chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody, Inappropriate schedule of drug administration, Therapeutic response decreased
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of decreased therapeutic response in a 39-year-old male subject who was vaccinated with ENGERIX B (Glaxosmithkline). On 12 September 2008, 10 October 2008 and 5 January 2009 the subject received 1st dose , 2nd dose and 3rd dose of ENGERIX B (20mcg/mL, left deltoid, right deltoid and left deltoid respectively).  On 05 January 2009, the subject experienced drug dose administration interval too short. On 20 March 2009, 74 days after vaccination with ENGERIX B, the subject experienced decreased therapeutic response. On 20 March 2009, hepatitis B surface antibody was low at less than 1.0. A product complaint was associated with this report. Reporter states that 5 out of 6 subjects who received dose one from the same lot, dose 2 from the same lot, and dose 3 from the same lot experienced this adverse event. The subjects received the doses on 0, 1, and 4 month schedule. The reporter did not believe there were any physical problems with the vaccines, but was questioning the quality and content of the vaccines. This reporter felt strongly that there was something potentially wrong with one of these vaccine lots because so many subjects did not become seroprotected. This is something she has not seen and she gives these vaccinations on a routine basis. Reporter believes a quality assurance problem caused the adverse event. Follow-up information was received on 14 May 2009 from Quality Assurance. Per the Quality statement: ENGERIX vaccine lot numbers AHBVB703AA, AHAVB584AA and AHBVB670AA met the requirements of Quality assurance's specifications and the batches were suitable for vaccination purposes.
Age: 58.0
Sex: F
Vaccine: HEP
Symptoms: Adverse event, Hepatitis B antibody, Inappropriate schedule of drug administration, Therapeutic response decreased
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of decreased therapeutic response in a 58-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). There were no concurrent medications. On 17 September 2008, 20 October 2008 and 22 January 2009 the subject received 1st dose, 2nd dose and 3rd dose of Engerix B (20 mcg/mL, left deltoid). 22 January 2009, the subject experienced drug dose administration interval too short. On 16 March 2009, 53 days after vaccination with the third dose of Engerix B, the subject experienced decreased therapeutic response. On 16 March 2009, hepatitis B surface antibody was low at 7.2. A product complaint was associated with this report. Reporter states that 5 out of 6 subjects who received dose one from the same lot, dose 2 from the same lot, and dose 3 from the same lot experienced this adverse event. The subjects received the doses on a 0, 1, and 4 month schedule. The reporter did not believe there were any physical problems with the vaccines, but was questioning the quality and content of the vaccines. This reporter felt strongly that there was something potentially wrong with one of these vaccine lots because so many subjects did not become seroprotected. This is something she has not seen and she gives these vaccinations on a routine basis. Reporter believes a quality assurance problem caused the adverse event. Please see A0778211A, A0778216A, A0778217A and A0778220A. Follow-up information was received on 14 May 2009 from Quality Assurance. Per the Quality Statement: Engerix vaccine lot numbers AHBVB703AA, AHBVB584AA and AHBV670AA met the requirements of Quality Assurance's specifications and the batches were suitable for vaccination purposes.
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody positive, Inappropriate schedule of drug administration, Product quality issue, Therapeutic response decreased
Clinical narrative: This case was reported by a health care professional and described the occurrence of decreases therapeutic response in a 32-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). There were no concurrent medications. The subject had received two historical HEPATITIS vaccinations on 25 March 1997 and 13 May 1997 prior to coming to the reporter's clinic. On 8 September 2008, 16 October 2008 and 12 February 2009 the subject received 1st dose, 2nd dose and 3rd of ENGERIX B (20 mcg/mL, left deltoid, left deltoid and right deltoid, respectively). On 10 October 2008, a titer was drawn which was negative at 7.8. On 12 February 2009, the subject experienced drug dose administration interval too short. On 10 March 2009, 26 days after vaccination which the third dose of ENGERIX B, the subject experienced decreased therapeutic response. On 10 March 2009, HEPATITIS B surface antibody was low at 8.9 mIU/mL. A product complaint was associated with this report. Reporter states that 5 out of 6 subjects who received dose one from the same lot, dose 2 from the same lot, and dose 3 from the same lot experienced this adverse event. The subjects received the doses on a 0, 1, and 4 month schedule. The reporter did not believe there were any physical problems with the vaccines, but ws questioning the quality and content of the vaccines. This reporter felt strongly that that there was something potentially wrong with one of these vaccine lots because sc many subjects did not become seroprotected. This is something she has not seen and she gives these vaccinations on a routine basis. Reporter believes a quality assurance problem caused the adverse event. Please see A0778211A, A0778216A, A0778217A, and A0778218A. Follow-up information was received on 14 May 2009 from Quality Assurance. Per the Quality Assurance. Per the Quality Statement: ENGERIX vaccine lot numbers AHBVB703AA, AHBVB584AA and AHBVB670AA met the requirements of Quality Assurance's specifications and the batches were suitable for vaccination purposes.
Sex: U
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 subject of unspecified age and gender who was vaccinated with HEPATITIS B vaccine, manufacturer unspecified. About three years prior to the date of reporting (06 April 2009), the subject received 1st dose, 2nd dose and 3rd dose of HEPATITIS B vaccine (unknown). After these initial three doses were given, two additional doses of HEPATITIS B vaccine were given on unspecified dates. It was reported that the subject did not respond to vaccination with HEPATITIS B vaccine. The subject, who was a nurse, received the HEATITIS B series about three years ago. The subject did not respond to the initial three dose series. Two additional doses were given and still titers were not indicative of sero-protection (see case id's A0778561A and A0778562A for more details on these subjects).
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Drug administered at inappropriate site, Injection site pain
Clinical narrative: This case was reported by a physician and described the occurrence of severe pain in shoulder joint in a female subject of unspecified age who was vaccinated with ENGERIX B (Glaxosmithkline). On 31 March 2009 the subject received unspecified dose of ENGERIX B (unknown, unknown arm). On 1 April 2009, one day after vaccination with ENGERIX B, the subject experienced severe pain in shoulder joint. Physician reported that the subject was given ENGERIX B too high in the deltoid and he believed some part of the vaccine may have caused the severe shoulder joint pain the subject experienced. At the time of reporting the event was unresolved.
Sex: U
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 subject of unspecified age and gender who was vaccinated with Hepatitis B vaccine (manufacturer unspecified). About three years prior to the date of reporting (06 April 2009), the subject received 1st dose, 2nd dose and 3rd dose of Hepatitis B vaccine (unknown). After these initial three doses were given, two additional doses of Hepatitis B vaccine were given on unspecified dates. It was reported that the subject did not respond to vaccination with Hepatitis B vaccine. The subject, who was a nurse, received the Hepatitis B series about three years ago. The subject did not respond to the initial three dose series. Two additional doses were given and still titers were not indicative of sero-protection. Limited data was available since this occurrence took place three years ago. The reporter also indicated that two additional subjects, who were also nurses, did not respond to initial three dose series of Hepatitis B vaccine series administered about three years ago and additional two doses were given and still titers were not indicative of sero-protection (please see case id's A0778492A and A0778562A for more details on these subjects).
Sex: U
Vaccine: HEP
Symptoms: Antibody test negative, 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 subject of unspecified age and gender who was vaccinated with ENGERIX vaccine (manufacturer unspecified). About three years prior to the date of reporting (06 April 2009), the subject received 1st dose, 2nd dose and 3rd dose of Hepatitis B vaccine (unknown). After these initial three doses were given, two additional doses of Hepatitis B vaccine were given on unspecified dates. It was reported that the subject did not respond to vaccination with Hepatitis B vaccine. The subject, who was a nurse, received the Hepatitis B series about three years ago. The subject did not respond to the initial three dose series. Two additional doses were given and still titers were not indicative of sero-protection. Limited data was available since this occurrence took place three years ago. The reporter also indicated that two additional subjects, who were also nurses, did not respond to initial three dose series of Hepatitis B vaccine series administered about three years ago and additional two doses were given and still titers were not indicative of sero-protection (please see case id's A0778492A and A0778561A for more details on these subjects).
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody abnormal, Therapeutic response decreased
Clinical narrative: This case was reported by a consumer and described the occurrence of decreased therapeutic response in a female subject aged between 40 and 49 years old  who was vaccinated with HEPATITIS B vaccine (manufacturer not reported). A physician or other health care professional has not verified this report.  On an unspecified date approximately twenty years ago, the subject received unspecified dose of HEPATITIS B vaccine (unknown). On 29 March 2009, approximately 20 years after vaccination with HEPATITIS B vaccine, the subject experienced decreased therapeutic response. The reporter indicated that the subject's titer was 0.40 and the subject was vaccinated approximately 20 years ago with an unknown manufacturer's hepatitis vaccine. The reporter also indicated that another subject, who also received an unknown manufacturer's hepatitis B vaccine ten years ago, experienced a titer level of 0.60 (see case for more details on this subject).
Age: 32.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody abnormal, Therapeutic response decreased
Clinical narrative: This case was reported by a consumer and described the occurrence of decreased therapeutic response in a 32-year-old male subject who was vaccinated with Hepatitis B vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. On an unspecified date ten years ago, the subject received unspecified dose of Hepatitis B vaccine (unknown). On an unspecified date, ten years after vaccination with Hepatitis B vaccine, the subject experienced decreased therapeutic response. The reporter indicated that the subject's titer was 0.60 and the subject was vaccinated ten years ago with an unknown manufacturer's hepatitis B vaccine. The reporter also indicated that another subject, who also received an unknown manufacturer's hepatitis B vaccine approximately 20 years ago, experienced a titer level of 0.40 (see case id A0778986A for more details on this subject).
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Anaemia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of antigenemia in a 18-year-old female subject who was vaccinated with ENGERIX B (Glaxosmithkline). On 10 April 2009 the subject received 2nd dose and ENGERIX B (20 mcg, unknown). On 13 April 2009, 3 days after vaccination with ENGERIX B, the subject experienced antigenemia. On 13 April 2009, her blood tested positive for hepatitis B surface antigen. Her blood had not been redrawn at the time of reporting, so it was unknown if it has resolved. The nurse believed that that subject received the 20 mcg dose. At the time of reporting the outcome of the event was unspecified. The healthcare professional considered the event was probably related to vaccination with ENGERIX B.
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: No therapeutic response
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a 36-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). On an unspecified date, before 2006, the subject received unspecified dose of Hepatitis B vaccine (unknown). In 2006, 3 years after vaccination with Hepatitis B vaccine, the subject experienced not responding to therapy. A physician reported to a medical assistant that he had a new patient who received an unknown hepatitis B vaccine at another facility several years ago. In 2006, a titer was drawn and the results were negative. This office gave the subject an ENGERIX B booster on 10 April 2009.
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: No reaction on previous exposure to drug, Rash generalised
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of generalized rash in a 42-year-old female subjected who was vaccinated with ENGERIX B adult (Glaxosmithkline). The subject had experienced no adverse events following previous vaccinations. On 14 April 2009 in the morning, the subject received 1st dose of ENGERIX B adult (unknown route, unknown deltoid). On 15 April 2009, approximately 1 day after vaccination with ENGERIX B adult, the subject experienced generalized rash. At the time of reporting the outcome of the event was unspecified. The healthcare professional considered the event was possibly related to vaccination with ENGERIX B adult.
Age: 59.0
Sex: F
Vaccine: HEP
Symptoms: Cytomegalovirus antigen, Hepatitis B antigen
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of antigenemia in an adult female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). The reporter was not aware of any adverse events following previous vaccinations. Concurrent medical conditions included peritoneal dialysis for unspecified condition. On 1 May 2009 the subject received 1st dose of ENGERIX B (details unknown). On 5 May 2009, 4 days after vaccination with ENGERIX B, the subject experienced antigenemia. Positive HEPATITIS B surface antigen was detected in the subject's blood. At the time of reporting the event was unresolved. The healthcare professional considered the event was probably related to vaccination with ENGERIX B. Follow-up information received on 01 June 2009 indicated that the subject was a 59 year old female. The subject received a 4th, or booster dose of ENGERIX B at 40 mcg intramuscularly in the right deltoid on 01 May 2009. A previous three dose series of ENGERIX B was completed in 2008, with doses given on 15 February 2008, 11 March 2008 and 30 September 2008. Antigenemia occurred on 05 May 2009 and resolved later on 12 May 2009. In the reporter's opinion, the event was related to treatment with 4th dose of ENGERIX B. The event was not considered to be serious. Concurrent medications included FERRLECIT and EPOGEN.
Age: 60.0
Sex: M
Vaccine: HEP
Symptoms: No therapeutic response
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). On an unspecified date, the subject received unspecified dose of ENGERIX B (unknown) and experienced not responding to therapy. Pharmacist reported, he was asked about a subject's immune status; he did not have any specific information about the event, subject, or timelines. The subject is described as a non-responder to ENGERIX B. Additional information from call audit on 24 September 2009: The subject had completed the series. Last dose was given two months prior to reporting. A titer was done and the subject had no hepatitis B protection. Follow-up information was received on 01 December 2009 from a nurse. The subject received ENGERIX B on 21 January 2009, 09 March 2009 and 08 June 2009. On 05 August 2009, hepatitis B surface antibody was non-reactive. The pharmacist reported that the event was unchanged. Series was restarted on 24 September 2009.
Sex: F
Vaccine: HEP
Symptoms: Abasia, Altered visual depth perception, Blood pressure increased
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of could not walk in an adult female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent medical conditions included kiwi allergy and sinus infection. Concurrent medications included TUBERSOL. On 12 May 2009 at 16:30, the subject received 1st dose of ENGERIX B (unknown, left arm). On 13 May 2009, 1 day after vaccination with ENGERIX B, the subject experienced could not walk, loss of depth perception and increased blood pressure. On 14 May 2009, the events were resolved. The healthcare professional considered the events were unlikely to be related to vaccination with ENGERIX B. The subject received vaccine and the next day, she began to have the following symptoms: lack of depth perception so that she could not see where she should place her foot in order to walk, therefore she could not walk. Also subject experienced increased blood pressure of greater that 160 systolic. These symptoms resolved entirely the next day and since, subject was seen by primary care physician and ENT physician who stated that her reaction was probably not due to the ENGERIX vaccine but due to a sinus infection, she was suffering from. Follow-up information was received on 20 October 2009 from the reporting nurse. ENGERIX B was given in the left deltoid. ENGERIX B was not reintroduced. The nurse and subject discussed and the subject chose not to continue-risk versus benefit.
Age: 8.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Mumps antibody test positive, No therapeutic response, Varicella zoster virus serology positive
Clinical narrative: This case was reported by a healthcare professional via other manufacturer Merck and described the occurrence of not responding to therapy in an adult male subject who was vaccinated with ENGERIX B. In October 1995, January 1996 and August 1996 the subject received 1st dose, 2nd dose and 3rd dose of ENGERIX B (unknown) and experienced drug dose administration interval too long. On an unknown date after vaccination with ENGERIX B, the subject experienced not responding to therapy. On 28 July 2009, a nurse reported that a subject received three doses of a Hepatitis B vaccine and now has a negative titer. It is unknown if it was Recombivax or another company. The vaccinations are given in October 1995, January 1996, and August 1996. On 18 August 2009, additional information was reported. The nurse stated that she investigated the subject's chart; the subject did not received Recombivax but received ENGERIX B from GSK. No additional information is available. Follow-up information received on 21 September 2009, via healthcare professional. Previous and/or concurrent vaccination included MMR vaccine (non-gsk); Merck; unknown given on 13 April 1999. On 13 October 1995, 31 January 1996 and 6 August 1996 the subject received 1st dose, 2nd dose and 3rd dose of ENGERIX B (unknown). The healthcare professional reported the subject had no adverse reaction. Laboratory test on 08 July 2009 showed no immunity.
Sex: U
Vaccine: HEP
Symptoms: Injection site pain, Injection site reaction
Clinical narrative: This case was reported by a pharmacist via sales representative and described the occurrence of injection site reaction in an unknown number of subjects of unspecified ages and gender who were vaccinated with ENGERIX B (GlaxoSmithKline). On unspecified dates, the subjects received unspecified dose of ENGERIX B (unknown). At unspecified times after vaccination with ENGERIX B, the subjects experienced injection site reactions. After receiving information from a nurse, a pharmacist inquired with a sales representative about a "difference in the adverse reactions between the vial and TipLock because the subjects are complaining of more injection site reactions with the TipLok". At the time of reporting the outcomes of the event were unspecified. Follow up was received on 02 October 2009 via a nurse, and described the occurrence of burning at injection site during injection in multiple subjects of unspecified ages and genders who were vaccinated with ENGERIX B (GlaxoSmithKline). On an unspecified date, the subjects received unspecified dose of ENGERIX B (40 mcg, intramuscular), and experienced burning at injection site during injection. The nurse reported increased burning on injection with the pre-filled syringe administration of ENGERIX B. The subjects did not complain of burning when previous immunizations were drawn from a vial. All subjects complained of the same signs and symptoms. At the time of reporting the burning at the injection sites during injection were resolved.
Age: 40.0
Sex: M
Vaccine: HEP
Symptoms: Adverse reaction, Dizziness, Incorrect dose administered, Nausea
Clinical narrative: This case was reported by a pharmacist and described the occurrence of dizziness in a 40-year-old male subject who was vaccinated with ENGERIX B, (GlaxoSmithKline).  On 22 September 2009 the subject received a dose of ENGERIX B (.5 ml, unknown), and experienced an under dose.  Within 24 hours of vaccination with ENGERIX B, the subject experienced dizziness and nausea.  The subject was monitored at a clinic.  The events were resolved on an unknown date.  The pharmacist considered the events were possibly related to vaccination with ENGERIX B.  This is one of three cases reported by this pharmacist where all three subjects experienced the same events with same lot number provided, see cases A0809418A and A0809419A for more details.  No further information was provided.
Sex: U
Vaccine: HEP
Symptoms: Dizziness, Nausea
Clinical narrative: This case was reported by a pharmacist and described the occurrence of dizziness and nausea in a subject of unspecified age and gender who was vaccinated with ENGERIX B (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of ENGERIX B (.5 ml). At an unknown time after vaccination with ENGERIX B, the subject experienced dizziness and nausea. At the time of reporting the outcome of the events were unspecified. This is one of three cases reported by this pharmacist where all three subjects experienced the same events with same lot number provided, see cases A0809417A and A0809419A for more details. No further information was provided.
Sex: U
Vaccine: HEP
Symptoms: Dizziness, Nausea
Clinical narrative: This case was reported by a pharmacist and described the occurrence of dizziness and nausea in a subject of unspecified age and gender who was vaccinated with ENGREIX B (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of ENGERIX B (.5 ml). At an unknown time after vaccination with ENGERIX B, the subject experienced dizziness and nausea. At the time of reporting the outcome of the events were unspecified. This is one of three cases reported by this pharmacist where all three subjects experienced the same events with same lot number provided, see cases A0809417A and A0809418A for more details. No further information was provided.
Age: 68.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, 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). Concurrent medical conditions included renal failure. In 2008 the subject received 1st dose, 2nd and 3rd dose of ENGERIX B (unknown) on unspecified dates, and experienced not responding to therapy. Relevant test results included anti-HBs antibody. The reporter stated that the subject had received three doses of ENGERIX B between 04 April 2008 and 19 November 2008. Titers were obtained at an unknown time and were negative for anti-HBs antibodies. Recently, titers were obtained again and anti-HBs were still negative. Follow up information was received on 20 October 2009 from the reporting health care provider. The subject (60-69 years of age) received the ENGERIX B 20mcg/ml, intramuscularly) on 04 April 2008, 03 June 2008, and 18 November 2008. Titers were ordered by another office and resulted in "unmounted" antibodies and requested that the subject was contacted and administered a second series of HEPATITIS B.
Age: 55.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Headache, Influenza like illness, Malaise, Pyrexia
Clinical narrative: This case was reported by a healthcare professional (the subject) and described the occurrence of fever in a 55-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Between June and September 2008, the subject received 1st dose of ENGERIX B (unknown). On an unspecified day between June and September in 2008, within four to eighteen hours of vaccination with ENGERIX B, the subject experienced fever, (horrible) headache, general malaise, and joint pain. On an unspecified date, the subject experienced flu-like symptoms. The subject was treated with TYLENOL or ADVIL for her flu-like symptoms. On an unspecified date between June and September in 2008, 48 hours after the start of the symptoms, the subject's fever, (horrible) headache, general malaise, and joint pain were resolved. The outcome of flu-like symptoms was unknown.
Age: 44.0
Sex: M
Vaccine: HEP
Symptoms: Dysgeusia
Clinical narrative: This case was reported by a consumer (who was also the subject) and described the occurrence of bad aftertaste in mouth in a 44-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject's medical history included blood pressure. Concurrent medications included ATACAND and ZOCOR. The subject had previously received 1st and 2nd dose of ENGERIX B on unspecified dates with no adverse effects. On 5 May 2009 at 15:00 the subject received 3rd dose of ENGERIX B (unknown route, left arm). On 5 May 2009, within 3 hours after vaccination with ENGERIX B, the subject experienced bad aftertaste in mouth. The bad taste occurred only after foods and was not constant, but was reported to be "like a rotten taste". The subject noticed it more at the back of his tongue and throat. It had been occurring for approximately a week at the time of reporting. The subject spoke to his physician who thought it may have been a "post nasal drip". The subject reported no other symptoms. The subject may consult an Ear, Nose and Throat specialist at the recommendation of his physician. At the time of reporting the event was unresolved.
Age: 28.0
Sex: M
Vaccine: DTAP, HEP, PPV
Symptoms: Blood culture positive, Hepatitis B DNA assay negative, Hepatitis B surface antigen positive, Inappropriate schedule of drug administration, Liver function test normal
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of antigenemia in a 28-year-old male subject who was vaccinated with Hepatitis B vaccine recombinant (Hepatitis B vaccine, manufacturer unspecified). Concurrent medical conditions included hemodialysis (started on 04 May 2009) and newly diagnosed renal failure. Concurrent vaccination included diphtheria and tetanus toxoids and acellular pertussis vaccine (manufacturer unspecified) given on 1 May 2009 and pneumococcal vaccines (manufacturer unspecified) given on 1 May 2009. Concurrent medications included PROCRIT. On 1 May 2009 the subject received 1st dose of Hepatitis B vaccine (20 mcg, unknown site). On 4 May 2009, 3 days after vaccination with Hepatitis B vaccine, the subject experienced antigenemia. He had entered the outpatient hemodialysis program and hepatitis B surface antigen was drawn, which came back positive. At that time, it was unknown that the subject had received a hepatitis B vaccination 3 days previously. The hepatitis B surface antigen was draw again on 13 May 2009 and was negative, and DNA virus tests were non-reactive. It was reported that liver function tests were normal. On 13 May 2009, the events was resolved. The healthcare professional considered the event was probably related to vaccination with Hepatitis B vaccine. Follow-up information received on 01 June 2009 indicated that antigenemia resolved on 21 May 2009, 17 days from onset. It was additionally indicated that the event was possibly related to treatment with hepatitis B vaccine.
Age: 60.0
Sex: F
Vaccine: HEP
Symptoms: Antimicrobial susceptibility 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 60-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). The subject had not experienced adverse events following previous vaccinations. The subject's medical history included allergies and high blood pressure. Concurrent medical conditions included diabetes controlled by diet. There were no concomitant vaccinations. Concurrent medications included SINGULAIR, isoprenaline and multivitamins. On 10 July 2008, 10 October 2008 and 29 January 2009 the subject received 1st dose, 2nd dose and 3rd dose of ENGERIX B (1 cc, unknown route, alternated between left and right deltoid). On 24 February 2009, 26 days after the vaccination series with ENGERIX B was completed, the subject had a negative titer result (not responding to therapy). The interval between the 1st and 2nd dose of ENGERIX B was longer than the recommended 1 month interval. At the time of reporting the event was unresolved. Follow-up received from reporting healthcare professional on 12 June 2009: The healthcare professional reported that an infectious disease physician recommended the subject be re-vaccinated with series of 3 (vaccine details not provided).
Age: 9.0
Sex: F
Vaccine: HEP
Symptoms: Body temperature, No reaction on previous exposure to drug, Pyrexia, Skin warm
Clinical narrative: This case was reported by a consumer (the subject's father) and described the occurrence of fever in a 9-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject's medical history included penicillin allergy. There were no concomitant medications or vaccinations. The subject had not experienced adverse events following previous vaccinations. On 10 June 2009 at 08:00 the subject received 1st dose of ENGERIX B (unknown route, left arm). On 10 June 2009, within hours of vaccination with ENGERIX B, the subject experienced fever and hot to touch. The subject received her 1st injection of ENGERIX B in the morning and was then sent off to school. The subject began to develop a fever around lunchtime. In the afternoon when she got home and her parents felt that she was hot, they measured her temperature and it read 101. They called the doctor, who instructed them to get her MOTRIN. However, she continued to have a fever and the reporter took the subject to the doctor's office. On 11 June 2009 her fever was still around 100. The subject was treated with MOTRIN. At the time of reporting the events were unresolved.
Age: 34.0
Sex: M
Vaccine: HEP, HEPA, TDAP, TYP
Symptoms: Burning sensation, Dermatitis contact, Rash erythematous, Rash pruritic
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of pimple-like rash in a 35-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). The subject had no relevant medical history and had experienced no adverse events following prior vaccinations. The subject had not previously received any influenza vaccination. Concurrent vaccination included HAVRIX (GlaxoSmithKline) given on 5 June 2009; BOOSTRIX (GlaxoSmithKline) given on 5 June 2009; TYPHIM VI (non-gsk) (Sanofi Pasteur MSD) given on 5 June 2009. On 5 June 2009 (mid-morning) the subject received 1st dose of ENGERIX B (1 ml, unknown route, right arm). On 10 June 2009 (evening), 5 days after vaccination with ENGERIX B, the subject experienced pimple-like rash on his knees that spread up to his hands and face. The pimples were described as "massive" on his thighs with smaller ones on his wrist. The subject was treated with BENADRYL and CORTIZONE. At the time of reporting the event was worse. Follow-up information was received by nurse via Merck on 25 June 2009. The nurse reported the subject was administered his 1st dose of ENGERIX B on 05 June 2009 and then developed an itchy, red rash on both knees on 10 June 2009. The has subsequently spread up to his groin, as well as both wrists and his face. No further information was provided. Follow-up information was received from the reporting nurse on 17 July 2009. The subject went to an urgent care facility on 15 June 2009. The subject's chief complaint at the urgent care was allergic reaction, June 2009 vaccines, itchy/burning rash. Concomitant medications included prednisone and XYZAL. The subject had no known drug allergies. The physician diagnosed severe contact dermatitis and decided the rash was unrelated to vaccines. The series was continued without further incident. When the subject came in to continue his hepatitis B series, the rash had resolved.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antigen, Laboratory test normal, No therapeutic response
Clinical narrative: This case was reported by a physician, via a GSK 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 (GlaxoSmithKline). No information was available regarding the subject's medical history or concomitant medications. Previous and/or concurrent vaccination included hepatitis A vaccine inactivated (GlaxoSmithKline) given on an unspecified date. On unspecified dates the subject received complete series of Hepatitis B vaccine and Hepatitis A vaccine (details unknown). It was unknown whether the subject received ENGERIX B and HAVRIX, or TWINRIX. Approximately one and a half months after completing the vaccination series with Hepatitis B vaccine, the subject experienced not responding to therapy. The physician reported that the subject's antigens were evaluated and the subject's hepatitis A antigens were within normal limits, and the subject's hepatitis B antigens indicated that he had no antigens. There was no further information available.
Sex: U
Vaccine: HEP
Symptoms: No therapeutic response, Product quality issue
Clinical narrative: This case was reported by a sales representative and described the occurrence of not responding to therapy in a subject of unspecified age and gender who was vaccinated with ENGERIX B (GlaxoSmithKline). On an unspecified date the subject received 1st dose, 2nd dose and 3rd dose of ENGERIX B (unknown). Forty-two days after vaccination with the 3rd dose of ENGERIX B, the subject experienced not responding to therapy. A product complaint was associated with this event. The sales representative received an email from a doctor's office. Vaccine was purchased through Henry Shrine and 42 days after all seven subjects were given the 3rd dose of ENGERIX B, a lab assay was completed. The lab reported that all seven subjects were non-reactive to hepatitis A and B. The healthcare professional believed that the event was caused by a quality issue. No other quality issues identified. The sales representative reported the event as "lack of effect".
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a sales representative and described the occurrence of not responding to therapy in a 26-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 22 July 2008, the subject received 1st dose of ENGERIX B (adult dose). On unspecified dates, the subject received 2nd dose and 3rd dose of ENGERIX B (unknown). On 16 April 2009, 42 days after vaccination with the third dose of ENGERIX B, the subject experienced not responding to therapy. A product complaint was associated with this event. The immunization series was reported to be delayed. At the time of reporting, the event was unresolved. The sales representative received an email from a doctor's office. Vaccine was purchased through a distributor and 42 days after all seven subjects were given the 3rd dose of ENGERIX B, a lab assay was completed. The lab reported that all seven subjects were non-reactive to hepatitis A and B. The healthcare professional believed that the event was caused by a quality issue. No other quality issues identified. The sales representative reported the event as "lack of effect".
Age: 31.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a sales representative and described the occurrence of not responding to the therapy in a 32-year-old male subject who was vaccinated with hepatitis B vaccine recombinant (Engerix B, GlaxoSmithKline) for prophylaxis. A physician or other health care professional has not verified this report. On 22 July 2008, the subject received 1st dose of Engerix (adult dosage). On unspecified dates, the subject received the 2nd dose and 3rd dose of Engerix B. On 16 April 2009, 42 days after vaccination with Engerix B, the subject experienced not responding to therapy. A product complaint was associated with this event. The immunization series was reported to be delayed. At the time of reporting the event was unresolved. The sales representative received an email from a doctor's office. Vaccine was purchased through Henry Shrine and 42 days after all seven subjects were given the 3rd dose of Engerix B, a lab assay was completed. The lab reported that all seven subjects were non-reactive to hepatitis A and B. The healthcare professional believed that the event was caused by a quality issue. No other quality issues identified. The sales representative reported the event as "lack of effect".
Age: 28.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a sales representative and described the occurrence of not responding to therapy in a 29-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 22 July 2008, the subject received 1st dose of ENGERIX B (adult dosage). On unspecified dates, the subject received 2nd dose and 3rd dose of ENGERIX B. On 16 April 2009, 42 days after vaccination with the third dose of ENGERIX B, the subject experienced not responding to therapy and product complaint. The immunization series was reported to be delayed. At the time of reporting the events were unresolved. The sales representative received an email from a doctor's office. Vaccine was purchased through distributor and 42 days after all seven subjects were given the 3rd dose of ENGERIX B, a lab assay was completed.  The lab reported that all seven subjects were non-reactive to hepatitis A and B. The healthcare professional believed that the event was caused by a quality issue. No other quality issues identified. The sales representative reported the event as "lack of effect".
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Laboratory test, No therapeutic response
Clinical narrative: This case was reported by a sales representative and described the occurrence of not responding to therapy in a 30-year-old female subject who was vaccinated with ENGERIX B. A physician or other health care professional has not verified this report. On an unspecified date the subject received 1st dose, 2nd dose and 3rd dose of ENGERIX B (unknown). Forty-two days after vaccination with the 3rd dose of ENGERIX B, the subject experienced not responding to therapy. A product complaint was associated with this event. At the time of reporting the outcome of the event was unspecified. The sales representative received an email from a doctor's office. Vaccine was purchased and 42 days after all seven subjects were given the 3rd dose of ENGERIX B, a lab assay was completed. The lab reported that all seven subjects were non-reactive to Hepatitis A and B. The healthcare professional believed that the event was caused by a quality issue. No other quality issues identified. The sales representative reported the event as "lack of effect".
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Laboratory test, No therapeutic response
Clinical narrative: This case was reported by a sales representative and described the occurrence of not responding to therapy in a 30-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received 1st dose, 2nd dose and 3rd dose of ENGERIX B (unknown). Forty-two days after vaccination with ENGERIX B, at an unspecified time after vaccination with ENGERIX B, the subject experienced not responding to therapy. At the time of reporting the outcome of the event was unspecified. The sales representative received an email from a doctor's office. Vaccine was purchased through a medical distributor and 42 days after all seven subjects were given the 3rd dose of ENGERIX B, a lab assay was completed. The lab reported that all seven subjects were non-reactive to hepatitis A and B. The healthcare professional believed that the event was caused by a quality issue. No other quality issues identified. The sales representative reported the event as "lack of effect".
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective, No therapeutic response
Clinical narrative: This case was reported by a sales representative and described the occurrence of not responding to therapy in a subject of unspecified age and gender who was vaccinated with Engerix B (GlaxoSmithKline). On an unspecified date the subject received 1st dose, 2nd dose and 3rd dose of Engerix B (unknown). Forty-two days after vaccination with the 3rd dose of Engerix B, the subject experienced not responding to therapy. A product complaint was associated with this event. The sales representative received an email from a doctor's office. Vaccine was purchased through a company and 42 days after all seven subjects were given the 3rd dose of Engerix B, a lab assay was completed. The lab reported that all seven subjects were non-reactive to hepatitis A and B. The healthcare professional believed that the event was caused by a quality issue. No other quality issues identified. The sales representatives reported the event as "lack of effect."
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Blood pressure decreased, Chest pain, Disorientation, Disturbance in attention, Dizziness
Clinical narrative: This case was reported by a consumer and described the occurrence of lightheadedness in a 47-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 12 August 2009 at 12:30 the subject received 1st dose of ENGERIX B (left arm). On 13 August 2009, 1 day after vaccination with ENGERIX B, the subject experienced lightheadedness and dizziness. On 20 August 2009, 8 days after vaccination with ENGERIX B, the subject experienced disorientation and blood pressure dropped. On an unspecified date(s), an unspecified time after vaccination with ENGERIX B, the subject experienced chest pain, intermittent and inability to concentrate. At the time of reporting, lightheadedness, dizziness, disorientation, blood pressure dropped and inability to concentrate were unresolved. The outcome of chest pain, intermittent was unspecified. On 13 August 2009, the subject experienced "vaccine lightheadedness and dizziness". On 20 August 2009, she experienced disorientation and blood pressure dropped into the 80's. She also experienced intermittent chest pain. The disorientation and drop in blood pressure comes and goes in waves. She can be fine for a few hours and then both issues return. She visited her physician the afternoon of 20 August 2009. She has been drinking more water to get her blood pressure back up and making sure she has iodine. She has not been able to get her blood pressure above the mid-90's. The night of 23 August 2009, she became disoriented again. The morning of 24 August 2009, her blood pressure was in the mid-80's. She can not concentrate. Follow-up information was received on 24 September 2009. The subject reported that the symptoms she previously reported (lightheadedness, dizziness, disorientation, blood pressure dropped) are all worse since last reported on 24 August 2009. The subject reported that this weekend (19 September 2009) she began to experience migraine headaches and visual problems (vision will go in and out of focus and not related to the migraine). The subject planned to continue follow-up with her physician and be evaluated by a neurologist on an unknown date. The subject reported that she has been unable to work because of her condition.