chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Warm red slightly patch to Kinrix site per provider.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PPV
Symptoms: Crying, Irritability, Somnolence, Vomiting
Clinical narrative: Increased fussiness, unconsolable crying for 2 hrs, vomiting, increased sleepiness, attempt to give Tylenol (vomited).
Age: 1.04
Sex: M
Vaccine: HEPA, MMRV, PPV
Symptoms: Decreased appetite, Hypersomnia, Irritability, Pyrexia, Rash
Clinical narrative: Fever, sleepiness, lack of appetite, crankiness, rash. Lots of sleep, Motrin, Tylenol round the clock for 3 days.
Age: 1.04
Sex: M
Vaccine: HEPA, MMRV, PPV
Symptoms: Somnolence
Clinical narrative: Fever, sleepiness, lack of appetite, crankiness, rash. Lots of sleep, Motrin, Tylenol round the clock for 3 days.
Age: 38.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: R deltoid swelling and pain and redness about 2 hours after getting the vaccine.  No difficulty breathing or wheezing. No rashes. No itching.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Rash macular, Skin warm
Clinical narrative: Erythema, pain, itching at site L deltoid with 7x12 cm of blotchy erythema, increased heat.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Rash pruritic
Clinical narrative: Pt was administered ZOSTAVAX here at store on 6-7-10. He said around 6-10-10 he broke out in a rash that was extremely itchy, but did not consult us until today (6-23-10). He said it was a "painful itch." We referred him to doctor, he was given PREDNISONE and BENADRYL.
Age: 21.0
Sex: F
Vaccine: MNQ
Symptoms: Unevaluable event
Clinical narrative: None stated. This patient was not seen on this date.  The adverse event was reported in error.  The entry was deleted from the VFC reporting site.  Please make note: Patient not seen, no vacc. given.  No adverse reaction. 7/21/10 Recipient received all doses of post exposure rabies vaccine.
Age: 1.49
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: R thigh swelling, induration 5x2.5cm.
Age: 0.15
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Body temperature increased, Crying
Clinical narrative: 3 hours after Immunizations-developed high pitched shrill cry lasted 1 hour + (1230pm) temp no higher than 100 degrees. 7 hours after developed rash on abdomen described as hives by parent (430pm). Rash described as macular-papular rash by ER doc. 6-21-10 at 1730.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus generalised
Clinical narrative: Pt complained of local and systemic reactions. Mostly severe itching all over.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local reaction
Clinical narrative: Local redness reported 24 hr after injection.  RPh circled redness, pt monitored and additional 24 hrs then called and said redness about 1 inch greater than circled mark on arm.  Pt referred to MD.
Age: 14.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: 6-8-10 four vaccines given.  Patient stated reaction started 6-9-10 morning.  Returned to clinic 6-10-10 cellulitis to outer aspect right arm.  Placement of VARICELLA vaccine.  Annular erythematous.  Measured 85 mm X 65 mm.  Warm to touch.  Patient prescribed BACTRIM DS X 10 days.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Body temperature increased, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Pt (R) upper arm swollen and red, pt states it is itching. T 99.1. Seen by PCP. TYLENOL given for high temp & antibiotics, PREDNISONE, LORATADINE - Pt to follow up 6/24/10.
Age: 0.91
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Shock
Clinical narrative: Pt. was given all 3 vaccines and within 2 minutes went into a shock like state and then had a seizure that lasted less than 5 minutes.
Age: 52.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Edema, redness and pain at the injection site. Worst yesterday. Resolving today. No treatment.
Age: 40.0
Sex: F
Vaccine: FLUN3, FLUN(H1N1)
Symptoms: Laboratory test, Myalgia, Paraesthesia
Clinical narrative: I started getting tingling on left side of my body. Was tired and extremely scared on what was going on.  I wish so badly that I never had this vaccine.  This has been an incredibly awful experience and I will NEVER trust the government or get antoher vaccine in my life.
Age: 40.0
Sex: F
Vaccine: FLUN3, FLUN(H1N1)
Symptoms: Blood test normal, Fatigue, Nuclear magnetic resonance imaging normal, Paraesthesia
Clinical narrative: I started getting tingling on left side of my body. Was tired and extremely scared on what was going on.  I wish so badly that I never had this vaccine.  This has been an incredibly awful experience and I will NEVER trust the government or get antoher vaccine in my life.
Age: 59.0
Sex: F
Vaccine: FLUX(H1N1), FLUX(H1N1)
Symptoms: Alanine aminotransferase increased, Anaemia haemolytic autoimmune, Antinuclear antibody negative, Aspartate aminotransferase increased, Basophil percentage
Clinical narrative: Pt is a 59YO female who was admitted to Hospital on January 13th with a hgb of 6.9 and elevated indirect bilirubin and LDH consistent with autoimmune hemolytic anemia as Coomb's test was positive for a warm IgG auto-antibody and haptoglobin was undetectable. Reticulocyte count was not elevated, though did not have any prodromal viral symptoms. Pt received the H1N1 just about four weeks before the development of the autoimmune hemolytic anemia. Parvovirus IgM was low. ANA was negative. Pt was started on steroids.
Age: 59.0
Sex: F
Vaccine: FLUX(H1N1), FLUX(H1N1)
Symptoms: Blood albumin normal, Blood alkaline phosphatase normal, Blood amylase decreased, Blood bilirubin increased, Blood bilirubin unconjugated increased
Clinical narrative: Pt is a 59YO female who was admitted to Hospital on January 13th with a hgb of 6.9 and elevated indirect bilirubin and LDH consistent with autoimmune hemolytic anemia as Coomb's test was positive for a warm IgG auto-antibody and haptoglobin was undetectable. Reticulocyte count was not elevated, though did not have any prodromal viral symptoms. Pt received the H1N1 just about four weeks before the development of the autoimmune hemolytic anemia. Parvovirus IgM was low. ANA was negative. Pt was started on steroids.
Age: 59.0
Sex: F
Vaccine: FLUX(H1N1), FLUX(H1N1)
Symptoms: Blood calcium normal, Blood chloride increased, Blood creatinine normal, Blood glucose normal, Blood lactate dehydrogenase increased
Clinical narrative: Pt is a 59YO female who was admitted to Hospital on January 13th with a hgb of 6.9 and elevated indirect bilirubin and LDH consistent with autoimmune hemolytic anemia as Coomb's test was positive for a warm IgG auto-antibody and haptoglobin was undetectable. Reticulocyte count was not elevated, though did not have any prodromal viral symptoms. Pt received the H1N1 just about four weeks before the development of the autoimmune hemolytic anemia. Parvovirus IgM was low. ANA was negative. Pt was started on steroids.
Age: 59.0
Sex: F
Vaccine: FLUX(H1N1), FLUX(H1N1)
Symptoms: Blood potassium normal, Blood sodium normal, Blood urea normal, Carbon dioxide normal, Coombs test positive
Clinical narrative: Pt is a 59YO female who was admitted to Hospital on January 13th with a hgb of 6.9 and elevated indirect bilirubin and LDH consistent with autoimmune hemolytic anemia as Coomb's test was positive for a warm IgG auto-antibody and haptoglobin was undetectable. Reticulocyte count was not elevated, though did not have any prodromal viral symptoms. Pt received the H1N1 just about four weeks before the development of the autoimmune hemolytic anemia. Parvovirus IgM was low. ANA was negative. Pt was started on steroids.
Age: 59.0
Sex: F
Vaccine: FLUX(H1N1), FLUX(H1N1)
Symptoms: Eosinophil percentage, Haematocrit decreased, Haemoglobin decreased, Lymphocyte percentage, Mean cell haemoglobin concentration
Clinical narrative: Pt is a 59YO female who was admitted to Hospital on January 13th with a hgb of 6.9 and elevated indirect bilirubin and LDH consistent with autoimmune hemolytic anemia as Coomb's test was positive for a warm IgG auto-antibody and haptoglobin was undetectable. Reticulocyte count was not elevated, though did not have any prodromal viral symptoms. Pt received the H1N1 just about four weeks before the development of the autoimmune hemolytic anemia. Parvovirus IgM was low. ANA was negative. Pt was started on steroids.
Age: 59.0
Sex: F
Vaccine: FLUX(H1N1), FLUX(H1N1)
Symptoms: Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal, Mean cell volume normal, Monocyte percentage, Neutrophil percentage
Clinical narrative: Pt is a 59YO female who was admitted to Hospital on January 13th with a hgb of 6.9 and elevated indirect bilirubin and LDH consistent with autoimmune hemolytic anemia as Coomb's test was positive for a warm IgG auto-antibody and haptoglobin was undetectable. Reticulocyte count was not elevated, though did not have any prodromal viral symptoms. Pt received the H1N1 just about four weeks before the development of the autoimmune hemolytic anemia. Parvovirus IgM was low. ANA was negative. Pt was started on steroids.
Age: 59.0
Sex: F
Vaccine: FLUX(H1N1), FLUX(H1N1)
Symptoms: Parvovirus B19 test, Platelet count normal, Protein total decreased, Red blood cell count decreased, Red cell distribution width increased
Clinical narrative: Pt is a 59YO female who was admitted to Hospital on January 13th with a hgb of 6.9 and elevated indirect bilirubin and LDH consistent with autoimmune hemolytic anemia as Coomb's test was positive for a warm IgG auto-antibody and haptoglobin was undetectable. Reticulocyte count was not elevated, though did not have any prodromal viral symptoms. Pt received the H1N1 just about four weeks before the development of the autoimmune hemolytic anemia. Parvovirus IgM was low. ANA was negative. Pt was started on steroids.
Age: 59.0
Sex: F
Vaccine: FLUX(H1N1), FLUX(H1N1)
Symptoms: Reticulocyte count normal, White blood cell count normal
Clinical narrative: Pt is a 59YO female who was admitted to Hospital on January 13th with a hgb of 6.9 and elevated indirect bilirubin and LDH consistent with autoimmune hemolytic anemia as Coomb's test was positive for a warm IgG auto-antibody and haptoglobin was undetectable. Reticulocyte count was not elevated, though did not have any prodromal viral symptoms. Pt received the H1N1 just about four weeks before the development of the autoimmune hemolytic anemia. Parvovirus IgM was low. ANA was negative. Pt was started on steroids.
Age: 59.0
Sex: F
Vaccine: FLUX(H1N1), FLUX(H1N1)
Symptoms: Alanine aminotransferase increased, Anaemia haemolytic autoimmune, Antinuclear antibody negative, Aspartate aminotransferase increased, Basophil percentage decreased
Clinical narrative: Pt is a 59YO female who was admitted to Hospital on January 13th with a hgb of 6.9 and elevated indirect bilirubin and LDH consistent with autoimmune hemolytic anemia as Coomb's test was positive for a warm IgG auto-antibody and haptoglobin was undetectable. Reticulocyte count was not elevated, though did not have any prodromal viral symptoms. Pt received the H1N1 just about four weeks before the development of the autoimmune hemolytic anemia. Parvovirus IgM was low. ANA was negative. Pt was started on steroids.
Age: 59.0
Sex: F
Vaccine: FLUX(H1N1), FLUX(H1N1)
Symptoms: Blood albumin normal, Blood alkaline phosphatase normal, Blood bilirubin increased, Blood bilirubin unconjugated increased, Blood calcium normal
Clinical narrative: Pt is a 59YO female who was admitted to Hospital on January 13th with a hgb of 6.9 and elevated indirect bilirubin and LDH consistent with autoimmune hemolytic anemia as Coomb's test was positive for a warm IgG auto-antibody and haptoglobin was undetectable. Reticulocyte count was not elevated, though did not have any prodromal viral symptoms. Pt received the H1N1 just about four weeks before the development of the autoimmune hemolytic anemia. Parvovirus IgM was low. ANA was negative. Pt was started on steroids.
Age: 59.0
Sex: F
Vaccine: FLUX(H1N1), FLUX(H1N1)
Symptoms: Blood chloride increased, Blood creatinine normal, Blood lactate dehydrogenase increased, Blood potassium normal, Blood sodium normal
Clinical narrative: Pt is a 59YO female who was admitted to Hospital on January 13th with a hgb of 6.9 and elevated indirect bilirubin and LDH consistent with autoimmune hemolytic anemia as Coomb's test was positive for a warm IgG auto-antibody and haptoglobin was undetectable. Reticulocyte count was not elevated, though did not have any prodromal viral symptoms. Pt received the H1N1 just about four weeks before the development of the autoimmune hemolytic anemia. Parvovirus IgM was low. ANA was negative. Pt was started on steroids.
Age: 59.0
Sex: F
Vaccine: FLUX(H1N1), FLUX(H1N1)
Symptoms: Blood urea increased, Carbon dioxide normal, Coombs test positive, Eosinophil percentage decreased, Haematocrit decreased
Clinical narrative: Pt is a 59YO female who was admitted to Hospital on January 13th with a hgb of 6.9 and elevated indirect bilirubin and LDH consistent with autoimmune hemolytic anemia as Coomb's test was positive for a warm IgG auto-antibody and haptoglobin was undetectable. Reticulocyte count was not elevated, though did not have any prodromal viral symptoms. Pt received the H1N1 just about four weeks before the development of the autoimmune hemolytic anemia. Parvovirus IgM was low. ANA was negative. Pt was started on steroids.
Age: 59.0
Sex: F
Vaccine: FLUX(H1N1), FLUX(H1N1)
Symptoms: Haemoglobin decreased, Haptoglobin decreased, International normalised ratio normal, Laboratory test normal, Lymphocyte percentage decreased
Clinical narrative: Pt is a 59YO female who was admitted to Hospital on January 13th with a hgb of 6.9 and elevated indirect bilirubin and LDH consistent with autoimmune hemolytic anemia as Coomb's test was positive for a warm IgG auto-antibody and haptoglobin was undetectable. Reticulocyte count was not elevated, though did not have any prodromal viral symptoms. Pt received the H1N1 just about four weeks before the development of the autoimmune hemolytic anemia. Parvovirus IgM was low. ANA was negative. Pt was started on steroids.
Age: 59.0
Sex: F
Vaccine: FLUX(H1N1), FLUX(H1N1)
Symptoms: Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal, Mean cell volume normal, Monocyte percentage, Neutrophil percentage increased
Clinical narrative: Pt is a 59YO female who was admitted to Hospital on January 13th with a hgb of 6.9 and elevated indirect bilirubin and LDH consistent with autoimmune hemolytic anemia as Coomb's test was positive for a warm IgG auto-antibody and haptoglobin was undetectable. Reticulocyte count was not elevated, though did not have any prodromal viral symptoms. Pt received the H1N1 just about four weeks before the development of the autoimmune hemolytic anemia. Parvovirus IgM was low. ANA was negative. Pt was started on steroids.
Age: 59.0
Sex: F
Vaccine: FLUX(H1N1), FLUX(H1N1)
Symptoms: Parvovirus B19 test positive, Platelet count normal, Protein total decreased, Prothrombin time shortened, Red blood cell count decreased
Clinical narrative: Pt is a 59YO female who was admitted to Hospital on January 13th with a hgb of 6.9 and elevated indirect bilirubin and LDH consistent with autoimmune hemolytic anemia as Coomb's test was positive for a warm IgG auto-antibody and haptoglobin was undetectable. Reticulocyte count was not elevated, though did not have any prodromal viral symptoms. Pt received the H1N1 just about four weeks before the development of the autoimmune hemolytic anemia. Parvovirus IgM was low. ANA was negative. Pt was started on steroids.
Age: 59.0
Sex: F
Vaccine: FLUX(H1N1), FLUX(H1N1)
Symptoms: Red cell distribution width increased, Reticulocyte count normal, White blood cell count normal
Clinical narrative: Pt is a 59YO female who was admitted to Hospital on January 13th with a hgb of 6.9 and elevated indirect bilirubin and LDH consistent with autoimmune hemolytic anemia as Coomb's test was positive for a warm IgG auto-antibody and haptoglobin was undetectable. Reticulocyte count was not elevated, though did not have any prodromal viral symptoms. Pt received the H1N1 just about four weeks before the development of the autoimmune hemolytic anemia. Parvovirus IgM was low. ANA was negative. Pt was started on steroids.
Age: 39.0
Sex: M
Vaccine: ANTH
Symptoms: Body temperature increased, Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Swollen, itchy, hot, red and temperature.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Erythema, Induration, Pain in extremity, Rash vesicular, Swelling
Clinical narrative: Within 24 hrs of vaccination reported "knots with ? bumps. No fever. Returned Day 3, afebrile but with vesicular rash (Rt) mid deltoid. Painful, red, edematous. PN: HSVI-asymptomatic now.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Viral test
Clinical narrative: Within 24 hrs of vaccination reported "knots with ? bumps. No fever. Returned Day 3, afebrile but with vesicular rash (Rt) mid deltoid. Painful, red, edematous. PN: HSVI-asymptomatic now.
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Neonatal disorder
Clinical narrative: Information has been received from a pediatrician via medical records concerning a male baby who was born to a 17 year old mother with mild intermittent asthma. On 10-AUG-2009 the mother was vaccinated with the first doses of GARDASIL (Lot # 662300/0100Y). On 09-MAR-2010, 37.6 weeks from LMP the mother delivered a normal, healthy male baby weighing 7 pounds, the mother delivered a normal, healthy male baby weighing 7 pounds, length 19.5 inches, apgar score 9.9, head circumference 13. The mother had no complication and no infections or illnesses during pregnancy. The mother had no complication during labor/delivery. On 19-MAR-2010, the baby was brought to the pediatrician's office. It was reported that the baby weighing 7.9 pounds, length 20 inches, head circumference 14, body temperature 99.1 degree F. The baby was fed every 2-3 hours and he had been spitting up. The baby was diagnosed with mild GERD. On 14-APR-2010, the baby had a one month follow-up visit. It was reported that baby weighing 9.13 pounds, length 21 5/8 inches, head circumference 14 3/4, body temperature 97.8 degree F. The baby ate well, still spitted but not much. It was reported that the baby's left eye had been crusted ever since birth, spitting up a lot. The mother put child back on SIMILAC advance because ENFAMIL AR was causing constipation. On 21-APR-2010, the baby was brought to th pediatrician's office. The baby had cough symptoms, and stuff nose with body temperature 99.2 degree F. It was reported that the baby ate well, weighing 9.5 pounds. The baby was diagnosed with upper respiratory infection (URI). On 03-MAY-2010, the baby was brought to the pediatrician's office. The baby was weighted 11.7 pounds, body temperature was 98.8 degree F. It was reported that the baby cried for 2 days non stop and he had balls swollen. The baby was diagnosed with hydrocele, GERD and ?small hernia. On 19-MAY-2010, the baby was brought to the pediatrician's office. The baby was weighted 12.8 pounds, body temperature was 98.4 degree F. It was reported that the baby had left eye swollen, and can't open left eye in the morning. The baby was diagnosed with conjunctivitis. Left eye had been crusted ever since birth, hydrocele and ?small hernia were considered to be congenital anomalies. No further information is available. All available medical records will be provided upon request.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Caesarean section, Drug exposure during pregnancy, Obstructed labour, Ultrasound antenatal screen normal
Clinical narrative: Information has been received from a registered nurse, for the Pregnancy Registry for GARDASIL, concerning a 17 year old female patient with allergy to codeine who on 23-AUG-2009 was vaccinated intramuscularly with the first 0.5ml GARDASIL (lot # not reported). Fatal ultra sound was performed. The patient was 22 weeks pregnant on 22-Oct-2009. The patient sought medical attention via office visit. Follow up information has been received from a registered nurse concerning a 17 year old female patient with no previous pregnancies who on 12-AUG-2009 (reported as 23-AUG-2009 previously) was vaccinated intramuscularly with a 0.5ml GARDASIL (lot # 662229/1497X). On 12-OCT-2009 ultrasound was performed and it was found the patient was 22+5 weeks pregnant and normal anatomy. The nurse reported the patient's last menstrual period was 04-MAY-2009 and the estimated delivery date was 07-FEB-2010. She also reported that the date of last menstrual period could also be 20-JUN-2009 and the estimated delivery date was 17-MAR-2010. Follow-up information has been received from a medical assistant (MA). The MA pulled the patient's chart and provided pregnancy outcome information. The patient had a cesarean section on 07-FEB-2010, secondary to having a "bony pelvis". She delivered a healthy, 7lb 14oz baby. The MA also added that there was "nothing in the report to indicate there were any problems with the baby." The patient had recovered and didn't have any post operation complications. Upon internal review, cesarean section secondary to having a "bony pelvis" was determined to be an other important medical event. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Immediate post-injection reaction
Clinical narrative: Information has been received from a physician concerning a 15 year old female patient who on approximately 11-JUN-2010 ("either the end of last week 07-JUN-2010 or in the beginning of this week 14-JUN-2010") was vaccinated with the first dose of GARDASIL (lot# not reported). On approximately 11-JUN-2010, immediately after receiving the first dose of GARDASIL, the patient began to seize, but the seizing resolved almost immediately as well. Unspecified medical attention was sought. The physician reported that the patient recovered the day she received the first dose of GARDASIL. Upon internal review, seize was considered to be an other important medical event. Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Injection site pain
Clinical narrative: Pain in upper arm waxes and wanes since time of initial injection.
Age: 56.0
Sex: M
Vaccine: PPV
Symptoms: Flushing, Pruritus
Clinical narrative: Flushed in face and diffuse itching.
Age: 54.0
Sex: F
Vaccine: HEP
Symptoms: Dyspnoea, Feeling hot, Flushing, Hepatitis B antibody negative, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a Registered Nurse (R.N.) concerning a 54 year old female "new hire" employee with allergies to latex and bee stings who had received a Hepatitis B vaccine series in 2006 (Manufacturer: Unknown. 1st dose on 07-MAR-2006, 2nd dose on 23-MAY-2006 and a 3rd dose on 01-AUG-2006). Titers were drawn as part of her pre-employment screenings and her titer was less than 5. So the patient opted for a second series of the vaccine. On 27-APR-2010 the patient was vaccinated IM in the left arm with a dose of RECOMBIVAX HB (lot# 665623/1024Y, exp: 19-JUN-2012). The nurse combined two pediatric (0.5ml) doses to equal one adult (1 ml) dose. Not long after leaving the employee health department the patient was across the street at the pharmacy and began to feel hot, starting spitting up mucous, and became short of breath. She went back to the hospital and was seen in the emergency room. The patient was in the emergency room for three hours. She was given epinephrine and possibly other medications (The nurse stated that she would know exactly what procedures or lab were performed when she got the ER records on 28-APR-2010). The patient recovered on 27-APR-2010. She was discharged home with prednisone and was not allowed to return to work until 28-APR-2010. The nurse requested a lot check. Upon internal review, feeling hot, spitting up mucous and short of breath treated with epinephrine were determined to be other important medical events. A preliminary lot check investigation was performed. To date our investigation has found that this lot conformed to quality release parameters and the manufacturing was typical of a lot of RECOMBIVAX HB. Additional information will be provided upon finalization of this manufacturing investigation. A standard lot check investigation was performed. All in-process quality checks for lot number 665623/1024Y were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met requirements of the research center and was released. Follow-up information has been received from an employee of a healthcare facility concerning the 54 year old female who also had an allergy to sulfa. There was no visible illness at the time of vaccination. On 27-APR-2010, the patient experienced shortness of breath (SOB), swelling, flushed and audible wheezing. The patient recovered on the same day. The reporter considered the shortness of breath (SOB), swelling, flushed and audible wheezing were to be life threatening illness. No further information is available. The patient was seen in the emergency room.
Age: 54.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect drug dosage form administered, Increased upper airway secretion, Swelling, Vomiting, Wheezing
Clinical narrative: Information has been received from a Registered Nurse (R.N.) concerning a 54 year old female "new hire" employee with allergies to latex and bee stings who had received a Hepatitis B vaccine series in 2006 (Manufacturer: Unknown. 1st dose on 07-MAR-2006, 2nd dose on 23-MAY-2006 and a 3rd dose on 01-AUG-2006). Titers were drawn as part of her pre-employment screenings and her titer was less than 5. So the patient opted for a second series of the vaccine. On 27-APR-2010 the patient was vaccinated IM in the left arm with a dose of RECOMBIVAX HB (lot# 665623/1024Y, exp: 19-JUN-2012). The nurse combined two pediatric (0.5ml) doses to equal one adult (1 ml) dose. Not long after leaving the employee health department the patient was across the street at the pharmacy and began to feel hot, starting spitting up mucous, and became short of breath. She went back to the hospital and was seen in the emergency room. The patient was in the emergency room for three hours. She was given epinephrine and possibly other medications (The nurse stated that she would know exactly what procedures or lab were performed when she got the ER records on 28-APR-2010). The patient recovered on 27-APR-2010. She was discharged home with prednisone and was not allowed to return to work until 28-APR-2010. The nurse requested a lot check. Upon internal review, feeling hot, spitting up mucous and short of breath treated with epinephrine were determined to be other important medical events. A preliminary lot check investigation was performed. To date our investigation has found that this lot conformed to quality release parameters and the manufacturing was typical of a lot of RECOMBIVAX HB. Additional information will be provided upon finalization of this manufacturing investigation. A standard lot check investigation was performed. All in-process quality checks for lot number 665623/1024Y were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met requirements of the research center and was released. Follow-up information has been received from an employee of a healthcare facility concerning the 54 year old female who also had an allergy to sulfa. There was no visible illness at the time of vaccination. On 27-APR-2010, the patient experienced shortness of breath (SOB), swelling, flushed and audible wheezing. The patient recovered on the same day. The reporter considered the shortness of breath (SOB), swelling, flushed and audible wheezing were to be life threatening illness. No further information is available. The patient was seen in the emergency room.
Age: 0.16
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Diarrhoea haemorrhagic, Food intolerance, Haematochezia
Clinical narrative: Information has been received from a physician concerning an approximately 8 weeks female with milk allergy and gas who "at the two month visit", on approximately 19-MAR-2010 was vaccinated with the first dose of ROTATEQ, oral (lot number not reported). Concomitant therapy included the first dose of PENTACEL, first dose of PREVNAR, the second dose of RECOMBIVAX HB and ENFAMIL NUTRAMIGEN "at the two month visit" on approximately 19-MAR-2010. "At the patient's two months visit", in approximately 19-MAR-2010, the patient was very gassy and was diagnosed with a milk allergy, and was put on ENFAMIL NUTRAMIGEN (manufacturer unspecified). "About three weeks" after receiving ROTATEQ, in approximately April 2010, the patient developed 10 to 12 diarrhea stools which had blood in them. The physician reported that the patient then saw a gastroenteritic physician and an allergist and they could not tolerate ENFAMIL NUTRAMIGEN (manufacturer unspecified). The physician reported that the patient then came back at her four month visit and received all the four month vaccines except ROTATEQ. Subsequently, the patient recovered. Upon internal review, 10 to 12 diarrhea stools which had blood in them was considered to be an other important medical event. Additional information has been requested.
Age: 0.16
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, DTAPIPVHIB, HEP, PNC, RV5
Symptoms: C-reactive protein normal, Colitis, Diarrhoea, Frequent bowel movements, Full blood count normal
Clinical narrative: Information has been received from a physician concerning an approximately 8 weeks female with milk allergy and gas who "at the two month visit", on approximately 19-MAR-2010 was vaccinated with the first dose of ROTATEQ, oral (lot number not reported). Concomitant therapy included the first dose of PENTACEL, first dose of PREVNAR, the second dose of RECOMBIVAX HB and ENFAMIL NUTRAMIGEN "at the two month visit" on approximately 19-MAR-2010. "At the patient's two months visit", in approximately 19-MAR-2010, the patient was very gassy and was diagnosed with a milk allergy, and was put on ENFAMIL NUTRAMIGEN (manufacturer unspecified). "About three weeks" after receiving ROTATEQ, in approximately April 2010, the patient developed 10 to 12 diarrhea stools which had blood in them. The physician reported that the patient then saw a gastroenteritic physician and an allergist and they could not tolerate ENFAMIL NUTRAMIGEN (manufacturer unspecified). The physician reported that the patient then came back at her four month visit and received all the four month vaccines except ROTATEQ. Subsequently, the patient recovered. Upon internal review, 10 to 12 diarrhea stools which had blood in them was considered to be an other important medical event. Additional information has been requested.
Age: 0.16
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Occult blood positive, Radioallergosorbent test negative, Vaccination complication
Clinical narrative: Information has been received from a physician concerning an approximately 8 weeks female with milk allergy and gas who "at the two month visit", on approximately 19-MAR-2010 was vaccinated with the first dose of ROTATEQ, oral (lot number not reported). Concomitant therapy included the first dose of PENTACEL, first dose of PREVNAR, the second dose of RECOMBIVAX HB and ENFAMIL NUTRAMIGEN "at the two month visit" on approximately 19-MAR-2010. "At the patient's two months visit", in approximately 19-MAR-2010, the patient was very gassy and was diagnosed with a milk allergy, and was put on ENFAMIL NUTRAMIGEN (manufacturer unspecified). "About three weeks" after receiving ROTATEQ, in approximately April 2010, the patient developed 10 to 12 diarrhea stools which had blood in them. The physician reported that the patient then saw a gastroenteritic physician and an allergist and they could not tolerate ENFAMIL NUTRAMIGEN (manufacturer unspecified). The physician reported that the patient then came back at her four month visit and received all the four month vaccines except ROTATEQ. Subsequently, the patient recovered. Upon internal review, 10 to 12 diarrhea stools which had blood in them was considered to be an other important medical event. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site discolouration, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Received PNEUMOVAX on 6/21/10 in right deltoid. That evening pt. states her arm from the shoulder to elbow, was a "fire engine red and hot to the touch and painful". Also c/o nausea. Afebrile. Denies difficulty breathing or rash. States she took two 325 mg. ASA and applied ice. Reports today her arm is a "pale pink color, kind of like a slight sun burn." Reports some arm swelling stating her right upper arm is slightly larger than her left arm. Reports "hardness or firmness in the muscle area of my right arm". States nausea has subsided and yesterday she took two IBRUPROFEN, none today. Had received a PNEUMOVAX 10 years ago and did not have a reaction at that time.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Nausea
Clinical narrative: Received PNEUMOVAX on 6/21/10 in right deltoid. That evening pt. states her arm from the shoulder to elbow, was a "fire engine red and hot to the touch and painful". Also c/o nausea. Afebrile. Denies difficulty breathing or rash. States she took two 325 mg. ASA and applied ice. Reports today her arm is a "pale pink color, kind of like a slight sun burn." Reports some arm swelling stating her right upper arm is slightly larger than her left arm. Reports "hardness or firmness in the muscle area of my right arm". States nausea has subsided and yesterday she took two IBRUPROFEN, none today. Had received a PNEUMOVAX 10 years ago and did not have a reaction at that time.
Age: 2.0
Sex: M
Vaccine: HEPA, PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Mtr: stating (L) thigh hot to touch, with redness, tenderness and firmness at injection site the day after shots were received. Applied ice pack and given TYLENOL. Improved at follow-up 2 days post - vaccination - no warmth, mild redness lat to injection site about 3 cm diameter about 2 cm firm site nodule.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema
Clinical narrative: Red patch extended over (L) upper arm area with well defined margin. Has since resolved. No treatment needed at this time.
Age: 0.38
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Abnormal sleep-related event, Chest X-ray normal, Computerised tomogram head, Computerised tomogram normal, Electroencephalogram normal
Clinical narrative: On approximately 2/5, this previously healthy 4-month-old male received his 2-month vaccines (HepB, RV, DTaP, Hib, PCV, and IPV according to the recommended immunization schedule). The next day, he went limp for several seconds and then returned to normal. He then started having increasing frequent episodes of arm stiffening for 30 seconds, falling asleep for 5-10 minutes, and then returning to normal. Between episodes, he was otherwise well, with no fevers, and acting normally. On 2/12, after breast-feeding, all of his arms and legs started shaking and his eyes rolled back. After about 1 minute, he fell asleep. He was taken to the ED, where he had 2 episodes of tonic-clonic seizures that were treated with lorazepam. A lumbar puncture, head CT, and chest X-ray were normal. During transport to SD, he had arm stiffening and received another dose of lorazepam. After arrival, he continued to have arm stiffening with blinking. He received a loading dose of fosphenytoin IV and started on an IV maintenance dose. He had a normal neurological examination and an unremarkable EEG. He was diagnosed with encephalopathy probably secondary to DTaP. He was discharged the next day on phenytoin. At a follow-up appointment on 3/17, it was reported that he had no further episodes of encephalopathy or seizures and a plan was made to wean him off phenytoin. Note: there is no family history of seizures or encephalopathies. Note: Encephalopathy has been more frequently reported with DTaP than with any other vaccine (CDC.gov). Summary: new onset seizure disorder in an otherwise healthy patient started 1 day after the 2-month vaccines that included DTaP; resulted in a 1-day hospitalization. Dx: encephalopathy possibly secondary to DTaP.
Age: 0.38
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Encephalopathy, Excessive eye blinking, Gaze palsy, Grand mal convulsion, Hypotonia
Clinical narrative: On approximately 2/5, this previously healthy 4-month-old male received his 2-month vaccines (HepB, RV, DTaP, Hib, PCV, and IPV according to the recommended immunization schedule). The next day, he went limp for several seconds and then returned to normal. He then started having increasing frequent episodes of arm stiffening for 30 seconds, falling asleep for 5-10 minutes, and then returning to normal. Between episodes, he was otherwise well, with no fevers, and acting normally. On 2/12, after breast-feeding, all of his arms and legs started shaking and his eyes rolled back. After about 1 minute, he fell asleep. He was taken to the ED, where he had 2 episodes of tonic-clonic seizures that were treated with lorazepam. A lumbar puncture, head CT, and chest X-ray were normal. During transport to SD, he had arm stiffening and received another dose of lorazepam. After arrival, he continued to have arm stiffening with blinking. He received a loading dose of fosphenytoin IV and started on an IV maintenance dose. He had a normal neurological examination and an unremarkable EEG. He was diagnosed with encephalopathy probably secondary to DTaP. He was discharged the next day on phenytoin. At a follow-up appointment on 3/17, it was reported that he had no further episodes of encephalopathy or seizures and a plan was made to wean him off phenytoin. Note: there is no family history of seizures or encephalopathies. Note: Encephalopathy has been more frequently reported with DTaP than with any other vaccine (CDC.gov). Summary: new onset seizure disorder in an otherwise healthy patient started 1 day after the 2-month vaccines that included DTaP; resulted in a 1-day hospitalization. Dx: encephalopathy possibly secondary to DTaP.
Age: 0.38
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Lumbar puncture normal, Musculoskeletal stiffness, Neurological examination normal, Tremor
Clinical narrative: On approximately 2/5, this previously healthy 4-month-old male received his 2-month vaccines (HepB, RV, DTaP, Hib, PCV, and IPV according to the recommended immunization schedule). The next day, he went limp for several seconds and then returned to normal. He then started having increasing frequent episodes of arm stiffening for 30 seconds, falling asleep for 5-10 minutes, and then returning to normal. Between episodes, he was otherwise well, with no fevers, and acting normally. On 2/12, after breast-feeding, all of his arms and legs started shaking and his eyes rolled back. After about 1 minute, he fell asleep. He was taken to the ED, where he had 2 episodes of tonic-clonic seizures that were treated with lorazepam. A lumbar puncture, head CT, and chest X-ray were normal. During transport to SD, he had arm stiffening and received another dose of lorazepam. After arrival, he continued to have arm stiffening with blinking. He received a loading dose of fosphenytoin IV and started on an IV maintenance dose. He had a normal neurological examination and an unremarkable EEG. He was diagnosed with encephalopathy probably secondary to DTaP. He was discharged the next day on phenytoin. At a follow-up appointment on 3/17, it was reported that he had no further episodes of encephalopathy or seizures and a plan was made to wean him off phenytoin. Note: there is no family history of seizures or encephalopathies. Note: Encephalopathy has been more frequently reported with DTaP than with any other vaccine (CDC.gov). Summary: new onset seizure disorder in an otherwise healthy patient started 1 day after the 2-month vaccines that included DTaP; resulted in a 1-day hospitalization. Dx: encephalopathy possibly secondary to DTaP.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Dyspnoea, Rash pruritic, Urticaria
Clinical narrative: Within 15 minutes after receiving DTaP, MMR, and varicella virus vaccines, he developed a pruritic eruption and breathing difficulty. He presented to the ED with a diffuse urticarial rash on his face and trunk. He was given epinephrine 0.1 mg/kg IM, diphenhydramine PO, and prednisolone PO. He spit up the oral medications and was given diphenhydramine IV and methylprednisolone IV. He was discharged on prednisolone and diphenhydramine.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Soreness and swelling at site of the injection. Symptoms supposedly associated with 1 out of 3 Zostavax recipients.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Rash generalised
Clinical narrative: Child developed an all over rash afternoon after receiving vaccine.
Age: 1.28
Sex: M
Vaccine: MMR, PNC
Symptoms: Unevaluable event
Clinical narrative: None reported.
Age: 15.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Abdominal pain, Back pain, Pyrexia, Vomiting
Clinical narrative: High fever, vomiting, abdominal pain, back pain occurred the evening of same day vaccines were given. Evaluated in ER & discharged on 6-16-10. Re-evaluated in office on 6-17-10 & admitted to hospital. Diagnosed with possible viral illness.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Injection site pain, Joint range of motion decreased, Local swelling, Nausea
Clinical narrative: (1) Severe headache. (2) Motion (range of motion) decreased due to (L) deltoid and whole arm pain. (3) Extreme nausea, no ?. (4) Left neck "felt swollen". (5) Felt feverish - 99 temp at home.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: (1) Severe headache. (2) Motion (range of motion) decreased due to (L) deltoid and whole arm pain. (3) Extreme nausea, no ?. (4) Left neck "felt swollen". (5) Felt feverish - 99 temp at home.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Bilateral injection sites red, burning, itching and swollen superficial scratches right arm. Immunization records were not provided at time of visit. Monitor sites.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Redness, swollen, tender. Treatment: KEFLEX 1 1/2 tsp BID x 10 days.
Age: 24.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Convulsion
Clinical narrative: Never been ill her life - took vaccine and started having seizures. Have not stopped.
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Flushing, Headache, Nausea, Scintillating scotoma, Vision blurred
Clinical narrative: Pt. received her 2nd Hep B vaccine at 8:30 AM at 10:15 she felt nauseated, headache-blurred vision with loss of sight at periphery. Describes scintillating, scotoma vomited x 1 feels she is flushed T. 97.9 VS 140/90 P. 92 O2S at 97% lungs clear.
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Visual field defect, Vomiting
Clinical narrative: Pt. received her 2nd Hep B vaccine at 8:30 AM at 10:15 she felt nauseated, headache-blurred vision with loss of sight at periphery. Describes scintillating, scotoma vomited x 1 feels she is flushed T. 97.9 VS 140/90 P. 92 O2S at 97% lungs clear.
Sex: U
Vaccine: HEPA, MNQ, TYP, YF
Symptoms: Rash maculo-papular
Clinical narrative: Few hours after starting VIVOTIF  - developed a maculopapular rash over face/trunk/Ext. No facial swelling. No dizziness. No SOB.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Pt came to my clinic today 6/24/10 and showed me rash on rt ant chest and thoracic area, his pcp re ordered acyclovir per phone prior to this visit. Pt wanted confirmation if this was shingles like "worse than when I had shingles".
Age: 19.0
Sex: F
Vaccine: HPV2
Symptoms: Electromyogram abnormal, Grip strength decreased, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy
Clinical narrative: Hand numbness then loss of grip strength then progressed to leg weakness gradual onset. EMG positive for Guillain Barre Syndrome and Hospitalized for IVIG on 06/16/2010. Resolution of symptoms at office visit on 06/23/2010.
Age: 19.0
Sex: F
Vaccine: HPV2
Symptoms: Lumbar puncture abnormal, Muscular weakness
Clinical narrative: Hand numbness then loss of grip strength then progressed to leg weakness gradual onset. EMG positive for Guillain Barre Syndrome and Hospitalized for IVIG on 06/16/2010. Resolution of symptoms at office visit on 06/23/2010.
Age: 1.81
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash
Clinical narrative: High fever for three days, followed by body rash, beginning 06/19-still has it today 06/24.
Age: 14.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Cold sweat, Disorientation, Pallor, Syncope
Clinical narrative: Had patient seated and was observing patient after vaccination. Patient was pale and clammy-asked for wash cloth and then fainted. Caught patient as he fainted. Patient was disoriented for a couple minutes. Applied cool package on back of neck and observed patient for 15 minutes. Patient denied any further care and was walked out to vehicle. Instructed patient's mother to notify me of any other reactions. No reports.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site haematoma, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, soreness, swelling, raised bruise around administration site, itchy, hot to the touch.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: Redness, soreness, swelling, raised bruise around administration site, itchy, hot to the touch.
Age: 3.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Finger deformity, Hyperhidrosis, Pyrexia, Staring, Tremor
Clinical narrative: Mother called and reported her child received vaccine at local health department around 3pm. Child had a little bit of fever after shot; was given Tylenol. Went to sleep and woke up at 9pm "staring in another world", hands shaking, fingers crippled, not responding to her asking if he was o.k. Took him to the ER fo tx. Child had seizure in past, mother state this was not like seizures had in the past. Child was also sweating a lot complained of stomach hurting in past, prior to receiving shot and had been to the ER.
Age: 3.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Unresponsive to stimuli
Clinical narrative: Mother called and reported her child received vaccine at local health department around 3pm. Child had a little bit of fever after shot; was given Tylenol. Went to sleep and woke up at 9pm "staring in another world", hands shaking, fingers crippled, not responding to her asking if he was o.k. Took him to the ER fo tx. Child had seizure in past, mother state this was not like seizures had in the past. Child was also sweating a lot complained of stomach hurting in past, prior to receiving shot and had been to the ER.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site oedema, Injection site pruritus, Oedema
Clinical narrative: Left upper arm (site of vaccination) became edematous, erythematous, and pruritic.  Extended from left axillary to forearm, limited to left upper extremity.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pruritus, White blood cell count increased
Clinical narrative: Left upper arm (site of vaccination) became edematous, erythematous, and pruritic.  Extended from left axillary to forearm, limited to left upper extremity.