 wks. 4/10/09 Received hospital medical records of 12/14-12/15/2008. FINAL DX: serum sickness Records reveal patient experineced pruritic erythematous maculopapular lesions and red swollen left arm, bilateral knee pain w/swelling x 2 days. Tx w/antihistamines, NSAIDs & nebs. Had orthostatic hypotension w/dizziness & nausea/vomiting in ER & tx w/IVF w/improvement. D/C to home w/PCP f/u. Clinic visit 12/29/2008 s/p hospitalization. FINAL DX: serum sickness like reaction, suspect amoxicillin reaction Doing well w/rare use of NSAID for joint pain, daily zyrtec & intermittent albuterol for coughing. Meds were". "Cough (lingering) ("sinusitis")""none PMH: recent sinusitis & on amoxicillin at admit. Hives, viral illness, bronchitis, OM, nosebleeds. Family hx: eczema, hypothyroidism, GERD, IBS.""Serum Sickness LABS:WBC 15.85(H), lymphs 22.0(L), neutros 72.4(H). ESR 5(N), CRP<0.5(N). Complement C3(N), C4 15.4(L). UA w/trace ketones/protein." . During the same period patient was treated with "amoxicillin, Day 10". Patient was hospitalized Patient recovered.

INFLUENZA (FLUZONE) Side Effects Report # 342275
INFLUENZA (FLUZONE) side effect was reported on 03/20/2009. Male patient, child 1.3 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: blood culture, culture urine, full blood count, pyrexia, Fever up to 105. Few red papular scattered on chestNoneCBC. Blood and urine cultures . During the same period patient was treated with None. Patient recovered.

INFLUENZA (FLUZONE) Side Effects Report # 342289
INFLUENZA (FLUZONE) side effect was reported on 03/13/2009. Female patient, child 0.5 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: dehydration, full blood count, metabolic function test, pyrexia, vomiting"Vomiting, fever to 103 degrees. Fever was noted (rectal) 102.7 on admit to ER, uncontrollable vomiting. Dehydration. Neuro signs intact. Received IV fluids, ZOFRAN 1 mg IVP and TYLENOL 110mg.". ""stuffy nose""GE RefluxCBC; CMP . During the same period patient was treated with None. Patient recovered.

INFLUENZA (FLUZONE) Side Effects Report # 342800
INFLUENZA (FLUZONE) side effect was reported on 03/26/2009. Male patient, child 1.9 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: chest x-ray, febrile convulsion, full blood count, pyrexia, Fever ; Febrile Seizure. CoughNoneCBC + CXR . Patient recovered.

INFLUENZA (FLUZONE) Side Effects Report # 342868
INFLUENZA (FLUZONE) side effect was reported on 03/28/2009. Male patient, child 4.0 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: arthralgia, full blood count normal, gait disturbance, haemoglobin normal, injection site pain"Received Flu vaccine on 3/12/09. Had R leg pain starting on 3/18 and fever on 3/17. Seen in the office on 3/19 and noted to be walking slowly on toes, mainly wanting to be carried every where. On exam he had pain in hip with internal and external rotation, but no tenderness. CBC and ESR normal. I suspect he has transient synovitis. I called home today - a couple days after I saw him he was fine to 2 days. since that time he has intermittently c/o hip pain. Never as severe as on 3/19.". noneAsthma"see above - ESR 7, WBC 7.0 with 2 Bands, 36 SEGS and 43 lymph and 14 MONO. Hgb 12.9" . During the same period patient was treated with pulmicort and or albuterol. Patient recovered.

INFLUENZA (FLUZONE) Side Effects Report # 343308
INFLUENZA (FLUZONE) side effect was reported . Male patient, 84.0 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: blood culture negative, brain natriuretic peptide normal, chest x-ray normal, chills, computerised tomogram abnormal"Complete loss of control - 9-13-08. Hospitalized five days. Diagnosed virus syndrome. Home doctor said had Guillain Barre syndrome. 4/8/09 Received hospital medical records of 10/5-10/8/2008. FINAL DX: probable viral syndrome; dental abscess. Records reveal patient experienced generalized weakness, muscle pain, chills, productive cough, fever 101, toothache x 2 days. Tx w/antibiotics. ID consult done. Fever thought to be from dental abscess. D/C on continued oral antibiotics & referred to dentist & PCP. 4/20/09 Received vaccine & PCP medical records of 10/27-10/30/09. FINAL DX:viral syndrome, improved. Records reveal patient received flu vaccine on 10/2/08. RTC 10/27 seen s/p hospitalization w/no new c/o. RTC 10/30 w/persistent fatigue & body aches. Supportive tx given. No further med records available.". None"None PMH: HTN, CKD, pneumonia, chronic SDH s/p head trauma, BPH, cardiac disease. Ex-smoker. Allergy: lidocaine.""Community Hospital - virus syndrome LABS: Neutros 83.5%, lymphs 9.1%. H/H 13.0/28.1(L). BMP, BNP, troponin, UA, CXR WNL. Blood & urine c/s neg. MRI & CT head WNL & c/w old chronic SDH s/p left craniotomy. Carotid US WNL." . During the same period patient was treated with None. Patient was hospitalized Patient recovered.

INFLUENZA (FLUZONE) Side Effects Report # 343309
INFLUENZA (FLUZONE) side effect was reported on 04/01/2009. Female patient, child 0.9 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: acute disseminated encephalomyelitis, altered state of consciousness, aspiration tracheal, atelectasis, blood culture negative"Acute disseminated encephalomyelitis about 1 week after shot. Fever started. Extreme irritability and screaming. Altered state of consciousness 12 days after. ADEM diagnosed 14 days after, shot and high-dose steroids given. 5/11/09 hospital records received for DOS 12/14/08-1/6/09. FINAL DIAGNOSIS: Acute Disseminated Encephalomyelitis Transferred from another hospital. Altered mental status, quiet whine. Fever, downward gaze with vertical nystagmus. Subsequently intubated for respiratory distress and stridor. Impaired movement of extremities. Stiffening right side of body. Seizures.". NoneNone"5/11/09 hospital records received for DOS 12/14/08-1/6/09. LABS and DIAGNOSTICS: On admission: Normal WBC, LP negative for meningitis, CSF viral culture (-), CT scan brain negative for mass, bleed, hydrocephalus. 12/15/08 CT scan head foca" . During the same period patient was treated with None. Patient was hospitalized Patient recovered.

INFLUENZA (FLUZONE) Side Effects Report # 343314
INFLUENZA (FLUZONE) side effect was reported on 03/30/2009. Male patient, child 1.0 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: lymphadenopathy, pyrexia, rash, rash, rash erythematous"Patient developed fever up to 103.2 F rectally on 3/26/2009 - and an erythematous papular rash - descendant - started on face on 3/27/09. Fever resolved on 3/28/09. Rash is less prominent but still present today, on trunk/limb. Child also has small retruauricular adenopathies, soft, nontender.". NoneAllergic Rhinitis/one episode of RAD. . During the same period patient was treated with None. Patient recovered.

INFLUENZA (FLUZONE) Side Effects Report # 343323
INFLUENZA (FLUZONE) side effect was reported on 04/01/2009. Female patient, child 1.0 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: irritability, pyrexia, , , "fever of 101 degrees, rubbing @ head, increased fussiness There is a question of secondary viral illness". nonenone . Patient recovered.

INFLUENZA (FLUZONE) Side Effects Report # 343330
INFLUENZA (FLUZONE) side effect was reported on 03/27/2009. Male patient, child 12.0 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: dizziness, dizziness, fatigue, feeling hot, hyperhidrosis"Home visit B/P 106/60 Temp 98.4 Pulse 72 Resp. 20 - c/fired, dizzy. c/o feeling hot and sweating on & off. 1245 T malise 1245 T.C. to mother child taken to hospital informed of vaccine given and c/o melaise, feeling hot/sweaty - Imm. info 9:00 to MD and child felt faint ammonia given to inhale. Lasted x 20-25 min.". . Patient recovered.

INFLUENZA (FLUZONE) Side Effects Report # 343532
INFLUENZA (FLUZONE) side effect was reported on 04/02/2009. Male patient, child 8.0 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: abdominal pain upper, headache, influenza, influenza serology, pyrexia"This non serious case was received on 24 February 2009 from a health care professional. A nine year old patient received the INFLUENZA vaccine (manufacturer and lot number not reported) on an unspecified date. On an unspecified date the patient was diagnosed with flu strain B. No further details were provided. Recovery status was not provided. Follow-up information received 24 March 2009 from a health care professional. Based upon this new information received, this case meets seriousness criteria and has been upgraded to serious. The patient received a left deltoid injection of FLUZONE SV 2008-2009 (route not reported), lot number U2828AA on 20 November 2008 and 96 days later, he developed Flu Strain B with symptoms of headache, stomach pain and fever on 24 February 2009. A rapid flu test had been performed in the doctor's office and TAMIFLU was prescribed as corrective treatment. The patient had no illness at the time of vaccination. At the time of the report, the patient's recovery status was unknown. According to the reporter, the patient had a past history of "Flu" at eight-years of age following receipt of an unspecified INFLUENZA vaccine (manufacturer, lot number, route/site and date of administration not reported). No additional information was provided. List of Documents held by Sender: none.". "Not reported. From information received 24 March 2009, the patient had received two doses of INFLUENZA vaccine in the past. The patient also had a past history of the "Flu" at eight years of age following receipt of an unspecified INFLUENZA vaccination.""Not reported. From information received 24 March 2009, a rapid flu test was performed in the doctor's office." . Patient recovered.

INFLUENZA (FLUZONE) Side Effects Report # 343927
INFLUENZA (FLUZONE) side effect was reported on 12/31/2007. Male patient, child 1.0 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: anorexia, convulsion, electroencephalogram, nuclear magnetic resonance imaging, pyrexia"low appetite, fever, seizure". nonelaryngomalacia-resolved"MTI, EEG" . During the same period patient was treated with none. Patient recovered.

INFLUENZA (FLUZONE) Side Effects Report # 344265
INFLUENZA (FLUZONE) side effect was reported on 04/16/2009. Male patient, child 1.6 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: blister, ear infection, injection site erythema, injection site mass, injection site painLARGE RED LUMP WITH BLISTER L POSTERIOR UPPER ARM QUARTER SIZE DIAMETER. PAINFUL TO TOUCH. 3 SMALL BLISTERS AT L ELBOW. DEVELOPED 4/15/09. PT HAD STUFFY RUNNY NOSE WITH SLIGHT COUGH FOR 4 DAYS PRIOR TO DATE OF VACCINATION 4/2/09. TEMP 98.6 LUNGS CLEAR HEENT WNL..GETTING BETTER.4/7/09 PT DEVELOPED 103 FEVER WENT TO PMD DR 4/10 DX OTITIS PLACED ON AMOXICILLIN. 4/16/09 PT STILL HAS BLISTER TYPE RASH.. STUFFY NOSE FOR 4 DAYS WITH SLIGHT COUGH . Patient recovered.

INFLUENZA (FLUZONE) Side Effects Report # 344435
INFLUENZA (FLUZONE) side effect was reported on 04/20/2009. Female patient, child 1.0 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: bacteria urine, blood culture negative, blood urine present, bronchiolitis, c-reactive protein increased"vaccines admin 01/08/09, pt started with fever 01/09/09 3:00am - Mom states pt was "burning up" and guessed fever at 100 (did not measure it). Gave Tylenol. Then "spiked" fever at 5:00am, had a seizure and squad was called. Taken to Emergency room, and admitted for 3 days. Had a total of 3 seizures, but none after fever controlled with alternating Tylenol / Motrin at the hospital. Mom unsure if she was giving the appropriate dose of Tylenol at home. Mom stated "tests all came back fine but the doctor at the hospital said pt should have never gotten 8 shots". 4/21/09 MR received for DOS 1/9-11/2009 with D/C Dx: Acute Febrile seizure. Acute febrile illness. Bacteruria. Metabolic acidosis 2' to seizure or dehydration. Pt presented on the morning after vaccines with fever and several episodes of seizure. Pt initially seen by parent shaking with eyes rolled back. EMS called and pt had another episode in ambulance and one in ER. Tx with IV abx for ? UTI with improvement. No further seizures. D/C on po abx.". none reportednone reported PMH: RAD"Labs: UC (+) for mixed growth. UA (+) for blood, RBCs, 2-4 WBCs, many bacteria, trace ketones and 30 protein. Blood cx (-). CXR (+) for viral bronchiolitis. CRP 1.4" . During the same period patient was treated with unknown. Patient was hospitalized Patient recovered.

INFLUENZA (FLUZONE) Side Effects Report # 344477
INFLUENZA (FLUZONE) side effect was reported on 04/17/2009. Female patient, child 0.7 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: cough, crying, dyskinesia, irritability, nasopharyngitis"03/21/2009 started with cold & cough, gave TYLENOL for fever. On 3/26/09 Baby was very irritable R side of body- hand & leg would jerk simultaneously every 1/2 hour. Irritability & crying increased went to ER 3 27 09 gave given IV fluids and hosp. was told due to "shots"". NoneNone . During the same period patient was treated with None. Patient recovered.

INFLUENZA (FLUZONE) Side Effects Report # 344539
INFLUENZA (FLUZONE) side effect was reported on 04/21/2009. Male patient, child 6.0 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: erythema, haematoma, head injury, pyrexia, rashChild received PPD and Flu vaccine 4-15-09.Next day he developed fever.Red rashes developed on forehead.Mom gave a dose of benadryl elixir 1 tsp and rash seem to come down a little.That same morning he bumped his head on the bed railing and sustained a little hematoma on forehead.. nononone . Patient recovered.

INFLUENZA (FLUZONE) Side Effects Report # 348338
INFLUENZA (FLUZONE) side effect was reported on 06/02/2009. Male patient, child 1.0 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: diarrhoea, electroencephalogram normal, motor dysfunction, nuclear magnetic resonance imaging normal, pyrexia"Developed diarrhea for 3 weeks, fever, speech and motor regression, has been evaluated for autism by specialist, results inconclusive. MRI and EEG were normal.". "35 week twin gestation, IUGR, h/o maternal chlamydia and tobacco, mom with diet controlled gestational diabetes, breech delivery, h/o cellulitis R ankle MRSA, allergic rhinitis""MRI brain nl 1/8/09, Awake and drowsy EEG nl 1/13/09" . Patient recovered.

INFLUENZA (FLUZONE) Side Effects Report # 348342
INFLUENZA (FLUZONE) side effect was reported on 06/02/2009. Female patient, child 2.0 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: amino acid level abnormal, ataxia, back pain, balance disorder, chest x-ray normal"Progressing ataxia with onset approximately 11/08. Severe gross motor and fine motor impairment noted. 6/15/09 Received PCP medical records for 11/19/07-04/2009. FINAL DX: ataxia, hypertonia, tremors Records reveal when patient seen 11/19 experienced progressive walking abnormality, falls, irritability, balance difficulty, leg pain, weight loss, shaking, confusion, rhinorrhea, speech regression x 3 wks. Parent reported symptoms had been present prior to flu vaccine. Developed fatigue, back pain, excessive sleeping, otitis media w/effusion. Neuro -ophtho consult done 12/07 dx w/seizure disorder; normal optic nerves & retina; normal hyperopis. RTC 10/08 w/cough, decreased appetite, nasal congestion/drainage, fever, chills, shaking, falls, unsteady gait. Dx w/viral URI, gait disturbance. Referred to Neuro & Ophtho. Dx w/nystagmus thought to be neurological rather than optho in origin. Referred to genetics & eval of 4/09 revealed amino acid deficiencies.". none"none PMH: anemia. Family hx: early death secondary to amebiasis, childhood leukemia, DM, asthma.""Currently undergoing numerous neurological testing: CT scan, MRI, MRS, muscle testing. LABS: MRI brain, EKG, CXR, EMG WNL." . Patient recovered.

INFLUENZA (FLUZONE) Side Effects Report # 348928
INFLUENZA (FLUZONE) side effect was reported on 10/10/2008. Male patient, 51.0 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: chills, pyrexia, , , Fever 103 degree and rigor 12 hours after injection - Resolved 12 hours later without treatment.. NoneNoneNone . During the same period patient was treated with None. Patient recovered.

INFLUENZA (FLUZONE) Side Effects Report # 351855
INFLUENZA (FLUZONE) side effect was reported on 03/18/2009. Female patient was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: injection site swelling, pain in extremity, pyrexia, , "Initial report received from a healthcare professional on 08 December 2008. An adult female patient (age not reported) received a first intramuscular deltoid injection of ADACEL (lot number C3027BA) and a first intramuscular left deltoid injection of FLUZONE (lot number U2761AA) on 23 September 2008 and the following day, she developed a local reaction described as swelling, fever and sore arm. No diagnostic tests or lab data were performed. The patient received treatment symptomatically and recovered. No additional details were reported. Follow-up information received on 09 February 2009 from a health care professional. The injection site swelling was approximately one inch. According to the reporter, the events resolved in five to seven days. Follow-up information received 16 March 2009 from a health care professional. The reporter verified that the patient's right arm had been sore. ADACEL had been administered in the patient's right deltoid and FLUZONE was administered in the left deltoid and it had been greater than two years since the patient last received a Td booster. Corrective treatment consisted of a compress and exercise. No further information was provided. This patient's case was created as the result of follow-up received for a cluster of six patients. The other five patients were also identified and are recorded in cases 2008-02996, 2008-03924, 2008-03925, 2008-03926 and 2008-03923, all from the same reporter. Documents held by sender: None.". Not reported.None . Patient recovered.