chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, TDAP
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Fever of 102.4 F 1 day after shots nausea and vomiting 1 day after shot. CT feels alot better on 6/14 -2 days after shots with no fever then.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Dizziness, Fracture, Heart rate irregular, Vertigo
Clinical narrative: On her way to bathroom felt dizzy and lost balance (swirled around); fell broke shoulder and wrist taken to ER took a while for heart beat to normalize. Now wearing a cast ever since vax has vertigo when sit down or gets up, vertigo gradually improving.
Age: 8.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Blister, Erythema, Rash papular, Skin lesion
Clinical narrative: Scattered erythema papular vesicles lesion trunk (20) neck (5 or 6) edge of scalp (1) upper thighs and arms (3 or 4).
Age: 5.0
Sex: M
Vaccine: DTAP, HIBV, IPV, MMR, VARCEL
Symptoms: Erythema, Rash papular, Skin lesion
Clinical narrative: Scattered erythematous pap. pus, lesions on trunk (5 or 6), neck (1), legs and arms (1 or 2).
Age: 11.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL
Symptoms: Erythema, Induration
Clinical narrative: 2 inches diameter of redness and firmness located to left outer arm.
Age: 13.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Lethargy, Syncope
Clinical narrative: Syncope 13 hours after vaccines, lethargy by 20 No RX. Sx resolved.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Erythema, Local reaction, Swelling
Clinical narrative: 2056 pt had an extensive local reaction. Pt came back to doctors office and was seen by Dr at 13:30. Pt was given Benadryl 1/2 tsp PO. Pts mom was instructed to monitor patient for difficulty breathing, increased redness, swelling if this occurred to take pt to ER.
Sex: F
Vaccine: ANTH, TYP
Symptoms: Erythema, Mass, Pruritus, Skin burning sensation, Skin warm
Clinical narrative: Reddened, hard lump 6 cm x 6 1/2 cm warm to touch, itchy and burning
Age: 43.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Injection site erythema, Injection site warmth, Local reaction
Clinical narrative: Erythemic area about 20 cm at injection site. Warm to touch
Sex: M
Vaccine: ANTH, TYP
Symptoms: Mass
Clinical narrative: Rt upper hard bump
Age: 22.0
Sex: M
Vaccine: ANTH
Symptoms: Paralysis
Clinical narrative: Developed paralysis R side of face
Age: 5.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: At injection site of Varivax developed large red swollen area.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Cyanosis, Decreased appetite, Listless
Clinical narrative: Previously well child. Rec'd 2 mo immunizations (including Dtap) on 6/11/07. Approx 4 hours later child had poor feeding, then episode of cyanosis, limpness. Admitted to hospital. Never any fever. Neg septic work up.  7/17/07 Received hospital medical records which reveal patient experienced crying, pallor, cyanosis & not eating well after awakening from nap on 6/11/07 after receiving vax same date. Seen in ER w/fever, runny nose, nasal congestion, cough.  Admitted 6/12-6/13/07 & tx w/IV antibiotics.  Cardio consult done for murmur.  Continued to be febrile in hospital but all c/s neg.  D/C to home FINAL DX: fever & cyanotic spell.
Age: 61.0
Sex: U
Vaccine: TD
Symptoms: Activities of daily living impaired, Appetite disorder, Feeling hot, Malaise, Pain
Clinical narrative: 5/23 8:00PM-felt hot but had goosebumps, had sick hunger, a gnawing sensation, kept getting worse. Didn't feel well at all. Unable to drive. 5/24 sore muscles all over. Called ER, was told was a normal reaction. Suggested an anti-inflammatory so she took Motrin 400mg at hs. 5/25 Took Motrin x 3 5/26 A little sore but feeling better.
Age: 61.0
Sex: U
Vaccine: TD
Symptoms: Piloerection
Clinical narrative: 5/23 8:00PM-felt hot but had goosebumps, had sick hunger, a gnawing sensation, kept getting worse. Didn't feel well at all. Unable to drive. 5/24 sore muscles all over. Called ER, was told was a normal reaction. Suggested an anti-inflammatory so she took Motrin 400mg at hs. 5/25 Took Motrin x 3 5/26 A little sore but feeling better.
Age: 65.0
Sex: U
Vaccine: DT
Symptoms: Cold compress therapy, Injection site pain, Injection site swelling
Clinical narrative: Received DT injection in Rt arm 6/11/07. That night at 6:30 IM injection site became sore and as the night went on noticed swelling. Pt called office 06/12/07. Pt was instructed to apply cool compresses and take Tylenol for pain. Pt called 06/13/07 and stated swelling increasing. Recom. Pt come in. Arm was checked 6/14/07
Age: 1.3
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Swelling
Clinical narrative: Mom called in 3/29/07 and stated daughter 12/08/05 arm LD and LVL was getting real swollen. I advised mom to give Benadryl and use warm compresses. If symptoms get worse to take child to urgent care.
Age: 0.3
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Injection site rash, Pyrexia
Clinical narrative: Mother noticed little bumps on/around injection sites. child had fever day after injections.
Age: 0.17
Sex: M
Vaccine: RV5, DTAP, HIBV, IPV, RV5
Symptoms: Diarrhoea, Gastroenteritis rotavirus, Rotavirus test negative, Rotavirus test positive, Stool analysis abnormal
Clinical narrative: Initial information received on 31 May 2007 from another manufacturer, report# WAES0704USA00596. The initial reporter to this manufacturer had been a health care professional. Verbatim from the report:  "Information has been received from a physician concerning a two month old male who on 09-MAR-2007 was vaccinated with Rotateq PO first dose. Concomitant therapy included "two month old required vaccinations". The physician reported that the patient who received the vaccine on 09-MAR-2007 had vomited and was experiencing prolonged diarrhea by 15-MAR-2007. The patient was also experiencing weight loss due to the vomitting and prolonged diarrhea. The physician reported that they obtained three stool samples from the patient on 21-MAR-2007 the stool sample from the patient on 21-MAR-2007 the stool sample tested negative for rota virus. On 27 and 31-MAR-2007 the stool samples tested positive for rota virus. The physician reported that after the positive rota virus tests, the mother was advised to stop breast feeding the patient and recommended the patient be seen by a GI specialist. Further information has been received from the physician regarding this male with no illness at time of vaccination and no pre-existing allergies, medical conditions or birth defects who on 09-MAR-2007 was vaccinated with Rotateq PO first dose (Lot # 656185/1234F). Concomitant therapy included DTaP (Sanofi C2552AA) ActHib (unspecified carrier) (lot # UF087AA) and IPOL (Z0457). The physician reported that the infant vomited twice on 15-MAR-2007 then started having watery greened stools. The diarrhea persisted untill 09-MAY-2007. On 27-MAR-2007 stools tested positive for rotavirus. Other relevant diagnostic tests performed included CBC and sweat CL test which was negative. The patient had poor weight gain and the mother had to hold off nursing till 10-MAY-2007. The physician reported the patient had multiple office visits to check the weight and was referred to a pediatric GI specialist for co management. The patient was placed on formula with NURTRAMIGEN/NEOCATE. The patient was considered recovered on 09-MAY-2007. The physician reported that the rotavirus required emergency room/doctor office visits, resulted in prolonged hospitalization and persistent or significant disability and required medical/surgical intervention to prevent serious outcomes. Additional information is not expected." ActHib lot number UF087AA (also reported in the structured field of the report as ActHib, Sanofi pasteur, lot# B47442A-not a valid sanofi pasteur lot number) corresponds to sanofi pasteur ltd. lot number Z0998-2, Lot number Z0457 corresponds to the product IPOL, and lot number C2552AA corresponds to the product Daptacel. It was reported in the structured field of the report that all doses were dose 1.
Age: 0.17
Sex: M
Vaccine: RV5, DTAP, HIBV, IPV, RV5
Symptoms: Stool analysis normal, Vomiting, Weight decreased
Clinical narrative: Initial information received on 31 May 2007 from another manufacturer, report# WAES0704USA00596. The initial reporter to this manufacturer had been a health care professional. Verbatim from the report:  "Information has been received from a physician concerning a two month old male who on 09-MAR-2007 was vaccinated with Rotateq PO first dose. Concomitant therapy included "two month old required vaccinations". The physician reported that the patient who received the vaccine on 09-MAR-2007 had vomited and was experiencing prolonged diarrhea by 15-MAR-2007. The patient was also experiencing weight loss due to the vomitting and prolonged diarrhea. The physician reported that they obtained three stool samples from the patient on 21-MAR-2007 the stool sample from the patient on 21-MAR-2007 the stool sample tested negative for rota virus. On 27 and 31-MAR-2007 the stool samples tested positive for rota virus. The physician reported that after the positive rota virus tests, the mother was advised to stop breast feeding the patient and recommended the patient be seen by a GI specialist. Further information has been received from the physician regarding this male with no illness at time of vaccination and no pre-existing allergies, medical conditions or birth defects who on 09-MAR-2007 was vaccinated with Rotateq PO first dose (Lot # 656185/1234F). Concomitant therapy included DTaP (Sanofi C2552AA) ActHib (unspecified carrier) (lot # UF087AA) and IPOL (Z0457). The physician reported that the infant vomited twice on 15-MAR-2007 then started having watery greened stools. The diarrhea persisted untill 09-MAY-2007. On 27-MAR-2007 stools tested positive for rotavirus. Other relevant diagnostic tests performed included CBC and sweat CL test which was negative. The patient had poor weight gain and the mother had to hold off nursing till 10-MAY-2007. The physician reported the patient had multiple office visits to check the weight and was referred to a pediatric GI specialist for co management. The patient was placed on formula with NURTRAMIGEN/NEOCATE. The patient was considered recovered on 09-MAY-2007. The physician reported that the rotavirus required emergency room/doctor office visits, resulted in prolonged hospitalization and persistent or significant disability and required medical/surgical intervention to prevent serious outcomes. Additional information is not expected." ActHib lot number UF087AA (also reported in the structured field of the report as ActHib, Sanofi pasteur, lot# B47442A-not a valid sanofi pasteur lot number) corresponds to sanofi pasteur ltd. lot number Z0998-2, Lot number Z0457 corresponds to the product IPOL, and lot number C2552AA corresponds to the product Daptacel. It was reported in the structured field of the report that all doses were dose 1.
Age: 0.17
Sex: M
Vaccine: RV5, DTAP, HIBV, IPV, RV5
Symptoms: Diarrhoea, Faeces discoloured, Full blood count, Rotavirus test positive, Saliva analysis normal
Clinical narrative: Initial information received on 31 May 2007 from another manufacturer, report# WAES0704USA00596. The initial reporter to this manufacturer had been a health care professional. Verbatim from the report:  "Information has been received from a physician concerning a two month old male who on 09-MAR-2007 was vaccinated with Rotateq PO first dose. Concomitant therapy included "two month old required vaccinations". The physician reported that the patient who received the vaccine on 09-MAR-2007 had vomited and was experiencing prolonged diarrhea by 15-MAR-2007. The patient was also experiencing weight loss due to the vomitting and prolonged diarrhea. The physician reported that they obtained three stool samples from the patient on 21-MAR-2007 the stool sample from the patient on 21-MAR-2007 the stool sample tested negative for rota virus. On 27 and 31-MAR-2007 the stool samples tested positive for rota virus. The physician reported that after the positive rota virus tests, the mother was advised to stop breast feeding the patient and recommended the patient be seen by a GI specialist. Further information has been received from the physician regarding this male with no illness at time of vaccination and no pre-existing allergies, medical conditions or birth defects who on 09-MAR-2007 was vaccinated with Rotateq PO first dose (Lot # 656185/1234F). Concomitant therapy included DTaP (Sanofi C2552AA) ActHib (unspecified carrier) (lot # UF087AA) and IPOL (Z0457). The physician reported that the infant vomited twice on 15-MAR-2007 then started having watery greened stools. The diarrhea persisted untill 09-MAY-2007. On 27-MAR-2007 stools tested positive for rotavirus. Other relevant diagnostic tests performed included CBC and sweat CL test which was negative. The patient had poor weight gain and the mother had to hold off nursing till 10-MAY-2007. The physician reported the patient had multiple office visits to check the weight and was referred to a pediatric GI specialist for co management. The patient was placed on formula with NURTRAMIGEN/NEOCATE. The patient was considered recovered on 09-MAY-2007. The physician reported that the rotavirus required emergency room/doctor office visits, resulted in prolonged hospitalization and persistent or significant disability and required medical/surgical intervention to prevent serious outcomes. Additional information is not expected." ActHib lot number UF087AA (also reported in the structured field of the report as ActHib, Sanofi pasteur, lot# B47442A-not a valid sanofi pasteur lot number) corresponds to sanofi pasteur ltd. lot number Z0998-2, Lot number Z0457 corresponds to the product IPOL, and lot number C2552AA corresponds to the product Daptacel. It was reported in the structured field of the report that all doses were dose 1.
Age: 0.17
Sex: M
Vaccine: RV5, DTAP, HIBV, IPV, RV5
Symptoms: Stool analysis normal, Sweat chloride test normal, Vomiting, Weight decreased
Clinical narrative: Initial information received on 31 May 2007 from another manufacturer, report# WAES0704USA00596. The initial reporter to this manufacturer had been a health care professional. Verbatim from the report:  "Information has been received from a physician concerning a two month old male who on 09-MAR-2007 was vaccinated with Rotateq PO first dose. Concomitant therapy included "two month old required vaccinations". The physician reported that the patient who received the vaccine on 09-MAR-2007 had vomited and was experiencing prolonged diarrhea by 15-MAR-2007. The patient was also experiencing weight loss due to the vomitting and prolonged diarrhea. The physician reported that they obtained three stool samples from the patient on 21-MAR-2007 the stool sample from the patient on 21-MAR-2007 the stool sample tested negative for rota virus. On 27 and 31-MAR-2007 the stool samples tested positive for rota virus. The physician reported that after the positive rota virus tests, the mother was advised to stop breast feeding the patient and recommended the patient be seen by a GI specialist. Further information has been received from the physician regarding this male with no illness at time of vaccination and no pre-existing allergies, medical conditions or birth defects who on 09-MAR-2007 was vaccinated with Rotateq PO first dose (Lot # 656185/1234F). Concomitant therapy included DTaP (Sanofi C2552AA) ActHib (unspecified carrier) (lot # UF087AA) and IPOL (Z0457). The physician reported that the infant vomited twice on 15-MAR-2007 then started having watery greened stools. The diarrhea persisted untill 09-MAY-2007. On 27-MAR-2007 stools tested positive for rotavirus. Other relevant diagnostic tests performed included CBC and sweat CL test which was negative. The patient had poor weight gain and the mother had to hold off nursing till 10-MAY-2007. The physician reported the patient had multiple office visits to check the weight and was referred to a pediatric GI specialist for co management. The patient was placed on formula with NURTRAMIGEN/NEOCATE. The patient was considered recovered on 09-MAY-2007. The physician reported that the rotavirus required emergency room/doctor office visits, resulted in prolonged hospitalization and persistent or significant disability and required medical/surgical intervention to prevent serious outcomes. Additional information is not expected." ActHib lot number UF087AA (also reported in the structured field of the report as ActHib, Sanofi pasteur, lot# B47442A-not a valid sanofi pasteur lot number) corresponds to sanofi pasteur ltd. lot number Z0998-2, Lot number Z0457 corresponds to the product IPOL, and lot number C2552AA corresponds to the product Daptacel. It was reported in the structured field of the report that all doses were dose 1.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal X-ray, Barium double contrast, Intussusception, Ultrasound abdomen abnormal, X-ray abnormal
Clinical narrative: Information has been received from a registered nurse concerning a 22-week-old male with no pertinent medical history and no drug reactions/allergies who on 02-APR-2007 was vaccinated PO with a second dose of Rotateq (Lot # 655296/0979F). There was no concomitant medication. On 06-MAY-2007 the patient went to the emergency room because of vomiting and diarrhea. An x-ray of the abdomen was done to rule out intussusception. The results of the x-ray were given on 07-MAY-2007 and showed a "mass like effect on the right side of the abdomen". The patient was back to the emergency room on 07-MAY-2007 and an abdominal ultrasound was done which found a "highly suggested ilecolic intussusception". A ultrasound was "successful reduction of intussusception". The patient was seen by the clinic on 10-MAY-2007 and was recovering and by 05-JUN-2007 appeared to be completely recovered. The patient will not receive another dose of Rotateq. No further information was available. There was no product quality complaint. Upon internal review, intussusception was considered to be an other important medical event. Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Barium double contrast, Diarrhoea, Diet refusal, Flatulence, Intussusception
Clinical narrative: Information has been received from a registered nurse concerning a 22-week-old male with no pertinent medical history and no drug reactions/allergies who on 02-APR-2007 was vaccinated PO with a second dose of Rotateq (Lot # 655296/0979F). There was no concomitant medication. On 06-MAY-2007 the patient went to the emergency room because of vomiting and diarrhea. An x-ray of the abdomen was done to rule out intussusception. The results of the x-ray were given on 07-MAY-2007 and showed a "mass like effect on the right side of the abdomen". The patient was back to the emergency room on 07-MAY-2007 and an abdominal ultrasound was done which found a "highly suggested ilecolic intussusception". A ultrasound was "successful reduction of intussusception". The patient was seen by the clinic on 10-MAY-2007 and was recovering and by 05-JUN-2007 appeared to be completely recovered. The patient will not receive another dose of Rotateq. No further information was available. There was no product quality complaint. Upon internal review, intussusception was considered to be an other important medical event. Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Ultrasound abdomen abnormal, Vomiting, X-ray abnormal
Clinical narrative: Information has been received from a registered nurse concerning a 22-week-old male with no pertinent medical history and no drug reactions/allergies who on 02-APR-2007 was vaccinated PO with a second dose of Rotateq (Lot # 655296/0979F). There was no concomitant medication. On 06-MAY-2007 the patient went to the emergency room because of vomiting and diarrhea. An x-ray of the abdomen was done to rule out intussusception. The results of the x-ray were given on 07-MAY-2007 and showed a "mass like effect on the right side of the abdomen". The patient was back to the emergency room on 07-MAY-2007 and an abdominal ultrasound was done which found a "highly suggested ilecolic intussusception". A ultrasound was "successful reduction of intussusception". The patient was seen by the clinic on 10-MAY-2007 and was recovering and by 05-JUN-2007 appeared to be completely recovered. The patient will not receive another dose of Rotateq. No further information was available. There was no product quality complaint. Upon internal review, intussusception was considered to be an other important medical event. Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal X-ray, Abdominal mass, Barium double contrast, Barium enema, Diarrhoea
Clinical narrative: Information has been received from a registered nurse concerning a 22-week-old male with no pertinent medical history and no drug reactions/allergies who on 02-APR-2007 was vaccinated PO with a second dose of Rotateq (Lot # 655296/0979F). There was no concomitant medication. On 06-MAY-2007 the patient went to the emergency room because of vomiting and diarrhea. An x-ray of the abdomen was done to rule out intussusception. The results of the x-ray were given on 07-MAY-2007 and showed a "mass like effect on the right side of the abdomen". The patient was back to the emergency room on 07-MAY-2007 and an abdominal ultrasound was done which found a "highly suggested ilecolic intussusception". A ultrasound was "successful reduction of intussusception". The patient was seen by the clinic on 10-MAY-2007 and was recovering and by 05-JUN-2007 appeared to be completely recovered. The patient will not receive another dose of Rotateq. No further information was available. There was no product quality complaint. Upon internal review, intussusception was considered to be an other important medical event. Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Intussusception, Ultrasound abdomen abnormal, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning a 22-week-old male with no pertinent medical history and no drug reactions/allergies who on 02-APR-2007 was vaccinated PO with a second dose of Rotateq (Lot # 655296/0979F). There was no concomitant medication. On 06-MAY-2007 the patient went to the emergency room because of vomiting and diarrhea. An x-ray of the abdomen was done to rule out intussusception. The results of the x-ray were given on 07-MAY-2007 and showed a "mass like effect on the right side of the abdomen". The patient was back to the emergency room on 07-MAY-2007 and an abdominal ultrasound was done which found a "highly suggested ilecolic intussusception". A ultrasound was "successful reduction of intussusception". The patient was seen by the clinic on 10-MAY-2007 and was recovering and by 05-JUN-2007 appeared to be completely recovered. The patient will not receive another dose of Rotateq. No further information was available. There was no product quality complaint. Upon internal review, intussusception was considered to be an other important medical event. Additional information has been requested.
Age: 0.42
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, RV5
Symptoms: Intussusception
Clinical narrative: Information has been received from a physician concerning a 21 week old male patient who on 02-MAR-2007 was vaccinated with the first dose and on 02-MAY-2007 was vaccinated with second dose of Rotateq (Lot numbers were not provided). On 03-JUN-2007 the patient experienced intussusception and was hospitalized. On that same day, the patient underwent surgery. The patient's outcome was reported as recovering. Additional information has been requested.
Age: 0.42
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, RV5
Symptoms: Intussusception, Surgery
Clinical narrative: Information has been received from a physician concerning a 21 week old male patient who on 02-MAR-2007 was vaccinated with the first dose and on 02-MAY-2007 was vaccinated with second dose of Rotateq (Lot numbers were not provided). On 03-JUN-2007 the patient experienced intussusception and was hospitalized. On that same day, the patient underwent surgery. The patient's outcome was reported as recovering. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Hyperventilation, Injection site erythema, Injection site swelling
Clinical narrative: Adacel - Local redness and swelling, hard breathing.
Age: 21.0
Sex: F
Vaccine: YF
Symptoms: Injection site rash, Rash, Urticaria
Clinical narrative: Patient noticed a rash at the injection site on her left arm and on her neck the day after receiving yellow fever vaccine. She also had hives on her face. She took 50mg of Benadryl and both the rash and hives resolved by the end of the day.
Age: 0.6
Sex: F
Vaccine: HEP
Symptoms: Apnoea, Crying, Cyanosis, Decreased appetite, Fatigue
Clinical narrative: Information has been received from a physician concerning a 7-month-old female with no allergies and a history of a three day hospitalization for cyanosis, breath holding and pallor following vaccination with Rotateq (WAES #0702USA04116) who on 16-MAY-2007 was vaccinated IM with a dose of Recombivax HB (manufacturer unknown). On 21-MAY-2007, the patient was vaccinated with an IM dose of Prevnar. On 21-MAY-2007 the patient became tired looking. On 22-MAY-2007, the patient became more fussy, sleepy and had a decreased appetite. On 23-MAY-2007, the patient started crying alot, had "some body movements", turned purple around the lips and mouth with facial pallor. The patient was taken to the Emergency Room (ER) where a partial work-up for sepsis excluding LP were done. The patient was alert and oriented x3 and in no distress. The patient was noted to have an apneic event. Tests were negative and the patient was sent home. Recommendations included use of home apnea monitoring. At the time of this report, the outcome was unknown. Upon internal review, apnea was considered to be an other important medical event. Additional information has been requested. All available medical records will be provided upon request.
Age: 0.6
Sex: F
Vaccine: HEP
Symptoms: Irritability, Laboratory test normal, Pallor, Reaction to previous exposure to any vaccine, Somnolence
Clinical narrative: Information has been received from a physician concerning a 7-month-old female with no allergies and a history of a three day hospitalization for cyanosis, breath holding and pallor following vaccination with Rotateq (WAES #0702USA04116) who on 16-MAY-2007 was vaccinated IM with a dose of Recombivax HB (manufacturer unknown). On 21-MAY-2007, the patient was vaccinated with an IM dose of Prevnar. On 21-MAY-2007 the patient became tired looking. On 22-MAY-2007, the patient became more fussy, sleepy and had a decreased appetite. On 23-MAY-2007, the patient started crying alot, had "some body movements", turned purple around the lips and mouth with facial pallor. The patient was taken to the Emergency Room (ER) where a partial work-up for sepsis excluding LP were done. The patient was alert and oriented x3 and in no distress. The patient was noted to have an apneic event. Tests were negative and the patient was sent home. Recommendations included use of home apnea monitoring. At the time of this report, the outcome was unknown. Upon internal review, apnea was considered to be an other important medical event. Additional information has been requested. All available medical records will be provided upon request.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Facial pain, Facial palsy, Facial paresis, Pain in extremity, Syncope
Clinical narrative: Information has been received from a health professional concerning a 26 year old female with no medical history or allergies, who in June 2007, was vaccinated with a dose of Gardasil. There was no concomitant medication. In June 2007, the patient experienced severe pain in her arm, fainted, facial weakness, Bells Palsy, and facial pain after being vaccinated with Gardasil. The patient did go to the ER however, was not admitted to the hospital. At the time if this report, the patient had not recovered. No product quality complaint was involved. Severe pain in arm, fainted, facial weakness, Bells Palsy, and facial pain were considered to be disabling. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Laboratory test abnormal, Lymphadenopathy, Surgery
Clinical narrative: Information has been received from a physician concerning his daughter (age not reported) with no pertinent medical history or drug reactions/allergies who on an unspecified date was vaccinated with a first and second dose of Gardasil (Lot Numbers not provided). Concomitant therapy included cetrizine hydrochloride (ZYRTEC). Within 2 weeks of the first vaccination, the patient experienced enlarged lymph nodes at different locations (unspecified) on the same side as the Gardasil injection (side unspecified). Medical attention was sought. Outpatient surgery was performed to remove the lymph node (s) after the 1st dose of Gardasil and "it came back reactive". Within 2 weeks of receiving the second dose of the vaccine, the patient developed enlarged lymph nodes on the side of the neck. At the time of reporting the patient had not recovered and additional surgery was planned. The physician felt that the event was serious because outpatient surgery was performed (other important medical event). Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Swollen tongue
Clinical narrative: Information has been received from a Certified Medical Assistant (C.M.A) concerning a 65 year old female patient with bruising on the abdomen, rash on the left posterior shoulder, hypertension, mild diverticulitis, sulfonamide allergy, drug hypersensitivity to antihistamines (unspecified) and cetirizine hydrochloride (ZYRTEC) who on 19-APR-2007 was vaccinated IM in the right arm with a dose of Pneumovax 23, lot #655668/1004F. Concomitant therapy included Lovastatin, Bupropion HCl, Clobetasol propionate cream, Clobetasol propionate topical solution, Clotrimazole, Estradiol (ESTRACE), Flunisolide, Lorazepam, Metronidazole (METROGEL), metaxalone (SKELAXIN) and atenolo/chlorthalidone (TENORETIC). On 19-APR-2007, in the afternoon or early evening (within 24 hours on injection) the patient developed redness and swelling at the injection site. The area was hot to the touch. The reaction continued to get worse during the night. The patient had swelling of the tongue and went to the emergency room. Specific details on how the patient was treated at the emergency room or what tests were done was unknown. Subsequently, the patient recovered. The assistant mentioned that other patients have received injection from the same lot with no reactions. The reporter considered swelling of the tongue to be life threatening and considered the events to be other important medical events. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Drug administered at inappropriate site, Injection site abscess, Injection site erythema, Injection site induration, Injection site reaction
Clinical narrative: Information has been received from a registered nurse concerning an adult male who was hospitalized for pneumonia who on 30-MAY-2007 or 31-MAY-2007 was vaccinated into the abdomen with a dose of Pneumovax 23. Concomitant therapy included IV antibiotics, IV heparin and pain medication. The nurse wasn't entirely sure if the vaccine administered was Pneumovax 23 but was told it was administered to prevent pneumonia. On 01-JUN-2007, when the patient was discharged from the hospital he had a small, red, hard, hot to touch area at the injection site. The injection site reaction increased to a softball size and later to a football size reaction. The patient was seen by the physician and who said the reaction was an abscess. The patient was given antibiotics, ciprofloxacin hydrochloride (CIPRO) and heat as treatment. At the time of this report, the patient was recovering. No product quality complaint was involved. Injection site abscess was considered to be an other important medical event. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning an adult male who was hospitalized for pneumonia who on 30-MAY-2007 or 31-MAY-2007 was vaccinated into the abdomen with a dose of Pneumovax 23. Concomitant therapy included IV antibiotics, IV heparin and pain medication. The nurse wasn't entirely sure if the vaccine administered was Pneumovax 23 but was told it was administered to prevent pneumonia. On 01-JUN-2007, when the patient was discharged from the hospital he had a small, red, hard, hot to touch area at the injection site. The injection site reaction increased to a softball size and later to a football size reaction. The patient was seen by the physician and who said the reaction was an abscess. The patient was given antibiotics, ciprofloxacin hydrochloride (CIPRO) and heat as treatment. At the time of this report, the patient was recovering. No product quality complaint was involved. Injection site abscess was considered to be an other important medical event. Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster ophthalmic
Clinical narrative: Information has been received from a physician concerning a 75 year old male with a history of shingles several years ago who on 06-NOV-2006 was vaccinated in the left deltoid with a 0.65 ml dose of Zostavax. Concomitant therapy included hydrochlorothiazide (manufacturer unknown). Subsequently on 26-APR-2006 the patient developed ocular shingles which has affected his vision. He has not driven for one and half months plus he cannot see well. He was being treated with valacyclovir hydrochloride (VALTREX), pregabalin (LYRICA), "TRI-FLUOR" eye drops and Prednisone. The patient has had some improvement and was recovering. Ocular shingles was considered to be disabling by the physician. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Blood culture positive, Dialysis, Haemolytic anaemia, Haemolytic uraemic syndrome, Hepatic failure
Clinical narrative: Information regarding Prevnar vaccine was received from a healthcare professional regarding a 12-month-old female patient who completed her primary series, having received a fourth dose on 20-Mar-2007. The patient also received a dose of Varivax, a second dose of Hepatitis A Vaccine (manufacturer unknown) and a second dose of M-M-R II (Merck Sharp and Dome) on the same day. On 02-APR-2007, the patient was hospitalized for pneumococcal pneumonia, pneumococcal bacteremia, streptococcal pneumoniae induced hemolytic uremic syndrome, respiratory failure and liver failure. On 20-Mar-2007, the patient received a fourth dose of Prevnar, completing her primary series. On 02-Apr-2007, the patient was hospitalized with a fever (temperature not reported), pneumococcal pneumonia, and thrombocytopenia (laboratory values not available). A blood culture was performed and was positive for Streptococcus pneumoniae. No serotype results were available. The patient was diagnosed with Streptococcal pneumoniae induced hemolytic uremic syndrome which included hemolytic anemia requiring multiple blood transfusions, renal failure requiring peritoneal dialysis, respiratory failure requiring intubation for two weeks and liver failure. The patient was hospitalized for four weeks. It was reported she recovered from all events and was discharged to home on 02-May-2007. Discharge medications included Norvasc, Ativan, aspirin, folate and Poly-Vi-Sol. No additional information was available at the time of this report. Blood culture (results: positive for Streptococcus pneumoniae) was done in Apr-2007.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Mechanical ventilation, Pneumococcal bacteraemia, Pneumonia pneumococcal, Pneumonia streptococcal, Pyrexia
Clinical narrative: Information regarding Prevnar vaccine was received from a healthcare professional regarding a 12-month-old female patient who completed her primary series, having received a fourth dose on 20-Mar-2007. The patient also received a dose of Varivax, a second dose of Hepatitis A Vaccine (manufacturer unknown) and a second dose of M-M-R II (Merck Sharp and Dome) on the same day. On 02-APR-2007, the patient was hospitalized for pneumococcal pneumonia, pneumococcal bacteremia, streptococcal pneumoniae induced hemolytic uremic syndrome, respiratory failure and liver failure. On 20-Mar-2007, the patient received a fourth dose of Prevnar, completing her primary series. On 02-Apr-2007, the patient was hospitalized with a fever (temperature not reported), pneumococcal pneumonia, and thrombocytopenia (laboratory values not available). A blood culture was performed and was positive for Streptococcus pneumoniae. No serotype results were available. The patient was diagnosed with Streptococcal pneumoniae induced hemolytic uremic syndrome which included hemolytic anemia requiring multiple blood transfusions, renal failure requiring peritoneal dialysis, respiratory failure requiring intubation for two weeks and liver failure. The patient was hospitalized for four weeks. It was reported she recovered from all events and was discharged to home on 02-May-2007. Discharge medications included Norvasc, Ativan, aspirin, folate and Poly-Vi-Sol. No additional information was available at the time of this report. Blood culture (results: positive for Streptococcus pneumoniae) was done in Apr-2007.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Respiratory failure, Thrombocytopenia, Transfusion, Vaccination failure
Clinical narrative: Information regarding Prevnar vaccine was received from a healthcare professional regarding a 12-month-old female patient who completed her primary series, having received a fourth dose on 20-Mar-2007. The patient also received a dose of Varivax, a second dose of Hepatitis A Vaccine (manufacturer unknown) and a second dose of M-M-R II (Merck Sharp and Dome) on the same day. On 02-APR-2007, the patient was hospitalized for pneumococcal pneumonia, pneumococcal bacteremia, streptococcal pneumoniae induced hemolytic uremic syndrome, respiratory failure and liver failure. On 20-Mar-2007, the patient received a fourth dose of Prevnar, completing her primary series. On 02-Apr-2007, the patient was hospitalized with a fever (temperature not reported), pneumococcal pneumonia, and thrombocytopenia (laboratory values not available). A blood culture was performed and was positive for Streptococcus pneumoniae. No serotype results were available. The patient was diagnosed with Streptococcal pneumoniae induced hemolytic uremic syndrome which included hemolytic anemia requiring multiple blood transfusions, renal failure requiring peritoneal dialysis, respiratory failure requiring intubation for two weeks and liver failure. The patient was hospitalized for four weeks. It was reported she recovered from all events and was discharged to home on 02-May-2007. Discharge medications included Norvasc, Ativan, aspirin, folate and Poly-Vi-Sol. No additional information was available at the time of this report. Blood culture (results: positive for Streptococcus pneumoniae) was done in Apr-2007.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Cold sweat, Diarrhoea haemorrhagic, Muscle spasms, Pallor, Vomiting
Clinical narrative: 6/1/07 7PM threw up, pale, clammy, crampy - reported bloody diarrhea, discharged 6/3 after given, morphine and IV fluids - also began Asacol - pt has follow up appt with gastroenterologist.  07/02/2007 MR received for a 2 night admission 6/1-3/2007 for c/o rectal bleeding, abdominal cramping, nausea and vomiting.  Pt reports on and off rectal bleeding x 8 months which increased night prior to admission. Treated w/ bowel rest and Asacol. Principal DX: Colitis, probably 2' to ulcerative colitis vs. ischemic colitis. 2' DX:  HTN.  GERD. Hyperlipidemia. Left arm redness after a zoster vaccine. Depression on Lexapro.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal X-ray, Intussusception, Obstruction, Pyrexia, Small intestinal resection
Clinical narrative: This patient developed fever/vomiting and then had small bowel resection for intussusception at medical center.  6/19/07 Received vax record from PCP which confirms RO lot & dose as reported. 7/26/07 Received medical records from hospital via fax from CDC.  Records are primarily for ENT but IS mentioned on clinic note having been perfomed 6/1/07 w/resection of 5cm of bowel resected.  7/27/07 Received hospital medical records which reveal patient experienced nausea, bilious vomiting, fever & lethargy x 4 days.  Admitted 5/30-6/3/07. Tx w/IV antibiotics & taken to OR. Small bowel IS found at proximal mid ileum.  Did well post op w/o complications. FINAL DX: Intussusception; s/p exp lap & small bowel resection w/reanastomosis.  Records faxed to CDC.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Vomiting
Clinical narrative: This patient developed fever/vomiting and then had small bowel resection for intussusception at medical center.  6/19/07 Received vax record from PCP which confirms RO lot & dose as reported. 7/26/07 Received medical records from hospital via fax from CDC.  Records are primarily for ENT but IS mentioned on clinic note having been perfomed 6/1/07 w/resection of 5cm of bowel resected.  7/27/07 Received hospital medical records which reveal patient experienced nausea, bilious vomiting, fever & lethargy x 4 days.  Admitted 5/30-6/3/07. Tx w/IV antibiotics & taken to OR. Small bowel IS found at proximal mid ileum.  Did well post op w/o complications. FINAL DX: Intussusception; s/p exp lap & small bowel resection w/reanastomosis.  Records faxed to CDC.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Intussusception
Clinical narrative: This patient developed fever/vomiting and then had small bowel resection for intussusception at medical center.  6/19/07 Received vax record from PCP which confirms RO lot & dose as reported. 7/26/07 Received medical records from hospital via fax from CDC.  Records are primarily for ENT but IS mentioned on clinic note having been perfomed 6/1/07 w/resection of 5cm of bowel resected.  7/27/07 Received hospital medical records which reveal patient experienced nausea, bilious vomiting, fever & lethargy x 4 days.  Admitted 5/30-6/3/07. Tx w/IV antibiotics & taken to OR. Small bowel IS found at proximal mid ileum.  Did well post op w/o complications. FINAL DX: Intussusception; s/p exp lap & small bowel resection w/reanastomosis.  Records faxed to CDC.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal X-ray, Blood potassium increased, Blood sodium decreased, Blood urea normal, Intussusception
Clinical narrative: This patient developed fever/vomiting and then had small bowel resection for intussusception at medical center.  6/19/07 Received vax record from PCP which confirms RO lot & dose as reported. 7/26/07 Received medical records from hospital via fax from CDC.  Records are primarily for ENT but IS mentioned on clinic note having been perfomed 6/1/07 w/resection of 5cm of bowel resected.  7/27/07 Received hospital medical records which reveal patient experienced nausea, bilious vomiting, fever & lethargy x 4 days.  Admitted 5/30-6/3/07. Tx w/IV antibiotics & taken to OR. Small bowel IS found at proximal mid ileum.  Did well post op w/o complications. FINAL DX: Intussusception; s/p exp lap & small bowel resection w/reanastomosis.  Records faxed to CDC.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Laparotomy, Lethargy, Nausea, Obstruction, Pyrexia
Clinical narrative: This patient developed fever/vomiting and then had small bowel resection for intussusception at medical center.  6/19/07 Received vax record from PCP which confirms RO lot & dose as reported. 7/26/07 Received medical records from hospital via fax from CDC.  Records are primarily for ENT but IS mentioned on clinic note having been perfomed 6/1/07 w/resection of 5cm of bowel resected.  7/27/07 Received hospital medical records which reveal patient experienced nausea, bilious vomiting, fever & lethargy x 4 days.  Admitted 5/30-6/3/07. Tx w/IV antibiotics & taken to OR. Small bowel IS found at proximal mid ileum.  Did well post op w/o complications. FINAL DX: Intussusception; s/p exp lap & small bowel resection w/reanastomosis.  Records faxed to CDC.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Small intestinal anastomosis, Small intestinal resection, Surgery, Urinary system X-ray, Vomiting
Clinical narrative: This patient developed fever/vomiting and then had small bowel resection for intussusception at medical center.  6/19/07 Received vax record from PCP which confirms RO lot & dose as reported. 7/26/07 Received medical records from hospital via fax from CDC.  Records are primarily for ENT but IS mentioned on clinic note having been perfomed 6/1/07 w/resection of 5cm of bowel resected.  7/27/07 Received hospital medical records which reveal patient experienced nausea, bilious vomiting, fever & lethargy x 4 days.  Admitted 5/30-6/3/07. Tx w/IV antibiotics & taken to OR. Small bowel IS found at proximal mid ileum.  Did well post op w/o complications. FINAL DX: Intussusception; s/p exp lap & small bowel resection w/reanastomosis.  Records faxed to CDC.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: White blood cell count increased
Clinical narrative: This patient developed fever/vomiting and then had small bowel resection for intussusception at medical center.  6/19/07 Received vax record from PCP which confirms RO lot & dose as reported. 7/26/07 Received medical records from hospital via fax from CDC.  Records are primarily for ENT but IS mentioned on clinic note having been perfomed 6/1/07 w/resection of 5cm of bowel resected.  7/27/07 Received hospital medical records which reveal patient experienced nausea, bilious vomiting, fever & lethargy x 4 days.  Admitted 5/30-6/3/07. Tx w/IV antibiotics & taken to OR. Small bowel IS found at proximal mid ileum.  Did well post op w/o complications. FINAL DX: Intussusception; s/p exp lap & small bowel resection w/reanastomosis.  Records faxed to CDC.
Age: 30.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Blood glucose increased, Blood pressure decreased, Body temperature increased, Dyspnoea
Clinical narrative: Approx 15-20 seconds post injection pt stated she became flushed, diaphoretic and weak. Pt states she felt as if she could not take a deep breath. Pt temp 99 deg F. Pt feet elevated. BP 90/60, Pulse 83.Pt given orange juice and graham crackers and Tylenol 325 mg. After approx 15 min, pt verbalized she felt better. BP 110/60, pulse 83. Pt was pale, but color returned after 15 minutes. Blood Glucose 115. Pt was able to stand without difficulty and walk. Total time 20 minutes.
Age: 30.0
Sex: F
Vaccine: HPV4
Symptoms: Flushing, Hyperhidrosis, Inappropriate schedule of drug administration, Pallor
Clinical narrative: Approx 15-20 seconds post injection pt stated she became flushed, diaphoretic and weak. Pt states she felt as if she could not take a deep breath. Pt temp 99 deg F. Pt feet elevated. BP 90/60, Pulse 83.Pt given orange juice and graham crackers and Tylenol 325 mg. After approx 15 min, pt verbalized she felt better. BP 110/60, pulse 83. Pt was pale, but color returned after 15 minutes. Blood Glucose 115. Pt was able to stand without difficulty and walk. Total time 20 minutes.