chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Hypertonia, Moaning, Petit mal epilepsy, Screaming, Staring
Clinical narrative: Within 1 hour of receiving the Hib vaccine, our son clenched both arms in front of him, head got completely red and body shook and he was groaning for apprx 30 seconds. His eyes appeared vacant. The right side of his body was tense on 3 occasions. He stopped using his right hand, clubbed things he used to grab with left hand, stopped smiling, laughing, clapping and waving. He did not recognize/respond to his parents the next morning,stopped responding to pain, the list goes on. He cried and screamed throughout the night for the first week and we now observe absent seizures. He has continued to display behavior completely uncharacteristic to himself and can no longer eat the foods he once ate with no reactions.
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Tension, Tremor, Unresponsive to stimuli, Zinc deficiency
Clinical narrative: Within 1 hour of receiving the Hib vaccine, our son clenched both arms in front of him, head got completely red and body shook and he was groaning for apprx 30 seconds. His eyes appeared vacant. The right side of his body was tense on 3 occasions. He stopped using his right hand, clubbed things he used to grab with left hand, stopped smiling, laughing, clapping and waving. He did not recognize/respond to his parents the next morning,stopped responding to pain, the list goes on. He cried and screamed throughout the night for the first week and we now observe absent seizures. He has continued to display behavior completely uncharacteristic to himself and can no longer eat the foods he once ate with no reactions.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, PNC
Symptoms: Medication error
Clinical narrative: Administered HIb vaccine diluted with sterile water diluent instead of diluent that came with vaccine. No adverse Sxs. reported. Informed DON. Mother was notified to repeat vaccination in one month.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Blood culture negative, Blood glucose increased, CSF culture negative, CSF glucose normal, CSF lymphocyte count increased
Clinical narrative: Patient had episode of pallor, hypotonia and hyporesponsiveness approximately 2 hours after receiving his 2 month immunizations (DTap, Hib, PCV, IPV, Rota and Hep B).  The episode lasted approximately 1 hour then resolved spontaneously.  He had several shorter episodes of similar symptoms over the next 3 to 4 hours.  His parents called 911 shortly after the onset of the initial episode and he was transported by ambulance to the ER.  He was evaluated with a head CT and a sepsis workup and was started on Rocephin.  The CBC and CSF were not concerning for infection and the blood, urine and CSF cultures were eventually reported as negative.  He was hospitalized for 3 days and also had a normal EEG while in house.  He had no recurrance of symptoms during that time.  6/02/2008 MR received for DOS 4/18-21/2008 with D/C DX:  Apparent Life Threatening Event. Hypotonic-hyporesponsive episode after vaccination. Infant presented after several episodes of pallor, decreased responsiveness, and decreased muscle tone. In ambulance had episode of bradycardia into the 80s.  Only responsive to sternal rub. PE WNL. Pt improved and had no further episodes.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: CSF protein normal, CSF white blood cell count, Clostridium difficile toxin test, Culture stool negative, Culture urine negative
Clinical narrative: Patient had episode of pallor, hypotonia and hyporesponsiveness approximately 2 hours after receiving his 2 month immunizations (DTap, Hib, PCV, IPV, Rota and Hep B).  The episode lasted approximately 1 hour then resolved spontaneously.  He had several shorter episodes of similar symptoms over the next 3 to 4 hours.  His parents called 911 shortly after the onset of the initial episode and he was transported by ambulance to the ER.  He was evaluated with a head CT and a sepsis workup and was started on Rocephin.  The CBC and CSF were not concerning for infection and the blood, urine and CSF cultures were eventually reported as negative.  He was hospitalized for 3 days and also had a normal EEG while in house.  He had no recurrance of symptoms during that time.  6/02/2008 MR received for DOS 4/18-21/2008 with D/C DX:  Apparent Life Threatening Event. Hypotonic-hyporesponsive episode after vaccination. Infant presented after several episodes of pallor, decreased responsiveness, and decreased muscle tone. In ambulance had episode of bradycardia into the 80s.  Only responsive to sternal rub. PE WNL. Pt improved and had no further episodes.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Echocardiogram normal, Electrocardiogram normal, Electroencephalogram normal, Full blood count, Haematocrit decreased
Clinical narrative: Patient had episode of pallor, hypotonia and hyporesponsiveness approximately 2 hours after receiving his 2 month immunizations (DTap, Hib, PCV, IPV, Rota and Hep B).  The episode lasted approximately 1 hour then resolved spontaneously.  He had several shorter episodes of similar symptoms over the next 3 to 4 hours.  His parents called 911 shortly after the onset of the initial episode and he was transported by ambulance to the ER.  He was evaluated with a head CT and a sepsis workup and was started on Rocephin.  The CBC and CSF were not concerning for infection and the blood, urine and CSF cultures were eventually reported as negative.  He was hospitalized for 3 days and also had a normal EEG while in house.  He had no recurrance of symptoms during that time.  6/02/2008 MR received for DOS 4/18-21/2008 with D/C DX:  Apparent Life Threatening Event. Hypotonic-hyporesponsive episode after vaccination. Infant presented after several episodes of pallor, decreased responsiveness, and decreased muscle tone. In ambulance had episode of bradycardia into the 80s.  Only responsive to sternal rub. PE WNL. Pt improved and had no further episodes.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Haemoglobin decreased, Hypotonic-hyporesponsive episode, Neutrophil percentage decreased, Pallor, Platelet count increased
Clinical narrative: Patient had episode of pallor, hypotonia and hyporesponsiveness approximately 2 hours after receiving his 2 month immunizations (DTap, Hib, PCV, IPV, Rota and Hep B).  The episode lasted approximately 1 hour then resolved spontaneously.  He had several shorter episodes of similar symptoms over the next 3 to 4 hours.  His parents called 911 shortly after the onset of the initial episode and he was transported by ambulance to the ER.  He was evaluated with a head CT and a sepsis workup and was started on Rocephin.  The CBC and CSF were not concerning for infection and the blood, urine and CSF cultures were eventually reported as negative.  He was hospitalized for 3 days and also had a normal EEG while in house.  He had no recurrance of symptoms during that time.  6/02/2008 MR received for DOS 4/18-21/2008 with D/C DX:  Apparent Life Threatening Event. Hypotonic-hyporesponsive episode after vaccination. Infant presented after several episodes of pallor, decreased responsiveness, and decreased muscle tone. In ambulance had episode of bradycardia into the 80s.  Only responsive to sternal rub. PE WNL. Pt improved and had no further episodes.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Protein total increased, Red blood cell count decreased, Red blood cells CSF positive, Rotavirus test negative, Scan brain
Clinical narrative: Patient had episode of pallor, hypotonia and hyporesponsiveness approximately 2 hours after receiving his 2 month immunizations (DTap, Hib, PCV, IPV, Rota and Hep B).  The episode lasted approximately 1 hour then resolved spontaneously.  He had several shorter episodes of similar symptoms over the next 3 to 4 hours.  His parents called 911 shortly after the onset of the initial episode and he was transported by ambulance to the ER.  He was evaluated with a head CT and a sepsis workup and was started on Rocephin.  The CBC and CSF were not concerning for infection and the blood, urine and CSF cultures were eventually reported as negative.  He was hospitalized for 3 days and also had a normal EEG while in house.  He had no recurrance of symptoms during that time.  6/02/2008 MR received for DOS 4/18-21/2008 with D/C DX:  Apparent Life Threatening Event. Hypotonic-hyporesponsive episode after vaccination. Infant presented after several episodes of pallor, decreased responsiveness, and decreased muscle tone. In ambulance had episode of bradycardia into the 80s.  Only responsive to sternal rub. PE WNL. Pt improved and had no further episodes.
Age: 1.0
Sex: M
Vaccine: DTAP, HEPA, MMR, PNC, VARCEL
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Mother reports a generalized rash appearing 5/4/08 with fever  (103.9) appearing on 5/7/08 with persisting rash.  Seen at Urgent Care center and by personal physician.
Age: 17.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Medication error
Clinical narrative: Given  1 dose Varicella vaccine and 1 dose DTaP;was mistakenly given varicella. Was authorized to receive TDaP vaccination only
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: patient was given third varivax, booster had already been given
Age: 0.66
Sex: M
Vaccine: DTPIHI, HIBV, PNC, RV5
Symptoms: Medication error
Clinical narrative: No adverse events reported.  However, child was >32 weeks at time of visit.  Physician did NOT order third Rotavirus vaccine but medical assistant inadvertently administered the vaccine without an order for it.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Appendicectomy, Intussusception, Surgery, Vomiting
Clinical narrative: 4/4/08 Patient started having vomiting with every feeds.  Initially diagnosed as gastroenteritis.  Went to Emergency Dept 4/4/08, 4/6/08, and our office 4/7/08.  Diagnosed with intussucsception 4/8/08.  Unable to be reduced by radiology, and required surgery.  Had surgery for intussusception 4/8/08 and appendectomy. 9/11/08-records received for DOS 4/8-4/14/08-DC DX:Intussusception status post reduction and appendectomy. Presented with 4 day history of vomiting after every feeding, crying and increased fussiness.  Post operatively had increased distention and had NG tube placement after two episodes of bilious emesis on 4/9/08. Abdominal US and x-ray and barium enema did not revealed repeat intussusception. NG removed tolerating fluids.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Appendicectomy, Gastroenteritis, Intussusception, Surgery, Vomiting
Clinical narrative: 4/4/08 Patient started having vomiting with every feeds.  Initially diagnosed as gastroenteritis.  Went to Emergency Dept 4/4/08, 4/6/08, and our office 4/7/08.  Diagnosed with intussucsception 4/8/08.  Unable to be reduced by radiology, and required surgery.  Had surgery for intussusception 4/8/08 and appendectomy. 9/11/08-records received for DOS 4/8-4/14/08-DC DX:Intussusception status post reduction and appendectomy. Presented with 4 day history of vomiting after every feeding, crying and increased fussiness.  Post operatively had increased distention and had NG tube placement after two episodes of bilious emesis on 4/9/08. Abdominal US and x-ray and barium enema did not revealed repeat intussusception. NG removed tolerating fluids.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash erythematous
Clinical narrative: Pt recieved MMR, Varicella and Hep A vaccines 5-1-08. Pt has had Fever up to 104 over the past 4 days, and developed scattered erythematous lesions with raised center.
Age: 24.0
Sex: F
Vaccine: MMR
Symptoms: Urticaria
Clinical narrative: Went to Employee Health for MMR shot around 1015, Hives started that evening around 2100.
Age: 27.0
Sex: M
Vaccine: ANTH, HEP, TYP
Symptoms: Headache, Injection site erythema, Local reaction, Ultrasound scan normal
Clinical narrative: Pt c/o localized irritation, headache and redness times 3 days to injection site where he received anthrax immunization as part of military recall processing. During ER visit on 5/9/08 pt was given benadryl 25-50 mg q 6 hrs, keflex 500 mg QID, ultram 50 mg Q 8 hrs
Age: 24.0
Sex: F
Vaccine: ANTH
Symptoms: Autoimmune disorder, Systemic lupus erythematosus
Clinical narrative: Have come down with SLE(lupus) or Auto Immune complications.
Age: 16.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Polymerase chain reaction, Pyrexia, Rash, Varicella post vaccine, Viral DNA test positive
Clinical narrative: Received Varicella shot #2, 22 days later rash/fever began. Hospitalization for IV ZOVIRAX therapy due to hx of immunocompromised status and steroid therapy. Hospital notes sent with form also. Dx with post-vaccination varicella illness.  6/27/08 Reviewed hospital medical records of 5/3-5/4/2008. FINAL DX: varicella, chickenpox Records reveal patient experienced fever & rash approx 3 wks s/p vaccines.  Month prior had exacerbation of Crohn's disease & steroids increased.  Rash was mostly papular over trunk & head w/excoriation & scabbing & erythema over chest.  Admited to monitor due to immunosuppression.  Case reviewed w/GI & ID.  Tx w/IV antivirals, decreased of steroids & antibiotic ointment.  Improved & d/c to home on continued oral antivirals w/instruction to resume methotrexate & increase steroids as lesions crusted & cleared.
Age: 2.0
Sex: U
Vaccine: DTAP, FLU3
Symptoms: Injection site cellulitis
Clinical narrative: Signif cellulitis, left lat thigh progressed to lower leg
Age: 14.0
Sex: F
Vaccine: HPV4, TD, VARCEL
Symptoms: Incorrect route of drug administration
Clinical narrative: No adverse event - vaccine given SC instead of IM (HPV - Gardasil). When the nurse gave the vaccine- she drew back blood after hitting a vein.  No treatment needed- Nurse placed needle in sharps box & administered a new vaccine.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Back of lt arm, red raised and itching. Site of varicella vaccine give 4/22/08. Instructed by Dr Benadryl PO
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: At approximately 8:45 am-pt. brought into health center for Tdap shot- No contraindications and consent form signed and Tdap given. Due to pt's age NCIR stated not valid.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Abdominal pain, Chills, Myalgia, Pyrexia, Vomiting
Clinical narrative: Abdominal pain, fever, chills, myalgia, vomiting 24 hours after receiving vaccine - Rx Phenegran.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Full blood count, Similar reaction on previous exposure to drug, Tachycardia
Clinical narrative: Tdap booster. T=101 Tachycardia last booster >10 yrs
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Constipation, Incorrect dose administered
Clinical narrative: Mom states nurse gave 2 doses of ROTATEQ at 4 months WCC visit.  Mom states nurse told her she gives 2 in case patient spits some out.  Patient has had constipation since I received vaccine.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Constipation, Obstruction, Overdose, X-ray abnormal
Clinical narrative: Mom states nurse gave 2 doses of ROTATEQ at 4 months WCC visit.  Mom states nurse told her she gives 2 in case patient spits some out.  Patient has had constipation since I received vaccine.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Pruritus, Rash
Clinical narrative: Vaccines given in clinic approximately 12:00 pm.  Child left clinic at approximately 12:20 pm.  Returned to clinic at 01:10 pm complaining of itching lesions to upper back and neck observed by RN and referred to pediatrician for care 5:00 pm.  Mother states doctor ordered Claritin 5 mg every day for 5 days.  States rash and itching are better now - per phone call at 7:00.
Age: 1.0
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Rash morbilliform
Clinical narrative: Measles like rash to face and upper chest
Age: 1.8
Sex: M
Vaccine: DTAP, HEPA, PNC
Symptoms: Full blood count, Oxygen saturation, Pyrexia, Stridor
Clinical narrative: Fever and stridor approximately 24 hrs. after immunization; Orapred.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Varicella
Clinical narrative: Developed clinical varicella
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: After patient received varicella vaccine her left thigh became red about the size of a quarter with a puffy area in center (about the size of a pencil head).  The area continued to increase in redness.  PAC consulted with Dr. and Benadryl 0.4ml given IM L thigh; kept patient an additional 15 minutes; no further reaction noticed.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Pain, Pruritus, Skin warm, Swelling
Clinical narrative: pain, swelling redness, hot, itchy started the next day persisted through 5/12/08 max size 10 cm x 16.5 cm
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Eyelid oedema, Wheezing
Clinical narrative: Patient had swelling of eyelids & erythema with slight wheeze.  Decadon 4 mg subcutaneous w/ given.  Benadryl 12.5 mg x1 was given.  Wheezing stopped after 5 min.  All symptoms resolved after half an hour.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Expired drug administered
Clinical narrative: Expired MMR vaccine given in left lower thigh at approx. 11:00am 5/12/2008.
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC, RV5, DTAPHEPBIP, FLU3, HIBV, PNC, RV5
Symptoms: Intussusception
Clinical narrative: Intussusception.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4, HPV4
Symptoms: Anaemia, Chromaturia, Dyspnoea, Hepatomegaly, Lupus-like syndrome
Clinical narrative: Initial and follow up information has been received from a pediatrician and a consumer concerning his 19 year old daughter with an allergy to a medicine for acne that caused her to projectile vomit who on 23-NOV-2007, around Thanksgiving, was vaccinated with a first dose of GARDASIL (Lot# 658488/0930U). It was reported that she got sick and did nothing the next day. On 14-MAR-2008, the patient was vaccinated IM with a second 0.5 ml dose of GARDASIL (Lot# 659962/1740U). On 17-MAR-2008 three days after receiving the vaccine, the patient developed a fever that wouldn't go away. She tested positive for hemolytic anemia and was hospitalized. On 18-MAR-2008, four days after receiving the second dose the patient had complained of a sore throat, stomach and back ache and a fever up to 104 degrees. She had been in the hospital for the past week. Laboratory diagnostic studies performed was reported as "every test they could do". On 21-MAR-2008, the patient had a mononucleosis spot test and it was negative. The patient went back to college and her symptoms worsened. The patient was admitted to the hospital (dates unknown). She was then transferred to a different hospital. It was reported that the patient had 105 vials of blood drawn and the diagnosis of hemolytic anemia seemed to point to an autoimmune response from the second dose of GARDASIL. The patient was discharged from the hospital (hospitalization dates unknown) and it was reported that the patient remains on steroid therapy. At the time of this report, the patient had not recovered. It was also reported that the patient had to drop out of college. The reporting physician was consulting with an infectious disease specialist to confirm the cause of the diagnosis. No product quality complaint was involved. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4, HPV4
Symptoms: Mononucleosis syndrome, Pyrexia, Red blood cell count decreased, White blood cell count decreased
Clinical narrative: Initial and follow up information has been received from a pediatrician and a consumer concerning his 19 year old daughter with an allergy to a medicine for acne that caused her to projectile vomit who on 23-NOV-2007, around Thanksgiving, was vaccinated with a first dose of GARDASIL (Lot# 658488/0930U). It was reported that she got sick and did nothing the next day. On 14-MAR-2008, the patient was vaccinated IM with a second 0.5 ml dose of GARDASIL (Lot# 659962/1740U). On 17-MAR-2008 three days after receiving the vaccine, the patient developed a fever that wouldn't go away. She tested positive for hemolytic anemia and was hospitalized. On 18-MAR-2008, four days after receiving the second dose the patient had complained of a sore throat, stomach and back ache and a fever up to 104 degrees. She had been in the hospital for the past week. Laboratory diagnostic studies performed was reported as "every test they could do". On 21-MAR-2008, the patient had a mononucleosis spot test and it was negative. The patient went back to college and her symptoms worsened. The patient was admitted to the hospital (dates unknown). She was then transferred to a different hospital. It was reported that the patient had 105 vials of blood drawn and the diagnosis of hemolytic anemia seemed to point to an autoimmune response from the second dose of GARDASIL. The patient was discharged from the hospital (hospitalization dates unknown) and it was reported that the patient remains on steroid therapy. At the time of this report, the patient had not recovered. It was also reported that the patient had to drop out of college. The reporting physician was consulting with an infectious disease specialist to confirm the cause of the diagnosis. No product quality complaint was involved. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4, HPV4
Symptoms: Abdominal pain upper, Autoimmune disorder, Back pain, Epstein-Barr virus antibody negative, Haemolytic anaemia
Clinical narrative: Initial and follow up information has been received from a pediatrician and a consumer concerning his 19 year old daughter with an allergy to a medicine for acne that caused her to projectile vomit who on 23-NOV-2007, around Thanksgiving, was vaccinated with a first dose of GARDASIL (Lot# 658488/0930U). It was reported that she got sick and did nothing the next day. On 14-MAR-2008, the patient was vaccinated IM with a second 0.5 ml dose of GARDASIL (Lot# 659962/1740U). On 17-MAR-2008 three days after receiving the vaccine, the patient developed a fever that wouldn't go away. She tested positive for hemolytic anemia and was hospitalized. On 18-MAR-2008, four days after receiving the second dose the patient had complained of a sore throat, stomach and back ache and a fever up to 104 degrees. She had been in the hospital for the past week. Laboratory diagnostic studies performed was reported as "every test they could do". On 21-MAR-2008, the patient had a mononucleosis spot test and it was negative. The patient went back to college and her symptoms worsened. The patient was admitted to the hospital (dates unknown). She was then transferred to a different hospital. It was reported that the patient had 105 vials of blood drawn and the diagnosis of hemolytic anemia seemed to point to an autoimmune response from the second dose of GARDASIL. The patient was discharged from the hospital (hospitalization dates unknown) and it was reported that the patient remains on steroid therapy. At the time of this report, the patient had not recovered. It was also reported that the patient had to drop out of college. The reporting physician was consulting with an infectious disease specialist to confirm the cause of the diagnosis. No product quality complaint was involved. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4, HPV4
Symptoms: Malaise, Pharyngolaryngeal pain, Pyrexia, Vomiting projectile
Clinical narrative: Initial and follow up information has been received from a pediatrician and a consumer concerning his 19 year old daughter with an allergy to a medicine for acne that caused her to projectile vomit who on 23-NOV-2007, around Thanksgiving, was vaccinated with a first dose of GARDASIL (Lot# 658488/0930U). It was reported that she got sick and did nothing the next day. On 14-MAR-2008, the patient was vaccinated IM with a second 0.5 ml dose of GARDASIL (Lot# 659962/1740U). On 17-MAR-2008 three days after receiving the vaccine, the patient developed a fever that wouldn't go away. She tested positive for hemolytic anemia and was hospitalized. On 18-MAR-2008, four days after receiving the second dose the patient had complained of a sore throat, stomach and back ache and a fever up to 104 degrees. She had been in the hospital for the past week. Laboratory diagnostic studies performed was reported as "every test they could do". On 21-MAR-2008, the patient had a mononucleosis spot test and it was negative. The patient went back to college and her symptoms worsened. The patient was admitted to the hospital (dates unknown). She was then transferred to a different hospital. It was reported that the patient had 105 vials of blood drawn and the diagnosis of hemolytic anemia seemed to point to an autoimmune response from the second dose of GARDASIL. The patient was discharged from the hospital (hospitalization dates unknown) and it was reported that the patient remains on steroid therapy. At the time of this report, the patient had not recovered. It was also reported that the patient had to drop out of college. The reporting physician was consulting with an infectious disease specialist to confirm the cause of the diagnosis. No product quality complaint was involved. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4, HPV4
Symptoms: Abdominal pain, Activities of daily living impaired, Anaemia, Anorexia, Back pain
Clinical narrative: Initial and follow up information has been received from a pediatrician and a consumer concerning his 19 year old daughter with an allergy to a medicine for acne that caused her to projectile vomit who on 23-NOV-2007, around Thanksgiving, was vaccinated with a first dose of GARDASIL (Lot# 658488/0930U). It was reported that she got sick and did nothing the next day. On 14-MAR-2008, the patient was vaccinated IM with a second 0.5 ml dose of GARDASIL (Lot# 659962/1740U). On 17-MAR-2008 three days after receiving the vaccine, the patient developed a fever that wouldn't go away. She tested positive for hemolytic anemia and was hospitalized. On 18-MAR-2008, four days after receiving the second dose the patient had complained of a sore throat, stomach and back ache and a fever up to 104 degrees. She had been in the hospital for the past week. Laboratory diagnostic studies performed was reported as "every test they could do". On 21-MAR-2008, the patient had a mononucleosis spot test and it was negative. The patient went back to college and her symptoms worsened. The patient was admitted to the hospital (dates unknown). She was then transferred to a different hospital. It was reported that the patient had 105 vials of blood drawn and the diagnosis of hemolytic anemia seemed to point to an autoimmune response from the second dose of GARDASIL. The patient was discharged from the hospital (hospitalization dates unknown) and it was reported that the patient remains on steroid therapy. At the time of this report, the patient had not recovered. It was also reported that the patient had to drop out of college. The reporting physician was consulting with an infectious disease specialist to confirm the cause of the diagnosis. No product quality complaint was involved. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4, HPV4
Symptoms: Basophil count abnormal, Biopsy bone marrow abnormal, Blood immunoglobulin M, Chills, Chromaturia
Clinical narrative: Initial and follow up information has been received from a pediatrician and a consumer concerning his 19 year old daughter with an allergy to a medicine for acne that caused her to projectile vomit who on 23-NOV-2007, around Thanksgiving, was vaccinated with a first dose of GARDASIL (Lot# 658488/0930U). It was reported that she got sick and did nothing the next day. On 14-MAR-2008, the patient was vaccinated IM with a second 0.5 ml dose of GARDASIL (Lot# 659962/1740U). On 17-MAR-2008 three days after receiving the vaccine, the patient developed a fever that wouldn't go away. She tested positive for hemolytic anemia and was hospitalized. On 18-MAR-2008, four days after receiving the second dose the patient had complained of a sore throat, stomach and back ache and a fever up to 104 degrees. She had been in the hospital for the past week. Laboratory diagnostic studies performed was reported as "every test they could do". On 21-MAR-2008, the patient had a mononucleosis spot test and it was negative. The patient went back to college and her symptoms worsened. The patient was admitted to the hospital (dates unknown). She was then transferred to a different hospital. It was reported that the patient had 105 vials of blood drawn and the diagnosis of hemolytic anemia seemed to point to an autoimmune response from the second dose of GARDASIL. The patient was discharged from the hospital (hospitalization dates unknown) and it was reported that the patient remains on steroid therapy. At the time of this report, the patient had not recovered. It was also reported that the patient had to drop out of college. The reporting physician was consulting with an infectious disease specialist to confirm the cause of the diagnosis. No product quality complaint was involved. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4, HPV4
Symptoms: Cytomegalovirus infection, Cytomegalovirus test positive, Dyspnoea, Epstein-Barr virus infection, Epstein-Barr virus test positive
Clinical narrative: Initial and follow up information has been received from a pediatrician and a consumer concerning his 19 year old daughter with an allergy to a medicine for acne that caused her to projectile vomit who on 23-NOV-2007, around Thanksgiving, was vaccinated with a first dose of GARDASIL (Lot# 658488/0930U). It was reported that she got sick and did nothing the next day. On 14-MAR-2008, the patient was vaccinated IM with a second 0.5 ml dose of GARDASIL (Lot# 659962/1740U). On 17-MAR-2008 three days after receiving the vaccine, the patient developed a fever that wouldn't go away. She tested positive for hemolytic anemia and was hospitalized. On 18-MAR-2008, four days after receiving the second dose the patient had complained of a sore throat, stomach and back ache and a fever up to 104 degrees. She had been in the hospital for the past week. Laboratory diagnostic studies performed was reported as "every test they could do". On 21-MAR-2008, the patient had a mononucleosis spot test and it was negative. The patient went back to college and her symptoms worsened. The patient was admitted to the hospital (dates unknown). She was then transferred to a different hospital. It was reported that the patient had 105 vials of blood drawn and the diagnosis of hemolytic anemia seemed to point to an autoimmune response from the second dose of GARDASIL. The patient was discharged from the hospital (hospitalization dates unknown) and it was reported that the patient remains on steroid therapy. At the time of this report, the patient had not recovered. It was also reported that the patient had to drop out of college. The reporting physician was consulting with an infectious disease specialist to confirm the cause of the diagnosis. No product quality complaint was involved. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4, HPV4
Symptoms: Haemoglobin decreased, Inflammation, Liver disorder, Lymphadenopathy, Nausea
Clinical narrative: Initial and follow up information has been received from a pediatrician and a consumer concerning his 19 year old daughter with an allergy to a medicine for acne that caused her to projectile vomit who on 23-NOV-2007, around Thanksgiving, was vaccinated with a first dose of GARDASIL (Lot# 658488/0930U). It was reported that she got sick and did nothing the next day. On 14-MAR-2008, the patient was vaccinated IM with a second 0.5 ml dose of GARDASIL (Lot# 659962/1740U). On 17-MAR-2008 three days after receiving the vaccine, the patient developed a fever that wouldn't go away. She tested positive for hemolytic anemia and was hospitalized. On 18-MAR-2008, four days after receiving the second dose the patient had complained of a sore throat, stomach and back ache and a fever up to 104 degrees. She had been in the hospital for the past week. Laboratory diagnostic studies performed was reported as "every test they could do". On 21-MAR-2008, the patient had a mononucleosis spot test and it was negative. The patient went back to college and her symptoms worsened. The patient was admitted to the hospital (dates unknown). She was then transferred to a different hospital. It was reported that the patient had 105 vials of blood drawn and the diagnosis of hemolytic anemia seemed to point to an autoimmune response from the second dose of GARDASIL. The patient was discharged from the hospital (hospitalization dates unknown) and it was reported that the patient remains on steroid therapy. At the time of this report, the patient had not recovered. It was also reported that the patient had to drop out of college. The reporting physician was consulting with an infectious disease specialist to confirm the cause of the diagnosis. No product quality complaint was involved. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4, HPV4
Symptoms: Pain, Parvovirus B19 serology, Pharyngolaryngeal pain, Pyrexia, Red blood cell count decreased
Clinical narrative: Initial and follow up information has been received from a pediatrician and a consumer concerning his 19 year old daughter with an allergy to a medicine for acne that caused her to projectile vomit who on 23-NOV-2007, around Thanksgiving, was vaccinated with a first dose of GARDASIL (Lot# 658488/0930U). It was reported that she got sick and did nothing the next day. On 14-MAR-2008, the patient was vaccinated IM with a second 0.5 ml dose of GARDASIL (Lot# 659962/1740U). On 17-MAR-2008 three days after receiving the vaccine, the patient developed a fever that wouldn't go away. She tested positive for hemolytic anemia and was hospitalized. On 18-MAR-2008, four days after receiving the second dose the patient had complained of a sore throat, stomach and back ache and a fever up to 104 degrees. She had been in the hospital for the past week. Laboratory diagnostic studies performed was reported as "every test they could do". On 21-MAR-2008, the patient had a mononucleosis spot test and it was negative. The patient went back to college and her symptoms worsened. The patient was admitted to the hospital (dates unknown). She was then transferred to a different hospital. It was reported that the patient had 105 vials of blood drawn and the diagnosis of hemolytic anemia seemed to point to an autoimmune response from the second dose of GARDASIL. The patient was discharged from the hospital (hospitalization dates unknown) and it was reported that the patient remains on steroid therapy. At the time of this report, the patient had not recovered. It was also reported that the patient had to drop out of college. The reporting physician was consulting with an infectious disease specialist to confirm the cause of the diagnosis. No product quality complaint was involved. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4, HPV4
Symptoms: Spleen disorder, Viral infection, Virus serology test, Vomiting, Weight decreased
Clinical narrative: Initial and follow up information has been received from a pediatrician and a consumer concerning his 19 year old daughter with an allergy to a medicine for acne that caused her to projectile vomit who on 23-NOV-2007, around Thanksgiving, was vaccinated with a first dose of GARDASIL (Lot# 658488/0930U). It was reported that she got sick and did nothing the next day. On 14-MAR-2008, the patient was vaccinated IM with a second 0.5 ml dose of GARDASIL (Lot# 659962/1740U). On 17-MAR-2008 three days after receiving the vaccine, the patient developed a fever that wouldn't go away. She tested positive for hemolytic anemia and was hospitalized. On 18-MAR-2008, four days after receiving the second dose the patient had complained of a sore throat, stomach and back ache and a fever up to 104 degrees. She had been in the hospital for the past week. Laboratory diagnostic studies performed was reported as "every test they could do". On 21-MAR-2008, the patient had a mononucleosis spot test and it was negative. The patient went back to college and her symptoms worsened. The patient was admitted to the hospital (dates unknown). She was then transferred to a different hospital. It was reported that the patient had 105 vials of blood drawn and the diagnosis of hemolytic anemia seemed to point to an autoimmune response from the second dose of GARDASIL. The patient was discharged from the hospital (hospitalization dates unknown) and it was reported that the patient remains on steroid therapy. At the time of this report, the patient had not recovered. It was also reported that the patient had to drop out of college. The reporting physician was consulting with an infectious disease specialist to confirm the cause of the diagnosis. No product quality complaint was involved. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4, HPV4
Symptoms: White blood cell count decreased
Clinical narrative: Initial and follow up information has been received from a pediatrician and a consumer concerning his 19 year old daughter with an allergy to a medicine for acne that caused her to projectile vomit who on 23-NOV-2007, around Thanksgiving, was vaccinated with a first dose of GARDASIL (Lot# 658488/0930U). It was reported that she got sick and did nothing the next day. On 14-MAR-2008, the patient was vaccinated IM with a second 0.5 ml dose of GARDASIL (Lot# 659962/1740U). On 17-MAR-2008 three days after receiving the vaccine, the patient developed a fever that wouldn't go away. She tested positive for hemolytic anemia and was hospitalized. On 18-MAR-2008, four days after receiving the second dose the patient had complained of a sore throat, stomach and back ache and a fever up to 104 degrees. She had been in the hospital for the past week. Laboratory diagnostic studies performed was reported as "every test they could do". On 21-MAR-2008, the patient had a mononucleosis spot test and it was negative. The patient went back to college and her symptoms worsened. The patient was admitted to the hospital (dates unknown). She was then transferred to a different hospital. It was reported that the patient had 105 vials of blood drawn and the diagnosis of hemolytic anemia seemed to point to an autoimmune response from the second dose of GARDASIL. The patient was discharged from the hospital (hospitalization dates unknown) and it was reported that the patient remains on steroid therapy. At the time of this report, the patient had not recovered. It was also reported that the patient had to drop out of college. The reporting physician was consulting with an infectious disease specialist to confirm the cause of the diagnosis. No product quality complaint was involved. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4, HPV4
Symptoms: Antinuclear antibody positive, Autoimmune disorder, Body temperature increased, Computerised tomogram abnormal, Lymphadenopathy
Clinical narrative: Initial and follow up information has been received from a pediatrician and a consumer concerning his 19 year old daughter with an allergy to a medicine for acne that caused her to projectile vomit who on 23-NOV-2007, around Thanksgiving, was vaccinated with a first dose of GARDASIL (Lot# 658488/0930U). It was reported that she got sick and did nothing the next day. On 14-MAR-2008, the patient was vaccinated IM with a second 0.5 ml dose of GARDASIL (Lot# 659962/1740U). On 17-MAR-2008 three days after receiving the vaccine, the patient developed a fever that wouldn't go away. She tested positive for hemolytic anemia and was hospitalized. On 18-MAR-2008, four days after receiving the second dose the patient had complained of a sore throat, stomach and back ache and a fever up to 104 degrees. She had been in the hospital for the past week. Laboratory diagnostic studies performed was reported as "every test they could do". On 21-MAR-2008, the patient had a mononucleosis spot test and it was negative. The patient went back to college and her symptoms worsened. The patient was admitted to the hospital (dates unknown). She was then transferred to a different hospital. It was reported that the patient had 105 vials of blood drawn and the diagnosis of hemolytic anemia seemed to point to an autoimmune response from the second dose of GARDASIL. The patient was discharged from the hospital (hospitalization dates unknown) and it was reported that the patient remains on steroid therapy. At the time of this report, the patient had not recovered. It was also reported that the patient had to drop out of college. The reporting physician was consulting with an infectious disease specialist to confirm the cause of the diagnosis. No product quality complaint was involved. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4, HPV4
Symptoms: Pyrexia, White blood cell count decreased
Clinical narrative: Initial and follow up information has been received from a pediatrician and a consumer concerning his 19 year old daughter with an allergy to a medicine for acne that caused her to projectile vomit who on 23-NOV-2007, around Thanksgiving, was vaccinated with a first dose of GARDASIL (Lot# 658488/0930U). It was reported that she got sick and did nothing the next day. On 14-MAR-2008, the patient was vaccinated IM with a second 0.5 ml dose of GARDASIL (Lot# 659962/1740U). On 17-MAR-2008 three days after receiving the vaccine, the patient developed a fever that wouldn't go away. She tested positive for hemolytic anemia and was hospitalized. On 18-MAR-2008, four days after receiving the second dose the patient had complained of a sore throat, stomach and back ache and a fever up to 104 degrees. She had been in the hospital for the past week. Laboratory diagnostic studies performed was reported as "every test they could do". On 21-MAR-2008, the patient had a mononucleosis spot test and it was negative. The patient went back to college and her symptoms worsened. The patient was admitted to the hospital (dates unknown). She was then transferred to a different hospital. It was reported that the patient had 105 vials of blood drawn and the diagnosis of hemolytic anemia seemed to point to an autoimmune response from the second dose of GARDASIL. The patient was discharged from the hospital (hospitalization dates unknown) and it was reported that the patient remains on steroid therapy. At the time of this report, the patient had not recovered. It was also reported that the patient had to drop out of college. The reporting physician was consulting with an infectious disease specialist to confirm the cause of the diagnosis. No product quality complaint was involved. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4, HPV4
Symptoms: Fatigue, Haemolytic anaemia, Laboratory test, Muscular weakness, Nausea
Clinical narrative: Initial and follow up information has been received from a pediatrician and a consumer concerning his 19 year old daughter with an allergy to a medicine for acne that caused her to projectile vomit who on 23-NOV-2007, around Thanksgiving, was vaccinated with a first dose of GARDASIL (Lot# 658488/0930U). It was reported that she got sick and did nothing the next day. On 14-MAR-2008, the patient was vaccinated IM with a second 0.5 ml dose of GARDASIL (Lot# 659962/1740U). On 17-MAR-2008 three days after receiving the vaccine, the patient developed a fever that wouldn't go away. She tested positive for hemolytic anemia and was hospitalized. On 18-MAR-2008, four days after receiving the second dose the patient had complained of a sore throat, stomach and back ache and a fever up to 104 degrees. She had been in the hospital for the past week. Laboratory diagnostic studies performed was reported as "every test they could do". On 21-MAR-2008, the patient had a mononucleosis spot test and it was negative. The patient went back to college and her symptoms worsened. The patient was admitted to the hospital (dates unknown). She was then transferred to a different hospital. It was reported that the patient had 105 vials of blood drawn and the diagnosis of hemolytic anemia seemed to point to an autoimmune response from the second dose of GARDASIL. The patient was discharged from the hospital (hospitalization dates unknown) and it was reported that the patient remains on steroid therapy. At the time of this report, the patient had not recovered. It was also reported that the patient had to drop out of college. The reporting physician was consulting with an infectious disease specialist to confirm the cause of the diagnosis. No product quality complaint was involved. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4, HPV4
Symptoms: Pharyngolaryngeal pain, Pyrexia, Red blood cell count decreased, Viral infection, White blood cell count decreased
Clinical narrative: Initial and follow up information has been received from a pediatrician and a consumer concerning his 19 year old daughter with an allergy to a medicine for acne that caused her to projectile vomit who on 23-NOV-2007, around Thanksgiving, was vaccinated with a first dose of GARDASIL (Lot# 658488/0930U). It was reported that she got sick and did nothing the next day. On 14-MAR-2008, the patient was vaccinated IM with a second 0.5 ml dose of GARDASIL (Lot# 659962/1740U). On 17-MAR-2008 three days after receiving the vaccine, the patient developed a fever that wouldn't go away. She tested positive for hemolytic anemia and was hospitalized. On 18-MAR-2008, four days after receiving the second dose the patient had complained of a sore throat, stomach and back ache and a fever up to 104 degrees. She had been in the hospital for the past week. Laboratory diagnostic studies performed was reported as "every test they could do". On 21-MAR-2008, the patient had a mononucleosis spot test and it was negative. The patient went back to college and her symptoms worsened. The patient was admitted to the hospital (dates unknown). She was then transferred to a different hospital. It was reported that the patient had 105 vials of blood drawn and the diagnosis of hemolytic anemia seemed to point to an autoimmune response from the second dose of GARDASIL. The patient was discharged from the hospital (hospitalization dates unknown) and it was reported that the patient remains on steroid therapy. At the time of this report, the patient had not recovered. It was also reported that the patient had to drop out of college. The reporting physician was consulting with an infectious disease specialist to confirm the cause of the diagnosis. No product quality complaint was involved. Additional information has been requested.