chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: HEP
Symptoms: Vitamin B12 deficiency
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.
Age: 11.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from a company representative and a physician concerning a 10 to 11 year old male who was vaccinated with the three does series of RECOMBIVAX HB as an infant. A recent titer was negative so the patient received one additional 0.5 mcg (0.5 mL) dose of RECOMBIVAX HB (LOT# not reported). A repeat titer was still negative. The patient sought unspecified medical attention. At this time of reporting, the patient was reported as not recovered. Additional information has been requested.
Age: 0.26
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from a medical technician concerning an approximately 16 year old female patient with asthma and no known drug allergies, who had been vaccinated with the first, second and third dose of RECOMBIVAX HB, 5 mcg/0.5 ml, 0.5 ml (lot #, route and injection site not reported) on 21-SEP-1993 (at the age of 3 months), 23-NOV-1993 (at the age of 5 months) and 26-APR-1994 (at the age of 10 months), respectively. Concomitant therapy was not reported. In June 2009 the patient had titers done and she was not immuned based on the titer results. The patient visited doctor office for medical attention. Additional information has been requested. This is one of several reports received from the same source.
Age: 34.0
Sex: M
Vaccine: HEP
Symptoms: Anti-HBs antibody negative, Hepatitis B antibody negative
Clinical narrative: Information has been received from a nurse concerning a 34 year old male (in 2006) with no pertinent medical history and no known drug allergies who on unspecified dates were vaccinated with two complete series of RECOMBIVAX HB (10mcg/1mL). The dates of administration and lot numbers were unknown. The second series was administered about 10 years ago. The nurse reported that the patient had negative anti-HBs antibody after administration of two complete series of RECOMBIVAX HB. It was also reported that in 2006 a hepatitis B antibody levels test revealed that it was negative. Unspecified medical attention was sought. The patient was not recovered at this time of reporting. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from an approximately 19 year old female medical technician with no known drug allergy or pertinent medical history reporting on herself. In 1996 (at the age about 10 years), the patient received 3 doses of RECOMBIVAX HB (lot #, route, injection site and date for each dose not reported). She went to doctor in 2005 and had a titer done and was informed that she was not protected. The doctor gave her another 3 injection of RECOMBIVAX HB (lot #, route, injection site and date for each dose not reported) in 2005 (at the age about 19 years). The patient had another titer done 6 months after the third injection and again she did not have immunity. Additional information has been requested. This is one of several reports received from a same source.
Age: 16.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from a physician concerning a 16 year old female patient who in approximately 2007 "approximately 3 years ago" received and completed the RECOMBIVAX HB series (Lot numbers unknown) and a recent titer was antibody negative. At the time of the report, the patient's outcome was unknown. It was unknown if the patient sought medical attention. No further information is available.
Sex: F
Vaccine: HEP
Symptoms: Anti-HBs antibody negative
Clinical narrative: Information has been received from a licensed practical nurse concerning a female who was vaccinated with 3 doses  RECOMBIVAX HB as a child. The nurse reported that the patient did not seroconvert. The nurse stated that the child "is now 18 years of age". No adverse events reported. The outcome of the patient's event was unknown. This is an amended report. AE term now was mapped to anti-HBs antibody negative instead of seroconversion test negative. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: HEP
Symptoms: Anti-HBs antibody negative, Hepatitis B antibody abnormal
Clinical narrative: Information has been received from a physician concerning a 68 year old female with hypertension and hypercholesterolemia who was vaccinated with two complete series RECOMBIVAX HB and a booster (dates and Lot# unknown). In 2005 a seventh dose of RECOMBIVAX HB was administered as a booster. Concomitant therapy included CRESTOR and NORVASC. The patient reported that she had low anti-HBs titer. She was not able to confirm if RECOMBIVAX HB was used for either series or booster. The patient did not seek medical attention. At the time of the report, the outcome was unknown. This is one of several reports received from the same source. 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 who had vaccinated with all three doses of RECOMBIVAX HB (Pediatric dose, so should 0.5 mL each dose) (LOT# not reported). On an unspecified date, the patient had titers drawn and the titers came back negative. The physician was not sure if she (reports as 'he") would have to give all three doses again or just a booster shot. No further information was provided at this time of  reporting. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from a physician assistant concerning a 14 year old patient who was vaccinated when she was a child with three separate doses of RECOMBIVAX HB (manufacturer unknown), the first dose was given on 24-JUL-1996. T he physician assistant reported that the patient failed to have a positive titer after receiving the 3 doses listed above. On 16-JUL-2010, the titer was drawn and the result was negative, subsequently on 07-AUG-2010, the patient was vaccinated with another dose of RECOMBIVAX HB (Lot#: not reported). No adverse effect was reported. The patient sought unspecified medical attention. At the time of the repot, the patient's outcome was unknown. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B test negative, No therapeutic response
Clinical narrative: Information has been received from a register nurse concerning an approximately 25 year old female who on an unspecified date was vaccinated with 3 doses of RECOMBIVAX HB (therapy dose, route and site unknown). But the patient had not seroconverted. No adverse events reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from a physician concerning a college student who was vaccinated with one complete series RECOMBIVAX HB (dates and Lot# unknown). Subsequently, the patient had low anti-HBs titer. It was unspecified if the patient had sought medical attention. At the time of the report, the outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Anti-HBs antibody negative, Seroconversion test negative
Clinical narrative: Information has been received from a medical assistant concerning a 23 year old female patient who on an unspecified date was vaccinated with three doses of RECOMBIVAX HB and failed to seroconvert. The outcome of the patient was not reported. It was unknown if the patient sought medical attention. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: DT, MMR
Symptoms: Central nervous system inflammation, Laboratory test abnormal, Multiple sclerosis, Myelitis transverse, Serology test
Clinical narrative: Information has been received from a lawyer regarding a case in litigation that was reported in a published article. A 23 year old female received two rounds of vaccines in the summer of 2005, RECOMBIVAX HB (manufacturer unspecified) and meningococcal vaccine (unspecified) on 07-JUL-2005 and the MMR II (MSD) (Lot # not reported) and TD on 02-AUG-2005. After the second round (in August 2005), the patient developed symptoms of inflammation in various locations in her central nervous system. The patient also had serologic studies that showed autoimmune activity. She was diagnosed with transverse myelitis (TM) on 22-AUG-2005. Her treating neurologist opined that her TM was secondary to vaccination. The patient's expert, another neurologist could not say which of five vaccines (tetanus toxoid, diphtheria toxoid, measles, mumps, rubella) triggered the autommune response that caused what was first diagnosed transverse myelitis and ultimately MS (multiple sclerosis). The expert thought one vaccine was more likely than a combination of vaccines to be the cause of the inflammation in the patient's nervous system since immune responses were very specific. He thought one of the antigen components of one of these vaccines activated a subset of T-cells that also responded to a central nervous system antigen in the patient and, in doing so, caused an area of inflammation in her cervical spinal cord 20 days later, causing her neurologic symptoms. The expert testified that the medical theory connecting tetanus/diphtheria and measles-mumps-rubella vaccine (MSD) to TM/MS could be explained though molecular minicry, T-Cell degeneracy, or bystander activation. Upton internal review, multiple sclerosis was considered to be an other important medical event. No further information is available.
Age: 16.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from a physician concerning a patient who was age 10 and up both female and male, who on unspecified dates were vaccinated RECOMBIVAX HB (manufacturer unknown) (Lot # unknown) and tested negative titer for Hep B. Follow up information has been received from an office manager and a physician concerning a 16 year old male patient who on 19-APR-1994 and 17-NOV-1994 was vaccinated with the second and third doses of RECOMBIVAX HB (lot number 607881/0941W, T-cont, in the right leg for the second dose and lot number 611290/0048A in the left arm for the third dose). On 15-FEB-1994, the first dose of RECOMBIVAX HB (manufacturer unknown) was administered. Concomitant vaccines included: DTP (manufacturer Connaught) administered on 19-APR-1994 (lot number 3D51083, in the left leg); OPV (manufacturer leaderle) administered on 19-APR-1994 (lot number 368-949-0698D, orally); Hib conj vaccine (tet toxoid) (manufacturer Praxis) administered on 19-APR-1994 (lot number MOO5KD), in the right leg). Patient had initial Hepatitis B series and was no longer immune per blood test titers. The patient was appointed to start the second series on 18-AUG-2010. Past drug history included: GARDASIL (manufacturer Sanofi) administered on 03-JUL-2007 in the left arm and on 19-JUL-2010 in the left arm; Hib conj vaccine (tet toxoid) (manufacturer Praxis) administered on 17-MAY-1995 (lot number M315LE) in the right arm; DTP (manufacturer Connaught) administered on 22-JUN-1994 (lot number 3E51112, in the left arm) and 18-AUG-1994 (lot number 4H51508, in the left arm); DTAP (manufacturer Leaderle) administered on 23-AUG-1995 (lot number 378-909) in the left arm and on 23-FEB-1999 DTAP (manufacturer Connaught) (lot number 0970140) in the left arm; BOOSTRIX administered on 17-JUL-2006 in the left arm; Hib conj vaccine (tet toxoid) (manufacturer Praxis) administered on 22-JUN-1994 (lot number M460LA, in the right leg) and 18-AUG-1994 (lot number M28543, in the right leg); MMR II administered on 19-FEB-1995 (lot number 1708W-0889A) in the left arm and on 23-FEB-1999 (lot number 628903/1359H) in the right arm; OPV (manufacturer Leaderle) administered on 23-AUG-1995 (lot number 396-925-0717A) and on 23-FEB-1999 (lot number 057-839-0795E) and on 22-JUN-1994 (lot number 368-949-0698D, orally); VARIVAX (Merck) administered on 05-DEC-1995 (lot number 610257/0750B, in the left arm) and on 29-JUL-2008 (lot number 659456/1912U, in the left arm). This is one of several reports from the same source. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody positive, Mass
Clinical narrative: Information has been received from a registered nurse concerning a 37 year old female patient with penicillin allergy, egg allergy, asthma and borderline hypothyroidism who on an unspecified date was vaccinated a second dose of RECOMBIVAX HB (manufacturer unknown) (lot number not provided). There was no concomitant medication. The nurse reported that the patient had a large baseball size bump in the deltoid region. The patient did not get the third dose because it was found that the patient had high titers after only 2 doses. At the time of the report the patient had recovered. The patient sought medical attention by a phone call. No further information is available.
Age: 0.19
Sex: F
Vaccine: DTAP, HEP, HIBV, OPV
Symptoms: Anti-HBs antibody negative, Antibody test
Clinical narrative: Information has been received from a physician via medical records concerning a 10 week old female, who on 05-AUG-1992 was vaccinated with a first dose of hepatitis B virus vaccine (unspecified) (manufacturer unknown). On 13-OCT-1992 she was vaccinated with a second dose of RECOMBIVAX HB (lot # 603895/0748V, also reported as 0748O) in her left leg. The patient was vaccinated with a third dose of ENGERIX-B (lot # ENG097A2) in her left leg (vaccination date reported as 24-FEB-1992). Concomitant therapy included doses of ACEL-IMUNE, poliovirus vaccine and HIBTITER. On 09-JUN-2010 the patient had a hepatitis B surface antibody test (<5 mIU/mL); It was reported that the patient did not develop immunity to hepatitis B virus after the initial hepatitis B vaccination series. On the same date the patient had a varicella zoster virus antibody IgM test (0.24 ISR) and a varicella zoster virus antibody IgG test (2.03). The patient also received the following vaccines: the first dose of MMR II (lot # 603966/0537W) in her left arm on 03-NOV-1993; the second dose of MMR II (lot # 638512/0165L, HSA) in her left arm on 13-AUG-2001; the first dose of ADACEL (lot # 01340AA) in her left arm; the first dose of influenza virus vaccine (unspecified) (manufacturer unknown) on 28-OCT-2005; second dose of influenza virus vaccine (unspecified) (manufacturer unknown) on 29-DEC-2006, third dose of influenza virus vaccine (unspecified) (manufacturer unknown) on 19-NOV-2007; first dose of MENACTRA (lot # 42619AA) in her left arm on 23-JUN-2008; fourth dose of influenza virus vaccine (unspecified) (manufacturer unknown) on 13-OCT-2008 and fifth dose of influenza virus vaccine (unspecified) (manufacturer unknown) on 01-SEP-2009. At the time of the report the patient's present status was unknown. This is one of several reports received from the same source. Additional information is not expected.
Age: 0.48
Sex: F
Vaccine: DTAP, DTAPH, HEP
Symptoms: Anti-HBs antibody negative
Clinical narrative: Information has been received from a physician via medical records concerning a 15 year old female. The patient's past drug therapy included the first and the second doses of ORIMUNE, on 18-JAN-1995 (lot # 314-436070014) and on 11-MAR-1995 (lot # 386-942-071473). On 15-NOV-1994 the patient was vaccinated with a first dose of RECOMBIVAX HB. On 18-JAN-1995 the patient was vaccinated with a second dose of RECOMBIVAX HB (lot # 611290/0048A) in her right leg and on 08-MAY-1995 the patient was vaccinated with a third dose of RECOMBIVAX HB (lot # 613667/1286A) in her right leg. Concomitant therapy given in 08-MAY-1995 included the third dose of DTAP and the third dose of DTAP + HIB (lot # 384-975), in her left leg. On 27-AUG-2010 the patient had a hepatitis B surface antibody test (<5 mIU/mL); it was reported that the patient did not developed immunity to hepatitis B virus after the initial hepatitis B vaccination. The patient also received the following vaccines: first dose of MMR II (lot # 615318/0470B, HSA), in her left arm on 16-NOV-1995; the fourth dose of HIBTITER (lot # m005LP) in her left arm on 15-FEB-1996; the third dose of ORIMUNE (lot # 430-18707342) on 02-MAY-1996; the first dose of VARIVAX (Merck) (lot # 620617/1105D) in her left arm on 18-NOV-1996; the fourth dose of ORIMUNE (lot # 457-8390795E) on 19-NOV-1998; the second dose of MMR II (lot # 626052/0230H, HSA), in her left arm on 19-NOV-1998; the first dose of BOOSTRIX (lot # AC5280246A) in her left arm on 02-SEP-2008; the first dose of MENACTRA (lot # U2422AA) in her left arm on 02-SEP-2008; the second dose of VARIVAX (Merck) (lot # 660560/0135X) in her left arm on 02-SEP-2008; and a first dose of TWINRIX (lot # AHAVB427BA) in her left arm on 04-JAN-2010. At the time of the report the patient's present status was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.85
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody, Hepatitis B antibody negative
Clinical narrative: Information has been received from a physician via medical records concerning an 17 year old male patient who on 02-JUL-1993 was vaccinated with the first dose of RECOMBIVAX HB (Lot number 154A2), the first dose of diphtheria toxoid/tetanus toxoid (Lot number 399-905), 382-948-06796) and the fist dose of HIBTITER () Lot number H015TL). On 07-SEP-1993 the patient received a "second dose" of RECOMBIVAX HB (manufacturer unknown) (lot number not reported). The second dose of diphtheria toxoid/tetanus toxoid (Lot number 249-905) and the second dose of HIBTITER () Lot number M170KB). On 10-NOV-1993, the patient received the third dose of diphtheria toxoid/tetanus toxoid (Lot number 4938032) and the first dose of HIBTITER () Lot number H015TL). On 08-MAR-1994, the patient received the "third" dose of RECOMBIVAX HB (lot number 607974/0989W) (thimerosal containing). On 16-APR-2010 the patient's serum hepatitis B surface antibody screen was <0.5, reported as does not have immunity to hepatitis B virus. The patient's past vaccination history included: ORIMUNE on 02-DEC-1994, 02-JUL-1993, 07-SEP-1993 and 21-AUG-1998. MMR II on 01-SEP-1994 and on 21-AUG-1998. VARIVAX (Merck) on 03-MAY-1996 and on 11-MAR-2009. MENACTRA on approximately 15-APR-2007. Tuberculin purified protein derivative in August 1998. At the time of the report the patient's status was unknown. This is one of several reports received from the same source. No further information is expected.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from a physician concerning a 13 year old female who on 26-MAY-1997 was vaccinated with the first 2.5 mcg dose of RECOMBIVAX HB. Concomitant therapy included TETRAMUNE, ORIMUNE and ENGERIX-B. Per serum hepatitis B surface antibody screen done on 29-JUL-2010, the patient did not have immunity to hepatitis B. Result was less than 5. At the time of the report, the outcome of the patient was unknown. Additional information has been requested.
Age: 0.08
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from a physician concerning a 18 year old male who on 10-JUN-1992 was vaccinated with the first dose of RECOMBIVAX HB (lot # 602638/0310V) into the left thigh. On 02-JUL-1992, the patient received the second dose of RECOMBIVAX HB and on 23-MAR-1993, the patient received a third dose of hepatitis B virus vaccine (unspecified) (lot # 1094A2). Concomitant therapy included ORIMUNE (lot # 320-932). Per serum hepatitis B surface antibody screen done on 29-JUL-2010, the patient was no longer immune. Result was 0.23, inconsistent with immunity. At the time of the report, the outcome of the patient was unknown. Additional information has been requested.
Age: 0.53
Sex: M
Vaccine: DTAP, HEP, HIBV
Symptoms: Anti-HBs antibody negative, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician via medical records concerning a 20 weeks male patient who on 24-SEP-1992 was vaccinated with the first dose of RECOMBIVAX HB (lot number 603895/0748V) in the right leg. In the same day the patient received the second dose of HIBTITER (Lot number M125JD), ORIMUNE (Lot number 32093106590) and ACEL-IMUNE (Lot number 318908). On 17-NOV-1992, the patient received the second dose of RECOMBIVAX HB (Lot number 603895/0748V) in the left leg. On the same day the patient received the third dose of HIBTITER (Lot number M020JE) and ACEL-IMUNE (Lot number 318908). On 11-AUG-1993, the patient received the fourth dose of HIBTITER (Lot number M170KB). On 10-NOV-1993 the patient received the fourth dose of ACEL-IMUNE. On 09-JUN-1994, the patient received the third dose of RECOMBIVAX HB (Lot number) in the right arm. On 14-MAY-1997, the patient received the fourth dose of ORIMUNE and the fifth dose of DTaP. The patient's vaccination history also included: 07-MAY-1992 the patient received the first dose of HIBTITER (Lot number M600JD), the first dose of ORIMUNE (Lot number 31493706464) and the first dose of ACEL-IMUNE (Lot number 318908). The patient also received MMR II on 05-AUG-1997 and on 09-NOV-2001. VARIVAX (Merck) on 24-JAN-1996 and on 02-OCT-2007. MENACTRA on 02-OCT-2007. On 22-JUN-2010 the patient's serum hepatitis B surface antibody screen showed a value of 0.71, it was reported that he was no longer immune per blood test titers. At the time of the report the patient's present status was unknown. This is an amended report. The adverse event of overdose was deleted since the dose administered was not specified. In addition, an adverse event of inappropriate schedule of vaccine administered was added to reflect that the second dose of RECOMBIVAX HB was administered later than one month of receiving the first dose. Additional information is not expected.
Age: 0.77
Sex: M
Vaccine: HEP
Symptoms: Anti-HBs antibody negative
Clinical narrative: Information has been received from a physician via medical records concerning a currently a 16 year old male who on 21-JUN-1994 at the age of 62 days, was vaccinated with a first dose of RECOMBIVAX HB (route and site of injection unspecified, lot number: 607878/0990W) in the right thigh. On 24-AUG-1994, the patient was vaccinated with a second dose of RECOMBIVAX HB (route and lot number unspecified) (Smith Kline Beechum) in the right thigh. On 31-JAN-1995, the patient received the third dose of RECOMBIVAX HB (route unspecified and lot number: 613382/1065A) in the left arm. The patient's vaccination history also included: In 1994, the patient was vaccinated with a first dose of ACEL-IMMUNE (Lot number:3651112). On 04-JUN-1994, the patient was vaccinated with a first dose of ORIMUNE. On 24-AUG-1994, the patient was vaccinated with a second dose of ORIMUNE and second dose of ACEL-IMUNE (Lot number: UH51058). On 01-NOV-1994, third dose of ACEL-IMUNE (Lot number:3M41116). On 25-OCT-1995, the patient was vaccinated with the fourth dose of ACEL-IMUNE (Lot number:5G61001). On 25-MAR-1995, a first dose of MMR II in the left arm. On 26-JUL-1995, the patient received a third dose of HIBTITER. In 1998, the patient was vaccinated with a third dose of ORIMUNE. On 25-APR-1998, the patient was vaccinated with a first dose of VARIVAX (Merck). On 16-JUN-1999, received the fifth dose of ACEL-IMUNE (Lot number:0970140) and ORIMUNE (lot number 07952), tuberculin purified protein derivative and a second dose of MMR II in the left arm. On 21-MAR-2006, the patient was vaccinated with a dose of HAVRIX in the left arm (lot number:AHAB427BA). On 22-JAN-2007, the patient received a dose of BOOSTRIX. 14-MAR-2008, the patient was vaccinated with a dose of VARIVAX (Merck). On an unspecified date received a dose of MENACTRA. On 25-AUG-2010, the patient's serum hepatitis B surface antibody screen showed a value of <5 mIU/mL, it was reported that he was no longer immune per blood test titers. At the time of the report the patient's present status was unknown. Additional information is expected.
Age: 0.75
Sex: M
Vaccine: HEP
Symptoms: Anti-HBs antibody negative
Clinical narrative: Information has been received from a physician via medical records concerning a 9 month old male who on 07-DEC-1998 was vaccinated with a first dose of RECOMBIVAX HB (route lot number, and site of injection unspecified). On 09-FEB-1999, the patient was vaccinated with a second dose of RECOMBIVAX HB (route unspecified and lot number: 11904) in the left thigh. On 07-SEP-1999, the patient received the third dose of RECOMBIVAX HB (route lot umber, and site of injection unspecified) and a dose of tuberculin purified protein derivative. The patient's vaccination history also included: On 09-FEB-2009, the patient was vaccinated with the following vaccines: a first dose of ACEL-IMUNE (Lot number: 0970140), a first dose of ORIMUNE in the right thigh (lot number:NO597) and a first dose of HIBTITER (lot number:3615026) in the left thigh. On 13-MAR-1999, the patient received the following vaccines: a second dose of ACEL-IMUNE (Lot number:0984570) in the left arm, a second dose of HIBTITER (lot number:0303A) in the right thigh and a second dose of ORIMUNE in the right thigh (lot number:NO724) in the right thigh. On 14-JUN-1999, the patient received the following vaccines: a third dose of ACEL-IMUNE (Lot number:0984570), and a third dose of HIBTITER (lot number:423203A) in the left thigh. On 12-JAN-2000, the patient was vaccinated with the following vaccines: a first dose of MMR II (lot number: 632457/1084J) HAS, a first dose of VARIVAX (Merck). On 23-JUN-2000, a fourth dose of ACEL-IMUNE, a fourth dose of ORIMUNE in the right thigh. On 21-JAN-2004, the patient received a fifth dose of ACEL-IMUNE, a fourth dose of ORIMUNE and a second dose of MMR II (manufacturer unspecified). On 27-JAN-2004, the patient was vaccinated with a dose of tuberculin purified protein derivative. On 28-JAN-2008, the patient received the first dose of MENACTRA. On 18-AUG-2008, received the second dose of MENACTRA (lot numberU3011AA). On 03-AUG-2010, the patient was vaccinated with a second dose of VARIVAX (Merck). On 25-AUG-2010, the patient's serum hepatitis B surface antibody screen showed a value of <5, it was reported that he was no longer immune per blood test titers. At the time of the report the patient's present status was unknown. Additional information is not expected.
Age: 0.75
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from a physician concerning a 12 year old male patient who on 07-DEC-1998 was vaccinated with the first dose of RECOMBIVAX HB (lot# not reported), on 09-FEB-1999 the patient was vaccinated with the second dose of RECOMBIVAX HB (lot# 626479/0341H) and on 07-SEP-1999, the patient was vaccinated with the third dose of RECOMBIVAX HB (lot# not reported). Concomitant therapy included ACEL-IMUNE (lot # 09701401 (D1), 0974500 (D2) and 0910140 (D3)), HIBTITER (lot# 4103024700 (D1), 423753A (D2) and 36150314 (D3)) and ORIMUNE. The patient had initial hepatitis B series and was no longer immune per blood test titers. On 25-AUG-2010, the patient had a hepatitis B surface antibody test performed showing <5. At the time of this report, the patient's outcome was unknown. This is one of several reports from the same source. No further information is available.
Age: 0.18
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody, Hepatitis B antibody negative
Clinical narrative: Information has been received from a physician concerning a 16 year old male patient who on 01-AUG-1994 at age 1 day was vaccinated with the first dose of RECOMBIVAX HB (lot# not reported) thimerosal containing. On 03-OCT-1994, the patient received the second dose of RECOMBIVAX HB (lot# not reported) (lot# 611290/0048A) and on 06-FEB-1995 was vaccinated with the third dose of RECOMBIVAX HB (lot# 613382/1065A) thimerosal containing. Concomitant therapy included ACEL-IMUNE (lot # 4H51058 (D1), 7390AA (D2), HIBTITER (lot # 312-935 (D1)), ORIMUNE (lot # 314-9360700H (D1) and 314-070014 (D2), and MMR II (lot # 630119/1983H (D2). The patient had initial hepatitis B series and was no longer immune per blood test titers. On 23-AUG-2010, the patient had a hepatitis B surface antibody test performed showing <5. This is one of several reports from the same source. No further information is available.
Age: 0.08
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from a physician concerning an 18 year old female who on 21-JUL-1992 was vaccinated with a second dose of RECOMBIVAX HB (lot # 603897/0750V) in the left leg. The patient also received a first dose of hepatitis B virus vaccine (unspecified) on 23-JUN-1992 in hospital and a dose of ENGERIX-B (GSK, lot # ENG103O92) on 18-JAN-1993. On 19-AUG-2010 sample was collected and the patient did not have immunity to hepatitis b virus vaccine. The office spoke with the patient who said she would call when she came home for Thanksgiving break to schedule first shot. At the time of the reporting, the patient's status was unknown. Additional information has been requested.
Age: 0.1
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from a physician concerning an 18 year old male who on 29-JUN-1992 was vaccinated in the hospital with a dose of RECOMBIVAX HB (unspecified), on 29-JUL-1992, was vaccinated with a dose of RECOMBIVAX HB (LOT# 603897/0750V) in the right leg and on 22-DEC-1992 was vaccinated with a dose of ENGERIX B in the left leg. Concomitant therapy included ENGERIX-B, ADACEL, ORIMUNE, MMR vaccine, HAVRIX, Hib conj vaccine (unspecified carrier) and MENACTRA. On 19-AUG-2010, sample was collected and the patient did not have immunity to hepatitis b virus vaccine and hepatitis B surface antibody quantitative test was < 5 mIU/mL. At the time of the reporting, the patient's status was unknown. Additional information has been requested.
Age: 0.13
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Tuberculin test negative
Clinical narrative: Information has been received from a physician concerning an 18 year old male who on 17-JUL-1992 was vaccinated in the hospital with a dose of hepatitis B virus vaccine (unspecified), on 02-SEP-1992 was vaccinated with a dose of RECOMBIVAX HB (LOT # 603897/0750V) in the left leg and on 08-FEB-1993 was vaccinated with a dose of hepatitis B virus vaccine (unspecified) in the left leg. Concomitant vaccinations included TRI-IMMUNOL, DTP, DTaP, DT, ORIMUNE, MMR II (LOT# 603966/0537W, HSA and 634378/1385K, HSA), Hib conj vaccine (unspecified carrier), VARIVAX (LOT# 617911/0778D, 659154/1495U) and MENACTRA. PPD on 02-AUG-2010 at forearm and on 04-AUG-2010 read as negative. On 05-AUG-2010 sample was collected and the patient did not have immunity to hepatitis B virus vaccine and hepatitis B surface antibody quantitative test was < 5 mIU/mL. At the time of the reporting, the patient's status was unknown. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Anti-HBs antibody negative, Hepatitis B antibody negative
Clinical narrative: Information has been received from a physician concerning 3 patients who were age 10 and up both female and male, who on unspecified dates were vaccinated RECOMBIVAX HB (manufacturer unknown) (Lot # unknown) and tested negative titer for Hep B. Additional information has been received from a female office manager reported that there were 45 patients that didn't seroconvert. In follow-up, one of the 45 patients was identified (WAES # 1008USA01261). Follow up information has been received from the physician indicated that there were a group of patients that had Hepatitis B vaccine (unspecified) (manufacturer unknown) and no longer immune. Attempts are being made to contain additional identifying information to distinguish the remaining multiple patients mentioned in this report. Additional information will be provided if available. This is one of several reports received from the same source. Additional information has been requested. This is an amended report, AE term was updated from "test negative for Hep B" to "negative titer results/no longer immune per blood test titers" and mapped to "Anti-HBs Antibody Negative".
Sex: F
Vaccine: HEP
Symptoms: Adverse reaction
Clinical narrative: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with a dose of RECOMBIVAX HB (lot number and manufacturer unknown) and had a reaction to the vaccine. It was unknown if the patient sought medical attention. At the time of report, the patient's outcome was unknown. Additional information has been requested.
Age: 0.8
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a 9 month old female patient who "about a month ago", in approximately August 2010, was vaccinated with once 0.5 ml dose of RECOMBIVAX HB. After receiving RECOMBIVAX HB, the patient developed severe generalized hives. The patient was administered ADRENALINE and had a total recovery almost instantly. Upon internal review administered ADRENALINE was considered to be an other important medical event. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from a nurse concerning an 18 year old female patient who did not develop an adequate titer response following vaccination with an unknown manufacturer's Hepatitis B vaccine. The patient was revaccinated with a second series of RECOMBIVAX HB, receiving the first dose of on 06-MAY-2010, the second dose on 09-JUN-2010. They were planning to vaccinate the patient (who was present in the office) with the third dose at the time of call. The patient's outcome was unknown. The patient sought medical attention by office visit. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from a female physician concerning her husband who had received a 3 doses of RECOMBIVAX HB (manufacturer unknown) and was found not to be protected so he was vaccinated with 2 more doses and now was protected. This is one of several reports from the same source. No further information is available.
Age: 26.0
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from a physician concerning a 26 year old patient who on unspecified dates was vaccinated with a first and second dose of RECOMBIVAX HB (lot# not reported). On an unspecified date the physician tested the hepatitis B titer on this patient and the patient had a negative titer. This was after 2 complete RECOMBIVAX HB series. Follow up information received indicating the patient was not a patient in their practice, but the child of a patient. Additional information has been requested.
Age: 0.83
Sex: F
Vaccine: HEP
Symptoms: Crying, Expired drug administered, Irritability
Clinical narrative: Information has been received from a medical assistant concerning her 10 months old daughter, who on approximately 15-SEP-2010 was vaccinated with her third 0.5 mL dose of RECOMBIVAX HB (lot # unknown). The medical assistant reported that her daughter received expired RECOMBIVAX HB. The child had been cranky and crying since vaccination. The mother did not know when the vaccine expired. The child was premature and spent her first month of life in the neonatal intensive care unit. The mother also reported that her child was cranky and cries a lot in general. At the time of report, the patient had not recovered. The patient sought medical attention by a call to the office. No further information is available.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from a registered nurse concerning a patient who in approximately 2000 "over 10 years" was vaccinated with a dose of RECOMBIVAX HB (lot # unknown). The nurse stated that on 04-OCT-2010 the patient had a negative antibody titer. No adverse effect was reported. It was unknown if the patient sought medical attention. No further information is available. This is an amended report. Upon review of the file, the code was changed from antibody test negative to Anti-HBs antibody negative.
Age: 0.07
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from a health professional concerning a 25 day old female patient who on 18-MAR-1992 was vaccinated with a first dose of RECOMBIVAX HB (Lot# unknown). Second dose of RECOMBIVAX HB (Lot# unknown) was given on 10-APR-1992. Third dose of RECOMBIVAX HB (Lot# unknown) was given on 02-MAR-1993. The reporter was not sure where the patient received the vaccines. It was reported that on 23-AUG-2010, at the age of 18, the patient had negative titers for hepatitis B that were ran at another medical center. At the time of the report, the patient's outcome was unknown. The patient did not seek medical attention. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HEP
Symptoms: Haematology test abnormal, Hepatitis B antibody negative
Clinical narrative: Information has been received from a registered nurse concerning a 13 year old male patient who on unspecified dates was vaccinated with the series of RECOMBIVAX HB. The nurse stated that the patient showed no hepatitis B antibodies in his bloodwork, despite completing the series of RECOMBIVAX HB. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: HEP
Symptoms: Decreased appetite, Diarrhoea, Dizziness
Clinical narrative: Information has been received from a 64 year old female patient with no pertinent medical history who on 27-SEP-2010 was vaccinated with the first dose of RECOMBIVAX HB (unspecified manufacturer). There was no concomitant medication. On 01-OCT-2010 the patient experienced diarrhea, loss of appetite and dizziness. It had not had lab diagnose study performed. The patient stated that the symptoms have not abated as of the time of the call. The patient was unable to identify the manufacturer of the Hepatitis B vaccine, the dose or route of administration. The patient stated that she was not able to take any medications, that any medications ever administered have made her ill in one way or another. The patient was not willing to get into the specifics of these other medication reactions. No further information is available.
Age: 30.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody abnormal
Clinical narrative: Information has been received from an approximately 30 year old male consumer (now 31 year old) with no pertinent medical history and no drug reaction or allergies who on approximately 10-DEC-2009 "on about 10-DEC-2009", was vaccinated IM with 10 mcg dose of RECOMBIVAX HB (Lot# not reported). There was no concomitant medication. The consumer stated that he thought he had received the third dose of the three part series on about December 2009. The consumer's physician only had a record of two parts of the series. The consumer also stated that his titers were low when he checked nine months after receiving the last dose on 10-DEC-2009. The consumer's physician recommended him repeat the three part series. At the time of the report, the patient's outcome was unknown. The consumer sought unspecified medical attention. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Rash
Clinical narrative: Information has been received from a registered pharmacist concerning a male patient who on an unspecified date was vaccinated with a dose of RECOMBIVAX HB (Lot# not reported) (manufacturer unknown). It was reported that following vaccination on an unspecified date, the patient developed a rash that persisted for six months. At the time of the report, the patient's outcome was unknown. It was unknown if the patient sought medical attention. Follow up information has been received from the pharmacist who stated that the patient was interested in getting the PNEUMOVAX 23 vaccine, but wanted to make sure it did not contain any methylparabens due to a previous reaction to the RECOMBIVAX HB (manufacturer unknown). Patient indicated that he got a rash. No further information is expected.
Sex: F
Vaccine: HEP
Symptoms: Poor quality sleep
Clinical narrative: Information has been received from a pharmacist concerning his wife with rheumatoid arthritis who in August 2010, was vaccinated with the second 0.5 ml pediatric dose of RECOMBIVAX HB (Lot# not reported). Secondary suspect included the first pediatric dose of ENGERIX-B on July 2010, and on an unspecified date, the patient was vaccinated with the third 1 ml dose of ENGERIX-B. Concomitant medication included ENBREL. It was reported that his wife did not sleep well the night after the third dose. At the time of the report, the patient's outcome was unknown. The patient did not seek medical attention. Additional information has been requested.
Age: 0.42
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from a medical assistant concerning a 17 year old male patient who on 06-APR-1993 was vaccinated with the first dose of RECOMBIVAX HB, and on 06-May-1993 and on 06-SEP-1993 with the second and third doses of RECOMBIVAX HB respectively. The medical assistant reported that recently the patient received 2 pediatric booster 0.5 ml doses of RECOMBIVAX HB on 05-MAR-2010 and 13-OCT-2010 in preparation for nursing school. On 19-AUG-2010 the titers were drawn and the patient was still testing negative for titers. No other adverse experiences were reported. The patient sought unspecified medical attention. At the time of reporting, the outcome of the patient was not provided. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from a medical assistant concerning an unspecified employee in the practice who on an unspecified date was vaccinated with an unspecified RECOMBIVAX HB, had negative or insufficient titers of hepatitis B antibodies. It was unknown of the patient had sought medical attention. No further information is available.
Age: 9.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from a healthcare worker concerning a currently 23 year old male patient whose mother was a non-responder to Hepatitis B vaccination (unspecified). On 17-AUG-1995, 09-OCT-1995 and on 27-AUG-1996, the patient was vaccinated with the first, second and third doses of RECOMBIVAX HB (manufacturer unspecified). Subsequently, on an unspecified date, the patient tested negative for Hepatitis B antibodies after these first series. Then, the patient was vaccinated with the second series which consisted of 3 pediatric doses of RECOMBIVAX HB, two each, to total 1.0 mL solution on the following dates: 20-AUG-2010 (Lot # 0438Y) thimerosal free, 10-JUN-2010 (Lot # 0438Y) thimerosal free and 20-OCT-2010 (Lot # 666188/1491Y) thimerosal free, respectively. The patient had not been tested for Hepatitis antibody titers after this second series. At the time of the report the patient's outcome was not specified. The patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from a nurse concerning a female patient who "previously" on an unspecified date was vaccinated with a dose of RECOMBIVAX HB (Lot # not provided). On approximately 21-OCT-2010 "the patient is now found to have negative antibody titers". The patient sought unknown medical attention. Diagnostic laboratory test Hep B antibody testing performed. The patient's negative antibody titers persisted. Additional information has been requested.
Age: 0.11
Sex: M
Vaccine: HEP, HEPA
Symptoms: Immediate post-injection reaction, Sudden onset of sleep, Wrong drug administered
Clinical narrative: Information has been received from a consumer concerning her 40 days old grandson with cystic fibrosis gene carrier and no drug reactions or allergies who on 25-OCT-2010 was administered VAQTA (manufacturer unknown) instead of RECOMBIVAX HB due to nurse's medical error. Concomitant therapy included MYLICON. Consumer did not know product name or the manufacturer of the vaccine. Mistake was discovered by the nurse and RECOMBIVAX HB was administered as well during the same visit. She noticed that her grandson fell asleep right away after receiving both vaccines. No lab diagnostics studies were performed. At the time of the report, the patient's outcome was unknown. Patient sought medical attention via telephone. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Blood glucose increased, Vaccine positive rechallenge
Clinical narrative: Information has been received from a 23 year old female with a history of type 1 diabetes mellitus and no allergies, who on 22-SEP-2010 was vaccinated with a first dose of RECOMBIVAX HB. After the vaccination the patient's blood sugar went up and lasted for 4-5 days. On 25-OCT-2010 the patient was vaccinated with a second dose of RECOMBIVAX HB and her glucose level went up again. Concomitant therapy included HUMALOG, LANTUS, LEVOXYL, SEASONIQUE and vitamins (unspecified). No laboratories studies performed. The patient did not seek medical attention. At the time of this report the patient had not recovered from elevated glucose level. Additional information has been requested.