chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, RV5
Symptoms: Mucous stools, Surgery, Vomiting
Clinical narrative: Information has been received from a nurse practitioner concerning a 25 week old male who on 01-MAY-2008 was vaccinated PO with a dose of ROTATEQ (lot# 657670/1108U). Suspect vaccination administered that same day included a dose of PEDVAXHIB. Concomitant vaccinations administered that same day included a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid and a dose of poliovirus vaccine inactivated (unspecified). On 07-MAY-2008 the patient developed vomiting and rectal bleeding. The patient was hospitalized on 08-MAY-2008 due to an intussusception that was also surgically corrected on that same day. Therapy with ROTATEQ was discontinued. The patient was noted to be recovering. There was no product quality complaint. No other information was available. Intussusception was also considered to be immediately life-threatening and an other important medical event (surgery) by the reporter. A lot check has been initiated. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, RV5
Symptoms: Intussusception, Rectal haemorrhage, Surgery, Vomiting
Clinical narrative: Information has been received from a nurse practitioner concerning a 25 week old male who on 01-MAY-2008 was vaccinated PO with a dose of ROTATEQ (lot# 657670/1108U). Suspect vaccination administered that same day included a dose of PEDVAXHIB. Concomitant vaccinations administered that same day included a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid and a dose of poliovirus vaccine inactivated (unspecified). On 07-MAY-2008 the patient developed vomiting and rectal bleeding. The patient was hospitalized on 08-MAY-2008 due to an intussusception that was also surgically corrected on that same day. Therapy with ROTATEQ was discontinued. The patient was noted to be recovering. There was no product quality complaint. No other information was available. Intussusception was also considered to be immediately life-threatening and an other important medical event (surgery) by the reporter. A lot check has been initiated. Additional information has been requested.
Age: 1.3
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: CSF test normal, Febrile convulsion, Lumbar puncture normal
Clinical narrative: Simple febrile seizure  6/13/08 Reviewed ER medical records of 6/1/2008. FINAL DX: febrile seizure; viral syndrome; dehydration Records reveal patient experienced fever, tiredness, irritability, diarrhea, decreased appetite & decreased urine output, cough, congestion.  Awoke from nap & became stiff, gasping respirations & unresponsive.  Tx w/IVF
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Blood culture negative, Blood lactic acid decreased, C-reactive protein normal, Full blood count normal, Heart rate decreased
Clinical narrative: Patient became limp, pale, decreased hear rate within minutes of vaccinations. Given O2; transferred to ER -> hospitalized overnight for observation  7/11/08 Reviewed hospital medical records of 5/12-5/13/2008. FINAL DX: ALTE  Records reveal patient experienced limpness, decreased responsiveness & pallor immediately s/p vaccinations & lasting approx 5 min.  In ER, fully awake, irritable but w/neg exam.  Admitted for overnight observation.  No further episodes & d/c to home next day.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Hypotonia, Laboratory test normal, Pallor, Urine analysis normal
Clinical narrative: Patient became limp, pale, decreased hear rate within minutes of vaccinations. Given O2; transferred to ER -> hospitalized overnight for observation  7/11/08 Reviewed hospital medical records of 5/12-5/13/2008. FINAL DX: ALTE  Records reveal patient experienced limpness, decreased responsiveness & pallor immediately s/p vaccinations & lasting approx 5 min.  In ER, fully awake, irritable but w/neg exam.  Admitted for overnight observation.  No further episodes & d/c to home next day.
Age: 1.1
Sex: F
Vaccine: DTAP, PNC, VARCEL
Symptoms: Body temperature increased, Inflammation, Muscle twitching, Pharyngitis, Streptococcal identification test negative
Clinical narrative: Pt has had DTaP 3x's as PEDIARIX combo. Temp about 102 with "twitches" of arms and legs at times for about 2 days. S/P PREVNAR, DTaP, VARIVAX vaccines on 5/20/08. Pt seen on 5/22 and had pharyngitis with exudate on tonsils.
Age: 1.0
Sex: M
Vaccine: HEPA, PNC
Symptoms: Erythema, Induration
Clinical narrative: (L) thigh 3x5cm induration, surrounding skin is mild red. Observation and warm compress.
Age: 66.0
Sex: F
Vaccine: MMR
Symptoms: Arthropathy, Hyperhidrosis, Rhinorrhoea
Clinical narrative: Joint problem, nose drips, hot sweats, 96 deg Temp. 10 days weak in bed
Age: 63.0
Sex: M
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Ear pain, Impaired work ability, Local swelling, Lymph node pain
Clinical narrative: On Friday May 9th I received a combination shot of TDAP. Saturday May 10th I woke up with right lymph gland swollen larger than a lemon. Did not hurt for a few days. Then about the third day it swelled even worse. I started to experience a terrible pain that wouldn't let up. Pain that ran all the way under my ear. The whole side of my head swelled, even the back of my neck. I ached all over. I have never had worse pain - ever. Could not open my mouth to eat for several days. Could not work and stayed in bed for most of those days. Today is the 27th May and today is the first time I've been out of the house except to go to the ER. I finally went to the ER on 05-18-08. Dr didn't know for sure the cause but I do. Nothing had changed, nothing out of the ordinary. Nothing new except the shot. Dr put me or LORTAB 5/500 mg and AUGMENTIN 875 mg. Tried to use warm moist heat. 9 days after my visit to the ER, I'm better, but still not completely over it.
Age: 63.0
Sex: M
Vaccine: TDAP
Symptoms: Lymphadenopathy, Oral intake reduced, Oral pain, Pain, Swelling face
Clinical narrative: On Friday May 9th I received a combination shot of TDAP. Saturday May 10th I woke up with right lymph gland swollen larger than a lemon. Did not hurt for a few days. Then about the third day it swelled even worse. I started to experience a terrible pain that wouldn't let up. Pain that ran all the way under my ear. The whole side of my head swelled, even the back of my neck. I ached all over. I have never had worse pain - ever. Could not open my mouth to eat for several days. Could not work and stayed in bed for most of those days. Today is the 27th May and today is the first time I've been out of the house except to go to the ER. I finally went to the ER on 05-18-08. Dr didn't know for sure the cause but I do. Nothing had changed, nothing out of the ordinary. Nothing new except the shot. Dr put me or LORTAB 5/500 mg and AUGMENTIN 875 mg. Tried to use warm moist heat. 9 days after my visit to the ER, I'm better, but still not completely over it.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Abnormal behaviour, Affect lability, Anxiety, Depression, Feeling abnormal
Clinical narrative: Given 1st HPV4 on 11-14-07 about 2 weeks after received vaccine began to have symptoms of depression, increased crabby, feeling of doom, emotional. Went to the doctors in March when symptoms didn't go away. Did not notice any change after the 2nd dose. While getting the 3rd dose told this info to nurse and VAERS was completed
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Irritability
Clinical narrative: Given 1st HPV4 on 11-14-07 about 2 weeks after received vaccine began to have symptoms of depression, increased crabby, feeling of doom, emotional. Went to the doctors in March when symptoms didn't go away. Did not notice any change after the 2nd dose. While getting the 3rd dose told this info to nurse and VAERS was completed
Age: 0.6
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC, RV5
Symptoms: Crying, Erythema, Pyrexia
Clinical narrative: Child had fever of 103deg - non-stop crying; red legs. on 2-14-08. Fever on 2-15-08 was 99deg - no longer crying - slept through night on 2-14-08.
Age: 18.0
Sex: F
Vaccine: HEP, MNQ, TDAP
Symptoms: Chills, Dizziness, Eating disorder, Hyperhidrosis, Immediate post-injection reaction
Clinical narrative: Patient dizzy, diaphoretic, light-headed immediately after vaccination; fever and chills at 11:00 PM on 27th - vomiting x 1 during night, unable to eat until evening on 28th - feeling fine on the 29th.
Age: 18.0
Sex: F
Vaccine: HEP, MNQ, TDAP
Symptoms: Pyrexia, Vomiting
Clinical narrative: Patient dizzy, diaphoretic, light-headed immediately after vaccination; fever and chills at 11:00 PM on 27th - vomiting x 1 during night, unable to eat until evening on 28th - feeling fine on the 29th.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza like illness, Injection site erythema, Injection site pruritus
Clinical narrative: Pt received ZOSTAVAX injection at approx 2 PM on 5/23/08. Pt reports that 1-2 hrs later, she developed headache. She took TYLENOL but said it resolved the next day. She also experienced flu like symptoms - body ache and chills on 5/24 which lasted for approx 24 hrs. Pt experienced a slightly raised area around injection site which was itchy within 1 hour after injection on 5/30. The area was flat, non itchy but still red.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Pain
Clinical narrative: Pt received ZOSTAVAX injection at approx 2 PM on 5/23/08. Pt reports that 1-2 hrs later, she developed headache. She took TYLENOL but said it resolved the next day. She also experienced flu like symptoms - body ache and chills on 5/24 which lasted for approx 24 hrs. Pt experienced a slightly raised area around injection site which was itchy within 1 hour after injection on 5/30. The area was flat, non itchy but still red.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 7.5 x 9 cm redness and induration; surrounding injection site at 72 hours
Age: 1.06
Sex: M
Vaccine: DTAP, HEPA, MMRV, PNC
Symptoms: Convulsion, Ear pain, Pyrexia, Rash generalised
Clinical narrative: 12 hours after the vaccines had fever around 41 degrees and when it went up to 41.7 C had convulsions.  After controlling the fever a rash appeared all over body.  He still is complaining of earaches.
Age: 70.0
Sex: F
Vaccine: HEP
Symptoms: Guillain-Barre syndrome, Miller Fisher syndrome
Clinical narrative: Guillain Barre - Miller-Fisher - hospitalized, treated IVIG. 10/23/08-records received for DOS 5/9/5/15/08-DC DX:Guillain-Barre Syndrome with Miller-Fisher Variant. Developed blurred vision 1 week ago along with numbness and tingling in fingertips. Headache 3 days ago. Recent travel to China and returned this past Wednesday. Difficulty walking. Nonproductive cough.  PE: decreased sensation from midcalf distally and decreased vibration from ankles distally. Treated with IVIG.
Age: 1.1
Sex: F
Vaccine: MMR
Symptoms: Food allergy, Milk allergy, Radioallergosorbent test positive, Urticaria
Clinical narrative: Hives occurred 20 minutes after 1/2 dose (0.25 mL) vaccine given (done due to h/o RAST + for egg).  Child's urticaria worsened for 30 min after given diphenhydramine and prednisone than resolved.  No respiratory symptoms or facial swelling.
Age: 31.0
Sex: F
Vaccine: TTOX
Symptoms: Erythema, Injection site induration, Pain in extremity
Clinical narrative: Donor received shot on 5-14-08. No adverse rxn noted. On 5-16-08 donor states arm was sore after doing a lot of heaving lifting and yard work. On 5-18-08 donor phoned clinic to report to medical staff. Asked donor to come to center. Donor presents at center with 6"x4" red area with 2x2" hard area at injection site.
Sex: F
Vaccine: HEP
Symptoms: Overdose
Clinical narrative: No adverse events reported.  PT. did receive two doses of RECOMBIVAX-HB approximately 3.5 hours apart, 5mcg of preservative-free vaccine IM given to two day old patient.  CDC + poison center consulted.  Recs were to observe for increased injection site reactions only.
Age: 1.5
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and erythema 12 x 7 cm R thigh.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 1 day after vaccines (DTaP/HAV) in L arm, dev. redness/induration.  Came into clinic 5/22/08; induration (small area) + erythema (7.5 x 9cm) L arm - "Better" per mom.  No fever.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC, VARCEL
Symptoms: Rash, Rash maculo-papular
Clinical narrative: On 5/29/08 he developed 100 temp have maculopapular rash at face (behind ears) first spreading and torso, extremities. A few lesions at face and extremities papulo postor ear.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site cellulitis
Clinical narrative: Patient developed cellulitis on left deltoid area after receiving varicella vaccine.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Computerised tomogram normal, Convulsion, Electroencephalogram abnormal
Clinical narrative: Seizure 4/22/08 associated with ongoing EEG abnormalities, not previously recognized.  Vaccine given (varicella 4/18/08).  6/26/08 Reviewed hospital medical records for 4/23/2008. FINAL DX: Seizure disorder vs TIA. Records reveal patient experienced slurred speech, drooling & left sided face & arm weakness.  Symptoms largely resolved by the time reached ER.  Admitted for observation.  Neuro consult done.  No further episodes & d/c to home to continue w/u as outpatient.
Age: 1.2
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Rash
Clinical narrative: Rash.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Faeces discoloured, Stomach discomfort
Clinical narrative: Information has been received from a 64 year old female with hives from sulindac (WAES# 0805USA06072) and horse serum who in approximately March 2008, "about 2 months ago" was vaccinated with ZOSTAVAX. Concomitant therapy included IMDUR, atenolol, LIPITOR, oxybutynin, amitriptyline hydrochloride, furosemide, amlodipine besylate, isosorbide and aspirin. In approximately March 2008, "the day after the shot" the patient experienced a "very debilitating adverse reaction." The patient reported that the ZOSTAVAX gave her diarrhea, white stools and "tore up her stomach." No lab tests were performed. The patient reported that she sought unspecified medical attention. Approximately 4 days after stopping therapy, the patient recovered from the diarrhea, white stools and tore up my stomach. The patient also reported her experience from a pneumonia vaccine (WAES 0805USA06073). Additional information is not expected.
Age: 1.5
Sex: F
Vaccine: HEPA
Symptoms: Autism, Childhood disintegrative disorder, Grunting, Immobile, Paralysis
Clinical narrative: Information has been received from a consumer concerning her 18 month old daughter with no medical history who on 10-OCT-2006 was vaccinated with a first dose of VAQTA.  Concomitant therapy included TYLENOL.  On 12-OCT-2006, 40 hours after vaccination with VAQTA, the subject experienced regression in development, speech deterioration, screaming, and grunting.  On unspecified dates in December of 2006, the subject experienced periods of immobility or paralysis, which occurred on two separate episodes.  On 10-APR-2007, the subject received the 2nd dose of VAQTA (unknown) and experienced five episodes of immobility within the next six months.  The reporter reported that her daughter was diagnosed with mild autism (date of diagnosis unspecified).  It was reported that a physician or other health care professional has not verified this report.  The subject's mother considered the events to be disabling.  The subject's mother stated that she is in the early stages of investigating vaccines that her daughter has received which may contain ingredients the child may be allergic to.  Per the subject's mother, there were no signs of regression until 12-OCT-2006.  At the time of the report, the child has been in therapy for 19 months and her condition has improved, but she remains behind her peers.  The patient's vaccination history included a third dose of ENGERIX B given in the left thigh on 21-OCT-2005.
Age: 1.5
Sex: F
Vaccine: HEPA
Symptoms: Screaming
Clinical narrative: Information has been received from a consumer concerning her 18 month old daughter with no medical history who on 10-OCT-2006 was vaccinated with a first dose of VAQTA.  Concomitant therapy included TYLENOL.  On 12-OCT-2006, 40 hours after vaccination with VAQTA, the subject experienced regression in development, speech deterioration, screaming, and grunting.  On unspecified dates in December of 2006, the subject experienced periods of immobility or paralysis, which occurred on two separate episodes.  On 10-APR-2007, the subject received the 2nd dose of VAQTA (unknown) and experienced five episodes of immobility within the next six months.  The reporter reported that her daughter was diagnosed with mild autism (date of diagnosis unspecified).  It was reported that a physician or other health care professional has not verified this report.  The subject's mother considered the events to be disabling.  The subject's mother stated that she is in the early stages of investigating vaccines that her daughter has received which may contain ingredients the child may be allergic to.  Per the subject's mother, there were no signs of regression until 12-OCT-2006.  At the time of the report, the child has been in therapy for 19 months and her condition has improved, but she remains behind her peers.  The patient's vaccination history included a third dose of ENGERIX B given in the left thigh on 21-OCT-2005.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Asthma, Herpes zoster
Clinical narrative: Information has been received from a physician and a mother concerning a 7 year old boy with "bad immune system", asthma, eczema and allergy to amoxicillin and a history of dermatitis and molluscum who on 16-OCT-2001 was vaccinated with VARIVAX (Oka/Merck).  Concomitant therapy included albuterol and montelukast sodium (MSD).  The mother reported that her son had shingles from the VARIVAX (Oka/Merck).  The patient has been having outbreaks on his hips and waistline.  The mother could not remember when the outbreaks started.  Her son currently has an outbreak on the back of his neck.  She said the outbreaks seem to happen when he is in the sun.  The patient has been hospitalized for asthma, but not for the outbreaks.  As of 27-MAY-2008, the patient's outbreak on the back of his neck persisted.  Outcomes of asthma and outbreak on his hip and waistline were not reported.  The physician confirmed the patient has shingles and explained that he was exposed to severe sunlight that she feels exacerbated things.  The patient's mother also reported that the patient had been hospitalized for asthma, but not for outbreaks (hospitalization date not reported).  Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Clostridium difficile toxin test, Diagnostic procedure, Full blood count, Hypotonia, Lethargy
Clinical narrative: Information has been received from a healthcare worker from a physician's office concerning an 8 week old (10lbs., 6oz., 21.25 in) female with no pre-existing medical conditions or allergies who on 14-APR-2008 at 14:45 was vaccinated PO with her first dose of ROTATEQ (lot# 659773/0020X).  There was no illness at the time of vaccination.  Concomitant vaccinations administered on that same day at 14:45 included the first dose of PREVNAR (lot# C49920) in the lower left thigh, the first dose of PEDIARIX (lot# AC21B139AA) in the right thigh and the first dose of ACTHIB (lot# UF241AC) in the upper left thigh.  On 15-APR-2008 in the evening, the patient experienced shock-like syndrome, collapse, hypotonic, unresponsive, lethargic and pale and was hospitalized for 2 days.  Laboratory diagnostic studies included a CBC, CDD, pneumogram and BMP.  Subsequently, the patient recovered.  It was also noted that the baby's grandmother (WAES# 0805USA00049) and mother (WAES# 0804USA05564) experienced rotavirus after the baby received ROTATEQ (lot# 659773/0020X).  Shock-like syndrome, collapse, hypotonia, unresponsive, lethargic and pallor were considered to be immediately life-threatening by the reporter.  A lot check has been initiated.  Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Metabolic function test, Pallor, Shock, Syncope, Unresponsive to stimuli
Clinical narrative: Information has been received from a healthcare worker from a physician's office concerning an 8 week old (10lbs., 6oz., 21.25 in) female with no pre-existing medical conditions or allergies who on 14-APR-2008 at 14:45 was vaccinated PO with her first dose of ROTATEQ (lot# 659773/0020X).  There was no illness at the time of vaccination.  Concomitant vaccinations administered on that same day at 14:45 included the first dose of PREVNAR (lot# C49920) in the lower left thigh, the first dose of PEDIARIX (lot# AC21B139AA) in the right thigh and the first dose of ACTHIB (lot# UF241AC) in the upper left thigh.  On 15-APR-2008 in the evening, the patient experienced shock-like syndrome, collapse, hypotonic, unresponsive, lethargic and pale and was hospitalized for 2 days.  Laboratory diagnostic studies included a CBC, CDD, pneumogram and BMP.  Subsequently, the patient recovered.  It was also noted that the baby's grandmother (WAES# 0805USA00049) and mother (WAES# 0804USA05564) experienced rotavirus after the baby received ROTATEQ (lot# 659773/0020X).  Shock-like syndrome, collapse, hypotonia, unresponsive, lethargic and pallor were considered to be immediately life-threatening by the reporter.  A lot check has been initiated.  Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: RV5
Symptoms: Haematochezia
Clinical narrative: Information has been received from a physician concerning a 4 month old male who was vaccinated with his second dose of ROTATEQ. Subsequently the patient experienced hematochezia within 48 hours of vaccination. The patient was seen by the physician for medical attention. The outcome was unknown. There was no product quality complaint. Upon internal review, hematochezia was determined to be an other important medical event. Additional information has been requested.
Age: 1.2
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Inappropriate schedule of drug administration, Pyrexia, Rotavirus test positive, Vomiting
Clinical narrative: Information has been received from a physician concerning a 14 month old female who was vaccinated PO with the second 2.0 ml dose of ROTATEQ.  While the patient was in the hospital for adenoidectomy the patient experienced vomiting, diarrhea and fever and remained hospitalized for 5 days.  The patient tested positive for rotavirus.  The outcome was unknown.  There was no product quality complaint.  No further information was provided.  Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Acidosis, Dehydration, Diarrhoea, Rotavirus test positive
Clinical narrative: Information has been received from a physician concerning a 2 month old female who on an unspecified date was vaccinated with a dose of ROTATEQ along with other childhood vaccines (not reported). The physician reported that one week later the patient was admitted to the hospital for diarrhea, dehydration and acidosis. The stool was rotavirus positive. The patient has recovered and was discharged. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: HIBV, MMRV, PNC
Symptoms: Body temperature increased, Grand mal convulsion, Postictal state, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 12-month-old female who on 24-AUG-2007 was vaccinated with a dose of PROQUAD (lot# 658187/0790U).  On 28-AUG-2007 the patient was seen by the physician for a fever of 101F.  In the evening of 28-AUG-2007 the patient had a seizure.  No other seizure activity reported.  No treatment rendered.  No product quality complaint was involved.  Follow-up information has been received concerning a white, 12-month-old female with no pre-existing allergies, birth defects or medical conditions.  On 24-Aug-2007 between 10:30 and 11:00 AM the patient received a first dose in the left arm of PROQUAD (lot# 658187/0790U), and a third dose in the left thigh of PEDVAXHIB (lot# 655546/0075U).  Additional vaccination included a fourth dose of PREVNAR (lot# B26570E).  It was reported that at the time of vaccination the patient had viral syndrome.  On 28-Aug-2007 the patient had a generalized tonic clonic seizure lasting approximately 2 minutes with post-ictal state lasting approximately 5 minutes.  Unspecified medical attention was sought.  The patient recovered from the grand-mal convulsion on 28-Aug-2007.  It was also reported that the patient and her sibling have had no adverse events following prior vaccinations.  Upon internal review, grand-mal convulsion was considered to be an other important medical event.  Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Laboratory test, Pregnancy test positive
Clinical narrative: Initial and follow-up information has been received from the Merck Pregnancy Registry from an 18 year old female with a penicillin allergy who in May 2007 was vaccinated with a dose of GARDASIL. Concomitant therapy included hormonal contraceptives (unspecified). Subsequently the patient became pregnant. A pregnancy test was performed to confirm the patient's pregnancy. The patient's last menstrual period was on 23-MAY-2007. The patient's estimated date of delivery was 27-FEB-2007. The patient did not continue series of GARDASIL during her pregnancy. Unspecified medical attention was sought. At the time of the initial report, the patient was nine weeks gestation. Follow-up reported that on approximately 07-AUG-2007, the patient miscarried at 11 weeks. It was reported that had no procedures done and was doing "fine." At the time of the follow-up report, the patient was pregnant again (WAES #0805USA06056). Upon internal review, miscarried at 11 weeks was considered to be an other important medical event. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Condition aggravated, Drug exposure during pregnancy, Foetal heart rate, Haemorrhage
Clinical narrative: Initial and follow-up information has been received from a certified medical assistant, for the Pregnancy Registry, concerning a 25 year old female with anxiety, herpes, and no drug allergies, and with a history of pyelonephritis (reported as phylonephritis), caesearean section in 2002, chlamydia, 3 previous pregnancies, 1 full term delivery, 2 elective terminations, who on 29-NOV-2007 was vaccinated IM with a first dose of GARDASIL (lot # 659437/1266U) and on 05-FEB-2008 was vaccinated IM with a second dose of GARDASIL (lot # 659653/1448U). Concomitant therapy included EFFEXOR, KLONOPIN, and VALTREX. The patient was pregnant. The patient's last menstrual period was 06-FEB-2008 and her estimated delivery date was 13-NOV-2008. The patient saw her physician for medical attention. On 19-MAR-2008 an ultrasound was performed for viability and the results were viable, the fetal heart tones were positive. On 25-MAR-2008 an ultrasound was performed for a threatened Ab and the results were viable. On 07-APR-2008 an ultrasound was performed due to first trimester bleeding and the results nonviable and a probable spontaneous abortion. On 07-APR-2008 at 8 4/7 weeks from her last menstrual period the patient experienced a spontaneous abortion. The products of conception were not examined. It was unknown if the fetus was normal. The complications during the pregnancy was first trimester bleeding. Illnesses during the pregnancy were Herpes and Ureaplasma urealyticum. The patient's outcome was unknown. A product quality complaint was not involved. Upon internal review the spontaneous abortion was considered to be an other important medical event. Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Herpes virus infection, Ultrasound scan abnormal, Ureaplasma infection
Clinical narrative: Initial and follow-up information has been received from a certified medical assistant, for the Pregnancy Registry, concerning a 25 year old female with anxiety, herpes, and no drug allergies, and with a history of pyelonephritis (reported as phylonephritis), caesearean section in 2002, chlamydia, 3 previous pregnancies, 1 full term delivery, 2 elective terminations, who on 29-NOV-2007 was vaccinated IM with a first dose of GARDASIL (lot # 659437/1266U) and on 05-FEB-2008 was vaccinated IM with a second dose of GARDASIL (lot # 659653/1448U). Concomitant therapy included EFFEXOR, KLONOPIN, and VALTREX. The patient was pregnant. The patient's last menstrual period was 06-FEB-2008 and her estimated delivery date was 13-NOV-2008. The patient saw her physician for medical attention. On 19-MAR-2008 an ultrasound was performed for viability and the results were viable, the fetal heart tones were positive. On 25-MAR-2008 an ultrasound was performed for a threatened Ab and the results were viable. On 07-APR-2008 an ultrasound was performed due to first trimester bleeding and the results nonviable and a probable spontaneous abortion. On 07-APR-2008 at 8 4/7 weeks from her last menstrual period the patient experienced a spontaneous abortion. The products of conception were not examined. It was unknown if the fetus was normal. The complications during the pregnancy was first trimester bleeding. Illnesses during the pregnancy were Herpes and Ureaplasma urealyticum. The patient's outcome was unknown. A product quality complaint was not involved. Upon internal review the spontaneous abortion was considered to be an other important medical event. Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Confusional state, Convulsion, Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a registered nurse concerning her 22 year old daughter with a history of a seizure disorder who "recently" (date unspecified), was vaccinated intramuscularly with the third 0.5 ml dose of GARDASIL.  Two hours post vaccination, the patient developed pain and redness at the injection site.  About four hours post vaccination, the patient had a seizure and seemed confused for the next 24 hours.  The patient sought unspecified medical attention.  The patient has since recovered.  No product quality complaint was involved.  Upon internal review, seizure was considered to be an other important medical event.  Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Blood pressure immeasurable, Cold sweat, Heart rate, Heart rate normal, Hypotonia
Clinical narrative: Pt. was slumped over to Rt side, skin pale, cool & clammy to touch, c/o severe pain to Rt arm, cool compress applied to forehead & feet elevated, v/s unable to obtain B/P x3, P 68, SPO2 97%.  EMS responded, wheezing auscultated x3 lobes, albuterol breathing Tx given, EMS transported pt to ER for evaluation.
Age: 18.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Oxygen saturation normal, Pain in extremity, Pallor, Wheezing
Clinical narrative: Pt. was slumped over to Rt side, skin pale, cool & clammy to touch, c/o severe pain to Rt arm, cool compress applied to forehead & feet elevated, v/s unable to obtain B/P x3, P 68, SPO2 97%.  EMS responded, wheezing auscultated x3 lobes, albuterol breathing Tx given, EMS transported pt to ER for evaluation.
Age: 39.0
Sex: F
Vaccine: MU, TDAP
Symptoms: Neck pain, Pyrexia
Clinical narrative: Fever of 101 degrees 24 hrs after mumps + Tdap vaccines then soreness in neck 48 hrs after.  Fever lasted 24 hrs.  Soreness is present currently.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Urticaria, Wheezing
Clinical narrative: HIVES,WHEEZING
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Dyspnoea, Nausea, Syncope
Clinical narrative: 24 hours after receiving vaccination patient complain of nausea, dizziness, shortness of breath, and fainting spells
Age: 16.0
Sex: F
Vaccine: HEPA
Symptoms: Axillary mass, Axillary pain, Back pain, Injection site pain
Clinical narrative: RECEIVED HEPATITS A VACCINE #2 IM LEFT DELTOID ON 5/3/2008. ENTIRE LEFT SHOULDER BECAME VERY SORE, WITH PAIN RADIATING TO MID-BACK ON LEFT SIDE. ON 6/1 LEFT AXILLARY AREA  VERY SORE; REPORTED FEELING A LUMP IN THE AXILLA, MOTHER NOT ABLE TO REPORT THE SIZE OF LUMP TO ME. PATIENT IS TAKING TYLENOL FOR THE DISCOMFORT. PAIN IS IMPROVED TODAY; PATIENT WENT TO SCHOOL. MOTHER FELT IT IMPORTANT TO REPORT AS SYMPTOMS SEEM TO INVOLVE THE LYMPHATICS IN AXILLA. WILL SEE MD IF SYMPTOMS DON'T IMPROVE GREATLY BY TOMORROW, 6/3. PATIENTHAS NO SYMPTOMS OF A CONCURRENT ILLNESS AT PRESENT.
Age: 14.0
Sex: M
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Blood pressure, Hyperhidrosis, Immediate post-injection reaction, Malaise, Pallor
Clinical narrative: Immediately following last vaccine which was MCV4, client began sweating and became pale.  Stated "He did not feel good."  Orange juice was given, BP was 60/38, 80/60, then he was moved to the floor.  BP increased to 110/60, 110/80.  Remained supine for 10 minutes.  Stated he felt better.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: RT ARM SUB CUT REACTION TO VARICELLA- REDNESS AND WARM TO THE TOUCH, PT HAS BEEN SCRATCHING HIS ARM- ARM MEASURES 12CM X 12CM- PT WAS TREATED WITH COOL COMPRESSES AND ADVISED TO TAKE BENADRYL BY NP
Age: 0.63
Sex: M
Vaccine: DTAPHEPBIP, HIBV, UNK
Symptoms: Pyrexia
Clinical narrative: Fever of 102.9 per ear w/in 45 minutes of receiving shots. Continued w/intermittent fever up to 102.9 off and on for the next 40 hours. Gave ibuprofen and monitored.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Chest pain, Dyspnoea, Pericardial effusion, Pericarditis
Clinical narrative: 05/31/08- SOB and chest pain                     06/01/08- Chest pain, pericardial effusion, Pericarditis 6/3/08-records received for DOS 5/31-6/2/08-DC DX: Pericarditis. Presented with chest pain for about 10 days and 2 days after vaccination for human papilloma virus.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Chest X-ray, Chest pain, Computerised tomogram, Echocardiogram, Laboratory test
Clinical narrative: 05/31/08- SOB and chest pain                     06/01/08- Chest pain, pericardial effusion, Pericarditis 6/3/08-records received for DOS 5/31-6/2/08-DC DX: Pericarditis. Presented with chest pain for about 10 days and 2 days after vaccination for human papilloma virus.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Pericarditis
Clinical narrative: 05/31/08- SOB and chest pain                     06/01/08- Chest pain, pericardial effusion, Pericarditis 6/3/08-records received for DOS 5/31-6/2/08-DC DX: Pericarditis. Presented with chest pain for about 10 days and 2 days after vaccination for human papilloma virus.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Anion gap increased, Blood creatine phosphokinase increased, Chest pain, Computerised tomogram abnormal, Dyspnoea
Clinical narrative: 05/31/08- SOB and chest pain                     06/01/08- Chest pain, pericardial effusion, Pericarditis 6/3/08-records received for DOS 5/31-6/2/08-DC DX: Pericarditis. Presented with chest pain for about 10 days and 2 days after vaccination for human papilloma virus.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Eosinophil percentage decreased, Fibrin D dimer increased, Globulins increased, Pericardial effusion, Pericarditis
Clinical narrative: 05/31/08- SOB and chest pain                     06/01/08- Chest pain, pericardial effusion, Pericarditis 6/3/08-records received for DOS 5/31-6/2/08-DC DX: Pericarditis. Presented with chest pain for about 10 days and 2 days after vaccination for human papilloma virus.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Protein total increased, White blood cell count increased
Clinical narrative: 05/31/08- SOB and chest pain                     06/01/08- Chest pain, pericardial effusion, Pericarditis 6/3/08-records received for DOS 5/31-6/2/08-DC DX: Pericarditis. Presented with chest pain for about 10 days and 2 days after vaccination for human papilloma virus.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Rash papular, Rash pruritic
Clinical narrative: MCV4 vaccine given morning of April 29, 2008 and patient played soccer that evening. Patient presented to school nurse's office April 30th with a raised, pruritic rash on face, neck, face, and legs. Patient indicated that rash started evening of April 29th. Oral Benadryl was given as needed. Patient was not seen by a physician, no diagnosis was given. Rash completed resolved after 1 week.
Age: 38.0
Sex: M
Vaccine: HEP
Symptoms: Neck pain
Clinical narrative: HAD SEVERE (8-9 SCALE) NECK PAIN 4-5 DAYS POST VACCINATION #2 AND #3 OF HEPATITIS B VACCINE
Age: 20.0
Sex: F
Vaccine: HEP, HEPA, HPV4, MNQ
Symptoms: Cold sweat, Dizziness, Loss of consciousness, Muscle rigidity, Oral contraception
Clinical narrative: On 06/02/2008 at approximately 11:20 a.m. client (20 years of age)lost consciousness after she received four vaccines (HPV #1; Adult dose of Hepatitis A; Adult dose of Hepatitis B; and Meningococcal Conjugate). Client stated that she was feeling light-headed after receiving the vaccines. She was instructed to lower her head beneath the level of the heart when she leaned over. She was escorted to the floor when her feet were elevated above the level of her head. Client did not strike her body or her head to the ground. Client's body was fully extended and rigid like fashion for a couple of seconds. The episode lasted for approximately 8-10 seconds and client regained consciousness. She immediately asked for a cookie. Client was asked if she had lost consciousness and she stated "yes". Client was asked to remain on the floor for a little while. Her feet were cold and her head was clammy. Client was asked if she could sit up. She was assisted to a sitting position and then she was sat in a chair. Client stated that she does not have a history of seizures; however, she stated that it was common for her to pass-out when she is hypoglycemic. Client stated that she had not eaten anything for breakfast. Client recovered and stated that she was well. She did refuse medical attention. Client is currently taking birth control pill (Drospirenone/Ethinyl Estradiol 3mg/.02mg once daily by mouth. Also, she stated that she completed a six day regimen of Azithromycin 250 mg once daily by mouth for a throat infection. Azithromycine was last taken on 06/01/2008. Client stated that she is not currently under a doctor's care and has no medical history. Client was escorted to the lobby where she waited 20 minutes before leaving the clinic.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 4/23/2008 pT DEVELOPED INCREASED REDNESS & SWELLING RIGHT ARM 27CM BY 16CM EXTENDING FROM SITE OF INJECTION TO THE RIGHT ELBOW. aFEBRILE. sEEN BY sCHOOL np & STARTED ON kEFLEX. 4/25 Redness almost reaching wrist, pt seen by MD.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Acne, Allergy test, Chills, Condition aggravated, Fatigue
Clinical narrative: Shot 1: Headache lasting several days; Shot 2: Headache lasting several days; Shot 3: Starting with 1 "pimple" on the day of the shot, there is a gradual developing folliculitis or rash on face and upper neck and hairline. This was treated as acne initially, because it took 2 weeks for me to realize my symptoms were from the shot. I suddenly  began getting very frequent migraines almost immediately after the shot and they are ongoing. I also had a petit mal seizure after 1 week. I haven't had a seizure in years; the timing is proof that it is related to the shot. I have increasingly swollen glands, after a week and a half I developed sores on my gums, chills, fatigue, and now after 2 weeks I am unable to tame this painful scabbing rash all over my face.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Folliculitis, Headache, Lymphadenopathy, Migraine, Pain
Clinical narrative: Shot 1: Headache lasting several days; Shot 2: Headache lasting several days; Shot 3: Starting with 1 "pimple" on the day of the shot, there is a gradual developing folliculitis or rash on face and upper neck and hairline. This was treated as acne initially, because it took 2 weeks for me to realize my symptoms were from the shot. I suddenly  began getting very frequent migraines almost immediately after the shot and they are ongoing. I also had a petit mal seizure after 1 week. I haven't had a seizure in years; the timing is proof that it is related to the shot. I have increasingly swollen glands, after a week and a half I developed sores on my gums, chills, fatigue, and now after 2 weeks I am unable to tame this painful scabbing rash all over my face.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Petit mal epilepsy, Rash, Scab, Stomatitis, Streptococcal identification test
Clinical narrative: Shot 1: Headache lasting several days; Shot 2: Headache lasting several days; Shot 3: Starting with 1 "pimple" on the day of the shot, there is a gradual developing folliculitis or rash on face and upper neck and hairline. This was treated as acne initially, because it took 2 weeks for me to realize my symptoms were from the shot. I suddenly  began getting very frequent migraines almost immediately after the shot and they are ongoing. I also had a petit mal seizure after 1 week. I haven't had a seizure in years; the timing is proof that it is related to the shot. I have increasingly swollen glands, after a week and a half I developed sores on my gums, chills, fatigue, and now after 2 weeks I am unable to tame this painful scabbing rash all over my face.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Vaccine positive rechallenge
Clinical narrative: Shot 1: Headache lasting several days; Shot 2: Headache lasting several days; Shot 3: Starting with 1 "pimple" on the day of the shot, there is a gradual developing folliculitis or rash on face and upper neck and hairline. This was treated as acne initially, because it took 2 weeks for me to realize my symptoms were from the shot. I suddenly  began getting very frequent migraines almost immediately after the shot and they are ongoing. I also had a petit mal seizure after 1 week. I haven't had a seizure in years; the timing is proof that it is related to the shot. I have increasingly swollen glands, after a week and a half I developed sores on my gums, chills, fatigue, and now after 2 weeks I am unable to tame this painful scabbing rash all over my face.
Age: 11.0
Sex: M
Vaccine: HEPA
Symptoms: Erythema, Headache, Local reaction, Skin lesion
Clinical narrative: Localized erythema to Left upper outer arm.  Bull's eye type lesion measuring 6.5cm x 7 cm. Patient also c/o of mild headaches.
Age: 2.0
Sex: M
Vaccine: PNC
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Left upper thigh, swollen red and tender to to the touch.Redness goes two inches wide on both sides of immunization spot.
Age: 1.42
Sex: M
Vaccine: DTAP
Symptoms: Erythema
Clinical narrative: LOCAL ERYTHEMA, IMPROVING WITHIN 2 DAYS
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Ageusia, Anosmia, Computerised tomogram normal, Diplopia, Nuclear magnetic resonance imaging normal
Clinical narrative: Significant loss of sense of taste and of smell; some incidents of double vision in one eye.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Wrong technique in drug usage process
Clinical narrative: Patient had TDAP injection administered to right arm in subcutaneous tissue. area is reddenned, warm to touch. no complaints of pain. has some swelling.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: pt developed a shingles/herpetic like rash over elbow on same side where vaccine was given about a month after vaccine was given (painful) resolved on its own but now has recurred (about 6 months later)
Age: 43.0
Sex: M
Vaccine: HEPA
Symptoms: Blood pressure, Dizziness, Electrocardiogram, Fall
Clinical narrative: Less than 10 minutes after receiving one dose Havrix 1440 ELU/ml IM left deltoid, pt falls forward lands on chairs.He was observed by me & talking with me until his fall.I was assisted by tech to get pt to ground & made sure pt was breathing & had a carotid pulse.I turned him on his back while my tech got my BP monitor-first BP was 110/45,P48 @ 10min post injection. I maintained q2min BP checks.No signs of allergy-I asked about swallowing, tongue, observed eyes, skin - no redness.  Maintained conversation with pt who answered appropriately.He tried to sit up @ 6Min, but became dizzy so I laid him back down & continued BP q2min. Paramedics arrived @ 21min after initial tx by me.They gave no meds, but advised transport since they detected a possible arrhythmia on EKG.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, IPV, MMR, VARCEL
Symptoms: Inappropriate schedule of drug administration, Overdose, Wrong drug administered
Clinical narrative: Wrong Vaccine given. Pediarix was given instead of DTAP alone. This resulted in two IPV doses administered simultaneously and an unnecessary fourth dose of Hepatitis B Vaccine. No immediate side effects.
Age: 1.5
Sex: F
Vaccine: DTAP, FLU3, HEPA
Symptoms: Diarrhoea, Pyrexia, Somnolence, Vomiting
Clinical narrative: Mom states that two days after receiving vaccines, child was hospitalized for vomiting, diarrhea, high fever and "extreme drowsiness"- The child remained in the hospital for two days. The child was also seen by a private pediatrician before and after hospitalization.  6/13/08 Reviewed hospital medical records of 4/12-4/13/08. FINAL DX: acute gastroenteritis; dehydration; leukocytosis w/neutrophilia. Records reveal patient experienced vomiting w/bilious emeis & abdominal discomfort x 2 days.  Seen by PCP & tx w/meds but no improvement.  Urine output decreased & oral intake reduced.  Tx w/IVF  & antiemetic meds.  Improved & d/c to home w/PCP f/u.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Inappropriate schedule of drug administration, Unevaluable event
Clinical narrative: None stated.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site oedema, Injection site pain, Lymphadenopathy
Clinical narrative: Tdap 0.5 mL IM R deltoid 5-20-2008.  Edema R deltoid & clavicle & supraclavicular lymphadenopathy R; R pain in deltoid.  Eval done 5-22-2008 & MOTRIN advised by Dr.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5, RV5
Symptoms: Abdominal pain, Intussusception, Lethargy, Mucous stools, Urinary system X-ray
Clinical narrative: Presented with currant-jelly stool and lethargy and abdominal pain on 5/29/08- Found to have intussusception, Treated with Barium Enema at clinic.  6/12/2008 MR received for DOS 5/29-30/2008 with DX: Intussusception S/P reduction with Barium Enema.  Infant presented to ER from PCP's office with vomiting, bloody diarrhea and currant jelly stool. Infant fussy. IS reduced with BE. No further problems and D/C next day.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5, RV5
Symptoms: Intussusception
Clinical narrative: Presented with currant-jelly stool and lethargy and abdominal pain on 5/29/08- Found to have intussusception, Treated with Barium Enema at clinic.  6/12/2008 MR received for DOS 5/29-30/2008 with DX: Intussusception S/P reduction with Barium Enema.  Infant presented to ER from PCP's office with vomiting, bloody diarrhea and currant jelly stool. Infant fussy. IS reduced with BE. No further problems and D/C next day.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site warmth, Oedema peripheral
Clinical narrative: Redness at site, swelling to upper left arm, warm at site.
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Ultrasound scan
Clinical narrative: LMP 2/5/08 GARDASIL #3 given 2/20/08 pt. current pregnant.
Age: 18.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site papule, Rash papular
Clinical narrative: Large papules approx quater size on R arm around injection site and under arm