chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Borrelia burgdorferi serology negative, Cerebellar ataxia, Fatigue, Foreign travel, Headache
Clinical narrative: Information has been received from a physician concerning a 13 year old female who on 20-JUN-2008 was vaccinated with GARDASIL.  Approximately two weeks after vaccination with GARDASIL, the patient travelled to another country.  Approximately two weeks prior to travelling to another country, the patient had attended a picnic in a wooded area and one of the other people at the picnic had developed a skin lesion and was commenced on antibiotic treatment for Lyme disease.  Subsequently, on 25-JUN-2008 the patient experienced headache, ataxia, dysarthria, malaise, mental impairment and somnolence and on 05-JUL-2008 she was hospitalised.  The report description was as follows: "Five days of intermittent headache, 5 days of malaise, 2 days of dysarthria and ataxia, drowsiness, slow mentation.  Never febrile, no rash, purely cerebellar signs, no bulbar signs, speech is dysarthric and very slow with poverty of words.  There is no dysphasia".  The patient had no significant medical history.  Laboratory tests results were as follows (dates of tests and units not specified): C-Reactive protein - <3; white blood cells and differential were normal; creatinine and liver function tests were all normal; haemoglobin - 128; platelets - 223.  On 05-JUL-2008 a magnetic resonance imaging scan showed features corresponding most closely with cerebellitis (cerebellar encephalitis).  No associated cerebral encephalitis.  Mass effect protruding inferior cerebellar tonsillar ectopia.  No hydrocephalus.  On 07-JUL-2008 an MRI showed acute cerebellitis.  The differential diagnosis is quite wide and includes lead and cyanide toxicity, demyelination, vasculitis, childhood viral illnesses and a manifestion of acute disseminated encephalomyelitis.  The patient was discussed with a paediatric neurologist.  Treatment was as follows:  "She was commenced on acyclovir, dexamethasone 4mg every six hours since 05-JUL-2008 and added on 07-JUL-2008 were ceftriaxone 2g twice daily (for Lyme disease) and ampicillin 2g every four hours (for Listeria, seems unlikely epidemiologically).  Arithromycin was recommended but not started today after a minor improvement with the current antibiotics."  Comment from the patient's treating doctor.  "We have found several case reports of cerebellitis associated with Lyme neuroborelliosis, but all had subacute presentations.  A variety of serologies for viral infections and Lyme disease have been sent.  LP is precluded by the evidence of tonsillar herniation".  At the time of reporting to the agency on 14-JUL-2008, the patient had not yet recovered from headache, ataxia, dysarthria, malaise, mental impairment and somnolence.  The reporter considered that headache, ataxia, dysarthria, malaise, mental impairment and somnolence were possibly related to vaccination with GARDASIL.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Malaise, Serology abnormal
Clinical narrative: Information has been received from a physician concerning a 13 year old female who on 20-JUN-2008 was vaccinated with GARDASIL.  Approximately two weeks after vaccination with GARDASIL, the patient travelled to another country.  Approximately two weeks prior to travelling to another country, the patient had attended a picnic in a wooded area and one of the other people at the picnic had developed a skin lesion and was commenced on antibiotic treatment for Lyme disease.  Subsequently, on 25-JUN-2008 the patient experienced headache, ataxia, dysarthria, malaise, mental impairment and somnolence and on 05-JUL-2008 she was hospitalised.  The report description was as follows: "Five days of intermittent headache, 5 days of malaise, 2 days of dysarthria and ataxia, drowsiness, slow mentation.  Never febrile, no rash, purely cerebellar signs, no bulbar signs, speech is dysarthric and very slow with poverty of words.  There is no dysphasia".  The patient had no significant medical history.  Laboratory tests results were as follows (dates of tests and units not specified): C-Reactive protein - <3; white blood cells and differential were normal; creatinine and liver function tests were all normal; haemoglobin - 128; platelets - 223.  On 05-JUL-2008 a magnetic resonance imaging scan showed features corresponding most closely with cerebellitis (cerebellar encephalitis).  No associated cerebral encephalitis.  Mass effect protruding inferior cerebellar tonsillar ectopia.  No hydrocephalus.  On 07-JUL-2008 an MRI showed acute cerebellitis.  The differential diagnosis is quite wide and includes lead and cyanide toxicity, demyelination, vasculitis, childhood viral illnesses and a manifestion of acute disseminated encephalomyelitis.  The patient was discussed with a paediatric neurologist.  Treatment was as follows:  "She was commenced on acyclovir, dexamethasone 4mg every six hours since 05-JUL-2008 and added on 07-JUL-2008 were ceftriaxone 2g twice daily (for Lyme disease) and ampicillin 2g every four hours (for Listeria, seems unlikely epidemiologically).  Arithromycin was recommended but not started today after a minor improvement with the current antibiotics."  Comment from the patient's treating doctor.  "We have found several case reports of cerebellitis associated with Lyme neuroborelliosis, but all had subacute presentations.  A variety of serologies for viral infections and Lyme disease have been sent.  LP is precluded by the evidence of tonsillar herniation".  At the time of reporting to the agency on 14-JUL-2008, the patient had not yet recovered from headache, ataxia, dysarthria, malaise, mental impairment and somnolence.  The reporter considered that headache, ataxia, dysarthria, malaise, mental impairment and somnolence were possibly related to vaccination with GARDASIL.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Cognitive disorder, Headache, Neurogenic bladder, Optic neuritis, Urine analysis
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with a dose of GARDASIL. Concomitant vaccinations included MENACTRA and DTaP (unspecified). But it was unknown at the time of report if the other vaccinations were administered at the same time. On an unspecified date, the patient developed multiple sclerosis (MS). Upon internal review, multiple sclerosis was determined to be an other important medical event. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Urodynamics measurement, Visual evoked potentials
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with a dose of GARDASIL. Concomitant vaccinations included MENACTRA and DTaP (unspecified). But it was unknown at the time of report if the other vaccinations were administered at the same time. On an unspecified date, the patient developed multiple sclerosis (MS). Upon internal review, multiple sclerosis was determined to be an other important medical event. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Multiple sclerosis
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with a dose of GARDASIL. Concomitant vaccinations included MENACTRA and DTaP (unspecified). But it was unknown at the time of report if the other vaccinations were administered at the same time. On an unspecified date, the patient developed multiple sclerosis (MS). Upon internal review, multiple sclerosis was determined to be an other important medical event. Additional information has been requested.
Age: 1.1
Sex: M
Vaccine: MMR
Symptoms: Autism
Clinical narrative: Information has been received from a health professional concerning a 36 month old male patient who on 12-JAN-2006 was vaccinated with MMR II (Lot# 648479/0635P) at a local health unit. Subsequently the patient developed autism. The patient has not recovered from autism. No product quality complaint was involved. Upon internal review, autism was considered to be an other important medical event. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a female who received the three doses of GARDASIL.  Recently in July 2008, the patient had soft tissue pain and swelling over the injection site which has persisted since the third injection.  The patient complained of pain when raising her arm.  The patient was referred to physical therapy.  Soft tissue pain and swelling over the injection site and pain when raising her arm, were considered to be disabling.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Haemorrhage
Clinical narrative: Information has been received for the pregnancy registry for GARDASIL from a nurse practitioner concerning a 15 year old female patient who on 06-JUN-2008 was vaccinated with the first dose of GARDASIL IM.  The day after receiving the first dose of GARDASIL, the patient found out she was pregnant (gestation or last menstrual period of "1 month").  On 11-JUN-2008 the patient started bleeding and went to the emergency room on 17-JUN-2008, where it was determined she had a miscarriage.  Upon internal review, miscarriage was considered to be other important medical event.  Additional information has been requested.
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Immediate post-injection reaction, Myelitis transverse, Paralysis
Clinical narrative: Information has been received from a physician concerning a female between 9 and 18 years of age who on approximately 24-JUL-2008 was vaccinated with a dose of GARDASIL.  The patient developed paralysis immediately after the vaccination.  She was taken to a hospital and diagnosed with transverse myelitis.  She is still in the hospital.  The patient's outcome was unknown.  Transverse myelitis was considered disabling.  No further information is available.
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Myelitis transverse
Clinical narrative: Information has been received from a physician concerning a female between 9 and 18 years of age who on approximately 24-JUL-2008 was vaccinated with a dose of GARDASIL.  The patient developed paralysis immediately after the vaccination.  She was taken to a hospital and diagnosed with transverse myelitis.  She is still in the hospital.  The patient's outcome was unknown.  Transverse myelitis was considered disabling.  No further information is available.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a physician concerning a 23 year old female with seizure disorder who on approximately 25-JUL-2008 was vaccinated intramuscularly with the first dose of GARDASIL.  After vaccination on approximately 25-JUL-2008 the patient experienced a seizure.  Medical attention was sought via calling ambulance.  Subsequently, the patient recovered from seizure.  No product quality complaint was involved.  Upon internal review, seizure was determined to be an other important medical event.  Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTP, IPV, MMR, VARCEL
Symptoms: Abdominal pain upper, Blood pressure decreased, Cold sweat, Swelling face, Urticaria
Clinical narrative: 5 mins after after complained of stomach ache - had BM. 10 min after, cold, clammy, BP decreased to 70/40. Broke out in hives all over body. Face got puffy. Epi Pen Tx R. Provider had admitted to hospital ICU; Discharged 7/22/08.  9/12/08 Reviewed hospital medical records of 7/21-7/22/2008. FINAL DX: none provided.  H&P : Type I hypersensitivity reaction possibly to vaccines; anaaphylaxis. Records reveal patient experienced stomach ache, itching, redness, facial flushing & swelling, hives, cold clammy extremities.  No reaction to prior vaccinations.  Referred for Allergy consult.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Apnoea, Depressed level of consciousness, Pallor, Somnolence
Clinical narrative: - Baby pale, quiet difficult to arouse apneic - all within 30 minutes of vaccine - was hospitalized overnight - sent home on apnea monitor  8/22/08 Reviewed hospital medical records for 7/28-7/31/08 admission. FINAL DX: immunization reactin Records reveal patient experienced good health on day of vaccination.  Immediately after vaccination cried but was consolable.  Within about 20 minutes had shallow respirations, pale & unresponsive.  Returned to office & noted to have decreased activity but returned to baseline quickly.  D/C to home.  Episode repeated & was admitted for observation & management.  Cardiac monitor revealed bradycardia & was irritable.  Oxygen sats 95-100%.  Remained stable & d/c to home w/continued w/u as outpatient.
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Pyrexia, Screaming
Clinical narrative: Mother reports, at 6 month visit, that several hrs after the 4-month shots, baby was screaming inconsolably for 6 hrs and had fever for 3-4 days.  Fully recovered now.
Age: 33.0
Sex: F
Vaccine: RUB
Symptoms: Rash maculo-papular
Clinical narrative: Maculo-papular rash face, thorax, upper extrem.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Injection site erythema, Injection site induration, Injection site warmth, Vomiting
Clinical narrative: Pt. received VARIVAX on 7/25/08.  On 7/26 injection site red, hard & warm.  On 7/27 went to ER due to vomiting x1 & development of blisters, tx'd with clindamycin.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Pruritus, Rash macular
Clinical narrative: 7/26/08 - raised red pruritic papule, dime size, at injection site; 7/27/08 - Flat red mark left cheek (Non-pruritic); 7/27/08 - Flat red mark right cheek (Non-pruritic); Flat red oblong mark 4" length, abdomen - pruritic; All faded gradually by 8/2/08. No treatment needed.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Myalgia
Clinical narrative: C/O myalgias in joint.  W/U by rheum/neuro.  ANA-Neg, Lyme-Neg, B12-Normal, Sed rate-26.  9/23/08 Reviewed PCP medical records of 2/25-7/17/2008. FINAL DX: lymphadenopathy; allergic urticaria; acute sinusitis; allergic rhinitis Records reveal patient experienced tender lump on throat, sore throat & difficulty swallowing, frequent HA x 1 week on the day of vaccination.  Exam revealed swollen turbinates, shotty tender cervical lymph nodes.  RTC 6/14 w/itchy rash all over x 2 days.  Had started Topamax 2 wks prior & was on accutane as well.  Tx w/steroids.  RTC 7/9 w/dysuria, hematuria & lower back pain x 4 days.  Tx w/antibiotics.  RTC 7/17 w/allergy s/s, sinus congestion.  Reported having myalgias & athralgias s/p 1st HPV injection 2/21/08.  Tx w/antibiotics & received Menactra that day.  10/3/08 Reviewed neuro medical records of 6/5-8/5/2008. FINAL DX: none provided Records reveal patient experienced multi neuro symptoms: sleep disturbance since childhood, mild sleep apnea, excessive fatigue x 1 year, chronic nausea, HA, tremor, joint & muscle pain, feeling out of it, depression, anxiety & mood disturbance.  Stated contraception 1 year prior.  Referred for MRI, EEG & labs.  Responded to tx w/meds.
Age: 42.0
Sex: F
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: None known - nurse advised pt. to be aware of rash, joint pain, fever, etc.  Contact MD if any s/s are worrisome.
Age: 1.4
Sex: F
Vaccine: DTAPHEPBIP, MMR, VARCEL
Symptoms: Febrile convulsion, Pyrexia, Reaction to previous exposure to any vaccine
Clinical narrative: Parent does not feel reaction was related to vaccine. Every time patient has fever, she gets seizures, with or without vaccine. Patient had fever/seizure evening after vaccine. Parent stated this has happened after previous vaccines also.
Age: 19.0
Sex: M
Vaccine: MNQ
Symptoms: Asthenia, Injection site erythema, Pain, Pyrexia
Clinical narrative: Severe weakness, body ache, fever, and redness at injection site. Adverse event per doctor.
Age: 3.0
Sex: M
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMRV, PNC
Symptoms: Fatigue, Feeling hot, Rash generalised
Clinical narrative: Patient's mom referred patient started with rash on the evening of 07/29/08.  The rash is present on the neck, face and buttocks area.  Patient was feeling tired and mom referred he felt warm like having a fever (she did not measure his temperature).
Age: 1.0
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 2.5 cm x 2.5 cm indurated, red area (L) thigh site of 7/22/08 VARIVAX.
Age: 17.0
Sex: F
Vaccine: HEP, HEPA, HPV4, MNQ, TDAP
Symptoms: Blood pressure, Confusional state, Fatigue, Feeling abnormal, Heart rate normal
Clinical narrative: P-60 B/P-120/64  Patient slumped down while in sitting position and I laid her down on exam table.  Her eyes were closed and she began to tremor and all extremities became rigid.  This lasted about 5 seconds then she relaxed & opened her eyes and asked what happened.  She was confused she said & felt tired & not normal.
Age: 17.0
Sex: F
Vaccine: HEP, HEPA, HPV4, MNQ, TDAP
Symptoms: Hypotonia, Muscle rigidity, Tremor
Clinical narrative: P-60 B/P-120/64  Patient slumped down while in sitting position and I laid her down on exam table.  Her eyes were closed and she began to tremor and all extremities became rigid.  This lasted about 5 seconds then she relaxed & opened her eyes and asked what happened.  She was confused she said & felt tired & not normal.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Erythema - up to 4cm from the site of injection persisting up to 2 days after injection.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site induration, Pain
Clinical narrative: R deltoid red indurated, c/o pain.
Age: 5.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Incorrect route of drug administration
Clinical narrative: Pediatric Hepatitis B was administered. Subcutaneously instead of I.M.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Oedema peripheral, Skin warm, Tenderness
Clinical narrative: Swelling, tenderness, warm over L thigh 6 hrs after vaccine administration.
Age: 11.0
Sex: F
Vaccine: MEN, TDAP, VARCEL
Symptoms: Dizziness, Hypersomnia, Pain, Pyrexia
Clinical narrative: The doctor convinsed my daughter to take 3 shots (Tdap, MCV4 and Varicella - chickenpox) in same time.  After 5 hours of vaccine, she started fever 99.8 F at 5:00 pm on 7/23, 101.6 F at 7:54 am, 10:02 am 102 F, 100.5 F, 99.2 F at 5:00 pm.  I gave her pain relief (Acetaminophen).  She slept 2 days, pain and dizzy.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Neuralgia
Clinical narrative: I'm in good health with no underlying problems other than osteoarthritis. Developed case of shingles. None of the typical symptoms that usually precede this disease. Only very severe sciatic pain the day before-Had 19 blistes-Took VALTREX=effective blisters lasted 7-10 days
Age: 10.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: 11 cm x 9.75 cm area of erythema/edema (R) deltoid.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Loss of consciousness, Paraesthesia
Clinical narrative: Pt. passed out in office less than 5 minutes after vaccination. Approximately 1 month later started having paresthesia to left groin and right LE, which has not resolved.  8/15/08 Reviewed PCP medical records of 3/08-8//2008. FINAL DX: scabies; paresthesia left groin & right leg. Records reveal patient experienced fatigue since 10/2007 when began Depo for contraception, left scapula prominence & possible leg length discrepancy, mild clinical depression on 3/3/2008.  Referred to ortho & GYN.  Next office note is for 8/1/2008 for red bumpy rash all over body x 2 mo w/numbness of both legs starting 1 mo after HPV.  Stopped contraception after numbness started with no improvement.  Exam revealed red papules w/scabbing between fingers & toes, abdomen & lower arms; decreased sensation to left groin.  Referred to neuro.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Asthenia, Hyperhidrosis, Pallor, Visual disturbance
Clinical narrative: Client became pale, diaphoretic, and weak. Client states she was seeing "purple spots". Client was moved to supine position with feet elevated. Vital signs were monitored every 3-5 minutes. Symptoms resolved in 10 minutes from onset.
Age: 21.0
Sex: U
Vaccine: HEPA, MNQ, TDAP, TYP
Symptoms: Abdominal pain, Diarrhoea, Enteritis, Nausea, Vomiting
Clinical narrative: Symptoms: Diarrhea, Nausea w/ vomiting, abdominal Pain.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Blood pressure normal, Dyspnoea, Hypoaesthesia, Paraesthesia, Reaction to previous exposure to any vaccine
Clinical narrative: Received Hepatitis A, Menactra, Varivax, and Gardasil. Received Hepatitis A, Menactra, and Varivax first, and was fine.  The nurse went to get a different needle for the Gardasil vaccine and was gone for 3-4 minutes. She returned and gave the shot. Within a few seconds, patient complained that her throat felt "like someone had [her] in a headlock". She also complained of pins and needles sensation on her face. She had short, quick breaths but did not initially have shaking or numbness of the hands.  We had her lay down and put some ice behind her neck. We also had her blow into a paper bag. She still complained of the pins and needles sensation on her face. We also gave her some Gatorade. 10 minutes later she felt better but was then having shakineess and numbness of extremities. No headache, no vision changes, no syncope. Blood pressure was fine. 20 minutes later the pins and needles sensation was gone, she felt better, and went home. This same patient did have a reaction to a pertussis vaccine (Tetramune) in October 1994, but otherwise has not reacted to vaccines and has had all of them.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Throat tightness, Tremor
Clinical narrative: Received Hepatitis A, Menactra, Varivax, and Gardasil. Received Hepatitis A, Menactra, and Varivax first, and was fine.  The nurse went to get a different needle for the Gardasil vaccine and was gone for 3-4 minutes. She returned and gave the shot. Within a few seconds, patient complained that her throat felt "like someone had [her] in a headlock". She also complained of pins and needles sensation on her face. She had short, quick breaths but did not initially have shaking or numbness of the hands.  We had her lay down and put some ice behind her neck. We also had her blow into a paper bag. She still complained of the pins and needles sensation on her face. We also gave her some Gatorade. 10 minutes later she felt better but was then having shakineess and numbness of extremities. No headache, no vision changes, no syncope. Blood pressure was fine. 20 minutes later the pins and needles sensation was gone, she felt better, and went home. This same patient did have a reaction to a pertussis vaccine (Tetramune) in October 1994, but otherwise has not reacted to vaccines and has had all of them.
Age: 1.0
Sex: F
Vaccine: HEPA, PNC, VARCEL
Symptoms: Body temperature increased
Clinical narrative: Temp. 105,No other Sympyoms
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Abdominal X-ray, Crying, X-ray normal
Clinical narrative: On 8/6/09, the patient had inconsolable crying for about 5 to 6 hours after vaccination.  She required evaluation in the emergency room.  SHe had an abdominal X ray and fluoresin place din her eyes to rule out a corneal abrasion.  Her evaluation was normal except for crying.  She was given Valium and discharged home. The next day she followed up with her primary care pediatrician in the office.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: IMMUNIZATION GIVEN IN LEFT ARM(08-05-2008)REACTION NOTED WEDNESDAY. PT SEEN IN OFFICE THURSDAY AM NOTED 6 X 6 CM RED SWOLLEN AREA AT IMMUNIZTION SITE. WARM TO TOUCH NO RX GIVEN. ADVISED TO MONITOR AND USE COOL COMPRESSES.
Age: 69.0
Sex: F
Vaccine: DTAP
Symptoms: Blood pressure, Body temperature, Heart rate normal, Injection site erythema, Injection site swelling
Clinical narrative: Pt called 6 days s/p injection ADACEL-Tdap c/o red raised area at injection site starting 3d after injection going from quarter to "fist" size in diameter. No relief with topical benedryl/cool compress. Brought into office that day. 8x15cm warm erythemetous plaque, slightly raised with irregular shape noted on left upper arm. Physician called into room. Vital signs stable. Pt advised to take oral Benedryl,topical hydrocortisone, monitor temp, flup in 2 days for re-evaluation.
Age: 69.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site warmth
Clinical narrative: Pt called 6 days s/p injection ADACEL-Tdap c/o red raised area at injection site starting 3d after injection going from quarter to "fist" size in diameter. No relief with topical benedryl/cool compress. Brought into office that day. 8x15cm warm erythemetous plaque, slightly raised with irregular shape noted on left upper arm. Physician called into room. Vital signs stable. Pt advised to take oral Benedryl,topical hydrocortisone, monitor temp, flup in 2 days for re-evaluation.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Malaise, Pain, Pyrexia
Clinical narrative: malaise, pain, slight fever; reaction much worse than experienced with gardasil doses 1 & 2. think it may be due to menactra vaccine given on same day; treatment rest, ibuprofen
Age: 14.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Asthenia, Dizziness, Nausea
Clinical narrative: Approximately 5-10 minutes after injections given, she felt faint, weak and nauseated.  She did not faint, and recovered fully after approximately 10 minutes sitting in a chair and sipping water.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Convulsion, Cyanosis, Loss of consciousness, Pallor, Syncope
Clinical narrative: Client experienced an episode of syncope approximately 30 minutes post vaccination in car on the way home. Mother pulled off the road and called 911. Mother states the child turned pale and lips were blue.  States child had loss of conscienousness for 10 seconds and experienced a small seizure lasting 10 seconds.  Child was assessed by EMT and found to be OK; not taken to ER.  I spoke with mother 08/07/2008; client doing well.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site rash
Clinical narrative: Patient developed a rash on upper arm of the arm that was injected.  Dr said it resembled a slight case of shingles.  No major problems reported.
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: No reaction on previous exposure to drug, Pruritus, Rash
Clinical narrative: Patient states she began itching after shot on 8/6/08 while walking to car, later at home full rash developed with severe itching, she took Benadryl and it resolved.  Upon exam, fine rash was noted today 8/7/08 on bilateral arms and a few spots on back.  STATES SHE RECEIVED 2 PREVIOUS INJECTIONS AT ANOTHER EMPLOYER WITH NO REACTION.
Age: 26.0
Sex: F
Vaccine: TYP
Symptoms: Asthenia, Diarrhoea, Headache, Nausea
Clinical narrative: Nausea/diarrhea/headache/weakness
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Abnormal behaviour, Constipation, Crying, Diarrhoea, Grunting
Clinical narrative: Our daughter received her third dose of Rotateq yesterday and has been visibly different behaviorally. She has been showing signs of being constipated, grunting and crying before any gas. This happened before with the 2nd vaccine dose 2 months ago and back then, she was obstipated and I had to manually disimpact her to release copious amounts of watery diarrhea.  She had obstipation first at about 2 months of age so when it happened after the 2nd dose, we thought it might be related to the vaccine but were willing to attribute it possibly chance. Now it has happened again, within 24 hrs of the vaccine, it seems most likely related to the vaccine, given the track record of the previous rotavirus vaccine Rotashield (even though there has been no data yet linking this current generation of vaccines to intussuception).
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Vaccine positive rechallenge
Clinical narrative: Our daughter received her third dose of Rotateq yesterday and has been visibly different behaviorally. She has been showing signs of being constipated, grunting and crying before any gas. This happened before with the 2nd vaccine dose 2 months ago and back then, she was obstipated and I had to manually disimpact her to release copious amounts of watery diarrhea.  She had obstipation first at about 2 months of age so when it happened after the 2nd dose, we thought it might be related to the vaccine but were willing to attribute it possibly chance. Now it has happened again, within 24 hrs of the vaccine, it seems most likely related to the vaccine, given the track record of the previous rotavirus vaccine Rotashield (even though there has been no data yet linking this current generation of vaccines to intussuception).
Age: 15.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site irritation, Injection site swelling
Clinical narrative: Redness, swoolen and burning sensation at injection site
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Anaphylactic reaction, Immediate post-injection reaction, Injection site haemorrhage, Post procedural haemorrhage, Pyrexia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of bleeding from colostomy in a 4-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline). The subject has a history of Downs Syndrome, pulmonary stenosis, imperforated anus with malrotation of intestine (subject has surgery scheduled for 26 August 2008 to correct this issue) and a colostomy placed at birth. The subject has no history of adverse events following previous vaccinations. Concurrent vaccination included ACTHIB (Sanofi Pasteur) given in the left thigh and PREVNAR (Wyeth) given in the left thigh both on 31 July 2008. Concurrent medications included an unknown medication (Progetameal for feeding with a colostomy). On 31 July 2008 at 13:30 the subject received 2nd dose of PEDIARIX at 0.5 ml in the right thigh. On 31 July 2008, immediately after vaccination with PEDIARIX, the subject experienced injection site bleeding, which resolved the same day. The following day, on 01 August 2008, the subject developed a high fever and rash. A systemic reaction. It was also reported that the subject was bleeding from his colostomy. The subject was hospitalised because he is suppose to undergo surgery on 26 August 2008 and they wanted to monitor the subject prior to the surgery. At the time of reporting the outcomes of fever, rash and bleeding from the colostomy were unspecified.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Rash
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of bleeding from colostomy in a 4-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline). The subject has a history of Downs Syndrome, pulmonary stenosis, imperforated anus with malrotation of intestine (subject has surgery scheduled for 26 August 2008 to correct this issue) and a colostomy placed at birth. The subject has no history of adverse events following previous vaccinations. Concurrent vaccination included ACTHIB (Sanofi Pasteur) given in the left thigh and PREVNAR (Wyeth) given in the left thigh both on 31 July 2008. Concurrent medications included an unknown medication (Progetameal for feeding with a colostomy). On 31 July 2008 at 13:30 the subject received 2nd dose of PEDIARIX at 0.5 ml in the right thigh. On 31 July 2008, immediately after vaccination with PEDIARIX, the subject experienced injection site bleeding, which resolved the same day. The following day, on 01 August 2008, the subject developed a high fever and rash. A systemic reaction. It was also reported that the subject was bleeding from his colostomy. The subject was hospitalised because he is suppose to undergo surgery on 26 August 2008 and they wanted to monitor the subject prior to the surgery. At the time of reporting the outcomes of fever, rash and bleeding from the colostomy were unspecified.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: Red area 3 1/2" diameter with 1/4" area of redness in center. Sore and warm to touch.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Pallor, Syncope
Clinical narrative: Immediately after receiving GARDASIL - fainted - went pale - last less than one minute.  Had her elevate feet and rest til no longer faint.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Blood pressure, Dizziness, Headache, Heart rate normal, Malaise
Clinical narrative: Patient complained of "feeling sick" about 15 min after injections c/o HA, nausea and dizziness. Vitals: BP 100/60, P 80 observed. Patient at office for about 30 minutes past injections. Vitals again: BP 100/60, P 88 patient also had similar episodes after GARDASIL 1 & 2 which were not reported to our office.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Nausea, Vaccine positive rechallenge
Clinical narrative: Patient complained of "feeling sick" about 15 min after injections c/o HA, nausea and dizziness. Vitals: BP 100/60, P 80 observed. Patient at office for about 30 minutes past injections. Vitals again: BP 100/60, P 88 patient also had similar episodes after GARDASIL 1 & 2 which were not reported to our office.
Age: 53.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Erythema, Local reaction, Pain, Swelling
Clinical narrative: With redness, pain; Local swelling on both arms. No fever
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Tdap injection admin IM on 8/5/08 at 1300.  Immediately after injection R arm site became reddened & swollen.  Resp event unlabored.  8/7/08 R arm with erythematous 8cm macular rash, swollen, warm to touch, painful at injection site-mod reaction to Tdap.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site warmth, Rash macular
Clinical narrative: Tdap injection admin IM on 8/5/08 at 1300.  Immediately after injection R arm site became reddened & swollen.  Resp event unlabored.  8/7/08 R arm with erythematous 8cm macular rash, swollen, warm to touch, painful at injection site-mod reaction to Tdap.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Cellulitis, Erythema, Induration, Tenderness
Clinical narrative: L arm mild cellulitis - 1" x 1 1/2" marked, tender erythematous, indurated.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Bronchospasm, Chest X-ray, Injection site erythema, Injection site oedema
Clinical narrative: Erythematous edematous (L) upper arm, bronchospasms. Rocephin, Prelone syrup, CXR. F/U in 1 day.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: Immunizations given 3 days ago.  Developed tenderness at injection site with erythema that increased in diameter.  Now with indurated erythematous plaque 3x3 cm at injection site with surrounding non-confluent erythema that is pruritic.
Age: 1.8
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Large area of induration and erythema on right thigh where received DTaP and HEP A 2 days prior.  No systemic symptoms.
Age: 11.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Convulsion, Dizziness, Gaze palsy, Pallor, Urinary incontinence
Clinical narrative: Client received vaccine without incident (no crying or flinching).  Called at 1107 from parking lot for help to call 911 nurse x2 to client: 911 called.  Client had urinated & was a/o x3 very pale.  States felt dizzy.  Mom said she helped her down to ground (no hitting of head), eyes rolled back in head & had a seizure.  Mom states never had before.  Hand grasps weak but equal.  Moving toes equally, tongue out equally able to touch fingers to nose.  Fire arrive.  Information given.  Client transported by ambulance to hospital.  Mom asked by writer to call with outcome.  No slurred speech no diaphoresis.  No breakfast.  1200 8-7-08 P.C. clients HCP states surprised no postictal state.  Will send for neurology consult.
Age: 1.1
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Varicella
Clinical narrative: Developed "modified chicken pox"
Age: 4.0
Sex: U
Vaccine: DTAP, HEPA, IPV, MMR, PNC, VARCEL
Symptoms: Syncope vasovagal
Clinical narrative: Ten minutes after pt. received six vaccines prior to moving abroad pt. had a vasovagal reaction & needed to lie down for 15-20 minutes before recovering.  She had not been crying hysterically at the time; was calmer & ready to leave.  In 31 years of pediatric nursing, I have not seen a child this young nearly faint.
Age: 3.0
Sex: F
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Breath holding, Fall, Head injury, Hypotonia, Screaming
Clinical narrative: 3 year old in 2007 came for a physical 7/30/08 w/o immunization records.  Returned for shot.  Only visit on 8/1/08 and needed 4 shots and PPD.  I administered vaccines and child did not cry or move.  I then gave her a PPD and she held very still.  Smiling afterwards.  10-15 minutes later as paperwork for school was being prepared, patient became limp and fell forward striking her head.  She held her breath for more then a minute, then screamed and recovered.  No sx vasovagal event.  No hx seizures or breath holding events, per parents.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left deltoid had redness, swelling and warm to touch. No fever. No pain. Patient directed to use ice and Benadryl.
Age: 12.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Dyspnoea, Injection site erythema, Injection site induration, Injection site scab
Clinical narrative: Area on L upper arm reddened et indurated with scabbed area noted.  Pt had SOB 2 hours after varicella immunization et went to ER.  Pt put on MEDROL DOSE PACK, loratadine 10mg #30 with l.  Increase fluids.  Go to ER if SOB becomes worse.
Age: 5.0
Sex: F
Vaccine: DTAPHEPBIP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Increased swelling and erythema initially now 24 hr post 48 hr includes deltoid upper shoulder distal to elbow. (L) arm
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: He has had increasing warmth, erythema, and pruritus at all injection sites since yesterday, day of vaccinations.  R thigh - 9.5cm x 12cm area of warmth, erythema, L thigh with 7cm x 4cm area of bright erythema, L deltoid with 3cm x 3cm area erythema.
Age: 10.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: 2 days after injection of VARIVAX arm red and swollen size of tennis ball painful to touch per mom.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Patient was given DTAP vaccine today after having a DTAP 21 days ago.  Patient didn't have any signs or symptoms per mom after vaccine.  Per doctor no treatment required.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness/swelling at injections site about 16-18 hours after vaccine.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Urticaria
Clinical narrative: Hives on torso, arms, legs about 3 hours after injection
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Depressed level of consciousness, Dizziness, Feeling hot, Hyperhidrosis, Tremor
Clinical narrative: When I walked everything started to fade slowly, and while my mom was filling out papers I got really dizzy and my hands were shaking.  And when I sat down I started feeling hot and I started to sweat.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Vaginal haemorrhage
Clinical narrative: Pt reports that she had heavy vaginal bleeding for 3 days. The bleeding began about 2 hrs after receiving HPV vaccine.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Anaemia, Barium double contrast, Decreased appetite, Haematochezia, Haemoglobin decreased
Clinical narrative: Information has been received on request from the FDA under an Act regarding a 2 month old female with a history of umbilical hernia who on 07-NOV-2007 was vaccinated orally with her first dose of ROTATEQ (Lot # reported as 657659/0969U).  Suspect therapy given IM in the right leg included a first dose of PEDVAXHIB (OMPC) (MSD) (Lot # reported as 656517/0257U).  Concomitant therapy included a first dose of IM PEDIARIX (Lot # AC21B125CB) in the left leg and a first dose of IM PREVNAR (Lot # B08700K) in the right leg.  Subsequently, on 04-DEC-2007 the patient experienced anaemia, decreased appetite, hematochezia, intussusception, rectal haemorrhage, somnolence, vomiting and vomiting projectile.  The patient was hospitalized.  There was a documented case of intussusception 4 weeks after the dose of ROTATEQ.  Records received on 10-JAN-2008 for dates of service from 04-DEC-2007 to 07-DEC-2007 noted that an air contrast enema confirmed intussusception.  The intussusception was in the region of hepatic flexure of the colon.  The patient's hemoglobin was 8.8.  UGI None.  At the time of the report the patient had successful pneumatic reduction of ileocolic intussusception.  The outcome of the anaemia, decreased appetite, rectal haemorrhage, and somnolence was not reported.  Discharge diagnosis: Intussusception.  Hematochezia, resolved.  Vomiting resolved.  Physiologic anemia in infancy.  C/O bright red blood from rectum, emesis, vomiting projectile in nature.  Decreased appetite and increased sleep.  The original reporting source was not provided.  The VAERS ID # is 299129.  A Lot check has been requested for ROTATEQ (lot # 657659/0969U) and PEDVAXHIB (OMPC) (MSD) ((lot # 56517/0257U).  All in-process quality checks for the lot numbers in question were satisfactory.  In addition, expanded lot check investigations were performed.  The testing performed on the batches prior to release met all release specifications.  The lots met the requirements of the center and were released.  No further information is available.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Intussusception, Rectal haemorrhage, Somnolence, Vomiting, Vomiting projectile
Clinical narrative: Information has been received on request from the FDA under an Act regarding a 2 month old female with a history of umbilical hernia who on 07-NOV-2007 was vaccinated orally with her first dose of ROTATEQ (Lot # reported as 657659/0969U).  Suspect therapy given IM in the right leg included a first dose of PEDVAXHIB (OMPC) (MSD) (Lot # reported as 656517/0257U).  Concomitant therapy included a first dose of IM PEDIARIX (Lot # AC21B125CB) in the left leg and a first dose of IM PREVNAR (Lot # B08700K) in the right leg.  Subsequently, on 04-DEC-2007 the patient experienced anaemia, decreased appetite, hematochezia, intussusception, rectal haemorrhage, somnolence, vomiting and vomiting projectile.  The patient was hospitalized.  There was a documented case of intussusception 4 weeks after the dose of ROTATEQ.  Records received on 10-JAN-2008 for dates of service from 04-DEC-2007 to 07-DEC-2007 noted that an air contrast enema confirmed intussusception.  The intussusception was in the region of hepatic flexure of the colon.  The patient's hemoglobin was 8.8.  UGI None.  At the time of the report the patient had successful pneumatic reduction of ileocolic intussusception.  The outcome of the anaemia, decreased appetite, rectal haemorrhage, and somnolence was not reported.  Discharge diagnosis: Intussusception.  Hematochezia, resolved.  Vomiting resolved.  Physiologic anemia in infancy.  C/O bright red blood from rectum, emesis, vomiting projectile in nature.  Decreased appetite and increased sleep.  The original reporting source was not provided.  The VAERS ID # is 299129.  A Lot check has been requested for ROTATEQ (lot # 657659/0969U) and PEDVAXHIB (OMPC) (MSD) ((lot # 56517/0257U).  All in-process quality checks for the lot numbers in question were satisfactory.  In addition, expanded lot check investigations were performed.  The testing performed on the batches prior to release met all release specifications.  The lots met the requirements of the center and were released.  No further information is available.
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Enema administration, Haematochezia, Intussusception, Irritability, Lethargy
Clinical narrative: Information has been received on request from the FDA under the Freedom of Information Act regarding a 3 month old female who on 18-OCT-2007 was vaccinated orally with her second dose of ROTATEQ (Lot # reported as 657045/1053U). Suspect therapy given IM In the right leg included a second dose of HIB conj vaccine (Lot # reported as 654680/0072U). Concomitant therapy included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (Sanofi Pasteur Lot # C2489AA), pneumococcal vaccine (unspecified) (Wyeth Lot #B08657F) and poliovirus vaccine (Sanofi Pasteur Lot # 202402). On 15-NOV-2007 the patient  experienced enema administration, haematochezia, intussusception, irritability, lethargy, oral intake reduced, ultrasound abdomen abnormal and vomiting and was hospitalized. Intussusception required reduction. Repeat intussusception needing second procedure. 21-DEC-2007 Reviewed vax record which confirms dose and lot #'s as reported. 28-DEC-2007 Reviewed hospital medical records which revealed patient experienced vomiting, bloody stool, reduced oral intake, irritability and lethargy. Admitted 16/17-NOV-2007. Enema successfully reduced IS. Admitted for overnight observation. Did well and was d/c to home. Readmitted 19/20-NOV-2007 for recurrence of vomiting and bloody stools. 2nd abdominal US (+)  for IS and was successfully reduced w/air contrast enema. Kept overnight for observation. Did well and d/c to home. FINAL DX: Recurrent ileocecal intussusception at hepatic flexure, enema reduced X2. Radiological LABS: KUB dilated loops of small bowel. Abdominal US (+) for IS X 2. Air enema reduction X 2. Enema administration, haematochezia, intussusception, irritability, lethargy, oral intake reduced, ultrasound abdomen abnormal and vomiting were considered to be immediately life-threatening. The original reporting source was not provided. The VAERS ID # is 300448. Lot check has been requested. Standard lot check investigations were performed. All in-process quality checks for the lot numbers in question were satisfactory. In addition, expanded lot check investigations were performed. The testing performed on the batches prior to release met all release specifications. The lots met the requirements and were released. No further information is available.