chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: M
Vaccine: ANTH
Symptoms: Coagulation factor level normal, Decreased appetite, Dysphagia, Eosinophil count normal, Eosinophil percentage
Clinical narrative: The patient is a recalled reservist preparing to deploy over seas.  The pt received AVA #1 on 9/18/09.  He had no local reaction.  On 9/20/09 the pt noted generalized body achiness (7/10).  That evening he noted chills and a minor sore throat.  He denied: fever, cough, sneezing, rhinorrhea, or congestion.  The pt took MOTRIN and on 9/21/09 am his muscle achiness was improved but he had a decreased appetite, no N, no V, no diarrhea, no abd pain.  He continued with a "minor" sore throat until 9/22/09.  When the pt awoke on 9/22/09 he noted difficulty opening the MOTRIN bottle.  He also had difficulty with tying his shoe laces and buttoning his shirt.  Later on the 22nd he received the SMALLPOX, TDAP and FLUMIST vaccinations.  On 9/23/09 the pt's symptoms of bilateral hand weakness were worse so he went to hospital for evaluation.  The pt was referred to the health center and Neurology.  When evaluated on 9/24/09 he stated that he was slightly better in that he could tie his shoes more easily.  He also noted that for the last 12 hours he had some intermittent tingling in his index and middle fingers (bilaterally).  The pt denied lower extremity symptoms or issues with swallowing, speech, ocular symptoms, or visual changes.  The exam revealed hand weakness, no shoulder, arm or neck weakness.  No sensory deficits.  The pt was also evaluated by Neurology on 9/24/09.  See ahlta note for details.  MRI of C Spine and labs were ordered (see results below).  On reevaluation by neurology on 9/28/09 it was noted that the "symptoms have dramatically improved.  The exact etiology of his transient weakness is unclear-given the mild elevated CK along with mild generalized myalgias and weakness without sensory symptoms or reflex changes, would consider a postvaccinial myositis.  GBS seems unlikely and there is no evidence to suggest a central etiology."  The pt was released to full duty without deployment restrictions from a neurological standpoint.  The pt was referred to Hematology for evaluation of an elevated PTT X 2.
Age: 39.0
Sex: M
Vaccine: ANTH
Symptoms: Globulin, Haematocrit normal, Haemoglobin normal, Lymphocyte count normal, Lymphocyte percentage
Clinical narrative: The patient is a recalled reservist preparing to deploy over seas.  The pt received AVA #1 on 9/18/09.  He had no local reaction.  On 9/20/09 the pt noted generalized body achiness (7/10).  That evening he noted chills and a minor sore throat.  He denied: fever, cough, sneezing, rhinorrhea, or congestion.  The pt took MOTRIN and on 9/21/09 am his muscle achiness was improved but he had a decreased appetite, no N, no V, no diarrhea, no abd pain.  He continued with a "minor" sore throat until 9/22/09.  When the pt awoke on 9/22/09 he noted difficulty opening the MOTRIN bottle.  He also had difficulty with tying his shoe laces and buttoning his shirt.  Later on the 22nd he received the SMALLPOX, TDAP and FLUMIST vaccinations.  On 9/23/09 the pt's symptoms of bilateral hand weakness were worse so he went to hospital for evaluation.  The pt was referred to the health center and Neurology.  When evaluated on 9/24/09 he stated that he was slightly better in that he could tie his shoes more easily.  He also noted that for the last 12 hours he had some intermittent tingling in his index and middle fingers (bilaterally).  The pt denied lower extremity symptoms or issues with swallowing, speech, ocular symptoms, or visual changes.  The exam revealed hand weakness, no shoulder, arm or neck weakness.  No sensory deficits.  The pt was also evaluated by Neurology on 9/24/09.  See ahlta note for details.  MRI of C Spine and labs were ordered (see results below).  On reevaluation by neurology on 9/28/09 it was noted that the "symptoms have dramatically improved.  The exact etiology of his transient weakness is unclear-given the mild elevated CK along with mild generalized myalgias and weakness without sensory symptoms or reflex changes, would consider a postvaccinial myositis.  GBS seems unlikely and there is no evidence to suggest a central etiology."  The pt was released to full duty without deployment restrictions from a neurological standpoint.  The pt was referred to Hematology for evaluation of an elevated PTT X 2.
Age: 39.0
Sex: M
Vaccine: ANTH
Symptoms: Mean cell haemoglobin concentration normal, Mean cell volume normal, Mean platelet volume decreased, Metabolic function test, Monocyte count normal
Clinical narrative: The patient is a recalled reservist preparing to deploy over seas.  The pt received AVA #1 on 9/18/09.  He had no local reaction.  On 9/20/09 the pt noted generalized body achiness (7/10).  That evening he noted chills and a minor sore throat.  He denied: fever, cough, sneezing, rhinorrhea, or congestion.  The pt took MOTRIN and on 9/21/09 am his muscle achiness was improved but he had a decreased appetite, no N, no V, no diarrhea, no abd pain.  He continued with a "minor" sore throat until 9/22/09.  When the pt awoke on 9/22/09 he noted difficulty opening the MOTRIN bottle.  He also had difficulty with tying his shoe laces and buttoning his shirt.  Later on the 22nd he received the SMALLPOX, TDAP and FLUMIST vaccinations.  On 9/23/09 the pt's symptoms of bilateral hand weakness were worse so he went to hospital for evaluation.  The pt was referred to the health center and Neurology.  When evaluated on 9/24/09 he stated that he was slightly better in that he could tie his shoes more easily.  He also noted that for the last 12 hours he had some intermittent tingling in his index and middle fingers (bilaterally).  The pt denied lower extremity symptoms or issues with swallowing, speech, ocular symptoms, or visual changes.  The exam revealed hand weakness, no shoulder, arm or neck weakness.  No sensory deficits.  The pt was also evaluated by Neurology on 9/24/09.  See ahlta note for details.  MRI of C Spine and labs were ordered (see results below).  On reevaluation by neurology on 9/28/09 it was noted that the "symptoms have dramatically improved.  The exact etiology of his transient weakness is unclear-given the mild elevated CK along with mild generalized myalgias and weakness without sensory symptoms or reflex changes, would consider a postvaccinial myositis.  GBS seems unlikely and there is no evidence to suggest a central etiology."  The pt was released to full duty without deployment restrictions from a neurological standpoint.  The pt was referred to Hematology for evaluation of an elevated PTT X 2.
Age: 39.0
Sex: M
Vaccine: ANTH
Symptoms: Monocyte percentage, Myalgia, Myositis, Neutrophil count decreased, Neutrophil percentage
Clinical narrative: The patient is a recalled reservist preparing to deploy over seas.  The pt received AVA #1 on 9/18/09.  He had no local reaction.  On 9/20/09 the pt noted generalized body achiness (7/10).  That evening he noted chills and a minor sore throat.  He denied: fever, cough, sneezing, rhinorrhea, or congestion.  The pt took MOTRIN and on 9/21/09 am his muscle achiness was improved but he had a decreased appetite, no N, no V, no diarrhea, no abd pain.  He continued with a "minor" sore throat until 9/22/09.  When the pt awoke on 9/22/09 he noted difficulty opening the MOTRIN bottle.  He also had difficulty with tying his shoe laces and buttoning his shirt.  Later on the 22nd he received the SMALLPOX, TDAP and FLUMIST vaccinations.  On 9/23/09 the pt's symptoms of bilateral hand weakness were worse so he went to hospital for evaluation.  The pt was referred to the health center and Neurology.  When evaluated on 9/24/09 he stated that he was slightly better in that he could tie his shoes more easily.  He also noted that for the last 12 hours he had some intermittent tingling in his index and middle fingers (bilaterally).  The pt denied lower extremity symptoms or issues with swallowing, speech, ocular symptoms, or visual changes.  The exam revealed hand weakness, no shoulder, arm or neck weakness.  No sensory deficits.  The pt was also evaluated by Neurology on 9/24/09.  See ahlta note for details.  MRI of C Spine and labs were ordered (see results below).  On reevaluation by neurology on 9/28/09 it was noted that the "symptoms have dramatically improved.  The exact etiology of his transient weakness is unclear-given the mild elevated CK along with mild generalized myalgias and weakness without sensory symptoms or reflex changes, would consider a postvaccinial myositis.  GBS seems unlikely and there is no evidence to suggest a central etiology."  The pt was released to full duty without deployment restrictions from a neurological standpoint.  The pt was referred to Hematology for evaluation of an elevated PTT X 2.
Age: 39.0
Sex: M
Vaccine: ANTH
Symptoms: Nuclear magnetic resonance imaging abnormal, Oropharyngeal pain, Pain, Paraesthesia, Platelet count normal
Clinical narrative: The patient is a recalled reservist preparing to deploy over seas.  The pt received AVA #1 on 9/18/09.  He had no local reaction.  On 9/20/09 the pt noted generalized body achiness (7/10).  That evening he noted chills and a minor sore throat.  He denied: fever, cough, sneezing, rhinorrhea, or congestion.  The pt took MOTRIN and on 9/21/09 am his muscle achiness was improved but he had a decreased appetite, no N, no V, no diarrhea, no abd pain.  He continued with a "minor" sore throat until 9/22/09.  When the pt awoke on 9/22/09 he noted difficulty opening the MOTRIN bottle.  He also had difficulty with tying his shoe laces and buttoning his shirt.  Later on the 22nd he received the SMALLPOX, TDAP and FLUMIST vaccinations.  On 9/23/09 the pt's symptoms of bilateral hand weakness were worse so he went to hospital for evaluation.  The pt was referred to the health center and Neurology.  When evaluated on 9/24/09 he stated that he was slightly better in that he could tie his shoes more easily.  He also noted that for the last 12 hours he had some intermittent tingling in his index and middle fingers (bilaterally).  The pt denied lower extremity symptoms or issues with swallowing, speech, ocular symptoms, or visual changes.  The exam revealed hand weakness, no shoulder, arm or neck weakness.  No sensory deficits.  The pt was also evaluated by Neurology on 9/24/09.  See ahlta note for details.  MRI of C Spine and labs were ordered (see results below).  On reevaluation by neurology on 9/28/09 it was noted that the "symptoms have dramatically improved.  The exact etiology of his transient weakness is unclear-given the mild elevated CK along with mild generalized myalgias and weakness without sensory symptoms or reflex changes, would consider a postvaccinial myositis.  GBS seems unlikely and there is no evidence to suggest a central etiology."  The pt was released to full duty without deployment restrictions from a neurological standpoint.  The pt was referred to Hematology for evaluation of an elevated PTT X 2.
Age: 39.0
Sex: M
Vaccine: ANTH
Symptoms: Protein total increased, Prothrombin time prolonged, Red blood cell count normal, Red blood cell sedimentation rate normal, Red cell distribution width normal
Clinical narrative: The patient is a recalled reservist preparing to deploy over seas.  The pt received AVA #1 on 9/18/09.  He had no local reaction.  On 9/20/09 the pt noted generalized body achiness (7/10).  That evening he noted chills and a minor sore throat.  He denied: fever, cough, sneezing, rhinorrhea, or congestion.  The pt took MOTRIN and on 9/21/09 am his muscle achiness was improved but he had a decreased appetite, no N, no V, no diarrhea, no abd pain.  He continued with a "minor" sore throat until 9/22/09.  When the pt awoke on 9/22/09 he noted difficulty opening the MOTRIN bottle.  He also had difficulty with tying his shoe laces and buttoning his shirt.  Later on the 22nd he received the SMALLPOX, TDAP and FLUMIST vaccinations.  On 9/23/09 the pt's symptoms of bilateral hand weakness were worse so he went to hospital for evaluation.  The pt was referred to the health center and Neurology.  When evaluated on 9/24/09 he stated that he was slightly better in that he could tie his shoes more easily.  He also noted that for the last 12 hours he had some intermittent tingling in his index and middle fingers (bilaterally).  The pt denied lower extremity symptoms or issues with swallowing, speech, ocular symptoms, or visual changes.  The exam revealed hand weakness, no shoulder, arm or neck weakness.  No sensory deficits.  The pt was also evaluated by Neurology on 9/24/09.  See ahlta note for details.  MRI of C Spine and labs were ordered (see results below).  On reevaluation by neurology on 9/28/09 it was noted that the "symptoms have dramatically improved.  The exact etiology of his transient weakness is unclear-given the mild elevated CK along with mild generalized myalgias and weakness without sensory symptoms or reflex changes, would consider a postvaccinial myositis.  GBS seems unlikely and there is no evidence to suggest a central etiology."  The pt was released to full duty without deployment restrictions from a neurological standpoint.  The pt was referred to Hematology for evaluation of an elevated PTT X 2.
Age: 39.0
Sex: M
Vaccine: ANTH
Symptoms: Reflexes abnormal, Rheumatoid factor negative, Speech disorder, Visual impairment, Vitamin B12 abnormal
Clinical narrative: The patient is a recalled reservist preparing to deploy over seas.  The pt received AVA #1 on 9/18/09.  He had no local reaction.  On 9/20/09 the pt noted generalized body achiness (7/10).  That evening he noted chills and a minor sore throat.  He denied: fever, cough, sneezing, rhinorrhea, or congestion.  The pt took MOTRIN and on 9/21/09 am his muscle achiness was improved but he had a decreased appetite, no N, no V, no diarrhea, no abd pain.  He continued with a "minor" sore throat until 9/22/09.  When the pt awoke on 9/22/09 he noted difficulty opening the MOTRIN bottle.  He also had difficulty with tying his shoe laces and buttoning his shirt.  Later on the 22nd he received the SMALLPOX, TDAP and FLUMIST vaccinations.  On 9/23/09 the pt's symptoms of bilateral hand weakness were worse so he went to hospital for evaluation.  The pt was referred to the health center and Neurology.  When evaluated on 9/24/09 he stated that he was slightly better in that he could tie his shoes more easily.  He also noted that for the last 12 hours he had some intermittent tingling in his index and middle fingers (bilaterally).  The pt denied lower extremity symptoms or issues with swallowing, speech, ocular symptoms, or visual changes.  The exam revealed hand weakness, no shoulder, arm or neck weakness.  No sensory deficits.  The pt was also evaluated by Neurology on 9/24/09.  See ahlta note for details.  MRI of C Spine and labs were ordered (see results below).  On reevaluation by neurology on 9/28/09 it was noted that the "symptoms have dramatically improved.  The exact etiology of his transient weakness is unclear-given the mild elevated CK along with mild generalized myalgias and weakness without sensory symptoms or reflex changes, would consider a postvaccinial myositis.  GBS seems unlikely and there is no evidence to suggest a central etiology."  The pt was released to full duty without deployment restrictions from a neurological standpoint.  The pt was referred to Hematology for evaluation of an elevated PTT X 2.
Age: 39.0
Sex: M
Vaccine: ANTH
Symptoms: White blood cell count decreased, X-ray abnormal
Clinical narrative: The patient is a recalled reservist preparing to deploy over seas.  The pt received AVA #1 on 9/18/09.  He had no local reaction.  On 9/20/09 the pt noted generalized body achiness (7/10).  That evening he noted chills and a minor sore throat.  He denied: fever, cough, sneezing, rhinorrhea, or congestion.  The pt took MOTRIN and on 9/21/09 am his muscle achiness was improved but he had a decreased appetite, no N, no V, no diarrhea, no abd pain.  He continued with a "minor" sore throat until 9/22/09.  When the pt awoke on 9/22/09 he noted difficulty opening the MOTRIN bottle.  He also had difficulty with tying his shoe laces and buttoning his shirt.  Later on the 22nd he received the SMALLPOX, TDAP and FLUMIST vaccinations.  On 9/23/09 the pt's symptoms of bilateral hand weakness were worse so he went to hospital for evaluation.  The pt was referred to the health center and Neurology.  When evaluated on 9/24/09 he stated that he was slightly better in that he could tie his shoes more easily.  He also noted that for the last 12 hours he had some intermittent tingling in his index and middle fingers (bilaterally).  The pt denied lower extremity symptoms or issues with swallowing, speech, ocular symptoms, or visual changes.  The exam revealed hand weakness, no shoulder, arm or neck weakness.  No sensory deficits.  The pt was also evaluated by Neurology on 9/24/09.  See ahlta note for details.  MRI of C Spine and labs were ordered (see results below).  On reevaluation by neurology on 9/28/09 it was noted that the "symptoms have dramatically improved.  The exact etiology of his transient weakness is unclear-given the mild elevated CK along with mild generalized myalgias and weakness without sensory symptoms or reflex changes, would consider a postvaccinial myositis.  GBS seems unlikely and there is no evidence to suggest a central etiology."  The pt was released to full duty without deployment restrictions from a neurological standpoint.  The pt was referred to Hematology for evaluation of an elevated PTT X 2.
Age: 11.0
Sex: M
Vaccine: FLUN3, MNQ
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Arm is sore and red around vaccine site. Symptoms started after the morning after the vaccine was administered.
Age: 15.0
Sex: F
Vaccine: FLUN3
Symptoms: Erythema, Swelling face
Clinical narrative: Approximately 15 minutes after vaccine had red and swollen area to right cheek 60mm x 50mm. Administered 50 mg Benadryl Mt 1600 10-6-09. At 10-7-09 0800 area approximately size of fifty cent piece.
Age: 39.0
Sex: F
Vaccine: SMALL
Symptoms: Arthralgia, Injection site pain, Pyrexia
Clinical narrative: Burning at site and some joint aches in shoulder of vac. site. Fever off and  on.
Sex: M
Vaccine: SMALL
Symptoms: Injection site pain, Injection site pruritus
Clinical narrative: Slight achiness and itching @ site (4/10)
Age: 36.0
Sex: M
Vaccine: ANTH
Symptoms: Unevaluable event
Clinical narrative: See attached forms: DD Form 2766 C vaccine administration record form 600 health record chronological record of medical care.
Age: 40.0
Sex: M
Vaccine: SMALL
Symptoms: Insomnia, Malaise, Pruritus
Clinical narrative: Slight malaise, diff. sleeping, itchy. 2 250 mg ibuprofen x BID 3 days prn.
Age: 27.0
Sex: F
Vaccine: SMALL
Symptoms: Arthralgia, Pruritus
Clinical narrative: She is very itchy since day 3, severe joint pain starting day 4 in shoulder, elbow and scapula, started on 1000mg/day NAPROXEN
Age: 54.0
Sex: M
Vaccine: SMALL
Symptoms: Pain, Swelling
Clinical narrative: Minor pain and swelling
Age: 8.0
Sex: F
Vaccine: FLUN3
Symptoms: Cough, Lobar pneumonia, Pyrexia
Clinical narrative: Cough/fever x 6 days-RUL pneumona (clinical).
Age: 55.0
Sex: M
Vaccine: HEPA, TDAP, TYP
Symptoms: Lip swelling, Pruritus
Clinical narrative: Took oral TYPHOID 10/2/09.  Took #2 pill on 10/4.  Noted puffy lips & itchy tongue which subsided after a "while".  Took dose #3 @ 3 am 10/6.  Swam at the health club & at 10 am noted puffy lips & itchy tongue returning.  Sent to ER.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Confusional state, Cough, Defaecation urgency, Erythema, Eye pruritus
Clinical narrative: Red, itchy, watery, blood shot eyes, runny nose, cough, slight rubbing to upper L posterior lobe, scratchy throat. Pt trying to clear throat, headache with pressure behind eyes, stated she felt slightly confused, flushing to face, redness to ears, stated she felt hot and sweaty lasting 15-20 min. then was freezing x 30 min. Felt like she needed to have BM-this lasted from start to finish x 5 hours-with symptoms diminishing as time passed. Pt used ALBUTEROL inhaler x 1 but denied using other medical treatment even though she was told she was having allergic reaction.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling of body temperature change, Flushing, Headache, Hyperhidrosis, Hypersensitivity
Clinical narrative: Red, itchy, watery, blood shot eyes, runny nose, cough, slight rubbing to upper L posterior lobe, scratchy throat. Pt trying to clear throat, headache with pressure behind eyes, stated she felt slightly confused, flushing to face, redness to ears, stated she felt hot and sweaty lasting 15-20 min. then was freezing x 30 min. Felt like she needed to have BM-this lasted from start to finish x 5 hours-with symptoms diminishing as time passed. Pt used ALBUTEROL inhaler x 1 but denied using other medical treatment even though she was told she was having allergic reaction.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Lacrimation increased, Ocular hyperaemia, Rhinorrhoea, Throat irritation
Clinical narrative: Red, itchy, watery, blood shot eyes, runny nose, cough, slight rubbing to upper L posterior lobe, scratchy throat. Pt trying to clear throat, headache with pressure behind eyes, stated she felt slightly confused, flushing to face, redness to ears, stated she felt hot and sweaty lasting 15-20 min. then was freezing x 30 min. Felt like she needed to have BM-this lasted from start to finish x 5 hours-with symptoms diminishing as time passed. Pt used ALBUTEROL inhaler x 1 but denied using other medical treatment even though she was told she was having allergic reaction.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Confusional state, Headache, Muscular weakness
Clinical narrative: Approx. 20 min after vaccine, employee stated she felt slightly confused with leg weakness, vital signs 145/60, 102. Employee took 15 min break, returned stated she felt better but now with a headache, rated a 4 on (1-10 pain scale). Employee took ibuprofen, 400 mg. Stated headache lasted x 12 hours but never increased above a 4 pain level. Denies taking anymore meds or seeking medical attention.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Aspartate aminotransferase increased, Blood creatine phosphokinase increased, Dialysis, Pyrexia, Renal failure
Clinical narrative: Rhabdomyolysis --> Renal Failure --> Dialysis. CPK >500,000. Fever 99.5 to 102. AST 2918.10/23/2009 hospital records for 10/2-10/9/2009 with Neuro and GI consults. Patient presented with c/o's rt hand numbness/tingling, poor grip strength and speech impairment. Patient found to have elevated LDH, LFT's and CPK, UA + for UTI. Tx: Dialysis, IV ABX . DC Dx Renal failure, Rhabdomyolysis ? etiology
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Rhabdomyolysis
Clinical narrative: Rhabdomyolysis --> Renal Failure --> Dialysis. CPK >500,000. Fever 99.5 to 102. AST 2918.10/23/2009 hospital records for 10/2-10/9/2009 with Neuro and GI consults. Patient presented with c/o's rt hand numbness/tingling, poor grip strength and speech impairment. Patient found to have elevated LDH, LFT's and CPK, UA + for UTI. Tx: Dialysis, IV ABX . DC Dx Renal failure, Rhabdomyolysis ? etiology
Age: 0.29
Sex: M
Vaccine: HEP
Symptoms: Listless, Rash, Unresponsive to stimuli
Clinical narrative: Patient became listless and unresponsive. EHS called by parent. Taken to ER and observed. No treatment given. Did have rash on R side of face. Right ear, temple, nose, and near eyes lasting approx. 12 hours.
Age: 36.0
Sex: M
Vaccine: ANTH
Symptoms: Acrochordon, Acute stress disorder, Anxiety, Arthralgia, Back pain
Clinical narrative: See attached forms: DD Form 2766C Vaccine Administration Record. Standard Form 600 Health Record Chronological Record of Medical Care.
Age: 36.0
Sex: M
Vaccine: ANTH
Symptoms: Depression, Dyskinesia, Dyspnoea, Exostosis, Fibrous histiocytoma
Clinical narrative: See attached forms: DD Form 2766C Vaccine Administration Record. Standard Form 600 Health Record Chronological Record of Medical Care.
Age: 36.0
Sex: M
Vaccine: ANTH
Symptoms: Gastrooesophageal reflux disease, Herpes simplex, Hyperlipidaemia, Inguinal hernia, Intervertebral disc degeneration
Clinical narrative: See attached forms: DD Form 2766C Vaccine Administration Record. Standard Form 600 Health Record Chronological Record of Medical Care.
Age: 36.0
Sex: M
Vaccine: ANTH
Symptoms: Intervertebral disc disorder, Intervertebral disc protrusion, Muscle spasms, Myelopathy, Palpitations
Clinical narrative: See attached forms: DD Form 2766C Vaccine Administration Record. Standard Form 600 Health Record Chronological Record of Medical Care.
Age: 36.0
Sex: M
Vaccine: ANTH
Symptoms: Respiratory disorder, Rhinitis, Sinusitis, Skin disorder, Sleep apnoea syndrome
Clinical narrative: See attached forms: DD Form 2766C Vaccine Administration Record. Standard Form 600 Health Record Chronological Record of Medical Care.
Age: 36.0
Sex: M
Vaccine: ANTH
Symptoms: Tinea cruris, Visual impairment
Clinical narrative: See attached forms: DD Form 2766C Vaccine Administration Record. Standard Form 600 Health Record Chronological Record of Medical Care.
Age: 36.0
Sex: M
Vaccine: ANTH
Symptoms: Unevaluable event
Clinical narrative: See attached form ID 2766CX Vaccine Administration Record. Standard Form 600 Health Record Chronological Record of Medical Care
Age: 36.0
Sex: M
Vaccine: ANTH, FLU3, MEN
Symptoms: Arthralgia, Disturbance in attention, Dyskinesia, Hypoaesthesia, Memory impairment
Clinical narrative: See attached forms: DD Form 2766C Vaccine Administration Record. Standard Form 600 Health Record Chronological; Record of Medical Care.
Age: 36.0
Sex: M
Vaccine: ANTH, FLU3, MEN
Symptoms: Oedema peripheral
Clinical narrative: See attached forms: DD Form 2766C Vaccine Administration Record. Standard Form 600 Health Record Chronological; Record of Medical Care.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Erythema, Induration
Clinical narrative: Erythema  6 cm - induration 4 cm. Centered vesicle. No systemic Sx - Rx-Ice, BENADRYL 25 mg - qbº
Age: 36.0
Sex: M
Vaccine: UNK
Symptoms: No adverse event
Clinical narrative: Pt. reports no record of adverse reactions to any vaccines.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Induration
Clinical narrative: Drastic local reaction 15 X12 cm induration  -18X 14 erythema.
Age: 62.0
Sex: F
Vaccine: UNK
Symptoms: Feeling of body temperature change, Gait disturbance, Hypersomnia, Pain in extremity
Clinical narrative: Two days after, I was hot and then two days after that I was freezing - was sleeping most of the time. Walked like I was 90 yrs old, legs hurt so bad.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Musculoskeletal stiffness, Unresponsive to stimuli
Clinical narrative: Pt had a possible seizure 8/21/09 had DAPTACEL and IPOL. Pt immediately stopped crying stiffened head then turned stiffly to the right and did not respond for 8-10 sec per mom, who did not report incident to us in office after vaccine. Reported to us 9/14/09.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Swelling
Clinical narrative: Localized swelling, and redness.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Blood product transfusion, CSF protein increased, Computerised tomogram normal, Gait disturbance, Headache
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 11 year old female patient with no pertinent medical history who on 13-MAY-2009 was vaccinated intramuscularly into the right arm with the third dose of GARDASIL (Lot # 659054/0315Y). On 27-MAY-2009, the patient experienced congestion; on 02-JUN-2009 patient had fever and leg pain; on 06-JUN-2009 the patient experienced headache and vomiting and on 10-JUN-2009, the patient experienced broad-based gait, facial weakness? and asymmetry. On an unspecified date, there were several exams performed; cerebrospinal fluid total protein was elevated, head computed axial tomography and magnetic resonance imaging were normal. The patient required an emergency room visit. The listing indicated that one or more of the events required hospitalization. The original reporting source was not provided. The VAERS ID # is 349128-1. Additional information has been received from a registered nurse concerning an 11 year old female patient who on 13-MAY-2009 at 4:00 pm was vaccinated with the third dose of GARDASIL. No other concomitant medications. On 27-MAY-2009 (previously reported as 31-MAY-2009) at 12:30 the patient went to the physician's office with a "virus" the she went into a sinus infection and then got a stomach virus all back to back over 2 weeks. Then she presented neurological dysfunctions in her facial muscles, speech, mouth motor skills, severe changes in her walking gait, extreme fatigue and dehydration. The patient was taken to the emergency room, and within 36 hours she was discharged with MILLER-FISHER syndrome. She went to the intensive care unit for several days and stayed in the hospital for two weeks. As of 15-JUN-2009, the patient was still recovering after intravenous immunoglobulin and involved in physical, occupational and speech therapies multiple times per week and was still on liquid thickeners. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Nuclear magnetic resonance imaging normal, Oropharyngeal pain, Pain in extremity, Pyrexia, Respiratory tract congestion
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 11 year old female patient with no pertinent medical history who on 13-MAY-2009 was vaccinated intramuscularly into the right arm with the third dose of GARDASIL (Lot # 659054/0315Y). On 27-MAY-2009, the patient experienced congestion; on 02-JUN-2009 patient had fever and leg pain; on 06-JUN-2009 the patient experienced headache and vomiting and on 10-JUN-2009, the patient experienced broad-based gait, facial weakness? and asymmetry. On an unspecified date, there were several exams performed; cerebrospinal fluid total protein was elevated, head computed axial tomography and magnetic resonance imaging were normal. The patient required an emergency room visit. The listing indicated that one or more of the events required hospitalization. The original reporting source was not provided. The VAERS ID # is 349128-1. Additional information has been received from a registered nurse concerning an 11 year old female patient who on 13-MAY-2009 at 4:00 pm was vaccinated with the third dose of GARDASIL. No other concomitant medications. On 27-MAY-2009 (previously reported as 31-MAY-2009) at 12:30 the patient went to the physician's office with a "virus" the she went into a sinus infection and then got a stomach virus all back to back over 2 weeks. Then she presented neurological dysfunctions in her facial muscles, speech, mouth motor skills, severe changes in her walking gait, extreme fatigue and dehydration. The patient was taken to the emergency room, and within 36 hours she was discharged with MILLER-FISHER syndrome. She went to the intensive care unit for several days and stayed in the hospital for two weeks. As of 15-JUN-2009, the patient was still recovering after intravenous immunoglobulin and involved in physical, occupational and speech therapies multiple times per week and was still on liquid thickeners. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 11 year old female patient with no pertinent medical history who on 13-MAY-2009 was vaccinated intramuscularly into the right arm with the third dose of GARDASIL (Lot # 659054/0315Y). On 27-MAY-2009, the patient experienced congestion; on 02-JUN-2009 patient had fever and leg pain; on 06-JUN-2009 the patient experienced headache and vomiting and on 10-JUN-2009, the patient experienced broad-based gait, facial weakness? and asymmetry. On an unspecified date, there were several exams performed; cerebrospinal fluid total protein was elevated, head computed axial tomography and magnetic resonance imaging were normal. The patient required an emergency room visit. The listing indicated that one or more of the events required hospitalization. The original reporting source was not provided. The VAERS ID # is 349128-1. Additional information has been received from a registered nurse concerning an 11 year old female patient who on 13-MAY-2009 at 4:00 pm was vaccinated with the third dose of GARDASIL. No other concomitant medications. On 27-MAY-2009 (previously reported as 31-MAY-2009) at 12:30 the patient went to the physician's office with a "virus" the she went into a sinus infection and then got a stomach virus all back to back over 2 weeks. Then she presented neurological dysfunctions in her facial muscles, speech, mouth motor skills, severe changes in her walking gait, extreme fatigue and dehydration. The patient was taken to the emergency room, and within 36 hours she was discharged with MILLER-FISHER syndrome. She went to the intensive care unit for several days and stayed in the hospital for two weeks. As of 15-JUN-2009, the patient was still recovering after intravenous immunoglobulin and involved in physical, occupational and speech therapies multiple times per week and was still on liquid thickeners. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Blood test, Borrelia burgdorferi serology, Computerised tomogram, Dehydration, Dyskinesia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 11 year old female patient with no pertinent medical history who on 13-MAY-2009 was vaccinated intramuscularly into the right arm with the third dose of GARDASIL (Lot # 659054/0315Y). On 27-MAY-2009, the patient experienced congestion; on 02-JUN-2009 patient had fever and leg pain; on 06-JUN-2009 the patient experienced headache and vomiting and on 10-JUN-2009, the patient experienced broad-based gait, facial weakness? and asymmetry. On an unspecified date, there were several exams performed; cerebrospinal fluid total protein was elevated, head computed axial tomography and magnetic resonance imaging were normal. The patient required an emergency room visit. The listing indicated that one or more of the events required hospitalization. The original reporting source was not provided. The VAERS ID # is 349128-1. Additional information has been received from a registered nurse concerning an 11 year old female patient who on 13-MAY-2009 at 4:00 pm was vaccinated with the third dose of GARDASIL. No other concomitant medications. On 27-MAY-2009 (previously reported as 31-MAY-2009) at 12:30 the patient went to the physician's office with a "virus" the she went into a sinus infection and then got a stomach virus all back to back over 2 weeks. Then she presented neurological dysfunctions in her facial muscles, speech, mouth motor skills, severe changes in her walking gait, extreme fatigue and dehydration. The patient was taken to the emergency room, and within 36 hours she was discharged with MILLER-FISHER syndrome. She went to the intensive care unit for several days and stayed in the hospital for two weeks. As of 15-JUN-2009, the patient was still recovering after intravenous immunoglobulin and involved in physical, occupational and speech therapies multiple times per week and was still on liquid thickeners. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Fatigue, Gait disturbance, Gastroenteritis viral, Intensive care, Miller Fisher syndrome
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 11 year old female patient with no pertinent medical history who on 13-MAY-2009 was vaccinated intramuscularly into the right arm with the third dose of GARDASIL (Lot # 659054/0315Y). On 27-MAY-2009, the patient experienced congestion; on 02-JUN-2009 patient had fever and leg pain; on 06-JUN-2009 the patient experienced headache and vomiting and on 10-JUN-2009, the patient experienced broad-based gait, facial weakness? and asymmetry. On an unspecified date, there were several exams performed; cerebrospinal fluid total protein was elevated, head computed axial tomography and magnetic resonance imaging were normal. The patient required an emergency room visit. The listing indicated that one or more of the events required hospitalization. The original reporting source was not provided. The VAERS ID # is 349128-1. Additional information has been received from a registered nurse concerning an 11 year old female patient who on 13-MAY-2009 at 4:00 pm was vaccinated with the third dose of GARDASIL. No other concomitant medications. On 27-MAY-2009 (previously reported as 31-MAY-2009) at 12:30 the patient went to the physician's office with a "virus" the she went into a sinus infection and then got a stomach virus all back to back over 2 weeks. Then she presented neurological dysfunctions in her facial muscles, speech, mouth motor skills, severe changes in her walking gait, extreme fatigue and dehydration. The patient was taken to the emergency room, and within 36 hours she was discharged with MILLER-FISHER syndrome. She went to the intensive care unit for several days and stayed in the hospital for two weeks. As of 15-JUN-2009, the patient was still recovering after intravenous immunoglobulin and involved in physical, occupational and speech therapies multiple times per week and was still on liquid thickeners. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Neurological symptom, Nuclear magnetic resonance imaging, Sinusitis, Speech disorder
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 11 year old female patient with no pertinent medical history who on 13-MAY-2009 was vaccinated intramuscularly into the right arm with the third dose of GARDASIL (Lot # 659054/0315Y). On 27-MAY-2009, the patient experienced congestion; on 02-JUN-2009 patient had fever and leg pain; on 06-JUN-2009 the patient experienced headache and vomiting and on 10-JUN-2009, the patient experienced broad-based gait, facial weakness? and asymmetry. On an unspecified date, there were several exams performed; cerebrospinal fluid total protein was elevated, head computed axial tomography and magnetic resonance imaging were normal. The patient required an emergency room visit. The listing indicated that one or more of the events required hospitalization. The original reporting source was not provided. The VAERS ID # is 349128-1. Additional information has been received from a registered nurse concerning an 11 year old female patient who on 13-MAY-2009 at 4:00 pm was vaccinated with the third dose of GARDASIL. No other concomitant medications. On 27-MAY-2009 (previously reported as 31-MAY-2009) at 12:30 the patient went to the physician's office with a "virus" the she went into a sinus infection and then got a stomach virus all back to back over 2 weeks. Then she presented neurological dysfunctions in her facial muscles, speech, mouth motor skills, severe changes in her walking gait, extreme fatigue and dehydration. The patient was taken to the emergency room, and within 36 hours she was discharged with MILLER-FISHER syndrome. She went to the intensive care unit for several days and stayed in the hospital for two weeks. As of 15-JUN-2009, the patient was still recovering after intravenous immunoglobulin and involved in physical, occupational and speech therapies multiple times per week and was still on liquid thickeners. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Blood product transfusion, Blood test, Borrelia burgdorferi serology, CSF test abnormal, Computerised tomogram head
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 11 year old female patient with no pertinent medical history who on 13-MAY-2009 was vaccinated intramuscularly into the right arm with the third dose of GARDASIL (Lot # 659054/0315Y). On 27-MAY-2009, the patient experienced congestion; on 02-JUN-2009 patient had fever and leg pain; on 06-JUN-2009 the patient experienced headache and vomiting and on 10-JUN-2009, the patient experienced broad-based gait, facial weakness? and asymmetry. On an unspecified date, there were several exams performed; cerebrospinal fluid total protein was elevated, head computed axial tomography and magnetic resonance imaging were normal. The patient required an emergency room visit. The listing indicated that one or more of the events required hospitalization. The original reporting source was not provided. The VAERS ID # is 349128-1. Additional information has been received from a registered nurse concerning an 11 year old female patient who on 13-MAY-2009 at 4:00 pm was vaccinated with the third dose of GARDASIL. No other concomitant medications. On 27-MAY-2009 (previously reported as 31-MAY-2009) at 12:30 the patient went to the physician's office with a "virus" the she went into a sinus infection and then got a stomach virus all back to back over 2 weeks. Then she presented neurological dysfunctions in her facial muscles, speech, mouth motor skills, severe changes in her walking gait, extreme fatigue and dehydration. The patient was taken to the emergency room, and within 36 hours she was discharged with MILLER-FISHER syndrome. She went to the intensive care unit for several days and stayed in the hospital for two weeks. As of 15-JUN-2009, the patient was still recovering after intravenous immunoglobulin and involved in physical, occupational and speech therapies multiple times per week and was still on liquid thickeners. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Dehydration, Facial paresis, Fatigue, Gait disturbance, Gastroenteritis viral
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 11 year old female patient with no pertinent medical history who on 13-MAY-2009 was vaccinated intramuscularly into the right arm with the third dose of GARDASIL (Lot # 659054/0315Y). On 27-MAY-2009, the patient experienced congestion; on 02-JUN-2009 patient had fever and leg pain; on 06-JUN-2009 the patient experienced headache and vomiting and on 10-JUN-2009, the patient experienced broad-based gait, facial weakness? and asymmetry. On an unspecified date, there were several exams performed; cerebrospinal fluid total protein was elevated, head computed axial tomography and magnetic resonance imaging were normal. The patient required an emergency room visit. The listing indicated that one or more of the events required hospitalization. The original reporting source was not provided. The VAERS ID # is 349128-1. Additional information has been received from a registered nurse concerning an 11 year old female patient who on 13-MAY-2009 at 4:00 pm was vaccinated with the third dose of GARDASIL. No other concomitant medications. On 27-MAY-2009 (previously reported as 31-MAY-2009) at 12:30 the patient went to the physician's office with a "virus" the she went into a sinus infection and then got a stomach virus all back to back over 2 weeks. Then she presented neurological dysfunctions in her facial muscles, speech, mouth motor skills, severe changes in her walking gait, extreme fatigue and dehydration. The patient was taken to the emergency room, and within 36 hours she was discharged with MILLER-FISHER syndrome. She went to the intensive care unit for several days and stayed in the hospital for two weeks. As of 15-JUN-2009, the patient was still recovering after intravenous immunoglobulin and involved in physical, occupational and speech therapies multiple times per week and was still on liquid thickeners. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released.