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INFLUENZA (FLUZONE) Safety Reports

Total INFLUENZA (FLUZONE) reports: 1637.

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INFLUENZA (FLUZONE) problem was reported from MN on May 22, 2007. Female patient , 17 years of age, was vaccinated with INFLUENZA (FLUZONE) on May 22, 2007. "generalized weakness, difficulty walking, photophobia, nausea. Started one hour after vaccine administered, lasted rest of day. Was gone the next morning. Occurred with first vaccine on 11-22-06 and with the second vaccine on 1-25-07. Also, after second vaccine only she vomitted one time.". ortho evra. "amoxicillin, latex allergies, recurrent uti's". Patient recovered.

INFLUENZA (FLUZONE) problem was reported from OH on May 23, 2007. Female patient , 46 years of age, was vaccinated with INFLUENZA (FLUZONE) on Apr 11, 2007. "Fisher variant of Guillian Barre with ataxia, L6th, L5th, accommodation, also R tract lesion with L periph visual loss L>R eye.". "HCTZ, Actonel, Prevacid". "Increased chol, Fibromyalgia, Osteopenia". Patient recovered.

INFLUENZA (FLUZONE) problem was reported from NC on May 24, 2007. Female patient , child 1.3 years of age, was vaccinated with INFLUENZA (FLUZONE) on Jan 05, 2007. "Child receive flu vaccine on 1-4-07 at 10:00 am. Child was put on Amoxicillin on 12-26-06. Mom noticed some bumps on child's inner thigh and this AM child's right knee was swollen and reluctant to walk. She has latex egg, egg products. Physicians diagnosis: allergic reaction with serum sickness like reaction. Patient came back in on 1-6-06. Patient is to follow up if no better.". none. no known drug allergies-now allergic to Amoxicillin. Patient recovered.

INFLUENZA (FLUZONE) problem was reported from FL on May 24, 2007. Male patient , child 10 years of age, was vaccinated with INFLUENZA (FLUZONE) on May 16, 2007. "Several lesions/spots inside (R) thigh, covering chest, some on head, arms and legs". . . Patient recovered.

INFLUENZA (FLUZONE) problem was reported from NJ on May 24, 2007. Female patient , child 1.0 years of age, was vaccinated with INFLUENZA (FLUZONE) on May 16, 2007. "Information has been received from a registered nurse concerning a 22 month old female with a peanut allergy who on 16-SEP-2005, was vaccinated SC with a first dose of Varivax (Oka/Merck) (lot# 649270/0987P). Concomitant vaccination included a first dose of FLUZONE (lot# U1743JA) IM and a fourth dose of PREVNAR (lot# A56H7F) IM. There was no illness at the time of vaccination. On approximately 14-JUL-2006 the patient developed bilateral otitis media and an upper respiratory tract infection which were treated with AUGMENTIN ES-600 bid for 10 days, with improvement. On 18-JUL-2006 the patient developed a breakthrough rash described as vesicles filled with clear fluid on her left arm, left leg, and face. On 20-JUL-2006 the patient was seen in the office and the physician noted 10 pink papules, 2 vesicles, and no fever. The patient was seen in the office and the physician noted 10 pink papules, 2 vesicles, and no fever. The patient was diagnosed with a possible mild varicella. Supportive care was provided. Subsequently, the patient recovered. There was no product quality complaint involved. Additional information is not expected.". . . Patient recovered.

INFLUENZA (FLUZONE) problem was reported from MA on May 24, 2007. Female patient , child 1.0 years of age, was vaccinated with INFLUENZA (FLUZONE) on May 16, 2007. "Information has been received from a registered nurse concerning a 13 month old female with no allergies or medical conditions who on 06-OCT-2006 was vaccinated SC in the right thigh with a first dose of varicella virus vaccine live (Oka/Merck) (lot # 652666/0248F). Concomitant vaccination on the same day included a SC first does in the left thigh of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Winstar RA 27/3) (MSD) (lot # 650753/0971R), and an IM first dose on the right thigh of influenza virus splint virion 3v vaccine inactivated (FLUZONE) (lot # U2A8AA). There was no illness at the time of vaccination. On 06-NOV-2006, the patient was seen in the office and noted to have 50-75 scattered, red, raised papules on both legs. A few looked vesicular. She was afebrile. No diagnostic laboratory tests were performed. The patient recovered on 08-NOV-2006. Additional information is not expected.". . None. Patient recovered.

INFLUENZA (FLUZONE) problem was reported from CA on May 24, 2007. Female patient , child 1.1 years of age, was vaccinated with INFLUENZA (FLUZONE) on May 16, 2007. "Information has been received from a medical assistant concerning a 13 month old female with reactive airways disease and a history of frequent ear infections, who on 27-NOV-2006 was vaccinated SC in the leg (also reported as thigh) with a first dose of Varivax (lot # 654610/1049F). Concomitant vaccination included a fourth dose of Prevnar (lot # B08681F given IM in the leg (also reported as thigh) and a first dose of Fluzone (lot # U2220BB) given IM in the leg (also reported as thigh). Concomitant medication included loratadine (CLARITIN0. There was no illness at the time of vaccination. On approximately 09-DEC-2006 the patient was seen in the physician's office for an unspecified reason, on the same date as a 4 month old infant with active varicella. On 13-DEC-2006 (also reported as 11-DEC-2006) the patient came in to the office with less than one dozen spots of varicella crops and crusted lesions visible on her trunk, in her mouth and on her lips. The patient was fussy, had a decreased appetite and had a low temperature (also reported as afebrile). It was reported that there were a few lesions with a honey colored crust and a few with the classic tear drop shaped blisters. It was reported that there was an ""active outbreak"" in this country. The patient was noted to have a laceration to the top of her phrenulum. The patient was treated with amoxicillin (AMOXIL) for prophylaxis. It was reported that the patient and her sibling had not had any adverse events followed prior vaccination (previously reported as the patient has experienced soreness and fever after previous vaccination with DTaP. No labs tests were performed, just a physical exam by the physician. Subsequently, on an unspecified date the patient recovered. No further information was available. Additional information is not expected.". Unknown. . Patient recovered.

INFLUENZA (FLUZONE) problem was reported from LA on May 25, 2007. Male patient , 51 years of age, was vaccinated with INFLUENZA (FLUZONE) on May 16, 2007. Pt felt nauseated on the first day of injection. Next day patient had shortness of breath and chest pain. Patient reported SOB lasted a couple of days. Pt reported wheezing and Fast heart beat on the second day as well. unk. Asthmas. Patient recovered.

INFLUENZA (FLUZONE) problem was reported from IL on May 25, 2007. Male patient , child 1.0 years of age, was vaccinated with INFLUENZA (FLUZONE) on May 25, 2007. Child received MMR and Influenza vaccine on 1/25/07. Developed seizures on 2/4/07 for which he was hospitalized from 2/4/07 to 2/13/07. Regression of developmental occurred which are gradually returning with therapy. Xopenex HFA as needed. "Prematurity, IUDE, hospitalized for RLTE< asthma, Ger, NKDA". Patient was hospitalized Patient recovered.

INFLUENZA (FLUZONE) problem was reported from KY on May 29, 2007. Female patient , child 1.1 years of age, was vaccinated with INFLUENZA (FLUZONE) on May 23, 2007. Pt came to clinic 5-14-07 with scattered papules in different stages of progression from small papules on an erythematous base to crusted ulcerated lesions Addendum: Pt came to clinic 5-22-07 with a superinfected chicken pox lesion on (L) shoulder 2.5 x 2.5 cm firm eryth. nodule. 5-22-07 Put on Clindamycin 75/5 (7 ml) po TID x 10 d. . Patient recovered.

INFLUENZA (FLUZONE) problem was reported from CA on June 07, 2007. Female patient , child 1.8 years of age, was vaccinated with INFLUENZA (FLUZONE) on June 07, 2007. "Per mom child seemed in pain, gradually guarded her walking, avoided walking at times. Child refuses to bear weight or both legs. Able to crawl and move lower extremities normally. No fever, redness and swelling from IZ sites. Per mom stated better now than 3 days ago.". . None. Patient recovered.

INFLUENZA (FLUZONE) problem was reported from IL on June 08, 2007. Female patient , 81 years of age, was vaccinated with INFLUENZA (FLUZONE) on May 21, 2007. Patient complains of soreness at injection site. Patient says soreness has lasted 6 months. Patient has seen her physician and has tried anti inflammatory medication.. . . Patient recovered.

INFLUENZA (FLUZONE) problem was reported from SC on June 11, 2007. Male patient , 24 years of age, was vaccinated with INFLUENZA (FLUZONE) on Apr 17, 2007. "Patient felt dizzy and light-headed shortly after immunizations. After 5 minutes, he began throwing up. After an additional 2 minutes, he began breathing quickly and deeply. At this time he stated feeling short of breath.". Zithromax 1gm Suspension. none known or aware of. Patient recovered.

INFLUENZA (FLUZONE) problem was reported from TX on June 19, 2007. Female patient , 19 years of age, was vaccinated with INFLUENZA (FLUZONE) on June 11, 2007. Swelling and tenderness to arm. Sprinte C 28. Seaford allergies. Patient recovered.

INFLUENZA (FLUZONE) problem was reported from FL on June 19, 2007. Female patient , 38 years of age, was vaccinated with INFLUENZA (FLUZONE) on June 18, 2007. "Patient STATES, ""10 DAYS AFTER THE ADMINISTRATION OF THE VACCINES, SHE DEVELOPED TWO ERASER SIZE RED AREAS WHERE THE TDAP WAS INJECTED. THE AREA WHERE THE FLU VACCINE WAS GIVEN WAS BRUSIED ONLY. THE VACCINES WERE INJECTED IN THE SAME ARM (PER REQUEST OF patient. THE TDAP SITE BEGAN TO INCREASE IN SIZE UP TO 1/2 INCH IN DIAMETER IN REDNESS. SHE STATES, ""THE SITE WAS NOT RAISED."" ""THE SKIN BEGAN TO DIE ON TOP."" SHE THEN PEELED IT OFF AND IT BEGAN TO BLEED. SHE DENIES ANY ITCHING AND SHE DID NOT FEEL LIKE SHE DEVELOPED A FEVER. TWO WEEKS AFTER THE TDAP VACCINE WAS GIVEN, Patient STATES ""THE SITE IS STILL RED AND ABOUT THE SAME SIZE BUT IT IS STILL NOT RAISED."" SHE CONTINUES TO DENY ANY ITCHING OR FEVER. SHE IS APPLYING ANTIBIOTIC OINTMENT TO THE TDAP VACCINE SITE. THE FLU SHOT SITE HAS COMPLETELY DISAPPEARED.". "CORTISONE INJECTIONS 2/20, 3/16, AND 3/23,SOMA PRN, NAPROXEN 500MG PRN, AND CENTRUM DAILY, VIT C DAILY". "LOWER LUMBER ""SWELLING,"" DENIES ANY ALLEGIES TO ANY MEDICATIONS". Patient recovered.

INFLUENZA (FLUZONE) problem was reported from GA on June 28, 2007. Male patient , child 1.8 years of age, was vaccinated with INFLUENZA (FLUZONE) on Mar 16, 2007. "This is a 1-year-old female who was admitted with a history of fever, vomiting and rash. Physical examination on admission has shown irritable child. Patient was initially admitted and started on intravenous antibiotics for tonsillitis. However, in view of increasing serum bili and high transaminases, antibiotics were withdrawn. Antihistamines were given for treatment of rash. Patient was monitored carefully and was placed on low fat diet. She improved over the next 4-5 days and showed decrease in irritability. Icterus, rash disappeared and the tonsillar congestion resolved. She was discharged home and also showed progressive improvement of biochemical markers of liver involvement. Diagnoses: Acute tonsillitis. Hepatitis, possibly viral or drug induced, improving. 1/2/07. DC DX:Acute tonsilitis. Hepatitis viral or drug induced. C/O Fever, vomiting, rash and irritability.". None. None. Patient was hospitalized Patient recovered.

INFLUENZA (FLUZONE) problem was reported from TX on June 28, 2007. Male patient , 50 years of age, was vaccinated with INFLUENZA (FLUZONE) on June 28, 2007. "Client was given the influenza vaccine on 2/5/07 to left deltoid. 3-4 days after the shot, client experienced pain in arm and limited range of motion. Client never went to a doctor and only notified clinic who administered vaccine on 6-26-07. The nurse assessed the arm w/no signs of swelling, redness or infection. Pain has continued since approx. 2-8-07.". . Unknown. Patient recovered.

INFLUENZA (FLUZONE) problem was reported from PA on June 28, 2007. Male patient , child 12 years of age, was vaccinated with INFLUENZA (FLUZONE) on June 27, 2007. Varicella vaccine stored in freezer at 28 deg x 24 deg. Recommended to revaccinated or draw titer.. . . Patient recovered.

INFLUENZA (FLUZONE) problem was reported from CA on July 03, 2007. Female patient , 62 years of age, was vaccinated with INFLUENZA (FLUZONE) on July 03, 2007. "C/O arm pain 1-2 days after vaccines given. C/O generalized muscle soreness, fevers on and off and exhaustion. Unable to pursue activities (walking and swimming) due to fatigue. Arm pain resolved. Other sxs persist.". . "GERD, HTN, Depression". Patient recovered.

INFLUENZA (FLUZONE) problem was reported from MN on July 09, 2007. Female patient , 66 years of age, was vaccinated with INFLUENZA (FLUZONE) on July 06, 2007. "Initial and follow-up information has been received from a registered nurse and a physician concerning a 66 year old female with penicillin allergy and allergies to LIPITOR, PRAVACOL, TRILEPTAL, and a history of hives with niacin and no illness at the time of vaccination who on 15-FEB-2007 was vaccinated intramuscularly in the right deltoid with a 0.5 ml first dose of Pneumovax 230(lot 655152/0889F). The patient was concomitantly vaccinated with a second dose of Fluzone (lot U2202AA). Concomitant therapy included ACIPHEX, aspirin, vitamin B (unspecified), vitamin B complex, ubidecarenone, CRESTOR, omega-3 marine triglycerides, glucosamine, LAMICTAL, NEXIUM and ezetimibe. On 15-FEB-2007, in the evening, the patient had extreme pain in the arm in which Pneumovax 23 was administered. The entire area from the right elbow to the shoulder/ upper arm was in pain. The patient had difficulty moving the right arm. The injection site was fine. The patient received the flu vaccine in the left arm which was not painful. The patient was still having pain the week following the vaccination. The patient was seen at an urgent care center. An x-ray done of right shoulder was normal. The patient was treated with PERCOCET, NAPROSYN, and ibuprofen and ice. The patient then switched therapy from PERCOCET to VICODIN. The patient saw her primary care physician on 21-FEB-2007 with ongoing shoulder pain. The patient was referred to sports and orthopedic medicine. The outcome was unknown. The patient's right shoulder pain was considered an other important medical event. No additional information is expected.". . NEXIUM. Patient recovered.

INFLUENZA (FLUZONE) problem was reported from DE on July 11, 2007. Female patient , 48 years of age, was vaccinated with INFLUENZA (FLUZONE) on Jan 09, 2007. Day after injection site is bright red with knot and hot - area is about 2 x 3 inches (Tetanus) aches in arm and neck.. Over the counter cold medicine. None. Patient recovered.

INFLUENZA (FLUZONE) problem was reported from OH on July 11, 2007. Female patient , 14 years of age, was vaccinated with INFLUENZA (FLUZONE) on June 30, 2007. "Fever - 12/29/06, bruising at the injection site 12/30/06, swelling approximately golf size at the injection site - 12/30/06.". None. None. Patient recovered.

INFLUENZA (FLUZONE) problem was reported from TX on July 23, 2007. Female patient , child 0.6 years of age, was vaccinated with INFLUENZA (FLUZONE) on July 20, 2007. "Information has been received from a office manager in a physician's office concerning a 10 month old female, with no allergies, no history of surgery, no prior history of intussusception, congenital malformation of the intestine, or cystic fibrosis, who was vaccinated with a first, second, and third dose of Rotateq on 18-JAN-2007 (Lot# 653980/0285F), 15-FEB-2007 (Lot# 654489/0941F), and 15-MAR-2007 (Lot# 655405/1113F), respectively. It was reported that the office received an operative report stating that the patient was admitted to the hospital on 10-JUN-2007 after a visit to the emergency room. She had an exploratory lapartomy with reduction of intussusception and appendectomy on 10-JUN-2007. The diagnosis was unreducable intussusception. It was noted that the patient's family had not reported any signs or symptoms prior to the emergency room visit. The patient had not been back to the office for a follow-up. No other information was provided. Additional information has been requested.". Unknown. None. Patient was hospitalized Patient recovered.

INFLUENZA (FLUZONE) problem was reported from OK on Aug 13, 2007. Female patient , 54 years of age, was vaccinated with INFLUENZA (FLUZONE) on Feb 08, 2007. "Severe headache - lasted to 2-6-07, pain right arm traveled to shoulder and elbow. Injection site red, swollen to armpit. Saturday unable to get out of bed 2-3-07. Sunday 2-4-07 - went to hospital, temp. 103, IV Benadryl. Issued Morphine and pain medication, temp. normal. Unable to move right arm until 2-7-07. March 1, 07 only complaint - muscle soreness in body.". "Celexa; Tramadol, Advair, Nexium, Darvocet". "Allergic to sulfa; COPD; Carpal tunnel, Degenerative disc disease - neck, mitral valve prolapse.". Patient recovered.

INFLUENZA (FLUZONE) problem was reported from OK on Aug 13, 2007. Female patient , 34 years of age, was vaccinated with INFLUENZA (FLUZONE) on Feb 09, 2007. State a few minutes after got MMR and Flu states burning sensation at shoulder and neck and back of neck felt stiff. After 15 minutes pt states burning is now just in shoulder of arm. Neck still a little stiff.. Nuvaring. None. Patient recovered.

INFLUENZA (FLUZONE) problem was reported from OK on Aug 13, 2007. Male patient , 66 years of age, was vaccinated with INFLUENZA (FLUZONE) on Dec 01, 2006. He states that his left arm swelled three times normal after receiving a flu shot. He states that it was so painful that he could not sleep that night. He saw PA the next day and was told it was an allergic reaction. His arm was warm to touch and swollen but not 3 times on 11/28/06. Unknown. Unknown. Patient recovered.

INFLUENZA (FLUZONE) problem was reported from OK on Aug 13, 2007. Female patient , child 1.0 years of age, was vaccinated with INFLUENZA (FLUZONE) on Feb 28, 2006. Developed rash (hives) swollen eyelids. . Birth mark on back. Patient recovered.

INFLUENZA (FLUZONE) problem was reported from CA on Aug 29, 2007. Female patient , 31 years of age, was vaccinated with INFLUENZA (FLUZONE) on Aug 24, 2007. "Initial report received 14 August 2007 from a health care professional. A 31-year-old female patient had received a prophylactic injection of Fluzone on 26 December 2006 during her second trimester of pregnancy. The patient's date of conception had been reported as 25 August 2006 with an estimated delivery date of 18 May 2007. Exposures reported during pregnancy included alcohol, passive smoke, caffeine, and mold ""in office"". During her third trimester, beginning on 12 February 2007, she experienced a cough which lasted seven days, ending on 18 February 2007. Then, beginning 08 March 2007, she experienced a temperature of 100 degrees Fahrenheit, and ""bronchitis/cold"" symptoms. Her temperature returned to normal the following day but her bronchitis/cold symptoms persisted until 04 May 2007. She had been prescribed ""antibiotics NCS"" from 01 April 2007 until 30 April 2007 and Z-PAKs from 15 April 2007 to 04 May 2007. An ultrasound performed 02 May 2007 revealed ""low amniotic fluid"" and a non-stress test performed on 08 May 2007 had normal results. The patient had a c-section after diagnosis of oligohydramnics on 18 May 2007, her AFI was 2. The baby had cyanosis at birth which resolved within 2 hours. Shortly after birth the baby started having difficulties breathing and was diagnosed with pulmonary hypertension and intubated for 24 hours and the pulmonary hypertension resolved. Oxygen was administered another 24 hours and on 20 May 2007, the baby was breathing normally. The baby had been prescribed antibiotics for one week and all laboratory results were normal, negative for infection. The baby had been monitored for five additional days and had been released on 26 May 2007. This case was originally reported as non-serious, however, it was upgraded to serious by manufacturer. This case is linked to the baby's case 2007-02795 (pulmonary hypertension, jaundice).". . . Patient recovered.

INFLUENZA (FLUZONE) problem was reported from CA on Aug 29, 2007. Male patient was vaccinated with INFLUENZA (FLUZONE) on Aug 23, 2007. "Initial report received 14 August 2007 from a health care professional. A male newborn baby had received a prophylactic dose of Fluzone transplacentally through maternal exposure during his second trimester of pregnancy on 26 December 2006. The baby was born on 18 May 2007 and presented with jaundice at birth which resolved within 2-3 days requiring no treatment. The baby had cyanosis at birth which resolved within 2 hours after birth. Shortly after birth, the baby started having difficulties breathing, he was diagnosis with pulmonary hypertension and intubated for 24 hours. Baby was admitted to the NICU for four days for pulmonary hypertension. The pulmonary hypertension resolved within 24 hours; however resolved within 24 hours; however the baby was breathing normally and no longer required supplemental oxygen. He was given prophylactic antibiotics for one week and all laboratory results were normal, he was not positive for any infection. The baby was monitored for five additional days and released from the hospital on 26 May 2007. Per the reporter, the baby's mother ""had a c-section after diagnosis of oligohydramnics on 18 May 2007, her AFI was 2. Her date of conception had been reported as 25 August 2006 with an estimated delivery date of 18 May 2006"". Maternal exposures reported during pregnancy included alcohol, passive smoke, caffeine, and mold ""in office"". During her third trimester, from 08 March 2007 until 04 May 2007, she experienced ""bronchitis/cold"" symptoms which had been treated with antibiotics from 01 April 2007 to 04 May 2007. An ultrasound had been performed on 02 May 2007 which revealed ""low amniotic fluid"". This case is linked to the mother's case 2007-02829 (Oligohydramnios).". . "Maternal. Patient was hospitalized Patient recovered.

INFLUENZA (FLUZONE) problem was reported from MO on Sept 04, 2007. Female patient , 66 years of age, was vaccinated with INFLUENZA (FLUZONE) on Aug 30, 2007. "A 67-year-old female patient, with a history of atrial fibrillation, received an intramuscular right deltoid injection of Fluzone (lot number U2165CA) on 31 October 2006, at 1:30 pm. By 8:00 pm, the patient reported that ""her heart was racing"". This continued for two days, and the patient called her primary care physician and was informed that ""it would subside"". She subsequently travelled to visit her daughter, and while there experienced a heart attack (dates not provided). According to the patient, she was hospitalized for one week and underwent a ""full cardiac work-up""; the events were considered to be resolved. Concomitant medications included Coumadin, Diovan, and Toprol XL.". "COUMADIN, DIOVAN, TOPROL XL". Atrial fibrillation. Patient was hospitalized Patient recovered.

INFLUENZA (FLUZONE) problem was reported from GA on Sept 13, 2007. Male patient , 13 years of age, was vaccinated with INFLUENZA (FLUZONE) on Sept 13, 2007. "Hives and redness at injection site, within 5 minutes of vaccine given". None. ADD. Patient recovered.

INFLUENZA (FLUZONE) problem was reported from IL on Sept 13, 2007. Male patient , 19 years of age, was vaccinated with INFLUENZA (FLUZONE) on June 18, 2007. "C/O difficulty breathing receiving Bicillin. Wheezing all lobes, Benadryl and Epi administered. IV Normal saline started. Transported to medical center via EMS.". None. None. Patient recovered.

INFLUENZA (FLUZONE) problem was reported from NJ on Sept 14, 2007. Female patient , 15 years of age, was vaccinated with INFLUENZA (FLUZONE) on Sept 14, 2007. "Redness, Pain, and Heat below injection site - Left arm 4.5"" x 5""". none. none. Patient recovered.

INFLUENZA (FLUZONE) problem was reported from PA on Sept 17, 2007. Female patient , 37 years of age, was vaccinated with INFLUENZA (FLUZONE) on Sept 12, 2007. "Initial serious report received from a health care professional on 31 August 2007. A 37-year-old female with a history of childhood asthma had received an intramuscular injection of Fluzone (Lot number U2436AA) to her left arm at 6:00 AM on 31 August 2007. At 9:45 AM that same day, the patient felt tightness in her chest and shortness of breath, described as, ""Like asthma attack"". The patient had no illness at the time of vaccination and had not received any other vaccinations within four weeks prior to this event. It was reported that the patient was not taking any concomitant medications. Recovery status was reported as ""Recovered"". No additional information has been provided at the time of this report.". . The patient has a history of childhood asthma. Concomitant medications: None. Patient recovered.

INFLUENZA (FLUZONE) problem was reported from PA on Sept 17, 2007. Male patient , 25 years of age, was vaccinated with INFLUENZA (FLUZONE) on Sept 12, 2007. "This case was reported by a health professional on 31 August 2007. A 25-year-old patient with a history of migraine received an intramuscular left arm injection of Fluzone (U2436AA) on 30 August 2007 at 2:00pm. The patient had a mild headache at the time of injection, and after receiving Fluzone took Relpax to treat the headache. Three hours later, at 5:00pm, the patient noticed ""tense muscles"". UNK. RELPAX. Patient recovered.

INFLUENZA (FLUZONE) problem was reported from CA on Sept 18, 2007. Female patient , child 8 years of age, was vaccinated with INFLUENZA (FLUZONE) on Sept 18, 2007. "PATIENT CAME IN 9/13/07 FOR 8YR PE AND VACCINES. NO RECENT OR CURRENT ILLNESS AT THE TIME. DURING ADMINISTRATION OF VACCINES, PATIENT APPARENTLY STRUGGLED AND MOVED. THE FOLLOWING DAY, PATIENT DEVELOPED REDNESS AND SWELLING OF THE RIGHT ARM AT THE VACCINE SITE. PATIENT WAS SEEN IN DOCTOR'S OFFICE FOR F/U ON 9/17/07 AND MOM STATED THAT REACTION SITE WAS IMPROVING. UPON EXAM, RIGHT MID DELTOID HAD APPROX. 4 CM OF REDNESS, WITH SOME SWELLING AND TENDERNES. MOM WAS INSTRUCTED TO PROVIDE SUPPORTIVE CARE AND TO F/U WITHIN 3 DAYS IF NO IMPROVEMENT SEEN.". NONE. . Patient recovered.

INFLUENZA (FLUZONE) problem was reported from VA on Sept 20, 2007. Male patient , child 1.0 years of age, was vaccinated with INFLUENZA (FLUZONE) on Sept 14, 2007. "MMR, Varivax, Hepatitis A, and Fluzone given on 9/4/07. 9/14/07 awoke with rash on torso, neck and face - blotchy, papular. 1 tsp Benadryl given.". None. None. Patient recovered.

INFLUENZA (FLUZONE) problem was reported from CA on Sept 21, 2007. Female patient , child 1.4 years of age, was vaccinated with INFLUENZA (FLUZONE) on Sept 19, 2007. "Febrile seizure, probable vaccine related. Tonic convulsion by postictal limping. Tylenol and cooling measures done at home, temperatures from 102.6 - 103.9.". . Develop delay/periventricular leukomalecia. Patient recovered.

INFLUENZA (FLUZONE) problem was reported from PA on Sept 24, 2007. Female patient , child 9 years of age, was vaccinated with INFLUENZA (FLUZONE) on Sept 21, 2007. "Information has been received from a physician concerning a 9 year old female who on 13-SEP-2007 was vaccinated with a dose of VAQTA. Suspect vaccination administered that day included a dose of VARIVAX and a dose of FLUZONE. On 14-SEP-2007 the patient was diagnosed with encephalitis characterized by headache, dizziness, stumbling, memory changes, and confusion. The patient was also noted to have mild facial palsy. The patient was seen by the physician and was subsequently hospitalized. The patient was not recovered. There was no product quality complaint. The physician also considered encephalitis and mild facial palsy to be disabling. Additional information has been requested.". Unknown. Unknown. Patient was hospitalized Patient recovered.

INFLUENZA (FLUZONE) problem was reported from NY on Sept 27, 2007. Female patient , 18 years of age, was vaccinated with INFLUENZA (FLUZONE) on Sept 26, 2007. "Patient became lightheaded after Gardasil and Flu vaccinations, BP lying down was 137/90, pulse 70, after 15 minutes, BP 132/88, patient c/o headache. Patient stated she felt better, after sitting up initially, BP 133/89, pulse 64, final BP 128/86. Pediatric vaccine information sheets given". . Asthma. Patient recovered.

INFLUENZA (FLUZONE) problem was reported from FL on Sept 27, 2007. Female patient , 45 years of age, was vaccinated with INFLUENZA (FLUZONE) on Sept 27, 2007. "Intense itch and exaserbation of scar tissue from poison oak contracted in 2004 on the right forearm, distal from the vaccin, arm heavy and small fluid filled blisters are noteed on the arm, some have been broken due to scratching. Also generalized aching, some tachycardia up to 24 + hours after injection. Skin on arm is red and there is also generalized itching, No respriatory symptoms. Applied cortizone otc cream 12 hours after injection, upon waking with the intense itching. This reactin is similar to a reaction seen on this patient upon recieving PPD injection...the skin gets red but not endurated. Also, pt took 50 mg of benadryl at hs the night of the injection (Approx. 7 hours after).". "Zoloft 100mg PO QD, Synthroid .005 mg, Alieve otc 220 mg po bid, Calcium 600 mg + vit D one tab po qd, Activella, one po qd,". . Patient recovered.

INFLUENZA (FLUZONE) problem was reported from TX on Sept 27, 2007. Female patient , 47 years of age, was vaccinated with INFLUENZA (FLUZONE) on Sept 27, 2007. "Patient had a recent hx of intestinal N/V, no fever, and was better. She received the Flu shot at 8:45 a.m. She was fine then around 10:00 she had some nausea, then vomited, and then started to shiver. she is also diabetic and her blood sugar was 68. She drank some ""Coke"" and rechecked blood sugar and it was 91, her Temp was 100.2 and continuing to shiver. Adminstered Acetaminophen 325 mg 2 tabs and gave her some saltine crackers to eat to raise her blod sugar. Her temp reached 101.3. By 11:00 the shivering had stopped, her temp was 99.2, and her blood sugar was 159.". "Humalog, Lantus Insulins". Diabetic. Patient recovered.

INFLUENZA (FLUZONE) problem was reported from MA on Sept 28, 2007. Female patient , 73 years of age, was vaccinated with INFLUENZA (FLUZONE) on Sept 28, 2007. "Redness, Swelling, Itching at injection site immidiately after injection that lasted 3-4 days. Tongue swelling that started 2 days after vaccine administered and lasted 1-2 days.". "Atenolol, Allegra, xanax, Plavix, celexa abilify, spiriva, firoranal". "Htn, smoker, hypoglycemia, copd, Fibromystosis". Patient recovered.

INFLUENZA (FLUZONE) problem was reported from MI on Oct 01, 2007. Female patient , 53 years of age, was vaccinated with INFLUENZA (FLUZONE) on Oct 01, 2007. "Patient c/o fever, body aches and lt arm was swollen with knot, red and warm to the touch.". . . Patient recovered.

INFLUENZA (FLUZONE) problem was reported from WA on Oct 01, 2007. Female patient , 84 years of age, was vaccinated with INFLUENZA (FLUZONE) on Sept 28, 2007. "Fever at least up to 2 days after injection. Redness of upper arm, not at injection site. Arm is sore and inflamed.". . None. Patient recovered.

INFLUENZA (FLUZONE) problem was reported from WA on Oct 01, 2007. Female patient , 77 years of age, was vaccinated with INFLUENZA (FLUZONE) on Oct 01, 2007. Pt got bruise at the site of injection on Saturday (she got the shot on Friday) - but she came in Monday.. . . Patient recovered.

INFLUENZA (FLUZONE) problem was reported from MI on Oct 01, 2007. Female patient , child 6 years of age, was vaccinated with INFLUENZA (FLUZONE) on Sept 28, 2007. The pt. was given adult Hep A. No adverse reactions were reported.. Melatonin; Remeron; Adderall; Zoloft. ADHD; Fructose Intolerance. Patient recovered.

INFLUENZA (FLUZONE) problem was reported from CA on Oct 02, 2007. Female patient , 57 years of age, was vaccinated with INFLUENZA (FLUZONE) on Oct 02, 2007. "Lightheadedness, dizziness, fast heartbeat, nervousness, shaking, confusion". . "Neurontin, Pentasa". Patient recovered.

INFLUENZA (FLUZONE) problem was reported from NC on Oct 03, 2007. Female patient , 24 years of age, was vaccinated with INFLUENZA (FLUZONE) on Oct 03, 2007. Hives on chest and swelling and redness on left arm. Present about 6 hrs after administration. Pt self treated with Benadryl.. "No, Orthotricyclen". "Pen Allergic, Biaxin Allergy, Codeine Allergy". Patient recovered.

INFLUENZA (FLUZONE) problem was reported from FL on Oct 03, 2007. Female patient , 46 years of age, was vaccinated with INFLUENZA (FLUZONE) on Oct 03, 2007. "10/03/07 Client return to Clinic 10 at aproximately 11:20 am. She reports that she developed redness, swelling and pain to her arm about 4 hours after she was vaccinated with the influenza and pneumococcal vaccines.She states that she had pain and swelling to arm and had applied ice pack for most of the night with minimal relief. Client presented with redness, swelling and complain of pain, arm warm to touch with noted induration to left upper arm where she received the pneumococcal vaccine 0.5mL dose subcutaneously. Treatment pending, referred to physician.". . Denies known allergies. Medical condition not disclosed at time of vaccination.. Patient recovered.

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