chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: F
Vaccine: HEP, HEPA, PPV
Symptoms: Activities of daily living impaired, Mobility decreased, Nausea, Pain in extremity
Clinical narrative: The day after her vaccines pts arm became very sore and it has not improved. She has trouble lifting her arm and needs help to get dressed. Doctor recommend ice and gentle ROM exercises. A sample of LIDODERM patch was given and Rx was prescribed for her nausea.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site swelling
Clinical narrative: Swelling at injection site.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Day following injection patient developed redness, swelling around site, fever - was seen by MD et started antibiotic for ? cellulitis.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Muscle twitching, Tic
Clinical narrative: Mom called 12-6-10 and stated that 2 days after pt got flu vaccine, he started having a "tic" - "twitching" or flapping of his hands - seems oblivious to it - does note an increase with stress or fatigue - pt has had "tics" in the past per mom, but not this one - wonders if other ones now may have been related to when he got flu vaccine in past? No previous tics documented in chart.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Day after immunization patient states hives arms, legs, back. Returned to clinic 12/8/10. Referred to MD or ER.
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Crying, Insomnia, Streptococcus test negative
Clinical narrative: Crying a lot, will not sleep.
Age: 7.0
Sex: F
Vaccine: FLUN3
Symptoms: Abdominal pain, Back pain, Full blood count normal, Metabolic function test, Nausea
Clinical narrative: Started with abd pain, nausea, lower back pain & rash on extremities.
Age: 7.0
Sex: F
Vaccine: FLUN3
Symptoms: Rash, Red blood cell sedimentation rate normal, Urine analysis normal
Clinical narrative: Started with abd pain, nausea, lower back pain & rash on extremities.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, X-ray limb
Clinical narrative: Severe pain by deltoid muscle past 5 days. Had pain after flu vaccine and has gotten worse.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling cold, Heart rate increased
Clinical narrative: Patient reports feeling very cold 6 hours post vaccination requiring her to increase covers and clothing. Her temp was normal. Her heart rate was elevated to 108. Incident resolved within 24 hours with no residual effects.
Age: 51.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: PNEUMOVAX 23 and FLUZONE given in same arm (2 inches apart) on same day. Pt was getting a TDAP at MD's office later same day in left arm on 12-8-10. Pt reported on 12-11-10 Rt arm is swollen, red & hurts.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Pt had flu shot on 12/6/10, evening of 12/7/10 child broke out in hives on arms, chest, back, face and neck, very itchy so took BENADRYL 12/8/10. Still with hives, took more BENADRYL. Seen in MD office at 4pm, 12/9/10 - called mom, no hives today.
Age: 1.99
Sex: M
Vaccine: DTAP, FLU3, HEPA
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Pt left leg (thigh) red, hard at injection site.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cold sweat, Decreased appetite, Malaise, Nausea
Clinical narrative: Initial report received from pharmacist on 12 Nov 2010: This patient was vaccinated with FLUVIRIN (batch number: 112945P1), intramuscularly on 11 Nov 2010. After 5 minutes of vaccination, the patient was not feeling well and nauseated. The patient also experienced cold sweat, chills, loss appetite and vomiting. The outcome of the events were reported as completely recovered on 12 Nov 2010. Follow up pharmacist report received on 30 Nov 2010: This patient had medical condition of hypothyroidism and was taking levothyroxine concomitantly. The patient received 0.5 ml of FLUVIRIN on 11 Nov 2010 at 15:30 hrs on left deltoid. The patient tolerated vaccine in past. The patient experienced cold sweat, nausea, vomiting, chills and loss of appetite after wards. Next day morning, the patient completely recovered. The reporter assessed the events as medically significant.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Initial report received from pharmacist on 12 Nov 2010: This patient was vaccinated with FLUVIRIN (batch number: 112945P1), intramuscularly on 11 Nov 2010. After 5 minutes of vaccination, the patient was not feeling well and nauseated. The patient also experienced cold sweat, chills, loss appetite and vomiting. The outcome of the events were reported as completely recovered on 12 Nov 2010. Follow up pharmacist report received on 30 Nov 2010: This patient had medical condition of hypothyroidism and was taking levothyroxine concomitantly. The patient received 0.5 ml of FLUVIRIN on 11 Nov 2010 at 15:30 hrs on left deltoid. The patient tolerated vaccine in past. The patient experienced cold sweat, nausea, vomiting, chills and loss of appetite after wards. Next day morning, the patient completely recovered. The reporter assessed the events as medically significant.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Pt said he had shot a couple months ago but it was in November. He said his arm is still sore from vaccine. The muscle is sore "it hurts deep in arm". Pt is referring to MD.
Age: 0.61
Sex: F
Vaccine: PNC13
Symptoms: Wrong drug administered
Clinical narrative: HIB ordered. M.A. gave MENVEO by accident.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Chemotherapy, Computerised tomogram abnormal, Hodgkin's disease, Lymph gland infection, Lymphadenopathy
Clinical narrative: Information has been received from a physician and the mother of a patient concerning a 17 year old female patient who provided a link to a forum. In August 2008, the patient was vaccinated with the first dose of GARDASIL (Lot# not reported). The patient was diagnosed with Hodgkin's lymphoma 6 weeks after her second dose of GARDASIL (Lot# not reported). She discovered a lump on her neck 4 weeks after her injection and was treated for a swollen gland infection at first. The lump got larger after 2 more weeks. In October 2008, the patient had a computerized axial tomography (CAT scan) and her pediatrician sent her to the hospital that same night. The patient underwent chemotherapy and radiation and by the time of the report she was in remission. In October 2009, the patient had another computerized axial tomography (CAT scan) (result not provided) and would be monitored for the next 5 years. Upon internal review, Hodgkin's lymphoma was considered to be an other important medical event. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Neck mass, Radiotherapy
Clinical narrative: Information has been received from a physician and the mother of a patient concerning a 17 year old female patient who provided a link to a forum. In August 2008, the patient was vaccinated with the first dose of GARDASIL (Lot# not reported). The patient was diagnosed with Hodgkin's lymphoma 6 weeks after her second dose of GARDASIL (Lot# not reported). She discovered a lump on her neck 4 weeks after her injection and was treated for a swollen gland infection at first. The lump got larger after 2 more weeks. In October 2008, the patient had a computerized axial tomography (CAT scan) and her pediatrician sent her to the hospital that same night. The patient underwent chemotherapy and radiation and by the time of the report she was in remission. In October 2009, the patient had another computerized axial tomography (CAT scan) (result not provided) and would be monitored for the next 5 years. Upon internal review, Hodgkin's lymphoma was considered to be an other important medical event. Additional information is not expected.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Limb discomfort, Oedema peripheral
Clinical narrative: Large (approx 7 inches) area of circumferential edema, erythema, and arm discomfort just below where IM was given. Remained like that until 11/08/2010, then slowly decreased until it was resolved by 11/16/2010.  Treatment was ice packs to arm, Tylenol and ibuprofen for comfort.
Age: 1.01
Sex: M
Vaccine: FLUX, HEPA, PPV, VARCEL
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Fever, followed by spots/rash across body
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Headache, Nausea, Pyrexia, Urticaria
Clinical narrative: Woke with Headache. 100.3 fever. By 6:30 pm Felt Dizzy and Nausea. Had to sit down. Hives.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Balance disorder, Chills, Cough, Headache, Pyrexia
Clinical narrative: Chills to where I was shaking uncontrollably for a few hours on and off. After awakening at 5:30 AM  12/09/2010 with severe headache and balance was off. Took Motrin at 5:30.  Fever of 100.6 and a dry cough was noticed at 7:30 AM. Had the headache all day and the cough lingers as of today 12/11/2010.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: Chills to where I was shaking uncontrollably for a few hours on and off. After awakening at 5:30 AM  12/09/2010 with severe headache and balance was off. Took Motrin at 5:30.  Fever of 100.6 and a dry cough was noticed at 7:30 AM. Had the headache all day and the cough lingers as of today 12/11/2010.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Epstein-Barr virus test, Full blood count, Headache, Liver function test, Myalgia
Clinical narrative: Pain in left arm, radiating to neck and head. Progressed to generalized, widespread pain or upper torso. Nighttimes shaking, sweating began approx. 2 weeks later and has persisted to date. All muscles continue to be sore.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Neck pain, Night sweats, Pain, Pain in extremity, Thyroid function test
Clinical narrative: Pain in left arm, radiating to neck and head. Progressed to generalized, widespread pain or upper torso. Nighttimes shaking, sweating began approx. 2 weeks later and has persisted to date. All muscles continue to be sore.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Tremor
Clinical narrative: Pain in left arm, radiating to neck and head. Progressed to generalized, widespread pain or upper torso. Nighttimes shaking, sweating began approx. 2 weeks later and has persisted to date. All muscles continue to be sore.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Influenza, Lymphadenopathy, Pruritus, Swelling
Clinical narrative: Severe swelling, redness itching flu symptoms enlarged lymph nodes
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Muscular weakness, Myalgia, Pain in extremity
Clinical narrative: I had muscle pain & in my arm and assumed it was from the injection.  After a couple days, it was obvious the pain wasn't from the injection because it wasn't located at the injection site.  The pain/weakness is located approximately from the area of mid-upper arm (6 inches above elbow) to approximately 3-4 inches below the elbow on my right arm (injection arm).  There is constant ache and with any pressure (lifting even a few ounces like a glass of water) there is an immediate onset of achy pain and weakness to the point where I must stop lifting.  Movement is not an issue other than the constant "ache".  The biggest problem is the sharper pain and immediate weakness upon use of the arm.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Computerised tomogram, Electromyogram, Herpes zoster, Movement disorder, Nuclear magnetic resonance imaging
Clinical narrative: According to patient's wife approximately 2 weeks after receiving vaccine he developed Shingles.  Shortly after he developed "bilateral polyneuropathy in both legs" resulting in the loss of function of his legs.  Patient's wife states he could no longer support his weight on his legs.  He was hospitalized on 11-29-10 and also developed blood clots in his legs.  He is currently in rehabilatation.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Polyneuropathy, Thrombosis, Weight bearing difficulty
Clinical narrative: According to patient's wife approximately 2 weeks after receiving vaccine he developed Shingles.  Shortly after he developed "bilateral polyneuropathy in both legs" resulting in the loss of function of his legs.  Patient's wife states he could no longer support his weight on his legs.  He was hospitalized on 11-29-10 and also developed blood clots in his legs.  He is currently in rehabilatation.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: Shoulder and arm swelling x3. Made it difficult to operate a computer mouse.  Took Ibuprofen for 24hrs, and swelling/pain diminished.
Age: 2.0
Sex: F
Vaccine: PNC13
Symptoms: Urticaria
Clinical narrative: Head to toes Hives
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Balance disorder, Dizziness, Feeling abnormal
Clinical narrative: Bent over raised back up had a head rush foggy light headed balance problem almost 5 weeks ago and symptoms have not cleared.
Age: 64.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site pain, Musculoskeletal pain, Pain in extremity
Clinical narrative: ACHING PAIN AT THE SITE OF THE INJECTION.  ACHING PAIN IN MY LEFT SHOULDER, LEFT UPPER ARM, LEFT SHOULDER BLADE AND LEFT SHOULDER.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Sleep disorder
Clinical narrative: Gave PNEUMOVAX shot approx 5:30 pm on 12/8/10. Pt reported on 12/9/10 (about 6 pm) the injection site is swollen & underside from elbow up is warm & red itches on underside. Pt states she had to take ADVIL to sleep.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Joint swelling, Sleep disorder
Clinical narrative: Swollen joint between thumb and wrist (not at injection site); very painful, had terrible night. MD could not explain reaction - asked if patient bruised it there and answer was no.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Cellulitis, Laboratory test
Clinical narrative: This 11 year old male consumer received 0.5mL of meningococcal polysaccharide vaccine (MCV4) on 10Nov2010 for immunizations at a local health center. The patient's relevant medical history includes: It is unknown if the patient had previous allergic reaction to MCV4. On 13Nov2010 the patient returned to the clinic with possible cellulitis. The patient was triaged by a doctor. Additional laboratory or diagnostic testing was performed. MCV4 was discontinued, the patient was treated with Benadryl, and the cellulitis resolved after that.
Age: 0.53
Sex: F
Vaccine: MMR
Symptoms: Culture urine negative, Febrile convulsion, Full blood count abnormal, Streptococcus test negative
Clinical narrative: Onset of Febrile Seizure with no other illness noted by ER at admission.  My daughter spiked a fever last evening that was controlled with Tylenol and today spiked fever that induced seizure.  The hospital found no evidence of any sickness other than blood work indicating a virus of some type.
Age: 52.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Chest pain, Feeling of body temperature change, Hyperhidrosis, Laryngitis, Lymphadenopathy
Clinical narrative: Sore throat, tremors, fever, chest pain. Swollen glands, laryngitis. Hot and cold sweats.
Age: 52.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Oropharyngeal pain, Pyrexia, Tremor
Clinical narrative: Sore throat, tremors, fever, chest pain. Swollen glands, laryngitis. Hot and cold sweats.
Age: 60.0
Sex: M
Vaccine: PER, TD, UNK
Symptoms: Muscle spasms, Pain in extremity
Clinical narrative: At first my arm became sore as I was told by the administering nurse would happen so I ignored it. Next the muscles in my middle back began to lock-up the next day.  Soon it moved to my lower back and hips, then to sciatic and thighs where it remains presently.
Age: 71.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Asthenia, Condition aggravated, Dyspnoea, Myasthenia gravis, Pneumonia
Clinical narrative: Acute onset shortness of breath and profound weakness.  Taken to ER and admitted with pneumonia.  During hospital stay myasthenia gravis was diagnosed. On reflection, patient had had some weakness for several years but no severe symptoms.
Age: 3.0
Sex: M
Vaccine: FLUX
Symptoms: Lethargy, Vomiting projectile
Clinical narrative: lethargy, projectile vomiting
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: Large, 3inch+ red patch at injection sight.  Patient treated it with hydrocortisone (x2), eventually resolved.
Age: 4.0
Sex: M
Vaccine: FLUX, FLUX(H1N1)
Symptoms: Urticaria
Clinical narrative: Hives covering entire body. Now lasting 4 days. Went to ER tonight as Benadryl would not work. Prescribed prednisone.
Age: 41.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Injection site pain
Clinical narrative: Soreness in arm two months after shot. Pain comes and goes. Sometimes severe. Pain is in upper arm, exact place where I received the vaccination.
Age: 27.0
Sex: F
Vaccine: FLUN(H1N1), FLUN(H1N1), FLU3
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Initial report was received from another manufacturer on 30 November 2010 (reference number MEDI-0011560). Additional information was retrieved from the scientific literature on 03 December 2010. A 27-year-old female patient received FLUZONE SV (lot number U3192AA) on 29 October 2009. She also received an intranasal dose of H1N1, Intranasal (MedImmune, lot number 500748P) on 20 November 2009. Medical history included remote cervical spine fusion, with no family history of autoimmune disorders. The patient reported no neurological symptoms and no gastrointestinal illness prior to symptoms onset. On 05 November 2009, 7 days post-vaccination with FLUZONE SV, the patient was treated for mycoplasma pneumonia. Four days after receiving H1N1, Intranasal (also reported as 30 November 2009), the patient began experiencing pain in her back, left hip, and lower extremities. She presented to a clinic with complaints of lower back pain and left radiculopathy. A CT scan of the lumbar spine on 01 December 2010 was negative, and the patient was treated with muscle relaxers and pain medications. She developed gradual weakness and paresthesias in the legs; symptoms eventually increased to include all extremities. On 09 December 2009, while diapering a child, her legs buckled and she had difficulty coming to her feet. She later developed tingling and burning in her hands, and reported difficulty opening jars. She returned to the clinic with continued back pain and urinary retention. Symptoms worsened overnight, and on 10 December she presented to the hospital and was admitted. Examination revealed mild proximal muscle weakness, with mildly diminished sensation of the upper extremities and moderate proximal weakness with profound sensory loss in the lower extremities. Sensation was also moderately diminished on the trunk, with a T4 sensory level. There was diffuse hyperreflexia, with silent plantar response and no clonus. A magnetic resonance imaging test (MRI) revealed extensive intramedullary nonenhancing T2 hyperintensity extending from the cervical medullary junction throughout the length of the thoracic cord. Brain MRI was negative for demyelinating lesions, and nerve conduction studies and visual evoked potentials were normal. Laboratory testing was negative for serum angiotensin-converting enzyme, antinuclear antibody, rheumatoid factor, neuromyelitis optica antibodies, human immunodeficiency virus, Lyme disease, and West Nile virus serologies. Epstein-Barr virus, cytomegalovirus, and mycoplasma IgG results (elevated at 1.22) were positive, but their respective IgM results were negative. Sedimentation rate and vitamin B12 levels were normal. Cerebrospinal fluid had a protein concentration of 0.223 g/dL, a glucose concentration of 41 mg/dL, and a white blood cell count of 517 uL with 98% lymphocytes. Bacterial, fungal, and viral cultures were negative. No oligoclonal bands were present. The patient was treated with daily intravenous
Age: 27.0
Sex: F
Vaccine: FLUN(H1N1), FLUN(H1N1), FLU3
Symptoms: Angiotensin converting enzyme, Antibody test negative, Antinuclear antibody negative, Areflexia, Arthralgia
Clinical narrative: Initial report was received from another manufacturer on 30 November 2010 (reference number MEDI-0011560). Additional information was retrieved from the scientific literature on 03 December 2010. A 27-year-old female patient received FLUZONE SV (lot number U3192AA) on 29 October 2009. She also received an intranasal dose of H1N1, Intranasal (MedImmune, lot number 500748P) on 20 November 2009. Medical history included remote cervical spine fusion, with no family history of autoimmune disorders. The patient reported no neurological symptoms and no gastrointestinal illness prior to symptoms onset. On 05 November 2009, 7 days post-vaccination with FLUZONE SV, the patient was treated for mycoplasma pneumonia. Four days after receiving H1N1, Intranasal (also reported as 30 November 2009), the patient began experiencing pain in her back, left hip, and lower extremities. She presented to a clinic with complaints of lower back pain and left radiculopathy. A CT scan of the lumbar spine on 01 December 2010 was negative, and the patient was treated with muscle relaxers and pain medications. She developed gradual weakness and paresthesias in the legs; symptoms eventually increased to include all extremities. On 09 December 2009, while diapering a child, her legs buckled and she had difficulty coming to her feet. She later developed tingling and burning in her hands, and reported difficulty opening jars. She returned to the clinic with continued back pain and urinary retention. Symptoms worsened overnight, and on 10 December she presented to the hospital and was admitted. Examination revealed mild proximal muscle weakness, with mildly diminished sensation of the upper extremities and moderate proximal weakness with profound sensory loss in the lower extremities. Sensation was also moderately diminished on the trunk, with a T4 sensory level. There was diffuse hyperreflexia, with silent plantar response and no clonus. A magnetic resonance imaging test (MRI) revealed extensive intramedullary nonenhancing T2 hyperintensity extending from the cervical medullary junction throughout the length of the thoracic cord. Brain MRI was negative for demyelinating lesions, and nerve conduction studies and visual evoked potentials were normal. Laboratory testing was negative for serum angiotensin-converting enzyme, antinuclear antibody, rheumatoid factor, neuromyelitis optica antibodies, human immunodeficiency virus, Lyme disease, and West Nile virus serologies. Epstein-Barr virus, cytomegalovirus, and mycoplasma IgG results (elevated at 1.22) were positive, but their respective IgM results were negative. Sedimentation rate and vitamin B12 levels were normal. Cerebrospinal fluid had a protein concentration of 0.223 g/dL, a glucose concentration of 41 mg/dL, and a white blood cell count of 517 uL with 98% lymphocytes. Bacterial, fungal, and viral cultures were negative. No oligoclonal bands were present. The patient was treated with daily intravenous
Age: 27.0
Sex: F
Vaccine: FLUN(H1N1), FLUN(H1N1), FLU3
Symptoms: Back pain, Bacterial test negative, Borrelia test negative, Burning sensation, CSF glucose decreased
Clinical narrative: Initial report was received from another manufacturer on 30 November 2010 (reference number MEDI-0011560). Additional information was retrieved from the scientific literature on 03 December 2010. A 27-year-old female patient received FLUZONE SV (lot number U3192AA) on 29 October 2009. She also received an intranasal dose of H1N1, Intranasal (MedImmune, lot number 500748P) on 20 November 2009. Medical history included remote cervical spine fusion, with no family history of autoimmune disorders. The patient reported no neurological symptoms and no gastrointestinal illness prior to symptoms onset. On 05 November 2009, 7 days post-vaccination with FLUZONE SV, the patient was treated for mycoplasma pneumonia. Four days after receiving H1N1, Intranasal (also reported as 30 November 2009), the patient began experiencing pain in her back, left hip, and lower extremities. She presented to a clinic with complaints of lower back pain and left radiculopathy. A CT scan of the lumbar spine on 01 December 2010 was negative, and the patient was treated with muscle relaxers and pain medications. She developed gradual weakness and paresthesias in the legs; symptoms eventually increased to include all extremities. On 09 December 2009, while diapering a child, her legs buckled and she had difficulty coming to her feet. She later developed tingling and burning in her hands, and reported difficulty opening jars. She returned to the clinic with continued back pain and urinary retention. Symptoms worsened overnight, and on 10 December she presented to the hospital and was admitted. Examination revealed mild proximal muscle weakness, with mildly diminished sensation of the upper extremities and moderate proximal weakness with profound sensory loss in the lower extremities. Sensation was also moderately diminished on the trunk, with a T4 sensory level. There was diffuse hyperreflexia, with silent plantar response and no clonus. A magnetic resonance imaging test (MRI) revealed extensive intramedullary nonenhancing T2 hyperintensity extending from the cervical medullary junction throughout the length of the thoracic cord. Brain MRI was negative for demyelinating lesions, and nerve conduction studies and visual evoked potentials were normal. Laboratory testing was negative for serum angiotensin-converting enzyme, antinuclear antibody, rheumatoid factor, neuromyelitis optica antibodies, human immunodeficiency virus, Lyme disease, and West Nile virus serologies. Epstein-Barr virus, cytomegalovirus, and mycoplasma IgG results (elevated at 1.22) were positive, but their respective IgM results were negative. Sedimentation rate and vitamin B12 levels were normal. Cerebrospinal fluid had a protein concentration of 0.223 g/dL, a glucose concentration of 41 mg/dL, and a white blood cell count of 517 uL with 98% lymphocytes. Bacterial, fungal, and viral cultures were negative. No oligoclonal bands were present. The patient was treated with daily intravenous
Age: 27.0
Sex: F
Vaccine: FLUN(H1N1), FLUN(H1N1), FLU3
Symptoms: Cytomegalovirus test positive, Dysstasia, Epstein-Barr virus antibody negative, Epstein-Barr virus antibody positive, Fungal test
Clinical narrative: Initial report was received from another manufacturer on 30 November 2010 (reference number MEDI-0011560). Additional information was retrieved from the scientific literature on 03 December 2010. A 27-year-old female patient received FLUZONE SV (lot number U3192AA) on 29 October 2009. She also received an intranasal dose of H1N1, Intranasal (MedImmune, lot number 500748P) on 20 November 2009. Medical history included remote cervical spine fusion, with no family history of autoimmune disorders. The patient reported no neurological symptoms and no gastrointestinal illness prior to symptoms onset. On 05 November 2009, 7 days post-vaccination with FLUZONE SV, the patient was treated for mycoplasma pneumonia. Four days after receiving H1N1, Intranasal (also reported as 30 November 2009), the patient began experiencing pain in her back, left hip, and lower extremities. She presented to a clinic with complaints of lower back pain and left radiculopathy. A CT scan of the lumbar spine on 01 December 2010 was negative, and the patient was treated with muscle relaxers and pain medications. She developed gradual weakness and paresthesias in the legs; symptoms eventually increased to include all extremities. On 09 December 2009, while diapering a child, her legs buckled and she had difficulty coming to her feet. She later developed tingling and burning in her hands, and reported difficulty opening jars. She returned to the clinic with continued back pain and urinary retention. Symptoms worsened overnight, and on 10 December she presented to the hospital and was admitted. Examination revealed mild proximal muscle weakness, with mildly diminished sensation of the upper extremities and moderate proximal weakness with profound sensory loss in the lower extremities. Sensation was also moderately diminished on the trunk, with a T4 sensory level. There was diffuse hyperreflexia, with silent plantar response and no clonus. A magnetic resonance imaging test (MRI) revealed extensive intramedullary nonenhancing T2 hyperintensity extending from the cervical medullary junction throughout the length of the thoracic cord. Brain MRI was negative for demyelinating lesions, and nerve conduction studies and visual evoked potentials were normal. Laboratory testing was negative for serum angiotensin-converting enzyme, antinuclear antibody, rheumatoid factor, neuromyelitis optica antibodies, human immunodeficiency virus, Lyme disease, and West Nile virus serologies. Epstein-Barr virus, cytomegalovirus, and mycoplasma IgG results (elevated at 1.22) were positive, but their respective IgM results were negative. Sedimentation rate and vitamin B12 levels were normal. Cerebrospinal fluid had a protein concentration of 0.223 g/dL, a glucose concentration of 41 mg/dL, and a white blood cell count of 517 uL with 98% lymphocytes. Bacterial, fungal, and viral cultures were negative. No oligoclonal bands were present. The patient was treated with daily intravenous
Age: 27.0
Sex: F
Vaccine: FLUN(H1N1), FLUN(H1N1), FLU3
Symptoms: Fungal test negative, HIV test negative, Hyperreflexia, Muscular weakness, Mycoplasma test positive
Clinical narrative: Initial report was received from another manufacturer on 30 November 2010 (reference number MEDI-0011560). Additional information was retrieved from the scientific literature on 03 December 2010. A 27-year-old female patient received FLUZONE SV (lot number U3192AA) on 29 October 2009. She also received an intranasal dose of H1N1, Intranasal (MedImmune, lot number 500748P) on 20 November 2009. Medical history included remote cervical spine fusion, with no family history of autoimmune disorders. The patient reported no neurological symptoms and no gastrointestinal illness prior to symptoms onset. On 05 November 2009, 7 days post-vaccination with FLUZONE SV, the patient was treated for mycoplasma pneumonia. Four days after receiving H1N1, Intranasal (also reported as 30 November 2009), the patient began experiencing pain in her back, left hip, and lower extremities. She presented to a clinic with complaints of lower back pain and left radiculopathy. A CT scan of the lumbar spine on 01 December 2010 was negative, and the patient was treated with muscle relaxers and pain medications. She developed gradual weakness and paresthesias in the legs; symptoms eventually increased to include all extremities. On 09 December 2009, while diapering a child, her legs buckled and she had difficulty coming to her feet. She later developed tingling and burning in her hands, and reported difficulty opening jars. She returned to the clinic with continued back pain and urinary retention. Symptoms worsened overnight, and on 10 December she presented to the hospital and was admitted. Examination revealed mild proximal muscle weakness, with mildly diminished sensation of the upper extremities and moderate proximal weakness with profound sensory loss in the lower extremities. Sensation was also moderately diminished on the trunk, with a T4 sensory level. There was diffuse hyperreflexia, with silent plantar response and no clonus. A magnetic resonance imaging test (MRI) revealed extensive intramedullary nonenhancing T2 hyperintensity extending from the cervical medullary junction throughout the length of the thoracic cord. Brain MRI was negative for demyelinating lesions, and nerve conduction studies and visual evoked potentials were normal. Laboratory testing was negative for serum angiotensin-converting enzyme, antinuclear antibody, rheumatoid factor, neuromyelitis optica antibodies, human immunodeficiency virus, Lyme disease, and West Nile virus serologies. Epstein-Barr virus, cytomegalovirus, and mycoplasma IgG results (elevated at 1.22) were positive, but their respective IgM results were negative. Sedimentation rate and vitamin B12 levels were normal. Cerebrospinal fluid had a protein concentration of 0.223 g/dL, a glucose concentration of 41 mg/dL, and a white blood cell count of 517 uL with 98% lymphocytes. Bacterial, fungal, and viral cultures were negative. No oligoclonal bands were present. The patient was treated with daily intravenous
Age: 27.0
Sex: F
Vaccine: FLUN(H1N1), FLUN(H1N1), FLU3
Symptoms: Paraesthesia, Plasmapheresis, Red blood cell sedimentation rate normal, Rheumatoid factor negative, Sensory loss
Clinical narrative: Initial report was received from another manufacturer on 30 November 2010 (reference number MEDI-0011560). Additional information was retrieved from the scientific literature on 03 December 2010. A 27-year-old female patient received FLUZONE SV (lot number U3192AA) on 29 October 2009. She also received an intranasal dose of H1N1, Intranasal (MedImmune, lot number 500748P) on 20 November 2009. Medical history included remote cervical spine fusion, with no family history of autoimmune disorders. The patient reported no neurological symptoms and no gastrointestinal illness prior to symptoms onset. On 05 November 2009, 7 days post-vaccination with FLUZONE SV, the patient was treated for mycoplasma pneumonia. Four days after receiving H1N1, Intranasal (also reported as 30 November 2009), the patient began experiencing pain in her back, left hip, and lower extremities. She presented to a clinic with complaints of lower back pain and left radiculopathy. A CT scan of the lumbar spine on 01 December 2010 was negative, and the patient was treated with muscle relaxers and pain medications. She developed gradual weakness and paresthesias in the legs; symptoms eventually increased to include all extremities. On 09 December 2009, while diapering a child, her legs buckled and she had difficulty coming to her feet. She later developed tingling and burning in her hands, and reported difficulty opening jars. She returned to the clinic with continued back pain and urinary retention. Symptoms worsened overnight, and on 10 December she presented to the hospital and was admitted. Examination revealed mild proximal muscle weakness, with mildly diminished sensation of the upper extremities and moderate proximal weakness with profound sensory loss in the lower extremities. Sensation was also moderately diminished on the trunk, with a T4 sensory level. There was diffuse hyperreflexia, with silent plantar response and no clonus. A magnetic resonance imaging test (MRI) revealed extensive intramedullary nonenhancing T2 hyperintensity extending from the cervical medullary junction throughout the length of the thoracic cord. Brain MRI was negative for demyelinating lesions, and nerve conduction studies and visual evoked potentials were normal. Laboratory testing was negative for serum angiotensin-converting enzyme, antinuclear antibody, rheumatoid factor, neuromyelitis optica antibodies, human immunodeficiency virus, Lyme disease, and West Nile virus serologies. Epstein-Barr virus, cytomegalovirus, and mycoplasma IgG results (elevated at 1.22) were positive, but their respective IgM results were negative. Sedimentation rate and vitamin B12 levels were normal. Cerebrospinal fluid had a protein concentration of 0.223 g/dL, a glucose concentration of 41 mg/dL, and a white blood cell count of 517 uL with 98% lymphocytes. Bacterial, fungal, and viral cultures were negative. No oligoclonal bands were present. The patient was treated with daily intravenous
Age: 27.0
Sex: F
Vaccine: FLUN(H1N1), FLUN(H1N1), FLU3
Symptoms: Urinary retention, Viral test negative, Visual evoked potentials normal, Vitamin B12 normal, West Nile virus test negative
Clinical narrative: Initial report was received from another manufacturer on 30 November 2010 (reference number MEDI-0011560). Additional information was retrieved from the scientific literature on 03 December 2010. A 27-year-old female patient received FLUZONE SV (lot number U3192AA) on 29 October 2009. She also received an intranasal dose of H1N1, Intranasal (MedImmune, lot number 500748P) on 20 November 2009. Medical history included remote cervical spine fusion, with no family history of autoimmune disorders. The patient reported no neurological symptoms and no gastrointestinal illness prior to symptoms onset. On 05 November 2009, 7 days post-vaccination with FLUZONE SV, the patient was treated for mycoplasma pneumonia. Four days after receiving H1N1, Intranasal (also reported as 30 November 2009), the patient began experiencing pain in her back, left hip, and lower extremities. She presented to a clinic with complaints of lower back pain and left radiculopathy. A CT scan of the lumbar spine on 01 December 2010 was negative, and the patient was treated with muscle relaxers and pain medications. She developed gradual weakness and paresthesias in the legs; symptoms eventually increased to include all extremities. On 09 December 2009, while diapering a child, her legs buckled and she had difficulty coming to her feet. She later developed tingling and burning in her hands, and reported difficulty opening jars. She returned to the clinic with continued back pain and urinary retention. Symptoms worsened overnight, and on 10 December she presented to the hospital and was admitted. Examination revealed mild proximal muscle weakness, with mildly diminished sensation of the upper extremities and moderate proximal weakness with profound sensory loss in the lower extremities. Sensation was also moderately diminished on the trunk, with a T4 sensory level. There was diffuse hyperreflexia, with silent plantar response and no clonus. A magnetic resonance imaging test (MRI) revealed extensive intramedullary nonenhancing T2 hyperintensity extending from the cervical medullary junction throughout the length of the thoracic cord. Brain MRI was negative for demyelinating lesions, and nerve conduction studies and visual evoked potentials were normal. Laboratory testing was negative for serum angiotensin-converting enzyme, antinuclear antibody, rheumatoid factor, neuromyelitis optica antibodies, human immunodeficiency virus, Lyme disease, and West Nile virus serologies. Epstein-Barr virus, cytomegalovirus, and mycoplasma IgG results (elevated at 1.22) were positive, but their respective IgM results were negative. Sedimentation rate and vitamin B12 levels were normal. Cerebrospinal fluid had a protein concentration of 0.223 g/dL, a glucose concentration of 41 mg/dL, and a white blood cell count of 517 uL with 98% lymphocytes. Bacterial, fungal, and viral cultures were negative. No oligoclonal bands were present. The patient was treated with daily intravenous
Age: 27.0
Sex: F
Vaccine: FLUN(H1N1), FLUN(H1N1), FLU3
Symptoms: Angiotensin converting enzyme, Antinuclear antibody negative, Arthralgia, Back pain, Bacterial test negative
Clinical narrative: Initial report was received from another manufacturer on 30 November 2010 (reference number MEDI-0011560). Additional information was retrieved from the scientific literature on 03 December 2010. A 27-year-old female patient received FLUZONE SV (lot number U3192AA) on 29 October 2009. She also received an intranasal dose of H1N1, Intranasal (MedImmune, lot number 500748P) on 20 November 2009. Medical history included remote cervical spine fusion, with no family history of autoimmune disorders. The patient reported no neurological symptoms and no gastrointestinal illness prior to symptoms onset. On 05 November 2009, 7 days post-vaccination with FLUZONE SV, the patient was treated for mycoplasma pneumonia. Four days after receiving H1N1, Intranasal (also reported as 30 November 2009), the patient began experiencing pain in her back, left hip, and lower extremities. She presented to a clinic with complaints of lower back pain and left radiculopathy. A CT scan of the lumbar spine on 01 December 2010 was negative, and the patient was treated with muscle relaxers and pain medications. She developed gradual weakness and paresthesias in the legs; symptoms eventually increased to include all extremities. On 09 December 2009, while diapering a child, her legs buckled and she had difficulty coming to her feet. She later developed tingling and burning in her hands, and reported difficulty opening jars. She returned to the clinic with continued back pain and urinary retention. Symptoms worsened overnight, and on 10 December she presented to the hospital and was admitted. Examination revealed mild proximal muscle weakness, with mildly diminished sensation of the upper extremities and moderate proximal weakness with profound sensory loss in the lower extremities. Sensation was also moderately diminished on the trunk, with a T4 sensory level. There was diffuse hyperreflexia, with silent plantar response and no clonus. A magnetic resonance imaging test (MRI) revealed extensive intramedullary nonenhancing T2 hyperintensity extending from the cervical medullary junction throughout the length of the thoracic cord. Brain MRI was negative for demyelinating lesions, and nerve conduction studies and visual evoked potentials were normal. Laboratory testing was negative for serum angiotensin-converting enzyme, antinuclear antibody, rheumatoid factor, neuromyelitis optica antibodies, human immunodeficiency virus, Lyme disease, and West Nile virus serologies. Epstein-Barr virus, cytomegalovirus, and mycoplasma IgG results (elevated at 1.22) were positive, but their respective IgM results were negative. Sedimentation rate and vitamin B12 levels were normal. Cerebrospinal fluid had a protein concentration of 0.223 g/dL, a glucose concentration of 41 mg/dL, and a white blood cell count of 517 uL with 98% lymphocytes. Bacterial, fungal, and viral cultures were negative. No oligoclonal bands were present. The patient was treated with daily intravenous
Age: 27.0
Sex: F
Vaccine: FLUN(H1N1), FLUN(H1N1), FLU3
Symptoms: Borrelia test negative, Burning sensation, CSF glucose decreased, CSF oligoclonal band absent, CSF protein
Clinical narrative: Initial report was received from another manufacturer on 30 November 2010 (reference number MEDI-0011560). Additional information was retrieved from the scientific literature on 03 December 2010. A 27-year-old female patient received FLUZONE SV (lot number U3192AA) on 29 October 2009. She also received an intranasal dose of H1N1, Intranasal (MedImmune, lot number 500748P) on 20 November 2009. Medical history included remote cervical spine fusion, with no family history of autoimmune disorders. The patient reported no neurological symptoms and no gastrointestinal illness prior to symptoms onset. On 05 November 2009, 7 days post-vaccination with FLUZONE SV, the patient was treated for mycoplasma pneumonia. Four days after receiving H1N1, Intranasal (also reported as 30 November 2009), the patient began experiencing pain in her back, left hip, and lower extremities. She presented to a clinic with complaints of lower back pain and left radiculopathy. A CT scan of the lumbar spine on 01 December 2010 was negative, and the patient was treated with muscle relaxers and pain medications. She developed gradual weakness and paresthesias in the legs; symptoms eventually increased to include all extremities. On 09 December 2009, while diapering a child, her legs buckled and she had difficulty coming to her feet. She later developed tingling and burning in her hands, and reported difficulty opening jars. She returned to the clinic with continued back pain and urinary retention. Symptoms worsened overnight, and on 10 December she presented to the hospital and was admitted. Examination revealed mild proximal muscle weakness, with mildly diminished sensation of the upper extremities and moderate proximal weakness with profound sensory loss in the lower extremities. Sensation was also moderately diminished on the trunk, with a T4 sensory level. There was diffuse hyperreflexia, with silent plantar response and no clonus. A magnetic resonance imaging test (MRI) revealed extensive intramedullary nonenhancing T2 hyperintensity extending from the cervical medullary junction throughout the length of the thoracic cord. Brain MRI was negative for demyelinating lesions, and nerve conduction studies and visual evoked potentials were normal. Laboratory testing was negative for serum angiotensin-converting enzyme, antinuclear antibody, rheumatoid factor, neuromyelitis optica antibodies, human immunodeficiency virus, Lyme disease, and West Nile virus serologies. Epstein-Barr virus, cytomegalovirus, and mycoplasma IgG results (elevated at 1.22) were positive, but their respective IgM results were negative. Sedimentation rate and vitamin B12 levels were normal. Cerebrospinal fluid had a protein concentration of 0.223 g/dL, a glucose concentration of 41 mg/dL, and a white blood cell count of 517 uL with 98% lymphocytes. Bacterial, fungal, and viral cultures were negative. No oligoclonal bands were present. The patient was treated with daily intravenous
Age: 27.0
Sex: F
Vaccine: FLUN(H1N1), FLUN(H1N1), FLU3
Symptoms: CSF white blood cell count positive, Computerised tomogram normal, Cytomegalovirus test negative, Dysstasia, Epstein-Barr virus test negative
Clinical narrative: Initial report was received from another manufacturer on 30 November 2010 (reference number MEDI-0011560). Additional information was retrieved from the scientific literature on 03 December 2010. A 27-year-old female patient received FLUZONE SV (lot number U3192AA) on 29 October 2009. She also received an intranasal dose of H1N1, Intranasal (MedImmune, lot number 500748P) on 20 November 2009. Medical history included remote cervical spine fusion, with no family history of autoimmune disorders. The patient reported no neurological symptoms and no gastrointestinal illness prior to symptoms onset. On 05 November 2009, 7 days post-vaccination with FLUZONE SV, the patient was treated for mycoplasma pneumonia. Four days after receiving H1N1, Intranasal (also reported as 30 November 2009), the patient began experiencing pain in her back, left hip, and lower extremities. She presented to a clinic with complaints of lower back pain and left radiculopathy. A CT scan of the lumbar spine on 01 December 2010 was negative, and the patient was treated with muscle relaxers and pain medications. She developed gradual weakness and paresthesias in the legs; symptoms eventually increased to include all extremities. On 09 December 2009, while diapering a child, her legs buckled and she had difficulty coming to her feet. She later developed tingling and burning in her hands, and reported difficulty opening jars. She returned to the clinic with continued back pain and urinary retention. Symptoms worsened overnight, and on 10 December she presented to the hospital and was admitted. Examination revealed mild proximal muscle weakness, with mildly diminished sensation of the upper extremities and moderate proximal weakness with profound sensory loss in the lower extremities. Sensation was also moderately diminished on the trunk, with a T4 sensory level. There was diffuse hyperreflexia, with silent plantar response and no clonus. A magnetic resonance imaging test (MRI) revealed extensive intramedullary nonenhancing T2 hyperintensity extending from the cervical medullary junction throughout the length of the thoracic cord. Brain MRI was negative for demyelinating lesions, and nerve conduction studies and visual evoked potentials were normal. Laboratory testing was negative for serum angiotensin-converting enzyme, antinuclear antibody, rheumatoid factor, neuromyelitis optica antibodies, human immunodeficiency virus, Lyme disease, and West Nile virus serologies. Epstein-Barr virus, cytomegalovirus, and mycoplasma IgG results (elevated at 1.22) were positive, but their respective IgM results were negative. Sedimentation rate and vitamin B12 levels were normal. Cerebrospinal fluid had a protein concentration of 0.223 g/dL, a glucose concentration of 41 mg/dL, and a white blood cell count of 517 uL with 98% lymphocytes. Bacterial, fungal, and viral cultures were negative. No oligoclonal bands were present. The patient was treated with daily intravenous