chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: M
Vaccine: HEP, IPV, SMALL
Symptoms: Oral mucosal blistering, Protein urine present, Pruritus, Pyrexia, Rash
Clinical narrative: Asthma, Rhinitis, I suffer of chronic bronchial asthma and allergic rhinitis under chronic medical treatment (Advair 250/50, Singulair 10 mg, Prednisone 20 mg. Acid reflux, allergies, cough, respiratory (bronchitis), Sinusitis, anxiety, depression, nervousness, blisters in mouth, skin itching, pain lower back, high blood cholesterol, conjunctivitis, Flatulence, Sleep (insomnia), memory trouble remembering recent information, vision problems, energy loss, tiredness, hemorrhoids, rectal bleeding. 4/7/06 Received medical records from patient which reveal an extensive hx of asthma for approx 3 years (received vax 2003) with frequent exacerbations & was declared unfit for duty & d/c from military 1/2005.  PMH: HTN, high cholesterol & + protein in urine/ss. Information received from the 60 day follow-up states after being vaccinated I started having fever, rash and itching throughout my body. After being vaccinated I started having fever, rash and itching throughout my body.  During the time I was active in the war over seas I suffered bronchitis, critical sinus and asthma.  I continously suffer chronic asthma.  I am receiving treatment in the Veteran's hospital and private doctor.
Age: 46.0
Sex: M
Vaccine: HEP, IPV, SMALL
Symptoms: Rectal haemorrhage, Rhinitis allergic, Sinusitis, Skin disorder, Visual disturbance
Clinical narrative: Asthma, Rhinitis, I suffer of chronic bronchial asthma and allergic rhinitis under chronic medical treatment (Advair 250/50, Singulair 10 mg, Prednisone 20 mg. Acid reflux, allergies, cough, respiratory (bronchitis), Sinusitis, anxiety, depression, nervousness, blisters in mouth, skin itching, pain lower back, high blood cholesterol, conjunctivitis, Flatulence, Sleep (insomnia), memory trouble remembering recent information, vision problems, energy loss, tiredness, hemorrhoids, rectal bleeding. 4/7/06 Received medical records from patient which reveal an extensive hx of asthma for approx 3 years (received vax 2003) with frequent exacerbations & was declared unfit for duty & d/c from military 1/2005.  PMH: HTN, high cholesterol & + protein in urine/ss. Information received from the 60 day follow-up states after being vaccinated I started having fever, rash and itching throughout my body. After being vaccinated I started having fever, rash and itching throughout my body.  During the time I was active in the war over seas I suffered bronchitis, critical sinus and asthma.  I continously suffer chronic asthma.  I am receiving treatment in the Veteran's hospital and private doctor.
Age: 24.0
Sex: M
Vaccine: ANTH
Symptoms: Amnesia, Arthralgia, Fatigue, Gastrooesophageal reflux disease, Mood swings
Clinical narrative: Mood swings, joint pain, fatigue, nausea, itchy skin on March 01 2003 was diagnosed with GERD in April 03 and given Prilosec. Proteinuria on May 2005 was later sent to ER because of vomiting profusely. Diagnosed with focal segmental glomerulosclerosis. Currently on Meds. Rashes May 2005 depreciating strength in left arm Jun 05. Additional terms from Medical Record rec'd 01/18/2006: preexisting condition--chronic back and shoulder pain/sr Per 60 day follow up report-Painful joints in neck, lower, upper back, itchy skin, rashes, nausea, vomiting, fatigue, memory loss (short term) unable to focus. Depreciated strength in left side arm, shoulder. I have been to numerous specialist and I can not find out what is wrong with me. There is no other logical explanation I have too many symptoms for doctors to understand.
Age: 24.0
Sex: M
Vaccine: ANTH
Symptoms: Nausea, Proteinuria, Pruritus, Rash, Renal disorder
Clinical narrative: Mood swings, joint pain, fatigue, nausea, itchy skin on March 01 2003 was diagnosed with GERD in April 03 and given Prilosec. Proteinuria on May 2005 was later sent to ER because of vomiting profusely. Diagnosed with focal segmental glomerulosclerosis. Currently on Meds. Rashes May 2005 depreciating strength in left arm Jun 05. Additional terms from Medical Record rec'd 01/18/2006: preexisting condition--chronic back and shoulder pain/sr Per 60 day follow up report-Painful joints in neck, lower, upper back, itchy skin, rashes, nausea, vomiting, fatigue, memory loss (short term) unable to focus. Depreciated strength in left side arm, shoulder. I have been to numerous specialist and I can not find out what is wrong with me. There is no other logical explanation I have too many symptoms for doctors to understand.
Age: 24.0
Sex: M
Vaccine: ANTH
Symptoms: Vision blurred, Vomiting
Clinical narrative: Mood swings, joint pain, fatigue, nausea, itchy skin on March 01 2003 was diagnosed with GERD in April 03 and given Prilosec. Proteinuria on May 2005 was later sent to ER because of vomiting profusely. Diagnosed with focal segmental glomerulosclerosis. Currently on Meds. Rashes May 2005 depreciating strength in left arm Jun 05. Additional terms from Medical Record rec'd 01/18/2006: preexisting condition--chronic back and shoulder pain/sr Per 60 day follow up report-Painful joints in neck, lower, upper back, itchy skin, rashes, nausea, vomiting, fatigue, memory loss (short term) unable to focus. Depreciated strength in left side arm, shoulder. I have been to numerous specialist and I can not find out what is wrong with me. There is no other logical explanation I have too many symptoms for doctors to understand.
Age: 16.0
Sex: F
Vaccine: FLUX, HEPA, TDAP
Symptoms: Medication error
Clinical narrative: NONE, Flu vaccine given today, and pt had flu vaccine 12/05/2005.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Pt C/o arm at injection site being warm to touch, swollen and somewhat painful. Pt seen in office on 12/14/2005 redness almost gone. No further treatment per Dr.
Age: 41.0
Sex: F
Vaccine: FLUN3
Symptoms: Cough, Decreased appetite, Headache, Influenza like illness, Malaise
Clinical narrative: Within 10-12 hours post flu mist, pt noted onset of nasal congestion, headaches, body aches and nausea. Symptoms have not subsided and continue today. Also reports sinus congestion, dry cough, and decreased appetite. Stated nasal drainage is clear and denies any problems with seasonal allergies. has seen a provider and was treated with Cefzil, Flonase and Maxiphed, with no improvement. Was also given a Z pack. pt is concerned about feeling ill for so long. Nasal drainage start 11/09/2005, headache, general started 11/09/2005, Flu like symptoms 96 hours start 11/09/2005, nausea w/o vomiting start 11/09/2005.
Age: 41.0
Sex: F
Vaccine: FLUN3
Symptoms: Nasal congestion, Nausea, Pain, Rhinorrhoea, Sinus congestion
Clinical narrative: Within 10-12 hours post flu mist, pt noted onset of nasal congestion, headaches, body aches and nausea. Symptoms have not subsided and continue today. Also reports sinus congestion, dry cough, and decreased appetite. Stated nasal drainage is clear and denies any problems with seasonal allergies. has seen a provider and was treated with Cefzil, Flonase and Maxiphed, with no improvement. Was also given a Z pack. pt is concerned about feeling ill for so long. Nasal drainage start 11/09/2005, headache, general started 11/09/2005, Flu like symptoms 96 hours start 11/09/2005, nausea w/o vomiting start 11/09/2005.
Age: 64.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain
Clinical narrative: Arm red and painful -9 (1-10).
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash, Skin discolouration
Clinical narrative: Started small bump on knuckles then arms and legs, itchy. No fever lasting 3-4 days, left small dark areas on skin. Mother do not report to office until 12/13/2005.
Age: 5.0
Sex: F
Vaccine: DTAP, FLU3
Symptoms: Unevaluable event
Clinical narrative: None Stated.
Age: 1.39
Sex: M
Vaccine: DTAP, FLU3, HIBV, MMR
Symptoms: Rash
Clinical narrative: Rash 2 weeks after vaccine.
Age: 1.02
Sex: F
Vaccine: FLU3, MMR, PNC, VARCEL
Symptoms: Pyrexia
Clinical narrative: Ran a fever of 103 four days after being vaccinated.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Pt received flu vaccine on 12/02/2005. Pt called MD on 12/09/2005 and stated he broke out in welts on arm and chest on 12/07/2005 then more appeared on legs 12/08/2005. No itchiness. Referred to PMD pt agreeable to f/u with PMD.
Age: 29.0
Sex: M
Vaccine: FLU3, HEP, VARCEL
Symptoms: Viral infection
Clinical narrative: Pt with development of varicella following vaccination.
Age: 89.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Slight swelling and severe redness to left arm from sight of injection in deltoid muscle to elbow. This was observed by family 2 days after injection. Reaction began clearing up by 5-6 days after injection. No sign of redness or swelling 7 days after injection.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Cough
Clinical narrative: Approximately 1 hr after receiving flu vaccine client began to experience chest tightness accompanied by cough. She fell asleep approximately 4 hrs after receiving the vaccine, still coughing with chest tightness. When she woke up 1 hr later her symptoms were gone and she felt better. No further symptoms have been experienced.
Age: 43.0
Sex: M
Vaccine: ANTH
Symptoms: Dermatitis atopic, Eosinophilia, Hyperkeratosis, Hypersensitivity, Psoriasis
Clinical narrative: After he arrived in Kuwait in 1988, he noted a rash on his buttocks. the rash continued after he was stateside again; he treated it with a topical ointment; his wife, who is a nurse thought it looked like ringworm; it cleared almost completely, but has never completely resolved. He continued the anthrax vaccine series and cannot recall if the rash got worse after each shot. he has had several visits with PCP to evaluate his rash, and was referred to an Internist and at least 2 dermatologist; he has had tissue biopsies and a liver biopsy done. In 2004, he had an exacerbation where the rash was primarily located from his thighs to his umbilicus (posterior worse than anterior); no rash or lesions around any vaccine sites - refer  to Clinical Summary.
Age: 43.0
Sex: M
Vaccine: ANTH
Symptoms: Rash, Seborrhoeic dermatitis
Clinical narrative: After he arrived in Kuwait in 1988, he noted a rash on his buttocks. the rash continued after he was stateside again; he treated it with a topical ointment; his wife, who is a nurse thought it looked like ringworm; it cleared almost completely, but has never completely resolved. He continued the anthrax vaccine series and cannot recall if the rash got worse after each shot. he has had several visits with PCP to evaluate his rash, and was referred to an Internist and at least 2 dermatologist; he has had tissue biopsies and a liver biopsy done. In 2004, he had an exacerbation where the rash was primarily located from his thighs to his umbilicus (posterior worse than anterior); no rash or lesions around any vaccine sites - refer  to Clinical Summary.
Age: 16.0
Sex: M
Vaccine: HEP, TD
Symptoms: Pityriasis rosea
Clinical narrative: Pityriasis Rosea times 1 day. Tx Caladryl PRN
Age: 5.0
Sex: F
Vaccine: IPV, MMR
Symptoms: Abscess, Erythema, Oedema
Clinical narrative: 1 day after vaccine red thigh. 2nd day swollen red.
Age: 49.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Musculoskeletal stiffness, Pain, Pyrexia
Clinical narrative: On 12-1-05 received 3rd dose of hepatitis B in clinic. Client states 1 hours after started to get a headache also ran a fever. Shortly afterward started to get a stiff neck with pain on left side of neck radiating down to shoulder blades. Has had the pain in neck and back along with headache and intermittent fever since getting the vaccine.
Age: 63.0
Sex: F
Vaccine: PPV, TD
Symptoms: Erythema, Feeling hot, Pruritus, Rash, Swelling
Clinical narrative: Swelling, redness heat - entire upper arm, itchiness approx 4 hrs after inj. Progress to rash on arm over next 24 hrs.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Fall, Injection site erythema, Injection site warmth, Myalgia, Sleep disorder
Clinical narrative: Large red hot spot injection site and arm very sore. Slept more, fatigue two days. Syncopal episode and fall 11-11-05 with facial injuries. Had never had episode like this before.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Syncope
Clinical narrative: Large red hot spot injection site and arm very sore. Slept more, fatigue two days. Syncopal episode and fall 11-11-05 with facial injuries. Had never had episode like this before.
Age: 1.33
Sex: F
Vaccine: VARCEL
Symptoms: Erythema
Clinical narrative: Multiple erythematous papules some with vesicles, some with scabs in center located chest, back, upper legs supportive at home care.
Age: 0.94
Sex: F
Vaccine: UNK
Symptoms: Viral infection
Clinical narrative: Broke out with chicken pox on 12-7-05. Form completed as much as possible. Vaccine not given in our office
Age: 1.39
Sex: M
Vaccine: VARCEL
Symptoms: Viral infection
Clinical narrative: Chicken pox (varicella)
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Chest pain, Hyperhidrosis, Pallor, Respiratory rate increased
Clinical narrative: Client was anxious about getting an injection. After injection client waiting to pay. She suddenly started to complain of chest and back pain, color pale, rapid breathing, slightly diaphoretic. Had client lay down monitored vital signs, encourage to slow deep breathing after 30 min. she felt better and was discharged home.
Age: 1.28
Sex: M
Vaccine: DTAP, HBHEPB, IPV, MMR
Symptoms: Erythema multiforme, Rash, Rash macular
Clinical narrative: MMR vaccinated on 11/22/2005. Developed a few discrete circular eruptions on face and trunk on 11/30/2005. I developed further macular and multiform erythema eruption generalized to trunk, neck and extremities, without much constitutional SX.
Age: 21.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Fatigue, Lymphadenopathy, Pyrexia, Rash
Clinical narrative: Swollen Glands, fever, rash, joint pain and fatigue, lasted 2-3 days. Took Advil.
Age: 11.0
Sex: F
Vaccine: TD
Symptoms: Injection site hypersensitivity, Injection site swelling, Injection site warmth
Clinical narrative: Mom noticed raised, reddened, circular area, warm to touch at site of injection.
Age: 14.0
Sex: F
Vaccine: DTAP, HEP, IPV, MMR, VARCEL
Symptoms: Medication error
Clinical narrative: Given DTap instead of TD no adverse reaction, Given 3rd MMR no adverse reaction should have been given 2nd Hep A.
Age: 43.0
Sex: M
Vaccine: HEPAB
Symptoms: Erythema, Pruritus, Rash, Urticaria
Clinical narrative: 11/23/2005 received 2nd dose of Twinrix. Noticed rash 11/23/05 pm. 11/26/05 went to walk in clinic received cortisone shot and PO antihistamines. Client states very rapid resolution of rash. States they were slightly reddened hives that itched. 11/28/05 client followed up with his primary physician, no further treatment or Meds given.
Age: 11.0
Sex: F
Vaccine: DTAP, HEP, IPV, MMR
Symptoms: Medication error
Clinical narrative: Given DTaP instead of TD no adverse reaction.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Viral infection
Clinical narrative: Thru Sept small blisters appeared on face and shoulder, than a few days later on arms, then buttocks and legs. They looked like insect bites but scabbed over, exactly like my other child's case of chickenpox.
Age: 76.0
Sex: M
Vaccine: PPV
Symptoms: Hypokinesia, Myalgia
Clinical narrative: Approximately 4 1/2 hours after the flu shot was administered the client called me to report severe muscular pain, so severe, he couldn't raise his left arm or lie on his left side. Denied fever.
Age: 36.0
Sex: F
Vaccine: HEPA, TD
Symptoms: Erythema, Feeling hot, Injection site abscess, Injection site induration, Oedema
Clinical narrative: Local soreness in left deltoid, redness, swelling, slightly warm to touch, nickel size area became hard, started draining yellow puss like substance on 09/23 and continued to drain for a week. Seen in an ER. No antibiotic, "just let it drain".
Age: 36.0
Sex: F
Vaccine: HEPA, TD
Symptoms: Pain
Clinical narrative: Local soreness in left deltoid, redness, swelling, slightly warm to touch, nickel size area became hard, started draining yellow puss like substance on 09/23 and continued to drain for a week. Seen in an ER. No antibiotic, "just let it drain".
Age: 1.02
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Blister, Erythema, Rash papular
Clinical narrative: Patient came to office this am with skin papules with erythematous basis, few vesicles.
Age: 6.0
Sex: F
Vaccine: IPV, MMR, VARCEL, VARCEL
Symptoms: Dermatitis bullous, Skin ulcer
Clinical narrative: Child was with another practice for vaccine. 50 lesions.
Age: 6.0
Sex: F
Vaccine: IPV, MMR, VARCEL, VARCEL
Symptoms: Skin ulcer
Clinical narrative: Child was with another practice for vaccine. 50 lesions.
Age: 48.0
Sex: F
Vaccine: FLUX, FLU3, FLU3
Symptoms: Cough, Dysphagia, Eye discharge, Headache, Lethargy
Clinical narrative: Initial report received from a health care professional on 08/Dec/2005. A 48 year old female patient received an intra-muscular dose of Fluzone SV 2004-2005 USP, lot number U1863AA, in the left deltoid on 11/Nov/2005 at 2:00 pm. Three hours later, she felt swelling in her throat and noticed that her eyes were "puffy." She did not experience any itching or difficulty breathing. The patient was seen by a physician and was treated with Zantac. The symptoms resolved one hour after treatment.
Age: 48.0
Sex: F
Vaccine: FLUX, FLU3, FLU3
Symptoms: Ocular hyperaemia, Throat tightness
Clinical narrative: Initial report received from a health care professional on 08/Dec/2005. A 48 year old female patient received an intra-muscular dose of Fluzone SV 2004-2005 USP, lot number U1863AA, in the left deltoid on 11/Nov/2005 at 2:00 pm. Three hours later, she felt swelling in her throat and noticed that her eyes were "puffy." She did not experience any itching or difficulty breathing. The patient was seen by a physician and was treated with Zantac. The symptoms resolved one hour after treatment.
Age: 48.0
Sex: F
Vaccine: FLUX, FLU3, FLU3
Symptoms: Pharyngeal oedema
Clinical narrative: Initial report received from a health care professional on 08/Dec/2005. A 48 year old female patient received an intra-muscular dose of Fluzone SV 2004-2005 USP, lot number U1863AA, in the left deltoid on 11/Nov/2005 at 2:00 pm. Three hours later, she felt swelling in her throat and noticed that her eyes were "puffy." She did not experience any itching or difficulty breathing. The patient was seen by a physician and was treated with Zantac. The symptoms resolved one hour after treatment.
Age: 48.0
Sex: F
Vaccine: FLUX, FLU3, FLU3
Symptoms: Eye swelling, Pharyngeal oedema
Clinical narrative: Initial report received from a health care professional on 08/Dec/2005. A 48 year old female patient received an intra-muscular dose of Fluzone SV 2004-2005 USP, lot number U1863AA, in the left deltoid on 11/Nov/2005 at 2:00 pm. Three hours later, she felt swelling in her throat and noticed that her eyes were "puffy." She did not experience any itching or difficulty breathing. The patient was seen by a physician and was treated with Zantac. The symptoms resolved one hour after treatment.
Age: 18.0
Sex: M
Vaccine: MNQ, FLU3, MNQ, FLU3, MNQ
Symptoms: Balance disorder, Dysuria, Fall, Gait disturbance, Headache
Clinical narrative: Initial report received from the Centers for Disease Control and Prevention (VAERS numbers 247539 and 247440) on 22/Nov/2005. An 18 year old male patient received a dose of Menactra, lot number U1821AA, in the right arm and a dose of Fluzone SV 2005-2005 USP in the right arm on 29/Oct/2005 at 11:00 am. Eight days later the patient experienced chills, body aches, headache, fever and trouble urinating. The following day he had difficulty walking (also reported as inability to walk balanced). He was seen in the emergency room and also complained of a cold and tingling sensation in his feet and legs. A catheter was inserted and the patient was prescribed antibiotics. On 09/Nov/2005, the patient had much difficulty walking and fell over. He returned to the emergency room and was transferred to a clinic. He was treated with ceftriaxone and Acyclovir. The admission note state that the impression was "probably ADE (acute disseminated encephalopathy) likely secondary to Menactra." The patient had a high cervical sensory level and bilateral pyramidal signs. He had an abnormal MRI, which showed bilateral patchy white matter signals. The patient's recovery status is unknown. This information had previously been submitted to the FDA. Follow-up information received on 30/Nov/2005 from the Centers for Disease Control and Prevention. Admission date to the hospital was 09/Nov/20052. The patient was transferred for rehabilitation on 15/Nov/2005. At that time, a lack of sensation below the shoulder remained. At the time of this report, the patient had not recovered. Follow-up information received on 08/Dec/2005 from the consulting neurologist. It was reported that the patient had a viral upper respiratory infection about two weeks prior to his admission to the hospital. Following the onset of the reported symptoms of ADEM. he was admitted to the hospital on 09/Nov/205. The principal diagnosis was acute disseminating encephalopathy.  A lumbar puncture on 10/Nov/2005 showed a red blood cell count of 13, white blood cell count of 99, protein 84, glucose 99, elevated IgG 8.4, albumin 58.1. A gram stain was negative and culture of the CSF showed no growth. PCR for herpes simplex was negative. Empiric therapy of Acyclovir and ceftriaxone were started upon admission, but were discontinued upon receiving the laboratory work. The patient was treated with a four day course of IV Solu-Medrol, which resulted in a clinical and neurological improvement. Physical and occupational therapies were also initiated,and it was noted that the patient had good progression of retaining lower extremity strength. An ophthalmologic examination confirmed that the retinal and optic nerves were not involved. On 14/Nov/2005, the IV Solu-Medrol was discontinued and oral prednisone therapy was begun. The patient continued to require physical and occupational therapy to regain strength and control. He was, however, stooling and voiding spontaneously. On 15/Nov/2005, the patient was transferred to a rehabilitation hospital in good condition.
Age: 18.0
Sex: M
Vaccine: MNQ, FLU3, MNQ, FLU3, MNQ
Symptoms: Hypokinesia, Pain, Paraesthesia, Peripheral coldness, Pyrexia
Clinical narrative: Initial report received from the Centers for Disease Control and Prevention (VAERS numbers 247539 and 247440) on 22/Nov/2005. An 18 year old male patient received a dose of Menactra, lot number U1821AA, in the right arm and a dose of Fluzone SV 2005-2005 USP in the right arm on 29/Oct/2005 at 11:00 am. Eight days later the patient experienced chills, body aches, headache, fever and trouble urinating. The following day he had difficulty walking (also reported as inability to walk balanced). He was seen in the emergency room and also complained of a cold and tingling sensation in his feet and legs. A catheter was inserted and the patient was prescribed antibiotics. On 09/Nov/2005, the patient had much difficulty walking and fell over. He returned to the emergency room and was transferred to a clinic. He was treated with ceftriaxone and Acyclovir. The admission note state that the impression was "probably ADE (acute disseminated encephalopathy) likely secondary to Menactra." The patient had a high cervical sensory level and bilateral pyramidal signs. He had an abnormal MRI, which showed bilateral patchy white matter signals. The patient's recovery status is unknown. This information had previously been submitted to the FDA. Follow-up information received on 30/Nov/2005 from the Centers for Disease Control and Prevention. Admission date to the hospital was 09/Nov/20052. The patient was transferred for rehabilitation on 15/Nov/2005. At that time, a lack of sensation below the shoulder remained. At the time of this report, the patient had not recovered. Follow-up information received on 08/Dec/2005 from the consulting neurologist. It was reported that the patient had a viral upper respiratory infection about two weeks prior to his admission to the hospital. Following the onset of the reported symptoms of ADEM. he was admitted to the hospital on 09/Nov/205. The principal diagnosis was acute disseminating encephalopathy.  A lumbar puncture on 10/Nov/2005 showed a red blood cell count of 13, white blood cell count of 99, protein 84, glucose 99, elevated IgG 8.4, albumin 58.1. A gram stain was negative and culture of the CSF showed no growth. PCR for herpes simplex was negative. Empiric therapy of Acyclovir and ceftriaxone were started upon admission, but were discontinued upon receiving the laboratory work. The patient was treated with a four day course of IV Solu-Medrol, which resulted in a clinical and neurological improvement. Physical and occupational therapies were also initiated,and it was noted that the patient had good progression of retaining lower extremity strength. An ophthalmologic examination confirmed that the retinal and optic nerves were not involved. On 14/Nov/2005, the IV Solu-Medrol was discontinued and oral prednisone therapy was begun. The patient continued to require physical and occupational therapy to regain strength and control. He was, however, stooling and voiding spontaneously. On 15/Nov/2005, the patient was transferred to a rehabilitation hospital in good condition.
Age: 18.0
Sex: M
Vaccine: MNQ, FLU3, MNQ, FLU3, MNQ
Symptoms: Balance disorder, Chills, Difficulty in walking, Dysuria, Encephalopathy
Clinical narrative: Initial report received from the Centers for Disease Control and Prevention (VAERS numbers 247539 and 247440) on 22/Nov/2005. An 18 year old male patient received a dose of Menactra, lot number U1821AA, in the right arm and a dose of Fluzone SV 2005-2005 USP in the right arm on 29/Oct/2005 at 11:00 am. Eight days later the patient experienced chills, body aches, headache, fever and trouble urinating. The following day he had difficulty walking (also reported as inability to walk balanced). He was seen in the emergency room and also complained of a cold and tingling sensation in his feet and legs. A catheter was inserted and the patient was prescribed antibiotics. On 09/Nov/2005, the patient had much difficulty walking and fell over. He returned to the emergency room and was transferred to a clinic. He was treated with ceftriaxone and Acyclovir. The admission note state that the impression was "probably ADE (acute disseminated encephalopathy) likely secondary to Menactra." The patient had a high cervical sensory level and bilateral pyramidal signs. He had an abnormal MRI, which showed bilateral patchy white matter signals. The patient's recovery status is unknown. This information had previously been submitted to the FDA. Follow-up information received on 30/Nov/2005 from the Centers for Disease Control and Prevention. Admission date to the hospital was 09/Nov/20052. The patient was transferred for rehabilitation on 15/Nov/2005. At that time, a lack of sensation below the shoulder remained. At the time of this report, the patient had not recovered. Follow-up information received on 08/Dec/2005 from the consulting neurologist. It was reported that the patient had a viral upper respiratory infection about two weeks prior to his admission to the hospital. Following the onset of the reported symptoms of ADEM. he was admitted to the hospital on 09/Nov/205. The principal diagnosis was acute disseminating encephalopathy.  A lumbar puncture on 10/Nov/2005 showed a red blood cell count of 13, white blood cell count of 99, protein 84, glucose 99, elevated IgG 8.4, albumin 58.1. A gram stain was negative and culture of the CSF showed no growth. PCR for herpes simplex was negative. Empiric therapy of Acyclovir and ceftriaxone were started upon admission, but were discontinued upon receiving the laboratory work. The patient was treated with a four day course of IV Solu-Medrol, which resulted in a clinical and neurological improvement. Physical and occupational therapies were also initiated,and it was noted that the patient had good progression of retaining lower extremity strength. An ophthalmologic examination confirmed that the retinal and optic nerves were not involved. On 14/Nov/2005, the IV Solu-Medrol was discontinued and oral prednisone therapy was begun. The patient continued to require physical and occupational therapy to regain strength and control. He was, however, stooling and voiding spontaneously. On 15/Nov/2005, the patient was transferred to a rehabilitation hospital in good condition.
Age: 18.0
Sex: M
Vaccine: MNQ, FLU3, MNQ, FLU3, MNQ
Symptoms: Pyrexia, Sensory disturbance
Clinical narrative: Initial report received from the Centers for Disease Control and Prevention (VAERS numbers 247539 and 247440) on 22/Nov/2005. An 18 year old male patient received a dose of Menactra, lot number U1821AA, in the right arm and a dose of Fluzone SV 2005-2005 USP in the right arm on 29/Oct/2005 at 11:00 am. Eight days later the patient experienced chills, body aches, headache, fever and trouble urinating. The following day he had difficulty walking (also reported as inability to walk balanced). He was seen in the emergency room and also complained of a cold and tingling sensation in his feet and legs. A catheter was inserted and the patient was prescribed antibiotics. On 09/Nov/2005, the patient had much difficulty walking and fell over. He returned to the emergency room and was transferred to a clinic. He was treated with ceftriaxone and Acyclovir. The admission note state that the impression was "probably ADE (acute disseminated encephalopathy) likely secondary to Menactra." The patient had a high cervical sensory level and bilateral pyramidal signs. He had an abnormal MRI, which showed bilateral patchy white matter signals. The patient's recovery status is unknown. This information had previously been submitted to the FDA. Follow-up information received on 30/Nov/2005 from the Centers for Disease Control and Prevention. Admission date to the hospital was 09/Nov/20052. The patient was transferred for rehabilitation on 15/Nov/2005. At that time, a lack of sensation below the shoulder remained. At the time of this report, the patient had not recovered. Follow-up information received on 08/Dec/2005 from the consulting neurologist. It was reported that the patient had a viral upper respiratory infection about two weeks prior to his admission to the hospital. Following the onset of the reported symptoms of ADEM. he was admitted to the hospital on 09/Nov/205. The principal diagnosis was acute disseminating encephalopathy.  A lumbar puncture on 10/Nov/2005 showed a red blood cell count of 13, white blood cell count of 99, protein 84, glucose 99, elevated IgG 8.4, albumin 58.1. A gram stain was negative and culture of the CSF showed no growth. PCR for herpes simplex was negative. Empiric therapy of Acyclovir and ceftriaxone were started upon admission, but were discontinued upon receiving the laboratory work. The patient was treated with a four day course of IV Solu-Medrol, which resulted in a clinical and neurological improvement. Physical and occupational therapies were also initiated,and it was noted that the patient had good progression of retaining lower extremity strength. An ophthalmologic examination confirmed that the retinal and optic nerves were not involved. On 14/Nov/2005, the IV Solu-Medrol was discontinued and oral prednisone therapy was begun. The patient continued to require physical and occupational therapy to regain strength and control. He was, however, stooling and voiding spontaneously. On 15/Nov/2005, the patient was transferred to a rehabilitation hospital in good condition.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Asthenia, Bone disorder, Chills, Eye disorder
Clinical narrative: The vaccine was given Thursday, 10/13/2005 about 12:00pm. Friday 10/14/05 I was cold and sluggish all day. About 6:00pm I went to bed and did not wake until Sat 10/15/05 about 9:00am. I woke up with a headache, my entire body was aching, muscles, joints, fingers, feet, shoulders. I could hardly get out of bed, I was bent over as I moved slowly to the bathroom. Chills were running up and down my muscles. The arms, hands and wrist were so swollen I could not make a fist, wring water out of my bath cloth or dish cloth, neither could I turn on my shower. When I moved my bones made loud cracking sounds. Pain to move my neck. My gums were sore and aching event though teeth had been pulled out years ago. Elbow ached, made cracking sounds. I would wake up about 5:00am with aching fingers, wrist, joints. Feet were aching, the toenail on right foot was split down the middle. Right eyelid is dropping (noticeable). Lumps or swelling are under the skin in my arms and hands. I had to take one step at at time, could not squat. Had difficulty getting out of bed. Weakness in my knees.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling cold, Headache, Hypokinesia, Laboratory test abnormal, Nail disorder
Clinical narrative: The vaccine was given Thursday, 10/13/2005 about 12:00pm. Friday 10/14/05 I was cold and sluggish all day. About 6:00pm I went to bed and did not wake until Sat 10/15/05 about 9:00am. I woke up with a headache, my entire body was aching, muscles, joints, fingers, feet, shoulders. I could hardly get out of bed, I was bent over as I moved slowly to the bathroom. Chills were running up and down my muscles. The arms, hands and wrist were so swollen I could not make a fist, wring water out of my bath cloth or dish cloth, neither could I turn on my shower. When I moved my bones made loud cracking sounds. Pain to move my neck. My gums were sore and aching event though teeth had been pulled out years ago. Elbow ached, made cracking sounds. I would wake up about 5:00am with aching fingers, wrist, joints. Feet were aching, the toenail on right foot was split down the middle. Right eyelid is dropping (noticeable). Lumps or swelling are under the skin in my arms and hands. I had to take one step at at time, could not squat. Had difficulty getting out of bed. Weakness in my knees.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Neck pain, Oedema, Oedema peripheral, Pain, Sluggishness
Clinical narrative: The vaccine was given Thursday, 10/13/2005 about 12:00pm. Friday 10/14/05 I was cold and sluggish all day. About 6:00pm I went to bed and did not wake until Sat 10/15/05 about 9:00am. I woke up with a headache, my entire body was aching, muscles, joints, fingers, feet, shoulders. I could hardly get out of bed, I was bent over as I moved slowly to the bathroom. Chills were running up and down my muscles. The arms, hands and wrist were so swollen I could not make a fist, wring water out of my bath cloth or dish cloth, neither could I turn on my shower. When I moved my bones made loud cracking sounds. Pain to move my neck. My gums were sore and aching event though teeth had been pulled out years ago. Elbow ached, made cracking sounds. I would wake up about 5:00am with aching fingers, wrist, joints. Feet were aching, the toenail on right foot was split down the middle. Right eyelid is dropping (noticeable). Lumps or swelling are under the skin in my arms and hands. I had to take one step at at time, could not squat. Had difficulty getting out of bed. Weakness in my knees.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Stomatitis, Systemic lupus erythematosus
Clinical narrative: The vaccine was given Thursday, 10/13/2005 about 12:00pm. Friday 10/14/05 I was cold and sluggish all day. About 6:00pm I went to bed and did not wake until Sat 10/15/05 about 9:00am. I woke up with a headache, my entire body was aching, muscles, joints, fingers, feet, shoulders. I could hardly get out of bed, I was bent over as I moved slowly to the bathroom. Chills were running up and down my muscles. The arms, hands and wrist were so swollen I could not make a fist, wring water out of my bath cloth or dish cloth, neither could I turn on my shower. When I moved my bones made loud cracking sounds. Pain to move my neck. My gums were sore and aching event though teeth had been pulled out years ago. Elbow ached, made cracking sounds. I would wake up about 5:00am with aching fingers, wrist, joints. Feet were aching, the toenail on right foot was split down the middle. Right eyelid is dropping (noticeable). Lumps or swelling are under the skin in my arms and hands. I had to take one step at at time, could not squat. Had difficulty getting out of bed. Weakness in my knees.
Age: 87.0
Sex: F
Vaccine: PPV
Symptoms: Anaemia, Chills, Erythema, Feeling hot, Pain
Clinical narrative: Chills and shakes night of vaccination 11/22/2005, arm upper part red and hot, terrible pain arm remained red and sore, assessed by Dr 11/25/2005 RX ASA, cold packs.
Age: 87.0
Sex: F
Vaccine: PPV
Symptoms: Tremor
Clinical narrative: Chills and shakes night of vaccination 11/22/2005, arm upper part red and hot, terrible pain arm remained red and sore, assessed by Dr 11/25/2005 RX ASA, cold packs.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot, Oedema
Clinical narrative: Swollen, red, warm to touch left thigh.
Sex: M
Vaccine: DTAPHEPBIP, IPV, MMR
Symptoms: Injection site rash, Pyrexia
Clinical narrative: Rash at site, fever.
Age: 48.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site reaction, Rash
Clinical narrative: Initial report received from a health care provider on 12/Oct/2005. A 48 year old female patient with a pre-existing medical history reported as "no egg allergies," had been hospitalized for unspecified reasons, and received an injection of Fluzone SV 2005-2006, lot number unknown; and Pneumovax, manufacturer lot number unknown, at the time of hospital discharge on 05/Oct/2005. The sites and routes of vaccination were unknown. Five days later, she developed a scattered pinpoint rash on her torso that became generalized over her entire body. The patient had no illness at the time of vaccination, and information regarding other medications was unknown. The patient was examined in the emergency room and treated with steroids and Benadryl. Per the reporter, the patient returned to the emergency room 12 hours later and received the same treatment. The patient was examined during an office visit on 12/Oct/2005, and the symptoms had resolved. The patient was not hospitalized for these events. At the time of this report, the patient had recovered. Follow-up information received on 28/Nov/2005 from a health care professional. It was reported that the patient had been hospitalized due to a possible vascular occlusion of the third right finger prior to receiving the vaccine on 05/Oct/2005. An angiogram at the time of hospitalization was negative. The patient had not received any influenza vaccines in the past. Following the event of generalized rash on 10/Oct/2005, the patient improved and the reaction had "mostly resolved" at the time of this report (it was previously reported that the patient had recovered). No other information was provided at this time. Follow-up information received on 07/Dec/2005 from another company (reference number WAES0510USA06778). It was reported that the Fluzone SV 2005-2006 and the Pneumovax vaccinations were administered in opposite arms, but no specific site was reported. Following the onset of the events on 10/Oct/2005, the patient was seen in an emergency room twice on the same day. On the first visit she was treated with oral prednisone and diphenhydramine hydrochloride (Benadryl). During the second emergency room visit, she was treated with IV steroids and diphenhydramine hydrochloride (Benadryl)., and was placed on oral prednisone. It was noted that the patient experienced a local site reaction of the arm, but it was not reported whether the reaction occurred at the site of the Fluzone SV 2005-2006 or Pneumovax injection. The patient was seen by the physician on 12/Oct/2005 and the symptoms had resolved at that time. The reporter noted that the patient was not hospitalized for the events. At the time of this report, the patient had recovered. The reporting physician considered the diffused rash and local site reaction of the arm to be disabling and other important medical events. Based upon this new information, this case is being upgraded to serious.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chest discomfort, Dyspnoea, Injection site erythema, Injection site reaction
Clinical narrative: Initial report received on 07/Dec/2005 from a health care professional. A 40 year old female with no significant medical history, had received an intra-muscular injection of Fluzone SV '2005-'2006 USP, lot number U1775AA, in the right deltoid and an intra-dermal injection of TUBERSOL 5 TU, lot number C2079AA, in the right arm on 07/Dec/2005. Fifteen minutes later, the patient had a large red area at the injection site (side was not identified), difficulty breathing, chest tightness and weakness in her legs. She was transferred in a wheel chair to the nurse office and was given oxygen. An electrocardiogram was done and she was transferred to the hospital. It is unknown if the patient recovered from these events at the time of this report.
Age: 29.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Hypertension, Laboratory test abnormal, Obesity, Renal failure
Clinical narrative: Status Asthmaticus. Information from Follow-up states: Your request for information for the above named patient has been received. We are sending back your request due to the following reason: There is not a discharge summary available at this time. No new information added from Other Correspondence rec'd 12/28/2005./sr3/7/06 Received Discharge Summary which revealed patient experienced acute exacerbation of asthma w/SOB & wheezing.  PMH: obesity, HTN, renal insufficiency.  Abnormal labs of elevated WBC & increased creatinine./ss
Age: 29.0
Sex: F
Vaccine: PPV
Symptoms: Status asthmaticus, Wheezing
Clinical narrative: Status Asthmaticus. Information from Follow-up states: Your request for information for the above named patient has been received. We are sending back your request due to the following reason: There is not a discharge summary available at this time. No new information added from Other Correspondence rec'd 12/28/2005./sr3/7/06 Received Discharge Summary which revealed patient experienced acute exacerbation of asthma w/SOB & wheezing.  PMH: obesity, HTN, renal insufficiency.  Abnormal labs of elevated WBC & increased creatinine./ss
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dry throat, Ear discomfort, Fatigue, Flat affect
Clinical narrative: About 2-3 days after receiving flu shot, started to develop weakness and tingling in arm. Then began to have cramping sharp pain in different parts of the arm and on admission (hospital) was experiencing chronic headache, neck pain, shooting pain in arm from shoulder into forearm associated with weakness and loss of feeling. Ears plugged, throat dry. Is recovering somewhat according to recent report. Discharge summary states pain in arm, fatigue, hypotension. msv Per 60 day follow up report-Patient states she is about 85% recovered. Occassionally experiences a "spasm" when lifting a heavy object or when bending arm back to put on a coat which causes a feeling of weakness from neck to elbow. Back to work at a .7 fte which is what she was working before the incident. Patient states that she goes to physical therapy about twice a month now compared to 4 times weekly just after the incident. 02/02/07 Stated to me that about twice each month she gets weakness in her left upper arm and pain that radiates into her neck on the left side accompanied by a migraine headache.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Hypotension, Muscle spasms, Muscle spasms, Neck pain
Clinical narrative: About 2-3 days after receiving flu shot, started to develop weakness and tingling in arm. Then began to have cramping sharp pain in different parts of the arm and on admission (hospital) was experiencing chronic headache, neck pain, shooting pain in arm from shoulder into forearm associated with weakness and loss of feeling. Ears plugged, throat dry. Is recovering somewhat according to recent report. Discharge summary states pain in arm, fatigue, hypotension. msv Per 60 day follow up report-Patient states she is about 85% recovered. Occassionally experiences a "spasm" when lifting a heavy object or when bending arm back to put on a coat which causes a feeling of weakness from neck to elbow. Back to work at a .7 fte which is what she was working before the incident. Patient states that she goes to physical therapy about twice a month now compared to 4 times weekly just after the incident. 02/02/07 Stated to me that about twice each month she gets weakness in her left upper arm and pain that radiates into her neck on the left side accompanied by a migraine headache.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain, Pain in extremity, Paraesthesia
Clinical narrative: About 2-3 days after receiving flu shot, started to develop weakness and tingling in arm. Then began to have cramping sharp pain in different parts of the arm and on admission (hospital) was experiencing chronic headache, neck pain, shooting pain in arm from shoulder into forearm associated with weakness and loss of feeling. Ears plugged, throat dry. Is recovering somewhat according to recent report. Discharge summary states pain in arm, fatigue, hypotension. msv Per 60 day follow up report-Patient states she is about 85% recovered. Occassionally experiences a "spasm" when lifting a heavy object or when bending arm back to put on a coat which causes a feeling of weakness from neck to elbow. Back to work at a .7 fte which is what she was working before the incident. Patient states that she goes to physical therapy about twice a month now compared to 4 times weekly just after the incident. 02/02/07 Stated to me that about twice each month she gets weakness in her left upper arm and pain that radiates into her neck on the left side accompanied by a migraine headache.
Age: 5.0
Sex: F
Vaccine: DTAP, FLU3, IPV, MMR
Symptoms: Erythema, Oedema, Pruritus
Clinical narrative: Right arm swelling 5x5, itchy and red. Ice pack with Tylenol.
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Malaise, Pain
Clinical narrative: At 6pm the day vaccine was administered, patient developed chills (no temperature was taken) and achiness. The following day the patient still did not feel well with chills and achiness. He remained at rest the entire day. By 11/25 symptoms completely resolved.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site induration, Myalgia, Swelling
Clinical narrative: Swollen upper left arm, sore, hard, reddened. (twice the size)  Had received pneumonia vaccine on 11/14/03-but did not remember it when screened on 11-14-05.
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Eosinophilia, Hypersensitivity, Injection site induration
Clinical narrative: 3x3x5 cm region of induration with eczematons patch at injection site.  Mild elevation in eosinophils on CBC 10%.  WBC 9,100; Poly 32; Lymph 52; Mono 5 Eo 10 Base 1.
Age: 4.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Swelling
Clinical narrative: L arm swelling and fever-seen in ER on Saturday and in office on Monday.  Got shots on Friday at Health Dept..
Age: 80.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Insomnia, Oedema, Pyrexia
Clinical narrative: Patient states he could not sleep the night of injection got up at 3:00am, noticed redness and swelling under his left arm, armpit to elbow. Fever all day 12/07/2005. He saw DR 12/09/2005 and was started on Ketek 400mg 2 QD x 5 days for cellulitis.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Flu shot 10/18/05, 12/8/05 about 3 days with 2nd dose hives on stomach/neck.  zero trouble breathing.
Age: 55.0
Sex: F
Vaccine: FLU3, SMALL
Symptoms: Erythema, Fatigue
Clinical narrative: 12/6/05:started feeling extremely tired, headache; removed Bandaid entire area underneath was red; 12/7/05: noticed "scratch marks" approx 2-3" away from site; 12/8/05: stayed home from work for rest; 12/9/05: Contacted VAERS, was advised to see to see a doctor; Contacted 122 MDG, sent to Dupont ER for immediate treatment.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Swelling
Clinical narrative: LD IM injection pneumovax.  Pt RTC for BP check 11/30/05.  L upper arm/bicep -Erythema, swelling, TTP, good ROM strength with it, radial pulse. RTC 12/1/05 decrease erythema, swelling.  RTC 12/6/05 symptoms mostly resolved.