chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: M
Vaccine: HEP
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a licensed practical nurse concerning an 18 year old male patient who in July 2004, on 26-NOV-2004 was vaccinated with his first, second doses of RECOMBIVAX HB, lot number was not available. On 18-JUN-2010 the 18 year old patient was vaccinated two vials of RECOMBIVAX HB pediatric formulation (5 mcg) for his third dose of RECOMBIVAX HB (lot#664736/0715Y, thimerosal free, expiration date in March 2012). There was no adverse effect reported. The nurse also stated that the office's policy was to administer 10 mcg (adult dose) to patient over 16 years of age who weigh over 100 lbs. At the time of report the patient's status was unknown. Follow up information has been received from a physician concerning the patient who on 18-JUN-2010 was vaccinated IM with two vials of RECOMBIVAX HB pediatric formulation (5 mcg) for his third dose of RECOMBIVAX HB (lot number 664736/0715Y, thimerosal free). On an unspecified date the patient only complained of sore arm. At the time of report the patient's status was unknown. Follow up information was received which reported that the 18 year old male patient with penicillin allergy and no illness at time of vaccination or pertinent medical history. There was no adverse reaction reported to clinic after vaccination on 18-JUN-2010. Additional information is not expected.
Age: 5.0
Sex: M
Vaccine: HEP
Symptoms: Anti-HBs antibody negative
Clinical narrative: Information has been received from a physician concerning her currently 23 year old son with pertinent medical history or allergies who on 15-MAY-1992, at the age of 5 year old, was vaccinated intramuscularly with the first 0.25ml dose of RECOMBIVAX HB (lot# 602638/0310V). On 24-OCT-1992, the patient was vaccinated intramuscularly with the second 0.25ml dose of RECOMBIVAX HB (lot # 604946/1163V). On 24-FEB-1993, the patient was vaccinated intramuscularly with the third 0.25ml dose of RECOMBIVAX HB (lot # 606130/1517V). There was no concomitant medication. The physician mentioned that the patient had negative titers after received 3 dose series of RECOMBIVAX HB. On 19-MAY-2010, the patient was vaccinated intramuscularly with the fourth dose of RECOMBIVAX HB (lot # not reported) because of negative titer. The patient still had negative titers. Additional information has been requested. This is an amended report. The codes of negative titers were changed from antibody test negative to Anti-HBs antibody negative.
Sex: M
Vaccine: HEP
Symptoms: Arthralgia, Fatigue, Juvenile arthritis, Musculoskeletal stiffness, Myalgia
Clinical narrative: Information has been received from a case in litigation concerning a male child who 17-SEP-1996 and 15-OCT-1996 was vaccinated with first and second doses of RECOMBIVAX HB (manufacturer unknown). It was reported that the patient exhibited the first symptoms of Juvenile rheumatoid arthritis 11 days after the second vaccination, including muscle ache, rash, fatigue, joint pain, swelling and stiffness. Additional information is not expected.
Sex: M
Vaccine: HEP
Symptoms: Rash, Swelling
Clinical narrative: Information has been received from a case in litigation concerning a male child who 17-SEP-1996 and 15-OCT-1996 was vaccinated with first and second doses of RECOMBIVAX HB (manufacturer unknown). It was reported that the patient exhibited the first symptoms of Juvenile rheumatoid arthritis 11 days after the second vaccination, including muscle ache, rash, fatigue, joint pain, swelling and stiffness. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a 20 year old female who in "6 years ago", was vaccinated with the second dose of RECOMBIVAX HB, and 2 weeks later the patient experienced hives. The patient received unspecified medical attention. The patient recovered on an unspecified date. No further information is available.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from a nurse concerning a patient who was vaccinated with RECOMBIVAX HB series several years ago and did not have hepatitis B antibodies. At the time of the report, the outcome was unknown. Additional information has been requested. This is one of two reports received from the same source.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Seroconversion test negative
Clinical narrative: Information has been received from a physician concerning a pediatric patient who was vaccinated with 3 doses of RECOMBIVAX HB. The patient failed to seroconvert after receiving 3 doses. The patient received unspecified medical attention. At the time of the report, the patient's status was unknown. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from a physician concerning a female patient who several years ago, on unspecified dates was vaccinated with the three doses of RECOMBIVAX HB (manufacturer unknown). On an unspecified date, the patient had a low or negative Hepatitis B titer. Subsequently, the patient was vaccinated with a fourth dose of RECOMBIVAX HB (manufacturer unknown). Then the patient's Hepatitis B titer levels were very high when they were retested. Additional information has been requested.
Age: 1.51
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from a nurse concerning a female patient with no pertinent medical history and no known drug reactions/allergies who in 2005 was vaccinated with her first three doses of RECOMBIVAX HB (manufacturer unknown). There was no concomitant medication. On 21-SEP-2005 the patient was tested for Hepatitis B titers and showed no immunity. On 07-FEB-2006 the patient was vaccinated with a dose of RECOMBIVAX HB (lot# 650890/0144R). On 13-MAR-2006 the patient was vaccinated with a dose of RECOMBIVAX HB (lot# 651363/0336R). On 01-AUG-2006 the patient was vaccinated with a dose of RECOMBIVAX HB (lot# 652711/1213R). The patient was recently tested for Hepatitis B titers again and showed no immunity. The patient sought unspecified medical attention. At the time of the report, the outcome of the patient was unknown. Additional information has been requested.
Age: 42.0
Sex: M
Vaccine: HEP
Symptoms: Anti-HBs antibody negative
Clinical narrative: Information has been received from a Registered Nurse (R.N.) concerning a now 44 year old male patient with no medical history or drug allergies who on 26-NOV-2007, 03-JAN-2008 and 28-MAR-2008 was vaccinated IM with the first (lot# 656680/0010U), second (lot# 656680/0010U) and third (lot# 659265/1609U) 1 ml dose of RECOMBIVAX HB, respectively. There was no concomitant medication. Subsequently the patient found to have negative antibody titers. Hepatitis B antibody test was performed. The patient contacted nurse by phone. The patient's negative antibody titers persisted. This is one of several reports from the same source. This is an amended report. AE term now was mapped to anti-HBs antibody negative instead of negative antibody titers. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody positive
Clinical narrative: Information has been received from a registered nurse concerning a patient who received the RECOMBIVAX HB series on schedule in 2008 and had a slightly positive hepatitis B titer. The patient received vaccinations from lot #s 660951/0398X, 662114/0866X and 660951/0399X (not corresponding doses specified). The nurse also stated that the RECOMBIVAX HB was properly stored while in her facility. At the time of the report the patient had not recovered. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Age: 39.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from a Registered Nurse (R.N.) concerning a male patient with no medical history or drug allergies who on 26-NOV-2007, 11-JAN-2008 and 25-MAR-2008 was vaccinated IM with the first (lot# 656680/0010U), second (lot # 656680/0010U) and third (lot # 659265/1609U) 1 ml dose of RECOMBIVAX HB, respectively. There was no concomitant medication. Subsequently the patient found to have negative antibody titers. Hepatitis B antibody test was performed. The patient contacted nurse by phone. The patient's negative antibody titers persisted. This is one of several reports from the same source. Additional information has been requested. This is an amended report. Upon review of the file, the code was changed from antibody test negative to Anti-HBs antibody negative.
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from a nurse practitioner concerning a 52 year old female who received a complete series of RECOMBIVAX HB. The vaccination dates were November 2006, December 2006 and July 2007. On 28-APR-2010, the patient had a negative hepatitis B titer. The patient's negative hepatitis B titer persisted. Additional information has been requested.
Age: 0.23
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody
Clinical narrative: Information has been received from a Health Care Department concerning at least 4 patients who over the past two months were vaccinated with a fourth dose of RECOMBIVAX HB (lot number not provided). It was unspecified if the patients sought medical attention. Follow up information has been received from an office manager concerning a female patient who after having received three doses of RECOMBIVAX HB, had an hepatitis B surface antibody test which was negative (less than 5), "not immune", requiring a fourth dose of RECOMBIVAX HB (lot number was not available). The hepatitis B surface antibody was repeated a month after the fourth dose was given to the patient and the result was 80. The patient did not develop Hepatitis B. No other adverse events were reported. At the time of the report the patient's outcome was unknown. It was unspecified if the patient sought medical attention. Follow up information has been receive from an office manager via medical records concerning a 17 year old female patient who on 25-NOV-1992 was vaccinated with the first dose of RECOMBIVAX HB, on 07-APR-1993, received her second dose of RECOMBIVAX HB, on 18-AUG-1993 her third dose of RECOMBIVAX HB. On 19-APR-2010 the patient's hepatitis B surface antibody came back negative (<0.5). On 26-APR-2010, the patient received a booster dose of RECOMBIVAX HB. On 03-MAY-2010 the patient's hepatitis B surface antibody came back negative (<0.5). On 10-JUN-2010, the patient's hepatitis b surface antibody was 80. This is one of several reports received from the same source. Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: HEP
Symptoms: Body temperature, Cough, Dyspnoea, Erythema, Immediate post-injection reaction
Clinical narrative: Information has been received from a Registered Nurse (also reported as a nurse practitioner) concerning a current 19 year old male patient who when he was approximately 4 year old, on 13-OCT-1995 was vaccinated with a first dose of RECOMBIVAX HB (route and lot number unspecified). After the first injection the mother contacted the physician and she reported that she noted a large erythematous area in child's arm. On 27-NOV-1995, the patient was vaccinated with a second dose of RECOMBIVAX HB (route, lot number and expiration date not provided). And the mother reported to the physician that immediately after receiving the vaccine the child experienced difficulty breathing, he was coughing and wheezing. The patient had a temperature for four days and a large erythematous area on his arm that was larger than the one she noted on 13-OCT-1995. The patient contacted the physician. When the patient was seen at the physician's office the child had recovered. Follow-up information has been received from an office manager who reported that she had not had an adverse event associated with any of her patients at her office. Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: HEP
Symptoms: Wheezing
Clinical narrative: Information has been received from a Registered Nurse (also reported as a nurse practitioner) concerning a current 19 year old male patient who when he was approximately 4 year old, on 13-OCT-1995 was vaccinated with a first dose of RECOMBIVAX HB (route and lot number unspecified). After the first injection the mother contacted the physician and she reported that she noted a large erythematous area in child's arm. On 27-NOV-1995, the patient was vaccinated with a second dose of RECOMBIVAX HB (route, lot number and expiration date not provided). And the mother reported to the physician that immediately after receiving the vaccine the child experienced difficulty breathing, he was coughing and wheezing. The patient had a temperature for four days and a large erythematous area on his arm that was larger than the one she noted on 13-OCT-1995. The patient contacted the physician. When the patient was seen at the physician's office the child had recovered. Follow-up information has been received from an office manager who reported that she had not had an adverse event associated with any of her patients at her office. Additional information is not expected.
Age: 0.21
Sex: M
Vaccine: DTAP, HEP, HIBV, OPV
Symptoms: Hepatitis B antibody negative, No adverse event
Clinical narrative: Information has been received from an office manager concerning an approximately 17 year old male patient who on an unspecified date was vaccinated with a fourth dose of RECOMBIVAX HB (lot number unspecified). The office manager reported that after the three doses of RECOMBIBAX HB were given to the patient, all blood work (hepatitis B surface antibody) came back negative, not immune. The patient was administered at least one dose of RECOMBIVAX HB, lot# 603895/0748V. The patient required a fourth dose of the vaccine (lot# and date unspecified). The patient's titer after the fourth dose was unknown due to lack of follow up. No other adverse experience was reported. The patient did not develop hepatitis B. At the time of the report the patient's outcome was unknown. It was unspecified if the patient sought medical attention. The office wanted to know if lot# 603895/0748V was associated with failed immunity. Follow up information has been received from the office manager who reported that on 30-NOV-1992 (at the age of 10 weeks) the patient was vaccinated with a dose of RECOMBIVAX HB (lot number lot# 603895/0748V), (adult dose, vaccine; actual dose unspecified), as an infant. The office manager could not confirm if the vaccine was stored correctly back in 1992. A lot check has been initiated. A preliminary lot check investigation was performed. To date our investigation has found that this lot conformed to quality release parameters and the manufacturing was typical of a lot of RECOMBIVAX HB. Additional information will be provided upon finalization of this manufacturing investigation. Follow-up information has been received from an office manager who indicated that the currently 17 year old patient non-smoker with no pre-existing allergies or medical conditions on 16-SEP-2010 was vaccinated with a first dose of RECOMBIVAX HB (manufacturer unknown). On 30-NOV-1992 the patient was vaccinated with a second dose of RECOMBIVAX HB (lot# 603895/0748V) in his left leg. On 08-APR-1993 the patient was vaccinated with a third dose of RECOMBIVAX HB (manufacturer unknown). Concomitant vaccination administered on 30-NOV-1992 included a first dose of ACEL-IMUNE (lot# 330-910) in his left leg, an oral first dose of ORIMUNE (lot# 334-9500667E) and a first dose of B-CAPSA 1 (lot# M020JE) in his left leg. On 20-MAR-2010 a hepatitis B surface antibody test was performed, result was negative: "patient is presumed to be not immune to infection with HBV". On 05-APR-2010 the patient was vaccinated with a fourth dose of RECOMBIVAX HB (manufacturer unknown). On an unknown date another Hepatitis B surface antibody test was performed, results were pending. The reporter considered the events to be non-serious. This is one of several reports received from the same source. Additional information is not expected. This is an amended report event "vaccinated with lot # 0748V on 13-NOV-1992" coded to overdose was deleted and narrative was updated. The patient had laboratory work (hepatitis B surface antibody quantitative).
Age: 0.47
Sex: M
Vaccine: DTAP, HEP, HIBV, OPV
Symptoms: Anti-HBs antibody negative, Blood test
Clinical narrative: Information has been received from an office manager concerning an 18 year old male patient who on 14-JUN-2010 was vaccinated with a fourth dose of RECOMBIVAX HB (lot number unspecified). The office manager reported that after the three doses of RECOMBIVAX HB were given to the patient, all blood work (hepatitis B surface antibody) came back negative, not immune (lab was less than 5); requiring a fourth dose of the vaccine. The patient was vaccinated with lot# 603895/0748V but it was unknown which dose. The hepatitis B surface antibody was repeated a month after the fourth dose was given to the patient. On 15-JUL-2010 the result was 660. The patient did not develop hepatitis B. No other adverse experience was reported. At the time of the report the patient's outcome was unknown. It was unspecified if the patient sought medical attention. The office wanted to know if lot# 603895/0748V was associated with failed immunity. Follow up information has been received from the office manager who reported that the patient was vaccinated twice with RECOMBIVAX HB (lot number lot# 603895/0748V) on 30-SEP-1992 (at the age of 24 weeks) and on 02-DEC-1992 (adult dose), as an infant. The office manager could not confirm if the vaccines were stored correctly back in 1992. A lot check has been initiated. A preliminary lot check investigation was performed. To date our investigation has found that this lot conformed to quality release parameters and the manufacturing was typical of a lot of RECOMBIVAX HB. Additional information will be provided upon finalization of this manufacturing investigation. Follow up information has been received from a physician via medical records concerning the now 24 year old male who on 30-SEP-1992 was vaccinated with the first dose of RECOMBIVAX HB (Lot number 603895/0748V) in the right leg. On the same day the patient received a second dose of ACEL-IMUNE (Lot number 318-908) in the left leg, ORIMUNE (Lot number 32093206530) orally and HIBTITER (Lot number M125JD) in the right leg. On 02-DEC-2009, the patient received the second dose of RECOMBIVAX HB (Lot number 603895/0748V) in the right leg. On the same day the patient received the third dose of ACEL-IMUNE (Lot number 330910) in the left leg and HIBTITER (Lot number M020JE) in the right leg. On 16-APR-1993, the patient received the third dose of RECOMBIVAX HB (Lot number ENG1108A2). On 05-JUN-2010 the patient underwent an anti-hbs antibody which was <0.5 (did not have immunity to hepatitis B virus) and his varicella zoster virus Ab was 1.75. On 14-JUN-2010, the patient received a booster dose (4th dose) of ENGERIX-B (Lot number AHBVB789AA) and on 13-JUL-2010 his anti-hbs antibody was 660 (Immunity to Hepatitis B virus). This is one of several report received from the same source. Additional information is not expected. The patient had laboratory work (hepatitis B surface antibody quantitative).
Age: 0.6
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from an office manager concerning a 18 year old male patient with a history of birth twin who on 14-JUN-2010 was vaccinated with a fourth dose of RECOMBIVAX HB (lot number unspecified). The office manager reported that after the three doses of RECOMBIVAX HB were given to the patient, all blood work (hepatitis B surface antibody) came back negative, not immune (lab was less than 5); requiring a fourth dose of the vaccine. The patient received lot # 603895/0748V but it was unknown which dose. At the time of the report, no follow up laboratories had been performed yet. The patient did not develop hepatitis B. No adverse experience was reported. The patient's outcome was unknown. It was unspecified if the patient sought medical attention. The office wanted to know if lot# 603895/0748V was associated with failed immunity. Follow up information has been received from the office manager who reported that on 02-DEC-1992 (at the age of 7 months) the patient was vaccinated with a dose of RECOMBIVAX HB (lot number lot# 603895/0748V), (adult dose vaccine; actual dose unspecified), as an infant. The office manager could not confirm if the vaccine was stored correctly back in 1992. Follow up information has been received from the office manager via medical records concerning a currently 18 years old male patient who on 11-MAY-1992 the patient received his first dose (lot # unknown), 11-JUN-2002 he received his second dose (lot # 602638/0310V), and 02-DEC-1992 was vaccinated with the third dose of RECOMBIVAX HB (Lot # 603895/0748V) into the left leg. Concomitant vaccines given on 20-NOV-1992 included the third dose of Hib conj vaccine (unspecified carrier) and the third dose of DTaP. It was reported that on 25-JAN-2010, a hepatitis B surface antibody (quantitative) was performed and the results showed <5. The physician stated that the patient needed a booster in 1 month. On 14-JUN-2010, the patient received a fourth dose of RECOMBIVAX HB (lot # (manufacturer unknown; lot # AHBVB789AA). On 30-JUL-2010, a hepatitis B surface antibody (quantitative) revealed 20 mlU/mL; patient had immunity to hepatitis B virus. A lot check had been initiated. A preliminary lot check investigation was performed. To date our investigation has found that this lot conformed to quality release parameters and the manufacturing was typical of a lot of RECOMBIVAX HB. Additional information will be provided upon finalization of this manufacturing investigation. This is one of several reports received from the same source. No further information is available.
Age: 0.67
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Varicella virus test positive
Clinical narrative: Information has been received from an office manager concerning a 18 years old male patient who on 15-JUN-2010 was vaccinated with a fourth dose of RECOMBIVAX HB (lot number unspecified). The office manager reported that after the three doses of RECOMBIVAX HB were given to the patient, all blood work (Hepatitis B surface antibody) came back negative, not immune (lab was 5); requiring a fourth dose of the vaccine. The patient received lot# 603895/0748V but it was unknown which dose. At the time of the report, no follow up laboratories had been performed yet. The patient did not develop Hepatitis B. No other adverse experience was reported. At the time of the report the patient's outcome was unknown. It was unspecified if the patient sought medical attention. The office wanted to know if lot# 603895/0748V was associated with failed immunity. Follow up information has been received from the office manager who reported that on 29-SEP-1992 (at the age of 7 months) the patient was vaccinated with a dose of RECOMBIVAX HB (lot# 603895/0748V), (adult dose vaccine; actual dose unspecified), as an infant. The office manager could not confirm if the vaccine was stored correctly back in 1992. A preliminary lot check investigation was performed. To date our investigation has found that this lot conformed to quality release parameters and the manufacturing was typical of a lot of RECOMBIVAX HB. Additional information will be provided upon finalization of this manufacturing investigation. Follow up information received from a physician via medical records indicated that the patient who is a 18 years old non smoker male (weight 250 pounds, height 72 inches), with no allergies, birth defects and or medical conditions, who on 27-AUG-1992 was vaccinated with a first dose of RECOMBIVAX HB (lot # 603897/0750V). The patient received a second dose of RECOMBIVAX HB, (lot# 603895/0748V), (adult dose) in his right arm on 29-SEP-1992. On 03-MAY-1993 the patient received a third dose of RECOMBIVAX HB, (lot number lot# "1100AL"). On 07-JUN-2010, the patient had a serum hepatitis B surface antibody screen (5 mIU/mL), which indicated that the patient did not have immunity to hepatitis B virus. On the same date the patient had a serum varicella zoster virus antibody test (2.92); the results indicated the presence of IgG VZV antibody, which was consistent with the immunity. On 15-JUN-2010 the patient had a fourth dose of hepatitis B virus vaccine (unspecified) (lot # AHBVB789AA) (Manufacturer unknown). At the time of this report the outcome of the patient's Anti-HBs Antibody Negative was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from a Registered Nurse concerning a patient who in November 2009, was vaccinated with a first dose of RECOMBIVAX HB (Lot # unknown). Second dose of RECOMBIVAX HB (Lot #  unknown) was given on an unspecified date. Third dose of RECOMBIVAX HB (Lot # unknown) was given in April 2010. The nurse reported that the patient received all 3 doses of RECOMBIVAX HB and still had low titers. Titers were conducted "this week" on approximately 13-JUL-2010. The outcome of the patient was not reported. It was unknown if the patient sought medical attention. This is one of several reports from the same source. Follow-up information was received from the registered nurse who stated that the patient did not have exposure problems; she reported that the patient simply had series of shots and negative titers. There were no adverse reactions. No further information is available.
Age: 17.0
Sex: M
Vaccine: HEP
Symptoms: Anti-HBs antibody negative, Hepatitis B antibody negative, Varicella virus test positive
Clinical narrative: Information has been received from an office manager concerning a 17 year old male patient who on 04-MAY-2010 was vaccinated with a fourth dose of RECOMBIVAX HB (lot number not available). The office manager reported that after the patient was vaccinated with the three doses of RECOMBIVAX HB, all blood work (hepatitis B surface antibody) came back negative (less than 5), "not immune", requiring a fourth dose of RECOMBIVAX HB. The patient did not develop hepatitis B. No other adverse events were reported. At the time of the report the patient had not had follow up laboratories. The patient's outcome was unknown. It was unspecified if the patient sought medical attention. Follow up information received via medical records indicated that the patient was a non smoker male. The patient's past drug therapy included first doses of IPV (unspecified), DPT and Hib conj vaccine (unspecified carrier) on 02-SEP-1992. On 11-JUL-1992 the patient received a first dose of hepatitis B virus vaccine (unspecified) (manufacturer unknown); on 05-AUG-1992 the patient received a second dose of hepatitis B virus vaccine (unspecified) (manufacturer unknown) and on 03-JAN-1993 the patient received a third dose of hepatitis B virus vaccine (unspecified) (manufacturer unknown). On 23-APR-2010 the patient had an anti-HBs titer (less than 5); it was reported that the patient did not have immunity to hepatitis B virus. On the same date a Varicella zoster virus IGG AB indicated that the presence of IgG VZV antibody was consistent with immunity. On 04-MAY-2010 the patient was vaccinated with a fourth dose of RECOMVIBAX HB (manufacturer unknown) (lot # AHBVB7URAA). On 24-JUL-2010 the patient had another anti-HBs titer which showed that the patient had immunity to hepatitis B virus (145 mIU/mL). This is one of several reports received from the same source. No further information is available.
Age: 1.31
Sex: F
Vaccine: HEP
Symptoms: Anti-HBs antibody negative, Hepatitis B antibody negative, Varicella virus test positive
Clinical narrative: Information has been received from an office manager concerning an 18 year old female patient with a history of twin birth who on 18-MAY-2010 was vaccinated with a fourth dose of RECOMBIVAX HB (lot number not available). The office manager reported that after the patient was vaccinated with the three doses of RECOMBIVAX HB, all blood work (hepatitis B surface antibody) came back negative (lab was 7), "not immune", requiring a fourth dose of RECOMBIVAX HB. The patient did not develop hepatitis B. No other adverse events were reported. At the time of the report the patient had not had follow up laboratories. The patient's outcome was unknown. It was unspecified if the patient sought medical attention. Follow-up information was received from the office manager who reported that the non-smoker female patient on 29-SEP-1992, was vaccinated with the first dose of RECOMBIVAX HB (lot number not available). On 18-DEC-1992, the patient received the second dose of RECOMBIVAX HB (lot number not available) and on 24-JUL-1993; the patient received the third dose of RECOMBIVAX HB (lot number not available). On 08-MAY-2010 an anti-HBs titer was performed which result was 7. The patient did not have immunity to hepatitis B virus at that moment. On the same day, a varicella zoster virus AB (IGG) was done which result was 2.89 (positive). On 18-MAY-2010, the patient received a forth dose of RECOMBIVAX HB (lot # AHBVB772CA). On 15-JUL-2010, an hepatitis B surface antibody test was performed which result was more than 1000. The patient had now immunity to hepatitis B virus. No adverse events were reported. It was unknown if the patient had any illness at the time of vaccination. This is one of several reports received from the same source. No further information is available.
Age: 17.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, No therapeutic response
Clinical narrative: Information has been received from an office manager concerning a 17 year old male patient who on 07-JUN-2010 was vaccinated with a fourth dose of RECOMBIVAX HB (lot number not available). The office manager reported that after the patient was vaccinated with the three doses of RECOMBIVAX HB, all blood work (hepatitis B surface antibody) came back negative (less than 5), "not immune", requiring a fourth dose of RECOMBIVAX HB. The patient did not develop hepatitis B. No other adverse events were reported. At the time of the report the patient had not had follow up laboratories. The patient's outcome was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Follow-up information was received from the office manager concerning the 17 year old male patient with no pertinent medical history and no known drug reactions or allergies who on 23-JUN-1992, 21-JUL-1992 and 14-JAN-1993 received the first, second and third dose of RECOMBIVAX HB (lot number not available) respectively. On 25-MAY-2010, the patient had a hepatitis B surface antibody (quant) and the result was <5 which showed that the patient did not have immunity to hepatitis B virus. It was stated that the patient needed a fourth dose of RECOMBIVAX HB and then should repeat hepatitis B virus titers after 4 weeks. On 07-JUN-2010, the patient had the fourth dose of RECOMBIVAX HB. On 18-AUG-2010, the patient repeated the hepatitis B surface antibody (quant) and the result was <5 which showed the patient did not have immunity to hepatitis B virus. It was reported that the patient did not respond to the fourth dose of RECOMBIVAX HB, and that there was no need for further doses. At the time of the report, the patient's outcome was unknown. No further information is available.
Age: 0.71
Sex: F
Vaccine: HEP
Symptoms: Anti-HBs antibody negative, Varicella virus test positive
Clinical narrative: Information has been received from an office manager concerning a 17 year old female patient who on 02-JUL-2010 was vaccinated with a fourth dose of RECOMBIVAX HB (lot number not available). The office manager reported that after the patient was vaccinated with the three doses of RECOMBIVAX HB, all blood work (Hepatitis B surface antibody) came back negative (less than 5), "not immune", requiring a fourth dose of RECOMBIVAX HB. The patient did not develop hepatitis B. No other adverse events were reported. At the time of the report the patient had not had follow up laboratories. The patient's outcome was unknown. It was unspecified if the patient sought medical attention. Follow-up information was received from the office manager who reported that the female, non-smoker patient was vaccinated with the first dose of RECOMBIVAX HB (lot number not available) on 22-AUG-1992. On 17-SEP-1992, the patient received the second dose of RECOMBIVAX HB (lot number not available) and on 10-MAY-1993, the patient received the third dose of RECOMBIVAX HB (lot number not available). On 15-JUN-2010 an anti-HBs titer was performed which result was less than 5. The patient did not have immunity to hepatitis B virus at that time. On the same day, a varicella zoster virus AB (IGG) was done which result was 2.17 (positive). On 02-JUL-2010, the patient received a forth dose of RECOMBIVAX HB (lot # AHBVB789AA). On 10-AUG-2010, hepatitis B surface antibody test was performed which was 263. The patient now had immunity to hepatitis B virus. No adverse events were reported. It was unknown if the patient had any illness at time of vaccination. This is one of several reports received from the same source. No further information is available.
Age: 17.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from an office manager concerning a 17 year old female patient who on 23-JUN-2010 was vaccinated with a fourth dose of RECOMBIVAX HB (lot number not available). The office manager reported that after the patient was vaccinated with the three doses of RECOMBIVAX HB, all blood work (hepatitis B surface antibody) came back negative (less than 5), "not immune", requiring a fourth dose of RECOMBIVAX HB. The patient did not develop hepatitis B. No other adverse events were reported. At the time of the report the patient had not had follow up laboratories. The patient's outcome was unknown. It was unspecified if the patient sought medical attention. Follow up information received via medical records indicated that the patient was a female (weight 151, height 64 1/4) with no illness at the time of vaccination, who on 23-JUN-2010 was vaccinated with a fourth dose of RECOMBIVAX HB (manufacturer unknown) (lot # AHBVB789AA). On 26-SEP-1992 the patient received a first dose of hepatitis B virus vaccine (unspecified) (manufacturer unknown); on 23-NOV-1992 the patient received a second dose of hepatitis B virus vaccine (unspecified) (manufacturer unknown) (lot # ENG1057A2) and on 01-OCT-1993 the patient received a third dose of hepatitis B virus vaccine (unspecified) (manufacturer unknown) (lot # ENG1057A2). On 16-JUN-2010 the patient had an anti-HBs titer (less than 5); it was reported that the patient did not have immunity to hepatitis B virus. On 30-JUL-2010 the patient had another anti-HBs titer which came back reactive. This is one of several reports received from the same source. No further information is available.
Age: 17.0
Sex: M
Vaccine: HEP
Symptoms: Anti-HBs antibody negative, Hepatitis B antibody negative, Varicella virus test positive
Clinical narrative: Information has been received from an office manager concerning a 17 years old male patient who on 29-JUN-2010 was vaccinated with a fourth dose of RECOMBIVAX HB (lot number not available). The office manager reported that after the patient was vaccinated with the three doses of RECOMBIVAX HB, all blood work (Hepatitis B surface antibody) came back negative (less than 5), "not immune", requiring a fourth dose of RECOMBIVAX HB. The patient did not develop hepatitis B. No other adverse events were reported. At the time of the report the patient had not had follow up laboratories. The patient's outcome was unknown. It was unspecified if the patient sought medical attention. Follow up information received via medical records indicated that the patient was a non smoker male (height 78, weight 178), who on 29-JUN-2010 was vaccinated with a fourth dose of RECOMBIVAX HB (manufacturer unknown) (lot # AHBVB7989AACA). On 14-JUL-1992 the patient received a first dose of hepatitis B virus vaccine (unspecified) (manufacturer unknown); on 09-SEP-1992 the patient received a second dose of hepatitis B virus vaccine (unspecified) (manufacturer unknown) and on 10-MAR-1993 the patient received a third dose of hepatitis B virus vaccine (unspecified) (manufacturer unknown). On 22-JUN-2010 the patient had an anti-HBs titer (less than 5) it was reported that the patient did not developed immunity to hepatitis B virus. On the same date the patient had a varicella zoster virus IGG AB (2.44, the presence of IgG VZV antibody was consistent with immunity). On 17-AUG-2010 the patient had another anti-HBs titer (> 1000; patient had immunity to hepatitis B virus). This is one of several reports received from the same source. No further information is available.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from a licensed practical nurse concerning a female patient who on 04-JAN-1993, 25-FEB-1993 and 29-JUL-1993 was vaccinated IM with the first, second and third 0.5 ml (5 mcg) doses of RECOMBIVAX HB. The lot number and expiration dates were not provided. Then the patient had a hepatitis B antibody titer test and had negative antibody titer. The patient sought unspecified medical attention. At the time of report the patient's status was unknown. Additional information has been requested. This is an amended report. AE term was updated to map to "Anti-HBs Antibody Negative".
Age: 0.77
Sex: M
Vaccine: HEP
Symptoms: Anti-HBs antibody negative
Clinical narrative: Information has been received from an office manager concerning a 17 year old male patient who on 29-JUN-2010 was vaccinated with a fourth dose of RECOMBIVAX HB (lot number not available). The office manager reported that after the patient was vaccinated with the three doses of RECOMBIVAX HB, all blood work (Hepatitis B surface antibody) came back negative (less than 5), "not immune", requiring a fourth dose of RECOMBIVAX HB. The patient did not develop hepatitis B. No other adverse events were reported. At the time of the report the patient had not had follow up laboratories. The patient's outcome was unknown. It was unspecified if the patient sought medical attention. Follow-up information received via medical records indicated that the patient was a non-smoker male. The patient's past drug therapy included first doses of IPV (unspecified), diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid and Hib conj vaccine (unspecified carrier) on 21-SEP-1992. On 30-JUL-1992 the patient received a first dose of hepatitis B virus vaccine (unspecified) (manufacturer unknown); on 21-SEP-1992 the patient received a second dose of hepatitis B virus vaccine (unspecified) (manufacturer unknown) and on 29-APR-1993 the patient received a third dose of hepatitis B virus vaccine (unspecified) (manufacturer unknown). On 25-JUN-2010 the patient had an anti-HBs titer (less than 5); it was reported that the patient did not have immunity to hepatitis B virus. On 29-JUN-2010, the patient was vaccinated with a fourth dose of hepatitis B virus vaccine (unspecified) (manufacturer unknown) (lot # AHBVB789AA). On 29-JUL-2010 the patient had another anti-HBs titer which showed that the patient had immunity to hepatitis B virus (461 mIU/mL). This is one of several reports received from the same source. No further information is available.
Age: 2.0
Sex: F
Vaccine: HEP
Symptoms: Anti-HBs antibody negative
Clinical narrative: Information has been received from an office manager concerning a female patient who on an unspecified date completed vaccination with the three dose series of RECOMBIVAX HB (lot number not available). The office manager reported that after the patient was vaccinated with the three doses of RECOMBIVAX HB, all blood work (hepatitis B surface antibody) came back negative (less than 5), "not immune". The patient did not develop hepatitis B. No other adverse events were reported. The patient's outcome was unknown. It was unspecified if the patient sought medical attention. Follow up information has been received from an office manager. It was reported that the 17 year old non smoker female patient was vaccinated on 28-SEP-1993 with the first dose of RECOMBIVAX HB (manufacturer and lot number unknown). On 11-NOV-1993 the patient received the second dose of RECOMBIVAX HB (manufacturer and lot number unknown), and on 01-MAR-1994 the patient received the third dose of RECOMBIVAX HB (manufacturer and lot number unknown). On 24-JUN-2010 a hepatitis B surface antibody test was performed; the result was <5, it was confirmed that the patient did not have immunity to hepatitis B virus. On 23-AUG-2010 the patient was vaccinated with a booster dose of hepatitis B virus vaccine (unspecified) (manufacturer unknown) (lot number AHBVB789BA). At the time of the report additional anti hepatitis B titer results were awaiting. The patient did not seek medical attention. This is one of several reports received from the same source. No further information is expected.
Age: 17.0
Sex: M
Vaccine: HEP
Symptoms: Anti-HBs antibody negative
Clinical narrative: Information has been received from an office manager concerning a 17 year old male patient who on 13-JUL-2010 was vaccinated with a fourth dose of RECOMBIVAX HB (lot number not available). The office manager reported that after the patient was vaccinated with the three doses of RECOMBIVAX HB, all blood work (hepatitis B surface antibody) came back negative (less than 1), "not immune", requiring a fourth dose of RECOMBIVAX HB. The patient did not develop hepatitis B. No other adverse events were reported. At the time of the report the patient had not had follow up laboratories. The patient's outcome was unknown. It was unspecified if the patient sought medical attention. Follow up information was received from the physician reporting that on 01-JAN-1993 the male patient was vaccinated with the first dose of RECOMBIVAX HB. On 02-MAR-1993, the patient was vaccinated with the second dose of RECOMBIVAX HB and on 08-JUL-1993 was vaccinated with the third dose of RECOMBIVAX HB. On 22-JUN-2010 serum hepatitis B surface antibody was <1. On 13-JUL-2010, the patient was vaccinated with a booster dose of RECOMBIVAX HB (lot# 789BA) On 13-AUG-2010 serum hepatitis B surface antibody screen was <1. This is one of several reports received from the same source. Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a Registered Nurse concerning an unspecified number of patients who on an unspecified dates were vaccinated with all 3 doses of RECOMBIVAX HB (Lot # unknown). Then years later, the patients presented with low titers. She stated these patients were usually given 1 dose of RECOMBIVAX HB and then titers were conducted. The patients were usually found to have a titer indicating coverage. The outcome of the patients was not reported. It was unknown if the patients sought medical attention. This is one of several reports from the same source. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, No therapeutic response
Clinical narrative: Information has been received from a nurse practitioner concerning a 26 year old female patient who was vaccinated with the 3 doses of RECOMBIVAX HB (manufacturer unknown) 5-6 years ago and titers were now negative. The patient did respond to the vaccine she got the 3 dose series 5-6 years ago. No further information is available. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: HEP
Symptoms: Antinuclear antibody positive, Blood disorder, Mouth ulceration, Nuclear magnetic resonance imaging spinal cord abnormal, Spinal muscular atrophy
Clinical narrative: This case was reported in a published article, regarding a 60 year old woman, who claimed that the RECOMBIVAX HB (manufacturer unspecified) thimerosal containing caused her three separate autoimmune disorders, she had not proved that she had any of them, a vaccine court special master ruled in a decision made public on 13-APR-2010. The patient claimed she suffered from transverse myelitis (TM), chronic fatigue syndrome (CFS) and systemic lupus erythematosus (SLE). A Special Master said that the patient did not satisfy the diagnosis criteria for those conditions. For example, the special master said that a magnetic resonance imaging (MRI) study of the patient's thoracic spine showed atrophy, instead of a lesion that would have been diagnostic of transverse myelitis. There were no diagnostic tests for CFS, the special master said, but the petitioner failed to rule out conditions that may produce chronic fatigue, including nutritional deficits such as the petitioner's vitamin B12 deficiency. The patient did not raise the possibility of lupus until eight years after filing her initial petition. Special Master said and she failed to establish diagnostic criteria for that as well. For example, the special master said that the patient did not exhibit a malar rash, described as "fixed erythema, flat or raised. Over the malar eminences, tending to spare the nasolabial folds", or a discoid rash, described as "erythematous raised parches with adherent keratotic scaling and follicular plugging; atrophic scaring may occur in older lesions". It was mentioned that "at best, the petitioner fulfilled three of the eleven criteria for a diagnosis of systemic lupus erythematosus". Special Master said. "The three criteria that petitioner satisfied are oral ulcers, hematological disorder and antinuclear antibody. Petitioner must fulfill at least four of the eleven criteria to satisfy the diagnostic criteria for SLE. Thus, the patient did not suffer from systemic lupus erythematosus, a finding that petitioner did not present a preponderant amount of evidence indicating that she suffered from SLE was consistent with the work of her treating doctors. From the period of 1997 to 2007, none of the patient's treating doctors diagnosed her as suffering from SLE. Two of the patient's treating physicians considered lupus and ruled it out". Upon internal review transverse myelitis and systemic lupus erythematosus were considered other important medical events. Additional information is not expected.