chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HEP
Symptoms: Hypophagia, Rash erythematous, Rash maculo-papular, Urine output decreased
Clinical narrative: Information has been received from a physician via medical record concerning an 11 day old male with right congenital clubfoot who on 27-APR-2009 was vaccinated with a dose of RECOMBIVAX HB (manufacturer unknown). On 06-MAY-2009 the baby was taken to the emergency department by his mother. His mom described that the he had a "normal baby rash" in the nursery over his abdomen and face. Before his bath that day, mom took off onesie and noted increased erythema of the rash, with spread to arms as well. Mom described rash as red, and looking pimples, no blisters. Initially mom thought baby had heat rash as he had an onesie, sleeper and blanket on, but did not have tactile temperatures. No fever, congestion, cough, emesis or diarrhea. No one else with similar rash, no sick contacts. The baby had some increased crying that day, and took a longer nap than usual (4 hrs) but mom sometimes had to wake him for feeds and stated that she forgot to wake him that day. Otherwise, taking breast milk and formula supplementation (1-1.5 oz) q2h, wet diapers 7/day, BMs 2/day. The baby was an ex-39 weeker, 7 lb 15 oz, NSVD, normal pregnancy and home with mom. Physical exam showed that erythematous, maculopapular rash over chest, abdomen, decreased on arms and back. No rash on legs. The physician's impression was erythema toxicum neonatorum. The condition was stable. The baby was disposed to home and recommended to return to the ED if symptoms worsen or change, and follow up PCP. The physician reported the baby improved with the therapy. On 19-JUN-2009 at 15:21 the patient's mom called the office to report that the patient did not eat much that day and had not had a wet diaper since 09:00. She was advised to take the patient to the ER. It was not reported if the patient was taken to the ER. On 23-JUN-2009 the baby was vaccinated with a dose of RECOMBIVAX HB (manufacturer unknown), a dose of PREVNAR, a dose of ROTATEQ, a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, a dose of Hib conj vaccine (unspecified carrier) and a dose of poliovirus vaccine inactivated (unspecified). Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Oedema peripheral, Rash erythematous
Clinical narrative: Information has been received from a 22 year old nurse with penicillin allergy and no pertinent medical history who on 21-NOV-2007, 21-DEC-2007, and 21-MAY-2008 was vaccinated IM with the first, second and third 0.5 ml doses of RECOMBIVAX HB. There was no concomitant medication. Within 24 to 48 hours after the nurse received the first does of RECOMBIVAX, the nurse experienced reddish slightly raised rash appeared on inner elbow area right arm and left arm. Rash did not itch. The nurse reported that ever since starting the RECOMBIVAX HB series her rash had not gone away and it only faded in the sunlight and had spread to back. The nurse consulted with physicians but diagnosis remained undermined. The nurse reported that she had used the over the counter creams hydrocortisone and selenium but they did not do anything. No diagnostic study was performed. The patient saw a physician on an unspecified date. At the time of the report, the patient had not recovered. Rash was considered to be an other important medical event. Additional information has been requested.
Age: 0.16
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC
Symptoms: Candidiasis
Clinical narrative: Information has been received from a licensed practical nurse via pediatric medical records concerning a 10 weeks old male with a history of cough, dacryostenosis congenital, adverse event, dermatitis, dermatitis diaper, dyspnea, gastroenteritis, lacrimination increased, mass, rhinorrhea, pyrexia, upper respiratory infection, vomiting and wheezing after exposure to GARDASIL vaccine (MSD WAES# 0809USA00346) who on 15-MAY-2009 was vaccinated with RECOMBIVAX HB (manufacturer unknown). Concomitant therapy included PREVNAR vaccine and PENTACEL vaccine. On 01-JUN-2009 the patient developed thrush. The infant was prescribed DIFLUCAN 10mg/mL, 1.5mL, by mouth everyday for 14 days. On 05-JUN-2009, the infant was seen in the office to check his weight and to discuss his feeding. The examination revealed good weight gain and that the infant was doing well. On 09-JUL-2009, the infant had a well visit and was vaccinated with PENTACEL, ROTATEQ and PREVNAR. At the time of this report the patient had recovered. Additional information is not expected. All medical records are available upon request.
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Body temperature increased, Myalgia, Pyrexia
Clinical narrative: Information has been received from a licensed visiting nurse concerning her female coworker with penicillin allergy and no pertinent medical history who on 06-AUG-2009, was vaccinated with a RECOMBIVAX HB (lot # 6664769/0652Y, thimerosal free),  1 mL, intramuscular route. Concomitant therapy included CELEXA. It was reported that on 06-AUG-2009, the patient complained of muscle aches, weakness, and fever of 101 degrees F after receiving RECOMBIVAX HB. On 07-AUG-2009, the patient recovered. The patient did not seek medical attention. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Death, Rheumatoid arthritis
Clinical narrative: Information has been received via a litigation article regarding a concerning a deceased male patient who in January and February of 1994 was vaccinated with RECOMBIVAX HB. An otherwise viable petition for rheumatoid arthritis vaccine injury survived the death of the petitioner even when that death was not vaccine related. The patient filed a petition on 02-JUL-1999, alleging that RECOMBIVAX vaccinations he received in January and February 1994 caused him to suffer an unspecified adverse reaction later identified as RA. He died on 09-SEP-2006 of unrelated causes. No further information is available.
Sex: F
Vaccine: HEP
Symptoms: Palpitations, Rash
Clinical narrative: Information has been received from a licensed practical nurse concerning a female with penicillin allergy and no pertinent medical history who was vaccinated with the first dose of RECOMBIVAX HB (dose, route and lot# not reported). Concomitant therapy included GLUCOPHAGE. Subsequently the patient developed rash and palpitations after receiving the first and only dose of RECOMBIVAX HB. Subsequently, the patient recovered from rash and palpitations on unspecified date. No lab diagnostics study was performed. The patient did not seek medical attention. Follow up information has been received from a health care professional indicated that the patient was given the vaccine at another doctor's office and they did not have any information. Additional information is not expected.
Sex: M
Vaccine: HEP
Symptoms: Oral candidiasis, Rash
Clinical narrative: Information has been received from a physician via medical records concerning an approximately 15 day old male with bruising of nose and scalp and a history of respiratory distress, bilirubin increased and circumcision (WAES #0906USA02122) who on 18-MAR-2009 was vaccinated with a first dose of RECOMBIVAX HB. On 31-MAR-2009 the patient was seen by the physician. Physical examination showed scant oral thrush and a rash in the groin. The physician suggested that he use DESOTIN ointment for his rash in groin and do not use perfume wipes. It was noted that patient had used oral thrush medication and it was relieved. The outcome of the rash was no provided. Additional information is not expected.
Sex: M
Vaccine: HEP
Symptoms: Feeling abnormal
Clinical narrative: Information has been received from a male patient who on an unspecified date was vaccinated with a dose of RECOMBIVAX HB (lot # not reported). On an unspecified date "he experienced weird side effects after receiving a dose of RECOMBIVAX HB. No further information is available.
Sex: F
Vaccine: HEP
Symptoms: Immunisation reaction
Clinical narrative: Information has been received from a female with allergic reactions to environmental, paints, cleaning supplies, perfumes, phenol and sulfur containing drugs, CELEBREX and morphine (manufacturer unknown) who in 2000 was vaccinated with a dose of RECOMBIVAX HB (manufacturer unknown) (dose, route, and lot# not reported). The patient had severe reaction to the RECOMBIVAX HB. At the time of the report,  the patient's outcome was unknown. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Bilirubin conjugated, Blood bilirubin increased, Frequent bowel movements, Infantile spitting up, Jaundice
Clinical narrative: Information has been received from a physician concerning a 6 days old male baby who on 17-JUL-2007 was vaccinated with a dose of RECOMBIVAX HB (manufacturer unknown). On 23-JUL-2009 the baby was checked in his first visit, it was reported that the baby was spitting up his formula with loose bowel movements. The baby's height was 19.25 inches, weight 6pd and 12 oz, pulse 150 and respiratory rate 42, otherwise physical examination was normal.  The baby had no known allergies but a family history of allergies/asthma (mom), diabetes and stroke (maternal grandmother) from his mom. The physician also reported that the baby icterus (mild) on face and trunk. The patient was diagnosed with jaundice. A total serum bilirubin test: 0.5mg/dl (normal range form 0 to 0.2 mg/dl). This is one of two reports from the same source. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Arthritis, Fibromyalgia, Myalgia, Nervous system disorder
Clinical narrative: Information has been received from a case in litigation via a case report concerning a female patient who on 14-OCT-1997 and 02-DEC-1997 was vaccinated with RECOMBIVAX HB (Lot number not reported). On an unspecified date, 24 hours post vaccination, the patient developed and continued to suffer from an ill defined neurologic disorder characterized by myalgias, and arthritis and consistent with fibromyalgia. No further information is available.
Sex: F
Vaccine: HEP
Symptoms: Headache, Hepatitis B antibody positive, Influenza like illness, Malaise, Musculoskeletal stiffness
Clinical narrative: Information has been received from a registered nurse who was vaccinated with a three dose series of RECOMBIVAX HB (manufacturer unknown) years ago. When she did not have an adequate titer after the series, she required to get a booster dose. After the booster dose, the patient developed flu like symptoms and was "quite sick". It was unknown if the patient sought medical attention. On an unknown date, the patient recovered. Follow-up information has been received from the nurse with allergies to iodine, cashews and soy and no illness at the time of vaccination who in 1994 (approximately at the age of 53 year old) received a three dose series of RECOMBIVAX HB (manufacturer unknown) in upper deltoid but was non-immune. After receiving a fourth booster dose in 1994, the patient became very ill with flu like symptoms including fever, muscle pains, headache and extremely stiff neck for 3 days. The flu like symptoms rapidly resolved after emesis on the third afternoon. The patient didn't seek medical attention. It was reported that "no residual symptoms but unable to done to blood now, due to antibodies to hepatitis B virus in blood". Additional information is not expected.
Sex: F
Vaccine: HEP
Symptoms: Myalgia, Pyrexia, Vomiting
Clinical narrative: Information has been received from a registered nurse who was vaccinated with a three dose series of RECOMBIVAX HB (manufacturer unknown) years ago. When she did not have an adequate titer after the series, she required to get a booster dose. After the booster dose, the patient developed flu like symptoms and was "quite sick". It was unknown if the patient sought medical attention. On an unknown date, the patient recovered. Follow-up information has been received from the nurse with allergies to iodine, cashews and soy and no illness at the time of vaccination who in 1994 (approximately at the age of 53 year old) received a three dose series of RECOMBIVAX HB (manufacturer unknown) in upper deltoid but was non-immune. After receiving a fourth booster dose in 1994, the patient became very ill with flu like symptoms including fever, muscle pains, headache and extremely stiff neck for 3 days. The flu like symptoms rapidly resolved after emesis on the third afternoon. The patient didn't seek medical attention. It was reported that "no residual symptoms but unable to done to blood now, due to antibodies to hepatitis B virus in blood". Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Device malfunction, Drug dose omission, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning two patients who on unspecified dates 'last week" were vaccinated IM with doses of RECOMBIVAX HB (lot# 0438Y, thimerosal free). The medical assistant reported that the patients were unable to receive the complete doses of RECOMBIVAX HB vaccine because the syringe malfunctioned. The products were adult prefilled syringes and the size of the container was 3. The medical assistant reported that in both cases the plunger came out of the syringe following insertion of needle into muscle during aspiration. She stated that the syringes looked intact. The cellophanes were intact and the trays undamaged. She attached the needle onto the syringe and injected the patient. When she pulled the plunger backwards to check for blood, the green portion of the plunger fell out and separated from the gray part. The gray stopper portion stayed inside. She stated that the same thing happened with the second syringe. No adverse effect was reported. A product quality complaint was involved. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Follow up information has been received from a medical assistant who confirmed the events, she stated that the patient were never injected with the vaccine. The health care professional contacted during telephone follow-up could not supply the following information: patients name, dates of birth, dates of vaccination/therapy, dose numbers, lot numbers or dates of events. The SR# is 13353358562.
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Hypersensitivity
Clinical narrative: Information has been received from an approximately 40 year old female consumer who has an allergic reaction to the Flu vaccine in 1976.  In 1988 she was vaccinated with an injection of RECOMBIVAX HB (manufacturer unknown) (dose and frequency unknown) (dose and frequency unknown) and she experienced an allergic reaction.  The consumer sought unspecified medical attention and her present status was not specified.  No further information is available.
Sex: F
Vaccine: HEP
Symptoms: Autoimmune hepatitis
Clinical narrative: Information has been received for a case in litigation from litigation report information obtained from a published report (title as stated above), concerning a female patient who was vaccinated with RECOMBIVAX HB and experienced autoimmune hepatitis (AIH). Given the special masters errors, the judge said, she would issue her own causing findings and remand only for damages determinations. Regarding generic causation, the judge said the physician's testimony and references to the literature were sufficient to show that the vaccine could cause autoimmune hepatitis through dysfunction of the CD4+ regulatory T cells in generically predisposed individuals. Among the physician's sources. "The physician then described various mechanisms by which infections and vaccines can cause autoimmune disease - molecular mimicry, bystander activation polyclonal activation, and dysfunction of the CD 4+ regulatory T cells (or 'T-reg cell dysfunction'), the judge said, "Over the course of the hearings in these cases, the last theory, CD4+ regulatory T cell dysfunction, rose to the forefront as a promising theory by which AIH might be triggered by a vaccine, such as hepatitis B." "The respondent's attack of the petitioners' evidence of a medical theory was largely focused on the quantum of evidence in the scientific literature underlying the physician's assertions," The judge said. "They did not present any medical literature that negated the physician's medical theory. Instead, they emphasized the fact that no link between the hepatitis B vaccine and AIH has been directly proven in the literature. The judge affirmed special master's rejection of benefits. She said he did not have AIH but had non-alcoholic steatohepatitis (NASH) and had presented no theory of causation for that condition. The judge said NASH is a metabolic disease, not an autoimmune condition that might be traced to vaccines. The judge said, she did not present an appropriate time frame between vaccination and the development of her condition as required. Moreover, the judge said she had been taking an antibiotic used to treat acne and known to cause autoimmune hepatitis, for approximately 13 months before having an abnormal liver test in August, when she was 40 years old. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: HEP
Symptoms: Cerebral disorder, Multiple sclerosis, Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging normal, Optic neuritis
Clinical narrative: Information has been received from a case in litigation concerning a 60 year old female patient who on 26-Sep-20 was vaccinated with the third dose of RECOMBIVAX HB. On 07-Oct-2000, 11 days after the vaccination, the patient presented with diminished vision in the lower field of her right eye. A magnetic resonance imaging study result was normal. The patient was diagnosed with optic neuritis. On 11-Apr-2001, the MRI results showed mild nonspecific bilateral white mater disease. The patient was diagnosed with multiple sclerosis. The reporter felt that optic neuritis and multiple sclerosis were related to therapy with RECOMBIVAX HB stating that "there is a biologically plausible medical theory here in that patient's white cells interpreted the hepatitis B surface antigen as having some similarity to brain tissue and proceeded to attack the tissue. There is a logical sequence of cause and effect in that petitioner's receipt of her first two vaccinations primed her immune system, and the third vaccination in effect pushed her over the immunologic edge. And there is an appropriate medical interval between vaccination and injury. The physician testified that without the hepatitis B vaccinations, the patient would not have had optic neuritis and MS. Upon internal review, multiple sclerosis was considered to be an other important medical event. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: HEP
Symptoms: Visual acuity reduced
Clinical narrative: Information has been received from a case in litigation concerning a 60 year old female patient who on 26-Sep-20 was vaccinated with the third dose of RECOMBIVAX HB. On 07-Oct-2000, 11 days after the vaccination, the patient presented with diminished vision in the lower field of her right eye. A magnetic resonance imaging study result was normal. The patient was diagnosed with optic neuritis. On 11-Apr-2001, the MRI results showed mild nonspecific bilateral white mater disease. The patient was diagnosed with multiple sclerosis. The reporter felt that optic neuritis and multiple sclerosis were related to therapy with RECOMBIVAX HB stating that "there is a biologically plausible medical theory here in that patient's white cells interpreted the hepatitis B surface antigen as having some similarity to brain tissue and proceeded to attack the tissue. There is a logical sequence of cause and effect in that petitioner's receipt of her first two vaccinations primed her immune system, and the third vaccination in effect pushed her over the immunologic edge. And there is an appropriate medical interval between vaccination and injury. The physician testified that without the hepatitis B vaccinations, the patient would not have had optic neuritis and MS. Upon internal review, multiple sclerosis was considered to be an other important medical event. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Arthritis reactive, Oedema peripheral, Similar reaction on previous exposure to drug
Clinical narrative: Information has been received from a nurse practitioner who on an unspecified date was vaccinated with a dose of RECOMBIVAX HB (Lot number not provided) (manufacturer unknown). The consumer reported that in the "mid 1990s" after the first two vaccinations she had swollen feet. Subsequently, after the third vaccination she had arthritic reaction that lasted 8 months. At the time of the report the status of the patient was unknown. Follow-up information has been received from the nurse practitioner who reported that she was vaccinated with the three doses of RECOMBIVAX HB between 1992 and 1994, she was unable to given exact dates. She stated that she has informed her internist of the vaccine and the post symptoms. Additional information is not expected.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody positive, Hepatitis B antigen positive, Hepatitis B core antigen positive
Clinical narrative: Information has been received from a health professional concerning an 18 year old female patient with seasonal allergies and no pertinent medical history who at age of 2 months, was vaccinated with a 3 dose series of RECOMBIVAX HB (lot number not provided). A hepatitis B titer done at age 6 or 7 years was core antigen negative and surface antigen positive at 20.1mIU/ml. A recent titer was core antigen positive and surface antigen positive at 10.84mIU/ml. The patient sought medical attention in the office. At the time of the report, the patient did not recover from this event. Additional information has been requested.
Age: 0.02
Sex: M
Vaccine: HEP, HPV4
Symptoms: Body temperature normal, Diarrhoea, Faeces discoloured, Gastrooesophageal reflux disease, Irritability
Clinical narrative: Information has been received from a physician concerning a 19 day old male patient with hypospadias and a history of unconjugated hyperbilirubinemia, hypermagnesaemia, premature baby and no known drug allergies who on 16-SEP-2009 was vaccinated with a dose of RECOMBIVAX HB (Manufacturer unknown). Concomitant therapy included vitamins (unspecified) (POLY-VI-SOL) and ferrousSO4. On 26-SEP-2009 the patient was seen by a physician for vomiting after each feeding, wheezing and fussy. His physical examination revealed a 5.11 lb baby, and no other important finding. It was also reported that the baby had a projectile vomiting on 25-SEP-2009 at 3:00 pm. His appetite was normal and his stools were yellow (6 times) and clear like. The patient was diagnosed with gastrointestinal reflux (GER) and was prescribed with MYLICON and Ranitidine. The recommended diet was SIMILAC advance every two hours. On 30-SEP-2009, the patient was seen by a physician again for a follow up check. It was reported that the patient had fever (98.7 degrees F) on 29-SEP-2009. The patient continued vomiting after feeding and had diarrhea. His stools were yellow and not firm. His appetite was 3 oz every 3 hours. The patient's GER was better and NEOSURE was recommended. Additional information has been requested. All available medical records will be provided upon request.
Age: 0.02
Sex: M
Vaccine: HEP, HPV4
Symptoms: Pyrexia, Vomiting projectile, Wheezing
Clinical narrative: Information has been received from a physician concerning a 19 day old male patient with hypospadias and a history of unconjugated hyperbilirubinemia, hypermagnesaemia, premature baby and no known drug allergies who on 16-SEP-2009 was vaccinated with a dose of RECOMBIVAX HB (Manufacturer unknown). Concomitant therapy included vitamins (unspecified) (POLY-VI-SOL) and ferrousSO4. On 26-SEP-2009 the patient was seen by a physician for vomiting after each feeding, wheezing and fussy. His physical examination revealed a 5.11 lb baby, and no other important finding. It was also reported that the baby had a projectile vomiting on 25-SEP-2009 at 3:00 pm. His appetite was normal and his stools were yellow (6 times) and clear like. The patient was diagnosed with gastrointestinal reflux (GER) and was prescribed with MYLICON and Ranitidine. The recommended diet was SIMILAC advance every two hours. On 30-SEP-2009, the patient was seen by a physician again for a follow up check. It was reported that the patient had fever (98.7 degrees F) on 29-SEP-2009. The patient continued vomiting after feeding and had diarrhea. His stools were yellow and not firm. His appetite was 3 oz every 3 hours. The patient's GER was better and NEOSURE was recommended. Additional information has been requested. All available medical records will be provided upon request.
Age: 0.02
Sex: M
Vaccine: HEP, HPV4
Symptoms: Blood bilirubin increased, Blood magnesium increased, Body temperature normal, Caesarean section, Crying
Clinical narrative: Information has been received from a physician concerning a 19 day old male patient with hypospadias and a history of unconjugated hyperbilirubinemia, hypermagnesaemia, premature baby and no known drug allergies who on 16-SEP-2009 was vaccinated with a dose of RECOMBIVAX HB (Manufacturer unknown). Concomitant therapy included vitamins (unspecified) (POLY-VI-SOL) and ferrousSO4. On 26-SEP-2009 the patient was seen by a physician for vomiting after each feeding, wheezing and fussy. His physical examination revealed a 5.11 lb baby, and no other important finding. It was also reported that the baby had a projectile vomiting on 25-SEP-2009 at 3:00 pm. His appetite was normal and his stools were yellow (6 times) and clear like. The patient was diagnosed with gastrointestinal reflux (GER) and was prescribed with MYLICON and Ranitidine. The recommended diet was SIMILAC advance every two hours. On 30-SEP-2009, the patient was seen by a physician again for a follow up check. It was reported that the patient had fever (98.7 degrees F) on 29-SEP-2009. The patient continued vomiting after feeding and had diarrhea. His stools were yellow and not firm. His appetite was 3 oz every 3 hours. The patient's GER was better and NEOSURE was recommended. Additional information has been requested. All available medical records will be provided upon request.
Age: 0.02
Sex: M
Vaccine: HEP, HPV4
Symptoms: Drug exposure during pregnancy, Haematocrit decreased, Hyperbilirubinaemia neonatal, Hypermagnesaemia, Hypospadias
Clinical narrative: Information has been received from a physician concerning a 19 day old male patient with hypospadias and a history of unconjugated hyperbilirubinemia, hypermagnesaemia, premature baby and no known drug allergies who on 16-SEP-2009 was vaccinated with a dose of RECOMBIVAX HB (Manufacturer unknown). Concomitant therapy included vitamins (unspecified) (POLY-VI-SOL) and ferrousSO4. On 26-SEP-2009 the patient was seen by a physician for vomiting after each feeding, wheezing and fussy. His physical examination revealed a 5.11 lb baby, and no other important finding. It was also reported that the baby had a projectile vomiting on 25-SEP-2009 at 3:00 pm. His appetite was normal and his stools were yellow (6 times) and clear like. The patient was diagnosed with gastrointestinal reflux (GER) and was prescribed with MYLICON and Ranitidine. The recommended diet was SIMILAC advance every two hours. On 30-SEP-2009, the patient was seen by a physician again for a follow up check. It was reported that the patient had fever (98.7 degrees F) on 29-SEP-2009. The patient continued vomiting after feeding and had diarrhea. His stools were yellow and not firm. His appetite was 3 oz every 3 hours. The patient's GER was better and NEOSURE was recommended. Additional information has been requested. All available medical records will be provided upon request.
Age: 0.02
Sex: M
Vaccine: HEP, HPV4
Symptoms: Intensive care, Premature baby, Umbilical cord around neck
Clinical narrative: Information has been received from a physician concerning a 19 day old male patient with hypospadias and a history of unconjugated hyperbilirubinemia, hypermagnesaemia, premature baby and no known drug allergies who on 16-SEP-2009 was vaccinated with a dose of RECOMBIVAX HB (Manufacturer unknown). Concomitant therapy included vitamins (unspecified) (POLY-VI-SOL) and ferrousSO4. On 26-SEP-2009 the patient was seen by a physician for vomiting after each feeding, wheezing and fussy. His physical examination revealed a 5.11 lb baby, and no other important finding. It was also reported that the baby had a projectile vomiting on 25-SEP-2009 at 3:00 pm. His appetite was normal and his stools were yellow (6 times) and clear like. The patient was diagnosed with gastrointestinal reflux (GER) and was prescribed with MYLICON and Ranitidine. The recommended diet was SIMILAC advance every two hours. On 30-SEP-2009, the patient was seen by a physician again for a follow up check. It was reported that the patient had fever (98.7 degrees F) on 29-SEP-2009. The patient continued vomiting after feeding and had diarrhea. His stools were yellow and not firm. His appetite was 3 oz every 3 hours. The patient's GER was better and NEOSURE was recommended. Additional information has been requested. All available medical records will be provided upon request.
Age: 19.0
Sex: M
Vaccine: FLU3, HEPA, TYP, YF
Symptoms: Anaphylactic reaction
Clinical narrative: This case was reported by a healthcare professional sales representative and described the occurrence of anaphylactic reaction in a 19-year-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline), FLUVARIX, THYPOID (unspecified non-GSK manufacturer) and Yellow fever (unspecified non-GSK manufacturer). The subject's medical history concurrent conditions, and concurrent medications were not reported. On the afternoon of 1 November 2007 the subject received 1st dose of HAVRIX (unknown, adult dose), 1st dose of FLUARIX (unknown), unspecified dose of Typhoid vaccine (unknown), and unspecified dose of Yellow fever (unknown). The sites of administration of the vaccines were not provided. On 1 November 2007, less than one day after vaccination with FLUVARIX, HAVRIX, Typhoid vaccine and Yellow fever, the subject experienced anaphylactic reaction. The subject was treated in an emergency room. The exact time to the onset of the event, after vaccination was not known.  The vaccination course with HAVRIX was discontinued. At the time of initial reporting, 02 November 2007, the event was resolved. The healthcare professional reported to the sales representative that she did not know which of the vaccines may have cause the event. Note: Anaphylactic reaction was assessed as medically serious by GSK.
Age: 18.0
Sex: M
Vaccine: HEP
Symptoms: Dyspnoea, Hypersensitivity, Urticaria
Clinical narrative: Information has been received from a Doctor of Pharmacy concerning an 18 year old male who on unspecified date reported as "many years ago" was vaccinated with a dose of RECOMBIVAX HB (manufacturer unknown).  The reporter mentioned that the patient had an allergic reaction; he had hives and difficulty breathing.  It was unknown if the patient sought medical attention.  At the time of reporting the patient's outcome was unspecified.  Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Blister, Rash
Clinical narrative: Information has been received from a medical assistant concerning a patient who on an unspecified date was vaccinated with RECOMBIVAX HB. On an unknown date, the patient developed a "blistering rash" after receiving RECOMBIVAX HB. At the time of reporting, the patient had recovered. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: HEP
Symptoms: Anaphylactic reaction, Lip swelling, Swollen tongue, Urticaria
Clinical narrative: Information has been received from a 59 year old female patient with an allergy to LEVAQUIN and bee stings who a long time ago when she worked in a tuberculosis center, was vaccinated with a 0.5ml dose of RECOMBIVAX HB. There was no concomitant medication. Subsequently, later that day after receiving RECOMBIVAX HB the patient started to developed hives on her back, buttocks, stomach and chest. She went to a hospital every to six hours to get (BENADRYL, manufacturer unspecified) since her physician was away. But the patient was never admitted to the hospital. It was reported that on third day her lips and tongue started to swell so she went back to the hospital. The patient was given Prednisone (manufacturer unknown) since she was having an anaphylactic reaction. While on Prednisone (manufacturer unknown) she eventually was put down to a lower dose and then her anaphylactic reaction came back and she would have to up her dose of Prednisone (manufacturer unknown) again. Eventually the Prednisone  (manufacturer unknown) dose was lowered again. The patient saw a physician for medical attention. No laboratory diagnostics studies were performed. Therapy with RECOMBIVAX HB was discontinued. It was also reported that it took the patient about a month and a half to recover. No further information is available. The patient went to hospital for medical attention.
Sex: U
Vaccine: HEP
Symptoms: Medical device complication
Clinical narrative: Information has been received from a physician who called in to report that he had received a non-safety device of RECOMBIVAX HB (lot #0438Y, thimerosal free) while he was using it.  He stated that he had injected the patient's arm and was pulling on the plunger to check for a vein when the plunger fell out through the bottom of the syringe and the vaccine leaked out everywhere-on the floor and the medical chart.  He also stated that the gray stopper came out along with the plunger.  There was no damage to the tray or the cellophane, and he discarded the syringe.  (SR# 13358579730).  Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a female consumer who in 1997 was vaccinated with RECOMBIVAX HB.  In 1997 the consumer's arm became sore after receiving three doses of RECOMBIVAX HB.  It is unknown if the consumer sought medical attention.  At the time of the report, the outcome of the patient was unknown.  The consumer also reported that she has experienced arm soreness after receiving hepatitis A virus vaccine inactivated (MSD) (WAES # 0911USA04201).  Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Abdominal discomfort, Weight decreased
Clinical narrative: Information has been received from a nurse practitioner concerning a female patient who on an unspecified date was vaccinated with the three dose series of RECOMBIVAX HB when she was in elementary school (lot number not provided). Post vaccination the patient developed gastrointestinal upset and lost 30 pounds. This occurred years ago and the patient has recovered. It was unspecified if the patient sought medical attention. No further information is available.
Age: 57.0
Sex: F
Vaccine: HEP
Symptoms: Addison's disease, Optic neuropathy, Photopsia, Retinopathy, Vision blurred
Clinical narrative: It was reported in a published report, regarding a case in litigation concerning a 57 year old female with autoimmune disorder who on 24-FEB-1993 was vaccinated with the third dose of RECOMBIVAX HB (lot # not provided).  Patient developed visual problems three on 27-FEB-1993 ("three days later"), beginning with a "dark blob" or a "floater mass" in the right eye.  Later she began experiencing flashes of light and her vision became cloudy.  She also developed spider web-appearing material in her vision.  Seven months later, optic neuropathy with enlarged blind spots in both eyes was observed.  On an unspecified date the patient was diagnosed with acute zonal occult outer retinopathy (AZOOR).  Subsequently, the patient developed Addison's disease (date not reported).  The outcome of the acute zonal occult retinopathy and Addison's disease was unknown.  No further information is available.
Age: 57.0
Sex: F
Vaccine: HEP
Symptoms: Visual impairment
Clinical narrative: It was reported in a published report, regarding a case in litigation concerning a 57 year old female with autoimmune disorder who on 24-FEB-1993 was vaccinated with the third dose of RECOMBIVAX HB (lot # not provided).  Patient developed visual problems three on 27-FEB-1993 ("three days later"), beginning with a "dark blob" or a "floater mass" in the right eye.  Later she began experiencing flashes of light and her vision became cloudy.  She also developed spider web-appearing material in her vision.  Seven months later, optic neuropathy with enlarged blind spots in both eyes was observed.  On an unspecified date the patient was diagnosed with acute zonal occult outer retinopathy (AZOOR).  Subsequently, the patient developed Addison's disease (date not reported).  The outcome of the acute zonal occult retinopathy and Addison's disease was unknown.  No further information is available.
Sex: M
Vaccine: HEP
Symptoms: Autoimmune disorder, Myelitis transverse, Reaction to preservatives
Clinical narrative: It was reported in a published report, title stated above, regarding a case in litigation concerning a male patient (a minor, age not given) who on an unspecified date was vaccinated with a dose of RECOMBIVAX HB thimerosal containing (manufacturer unspecified). It was reported by a physician in his expert report that RECOMBIVAX HB thimerosal containing did cause the patient's transverse myelitis. According to the reporter, "The vaccine caused an autoimmune disease through the process of molecular mimicry whereby in forming antibodies to the antigen in the vaccine, the body then proceeds to attack itself. The onset of patient's TM (transverse myelitis) six weeks after vaccination falls within the two month acceptable time limit for causation established. A number of case reports posit the same biologically plausible theory and timing that the physician described in his report. Additionally, the government did not file an expert report but instead filed a request for ruling on the record September 25 "denying that compensation was appropriate, but choosing not to expand further resources to defend the case." A special master said that general causation was established in an omnibus hepatitis B proceeding she presided over, in which the appropriate time frame was expanded to eight weeks post vaccination. She had the question whether the vaccine caused transverse myelitis in the patient, whose age was not given. The representatives from the petitioner and the respondent information were provided. Upon internal review transverse myelitis were determined to be another important medical events. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Chronic fatigue syndrome, Fatigue, Influenza like illness, Malaise
Clinical narrative: It was reported in a published report, title stated above, regarding a case in litigation concerning a female patient who in September 1997, was vaccinated with a second dose of RECOMBIVAX HB (Lot number unspecified) (manufacturer unknown). In September 1997, one hour after receiving the second dose of RECOMBIVAX HB the patient developed "malaise, flu like symptoms, fatigue and joint pain". Ten months later she complained that her symptoms had worsened. From 1998 to 1999 the patient consulted several specialists who provided varying diagnoses including chronic immune fatigue dysfunction syndrome, multiple sclerosis, myelitis and lupus. Upon internal review "multiple sclerosis and lupus" were considered to be other important medical events. No further information is available.
Sex: F
Vaccine: HEP
Symptoms: Multiple sclerosis, Myelitis, Systemic lupus erythematosus
Clinical narrative: It was reported in a published report, title stated above, regarding a case in litigation concerning a female patient who in September 1997, was vaccinated with a second dose of RECOMBIVAX HB (Lot number unspecified) (manufacturer unknown). In September 1997, one hour after receiving the second dose of RECOMBIVAX HB the patient developed "malaise, flu like symptoms, fatigue and joint pain". Ten months later she complained that her symptoms had worsened. From 1998 to 1999 the patient consulted several specialists who provided varying diagnoses including chronic immune fatigue dysfunction syndrome, multiple sclerosis, myelitis and lupus. Upon internal review "multiple sclerosis and lupus" were considered to be other important medical events. No further information is available.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a medical assistant concerning a 62 day old male with no pertinent medical history or drug allergies who on 02-MAR-2009 was vaccinated with the first dose of ROTATEQ vaccine (lot #: 663260/1794X). There was no concomitant medication. On 02-MAR-2009, after receiving the vaccine, the patient vomited. The patient recovered on 02-MAR-2009. The patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: RV5
Symptoms: Abnormal sensation in eye, Accidental exposure
Clinical narrative: Information has been received from a medical assistant. It was reported that a nurse was splashed in the eye with ROTATEQ vaccine that a child (WAES#: 0903USA00339) spit out on 02-MAR-2009. The nurse flushed her eye with water but reported "it feels funny". Nurse was not pregnant. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Regurgitation
Clinical narrative: Information has been received from a registered nurse concerning a 8 week old female who on 04-MAR-2009 was vaccinated with a first dose of ROTATEQ vaccine (lot # 663263/1489X), oral. On 04-MAR-2009 the patient vomited after receiving the ROTATEQ vaccine. The reporter believed the patient vomited the complete dose. The patient sought medical attention through an office visit. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, RV5
Symptoms: Expired drug administered, Feeling hot, Hypersomnia
Clinical narrative: Information has been received from a consumer concerning her 62 day old son who on 085-MAR-2009 was vaccinated with ROTATEQ vaccine (therapy dose, route, site unknown). Concomitant therapy included poliovirus vaccine, diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown) and Hib conj vaccine (unspecified carrier). The mother reported that her son on 05-MAR-2009 received ROTATEQ vaccine that expired on 01-FEB-2009. Her son was "a little hot and sleep a lot". They did not seek medical attention. As of 05-MAR-2009, the patient had not recovered. Additional information has been requested.
Age: 0.56
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician concerning a 29 week old patient who on 28-OCT-2008 was vaccinated with the first dose of ROTATEQ vaccine 2ml oral. On 09-MAR-2009 the patient would receive the second dose. No adverse effect reported. Additional information has been requested
Age: 0.3
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, Incorrect route of drug administration
Clinical narrative: Information has been received from a physician concerning a 16 week male who on 09-MAR-2009 was vaccinated with the first dose of ROTATEQ via injection. There was no concomitant medication or relevant medical history and past drug history was unknown. On 09-MAR-2009 this physician reported that she misunderstood the package insert and administered the first dose of ROTATEQ to a 16 week old infant. There was no relevant laboratory data. As of 09-MAR-2009 it was unknown if the infant would continue to get the ROTATEQ and it was unknown if he was experiencing any adverse reactions. Follow-up information was received from the physician. The physician said the patient was doing fine. The physician further reported that she called for clarification as to when an infant should receive ROTATEQ not to report an adverse event. Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning a 20 week old male who on 12-MAR-2009 was vaccinated with a first dose of ROTATEQ (lot # not reported). No adverse effects noted. The patient sought medical attention at physician's office. Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Faeces discoloured, Malaise
Clinical narrative: Information has been received from a physician concerning a 16 weeks old male who was vaccinated with the second 2ml dose of ROTATEQ vaccine. A week after receiving the second dose the patient experienced diarrhea and a green stool. The patient was sick for 3-4 days. At the time of this report, the patient was recovered. The patient sought unspecified medical attention. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, Rotavirus test negative
Clinical narrative: Information has been received from a consumer concerning her 6 year old son with a history of fever, diarrhea, lost appetite and "lost eye contact" after getting first dose of MMR (WAES #0903USA02669) on an unknown date, who "a month later" was vaccinated with ROTATEQ (manufacturer unknown). It was reported that the patient's antibody response negative. No further information is available.
Sex: F
Vaccine: RV5
Symptoms: Eye burns, Pain, Vaccination complication
Clinical narrative: Information has been received from a licensed practical nurse concerning a female nurse in her 20's who was administering a dose of ROTATEQ (lot# not provided) to an infant, and the infant spit out the vaccine into the her eye. The nurse administering the vaccine reported her eye was stinging. The nurse rinsed her eye with water. Patient spoke to a physician. At the time of this report the patient had not yet recovered. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.36
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning an 18 week male with unspecified illness at the time of vaccination and no drug allergies who on 17-FEB-2009 was orally vaccinated with a dose of ROTATEQ (lot number not available). He was also vaccinated with a dose of PENTACEL and a dose of PREVENAR on 17-FEB-2009. On 17-FEB-2009 the patient experienced diarrhea after receiving ROTATEQ. He recovered on an unspecified date. The patient sought unspecified medical attention. Follow up information was received which reported the male patient's birth weight was 7 pounds 11 ounces and did not have sibling. He had upper respiratory infection at the time of vaccination. There was no drug allergy or medical history. At 10:00 on 17-FEB-2009 he was orally vaccinated with the second dose of ROTATEQ (lot #660425/0278X). At the same time he was also intramuscularly vaccinated with the second dose of PENTACEL (lot #C8180AA) into the left thigh and the second dose of PREVENAR (lot # C65929) into the right thigh. Subsequently, the patient experienced diarrhea and had a doctor visit. On 22-FEB-2009 he recovered. Additional information is not expected.