chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 9.0
Sex: F
Vaccine: FLU3, PPV, VARCEL
Symptoms: Pyrexia, Red blood cell sedimentation rate increased, White blood cell count normal
Clinical narrative: Fever to 101-102. (R) arm erythema and severe pain out of proportion to exam - R/O invasive strep.  4/27/09 Received hospital medical records of 1/7-1/8/2009. FINAL DX: right arm with vaccine injection cellulitis Records reveal patient experienced pain in right upper arm since evening of vaccination.  Next day developed fever & RUE swelling & erythema with decreased right elbow ROM.  Erythema continued to enlarge w/warmth & increased pain & unable to fully extend elbow.  Tx w/oral antibiotics but condition did not improve.  PCP exam suggested possible invasive strep & pt hospitalized for IV antibiotics.  Remained stable, site improved & d/c to home on continued oral antibiotics.
Age: 2.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Hip surgery
Clinical narrative: L septic hip requiring prolonged IV antibiotics and surgery.  5/4/09 Received hospital medical records of 11/11/-11/25/20007. FINAL DX: left hip septic arthritis & acute suppurative otitis media Records reveal patient experienced sudden left hip pain unable to bear weight, fever, facial flushing, decreased appetite.  Seen in outlying ER & transferred to higher level of care for peds ortho consult.  Tx w/IV antibiotics, NSAIDS & pain meds.  Taken to OR for open drainage of left hip on 11/11.  Intermittent fever while hospitalized & OM w/perforated eardrum dx on 11/25.  Improved & D/C to home on antibiotic ear drops.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1, DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Abdominal X-ray, Enema administration, Exploratory operation, Intussusception, Lethargy
Clinical narrative: Pt. received vaccine 3/31/09. Presented with vomiting, lethargy on 4/14/09. Required surgery for Intussusception.  5/14/09 hospital discharge summary recieved DOA 4/9/09-4/13/09. FINAL DIAGNOSIS: Intussusception Post vaccination emesis, abdominal distention, lethargic, blood clots around anus.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1, DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Surgery, Vomiting, X-ray with contrast upper gastrointestinal tract
Clinical narrative: Pt. received vaccine 3/31/09. Presented with vomiting, lethargy on 4/14/09. Required surgery for Intussusception.  5/14/09 hospital discharge summary recieved DOA 4/9/09-4/13/09. FINAL DIAGNOSIS: Intussusception Post vaccination emesis, abdominal distention, lethargic, blood clots around anus.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1, DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Appendicectomy, Barium double contrast, Computerised tomogram abnormal, Enema administration, Intussusception
Clinical narrative: Pt. received vaccine 3/31/09. Presented with vomiting, lethargy on 4/14/09. Required surgery for Intussusception.  5/14/09 hospital discharge summary recieved DOA 4/9/09-4/13/09. FINAL DIAGNOSIS: Intussusception Post vaccination emesis, abdominal distention, lethargic, blood clots around anus.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1, DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Surgery
Clinical narrative: Pt. received vaccine 3/31/09. Presented with vomiting, lethargy on 4/14/09. Required surgery for Intussusception.  5/14/09 hospital discharge summary recieved DOA 4/9/09-4/13/09. FINAL DIAGNOSIS: Intussusception Post vaccination emesis, abdominal distention, lethargic, blood clots around anus.
Age: 1.47
Sex: M
Vaccine: DTAP, FLU3, HBHEPB, MMR, PNC
Symptoms: Abnormal behaviour, Aphasia, Constipation, Decreased eye contact, Developmental delay
Clinical narrative: On 10.14.04 - Patient received FLU, DTAP, COMVAX, MMR & PNEUM. conj after this did not talk, quiet, sick, tired, fever (HOT) 3-4 d. ibu. given did not eat with in 2 wks, eyes rolling (thought nl after vacc). Still does not eat well. Mom thought was regressing & mad abt being held down. In bed 3d. Mom lived with guilt for 10 mo, finally presented to Dr 9-7-05. Very severe delays/regression. Does not speak (did at 11 mo). Very restricted diet, refuses most foods.   5/8/09 Received vaccine & PCP medical records. FINAL DX: Autism spectrum disorder; mixed receptive-expressive language disorder; feeding difficulties; encopresis; constipation; dental caries Records reveal patient experienced runny nose s/p cold week prior to vaccination on 10/14/04.  Developed social withdrawal & speech loss.  2/24/05 dx w/RLL pneumonia; 12/05 bilat AOM & diaper rash; 4/06 viral URI; 10/06 viral pharyngitis. Loss of language, loss of eye contact, loss of reciprocal attention/joint attention. Parent remains adamently convinced that after these 5 injections her son was ill for a week (fever/lethargy) and never recovered his previous social nature. Language is slowly coming.
Age: 1.47
Sex: M
Vaccine: DTAP, FLU3, HBHEPB, MMR, PNC
Symptoms: Diet refusal, Disturbance in attention, Eye rolling, Fatigue, Lethargy
Clinical narrative: On 10.14.04 - Patient received FLU, DTAP, COMVAX, MMR & PNEUM. conj after this did not talk, quiet, sick, tired, fever (HOT) 3-4 d. ibu. given did not eat with in 2 wks, eyes rolling (thought nl after vacc). Still does not eat well. Mom thought was regressing & mad abt being held down. In bed 3d. Mom lived with guilt for 10 mo, finally presented to Dr 9-7-05. Very severe delays/regression. Does not speak (did at 11 mo). Very restricted diet, refuses most foods.   5/8/09 Received vaccine & PCP medical records. FINAL DX: Autism spectrum disorder; mixed receptive-expressive language disorder; feeding difficulties; encopresis; constipation; dental caries Records reveal patient experienced runny nose s/p cold week prior to vaccination on 10/14/04.  Developed social withdrawal & speech loss.  2/24/05 dx w/RLL pneumonia; 12/05 bilat AOM & diaper rash; 4/06 viral URI; 10/06 viral pharyngitis. Loss of language, loss of eye contact, loss of reciprocal attention/joint attention. Parent remains adamently convinced that after these 5 injections her son was ill for a week (fever/lethargy) and never recovered his previous social nature. Language is slowly coming.
Age: 1.47
Sex: M
Vaccine: DTAP, FLU3, HBHEPB, MMR, PNC
Symptoms: Malaise, Pneumonia, Pyrexia, Regressive behaviour, Rhinorrhoea
Clinical narrative: On 10.14.04 - Patient received FLU, DTAP, COMVAX, MMR & PNEUM. conj after this did not talk, quiet, sick, tired, fever (HOT) 3-4 d. ibu. given did not eat with in 2 wks, eyes rolling (thought nl after vacc). Still does not eat well. Mom thought was regressing & mad abt being held down. In bed 3d. Mom lived with guilt for 10 mo, finally presented to Dr 9-7-05. Very severe delays/regression. Does not speak (did at 11 mo). Very restricted diet, refuses most foods.   5/8/09 Received vaccine & PCP medical records. FINAL DX: Autism spectrum disorder; mixed receptive-expressive language disorder; feeding difficulties; encopresis; constipation; dental caries Records reveal patient experienced runny nose s/p cold week prior to vaccination on 10/14/04.  Developed social withdrawal & speech loss.  2/24/05 dx w/RLL pneumonia; 12/05 bilat AOM & diaper rash; 4/06 viral URI; 10/06 viral pharyngitis. Loss of language, loss of eye contact, loss of reciprocal attention/joint attention. Parent remains adamently convinced that after these 5 injections her son was ill for a week (fever/lethargy) and never recovered his previous social nature. Language is slowly coming.
Age: 0.55
Sex: F
Vaccine: HEP, PNC
Symptoms: Appendicectomy, Intestinal obstruction, Intussusception
Clinical narrative: Patient admitted to hospital for a bowel obstruction on 3-29-08. On 3/29/09 Lap appendectomy performed. Pt had RUQ intussusception reduced using endoscopy. On 3/29/09 at hospital.  5/8/09 Received hospital medical records of 3/29-4/3/2009. FINAL DX: Intussusception s/p laparotomy appendectomy Records reveal patient experienced abdominal pain & fever x 3 days, no BM x 2 days.  Seen in outlying ER 1 wk prior to admit for abdominal pain, nausea, projectile vomiting which resolved for a few days then recurred.  Returned to outlying hospital & was admitted.  Abdominal x-ray there c/w bowel obstruction & was transferred to higher level of care.  Temp there was 101.7 on admit w/distended abdomen & decreased bowel sounds.  Surgery consult done s/p enema reduction.  Taken to OR where lap appy & running of small bowel done, no sign of IS at that time.  Bowel was dilated but viable.  Tx w/NGT, IVF & IV antibiotics.  Febrile through post op day 1 then afebrile, diet progressed & d/c to home.
Age: 19.0
Sex: M
Vaccine: HEP
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Red slightly raised sand paper type rash Right cheek, itching.
Age: 45.0
Sex: M
Vaccine: HEP
Symptoms: Erythema, Pruritus, Rash pustular, Urticaria
Clinical narrative: Scattered red raised itching welts periorbital, both eyes, raised red itching pustules back of both hands. Began 3 days after vaccine, presented to clinic 7 days after vaccine.
Age: 6.0
Sex: F
Vaccine: PPV, VARCEL
Symptoms: Injection site cellulitis
Clinical narrative: L upper arm cellulitis at injection site.
Age: 6.0
Sex: M
Vaccine: FLU3, HEPA, PPV, PPV
Symptoms: Injection site cellulitis
Clinical narrative: R upper arm cellulitis at injection site.
Age: 6.0
Sex: M
Vaccine: FLU3, HEPA, PPV, PPV
Symptoms: Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: R upper arm cellulitis at injection site.
Age: 49.0
Sex: F
Vaccine: IPV
Symptoms: Urticaria
Clinical narrative: Hives around neck, hairline and bilateral ears.
Age: 1.1
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Oedema peripheral, Pyrexia, Rash erythematous, Urticaria
Clinical narrative: Erythematous rash, swelling of hands, fever < 104 X 6 days with negative labs, whelps/wheals
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Decreased appetite, Diarrhoea, Faeces discoloured, Gastrooesophageal reflux disease
Clinical narrative: Having runny yellow diarrhea stools every 3-4 hrs.  No vomiting.  No fever.  No URI symptoms.  Some decreased appetite X2d.  Tried pedialyte:  diarrhea continued currently on Augmentin and Ancid for GERD.
Age: 21.0
Sex: M
Vaccine: RAB, TDAP
Symptoms: Syncope
Clinical narrative: Fainted - had not eaten.
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Rash, Rash macular
Clinical narrative: 3/25/09 received vaccination. 3/30/09 developed rash along jaw bone on face worse on L then on R - rash at base of throat down midline shape triangle. 4/1/09 contacted pharmacy told rash not due vaccine. Used OTC allergist cream - area on face resolved but not on upper chest flat blotchy rash with pin point flat areas covers area 3 1/2" triangle area allergist made it worse. Causing severe itching.
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV1
Symptoms: Rash erythematous, Rash macular
Clinical narrative: Patients mother called office approximately after leaving clinic stating patient had broken out in a rash. Mother was instructed to bring patient back in for Dr. to evaluate. When patient arrived he was in no distress, brought to a room and Dr. looked at rash. Rash was an erythematous macular rash mostly on his face. We had patient and parents stay in clinic approximately 45 minutes to an hour. Patient was never in any distress, rash did not change at all. Dr. instructed parents to watch patient, if he became distressed call 911 or go to Emergency Room. 4/15/09 spoke with patients mom. She stated rash was almost gone, and patient was doing fine.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site pruritus, Injection site reaction, Injection site warmth, Rash
Clinical narrative: Pt noticed there was a 4" circle at injection site 48 hrs after received the vaccine, it was hard, itchy and warm to touch. The rash spread pass elbow 96 hrs after the injection. Pt went to the doctor on 4/15/09. Dr. did not think it was a reaction to vaccine, but thought it was a reaction to the vehicle, pt was given LIDEX Rx, ATIVAN and BACTRIM DS
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Nausea, Pruritus, Pyrexia, Rash
Clinical narrative: Onset of mild - mod fever, nausea, severe pain at injection site evening of 3/16/09. Onset of itching + mild rash over body 3/17/2009.
Age: 14.0
Sex: F
Vaccine: TD, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness with swelling to R deltoid.
Age: 0.5
Sex: F
Vaccine: DTP, HIBV, PNC, RV5
Symptoms: Convulsion, Pyrexia
Clinical narrative: Seizure with fever T 103.8.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Blister, Erythema, Immunisation reaction, Pain, Skin lesion
Clinical narrative: See attached chart note dated 4-15-09  Patient presents today for evaluation of reaction to VARICELLA vaccine given 2 days ago.  Red swollen and tender over last 24 hours.  Now with new blister formation.  Primarily right upper arm, but some redness and warmth of left arm as well.  Diffuse warm erythema measuring about 3.5 inches in diameter in deltoid region of right arm with a few small yellow fluid filled bulbous lesions superficially largest about 1/2 cm in size.  Left arm with some mild erythema and warmth, non tender.  Immunization reaction- Ice to affected area TID.  Wrapped with silvadene and telfa bandage.  TYLENOL #3 for pain.  F/U tomorrow if not improving or worsening.  Complete VAERS form given large degree of reaction.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Skin warm, Swelling, Tenderness
Clinical narrative: See attached chart note dated 4-15-09  Patient presents today for evaluation of reaction to VARICELLA vaccine given 2 days ago.  Red swollen and tender over last 24 hours.  Now with new blister formation.  Primarily right upper arm, but some redness and warmth of left arm as well.  Diffuse warm erythema measuring about 3.5 inches in diameter in deltoid region of right arm with a few small yellow fluid filled bulbous lesions superficially largest about 1/2 cm in size.  Left arm with some mild erythema and warmth, non tender.  Immunization reaction- Ice to affected area TID.  Wrapped with silvadene and telfa bandage.  TYLENOL #3 for pain.  F/U tomorrow if not improving or worsening.  Complete VAERS form given large degree of reaction.
Age: 23.0
Sex: M
Vaccine: HEP, MNQ
Symptoms: Headache, Muscular weakness, Pyrexia
Clinical narrative: Headache, fever muscle weakness.
Age: 1.2
Sex: F
Vaccine: UNK
Symptoms: Blister
Clinical narrative: Blisters on back and on face.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Seen on 01/04/08 for school exam, PPD, and immunization update. Varicella given in right upper arm. Pt. returned on 01/07/08 for PPD reading. PPD 4mm. Upper arm had large red area from shoulder to elbow with firm round area at site about 3 inches wide. Pt. did not appear sick.
Age: 51.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Burning sensation, Joint range of motion decreased, Pain in extremity
Clinical narrative: This case was received from a health professional on 02 April 2009. A 51-year-old female patient, with a history of hypertension, rheumatic fever, and allergies to sulfa and codeine, received a right deltoid intramuscular injection of FLUZONE SV 2008-2009 (lot number U2810AA) on 04 November 2008. Approximately two weeks post-vaccination, she began experiencing severe pain and burning sensations in her right upper arm. She described the pain as intermittent, with a severity of 10/10 at when symptoms were at their worst. She also stated that it has affected her range of motion in the right arm, and noted that she was unable to lay on her right side. No diagnostic or laboratory testing had been performed, and the event remained ongoing. Documents held by sender: none.
Age: 51.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Burning sensation, Injected limb mobility decreased, Pain in extremity
Clinical narrative: This case was received from a health professional on 02 April 2009. A 51-year-old female patient, with a history of hypertension, rheumatic fever, and allergies to sulfa and codeine, received a right deltoid intramuscular injection of FLUZONE SV 2008-2009 (lot number U2810AA) on 04 November 2008. Approximately two weeks post-vaccination, she began experiencing severe pain and burning sensations in her right upper arm. She described the pain as intermittent, with a severity of 10/10 at when symptoms were at their worst. She also stated that it has affected her range of motion in the right arm, and noted that she was unable to lay on her right side. No diagnostic or laboratory testing had been performed, and the event remained ongoing. Documents held by sender: none.
Age: 0.25
Sex: F
Vaccine: HIBV, MEN
Symptoms: Crying, Injection site erythema
Clinical narrative: ABOUT H+4 HOURS AFTER WE NOTICED THE RIGHT LEG OF OUR BABY REALLY RED (AROUND WHERE THE VACCINS WERE DONE). ABOUT H+6 HOURS AFTER THE VACCINATION WAS DONE, OUR BABY START CRYING LIKE SHE NEVER DID BEFORE, NON STOP. WE CALLED THE DOCTOR ABOUT 30 MINUTES AFTER AND HE TOLD US THIS WAS A NORMAL REACTION. HE ADVISED US TO GIVE OUR BABY SOME BABY TYLENOL (EVERY 4 TO 6 HOURS) ABOUT .4 ON THE GAGE.
Age: 1.2
Sex: M
Vaccine: MMR, VARCEL, MMR
Symptoms: Blood product transfusion, Contusion, Gingival bleeding, Petechiae, Platelet count decreased
Clinical narrative: Two weeks after my son received the MMR, vaccine. I noticed red blotches & bruises on his skin. I took my son to the ER, and was informed that patient has a low platelet cound (3000). He was air ambulanced to a facility. Patient was placed on IVIG for two days and now on prednisone.
Age: 1.2
Sex: M
Vaccine: MMR, VARCEL, MMR
Symptoms: Thrombocytopenic purpura
Clinical narrative: Two weeks after my son received the MMR, vaccine. I noticed red blotches & bruises on his skin. I took my son to the ER, and was informed that patient has a low platelet cound (3000). He was air ambulanced to a facility. Patient was placed on IVIG for two days and now on prednisone.
Age: 1.2
Sex: M
Vaccine: MMR, VARCEL, MMR
Symptoms: Blood product transfusion, Contusion, Platelet count decreased, Rash erythematous, Rash macular
Clinical narrative: Two weeks after my son received the MMR, vaccine. I noticed red blotches & bruises on his skin. I took my son to the ER, and was informed that patient has a low platelet cound (3000). He was air ambulanced to a facility. Patient was placed on IVIG for two days and now on prednisone.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion induced, Drug exposure during pregnancy, Pregnancy test positive
Clinical narrative: Information has been received from a registered nurse, for the Pregnancy Registry for GARDASIL, concerning a 19 year old female who on 21-AUG-2008 and 03-MAR-2009 was vaccinated with her second and third dose of GARDASIL (lot number of the 2nd and 3rd dose was 661952/1129X, the lot number of the 1st dose was 659184/0843X) 0.5ml IM. There was no concomitant medication. The patient had a pregnancy test and was now pregnant. The last menstrual period was 27-JAN-2009. The estimated delivery date was 03-Nov-2009. The patient had not experienced any known symptoms. The patient sought medical attention. Follow-up information has been received from the nurse via a pregnancy questionnaire. The patient with a questionable no previous pregnancies and a questionable history of rheumatoid arthritis on 20-MAR-2009 underwent elective termination (methotrexate). Products of conception were not examined. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4, MEN
Symptoms: Asthenia, Chest pain, Computerised tomogram, Convulsion, Dizziness
Clinical narrative: Information has been received from a consumer concerning her 17 year old daughter with no pertinent medical history and no known drug allergies/drug reactions who on 16-FEB-2009 was vaccinated with the first dose of GARDASIL. Concomitant therapy included meningococcal vaccine (manufacturer unknown). It was reported that "2 hours after getting the vaccine" the patient started having trouble breathing and feeling chest pains. The patient was taken to the emergency room but was not admitted overnight. "A full work up was performed at the emergency room (results not provided), also a computed axial tomography scan, electroencephalography and magnetic resonance imaging were performed (results not provided). It was reported that she had couple more breathing episodes since. The patient also experienced seizure like activity starting on 11-MAR-2009. It was reported that the first seizure was pretty severe and the patient did not calm down until she was given ATIVAN. It was reported that the patient overall was experiencing tiredness, weakness, chest pains, dizziness and nausea. The patient was seen at the practice. It was reported that the patient had not recovered at the time of the report. Upon internal review, seizure-like activity was determined to be other important medical event. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, MEN
Symptoms: Dyspnoea, Electroencephalogram, Fatigue, Laboratory test, Nausea
Clinical narrative: Information has been received from a consumer concerning her 17 year old daughter with no pertinent medical history and no known drug allergies/drug reactions who on 16-FEB-2009 was vaccinated with the first dose of GARDASIL. Concomitant therapy included meningococcal vaccine (manufacturer unknown). It was reported that "2 hours after getting the vaccine" the patient started having trouble breathing and feeling chest pains. The patient was taken to the emergency room but was not admitted overnight. "A full work up was performed at the emergency room (results not provided), also a computed axial tomography scan, electroencephalography and magnetic resonance imaging were performed (results not provided). It was reported that she had couple more breathing episodes since. The patient also experienced seizure like activity starting on 11-MAR-2009. It was reported that the first seizure was pretty severe and the patient did not calm down until she was given ATIVAN. It was reported that the patient overall was experiencing tiredness, weakness, chest pains, dizziness and nausea. The patient was seen at the practice. It was reported that the patient had not recovered at the time of the report. Upon internal review, seizure-like activity was determined to be other important medical event. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, MEN
Symptoms: Nuclear magnetic resonance imaging
Clinical narrative: Information has been received from a consumer concerning her 17 year old daughter with no pertinent medical history and no known drug allergies/drug reactions who on 16-FEB-2009 was vaccinated with the first dose of GARDASIL. Concomitant therapy included meningococcal vaccine (manufacturer unknown). It was reported that "2 hours after getting the vaccine" the patient started having trouble breathing and feeling chest pains. The patient was taken to the emergency room but was not admitted overnight. "A full work up was performed at the emergency room (results not provided), also a computed axial tomography scan, electroencephalography and magnetic resonance imaging were performed (results not provided). It was reported that she had couple more breathing episodes since. The patient also experienced seizure like activity starting on 11-MAR-2009. It was reported that the first seizure was pretty severe and the patient did not calm down until she was given ATIVAN. It was reported that the patient overall was experiencing tiredness, weakness, chest pains, dizziness and nausea. The patient was seen at the practice. It was reported that the patient had not recovered at the time of the report. Upon internal review, seizure-like activity was determined to be other important medical event. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Alpha 1 foetoprotein, Drug exposure during pregnancy, Foetal disorder, Gestational diabetes, Glucose tolerance test abnormal
Clinical narrative: This serious case was received on 01 April 2008 from a health care professional. A 37 year old female patient with a history of asthma, high blood pressure, and hypothyroidism received FLUZONE SV 2007-2008 (lot number not reported) on 15 November 2007. Date of conception was 24 August 2007. On 28 February 2008 the patient had a glucose tolerance test. Subsequently the patient was diagnosed with gestational diabetes. No further information was provided. On 08 March 2008, 18 March 2008, 01 April 2008, and 12 May 2008 the patient had visits to the ER, details were not provided. On 14 May 2008 the patient gave birth at 39.7 weeks gestation (gender not provided). The baby's birth weight was 3.130 kg. The APGAR score was a 9 at one and 5 minutes. With the exception of pyloric stenosis, there were no further congenital anomalies or complications reported. Recovery status was not reported. List of Documents held by Sender: None. The reporter of this case is the same as case number 2009-01355.
Age: 36.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Ultrasound scan
Clinical narrative: This serious case was received on 01 April 2008 from a health care professional. A 37 year old female patient with a history of asthma, high blood pressure, and hypothyroidism received FLUZONE SV 2007-2008 (lot number not reported) on 15 November 2007. Date of conception was 24 August 2007. On 28 February 2008 the patient had a glucose tolerance test. Subsequently the patient was diagnosed with gestational diabetes. No further information was provided. On 08 March 2008, 18 March 2008, 01 April 2008, and 12 May 2008 the patient had visits to the ER, details were not provided. On 14 May 2008 the patient gave birth at 39.7 weeks gestation (gender not provided). The baby's birth weight was 3.130 kg. The APGAR score was a 9 at one and 5 minutes. With the exception of pyloric stenosis, there were no further congenital anomalies or complications reported. Recovery status was not reported. List of Documents held by Sender: None. The reporter of this case is the same as case number 2009-01355.
Age: 36.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Alpha 1 foetoprotein, Drug exposure during pregnancy, Foetal non-stress test, Gestational diabetes, Glucose tolerance test abnormal
Clinical narrative: This serious case was received on 01 April 2008 from a health care professional. A 37 year old female patient with a history of asthma, high blood pressure, and hypothyroidism received FLUZONE SV 2007-2008 (lot number not reported) on 15 November 2007. Date of conception was 24 August 2007. On 28 February 2008 the patient had a glucose tolerance test. Subsequently the patient was diagnosed with gestational diabetes. No further information was provided. On 08 March 2008, 18 March 2008, 01 April 2008, and 12 May 2008 the patient had visits to the ER, details were not provided. On 14 May 2008 the patient gave birth at 39.7 weeks gestation (gender not provided). The baby's birth weight was 3.130 kg. The APGAR score was a 9 at one and 5 minutes. With the exception of pyloric stenosis, there were no further congenital anomalies or complications reported. Recovery status was not reported. List of Documents held by Sender: None. The reporter of this case is the same as case number 2009-01355.
Age: 36.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Neonatal disorder, Ultrasound scan
Clinical narrative: This serious case was received on 01 April 2008 from a health care professional. A 37 year old female patient with a history of asthma, high blood pressure, and hypothyroidism received FLUZONE SV 2007-2008 (lot number not reported) on 15 November 2007. Date of conception was 24 August 2007. On 28 February 2008 the patient had a glucose tolerance test. Subsequently the patient was diagnosed with gestational diabetes. No further information was provided. On 08 March 2008, 18 March 2008, 01 April 2008, and 12 May 2008 the patient had visits to the ER, details were not provided. On 14 May 2008 the patient gave birth at 39.7 weeks gestation (gender not provided). The baby's birth weight was 3.130 kg. The APGAR score was a 9 at one and 5 minutes. With the exception of pyloric stenosis, there were no further congenital anomalies or complications reported. Recovery status was not reported. List of Documents held by Sender: None. The reporter of this case is the same as case number 2009-01355.
Age: 0.6
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Computerised tomogram normal, Condition aggravated, Full blood count normal, Laboratory test normal, Lumbar puncture
Clinical narrative: Initial SAE report received on 04 April 2009. This subject is a female infant with no family history of seizures experienced febrile seizures while enrolled in a study of DAPTACEL which was administered along with ACTHIB, IPOL, PREVNAR (manufacturer Wyeth), ENGERIX (manufacturer GSK) on 28 August 2003 (lot numbers were not reported). The subject previously received INFANRIX (manufacturer GSK) on 27 March 2003 and PEDIARIX (manufacturer GSK) on 19 May 2003 (lot numbers not reported). The subject had suffered from seizures since birth (23 January 2003) which were controlled with phenobarbital and Dilantin. Her seizures were described as the subject turning red, giving a loud scream, jerking and stiffness which would last two to three minutes. On 09 July 2003 the subject had a neurology visit. During the visit it was noted that a recent EEG showed a relatively benign background, with photic driving on the left side and not on the right, suggested an asymmetry of the occipital lobe function on one side, possibly on the right. Developmentally at 6 months she had a high pitch cry as her mode of communication but had some babbling sounds emerging. She was not yet sitting up on her own, but would lie on her stomach and push herself into a V shape with her feet on the floor and then arch herself forward. Exam showed a weight of 7.35 kg, height of 25 inches, head circumference 16.5 inches. Neurological exam showed an alert, happy, interactive child. Facial movement was strong and symmetric. Motor examination showed relatively normal bulk, tone, and strength. MRI to be scheduled later that month and a referral was recommended due to the risk of developmental delays. In addition, hearing and ophthalmology screening tests will be performed due to risk in sensory areas. One day post vaccination, on 29 August 2003 the subject presented with a fever and change in mental status and was admitted to the hospital. The subject had a spinal tap which was negative and a CT scan of the brain which was normal. Her medication was adjusted and she did well, returning to baseline managed seizure disorder. The subject was discharged on 30 August 2003. On 29 October 2003 the subject had a neurology consultation. The subject continued to make excellent developmental progress and had been weaned off Dilantin. At the time the subject was taking on phenobarbital 4 ml twice a day. Upon assessment, her weight was 8.15 kg, height was 28 inches, head circumference 17 1/4 inches. Developmentally she was bearing weight, sitting independently, had a pincer grasp bilaterally, and reaching for objects. Impression included normal developmental and neurological examination. Follow up was recommended in three to six months. The fever was reported as "possibly due to receipt of vaccine". The seizure disorder was determined as congenital and unrelated. List of Documents held by Sender: progress notes and labs.
Age: 0.6
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Mental status changes, Neurological examination, Pyrexia, Urine analysis normal
Clinical narrative: Initial SAE report received on 04 April 2009. This subject is a female infant with no family history of seizures experienced febrile seizures while enrolled in a study of DAPTACEL which was administered along with ACTHIB, IPOL, PREVNAR (manufacturer Wyeth), ENGERIX (manufacturer GSK) on 28 August 2003 (lot numbers were not reported). The subject previously received INFANRIX (manufacturer GSK) on 27 March 2003 and PEDIARIX (manufacturer GSK) on 19 May 2003 (lot numbers not reported). The subject had suffered from seizures since birth (23 January 2003) which were controlled with phenobarbital and Dilantin. Her seizures were described as the subject turning red, giving a loud scream, jerking and stiffness which would last two to three minutes. On 09 July 2003 the subject had a neurology visit. During the visit it was noted that a recent EEG showed a relatively benign background, with photic driving on the left side and not on the right, suggested an asymmetry of the occipital lobe function on one side, possibly on the right. Developmentally at 6 months she had a high pitch cry as her mode of communication but had some babbling sounds emerging. She was not yet sitting up on her own, but would lie on her stomach and push herself into a V shape with her feet on the floor and then arch herself forward. Exam showed a weight of 7.35 kg, height of 25 inches, head circumference 16.5 inches. Neurological exam showed an alert, happy, interactive child. Facial movement was strong and symmetric. Motor examination showed relatively normal bulk, tone, and strength. MRI to be scheduled later that month and a referral was recommended due to the risk of developmental delays. In addition, hearing and ophthalmology screening tests will be performed due to risk in sensory areas. One day post vaccination, on 29 August 2003 the subject presented with a fever and change in mental status and was admitted to the hospital. The subject had a spinal tap which was negative and a CT scan of the brain which was normal. Her medication was adjusted and she did well, returning to baseline managed seizure disorder. The subject was discharged on 30 August 2003. On 29 October 2003 the subject had a neurology consultation. The subject continued to make excellent developmental progress and had been weaned off Dilantin. At the time the subject was taking on phenobarbital 4 ml twice a day. Upon assessment, her weight was 8.15 kg, height was 28 inches, head circumference 17 1/4 inches. Developmentally she was bearing weight, sitting independently, had a pincer grasp bilaterally, and reaching for objects. Impression included normal developmental and neurological examination. Follow up was recommended in three to six months. The fever was reported as "possibly due to receipt of vaccine". The seizure disorder was determined as congenital and unrelated. List of Documents held by Sender: progress notes and labs.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Blood glucose increased, Chills, Erythema, Fatigue
Clinical narrative: Pain, redness, swelling, fever(101), headache, tiredness, chills, body aches, sore joints, 3" hard mass at injection site, sugar spiked to 286 (norm has been 160)
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Injection site induration, Injection site mass, Pain, Pyrexia
Clinical narrative: Pain, redness, swelling, fever(101), headache, tiredness, chills, body aches, sore joints, 3" hard mass at injection site, sugar spiked to 286 (norm has been 160)
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Swelling, Tenderness
Clinical narrative: Pain, redness, swelling, fever(101), headache, tiredness, chills, body aches, sore joints, 3" hard mass at injection site, sugar spiked to 286 (norm has been 160)
Age: 1.6
Sex: M
Vaccine: FLU3, HEPA, PNC, VARCEL
Symptoms: Blister, Ear infection, Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: LARGE RED LUMP WITH BLISTER L POSTERIOR UPPER ARM QUARTER SIZE DIAMETER. PAINFUL TO TOUCH. 3 SMALL BLISTERS AT L ELBOW. DEVELOPED 4/15/09. PT HAD STUFFY RUNNY NOSE WITH SLIGHT COUGH FOR 4 DAYS PRIOR TO DATE OF VACCINATION 4/2/09. TEMP 98.6 LUNGS CLEAR HEENT WNL..GETTING BETTER.4/7/09 PT DEVELOPED 103 FEVER WENT TO PMD DR 4/10 DX OTITIS PLACED ON AMOXICILLIN. 4/16/09 PT STILL HAS BLISTER TYPE RASH.
Age: 1.6
Sex: M
Vaccine: FLU3, HEPA, PNC, VARCEL
Symptoms: Injection site vesicles, Pyrexia, Rash
Clinical narrative: LARGE RED LUMP WITH BLISTER L POSTERIOR UPPER ARM QUARTER SIZE DIAMETER. PAINFUL TO TOUCH. 3 SMALL BLISTERS AT L ELBOW. DEVELOPED 4/15/09. PT HAD STUFFY RUNNY NOSE WITH SLIGHT COUGH FOR 4 DAYS PRIOR TO DATE OF VACCINATION 4/2/09. TEMP 98.6 LUNGS CLEAR HEENT WNL..GETTING BETTER.4/7/09 PT DEVELOPED 103 FEVER WENT TO PMD DR 4/10 DX OTITIS PLACED ON AMOXICILLIN. 4/16/09 PT STILL HAS BLISTER TYPE RASH.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Staring, Unresponsive to stimuli
Clinical narrative: Parents reported blank stare and unrespoonsive after vaccine, lasting for 30 seconds.  Parents never sought medical attention after episode.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Anxiety, Injected limb mobility decreased, Irritability, Muscle rupture, Muscle spasms
Clinical narrative: I had local pain, irritation, swelling, and decreased range of motion within 30 min. of the injection to the left arm. Within 4 hours all of that pain radiated to my left shoulder and neck. Within 24 hours I continued to have all the previous mentioned symptoms along with palpitations, anxiety, bilateral hand and feet muscle spasm that ascended to the forearms and calves. At 35 hours post injection while running/sprinting both of my quadriceps became completely tight/frozen causing me to tear my right quad and strain my left quad. 48 hours post injection I continue to have bilateral hand and feet spasms, muscle cramping, nervous feeling that ascends along with intense thigh pain.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Muscle strain, Pain, Palpitations, Swelling
Clinical narrative: I had local pain, irritation, swelling, and decreased range of motion within 30 min. of the injection to the left arm. Within 4 hours all of that pain radiated to my left shoulder and neck. Within 24 hours I continued to have all the previous mentioned symptoms along with palpitations, anxiety, bilateral hand and feet muscle spasm that ascended to the forearms and calves. At 35 hours post injection while running/sprinting both of my quadriceps became completely tight/frozen causing me to tear my right quad and strain my left quad. 48 hours post injection I continue to have bilateral hand and feet spasms, muscle cramping, nervous feeling that ascends along with intense thigh pain.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, RV5
Symptoms: C-reactive protein normal, Complement factor normal, Juvenile arthritis, Red blood cell sedimentation rate normal, Rheumatoid factor negative
Clinical narrative: Polyarticular arthritis within 3days of vaccine administration. Infant was admitted with lab samples taken from CSF, blood and urine. He was given pain medication.  4/21/09 Received hospital medical records of 3/22-3/24/2009. FINAL DX: joint swelling, possible vaccine reaction; fever Records reveal patient experienced fever x 2 da & redness/warmth/swelling of elbows, feet & knees x 1 da w/irritability when picked up or moved.  Tx w/IV antibiotics & tylenol.  Rheum consult done.  Improved & d/c to home on no meds w/PCP f/u.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal pain, Tendonitis
Clinical narrative: Client c/o pain from Lt shoulder eight hours after receiving the tdap boost in the Lt Deltoid muscle. Client was seen by her Pvt MD and dx with tendonitis of the Lt shoulder. Client was told to take ibuprofen 800mg 3x a day for the pain.Client seen by MD on 03/31/09.Called client on 4/16/09 and she continues to have pain.Client states the pain had decreased a small amount and she continues to take ibuprofen. Client notified the health dept on 4/10/09 about her side effects from the Tdap vaccine
Age: 0.2
Sex: M
Vaccine: DTP, HIBV, DTAP, HIBV
Symptoms: Breath sounds abnormal, Change in sustained attention, Crying, Depressed level of consciousness, Dyspnoea
Clinical narrative: He received his vaccination on Monday April 13 around noon time. A fever began within 6- 8 hours after shots (102.5 F), sleepy and very irritable throughout the night crying hysterically on and off. His hunger is diminished although he is still eating. Tuesday he breaks out with a slight rash. Tuesday evening he has great trouble waking up. We don't hear him breathing as normal. Normally you can hear him breathe but Tuesday you can't hear him. My wife comes over to the bed and can't wake him up. It's as though he is unconscious. After running downstairs and doing everything he finally wakes up and begins to cry during feedings. Cry hysterically during feedings! He isn't latching on to his bottle as normal. Doesn't focus when looking around anymore and looks like as if he is staring around into the abyss. The following afternoon Wednesday April 15, his rash is breaking out all over. Once again we cannot wake him up. We call the doctor, and they urge us to bring him in. On the way to the doctor he falls back into his unconscious state. We can't hear him breathe. We can't wake him up! We are in a car going down the highway trying to get our son to open his eyes he does not. We can't hear him breathe. We call the doctor, they advise that we call 911 and have an ambulance come to our location. I suggest we just go to the hospital which is close by. Upon arrival at ER we explain to Doctor that he just had his shots. The chief doctor from the Children's Medical Group suggest he has an infection and recommend 3 things. 1. blood test, 2.Urine test, 3. Spinal tap. Spinal tap for Meningitis! I suggested that all these symptoms happened right after the shot and would like the doctors to consider that. They refuse to do so! They will not acknowledge that the shot could have something to do with it. They did acknowledge that he had a 99.1 fever and that he was pale at time of arrival and not alert.  5/14/2009 hospital records received DOS 4/15/09 to 4/16/09. FINAL DIAGNOSIS: R/O sepsis Post vaccination: epsodes of unresponsiveness and bluish discoloration. Fever. Diffuse rash. Swollen leg/foot due to IV infusion.
Age: 0.2
Sex: M
Vaccine: DTP, HIBV, DTAP, HIBV
Symptoms: Hypophagia, Infection, Irritability, Laboratory test normal, Pallor
Clinical narrative: He received his vaccination on Monday April 13 around noon time. A fever began within 6- 8 hours after shots (102.5 F), sleepy and very irritable throughout the night crying hysterically on and off. His hunger is diminished although he is still eating. Tuesday he breaks out with a slight rash. Tuesday evening he has great trouble waking up. We don't hear him breathing as normal. Normally you can hear him breathe but Tuesday you can't hear him. My wife comes over to the bed and can't wake him up. It's as though he is unconscious. After running downstairs and doing everything he finally wakes up and begins to cry during feedings. Cry hysterically during feedings! He isn't latching on to his bottle as normal. Doesn't focus when looking around anymore and looks like as if he is staring around into the abyss. The following afternoon Wednesday April 15, his rash is breaking out all over. Once again we cannot wake him up. We call the doctor, and they urge us to bring him in. On the way to the doctor he falls back into his unconscious state. We can't hear him breathe. We can't wake him up! We are in a car going down the highway trying to get our son to open his eyes he does not. We can't hear him breathe. We call the doctor, they advise that we call 911 and have an ambulance come to our location. I suggest we just go to the hospital which is close by. Upon arrival at ER we explain to Doctor that he just had his shots. The chief doctor from the Children's Medical Group suggest he has an infection and recommend 3 things. 1. blood test, 2.Urine test, 3. Spinal tap. Spinal tap for Meningitis! I suggested that all these symptoms happened right after the shot and would like the doctors to consider that. They refuse to do so! They will not acknowledge that the shot could have something to do with it. They did acknowledge that he had a 99.1 fever and that he was pale at time of arrival and not alert.  5/14/2009 hospital records received DOS 4/15/09 to 4/16/09. FINAL DIAGNOSIS: R/O sepsis Post vaccination: epsodes of unresponsiveness and bluish discoloration. Fever. Diffuse rash. Swollen leg/foot due to IV infusion.
Age: 0.2
Sex: M
Vaccine: DTP, HIBV, DTAP, HIBV
Symptoms: Pyrexia, Rash, Rash generalised, Somnolence, Staring
Clinical narrative: He received his vaccination on Monday April 13 around noon time. A fever began within 6- 8 hours after shots (102.5 F), sleepy and very irritable throughout the night crying hysterically on and off. His hunger is diminished although he is still eating. Tuesday he breaks out with a slight rash. Tuesday evening he has great trouble waking up. We don't hear him breathing as normal. Normally you can hear him breathe but Tuesday you can't hear him. My wife comes over to the bed and can't wake him up. It's as though he is unconscious. After running downstairs and doing everything he finally wakes up and begins to cry during feedings. Cry hysterically during feedings! He isn't latching on to his bottle as normal. Doesn't focus when looking around anymore and looks like as if he is staring around into the abyss. The following afternoon Wednesday April 15, his rash is breaking out all over. Once again we cannot wake him up. We call the doctor, and they urge us to bring him in. On the way to the doctor he falls back into his unconscious state. We can't hear him breathe. We can't wake him up! We are in a car going down the highway trying to get our son to open his eyes he does not. We can't hear him breathe. We call the doctor, they advise that we call 911 and have an ambulance come to our location. I suggest we just go to the hospital which is close by. Upon arrival at ER we explain to Doctor that he just had his shots. The chief doctor from the Children's Medical Group suggest he has an infection and recommend 3 things. 1. blood test, 2.Urine test, 3. Spinal tap. Spinal tap for Meningitis! I suggested that all these symptoms happened right after the shot and would like the doctors to consider that. They refuse to do so! They will not acknowledge that the shot could have something to do with it. They did acknowledge that he had a 99.1 fever and that he was pale at time of arrival and not alert.  5/14/2009 hospital records received DOS 4/15/09 to 4/16/09. FINAL DIAGNOSIS: R/O sepsis Post vaccination: epsodes of unresponsiveness and bluish discoloration. Fever. Diffuse rash. Swollen leg/foot due to IV infusion.