chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: M
Vaccine: DT, TYP, YF, TD, TYP, YF, TD, TYP, YF
Symptoms: Extensor plantar response, Foreign travel, Hyperreflexia, Hypoaesthesia, Lumbar puncture abnormal
Clinical narrative: The patient presented with acute onset of lower > upper ext weakness and numbness started on February 1st, after he came back from a trip, preceded by fever and transient rash. On presentation exam noted signs of UMN injury localized in the thoracic spinal cord (weakness mainly in the lower ext, sensory level, hyperreflexia with B/L Babinski, urinary and bowel retention) MRI of spine showed patchy high signal areas mainly in the thoracic spine, with post contrast patchy enhancement of the pons and medulla which is representing an encephalomyelitis (pons, medulla, and spine, mainly thoracic). Patient was treated with IV steroid and showed significant improvement. 04/07/08-records received for DOS 2/8-2/18/08-DX: encephalomyelitis with urinary retention. Acute onset of lower >upper extremity weakness and numbness after returning from a trip abroad. Likely has encephalomyelitis secondary to possible yellow fever vaccination. Initial C/O severe frontal headache, fever, urinary and fecal retention cutaneous hyperesthesia and evidence of CNS inflammation on analysis of his spinal fluid. Mosquito bites. Fever and chills. 5/28/08-records received for DOS 2/23/08-presented with headache, nausea and vomiting and ataxia since day before. Suprapubic catheter.
Age: 23.0
Sex: M
Vaccine: DT, TYP, YF, TD, TYP, YF, TD, TYP, YF
Symptoms: Muscular weakness, Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging brain abnormal, Pleocytosis, Pyrexia
Clinical narrative: The patient presented with acute onset of lower > upper ext weakness and numbness started on February 1st, after he came back from a trip, preceded by fever and transient rash. On presentation exam noted signs of UMN injury localized in the thoracic spinal cord (weakness mainly in the lower ext, sensory level, hyperreflexia with B/L Babinski, urinary and bowel retention) MRI of spine showed patchy high signal areas mainly in the thoracic spine, with post contrast patchy enhancement of the pons and medulla which is representing an encephalomyelitis (pons, medulla, and spine, mainly thoracic). Patient was treated with IV steroid and showed significant improvement. 04/07/08-records received for DOS 2/8-2/18/08-DX: encephalomyelitis with urinary retention. Acute onset of lower >upper extremity weakness and numbness after returning from a trip abroad. Likely has encephalomyelitis secondary to possible yellow fever vaccination. Initial C/O severe frontal headache, fever, urinary and fecal retention cutaneous hyperesthesia and evidence of CNS inflammation on analysis of his spinal fluid. Mosquito bites. Fever and chills. 5/28/08-records received for DOS 2/23/08-presented with headache, nausea and vomiting and ataxia since day before. Suprapubic catheter.
Age: 23.0
Sex: M
Vaccine: DT, TYP, YF, TD, TYP, YF, TD, TYP, YF
Symptoms: Rash, Upper motor neurone lesion, Urinary retention
Clinical narrative: The patient presented with acute onset of lower > upper ext weakness and numbness started on February 1st, after he came back from a trip, preceded by fever and transient rash. On presentation exam noted signs of UMN injury localized in the thoracic spinal cord (weakness mainly in the lower ext, sensory level, hyperreflexia with B/L Babinski, urinary and bowel retention) MRI of spine showed patchy high signal areas mainly in the thoracic spine, with post contrast patchy enhancement of the pons and medulla which is representing an encephalomyelitis (pons, medulla, and spine, mainly thoracic). Patient was treated with IV steroid and showed significant improvement. 04/07/08-records received for DOS 2/8-2/18/08-DX: encephalomyelitis with urinary retention. Acute onset of lower >upper extremity weakness and numbness after returning from a trip abroad. Likely has encephalomyelitis secondary to possible yellow fever vaccination. Initial C/O severe frontal headache, fever, urinary and fecal retention cutaneous hyperesthesia and evidence of CNS inflammation on analysis of his spinal fluid. Mosquito bites. Fever and chills. 5/28/08-records received for DOS 2/23/08-presented with headache, nausea and vomiting and ataxia since day before. Suprapubic catheter.
Age: 23.0
Sex: M
Vaccine: DT, TYP, YF, TD, TYP, YF, TD, TYP, YF
Symptoms: Blood immunoglobulin G normal, Blood immunoglobulin M increased, CSF cell count normal, Encephalitis, Pyrexia
Clinical narrative: The patient presented with acute onset of lower > upper ext weakness and numbness started on February 1st, after he came back from a trip, preceded by fever and transient rash. On presentation exam noted signs of UMN injury localized in the thoracic spinal cord (weakness mainly in the lower ext, sensory level, hyperreflexia with B/L Babinski, urinary and bowel retention) MRI of spine showed patchy high signal areas mainly in the thoracic spine, with post contrast patchy enhancement of the pons and medulla which is representing an encephalomyelitis (pons, medulla, and spine, mainly thoracic). Patient was treated with IV steroid and showed significant improvement. 04/07/08-records received for DOS 2/8-2/18/08-DX: encephalomyelitis with urinary retention. Acute onset of lower >upper extremity weakness and numbness after returning from a trip abroad. Likely has encephalomyelitis secondary to possible yellow fever vaccination. Initial C/O severe frontal headache, fever, urinary and fecal retention cutaneous hyperesthesia and evidence of CNS inflammation on analysis of his spinal fluid. Mosquito bites. Fever and chills. 5/28/08-records received for DOS 2/23/08-presented with headache, nausea and vomiting and ataxia since day before. Suprapubic catheter.
Age: 23.0
Sex: M
Vaccine: DT, TYP, YF, TD, TYP, YF, TD, TYP, YF
Symptoms: Rash
Clinical narrative: The patient presented with acute onset of lower > upper ext weakness and numbness started on February 1st, after he came back from a trip, preceded by fever and transient rash. On presentation exam noted signs of UMN injury localized in the thoracic spinal cord (weakness mainly in the lower ext, sensory level, hyperreflexia with B/L Babinski, urinary and bowel retention) MRI of spine showed patchy high signal areas mainly in the thoracic spine, with post contrast patchy enhancement of the pons and medulla which is representing an encephalomyelitis (pons, medulla, and spine, mainly thoracic). Patient was treated with IV steroid and showed significant improvement. 04/07/08-records received for DOS 2/8-2/18/08-DX: encephalomyelitis with urinary retention. Acute onset of lower >upper extremity weakness and numbness after returning from a trip abroad. Likely has encephalomyelitis secondary to possible yellow fever vaccination. Initial C/O severe frontal headache, fever, urinary and fecal retention cutaneous hyperesthesia and evidence of CNS inflammation on analysis of his spinal fluid. Mosquito bites. Fever and chills. 5/28/08-records received for DOS 2/23/08-presented with headache, nausea and vomiting and ataxia since day before. Suprapubic catheter.
Age: 23.0
Sex: M
Vaccine: DT, TYP, YF, TD, TYP, YF, TD, TYP, YF
Symptoms: Arthropod bite, Asthenia, Ataxia, CSF protein increased, CSF test abnormal
Clinical narrative: The patient presented with acute onset of lower > upper ext weakness and numbness started on February 1st, after he came back from a trip, preceded by fever and transient rash. On presentation exam noted signs of UMN injury localized in the thoracic spinal cord (weakness mainly in the lower ext, sensory level, hyperreflexia with B/L Babinski, urinary and bowel retention) MRI of spine showed patchy high signal areas mainly in the thoracic spine, with post contrast patchy enhancement of the pons and medulla which is representing an encephalomyelitis (pons, medulla, and spine, mainly thoracic). Patient was treated with IV steroid and showed significant improvement. 04/07/08-records received for DOS 2/8-2/18/08-DX: encephalomyelitis with urinary retention. Acute onset of lower >upper extremity weakness and numbness after returning from a trip abroad. Likely has encephalomyelitis secondary to possible yellow fever vaccination. Initial C/O severe frontal headache, fever, urinary and fecal retention cutaneous hyperesthesia and evidence of CNS inflammation on analysis of his spinal fluid. Mosquito bites. Fever and chills. 5/28/08-records received for DOS 2/23/08-presented with headache, nausea and vomiting and ataxia since day before. Suprapubic catheter.
Age: 23.0
Sex: M
Vaccine: DT, TYP, YF, TD, TYP, YF, TD, TYP, YF
Symptoms: CSF white blood cell count increased, Chills, Computerised tomogram abnormal, Faecaloma, Headache
Clinical narrative: The patient presented with acute onset of lower > upper ext weakness and numbness started on February 1st, after he came back from a trip, preceded by fever and transient rash. On presentation exam noted signs of UMN injury localized in the thoracic spinal cord (weakness mainly in the lower ext, sensory level, hyperreflexia with B/L Babinski, urinary and bowel retention) MRI of spine showed patchy high signal areas mainly in the thoracic spine, with post contrast patchy enhancement of the pons and medulla which is representing an encephalomyelitis (pons, medulla, and spine, mainly thoracic). Patient was treated with IV steroid and showed significant improvement. 04/07/08-records received for DOS 2/8-2/18/08-DX: encephalomyelitis with urinary retention. Acute onset of lower >upper extremity weakness and numbness after returning from a trip abroad. Likely has encephalomyelitis secondary to possible yellow fever vaccination. Initial C/O severe frontal headache, fever, urinary and fecal retention cutaneous hyperesthesia and evidence of CNS inflammation on analysis of his spinal fluid. Mosquito bites. Fever and chills. 5/28/08-records received for DOS 2/23/08-presented with headache, nausea and vomiting and ataxia since day before. Suprapubic catheter.
Age: 23.0
Sex: M
Vaccine: DT, TYP, YF, TD, TYP, YF, TD, TYP, YF
Symptoms: Hyperaesthesia, Hypoaesthesia, Leukoencephalomyelitis, Nausea, Nuclear magnetic resonance imaging abnormal
Clinical narrative: The patient presented with acute onset of lower > upper ext weakness and numbness started on February 1st, after he came back from a trip, preceded by fever and transient rash. On presentation exam noted signs of UMN injury localized in the thoracic spinal cord (weakness mainly in the lower ext, sensory level, hyperreflexia with B/L Babinski, urinary and bowel retention) MRI of spine showed patchy high signal areas mainly in the thoracic spine, with post contrast patchy enhancement of the pons and medulla which is representing an encephalomyelitis (pons, medulla, and spine, mainly thoracic). Patient was treated with IV steroid and showed significant improvement. 04/07/08-records received for DOS 2/8-2/18/08-DX: encephalomyelitis with urinary retention. Acute onset of lower >upper extremity weakness and numbness after returning from a trip abroad. Likely has encephalomyelitis secondary to possible yellow fever vaccination. Initial C/O severe frontal headache, fever, urinary and fecal retention cutaneous hyperesthesia and evidence of CNS inflammation on analysis of his spinal fluid. Mosquito bites. Fever and chills. 5/28/08-records received for DOS 2/23/08-presented with headache, nausea and vomiting and ataxia since day before. Suprapubic catheter.
Age: 23.0
Sex: M
Vaccine: DT, TYP, YF, TD, TYP, YF, TD, TYP, YF
Symptoms: Nuclear magnetic resonance imaging brain normal, Pyrexia, Rash, Urinary retention, Vomiting
Clinical narrative: The patient presented with acute onset of lower > upper ext weakness and numbness started on February 1st, after he came back from a trip, preceded by fever and transient rash. On presentation exam noted signs of UMN injury localized in the thoracic spinal cord (weakness mainly in the lower ext, sensory level, hyperreflexia with B/L Babinski, urinary and bowel retention) MRI of spine showed patchy high signal areas mainly in the thoracic spine, with post contrast patchy enhancement of the pons and medulla which is representing an encephalomyelitis (pons, medulla, and spine, mainly thoracic). Patient was treated with IV steroid and showed significant improvement. 04/07/08-records received for DOS 2/8-2/18/08-DX: encephalomyelitis with urinary retention. Acute onset of lower >upper extremity weakness and numbness after returning from a trip abroad. Likely has encephalomyelitis secondary to possible yellow fever vaccination. Initial C/O severe frontal headache, fever, urinary and fecal retention cutaneous hyperesthesia and evidence of CNS inflammation on analysis of his spinal fluid. Mosquito bites. Fever and chills. 5/28/08-records received for DOS 2/23/08-presented with headache, nausea and vomiting and ataxia since day before. Suprapubic catheter.
Age: 46.0
Sex: M
Vaccine: TDAP
Symptoms: Body temperature increased, Chills, Injection site swelling, Local swelling, Lymphadenopathy
Clinical narrative: Tdap administered on 2-11-08.  Patient contacted office on 2-12-08 stating that he had a low grade temp (99.4), body aches, chills, and swelling at site of injection (left deltoid) and some in his left axilla.  He was encouraged to take Tylenol or Ibuprofen and to apply ice to area.  He then called on 2-13-08 to state that he was feeling better.  Stated he had slept for 13 hours last night and that he no longer had any temp or body aches.  Stated he did still have some swelling in his left arm and axilla, but was going to apply ice to it during the day.  On 2-14-08, he presented to our office as he was concerned about the swelling in his left axilla and left neck.  He did have significant swelling in his left axilla and some in his left neck, both areas tender to palpation.  He also stated that his temp returned the previous evening, reaching as high as 101 degrees and that when his temp was up, he had body aches and chills.  He was seen by physician and treated with Medrol dose pack and Tylenol or Ibuprofen.
Age: 46.0
Sex: M
Vaccine: TDAP
Symptoms: Oedema peripheral, Pain, Swelling, Tenderness
Clinical narrative: Tdap administered on 2-11-08.  Patient contacted office on 2-12-08 stating that he had a low grade temp (99.4), body aches, chills, and swelling at site of injection (left deltoid) and some in his left axilla.  He was encouraged to take Tylenol or Ibuprofen and to apply ice to area.  He then called on 2-13-08 to state that he was feeling better.  Stated he had slept for 13 hours last night and that he no longer had any temp or body aches.  Stated he did still have some swelling in his left arm and axilla, but was going to apply ice to it during the day.  On 2-14-08, he presented to our office as he was concerned about the swelling in his left axilla and left neck.  He did have significant swelling in his left axilla and some in his left neck, both areas tender to palpation.  He also stated that his temp returned the previous evening, reaching as high as 101 degrees and that when his temp was up, he had body aches and chills.  He was seen by physician and treated with Medrol dose pack and Tylenol or Ibuprofen.
Age: 20.0
Sex: M
Vaccine: FLU3, HEP, HEPA
Symptoms: Pruritus, Throat irritation
Clinical narrative: 10.10 injections administered: HAV Lot# 0019U, HBV Lot # 0723F, Influenza No preservative U2476A 10.15 c/o itching, no rash 10.20 Benadryl OTC is given by personnel 10.30 Itching continues, c/o tingling in throat, no acute distress, no trouble breathing 11.00 Admitted to ER in stable condition, recovered completely, sent back to facility in stable condition
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Borrelia burgdorferi serology, Discomfort, Myalgia
Clinical narrative: Got two doses of Gardasil and notes muscle pain and discomfort globally (not at site) at nite 3 wks after admin.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Balance disorder, Computerised tomogram, Dyspnoea, Gait disturbance, Hypoaesthesia
Clinical narrative: Flu Vaccine on 11/06/2007, numbness of feet then legs and hands then severe weakness of limbs coming on gradually, starting 1-2 weeks after vaccine, now starting to improve but still symptomatic with weakness numbness and gait imbalance as of 02/14/2008. 1/20/2010 Improved but still weak from Guillian Barre. 02/29/2008 MR received from neurologist for multiple visits 1/2/08 to 2/14/08 with DX:  Guillain-Barre Syndrome. Initially presented 2/1/08 with 2 month hx of numbness in hands and feet and weakness of the legs and hands which has recently been worsening.  PE (+) for moderate hand weakness, mild weakness of dorsiflexors and plantar flexors of the foot and toes, inability to walk on toes or heels, stocking-glove sensory loss, and diminished vibratory sense of the feet and toes. Borderline Romberg's and gait difficulty. Pt later reported band-like numbness around the abdomen and increasing difficulty walking. Tx with plasmapheresis. Possible post vaccinal GBS.  3/31/08 MR received for hospital DOS 1/11-19/2008 with D/C Dx: Demyelinating neuropathy of recent/acute onset.  Barrett esophagitis.  Hx of cholecystitis, s/p recent cholecystectomy.  Hypercholesterolemia. Records also sent for DX of Cholecystitis DOS 12/21-24/2007 and 12/31/07-1/1/08 with c/o Leg and arm numbness and leg weakness.  Pt initially presented 12/31/07 with 6 week hx of numbness of the extremities and unsteady gait. PE (+) for decreased sensation in the feet, brisk DTRs, decreased motor strength, unsteady, staggering gait.   Tx with steroids and D/c to be f/u as an outpt. Pt presented again 1/11/08 with progressive numbness and admitted with DX of Acute Demyelinating Polyneuropathy for plasmapheresis. C/O dyspnea  noted on consult of 1/12/08. D/C to continue rehab as outpt. Pt. is improving in symptoms-this stated in Dr. visit on 3/26/08.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Laboratory test, Muscular weakness, Nuclear magnetic resonance imaging
Clinical narrative: Flu Vaccine on 11/06/2007, numbness of feet then legs and hands then severe weakness of limbs coming on gradually, starting 1-2 weeks after vaccine, now starting to improve but still symptomatic with weakness numbness and gait imbalance as of 02/14/2008. 1/20/2010 Improved but still weak from Guillian Barre. 02/29/2008 MR received from neurologist for multiple visits 1/2/08 to 2/14/08 with DX:  Guillain-Barre Syndrome. Initially presented 2/1/08 with 2 month hx of numbness in hands and feet and weakness of the legs and hands which has recently been worsening.  PE (+) for moderate hand weakness, mild weakness of dorsiflexors and plantar flexors of the foot and toes, inability to walk on toes or heels, stocking-glove sensory loss, and diminished vibratory sense of the feet and toes. Borderline Romberg's and gait difficulty. Pt later reported band-like numbness around the abdomen and increasing difficulty walking. Tx with plasmapheresis. Possible post vaccinal GBS.  3/31/08 MR received for hospital DOS 1/11-19/2008 with D/C Dx: Demyelinating neuropathy of recent/acute onset.  Barrett esophagitis.  Hx of cholecystitis, s/p recent cholecystectomy.  Hypercholesterolemia. Records also sent for DX of Cholecystitis DOS 12/21-24/2007 and 12/31/07-1/1/08 with c/o Leg and arm numbness and leg weakness.  Pt initially presented 12/31/07 with 6 week hx of numbness of the extremities and unsteady gait. PE (+) for decreased sensation in the feet, brisk DTRs, decreased motor strength, unsteady, staggering gait.   Tx with steroids and D/c to be f/u as an outpt. Pt presented again 1/11/08 with progressive numbness and admitted with DX of Acute Demyelinating Polyneuropathy for plasmapheresis. C/O dyspnea  noted on consult of 1/12/08. D/C to continue rehab as outpt. Pt. is improving in symptoms-this stated in Dr. visit on 3/26/08.
Age: 15.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Blister, Headache, Pain in extremity, Pruritus, Varicella
Clinical narrative: Patient and mother returned to the health dept. complaining of sudden sharp progressive pain in upper right deltoid region.  Stated pain begain one week after administration of vaccine with dull pain and progressing to sharp pain with upper movement of arm.  Patient also c/o headache and 3 itching bumps.  RN examined and appeared to be possible chicken pox vesicles.  Told patient to cover and not scratch vesicles further and apply warm compress to upper deltoid region and to see physician should the pain in her shoulder continue or progress.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure, Body temperature increased, Chills, Feeling cold, Headache
Clinical narrative: C/O chills and shaking approx. 3:00 pm 02/13/08 and feeling cold during the night/ took Tylenol ES one tab. Developed H/A and facial swelling this morning.  Temp 104.3, HR 120, BP 110/60, lungs clear, pulse SA 02 97%. Tylenol 325 mg 2 tabs and Benadryl 25mg one tablet given 10:00am today.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Heart rate, Oxygen saturation, Swelling face, Tremor
Clinical narrative: C/O chills and shaking approx. 3:00 pm 02/13/08 and feeling cold during the night/ took Tylenol ES one tab. Developed H/A and facial swelling this morning.  Temp 104.3, HR 120, BP 110/60, lungs clear, pulse SA 02 97%. Tylenol 325 mg 2 tabs and Benadryl 25mg one tablet given 10:00am today.
Age: 1.05
Sex: M
Vaccine: HIBV, IPV, PNC
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: PATIENT RECEIVED IPV # 4. PATIENT ALREADY HAD 3 PREVIOUS DOSES FOR IPV.
Age: 45.0
Sex: F
Vaccine: DTAP, FLU3, HEPAB
Symptoms: Anorexia, Asthenia, Dizziness, Fatigue, Nausea
Clinical narrative: Nausea, vomiting, dry heaving, lightheadedness, dizziness, low grade fever, loss of apeptite, weakness, fatigue/tiredness.
Age: 45.0
Sex: F
Vaccine: DTAP, FLU3, HEPAB
Symptoms: Pyrexia, Retching, Vomiting, Wrong drug administered
Clinical narrative: Nausea, vomiting, dry heaving, lightheadedness, dizziness, low grade fever, loss of apeptite, weakness, fatigue/tiredness.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Cow pox, Post vaccination autoinoculation
Clinical narrative: Autoinoculation with Vaccinia. Location: Forehead and upper lips.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Muscular weakness
Clinical narrative: This case was reported by a pharmacist and described the occurrence of arm soreness at injection site in a 58-year-old female subject who was vaccinated with Fluarix for prophylaxis. No relevant medical history. The subject had previously received influenza vaccines and had not experienced any reactions. On 14 November 2007 at 17:00 the subject received unspecified dose of Fluarix (.5 ml, unknown arm). No other vaccines were received on 14 November 2007 with Fluarix. On 14 November 2007, less than one day after vaccination with Fluarix, the subject experienced arm soreness at injection site and tenderness at arm injection site. Approximately one week after the subject was vaccinated with Fluarix, she experienced weak arm muscles, especially at night, and she could not use her arm very well. The pharmacist noted that this has "eased some" but at certain times her arm feels weak. Medical attention was required at the physician's office. The pharmacist considered the events were disabling. At the time of reporting the events were ongoing and improved. The pharmacist considered the events were probably related to vaccination with Fluarix.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Application site papules, Injection site discolouration, Injection site erythema
Clinical narrative: Well circumscribed confluence of papules 4x3 cm, red/purple in color at injection site.  Left posterior upper arm.  No drainage, no pain/paresthesia.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure, Loss of consciousness, Oxygen saturation normal, Syncope
Clinical narrative: Fainted within 5 sec of receiving immunization, unconscious for less than 1 min.
Age: 3.0
Sex: F
Vaccine: DTAPHEPBIP, MMR, VARCEL
Symptoms: Erythema, Skin warm
Clinical narrative: Right deltoid has a 3 inch rectangular region of erythema, warm to touch 2/11/08 after vaccine administration approximately 4 hours.  Treatment: Ibuprofen, ice applied, prescribed Atarax 10mg/5ml 1-2 tsp qid given.
Sex: U
Vaccine: DTAP, HEP, HEPA, IPV, MMRV
Symptoms: Injection site erythema, Injection site oedema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: L arm swollen, erythema, warm, pruritus.  Rxn extends from L shoulder to below elbow & is nearly circumferential, marked edema.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Arthralgia, Gait disturbance, Injection site reaction, Joint stiffness, Musculoskeletal stiffness
Clinical narrative: Received Gardasil injection #3 on 2/7/08.  Few days later developed neck stiffness and joint pain/stiffness, tightness both legs & L arm where inj./fever on 3rd day x24 hrs.  Can barely walk.  Sent to ER.  03/17/2008 MR recieved for DOS 2/18-21/2008 with DX: Severe polyarthragia and weakness 2' to SLE. Systemic Lupus Erythematosus. ADD. Anemia. Pt presented with hisory of joint pain and swelling, generalized weakness progressing to the point of having difficulty getting out of bed.  PE (+) for tenderness of both feet, ankles and hands.  Decreased hand grip.   Rheumatology consult with assessment of polyarthralgias, fevers, myalgias and hypocomplementemia.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pyrexia
Clinical narrative: Received Gardasil injection #3 on 2/7/08.  Few days later developed neck stiffness and joint pain/stiffness, tightness both legs & L arm where inj./fever on 3rd day x24 hrs.  Can barely walk.  Sent to ER.  03/17/2008 MR recieved for DOS 2/18-21/2008 with DX: Severe polyarthragia and weakness 2' to SLE. Systemic Lupus Erythematosus. ADD. Anemia. Pt presented with hisory of joint pain and swelling, generalized weakness progressing to the point of having difficulty getting out of bed.  PE (+) for tenderness of both feet, ankles and hands.  Decreased hand grip.   Rheumatology consult with assessment of polyarthralgias, fevers, myalgias and hypocomplementemia.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Arthralgia, Gait disturbance, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Received Gardasil injection #3 on 2/7/08.  Few days later developed neck stiffness and joint pain/stiffness, tightness both legs & L arm where inj./fever on 3rd day x24 hrs.  Can barely walk.  Sent to ER.  03/17/2008 MR recieved for DOS 2/18-21/2008 with DX: Severe polyarthragia and weakness 2' to SLE. Systemic Lupus Erythematosus. ADD. Anemia. Pt presented with hisory of joint pain and swelling, generalized weakness progressing to the point of having difficulty getting out of bed.  PE (+) for tenderness of both feet, ankles and hands.  Decreased hand grip.   Rheumatology consult with assessment of polyarthralgias, fevers, myalgias and hypocomplementemia.
Age: 1.1
Sex: F
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Erythema, Pyrexia, Rash maculo-papular
Clinical narrative: Received VZV vaccine on 2/4/08.  Had tactile fever on 2/12-2/13.  On 2/14/08 developed diffuse erythematous maculopapular rash on abdomen, chest, back, neck, cheeks.  Afebrile in clinic.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Erythematous swelling on L arm.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse reaction
Clinical narrative: None.  Pt. didn't need Hep A 3.  Already has received Hep A 1 7-26-00, Hep A 2 6-9-03.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema
Clinical narrative: Redness of left arm one week after Tdap vaccination.  Rx: cimetadin, Benadryl.
Age: 23.0
Sex: F
Vaccine: SMALL
Symptoms: Cellulitis, Erythema, Scab, Skin warm, Tenderness
Clinical narrative: Patient received small pox vaccine 1/25/08; read major re 2/1/08.  Returns 2/5/08 - small pox site - pustale forms scab surrounding erythema, tenderness, warmth, 3" diameter.  Diagnosis - cellulitis 2 small pox vaccination, prescribed Levaquin 750 mg.  2/4 cellulitis resolved.
Age: 34.0
Sex: F
Vaccine: SMALL
Symptoms: Cellulitis, Erythema, Injection site discharge, Injection site pustule, Skin warm
Clinical narrative: Small pox vaccine given 1-25-08, read major reaction 2-1-08.  Noted increased drainage surrounding skin (approx 3").  Became tender, red, warm to touch, partial skin torn off when removing bandage adjacent to pustule.  Diag: cellulitis secondary small pox.  Levaquin 750 mg 1 po qd #5. 2/18/08 cellulitis resolved.
Age: 34.0
Sex: F
Vaccine: SMALL
Symptoms: Tenderness
Clinical narrative: Small pox vaccine given 1-25-08, read major reaction 2-1-08.  Noted increased drainage surrounding skin (approx 3").  Became tender, red, warm to touch, partial skin torn off when removing bandage adjacent to pustule.  Diag: cellulitis secondary small pox.  Levaquin 750 mg 1 po qd #5. 2/18/08 cellulitis resolved.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Discomfort, Erythema, Pruritus, Skin warm
Clinical narrative: On 2-11-08 pt walks in to clinic to show Lt arm.  Redness, warm to touch noted about 2 1/2 inches below injection site.  Pt states felt discomfort the night of injection given.  On (2/5/08) pt felt discomfort and took Tylenol & applied warm towel 3-5 min. at night.  On 2-6 & 2-7-08 also felt discomfort but also itchy.  On 2-8-08 pt noted redness & warm to touch below injection site only.  On 2-9 & 2-10-08 with redness & warm to touch.  On 2-11-08 redness decreased.  Pt applied hydrocortisone cream for itching.  On 2-12-08 redness & itching gone.  On 2-13-08 pt denies any complaint.  Denies numbness, tingling; good ROM; no distress voiced from pt.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Erythema, Mass, Pain, Swelling
Clinical narrative: Persistent pain, weakness, left deltoid muscle.  No pain or problem at time of injection.  2 weeks later he felt pain in deltoid region.  Some upper arm movements.  1-2 times a week now in last 2 weeks he has noted this pain 3-4 times a day with swelling, redness or lump.
Age: 0.5
Sex: F
Vaccine: DTAP, IPV, PNC, RV5
Symptoms: Body temperature increased, Crying, Influenza serology negative, Irritability, Pallor
Clinical narrative: Received vaccines on 2/5/08.  On 2/6/08 mom called stating patient appeared pale, temperature 101.8, had a "shaking episode", crying a lot, fussy all night.
Age: 0.5
Sex: F
Vaccine: DTAP, IPV, PNC, RV5
Symptoms: Tremor
Clinical narrative: Received vaccines on 2/5/08.  On 2/6/08 mom called stating patient appeared pale, temperature 101.8, had a "shaking episode", crying a lot, fussy all night.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: High-pitched crying
Clinical narrative: Prolonged, high pitched crying > 3 hours.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema
Clinical narrative: 17 x 8 cm. redness (hive) on arm appearing day after injection
Age: 9.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: L arm red, swollen, approx 3" diameter, painful - both injections given in same site - advised to apply cool compresses and may take Tylenol q 4 hr for comfort.
Age: 44.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Dermatitis allergic, Swelling, Swelling face, Throat tightness, Urticaria
Clinical narrative: Vaccination given 01-14-08, on 01-16-08 client stated woke up with hives, wheezing, swollen to face & body & throat felt closed up.  Document from hospital ER tx on 01-19-08 for allergic dermatitis with prednisone.  Spoke with client on 02-7-08, stated has hives to torso area, not as bad & doing much better.
Age: 44.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Wheezing
Clinical narrative: Vaccination given 01-14-08, on 01-16-08 client stated woke up with hives, wheezing, swollen to face & body & throat felt closed up.  Document from hospital ER tx on 01-19-08 for allergic dermatitis with prednisone.  Spoke with client on 02-7-08, stated has hives to torso area, not as bad & doing much better.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Pt given 0.5 ml of Fluvirin. Made for 4 years and older. Warning on box but no warning on vial.
Age: 1.36
Sex: F
Vaccine: FLU3, HEP, PNC
Symptoms: Wrong drug administered
Clinical narrative: Pt was given 0.25 ml of Fluviron. Did not realize it was for ages 4 and older. No reactions. Warning was on box not on actual vial.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Activities of daily living impaired, Antinuclear antibody negative, Arthralgia, Culture throat negative, Dysgraphia
Clinical narrative: Initial report received 05 February 2008 from a health care professional. A 16-year-old female patient with an unknown medical history had received a dose of Menactra and Gardasil (lot numbers, routes and sites of administration not reported) on 22 January 2008 and two days later, she developed joint pain. Four days post immunization, the patient experienced increase arthralgias with difficulty walking. On 02 February 2008, the arthralgias had worsened and the patient was started on Medrol. On 05 February 2008, the arthralgias continued and the patient had difficulty walking and using her hands. At the time of the report, the patient had not recovered from the event.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Full blood count normal, Pharyngolaryngeal pain, Red blood cell sedimentation rate normal
Clinical narrative: Initial report received 05 February 2008 from a health care professional. A 16-year-old female patient with an unknown medical history had received a dose of Menactra and Gardasil (lot numbers, routes and sites of administration not reported) on 22 January 2008 and two days later, she developed joint pain. Four days post immunization, the patient experienced increase arthralgias with difficulty walking. On 02 February 2008, the arthralgias had worsened and the patient was started on Medrol. On 05 February 2008, the arthralgias continued and the patient had difficulty walking and using her hands. At the time of the report, the patient had not recovered from the event.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Activities of daily living impaired, Antinuclear antibody negative, Arthralgia, Full blood count normal, Joint swelling
Clinical narrative: Initial report received 05 February 2008 from a health care professional. A 16-year-old female patient with an unknown medical history had received a dose of Menactra and Gardasil (lot numbers, routes and sites of administration not reported) on 22 January 2008 and two days later, she developed joint pain. Four days post immunization, the patient experienced increase arthralgias with difficulty walking. On 02 February 2008, the arthralgias had worsened and the patient was started on Medrol. On 05 February 2008, the arthralgias continued and the patient had difficulty walking and using her hands. At the time of the report, the patient had not recovered from the event.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Oedema peripheral, Red blood cell sedimentation rate normal
Clinical narrative: Initial report received 05 February 2008 from a health care professional. A 16-year-old female patient with an unknown medical history had received a dose of Menactra and Gardasil (lot numbers, routes and sites of administration not reported) on 22 January 2008 and two days later, she developed joint pain. Four days post immunization, the patient experienced increase arthralgias with difficulty walking. On 02 February 2008, the arthralgias had worsened and the patient was started on Medrol. On 05 February 2008, the arthralgias continued and the patient had difficulty walking and using her hands. At the time of the report, the patient had not recovered from the event.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Arthralgia, Gait disturbance
Clinical narrative: Initial report received 05 February 2008 from a health care professional. A 16-year-old female patient with an unknown medical history had received a dose of Menactra and Gardasil (lot numbers, routes and sites of administration not reported) on 22 January 2008 and two days later, she developed joint pain. Four days post immunization, the patient experienced increase arthralgias with difficulty walking. On 02 February 2008, the arthralgias had worsened and the patient was started on Medrol. On 05 February 2008, the arthralgias continued and the patient had difficulty walking and using her hands. At the time of the report, the patient had not recovered from the event.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Arthralgia, Gait disturbance, Pain in extremity
Clinical narrative: Initial report received 05 February 2008 from a health care professional. A 16-year-old female patient with an unknown medical history had received a dose of Menactra and Gardasil (lot numbers, routes and sites of administration not reported) on 22 January 2008 and two days later, she developed joint pain. Four days post immunization, the patient experienced increase arthralgias with difficulty walking. On 02 February 2008, the arthralgias had worsened and the patient was started on Medrol. On 05 February 2008, the arthralgias continued and the patient had difficulty walking and using her hands. At the time of the report, the patient had not recovered from the event.
Age: 43.0
Sex: F
Vaccine: FLU3, TD
Symptoms: Injected limb mobility decreased, Myalgia, Tenderness
Clinical narrative: Since flu vaccination right arm tender. Few hours later gnawing ache right deltoid "Like someone punched arm" no fever. By Thursday 02/14/08 late PM increase pain, woke up Friday AM increase pain/unable to stretch right arm. Took Tylenol. Referral given for evaluation at pvt. MD.
Sex: U
Vaccine: FLU3
Symptoms: Influenza
Clinical narrative: Initial report received on 04 February 2008 from a health care professional. On an "unknown" date, 10 children (demographics not provided, ages "unknown") received a dose of Fluzone (Lot number U2493AA). The route and sites of administration were not provided. At an unspecified amount of time later, all 10 children developed influenza; however no diagnostic testing was performed, or strain identified. It was "unknown" if any of the children had any illnesses or pre-existing medical conditions at the time of the vaccination. No other relevant medically significant information was provided.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Dyspepsia, Gastritis, Laboratory test normal, Nausea
Clinical narrative: Information has been received from a 26 year old female dental hygienist with an allergy to penicillin and sulfonamide who on 07-MAY-2007 was vaccinated with the first dose of Gardasil (lot# not reported). There was no concomitant medication. On 21-May-2007 the patient developed vomiting which "lasted for one day". The patient also reported that she experienced nausea, dizziness and heartburn for one week following vomiting. The patient was examined in the emergency room (date not provided) and was diagnosed with gastritis. The patient reported that "blood work and an ultrasound (dates of tests not provided) were performed. The patient was not admitted to the hospital and was released that same day. The patient considered the events to be disabling. The patient reported that she recovered from gastritis and dizziness on 28-May-2007. On 04-Feb-2008 the patient received the second dose of Gardasil (lot# not reported). No additional information is expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound scan normal, Vomiting
Clinical narrative: Information has been received from a 26 year old female dental hygienist with an allergy to penicillin and sulfonamide who on 07-MAY-2007 was vaccinated with the first dose of Gardasil (lot# not reported). There was no concomitant medication. On 21-May-2007 the patient developed vomiting which "lasted for one day". The patient also reported that she experienced nausea, dizziness and heartburn for one week following vomiting. The patient was examined in the emergency room (date not provided) and was diagnosed with gastritis. The patient reported that "blood work and an ultrasound (dates of tests not provided) were performed. The patient was not admitted to the hospital and was released that same day. The patient considered the events to be disabling. The patient reported that she recovered from gastritis and dizziness on 28-May-2007. On 04-Feb-2008 the patient received the second dose of Gardasil (lot# not reported). No additional information is expected.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Haemorrhage, Head injury, Syncope
Clinical narrative: Medical assistant mentioned that a patient mentioned to the physician regarding her neighbor's daughter who was vaccinated with a dose of GARDASIL. Concomitant therapy included MENACTRA. Subsequently the patient became paralyzed. Unknown medical attention was sought. The patient's outcome is unknown. No product quality complaint was involved. Upon internal review paralysis is considered to be an other important medical event. This is a hearsay report in the absence of an identifiable patient. Attempts are being made to verify the existence of a patient." Additional information has been requested.   7/10/08-records received -11/20/07-collapsed on floor of doctor office, hit head, alert oriented. 11/21/07-follow up phone call sutures in head, returning to school.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Anxiety, Blood aluminium increased, Depression, Mental disorder, Serum serotonin decreased
Clinical narrative: Information has been received from a medical assistant concerning a female in her early 20's who on an unspecified date in 2007 the patient received her first dose of GARDASIL injection. Concomitant therapy on the same date also included another vaccine (therapy unspecified). On an unspecified date the patient received her second dose of GARDASIL. The patient had a "nervous breakdown; some kind of anxiety or severe depression". The patient was admitted to the hospital and was found to have decreased serotonin levels and aluminum toxicity. The dates of the hospitalization are not known but the patient was discharged and was started on an antidepressant (therapy unspecified). The patient has not received her third dose yet. At the time of reporting the patient was recovering. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Thrombosis
Clinical narrative: Information has been received from representative via a nurse practitioner concerning a 15 year old (also reported as 16 year old) female with a penicillin allergy who on an unspecified date was vaccinated with GARDASIL (lot# unknown). The patient's date of last menstrual period was 25-APR-2007. Subsequently, the patient developed blood clots and was hospitalized. Medical attention was sought. The representative reported that the number of doses administered were unknown, the number of days the patient was hospitalized was unknown and the details for the patient's pregnancy was unknown. Follow-up information was received from the nurse practitioner. The patient was administered GARDASIL on 18-MAY-2007. The patient was scheduled to be induced on 09-FEB-2008 since she was past her due date which was 30-JAN-2008. The details regarding the intervention for the blood clot in the hospital was unknown. Further information was not available. Additional information has been requested.  This is in follow-up to report (s) previously submitted oon 2/14/2008; 2/25/2008. Follow-up information was received from a physician's office via phone. The patient's name was updated. On 8-FEB-2008, the patient went into the hospital with contractions. The patient failled to progression and then the patient was induced. The patient delivered "as far as they know a healthy boy". The baby weighed 7 pounds 10 ounces. Follow-up information was received via pregnancy forms. On 27-JUN-2007 and 31-AUG-2007 ultrasounds were performed for dating of the pregnancy. During the pregnancy the patient had deep vein thrombosis in the left leg and a urinary tract infection. On 30-JUN-2007 the patient was given MACROBID 100 mg BID for 7 days for UTI, LOVENOX 1.5 mg on 30-NOV-2007 and heparin was given subcutaneously on 15-JAN-2008. The patient gave birth on 08-FEB-2008 41 weeks from LMP. Additional information is not expected.
Age: 0.4
Sex: M
Vaccine: PNC
Symptoms: Autism, Hair metal test abnormal, Laboratory test abnormal
Clinical narrative: This case was considered medically important. Information regarding Prevnar was received from a consumer regarding a 16-month-old male patient who developed autism. The patient received the second dose on 07-Jun-2006. Reporter denies patient has any other past medical history. Concomitant medications were not reported. The patient developed autism in Nov-2006. The outcome is unknown. Laboratory test (results: revealed high "porforin" levels) and hair metal test (results: revealed arsenic) were done in Jan-2008. No additional information was available at the time of this report.
Age: 35.0
Sex: M
Vaccine: HEP, SMALL, TYP
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Pt noticed red "bumps" with raised white centers over back, neck and partially over chest with mild itching, started approx 3 days post Smallpox immunization.
Age: 12.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Erythema, Rash, Urticaria
Clinical narrative: Patient developed redness on her ear the evening of 2/14/08 around 800pm, then redness at the back of her neck. She then developed a red welt like rash on both arms from shoulder to mid arms, large welts on her back. No rash on her face, but did have a few spots on both feet. Parent gave 25mg of Benadryl, the rash continued to spread, but completely resolved by morning.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Asthma, Back pain, Chills, Cough, Injection site anaesthesia
Clinical narrative: Employee received influenza vaccine on 2/13/08 at approximately 2:00 pm.  She immediately reported tingling and numbness to injection site on right arm radiating to right hand.  On 2/15/08 she reported that approximately 2 hours after injection she felt chills, bodyaches, watery eyes, runny nose, cough and pain to back along side spine and cramping to pelvic region.  She was escorted to ER for evaluation and treatment.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Lacrimation increased, Pain, Paraesthesia, Rhinorrhoea
Clinical narrative: Employee received influenza vaccine on 2/13/08 at approximately 2:00 pm.  She immediately reported tingling and numbness to injection site on right arm radiating to right hand.  On 2/15/08 she reported that approximately 2 hours after injection she felt chills, bodyaches, watery eyes, runny nose, cough and pain to back along side spine and cramping to pelvic region.  She was escorted to ER for evaluation and treatment.
Age: 61.0
Sex: F
Vaccine: TD
Symptoms: Headache, Injected limb mobility decreased, Myalgia, Pyrexia
Clinical narrative: WITHIN 24 HOURS OF A TETANUS SHOT I HAD EXTREME HEADACHE, MUSCLE PAIN, FEVER OF 101, INJECTED ARM WAS VERY PAINFUL TO MOVE AND UNDER ARM WAS SWOLLEN. I STAYED IN BED FOR 2 1/2 DAYS UNTIL I FELT BETTER.  I HAD ASKED THE NURSE TO SEE IF THERE WAS A PRESERVATIVE IN THE SHOT. SHE SAID IT WAS PRESERVATIVE FREE. I HAVE HAD SIMILAR REACTIONS TO FLU SHOTS AND NO LONGER GET THEM.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Skin warm
Clinical narrative: Patient receive pneumoccal vaccination in left deltoid muscle. Returned to clinic 2 days post vaccination with redness and warmth to lower part of left upper arm. Instructed patient to take Benadryl 25mg one tablet every 4-6 hrs prn and IBU 200mg prn for pain.