chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative, No therapeutic response, Product quality issue
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a 38-year-old female subject who was vaccinated with hepatitis B (manufacturer unspecified). Concurrent vaccination included tetanus toxoid, reduces diphtheria toxoid and acellular pertussis vaccine, adsorbed; manufacturer unspecified given on an unspecified date (with either the 1st or 3rd dose of hepatitis B vaccine). On unspecified dates the subject received 1st dose, 2nd dose and 3rd dose of hepatitis vaccine (1 ml, unknown route, unknown deltoid). The series was completed in 2009. On 4 June 2011, 2 years after completion of the vaccination series with hepatitis B vaccine, the subject experienced not responding to therapy. On 4 June 2011 titers were drawn and were less than 0.1 (units not provided). At the time of reporting, the subject was repeating the vaccination series and had received ENGERIX B on 14 June 2011 and 14 July 2011. This case involves a pharmaceutical product complaint. The healthcare professional reported that she had seen an increase in non-responders to vaccination with ENGERIX B and was concerned about the vaccine. It was noted that all the vaccines are monitored by several methods for temperature excursions. The healthcare professional reported 7 cases of not responding to therapy following hepatitis b vaccination. This is case 5 of 7 (see case IDs A0947199A, A0947239A-A0947241A, A0947243A, A0947244A for details of the other reports). Follow-up received from the reporting healthcare professional on 18 October 2011: On 03 June 2011, the subject's hepatitis B surface antibody was less than 0.1 mIU/mL (immunity was noted by the healthcare professional as greater than 0.99). The healthcare professional reported that the hepatitis B series was currently being repeated with doses of ENGERIX B administered on 14 June 2011 and 14 July 2011.
Age: 14.0
Sex: F
Vaccine: HEP
Symptoms: Antibody test negative, No therapeutic response
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of not responded to therapy in 14-year-old (approximately) female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). There were no concurrent medications. On unspecified dates (many years ago in 1998) the subject received 3rd dose, 2nd and 1st dose of ENGERIX B. A recent blood test showed no immunity, the subject had not responded to therapy. No additional information was provided.
Age: 35.0
Sex: M
Vaccine: HEP
Symptoms: Tendon pain
Clinical narrative: This case was reported a pharmacist and described the occurrence of tendon pain in hand in a 35-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent medical conditions included allergy to DEMEROL and possible anxiety disorder. On 31 May 2011 at 13:00 the subject received unspecified dose of ENGERIX B at 1.0 ml in the left arm. Within a month after vaccination with ENGERIX B, the subject experienced tendon pain in hand (tendons in the left hand were sore). The subject remarked that when he makes a fist, it feels like they are going to snap. At the time of reporting the outcome of the event was unspecified. The pharmacist considered the event was possibly related to vaccination with ENGERIX B. The pharmacist referred the subject to his physician.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Antibody test negative, Therapeutic response decreased
Clinical narrative: This case was reported by a sales preventative and described the occurrence of decreased therapeutic response in a 19-year-old female subject who was vaccinated with ENGERIX B pediatric (General Nutrition CA), ENGERIX B. A physician or other health care professional has not verified this report. There was no concurrent medications. On unspecified dates (about 20 years ago) the 19 year old subject received 1st, 2nd and 3rd dose of ENGERIX B pediatric to complete the three dose series. Titers taken 20 years later were low. The subject experienced decreased therapeutic response. No additional details were provided.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B virus test positive
Clinical narrative: This case was reported by a physician, via a GSK representative, and described the occurrence of hepatitis B positive in a child subject of unspecified age and gender who was vaccinated with Hepatitis B vaccine (manufacturer unspecified). The subject's medical history included elevated liver enzymes and sexually transmitted disease. On unspecified dates, as an infant, the subject received 1st dose, 2nd dose and 3rd dose of Hepatitis B vaccine (details unknown). At an unknown time after vaccination with Hepatitis B vaccine, the subject experienced hepatitis B positive. The physician reported that four subject's, all children from the same family, were vaccinated with the hepatitis B vaccine series (unknown manufacturer) as infants, and as the children are now older (unknown ages) two of the children have tested positive for hepatitis B, and two of the other children were tested as having no immunity/no protection. This is case 1 of 4 (see case IDs A0939314A, A0939315A, A0939316A for details of the other reports).
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B virus test positive
Clinical narrative: This case was reported by a physician, via a GSK representative, and described the occurrence of hepatitis B positive in a child subject of unspecified age and gender who was vaccinated with Hepatitis B vaccine (manufacturer unspecified). The subject's medical history included elevated liver enzymes and sexually transmitted disease. On unspecified dates, as an infant, the subject received 1st dose, 2nd dose and 3rd dose of Hepatitis B vaccine (details unknown). At an unknown time after vaccination with Hepatitis B vaccine, the subject experienced hepatitis B positive. The physician reported that four subject's, all children from the same family, were vaccinated with the hepatitis B vaccine series (unknown manufacturer) as infants, and as the children are now older (unknown ages) two of the children have tested positive for hepatitis B, and two of the other children were tested as having no immunity/no protection. This is case 2 of 4 (see case IDs A0938693A, A0939315A, A0939316A for details of the other reports).
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Hepatitis B virus test positive, No therapeutic response
Clinical narrative: This case was reported by a physician, via a GSK representative, and described the occurrence of hepatitis B positive in a child subject of unspecified age and gender who was vaccinated with Hepatitis B vaccine (manufacturer unspecified). The subject's medical history included elevated liver enzymes and sexually transmitted disease. On unspecified dates, as an infant, the subject received 1st dose, 2nd dose and 3rd dose of Hepatitis B vaccine (details unknown). At an unknown time after vaccination with Hepatitis B vaccine, the subject experienced not responding to therapy ("no immunity/no protection"). The physician reported that four subject's, all children from the same family, were vaccinated with the hepatitis B vaccine series (unknown manufacturer) as infants, and as the children are now older (unknown ages) two of the children have tested positive for hepatitis B, and two of the other children were tested as having no immunity/no protection. This is case 3 of 4 (see case IDs A0938693A, A0939314A, A0939316A for details of the other reports).
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Injury associated with device, Therapeutic response decreased
Clinical narrative: This case was reported by a physician and described the occurrence of decreased therapeutic response in a 44-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Previous vaccination included doses of ENGERIX B (GlaxoSmithKline) given on unspecified dates. There were no concurrent medications. On an unspecified date years ago, the subject completed a series of ENGERIX B. Dates were not specified. A titer were drawn on an unspecified date and hepatitis B antibody levels were found to be low. A second series of ENGERIX B was completed on unspecified dates. It was noted that the subject experienced a "needle stick accident" and titers for hepatitis B were tested and found to be low again. The subject received two complete ENGERIX B series and had experienced decreased therapeutic response. No additional details were provided.
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antigen positive
Clinical narrative: This case was reported by a physician via a sales representative and described the occurrence of hepatitis b antigen positive in a male subject of unspecified age who was vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent medical conditions included chronic renal failure and dialysis. On an unspecified date the subject received 1st dose of ENGERIX B. Five days after vaccination with ENGERIX B, the subject turned out to be hepatitis b antigen positive. It was noted that the subject was hepatitis B surface antigen negative previously. Five days after receiving his first dose of ENGERIX B vaccine, a hepatitis serology was mistakenly drawn and the result was that the subject tested positive. The result persisted out to day 18. On day 20 and 21, the test results were negative. All of the other results in the hepatitis serology were negative. The subject was to have another test on day 30. At the time of reporting the outcome of the event was resolved.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Chills, Diarrhoea, Dizziness, Eye irritation, Nausea
Clinical narrative: This case was reported by a physician and described the occurrence of dizziness in a 21-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Previous vaccination included ENGERIX B (GlaxoSmithKline; unknown given in May 2011). On 23 June 2011 the subject received 2nd dose of ENGERIX B (details unknown). On 24 June 2011, 1 day after vaccination with ENGERIX B, the subject experienced dizziness, nausea, vomiting, fever, diarrhea, chills and eyes burning. On 25 June 2011, the events were resolved without treatment. The physician considered the events were possibly related to vaccination with ENGERIX B.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Pyrexia, Vomiting
Clinical narrative: This case was reported by a physician and described the occurrence of dizziness in a 21-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Previous vaccination included ENGERIX B (GlaxoSmithKline; unknown given in May 2011). On 23 June 2011 the subject received 2nd dose of ENGERIX B (details unknown). On 24 June 2011, 1 day after vaccination with ENGERIX B, the subject experienced dizziness, nausea, vomiting, fever, diarrhea, chills and eyes burning. On 25 June 2011, the events were resolved without treatment. The physician considered the events were possibly related to vaccination with ENGERIX B.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, No therapeutic response
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of not responding to therapy in an adult female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent medications included Multivitamins (Multi Vitamin) and Birth control. On 20 October 1997, 20 May 1997 and 18 April 1997 the subject received 3rd dose, 2nd dose and 1st dose of ENGERIX B to complete the three dose series. Recently (date not specified) hepatitis B titers were drawn and showed 9 mIU/ml. The subject did not have protective titers and was considered to be a non-responder. No additional information was known.
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site redness in a female subject of unspecified age who was vaccinated with ENGERIX B (GlaxoSmithKline). On an unspecified dates the subject received 1st dose and 2nd dose of ENGERIX B (details unknown). On 03 April 2011 the subject received 3rd dose of ENGERIX B (10 mcg, left arm). On an unspecified date at an unknown time after the 1st dose ENGERIX B, the subject experienced injection site redness, swelling injection site, injection site pruritus and hotness at injection site. The events resolved on an unspecified date without intervention. After the next vaccination (2nd dose) with ENGERIX B the events recurred. On 03 April 2011, less than one day after vaccination with ENGERIX B (3rd dose), the subject experienced injection site redness, swelling injection site, injection site pruritus and hotness at injection site. The subject was treated with ice (Ice pack). At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with ENGERIX B. Follow-up information was received on 03 May 2011. It was reported that the events were all resolved and that they were probably related to treatment with ENGERIX B.
Sex: M
Vaccine: HEP
Symptoms: Antibody test negative, No therapeutic response
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a male subject of unspecified age who was vaccinated with ENGERIX B (GlaxoSmithKline). Years ago, on an unspecified date the subject received 1st and 2nd dose of ENGERIX B. Recently, on an unspecified date the subject completed another ENGERIX B (unknown) series and received 3rd, 4th and 5th dose. After an unspecified time after the 1st and 2nd dose of ENGERIX B, and approximately 1 month after the 3rd, 4th and 5th dose of ENGERIX B, the subject experienced not responding to therapy. The male subject received "at least two dose of ENGERIX B years ago". Recently the subject completed another full series with this clinic. Titers performed one month later were negative (absence of expected effect). The subject was recently exposed to bodily fluids and given hepatitis b immunoglobulin (HBIG). The reporting healthcare professional did not have subject details or refused to provide further information upon request.
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Influenza like illness, Injection site erythema, Injection site induration
Clinical narrative: This case was reported by a physician via an OSHA safety officer and described the occurrence of influenza symptoms in a 21-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). There were no concurrent medications. On 8 April 2011 the subject received 1st dose of ENGERIX B at 0.5 ml, intramuscularly, in the right arm. On 8 April 2011, less than one day after vaccination with ENGERIX B, the subject experienced severe influenza symptoms and developed a large, hard, area on her arm (hard spot at injection site and injection site redness). On 20 April 2011, the events were resolved. The physician considered the events were probably related to vaccination with ENGERIX B. Follow-up information was received on 03 May 2011. It was confirmed that the events resolved and were not considered to be serious. The reported stated that the subject did have a cold on the day of vaccination with ENGERIX B with sore throat, shortness of breath and lightheadedness from 08 April 2011 and ending 13 April 2011. The second dose of ENGERIX B was scheduled for 09 May 2011.
Sex: F
Vaccine: HEP
Symptoms: Application site nodule
Clinical narrative: This case was reported by a pharmacist and described the occurrence of application site knot in a female subject aged between 30 and 39 years old who was vaccinated with ENGERIX B (GlaxoSmithKline). In April 2011 (the week prior to reporting) the subject received unspecified dose of ENGERIX B at 20 mcg in the right arm. At an unspecified time after vaccination with ENGERIX B, the subject experienced application site knot (a knot in the arm where the vaccine was given). At the time of reporting the outcome of the event was unspecified. The ENGERIX B lot number was originally reported to be AHBV894BA and was noted to be incorrect on 03 May 2011 and corrected to AHBVB894BA.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Antibody test negative, No therapeutic response
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of non-seroconversion in a 20-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). On unspecified dates (as a child) the subject received three doses of ENGERIX B to complete the three dose series. Years later, as a 20 year old adult, the subject was tested and found to not have seroconverting antibody titer referred to as 'lack of expected effect.' This was non-seroconversion. No other information was provided.
Sex: U
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 subject of unspecified age and gender who was vaccinated with ENGERIX B (GlaxoSmithKline). On an unspecified date the subject completed the ENGERIX B primary series. It was found that the subject had not responded to therapy. No additional information was provided. It was noted that this event occurred in multiple vaccinated nursing students. No specifics were reported.
Sex: U
Vaccine: HEP
Symptoms: Condition aggravated, Immediate post-injection reaction, Interferon alpha level increased, Raynaud's phenomenon
Clinical narrative: This case was reported by a pharmacist and described the occurrence of a possible interferon alpha level increase in a subject of unspecified age and gender who was vaccinated with Hepatitis B vaccine (manufacturer unspecified). Concurrent medical conditions included scleroderma, systemic sclerosis and Raynaud's Syndrome. On an unspecified date the subject received unspecified dose of Hepatitis B vaccine (unknown). After vaccination with Hepatitis B vaccine, the subject experienced an immediate and very severe worsening of Raynaud's Syndrome. This may have been attributed to an interferon alpha level increase. At the time of reporting the outcome of the events was unspecified. It was noted that this event occurred in two subjects. Demographics were not known. Linked case is A0902892A.
Age: 55.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain, Asthenia, Decreased appetite, Diarrhoea, Dizziness
Clinical narrative: This case was reported by a consumer (the subject) and described the occurrence of unwell in a 55-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). A physician or other health care profession has not verified this report. Concurrent medical conditions included dust allergy (unspecified). Previous and/or concurrent vaccination included influenza virus vaccine; manufacturer unspecified; unknown; unknown given on 1 March 2011 with no adverse events noted. Concurrent medications included Allergy medications (Allergy shots), CLOROTRIMETON and FLONASE. On 17 January 2011 and 2 March 2011 the subject received 1st dose and 2nd dose of ENGERIX B (details unknown). The subject reported no ill effects after the first vaccination until 07 February 2011. On 07 February 2011, 21 days after vaccination with the 1st dose of ENGERIX B, the subject experienced unwell, nausea, vomiting, diarrhea, fatigue, lisping, vertigo, belching and abdominal pain. The subject visited the emergency room. She reported that the symptoms continued off and on. The subject received influenza vaccination on 01 March 2011 with no adverse events noted. After the next vaccination ENGERIX B the events recurred. On an unspecified date, less than one month after the 2nd vaccination with ENGERIX B, the subject experienced weakness, fatigue, vertigo "in head and neck", head feels heavy, liquid diarrhea, unable to drive and tiredness. The subject reported that these symptoms were ongoing off and on, "poor appetite, diarrhea stopped, no vomiting". The subject had consulted her physician a couple of times. Unspecified tests were reported as negative. The subject's physician had suggested an MRI due to feeling faint and heaviness of head. At the time of reporting th events were unresolved.
Age: 55.0
Sex: F
Vaccine: HEP
Symptoms: Eructation, Fatigue, Head discomfort, Impaired driving ability, Malaise
Clinical narrative: This case was reported by a consumer (the subject) and described the occurrence of unwell in a 55-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). A physician or other health care profession has not verified this report. Concurrent medical conditions included dust allergy (unspecified). Previous and/or concurrent vaccination included influenza virus vaccine; manufacturer unspecified; unknown; unknown given on 1 March 2011 with no adverse events noted. Concurrent medications included Allergy medications (Allergy shots), CLOROTRIMETON and FLONASE. On 17 January 2011 and 2 March 2011 the subject received 1st dose and 2nd dose of ENGERIX B (details unknown). The subject reported no ill effects after the first vaccination until 07 February 2011. On 07 February 2011, 21 days after vaccination with the 1st dose of ENGERIX B, the subject experienced unwell, nausea, vomiting, diarrhea, fatigue, lisping, vertigo, belching and abdominal pain. The subject visited the emergency room. She reported that the symptoms continued off and on. The subject received influenza vaccination on 01 March 2011 with no adverse events noted. After the next vaccination ENGERIX B the events recurred. On an unspecified date, less than one month after the 2nd vaccination with ENGERIX B, the subject experienced weakness, fatigue, vertigo "in head and neck", head feels heavy, liquid diarrhea, unable to drive and tiredness. The subject reported that these symptoms were ongoing off and on, "poor appetite, diarrhea stopped, no vomiting". The subject had consulted her physician a couple of times. Unspecified tests were reported as negative. The subject's physician had suggested an MRI due to feeling faint and heaviness of head. At the time of reporting th events were unresolved.
Age: 55.0
Sex: F
Vaccine: HEP
Symptoms: Nausea, Speech disorder, Vertigo, Vomiting
Clinical narrative: This case was reported by a consumer (the subject) and described the occurrence of unwell in a 55-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). A physician or other health care profession has not verified this report. Concurrent medical conditions included dust allergy (unspecified). Previous and/or concurrent vaccination included influenza virus vaccine; manufacturer unspecified; unknown; unknown given on 1 March 2011 with no adverse events noted. Concurrent medications included Allergy medications (Allergy shots), CLOROTRIMETON and FLONASE. On 17 January 2011 and 2 March 2011 the subject received 1st dose and 2nd dose of ENGERIX B (details unknown). The subject reported no ill effects after the first vaccination until 07 February 2011. On 07 February 2011, 21 days after vaccination with the 1st dose of ENGERIX B, the subject experienced unwell, nausea, vomiting, diarrhea, fatigue, lisping, vertigo, belching and abdominal pain. The subject visited the emergency room. She reported that the symptoms continued off and on. The subject received influenza vaccination on 01 March 2011 with no adverse events noted. After the next vaccination ENGERIX B the events recurred. On an unspecified date, less than one month after the 2nd vaccination with ENGERIX B, the subject experienced weakness, fatigue, vertigo "in head and neck", head feels heavy, liquid diarrhea, unable to drive and tiredness. The subject reported that these symptoms were ongoing off and on, "poor appetite, diarrhea stopped, no vomiting". The subject had consulted her physician a couple of times. Unspecified tests were reported as negative. The subject's physician had suggested an MRI due to feeling faint and heaviness of head. At the time of reporting th events were unresolved.
Age: 34.0
Sex: M
Vaccine: HEP, TDAP
Symptoms: Dizziness, Incorrect dose administered
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of lightheadedness in a 34-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline), BOOSTRIX. On 21 March 2011 the subject received 5th dose of ENGERIX B (20 mcg, unknown route, right arm) and 1st dose of BOOSTRIX (details unknown), and experienced extra dose administered (ENGERIX B). On 21 March 2011, less than one day after vaccination with BOOSTRIX and ENGERIX B, the subject experienced lightheadedness. At the time of reporting the lightheadedness was resolved. The healthcare professional considered the lightheadedness was possibly related to vaccination with ENGERIX B and BOOSTRIX.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Antibody test negative, Incorrect dose administered, No therapeutic response
Clinical narrative: This case was reported by a physician and described the occurrence of maladministration (asymptomatic/extra dose given) in a 27-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent medications included birth control. A full series of ENGERIX B was administered to the subject approximately 6 years ago. On an unspecified date the subject received 6th dose, 5th dose and 4th dose of ENGERIX B. A second series of ENGERIX B was administered in error. This was a maladministration (asymptomatic/extra dose given). It was additionally noted that the dose of ENGERIX B given to the adult subject was a pediatric dose of vaccine (0.5 ml). This was an inappropriate dose of drug administered. It was reported that the subject did not develop protective antibody levels (less than 10 mIU/ml). The subject did not respond to therapy. No additional details were provided. It was not completely clear if the subject received the 3rd dose of ENGERIX B to complete the second series, or if she only received the first two doses. Relevant test results included [laboratory results/hospital investigations].
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Burning sensation
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of burning feeling in cheek in a 27-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent medical conditions included upper respiratory infection. There were no concurrent medications. On 14 January 2011 at 10:00 the subject received unspecified dose of ENGERIX B (unknown route, left deltoid). On 14 January 2011, less than one day after vaccination with ENGERIX B, the subject experienced burning sensation of cheeks. There was no further information provided at the time of reporting. At the time of reporting, the outcome of the events was unspecified.
Age: 52.0
Sex: M
Vaccine: HEP
Symptoms: Arthritis, Hepatitis B antibody negative, Hypoaesthesia, Musculoskeletal stiffness, No therapeutic response
Clinical narrative: This case was reported by a consumer and described the occurrence of not responding to therapy in a 52-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 colonoscopy, rectal bleeding and umbilical hernia. Concurrent medical conditions included hepatitis c and sexually transmitted disease. Previous and/or concurrent vaccination included hepatitis A vaccine inactivated; manufacturer unspecified; unknown; unknown given on 2009. Concurrent medications included antibiotics. On unspecified dates in 2009, the subject received 1st, 2nd and 3rd dose of ENGERIX B (unknown). In 2009, at an unspecified time after vaccination with ENGERIX B, the subject experienced not responding to therapy. The subject reported he has had hepatitis C for 10 years and was recommended to have a hepatitis A and B vaccination series in 2009. The subject received both hepatitis A and B vaccination series in 2009. In the later part of 2009 it was discovered he didn't show antibodies for hepatitis B and he was revaccinated with hepatitis B in 2010 with three vaccinations. On unspecified date in 2010, the subject received 4th, 5th, and 6th dose of ENGERIX B (unknown). Two months ago in November 2010, the subject's blood tested negative for antibodies. On 15 November 2010, after an unspecified time after receiving the second ENGERIX B series the subject experienced ringing in the ears, arthritic conditions such as swelling, stiffness, tingling and numbness. The subject reported that he was treated for a sexually transmitted disease (STD) infection one month ago, with an antibiotic. The subject reported the ringing further described as "crickets" in the ear stopped after he received his antibiotic. The ringing stopped for one day but has returned periodically, occurring off and on now. The subject was recommended to repeat the series at double dose but he is refusing at this time. He also reported that he believed it was ENGERIX B that he received for both vaccination series. At the time of reporting the events of not responding to therapy, arthritis, swelling and stiffness were unresolved; events of cricket noises both ears, tingling and numbness were unspecified.
Age: 52.0
Sex: M
Vaccine: HEP
Symptoms: Paraesthesia, Swelling, Tinnitus
Clinical narrative: This case was reported by a consumer and described the occurrence of not responding to therapy in a 52-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 colonoscopy, rectal bleeding and umbilical hernia. Concurrent medical conditions included hepatitis c and sexually transmitted disease. Previous and/or concurrent vaccination included hepatitis A vaccine inactivated; manufacturer unspecified; unknown; unknown given on 2009. Concurrent medications included antibiotics. On unspecified dates in 2009, the subject received 1st, 2nd and 3rd dose of ENGERIX B (unknown). In 2009, at an unspecified time after vaccination with ENGERIX B, the subject experienced not responding to therapy. The subject reported he has had hepatitis C for 10 years and was recommended to have a hepatitis A and B vaccination series in 2009. The subject received both hepatitis A and B vaccination series in 2009. In the later part of 2009 it was discovered he didn't show antibodies for hepatitis B and he was revaccinated with hepatitis B in 2010 with three vaccinations. On unspecified date in 2010, the subject received 4th, 5th, and 6th dose of ENGERIX B (unknown). Two months ago in November 2010, the subject's blood tested negative for antibodies. On 15 November 2010, after an unspecified time after receiving the second ENGERIX B series the subject experienced ringing in the ears, arthritic conditions such as swelling, stiffness, tingling and numbness. The subject reported that he was treated for a sexually transmitted disease (STD) infection one month ago, with an antibiotic. The subject reported the ringing further described as "crickets" in the ear stopped after he received his antibiotic. The ringing stopped for one day but has returned periodically, occurring off and on now. The subject was recommended to repeat the series at double dose but he is refusing at this time. He also reported that he believed it was ENGERIX B that he received for both vaccination series. At the time of reporting the events of not responding to therapy, arthritis, swelling and stiffness were unresolved; events of cricket noises both ears, tingling and numbness were unspecified.
Sex: M
Vaccine: HEP
Symptoms: Open wound, Rash
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of rash in a male subject of unspecified age who was vaccinated with ENGERIX B (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of ENGERIX B (unknown). At an unspecified time after vaccination with ENGERIX B, the subject experienced rash, open wound and possibly allergic to thimerosal. The healthcare professional reported that the subject developed "a severe rash on his hands, and his physician thought that it might be from the thimerosal. The healthcare professional stated "we are having a difficult time treating him, and he continued to experience open wounds, which only clear up with prednisone. The subject was treated with prednisone. At the time of reporting the open wound was unresolved; rash and possibly allergic to thimerosal were unspecified.
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Incorrect dose administered, No therapeutic response
Clinical narrative: This case was reported by a pharmacist and described the occurrence of not responding to therapy in a 32-year-old female subject who was vaccinated with Hepatitis B vaccine (manufacturer unspecified), TWINRIX. On unspecified dates in 2010, after completing the vaccination series with Hepatitis B vaccine the subject experienced not responding to therapy. On 16 November 2010, the same day the subject received TWINRIX vaccination the subject experienced an extra dose administered. The subject reported receiving hepatitis B series in 2001 to 2002 and was tested for titers in 2010; the titers were undetectable. The subject stated that she also completed the hepatitis A series in the past and on 16 November 2010 she received TWINRIX "even though all she needed was just the hepatitis B vaccine". At the time of the report no other information was provided.
Sex: M
Vaccine: HEP
Symptoms: Dyspnoea
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of trouble breathing in a male subject of unspecified age who was vaccinated with ENGERIX B (GlaxoSmithKline). In 2011 approximately one to weeks ago the subject received unspecified dose of ENGERIX B (unknown route). In 2011 approximately one to weeks ago, 1 day after vaccination with ENGERIX B, the subject experienced trouble breathing. An emergency room visit was required. At the time of reporting the outcome of the event was unspecified. The healthcare professional reported three subjects experienced events with ENGERIX B. See cases A0953067A and A0953068A for details concerning the other two subjects.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, No therapeutic response
Clinical narrative: This case was reported by a healthcare professional via sales representative and described the occurrence of not responding to therapy in an adult female subject who was vaccinated with hepatitis B (manufacturer unspecified). In the 1990's, possibly 1995 the subject received hepatitis B vaccine series (unknown). On an unspecified date, after vaccination with hepatitis B vaccine, the subject experienced not responding to therapy. The sales representative reported an adult employee received hepatitis B series in 1990's, possibly in 199. Upon hiring, her hepatitis titer was drawn and came back negative. At the time of the report no adverse events occurred.
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, No therapeutic response
Clinical narrative: This case was reported by a healthcare professional also the subject and described the occurrence of not responding to therapy in an adult male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). In 1980 the subject completed two three dose series of ENGERIX B. The subject reported a negative titer after both the first and the second series of ENGERIX B. The subject had not responded to therapy. No adverse events were reported.
Age: 43.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Therapeutic response decreased
Clinical narrative: This case was reported by a physician (also the subject) and described the occurrence of decreased therapeutic response in a 43-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). There were no concurrent medications. On unspecified dates (in the subject's early 30's) the subject completed 2 primary ENGERIX B series (unknown arm each administration) and at the time of reporting was still showing low titers. This is considered to be decreased therapeutic response. No additional details were reported.
Age: 51.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Fatigue, Lymphadenopathy, Pain
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of lymph node swelling in a 51-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline), HAVRIX. Concurrent medical conditions included penicillin allergy. Concurrent medications included FLOVENT and COMBIVENT. On 14 October 2010 at 10:27 the subject received 1st dose of ENGERIX B at 1.0 ml in the right deltoid. On 14 October 2010 the subject also received 1st dose of HAVRX (unknown). That same day, the subject developed lymph node swelling. Additional events reported include pain and tiredness. Lymph node swelling resolved on 17 October 2010. At the time of reporting the outcome of pain and tiredness was unknown. Attribution of the events to ENGERIX B was not provided.
Sex: U
Vaccine: HEP
Symptoms: Condition aggravated, Immediate post-injection reaction, Interferon alpha level increased, Raynaud's phenomenon
Clinical narrative: This case was reported by a pharmacist and described the occurrence of a possible interferon alpha level increase in a subject of unspecified age and gender who was vaccinated with Hep B (manufacturer unspecified). Concurrent medical conditions included scleroderma, systemic sclerosis and Raynaud's Syndrome. On an unspecified date the subject received unspecified dose of Hep B (unknown). After vaccination with Hep B, the subject experienced an immediate and very severe worsening of Raynaud's Syndrome. This may have been attributed to an interferon alpha level increase. At the time of reporting the outcome of the events was unspecified. It was noted that this event occurred in two subjects. Demographics were not known. Linked case is A0902895A.
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Rash
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of chest rash in a 33-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). On 4 May 2011 the subject received 1st dose of ENGERIX B at 0.5 ml in the left arm. On 6 May 2011, 2 days after vaccination with ENGERIX B, the subject experienced chest rash and back rash. At the time of reporting the events were unresolved.
Sex: U
Vaccine: HEP
Symptoms: Antibody test, No therapeutic response
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of not responding to therapy in an adult subject of unspecified gender who was vaccinated with ENGERIX B (GlaxoSmithKline). On an unspecified date the subject received 3rd dose, 2nd dose and 1st dose of ENGERIX B (unknown) and experienced not responding to therapy. The subject was reported to have no response to the primary series. The office did a titer level, details not provided. The vaccine record showed the subject had 3 doses of ENGERIX B.
Age: 15.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Hepatitis B antigen, No therapeutic response
Clinical narrative: This case was reported by a physician and described the occurrence of not responding to therapy in a 15-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline), Hep B. On an unspecified date the subject received 3rd dose of ENGERIX B (.5 ml, unknown), 2nd dose of Hep B (unknown). On an unspecified date after vaccination series completion with ENGERIX B and Hep B, the subject experienced not responding to therapy. The physician reported the subject tested negative for hepatitis B antigen and antibody on a recent test. The subject completed the vaccination series "years ago", but the mother was antigen positive. Relevant test results included Hepatitis B antigen and antibody negative. The healthcare professional reported another case regarding ENGERIX B, see case A0890090A. Follow-up information was received on 16 November 2010 via physician who refused to be contacted. At the time of the report no other information was provided.
Sex: U
Vaccine: HEP
Symptoms: No therapeutic response
Clinical narrative: This case was reported by a physician via 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 unspecified dates the subject received "a series" of ENGERIX B (unknown) and was found to have not responded to therapy. No additional details were reported. This event reportedly occurred with multiple subjects at this physician's office.
Sex: M
Vaccine: HEP
Symptoms: Antibody test negative, No therapeutic response
Clinical narrative: This case was reported by a pharmacist and described the occurrence of not responding to therapy in a male subject of unspecified age who was vaccinated with ENGERIX B (GlaxoSmithKline). On 18 January 2002, 5 March 2002 and 15 August 2002 the subject received 1st dose, 2nd dose and 3rd dose of ENGERIX B (20 mcg, unknown). At an unspecified time after vaccination with ENGERIX B, the subject experienced not responding to therapy. The healthcare professional reported no titer levels detectable, absence of expected effect.
Sex: F
Vaccine: HEP
Symptoms: Nausea, Urticaria
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of hive in a female subject of unspecified age who was vaccinated with ENGERIX B (GlaxoSmithKline). In 2011 approximately four to six weeks ago the subject received unspecified dose of ENGERIX B (unknown route). In 2011 approximately four to six weeks ago, less than one day after vaccination with ENGERIX B, the subject experienced hives on her head, arm and scalp and nausea. At the time of reporting the outcome of the events was unspecified. The healthcare professional reported three subjects experienced events with ENGERIX B. See cases A0953067A and A0953069A for details concerning the other two subjects.
Sex: M
Vaccine: HEP
Symptoms: Dyspnoea, Feeling hot, Throat irritation
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of trouble catching breath in a male subject of unspecified age who was vaccinated with ENGERIX B (GlaxoSmithKline). In 2011 approximately four to six weeks ago, the subject received unspecified dose of ENGERIX B (unknown route). In 2011 approximately four to six weeks ago, less than one day after vaccination with ENGERIX B, the subject experienced trouble catching breath, "weird" warm sensation in mouth and sensation in his throat. An emergency room visit was required. At the time of reporting the outcome of the events was unspecified. The healthcare professional reported three subjects experienced events with ENGERIX B. See cases A0953068A and A0953069A for details concerning the other two subjects.
Age: 20.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Hepatitis B antigen, No therapeutic response
Clinical narrative: This case was reported by a physician and described the occurrence of not responding to therapy in a 20-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline), Hep B. On an unspecified date the subject received 3rd dose of ENGERIX B (.5 ml, unknown), 2nd dose and 1st dose of Hep B (unknown). On an unspecified date after vaccination series completion with ENGERIX B and Hep B, the subject experienced not responding to therapy. The physician reported the subject tested negative for hepatitis B antigen and antibody on a recent test. The subject completed the vaccination series "years ago", but the mother was antigen positive. Relevant test results included Hepatitis B antigen and antibody negative. The healthcare professional reported another case regarding ENGERIX B, see case A0890089A. Follow-up information was received on 16 November 2010 via physician who refused to be contacted. At the time of the report no other information was provided.
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative, No therapeutic response, Product quality issue
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a 51-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent medical conditions included allergy to DELSYM cough medicine, which causes hives. On 01 February 2011, 07 March 2011 and 10 August 2011 the subject received 1st dose, 2nd dose and 3rd dose of ENGERIX B (1 ml, unknown route, unknown deltoid). On 21 September 2011, 42 days after the 3rd vaccination with ENGERIX B, 7 months after 2nd vaccination with ENGERIX B, and 8 months after 1st vaccination with ENGERIX B, the subject experienced not responding to therapy. The subjects titers were drawn on 21 September 2011 and were 0.2 (units not provided). This case involves a pharmaceutical product complaint. The healthcare professional reported that she had seen an increase in non-responders to vaccination with ENGERIX B and was concerned about the vaccine. It was noted that all the vaccines are monitored by several methods for temperature excursions. The healthcare professional reported 7 cases of not responding to therapy following Hep B vaccination. This is case 6 of 7 (see case IDs A0947199A, A0947239A-A0947242A, A0947244A for details of the other reports). Follow-up received from the reporting healthcare professional on 18 October 2011: On 21 September 2011, the subject's hepatitis B surface antibody was less than 0.22 mIU/mL (immunity was noted by the healthcare professional as greater than 0.99). All 3 doses of ENGERIX B were administered intramuscularly, and doses 1 and 2 were given in the left deltoid, with dose 3 administered in the right deltoid.
Age: 53.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Therapeutic response decreased
Clinical narrative: This case was reported by a healthcare professional via sales representative and described the occurrence of decreased therapeutic response in a 53-year-old female subject of unspecified age who was vaccinated with ENGERIX B (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of ENGERIX B (unknown) and experienced decreased therapeutic response. This healthcare professional reported two employees may have completed Hep B series years ago but are not sure. Titers were drawn within the last year and were found to be low. This is one of two employees. For the second employee case see A0892914A. Follow-up information received via the reporter on 10 December 2010 indicated that there was little to no information on this report. Remark was made that the subject was not even sure that she was immunized. No additional information is available.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Antibody test negative, Therapeutic response decreased
Clinical narrative: This case was reported by a healthcare professional via sales representative and described the occurrence of decreased therapeutic response in a 25-year-old female subject of unspecified age who was vaccinated with ENERGIX B (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of ENGERIX B (unknown) and experienced decreased therapeutic response. This healthcare professional reported two employees may have completed Hep B series years ago but are not sure. Titers were drawn within the last year and were found to be low. This is the second of two employees. For the first employee case see A0892888A. Follow-up information received via the reporter on 10 December 2010 indicated that there was little to no information on this report. Remark was made that the subject was not even sure that she was immunized. No additional information is available.