chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Vaccination failure
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of a 48-year-old male subject not responding to therapy following vaccination with Engerix B for prophylaxis. Concurrent medical conditions included type II diabetes. Concurrent medications included Glyburide, Lisinopril, Metformin and Toprol XL. On 26 April 2004 and 10 October 2003 the subject received 4th dose and 3rd dose of Engerix B at 20 mcg. Dose 1 and dose 2 were administered at another facility and dates of vaccination were not known. The subject had an exposure in April of 2007 and a titer was negative. Following the booster dose of Engerix B administered on 26 April 2004, a titer was again drawn (11 July 2007) and found to be negative. The subject had not responded to therapy. At the time of reporting the event was unresolved.
Sex: F
Vaccine: HEP
Symptoms: Laboratory test, No therapeutic response
Clinical narrative: This case was reported by a physician via a representative and described the occurrence of an adult female subject not responding to therapy following vaccination with Engerix B (GlaxoSmithKline) for prophylaxis.  On an unspecified date the subject received 3rd dose of Engerix B (unknown) to complete the series.  The subject completed the Engerix B series approximately six months prior to reporting.  At an unknown time during that six month time period, a titer was drawn and was found to be low.  The subject had not responded to therapy.  At the time of reporting the outcome of the event was unspecified.
Sex: M
Vaccine: HEP
Symptoms: Detoxification, Ear infection, Hypotonia, Mobility decreased, Occupational therapy
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of hypotonia in an infant male subject who was vaccinated with Engerix B (GlaxoSmithKline) for prophylaxis.  Concurrent medical conditions included ear infection.  Concurrent medications included antibiotics.  In 2001 the subject received 3rd dose of Engerix B (lot numbers received: 5187A2 and 519082).  An unspecified amount of time after administration of the 3rd dose of Engerix B, the subject became floppy.  He was unable to raise his head.  This was further described as, he became hypotonic.  The physician felt that the hypotonia might be due to the thimerosal in the Engerix B.  The child required physical therapy and occupational therapy.  The subject had many ear infections that required antibiotics.  It was reported that it is thought that taking an antibiotic close to the vaccine delays the elimination of thimerosal from the body and may have contributed to the events.  The timing of the onset of the ear infections was not clarified.  The subject has undergone a detoxification process to remove the thimerosal from his system.  At the time of reporting, the subject was 6 years old.  At the time of reporting hypotonia was unresolved and the outcome of the other events was unspecified.
Sex: M
Vaccine: HEP
Symptoms: Physiotherapy
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of hypotonia in an infant male subject who was vaccinated with Engerix B (GlaxoSmithKline) for prophylaxis.  Concurrent medical conditions included ear infection.  Concurrent medications included antibiotics.  In 2001 the subject received 3rd dose of Engerix B (lot numbers received: 5187A2 and 519082).  An unspecified amount of time after administration of the 3rd dose of Engerix B, the subject became floppy.  He was unable to raise his head.  This was further described as, he became hypotonic.  The physician felt that the hypotonia might be due to the thimerosal in the Engerix B.  The child required physical therapy and occupational therapy.  The subject had many ear infections that required antibiotics.  It was reported that it is thought that taking an antibiotic close to the vaccine delays the elimination of thimerosal from the body and may have contributed to the events.  The timing of the onset of the ear infections was not clarified.  The subject has undergone a detoxification process to remove the thimerosal from his system.  At the time of reporting, the subject was 6 years old.  At the time of reporting hypotonia was unresolved and the outcome of the other events was unspecified.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP
Symptoms: Erythema, Medication error
Clinical narrative: This case was reported by a consumer and described the occurrence of erythema in an 8-week-old male subject who was vaccinated with Engerix B (GlaxoSmithKline) for prophylaxis.  A physician or other health care professional has not verified this report.  The reporting consumer is the patient's mother.  Concurrent vaccination included Infanrix (GlaxoSmithKline) given on 31 May 2007.  There were no concurrent medications.  On 31 May 2007 at 11:00 the subject received the 1st dose of Engerix B (0.5 ml, in the "upper leg").  On 31 May 2007, less than one day after vaccination with Engerix B, the subject experienced redness (not otherwise specified).  The reporter also believed that the subject "was vaccinated with a half dose of Engerix B vaccine" (possible medication error); however, it was noted that the lot number provided corresponded with the pediatric formulation for Engerix B.  On 1 June 2007, the redness was resolved.
Sex: U
Vaccine: HEP
Symptoms: No therapeutic response, Seroconversion test negative
Clinical narrative: This case was reported by a physician via a sales representative and described the occurrence of not responding to therapy in an unspecified number of adult subjects of unspecified gender who were vaccinated with Engerix B (GlaxoSmithKline), Havrix (GlaxoSmithKline), or Twinrix (GlaxoSmithKline) for prophylaxis.  The subjects' medical histories included HIV infection.  The physician reported that "some" HIV positive subjects received Engerix B (1 ml, unknown), Havrix (1 ml, unknown), or Twinrix (1 ml, unknown), and did not seroconvert for hepatitis B and/or hepatitis A.  Some of the subjects received booster doses after hepatitis titers were performed.  At the time of reporting the outcome of the event was unspecified.
Age: 53.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Hepatitis B antibody positive, Hepatitis B e antigen negative
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of hepatitis b surface antigen negative in a 53-year-old female subject who was vaccinated with Engerix B for prophylaxis.  Concurrent vaccination included unspecified vaccine (PPD; manufacturer unspecified) given on 1 April 1999 and 9 August 2000.  On 9 August 2000, 3 May 1999 and 1 April 1999 the subject received 3rd dose, 2nd dose and 1st dose of Engerix B at 20 mcg.  On 24 July 2007, approximately 7 years after completing the Engerix B series, the subject was determined to be hepatitis b surface antigen negative and hepatitis b core antibody positive.  At the time of reporting the events were unresolved.
Sex: M
Vaccine: HEP
Symptoms: Lymphadenopathy
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swollen lymph node on the right side of the neck in a male subject aged between 30 and 39 years old who was vaccinated with Engerix B (GlaxoSmithKline) for prophylaxis.  On 23 July 2007 the subject received 1st dose of Engerix B at 0.5 ml in the left arm.  On 23 July 2007, 12 hours after vaccination with Engerix B, the subject experienced swollen lymph node on the right side of the neck.  On 24 July 2007, the event was resolved.
Age: 63.0
Sex: M
Vaccine: HEP
Symptoms: Blood alkaline phosphatase increased, Hepatitis B surface antigen negative, No therapeutic response
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a male subject aged 64 or 65 years old who was vaccinated with hepatitis B vaccine (manufacturer unspecified) for prophylaxis.  The subject received unspecified concomitant medication(s).  In February 2005, April 2005 and December 2005 the subject received the first, second, and third doses of hepatitis B vaccine (unknown).  In July 2007, 19 months after the third vaccination with hepatitis B vaccine, a hepatitis B titer was negative.  This result was confirmed on 23 July 2007 by the reporting health care professional.  On an unspecified date, the subject also experienced an elevated alkaline phosphatase.  At the time of reporting the outcome of the events was unspecified.
Age: 51.0
Sex: M
Vaccine: HEP
Symptoms: No therapeutic response
Clinical narrative: This case was reported by a physician and described the occurrence of not responding to therapy in a 51-year-old male subject who was vaccinated with Engerix B for prophylaxis.  Concurrent medical conditions included arthritis and crohn's disease.  Concurrent medications included Infliximab (Remicade), Paroxetine hydrochloride (Paxil) and Iron supplements (Iron supplement).  On 20 April 2007, 17 November 2006 and 20 October 2006 the subject received 3rd dose, 2nd dose and 1st dose of Engerix B (20 mcg, unknown).  Three months after the third vaccination with Engerix B, 8 months aftersecond vaccination with Engerix B, 9 months after the first vaccination with Engerix B, the subject experienced not responding to therapy and decreased response for hepatitis b virus surface antigen.  At the time of reporting the outcome of the events were unspecified.
Sex: U
Vaccine: HEP
Symptoms: Laboratory test, No therapeutic response
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of a subject of unspecified age and gender not responding to therapy following vaccination with Engerix B (GlaxoSmithKline) for prophylaxis.  On an unspecified date the subject completed the Engerix B series.  At an unspecified time after completion of the Engerix B series, the subject was tested and found to have not responded to therapy.  The result of the test was indeterminate.  A subject was given a second Engerix B series and still did not respond.  Again, the result of a titer test was indeterminate.  At the time of reporting the outcome of the event was unspecified.
Sex: F
Vaccine: HEP
Symptoms: Heart rate increased, Irritability, Medication error
Clinical narrative: This case was reported by a pharmacist and described the occurrence of a medication error in a 18-day-old female subject who was vaccinated with Engerix B for prophylaxis.  Previous vaccination included Engerix B, given on 27 July 2007.  Concurrent medications included Nystatin (Nystatin cream), Paracetamol (Tylenol) and Iron supplements (Iron supplement).  On 28 July 2007 the subject inadvertently received 2nd dose of Engerix B at 10 mcg, unknown).  This was considered to be a medication error as the subject had already received an injection of Engerix B the day before, on 27 July 2007.  The same day of the 2nd injection of Engerix B, 28 July 2007, the subject developed increased heart rate (200 - 230 bpm) and increased fussiness.  The events were unresolved at the time of reporting.
Age: 68.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective, Hepatitis B surface antigen positive
Clinical narrative: This case was reported by a pharmacist and described the occurrence of hepatitis B surface antigen positive in an adult male subject who was vaccinated with Engerix B (GlaxoSmithKline) for prophylaxis.  Concurrent medical conditions included hemodialysis.  On an unspecified date the subject received unspecified dose of Engerix B (unknown).  At an unspecified time after vaccination with Engerix B, the subject experienced hepatitis B surface antigen positive and lack of effect.  At the time of reporting the events were worse. Follow-up received on 18 September 2007 via the clinical pharmacist.  It was reported that the subject was a 68 year old male with a history of coronary artery disease and T-cell lymphoma stage IV.  He was vaccinated with Engerix-B on 05 July 2007.  On 06 July 2007, the hepatitis B surface antigen was negative.  A follow-up test on 09 July 2007 was negative.  Subsequent testing on 08 August 2007 was also negative.  The pharmacist considered that the events were resolved and possibly related to the use of Engerix-B.
Age: 29.0
Sex: M
Vaccine: HEP
Symptoms: Hyperhidrosis, Hypersensitivity, Palpitations
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of diaphoresis in a subject of unspecified age and gender who was vaccinated with Engerix B (GlaxoSmithKline) for prophylaxis.  On an unspecified date the subject received unspecified dose of Engerix B (unknown).  Four hours after vaccination with Engerix B, the subject experienced diaphoresis and palpitation.  At the time of reporting the events were unresolved.  Follow-up information received on 06 September 2007 indicated that the subject was a 29 year old male with no significant medical history.  The subject received 1st dose of Engerix B, intramuscularly, at 20 mcg in the right deltoid on 25 January 2007.  An unspecified amount of time after administration of Engerix B, the subject experienced an allergic reaction on 25 January 2007.  Four hours after administration, diaphoresis and palpitations were noted.  The events completely resolved after 10 minutes, 25 January 2007.  In the reporter's opinion, the events were possibly related to treatment with Engerix B.
Sex: M
Vaccine: HEP
Symptoms: No therapeutic response
Clinical narrative: This case was reported by a physician, via a sales representative, and described the occurrence of decreased therapeutic response in a male subject of unspecified age who was vaccinated with Engerix B for prophylaxis.  On an unspecified date the subject received the Engerix B (unknown) series "years ago".  At an unspecified time after vaccination with Engerix B, the subject experienced decreased therapeutic response.  "Recently", the physician checked the subject's antibody levels for hepatitis B.  The subject's titre was 8 (units unspecified).  The sales representative believed that the titre should be at least 9 (units unspecified).  At the time of reporting, the sales representative had no further information.  At the time of reporting the event was unresolved.
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Pharmaceutical product complaint
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of hepatitis B antibody negative in a 32 year old female subject who was vaccinated with Engerix B (GlaxoSmithKline) for prophylaxis.  On 25 March 2007, 29 December 2006 and 27 November 2006 the subject received 3rd, 2nd and 1st dose of Engerix B (unknown deltoid) to complete the three dose series.  On an unspecified date following completion of the Engerix B series, the subject had a negative titer.  The reporter suspected a possible quality issue with the vaccine.  At the time of reporting the outcome of the events was unspecified.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of hepatitis B antibody negative in a subject of unknown age and gender who was vaccinated with Engerix B for prophylaxis.  On an unspecified date the subject received 3rd dose of Engerix B in an unknown deltoid to complete the three dose series.  On an unspecified date following completion of the Engerix B series, the subject had a negative titer.  The reporter suspected a possible quality issue with the vaccine.  At the time of reporting the outcome of the events was unspecified.  No additional information available.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Vaccination failure
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of hepatitis B antibody negative in a subject of unknown age and gender who was vaccinated with Engerix B for prophylaxis.  On an unspecified date the subject received 3rd dose of Engerix B in an unknown deltoid to complete the three dose series.  On an unspecified date following completion of the Engerix B series, the subject had a negative titer.  The reporter suspected a possible quality issue with the vaccine.  At the time of reporting the outcome of the events was unspecified.  No additional information available.
Age: 18.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Vaccination failure
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of hepatitis B antibody negative in an 18 year old male subject who was vaccinated with Engerix B for prophylaxis.  On an unspecified date the subject received 3rd dose of Engerix B in an unknown deltoid to complete the three dose series.  On an unspecified date following completion of the Engerix B series, the subject had a negative titer.  The reporter suspected a possible quality issue with the vaccine.  At the time of reporting the outcome of the events was unspecified.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B, Hepatitis B surface antigen positive, Vaccination failure
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of antigenemia in an infant female subject who was vaccinated with Engerix B for prophylaxis.  The infant's date of birth was either 30 June 2007 or 01 July 2007.  The subject's mother was hepatitis C positive and hepatitis B negative.  On 2 July 2007 at 15:30, the newborn subject received 1st dose of Engerix B (unknown).  On 3 July 2007, one day after vaccination with Engerix B, the subject experienced antigenemia.  On 03 July 2007, laboratory analysis revealed that the subject was hepatitis B surface antigen positive.  A repeat laboratory analysis was performed on 04 July 2007 to confirm these results and again revealed she was hepatitis B surface antigen positive.  According to the reporter, the event did not prolong the newborn's hospitalization stay after her birth.  At the time of reporting, the infant had been discharged.  At the time of reporting the event was unresolved.  The healthcare professional considered the event was probably related to vaccination with Engerix B.
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B test negative, Injection site pain, Insomnia, Muscle spasms, Nausea
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a female subject aged between 20 and 29 years old who was vaccinated with Engerix B (GlaxoSmithKline) for prophylaxis.  The subject's medical history included iodine allergy.  On an unspecified date the subject received unspecified dose of hepatitis B vaccine (unknown manufacturer).  In 2005, a hepatitis B titer was negative.  It was not specified whether  the subject had completed the hepatitis B vaccine series at the time of the titer.  On 5 July 2007, between 08:30 and 09:00, the subject received the fourth dose of Engerix B (20 mcg, unknown, left arm).  She received no concurrent vaccinations on that date.  The subject was 29 years old at the time of vaccination.  On 05 July 2007, less than one day after vaccination with Engerix B, the subject experienced a gradual onset of pain in her injection arm that proceeded to tingling of her fingers of the left arm.  The pain subsequently spread through her entire body.  She later experienced inability to sleep due to the pain, in addition to nausea from the pain which progressed to vomiting.  The subject also experienced muscle spasms in her entire body.  At the time of reporting the outcome of the events was unspecified.  The healthcare professional considered the events of left arm pain, tingling in left fingers, and body pain were possibly related to vaccination with Engerix B.
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: No therapeutic response, Pain, Paraesthesia, Vomiting
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a female subject aged between 20 and 29 years old who was vaccinated with Engerix B (GlaxoSmithKline) for prophylaxis.  The subject's medical history included iodine allergy.  On an unspecified date the subject received unspecified dose of hepatitis B vaccine (unknown manufacturer).  In 2005, a hepatitis B titer was negative.  It was not specified whether  the subject had completed the hepatitis B vaccine series at the time of the titer.  On 5 July 2007, between 08:30 and 09:00, the subject received the fourth dose of Engerix B (20 mcg, unknown, left arm).  She received no concurrent vaccinations on that date.  The subject was 29 years old at the time of vaccination.  On 05 July 2007, less than one day after vaccination with Engerix B, the subject experienced a gradual onset of pain in her injection arm that proceeded to tingling of her fingers of the left arm.  The pain subsequently spread through her entire body.  She later experienced inability to sleep due to the pain, in addition to nausea from the pain which progressed to vomiting.  The subject also experienced muscle spasms in her entire body.  At the time of reporting the outcome of the events was unspecified.  The healthcare professional considered the events of left arm pain, tingling in left fingers, and body pain were possibly related to vaccination with Engerix B.
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site soreness in a 40-year-old female subject who was vaccinated with Engerix B for prophylaxis.  In June 2007 the subject received 1st dose of Engerix B (20 mcg, unknown, right deltoid).  At an unknown time after vaccination with Engerix B, the subject experienced injection site soreness, injection site warmth and bumps around injection site.  At the time of reporting the events were unresolved.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Vaccination failure
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of a 27-year-old female subject not responding to therapy following vaccination with hepatitis B vaccine (manufacturer unspecified) for prophylaxis.  In 2001 the subject completed the three dose series of hepatitis B vaccine (unknown).  At that time, the subject's titer test was positive for protection from hepatitis B.  Approximately 6 years after completion of the hepatitis B series, the subject was tested again and showed a lack of immunity to hepatitis B.  At the time of reporting the outcome of the event was unspecified.
Sex: F
Vaccine: HEP
Symptoms: No therapeutic response
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of not responding to therapy in a female subject of unspecified age who was vaccinated with Engerix B (GlaxoSmithKline) for prophylaxis.  On unspecified dates the subject received 3 doses of Engerix B vaccine (unknown).  At an unspecified time after vaccination with Engerix B, the subject reported she did not seroconvert.  At the time of reporting the outcome of the event was unspecified.
Sex: F
Vaccine: HEP
Symptoms: No therapeutic response, Serology test
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of a female subject of unspecified age not responding to therapy following vaccination with hepatitis B vaccine (manufacturer unspecified) for prophylaxis.  On unspecified dates the subject completed a full series of hepatitis B vaccine (unknown) and did not respond.  She then received a second full series on unspecified dates.  At an unspecified time after completion of the second series of hepatitis B vaccine, serological testing determined that the subject was not responding to therapy.  At the time of reporting the outcome of the event was unspecified.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, No adverse reaction, Vaccination failure
Clinical narrative: This case was reported by a physician via a representative and described the occurrence of hepatitis B antibody negative in an infant subject of unspecified gender who was vaccinated with Engerix B, Pediarix for prophylaxis.  On an unspecified date the subject received 1st dose of Engerix B (unknown) and 2nd dose of Pediarix (unknown).  At an unspecified time after vaccination with Engerix B and Pediarix, the subject was tested and showed to be hepatitis B antibody negative.  At the time of reporting the outcome of the event was unspecified.  Follow-up information was received from the reporting physician on 13 July 2007.  The physician reported that the subject experienced a failure to seroconvert to HBV surface antibody positive and that there was no adverse reaction.
Age: 60.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B surface antigen positive
Clinical narrative: This case was reported by a physician and described the occurrence of hepatitis B surface antigen positive in a 60-year-old male subject who was vaccinated with Engerix B (GlaxoSmithKline) for prophylaxis.  Concurrent medical conditions included elevated prostate specific antigen, hemodialysis, IgE nephropathy, radiocarativity in one eye and proteinuria.  Concurrent medications included Epogen, Zemplar, Calcitrol, Diovan, Flomax, Fosamax, Lipitor, Niacin, prednisone, terazosin and Tramadol.  On 18 June 2007 the subject received 1st dose of Engerix B at 40 mcg.  The subject had been tested that same day and was found to be hepatitis B surface antigen negative.  On 21 June 2007, the subject was tested again and was found to be hepatitis B surface antigen positive.  At the time of reporting the outcome of the event was unspecified.  Follow-up information was received from the reporting physician on 06 July 2007.  The reporting physician considered the event of hepatitis B surface antigen positive to be related to Engerix B.  He considered the event was not serious.
Age: 67.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B surface antigen negative, No adverse reaction, Vaccination failure
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of hepatitis B surface antigen positive in a 67-year-old male subject who was vaccinated with Engerix B for prophylaxis.  Concurrent medical conditions included diabetes and hemodialysis.  Concurrent medications included Venofer, Paricalcitol (Zemplar), Epoetin alfa (Epogen), Metoclopramide hydrochloride (Reglan), Simvastatin, Aspirin, Cosopt, and Human Insulin (Novolin).  On 18 June 2007 the subject received 3rd dose of Engerix B at 40 mcg.  On 20 June 2007, two days after vaccination with Engerix B, the subject was tested and found to be hepatitis B surface antigen positive.  At the time of reporting the outcome of the event was unspecified.  Follow-up information was received from the reporting nurse.  The reporter did not consider the event to be serious.  On 27 June 2007, hepatitis B surface antigen was negative.  Per the reporter, the immunization series was not delayed or discontinued.  No symptoms recurred following subsequent administration of Engerix B.  The subject had not experienced any adverse events following previous vaccinations.
Sex: U
Vaccine: HEP
Symptoms: No therapeutic response
Clinical narrative: This case was reported by a physician and described the occurrence of a subject of unspecified age and gender not responding to therapy following vaccination with Engerix B (GlaxoSmithKline) for prophylaxis.  On unspecified dates the subject completed two full series of vaccinations with Engerix B at 1 ml.  An unspecified amount of time following completion of each series, the subject was found to not be responding to therapy.  At the time of reporting the outcome of the event was unspecified.
Age: 28.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Vaccination failure
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of hepatitis B antibody negative in a 28-year-old male subject who was vaccinated with hepatitis B vaccine (manufacturer unspecified) for prophylaxis.  On an unspecified date the subject completed the hepatitis B vaccine series.  When tested in 2007, the subject's titers came back showing non-protective levels for hepatitis B.  No additional details were provided.
Age: 47.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of hepatitis B antibody negative in a 47-year-old male subject who was vaccinated with hepatitis B vaccine (manufacturer unspecified) for prophylaxis.  On an unspecified date the subject completed the hepatitis B vaccine series.  When tested in 2007, the subject's titers came back showing non-protective levels for hepatitis B.  No additional details were provided.
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Vaccination failure
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of hepatitis b antibody negative in a 39-year-old female subject who was vaccinated with hepatitis B vaccine (manufacturer unspecified) for prophylaxis.  On an unspecified date the subject completed the hepatitis B vaccine series.  When tested in 2007, the subject's titers came back showing non-protective levels for hepatitis B.  No additional details were provided.
Age: 26.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Vaccination failure
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of hepatitis b antibody negative in a 26-year-old male subject who was vaccinated with hepatitis B vaccine (manufacturer unspecified) for prophylaxis.  On an unspecified date the subject completed the hepatitis B vaccine series.  He was tested and showed protective hepatitis B levels.  This was approximately two years ago.  When tested in 2007, the subject's titers came back showing non-protective levels for hepatitis B.  No additional details were provided.
Age: 18.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Vaccination failure
Clinical narrative: This case was reported by the mother of a consumer and described the occurrence of a 18-year-old male subject not responding to therapy following vaccination with Engerix B for prophylaxis.  A physician or other health care professional has not verified this report.  Concurrent medical conditions included asthma, decreased igg and plastic bronchitis.  Concurrent medications included Salbutamol sulphate (Albuterol).  In 1991 the subject completed the standard dosing schedule for vaccination with Engerix B (unknown).  A blood test for titer detection performed on 22 June 2007 revealed non-detectable titers for hepatitis B.  The subject was considered to have not responded to therapy.  At the time of reporting the event was unresolved.  No additional details expected.
Age: 53.0
Sex: M
Vaccine: HEP
Symptoms: No therapeutic response
Clinical narrative: This case was reported by a physician and described the occurrence of not responding to therapy in an approximately 53-year-old male subject who was vaccinated with Engerix B (GlaxoSmithKline) for prophylaxis.  There were no concurrent medications.  The subject's previous medical history included receiving a series of three doses (1st, 2nd, and 3rd doses) of Engerix-B on unspecified dates and not responding to therapy.  See related case id A0656984A.  On unspecified dates, about one year after receiving the first three dose series of Engerix B, the subject received an additional series of three doses (4th, 5th, and 6th doses) of Engerix-B (20 mcg, unknown).  At an unspecified time after vaccination with 4th, 5th, and 6th doses of Engerix B, the subject experienced not responding to therapy again.  At the time of reporting the event was unresolved.
Age: 52.0
Sex: M
Vaccine: HEP
Symptoms: Vaccination failure
Clinical narrative: This case was reported by a physician and described the occurrence of not responding to therapy in a 52-year-old male subject who was vaccinated with Engerix B for prophylaxis.  There were no concurrent medications or relevant medical history.  On unspecified dates, the subject received a series of three doses (1st, 2nd, and 3rd doses) of Engerix B (unknown).  At an unspecified time after vaccination with the series of three doses of Engerix B, the subject experienced not responding to therapy.  At the time of reporting, the event was unresolved.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B test negative, No therapeutic response
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a female subject of unspecified age who was vaccinated with Engerix B (GlaxoSmithKline) for prophylaxis. On 26 July 2006, 20 August 2006 and 26 January 2007 the subject received 1st dose, 2nd dose and 3rd dose of Engerix B (20 mcg, intramuscular, right and left deltoids). On 11 April 2007, 75 days after the 3rd vaccination with Engerix B, the subject had a titer drawn which was negative for immunity against hepatitis B. At the time of reporting the outcome of the event was unspecified.
Age: 39.0
Sex: M
Vaccine: HEP
Symptoms: Laboratory test, No therapeutic response
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a 39-year-old male subject who was vaccinated with Engerix B (GlaxoSmithKline) for prophylaxis.  On 20 July 2006, 19 August 2006 and 26 January 2007 the subject received 1st dose, 2nd dose and 3rd dose of Engerix B (20 mcg, intramuscular, right and left deltoids).  On 11 April 2007, 75 days after the 3rd vaccination with Engerix B, the subject had a titer drawn which was negative for immunity against hepatitis B.  At the time of reporting the outcome of the event was unspecified.  This case was reported by the same reporter in junction with another case of a subject not responding to therapy, case ID A0655093A.
Age: 35.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B test negative, No therapeutic response
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a 35-year-old male subject who was vaccinated with hepatitis B vaccine (manufacturer unspecified), hepatitis B vaccine for prophylaxis. The subject had no history of adverse events with previous vaccinations. The subject was not taking any concurrent medications and was noted to be "healthy". On unspecified dated the subject received the 1st dose, 2nd dose, and 3rd dose of a Hepatitis B vaccine (doses and manufacturer unspecified). A student health nurse reported that the subject did not respond to the initial three does series of the Hepatitis B vaccine. At the time of reporting, the subject had not experienced any adverse events. On 6 June 2007 the subject received a dose of Engerix B (1 cc), which was the 6th dose of a hepatitis B vaccine. The vaccine expired on 11 April 2007. At the time of reporting the outcome of the events was unspecified. Follow-up was received from a healthcare professional. The healthcare professional reported that the subject was completing his "number 6 dose of hepatitis B vaccine of a repeated series due to a negative titer after number 3 dose of hepatitis B" vaccine. The healthcare professional also reported that on 6 June 2007, an expired dose of Engerix-B was administered and that the expiration date was not verified before the vaccine was given. The subject was subsequently revaccinated.
Age: 0.3
Sex: U
Vaccine: HEP
Symptoms: Erythema multiforme
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of erythema multiforme in a 3-month-old subject of unspecified gender who was vaccinated with hepatitis B vaccine (manufacturer unspecified) for prophylaxis.  On an unspecified date in 2007 the subject received unspecified dose of hepatitis B vaccine.  At an unspecified time after vaccination with hepatitis B vaccine, the subject experienced erythema multiforme.  This case was assessed as medically serious by GSK.  At the time of reporting the outcome of the event was unspecified.
Age: 36.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B surface antigen negative, No therapeutic response
Clinical narrative: This case was reported by a physician and described the occurrence of a 38-year-old male subject not responding to therapy following vaccination with Engerix B for prophylaxis. On 21 March 2006, 12 December 2005 and 12 September 2005 the subject received 3rd dose, 2nd dose and 1st dose of Engerix B (unknown). Approximately 14 months after completion of the three dose series of Engerix B, the subject's titer was less than 5 mIU/ml. No other titers had previously been drawn. The subject had not responded to therapy with Engerix B. At the time of reporting the outcome of the event was unspecified.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, No therapeutic response
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of not responding to therapy in an adult female subject who was vaccinated with hepatitis B vaccine (manufacturer unspecified) for prophylaxis.  Concurrent medications included an unspecified inhaler used as needed.  In 2003, October 2005 and January 2006 the subject received 1st dose, 2nd dose and 3rd dose of Hepatitis B vaccine (20 mg/ml).  In February 2007, approximately 13 months after vaccination with the 3rd dose of Hepatitis B vaccine, 16 months after the 2nd dose of Hepatitis B vaccine, and 4 years after the first dose of Hepatitis B vaccine, the subject had a negative result for sero-conversion (not responding to therapy).  At the time of reporting the event was unresolved.
Sex: M
Vaccine: HEP
Symptoms: No therapeutic response
Clinical narrative: This case was reported by a healthcare professional, via a sales representative, and described the occurrence of not responding to therapy in an adult male subject who was vaccinated with Engerix B (GlaxoSmithKline) for prophylaxis.  The subject's medical history included human immunodeficiency virus.  On an unspecified date the subject received 3rd dose (20 mcg, unknown), 2nd dose (dose unspecified) and 1st dose of Engerix B (dose unspecified).  At an unspecified time after vaccination with three doses of Engerix B, the subject experienced not responding to therapy.  At the time of reporting the outcome of the event was unspecified.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Guillain-Barre syndrome
Clinical narrative: Information has been received from a physician, via a company representative, concerning an 18 year old female patient with a "lengthy medical history" (details not provided), who on 29-MAR-2007 was vaccinated with the first dose of Gardasil (lot #657006/0188U).  Concomitant therapy included a "lengthy medication list" (medications not provided).  On 13-APR-2007, 15 days after vaccination, the patient experienced symptoms of Guillain Barre syndrome.  On 14-APR-2007, she was admitted to the hospital, and was discharged on 22-APR-2007 (details not provided).  On 25-APR-2007, the patient was again admitted to the hospital, and released on 27-APR-2007 (details not provided).  At the time of this report, the patient was recovering from the event.  Additional information has been requested.  02/29/2008 Per email from CDC:  CDC's CISA staff has determined this case to be GBS Brighton level 2. 02/29/2008 MR received from CDC for visits from 5/2007 to 7/2007 from multiple sources including neurology. DX: Guillain-Barre Syndrome. Pt presented to ER 4/12/2007 with c/o leg weakness with PE suggestive of GBS (bilateral ascending paresthesias and weakness).  LP defered due to hx of spinal subdural hematoma.  Txd with IVIG. Admitted until 4/23/07.  Re-admitted 4/25/07 unable to walk and with c/o throat tremors, hand tremors,  difficulty lifting objects, and increased fatigue.  DTRs in lower extremities absent and decreased vibratory sensation.  Improvement noted by 7/2007 OV with new c/o headaches.
Age: 13.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, No therapeutic response
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a 13-year-old female subject who was vaccinated with Engerix B for prophylaxis. Prior vaccinations included Engerix B for prophylaxis given on 02 February 1999, 05 March 1999 and 10 September 1999. In November 2006, 7 years after these vaccinations with Engerix B, the subject did not have antibodies to Hepatitis B. On an unspecified date within or after November 2006, the subject received a 4th dose of Engerix B (20 mcg). On 14 May 2007, at an unspecified time after vaccination with the fourth dose of Engerix B, the subject's Hepatitis B antibodies test were again found to be negative. At the time of reporting the event was unresolved.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache
Clinical narrative: Information has been received from a medical assistant (MA), concerning a female patient (age not specified) with no pertinent medical history and no known allergies, who was vaccinated (date not specified) with the third dose of Gardasil (lot # not reported).  There was no concomitant medication.  After the third vaccination, on 26-NOV-2007 (time duration to onset not specified), the patient experienced headaches, and dizziness that has been so severe, that "she needed to sit down very often."  At the time of this report, the patient had not recovered.  The MA considered the events to be serious as disabling/incapacitating.  Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, No adverse reaction
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a 13-year-old female subject who was vaccinated with Engerix B for prophylaxis.  On 02 February 1999, 05 March 1999 and 10 September 1999 the subject received 1st dose, 2nd dose and 3rd dose of Engerix B (10 mcg).  In November 2006, 7 years after vaccination with Engerix B, the subject did not have antibodies to Hepatitis B.  At the time of reporting the event was unresolved.  Follow-up information was received from the reporting healthcare professional on 07 June 2007.  The reporter indicated that she had not reported the event to a regulatory agency.  There was no other additional information reported.
Age: 18.0
Sex: F
Vaccine: HEP, HPV4, MEN, TTOX, VARCEL
Symptoms: Drug exposure during pregnancy, Haematology test, Nasopharyngitis, Pregnancy test positive
Clinical narrative: Information has been received through the Merck pregnancy registry through an 18 year old female consumer who on 09-OCT-2007 was vaccinated with her first dose of Gardasil.  Concomitant therapy included hepatitis B virus vaccine (unspecified), varicella virus vaccine live (unspecified), meningococcal vaccine (unspecified) and tetanus toxoid.  The patient experienced mild cold symptoms for approximately 1 day following the vaccinations.  On 16-OCT-2007, the patient found out she was pregnant (LMP approximately 29-AUG-2007).  The patient sought unspecified medical attention with her physician.  The patient had a pregnancy test and unspecified blood work performed.  Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Rash papular
Clinical narrative: Information has been received from a physician concerning a 19 year old female who on 31-Oct-2007 was vaccinated with the second dose of Gardasil.  Concomitant therapy ending on 29-Oct-2007 included amoxicillin (AMOXIBRON (amoxicillin)).  On 31-Oct-2007 the patient experienced papular eruption and the symptom lasted for about a week.  The patient saw a physician.  No further information is available.  Additional information has been requested. 02/10/2010 Follow up informaiton confirmed the patient had mild popular dermatitis after injection which cleared within days. No futher information is available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Menstruation irregular
Clinical narrative: Information has been received from a physician concerning a 17 year old female who was vaccinated intramuscularly with the first dose of Gardasil. Subsequently the patient had "skipped her menstrual cycle for 2 months." The patient recovered from her skipped menstrual cycle. No further information was provided. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Vision blurred
Clinical narrative: Information has been received from a physician concerning a 12 year old female who on 06-DEC-2007 was vaccinated intramuscularly with the first dose of Gardasil. On 06-DEC-2007 the patient experienced "blurred vision and felt faint." No further information was provided and no lot number was given. The reporter felt that blurred vision and felt faint were not related to therapy with Gardasil. Additional information has been requested.
Age: 30.0
Sex: U
Vaccine: HEP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swelling injection site in a subject of unspecified age and gender who was vaccinated with Engerix B for prophylaxis. Concurrent medical conditions included crohn's disease. Concurrent medications included Flagyl, Remicade, Ascal, Clarinex, Xifaxan, and HCT. On 16 May 2007 and an unspecified date the subject received 2nd dose and 1st dose of Engerix B (unknown). At an unspecified time after 1st vaccination with Engerix B, the subject experienced mild pain at the injection site. Following the 2nd dose of Engerix B on 16 May 2007, the subject developed swelling about one inch across at the injection site and redness. The subject also reported injection site pain and swelling following the 2nd injection. At the time of reporting the outcome of the events were unspecified.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a nurse practitioner, via a company representative, concerning a 14 year old female patient, who was vaccinated on an unspecified date, with the second dose, 0.5 ml, of Gardasil (lot # not reported).  Subsequently, the patient experienced a "pit" (dent) on her arm where the injection was given.  At the time of this report, the patient had not recovered.  Additional information has been requested. Follow-up received 04/16/2008. Initial and follow-up information has been received from a nurse practitioner, concerning a 16 year old (previously reported as 14 year old) femal student with recurrent bronchitis, who on 10-JUL-2007 was vaccinated IM in the left deltoid with the first dose (lot #657006/D188U), and on 10-SEP-2007 was vaccinated in the left deltoid with the second dose, 0.5 ml. of GARDASIL vaccine (lot # 658490/0802U). There was no illness at the time of vaccination. Subsequently, the patient experienced a "pit" (dent), also described as 'dimpling" on her arm where the injection s were given. There was no pain at the injection site. At the time of this report, the outcome of the event was unknown. Additional information is not expected.