chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: CSF white blood cell count increased, Clumsiness, Confusional state, Cough, Dizziness
Clinical narrative: On May 13, 2008 (24 days post vaccincations) child had what his mother described as "flu symtoms"-cough, slight fever, headache.  He seemed to get better after a few days, and then on May 20, 2008, he had a worsening headache, complained of dizziness, and was "clumsy and confused" according to mom. He also had a few episodes of panicking, and "talking out of his head".  Mom also reported fever and some vomiting. The child was taken to Medical Center Emergency Room on May 21, 2008, then transferred to Hospital Emergency Room to be admitted to the Pediatric Unit.  Child is currently a patient at Medical Center Pediatric ICU.  Dx: Acute Disseminated Encephalomyelitis  06/23/2008  Partial MR received for DOS 5/22-7/25/2008 with DX:  Acute Disseminating Encephalomyelitis. Patient initially presented to local hospital with 1 week hx of flu-like sx of cough, fever, and headache. Seemed better for 2 days but then developed worsening h/s, dizziness, clumsiness and confusion. Parent reported some vomiting, panic episodes and disorientation. Transferred to current facility for eval and tx.  Given high dose steroids, plasmapheresis and IVIG without improvement. Intubated 2' to a lung puncture during an IJ insertion attempt, resulting in pneumothorax and chest tube insertion. Developed seizure-like spells. NG tube placed for nutrition. Posturing noted on 6/3/08 exam. Unable to follow commands. Spoke in nonsensical language. Developed agitation tx'd with meds, Candida and Saprophyticus UTIs. Improvement noted in July and pt able to ambulate with assistance. Getting speech, OT, and PT. Discharged to rehab facility.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Electroencephalogram abnormal, Haematocrit normal, Haemoglobin normal, Headache, Leukoencephalomyelitis
Clinical narrative: On May 13, 2008 (24 days post vaccincations) child had what his mother described as "flu symtoms"-cough, slight fever, headache.  He seemed to get better after a few days, and then on May 20, 2008, he had a worsening headache, complained of dizziness, and was "clumsy and confused" according to mom. He also had a few episodes of panicking, and "talking out of his head".  Mom also reported fever and some vomiting. The child was taken to Medical Center Emergency Room on May 21, 2008, then transferred to Hospital Emergency Room to be admitted to the Pediatric Unit.  Child is currently a patient at Medical Center Pediatric ICU.  Dx: Acute Disseminated Encephalomyelitis  06/23/2008  Partial MR received for DOS 5/22-7/25/2008 with DX:  Acute Disseminating Encephalomyelitis. Patient initially presented to local hospital with 1 week hx of flu-like sx of cough, fever, and headache. Seemed better for 2 days but then developed worsening h/s, dizziness, clumsiness and confusion. Parent reported some vomiting, panic episodes and disorientation. Transferred to current facility for eval and tx.  Given high dose steroids, plasmapheresis and IVIG without improvement. Intubated 2' to a lung puncture during an IJ insertion attempt, resulting in pneumothorax and chest tube insertion. Developed seizure-like spells. NG tube placed for nutrition. Posturing noted on 6/3/08 exam. Unable to follow commands. Spoke in nonsensical language. Developed agitation tx'd with meds, Candida and Saprophyticus UTIs. Improvement noted in July and pt able to ambulate with assistance. Getting speech, OT, and PT. Discharged to rehab facility.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Mean cell volume normal, Panic reaction, Platelet count normal, Pyrexia, Red blood cells CSF positive
Clinical narrative: On May 13, 2008 (24 days post vaccincations) child had what his mother described as "flu symtoms"-cough, slight fever, headache.  He seemed to get better after a few days, and then on May 20, 2008, he had a worsening headache, complained of dizziness, and was "clumsy and confused" according to mom. He also had a few episodes of panicking, and "talking out of his head".  Mom also reported fever and some vomiting. The child was taken to Medical Center Emergency Room on May 21, 2008, then transferred to Hospital Emergency Room to be admitted to the Pediatric Unit.  Child is currently a patient at Medical Center Pediatric ICU.  Dx: Acute Disseminated Encephalomyelitis  06/23/2008  Partial MR received for DOS 5/22-7/25/2008 with DX:  Acute Disseminating Encephalomyelitis. Patient initially presented to local hospital with 1 week hx of flu-like sx of cough, fever, and headache. Seemed better for 2 days but then developed worsening h/s, dizziness, clumsiness and confusion. Parent reported some vomiting, panic episodes and disorientation. Transferred to current facility for eval and tx.  Given high dose steroids, plasmapheresis and IVIG without improvement. Intubated 2' to a lung puncture during an IJ insertion attempt, resulting in pneumothorax and chest tube insertion. Developed seizure-like spells. NG tube placed for nutrition. Posturing noted on 6/3/08 exam. Unable to follow commands. Spoke in nonsensical language. Developed agitation tx'd with meds, Candida and Saprophyticus UTIs. Improvement noted in July and pt able to ambulate with assistance. Getting speech, OT, and PT. Discharged to rehab facility.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Vomiting, White blood cell count normal
Clinical narrative: On May 13, 2008 (24 days post vaccincations) child had what his mother described as "flu symtoms"-cough, slight fever, headache.  He seemed to get better after a few days, and then on May 20, 2008, he had a worsening headache, complained of dizziness, and was "clumsy and confused" according to mom. He also had a few episodes of panicking, and "talking out of his head".  Mom also reported fever and some vomiting. The child was taken to Medical Center Emergency Room on May 21, 2008, then transferred to Hospital Emergency Room to be admitted to the Pediatric Unit.  Child is currently a patient at Medical Center Pediatric ICU.  Dx: Acute Disseminated Encephalomyelitis  06/23/2008  Partial MR received for DOS 5/22-7/25/2008 with DX:  Acute Disseminating Encephalomyelitis. Patient initially presented to local hospital with 1 week hx of flu-like sx of cough, fever, and headache. Seemed better for 2 days but then developed worsening h/s, dizziness, clumsiness and confusion. Parent reported some vomiting, panic episodes and disorientation. Transferred to current facility for eval and tx.  Given high dose steroids, plasmapheresis and IVIG without improvement. Intubated 2' to a lung puncture during an IJ insertion attempt, resulting in pneumothorax and chest tube insertion. Developed seizure-like spells. NG tube placed for nutrition. Posturing noted on 6/3/08 exam. Unable to follow commands. Spoke in nonsensical language. Developed agitation tx'd with meds, Candida and Saprophyticus UTIs. Improvement noted in July and pt able to ambulate with assistance. Getting speech, OT, and PT. Discharged to rehab facility.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: PATIENT REPORTS THAT SHE HAD A SINGLE SHINGLE COME UP ON LEFT SIDE OF FOREHEAD. SHE SAW TWO DOCTORS WHO HAVE CALLED IT A SHINGLE. THIS WAS REPORTED TO ME ON 5/19/2008.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: PATIENT REPORTS THAT HE HAS HAD A ITCHY SINGLE SHINGLE APPEAR ON HIS ABDOMEN. HE SAW THE DR WHO CONFIRMED IT WAS A SHINGLE. THIS WAS REPORTED TO ME 5-19-2008.
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Chills, Dizziness, Full blood count normal, Hyperhidrosis, Metabolic function test normal
Clinical narrative: Lightheadedness, nausea, vomiting, sweats, and chills.
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Nausea, Vomiting
Clinical narrative: Lightheadedness, nausea, vomiting, sweats, and chills.
Age: 38.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Muscular weakness, Myalgia
Clinical narrative: Redness, pain and swelling at injection site, muscle aches/weakness,
Age: 1.0
Sex: M
Vaccine: DTAPHEPBIP, HEPA, MMR, VARCEL
Symptoms: Medication error, No adverse event
Clinical narrative: Pediarix given as 4th dose Dtap and IPV.  This also made the 4th dose for Hep B.  The child did not experience any adverse symptoms to our knowledge.  This event does not appear in the reportable list but the CDC recommended reporting.
Age: 1.17
Sex: M
Vaccine: DTAP, PNC
Symptoms: Injection site erythema, Injection site induration, Pain, Pyrexia
Clinical narrative: Onset of Erythema over large area with small induration to injection site on left mid thigh on 5/13/08 seen by provider recomm. cold compresses BID until subsides and Tylenol 1 tsp po q 4-6 hrs prn for fever or pain.
Age: 0.38
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Hypokinesia, Staring, Unresponsive to stimuli
Clinical narrative: After getting shots had 3 days of non-responsive, no smiling, no moving, just staring.
Age: 24.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Pruritus, Rash
Clinical narrative: Pt report rash 30MAY08, admitted 31MAY08, discharged on 1Jun08.  Rash lower arms & hands no pain some itchy. 7/14/08-records received-6/6/08-rash on bilateral arms, hands times 1 week. Elevated red patches, initially itchy. Occurred after 2nd anthrax vaccine. Impression:dermatitis. PE: multiple red-purple plaques on forearms. Seen at a hospital no records of admittion. 6/3/08-Impression:erythema multiforme.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis of the (L) deltoid arm at the site of injection. Rx Keflex x 5 days.
Age: 12.0
Sex: F
Vaccine: HEP, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: redness, swelling and warmth at injection site; treated with cool compress and OTC analgesics
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Patient had her 4 immunization given on both arms.  Passed out right after (sitting on chair) for few seconds, recovered right away.  VS taken, kept in bed for observation.  MD notified & evaluated, later discharged to mother.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Crying
Clinical narrative: Started crying 2 hours after shots & crying lasted about 3 hours.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient developed and swelling below site of injection - advised ice Advil
Age: 69.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: No adverse event, symptoms; Was advised to fill out because patient is 68 years old and ADACEL is approved only until age 64. No other problem reported.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Unevaluable event
Clinical narrative: "None"
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Cold sweat, Convulsion, Crying, Fall, Head injury
Clinical narrative: see attached; 6/3/05 approx 8:45Am; RN administered 4 vaccines to "patient" (age 5) (IPV, DTAp, MMR and Varicella). After child received the vaccines, she stood and walked around the child. She fell and hit her head on the floor. The child was experiencing a brief period of rigid seizure activity lasting several seconds. Child was hot/warm to touch and clammy. A cold wet cloth was placed on her forehead. After the seizure ended, child started to cry. RN unable to take pulse or other vital signs. Child still on the floor crying. Mother was holding child. 350AM: 911 was called. Husband was notified (left message) by RN. 855AM: Paramedics arrived spoke with mother. They advised mother to have the child taken to the hospital. Mother did not want them to take the child by ambulance. She would rather take her, herself by car. Child stable, conscious being held by mother. 910AM: paramedics called hospital to have child taken there. They notified the mother of the location of the hospital. 912AM: Child stable. Parent left carrying child in her arms. Mother stated that she was giving to take child to the hospital. Paramedics left also. Mother signed a document before leaving. Supervisor notified of the above events. RN 6/3/08 11AM
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Skin warm
Clinical narrative: see attached; 6/3/05 approx 8:45Am; RN administered 4 vaccines to "patient" (age 5) (IPV, DTAp, MMR and Varicella). After child received the vaccines, she stood and walked around the child. She fell and hit her head on the floor. The child was experiencing a brief period of rigid seizure activity lasting several seconds. Child was hot/warm to touch and clammy. A cold wet cloth was placed on her forehead. After the seizure ended, child started to cry. RN unable to take pulse or other vital signs. Child still on the floor crying. Mother was holding child. 350AM: 911 was called. Husband was notified (left message) by RN. 855AM: Paramedics arrived spoke with mother. They advised mother to have the child taken to the hospital. Mother did not want them to take the child by ambulance. She would rather take her, herself by car. Child stable, conscious being held by mother. 910AM: paramedics called hospital to have child taken there. They notified the mother of the location of the hospital. 912AM: Child stable. Parent left carrying child in her arms. Mother stated that she was giving to take child to the hospital. Paramedics left also. Mother signed a document before leaving. Supervisor notified of the above events. RN 6/3/08 11AM
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red swollen L upper arm.  Ice packs/MOTRIN.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Blood test normal, Culture throat negative, Pyrexia, Respiratory tract congestion
Clinical narrative: 5/20 High fever developed within 24 hrs (5/21)  of receiving 5 yr boosters. Temp went 103 and ranged from 101 to 105 for 6 days (5/26). After 72 hours from shots, she got congested. Antibiotics (5/24) were given as a precaution for infection but she reacted then to that. Fever broke 5/26-5/27 middle of night.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Swollen UR arm, red, hard & hot to touch.
Age: 5.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Injection site warmth, Urticaria
Clinical narrative: Welts to left leg, since vaccine.  3x3 cm red, warm, induration L ant thigh.  2x2 cm red, warm, induration L lat thigh.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Erythema, Feeling hot
Clinical narrative: 3 days post immunization, child presented to the office with 7 x 9 cm area of erythema and increased warmth to mid right thigh.  She had received her 5th DTaP/1st HEP A intramuscular injections and her second subcutaneous MMR in that leg.  The child did not complain of any pain or fever.
Age: 45.0
Sex: F
Vaccine: UNK
Symptoms: Injection site induration, Injection site warmth
Clinical narrative: 2 days post vaccine, EE had hard, warm area at injection site-did not report 5/20/08.  Referred to occmed MD for F/U.  Tx with BENADRYL & LIDEX cream.  Off work x 1 day to take meds.  MD thinks Rx secondary to NEOMYCIN sensitivity.  *EE did not reveal this at time of vaccine.
Age: 11.0
Sex: F
Vaccine: TD, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Local erythema, swelling, pain at site of injection of Varicella and Tdap which were both given together at same area at Public Health- left tricep area
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site pain, Oedema
Clinical narrative: R arm (upper) skin tender.  Mild erythema edema inferior aspect & elbow of arm.  Cool compresses.  Pt advised to take CLARITIN or BENADRYL.
Age: 6.0
Sex: M
Vaccine: HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 13cm x 13cm erythema & induration at R deltoid area - DTaP immunization given in R deltoid area 2 days earlier.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Contusion, Full blood count normal
Clinical narrative: Spontaneous bruising started 4 days after MMR.  Patient seen in office for bruising on 5/2/08.  Platelets were 7000 treated with 1 T.P.
Age: 21.0
Sex: F
Vaccine: TTOX
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Redness, warmth, tenderness and itching at site - +erythematous, circular area surrounding Td site & area 3 inches diameter.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Swelling
Clinical narrative: 16 x 12 cm local swelling and erythema left thigh.
Age: 27.0
Sex: F
Vaccine: UNK
Symptoms: Nasopharyngitis, Nausea
Clinical narrative: Became sick to stomach and had a bad cold.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Right deltoid red and swollen.
Age: 0.47
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Eye swelling, Oedema peripheral, Urticaria
Clinical narrative: Pt was seen in ER on 12/29/07 after developing urticaria. Pt had received immunizations on 12/28/07. Pt received Benadryl. Came into office on 12/31 mom stating urticaria resolved, but child was fussy and mom noticed eyes and hands were still swollen. Pt given Pediapred and symptoms resolved.
Age: 11.0
Sex: F
Vaccine: TTOX
Symptoms: Injection site cyst, Injection site induration
Clinical narrative: Patient developed hard cyst at injection site 24 hrs after injection.
Age: 5.0
Sex: F
Vaccine: IPV
Symptoms: Erythema, Oedema peripheral, Tenderness
Clinical narrative: Swelling entire upper arm, with redness and tenderness - Prescribed Benadryl, Prednisolone for 3 days, Augmentin for 5 days.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: None stated
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Dyspnoea, Movement disorder, Staring, Vomiting
Clinical narrative: DTAP given in AM - woke up from nap vomited - starring, strange movements. Gasping for air (as witnessed by grandmother) *Dx: DTAP reaction vs nightmare vs age
Age: 1.3
Sex: F
Vaccine: IPV, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: UR thigh - redness, swelling, hard to touch; mom applied ice.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Arthralgia, Pyrexia, Swelling, Urticaria
Clinical narrative: Developed urticaria, fever, joint pain & swelling approximately 8 hours after receiving DTaP #5, IPV #4.
Age: 8.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site urticaria
Clinical narrative: On 4-12-08 was seen for urticaria left upper arm.  On 4-10-08 was given VARIVAX and Hep A.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Cough, Dyspnoea, Urticaria
Clinical narrative: SOB, cough, hives; Treatment: Epi-Pen, Benadryl
Age: 0.5
Sex: M
Vaccine: IPV
Symptoms: Rash
Clinical narrative: Mom reports rash on abdomen/trunk, face, hairline, behind ears.  Patient seemed asymptomatic otherwise no px, no itching, no shortness of breath, not distressed.  Rash lasted around 4 hours and resolved on own.
Age: 0.6
Sex: F
Vaccine: PNC
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: R leg - red, swollen, feeling hot.  Warm wet compress for 15 min four times daily.  LOCOID LIPOCREAM twice daily.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Death, Intussusception
Clinical narrative: Information has been received from a physician concerning an 18-week-old male with a history of premature birth who on 24-NOV-2006 was vaccinated with a dose of ROTATEQ.  Concomitant vaccines included a dose of ACTHIB, PREVNAR and poliovirus vaccine.  On 29-NOV-2006 the patient died.  The cause of death was intussusception.  Intussusception was also considered to be immediately life-threatening.  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Cerebrovascular accident
Clinical narrative: Information has been received from a physician concerning a 20 year old female with a history of an unspecified blood disorder, who on an unspecified date was vaccinated with the first dose of GARDASIL, in the first week of May 2008, the patient was vaccinated with the second dose of GARDASIL lot # not provided. Concomitant therapy included hormonal contraceptives (unspecified). It was reported by a physician that the patient experienced a cerebrovascular accident, (CVA), three weeks after receiving her second dose of GARDASIL. The patient was admitted to the hospital on an unspecified date, and has since been released. At the time of reporting, the patient was recovering. The physician had discontinued therapy with GARDASIL. The reporter felt that the event was life-threatening. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Cerebrovascular accident, Contraception
Clinical narrative: Information has been received from a physician concerning a 20 year old female with a history of an unspecified blood disorder, who on an unspecified date was vaccinated with the first dose of GARDASIL, in the first week of May 2008, the patient was vaccinated with the second dose of GARDASIL lot # not provided. Concomitant therapy included hormonal contraceptives (unspecified). It was reported by a physician that the patient experienced a cerebrovascular accident, (CVA), three weeks after receiving her second dose of GARDASIL. The patient was admitted to the hospital on an unspecified date, and has since been released. At the time of reporting, the patient was recovering. The physician had discontinued therapy with GARDASIL. The reporter felt that the event was life-threatening. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Brain contusion, CSF protein increased, CSF white blood cell count increased, Cerebral haemorrhage, Computerised tomogram abnormal
Clinical narrative: Initial report received on 27 May 2008 from an agency VAERS report number E-22565.  The original reporter to the agency was a physician.  A report was also received the same day from the patient's father through a manufacturers reporting center.  A 22-year-old female patient who had no concurrent illnesses, pre-existing medical conditions, history of seizures, or history of reactions to prior vaccinations, had received on 06 May 2008 at around 19:00 pm a third intramuscular left arm injection of ADACEL (Lot # C2938AA), and a dose of Purified Protein Derivative tuberculin test.  The trade name, manufacturer name, Lot number, route and site of administration of the PPD test was not provided.  Approximately 35 hours post-vaccination and tuberculin test, around 6:10 a.m. on 08 May 2008, the subject awoke and e-mailed her boyfriend stating that she felt excruciating pain in her arm; it felt hot and she couldn't lift it.  She went back to bed and awoke at around 07:40 a.m. with a severe headache, nausea and vomiting.  Paramedics were called and the patient was transported to the emergency room.  According to the patient's father, paramedics noted the patient had blood in her left ear and it was subsequently determined that she had a fractured skull.  In the emergency room, a CAT scan revealed temporal fracture with frontal bilateral temporal lobe contusions with sub-arachnoid blood.  The patient had experienced a skull fracture and hemorrhagic brain contusions.  Spinal tap revealed that the cerebrospinal fluid was bloody with increase white blood cells and protein.  A repeat spinal tap did show some improvement.  An EEG revealed bilateral slowing; and a repeat EEG showed that the slowing had gotten worse; but a third EEG showed that the slowing was better.  None of the EEGs showed any spikes.  It was concluded during hospitalization that the patient most likely had a seizure.  The patient was hospitalized for nine days and released on 16 May 2008.  At the time of this report, the patient had not fully recovered.
Age: 22.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Convulsion, Electroencephalogram abnormal, Headache, Red blood cells CSF positive, Skull fracture
Clinical narrative: Initial report received on 27 May 2008 from an agency VAERS report number E-22565.  The original reporter to the agency was a physician.  A report was also received the same day from the patient's father through a manufacturers reporting center.  A 22-year-old female patient who had no concurrent illnesses, pre-existing medical conditions, history of seizures, or history of reactions to prior vaccinations, had received on 06 May 2008 at around 19:00 pm a third intramuscular left arm injection of ADACEL (Lot # C2938AA), and a dose of Purified Protein Derivative tuberculin test.  The trade name, manufacturer name, Lot number, route and site of administration of the PPD test was not provided.  Approximately 35 hours post-vaccination and tuberculin test, around 6:10 a.m. on 08 May 2008, the subject awoke and e-mailed her boyfriend stating that she felt excruciating pain in her arm; it felt hot and she couldn't lift it.  She went back to bed and awoke at around 07:40 a.m. with a severe headache, nausea and vomiting.  Paramedics were called and the patient was transported to the emergency room.  According to the patient's father, paramedics noted the patient had blood in her left ear and it was subsequently determined that she had a fractured skull.  In the emergency room, a CAT scan revealed temporal fracture with frontal bilateral temporal lobe contusions with sub-arachnoid blood.  The patient had experienced a skull fracture and hemorrhagic brain contusions.  Spinal tap revealed that the cerebrospinal fluid was bloody with increase white blood cells and protein.  A repeat spinal tap did show some improvement.  An EEG revealed bilateral slowing; and a repeat EEG showed that the slowing had gotten worse; but a third EEG showed that the slowing was better.  None of the EEGs showed any spikes.  It was concluded during hospitalization that the patient most likely had a seizure.  The patient was hospitalized for nine days and released on 16 May 2008.  At the time of this report, the patient had not fully recovered.
Age: 22.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Vomiting
Clinical narrative: Initial report received on 27 May 2008 from an agency VAERS report number E-22565.  The original reporter to the agency was a physician.  A report was also received the same day from the patient's father through a manufacturers reporting center.  A 22-year-old female patient who had no concurrent illnesses, pre-existing medical conditions, history of seizures, or history of reactions to prior vaccinations, had received on 06 May 2008 at around 19:00 pm a third intramuscular left arm injection of ADACEL (Lot # C2938AA), and a dose of Purified Protein Derivative tuberculin test.  The trade name, manufacturer name, Lot number, route and site of administration of the PPD test was not provided.  Approximately 35 hours post-vaccination and tuberculin test, around 6:10 a.m. on 08 May 2008, the subject awoke and e-mailed her boyfriend stating that she felt excruciating pain in her arm; it felt hot and she couldn't lift it.  She went back to bed and awoke at around 07:40 a.m. with a severe headache, nausea and vomiting.  Paramedics were called and the patient was transported to the emergency room.  According to the patient's father, paramedics noted the patient had blood in her left ear and it was subsequently determined that she had a fractured skull.  In the emergency room, a CAT scan revealed temporal fracture with frontal bilateral temporal lobe contusions with sub-arachnoid blood.  The patient had experienced a skull fracture and hemorrhagic brain contusions.  Spinal tap revealed that the cerebrospinal fluid was bloody with increase white blood cells and protein.  A repeat spinal tap did show some improvement.  An EEG revealed bilateral slowing; and a repeat EEG showed that the slowing had gotten worse; but a third EEG showed that the slowing was better.  None of the EEGs showed any spikes.  It was concluded during hospitalization that the patient most likely had a seizure.  The patient was hospitalized for nine days and released on 16 May 2008.  At the time of this report, the patient had not fully recovered.
Age: 22.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Convulsion, Ear haemorrhage, Electroencephalogram abnormal, Headache, Injected limb mobility decreased
Clinical narrative: Initial report received on 27 May 2008 from an agency VAERS report number E-22565.  The original reporter to the agency was a physician.  A report was also received the same day from the patient's father through a manufacturers reporting center.  A 22-year-old female patient who had no concurrent illnesses, pre-existing medical conditions, history of seizures, or history of reactions to prior vaccinations, had received on 06 May 2008 at around 19:00 pm a third intramuscular left arm injection of ADACEL (Lot # C2938AA), and a dose of Purified Protein Derivative tuberculin test.  The trade name, manufacturer name, Lot number, route and site of administration of the PPD test was not provided.  Approximately 35 hours post-vaccination and tuberculin test, around 6:10 a.m. on 08 May 2008, the subject awoke and e-mailed her boyfriend stating that she felt excruciating pain in her arm; it felt hot and she couldn't lift it.  She went back to bed and awoke at around 07:40 a.m. with a severe headache, nausea and vomiting.  Paramedics were called and the patient was transported to the emergency room.  According to the patient's father, paramedics noted the patient had blood in her left ear and it was subsequently determined that she had a fractured skull.  In the emergency room, a CAT scan revealed temporal fracture with frontal bilateral temporal lobe contusions with sub-arachnoid blood.  The patient had experienced a skull fracture and hemorrhagic brain contusions.  Spinal tap revealed that the cerebrospinal fluid was bloody with increase white blood cells and protein.  A repeat spinal tap did show some improvement.  An EEG revealed bilateral slowing; and a repeat EEG showed that the slowing had gotten worse; but a third EEG showed that the slowing was better.  None of the EEGs showed any spikes.  It was concluded during hospitalization that the patient most likely had a seizure.  The patient was hospitalized for nine days and released on 16 May 2008.  At the time of this report, the patient had not fully recovered.
Age: 22.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Lumbar puncture, Nausea, Pain in extremity, Red blood cells CSF positive, Skin warm
Clinical narrative: Initial report received on 27 May 2008 from an agency VAERS report number E-22565.  The original reporter to the agency was a physician.  A report was also received the same day from the patient's father through a manufacturers reporting center.  A 22-year-old female patient who had no concurrent illnesses, pre-existing medical conditions, history of seizures, or history of reactions to prior vaccinations, had received on 06 May 2008 at around 19:00 pm a third intramuscular left arm injection of ADACEL (Lot # C2938AA), and a dose of Purified Protein Derivative tuberculin test.  The trade name, manufacturer name, Lot number, route and site of administration of the PPD test was not provided.  Approximately 35 hours post-vaccination and tuberculin test, around 6:10 a.m. on 08 May 2008, the subject awoke and e-mailed her boyfriend stating that she felt excruciating pain in her arm; it felt hot and she couldn't lift it.  She went back to bed and awoke at around 07:40 a.m. with a severe headache, nausea and vomiting.  Paramedics were called and the patient was transported to the emergency room.  According to the patient's father, paramedics noted the patient had blood in her left ear and it was subsequently determined that she had a fractured skull.  In the emergency room, a CAT scan revealed temporal fracture with frontal bilateral temporal lobe contusions with sub-arachnoid blood.  The patient had experienced a skull fracture and hemorrhagic brain contusions.  Spinal tap revealed that the cerebrospinal fluid was bloody with increase white blood cells and protein.  A repeat spinal tap did show some improvement.  An EEG revealed bilateral slowing; and a repeat EEG showed that the slowing had gotten worse; but a third EEG showed that the slowing was better.  None of the EEGs showed any spikes.  It was concluded during hospitalization that the patient most likely had a seizure.  The patient was hospitalized for nine days and released on 16 May 2008.  At the time of this report, the patient had not fully recovered.
Age: 22.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Skull fracture, Subarachnoid haemorrhage, Vomiting
Clinical narrative: Initial report received on 27 May 2008 from an agency VAERS report number E-22565.  The original reporter to the agency was a physician.  A report was also received the same day from the patient's father through a manufacturers reporting center.  A 22-year-old female patient who had no concurrent illnesses, pre-existing medical conditions, history of seizures, or history of reactions to prior vaccinations, had received on 06 May 2008 at around 19:00 pm a third intramuscular left arm injection of ADACEL (Lot # C2938AA), and a dose of Purified Protein Derivative tuberculin test.  The trade name, manufacturer name, Lot number, route and site of administration of the PPD test was not provided.  Approximately 35 hours post-vaccination and tuberculin test, around 6:10 a.m. on 08 May 2008, the subject awoke and e-mailed her boyfriend stating that she felt excruciating pain in her arm; it felt hot and she couldn't lift it.  She went back to bed and awoke at around 07:40 a.m. with a severe headache, nausea and vomiting.  Paramedics were called and the patient was transported to the emergency room.  According to the patient's father, paramedics noted the patient had blood in her left ear and it was subsequently determined that she had a fractured skull.  In the emergency room, a CAT scan revealed temporal fracture with frontal bilateral temporal lobe contusions with sub-arachnoid blood.  The patient had experienced a skull fracture and hemorrhagic brain contusions.  Spinal tap revealed that the cerebrospinal fluid was bloody with increase white blood cells and protein.  A repeat spinal tap did show some improvement.  An EEG revealed bilateral slowing; and a repeat EEG showed that the slowing had gotten worse; but a third EEG showed that the slowing was better.  None of the EEGs showed any spikes.  It was concluded during hospitalization that the patient most likely had a seizure.  The patient was hospitalized for nine days and released on 16 May 2008.  At the time of this report, the patient had not fully recovered.
Sex: U
Vaccine: RV5
Symptoms: Rotavirus infection, Rotavirus test positive
Clinical narrative: Information has been received from a physician concerning a patient who on an unspecified date was vaccinated orally with a second dose of ROTATEQ. On an unspecified date the patient experienced a breakthrough case of ROTATEQ and was hospitalized. At the time of the report the patient's status was recovering. On an unknown date the patient had diagnostic studies performed to confirm rotavirus. A product quality complaint was not involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Hemiplegia
Clinical narrative: Information has been received from a physician concerning, a female patient who "10 days ago", on approximately 18-MAY-2008, was vaccinated SC with a first dose of ZOSTAVAX (Oka/Merck). The patient was taking concomitant medications (unspecified). About 48 hours after vaccination, on approximately 20-MAY-2008, the patient experienced unilateral paralysis. At the time of this report, the patient's unilateral paralysis persisted. No product quality complaint was involved. Upon internal review, unilateral paralysis was considered to be an other important medical event. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Inappropriate schedule of drug administration, Multiple sclerosis, Optic neuritis
Clinical narrative: Information has been received from a physician concerning a 29 year old female with no pertinent medical history or drug reactions/allergies who in July 2007, was vaccinated with a first dose of GARDASIL.  There was no concomitant medication.  In September and December 2007 the patient was vaccinated with a second and third dose of GARDASIL respectively.  The physician reported that on an unspecified date the patient was diagnosed with multiple sclerosis and it may be related to GARDASIL.  The patient has had optic neuritis and numbness on half of her body.  At the time of reporting the patient had not recovered.  No additional information has been reported by the physician.  The physician felt that multiple sclerosis was considered to be disabling.  Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Cataplexy, Computerised tomogram, Hallucination, Movement disorder, Narcolepsy
Clinical narrative: Information has been received from a physician concerning an 11 year old female with penicillin allergy and no pertinent medical history who in January 2008, was vaccinated with a third dose of GARDASIL.  There was no concomitant medication.  In January 2008, the patient developed cataplexy 1 to 3 days after vaccination.  About 2 months later in March 2008, the patient developed narcolepsy with hallucinations and a limb movement disorder.  The patient was seen in the physician's office and was treated with an unknown stimulant.  On unspecified dates the patient had a computed axial tomography, poly sleep latency tests and an magnetic resonance imaging (MRI) was ordered.  At the time of reporting the patient had not recovered.  The physician considered the patient's cataplexy and narcolepsy with hallucinations and limb movement disorder were considered to be disabling and other medical events.  Additional information has been requested.  8/13/2008 Outpatient records received from 3/2008 to 6/2008 with fnal dx: narcolepsy. Pt initially developed sx of dizziness, fatigue, decreased energy, interupted sleep and episodes offalling asleep/losing bodily control but not fully passing out following 3rd HPV shot in 1/2008. Initially thought to be vasodepressive sx tx'd with increased salt and fluids without improvement. Seen once in ER in 2/2008 for episode of shuddering, weakness, excessive sleepines/syncope without dx. Seen by neuro with w/u WNL. Has had episodes of slurred speech and difficulty catching breath. Picture more c/w cataplexy/narcolepsy.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Sleep study
Clinical narrative: Information has been received from a physician concerning an 11 year old female with penicillin allergy and no pertinent medical history who in January 2008, was vaccinated with a third dose of GARDASIL.  There was no concomitant medication.  In January 2008, the patient developed cataplexy 1 to 3 days after vaccination.  About 2 months later in March 2008, the patient developed narcolepsy with hallucinations and a limb movement disorder.  The patient was seen in the physician's office and was treated with an unknown stimulant.  On unspecified dates the patient had a computed axial tomography, poly sleep latency tests and an magnetic resonance imaging (MRI) was ordered.  At the time of reporting the patient had not recovered.  The physician considered the patient's cataplexy and narcolepsy with hallucinations and limb movement disorder were considered to be disabling and other medical events.  Additional information has been requested.  8/13/2008 Outpatient records received from 3/2008 to 6/2008 with fnal dx: narcolepsy. Pt initially developed sx of dizziness, fatigue, decreased energy, interupted sleep and episodes offalling asleep/losing bodily control but not fully passing out following 3rd HPV shot in 1/2008. Initially thought to be vasodepressive sx tx'd with increased salt and fluids without improvement. Seen once in ER in 2/2008 for episode of shuddering, weakness, excessive sleepines/syncope without dx. Seen by neuro with w/u WNL. Has had episodes of slurred speech and difficulty catching breath. Picture more c/w cataplexy/narcolepsy.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Full blood count normal, Laboratory test normal, Paralysis
Clinical narrative: Information has been received from a nurse practitioner concerning a female (age not reported) who on an unspecified date was vaccinated with her first and only dose of GARDASIL 0.5 mL.  There was no concomitant medication.  Subsequently "one week after vaccination" the patient developed total body paralysis and was hospitalized and all the lab tests which included a complete blood cell count came back negative.  Several days after the hospitalization, the patient got better and was released.  The reporter considered that total body paralysis to be disabling.  Additional information has been requested.  6/25/2008 MR received for ER visit 3/26/2008 with DX: Quadriparesis-resolved. Pt developed a h/a, took a nap and awoke with inability to move all 4 extremities. Parent reports that this is the 3rd episode of these sx. During triage, unable to move 4 extremities. 1 hr later continued to have some motor and sensory deficits.  Tingling reported in legs. Able to move toes after several hours and ambulating with slow unsteady gait and jerky movements in several more. D/C with resolution of sx in ~6 hrs from arrival.
Age: 61.0
Sex: M
Vaccine: RAB
Symptoms: Abscess, Back pain, Body temperature increased, Culture, Night sweats
Clinical narrative: Initial report was received 22 May 2008 from a health care provider.  A 61-year-old male patient with no past medical history, had received a pre-exposure right deltoid intramuscular injection of IMOVAX RABIES vaccine (lot number not reported) on 23 April 2008 and three days later, he developed a temperature of 103 Fahrenheit and night sweats.  The patient was prescribed a five day regimen of ZITHROMAX.  The patient had moved to another state to live with his son and developed a backache (onset date not provided).  He was evaluated by an orthopedic physician and had an MRI performed which indicated a positive abscess located at L4-L5 and was hospitalized.  Cultures were pending at the time of the report.  The reporter stated the patient had surgery on 21 May 2008 or 22 May 2008.  The patient had received two prior doses of IMOVAX RABIES vaccine on 02 April 2008 and 09 April 2008 as the first two doses of the pre-exposure series for foreign travel.  At the time of the report, the patient had not recovered from the event.
Age: 61.0
Sex: M
Vaccine: RAB
Symptoms: Nuclear magnetic resonance imaging abnormal, Surgery
Clinical narrative: Initial report was received 22 May 2008 from a health care provider.  A 61-year-old male patient with no past medical history, had received a pre-exposure right deltoid intramuscular injection of IMOVAX RABIES vaccine (lot number not reported) on 23 April 2008 and three days later, he developed a temperature of 103 Fahrenheit and night sweats.  The patient was prescribed a five day regimen of ZITHROMAX.  The patient had moved to another state to live with his son and developed a backache (onset date not provided).  He was evaluated by an orthopedic physician and had an MRI performed which indicated a positive abscess located at L4-L5 and was hospitalized.  Cultures were pending at the time of the report.  The reporter stated the patient had surgery on 21 May 2008 or 22 May 2008.  The patient had received two prior doses of IMOVAX RABIES vaccine on 02 April 2008 and 09 April 2008 as the first two doses of the pre-exposure series for foreign travel.  At the time of the report, the patient had not recovered from the event.
Age: 22.0
Sex: F
Vaccine: RAB
Symptoms: Anger, Anxiety, Chills, Crying, Dysphagia
Clinical narrative: SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT.  Initial report received from a patient's parent, who is also a health care professional, on 23 May 2008.  A 22-year-old female patient with a medical history of kidney stones, had received an intramuscular injection of IMOVAX RABIES, lot number A0484-2, as part of a pre-exposure series.  Two hours later, the patient experienced chills and muscle aches.  24 hours after vaccination, the patient developed behavioral changes described as "crying, angry, anxious".  She also had difficulty swallowing for 48 hours.  The patient was treated with MOTRIN and XANAX and the events resolved within 48 hours.  The patient had no complaints of shortness of breath or facial or throat swelling.  The patient recovered from the events.
Age: 22.0
Sex: F
Vaccine: RAB
Symptoms: Myalgia
Clinical narrative: SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT.  Initial report received from a patient's parent, who is also a health care professional, on 23 May 2008.  A 22-year-old female patient with a medical history of kidney stones, had received an intramuscular injection of IMOVAX RABIES, lot number A0484-2, as part of a pre-exposure series.  Two hours later, the patient experienced chills and muscle aches.  24 hours after vaccination, the patient developed behavioral changes described as "crying, angry, anxious".  She also had difficulty swallowing for 48 hours.  The patient was treated with MOTRIN and XANAX and the events resolved within 48 hours.  The patient had no complaints of shortness of breath or facial or throat swelling.  The patient recovered from the events.
Age: 61.0
Sex: M
Vaccine: RAB
Symptoms: Arthralgia, C-reactive protein normal, Full blood count normal, Lymphadenopathy, Malaise
Clinical narrative: Initial report received on 21 May 2008 from a physician.  A 61-year-old male patient who is a traveling lawyer, and who has a history of coronary artery disease, and no known allergies, had received prophylaxis post-exposure rabies vaccine consisting of a dose of "RIG" (trade name, manufacturer name, lot number, route and site of administration "unknown") on an unknown date, and five doses of IMOVAX RABIES vaccine on unknown dates.  Approximately four weeks prior to 21 May 2008, the patient received the fifth and last dose of IMOVAX RABIES vaccine (Lot number A0259-2 (route and site of administration not reported).  Approximately three to five days post-vaccination with the fifth dose of IMOVAX RABIES vaccine, the patient complained of persistent malaise, joint pain, myalgias, and muscle discomfort.  Lymphadenopathy was described, but it is not clear if this was localized or generalized lymphadenopathy.  Diagnostic laboratory data revealed a Complete Blood Count, C-Reactive Protein, and Sed Rate tests that were within normal limits.  The patient was placed on low dose steroids for an unknown period of time to help control symptoms.  At present the reporter, who is also the treating physician, plans to recommend symptomatic prescriptions with NSAIDS and if symptoms persist, he will contact the rabies branch at the Centers for Disease Control and Prevention.  At the time of this report, the patient had not recovered.  A corrective version was created on 03 June 2008, using the receipt date from the previous version, in order to amend the coding of RIG in the product screen.  No medically significant new information was added to the case.