chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEP
Symptoms: 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 an unspecified number of subject of unspecified ages and gender who were vaccinated with ENGERIX B (GlaxoSmithKline). On unspecified dates the subjects received unspecified doses of ENGERIX B (40 mcg, unknown). At unspecified times after vaccinations with ENGERIX B, the subjects experienced decreased therapeutic response. The healthcare professional reported the after administering the 40 mcg dose of ENGERIX B for the dialysis center's subjects, 60 to 70 percent of the subjects have to be revaccinated due to low titer levels. No subject specific details were available. At the time of the report, no other information was available.
Age: 55.0
Sex: F
Vaccine: HEP
Symptoms: No therapeutic response, Rash generalised
Clinical narrative: This case was reported by a consumer via Merck and described the occurrence of full body rash in a female subject of unspecified age who was vaccinated with ENGERIX B (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of ENGERIX B (unknown). At an unspecified time after vaccination with ENGERIX B, the subject experienced full body rash and unspecified event. The subject reported that she experienced a full body rash after receiving Hepatitis B vaccine. She also reported that the vaccine "did not take". At the time of the report, no other information was provided. At the time of reporting the outcome of the full body rash and unspecified event was unspecified. Follow-up information was reported on 16 March 2010 via consumer. The subject reported with the 1st dose of hepatitis B vaccine a rash covered body that night. She stated she reported the rash and was instructed to discontinue the vaccination series. The subject reported her transplant nephrologist arranged for her received the hepatitis B vaccine from a different pharmaceutical company (brand name not provided) and the doses were administered at his office in 2005. She was approved for a kidney transplant in 2005, started and completed vaccinations before January 2006 when she began dialysis followed by transplant in March 2006. On an unspecified date in 2010, the subject's blood was drawn and she was found to have no immunity to Hepatitis B. The subject restarted the Hepatitis B vaccination series with Merck product and is doing "o.k. so far". Follow-up information was received on 20 April 2010, via healthcare professional who reported the earliest onset of the events was 23 June 2005. The outcome of the events was noted to have improved, end date was unknown. The subject had no previous adverse event following first dose. The vaccination series was discontinued. No biopsy was performed. The reporting healthcare professional considered the events not serious. The healthcare professional associated the event to unknown, received multiple vaccines following kidney transplant surgery.
Sex: U
Vaccine: HEP
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site induration in a subject of unspecified age and gender who was vaccinated with ENGERIX B (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of ENGERIX B (unknown). At an unspecified time after vaccination with ENGERIX B, the subject experienced injection site induration and injection site redness. The subject received ENGERIX B and experienced red induration at the injection site. At the time of the report no other details were provided. At the time of reporting the injection site induration and injection site redness were unresolved. The pharmacist reported another adverse event with ENGERIX B, see case A0848459A.
Sex: U
Vaccine: HEP
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site induration in a subject of unspecified age and gender who was vaccinated with ENGERIX B (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of ENGERIX B (unknown). At an unspecified time after vaccination with ENGERIX B, the subject experienced injection site induration and injection site redness. The subject received ENGERIX B and experienced red induration at the injection site. At the time of the report no other details were provided. At the time of reporting the injection site induration and injection site redness were unresolved. The pharmacist reported another adverse event with ENGERIX B, see case A0848454A.
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Dyspnoea, Gastrointestinal disorder, Oropharyngeal pain, Pyrexia
Clinical narrative: This case was reported by a physician and described the occurrence of sore throat in a 33-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). On either 14 April 2010 or 19 April 2010 (conflicting information was provided), the subject received 1st dose of ENGERIX B (20 mcg, unknown route, left arm). On either 16 April 2010 or 21 April 2010, 48 hours after vaccination with ENGERIX B, the subject experienced sore throat, fever, shortness of breath and gastrointestinal symptoms. The subject visited an urgent care office and her heart rate was monitored (results not provided), but she was not treated and was not hospitalized. At the time of reporting the events were resolved. The physician considered the events of sore throat, shortness of breath and gastrointestinal symptoms were probably related to vaccination with ENGERIX B. Causality statement for the event of fever was not provided.
Sex: U
Vaccine: HEP
Symptoms: Herpes virus infection, Oral herpes
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of herpes flareup in a subject of unspecified age and gender who was vaccinated with Hepatitis Bvaccine (manufacturer unspecified). On an unspecified date the subject received unspecified dose of Hepatitis B vaccine (details unknown). At an unspecified time after vaccination with Hepatitis B vaccine, the subject experienced herpes flareup and herpetic mouth sore. At the time of reporting the outcome of the events was unspecified. The healthcare professional had inquired as to whether getting the Hepatitis B vaccine would cause a herpes flare up causing sores in mouth. No further information was provided.
Age: 46.0
Sex: M
Vaccine: HEP
Symptoms: Nausea, Vertigo
Clinical narrative: This case was reported by a pharmacist and described the occurrence of nausea in a 46-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent medical conditions included human immunodeficiency virus and hypothyroidism. Concurrent medications included Anti-viral medication and Thyroxine. On 6 May 2010 and 26 April 2010 the subject received 2nd dose and 1st dose of ENGERIX B (40 mcg, unknown). It was noted that within 24 hours of 2nd vaccination with ENGERIX B( administered in the morning), the subject experienced nausea and vertigo. It was suggested that these events occurred with 1st vaccination with ENGERIX B, however no specifics were provided. The events resolved and were considered to be possibly related to treatment with ENGERIX B. At the time of reporting the events were resolved. The pharmacist considered the events were possibly related to vaccination with ENGERIX B.
Age: 59.0
Sex: M
Vaccine: HEP
Symptoms: Heart rate increased
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of increased heart rate in a 59-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). On 9 June 2010 the subject inadvertently received 2nd dose of ENGERIX B via incorrect route (intravenous), and experienced intramuscular formulation administered by other route. On 9 June 2010, less than one day after vaccination with ENGERIX B, the subject experienced increased heart rate. At the time of reporting the events were resolved. The healthcare professional reported that the subject was stable and no other adverse events were observed.
Age: 40.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Allergy to vaccine
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of allergy to vaccine in a 40-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent medical conditions included allergy to yeast. Previous and/or concurrent vaccination included TDAP vaccine (non-gsk); Merck; unknown given on 12 June 2009. On 12 June 2009 and 27 July 2009 the subject received 1st dose and 2nd dose of ENGERIX B (20 mcg, unknown route). On 12 June 2009, less than one day after the 1st vaccination with ENGERIX B, the subject experienced allergy to vaccine. After the next vaccination with ENGERIX B the events recurred. On 27 July 2009, less one than day after the 2nd vaccination with ENGERIX B, the subject experienced allergy to vaccine. At the time of reporting the outcome of the events was unspecified. The healthcare professional reported that the subject on both occasions experienced "seasonal allergy like type of symptoms". The subject believed it may be attributable to the yeast component as she stated she had found out she is allergic to baker's yeast. The subject was due to attend the office to provide more details regarding medical history and specific symptoms.
Age: 18.0
Sex: M
Vaccine: HEP
Symptoms: Blood test abnormal, Gait disturbance, Joint effusion, Tremor
Clinical narrative: This case was reported by a healthcare professional (also the subject's mother) and described the occurrence of joint effusion in a 18-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). On 25 August 2003 the subject received 1st dose of ENGERIX B (unknown route, unknown arm). The subject did not receive the 2nd dose of ENGERIX B because he had a cold at the time it was due. The healthcare professional did not consider the cold related to vaccination with ENGERIX B. On an unspecified date in November 2003, approximately 3 months after vaccination with ENGERIX B, the subject experienced joint effusion of his knees, hands and elbows. He also experienced difficulty walking and hand tremor due to the joint effusion. Relevant test results included "slight blood work abnormalities, but nothing they were concerned about". The subject was treated with prednisone and evaluated by his physician. At the time of reporting the events were resolved. The vaccination course with ENGERIX B was discontinued.
Age: 61.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antigen positive
Clinical narrative: This case was reported by a physician and described the occurrence of hepatitis B surface antigen positive in a 61-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline) due to dialysis. Concurrent medical conditions included dialysis and hypertension. Concurrent medications included Unknown. On an unspecified date in July 2010 the subject received 1st dose of ENGERIX B (unknown route, unknown arm). One week after vaccination with ENGERIX B, the subject experienced hepatitis B surface antigen positive. At the time of reporting the outcome of the event was unspecified. The physician considered the event was possibly related to vaccination with ENGERIX B.
Age: 29.0
Sex: M
Vaccine: HEP
Symptoms: Arthralgia, Back pain, Fatigue, Malaise, Pyrexia
Clinical narrative: This case was reported by a pharmacist (also the subject) and described the occurrence of high fever in a 29-year-old male subject who was vaccinated with ENGERIX B pediatric (GlaxoSmithKline). Concurrent medications included Multivitamins. On 10 August 2010 at 09:00 the subject received 2 doses of ENGERIX B pediatric (unknown route, right deltoid) in place of the 3rd dose of ENGERIX B adult in the series. On 10 August 2010, less than one day after vaccination with ENGERIX B pediatric, the subject experienced high fever, joint pain and back pain. At the time of reporting the outcome of the events was unspecified. Follow-up information was received from the reporter on 23 August 2010. The subject was administered 0.5 ml of both ENGERIX B vaccinations intramuscularly. On 10 August 2010, less than one day after vaccination with ENGERIX B pediatric, the subject also experienced fatigue and malaise. The reporter did not consider the high fever, joint pain or back pain to be serious events. The subject was treated with TYLENOL Extra Strength and ADVIL.
Sex: U
Vaccine: HEP
Symptoms: No therapeutic response
Clinical narrative: This case was reported by a physician, via a GSK representative, and described the occurrence of not responding to therapy or decreased therapeutic response in 24 subjects of unspecified age and gender who were vaccinated with ENGERIX B (GlaxoSmithKline). On unspecified dates the subjects received doses of ENGERIX B (details unknown) or hepatitis B vaccines. On unknown dates after completion of the vaccination series with ENGERIX B or hepatitis B vaccine, the subjects experienced not responding to therapy or decreased therapeutic response. Some of the subjects were re-vaccinated. The physician reported that 24 subjects had titers drawn after completion of the vaccine series. The titer results for the subjects were low or showed no immunity at all. Not all of the subjects received ENGERIX B, but they did receive some hepatitis B vaccination. Follow-up received on 24 August 2010: The subjects were aged between 10-19 years. The physician reported that their labwork came back with no immune response and there was no further information available.
Age: 46.0
Sex: F
Vaccine: HEP, TTOX
Symptoms: Arthralgia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of shoulder arthralgia in an adult female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent vaccination included tetanus toxoid vaccine; manufacturer unspecified; unknown; unknown given in May 2010. On an unspecified date in May 2010 the subject received 3rd dose of ENGERIX B (unknown route, left arm). In May 2010, less than one month after vaccination with ENGERIX B, the subject experienced left shoulder arthralgia. At the time of reporting the outcome of the event was unspecified. The healthcare professional considered the event was probably related to vaccination with ENGERIX B. The healthcare professional did not have the subject's chart at the time of reporting, so was unable to provide further information. Follow-up information was received on 02 September 2010. It was reported that the female subject was 46 years old at the time of event and that she had received a 1.0 ml dose of ENGERIX B. The event of shoulder arthralgia began on an unspecified date in May 2010 and was worse at the time of follow-up. The event was still considered to be probably related to treatment with ENGERIX B.
Age: 2.0
Sex: F
Vaccine: HEP, HIBV
Symptoms: Abdominal pain, Crying, Movement disorder
Clinical narrative: This case was reported by a physician (the subject's father) and described the occurrence of abdominal pain in a 2-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent vaccination included Haemophilius influenza type b vaccine; manufacturer unspecified; unknown given on 28 April 2010. On 28 April 2010 the subject received unspecified dose of ENGERIX B (.5 ml, unknown route and site). On 28 April 2010, less than one day after vaccination with ENGERIX B, the subject experienced abdominal pain and cramps, crying, "squealing" and "squirming". The abdominal pain and cramps lasted for 45 minutes. At the time of reporting the outcome of the events was unspecified.
Age: 57.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Vision blurred
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of lightheadedness in a 57-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline) for pre-employment physical. On 19 August 2010 at 13:30 the subject received 1st dose of ENGERIX B (standard dose, unknown route, left arm). On 19 August 2010, 1 hour after vaccination with ENGERIX B, the subject experienced lightheadedness, dizziness and intermittent blurred vision. .The physician who discharged her noted nothing unusual. On 19 August 2010, the events were resolved.
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Therapeutic response decreased
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of decreased therapeutic response in a male subject of unspecified age who was vaccinated with ENGERIX B (GlaxoSmithKline). On unspecified dates the subject received 1st dose, 2nd dose and 3rd dose of ENGERIX B (details unknown). On unspecified dates at an unknown time later, the subject received another complete 3-dose series of ENGERIX B; the 3rd dose was given on an unknown date in 2009 (details unknown). The subject experienced decreased therapeutic response. On an unknown date his titers were measured as less than 5 mIU/mL. There were no adverse events. No further information was provided.
Age: 3.0
Sex: M
Vaccine: HEP
Symptoms: Blood test, Rash generalised
Clinical narrative: This case was reported by a healthcare professional (also the subject's mother) and described the occurrence of widespread rash in a 3-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). The subject's medical history included vaccine reaction following MMR vaccine (non-gsk); non-GSK manufacturer; unknown given on an unspecified date. On 4 August 2010 at 15:30 the subject received 1st dose of ENGERIX B (unknown route, left arm). On 10 August 2010, 6 days after vaccination with ENGERIX B, the subject experienced rash on his trunk. The rash spread to his legs and the subject was taken to the doctor on 12 August 2010. At that point, the rash was all over his body. The subject was taken to the Emergency Room on 15 August 2010 and blood work was done (results not specified). The subject was treated with prednisone. At the time of reporting the outcome of the event was unspecified. The vaccination course with ENGERIX B was discontinued.
Sex: M
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 male subject of unspecified age who was vaccinated with Hepatitis B vaccine, (manufacturer unspecified). On an unspecified date the subject received unspecified dose of Hepatitis B vaccine (details unknown), and experienced not responding to therapy. The nurse reported that the subject's son (case ID A0880945A) stated that his father was also vaccinated (manufacturer unknown) and did not respond to the hepatitis B vaccine either.
Age: 53.0
Sex: F
Vaccine: HEP
Symptoms: Injection site induration, Injection site nodule, Injection site pain
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site induration in a 53-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent medications included ADDERALL. On 25 August 2010 the subject received 1st dose of ENGERIX B (20 mcg, unknown, right arm). On 25 August 2010, less than one day after vaccination with ENGERIX B, the subject experienced injection site induration, further described as a hard nodule at the injection site that was tender to the touch. The subject was treated with warm compresses. No other symptoms were reported. At the time of reporting the injection site induration was unresolved. The healthcare professional considered the event was probably related to vaccination with ENGERIX B.
Age: 35.0
Sex: M
Vaccine: HEP
Symptoms: Therapeutic response decreased, Viral titre decreased
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of decreased therapeutic response in a 37-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). On 22 May 2009 and on unspecified dates the subject received 3rd dose, 2nd dose and 1st dose of ENGERIX B (unknown) respectively. On 24 August 2010, approximately, 15 months after vaccination series completion with ENGERIX B, the subject experienced decreased therapeutic response. The subject had complete the three dose of ENGERIX B series (last dose was 22 May 2009) and his titers performed on 24 August 2010 were " found to be less than 5".
Sex: M
Vaccine: HEP
Symptoms: Therapeutic response decreased
Clinical narrative: This case was reported by a pharmacist and described the occurrence of decreased therapeutic response in a male subject of unspecified age who was vaccinated with ENGERIX B (GlaxoSmithKline). On January 2010 and an unspecified date the subject received 3rd dose, 2nd dose and 1st dose of ENGERIX B (unknown). In 2010, [See text] after vaccination with ENGERIX B, the subject experienced decreased therapeutic response.
Age: 35.0
Sex: M
Vaccine: HEP
Symptoms: No therapeutic response
Clinical narrative: This case was reported by a physician and described the occurrence of not responding to therapy in a 36-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). The subject's medical history included positive ppd test. Concurrent medications included INH and Vitamin B6. On unspecified dates the subject received 1st dose and 2nd dose of ENGERIX B (20 mcg) and on 4 November 2009 he received 3rd dose of ENGERIX B (20 mcg). The subject experienced not responding to therapy. The physician reported that the subject had received 3 doses of ENGERIX B. Last dose on 04 November 2009. No response with recent testing (date not provided).
Sex: U
Vaccine: HEP
Symptoms: Anti-HBc antibody negative, Inappropriate schedule of drug administration, 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 31 July 1989, 5 September 1989 and September 1995 the subject received 1st dose, 2nd dose and 3rd dose of ENGERIX B (20 mcg, unknown route and site), and experienced not responding to therapy and drug dose administration interval too long. The 3rd dose of ENGERIX B was administered more than the recommended 6 months after the series was started. The healthcare professional reported that lab tests were performed recently which showed a non-reactive level of HBcAb IgM. No further details were provided.
Sex: M
Vaccine: HEP
Symptoms: No therapeutic response
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of not responding to therapy in a male subject of unspecified age who was vaccinated with Hepatitis B vaccine (manufacturer unspecified). On an unspecified date the subject received 3rd dose of Hepatitis B vaccine (unknown). At an unspecified time after vaccination with Hepatitis B vaccine, the subject experienced not responding to therapy. The reporter indicated that the subject had lack of effect and was unsure of the brand of hepatitis B vaccine that was given. At the time of reporting, the reporter was not aware of any adverse events.
Sex: F
Vaccine: HEP
Symptoms: Therapeutic response decreased, Viral titre decreased
Clinical narrative: This case was reported by a pharmacist and described the occurrence of decreased therapeutic response in an adult female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). On unspecified date(s) the subject received unspecified dose(s) of ENGERIX B (0.5 ml, details unknown). On an unknown date after vaccination with unspecified dose(s) of ENGERIX B, the subject experienced decreased therapeutic response. The pharmacist reported that the subject was a new physician in her health system and had received her Hepatitis B vaccine at an unknown time prior to coming to the facility. The subject completed the series "some time ago". The subject recently had a child and her titers were checked after the birth of her child. When her titers were recently checked, they were low. There was no further information provided.
Sex: U
Vaccine: HEP
Symptoms: Antibody test negative, No therapeutic response
Clinical narrative: This case was reported by a physician and described the occurrence of not responding to therapy in a subject of unspecified age and gender who was vaccinated with ENGERIX B (GlaxoSmithKline). On unspecified dates starting in October 2000, the subject received 1st, 2nd and 3rd dose of ENGERIX B (details unknown) per schedule. Approximately ten years after receiving 1st, 2nd, and 3rd doses of ENGERIX B, on an unspecified date in August 2010, the physician assessed an antibody titer and no antibodies were measured. The subject experienced not responding to therapy. At that time, on an unspecified date in August 2010, the subject received a 4th dose of ENGERIX B (details unknown). A second titer was drawn about six weeks later and still showed no antibodies and the subject experienced not responding to therapy for a second time. At the time of this report, the physician was not able to provide additional details due to pressure for time.
Sex: U
Vaccine: HEP
Symptoms: Seroconversion test negative, Vaccine positive rechallenge
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of non-seroconversion in a "few" subjects of unspecified age and gender who were vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent medical conditions included hemodialysis. On unspecified dates the subjects received 1st dose, 2nd dose, 3rd dose and 4th dose of ENGERIX B (details unknown). The subjects experienced non-seroconversion. At an unspecified time later, the subjects received a second series of 1st dose, 2nd dose, 3rd dose and 4th dose of ENGERIX B (details unknown). The subjects experienced non-seroconversion. The healthcare professional reported that she had a few hemodialysis subjects in a few facilities who did not seroconvert after vaccination with ENGERIX B series. Even after a second series they did not seroconvert. No additional information was provided.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Condition aggravated, Dizziness, Vomiting
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of lightheadedness in a female subject aged between 20 and 29 years old who was vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent medical conditions included vomiting, prior to receiving the vaccination. On the morning of 20 October 2010 the subject received unspecified dose of ENGERIX B (20 mcg, unknown route, unknown arm). On the morning of 20 October 2010, less than one day after vaccination with ENGERIX B, the subject experienced lightheadedness and vomiting. The subject attended the Emergency Room, but was not hospitalized. On 20 October 2010, the events were resolved. The healthcare professional considered the event of lightheadedness was probably related to vaccination with ENGERIX B, and the event of vomiting was possibly related to vaccination with ENGERIX B. The healthcare professional reported that 3 subjects had experienced lightheadedness after vaccination with ENGERIX B. This is case 1 of 3 (see case IDs A0888943A and A0888946A for the other reports). Follow-up information was received on 10 November 2010 via physician who reported the 21-year old subject's immunization series with ENGERIX B was discontinued. At the time of the report no other information was provided. The lot number was reported as AHBV855AA from the reporter; however, based on a safety lot number review, the lot number was updated to AHBVB855AA.
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of lightheadedness in a female subject aged between 20 and 29 years old who was vaccinated with ENGERIX B (GlaxoSmithKline). On the morning of 20 October 2010 the subject received unspecified dose of ENGERIX B (20 mcg, unknown route, unknown arm). On the morning of 20 October 2010, less than one day after vaccination with ENGERIX B, the subject experienced lightheadedness. The subject attended the Emergency Room, but was not hospitalized. On 20 October 2010, the event was resolved. The healthcare professional considered the event was probably related to vaccination with ENGERIX B. The healthcare professional reported that 3 subjects had experienced lightheadedness after vaccination with ENGERIX B. This is case 2 of 3 (see case IDs A0888918A and A0888946A for the other reports). Follow-up information was received on 10 November 2010 via physician who reported the 39-year old subject's immunization series with ENGERIX B was discontinued. At the time of the report no other information was provided. The lot number was reported as AHBV855AA from the reporter; however, based on a safety lot number review, the lot number was updated to AHBVB855AA.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of lightheadedness in a female subject aged between 20 and 29 years old who was vaccinated with ENGERIX B (GlaxoSmithKline). On the morning of 20 October 2010 the subject received unspecified dose of ENGERIX B (20 mcg, unknown route, unknown arm). On the morning of 20 October 2010, less than one day after vaccination with ENGERIX B, the subject experienced lightheadedness. The subject attended the Emergency Room, but was not hospitalized. On 20 October 2010, the event was resolved. The healthcare professional considered the event was probably related to vaccination with ENGERIX B. The healthcare professional reported that 3 subjects had experienced lightheadedness after vaccination with ENGERIX B. This is case 3 of 3 (see case IDs A0888918A and A0888943A for the other reports). Follow-up information was received on 10 November 2010 via physician who reported the 19-year-old subject's immunization series with ENGERIX B was discontinued. At the time of the report no other information was provided. The lot number was reported as AHBV855AA from the reporter; however, based on a safety lot number review, the lot number was updated to AHBVB855AA.
Age: 26.0
Sex: M
Vaccine: HEP
Symptoms: Rash generalised
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of rash all over body in a 26-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent medications included Vitamin and ALEVE. On the morning of 22 September 2010 the subject received 1st dose of ENGERIX B (1 ml, unknown route, left arm). On the evening of 22 September 2010, less than one day after vaccination with ENGERIX B, the subject experienced rash all over body (except for his face). The subject was treated with BENADRYL. On 29 September 2010, the event was resolved.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Therapeutic response decreased
Clinical narrative: This case was reported by a physician, via a GSK representative, and described the occurrence of decreased therapeutic response in a 19-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). On unspecified dates the subject received 1st dose, 2nd dose and 3rd dose of ENGERIX B (details unknown). The 3rd dose was administered 3 to 4 years prior to the time of the report. At an unspecified time later, the subject was found to have a low antibody titer. No further details were provided.
Sex: U
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 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). At an unspecified time after vaccination series completion with ENGERIX B, the subject experienced not responding to therapy and pharmaceutical product complaint. A total of six employees were vaccinated with three doses of ENGERIX B. All had titers drawn at an unknown period after the third dose and the titers were negative (0) for antibodies. There were two lots given to these six subjects at some point in the series, lots: AHBV13734AA and AHBV670AA. The lot numbers were reported as AHBV13734AA and AHBV670AA from the reporter; however, based on a safety lot number review, the lot numbers were updated to AHBVB734AA and AHBVB670AA respectively. For the other cases see A0891213A- A0891217A. Follow-up information was received on 09November 2010 via Quality Assurance, who stated there was no product complaint associate with the adverse event; therefore the pharmaceutical product complaint was voided.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, No therapeutic response
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of 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). At an unspecified time after vaccination series completion with ENGERIX B, the subject experienced not responding to therapy and pharmaceutical product complaint. A total of six employees were vaccinated with three doses of ENGERIX B. All had titers drawn at an unknown period after the third dose and the titers were negative (0) for antibodies. There were two lots given to these six subjects at some point in the series, lots: AHBV13734AA and AHBV670AA. The lot numbers were reported as AHBV13734AA and AHBV670AA from the reporter; however, based on a safety lot number review, the lot numbers were updated to AHBVB734AA and AHBVB670AA respectively. For the other cases see A0891212A, A0891214A- A0891217A. Follow-up information was received on 09November 2010 via Quality Assurance, who stated there was no product complaint associate with the adverse event; therefore the pharmaceutical product complaint was voided.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, No therapeutic response
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of 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, 2nd dose and 1st dose of ENGERIX B (unknown). At an unspecified time after vaccination series completion with ENGERIX B, the subject experienced not responding to therapy and pharmaceutical product complaint. A total of six employees were vaccinated with three doses of ENGERIX B. All had titers drawn at an unknown period after the third dose and the titers were negative (0) for antibodies. There were two lots given to these six subjects at some point in the series, lots: AHBV13734AA and AHBV670AA. The lot numbers were reported as AHBV13734AA and AHBV670AA from the reporter; however, based on a safety lot review, the lot numbers were updated to AHBVB734AA and AHBVB670AA respectively. For the other cases see A0891212A, A0891213A, A0891215A- A0891217A. Follow-up information was received on 09 November 2010 via Quality Assurance, who stated there was no product complaint associate with the adverse event; therefore the pharmaceutical product complaint was voided.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, No therapeutic response
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of 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). At an unspecified time after vaccination series completion with ENGERIX B, the subject experienced not responding to therapy and pharmaceutical product complaint. A total of six employees were vaccinated with three doses of ENGERIX B. All had titers drawn at an unknown period after the third dose and the titers were negative (0) for antibodies. There were two lots given to these six subjects at some point in the series, lots: AHBV13734AA and AHBV670AA. The lot numbers were reported as AHBV13734AA and AHBV670AA from the reporter; however, based on a safety lot number review, the lot numbers were updated to AHBVB734AA and AHBVB670AA respectively. For the other cases see A0891212A- A0891214A, A0891216A, and A0891217A. Follow-up information was received on 09 November 2010 via Quality Assurance, who stated there was no product complaint associate with the adverse event; therefore the pharmaceutical product complaint was voided.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, No therapeutic response
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of 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). At an unspecified time after vaccination series completion with ENGERIX B, the subject experienced not responding to therapy and pharmaceutical product complaint. A total of six employees were vaccinated with three doses of ENGERIX B. All had titers drawn at an unknown period after the third dose and the titers were negative (0) for antibodies. There were two lots given to these six subjects at some point in the series, lots: AHBV13734AA and AHBV670AA. The lot numbers were reported as AHBV13734AA and AHBV670AA from the reporter; however, based on a safety lot number review, the lot numbers were updated to AHBVB734AA and AHBVB670AA respectively. For the other cases see A0891212A- A0891215A, and A0891217A. Follow-up information was received on 09November 2010 via Quality Assurance, who stated there was no product complaint associate with the adverse event; therefore the pharmaceutical product complaint was voided.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, No therapeutic response
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of 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). At an unspecified time after vaccination series completion with ENGERIX B, the subject experienced not responding to therapy and pharmaceutical product complaint. A total of six employees were vaccinated with three doses of ENGERIX B. All had titers drawn at an unknown period after the third dose and the titers were negative (0) for antibodies. There were two lots given to these six subjects at some point in the series, lots: AHBV13734AA and AHBV670AA. The lot numbers were reported as AHBV13734AA and AHBV670AA from the reporter; however, based on a safety lot number review, the lot numbers were updated to AHBVB734AA and AHBVB670AA respectively. For the other cases see A0891212A- A0891216A. Follow-up information was received on 09 November 2010 via Quality Assurance, who stated there was no product complaint associate with the adverse event; therefore the pharmaceutical product complaint was voided.
Age: 49.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B surface antigen positive
Clinical narrative: This case was reported by a physician and described the occurrence of hepatitis B surface antigen positive in a 49-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent medications included Heparin and EPOGEN. The subject was on dialysis. Relevant medical history included congenital hypocomplimentgenemia and tubular basement membrane nephritis. On 27 August 2010, 27 September 2010 and 27 October 2010 the subject received 1st dose, 2nd dose and 3rd dose of ENGERIX B (40 mcg, unknown, left arm). On 1 November 2010, 5 days after vaccination with dose 3 of ENGERIX B, 35 days after vaccination with dose 2 ENGERIX B, 66 days after vaccination with dose 1 ENGERIX B, the subject experienced hepatitis B surface antigen positive. Relevant diagnostic findings included hepatitis B surface antigenemia identified in a blood sample on 01 November 2010. At the time of reporting the outcome of the event was unspecified. The physician considered  the event was possibly related to vaccination with ENGERIX B.
Age: 76.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antigen positive, Liver function test normal
Clinical narrative: This case was reported by a physician and described the occurrence of hepatitis B surface antigen positive in a 66-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). The subject's medical history included open heart surgery with aortic valve replacement approximately 6-8 months ago. Concurrent medical conditions included type 2 diabetes. The subject's LFT's had never been elevated and she had not been diagnosed with Hepatitis B infection. She has one family member who has active Hepatitis B under treatment. Concurrent medications included Heparin, EPOGEN, and HECTOROL. The subject was on dialysis. On 30 August 2010, 27 September 2010 and 29 October 2010 the subject received 1st dose, 2nd dose and 3rd dose of ENGERIX B (40 mcg, unknown, right arm). On 1 November 2010, 3 days after vaccination with dose 3 of ENGERIX B, 35 days after vaccination with dose 2 of ENGERIX B, 63 days after vaccination with dose 1 of ENGERIX B, the subject experienced hepatitis B surface antigen positive. Relevant diagnostic findings included hepatitis B surface antigenemia identified in a blood sample on 01 November 2010. At the time of reporting the outcome of the event was unspecified. The physician considered the event was possibly related to vaccination with ENGERIX B.
Age: 0.19
Sex: M
Vaccine: RV5
Symptoms: Biopsy oesophagus normal, Biopsy rectum normal, Dehydration, Diarrhoea, Endoscopy gastrointestinal normal
Clinical narrative: The day after my son got the RotaTeq Vaccine he started having diarrhea 10-12 times a day. Before he got this vaccine he had been constipated since he was born. He had to have numerous stool samples done and got dehydrated due to the diarrhea happening so often. His Dr sent us to a GI Dr. who tested for Cystic Fibrosis and did more stool samples. When everything came back normal from that test he had to have a biopsy done in 12 different places from his esophagus to his rectum to test for numerous things. The only thing that came back abnormal was he had low enzymes in his pancreas. The GI Dr. determined that because he had ruled out all other possibilities in his opinion my son had an adverse reaction to the RotaTeq vaccine. My son had to be supplemented with enzymes in his food to get the levels in his pancreas back to normal and finally 3 1/2 months after he got the RotaTeq vaccine his diarrhea went away. All tests since then have shown he is back to normal.
Age: 0.19
Sex: M
Vaccine: RV5
Symptoms: Pancreatic enzymes decreased, Sweat test normal
Clinical narrative: The day after my son got the RotaTeq Vaccine he started having diarrhea 10-12 times a day. Before he got this vaccine he had been constipated since he was born. He had to have numerous stool samples done and got dehydrated due to the diarrhea happening so often. His Dr sent us to a GI Dr. who tested for Cystic Fibrosis and did more stool samples. When everything came back normal from that test he had to have a biopsy done in 12 different places from his esophagus to his rectum to test for numerous things. The only thing that came back abnormal was he had low enzymes in his pancreas. The GI Dr. determined that because he had ruled out all other possibilities in his opinion my son had an adverse reaction to the RotaTeq vaccine. My son had to be supplemented with enzymes in his food to get the levels in his pancreas back to normal and finally 3 1/2 months after he got the RotaTeq vaccine his diarrhea went away. All tests since then have shown he is back to normal.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Abdominal distension, Abdominal pain, Abdominal tenderness, Asthenia, Diarrhoea
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 15 year old female with mole of skin who on 22-JUN-2007 was intramuscularly vaccinated with the first dose of GARDASIL (lot # 654272/0319U) in right arm. Secondary suspect therapy included hepatitis A vaccine (manufacturer unknown) and varicella virus vaccine live (manufacturer unknown). Concomitant therapy included MENACTRA and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. The patient had strange itchy rash months before diagnosis, doctor recommended her taking CARITAN, did not diagnose. The patient also had DM (diabetes mellitus) Type 1 symptoms months before diagnosis. The following information was obtained through follow-up and/or provided by the government. On 29-OCT-2010 PCP (Primary Care Physician) records received for DOS (Date of Service) from 22-JUN-2007 to 12-AUG-2010. The patient returned on 12-SEP-2007 for additional vaccinations (reported to be second dose of GARDASIL, hepatitis A and varicella). PE (Physical exam) was WNL (Within Normal Limits). The third dose of GARDASIL and MENACTRA were administered on 21-MAR-2008. There was rash on feet and  legs for 1 week which was noted on 23-JUL-2008. Food allergy was questioned and the patient was sent for RAST (radioallergosorbent test). On 13-FEB-2009 the patient went to OV (office visit), MD (Doctor of Medicine) noted DM Type 1 dx (Diagnosis) was made in OCT-2008. The patient complained of headache (H/A). Rash was noted again on 12-AUG-2010. On 1-NOV-2010 ER (emergency room) records were received for DOS 10-SEP-2009. Final impression was as follow: Infectious Mononucleosis. Patient "c/c ST", running nose, vomiting, diarrhea, fatigue and HA for 1 week. Physical exam (PE) was positive for neck lymphadenopathy, abdominal tenderness, tender palpable spleen. D/c to f/u (Follow up) with PCP. On 8-NOV-2010 hospital records were received for DOS from 2-DEC-2009 to 6-SEP-2010 when patient presented at the ER after syncopal episode. Final impression was as follow: hypoglycemia, syncope. PE(+) was tenderness on upper extremities, abrasions on hands. On 6-SEP-2010 patient presented at ER with c/c abdominal pain, nausea, bloating, weakness. Patient left ER w/o (without) being discharged. A lot check has been initiated. One or more of the events required hospitalization, was considered to be disabling, was considered to be immediately life-threatening. This was originally reported by a consumer. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, and expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.