chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEPAB
Symptoms: Syncope
Clinical narrative: This case was reported by an other manufacturer via a sales representative and described the occurrence of fainting in a subject of unspecified age and gender who was vaccinated with TWINRIX for prophylaxis. Other vaccinations that the subject received was GARDASIL. On an unspecified date the subject received unspecified dose of TWINRIX (unknown). Within hours of vaccination with TWINRIX, the subject experienced fainting. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the fainting was unspecified. It was also reported that four hours after the subject received TWINRIX, the subject came back in and received GARDASIL.
Age: 64.0
Sex: M
Vaccine: HEPAB
Symptoms: Hepatitis B surface antigen negative, Inappropriate schedule of drug administration
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of a 64-year-old male subject not responding to therapy following vaccination with TWINRIX for prophylaxis. Concurrent medications included Cyclosporin, Azathioprine, Lotrel, Atenolo, Sulphasalazine and Alendronate sodium. On 26 April 2007 the subject received 1st dose of TWINRIX at 1 ml in an unknown arm. On 26 June 2007, after the 1st vaccination with TWINRIX, hepatitis A and B surface antibody levels were drawn, and on 11 July 2007, the levels were both reported at negative. The subject had not responed to therapy. On either 20 July 2007 or 30 July 2007 (date not clear), the subject received his 2nd dose of 1 ml TWINRIX in the left arm. The third dose of 1ml TWINRIX was administered to the subject on 12 December 2007. This was considered to be an inappropriate schedule of drug administration as the 3rd dose of TWINRIX was administrated too close to the 2nd. On 17 December 2007, just five days following administration of the 3rd and final dose of TWINRIX, hepatitis B surface antibody levels were drawn and were found to be less than 5. This was considered to be a low hepatitis B surface antibody level. Hepatitis B antibody levels were drawn too close to the 3rd dose of TWINRIX. The subject experienced a systemic reaction. No additional adverse events were reported. At the time of reporting the outcome the not responding to therapy was unresolved and the outcome of the negative hepatitis B and A antibody level and the low hepatitis B antibody level were all unknown.
Sex: F
Vaccine: HEPAB
Symptoms: Hepatitis A antibody abnormal, Hepatitis B antibody abnormal
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of low hepatitis B antibody level in an adult female subject who was vaccinated with TWINRIX, GlaxoSmithKline.  In 2005 the subject received 1st and 2nd dose of TWINRIX at 1.0 ml.  At an unspecified time after the 2nd vaccination with TWINRIX, the subject was tested and did not show protection against hepatitis A and hepatitis B.  It was reported that the subject was not found to have protective levels for either hepatitis A or B (low hepatitis A antibody level and low hepatitis B antibody level).  At the time of reporting the outcome of the events was unspecified.
Age: 43.0
Sex: M
Vaccine: HEPAB
Symptoms: Arthralgia, Gait disturbance, Rash, Rash vesicular, Scab
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of pain in hip in a 43-year-old male subject who was vaccinated with TWINRIX, GlaxoSmithKline.  On 24 January 2008 at 13:30 the subject received 1st dose of TWINRIX at 1.0 ml in the left arm.  On 25 January 2008 (11:00) 1 day after vaccination with TWINRIX, the subject experienced pain in the hip, had trouble walking and developed a rash.  The subject experienced a systemic reaction.  On 27 January 2008, the subject's hip pain resolved and he was able to walk without a problem.  As of 28 January 2008, the subject's rash had improved, but it had not completely resolved.  The healthcare professional considered the events were possibly related to vaccination with TWINRIX.  Follow-up information received 28 February 2008 confirmed the previously reported events.  It was reported that the rash experienced by the subject had a hive-like component on both inner thighs and some on the upper thighs.  The rash later developed into a chicken pox - like rash, then scabbed over.  The subject developed pain in his hip joints that progressed to severe pain, leading him to go to bed.  He was unable to walk due to the pain.  By approximately 16:00 on 27 January 2008, pain had subsided completely and the subject returned to an ambulatory state.  By 28 January 2008, 13:00, only a small amount of the rash was still present and by 04 February, the rash was gone.  The events were reported to have ended by 04 February 2008 and were considered by the reporter to possibly be related to TWINRIX.  The TWINRIX immunization series was discontinued.
Age: 43.0
Sex: M
Vaccine: HEPAB
Symptoms: Urticaria
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of pain in hip in a 43-year-old male subject who was vaccinated with TWINRIX, GlaxoSmithKline.  On 24 January 2008 at 13:30 the subject received 1st dose of TWINRIX at 1.0 ml in the left arm.  On 25 January 2008 (11:00) 1 day after vaccination with TWINRIX, the subject experienced pain in the hip, had trouble walking and developed a rash.  The subject experienced a systemic reaction.  On 27 January 2008, the subject's hip pain resolved and he was able to walk without a problem.  As of 28 January 2008, the subject's rash had improved, but it had not completely resolved.  The healthcare professional considered the events were possibly related to vaccination with TWINRIX.  Follow-up information received 28 February 2008 confirmed the previously reported events.  It was reported that the rash experienced by the subject had a hive-like component on both inner thighs and some on the upper thighs.  The rash later developed into a chicken pox - like rash, then scabbed over.  The subject developed pain in his hip joints that progressed to severe pain, leading him to go to bed.  He was unable to walk due to the pain.  By approximately 16:00 on 27 January 2008, pain had subsided completely and the subject returned to an ambulatory state.  By 28 January 2008, 13:00, only a small amount of the rash was still present and by 04 February, the rash was gone.  The events were reported to have ended by 04 February 2008 and were considered by the reporter to possibly be related to TWINRIX.  The TWINRIX immunization series was discontinued.
Sex: U
Vaccine: HEPAB
Symptoms: Injection site irritation, Injection site pain
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site pain in approximately 30 adult subjects of unspecified gender who were vaccinated with TWINRIX (GlaxoSmithKline) for prophylaxis. Concurrent vaccination included unspecified vaccine given on an unspecified date. It was reported that it was possibly four other vaccines that were given on the same date as TWINRIX. On an unspecified date after September 2007 and before 07 February 2008, the subjects received unspecified dose of TWINRIX (1 ml, unknown deltoid). At the time of injection, the subject experienced injection site pain, injection site burning and injection site stinging. The adverse events resolved after the injection. This case was also associated with a pharmaceutical product complaint. The lot number that was reported was AHABB103AA. The reported noted that she had been using the thimersol free formulation based in NDC. The lot number and expiration that she reported was from January 2008 and she does not know the lot number that she used prior th that. The nurse contributes the increased discomfort to the reformulation of the product. At the time of reporting th outcome of th events were resolved. Follow-up was received on 25 February 2008 via the nurse. She reported that events resolved and she considered that the events were related to TWINRIX. She noted that the events were not serious. She noted that these events did happen to several subjects but she did not keep a list of names at the time.
Age: 51.0
Sex: F
Vaccine: HEPAB
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of diarrhea in a 51-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). The subject's medical history included gastrointestinal sensitivity, high blood pressure and sulfa allergy. Previous vaccination included the 1st dose of TWINRIX (GlaxoSmithKline) given on an unspecified date. Concurrent medications included Atenolol and PREMARIN. On 19 February 2008 the subject received the 2nd dose of TWINRIX (1ml unknown, right arm). On 19 February 2008, less than one day after vaccination with TWINRIX, the subject experienced diarrhea. On the morning of February 2008, the subject experienced nausea. Later in the day on 20 February 2008, the subject experienced vomiting. The nausea and vomiting resolved at an unspecified time on the same day the symptoms developed. At the time of this report, diarrhea was reported to be improved, but not resolved. The healthcare professional stated that the subject experienced no symptoms following her 1st dose of the TWINRIX vaccine. The healthcare professional considered the events were probably related to vaccination with TWINRIX. Follow-up information was received on 11 March 2008 via a nurse, who reported that the events were improved. The healthcare professional did not consider the events to be serious, and listed rest and time to recover as the only action taken following these events. The nurse stated that the immunization series had not been continued at the time of this report, as the subject is awaiting her physician's opinion as to whether the 3rd dose of the TWINRIX series should be administered.
Age: 27.0
Sex: F
Vaccine: HEPAB
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of elevated alanine aminotransferase in a 27-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). The subject's medical history was unknown. It was unknown if the subject had any concomitant medications or if she had any adverse events following previous vaccinations. Social history included a monogamous relationship. The subject denied intravenous drug use. On 25 March 2008, the subject received 1st dose of TWINRIX (1 ml, unknown, left arm). No other vaccinations were given on 25 March 2008. On 26 March 2008, 1 day after vaccination with TWINRIX, the subject had routine lab work done that showed elevated alanine aminotransferase and elevated aspartate aminotransferase. It was reported that the alanine aminotransferase was extremely high, but no specific numbers were provided. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified. The healthcare professional considered the events were possibly related to vaccination with TWINRIX.
Age: 61.0
Sex: M
Vaccine: HEPAB
Symptoms: No adverse event
Clinical narrative: This case was reported by a healthcare professional, via a GSK sales representative, and described the occurrence of pain in an adult male subject who was vaccinated with TWINRIX (GlaxoSmithKline). On 16 January 2008 and on an unspecified date, the subject received the 1st dose and 2nd dose of TWINRIX (1 ml, intramuscularly, left arm). At an unspecified time after vaccination with TWINRIX, the subject experienced pain and reduced range of motion. The sales representative had limited information to provide, but stated that the same adverse events occurred following the 1st and 2nd doses of TWINRIX. At the time of reporting, the outcome of the events was unspecified. Follow-up information was received on 09 May 2008 via a healthcare professional, who indicated that this case was reported to a Regulatory Agency (VAERS ID # 309478). The subject was a 61 year-old male who was reported to have a "cold" on the date of vaccination with TWINRIX. It was unspecified if the subject had the cold on the date (s) of the 1st and/or 2nd doses of the TWINRIX vaccination (s). Concomitant medications at the time of vaccination with TWINRIX included an unspecified thyroid medication. The subject had no history of adverse events following previous vaccinations. The immunization series was neither delayed, nor discontinued. The symptoms did not recur following subsequent vaccinations (dates and doses unspecified). The healthcare professional reported that the onset date of the earliest signs or symptoms occurred on 16 January 2008. The reporting healthcare professional indicated that the events were not serious, and considered the events to be unrelated to vaccination with TWINRIX. At the time of reporting, the outcome of the events was unknown.
Age: 57.0
Sex: F
Vaccine: HEPAB
Symptoms: No adverse event
Clinical narrative: This case was reported by a healthcare professional, via a GSK sales representative, and described the occurrence of pain in an adult female subject who was vaccinated with TWINRIX (GlaxoSmithKline). On 16 January 2008 and on an unspecified date, the subject received the 1st dose and 2nd dose of TWINRIX (1 ml, intramuscular, left arm). At an unspecified time after vaccination with TWINRIX, the subject experienced pain and reduced range of motion. The sales representative had limited information to provide, but stated that the same adverse events occurred following the 1st and 2nd doses of TWINRIX. At the time of reporting, the outcome of the events was unspecified. Follow-up information was received on 09 May 2008 via a healthcare professional, who indicated that this case was reported to a Regulatory Agency (VAERS ID #309493). The subject was a 57 year-old female who was taking the following concomitant medications at the time of vaccination with TWINRIX, CELEXA, LORAZEPAM, Glucosamine sulfate, SEROQUEL, Vitamins, VIVELLE-DOT, Aspirin, Calcium and GINKGO BILOBA. The subject had no history of adverse events following previous vaccinations. The immunization series was neither delayed, nor discontinued. The symptoms did not recur following subsequent vaccinations (dates and doses unspecified). The healthcare professional reported that the onset date of the earliest signs or symptoms occurred on 16 January 2008. The reporting healthcare professional indicated that the events were not serious, and considered the events to be unrelated to vaccination with TWINRIX. At the time of reporting, the outcome of the events was unknown.
Age: 88.0
Sex: F
Vaccine: HEPAB
Symptoms: Hepatitis A antibody, Hepatitis B antibody negative, Pharmaceutical product complaint
Clinical narrative: This case was reported by a physician via a representative and described the occurrence of an 88 year old female subject not responding to therapy following vaccination with TWINRIX, GlaxoSmithKline.  On 29 January 2008, the subject received 3rd dose of TWINRIX (unknown) to complete the vaccination series.  The 1st dose was given on 24 July 2007 and the 2nd on 28 August 2007.  On 28 April 2008, the subjects titers were tested and it was found that the subject had not responded to therapy.  She was hepatitis B antibody negative.  The physician felt that there might be something wrong with the TWINRIX vaccination (product complaint).  At the time of reporting the events were unresolved.  The physician considered the events were probably related to vaccination with TWINRIX.  The reporter gave details on two separate subjects (A0730576 and A0730976), but indicated that there were more that received this particular TWINRIX, completing the series and not achieving seroprotection.  For these additional subjects, refer to case A0731173A.
Sex: M
Vaccine: HEPAB
Symptoms: Hepatitis B antibody abnormal, Pharmaceutical product complaint, Therapeutic response decreased
Clinical narrative: this case was reported by a physician via a representative and described the occurrence of an adult male subject with decreased therapeutic response following vaccination with TWINRIX (GlaxoSmithKline) for prophylaxis. On an unspecified date the subject received 3rd dose of TWINRIX (unknown) to complete the vaccination series. At an unspecified time after vaccination with TWINRIX (thought by the sales representative to be 12 months from the completion of the series), the subject was tested and found to have a decreased therapeutic response with a hepatitis B surface antibody titer of 2 IM/ml. The physician felt that there might be something wrong with the TWINRIX vaccination (product complaint). At the time of reporting the events were unresolved. The physician considered the events were probably related to vaccination with TWINRIX. The reporter gave details on two separate subjects (A0730576 ans A0730976), but indicated that there were more that received this particular TWINRIX, completing the series and not achieving seroprotection. For these additional subjects, refer to case A0731173A.
Sex: U
Vaccine: HEPAB
Symptoms: No therapeutic response
Clinical narrative: This case was reported by a physician and described the occurrence of not responding to therapy in an unspecified number of subjects of unspecified ages and genders who were vaccinated with TWINRIX for prophylaxis. On an unspecified date (s) the subject (s) received the 1st, 2nd and 3rd dose of TWINRIX (unknown). On an unspecified date (s), unspecified titer (s) were tested and revealed that the subject (s) had not seroconverted. A physician reported that an unspecified number of subjects (ages and genders unspecified) completed the TWINRIX dosing series and were non-responders when post vaccination titers were tested. The physician reported that the results of the test were returning as "zero". The physician stated that post vaccination testing of the subjects occurred one month after the vaccination series was completed, and some of the subjects were tested 2 to 6 months after their dose of TWINRIX. The physician did not think the non-responders were due to a quality issue, but rather a combination vaccine issue. In addition, the physician stated that each subject has received a repeat series with monvalent Hepatitis B vaccines, and each subject and "high titers" following post vaccination testing. At the time of reporting, the outcome of the event's was unspecified.
Age: 56.0
Sex: M
Vaccine: HEPAB
Symptoms: Anorexia, Asthenia, Body temperature increased, Discomfort, Dizziness
Clinical narrative: This case was reported by a consumer and described the occurrence of blurred vision in a 56-year-old male subject who was vaccinated with TWINRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. There were no concurrent medications. In April 2008 (6 weeks ago), the subject received 1st dose of TWINRIX (unknown). At an unspecified time following the injection, the subject experienced a little weakness and loss of appetite, but he was otherwise fine. The subject purchased the TWINRIX that he received as his 2nd injection, but had it administered on 22 May 2008. He reported that two days later, on 24 May 2008, he was standing in from of his computer at work and experienced completely blurred vision and felt like fainting. He stated that he had to leave work immediately (unable to work) and was barely getting from one room to another (walking difficulty). He reported that the blurred vision and feeling of fainting improved. He stated that 10 to 15 minutes later, he was able to stand again. On 26 May 2006, 4 days following 2nd vaccination with TWINRIX, the subject threw up and developed a headache, which eventually improved. Also, on 26 May 2006, the subject developed a fever (100 to 101) for two days and a stiff neck, dizziness and no appetite. He was sleeping most of the time and was very uncomfortable. The subject kept a higher than normal temperature for a few more days. He also experienced muscle pain, especially in his legs. The subject continued to have dizziness and no appetite. He started to have pain in his left groin area. He also reported numbness in his groin area that spread to a part of his leg and was growing towards his lower abdomen. He reported that he is still tired to the point that he can't sit for long periods before he has to lie down. He reported that he took paracetamol for his fever and CIPRO for what he thought was an infection. The consumer felt that the TWINRIX had caused this systemic reaction. Not confirmed via a physician.
Age: 56.0
Sex: M
Vaccine: HEPAB
Symptoms: Fatigue, Gait disturbance, Groin pain, Headache, Hypoaesthesia
Clinical narrative: This case was reported by a consumer and described the occurrence of blurred vision in a 56-year-old male subject who was vaccinated with TWINRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. There were no concurrent medications. In April 2008 (6 weeks ago), the subject received 1st dose of TWINRIX (unknown). At an unspecified time following the injection, the subject experienced a little weakness and loss of appetite, but he was otherwise fine. The subject purchased the TWINRIX that he received as his 2nd injection, but had it administered on 22 May 2008. He reported that two days later, on 24 May 2008, he was standing in from of his computer at work and experienced completely blurred vision and felt like fainting. He stated that he had to leave work immediately (unable to work) and was barely getting from one room to another (walking difficulty). He reported that the blurred vision and feeling of fainting improved. He stated that 10 to 15 minutes later, he was able to stand again. On 26 May 2006, 4 days following 2nd vaccination with TWINRIX, the subject threw up and developed a headache, which eventually improved. Also, on 26 May 2006, the subject developed a fever (100 to 101) for two days and a stiff neck, dizziness and no appetite. He was sleeping most of the time and was very uncomfortable. The subject kept a higher than normal temperature for a few more days. He also experienced muscle pain, especially in his legs. The subject continued to have dizziness and no appetite. He started to have pain in his left groin area. He also reported numbness in his groin area that spread to a part of his leg and was growing towards his lower abdomen. He reported that he is still tired to the point that he can't sit for long periods before he has to lie down. He reported that he took paracetamol for his fever and CIPRO for what he thought was an infection. The consumer felt that the TWINRIX had caused this systemic reaction. Not confirmed via a physician.
Age: 56.0
Sex: M
Vaccine: HEPAB
Symptoms: Infection, Musculoskeletal stiffness, Myalgia, Pyrexia, Somnolence
Clinical narrative: This case was reported by a consumer and described the occurrence of blurred vision in a 56-year-old male subject who was vaccinated with TWINRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. There were no concurrent medications. In April 2008 (6 weeks ago), the subject received 1st dose of TWINRIX (unknown). At an unspecified time following the injection, the subject experienced a little weakness and loss of appetite, but he was otherwise fine. The subject purchased the TWINRIX that he received as his 2nd injection, but had it administered on 22 May 2008. He reported that two days later, on 24 May 2008, he was standing in from of his computer at work and experienced completely blurred vision and felt like fainting. He stated that he had to leave work immediately (unable to work) and was barely getting from one room to another (walking difficulty). He reported that the blurred vision and feeling of fainting improved. He stated that 10 to 15 minutes later, he was able to stand again. On 26 May 2006, 4 days following 2nd vaccination with TWINRIX, the subject threw up and developed a headache, which eventually improved. Also, on 26 May 2006, the subject developed a fever (100 to 101) for two days and a stiff neck, dizziness and no appetite. He was sleeping most of the time and was very uncomfortable. The subject kept a higher than normal temperature for a few more days. He also experienced muscle pain, especially in his legs. The subject continued to have dizziness and no appetite. He started to have pain in his left groin area. He also reported numbness in his groin area that spread to a part of his leg and was growing towards his lower abdomen. He reported that he is still tired to the point that he can't sit for long periods before he has to lie down. He reported that he took paracetamol for his fever and CIPRO for what he thought was an infection. The consumer felt that the TWINRIX had caused this systemic reaction. Not confirmed via a physician.
Age: 56.0
Sex: M
Vaccine: HEPAB
Symptoms: Vision blurred, Vomiting
Clinical narrative: This case was reported by a consumer and described the occurrence of blurred vision in a 56-year-old male subject who was vaccinated with TWINRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. There were no concurrent medications. In April 2008 (6 weeks ago), the subject received 1st dose of TWINRIX (unknown). At an unspecified time following the injection, the subject experienced a little weakness and loss of appetite, but he was otherwise fine. The subject purchased the TWINRIX that he received as his 2nd injection, but had it administered on 22 May 2008. He reported that two days later, on 24 May 2008, he was standing in from of his computer at work and experienced completely blurred vision and felt like fainting. He stated that he had to leave work immediately (unable to work) and was barely getting from one room to another (walking difficulty). He reported that the blurred vision and feeling of fainting improved. He stated that 10 to 15 minutes later, he was able to stand again. On 26 May 2006, 4 days following 2nd vaccination with TWINRIX, the subject threw up and developed a headache, which eventually improved. Also, on 26 May 2006, the subject developed a fever (100 to 101) for two days and a stiff neck, dizziness and no appetite. He was sleeping most of the time and was very uncomfortable. The subject kept a higher than normal temperature for a few more days. He also experienced muscle pain, especially in his legs. The subject continued to have dizziness and no appetite. He started to have pain in his left groin area. He also reported numbness in his groin area that spread to a part of his leg and was growing towards his lower abdomen. He reported that he is still tired to the point that he can't sit for long periods before he has to lie down. He reported that he took paracetamol for his fever and CIPRO for what he thought was an infection. The consumer felt that the TWINRIX had caused this systemic reaction. Not confirmed via a physician.
Sex: U
Vaccine: HEPAB
Symptoms: Arthralgia, Musculoskeletal pain, Neck pain, Pain, Pain in extremity
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of arm pain in a subject of unspecified age and gender who was vaccinated with TWINRIX manufacturer unspecified) for prophylaxis. On an unspecified date the subject received unspecified dose of TWINRIX at 1.0 ml. At the time of injection with TWINRIX, the subject experienced arm and shoulder pain. The reporter stated that this seems to be a recent problem, not experienced in the past and that it seems to occur irrespective of the person giving the vaccination or the technique used. subjects complain of a sudden, brief, but significant shooting pains to the elbow or sometimes up into the shoulder and neck. The reporter felt that a logical explanation would seem to be the fact that the Hepatitis A/Hepatitis B vaccine uses a larger volume (1.0ml) that many other vaccines (0.5ml), but it does not explain why these events have not happened in the past with this vaccine or why it does not happen when the same vaccines are given as separate injections. This was considered to be a product complaint. At the time of reporting the outcome of the events was unspecified. These events occurred in a number of different subjects from the same source. This case A0732483A serves as the master and other linked cases include A0732491A, and A0732492A. Additional linked cases include A0732500A, A0732501A, A0732515A, A0432528A, A0732533A, A0732539A, A0732540A, A0732936A and A0732944A.
Sex: U
Vaccine: HEPAB
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of arm pain in a subject of unspecified age and gender who was vaccinated with TWINRIX, manufacturer unspecified.  On an unspecified date the subject received unspecified dose of TWINRIX at 1.0 ml.  At the time of injection with TWINRIX, the subject experienced arm pain and shoulder pain.  The reporter stated that this seems to be a recent problem, not experienced in the past and that it seems to occur irrespective of the person giving the vaccination or the technique used.  Subjects complain of a sudden, brief, but significant pain that shoots down the arm to the elbow or sometimes up into the shoulder and neck.  The reporter felt that a logical explanation would seem to be the fact that the TWINRIX vaccine uses a larger volume (1.0ml) than many other vaccines (0.5ml), but it does not explain why these events have not happened in the past with this vaccine or why it does not happen when the same vaccines are given as separate injections.  This was considered to be a product complaint.  At the time time of reporting the outcome of the events was unspecified.  These events occurred in a number of different subjects from the same source, but with different contacts.  Case A0732483A serves as the master and other linked cases include A0732491A and A0732492A.  Additional linked cases include A0732500A, A0732501A, A0732515A, A0732528A, A0732533A, A0732539A, A0732540A, A0732936A and A0732944A.
Age: 33.0
Sex: M
Vaccine: HEPAB, TYP
Symptoms: Hepatitis B surface antigen positive
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of hepatitis B antigenemia in a male subject to unspecified age who was vaccinated with TWINRIX for prophylaxis. On an unspecified date the subject received unspecified dose of TWINRIX at 1.0 ml. At an unspecified time after vaccination with TWINRIX, the subject donated blood and tested positive for hepatitis B surface antigen. At the time of reporting the outcome of the event was unspecified. The healthcare professional considered the event was possibly related to vaccination with TWINRIX. Follow-up information received on 13 June 2008 indicated that the subject was 34 years old at the time of the event. The first dose of TWINRIX was administered to the subject on 14 April 2008. On 21 April 2008, the subject tested positive for hepatitis B surface antigen. Other concurrent vaccinations given on 14 April 2008 included Tdap vaccine and TYPHIM Vi, both given intramuscularly. The outcome of the event was unknown at the time of the follow-up and the event was considered possibly related to TWINRIX.
Sex: U
Vaccine: HEPAB
Symptoms: Injection site pain
Clinical narrative: This case was reported by a physician and described the occurrence of pain during injection in a subject of unspecified age and gender who was vaccinated with hepatitis A and hepatitis B (manufacturer unspecified). On an unspecified date the subject received unspecified dose of Hepatitis A/Hepatitis B vaccine (intramuscular, unknown). During vaccination with Hepatitis A/Hepatitis B vaccine, the subject experienced pain during injection. At the time of reporting the outcome of the event was unspecified. This case, A0732500A, is linked to a number of cases from the same source, but with different contacts. Linked cases include A0732483A, A0732491A, A00732492A, A0732501A, A0732515A, A0732528A, A0732533A, A0732539A, A0732540A, A0732936A and A0732944A.
Sex: U
Vaccine: HEPAB
Symptoms: Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of arm pain in a subject of unspecified age and gender who was vaccinated with TWINRIX(manufacturer unspecified) for prophylaxis. On an unspecified date the subject received unspecified dose of TWINRIX. At the time of injection with TWINRIX, the subject experienced arm pain and shoulder pain. The reporter stated that it seems to occur irrespective of the person giving the vaccination, technique used or the dose number. Subjects complain of a sudden, brief, but significant pain that shoots down the arm to elbow or sometimes up into the shoulder and neck. This was considered to be a product complaint. At the time of reporting the outcome of the events was unspecified. These events occurred in a number of different subjects from the same source, But with different contacts. Linked cases include A0732483A, A0732491A, A0732492A, A0732500A, A0732501A, A0732515A, A0732528A, A0732533A, A0732539A, A0732540A, A0732936A, and A0732944A.
Sex: M
Vaccine: HEPAB
Symptoms: Burning sensation, Paraesthesia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of burning in a male subject of unspecified age who was vaccinated with TWINRIX, manufacturer unspecified. On an unspecified date the subject received unspecified dose of TWINRIX. At an unspecified amount of time following injection tingling. The burning and tingling worked it's way down the arm. The reporter stated that the events only last 2 to 5 minutes and then seem to be fine. Resolution was not specifically stated. The reporter felt that this was not occurring say 6 months ago. These events occurred in a number of different subjects from the same source, but with different contacts. Linked cases include A0732540A, A0732491A, A0732492A, A0732500A, A0732501A, A0732515A, A73252BA, A0732533A, A0732539A, A0732540A, A0732936A and A0732944A.
Sex: F
Vaccine: HEPAB
Symptoms: Burning sensation, Paraesthesia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of burning in a female subject of unspecified age who was vaccinated with TWINRIX. On an unspecified date, the subject received unspecified dose of TWINRIX. At an unspecified amount of time following injection with TWINRIX, the subject experienced burning and tingling. The burning and tingling worked it's way down the arm. The reporter stated that the events only last 2 to 5 minutes and then seem to be fine. Resolution was not specifically stated. The reporter felt that this was not occurring say 6 months ago. These events occurred in a number of different subjects from the same source, but with different contacts. Linked cases included A0732483A, A0732491A, A0732492A, A0732500A, A0732501A, A0732515A, A732528A, A0732533A, A0732539A, A0732540A, A0732936A, A0732944A.
Sex: U
Vaccine: HEPAB
Symptoms: Injection site irritation, Injection site pain, Pain
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of burning pain in a subject of unspecified age and gender who was vaccinated with TWINRIX. On an unspecified date the subject received unspecified dose of TWINRIX. At an unspecified amount of time following injection with TWINRIX, the subject experienced burning pain that seemed to shoot down the arm lasting 2 to 3 minutes after the injection. The reporter consulted with the rep for this vaccine and was told that there have been other reports of "pain" during injection associated with this vaccine/ Since there has been no change in the formulation of  the TWINRIX used, the reason for this type of reaction in the last 4 to 5 months is unclear. This was considered to be a product complaint. The outcome of the events was unknown. These events occurred in a number of different subjects from the same source, but with different contacts. Linked cases include A0732483A, A0732491A, A0732492A, A0732500A, A0732501A, A0732515A, A0732528A, A0732533A, A0732539A, A0732936A and A0732944A.
Sex: U
Vaccine: HEPAB
Symptoms: Pain
Clinical narrative: This case was reported by a physician (also the subject) and described the occurrence of pain in subject of unspecified age and gender who was vaccinated with TWINRIX for prophylaxis. On an unspecified date the subject received unspecified dose of TWINRIX (unknown). At an unspecified time after vaccination with TWINRIX, the subject experienced a little pain. At the time of reporting the outcome of the event was unspecified. These events occurred in a number of different subjects from the same source, but with difference contacts. Linked case included A0732483A, A0732491A, A0732492A, A0732500A, A0732591A, A0732515A, A0732528A, A0732533A, A0732539A, A0732540A and A0732936A.
Age: 53.0
Sex: M
Vaccine: HEPAB
Symptoms: Injection site pain, Pyrexia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site tenderness in a 53-year-old male subject who was vaccinated with TWINRIX (GlaxoSmithKline), TYPHIM VI. There were no concurrent medications. On 3 June 2008, the subject received unspecified dose of Typhoid vaccine in the right deltoid. At an unspecified time after vaccination with typhoid vaccine, the subject developed some injection site tenderness. The outcome of the event was not reported. On 4 June 2008, at 13:15, the subject received 1st dose of TWINRIX at 1.0 ml in the left arm. On 4 June 2008, approximately 2 hours after vaccination with TWINRIX, the subject developed a low grade fever and later that evening, mild injection site tenderness. At the time of reporting, the events were improved. In the reporter's opinion, the event of injection site tenderness was probably related to treatment with TWINRIX. The relationship of the fever to TWINRIX was not known. Follow-up information received on 08 July 2008, indicated that the onset of low grade fever and injection site tenderness began on 05 June 2008, 1 day following administration of TWINRIX. All of the events were resolved by 12 June 2008. The events were related to treatment with suspect vaccines, Typhoid and TWINRIX. It was noted that TWINRIX had been administered intramuscularly and the 2nd dose had not been given yet.
Age: 39.0
Sex: M
Vaccine: HEPAB
Symptoms: Injection site irritation, Injection site pain
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of burning down arm in a subject of unspecified age and gender who was vaccinated with TWINRIX (GlaxoSmithKline) for prophylaxis. On an unspecified date the subject received unspecified dose of TWINRIX (unknown). At an unspecified time after vaccination with TWINRIX, the subject experienced burning down arm. At the time of reporting th outcome of the event was unspecified. Follow-up information received on 08 July 2008 indicated that the subject was a 39 year old male. At the time of injection of the 1st dose of TWINRIX,  intramuscularly, the subject experienced burning down the arm and aching at the time of injection. The events resolved and were considered by the reporter to be related to treatment with TWINRIX. The reporter stated that she has had several clients in the past 2 to 3 months complain of these symptoms at the time of injection without ongoing effect.
Age: 39.0
Sex: M
Vaccine: HEPAB
Symptoms: Injection site pain, Skin burning sensation
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of burning down arm in a subject of unspecified age and gender who was vaccinated with TWINRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of TWINRIX (unknown). At an unspecified time after vaccination with TWINRIX, the subject experienced burning down arm. At the time of reporting the outcome of the event was unspecified. Follow-up information received on 08 July 2008 indicated that the subject was a 39 year old male. At the time of injection of the 2nd dose of TWINRIX, intramuscularly, the subject experienced burning down the arm and aching at the time of injection. The events resolved and were considered by the reporter to be related to treatment with TWINRIX. The reporter stated that she has had several clients in the past 2 to 3 months complain of these symptoms at the time of injection without ongoing effect.
Age: 39.0
Sex: M
Vaccine: HEPAB
Symptoms: Vaccine positive rechallenge
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of burning down arm in a subject of unspecified age and gender who was vaccinated with TWINRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of TWINRIX (unknown). At an unspecified time after vaccination with TWINRIX, the subject experienced burning down arm. At the time of reporting the outcome of the event was unspecified. Follow-up information received on 08 July 2008 indicated that the subject was a 39 year old male. At the time of injection of the 3rd dose of TWINRIX intramuscularly, the subject experienced burning down the arm and aching at the time of injection. The events resolved and were considered by the reporter to be related to treatment with TWINRIX. The reporter stated that she has had several clients in the past 2 to 3 months complain of these symptoms at the time of injection without ongoing effect.
Sex: U
Vaccine: HEPAB
Symptoms: Injection site irritation, Injection site pain
Clinical narrative: This case was reported by a healthcare professional, via a GSK sales representative, that described the occurrence of injection site burning in an unspecified number of adult subjects of unspecified gender who were vaccinated with TWINRIX (GlaxoSmithKline). On an unspecified date (s), the subject (s) received an unspecified dose of TWINRIX (unknown). At an unspecified time after vaccination with TWINRIX, the subject (s) experienced injection site burning. A nurse reported that she has noticed an increase in the number of subjects experiencing burning after administration of TWINRIX. The nurse had no patient specific information, but stated that the subjects were adults vaccinated in the last few months. At the time of reporting, the outcome of the event was unspecified. Follow-up information was received on 18 July 2008 via a nurse, who reported that over the past few months, approximately one in four subjects complained of burning and pain with injection. The nurse stated that this is a tend she has noticed, as she had not previously heard those types of comments from vaccination subjects. The nurse further stated that these events are not related to time of day, injection with other vaccines, age or sex of the vaccination subjects.
Age: 45.0
Sex: M
Vaccine: HEPAB
Symptoms: Oropharyngeal pain, Pyrexia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of low grade temperature in a male subject of unspecified age who was vaccinated with TWINRIX (GlaxoSmithKline). Concurrent medical conditions included sarcoidosis. On 20 June 2008, the subject received 1st dose of TWINRIX (1 ml, unknown). On 24 June 2008, four days after vaccination with TWINRIX, the subject returned to the medical office and reported a low grade temperature and sore throat. The reporting healthcare professional was unsure if the events were related to the TWINRIX vaccination or some other illness. At the time of reporting, the sore throat was worse, and the outcome of the fever was unknown. Follow-up information was received on 21 July 2008 via a healthcare professional, who reported that the subject was a 45-year-old male. In addition to the previously reported adverse events to be serious nor related to vaccine with TWINRIX. The related professional stated that several patients reported similar symptoms, all of which resolved within 24 hours. However, none of the other patients with these symptoms received a TWINRIX vaccination.
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of drug administration, Seroconversion test negative
Clinical narrative: This case was reported by a health care professional (also the consumer) and described the occurrence of non-seroconversion in a female subject of unspecified age who was vaccinated with TWINRIX (GlaxoSmithKline). On an unspecified date the subject completed a three dose series of TWINRIX. At an unspecified time after completion of the TWINRIX series, it was discovered that the subject had not seroconverted. It was also noted that the 3rd dose of TWINRIX was administered too early. This was an inappropriate scheduled of drug administration. No adverse events were reported.
Sex: M
Vaccine: HEPAB
Symptoms: Hepatic enzyme increased, Hepatitis, Jaundice
Clinical narrative: This case was reported by a consumer and described the occurrence of hepatitis in a male subject of unspecified age who was vaccinated with TWINRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date, the subject received the 3rd dose of the TWINRIX vaccination series (unknown). At an unspecified time after vaccination with TWINRIX, the subject developed jaundice and was admitted to the hospital (dates and duration unspecified) with non specific hepatitis, and elevated liver enzyme tests. At the time of reporting, the outcome of the events was unspecified.
Age: 40.0
Sex: F
Vaccine: DTAP, HEPAB, IPV, TYP
Symptoms: Urticaria
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of mild hives in a female subject aged 40 and 29 years old who was vaccinated with TWINRIX (GlaxoSmithKline), Polio vaccine, DTAP and Typhoid injection. There were no concurrent medications. In June 2008 the subject received 1st dose of TWINRIX at 1.0 ml in an unknown arm. On the same day, the subject also received unspecified dose of Polio vaccine (unknown), unspecified dose of DTAP (unknown), unspecified dose of Typhoid injection (unknown). One day after receiving TWINRIX and other vaccines, the subject developed mild hives. She treated herself with BENADRYL and the hives resolved right away (the same day).
Age: 63.0
Sex: F
Vaccine: HEPAB
Symptoms: Hepatitis B, Hepatitis B surface antigen positive
Clinical narrative: This case was reported by a pharmacist and described the occurrence of hepatitis b surface antigen positive in a 63-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). There were no concurrent medications. On 25 June 2008 the subject received 1st dose of TWINRIX at 1.0 ml intramuscularly in the right arm. This was the 1st dose in the accelerated schedule for administering TWINRIX. Following this 1st injection, the subject donated blood. Recently, the subject received a letter stating that she could no longer give blood because her blood tested positive for hepatitis B surface antigens which to them indicated that she has hepatitis B. As of 17 July, 2008 the subject has received three of the  four doses of TWINRIX at the accelerated schedule. Follow-up information was received on 11 August 2008 via a pharmacist, who reported that the TWINRIX vaccination series was neither delayed nor discontinued. The pharmacist stated that the subject was removed from the blood donor list. At the time of reporting, the events were unresolved. The reporting pharmacist did not consider the events to be serious, indicating that the events have been due to a lack of knowledge on behalf of the blood center.
Sex: F
Vaccine: HEPAB
Symptoms: Cytomegalovirus antibody positive, Hepatitis B surface antigen positive
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of antigenemia in an adult female subject who was vaccinated with TWINRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of TWINRIX (unknown). It was reported that approximately one month after the subject's 1st vaccination with TWINRIX, she experienced antigenemia. No additional information was reported.