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Back pain from INFLUENZA (SEASONAL) (AFLURIA) 2009

Vaccine Manufacturer:CSL LIMITED
Vaccine Code:FLU
Vaccine Type:INFLUENZA VIRUS VACCINE
Vaccine Name:INFLUENZA (SEASONAL) (AFLURIA)
Year Reported:2009
Symptom Reported:Back pain

INFLUENZA (SEASONAL) (AFLURIA) Side Effects Report #356356
INFLUENZA (SEASONAL) (AFLURIA) vaccine side effect was reported on 09/02/2009. Female patient, 56.0 years of age, was vaccinated with INFLUENZA (SEASONAL) (AFLURIA). Patient symptoms: Back pain, "At the time of the vaccination, she felt a burning sensation down to her wrist, daily pain with radiation of pain down back and neck. Site never got red or swollen. She felt that the placement of the vaccine was placed too high on her shoulder area." noneLeiden Factor . During the same period patient was treated with "coumadin, sertraline, albuterol, singular". Patient recovered.

INFLUENZA (SEASONAL) (AFLURIA) Side Effects Report #357000
INFLUENZA (SEASONAL) (AFLURIA) vaccine side effect was reported on 09/11/2009. Male patient, 54.0 years of age, was vaccinated with INFLUENZA (SEASONAL) (AFLURIA). Patient symptoms: Back pain, "Patient first experienced headache and posterior neck pain that lasted approximately 48 hours. Following that he developed severe cervical neck pain that lasted 1.5 hours. The pain then traveled down his spine and was accompanied by allodynia, both of which lasted approximately 48 hours. By the afternoon the patient experienced pain and allodynia all down his back, into the posterior of his legs, throughout his hips, and into his knees." NoneChronic neck pain; spondylosis of lumbar region.Upon examination a blood test showed WBCs within normal limits. Patient's vitals were checked and the patient had a temperature of 99.8 (from 96.5 at time of vaccination.) Also a flu A&B swab was done and was negative. . During the same period patient was treated with None. Patient recovered.

INFLUENZA (SEASONAL) (AFLURIA) Side Effects Report #357144
INFLUENZA (SEASONAL) (AFLURIA) vaccine side effect was reported on 09/08/2009. Female patient, 61.0 years of age, was vaccinated with INFLUENZA (SEASONAL) (AFLURIA). Patient symptoms: Back pain, Noted pain (Lt) lower back. While driving home had received flu vaccine prior to pain also noted staring in abd. and numbness lower (Lt) abd and left side vaginal area. . Patient recovered.

INFLUENZA (SEASONAL) (AFLURIA) Side Effects Report #358080
INFLUENZA (SEASONAL) (AFLURIA) vaccine side effect was reported on 04/20/2009. Female patient, 59.0 years of age, was vaccinated with INFLUENZA (SEASONAL) (AFLURIA). Patient symptoms: Back pain, "(See attached). 10/12/09 Hospital records, DC summary, received service dates 11/26/08 to 12/03/08. Assessment: Guillain-Barre Syndrome. Patient noted achiness in her back and down into her legs one week ago. Pain increased and developed in palms and fingertips, generalized tingling sensation in toes and finger tips. Patient presents with burning sensation in lateral thighs and aching feeling in calves. Fingertips and feet are numb. Urinary frequency. Little sleep at night. Muscle weakness extremities, deceased temperature and pain sensation. Wide-based, ataxic gait. Needs assistance with ambulation. IVIG. ICD-9 Codes: 357.0 Ac Infect Polyneuritis, 781.3 Lack of Coordination, 782.0 Skin Sensation Disturbance, 788.41 Urinary Frequency, 781.2 Abnormality of Gait. 10/14/09 Neurology consult records received, service dates 11/25/08 to 8/25/09. Assessment: Guillain Barre Syndrome. Patient presented with a 1 week history of weakness, pain, and achiness in back and legs. Pain in palms and fingertips, tingling and parasthesias. Tingling progressed to the toes. She also developed imbalance and weakness with several falls. Reflexes are absent throughout. Upon follow up from hospitalization: remains unsteady, using a cane. Unable to drive. Feet feel like bricks. Needs assistance with ADL's (showering). Pain can be incapacitating. Knee pain since fall 6 weeks ago. Absent reflexes in LE's, diminished reflexes in biceps. Gait is shaky. 8/25/09-Compared with the initial study on 11/26/09 the degree of demyelination and axonal loss is worse, likely a reflection of continued injury to the nerves during the acute phase of her illness." None"Uterine fibroids. 10/12/09 Hospital records, DC summary, received service dates 11/26/08 to 12/03/08. Tonsillectomy, chevron osteotomy, ectopic pregnancy. Former smoker. 2 glasses wine per night. 10/14/09 Neurology consult records received, service dates 11/25/08 to 8/25/09.PMH: Depression and as above.""(See attached). 10/12/09 Hospital records, DC summary, received service dates 11/26/08 to 12/03/08. LABS and DIAGNOSTICS: CSF - RBC 3 /mm3 (H), Protein 120 mg/dL (H). CHEM - Sodium 132 mmol/L (L) BUN 24 mg/dL (H). CBC - WBC 4.53 K/MM3 (L)." . During the same period patient was treated with (See attached). Patient was hospitalized Patient recovered.

INFLUENZA (SEASONAL) (AFLURIA) Side Effects Report #358672
INFLUENZA (SEASONAL) (AFLURIA) vaccine side effect was reported on 09/16/2009. Female patient, 64.0 years of age, was vaccinated with INFLUENZA (SEASONAL) (AFLURIA). Patient symptoms: Back pain, Pt contacted clinic on the day after the vaccine was administered -stated c/r felt pain up her neck and back following administration - As the evening progressed she felt muscle pain throughout her body and headache. Clinic advised her to contact her physician. Physician advised MOTRIN. Pt stated symptoms resolving NoneFibromyalgia . Patient recovered.

INFLUENZA (SEASONAL) (AFLURIA) Side Effects Report #359302
INFLUENZA (SEASONAL) (AFLURIA) vaccine side effect was reported on 09/25/2009. Female patient, 41.0 years of age, was vaccinated with INFLUENZA (SEASONAL) (AFLURIA). Patient symptoms: Back pain, "Pt c/o R lower back pain radiating on R buttock 10 min after pt received the pt received the influenza vaccine. Pt also c/o both eyes red when she got home. No pain, no itching." NoneNone . Patient recovered.

INFLUENZA (SEASONAL) (AFLURIA) Side Effects Report #359359
INFLUENZA (SEASONAL) (AFLURIA) vaccine side effect was reported . Male patient, 75.0 years of age, was vaccinated with INFLUENZA (SEASONAL) (AFLURIA). Patient symptoms: Back pain, "Shot received 8/27/09- 8/29- Severe sweats- Pain in lower butt. Could not sleep prone 9/1- Saw family M.D. - X-rays; Pain meds - Back to M.D. 9/4 - pain progressed to shoulders- whole back- V. severe - 9/9 ER -Bel. pressure mild/saw Spinal specialist- 9/11 -back to family DR. - 9/12 ER - admitted -to host - 9/13 kidneys scan - chem stress test -Aorta test - Neurologist called/Spinal Taps / IGIV - intravenous 5days 9/20-9/24 Diag as GUILLAIN BARRE Syn. 10/7/09 Rehab records received for dates 9/16/09 to 9/28/09. DX: Acute Demyelinating Polyneuropathy, Bells palsy, neuropathy, gait abnormality, CAD, back pain. Recently dx with GBS. Adverse event occured 8/29/09. Presenting SX: Pt c/o prior to admission pt was completely independent with ADL's now presenting with unsteady gait/ataxic gait pattern backpain after receiving influenza vaccine 2 days prior. Assessment: PE neuro (+)numbness, tingling, weakness. ICD9 codes: 782.0, 351.0, 781.2, 357.0, 724.5, 357.0, 276.1, 401.9, 414.01, V45.82, V14.8, 781.2, 351.0, 272.4, 564.0, 780.93, V12.54, 427.31, V58.61 10/13/09: Additional Medical Records (Cardiology Consultation) and Discharge Summary received. Date of Service 9/16/09 to 9/28/09 Dx: Pain and weakness with AIDP/Guillian Barre. Carotid disease bilaterally less than 50%, hyponatremia, dyslipidemia, constipation. Cardiology consult: Noted hematuria which resolved during hospital course and memory difficulty. Pt. notes to cardiologist feeling of fatigue and chills. Decreased breath sounds diffusely, bibasilar rales. 1+ pitting edema RLE. Positive for focal weakness, sensory change, speech change. Parasthesia of left hand. Worsening Bell's palsy on the right (patient is unable to close right eye). Decreased fine coordination RUE, hand. Decreased coordination heel to shin LLE. Decreased DTR both UE and LLE. Joint pain, myalgias and neck pain all positive. Pt. treated with 5 doses of IVIG. Condition at discharge afebrile, ambulating, eating, drinking, voiding and stable." Has heart stents/atrial fibrillation"See #18 10/7/09 Rehab records received for dates 9/16/09 to 9/28/09. PMH: Elevated cholesterol, A-Fib, HTN, unspecified arthropathy CVA. Allergy to prednisone. 10/13/09: Additional Medical Records (Cardiology Consultation) and Discharge Summary received. Date of Service 9/16/09 to 9/28/09 PMH: Hernia repair. heart stents/ atrial fibrillation.""See above. 10/7/09 Rehab records received for dates 9/16/09 to 9/28/09. Diagnostics/Labs: CXR(-), CT chest/abdomen(-), US retroperitoneal(-), EKG (+)A-fib. EKG stress test(-), stress SPECT(-), LP unsuccessful, CT head - remote left cerebe" . During the same period patient was treated with Lisinopril; Atenolol; Simvastatin; Warfarin/ Aspirin (baby). Patient was hospitalized Patient recovered.

INFLUENZA (SEASONAL) (AFLURIA) Side Effects Report #360334
INFLUENZA (SEASONAL) (AFLURIA) vaccine side effect was reported on 10/09/2009. Female patient, 88.0 years of age, was vaccinated with INFLUENZA (SEASONAL) (AFLURIA). Patient symptoms: Back pain, "Guillain Barre syndrome (LE Weakness, numbness and tingling in extremities, severe back pain). TX: IV Ig. 10/23/09: Hospital Records and Discharge Summary received for dates of service 9/28/09 to 10/14/09. GBS, Severe back pain, UTI, Hypokalemia, Hyponatremia, Constipation, Syncope, Left humeral fractures, Accelerated HTN, PVD, Dyslipidemia, Osteoporosis with degenerative joint disease and disk disease, Anxiety. Assessment: Presented with severe abdominal and back pain (8/10) after syncope episode. Had some nausea and vomiting 36 hours prior to admission. Patient fell recently and had left humeral fractures. C/o numbness and tingling in LE's and UE's and significant pain not well controlled by meds as well as LE weakness. Neuro consult & LP done. IVIG started for 5 days with slight improvement in motor function and motor strength. Placed on a fentanyl patch and morhpine sulfate for back and hip pain. UTI was treated which reduced pelvic and hip pain. Had trouble swallowing and and NG Tube was placed but pt. began gurgling up with NG tube, so a PEG tube was placed. Blood pressure fluctuated throughout LOS, thought to be due to vasormotor instability secondary to GBS. Discharged to long term care facility." HTN; left humeral fracture; PVD; DJD"Allergy to codeine (nausea / vomiting - SE). 10/23/09: Hospital Records and Discharge Summary received for dates of service 9/28/09 to 10/14/09. PMH: COPD, HTN, Hyperlipidemia, Osteoporosis, PVD, Obstructive sleep apnea, Osteopenia, Degenerative joint disease, Anxiety disorder, Tonsilectomy, Left and Right Cateract repairs, R breast cyst removal, Hemorrhoidectomy, Dental surger""CSF (protein, cell count, stain, culture); EMG. 10/23/09: Hospital Records and Discharge Summary received for dates of service 9/28/09 to 10/14/09. Labs and Diagnostics: CSF: protein 68(H), glucose 59(N), c/s neg. EMG/NCS abnormal." . Patient recovered.


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