chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.2
Sex: F
Vaccine: DTAP
Symptoms: Hypersomnia, Lethargy, Pyrexia, Screaming
Clinical narrative: Pertussis - patient slept more then normal amounts of time after receiving her DTaP shot, seeming very lathargic, and when she was awake, would scream non-stop like she was in severe pain.  This lasted about 2-3 days, along with a fever.  We have since not vaxed her for Pertussis.
Age: 0.67
Sex: F
Vaccine: DTAPHEPBIP, PNC, RV5, DTAPHEPBIP, PNC, RV5
Symptoms: Intussusception, Surgery
Clinical narrative: Information has been received concerning an 8 month old female, with no medical history, who on 08-DEC-2006, at 10:00am, was vaccinated with a third oral dose of Rotateq (lot #653981/0411F). Concomitant vaccines administered on the same day included a third intramuscular dose in the left leg of Pediarix (lot #AC21B059AA) and a third intramuscular dose in the left leg of Prevnar (lot #B08658H). There was no illness at the time of vaccination. On 26-JAN-2007, at 8:00am, the patient experienced intussusception requiring surgery and was hospitalized for two days. Subsequently, the patient recovered. The patient's experience was considered to be immediately life-threatening by the reporter. A lot check was requested. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements and was released. Additional information has been requested.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Barium enema, Haematochezia, Intussusception, Irritability, Laparotomy
Clinical narrative: Information has been received from a physician concerning  24 week old male, with no medical history and no allergies, who was vaccinated with oral first and second doses of Rotateq (human-bovine) (Lot# 655175/0849F and 655296/0979F, respectively), on 20-OCT-2006 and 19-DEC-2006, respectively. Concomitant vaccinations included a first and second dose in the left leg of Pediarix (Lot# AC2113089AA), on 20-OCT-2006 and 19-DEC-2006, respectively, a first and second intramuscular dose in the right leg of ActHib (Lot#UE867AA), on 20-OCT-2006 and 19-DEC-2006, respectively,a nd a first and second intramuscular dose in the right leg of Prevnar (Lot# B08646F), on 20-OCT-2006 and 19-DEC-2006, respectively. "Five days prior to the onset of intussusception," on 04-FEB-2007, the patient came into the office with a cold and ear infection. The patient was prescribed amoxicillin for his ear infection. On 09-FEB-2007, at 6:00 a.m., the patient developed irritability, bilious vomiting, and bloody stool. The patient was diagnosed with intussusception, but was deemed not successful. The patient required laparotomy, manual reduction, and a bowel resection of the necrotic portion. The patient was discharged from the hospital on 14-FEB-2007. The physician indicated that the patient was doing well now and was recovered. No other information was provided. The patient's intussusception was considered to be disabling, immediately life threatening,and an other important medical event by the reporter. Lot checks have been requested. Additional information has been requested.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning  24 week old male, with no medical history and no allergies, who was vaccinated with oral first and second doses of Rotateq (human-bovine) (Lot# 655175/0849F and 655296/0979F, respectively), on 20-OCT-2006 and 19-DEC-2006, respectively. Concomitant vaccinations included a first and second dose in the left leg of Pediarix (Lot# AC2113089AA), on 20-OCT-2006 and 19-DEC-2006, respectively, a first and second intramuscular dose in the right leg of ActHib (Lot#UE867AA), on 20-OCT-2006 and 19-DEC-2006, respectively,a nd a first and second intramuscular dose in the right leg of Prevnar (Lot# B08646F), on 20-OCT-2006 and 19-DEC-2006, respectively. "Five days prior to the onset of intussusception," on 04-FEB-2007, the patient came into the office with a cold and ear infection. The patient was prescribed amoxicillin for his ear infection. On 09-FEB-2007, at 6:00 a.m., the patient developed irritability, bilious vomiting, and bloody stool. The patient was diagnosed with intussusception, but was deemed not successful. The patient required laparotomy, manual reduction, and a bowel resection of the necrotic portion. The patient was discharged from the hospital on 14-FEB-2007. The physician indicated that the patient was doing well now and was recovered. No other information was provided. The patient's intussusception was considered to be disabling, immediately life threatening,and an other important medical event by the reporter. Lot checks have been requested. Additional information has been requested.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Barium enema, Ear infection, Gastrointestinal necrosis, Haematochezia, Intussusception
Clinical narrative: Information has been received from a physician concerning  24 week old male, with no medical history and no allergies, who was vaccinated with oral first and second doses of Rotateq (human-bovine) (Lot# 655175/0849F and 655296/0979F, respectively), on 20-OCT-2006 and 19-DEC-2006, respectively. Concomitant vaccinations included a first and second dose in the left leg of Pediarix (Lot# AC2113089AA), on 20-OCT-2006 and 19-DEC-2006, respectively, a first and second intramuscular dose in the right leg of ActHib (Lot#UE867AA), on 20-OCT-2006 and 19-DEC-2006, respectively,a nd a first and second intramuscular dose in the right leg of Prevnar (Lot# B08646F), on 20-OCT-2006 and 19-DEC-2006, respectively. "Five days prior to the onset of intussusception," on 04-FEB-2007, the patient came into the office with a cold and ear infection. The patient was prescribed amoxicillin for his ear infection. On 09-FEB-2007, at 6:00 a.m., the patient developed irritability, bilious vomiting, and bloody stool. The patient was diagnosed with intussusception, but was deemed not successful. The patient required laparotomy, manual reduction, and a bowel resection of the necrotic portion. The patient was discharged from the hospital on 14-FEB-2007. The physician indicated that the patient was doing well now and was recovered. No other information was provided. The patient's intussusception was considered to be disabling, immediately life threatening,and an other important medical event by the reporter. Lot checks have been requested. Additional information has been requested.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Irritability, Laparotomy, Nasopharyngitis, Small intestinal resection, Surgery
Clinical narrative: Information has been received from a physician concerning  24 week old male, with no medical history and no allergies, who was vaccinated with oral first and second doses of Rotateq (human-bovine) (Lot# 655175/0849F and 655296/0979F, respectively), on 20-OCT-2006 and 19-DEC-2006, respectively. Concomitant vaccinations included a first and second dose in the left leg of Pediarix (Lot# AC2113089AA), on 20-OCT-2006 and 19-DEC-2006, respectively, a first and second intramuscular dose in the right leg of ActHib (Lot#UE867AA), on 20-OCT-2006 and 19-DEC-2006, respectively,a nd a first and second intramuscular dose in the right leg of Prevnar (Lot# B08646F), on 20-OCT-2006 and 19-DEC-2006, respectively. "Five days prior to the onset of intussusception," on 04-FEB-2007, the patient came into the office with a cold and ear infection. The patient was prescribed amoxicillin for his ear infection. On 09-FEB-2007, at 6:00 a.m., the patient developed irritability, bilious vomiting, and bloody stool. The patient was diagnosed with intussusception, but was deemed not successful. The patient required laparotomy, manual reduction, and a bowel resection of the necrotic portion. The patient was discharged from the hospital on 14-FEB-2007. The physician indicated that the patient was doing well now and was recovered. No other information was provided. The patient's intussusception was considered to be disabling, immediately life threatening,and an other important medical event by the reporter. Lot checks have been requested. Additional information has been requested.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Vomiting, X-ray
Clinical narrative: Information has been received from a physician concerning  24 week old male, with no medical history and no allergies, who was vaccinated with oral first and second doses of Rotateq (human-bovine) (Lot# 655175/0849F and 655296/0979F, respectively), on 20-OCT-2006 and 19-DEC-2006, respectively. Concomitant vaccinations included a first and second dose in the left leg of Pediarix (Lot# AC2113089AA), on 20-OCT-2006 and 19-DEC-2006, respectively, a first and second intramuscular dose in the right leg of ActHib (Lot#UE867AA), on 20-OCT-2006 and 19-DEC-2006, respectively,a nd a first and second intramuscular dose in the right leg of Prevnar (Lot# B08646F), on 20-OCT-2006 and 19-DEC-2006, respectively. "Five days prior to the onset of intussusception," on 04-FEB-2007, the patient came into the office with a cold and ear infection. The patient was prescribed amoxicillin for his ear infection. On 09-FEB-2007, at 6:00 a.m., the patient developed irritability, bilious vomiting, and bloody stool. The patient was diagnosed with intussusception, but was deemed not successful. The patient required laparotomy, manual reduction, and a bowel resection of the necrotic portion. The patient was discharged from the hospital on 14-FEB-2007. The physician indicated that the patient was doing well now and was recovered. No other information was provided. The patient's intussusception was considered to be disabling, immediately life threatening,and an other important medical event by the reporter. Lot checks have been requested. Additional information has been requested.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Barium enema, Ear infection, Haematochezia, Intussusception, Irritability
Clinical narrative: Information has been received from a physician concerning  24 week old male, with no medical history and no allergies, who was vaccinated with oral first and second doses of Rotateq (human-bovine) (Lot# 655175/0849F and 655296/0979F, respectively), on 20-OCT-2006 and 19-DEC-2006, respectively. Concomitant vaccinations included a first and second dose in the left leg of Pediarix (Lot# AC2113089AA), on 20-OCT-2006 and 19-DEC-2006, respectively, a first and second intramuscular dose in the right leg of ActHib (Lot#UE867AA), on 20-OCT-2006 and 19-DEC-2006, respectively,a nd a first and second intramuscular dose in the right leg of Prevnar (Lot# B08646F), on 20-OCT-2006 and 19-DEC-2006, respectively. "Five days prior to the onset of intussusception," on 04-FEB-2007, the patient came into the office with a cold and ear infection. The patient was prescribed amoxicillin for his ear infection. On 09-FEB-2007, at 6:00 a.m., the patient developed irritability, bilious vomiting, and bloody stool. The patient was diagnosed with intussusception, but was deemed not successful. The patient required laparotomy, manual reduction, and a bowel resection of the necrotic portion. The patient was discharged from the hospital on 14-FEB-2007. The physician indicated that the patient was doing well now and was recovered. No other information was provided. The patient's intussusception was considered to be disabling, immediately life threatening,and an other important medical event by the reporter. Lot checks have been requested. Additional information has been requested.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Laparotomy, Nasopharyngitis, Small intestinal resection, Vomiting, X-ray
Clinical narrative: Information has been received from a physician concerning  24 week old male, with no medical history and no allergies, who was vaccinated with oral first and second doses of Rotateq (human-bovine) (Lot# 655175/0849F and 655296/0979F, respectively), on 20-OCT-2006 and 19-DEC-2006, respectively. Concomitant vaccinations included a first and second dose in the left leg of Pediarix (Lot# AC2113089AA), on 20-OCT-2006 and 19-DEC-2006, respectively, a first and second intramuscular dose in the right leg of ActHib (Lot#UE867AA), on 20-OCT-2006 and 19-DEC-2006, respectively,a nd a first and second intramuscular dose in the right leg of Prevnar (Lot# B08646F), on 20-OCT-2006 and 19-DEC-2006, respectively. "Five days prior to the onset of intussusception," on 04-FEB-2007, the patient came into the office with a cold and ear infection. The patient was prescribed amoxicillin for his ear infection. On 09-FEB-2007, at 6:00 a.m., the patient developed irritability, bilious vomiting, and bloody stool. The patient was diagnosed with intussusception, but was deemed not successful. The patient required laparotomy, manual reduction, and a bowel resection of the necrotic portion. The patient was discharged from the hospital on 14-FEB-2007. The physician indicated that the patient was doing well now and was recovered. No other information was provided. The patient's intussusception was considered to be disabling, immediately life threatening,and an other important medical event by the reporter. Lot checks have been requested. Additional information has been requested.
Age: 39.0
Sex: M
Vaccine: ANTH, FLUX, HEP, HEPA, MEN, MMR, TD, TYP
Symptoms: Amnesia, Arthralgia, Neck pain, Nuclear magnetic resonance imaging, Vision blurred
Clinical narrative: Constant pain in the neck, diagnosed as arthritic after MRI in 2004 showed nothing related to trauma, treatment still ongoing, as traction only temporarily relieves pain, issued a cervical device to provide self administered traction for use during periods of no health care coverage. Prescribed Celebrex to lessen the pain, however due to inadequate medical care, after release from active duty, could not afford to continue regimen. Inability to focus on tasks within a few days of the initial series, and spouse noticed almost immediately a marked loss of short term memory continuing to the present.  No treatment.
Age: 0.0
Sex: U
Vaccine: ANTH
Symptoms: Amnesia, Arthralgia, Neck pain, Nuclear magnetic resonance imaging, Vision blurred
Clinical narrative: Constant pain in the neck, diagnosed as arthritic after MRI in 2004 showed nothing related to trauma, treatment still ongoing, as traction only temporarily relieves pain, issued a cervical device to provide self administered traction for use during periods of no health care coverage. Prescribed Celebrex to lessen the pain, however due to inadequate medical care, after release from active duty, could not afford to continue regimen.    Inability to focus on tasks within a few days of the initial series, and spouse noticed almost immediately a marked loss of short term memory continuing to the present.  No treatment.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Change of bowel habit, Diarrhoea, Frequent bowel movements
Clinical narrative: 6 days after receiving the RotaTeq vaccine, my son's bowel pattern changed DRASTICALLY. He was having a BM approximately once a week, with a consistancy not quite as thick as peanut butter. Six days after he receive the vaccine, he began to have much looser stools, and the frequency jumped to as many as 7 movements per day. Over the next 8 days, it got looser and looser, until there was more clear liquid than "solid" yellow in his diapers. His pediatrician refuses to admit it could be related to the vaccine, and refused to see my child. We are now 17 days into this new pooping schedule, and it shows very little sign of improvement yet. I am at my wits end with the runny poo, and am switching pediatricians and making an appointment for Monday to have a stool sample cultured. I'm quite worried about my son. If he happens to finish a BM during a diaper change, it looks like sputum, not poop. I've read elsewhere that diarrhea is a side effect of this vaccine, but 2 1/2 weeks of diarrhea is a bit drastic. The CDC said to report any changes in bowel movements to the Doctor, but the Doctor has blown it off, so I'm taking it a step further.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site rash
Clinical narrative: PATIENT NOTED "SPOTS" ON LEFT ARM NEAR SITE OF VACCINE 36 HOURS AFTER ADMINISTERED VACCINE
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Body temperature increased, Dyspnoea, Erythema, Pyrexia
Clinical narrative: Patient had his shots between 1:00pm and 1:30pm on Aug 7 2006. That evening around 7:00 he started to get a fever (101.7). By 7:30 his temp was 103.5 so I gave him infant tylenol and waited...his fever continued to climb, I contacted our  doctor and by the time I spoke to a doctor patient had a fever of 104.9 and was red all over his body as well as when he breathed it wounded like he was wheezing and he was breathing faster. The doctor told me to monitor him and he was fine as long as I felt ok watching him. His fever was at 105 for at least 48 hours as well as the reddness of his skin and breathing.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Body temperature increased, Crying, Dyspnoea, Vaccination complication
Clinical narrative: Patients mom reported 0n 2/22/07 that an hour after her infant's first series of vaccines (12/11/06)the infant had intermittent crying spells with low grade temp and at times, seemed as though she was having difficulty breathing and perhaps gasping. These symptoms reportedly persisted throughout the evening and into the early hours of the next morning when the symptoms resolved. The patients mom denied any acute distress, cyanosis, limpness or seizures. On Exam 2/22/07, the patient was afebrile and displayed no signs or symptoms of distress or any symptoms related to the above. At the time of her office visit on 02/22/07 a specialist in infectious diseases was consulted and indicated that these symptoms were consistent with an adverse reaction to DtaP (Daptacel). The next series of vaccines were held and the patient is to follow up in my office for evaluation in one week.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Erythema, Oedema, Tenderness
Clinical narrative: Lt. leg erythema, edema & tenderness. Edema of 10 cm x 11 1/2 cm in area.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site nodule, Injection site pain
Clinical narrative: Left leg positive for erythematous area, positive tenderness, & positive nodule. Lt. leg red @ injection site. Child uncooperative. Not able to take measurements for erythema.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Discomfort, Hypersensitivity, Rash
Clinical narrative: Noticable rash and discomfort after first innoculation and severe reaction after second innoculation.  Minimizing allergic reaction required multiple visits to the clinic and multiple persciptions.  (Note of interest:  this patients child almost died after second Hep B innoculation and was granted a school waiver for the third shot in the series).
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Barium enema, Intussusception
Clinical narrative: Pt received Rotateq #1 12/29/06. Pt developed intussusception 2/23/07 which was successfully reduced by barium enema. Child did well following reduction without significant sequelae. 3/15/07 Received medical records from hospital which reveal patient experienced loose stools 1 of which was bloody.  Became lethargic w/low grade fever. BE enema successful.  Held overnight for observation.  Did well & was d/c home next day. FINAL DX: Intussusception, successfully reduced w/BE enema.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal X-ray, Barium enema, Intussusception
Clinical narrative: Pt received Rotateq #1 12/29/06. Pt developed intussusception 2/23/07 which was successfully reduced by barium enema. Child did well following reduction without significant sequelae. 3/15/07 Received medical records from hospital which reveal patient experienced loose stools 1 of which was bloody.  Became lethargic w/low grade fever. BE enema successful.  Held overnight for observation.  Did well & was d/c home next day. FINAL DX: Intussusception, successfully reduced w/BE enema.
Age: 0.32
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Irritability, Rash, Wheezing
Clinical narrative: Following immunizations, child developed facial rash that extended to neck and chest and some bilateral lower extremity involvement within 15 minutes of getting vaccines.  Child very fussy.  Given Benadryl and rash resolved but returned within 30 minutes.  Child sick with afebrile uri at time of vaccination.  Child had some wheezing during visit as well. 3/30/07 Received medical records from hospital which reveal patient experienced a 1 week history of bronchiolitis w/home nebs.  Seen on 12/28/06 by PCP for recheck & was given vax.  Within 15 min developed rash & had respiratory distress.  Received Benadryl in office which he vomited & dose repeated along w/oral steroids & neb treatment.  Had low grade fever & runny nose.  Afebrile on admission, O2 sat was 100% on RA.  Lungs had occasional rhonchi & wheeze.  Rash had resolved prior to ER.  Admitted overnight for continued observation.  Progressed well w/some emesis overnight & small rash noted on cheeks.  D/C to home next day on continued oral steroids & nebs. FINAL DX: Allergic reaction; resolving bronchiolitis; & resolving thrush.
Age: 19.0
Sex: M
Vaccine: MMR, TD, VARCEL
Symptoms: Hypokinesia, Oedema peripheral, Pain in extremity, Tenderness
Clinical narrative: C/O swelling, tenderness, pain in R delt. Client states unable to lift R arm above head r/t pain. Client demonstrated only able to lift R arm 20 degrees laterally to body, demonstrated full range of motion w/ L arem. Client reports pain to touch, denies fever.  Minimal swelling noted along R delt and behind R tricep. No redness, bruising noted. All submandibular, submental and axillary lymph nodes nonpalable. Client states employer will not allow him to return to work without note from physician. Referred to PCP for eval.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Erythema, Herpes zoster, Pain, Paraesthesia, Pruritus
Clinical narrative: ON 2/22/07 PATIENT STARTED WITH TINGLY,ITCHY AREA ON BACK THAT BECAME A RAISED ,RED RASH ON BACK. IT IS MOSTLY ON ONE SIDE MORE THAN THE OTHER AND IS VERY PAINFUL AND CAUSES HER LEFT SIDE TO BE TINGLY. SHE WENT TO THE WALK-IN BECAUSE IT WAS THE WEEKEND AND THEY DIAGNOSED HER WITH SHINGLES. SHE WAS STARTED ON A COURSE OF VALTREX TO TAKE TID FOR ONE WEEK. SHE IS FOLLOWING UP WITH HER PRIMARY CAE M.D. WHO IS POSSIBLY TO DO LAB WORK.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Rash
Clinical narrative: ON 2/22/07 PATIENT STARTED WITH TINGLY,ITCHY AREA ON BACK THAT BECAME A RAISED ,RED RASH ON BACK. IT IS MOSTLY ON ONE SIDE MORE THAN THE OTHER AND IS VERY PAINFUL AND CAUSES HER LEFT SIDE TO BE TINGLY. SHE WENT TO THE WALK-IN BECAUSE IT WAS THE WEEKEND AND THEY DIAGNOSED HER WITH SHINGLES. SHE WAS STARTED ON A COURSE OF VALTREX TO TAKE TID FOR ONE WEEK. SHE IS FOLLOWING UP WITH HER PRIMARY CAE M.D. WHO IS POSSIBLY TO DO LAB WORK.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Herpes zoster, No adverse effect, Paraesthesia
Clinical narrative: ON 2/22/07 PATIENT STARTED WITH TINGLY,ITCHY AREA ON BACK THAT BECAME A RAISED ,RED RASH ON BACK. IT IS MOSTLY ON ONE SIDE MORE THAN THE OTHER AND IS VERY PAINFUL AND CAUSES HER LEFT SIDE TO BE TINGLY. SHE WENT TO THE WALK-IN BECAUSE IT WAS THE WEEKEND AND THEY DIAGNOSED HER WITH SHINGLES. SHE WAS STARTED ON A COURSE OF VALTREX TO TAKE TID FOR ONE WEEK. SHE IS FOLLOWING UP WITH HER PRIMARY CAE M.D. WHO IS POSSIBLY TO DO LAB WORK.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea, Faeces discoloured
Clinical narrative: Prolonged non-bloody, green, watery diarrhea x 3 weeks post vaccination.  Supportive treatment only including rice cereal and pedialyte.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, IPV, MMRV
Symptoms: Body temperature increased, Erythema, Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Few hours after receiving vaccines listed below, child's left upper arm became painful, red, and swollen.  Mother reports that child "felt" warm.  SHe gave him ibuprofen x ! yesterday.  Today (2pm) child's upper left arm is swollen, warm to touch, red (shoulder to elbow). T-100.2 No enlarged lymph nodes, Less painful today.
Age: 0.15
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea
Clinical narrative: 2wks after Rotavirus pt presented to clinic for diarrhea total of 5d. I called pt today to see how she is doing and per mom pt is fine and diarrhea has resolved.
Age: 13.0
Sex: M
Vaccine: HEPA, YF
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: 2/6/07 pt awoke feeling achy and fatigued. Mother reports fever of 99 degrees.  Home from school for 2 days.  Illness resolved.
Age: 47.0
Sex: F
Vaccine: HEPA, IPV, TYP, YF
Symptoms: Eye swelling, Ocular hyperaemia, Pruritus
Clinical narrative: Itchy, swollen, red eyelids starting 2/13/07. Condition has not resolved as of 2/26/07
Age: 0.25
Sex: F
Vaccine: HEP, HIBV, OPV, PNC
Symptoms: Blood HIV RNA increased, CD4 lymphocytes increased, Death, Dermatitis diaper, Pneumonia
Clinical narrative: The subject was a three month, 22 day old infant female, HIV infected, enrolled in a study, who expired at home on January 04, 2007. The subject received three doses of Prevnar on November 6, 2006, December 4, 2006, and December 28, 2006. At screening, the subject's CD4 count was 1534 cells/mm3 (28.2%) and HIV-1 viral load was > 750,000 copies/ml. On December 28, 2006, during the subject's routine study visit, the investigator found the subject had diaper dermatitis but was otherwise well. The subject was not seen for the next scheduled study visit on January 29, 2007. The site contacted the mother and learned that the subject had died January 4, 2007. According to mother, the subject died as a result of a "chest problem." The mother stated the subject had developed a fever but did not know the exact temperature. The site Principal Investigator stated that the only information available was provided by the mother and that, it is assumed the subject developed pneumonia that resulted in death but no concrete evidence is available to substantiate this. There was no post-mortem examination performed. The site Principal Investigator assessed the relationship as possibly related to the study agent, Prevnar. The DAIDS Medical Officer has deemed the adverse event as probably not related, but cannot rule out relationship to study agent, Prevnar. Concomitant medications included: cotrimoxazole and the subject had also received oral poliovirus vaccine(OPV), hepatitis B and CombAct-HIB vaccines.
Age: 0.25
Sex: F
Vaccine: HEP, HIBV, OPV, PNC
Symptoms: Pyrexia
Clinical narrative: The subject was a three month, 22 day old infant female, HIV infected, enrolled in a study, who expired at home on January 04, 2007. The subject received three doses of Prevnar on November 6, 2006, December 4, 2006, and December 28, 2006. At screening, the subject's CD4 count was 1534 cells/mm3 (28.2%) and HIV-1 viral load was > 750,000 copies/ml. On December 28, 2006, during the subject's routine study visit, the investigator found the subject had diaper dermatitis but was otherwise well. The subject was not seen for the next scheduled study visit on January 29, 2007. The site contacted the mother and learned that the subject had died January 4, 2007. According to mother, the subject died as a result of a "chest problem." The mother stated the subject had developed a fever but did not know the exact temperature. The site Principal Investigator stated that the only information available was provided by the mother and that, it is assumed the subject developed pneumonia that resulted in death but no concrete evidence is available to substantiate this. There was no post-mortem examination performed. The site Principal Investigator assessed the relationship as possibly related to the study agent, Prevnar. The DAIDS Medical Officer has deemed the adverse event as probably not related, but cannot rule out relationship to study agent, Prevnar. Concomitant medications included: cotrimoxazole and the subject had also received oral poliovirus vaccine(OPV), hepatitis B and CombAct-HIB vaccines.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Incorrect dose administered, Lymphadenectomy, Oedema, Skin lesion
Clinical narrative: Information has been received from a physician concerning a 73 year old female with a history of breast cancer and lymphadenectomy who on 20-NOV-2006 was vaccinated SC with a 0.5ml dose of Zostavax (lot #652946/1012F). On 25-JAN-2007 the patient developed shingles. The patient has symptoms of herpes zoster 5-7 days prior to being seen. The patient also developed some edema near the lesions. The patient was seen by the physician and was treated with Valcyclovir. It was reported that the patient has had the herpes zoster in the dermatone of the lymphadenectomy and had a prolonged recovery. As of 13-FEB-2007 she may still have active lesions and was recovering. There was no product quality complaint involved. The patient's shingles and edema were considered to be disabling. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Varicella zoster virus serology positive
Clinical narrative: Information has been received from a physician concerning a 73 year old female with a history of breast cancer and lymphadenectomy who on 20-NOV-2006 was vaccinated SC with a 0.5ml dose of Zostavax (lot #652946/1012F). On 25-JAN-2007 the patient developed shingles. The patient has symptoms of herpes zoster 5-7 days prior to being seen. The patient also developed some edema near the lesions. The patient was seen by the physician and was treated with Valcyclovir. It was reported that the patient has had the herpes zoster in the dermatone of the lymphadenectomy and had a prolonged recovery. As of 13-FEB-2007 she may still have active lesions and was recovering. There was no product quality complaint involved. The patient's shingles and edema were considered to be disabling. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Dyspnoea, Impaired work ability, Injection site erythema, Injection site pruritus, Pruritus
Clinical narrative: Information has been received from a 71 year old male with multiple drug hypersensitivities Benadryl, Claritin, Aclovate, hypercholesterolemia and a history of constipation, dermotologic rash in right ankle, and heart stent placement (1996), on on 05-FEB-2007 was vaccinated in the left arm, IM, with a dose of Pneumovax (lot #651437/0899F). On 06-FEB-2007 the consumer experienced itching and developed redness in his vaccinated arm. He also stated that by 09-FEB-2007 he developed a rash all over his body except for his face (specifically mentioned his chest, stomach, back, buttock and legs). The consumer reported that on 10-FEB-2007, he experience difficulty in breathing, but did not visit the emergency room. The consumer reported that he took 10 mg Valium for his shortness of breath. On an unspecified date, the patient was seen by an allergy specialist who also prescribed prednisone, 10mg twice daily, to be taken from 15-FEB-2007 to 19-FEB-2007 for his rash. His breathing returned to normal (date not reported), but as of 19-FEB-2007, his rash remained. In addition, the consumer reported his "kidneys shut down for a period" (date not specified) but confirmed he had not been hospitalized, he stated he "has not been able to work since the vaccination" (05-FEB-2007). The consumer reported he "attempted to contact his physician but the physician would not seen him," and added that "the prescribing physician will not return his calls". He further noted that " if he had known that the side effects of the vaccine were skin rash and urticaria, he would not have accepted the vaccine because of his extensive allergy history." The consumer also mentioned that when he took Lipitor for four days he experienced constipation for 45 days. The event impaired work ability was considered disabling ("has not been able to work since the vaccination"). A concern regarding the lot was expressed. A lot check has been initiated.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Rash generalised, Renal failure, Urticaria
Clinical narrative: Information has been received from a 71 year old male with multiple drug hypersensitivities Benadryl, Claritin, Aclovate, hypercholesterolemia and a history of constipation, dermotologic rash in right ankle, and heart stent placement (1996), on on 05-FEB-2007 was vaccinated in the left arm, IM, with a dose of Pneumovax (lot #651437/0899F). On 06-FEB-2007 the consumer experienced itching and developed redness in his vaccinated arm. He also stated that by 09-FEB-2007 he developed a rash all over his body except for his face (specifically mentioned his chest, stomach, back, buttock and legs). The consumer reported that on 10-FEB-2007, he experience difficulty in breathing, but did not visit the emergency room. The consumer reported that he took 10 mg Valium for his shortness of breath. On an unspecified date, the patient was seen by an allergy specialist who also prescribed prednisone, 10mg twice daily, to be taken from 15-FEB-2007 to 19-FEB-2007 for his rash. His breathing returned to normal (date not reported), but as of 19-FEB-2007, his rash remained. In addition, the consumer reported his "kidneys shut down for a period" (date not specified) but confirmed he had not been hospitalized, he stated he "has not been able to work since the vaccination" (05-FEB-2007). The consumer reported he "attempted to contact his physician but the physician would not seen him," and added that "the prescribing physician will not return his calls". He further noted that " if he had known that the side effects of the vaccine were skin rash and urticaria, he would not have accepted the vaccine because of his extensive allergy history." The consumer also mentioned that when he took Lipitor for four days he experienced constipation for 45 days. The event impaired work ability was considered disabling ("has not been able to work since the vaccination"). A concern regarding the lot was expressed. A lot check has been initiated.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Fall, Loss of consciousness
Clinical narrative: Information has been received from a physician and a nurse in the physician's office concerning a 14 year old female who on 12-FEB-2007 was vaccinated with the first 0.5ml dose of Gardasil. within two minutes of receiving the shot, the patient passed out. it was reported that as she was falling to the ground, it was observed that she was having a seizure. The seizure was described as a "drawing of the right arm". The patient did not have full body tremors. The seizure lasted approximately one minute. The patient was sent to the emergency room, however, was reported as being "Fine" when she left the office. The patient was not admitted to the hospital. The nurse did not know of any treatment given in the ER and believed that the patient was just observed and released. The physician reported that the patient was fine after being released from the emergency room. On 12-FEB-2007, the patient has recovered from the events. It was reported that the patient had no history of seizures and the nurse stated that the patient will continue with the Gardasil series. Upon internal reviews, seizure was considered to be an other important medical event. Additional information has been requested.
Age: 1.51
Sex: F
Vaccine: HEPA
Symptoms: Diarrhoea, Hepatitis A antibody positive, Liver function test abnormal, Vomiting
Clinical narrative: Information has been received from a physician concerning an 18 month old female with no medical history or allergies who on 08-JAN-2007 was vaccinated with a 0.5 ml IM dose of Vaqta (lot #656495/1209F). There was no concomitant medication. On 30-JAN-2007 the patient developed vomiting and diarrhea. Labs showed mildly elevated liver function tests and positive Hepatitis A immunoassays. Medical attention was sought. Subsequently, the patient recovered. There was no product quality complaint involved. The physician considered the patient's adverse events to be other important medical events. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: VARCEL
Symptoms: Antibody test negative, Eczema nummular, Rash, Seroconversion test negative
Clinical narrative: Information has been received from a 69 year old physician with hypertension who "a year ago", in approximately February 2006, was vaccinated with a second dose of Varivax. Concomitant therapy included unspecified medication for hypertension. It was reported that the patient was vaccinated when he "was younger" with a first dose of Varivax. He did not seroconvert after the first vaccination. After vaccination with the second dose the patient developed a rash. The rash ranged from pin size to 10 - 12 cm in diameter. The rash had remained constant but changed in degrees. At times the rash lessened then returned. There were also areas of scarring related to the rash. The patient was seen by two dermatologist and was diagnosed with nummular eczema. He continued to use LIDEX, triamcinome cream (steroid cream), ultraviolet therapy 1-2 times a week, and CUTAR baths at home 2 times per week. Three months after the second dose the patient had another titer and still had not seroconverted. At the time of the report the patient had not yet recovered. There was no product quality complaint involved. The patient's nummular eczema was considered to be an other important medical event. Additional information has been requested.
Age: 0.25
Sex: M
Vaccine: RV5
Symptoms: Haematochezia
Clinical narrative: Information has been received from a physician concerning a male "between two and four months old" who was vaccinated with a first oral dose of Rotateq (human-bovine). Subsequently the patient developed bloody stool. Approximately one week later the bloody stool was resolved and went away. The physician stated that he believes that the bloody stool was not due to Rotateq (human-bovine). He believes that it was due to the early introduction of cereals and other food products including guacamole to the infant at such a young age. Medical attention was sought. There was no product quality complaint involved. The patient's bloody stool was considered to be an other important medical event. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: TD, TD
Symptoms: Pain in extremity, Radiculitis brachial, Skin burning sensation
Clinical narrative: Extreme pain, burning in upper R arm/starting a couple of weeks after vaccine. Diagnosed w/brachial neuritis. Doctor said "it will not improve" expect to get worse. Pain management /Nerve blocks. 03/20/07-records received from facility for DOS 10/22/04-8/9/05.C/O rash on right arm of 8 weeks duration. Rash itchy, red, irritated, painful, bleeds and is scaly.  PE:No primary lesions noted on right arm, classic triangular pick excoriation of upper right arm, several scabs from previous episodes of picking. DX: Xerosis which might cause some itching. Pruitis of unknown origin. Subsequent visit c/o burning sensation in arm and forearm, no weakness. in PMH:6/04 struck by a desk when a car broke through the window of her office and struck the desk pushing it into her. She suffered soft tissue injuries to the arm as well as pieces of glass which have been removed. DX:uncomfortable paresthesias and burning of the arm. On 8/9/05-DX: radiculopathic symptoms without definite evidence of a neurologic etiology.
Age: 43.0
Sex: F
Vaccine: TD, TD
Symptoms: Biopsy skin, Burning sensation, Computerised tomogram, Injection site erythema, Injection site pain
Clinical narrative: Extreme pain, burning in upper R arm/starting a couple of weeks after vaccine. Diagnosed w/brachial neuritis. Doctor said "it will not improve" expect to get worse. Pain management /Nerve blocks. 03/20/07-records received from facility for DOS 10/22/04-8/9/05.C/O rash on right arm of 8 weeks duration. Rash itchy, red, irritated, painful, bleeds and is scaly.  PE:No primary lesions noted on right arm, classic triangular pick excoriation of upper right arm, several scabs from previous episodes of picking. DX: Xerosis which might cause some itching. Pruitis of unknown origin. Subsequent visit c/o burning sensation in arm and forearm, no weakness. in PMH:6/04 struck by a desk when a car broke through the window of her office and struck the desk pushing it into her. She suffered soft tissue injuries to the arm as well as pieces of glass which have been removed. DX:uncomfortable paresthesias and burning of the arm. On 8/9/05-DX: radiculopathic symptoms without definite evidence of a neurologic etiology.
Age: 43.0
Sex: F
Vaccine: TD, TD
Symptoms: Laboratory test, Nuclear magnetic resonance imaging, Radiculitis brachial
Clinical narrative: Extreme pain, burning in upper R arm/starting a couple of weeks after vaccine. Diagnosed w/brachial neuritis. Doctor said "it will not improve" expect to get worse. Pain management /Nerve blocks. 03/20/07-records received from facility for DOS 10/22/04-8/9/05.C/O rash on right arm of 8 weeks duration. Rash itchy, red, irritated, painful, bleeds and is scaly.  PE:No primary lesions noted on right arm, classic triangular pick excoriation of upper right arm, several scabs from previous episodes of picking. DX: Xerosis which might cause some itching. Pruitis of unknown origin. Subsequent visit c/o burning sensation in arm and forearm, no weakness. in PMH:6/04 struck by a desk when a car broke through the window of her office and struck the desk pushing it into her. She suffered soft tissue injuries to the arm as well as pieces of glass which have been removed. DX:uncomfortable paresthesias and burning of the arm. On 8/9/05-DX: radiculopathic symptoms without definite evidence of a neurologic etiology.
Age: 9.0
Sex: F
Vaccine: PPV, PPV
Symptoms: C-reactive protein normal, Cellulitis, Erythema, Pain, Pyrexia
Clinical narrative: 2/23: Cellulitis of left thigh: fever, pain, redness admitted for IV antibiotics. 03/05/07-records received from facility for DOS 02/23-02/26/07 DC DX: Cellulitis left anterolateral thigh, resolving. Immunization reaction  Patient needs subacute bacterial endocarditis prophylaxis.  Hospital course-24 hours after pneumovax vaccine developed progressive pain, reness and swelling around the injection site.
Age: 9.0
Sex: F
Vaccine: PPV, PPV
Symptoms: White blood cell count normal
Clinical narrative: 2/23: Cellulitis of left thigh: fever, pain, redness admitted for IV antibiotics. 03/05/07-records received from facility for DOS 02/23-02/26/07 DC DX: Cellulitis left anterolateral thigh, resolving. Immunization reaction  Patient needs subacute bacterial endocarditis prophylaxis.  Hospital course-24 hours after pneumovax vaccine developed progressive pain, reness and swelling around the injection site.
Age: 9.0
Sex: F
Vaccine: PPV, PPV
Symptoms: C-reactive protein decreased, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 2/23: Cellulitis of left thigh: fever, pain, redness admitted for IV antibiotics. 03/05/07-records received from facility for DOS 02/23-02/26/07 DC DX: Cellulitis left anterolateral thigh, resolving. Immunization reaction  Patient needs subacute bacterial endocarditis prophylaxis.  Hospital course-24 hours after pneumovax vaccine developed progressive pain, reness and swelling around the injection site.
Age: 9.0
Sex: F
Vaccine: PPV, PPV
Symptoms: White blood cell count increased
Clinical narrative: 2/23: Cellulitis of left thigh: fever, pain, redness admitted for IV antibiotics. 03/05/07-records received from facility for DOS 02/23-02/26/07 DC DX: Cellulitis left anterolateral thigh, resolving. Immunization reaction  Patient needs subacute bacterial endocarditis prophylaxis.  Hospital course-24 hours after pneumovax vaccine developed progressive pain, reness and swelling around the injection site.
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5, DTAPHEPBIP, PNC, RV5
Symptoms: Diarrhoea haemorrhagic, Intussusception, Mucous stools, Surgery, Vomiting
Clinical narrative: He started vomiting at midnight 2/24/07, then had mucus and blood in a diarrhea stool was admitted to the hospital and had surgery for intusussecption. Could not be reduced by an enema.  3/15/07 Received medical records from hospital which reveal patient experienced a 2 day history of bloody diarrhea.  Had been seen at outlying ER & transferred for higher level of care.  Taken to OR for exp lap for bowel obstruction.  Intussusception reduced & appendectomy was performed.  Held overnight for observation.  Did well & d/c to home. FINAL DX: Intussusception, surgically reduced.
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5, DTAPHEPBIP, PNC, RV5
Symptoms: Diarrhoea haemorrhagic, Enema administration, Intussusception, Mucous stools, Surgery
Clinical narrative: He started vomiting at midnight 2/24/07, then had mucus and blood in a diarrhea stool was admitted to the hospital and had surgery for intusussecption. Could not be reduced by an enema.  3/15/07 Received medical records from hospital which reveal patient experienced a 2 day history of bloody diarrhea.  Had been seen at outlying ER & transferred for higher level of care.  Taken to OR for exp lap for bowel obstruction.  Intussusception reduced & appendectomy was performed.  Held overnight for observation.  Did well & d/c to home. FINAL DX: Intussusception, surgically reduced.
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5, DTAPHEPBIP, PNC, RV5
Symptoms: Vomiting
Clinical narrative: He started vomiting at midnight 2/24/07, then had mucus and blood in a diarrhea stool was admitted to the hospital and had surgery for intusussecption. Could not be reduced by an enema.  3/15/07 Received medical records from hospital which reveal patient experienced a 2 day history of bloody diarrhea.  Had been seen at outlying ER & transferred for higher level of care.  Taken to OR for exp lap for bowel obstruction.  Intussusception reduced & appendectomy was performed.  Held overnight for observation.  Did well & d/c to home. FINAL DX: Intussusception, surgically reduced.
Age: 1.28
Sex: F
Vaccine: DTAP
Symptoms: Cough, Flushing, Hypoxia, Respiratory distress, Wheezing
Clinical narrative: Developed cough within minutes of injection, followed by facial flushing and severe wheezing with resp distress and hypoxia within 5 min of injection. TX IM Epi, Albuterol neb, Benadryl and IM Steroids.  02/27/2007 Spoke with reporter.  Box 10 and 11 information received and recorded in VAERS. 02/27/2007 MR received for office visit of 02/19/2007 for well child 15 month visit. PE WNL.  DTaP received.  Child immediately began coughing slightly.  Mom returned shortly with child with child wheezing and in distress.  No hives.  O2 sat 91-93%.  Face flushed without edema.  Txd with po Benadryl, injectable steroids, Epi-pen, and albuterol nebs.  O2 sats returned to normal 98% within a few minutes.  Observed 1 1/2 hours and  discharged home. DX: Anaphylactic Reaction. Unlikely DTaP, but no other known exposure.