chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Blood pressure increased, Chest pain, Dizziness, Hypersensitivity, Laboratory test abnormal
Clinical narrative: This case was reported by a consumer, who was also a nurse, and described the occurrence of an allergic reaction a 42 year old female subject who was vaccinated with Engerix-B for prophylaxis. Concurrent medications included Nexium. Relevant medical history included gastroesophageal reflux disease. The subject had previously received three doses of hepatitis B vaccination in 1999 (manufacturer unknown). The subject had not experienced any adverse reactions following these previous hepatitis B vaccinations. In 2006, it was determined that the subject had a decreased therapeutic response to the hepatitis B vaccinations she received in 1999, because her antibody titers were not sufficient to confer immunity to hepatitis B. The subject required subsequent hepatitis B immunization which was the subject's 4th dose of hepatis B vaccine. On 03 August 2006, immediately after receiving the vaccination with Engerix-B, the subject experienced an allergic reaction in which she developed sudden blotches of hives on her face, tingling in hands and feet, tachycardia up to 150 beats per minute, increase in blood pressure, dizziness, and chest pain with palpitations. The subject was taken to the emergency room and treated with Solu Medrol and Benadryl. At the time of reporting at 3:15pm on 03 August 2006, the subject was at home and the events were unresolved. The subject, who was a healthcare professional, considered the events were probably related to vaccination with Engerix B.
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Palpitations, Paraesthesia, Rash macular, Tachycardia, Urticaria
Clinical narrative: This case was reported by a consumer, who was also a nurse, and described the occurrence of an allergic reaction a 42 year old female subject who was vaccinated with Engerix-B for prophylaxis. Concurrent medications included Nexium. Relevant medical history included gastroesophageal reflux disease. The subject had previously received three doses of hepatitis B vaccination in 1999 (manufacturer unknown). The subject had not experienced any adverse reactions following these previous hepatitis B vaccinations. In 2006, it was determined that the subject had a decreased therapeutic response to the hepatitis B vaccinations she received in 1999, because her antibody titers were not sufficient to confer immunity to hepatitis B. The subject required subsequent hepatitis B immunization which was the subject's 4th dose of hepatis B vaccine. On 03 August 2006, immediately after receiving the vaccination with Engerix-B, the subject experienced an allergic reaction in which she developed sudden blotches of hives on her face, tingling in hands and feet, tachycardia up to 150 beats per minute, increase in blood pressure, dizziness, and chest pain with palpitations. The subject was taken to the emergency room and treated with Solu Medrol and Benadryl. At the time of reporting at 3:15pm on 03 August 2006, the subject was at home and the events were unresolved. The subject, who was a healthcare professional, considered the events were probably related to vaccination with Engerix B.
Sex: F
Vaccine: HEP
Symptoms: Laboratory test abnormal, Pregnancy, Therapeutic response decreased
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of decreased therapeutic response in an adult female subject, who was vaccinated with Engerix-B for prophylaxis. The subject has a history of Lupus. Additional information concerning concurrent conditions and concurrent medications were not reported. On an unspecified date the subject received 3rd dose, 2nd dose and 1st dose of Engerix-B (lot number and expiration date not reported) at 20 mcg, Approximately 6 to 8 weeks following administration of the 3rd dose of Engerix-B, the subject had an unspecified test performed, which came back with a 4.6mIU/ml level. Information received reported that titres are drawn 6 to 8 weeks following adminstration of the third dose of Engerix-B. This was considered to be a decreased therapeutic response. Pregnancy was also reported. No additional details were known at the time of reporting. At the time of reporting the outcome of the events were unspecified.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Prophylaxis
Clinical narrative: This case was reported by a physician's assistant and described the occurrence of dizziness in an 30 year old female subject who was vaccinated with Engerix-B for prophylaxis. The subject's medical history, concurrent conditions and concurrent medications were not provided. On 26 July 2006 the subject received a dose of Engerix-B (dose number and lot number not provided). On 26 July 2006, two hours after vaccination with Engerix-B, the subject experienced dizziness. The event resolved four hours later after the patient slept. Further information was not provided.
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a pharmacy technician and described a subject (age and gender unknown) who did not respond to immunization to the Engerix-B immunizations series. Past medical history, concurrent conditions and concurrent medications were unknown. On an unspecified date before 27 July 2006, the subject received a dose of Engerix-B. On an unspecified date after vaccination with Engerix-B, it was reported that the vaccine was "not effective." Further information was not reported.
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a pharmacy technician and described a subject (age and gender unknown) who did not respond to immunization to the Engerix B immunization series. Past medical history, concurrent conditions and concurrent medications were unknown. On an unspecified date before 27 July 2006, the subject received a dose of Engerix-B. On an unspecified date after vaccination with Engerix-B, it was reported that the vaccine was "not effective." Further information was not reported.
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a pharmacy technician and described a subject (age and gender unknown) who did not respond to immunization to the Engerix-B immunization series. Past medical history,concurrent conditions and concurrent medications were unknown. On an unspecified date before 27 July 2006, the subject received a dose of Engerix-B. On an unspecified date after vaccination with Engerix-B, it was reported that the vaccine was "not effective." Further information was not reported.
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a pharmacy technician and described a subject (age and gender unknown) who did not respond to immunization to the Engerix-B immunization series. Past medical history, concurrent conditions and concurrent medications were unknown. On an unspecified date before 27 July 2006, the subject received a dose of Engerix-B. On an unspecified date after vaccination with Engerix-B, it was reported that the vaccine was "not effective." Further information was not reported.
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a pharmacy technician and described a subject (age and gender unknown) who did not respond to immunization to the Engerix-B immunization series. Past medical history, concurrent conditions and concurrent medications were unknown. On an unspecified date before 27 July 2006, the subject received a dose of Engerix-B. On an unspecified date after vaccination with Engerix-B, it was reported that the vaccine was "not effective." Further information was not reported.
Age: 57.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B surface antigen positive, Prophylaxis
Clinical narrative: This case was reported by a nurse and described the occurrence of positive hepatitis B surface antigen in a 56 year old male subject who was vaccinated with Engerix-B for prophylaxis. The subject's concurrent medications were not provided. On 20 July 2006 at 15:30, the subject received the 3rd dose of Engerix-B (1 ml-two pediatric single dose vials, unknown, right deltoid). Engerix-B was administered as post exposure prophylaxis after the subject was exposed to blood from a hepatitis C positive patient in February 2006. As a part of the post-exposure follow up procedure, the subject had a hepatitis panel done to detect hepatitis A, B, and C antibodies and antigens. The panel was performed three days after Engerix-B was given. On 23 July 2006, three days after vaccination with Engerix-B, the panel was positive for hepatitis B surface antigen. The nurse reported that the did not know whether or not this was a false positive due to the vaccine. Follow up information received on 10 August 2006 indicated that the subject previously received hepatitis B vaccine on 08 March 2006 and on 05 February 2006. No additional details were provided regarding the outcome.
Age: 34.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Hepatitis B surface antigen negative, Therapy non-responder
Clinical narrative: This case was reported by a nurse practitioner and described the occurrence of not responding to therapy in a 34 year old male subject who was vaccinated with Engerix-B for prophylaxis. The subject had no relevant medical history or concurrent medications. The subject received 1st dose and 2nd dose of Engerix (lot number AhBZB172AA) on 31 October 2005 and 08 December 2005, respectively. The subject also received 2nd dose of Havrix (lot number AHBZB229AA) on 08 May 2006. On an unspecified date in June 2006, five weeks after receiving 3rd dose of Engerix, the subject's hepatitis B antibody titer resulted in a negative result. It was considered that the subject did not respond to therapy. No additional information was reported.
Sex: F
Vaccine: HEP
Symptoms: Listless, Prophylaxis, Pyrexia
Clinical narrative: Pyrexia, Listless This case was reported by a nurse and described the occurrence of fever in a female subject (age not specified) who was vaccinated with hepatitis B vaccine recombinant (Engerix-B, GlaxoSmithKline) for prophylaxis.  There were no concurrent medications.  On on unspecified date, the subject received the1st dose of Engerix-B. At an unspecified time before 25 July 2006, one day after the vaccination with the first dose of Engerix-B, the subject experienced fever (103 degrees Fahrenheit) and became listless.  Further information was not provided.
Age: 77.0
Sex: M
Vaccine: HEP
Symptoms: Diabetic end stage renal disease, Dialysis, Hepatitis B antigen positive, Immunology test abnormal, Prophylaxis
Clinical narrative: Immunology test abnormal. This case was reported by a nurse and described the occurrence of antigenemia in a 77-year-old male subject who was vaccinated with hepatitis B vaccine recombinant (Engerix-B, GlaxoSmithKline) for prophylaxis.  Concurrent medical conditions included dialysis and end stage renal disease.  Medical history included polycythemia vera. The subject was reported to be on "lots" of medications. On 17 June 2006, the subject tested negative for hepatitis B.  On 14 July 2006 at 09:20 am, the subject received the 3rd dose of Engerix-B (40 mcg, left deltoid). On 17 July 2006, three days after vaccination with Engerix-B, the subject experienced antigenemia.  At the time of reporting, the outcome of the event was was unspecified.  Per facility protocol, the subject was to be placed in isolation.  Follow-up information was received on 11 August 2006. Follow-up indicated that the subject did require isolation and that the subject was tested for Hbs antibody, HBcIgM, HBeAg and HBCIgG on 21 July 2006 and all were negative (less than 10). The subject was treated for HbSAG on 04 August 2006 and this test was also negative.  Concurrent medications included Zemplar, Protonix, Nephro cap, Phoslo and Ferrous Sulfate.  The outcome of the event was not provided.
Age: 72.0
Sex: M
Vaccine: HEP
Symptoms: Diabetic end stage renal disease, Dialysis, Immunology test abnormal, Prophylaxis
Clinical narrative: Immunology test abnormal.  This case was reported by a nurse and described the occurrence of antigenemia in an approximately 72-year-old male subject who was vaccinated with hepatitis B vaccine recombinant (Engerix-B, GlaxoSmithKline) for prophylaxis.  Concurrent medical conditions included dialysis and end stage renal disease.  Medical history included cancer, coronary artery disease, and Lyme disease.  The subject was reported to be on "lots" of medications.  On 17 June 2006, the subject tested negative for hepatitis B.  On 14 July 2006 at 13:00, the subject received the 2nd dose of Engerix-B (40 mcg, right arm). On 17 July 2006, three days after vaccination with Engerix-B, the subject experienced antigenemia.  At the time of reporting, the outcome of the event was was unspecified.  Per facility protocol, the subject was to be placed in isolation.
Age: 62.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective, Prophylaxis
Clinical narrative: Therapy non-responer, Pharmaceutical product complaint.  This case was reported by a physician and described the occurrence of a 62 year-old male subject not responding to therapy following vaccination with hepatitis B vaccine recombinant (Engerix-B, GlaxoSmithKline) for prophylaxis.  The subject has no significant medical histoy or concurrent medical conditions. Concurrent medications were not known.  On 30 September 2005 the subject received unspecified dose of Engerix-B (lot number AHBVB135AA, expiration date not provided) at 20 mcg. It was not know if the subject had completed the Engerix-B series.  In 11 July 2006, after vaccination with Engerix-B in September, the subject was tested for hepatitis B surface antibodies and was found to be negative.  The subject had not responded to therapy with Engerix-B. The reporting physician was questioning the efficacy of the Engerix-B lot. No additional details were known at the time of reporting.
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective, Hepatitis B surface antigen
Clinical narrative: therapy non-responder  This case was reported by a consumer and described an adult female subject who did not respond to immunization to the hepatitis B vaccine recombinant (Engerix-B, GlaxoSmithKline) immunization series. The reporter is the subject.  A physician or other health care professional has not verified this report.  There were no concurrent medications.  On an unspecified date in October 2005, the subject received the 3rd dose of Engerix-B.  On an unspecified date in November 2005, one month after vaccination with 3rd dose Engerix-B, a hepatitis B surface antibody titer was negative. Reporter received via Merck & Co., Inc.
Age: 15.0
Sex: M
Vaccine: HEP
Symptoms: Rash
Clinical narrative: This case was reported by a nurse and described the occurrence of rash in a 15 year old male patient who received Engerix B. The patient had no pre existing medical conditions. On 12 June 2006, the patient received the first dose of Engerix B. One week after vaccination with Engerix B, on an unspecified date in June 2006, the patient experienced a rash on the left deltoid region that was approximately the size of an apricot. The reporter considered that the event was possibly related to the use of Engerix B. The outcome was unknown at the time of reporting.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site irritation, Injection site oedema, Injection site pain, Injection site pruritus
Clinical narrative: This case was reported by a health care professional and described the occurrence of injection site redness in a 20 year old female subject who was vaccainted with Engerix B for prophylaxis. Medical history included not allergic to yeast. On 06 June 2006 the subject received 1st dose of intramuscular Engerix B in Unknown deltoid (lot AHBVB248AA). The health care professional reported that on 06 June 2006, less than one day after vaccination with Engerix B, the injection site was swollen to the size of half dollar and hard. The red area became the size of a tennis ball. The subject also reported to the healthcare professional that the site was tender to the touch with itching and burning occurring. The subject was seen at a physician's office. At the time of initial reporting, 08 June 2006, the events were ongoing. The healthcare professional considered the events were probably related to vaccination with Engerix B. Follow up information received on 03 July 2006 indicated that the events resolved by 09 July 2006. In the reporters opinion, the events were possibly related to vaccination with Engerix B. No additional information was reported.
Sex: U
Vaccine: HEP
Symptoms: Developmental delay, Speech disorder
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of developmental delay in a subject of unspecified age and gender who was vaccinated with Engerix B for prophylaxis. On an unspecified date before 07 June 2006, the subject received 3rd dose of Engerix B (lot ENG3329A2). At an unspecified time after vaccination with Engerix B, on an unspecified date before 07 June 2006, the subject experienced developmental delay and delayed speech. The events resolved on an unspecified date on or before 07 June 2006. The healthcare professional considered the developmental delays to not be related to vaccination with Engerix B. The healthcare professional did not report whether the speech delay was related to Vaccination with Engerix B.
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a healthcare professional and described a 42 year old female subject who did not respond to immunization to the Engerix B immunization series. The subjects medical history included non smoker and social alcohol drinker (one or two drinks per week. The subject had no known allergies. The subject received a series of 3 doses of Engerix B on 26 July 2005 (lot AHBVB125AA), 29 August 2005 (lot AHBVB125AA), and 22 February 2006 (lot AHBVB135AB). The reporter referred to this series as, the 2nd set of hepatitis B vaccine. On 09 May 2006, 76 days after vaccination with the last dose of Engerix B, a hepatitis B surface antibody titer was again negative. The healthcare professional considered the events were related to vaccination with Engerix B.
Age: 53.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a healthcare professional and described a 53 year old female subject who did not respond to immunization to Engerix B immunization series. The subject's medical history included non smoker and social alcohol drinker (one drink per week). The subject had no know allergies. On an unspecified date in 1995, the subject received hepatitis B vaccine (unknown manufacturer, dose number an lot number nor provided). On an unspecified date in 2005, on or before 26 July 2005, a hepatitis B surface antibody titer was negative. The subject repeated the hepatitis B immunization series with Engerix B given on 26 July 2005 (lot AHBVB125AA, 26 August 2005 (lot AHBVB125AA), and 21 February 2006 (Lot AHBVB183AB). On 10 May 2006, 78 days after vaccination with the last dose of Engerix B, a hepatitis B surface antibody titer was again negative. The healthcare professional considered the events were related to vaccination with Engerix B.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis C
Clinical narrative: Hepatitis C  This case was reported by a sales representative via a physician and described the occurrence of hepatitis C in a subject (age and gender unspecified) who received hepatitis b vaccine recombinant (Engerix-B).   On an unspecified date, the patient received a dose of Engerix-B (dose and lot number not provided). At an unspecified time following the administration of Engerix-B, on an unspecified date, the patient experienced hepatitis C. The outcome of the event was not reported.
Sex: U
Vaccine: HEP
Symptoms: Hypersensitivity, Prophylaxis
Clinical narrative: Hypersensitivity.  This case was reported by a physician via a sales representative and described a subject of unspecified age and gender who developed allergies after vaccination with hepatitis B vaccine recombinant (Engerix-B, GlaxoSmithKline) for prophylaxis. On an unspecified date the subject received an unspecified dose of Engerix-B (10 mcg, unknown).  Immediately after vaccination with Engerix-B, the subject developed allergies.  At the time of reporting the outcome of the event was was unspecified.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain
Clinical narrative: Abdominal pain  This case was reported by a medical assistant and described the occurrence of abdominal pain in a 19 year-old female subject who received hepatitis B vaccine recombinant (Engerix-B).  No history of problems with the initial dose of Engerix-B.  On 15 May 2006, the subject received the second dose of Engerix-B (lot AHEXB180AC) in her arm.  Approximately two hours following the administration of Engerix-B, the patient experienced an abdominal pain and abdominal cramps.  The reporter considered that the events were probably related to the use of Engerix-B.  The outcome of the abdominal pain and cramps was worse. Later on follow-up, the physician noted that the subject was doing  fine and the abdominal pain was not due to Engerix-B.
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective, Hepatitis B surface antigen
Clinical narrative: Therapy non-responder  This case was reported by a nurse and described the occurrence of not responding to therapy in a 52 year-old female subjects who was vaccinated with hepatitis B vaccine (manufacturer unspecified) for prophylaxis.  The subject's medical history included non-smoker and non-drinker.  The subject's concurrent conditions and concurrent medications were not reported.  On 12 October 1992, the subject received the third dose of hepatitis B vaccine (dosing was not specified). The subject received the second dose on approximately 45 days after vaccination with the first dose of hepatitis B vaccine, a hepatitis B surface antibody titer was negative. A fourth dose of hepatitis B vaccine was given on 02 May 1997. On 05 May 2006, approximately nine years after the fourth dose of hepatitis B vaccine, a hepatitis B surface antibody titer was also negative.  The nurse considered the event to possibly be related to vaccination with hepatitis B vaccine.
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective, Hepatitis B surface antigen
Clinical narrative: Therapy non-responder  This case was reported by a nurse and described a subject (age and gender unknown) who did not respond to immunization to hepatitis B vaccine recombinant (Engerix-B).  On unspecified dates, the subject received Engerix-B. On an unspecified date before 12 May 2006, a hepatitis B surface antibody titer was negative.  It was reported that the titers were taken from one to five months after the third dose of Engerix-B was received. No adverse events were reported.
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective, Hepatitis B surface antigen
Clinical narrative: Therapy non-responder  This case was reported by a nurse and described a subject (age and gender unknown) who did not respond to immunization to hepatitis B vaccine recombinant (Engerix-B).  On unspecified dates, the subject received Energix-B. On an unspecified date before 12 May 2006, a hepatitis B surface antibody titer was negative. It was reported that the titers were taken from one to five months after the third dose of Engerix-B was received.  No adverse events were reported.
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective, Hepatitis B surface antigen
Clinical narrative: therapy non-responder  This case was reported by a nurse and described a subject (age and gender unknown) who did not respond to immunization to hepatitis B vaccine recombinant (Engerix-B).  On unspecified dates, the subject received Energix-B. On an unspecified date before 12 May 2006, a hepatitis B surface antibody titer was negative. It was reported that the titers were taken from one to five months after the third dose of Engerix-B was received. No adverse events were reported.
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective, Hepatitis B surface antigen
Clinical narrative: Therapy non-responder  This case was reported by a nurse and described a subject (age and gender unknown) who did not respond to immunization to hepatitis B vaccine recombinant (Engerix-B).  On unspecified dates, the subject received Energix-B. On an unspecified date before 12 May 2006, a hepatitis B surface antibody titer was negative. It was reported that the titers were taken from one to five months after the third dose of Engerix-B was received. No adverse events were reported.
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a nurse and described a subject (age and gender unknown) who did not respond to immunization to Engerix-B. On unspecified dates, the subject received Engerix-B. On an unspecified date before 12 May 2006, a hepatitis B surface antibody titer was negative after the third dose of Engerix-B was received. No adverse events were reported.
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a nurse and described a subject (age and gender unknown) who did not respond to immunization to Engerix-B. On an unspecified dates, the subject received Engerix-B. On an unspecified date before that the titers were taken from one to five months after the third dose of Engerix-B. No adverse events were reported.
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a nurse and described a subject (age and gender unknown) who did not respond to immunization to Engerix-B. On an unspecified dates, the subject received Engerix-B. On an unspecified date before 12 May 2006, a hepatitis B antibody titer was negative. It was reported that the titers were taken from one to five months after the third dose of Engerix-B was received. No adverse events were reported.
Age: 61.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective, Inappropriate schedule of drug administration, Incorrect dose administered, Therapy non-responder
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of a 60-year-old male subject not responding to therapy following vaccination with Engerix-B) for prophylaxis. The subject has a medical history of asthma. No concurrent conditions or medications were reported. On 15 December 2004, the subject began receiving his first series of intramuscular, 20 mcg, Engerix-B. The first dose was administered on 15 December 2004, the second dose was administered on 21 January 2005 and the third dose of the series was administered on 15 June 2005. The interval between the second dose and third doses of Engerix-B was considered to be an inappropriate schedule of drug administration as the interval was too short. An interval of 6 months is recommended between the second and third doses of Engerix-B and this subject's interval was 5 months. A negative surface antibody test performed on 10 August 2005, following completion of the series, showed that the patient was not responding to therapy. A second intramuscular Engerix-B series was started that the patient was not responding to therapy. A second intramuscular Engerix-B series was started on 23 August 2005. The first dose of Engerix-B administered in the series was 20 mcg and was given on 23 August 2005. The second dose of Engerix-B was given on 03 October 2005 and the third dose was given on 28 February 2006. The second and third doses of Engerix-B in this series were given intramuscularly in the left arm as two pediatric doses of 10 mcg (given together each time) for a total of 20 mcg which equals the adult dosage. The lot number of the pediatric doses was AHBVB092AA and the expiration date for this lot was 11 June 2006. This was considered to be an inappropriate dose of drug administration as an adult subject received pediatric Engerix-B. Also, the interval between the second and third doses of Engerix-B in this series was too short. The recommended interval between the second and third Engerix-B vaccinations is 6 months. The interval for this subject was just short of 5 months. This was considered to be an inappropriate schedule of drug administration. A negative surface antibody test performed on 25 April 2006, following completion of the second series of EngerixB, showed that the patient was still not responding to therapy. Additional Engerix-B lot numbers used in the two series administered to this subject were AHBVB092AA with expiration 11 June 2006. Specific dates of administration of each lot were not provided. No adverse events were reported.
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a nurse and described a subject (age and gender unknown) who did not respond to immunization to Engerix-B. On an unspecified dates, the subject received Engerix-B. On an unspecified date before 12 May 2006, a hepatitis B surface antibody titer was negative. It was reported that the titers were taken from one to five months after the third dose of Engerix-B was received. No adverse events were reported.
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective, Therapy non-responder
Clinical narrative: This case was reported by a healthcare professional and described a 40-year-old female subject who did not respond to immunization to hepatitis B vaccine (manufacturer unspecified). On an unspecified dates, the subject received " a series" of hepatitis titer was negative. On 05 April 2006 the subject received a dose of Hepatitis B vaccine recombinant (Engerix-B; dose number not reported; lot AHBVBA059AA). The expiration date for this lot of Engerix-B is 09 October 2005.
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Prophylaxis
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of a 40 year old female subject who was vaccinated with Engerix-B for prophylaxis and has not responded to therapy. The subject's medical history, concurrent conditions and concurrent medications were not provided. On unspecified date the subject received two series of Engerix-B, dosing not provided. Lot numbers and expiration dates were not reported. Three dose of Engerix-B were administered per series. The subject was reportedly not responding to therapy. No additional information was provided. Follow up received on 09 June 2006 did not indicate that the subject experienced any adverse events after receiving Engerix-B.
Sex: F
Vaccine: HEP
Symptoms: Myalgia, Nausea, Vomiting
Clinical narrative: This case was reported by a physician and described the occurrence of nausea in an adult female subject who was vaccinated with Engerix-B for prophylaxis. On an unspecified date in April 2006, the subject received 1st dose of Engerix-B. On the same day as the 1st dose of Engerix-B, the subject experienced nausea, vomiting and aching muscles. The vomiting resolved after 3 hours and the nausea and aching muscles resolved on an unspecified date before 10 May 2006. The physician considered the nausea to probably be related to vaccination with Engerix-B.
Sex: U
Vaccine: HEP
Symptoms: Prophylaxis
Clinical narrative: This case was reported by a physician 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) for prophylaxis. The subject's medical history, concurrent conditions and concurrent medications were not reported. On an unspecified date the subject received primary course of Hepatitis B vaccine (dosing was not specified). It was indicated that the subject received a "series", however, the reporter was not sure if the series was Engerix-B or another manufacturer's product. The series was not given in the reporter's office. The subject was not responding to therapy (negative titer test). No additional information is available.
Sex: U
Vaccine: HEP
Symptoms: Therapeutic response decreased
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of decreased therapeutic response in a subject of unspecified age and gender who was vaccinated with hepatitis B vaccine (manufacturer unspecified) for prophylaxis. The subject's medical history, concurrent conditions and concurrent medications were not reported. On an unspecified date the subject received unspecified dose of Hepatitis B vaccine (lot numbers and expirations dates were not known). At an unspecified time after vaccination with hepatitis B vaccine, the subject experienced decreased therapeutic response described as low hepatitis B titers (values not specified). No additional information was known. The reporter was unsure if the patient received Engerix-B or another companies vaccine.
Sex: F
Vaccine: HEP
Symptoms: Injection site irritation
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of burning sensation injection site in an adult female subject who was vaccinated with Engerix-B for prophylaxis. The reporter is the subject. The subject's medical history included seasonal allergy. Concurrent medications included Depo provera. On an unspecified date before 03 May 2006, the subject received a dose of Engerix-B in the left arm (dose number and lot number not provided). Less than one day after vaccination with Engerix-B, the subject experienced burning sensation injection site. The event resolved after "about one minute." The healthcare professional considered the event was probably related to vaccination with Engerix-B.
Age: 58.0
Sex: F
Vaccine: HEP, HEPA, HEP, HEPA
Symptoms: Pruritus
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of itching in a 58 year old female subject who was vaccinated with Engerix-B plus a separate injection of Vaqta for prophylaxis. On 24 April 2006 the subject received 1st dose of Engerix-B (lot AHBVB156AA) and an unspecified dose of Vaqta. ON 24 April 2006, less than one day after vaccination with Engerix-B and Vaqta, the subject experienced itching. The subject was seen in an emergency room and was treated with Benadryl and Claritin. The healthcare professional considered the event to be clinically significant (or requiring intervention). The immunization series with Vaqta was discontinued. On 1 May 2006, the event resolved.
Sex: U
Vaccine: HEP
Symptoms: Injection site haemorrhage
Clinical narrative: This case was reported by a pharmacist to a sales representative and described the occurrence of injection site hemmorhage in a subject of unspecified age and gender who was vaccinated with Engerix-B for prophylaxis. The pharmacist reported that more than one subject experienced injection site bleeding, however,a specific number of subjects was not reported. On an unspecified date on or before 24 April 2006, the subject received a dose of Engerix-B at an unspecified site of administration (dose number and lot number not reported). Less than one day after vaccination with Engerix-B, on an unspecified date on or before 24  April 2006, the subject experienced injections site bleeding. The pharmacist reported that, "the TIP-LOK syringes were making the patients bleed." The outcome of the event was not reported.
Age: 62.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody, Hypercholesterolaemia, Therapeutic response decreased
Clinical narrative: This case was reported by a physician and described the occurrence of decreased therapeutic response in a 62 year old female subject who was vaccinated with Hepatitis B vaccine (manufacturer unspecified) for prophylaxis approximately 15 years ago. The subject's medical history, concurrent conditions and concurrent medications were not reported. On an unspecified date, approximately 15 years ago, the subject received a three dose immunization series of hepatitis B vaccine (unknown dosing, lot numbers and expiration). In October of 200f, the patient had a hepatitis B antibody level of 7 versus the recommended level of 10 following a complete hepatitis B vaccination series. This was considered to be a decreased therapeutic response. No additional information was provided at the time of reporting. Follow up information received on 12 May 2006 indicated that the subject received a booster vaccine. Specified details were not provided. It was also reported that the patient had a concurrent condition of hypercholesterolemia. No additional information was provided.
Sex: F
Vaccine: HEP
Symptoms: Dizziness
Clinical narrative: This case was reported by a pharmacist and described the occurrence of dizziness in an adult female subject who was vaccinated with Engerix-B for prophylaxis. The subject's medical history included needle stick injury which occurred on an unspecified date in April 2006 prior to the administration of Engerix-B. On 26 April 2006 the subject received a dose of Engerix-B (dose number and lot number not provided). On 26 April 2006, less than one day after vaccination with Engerix-B, the subject experienced dizziness. The outcome of the event was not reported. The pharmacist considered the event was probably related to vaccination with Engerix-B.
Age: 63.0
Sex: F
Vaccine: HEP
Symptoms: Therapy non-responder
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a 63 year old female subject, who was vaccinated with Engerix-B, hepatitis B vaccine for prophylaxis. The subject's medical history, concurrent conditions and concurrent medications were not reported. The subject received two three dose series of hepatitis B vaccine, one series in 1988 and one in 1993. The reporting nurse believed that the subject received Engerix-B (1.0 ml) for at least one of the series, but did not have specific information regarding brand, lot number or expiration dates. All doses of hepatitis B vaccine were given in the subject's left arm. The nurse stated that the subject did not sero-convert following either series of hepatitis B vaccine. The subject was not responding to therapy. No additional information was known at the time of reporting.
Age: 53.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a consumer and described the occurrence of not responding to therapy in a 53-year-old male subject who was vaccinated with hepatitis B recombinant vaccine series. A physician or other health care professional has not verified this report. The subject's relevant medical history included gastroesophageal reflux disease, hypercholesterolemia, hypertension, acquired immune deficiency syndrome, herpes and human immunodeficiency virus. Concurrent vaccination included hepatitis A vaccine. Concomitant medications included acyclovir, atenolol, triamterene + hydrochlorothiazide (Maxzide), famotidine (Pepcid) and lovastatin. It was unknown if the patient was taking these concomitant medications at the time of the hepatitis B vaccinations. On an unspecified date, the subject received 3rd dose of hepatitis B recombinant vaccine. Approximately one year after receiving the 3rd dose of hepatitis B recombinant vaccine, a hepatitis B surface antibody titer was negative. The subject sought medical attention at his doctor's office.
Age: 53.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Abdominal pain, Abdominal pain upper, Back pain, Chills, Fatigue
Clinical narrative: This case was reported by a pharmacy intern and described the occurrence of nausea in a 53-year-old female subject who was vaccinated with Engerix-B for prophylaxis. Concurrent vaccination included Vaqta. The subject was not on any concurrent medications and was reported to be in good health. On 14 April 2006, the subject received a 3rd dose of Engerix-B at 20 mcg in the right deltoid, Lot number AHBVB141AA. On 15 April 2006, one day after vaccination with Engerix-B and Vaqta, the subject experienced gastrointestinal complaints. abdominal pain, nausea, stomach cramping, chills, back pain, and fatigue. At the time of reporting the events were unresolved. The pharmacy intern considered the events were possibly related to vaccination with Engerix-B. On 24 April 2006, follow-up information was reported by a pharmacist. She reported that the subject "was complaining mostly about gastrointestinal complaints not joint pain".  Follow-up information received on 02 June 2006 indicated that the subject had a medical history of mild asthma. Normal diagnostic tests included urinalysis, glucose, creatinine and liver function. The subject's condition resolved by 15 May 2006. In the reporter's opinion, the events were possibly related to treatment with Engerix-B.
Age: 53.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Gastrointestinal disorder, Nausea
Clinical narrative: This case was reported by a pharmacy intern and described the occurrence of nausea in a 53-year-old female subject who was vaccinated with Engerix-B for prophylaxis. Concurrent vaccination included Vaqta. The subject was not on any concurrent medications and was reported to be in good health. On 14 April 2006, the subject received a 3rd dose of Engerix-B at 20 mcg in the right deltoid, Lot number AHBVB141AA. On 15 April 2006, one day after vaccination with Engerix-B and Vaqta, the subject experienced gastrointestinal complaints. abdominal pain, nausea, stomach cramping, chills, back pain, and fatigue. At the time of reporting the events were unresolved. The pharmacy intern considered the events were possibly related to vaccination with Engerix-B. On 24 April 2006, follow-up information was reported by a pharmacist. She reported that the subject "was complaining mostly about gastrointestinal complaints not joint pain".  Follow-up information received on 02 June 2006 indicated that the subject had a medical history of mild asthma. Normal diagnostic tests included urinalysis, glucose, creatinine and liver function. The subject's condition resolved by 15 May 2006. In the reporter's opinion, the events were possibly related to treatment with Engerix-B.
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antigen positive
Clinical narrative: This case was reported by a technician and described an adult male subject who was vaccinated with Engerix-B and subsequently tested positive hepatitis B surface antigen. The subject was a dialysis patient. On 20 March 2006, the subject had a negative hepatitis B surface antigen blood test. On 12 April 2006, the subject received a dose of Engerix-B (lot number AHVB268CA). This was thought to be his first dose of Engerix-B, vaccine. On 17 April 2006, five days after the vaccination with Engerix-B, the subject's blood-work showed a positive result for hepatitis B surface antigen.
Age: 26.0
Sex: M
Vaccine: HEP
Symptoms: Erythema, Rash, Urticaria
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of arm rash in a 26 year old male subject who was vaccinated with Engerix-B for prophylaxis. There was no concurrent medications. No medical history or concurrent conditions were reported. The patient was in good health. On an unspecified date the subject received his 1st dose of intramuscular Engerix-B (unknown dosing). At an unspecified time after vaccination with Engerix-B, the subject experienced arm rash and rash on trunk. The rash was described as red and raised. The subject was treated with diphenhydramine hydrochloride (Benadryl).  At the time of reporting the events were unresolved and the subject continued to treat himself with Benadryl. Follow-up information on 26 May 2006 indicated that the subject developed a rash all over his body. Symptoms began on 02 February 2006 and were unresolved at the time of follow-up. The immunization series was discontinued. In the reporter's opinion, the events were possibly related to treatment with Engerix-B. Additional follow-up information was received via  a physician on 31 May 2006. Follow-up indicated that the subject received a 2nd dose of Engerix-B approximately three months ago and developed generalized hives within one day receiving the dose . The physician reports that the hives have been non-stop ever since the first dose.
Age: 45.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antigen positive
Clinical narrative: This case was reported by a healthcare professional, the wife of the subject, and described the occurrence of antigenemia in a 45-year-old male subject who was vaccinated with Engerix-B. The subject is a hemodialysis patient. Medical history, concurrent medical conditions and concurrent medication (other than Engerix-B) was not known. On 23 February 2006, the subject received the 1st dose (primary dose) of Engerix-B (40 mcg, unknown). On 1 April 2006, the subject received a 2nd dose (booster) of  Engerix-B (20 mcg, unknown). An unknown amount of the time after receiving the booster dose of Engerix-B, the subject experienced antigenemia. A titer for the antibody to be hepatitis B surface antigen was performed following the administration of the 2nd Engerix-B dose and was positive. The reporting nurse stated that "the dialysis center should not have done blood work for his hep B status until he finished the series". At the time of reporting the events were unresolved.
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective, Hepatitis B antigen positive
Clinical narrative: This case was reported by a nurse and described a 44-year-old female subject who was vaccinated with Engerix-B. The subject's medical history included renal failure (cause not specified) requiring hemodialysis, diabetes, and hypertension. Concurrent medications included Venofer, Epoetin alfa (Epogen), Etofenamate (Fenax), Nifedipine (Procardia), Hydralazine (Hydralazine), Human Insulin (Novolin), Atorvastatin calcium (Lipitor), Thyroxine sodium (Synthyroid), Calcium salt (Calcium) and Ramipril (Altace). On 23 March 2006 the subject received 1st dose of Engerix-B (Lot AHBVB171AA). On an unspecified date on or after 23 March 2006 and on or before 30 March 2006, less than one week after vaccination with Engerix-B, the subject "tested positive for hepatitis B". The nurse reported that the subject "tested negative for hepatitis B on December 2005, January 2006 and February 2006". At the time of initial reporting, 30 March 2006, the event was ongoing.
Age: 52.0
Sex: F
Vaccine: HEP, TTOX
Symptoms: Incorrect dose administered, Injection site reaction, Medication error
Clinical narrative: This case was reported by a nurse and described the occurrence of injection site soreness in a 52-year-old female subject who was inadvertently vaccinated with the incorrect dose of Engerix-B for prophylaxis. On 28 March 2006 the subject received 1st dose of Engerix-B in the left deltoid (lot AHBVB185AB). The nurse reported that the subject inadvertently received the "pediatric dose" of Engerix-B. The pediatric, 10 mg, dose of Engerix-B is recommended for immunizing individuals 19 years of age and younger. On 28 March 2006, less than one day after vaccination with Engerix-B, the subject experienced injection site soreness. The injection site soreness resolved on or after 28 March 2006 and on before 21 April 2006. On 28 March 2006, the subject also received tetanus and diphtheria toxoids adsorbed at an unspecified site of injection.
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered, Injection site reaction, Medication error
Clinical narrative: This subject was reported by a nurse and described the occurrence of injection site soreness in a 43-year-old female subject who was inadvertently vaccinated with the incorrect dose of Engerix-B for prophylaxis. On 28 March 2006 the subject received 2nd dose of Engerix-B in the left arm (lot AHBVB185AB). The nurse reported that the subject inadvertently received the "pediatric dose" of Engerix-B. The pediatric, 10 mcg, dose of Engerix-B is recommended for immunizing individuals 19 years of age and younger. On 28 March 2006, less than one day after vaccination with Engerix-B, the subject experienced injection site soreness. The injection site soreness resolved on or after 28 March 2006 and on or before 21 April 2006.