chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEP
Symptoms: No therapeutic response, Obesity
Clinical narrative: This  case was reported by a pharmacist and described the occurrence of not responding to therapy in a subject of unspecified age and gender who was vaccinated with ENGERIX B (GlaxoSmithKline).  The subject was reportedly obese.  On an unspecified date the subject received unspecified dose of ENGERIX B (unknown).  Following vaccination with ENGERIX B,  the subject experienced not responding to therapy.  The outcome was not reported.  The reporting pharmacist stated that a physician contacted her and reported that he had an obese subject who had been vaccinated with ENGERIX B several times and antibodies are not showing up.  No further details were given at the time of reporting.
Age: 10.0
Sex: F
Vaccine: HEP
Symptoms: Malaise, Pruritus, Rash erythematous, Urticaria
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of urticaria in a 10-year-old female subject who was vaccinated with ENGERIX B, GlaxoSmithKline.  On 22 September the subject received 1st dose of ENGERIX B at 10 mcg.  On 23 September 2000, 1 day after vaccination with ENGERIX B, the subject experienced urticaria, raised red bumps, itching and feeling unwell.  The events resolved within a few days.  The subject did not believe that the events were related to treatment with ENGERIX B.
Age: 39.0
Sex: M
Vaccine: HEP
Symptoms: Local reaction, Muscle fatigue, Muscular weakness, Sensory disturbance
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of arm weakness in a 39-year-old male subject who was vaccinated with ENGERIX B, GlaxoSmithKline.  Previous vaccination included TETANUS TOXOID vaccine; unknown; left deltoid given on 04 September 2008.  On 16 September 2008 at 19:00, the subject received the 3rd dose of ENGERIX B (20 mcg, unknown, right deltoid).  On 16 September 2008, less than one day after vaccination with ENGERIX B, the subject experienced arm weakness, pulling sensation and arm fatigue.  The events were reported to be systemic.  On 06 October 2008, the subject reported to a nurse that his symptoms had improved over time, but when he played ball with his daughter over the weekend, the symptoms were noticeable again.  The subject treated his symptoms with IBUPROFEN.  Follow-up information was received on 17 November 2008, via healthcare professional who reported the subject's events were localized to his right arm.  The healthcare professional associated the events to medical history of the subject receiving the TETANUS vaccine on 04 September 2008 in the left arm.  Also on 04 September 2008, the subject was treated with decongestants for a right ear infection.  On 11 October 2008, the events were resolved.  The healthcare professional considered the events were possibly related to vaccination with ENGERIX B.
Sex: F
Vaccine: HEP
Symptoms: No therapeutic response
Clinical narrative: This case was reported by a physician (also the subject) via a sales representative and described the occurrence of a young adult female subject of unspecified age not responding to therapy following vaccination with hepatitis B vaccine recombinant (Hepatitis B vaccine, manufacturer unspecified).  On unspecified dates the subject completed the hepatitis B vaccination series and did not respond to therapy.  The subject then completed a 2nd hepatitis B vaccination series (dates not known) and still did not respond.  The outcome of event was not reported.
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Incorrect route of drug administration
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of wrong route of administration in a 38-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent medical conditions included dialysis and hypertension. Concurrent medications included EPOGEN, VENOFER, NEXIUM, PHOS-LO. On 1 October 2008 at 15:00 the subject received 3rd dose of ENGERIX B at 40 mcg, intravenously. This was the wrong route of administration. ENGERIX B should be given intramuscularly. On 1 October 2008, less than one day after vaccination with ENGERIX B, the subject experienced headache. At the time of reporting the event of headache was unresolved. The healthcare professional considered the event of headache to be unrelated to vaccination with ENGERIX B and related to the subject's dialysis.
Age: 8.0
Sex: F
Vaccine: HEP
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer and described the occurrence of foot pain in a 8-year-old female subject who was vaccinated with hepatitis B vaccine recombinant (Hepatitis B vaccine, manufacturer unspecified).  A physician or other health care professional has not verified this report.  Previous vaccinations included the 1st and 2nd doses of hepatitis B vaccine recombinant;  manufacturer unspecified; given on an unspecified dates.  On an unspecified date in 1994, the subject received the 3rd dose of a Hepatitis B vaccine (unknown).  At an unspecified time after vaccination with Hepatitis B vaccine in 1994, the subject experienced foot pain.  At the time of reporting, the outcome of the event was unspecified.
Sex: U
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 a subject of unspecified age and gender not responding to therapy following vaccination with ENGERIX B. On an unspecified date the subject completed the ENGERIX B series. The subject was found at an unspecified amount of time later to have a negative titer  for HEP B. The subject had not responded to therapy. No other events were reported.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B, Hepatitis B surface antigen positive, Polymerase chain reaction
Clinical narrative: This case was reported by a physician and described the occurrence of hepatitis b antigen positive in an adult subject of unspecified gender who was vaccinated with ENGERIX B, GlaxoSmithKline.  The subject's medical history included being bitten by a student.  On an unspecified date in 2008, the subject received 1st dose of ENGERIX B (unknown).  On an unspecified date in August 2009, within one to two weeks of vaccination with ENGERIX B, the subject had a positive laboratory test result for hepatitis b antigen.  A polymerase chain reaction (PCR) test was performed which showed a low positive result.  The reporting physician believes that a repeat laboratory test showed that the subject's positive hepatitis B antigens resolved and the subject's antibodies had increased as would be expected from the vaccine.   However, the reporting physician did not have access to the repeat laboratory results to confirm that the positive hepatitis B antigens had resolved, as he was being consulted on this report.  The physician stated that he had limited information to provide, as he learned of the event from his wife, who was employed by the school where the bite and subsequent vaccination and testing occurred.  At the time of reporting, the outcome of the event was unspecified.  The physician considered the event was probably related to vaccination with ENGERIX B, but stated that in his opinion the positive hepatitis B antigen result was just within the normal course of events after vaccination, and that the subject should not have been tested for hepatitis B antigen one to two weeks after receiving the vaccine.
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis A antibody negative, Hepatitis B antibody negative, No therapeutic response
Clinical narrative: This case was reported by a healthcare professional, who was also the vaccination subject,  that described the occurrence of not responding to therapy in a 48-year-old female subject who was vaccinated with hepatitis B vaccine recombinant (Hepatitis B vaccine, manufacturer unspecified), and hepatitis A vaccine inactivated (Hepatitis A vaccine, manufacturer unspecified).  The subject's  medical history included a non-cancerous abnormal pap smear, measles and mumps.  Previous vaccinations included Typhoid and Salmonella typhi Vi capsular polysaccharide vaccines;  manufacturers unspecified;  given on 28 September 2004; tuberculin ppd; manufacturer unspecified; given on 23 August 2004;  diphtheria and tetanus toxoids adsorbed;  manufacturer unspecified;  given on 26 July 2004;  meningitis vaccine, strain  not specified;  manufacturer unspecified;  given on 26 July 2004.  Concurrent medications included Multivitamins.  On unspecified dates in 1988, the subject received that 1st dose, 2nd dose and 3rd dose of Hepatitis B vaccine (unknown, intramuscularly).  On unspecified dates in 1998, the subject repeated the three dose Hepatitis B vaccination series.   The subject could not recall if she received any concomitant vaccinations at that time.  On 26 July 2004 and 31 January 2005, the subject received the 1st dose and 2nd dose of Hepatitis A vaccine (unknown).  On an unspecified date in 2008, the subject had titers drawn for Hepatitis A and Hepatitis B.  Test results showed that the subject was negative for both antibodies.  The subject stated that she was recently prescribed ENGERIX B by her physician, which was to be given intradermally.  ENGERIX B is not recommended for intradermal use.  At the time of reporting, the outcome of the events was unresolved.
Age: 0.3
Sex: F
Vaccine: HEP
Symptoms: Rash
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of rash on trunk in a 35-year-old female subject who was vaccinated with ENGERIX B. On 21 August 2008, the subject received the 2nd dose of ENGERIX B. On 21 August 2008, 6 to 7 hours after vaccination with ENEGERIX B, the subject experienced a rash on her trunk, arms, and legs. The subject was treated with Benadryl and ZYRTEC. At the time of reporting, the outcome of the events was unspecified. The reporting nurse stated that the subject did not experience any events following the 1st dose of ENGERIX B. The healthcare professional considered the events were possibly related to vaccination with ENGERIX B.
Sex: F
Vaccine: HEP
Symptoms: Facial pain, Injection site pain, Paraesthesia, Pruritus
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site pain in an adult female subject who was vaccinated with ENGERIX B. A physician or other health care professional has not verified this report. On 19 August 2008, the subject received 2nd dose of ENGERIX B (unknown, right arm). On 19 August 2008, less than one day after vaccination with ENGERIX B, the subject experienced injection site pain described as a prickly feeling at the injection site and a prickly feeling on the middle finger of the right hand. On 21 August 2008, two days after vaccination with ENGERIX B, the subject experienced facial pain pruritis. At the time of reporting, the events were unresolved. The caller was reporting on behalf of vaccination subject, and had minimal information to provide. The reporter stated that the vaccination series was neither discontinued nor delayed, but was unsure if the subject checked with her physician for treatment. Please reference report A0746681A.
Sex: F
Vaccine: HEP
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site soreness in an adult female subject who was vaccinated with ENGERIX B, GlaxoSmithKline.  A physician or other health care professional has not verified this report.  On 19 July 2008, the subject received 1st dose of ENGERIX B (unknown, left arm).  On 19 July 2008, less than one day after vaccination with ENGERIX B, the subject experienced injection site soreness of the left arm.  After an unspecified amount of time, the event resolved.  The caller was reported on behalf of the vaccination subject, and had minimal information to provide.  The reporter stated that the vaccination series was neither discontinued nor delayed, but was unsure if the subject checked with her physician for treatment.  Please reference report A07466B1B.
Age: 0.1
Sex: M
Vaccine: HEP
Symptoms: Hepatitis A antibody, Hepatitis B antibody negative, Hepatitis B surface antigen positive, Hepatitis C antibody negative
Clinical narrative: This case was reported by a pharmacist and described the occurrence of hepatitis B surface antigen positive in a 2-month-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline).  Concurrent medical conditions included premature infant.  On 28 July 2008 and 27 August 2008, the infant subject received the 1st dose and 2nd  dose of ENGERIX B (.5 ml, unknown).  On 28 August 2008, 31 days after receiving the 1st dose of ENGERIX B, and one day after receiving the 2nd dose of ENGERIX B, the subject was tested for hepatitis on a routine panel and was found to be hepatitis be surface antigen positive.  The subject was a premature infant, who had been hospitalized in the neonatal intensive care unit since birth on 28 June 2008, for a period of two months.  The subject received the 1st dose of ENGERIX B at 1-month-old, and the 2nd dose of ENGERIX B at 2 months-old.  This was considered to be an inappropriate schedule of vaccine administered.  The reporting pharmacist stated that subject was preparing to be discharged form the hospital when the 2nd dose of ENGERIX B was "inadvertently" administered.  At the time of reporting, the hepatitis B surface antigen positive was unresolved.  The inappropriate schedule of vaccine administration was reported to be resolved.  The pharmacist considered the events were probably related to vaccination with ENGERIX B.  Follow-up information received 17 November 2008 was unclear, but seemed to indicate the following.  The neonate did not received an inadvertent 2nd dose of ENGERIX B on 27 August 2008,  but a dose of PEDIARIX which he has intended to get.  The nurse administering the PEDIARIX experienced an inadvertent needle stick which prompted the hepatitis panel to be run on the baby.  At that time, the baby's hepatitis B surface antigen was found to be positive.  It was reported that the event resolved.  Please see case number A762868A for details regarding the needle stick.
Age: 38.0
Sex: F
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 49-year-old female subject who was vaccinated with hepatitis B vaccine recombinant (HEPATITIS B vaccine, manufacturer unspecified).  On 16 January 1998, 16 February 1998 and 17 July 1998, the subject received the 1st dose, 2nd dose and 3rd dose of HEPATITIS B vaccine (unknown).  On an unspecified date in August 2008, 10 years after vaccination with HEPATITIS B vaccine, a titer was drawn and the subject was found to be hepatitis b antibody negative.  At the time of reporting, the outcome of the event was unspecified.
Age: 26.0
Sex: M
Vaccine: HEP
Symptoms: Joint swelling, Monarthritis, Pain
Clinical narrative: This case was reported by a health care professional and described the occurrence of swelling of knees in a 26-year-old male subject who was vaccinated with ENERGIX B. On 25 June 2008 the subject received 1st dose of ENGERIX B at 1.0ml. On 26 June 2008, 1 day after vaccination with ENEGERIX B, the subject experienced swelling of knees and pain. On 28 June 2008, two days later, the events were resolved. The healthcare professional considered the events were possibly related to vaccination with ENGERIX B. Follow- up information was received on 12 September 2008 via physician assistant, who reported that the subject was diagnosed with monoarticular, arthritis, with a date of onset listed as 26 June 2008. All events were reported to be resolved as of 28 June 2008. The healthcare professional did not consider the events to be serious, and to be possibly related to vaccination with ENGERIX B. The healthcare professional also indicated that the events could have been associated with obesity and possible arthritis / tendonitis.
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of hives in an infant female subject who was vaccinated with hepatitis B vaccine recombinant (hepatitis B vaccine, manufacturer unspecified).  On an unspecified date subject received 1st dose of hepatitis B vaccine (unknown).  At an unspecified time after vaccination with hepatitis B vaccine, the subject experienced hives.  At the time of reporting the event was resolved.  This report was received when subject, now 11 years of age, was refused a Tdap vaccine at her local health department because of the event above following administration of an unspecified hepatitis B vaccine.  The subject had completed her childhood Dtap vaccinations without incidence.
Sex: U
Vaccine: HEP
Symptoms: Anaphylactic reaction, Body temperature increased
Clinical narrative: This case was reported by a physician via a nurse and described the occurrence of allergic reaction in a subject of unspecified and and gender who was vaccinated with ENGERIX B, GlaxoSmithKline.  On an unspecified date the subject received a dose of ENGERIX B, the subject experienced an anaphylactic reaction.  The outcome of the event was not reported.
Sex: M
Vaccine: HEP
Symptoms: Abdominal pain upper, Diarrhoea, Irritability, Wrong drug administered
Clinical narrative: This case was reported by a consumer, who was also a GSK sales representative, that described that occurrence of irritability in an adult male subject who was vaccinated with HEPATITIS B vaccine, (manufacturer unspecified).  A physician or other health care professional has not verified this report.  Previous vaccination included the 1st dose of TWINRIX, (GlaxoSmithKline); unknown; unknown given on 07 July 2008.  On 16 July 2008, the subject inadvertently received an unspecified dose of Hepatitis B vaccine (unknown, right arm), instead of the intended 2nd dose of TWINRIX.  The subject received the 1th dose of TWINRIX on 07 July 2008 on an accelerated dosing schedule.  The subject was scheduled for the 2nd dose of the TWINRIX series on 14 July 2008, but stated that he came back late to receive the dose on 16 July 2008, when he inadvertently received a monovalent hepatitis B vaccine instead.  On the evening of 06 August 2008, 21 days after vaccination with the Hepatitis B vaccine, the subject experienced diarrhea, stomach cramps and stomach pain, which made him irritable.  The subject stated that he initially thought that the events were just due to an unspecified illness and did not relate the events to the vaccine.  However, upon learning that the physician's office inadvertently gave him the wrong vaccine for the 2nd dose in the TWINRIX series, he began to question if the monovalent hepatitis B dose may have caused the events.  At the time of this report, the subject had not required treatment for these events, but stated that he was scheduled to return to the physician's office on 12 August 2008 for further evaluation.  It was unknown at the time of this report how the TWINRIX vaccination series will be completed.  At the time of reporting, the events were unresolved.
Age: 50.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antigen positive, Inappropriate schedule of drug administration
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of hepatitis B antigen positive in a 50-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline).  Concurrent medical conditions included hemodialysis, hypertension and renal failure.  On 1 August 2008, 30 June 2008 and 26 May 2008 the subject received 3rd, 2nd and 1st dose of ENGERIX B (unknown).  On 4 August 2008, 3 days after receiving the 3rd vaccination with ENGERIX B, the subject tested positive for hepatitis B antigen.  At the time of reporting the outcome of the event was unspecified.  The 3rd dose of ENGERIX B was also administered approximately one month too early.  This was considered to be an inappropriate schedule of drug administration.  No adverse events resulted.  Follow-up information was received on 03 September 2008 via a nurse, who reported that the subject received 40 mcg doses of ENGERIX B on 26 May, 30 June, and 01 August 2008.  The healthcare professional considered the hepatitis B antigen positive result to be related to vaccination with ENGERIX B.  On 18 August 2008, the subject tested negative for hepatitis B antigen and the reporting healthcare professional indicated that the event was resolved.  The healthcare professional indicated that the hepatitis B vaccination series was neither discontinued nor delayed, but the subject had not received the 4th dose of the series at the time of this report.
Age: 72.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antigen positive
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of hepatitis B antigen positive in a 72-year-old male subject who was vaccinated with ENGERIX B, (GlaxoSmithKline).  Concurrent medical conditions included hemodialysis and type 2 diabetes.  On 1 August 2008 and 25 June 2008 the subject received 2nd dose and 1st dose of ENGERIX B (unknown).  On 4 August 2008, 3 days after receiving the 2nd vaccination with ENGERIX B, the subject tested positive for hepatitis B antigen.  At the time of reporting the outcome of the event was unspecified.  Follow-up information was received on 03 September 2008 via a nurse, who reported that the subject received 40 mcg doses of ENGERIX B on 25 June and 01 August 2008.  The healthcare professional considered the hepatitis B antigen positive result to be related to vaccination with ENGERIX B.  On 18 August 2008, the subject tested negative for hepatitis B antigen and the reporting healthcare professional indicated that the event was resolved.  The healthcare professional indicated that the hepatitis B vaccination series was neither discontinued nor delayed, but the subject had not received the 3rd and 4th doses of the series at the time of this report.
Age: 45.0
Sex: M
Vaccine: HEP
Symptoms: Blood test normal, Hepatitis B antigen positive
Clinical narrative: This case was reported by a healthcare professional  and described the occurrence of hepatitis B antigen positive in a 45-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline).  Concurrent medical conditions included diabetes and renal failure.  The subject was hoping to received a kidney transplant.  Concurrent medications included EPOGEN, ZEMPLAR, CYMBALTA, NEXIUM, LYRICA, REQUIP and RENAGEL.  On 30 April 2008 the subject received 1st dose of ENGERIX B at 40 mcg in the right arm.  On 5 May 2008, 5 days after vaccination with ENGERIX B, the subject was found to be hepatitis B antigen positive.  Three more blood levels taken on unspecified dates after this were all negative.  The reporter was concerned because the subject is being evaluated to receive a kidney transplant and the reporter is now being told that the subject needs to have a liver biopsy due to the positive antigen result.  At the time of reporting the outcome of the event was unspecified.
Sex: F
Vaccine: HEP
Symptoms: Burning sensation, Pain in extremity
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of arm burning in an adult female subject who was vaccinated with ENGERIX B (GlaxoSmithKline).  There were no concurrent medications.  In July 2008 the subject received unspecified dose of ENGERIX B in the left arm.  At an unspecified time after vaccination with ENGERIX B, the subject experienced burning and stinging in the left arm.  At the time of reporting the outcome of the events was unspecified.
Sex: M
Vaccine: HEP
Symptoms: Pain, Skin burning sensation
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of arm burning in an adult male subject who was vaccinated with ENGERIX B. There were no concurrent medications. In July 2008 the subject received unspecified dose of ENEGERIX B in the left arm. At unspecified time after vaccination with ENGERIX B, the subject experienced burning and stinging in the left arm. At the time of reporting the outcome of the events was unspecified.
Sex: M
Vaccine: HEP
Symptoms: Burning sensation, Pain in extremity
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of arm burning in an adult male subject who was vaccinated with ENGERIX B, (GlaxoSmithKline).  There were no concurrent medications.  In July 2008 the subject received unspecified dose of ENGERIX B in the left arm.  At an unspecified time after vaccination with ENGERIX B, the subject experienced burning and stinging in the left arm.  At the time of reporting the outcome of the events was unspecified.
Age: 3.0
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of hives in a 3-year-old female subject who was vaccinated with ENGERIX B, (GlaxoSmithKline).  Concurrent medications included TOBREX and BACTROBAN.  On 28 December 1993 the subject received 1st dose of ENGERIX B at 0.5 ml in an unknown thigh.  Twenty four hours after vaccination with ENGERIX B, the subject experienced hives and a high fever.  A systemic reaction.  The subject's mother attempted to use BENADRYL to treat the hives with no relief.  She contacted the physician's office who then prescribed ATARAX.  At the time of reporting the events were resolved.  Follow-up information was received on 25 August 2008 via a nurse, who reported that the onset of the events was on 29 December 1993.  The reporting nurse considered the event to be related to vaccination with ENGERIX B, but did not consider the events to be serious.  The nurse indicated that the ENGERIX B vaccination series was discontinued, and that the events were resolved on an unspecified date.  The nurse indicated that this case was reported to a Regulatory Agency (VAERS number was not provided).
Sex: F
Vaccine: HEP
Symptoms: Body temperature increased, Diarrhoea, Hypersensitivity, Malaise, Muscle spasms
Clinical narrative: This case was reported by a nurse and described the occurrence of allergic reaction in an adult female subject of unspecified age who was vaccinated with ENGERIX B. On an Unspecified date the subject received 1st dose of ENGERIX B. An unspecified amount of time after administration of ENEGERIX B, the subject developed malaise and frequent diarrhea with cramping. On unspecified date, the subject later received 2nd dose, the subject developed a fever to 102 f that lasted for 3 months. The reporter referred to these symptoms as an allergic reaction. The outcome of the events was not reported.
Sex: F
Vaccine: HEP
Symptoms: Pyrexia
Clinical narrative: This case was reported by a nurse and described the occurrence of allergic reaction in an adult female subject of unspecified age who was vaccinated with ENGERIX B. On an Unspecified date the subject received 1st dose of ENGERIX B. An unspecified amount of time after administration of ENEGERIX B, the subject developed malaise and frequent diarrhea with cramping. On unspecified date, the subject later received 2nd dose, the subject developed a fever to 102 f that lasted for 3 months. The reporter referred to these symptoms as an allergic reaction. The outcome of the events was not reported.
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody abnormal, Hepatitis B antibody negative
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of low hepatitis b antibody level in a male subject of unspecified age who was vaccinated with ENGERIX B, manufacturer unspecified.  The subject completed the hepatitis B series in 1998 and in 2001.  A recent titer showed that the subjects hepatitis B antibody level was less than 9 (negative).  No additional information was provided.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antigen positive, Hepatitis B surface antigen positive
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of hepatitis b surface antigen positive in a 27-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline).  On 10 June 2008, the subject received the 1st dose of ENGERIX B (unknown, left arm).  At an unspecified time after vaccination with ENGERIX B, blood work was drawn, and the subject was found to be hepatitis b surface antigen positive.  On 11 June 2008, the subject donated plasma.  a plasma donation center reported a hepatitis b surface antigen in the subject's donated plasma.  The reporting nurse was unsure if the test results were reported in June or July of 2008.  The vaccination subject told the nurse about the test results when she visited the clinic for her 2nd ENGERIX B dose in July 2008.  The subject was administered the 2nd dose of ENGERIX B on an unspecified date.  At the time of reporting, the event was unresolved.  The healthcare professional considered the event to be related to vaccination with ENGERIX B, but indicated that the event was not serious.
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Arthritis, Myalgia, Pyrexia, Rash
Clinical narrative: This case was reported by a physician and described the occurrence of fever in a female subject of unspecified age who was vaccinated with hepatitis B vaccine recombinant (Hepatitis B vaccine, manufacturer unspecified).  On unspecified dates in 1998, the subject received the 1st dose, 2nd dose and 3rd dose of Hepatitis B vaccine (unknown).  In 1998, at an unspecified time after vaccination with the 1st dose of Hepatitis B vaccine, the subject experienced fever.  In 1998, at an unspecified time after vaccination with the 2nd dose of Hepatitis B vaccine, the subject experienced rash and swelling.  In 1998, at an unspecified time after vaccination with the 3rd dose of Hepatitis B vaccine, the subject experienced myalgia, joint pain, arthritis-like symptoms, arthralgia and arthritis.  The subject was reported to be debilitated for approximately three years.  The physician stated that the subject has undergone "an extensive work-up since then", but it was unknown if the patient was ever hospitalized.  No patient specific demographics were provided for the subject.  The physician considered the events to be disabling and clinically significant (or requiring intervention).  As of 2001, the events were resolved.  The physician considered the events to be probably related to vaccination  with Hepatitis B vaccine.
Sex: F
Vaccine: HEP
Symptoms: Swelling
Clinical narrative: This case was reported by a physician and described the occurrence of fever in a female subject of unspecified age who was vaccinated with hepatitis B vaccine recombinant (Hepatitis B vaccine, manufacturer unspecified).  On unspecified dates in 1998, the subject received the 1st dose, 2nd dose and 3rd dose of Hepatitis B vaccine (unknown).  In 1998, at an unspecified time after vaccination with the 1st dose of Hepatitis B vaccine, the subject experienced fever.  In 1998, at an unspecified time after vaccination with the 2nd dose of Hepatitis B vaccine, the subject experienced rash and swelling.  In 1998, at an unspecified time after vaccination with the 3rd dose of Hepatitis B vaccine, the subject experienced myalgia, joint pain, arthritis-like symptoms, arthralgia and arthritis.  The subject was reported to be debilitated for approximately three years.  The physician stated that the subject has undergone "an extensive work-up since then", but it was unknown if the patient was ever hospitalized.  No patient specific demographics were provided for the subject.  The physician considered the events to be disabling and clinically significant (or requiring intervention).  As of 2001, the events were resolved.  The physician considered the events to be probably related to vaccination  with Hepatitis B vaccine.
Sex: U
Vaccine: HEP
Symptoms: Nausea
Clinical narrative: This case was reported by a pharmacist and described the occurrence of nausea in three subject of unspecified ages and genders who were vaccinated with ENGERIX B, (GlaxoSmithKline).  On the morning of 10 July 2008, the subjects received unspecified doses of ENGERIX B (unknown).  After an unspecified amount of time following vaccination nausea.  All three subjects received doses of ENGERIX B from lot #AHBVB584AA, expiration date 06 November 2010.  At the time of reporting, the events were unresolved.  No further information was available at the time of this report.
Sex: U
Vaccine: HEP
Symptoms: Nausea
Clinical narrative: This case was reported by a pharmacist and described the occurrence of nausea in three subjects of unspecified ages and genders who were vaccinated with ENGERIX B, (GlaxoSmithKline).  On the morning of 10 July 2008, the subjects received unspecified doses of ENGERIX B (unknown).  After an unspecified amount of time following vaccination with ENGERIX B, on the morning of 10 July 2008, the subjects experienced nausea.  All three subjects received doses of ENGERIX B from lot #AHBVB584AA; expiration date 06 November 2010.  At the time of reporting, the events were unresolved.  No further information was available at the time of this report.
Sex: U
Vaccine: HEP
Symptoms: Nausea
Clinical narrative: This case was reported by a pharmacist and described the occurrence of nausea in three subjects of unspecified ages and genders who were vaccinated with ENGERIX B, (GlaxoSmithKline).  On the morning of 10 July 2008,  the subjects received unspecified doses of ENGERIX B (unknown).  After an unspecified amount of time following vaccination with ENGERIX B, on the morning of 10 July 2008,  the subjects experienced nausea.  All three subjects received doses of ENGERIX B from lot #AHBVB584AA; expiration date 06 November 2010.  At the time of reporting, the events were unresolved.  No further information was available at the time of this report.
Age: 50.0
Sex: M
Vaccine: HEP
Symptoms: False positive laboratory result, Hepatitis B surface antigen positive, Immunology test abnormal
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of a false positive hepatitis test in a male subject aged between 50 and 59 years old who was vaccinated with ENGERIX B (GlaxoSmithKline).  Concurrent medical conditions included renal failure.  Concurrent medications included Hemodialysis.  On 16 June 2008 the subject received 3rd dose of ENGERIX B at 40 mcg. On 19 June 2008, 3 days after vaccination with ENGERIX B, the subject underwent hepatitis screening and showed positive for hepatitis B surface antigen and negative for hepatitis B core antigen.  This case of antigenemia was considered to be a systemic reaction.  It was reported that the subject experienced a false positive hepatitis test.  The outcome of the false positive hepatitis test was unresolved and in the healthcare professional's opinion, this event was probably related to vaccination with ENGERIX B.
Sex: U
Vaccine: HEP
Symptoms: Therapeutic response decreased
Clinical narrative: This case was reported by a pharmacist and described the occurrence of decreased therapeutic response in an unspecified number of subjects of unspecified ages and genders who were vaccinated with ENGERIX B (GlaxoSmithKline).  On unspecified dates, the subject (s) received the three dose ENGERIX B (unknown) series.  At an unspecified time after vaccination with ENGERIX B, the subject (s) experienced decreased therapeutic response.  A pharmacist reported that several employees completed the three dose ENGERIX B vaccination series "a few years ago".  Recent titer testing indicated that the subjects ha lower than normal titer levels.  The pharmacist was inquiring about the need for possible booster dosing for the subjects.  No further information was provided.  At the time of reporting, the outcome of the events was unspecified.
Sex: M
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 an adult male subject (a dentist) not responding to therapy following vaccination with HEPATITIS B vaccine (manufacturer unspecified).  In the 1980's, the subject received a three dose series of HEPATITIS B vaccine (unknown).  A titer was taken on an unspecified date after the series and at that time, the subject showed negative HEPATITIS B antibody titers.  The subject received a second three dose series of HEPATITIS B vaccine in the 1990's.  The reporter did not think a titer was taken after completion of the 1990 series.  An antibody titer taken in JUNE 2008 was negative.  Twice the subject did not respond to therapy with HEPATITIS B vaccine.  At the time of reporting the outcome of the events was unspecified.
Sex: M
Vaccine: HEP
Symptoms: No therapeutic response
Clinical narrative: This case was reported by a pharmacist and described the occurrence of an adult male subject (a physician) not responding to therapy following vaccination with HEPATITIS B vaccine (manufacturer unspecified).  On an unspecified date the subject completed his hepatitis B series (20 mcg doses administered).  At an unspecified time after completion of the hepatitis B vaccine series, the subject was found to have not responded to therapy.  At the time of reporting the outcome of the event was unspecified.  This event occurred in two subjects (two physicians) with case A0734383A serving as the master and linked to A0734385A (active) and A0734386A (created in error-void).
Sex: M
Vaccine: HEP
Symptoms: No therapeutic response
Clinical narrative: This case was reported by a pharmacist and described the occurrence of an adult male subject not responding to therapy following vaccination with Hepatitis B vaccine. On an unspecified date the subject completed his Hepatitis B series. At an unspecified time after completion of the Hepatitis B vaccine series, the subject was found to have not responded to therapy. At the time of reporting the outcome of the event was unspecified. This event occurred in two subjects with this case, A0734383A serving as the master and linked to A07343B5A and A0734386A in error-void.
Age: 22.0
Sex: M
Vaccine: HEP
Symptoms: Malaise, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a pharmacist, who was also the consumer, that described the occurrence of fever in a 22-year-old male subject who was vaccinated with ENGERIX B vaccine. On an unspecified date in 2005, the subject received the 1st dose of ENGERIX B vaccine (1 ml, unknown, left arm). Less than one day after with vaccination with ENGERIX B, the subject experienced fever, malaise and sore arm. Twenty-four hours after vaccination with ENGERIX B, the event were resolved. The reporting pharmacist/consumer considered the events to be probably related to vaccination with ENGERIX B.
Age: 18.0
Sex: F
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 23-year-old female patient who was vaccinated with ENGERIX B (GlaxoSmithKline). On 22 January 2001, the subject received the 3rd dose of ENGERIX B (unknown), to complete the three dose series. The 2nd dose of ENGERIX B (unknown) was given on 16 October 2000, and the 1st dose of ENGERIX B (unknown) was given on 14 September 2000. On 12 June 2007, approximately six  years after receiving the 3rd dose in the Hepatitis B antibody negative. At the time of reporting the outcome of the event was unspecified.
Sex: U
Vaccine: HEP
Symptoms: Medication error, No therapeutic response
Clinical narrative: This case was reported a physician, via sales representative and described the occurrence of not responding to therapy in a subject of unspecified age and gender who was vaccinated with Hepatitis B vaccine, (manufacturer unspecified). On an unspecified date the subject received unspecified dose of Hepatitis B vaccine, the subject experienced not responding to therapy. The physician reported that the subject received an unknown hepatitis B vaccine series and did not seroconvert. The subject still did not seroconvert after receiving a total of four or five dosed (one or two doses after the initial three dose series (vaccination error)). The series was administered years ago. At the time of reporting the outcome of the event was unspecified.
Age: 36.0
Sex: M
Vaccine: HEP, UNK
Symptoms: Blood cholesterol increased, Blood pressure, Blood triglycerides increased, Dizziness, Nausea
Clinical narrative: The subject was in clinic for day 180 on 03 October 20005. Pre-injection vitals were normal with blood pressure (BP) of 114/84. The subject did not have any complaints. About 15 minutes after received the injection the subject experienced mild nausea, lightheadedness dizziness with blurred vision. He was not diaphoretic and head not experienced these or any other symptoms on earlier injection day (was previously given injections on two separate occasions for this study). The subject had not eaten since 2100 the night before (injections given at 1200). The subject was given orange juice to drink and the lightheadedness, dizziness and nausea were resolved with in a few minutes. Blurred vision was resolved within 15 minutes. He is not a known diabetic and was on no Anti-retroviral (ARV) medications. A physical exam was performed and BP was taken lying down, which was 110/710. About five minute later, while sitting it as 140/100 and standing it was 140/100. Heart sounds were normal. After speaking to the subject later that day, he remained without the above symptoms. The following day his only complaints were slight headache and sluggishness. The reporting physician (PMD) deems this was possibly related to study treatment.
Age: 36.0
Sex: M
Vaccine: HEP, UNK
Symptoms: Protein total increased, Vision blurred
Clinical narrative: The subject was in clinic for day 180 on 03 October 20005. Pre-injection vitals were normal with blood pressure (BP) of 114/84. The subject did not have any complaints. About 15 minutes after received the injection the subject experienced mild nausea, lightheadedness dizziness with blurred vision. He was not diaphoretic and head not experienced these or any other symptoms on earlier injection day (was previously given injections on two separate occasions for this study). The subject had not eaten since 2100 the night before (injections given at 1200). The subject was given orange juice to drink and the lightheadedness, dizziness and nausea were resolved with in a few minutes. Blurred vision was resolved within 15 minutes. He is not a known diabetic and was on no Anti-retroviral (ARV) medications. A physical exam was performed and BP was taken lying down, which was 110/710. About five minute later, while sitting it as 140/100 and standing it was 140/100. Heart sounds were normal. After speaking to the subject later that day, he remained without the above symptoms. The following day his only complaints were slight headache and sluggishness. The reporting physician (PMD) deems this was possibly related to study treatment.
Age: 13.0
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: This case was reported by a physician via a representative and described the occurrence of HEPATITIS B antibody negative in a 13-year-old subject of unspecified gender who was vaccinated with HEPATITIS B vaccine (manufacturer unspecified). On an unspecified date the subject received 3rd dose of HEPATITIS B vaccine at 0.5 ml to complete the primary Hepatitis B series. At an unspecified time after completion of the Hepatitis B antibody negative. At the time of reporting the event was unresolved.
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pain, Medication error
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of vaccination error in a subject of unspecified age and gender who was vaccinated with HEPATITIS vaccine not otherwise specified (manufacturer unspecified). On an unspecified date, the subject received unspecified dose of HEPTITIS vaccine (unknown). At an unspecified time after vaccination with HEPATITIS vaccine, the subject experienced vaccination error and incorrect storage of drug. A HEPATITIS vaccine was administered after the vaccine had been improperly stored due to refrigeration being down over recent Spring Break. Follow-up received on 23-April-2008 via the nurse. She reported that the subject was a female in her thirties who received the third dose of ENGERIX B at 08:30 am (20mcg, given in left arm) manufactured by GlaxoSmithKline on 15 April 2008. The nurse reported that the refrigerator was turned off for over 11 days during spring break and the ENGERIX B was exposed to warmer temperatures than recommended. The nurse also reported that on the same day the subject was vaccinated with ENGERIX B, she experienced pain at the sith of the injection compared to the previous vaccinations. The symptoms resolved on an unknown date. Follow-up information was received on 20 May 2008 via a registered nurse, who reported that the subject was a 37-year old female. The nurse reported that the onset date of the symptoms was 15 April 2008, which resolved on 17 April 2008. The reporting nurse considered the events to be possibly related to vaccination with ENGERIX B. The nurse indicated that the vaccination series with ENGERIX B was delayed, as the subject was re-administered the 3rd dose of ENGERIX B, the subject again experienced minor pain at the injection site. The outcome of the injection site pain following the repeat 3rd dose ENGERIX B was unspecified.
Age: 55.0
Sex: M
Vaccine: HEP
Symptoms: Dysgeusia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of metallic taste in a 57-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). On 4 April 2008 the subject received 2nd dose of ENGERIX B (1cc, unknown, right arm). On April 2008, 30 minutes after vaccination with ENGERIX B, the subject experienced metallic taste. The subject had reported that the metallic taste was persisting. At the time of reporting the event was unresolved. The healthcare professional considered the event was possibly related to vaccination with ENGERIX B. Follow-up information was received on 13 May 2008 via a healthcare professional, who reported that that the immunization series with ENGERIX B was discontinued. The reporting healthcare professional did not consider the event to be serious. As of 02 May 2008, the event was resolved without treatment.
Age: 77.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antigen positive
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of possible HEPATITIS B in an elderly female subject who was vaccinated with ENGERIX B, (GlaxoSmithKline).  Concurrent medical conditions included dialysis, hypertension and renal failure.  Concurrent medications included alot of unknown concurrent medications.  In March 2007 the subject received unspecified dose of ENGERIX B (1 cc, unknown).  At an unspecified time after vaccination with ENGERIX B, the subject had lab work that "looks like an elderly female had HEP B disease."  The nurse questioned transient antigenemia.  At the time of reporting the outcome of the events were unspecified.  Follow-up information received on 20 May 2008 indicated that the subject was 78 years of age at the time of event.  The events resolved on an unspecified date.  A HEPATITIS B surface antigen test performed on 08 April 2008 was positive.  A repeat test performed on 15 April 2008 was negative.  The reporter suggested that the first test was a possible false positive due to receiving the vaccine a few days prior to the lab draw.  According to follow-up, the subject started dialysis on 16 May 2007 and it is continuing.  The subject has a concurrent medical condition of renal failure and a medical history of hypertension.  It was reported that the subject had the complete 1st series of 4 hepatitis B injections.