Dyspnoea

INFLUENZA (FLUZONE) Side Effects Report # 336403
INFLUENZA (FLUZONE) side effect was reported on 12/23/2008. Male patient, 60.0 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: cardioversion, chest x-ray abnormal, chest discomfort, chest pain, death"Chest tightness, shortness of breath, and rapid demise to death within 4 hours of receiving vaccine. 1/7/09-records received for ED DOS 9/29/08-presented to ED with C/O chest pain, while enroute to ED became diaphoretic, SOB required cardioconversion, intubation. V fib. DX and COD-Pulmonary embolus. Expired 9/29/08. 2/9/09-COD-pulmonary embolism.". No acute illness"Pernicious anemia; CAD; MI; Lumbar disc disease; Peripheral neuropathy; Hypothyroidism; Cardiomyopathy; GERD; Cervical disc disease; Nonunion R hip fx-repaired; AODM; BPH; MOTRIN; MYCARDIS; PREVACID; FLOMAX; trimethoprim 1/7/09-records received-PMH: CHF, pancreatitis, UTI, Diabetic, coronary stents. Stroke."1/7/09-records received-Chest x-ray infiltrate at left lung base and possible infiltrate right upper lobe. . During the same period patient was treated with LEVAQUIN; LOPRESSOR; NEURONTIN; ELAVIL. Patient died on 9//08/09/2.


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 # 337173
INFLUENZA (FLUZONE) side effect was reported on 01/13/2009. Female patient, 58.0 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: body temperature increased, bronchospasm, cough, dyspnoea, fatigue"10/16/08 1 PM-PT REPORTED FREQ NON-PRODUCTIVE COUGH AND BRONCHOCONSTRICTION (FELT LIKE CHILDHOOD ASTHMA, BUT NOT ANAPHYLAXIS). 5 PM-PT REPORTED LABORED BREATHING, MALAISE, HA, UPPER LIP SWELLING. PT TOOK 2 BENADRYL (50 MG) AND LIP SWELLING IMPROVED. TEMP SPIKE 101 F, VERY TIRED, HARD TO MOVE. 7 PM-PT REPORTED VISIT TO URGENT CARE. NP SAID LUNGS SOUNDED OK, MOVING AIR FINE. NP TOLD PT LIKELY SHE WAS MOUNTING AN IMMUNE RESPONSE. 10/17/08 AM-PT REPORTED FEELING TIRED BUT NO FEVER OR DIFFICULTY BREATHING.". NONE"ALL: SULFA (ANAPHYLAXIS); GENTAMICIN, TETRACYCLINE, ULTRAM (RASH). BIRTH DEFECTS: NONE. MED CONDITIONS: HRT, HIP & BACK ARTHRITIS."NONE . During the same period patient was treated with "ESTROGEN, TESTOSTERONE CREAM, VOLTAREN, CALCIUM, GLUCOSAMINE, MULTIVITAMIN". Patient recovered.

INFLUENZA (FLUZONE) Side Effects Report # 337335
INFLUENZA (FLUZONE) side effect was reported on 01/14/2009. Male patient, 36.0 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: cough, dyspnoea, eyelid oedema, sneezing, Approximately 2 hours after received flu shot client starting sneezing and coughing. Eye lids began to swell and had difficulty breathing.. noClient states he takes allergy medication for environmental allergies . Patient recovered.

INFLUENZA (FLUZONE) Side Effects Report # 337341
INFLUENZA (FLUZONE) side effect was reported on 01/14/2009. Female patient, 26.0 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: chest discomfort, cough, dyspnoea, palpitations, upper respiratory tract congestion"4 hours after shot administered, felt chest pressure, heart pounding, congested chest & cough. Breathing problems also which lasted about 25 minutes, rest of symptoms persisted for about 3.5 hours.". nonenone . During the same period patient was treated with none. Patient recovered.

INFLUENZA (FLUZONE) Side Effects Report # 337615
INFLUENZA (FLUZONE) side effect was reported on 01/16/2009. Male patient, 33.0 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: chest discomfort, cough, dyspnoea, eye pruritus, eye swelling"eyes itching, tightness in chest, cough, swelling around his eyes and a bit of difficulty breathing. It was about 4 hours after the shot.". . 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 # 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 # 338260
INFLUENZA (FLUZONE) side effect was reported on 01/26/2009. Male patient, 18.0 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: anxiety, atrial fibrillation, bradycardia, bundle branch block, cardiac ablation"3-4 hours after being vaccinated pt. began having SOB and then palpitations with heart racing. Pt. taken to ER and admitted with tachycardia and BBB. Pt. diagnosed with Wolf-Parkinson-White Syndrome and treated with cardioablation and B-blocker therapy. 2/2/09 PCP records received for 18 yr old PE dated 1/7/09. PE WNL. Flu shot given. F/U note that pt began having SOB and heart racing that pm. Dx: Wolfe-Parkinson-White syndrome and had a cardioablation and placed on B-blocker. 2/20/09 MR received for DOS 1/8-13/2009 with Final DX: Atrial fibrillation. Anxiety state. Reflux disease. Pt presented with 1 day hx of intermittent palpitations with SOB. Atrial fib with rapid ventricular response noted on EKG on arrival in ED, one episode of SVT. Admitted and started on Beta blockers. Episode of bradycardia in the 40's on 1/11/09 and chest pressure that pm. CP likely GERD. AV node ablation performed with resolution of arrhythmia. D/C on Beta blocker.". NoneNone. PMH: EIA. T&A. allergic to beestings.EKG in ER showed IRBBB and tachycardia. Echocardiogram and CXR negative. Labs and Diagnostics: EP study abnormal-recuurant AV nodal echo beats. CXR WNL. Myoglobin WNL. Serial cardiac enzymes WNL except final Troponin I 0.57. Echo (+) . During the same period patient was treated with None at the time of vaccination.. Patient was hospitalized Patient recovered.

INFLUENZA (FLUZONE) Side Effects Report # 339529
INFLUENZA (FLUZONE) side effect was reported on 02/12/2009. Female patient, child 9.0 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: blood pressure normal, bronchospasm, dyspnoea, oxygen saturation normal, "Pt had severe bronchospasm and shortness of breath 40 minutes after vaccine. No EPi needed; Stable Bp and O2 SAT, 911 to ER -discharged home.". NoneH/o exercise induced asthma; Congenital abnl kidney - removedNone . During the same period patient was treated with None. Patient recovered.

INFLUENZA (FLUZONE) Side Effects Report # 339997
INFLUENZA (FLUZONE) side effect was reported on 02/12/2009. Female patient was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: anxiety, blood pressure increased, bronchospasm, dizziness, dyspnoea"First dizzy, increased blood pressure-racing pulse, nauseous, bronchial spasms, difficulty breathing and speaking- Taken to ER given BENADRYL and anxiety medicine by IV-Prednisone 5 days". None"Allergic to yellow dye, antibiotics, sodium phosphate"Allergic reaction causing anxiety reaction . Patient recovered.

INFLUENZA (FLUZONE) Side Effects Report # 340818
INFLUENZA (FLUZONE) side effect was reported on 01/08/2009. Female patient, 59.0 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: dyspnoea, throat irritation, , , "Pt called clinic reporting SOB, throat feels funny. Instructed to go to ER. At ER, patient did well and left with BENADRYL. There was some confusion of symptoms related to new use of Niacin but symptoms did not recur.". "Allergies- Morphine, adhesive tape, HCTZ, Verapamil" . Patient recovered.

INFLUENZA (FLUZONE) Side Effects Report # 341107
INFLUENZA (FLUZONE) side effect was reported . Female patient, 53.0 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: dyspnoea, swollen tongue, , , Swelling in tongue - Labored breathing - BENADRYL. NoneHigh blood pressure; Allergies - penicillin; Cephalosporins; ketones & mocrotides; Busperione; Hydroxyzine hclNone . During the same period patient was treated with Lisinopril 20 mg qd; AMBIEN 10mg pHS. Patient recovered.

INFLUENZA (FLUZONE) Side Effects Report # 341571
INFLUENZA (FLUZONE) side effect was reported on 03/12/2009. Female patient, 26.0 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: acidosis, anaphylactic reaction, blood bicarbonate decreased, blood glucose increased, blood phosphorus decreased"Head to toe rash, respiratory distress, elevated temperature, (102 and higher), tachycardia. Treatment required three trips to the emergency room where patient was given intravenous Benadryl, a selection of steroids, oxygen, antipyretics and supportive care. 4/3/09 MR received for DOS 3/12-15/2009 with D/C DX: Anaphylaxis, likely 2' to influenza and pneumococcal vaccines. Recurrent wheezing and SOB x 48 hrs. Pt initially presented to ER 3/10/09 with throat swelling and hives. Tx and d/c. Returned with same sx 3/11/09 and tx and d/c. Returned 3/12/09 with recurring sx. Noted to be acidotic, tachycardic with low Phosphorus and elevated WBCs. Admitted for IV steroids with resolution of hives, rash, SOB, cough, wheezing and throat swelling.". "No other illness at the time. Information regarding manufacturer, lot number and other blanks will need to be filled in by admin"None. PMH: tachycardia. Intersticial cystitis. Smoker"Chest radiography, numerous laboratory testing including CBC, ESR. Labs: WBCs 20K. Bicrb 19. Phosphorus 0.9 up to 2.7. BS up to 113 s/p steroids. CXR WNL. HR 160s." . Patient was hospitalized Patient recovered.


INFLUENZA (FLUZONE) Side Effects Report # 342460
INFLUENZA (FLUZONE) side effect was reported on 03/23/2009. Female patient, 30.0 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: atrial flutter, atrial tachycardia, bradycardia, cardiac electrophysiologic study, chest pain"supraventricular tachycardia, dizziness, chest pain. Brought to emergency room by ambulance and admitted to a cardiac telemetry unit for 7 days. Numerous tests and procedures performed, ie, echo, EPS, tilt table... 4/28/09 Received hospital medical records of 1/28-2/4/2009. FINAL DX: supraventricular tachycardia; vasovagal syncope Records reveal patient experienced palpitations upon awakening similar to prior episodes but she was unable to break out of it with vagal maneuvers. Also had chest pain, SOB, diaphoresis, dizziness & nausea. Admitted to CCU for monitoring. Had couple of pre-syncope episodes while hospitalized. No episodes of SVT on monitor.". none"PMH: MVP, SVT, herniated disc. Allergy: latex."Diagnosed with Postural Tachycardia Syndrome LABS: electro physiology study abnormal w/atrial tachycardia & atrial flutter. Tilt table test (+) w/bradycardia & hypotension. echocardiogram. . During the same period patient was treated with none. Patient was hospitalized Patient recovered.

INFLUENZA (FLUZONE) Side Effects Report # 345467
INFLUENZA (FLUZONE) side effect was reported on 04/29/2009. Male patient, child 7.0 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: dyspnoea, hypersensitivity, throat irritation, urticaria, wheezing"Allergic reaction - hives - severe wheezing, breathing, throat.". NoneAsthma . Patient recovered.

INFLUENZA (FLUZONE) Side Effects Report # 346220
INFLUENZA (FLUZONE) side effect was reported on 05/12/2009. Male patient, child 4.0 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: body temperature increased, bronchitis, crying, dyspnoea, heart rate increased"5-7-09 Crying, sore arms, couldn't move arms; temp 105 degrees F; mother gave Tylenol suppository; child projectile vomiting. Tylenol lowered fever but not completely. 5-8-09 Fever broke 1pm; couldn't move both arms; left arm swollen twice size of right arm; hot to touch. 5-9-09 Arms same, running nose. 5-10-09 7am Difficulty breathing, increased heart rate; 1pm to ER; Diagnosis: Bronchitis". nonenormal seasonal allergiesn/a . During the same period patient was treated with none. Patient recovered.

INFLUENZA (FLUZONE) Side Effects Report # 351415
INFLUENZA (FLUZONE) side effect was reported on 07/07/2009. Male patient, 16.0 years of age, was vaccinated with INFLUENZA (FLUZONE). After vaccination, patient experienced the following side effects: abdominal pain, abdominal pain, amnesia, balance disorder, colonoscopy normal"Severe nausea; weight loss over 20 lbs; dizziness; balance problems; impaired concentration; vertigo; inflammation of esophagus; abdominal pain, especially 30 minutes to 1 hour after meals; difficulty with speech articulation, impaired short term memory/recall; bilateral hand tremors; extreme fatigue; shortness of breath. 7/29/09 Consultant medical records received DOS 6/30/09. Assessment: Cerebellar tonsillar ectopia. Patient presents with headaches, dizziness, nausea, weight loss, fatigue, and low-lying cerebellar tonsils. Lack of endurance when running. Can hear pulse in ears. Balance disturbance. Occasional high blood pressure. Nausea and pain after meals. Fasciitis. Vertigo.". Had cold dx but deemed stable for flu shot 12/30/08Exertional compartment syndrome - bilateral fasciotomy. 7/29/09 Consultant medical records received DOS 6/30/09. Compartment syndrome of legs - fasciotomies. Ear tubes. Allergic esophagitis possibly to dairy products.Numerous - labs normal; brain MRI essentially normal per neurosurgeon; gall bladder HIDA scan essentially normal; colonoscopy normal. LABS and DIAGNOSTICS: MRI Brain - 3 to 4 mm cerebellar tonsillar ectopia. X-Ray Cervical Spine - Normal . During the same period patient was treated with Vitamin C 500 mg daily. 7/29/09 Consultant medical records received DOS 6/30/09. Prilosec and vitamin C.. Patient was hospitalized Patient recovered.