chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
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 male subject of unspecified age who was vaccinated with hepatitis B vaccine recombinant (Hepatitis B vaccine, manufacturer unspecified).  On an unspecified date the subject received two series of an unspecified dose of Hepatitis B vaccine (1ml, unknown).  At an unspecified time after vaccination with Hepatitis B vaccine, the subject did not develop a positive titer to be considered a responder to the series.  At the time of reporting the outcome of the event was unspecified.  The physician did not know any details about the subject, when the subject was vaccinated or even if they had received ENGERIX-B.
Sex: U
Vaccine: HEP
Symptoms: 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 male subject who was vaccinated with Hepatitis B. In 2001 the subject completed the Hepatitis B vaccine series. Seven years after vaccination with Hepatitis B vaccine, the subject was tested and showed a Hepatitis B series again. His titer was taken and shown to be 12500 following completion of the second series of Hepatitis B vaccine. At the time of reporting the event was considered to be resolved.
Age: 62.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of HEPATITIS B antibody negative in a 63-year-old male subject who was vaccinated with ENGERIX B, (GlaxoSmithKline).  On 30 October 2007, the subject received 3rd dose of ENGERIX B (20 mcg/ml, intramuscularly) in the right deltoid to complete the three dose series.  The 2nd dose of ENGERIX B (20 mcg/ml, intramuscularly) was given on 30 May 2007 in the left deltoid and the 1st dose (20 mcg/ml, intramuscularly) was given on 27 April 2007 in the right deltoid.  On 27 March 2008, 5 months after the 3rd vaccination with ENGERIX B, the subject had a titer drawn that was HEPATITIS B antibody negative.  At the time of reporting the outcome of the event was unspecified.  The healthcare professional considered the event was possibly related to vaccination with ENGERIX B.
Sex: U
Vaccine: HEP
Symptoms: No therapeutic response
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of a subject of unspecified age and gender not responding to therapy following vaccination with ENGERIX B, (GlaxoSmithKline).  On an unspecified date the subject received unspecified dose of ENGERIX 3 (unknown).  At an unspecified time after vaccination with ENGERIX B, it was noted that the subject had not responded to therapy.  At the time of reporting the outcome of the event was unspecified.
Sex: F
Vaccine: HEP
Symptoms: Rash
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of rash in a female subject aged between 20 and 29 years old who was vaccinated with ENGERIX B. In March 2008 the subject received 2nd dose of ENGERIX B (20 mcg, unknown, left arm). At an unspecified time after vaccination with ENGERIX B, the subject experienced rash below the injection site on the same arm where she received the vaccination. She was seen by her physician and some blood was draw. The reason for the blood draw was unknown. The reporter also noted that the subject did not have this issue with the first dose. At the time of reporting the event was unresolved.
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: This case was reported by healthcare professional and described the occurrence of hives on head in a 29-year-old female subject who was vaccinated with ENGERIX B. The subject's medical history included allergy to seafood. Concurrent medications included inhaler. On 26 February 2008, the subject received the 1st dose of ENGERIX B. Approximately twenty minutes after vaccination with ENGERIX B, the subject experienced hives on her head, facial hives and hives behind her ears. The subject was treated with Benadryl and the events resolved on the same day. The ENGERIX B vaccination series was discontinued. The healthcare professional considered the events were possibly related to vaccination with ENGERIX B. follow-up information was received on 18 April 2008, via healthcare provider, who reported the hives appeared approximately 20 minutes after receiving the ENGERIX B on 26 February 2008. The hives resolved on 26 February 2008 after treatment with Benadryl. The immunization series with ENGERIX B was discontinued.
Age: 42.0
Sex: M
Vaccine: HEP
Symptoms: No therapeutic response
Clinical narrative: This case was reported by a physician and described the occurrence of a 43-year-old male subject not responding to therapy following vaccination with ENGERIX B, (GlaxoSmithKline).  Concurrent medical conditions included obesity.  In 2005 the subject completed a vaccination series of ENGERIX B and did not seroconvert.  A second series of ENGERIX B was administered with 1st, 2nd and 3rd dose in June 2007, July 2007 and the 3rd dose administered on 27 November 2007.  A titer completed in March 2008 was negative for antibodies.  The subject had again, not responded to therapy.  At the time of reporting the events were unresolved.  The physician considered the events were probably related to vaccination with ENGERIX B.
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Diarrhoea, Expired drug administered, Incorrect dose administered
Clinical narrative: This case was reported by a consumer and described the occurrence of diarrhea in a 31-year-old female subject who was vaccinated with ENGERIX B, (GlaxoSmithKline).  A physician or other health care professional has not verified this report.  On 23 March 2008 at 17:00 the subject received 3rd dose of ENGERIX B (.5 ml, unknown).  The subject received an expired pediatric dose (expiration date: 21 March 2008) of ENGERIX B On 25 March 2008, 2 days after vaccination with ENGERIX B, the subject experienced diarrhea.  At the time of reporting the outcome of diarrhea was unspecified.
Sex: F
Vaccine: HEP
Symptoms: Unresponsive to stimuli
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of not responding to therapy in an adult female subject who was vaccinated with HEPATITIS B vaccine, (manufacturer unspecified).  The reporter was the subject.  On an unspecified date the subject received the first series of HEPATITIS B vaccine (unknown).  At an unspecified time after vaccination with the first series of HEPATITIS B vaccine, the subject experienced not responding to therapy.  The subject reported that she did respond after the second series.  At the time of reporting the outcome of the event was unspecified.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of hepatitis B antibody negative in an adult female subject of unspecified age who was vaccinated with ENGERIX B. There were no concurrent medications. The subject had no relevant medical history and experienced no adverse events following previous vaccinations. The subject had an unclear vaccination history. On an unspecified date the subject received 2nd dose of ENGERIX B (20 mcg, unknown, unknown deltoid). A titer was drawn following the 2nd dose because the subject was stuck by a dirty instrument, The titer following the 2nd dose was negative. The reporter did not know exact time frame around the doses given or when the titer had been drawn. At the time of reporting the outcome of the event was unspecified.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antigen positive
Clinical narrative: This case was reported by a physician from a blood center and described the occurrence of HEPATITIS B surface antigen positive in a subject of unspecified age and gender who was vaccinated with HEPATITIS B vaccine, (manufacturer unspecified).  On an unspecified date the subject received unspecified dose of HEPATITIS B vaccine (unknown).  One day after vaccination with HEPATITIS B vaccine, the subject presented to donate blood and when the blood was tested HEPATITIS B surface antigen was found to be positive.  The physician did not have any information regarding the subject.  At the time of reporting the outcome of the event was unspecified.
Sex: U
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 subject of unspecified age and gender who was vaccinated with ENGERIX B. Concurrent medical conditions included dialysis. On an unspecified date the subject received unspecified dose of ENGERIX B. At an unspecified time after vaccination with ENGERIX B, the subject experienced Hepatitis B surface antigen positive. Relevant test results included Hepatitis B surface antigen positive. At the time of reporting the outcome of the event was unspecified.
Age: 75.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antigen positive
Clinical narrative: This case was reported by a healthcare professional at a dialysis unit and described the occurrence of HEPATITIS B antigen positive in a 77-year-old male subject who was vaccinated with ENGERIX B, (GlaxoSmithKline).  Concurrent medical conditions included diabetes.  In October 2006 the subject received unspecified dose of ENGERIX B (40 mcg, unknown, right arm).  At an unspecified time after vaccination with ENGERIX B, the subject experienced HEPATITIS B antigen positive.   At the time of reporting the outcome of the event was unspecified.
Age: 52.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antigen positive
Clinical narrative: This case was reported by a healthcare professional at a dialysis clinic and described the occurrence of HEPATITIS B antigen positive in a 52-year-old male subject who was vaccinated with ENGERIX B, (GlaxoSmithKline).  Concurrent medical conditions included diabetes. On 23 February 2008 in the afternoon, the subject received unspecified dose of ENGERIX B (40 mcg, unknown, right arm).  On 26 February 2008, 3 days after vaccination with ENGERIX B, the subject tested positive for the HEPATITIS B antigen.  At the time of reporting the outcome of the event was unspecified.
Sex: U
Vaccine: HEP
Symptoms: Immunology test abnormal
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of non-seroconversion in a subject of unknown age and gender who received HEPATITIS B vaccine (unknown manufacturer).  On 20 July 2007, 06 March 2007 and 30 January 2007 the subject received 1st, 2nd and 3rd dose of HEPATITIS B vaccine to complete a three dose series.  On 08 January 2008, 19 October 2007 and 12 September 2007, the subject received 1st, 2nd and 3rd dose of HEPATITIS B vaccine to complete a second three dose series.  At an unknown time following completion of two series of HEPATITIS B vaccine it was reported that the subject failed to achieve serological antibodies (non-seroconversion).  At the time of reporting, the outcome of the event was unknown.  It was also noted that the interval between the 2nd and 3rd doses of HEPATITIS B vaccine in both series was too short.  This was considered to be an inappropriate schedule of drug administration.  No adverse events were reported.  No other details provided.
Age: 25.0
Sex: M
Vaccine: HEP
Symptoms: Dysgeusia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of strange taste in a 25-year-old male subject who was vaccinated with ENGERIX B, (GlaxoSmithKline).  There were no concurrent medications.  On 24 January 2008 at 09:30 the subject received 1st dose of ENGERIX B at 20 mcg.  On 24 January 2008, 20 to 30 minutes after vaccination with ENGERIX B, the subject experienced a strange taste in his mouth which resolved (end date 24 January 2008).  The subject experienced no allergy like symptoms.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site redness in a 23-year-old female subject who was vaccinated with ENGERIX B. Previous and/ or concurrent vaccination included ENGERIX B, GlaxoSmithkline; unknown; unknown given on an unspecified date. Concurrent medications included Ortho Tri-Cyclen. On 22 February 2008, the subject received 3rd dose of ENGERIX B. On 23 February 2008, 1 day after vaccination with ENGERIX B, the subject experienced injection site redness, injection site at the time of reporting, the events were unresolved.
Age: 32.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Arthralgia, Incorrect dose administered, Influenza like illness, Vomiting
Clinical narrative: This case was reported by a consumer and described the occurrence of flu like symptoms in a 32-year-old female subject who was vaccinated with ENGERIX B. A physician or other health care professional has not verified this report. The subject's medical history included gastric bypass. Previous and/or concurrent vaccination included HARVIX; unknown; unknown given on 15 February 2008. Concurrent medications included Cyanocobalamin (Vitamin b12) and Multivitamins. On 15 February 2008, the subject received 1st dose of ENGERIX B (unknown, unknown arm) and experienced wrong dose administered. The subject was given the pediatric dose of ENGERIX B. On 17 February 2008, two days after vaccination with ENGERIX B, the subject experienced flu like symptoms, vomiting, and joint pain. It was reported that the subject was given the wrong vaccine by the pharmacy. At the time of reporting, the flu like symptoms and vomiting and improved and joint pain was unresolved.
Age: 54.0
Sex: F
Vaccine: HEP
Symptoms: No therapeutic response
Clinical narrative: This case was reported by a pharmacist and described the occurrence of not responding to therapy in a 54-year-old female subject who was vaccinated with ENGERIX B. Concurrent medical conditions included gastric bypass, pedal edema and tummy tuck. Concurrent medications included Synthroid, blood pressure medication, Vitamin C and Calcium. In 1992 the subject received unspecified doses of ENGERIX B (unknown). On May 2006, June 2006 and December 2006 the subject received unspecified dose of ENGERIX B (20 mg, unknown). Approximately fourteen years after vaccination with ENGERIX B, approximately 13 months after vaccination with third dose of ENGERIX B, approximately 19 months after vaccination with the second dose of ENGERIX B, approximately 20 months after vaccination with the first ENGERIX B, the subject experienced not responding to therapy as a titer was negative. The titer was done about two weeks prior to 22 February 2008. At the time of reporting the outcome of the event was unspecified.
Age: 79.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antigen positive
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of hepatitis B antigen positive in a 79-year-old male subject who was vaccinated with ENGERIX B. The subject's medical history included bypass surgery. Concurrent medical conditions included bladder cancer, colon cancer, hemodialysis , hypertension and pacemaker. Concurrent medication included EPOGEN, TYLENOL, COUMADIN, PRILOSEC, RENAL, XANAX and PHOSLO. On 9 February 2008 at 13:15 the subject received two doses of ENGERIX B at 20 mcg per dose for a total dose of 40 mcg. This was considered to be the 1st in a three dose series of ENGERIX B. On 12 February 2008, 3 days after vaccination with ENGERIX B, lab work for the subject was positive for hepatitis B antigen. At the time of reporting the outcome of the event was unspecified. Follow-up received on 11 March 2008 indicated that lab work from 18 February 2008 was negative for hepatitis B antigen. The events resolved by 18 February 2008 and were considered by the reporter to be related to treatment with ENGERIX B.
Age: 30.0
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 in a male subject aged between 30 and 40 years old who was vaccinated with ENGERIX B, (GlaxoSmithKline).  The subject's medical history included foreign travel and unprotected sexual intercourse.  Previous and/or concurrent vaccination included HAVRIX; (GlaxoSmithKline); unknown given on an unspecified date.  In January 2008 (six weeks prior to this report) and in February 2008 (2 weeks prior to this report) the subject received 1st dose and 2nd dose of ENGERIX B (20 mcg, unknown).  In February 2008, 1 day after the 2nd vaccination with ENGERIX B, 4 weeks after the 1st vaccination with Engerix B, the subject experienced HEPATITIS B core antibody, in which the subject has been negative "the entire time" and was positive for HEPATITIS B surface antigen.  In February 2008, the events were resolved.
Age: 78.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antigen positive
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of hepatitis B antigen positive in a 78-year-old female subject who was vaccinated with ENGERIX B, (GlaxoSmithKline).  Concurrent medications included METOPROLOL, NITROGLYCERIN, SIMVASTATIN, NEPHRO-VITE, RANITIDINE, RENAGEL, PROPOXY-N, and APAP.  On 1 February 2008 the subject received two doses of ENGERIX B at 20 mcg, one in each arm.  This was considered to be the 3rd adult dosage of ENGERIX B for this subject.  This subject received two doses at 20 mcg each.  On 6 February 2008, 5 days after vaccination with ENGERIX B, the subject was tested and found to be hepatitis B antigen positive.  The office was assuming the results of the hepatitis antigen was a false positive.  At the time of reporting the outcome of positive hepatitis B antigen was unknown.  Follow-up information was received from the healthcare professional on 13 March 2008.  On 15 February 2008, the subject was tested and found to be hepatitis B antigen negative.  The events resolved on 15 February 2008.  The healthcare professional considered the events were related to vaccination with ENGERIX B.  The immunization series with ENGERIX B was not delayed or discontinued.
Age: 76.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antigen positive
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of Hepatitis B antigen positive in a 76-year-old female subject who was vaccinated with ENGERIX B. Concurrent medications included EMLA, Flurazepam, Hydralazine, Allegra, Prilosec, Lasix, Tylenol and Remegel. On 2 February 2008 the subject received two doses of ENGERIX B at 0.5ml, one in each arm. This was considered to be the 1st adult dosage of ENGERIX B for this subject, however, an inappropriate dose of vaccine was administered. One dose of ENGERIX B at 1.0ml is indicated for adult subjects. This subject received two pediatric doses at 0.5ml each. On 7 February 2008, 5 days after vaccination with ENGERIX B , the subject was tested and found to be hepatitis B antigen positive. The subject experienced  a systemic reaction. The office was assuming the results of the Hepatitis antigen was a false positive. At the time of reporting the outcome of positive Hepatitis B antigen was unresolved. Follow-up information was received on 13 March 2008, via healthcare professional from a dialysis clinic, who reported the subject was not taking Allegra or Prilosec. The subject received two 1ml doses of ENGERIX B on 02 February 2008 instead of two 0.5ml doses as previously reported. On 07 February 2008, the subject tested positive for hepatitis B surface antigen and was negative for the same test on 21 February 2008. The reporting healthcare professional considered the events related to vaccination with ENGERIX B. The events resolved on 21 February 2008.
Age: 60.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect route of drug administration, Injection site haematoma
Clinical narrative: This case was reported by a consumer and described the occurrence of bruise injection site in a 60-year-old female subject who was vaccinated with ENGERIX B. A physician or other health care professional has not verified this report. Concurrent medications included Hepatitis B immunoglobulin. On 27 January 2008, the subject received 1st dose of ENGERIX B (20 mcg, unknown, unknown gluteal) and experienced bruise injection site and intramuscular formulation administered by other route. At the time of reporting the outcome of the events were unspecified.
Sex: U
Vaccine: HEP
Symptoms: No therapeutic response
Clinical narrative: This case was reported by a physician via a sales representative and described the occurrence of not responding to therapy in a subject of unspecified age and gender who was vaccinated with hepatitis B vaccine recombinant (Hepatitis B vaccine, manufacturer unspecified).  It was reported that the physician had at least one patient and possibly more.  On an unspecified date the subject received 3rd dose of Hepatitis B vaccine (unknown) to complete the series.  At an unspecified time after vaccination with Hepatitis B vaccine, the subject experienced not responding to therapy.  At an unspecified time later, the subject received the entire hepatitis B vaccine (unknown) series a second time.  At an unspecified time after vaccination with the second series of Hepatitis B vaccine, the subject experienced not responding to therapy.  The reporter noted that the type of testing or quantitative values for the subject's levels were unknown.  It was reported that the subject had the entire series twice and still did not "show seroprotective levels."  At the time of reporting the outcome of the events were unspecified.
Age: 58.0
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 48-year-old male subject who was vaccinated with ENGERIX B. Concurrent medical conditions included reflux symptoms (nos). On 28 November 2007 the subject received 1st dose of ENGERIX B (unknown, right arm). Two days after vaccination with ENGERIX B, the subject donated blood and a positive surface antigen test was reported. The subject was seen by his physician and six weeks later the surface antigen test was negative. The subject received a second dose of ENGERIX B at an unspecified time and experienced inappropriate schedule of vaccine administered. Following the second dose of ENGERIX- B, the surface antigen test was also negative. At the time of reporting the hepatitis B surface antigen positive was resolved. The physician considered the hepatitis B surface antigen positive was probably related to vaccination with ENGERIX B.
Sex: U
Vaccine: HEP
Symptoms: Injection site discomfort
Clinical narrative: This case was reported by a pharmacist via a sales representative and described the occurrence of discomfort at time of injection in an unspecified number of subjects of unspecified age and gender who was vaccinated with ENGERIX B. On an unspecified date the subject received unspecified dose of ENGERIX B (20 mcg, unknown) and experienced discomfort at the time of injection. At the time of reporting the outcome of the event was unspecified. It was also reported that the site had observed increased reports of discomfort with injection of ENGERIX B since they had switched from the competitor product.
Sex: U
Vaccine: HEP
Symptoms: 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 a subject of unspecified age and gender who was vaccinated with ENGERIX B. On an unspecified date the subject completed the hepatitis B vaccine series. At an unspecified time following completion of the hepatitis B vaccine series, it was discovered that the subject did not achieve titer levels to be protected. At the time of reporting the outcome of the event was unspecified. The entire hepatitis B series was repeated.
Age: 53.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B, Vaccination failure
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of vaccination failure in a 53-year-old female subject who was vaccinated with ENGERIX B. On an unspecified date the subject received 3rd dose of ENGERIX B (unknown). The subject completed the hepatitis B vaccination series between 1992 and 1994. A serology titer was not completed after the series, so protection status was not known. The subject developed symptoms (not specified) of hepatitis B in September 2007 and was hospitalizes for an unknown period of time. The healthcare professional considered the events were clinically significant (or requiring intervention). In January 2008, the events were resolved. The healthcare professional considered the events were probably related to vaccination with ENGERIX B.
Sex: M
Vaccine: HEP
Symptoms: Abdominal pain upper, Headache, Inappropriate schedule of drug administration, Lethargy
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of stomach pain in a male subject of unspecified age who was vaccinated with ENGERIX B. Previous and/or concurrent vaccination included hepatitis B vaccine recombinant; given on 10 September 1997. On 1 October 2007 the subject received 2nd dose of ENGERIX B (unknown) and experienced stomach pain, headache, lethargy and inappropriate schedule of vaccine administered. At the time of reporting the outcome of the headache, stomachache and lethargy were unspecified.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody abnormal, No therapeutic response
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of not responding to therapy in an unspecified number of adult subjects of unspecified gender who were vaccinated with ENGERIX B. On an unspecified date the subjects received ENGERIX B series. At an unspecified time after vaccination with ENGERIX B vaccine series, the subjects experienced not responding to therapy. The nurse reported that the insufficient hepatitis B antibody titers show immunity to hepatitis B even though previously vaccinated with the ENGERIX B vaccine series. The reporter did not know how long ago the subjects received the vaccine or if they ever demonstrated an initial response to the vaccine at the time. The vaccination were all done at the other clinics. At the time of reporting the outcome of the events was unspecified.
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B surface antigen negative, Therapeutic response decreased
Clinical narrative: This case was reported by a physician and described the occurrence of decreased therapeutic response in an adult male subject who was vaccinated with ENGERIX B. On unspecified dates, the subject received 1st and 2nd doses of ENGERIX B (unknown) and received the 3rd dose in July 2007, completing the vaccination series. At an unspecified time after vaccination with ENGERIX B, the subject experienced decreased therapeutic response. The physician reported the subject did not develop a seroprotective titer of ant-hepatitis B surface antigen antibody after he was tested in December 2007 and showed inadequate protection. 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.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antigen negative, 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 an adult female subject who was vaccinated with ENGERIX B, (GlaxoSmithKline).  Previous and/or concurrent vaccination included ENGERIX B; (GlaxoSmithKline); unknown; unknown given on an unspecified date.  In November 2007, the subject received 2nd dose of ENGERIX B (20 mcg, unknown).  In November 2007, 1 day after vaccination with ENGERIX B, the subject gave blood and experienced HEPATITIS B surface antigen positive.  At the time of reporting the outcome of the event was unspecified.
Age: 53.0
Sex: M
Vaccine: HEP
Symptoms: Alopecia
Clinical narrative: This case was reported by a consumer and described the occurrence of hair loss in a 53-year-old male subject who was vaccinated with ENGERIX B. A physician or other health care professional has not verified this report. On 2 June 2007 and 4 July 2007, the subject received 1st and 2nd dose of ENGERIX B (unknown). In September 2007, within two and three months of vaccination with ENGERIX B, the subject experienced hair loss. The subject required attention at he doctor's office. Many lab test were done to rule out many other disease states. The immunization series was discontinued. At the time of reporting the event was unresolved.
Sex: F
Vaccine: HEP
Symptoms: Laboratory test normal, No therapeutic response
Clinical narrative: This case was reported by a healthcare professional via another manufacturer and described the occurrence of not responding to therapy in an adult female subject who was vaccinated with ENGERIX B, (GlaxoSmithKline).  Concurrent medical conditions included immunocompromised.  On an unspecified date three years ago the subject received three doses of ENGERIX B (unknown).  At an unspecified time after vaccination with ENGERIX B, the subject experienced not responding to therapy as a titer after vaccination was negative.  At the time of reporting the outcome of the event was unspecified.
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Injection site pain, Injection site rash, Injection site urticaria, Mobility decreased
Clinical narrative: This case was reported by a physician and described the occurrence of pain in arm post vaccination in a 29-year-old female subject who was vaccinated with ENGERIX B, (GlaxoSmithKline).  Concurrent medical conditions included penicillin allergy.  Concurrent medications included CLARITIN D.  No other vaccines were given the same day as ENGERIX-B.  On 8 November 2007 the subject received 2nd dose of ENGERIX B (.5 unknown, left arm).  On 8 November 2007, less than one day after vaccination with ENGERIX B, the subject experienced pain in left arm post vaccination.  The following day she experienced difficulty moving arm without pain and was treated with hot packs.  The same days she had red spots and thought she was "burned" by the hot packs.  She was diagnosed with urticaria or rash from the injection.  One month later, she continues to have arm pain at the injection site.  The subject was seen in a physician's office.  At the time of reporting the outcome of the pain in the left arm and urticaria was unresolved and the other events were unspecified.  Follow-up received on 08 January 2008 via the physician.  She reported that on 09 November 2007, on day following vaccination with ENGERIX B, the subject experienced pain in arm post vaccination, urticaria, difficulty moving her arm, red spots, burn, rash and injection site pain.  She also noted that on the same day that the subject received ENGERIX B, treatment with CHANTIX for smoking cessation was started.  The subject was diagnosed with a possible allergic reaction.  It was reported that the red spots faded quickly to normal skin over four hours and the rash was gone completely in eight to twelve hours.  One month after the ENGERIX B injection the subject states that she needs to take eight MOTRIN daily to control pain which shoots up and down her arm from the injection site.  The physician indicated that she considered that the events could have been associated with the CHANTIX as it was started on the same day as the ENGERIX B was given.  The subject requested to discontinue the use of CHANTIX on 12 December 2007.  The physician reported that the subject was healthy, the vaccine was given by a qualified nurse in standard fashion and "no breech known."  The physician noted at this time that she did not know if the events were serious as they had not resolved and they could become serious.  She considered that the events were unresolved and possibly related to the use of ENGERIX B.
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Thermal burn
Clinical narrative: This case was reported by a physician and described the occurrence of pain in arm post vaccination in a 29-year-old female subject who was vaccinated with ENGERIX B, (GlaxoSmithKline).  Concurrent medical conditions included penicillin allergy.  Concurrent medications included CLARITIN D.  No other vaccines were given the same day as ENGERIX-B.  On 8 November 2007 the subject received 2nd dose of ENGERIX B (.5 unknown, left arm).  On 8 November 2007, less than one day after vaccination with ENGERIX B, the subject experienced pain in left arm post vaccination.  The following day she experienced difficulty moving arm without pain and was treated with hot packs.  The same days she had red spots and thought she was "burned" by the hot packs.  She was diagnosed with urticaria or rash from the injection.  One month later, she continues to have arm pain at the injection site.  The subject was seen in a physician's office.  At the time of reporting the outcome of the pain in the left arm and urticaria was unresolved and the other events were unspecified.  Follow-up received on 08 January 2008 via the physician.  She reported that on 09 November 2007, on day following vaccination with ENGERIX B, the subject experienced pain in arm post vaccination, urticaria, difficulty moving her arm, red spots, burn, rash and injection site pain.  She also noted that on the same day that the subject received ENGERIX B, treatment with CHANTIX for smoking cessation was started.  The subject was diagnosed with a possible allergic reaction.  It was reported that the red spots faded quickly to normal skin over four hours and the rash was gone completely in eight to twelve hours.  One month after the ENGERIX B injection the subject states that she needs to take eight MOTRIN daily to control pain which shoots up and down her arm from the injection site.  The physician indicated that she considered that the events could have been associated with the CHANTIX as it was started on the same day as the ENGERIX B was given.  The subject requested to discontinue the use of CHANTIX on 12 December 2007.  The physician reported that the subject was healthy, the vaccine was given by a qualified nurse in standard fashion and "no breech known."  The physician noted at this time that she did not know if the events were serious as they had not resolved and they could become serious.  She considered that the events were unresolved and possibly related to the use of ENGERIX B.
Age: 15.0
Sex: M
Vaccine: HEP, MNQ, TDAP, VARCEL
Symptoms: Abdominal pain upper, Headache, Hypersomnia, Lethargy, Nausea
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of nausea in a 15-year-old male subject who was vaccinated with ENGERIX B, VARIVAX, MENACTRA and ADACEL. No relevant medical history, concurrent medications or adverse events following previous vaccinations. On 1 October 2007 the subject received 2nd dose of ENGERIX B (10 mcg, left arm), 1st dose of VARIVAX (unknown) , 1st dose of MENACTRA (unknown), and 1st dose of ADACEL (unknown). One day after vaccination with ADACEL, ENGERIX B, MENACTRA and VARIVAX, the subject experienced nausea, stomach ache, headache, lethargy and sleeping a lot. The nurse reported that she did not know what caused the nausea, stomach ache, headache or lethargy. The nausea, stomach ache, headache and lethargy resolved on 04 October 2007 and the outcome of sleeping a lot was unspecified. Follow-up information was received on 11 April 2008 via a nurse, who reported that the adverse events occurred on 03 October 2007. The nurse stated that the events were resolved at the time of this report, but the exact date of resolution was unknown since the subject reported the adverse events two months after their occurrence. The reporting healthcare professional considered the events to be possible related to vaccination with ENGERIX B, but indicated that the events were not serious.
Sex: U
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 subject of unspecified age and gender who was vaccinated with ENGERIX B. On an unspecified date the subject received 1st dose, 2nd dose and 3rd dose of ENGERIX B (unknown). At  an unspecified time after completing the vaccination series with ENGERIX B, the subject experienced not responding to therapy and "failed to seroconvert". No other information was available at the time of this report.  At the time of reporting the outcome of the event was unspecified.
Sex: U
Vaccine: HEP
Symptoms: No therapeutic response
Clinical narrative: This case was reported by a healthcare professional via Merck and described the occurrence of not responding to therapy in an unknown number of subjects of unspecified ages and gender who were vaccinated with ENGERIX B, (GlaxoSmithKline).  The subjects medical history included hepatitis C.  On unspecified dates, the subjects received unspecified doses of ENGERIX B (unknown) and experienced not responding to therapy.  The reporter stated "one-third" of her hepatitis C subjects who had received ENGERIX B did not seroconvert.  No other information was provided.  At the time of reporting the outcome of the event was unspecified.
Sex: M
Vaccine: HEP
Symptoms: Alopecia
Clinical narrative: This case was reported by a physician via sale representative and described the occurrence of alopecia in an infant male subject who was vaccinated with ENGERIX. Previous and/or concurrent vaccination included ENGERIX B; unknown; unknown given on unspecified date. On an unspecified date the subject received 2nd dose of ENGERIX B (unknown). At an unspecified time after the vaccination with ENGERIX B, the subject developed alopecia. The subject did not complete the series and never received a 3rd dose of ENGERIX B. The reporting physician, who was not the subject's caregiver at the time of the event, was inquiring about ENGERIX B causing alopecia. It was unknown which manufactured Hepatitis B vaccine the infant subject actually received. The subject is now in middle school. At the time of reporting the event was resolved.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, No therapeutic response
Clinical narrative: This case was reported by a healthcare professional via sales representative and described the occurrence of not responding to therapy in several subjects of unspecified ages and gender who were vaccinated with ENGERIX B. On unspecified dates the subjects received complete series of ENGERIX B (unknown). At an unspecified time after vaccinations with ENGERIX B, the subjects experienced not responding to therapy. Six weeks after completing the ENGERIX B vaccination series, the subjects titers were drawn and did not show antibodies (hepatitis B antibody negative). At the time of reporting the outcome of the events were unspecified.
Sex: U
Vaccine: HEP
Symptoms: Hypersensitivity
Clinical narrative: This Case was reported by a pharmacist and described the occurrence of allergic reaction in a subject of unspecified age and gender who was vaccinated with ENGERIX B. On an unspecified date the subject received unspecified dose of ENGERIX B. At an unspecified time after vaccination with ENGERIX B, the subject experienced allergic reaction. The reporter was inquiring about administering HAVRIX to a subject who had an allergic reaction to ENGERIX B in the past. It was unknown if the subject received HAVRIX. At this time of reporting the outcome of the event was unspecified.
Age: 56.0
Sex: F
Vaccine: HEP
Symptoms: Accidental exposure, Hepatitis B surface antigen positive
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of hepatitis B surface antigen positive in a female subject of unspecified age who was vaccinated with ENGERIX B, (GlaxoSmithKline).  The subject's medical history included hemodialysis and renal failure.  On an unspecified date the subject received unspecified dose of ENGERIX B (40 mcg, unknown).  Two days after vaccination with ENGERIX B, the subject experienced hepatitis B surface antigen positive.  The blood was tested because the subject had a possible exposure incident after she received ENGERIX-B.  The reporter believed the the positive hepatitis B surface antigen may be a false positive from the ENGERIX-B but she is not certain.  Medical attention was not required.  At the time of reporting the outcome of the event was unspecified.  Follow-up information was received on 17 December 2007, via nurse, who provided additional demographic information on the subject.  The nurse considered the events related to ENGERIX B.  The nurse also suggested the hepatitis B surface antigen positive was associated with the subject's blood drawn two days after vaccination with ENGERIX B.  The nurse reported the events resolved.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antigen positive
Clinical narrative: On 18 September 2007 the subject received a birth dose of ENGERIX B (10 mcg, unknown). On September 2007, same day as the vaccination with ENGERIX B the subject tested positive for hepatitis B surface antigen. The subject was born to a hepatitis B surface antigen negative mother. Two vaccination dates were provided for ENGERIX B administration dates, 18 September 2007 and 19 September 2007. The laboratory report stated the hepatitis B surface antigen detection was performed on 18 September. No other information was provided. 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. (GlaxoSmithKline).
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B surface antigen positive
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of hepatitis B surface antigen positive in an infant male subject who was vaccinated with ENGERIX B. On 7 August 2007 the subject received a birth dose of ENGERIX B (10 mcg, unknown, right thigh). On 9 August 2007, two days after vaccination with ENGERIX B, the subject tested positive for hepatitis B surface antigen negative mother. At the time of reporting the outcome of the event was unspecified. The healthcare professional considered the event was probably related to vaccination with ENGERIX B.
Age: 21.0
Sex: M
Vaccine: HEP, TDAP
Symptoms: Hepatitis B surface antigen positive, Inappropriate schedule of drug administration, Incorrect dose administered
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of inappropriate dose of vaccine administered in a 21-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline).  Previous and/or concurrent vaccination included tetanus and diphtheria toxoids adsorbed;  manufacturer unspecified; unknown given on 27 June 2005.  On 27 June 2005, 17 August 2005 and 26 June 2006 the subject received 1st dose, 2nd dose and 3rd dose of ENGERIX B (.5 ml, unknown).  The subject experienced inappropriate dose of vaccine administered and inappropriate schedule of drug administration.  The healthcare professional stated that no adverse event were reported.  They are doing laboratory work to see if the subject is protected.  Follow-up information was received on 11 December 2007, via healthcare professional, who reported the events were associated with lack of efficacy because not enough vaccine was administered.  On 19 November 2007, the subject had a hepatitis B surface antigen (quant) performed;  the results were >1000.  No other information was provided.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, RV5
Symptoms: Rash generalised, Urticaria
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of hive-like rash over the body in a 6-month-old male subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis adsorbed, HEPATITIS B RECOMBINANT and (PEDIARIX, GlaxoSmithKline), rotavirus vaccine (MERCK) for prophylaxis. There were no concurrent medications. On 22 September 2008 at 10:00 the subject received 3rd dose of PEDIARIX at 0.5 ml in the left thigh and 3rd dose of ROTAVIRUS vaccine (MERCK). On 23 September 2008, 1 day after vaccination with PEDIARIX, at an unspecified time after vaccination with ROTAVIRUS vaccine, the subject experienced hive-like rash all over the body. At the time of reporting the event was improved but not completely resolved. The healthcare professional considered the event was probably related to vaccination with PEDIARIX.
Age: 5.0
Sex: M
Vaccine: DTAPHEPBIP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Medication error, Pharmaceutical product complaint
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swollen thigh (injection site) in a 5-year-old male subject who was vaccinated with PEDIARIX, (GlaxoSmithKline).  Concurrent vaccinations given on 20 August 2008 included the 2nd dose of MMR II, (Merck); and the 2nd dose of VARICELLA Virus vaccine; Merck.  On 20 August 2008, the subject received a dose of PEDIARIX (.5 ml, unknown, left thigh), as his 5th dose of a DTAP vaccine.  This was considered to be a drug maladministration, as PEDIARIX is not indicated for use as a booster dose following a three dose primary series of the vaccine.  On 21 August 2008, one day after vaccination with PEDIARIX, the subject experienced a swollen thigh (injection site) and injection site redness.  The reporting nurse stated that the subject presented to the emergency room (date unspecified), and was also seen in the physician's office (date unspecified) with entire thigh swelling and redness.  A product complaint was lodged for this report, as the nurse inquired if GSK had changed the formulation or if there were "hot" lots with the company's DTAP vaccines.  At the time of reporting the events were resolved.  The healthcare professional considered the events were probably related to vaccination with PEDIARIX.  Follow-up information received on 21 October 2008 indicated that the events began on 21 August 2008.  The events resolved and were considered by the reporter to be possibly related to treatment with PEDIARIX.  It was clarified that the subject did not go to the emergency room, but was seen in the physician's office on 21 August 2008.  PEDIARIX had been administered intramuscularly on 20 August 2008 and this was the 5th dose.  Additionally, MMR II vaccine injection and VARICELLA vaccine injection were given intramuscularly on 20 August 2008.  Vaccines administered previously included INFANRIX (31 July 2003), PEDIARIX (03 October 2003), INFANRIX (22 December 2003) and INFANRIX (21 June 2005).
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Injection site reaction
Clinical narrative: This case was reported by a physician and described the occurrence of injection site reaction in a 2-year-old male subject who was vaccinated PEDIARIX. There were no concurrent medications.  In May 2008 the subject received 1st dose of PEDIARIX at 0.5ml. In May 2008, at unspecified time after vaccination with PEDIARIX, the subject experienced injection site reaction. At the time of reporting the event was worse.