chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Toxicologic test normal
Clinical narrative: About 48 hrs vaccines given, the patient was noted to have lethargy, unsteady gait, truncal ataxia, nystagmus, and dysarthria that lasted ~24 hrs.  No treatment was given.  5/27/2008 MR received for DOS 4/17-18/2008 with D/C DX:  Acute Cerebellar Ataxia (Cerebellitis).  Pt presented to ER with unstable gait and lethargy.  Pt was in usual state last night but was difficult to wake, irritable and kept falling asleep in am. (+) mental status changes as well as staring episodes.  PE (+) for ataxia and delayed finger to nose. Improvement noted o/n and d/c.
Age: 83.0
Sex: M
Vaccine: DTAP
Symptoms: Inappropriate schedule of drug administration, Injection site haematoma
Clinical narrative: (R) Deltoid presents hematoma that goes down to the elbow. 3cc/22Gx1 1/2 vanishpoint syringe used. PT CONCERNED ABOUT HIS ARM. HE CAME BACK TODAY TO THE CLINIC. REPORTS IT IS GETTING BETTER. SEEN BY A NP WHO INDICATED TO REPORT THE ADVERSE REACTION TO CDC.
Age: 53.0
Sex: F
Vaccine: HEPAB
Symptoms: Hypoaesthesia, Oedema peripheral
Clinical narrative: Received a T.C. from client 4/17/2008 that she had hand swelling and numbness of opposite arm where vaccine was administered.  She had gone to the local health clinic and then called.  She was told to come to the HD where she got the vaccine.  She presented the next morning.
Age: 25.0
Sex: F
Vaccine: MMR, TD
Symptoms: Blood creatine phosphokinase increased, Gait disturbance, Myalgia, Myositis, Nausea
Clinical narrative: Received MMR and Td on 4/10/08. Reports overall muscle achiness since then, mostly in her thighs.  Reported severe thigh pain on 4/15/08 that made her nauseated.  Felt as if she could "barely walk".  Was sent to ER and diagnosed with Myositis.
Age: 25.0
Sex: F
Vaccine: MMR, TD
Symptoms: Pain in extremity, Red blood cell sedimentation rate normal
Clinical narrative: Received MMR and Td on 4/10/08. Reports overall muscle achiness since then, mostly in her thighs.  Reported severe thigh pain on 4/15/08 that made her nauseated.  Felt as if she could "barely walk".  Was sent to ER and diagnosed with Myositis.
Age: 52.0
Sex: F
Vaccine: HEPAB
Symptoms: Burning sensation, Dizziness, Dry throat, Erythema, Eye swelling
Clinical narrative: Corrected copy for previous form as it was a Twinrix #2 rather than Hep B #2 administered on 4/16/08.  One hour afterward, throat became dry and arms became red.  On 17th, arms became itchy and she felt like she was on fire all over.  Also felt like she was going to pass out.  Stated eyes were swollen.
Age: 52.0
Sex: F
Vaccine: HEPAB
Symptoms: Hepatitis B antibody, Pruritus
Clinical narrative: Corrected copy for previous form as it was a Twinrix #2 rather than Hep B #2 administered on 4/16/08.  One hour afterward, throat became dry and arms became red.  On 17th, arms became itchy and she felt like she was on fire all over.  Also felt like she was going to pass out.  Stated eyes were swollen.
Age: 38.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Diarrhoea, Headache, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: Headache, fever, body ache, rash, axillary adenopathy, diarrhea.
Age: 38.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Rash
Clinical narrative: Headache, fever, body ache, rash, axillary adenopathy, diarrhea.
Age: 38.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Back pain, Biopsy intestine, Biopsy kidney, Candidiasis, Chest pain
Clinical narrative: Headache, fever, body ache, rash, axillary adenopathy, diarrhea.
Age: 38.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Diarrhoea, Drug toxicity, Dyspnoea, Ear, nose and throat examination, Fatigue
Clinical narrative: Headache, fever, body ache, rash, axillary adenopathy, diarrhea.
Age: 38.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Liver function test, Malaise, Migraine, Pyrexia, Renal pain
Clinical narrative: Headache, fever, body ache, rash, axillary adenopathy, diarrhea.
Age: 38.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Skin disorder, Urticaria
Clinical narrative: Headache, fever, body ache, rash, axillary adenopathy, diarrhea.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site rash, Pain
Clinical narrative: Mother called, stating pt has rash on upper L arm with redness.  Child told mom arm hurts.  Instructed mom to see PCP and to call RN back with follow-up info.  4/16/08--TC to mother.  Stated took child to ER on 2/28/08 and MD said was reaction to shot.  No restrictions on future vaccines.
Age: 1.01
Sex: M
Vaccine: DTAP, MMR, PNC, VARCEL
Symptoms: Irritability, Rash maculo-papular, Sleep disorder
Clinical narrative: Diffuse macular papular rash 7 days after vaccines. No vesicles. No fevers. He has been irritable and not sleeping well for 2-3 days.
Age: 1.17
Sex: F
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: We are reporting this event as the child received an adult dose of Hep A as well as a pediatric dose of Hep A in the same visit. As far as we know there have been no adverse events from this med. administration error but we will keep in touch with the mother.
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Dizziness, Pyrexia, Vomiting
Clinical narrative: Injection given 3/4/08-within 24 hours, she complained of fever, weakness, vomiting, and severe dizziness. Was also given a PPD that day Parkedale Pharmaceuticals Lot # 44608 exp 4/09.
Age: 1.53
Sex: F
Vaccine: DTAP
Symptoms: Convulsion, Febrile convulsion
Clinical narrative: SEIZURE. FEBRILE VS. VACCINE RELATED SEIZURE.
Age: 0.37
Sex: F
Vaccine: DTAP, PNC
Symptoms: Rash
Clinical narrative: Rash occurred after vaccination.  Patient did not seek medical attention.  No treatment was provided.  Even reported by family 2 days after vaccine administered.
Age: 9.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: 1 day later developed large swollen, hot pruritic site on her arm that was painful.
Age: 1.22
Sex: M
Vaccine: MMR
Symptoms: Abnormal behaviour, Aphasia, Autism, Childhood disintegrative disorder, Psychomotor hyperactivity
Clinical narrative: Child went from talking and acting normal to being non-verbal and perseverating, hyperactive, stimming.  Child is now autistic.  7/11/08 Received medical record from parent w/corrected MD contact info.  Record dated 12/1996 reveals patient w/fever, not sleeping, runny nose, irritable, left ear drainage.  Dx w/chronic left OM. Received vaccinations 12/30/1996 as well as antibiotics.  Returned 1/1997 for f/u visit & was well.  Parent called MD later that month for green nasal discharge & abdominal discomfort.  8/8/08 Reviewed medical records of 2002-2006. FINAL DX: ADHD; Asperger's  Records reveal patient experienced hyperactivity, ear tubes, walking on tip toes, hand flapping, temper tantrums, separation difficulties, difficult mental focusing, temporary speech loss @ approx 15 mos,  screaming, constipation, sleep difficulties, bedwetting, aggressive behavior, poor impulse control.  On multiple meds w/multiple med changes. 1/21/2010 Patient still has autism and all accompanying autism symptoms. There has been no relief or change of any of his symptoms.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Blood test, Lumbar puncture, Pyrexia
Clinical narrative: Pt had 2 month immunizations on 4-16-08. Came into office with fever of 103.5 next day (4-16-08). Was admitted to hosp for wk-up.  4/30/2008 MR received for DOS 4/16-19/2008 with DX: Fever of Unknown Origin, Prematurity, Flat occipital area, Feeding dysfunction. Infant presented with FUO. Temp 103'F in PMD office with flattened occipital area. Admitted for w/u.  PE (+) for tachycardia in the 200's. Initially thought to be meningitis, but r/o with 2nd LP. Improvement noted with abx.
Age: 2.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Erythema, Skin warm, Swelling, Wrong drug administered
Clinical narrative: It was swollen, red and warm. Patient was seen by a doctor; was Rx Keflex antibiotics and warm soaker
Age: 17.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Blood pressure, Hypotonia, Memory impairment, Muscle twitching
Clinical narrative: Patient given immunizations-about 2-5 min afterwards slumped in chair arms and head began to twitch.  Upon touching arm calling name child-said what, assisted to chair vitals stable BP102/80-no knowledge of event.  Kept in office for
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pruritus, Pyrexia
Clinical narrative: Patient reports redness and swelling at site of injection 3 days post vaccinations. She also reports itching and low grade fever 99.6. However, she admits that fever has been present prior to vaccination.
Age: 18.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Fatigue, Headache, Heart rate increased, Pain
Clinical narrative: Started with a headache.  Developed fatigue and achiness.  Fever, chills, increased heart rate, pallor.  Temperature max 103 F, lasted 2-3 days.
Age: 18.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pallor, Pyrexia
Clinical narrative: Started with a headache.  Developed fatigue and achiness.  Fever, chills, increased heart rate, pallor.  Temperature max 103 F, lasted 2-3 days.
Age: 1.0
Sex: M
Vaccine: DTAP, HEPA, MMRV, PNC
Symptoms: Blood test normal, Bruxism, Cyanosis, Nervousness, Pallor
Clinical narrative: 4/8/08-Pt woke up, clenched teeth on GM's hand, started shaking all over - became pale - blue around lips - lasted about 2 minutes, then sleepy for about 35 minutes.  Taken by paramedics to ER.
Age: 1.0
Sex: M
Vaccine: DTAP, HEPA, MMRV, PNC
Symptoms: Somnolence, Urine analysis normal
Clinical narrative: 4/8/08-Pt woke up, clenched teeth on GM's hand, started shaking all over - became pale - blue around lips - lasted about 2 minutes, then sleepy for about 35 minutes.  Taken by paramedics to ER.
Age: 10.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Left upper arm 2 x 4 cm indurated, erythematous patch, slight tender to palpation, no limitation of arm movement.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Large area of redness and induration to left thigh surrounding immunization site.
Age: 0.53
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Rash erythematous
Clinical narrative: Erythematous rash on extremities and trunk
Age: 1.2
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Injection site erythema, Injection site rash, Local reaction
Clinical narrative: Band Aids were placed at each injection site.  Child removed bandage from HepA site immediately.  The three other sites developed a localized red rash in minutes.  All Band Aids were removed at that point & rash improved.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Swelling, redness and a knot on arm where vaccine given.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Mydriasis, Somnolence
Clinical narrative: Parent called on-call physician with complaint of child sleeping most of the afternoon and very sedate; call came at 7:07 pm - child was awake and alert at that time with eyes described as very dilated but reactive
Age: 31.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Erythema, Injection site erythema, Injection site warmth, Pruritus, Rash macular
Clinical narrative: (1) macular lesions with scornt surrounding erythema-very pruritic on neck, face, shoulders, hands, abd, pelvic, torso, back. (2) also-6 cm x 4 cm raised red, hot, hard indurance at site of vaccine
Age: 35.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 5cm x 5cm red, swollen are at shot site.  Suspect allergic reaction.  Doubt cellulitis.
Age: 35.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Neck pain, Pain
Clinical narrative: Red on 4/15/08-on 4/17/08 Developed redness increasing to pain and neck across to chest- Seen in ED- gave steroid and anti-inflammatory
Age: 1.8
Sex: M
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMR, VARCEL
Symptoms: Pyrexia, Varicella
Clinical narrative: Chicken pox, Feverish
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site swelling, Injection site warmth
Clinical narrative: Had varicella on 4-8-08 SQ in L thigh which later swelled with edema & became red.  Area continues to swell more and is "hot" to touch - mom to take child to MD 4-11-08.
Age: 1.6
Sex: F
Vaccine: DTAP
Symptoms: Decreased appetite, Pyrexia
Clinical narrative: fever for 3 days and decreased appetite
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Body temperature increased, Rash, Rash generalised
Clinical narrative: Mom phoned to clinic this am (4/14/08) stating over the weekend, patient was running temperature of 101-102.5.  Sunday patient broke out with rash on face.  Rash has now spread to chest, abdomen, and hands.  As of this morning (4/14/08) patient is afebrile.  Mom states patient is in good spirits.  Chicken pox protocol started.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Cellulitis, Erythema, Pain, Swelling
Clinical narrative: red, swollen, painful left lateral thigh/possible cellulitis
Age: 45.0
Sex: F
Vaccine: TD
Symptoms: Body temperature increased, Chills, Flushing, Hyperhidrosis
Clinical narrative: Temp- 101.1.  Sweating with chills.  Flushed.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Induration
Clinical narrative: 2 3/4 x 2 3/4 red area hard (warm) right arm
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Erythema, Urticaria
Clinical narrative: Seen in Primary Care Clinic 4-12-2008.  Complained of right deltoid with raised red area since recurring vaccine injections 4-10-2008.  Treatment: warm moist packs alternating with cool pack at site.  Ibuprofen as directed every 6 hours or PMD.
Age: 0.7
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: No adverse event
Clinical narrative: None - no adverse event.  Vaccines given early.
Age: 1.1
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Body temperature increased, Febrile convulsion, Full blood count normal, Laboratory test normal
Clinical narrative: Febrile seizures 8 days after MMR/Varivax.  CBC and chem 8 drawn.  Temperature of 101 (Rectal).
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Rash
Clinical narrative: Rash 11 days after MMR vaccine.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: rash and fever 11 days after getting MMR vaccine
Age: 10.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Inflammation, swelling, pruritic, painful, erythematous area to L upper arm.
Age: 1.0
Sex: F
Vaccine: HEPA, PNC
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Area of erythema and induration on R arm 30x30mm L arm 9x10mm.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site discolouration, Injection site swelling, Musculoskeletal pain, Pain in extremity, Somnolence
Clinical narrative: Arm hurt up to shoulder, swollen at site, red and purple at site. Child very sleepy
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Reports redness, warmth, swelling to right and left arm; worse in left.  Occurred within 48 hours of injections.  Giving Tylenol.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling, redness, itching R arm x2 days.  Multiple bumps from shoulder to wrist L arm - mom used oral and topical Benadryl.  No fever.
Age: 1.4
Sex: F
Vaccine: DTAP
Symptoms: Injection site bruising, Injection site erythema, Injection site induration
Clinical narrative: Large erythema/bruising & sl induration around injection site.  Erythema 4x5 inches, no warmth.  Walking fine.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Ecchymosis, Erythema
Clinical narrative: Localized redness, ecchymosis over deltoid and subcutaneous triceps.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Patient had received DTAP upper right 4/1/08. Mother brought child into clinic. Right upper arm red, swollen, warm. Mother informed to use ice. Ring was drawn around area to make reaction decreases.
Age: 39.0
Sex: M
Vaccine: TTOX
Symptoms: Dizziness, Hyperhidrosis, Pallor
Clinical narrative: Donor became pale and lighthead 15 min after vaccination.  Donor assisted to bed and placed supine.  Diaphoretic.  No LOC.  Vitals taken.  No nausea.  Donor felt better after 27 min. and was released.
Age: 1.1
Sex: M
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMR, PNC, VARCEL
Symptoms: Diarrhoea, Rash erythematous, Rash papular
Clinical narrative: Mom called stating...around 10:00 am on his legs, by 3-26-08 the bumps...arm; his buttocks, and around his eyes.  Mom stated the bumps were red & raised but stated child was not itching & had no drainage, bumps are just red.  Mom denied child had fever but he did have diarrhea.  Instructed mom to follow up with MD & our clinic.  4-3-08 Mom states had MD appt yesterday & MD feels the break out of bumps could be related to environmental allergies or other allergies & doesn't feel the rash is caused from the immunizations & it's O.K. to receive future immunizations.  He was also referred to an allergist.  Requested mom to get prescription from MD to administer future immunizations.  1-9-08 Child has missed 2 immunization appointments.  Did not reschedule again.
Age: 72.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: None; This is a notification that Varivax was administered instead of Zostavax
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Dizziness, Dysphagia, Dyspnoea, Heart rate increased
Clinical narrative: Within a half an hour from the time of the injection, my arms and hands began to go numb.  Both hands were so numb, and my whole body was shaking so badly I had difficulty holding on to the steering wheel trying to drive home.  Then severe dizziness set in, and difficulty swallowing and breathing.  My heart was beating very hard and fast, and I had a bunch of palpitations.  I drove to the emergency room, and was treated with oral steroids to keep my throat open, and an IV with antihistamines.  The next day I was still very dizzy, still had some difficulty swallowing, had another short episode of numbness in my hands, still had palpitations, the muscles in my arms and legs hurt, and my whole body just felt weak.  Today is day three, and I still feel miserable, my body aches.  I have been unable to really sleep since the injection.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Impaired driving ability, Myalgia, Pain, Palpitations
Clinical narrative: Within a half an hour from the time of the injection, my arms and hands began to go numb.  Both hands were so numb, and my whole body was shaking so badly I had difficulty holding on to the steering wheel trying to drive home.  Then severe dizziness set in, and difficulty swallowing and breathing.  My heart was beating very hard and fast, and I had a bunch of palpitations.  I drove to the emergency room, and was treated with oral steroids to keep my throat open, and an IV with antihistamines.  The next day I was still very dizzy, still had some difficulty swallowing, had another short episode of numbness in my hands, still had palpitations, the muscles in my arms and legs hurt, and my whole body just felt weak.  Today is day three, and I still feel miserable, my body aches.  I have been unable to really sleep since the injection.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Sleep disorder, Tremor
Clinical narrative: Within a half an hour from the time of the injection, my arms and hands began to go numb.  Both hands were so numb, and my whole body was shaking so badly I had difficulty holding on to the steering wheel trying to drive home.  Then severe dizziness set in, and difficulty swallowing and breathing.  My heart was beating very hard and fast, and I had a bunch of palpitations.  I drove to the emergency room, and was treated with oral steroids to keep my throat open, and an IV with antihistamines.  The next day I was still very dizzy, still had some difficulty swallowing, had another short episode of numbness in my hands, still had palpitations, the muscles in my arms and legs hurt, and my whole body just felt weak.  Today is day three, and I still feel miserable, my body aches.  I have been unable to really sleep since the injection.
Age: 13.0
Sex: M
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Unevaluable event
Clinical narrative: Cellulitis R arm
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blood potassium increased, Blood test normal, Convulsion, Electrocardiogram normal, Electroencephalogram
Clinical narrative: My daughter experienced what appeared to be a seizure/staring spell on April 15th, five days after receiving her vaccines.  The seizure lasted between one to two minutes and upon coming out of the seizure, she was upset/scared, etc.  Her vaccines were given at approximately 10:30am on the 10th of April and her seizure was at approximately 1:15pm on the 15th.  She was seen at the emergency room and a follow up EEG has been ordered, along with a follow up neurology appointment.  Both the attending ER physicians, as well as the neurologists believe she had a seizure/"spell".  In addition, she experienced a low grade fever on the 18th and 19th of April.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: My daughter experienced what appeared to be a seizure/staring spell on April 15th, five days after receiving her vaccines.  The seizure lasted between one to two minutes and upon coming out of the seizure, she was upset/scared, etc.  Her vaccines were given at approximately 10:30am on the 10th of April and her seizure was at approximately 1:15pm on the 15th.  She was seen at the emergency room and a follow up EEG has been ordered, along with a follow up neurology appointment.  Both the attending ER physicians, as well as the neurologists believe she had a seizure/"spell".  In addition, she experienced a low grade fever on the 18th and 19th of April.
Age: 9.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Pyrexia, Vomiting
Clinical narrative: High fever 2-3 days after receiving HPV #1 for 2-3 days; with vomiting for 1 day and Rt sided stomach ache for 1 day, mother took her to ER; seen at medical center; came for checkup today and the clinic was informed today only (4-30-08).
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Dizziness, Dyskinesia, Loss of consciousness, Orthostatic hypotension, Vaccine positive rechallenge
Clinical narrative: Information has been received on request from the government under the Act regarding an 18 year old female who on 02-AUG-2007 was vaccinated with her first dose of Gardasil (Lot 658488/0930U) in the left arm. Concomitant therapy included MENACTRA on the same day. After receiving both vaccinations the patient passed out briefly for 3-5 minutes in the reception area. The patient regained consciousness after a few seconds. Assessment: Postural Hypotension-increased fluids were advised. On 08-OCT-2007 the patient received her second dose of Gardasil in the left arm. Patient felt dizzy and passed . ? Vagal effect or hypoglycemia. Patient was seen having jerky movements when down. No further information was available. A standard lot check investigation was performed. 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 government and was released. The reporter felt that the events were life threatening.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, TDAP, HEPA, HPV4, TDAP
Symptoms: CSF protein increased, CSF virus no organisms observed, CSF white blood cell count increased, Meningitis aseptic, Viral test negative
Clinical narrative: Initial report received on 14 April 2008 from an other manufacturer, report number WAES0804USA00597.  The other manufacturer obtained the report from a line listing the Company requested from the FDA, VAERS # 306198.  The original reporting source was not identified.  Verbatim from report.  "This report was identified from a line listing obtained on requested by the Company from the FDA under the Act.  A 15 year old female patient with no pertinent medical history, on 16-JAN-2008 was vaccinated IM in the right arm with the first dose of Gardasil (lot # 659653/1448U).  Commitant suspect vaccine therapy included the first dose, IM in the right arm of HAVRIX (lot # AHAUB225BC), and the first dose, IM in the left arm, of ADACEL (lot # C2864AA).  There was no illness at the time of vaccination.  On 28-JAN-2008 the patient was hospitalized with aseptic meningitis.  The cerebrospinal fluid (CSF) sample revealed a high CSF white blood count, and a high CSF protein.  The CSF cultures, both bacterial and viral, were negative.  Hospitalization lasted for 5 days.  The outcome of the event was not specified."  "28-JAN-2008: cerebrospinal fluid white cell count, high" "28-JAN-2008: cerebrospinal fluid total protein, high" "28-JAN-2008: cerebrospinal fluid culture, negative viral & bacterial."  "The original reporting source was not identified.  The VAERS identification # is 306198."
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, TDAP, HEPA, HPV4, TDAP
Symptoms: Bacterial culture negative, CSF culture negative, CSF protein increased, CSF white blood cell count positive, Meningitis aseptic
Clinical narrative: Initial report received on 14 April 2008 from an other manufacturer, report number WAES0804USA00597.  The other manufacturer obtained the report from a line listing the Company requested from the FDA, VAERS # 306198.  The original reporting source was not identified.  Verbatim from report.  "This report was identified from a line listing obtained on requested by the Company from the FDA under the Act.  A 15 year old female patient with no pertinent medical history, on 16-JAN-2008 was vaccinated IM in the right arm with the first dose of Gardasil (lot # 659653/1448U).  Commitant suspect vaccine therapy included the first dose, IM in the right arm of HAVRIX (lot # AHAUB225BC), and the first dose, IM in the left arm, of ADACEL (lot # C2864AA).  There was no illness at the time of vaccination.  On 28-JAN-2008 the patient was hospitalized with aseptic meningitis.  The cerebrospinal fluid (CSF) sample revealed a high CSF white blood count, and a high CSF protein.  The CSF cultures, both bacterial and viral, were negative.  Hospitalization lasted for 5 days.  The outcome of the event was not specified."  "28-JAN-2008: cerebrospinal fluid white cell count, high" "28-JAN-2008: cerebrospinal fluid total protein, high" "28-JAN-2008: cerebrospinal fluid culture, negative viral & bacterial."  "The original reporting source was not identified.  The VAERS identification # is 306198."
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, TDAP, HEPA, HPV4, TDAP
Symptoms: Virus culture negative
Clinical narrative: Initial report received on 14 April 2008 from an other manufacturer, report number WAES0804USA00597.  The other manufacturer obtained the report from a line listing the Company requested from the FDA, VAERS # 306198.  The original reporting source was not identified.  Verbatim from report.  "This report was identified from a line listing obtained on requested by the Company from the FDA under the Act.  A 15 year old female patient with no pertinent medical history, on 16-JAN-2008 was vaccinated IM in the right arm with the first dose of Gardasil (lot # 659653/1448U).  Commitant suspect vaccine therapy included the first dose, IM in the right arm of HAVRIX (lot # AHAUB225BC), and the first dose, IM in the left arm, of ADACEL (lot # C2864AA).  There was no illness at the time of vaccination.  On 28-JAN-2008 the patient was hospitalized with aseptic meningitis.  The cerebrospinal fluid (CSF) sample revealed a high CSF white blood count, and a high CSF protein.  The CSF cultures, both bacterial and viral, were negative.  Hospitalization lasted for 5 days.  The outcome of the event was not specified."  "28-JAN-2008: cerebrospinal fluid white cell count, high" "28-JAN-2008: cerebrospinal fluid total protein, high" "28-JAN-2008: cerebrospinal fluid culture, negative viral & bacterial."  "The original reporting source was not identified.  The VAERS identification # is 306198."
Age: 7.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Body temperature increased, Bronchitis, Convulsion, Dyskinesia, Eosinophil count normal
Clinical narrative: Information was received from a consumer, the grandmother of a seven year old male with no pertinent medical history, drug reactions or allergies who on 21-JAN-2008 had undergone a dental examination, which was fine, followed by a visit to his physician for a well check up, at which time he was vaccinated with a second dose of Varivax (Oka/Merck).  There was no concomitant medication.  It was reported that about 20 minutes post vaccination the grandmother noticed that the patient was sluggish, and did not want to eat, his eyes turned red, and he was warm to touch and wanted to go home.  The grandmother reported that about 6 hours later the patient was running a 103.2 degree fever, with swelling of his arms, and a huge bruise with red veins coming out of the injection site, which was on his right arm.  Around 8:30 that evening the patient had a fever of 104.8.  The grandmother reported that she had called the patient's physician and was told that it was a low grade fever and to give the patient MOTRIN and TYLENOL.  Later that week the patient was still running a fever of 103 2, and his hands were shaking, and he was itching and the grandmother took him to seen an ears, nose and throat specialist, the outcome of which was not reported.  She also took the patient to see her own physician who she reported "told her to go home".  The consumer reported that on the night of 6 FEB 2008 the patient was acting strange, and could not do his school work, would not eat, play games and would stare into space.  On 7 FEB 2008 the consumer reported that she went upstairs to get the patient up for school and the patient's eyes were shifted to the left, his tongue was swollen, he could not speak, and his hands were pulled under his chin and his whole body was jerking severely and his face was distorted.  At the emergency room the patient had a fever and his body would not stop jerking.  The consumer reported that the physician there could not determine what it was.  The patient was hospitalized for an unreported period of time.  Unspecified lab work was obtained, as was a brain scan, the results of which were not reported.  There was no product quality complaint.  At the time of reporting the patient had not yet recovered.  No further information is available.
Age: 7.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Feeling hot, Haematocrit normal, Lymphocyte count increased, Malaise, Mean platelet volume decreased
Clinical narrative: Information was received from a consumer, the grandmother of a seven year old male with no pertinent medical history, drug reactions or allergies who on 21-JAN-2008 had undergone a dental examination, which was fine, followed by a visit to his physician for a well check up, at which time he was vaccinated with a second dose of Varivax (Oka/Merck).  There was no concomitant medication.  It was reported that about 20 minutes post vaccination the grandmother noticed that the patient was sluggish, and did not want to eat, his eyes turned red, and he was warm to touch and wanted to go home.  The grandmother reported that about 6 hours later the patient was running a 103.2 degree fever, with swelling of his arms, and a huge bruise with red veins coming out of the injection site, which was on his right arm.  Around 8:30 that evening the patient had a fever of 104.8.  The grandmother reported that she had called the patient's physician and was told that it was a low grade fever and to give the patient MOTRIN and TYLENOL.  Later that week the patient was still running a fever of 103 2, and his hands were shaking, and he was itching and the grandmother took him to seen an ears, nose and throat specialist, the outcome of which was not reported.  She also took the patient to see her own physician who she reported "told her to go home".  The consumer reported that on the night of 6 FEB 2008 the patient was acting strange, and could not do his school work, would not eat, play games and would stare into space.  On 7 FEB 2008 the consumer reported that she went upstairs to get the patient up for school and the patient's eyes were shifted to the left, his tongue was swollen, he could not speak, and his hands were pulled under his chin and his whole body was jerking severely and his face was distorted.  At the emergency room the patient had a fever and his body would not stop jerking.  The consumer reported that the physician there could not determine what it was.  The patient was hospitalized for an unreported period of time.  Unspecified lab work was obtained, as was a brain scan, the results of which were not reported.  There was no product quality complaint.  At the time of reporting the patient had not yet recovered.  No further information is available.
Age: 7.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Muscle twitching, Neck pain, Nervous system disorder, Neutrophil percentage decreased, Platelet count increased
Clinical narrative: Information was received from a consumer, the grandmother of a seven year old male with no pertinent medical history, drug reactions or allergies who on 21-JAN-2008 had undergone a dental examination, which was fine, followed by a visit to his physician for a well check up, at which time he was vaccinated with a second dose of Varivax (Oka/Merck).  There was no concomitant medication.  It was reported that about 20 minutes post vaccination the grandmother noticed that the patient was sluggish, and did not want to eat, his eyes turned red, and he was warm to touch and wanted to go home.  The grandmother reported that about 6 hours later the patient was running a 103.2 degree fever, with swelling of his arms, and a huge bruise with red veins coming out of the injection site, which was on his right arm.  Around 8:30 that evening the patient had a fever of 104.8.  The grandmother reported that she had called the patient's physician and was told that it was a low grade fever and to give the patient MOTRIN and TYLENOL.  Later that week the patient was still running a fever of 103 2, and his hands were shaking, and he was itching and the grandmother took him to seen an ears, nose and throat specialist, the outcome of which was not reported.  She also took the patient to see her own physician who she reported "told her to go home".  The consumer reported that on the night of 6 FEB 2008 the patient was acting strange, and could not do his school work, would not eat, play games and would stare into space.  On 7 FEB 2008 the consumer reported that she went upstairs to get the patient up for school and the patient's eyes were shifted to the left, his tongue was swollen, he could not speak, and his hands were pulled under his chin and his whole body was jerking severely and his face was distorted.  At the emergency room the patient had a fever and his body would not stop jerking.  The consumer reported that the physician there could not determine what it was.  The patient was hospitalized for an unreported period of time.  Unspecified lab work was obtained, as was a brain scan, the results of which were not reported.  There was no product quality complaint.  At the time of reporting the patient had not yet recovered.  No further information is available.
Age: 7.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Pyrexia, Red cell distribution width decreased, Speech disorder, Staring, Streptococcal identification test positive
Clinical narrative: Information was received from a consumer, the grandmother of a seven year old male with no pertinent medical history, drug reactions or allergies who on 21-JAN-2008 had undergone a dental examination, which was fine, followed by a visit to his physician for a well check up, at which time he was vaccinated with a second dose of Varivax (Oka/Merck).  There was no concomitant medication.  It was reported that about 20 minutes post vaccination the grandmother noticed that the patient was sluggish, and did not want to eat, his eyes turned red, and he was warm to touch and wanted to go home.  The grandmother reported that about 6 hours later the patient was running a 103.2 degree fever, with swelling of his arms, and a huge bruise with red veins coming out of the injection site, which was on his right arm.  Around 8:30 that evening the patient had a fever of 104.8.  The grandmother reported that she had called the patient's physician and was told that it was a low grade fever and to give the patient MOTRIN and TYLENOL.  Later that week the patient was still running a fever of 103 2, and his hands were shaking, and he was itching and the grandmother took him to seen an ears, nose and throat specialist, the outcome of which was not reported.  She also took the patient to see her own physician who she reported "told her to go home".  The consumer reported that on the night of 6 FEB 2008 the patient was acting strange, and could not do his school work, would not eat, play games and would stare into space.  On 7 FEB 2008 the consumer reported that she went upstairs to get the patient up for school and the patient's eyes were shifted to the left, his tongue was swollen, he could not speak, and his hands were pulled under his chin and his whole body was jerking severely and his face was distorted.  At the emergency room the patient had a fever and his body would not stop jerking.  The consumer reported that the physician there could not determine what it was.  The patient was hospitalized for an unreported period of time.  Unspecified lab work was obtained, as was a brain scan, the results of which were not reported.  There was no product quality complaint.  At the time of reporting the patient had not yet recovered.  No further information is available.
Age: 7.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Tic, Vomiting, White blood cell count
Clinical narrative: Information was received from a consumer, the grandmother of a seven year old male with no pertinent medical history, drug reactions or allergies who on 21-JAN-2008 had undergone a dental examination, which was fine, followed by a visit to his physician for a well check up, at which time he was vaccinated with a second dose of Varivax (Oka/Merck).  There was no concomitant medication.  It was reported that about 20 minutes post vaccination the grandmother noticed that the patient was sluggish, and did not want to eat, his eyes turned red, and he was warm to touch and wanted to go home.  The grandmother reported that about 6 hours later the patient was running a 103.2 degree fever, with swelling of his arms, and a huge bruise with red veins coming out of the injection site, which was on his right arm.  Around 8:30 that evening the patient had a fever of 104.8.  The grandmother reported that she had called the patient's physician and was told that it was a low grade fever and to give the patient MOTRIN and TYLENOL.  Later that week the patient was still running a fever of 103 2, and his hands were shaking, and he was itching and the grandmother took him to seen an ears, nose and throat specialist, the outcome of which was not reported.  She also took the patient to see her own physician who she reported "told her to go home".  The consumer reported that on the night of 6 FEB 2008 the patient was acting strange, and could not do his school work, would not eat, play games and would stare into space.  On 7 FEB 2008 the consumer reported that she went upstairs to get the patient up for school and the patient's eyes were shifted to the left, his tongue was swollen, he could not speak, and his hands were pulled under his chin and his whole body was jerking severely and his face was distorted.  At the emergency room the patient had a fever and his body would not stop jerking.  The consumer reported that the physician there could not determine what it was.  The patient was hospitalized for an unreported period of time.  Unspecified lab work was obtained, as was a brain scan, the results of which were not reported.  There was no product quality complaint.  At the time of reporting the patient had not yet recovered.  No further information is available.
Age: 7.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Abnormal behaviour, Aphasia, Body temperature increased, Computerised tomogram head, Dental examination normal
Clinical narrative: Information was received from a consumer, the grandmother of a seven year old male with no pertinent medical history, drug reactions or allergies who on 21-JAN-2008 had undergone a dental examination, which was fine, followed by a visit to his physician for a well check up, at which time he was vaccinated with a second dose of Varivax (Oka/Merck).  There was no concomitant medication.  It was reported that about 20 minutes post vaccination the grandmother noticed that the patient was sluggish, and did not want to eat, his eyes turned red, and he was warm to touch and wanted to go home.  The grandmother reported that about 6 hours later the patient was running a 103.2 degree fever, with swelling of his arms, and a huge bruise with red veins coming out of the injection site, which was on his right arm.  Around 8:30 that evening the patient had a fever of 104.8.  The grandmother reported that she had called the patient's physician and was told that it was a low grade fever and to give the patient MOTRIN and TYLENOL.  Later that week the patient was still running a fever of 103 2, and his hands were shaking, and he was itching and the grandmother took him to seen an ears, nose and throat specialist, the outcome of which was not reported.  She also took the patient to see her own physician who she reported "told her to go home".  The consumer reported that on the night of 6 FEB 2008 the patient was acting strange, and could not do his school work, would not eat, play games and would stare into space.  On 7 FEB 2008 the consumer reported that she went upstairs to get the patient up for school and the patient's eyes were shifted to the left, his tongue was swollen, he could not speak, and his hands were pulled under his chin and his whole body was jerking severely and his face was distorted.  At the emergency room the patient had a fever and his body would not stop jerking.  The consumer reported that the physician there could not determine what it was.  The patient was hospitalized for an unreported period of time.  Unspecified lab work was obtained, as was a brain scan, the results of which were not reported.  There was no product quality complaint.  At the time of reporting the patient had not yet recovered.  No further information is available.
Age: 7.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Diet refusal, Dyskinesia, Dysmorphism, Gaze palsy, Injection site bruising
Clinical narrative: Information was received from a consumer, the grandmother of a seven year old male with no pertinent medical history, drug reactions or allergies who on 21-JAN-2008 had undergone a dental examination, which was fine, followed by a visit to his physician for a well check up, at which time he was vaccinated with a second dose of Varivax (Oka/Merck).  There was no concomitant medication.  It was reported that about 20 minutes post vaccination the grandmother noticed that the patient was sluggish, and did not want to eat, his eyes turned red, and he was warm to touch and wanted to go home.  The grandmother reported that about 6 hours later the patient was running a 103.2 degree fever, with swelling of his arms, and a huge bruise with red veins coming out of the injection site, which was on his right arm.  Around 8:30 that evening the patient had a fever of 104.8.  The grandmother reported that she had called the patient's physician and was told that it was a low grade fever and to give the patient MOTRIN and TYLENOL.  Later that week the patient was still running a fever of 103 2, and his hands were shaking, and he was itching and the grandmother took him to seen an ears, nose and throat specialist, the outcome of which was not reported.  She also took the patient to see her own physician who she reported "told her to go home".  The consumer reported that on the night of 6 FEB 2008 the patient was acting strange, and could not do his school work, would not eat, play games and would stare into space.  On 7 FEB 2008 the consumer reported that she went upstairs to get the patient up for school and the patient's eyes were shifted to the left, his tongue was swollen, he could not speak, and his hands were pulled under his chin and his whole body was jerking severely and his face was distorted.  At the emergency room the patient had a fever and his body would not stop jerking.  The consumer reported that the physician there could not determine what it was.  The patient was hospitalized for an unreported period of time.  Unspecified lab work was obtained, as was a brain scan, the results of which were not reported.  There was no product quality complaint.  At the time of reporting the patient had not yet recovered.  No further information is available.
Age: 7.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Injection site erythema, Laboratory test, Ocular hyperaemia, Oedema peripheral, Pruritus
Clinical narrative: Information was received from a consumer, the grandmother of a seven year old male with no pertinent medical history, drug reactions or allergies who on 21-JAN-2008 had undergone a dental examination, which was fine, followed by a visit to his physician for a well check up, at which time he was vaccinated with a second dose of Varivax (Oka/Merck).  There was no concomitant medication.  It was reported that about 20 minutes post vaccination the grandmother noticed that the patient was sluggish, and did not want to eat, his eyes turned red, and he was warm to touch and wanted to go home.  The grandmother reported that about 6 hours later the patient was running a 103.2 degree fever, with swelling of his arms, and a huge bruise with red veins coming out of the injection site, which was on his right arm.  Around 8:30 that evening the patient had a fever of 104.8.  The grandmother reported that she had called the patient's physician and was told that it was a low grade fever and to give the patient MOTRIN and TYLENOL.  Later that week the patient was still running a fever of 103 2, and his hands were shaking, and he was itching and the grandmother took him to seen an ears, nose and throat specialist, the outcome of which was not reported.  She also took the patient to see her own physician who she reported "told her to go home".  The consumer reported that on the night of 6 FEB 2008 the patient was acting strange, and could not do his school work, would not eat, play games and would stare into space.  On 7 FEB 2008 the consumer reported that she went upstairs to get the patient up for school and the patient's eyes were shifted to the left, his tongue was swollen, he could not speak, and his hands were pulled under his chin and his whole body was jerking severely and his face was distorted.  At the emergency room the patient had a fever and his body would not stop jerking.  The consumer reported that the physician there could not determine what it was.  The patient was hospitalized for an unreported period of time.  Unspecified lab work was obtained, as was a brain scan, the results of which were not reported.  There was no product quality complaint.  At the time of reporting the patient had not yet recovered.  No further information is available.