chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Hepatitis B test negative, Vaccination failure
Clinical narrative: Information has been received from a nurse concerning a 24 year old Asian female lab assistant embryologist who was vaccinated, as a child, in her native "country", with 3 dose RECOMBIVAX HB series, manufacturer unknown. In 19-JUN-2003, the patient received a RECOMBIVAX HB booster (manufacturer unknown) in the left deltoid. In 2003, the patient underwent an antibody blood test drawn and failed to seroconvert, results were less than 10. Nurse states one booster dose of RECOMBIVAX HB, unknown which hepatitis B, was administered in 2003, and another titer drawn post vaccination showed client still failed to seroconvert. In follow-up, it was reported that the patient Hepatitis B serum antibody test February 2007 was <3.0. The patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Body temperature increased, Nausea, Pain, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a female (age not reported) who was vaccinated with a dose of RECOMBIVAX HB (manufacturer unknown). On an unspecified date, the patient had nausea, body aches and fever after the vaccination. The patient's status was not reported. There was no product quality complaint. Follow-up information received from the physician indicated that they do not administer RECOMBIVAX HB to patients. No further information is available.
Age: 5.0
Sex: M
Vaccine: HEP
Symptoms: Developmental delay
Clinical narrative: Information was received from a registered nurse, concerning an approximately 5 year old who was vaccinated with a first, second and third dose of RECOMBIVAX HB, (lot numbers 638078/1474K, 638715/0004L). It was not known which lot number corresponded with which dose. Subsequently, the patient was "developmentally late". Unspecified medical attention was sought. The patient has not recovered. No product quality complaint involved. Additional information has been requested.
Age: 42.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B test negative, Serology negative, Vaccination failure
Clinical narrative: Information has been received from a pharmacist concerning a 42 year old male, who on 29-DEC-2006 completed the 3-dose series of RECOMBIVAX HB and his serology test done on 21-FEB-2007 was "inconsistent with immunity". Unspecified attention was sought. No other information was provided. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, No adverse event, Seroconversion test negative, Vaccination failure
Clinical narrative: Information has been received from a pharmacist concerning a male patient who has received three 10 mcg doses of RECOMBIVAX HB and failed to seroconvert. Concomitant therapy included REMICADE. The last dose of RECOMBIVAX HB was administered in June 2006. Unspecified medical attention was sought. No adverse experience is related to this event. There was no product quality complaint. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Vaccination failure
Clinical narrative: Information has been received from a registered nurse concerning a patient who was vaccinated IM with RECOMBIVAX HB. Subsequently the patient had negative hepatitis B virus (HBV) antibody titers/ had not seroconverted. The patient's outcome was not reported. Follow up information indicated that the patient did not seroconvert following vaccination. There was no patient information to provide. No additional information is expected. This is one of several reports received from the same source.
Age: 0.5
Sex: F
Vaccine: DTOX, HEP, HIBV
Symptoms: Adverse event
Clinical narrative: Information has been received from an office manager concerning a 6 month old female with no medical history who on 07-AUG-2006 was vaccinated with a dose of RECOMBIVAX HB (lot # 651736/0672R), intramuscularly. Concomitant therapy that day included diphtheria toxoid/tetanus toxoid (lot # C2630AA) (IM) and PROHIBIT (lot # UE876AC) (IM). There was no illness at the time of vaccination. Subsequently the patient experienced unspecified adverse event. There were no relevant diagnostic tests or laboratory data. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B test negative, Rubella antibody test, Seroconversion test negative, Vaccination failure
Clinical narrative: Information has been received from a physician concerning a male received (age not reported) with no allergies or medical history who received three doses of RECOMBIVAX HB and did not seroconvert. The patient sought unspecified medical attention. The patient's outcome was reported as not recovered. There was no product quality complaint.
Sex: F
Vaccine: HEP
Symptoms: Hypersensitivity
Clinical narrative: Information has been received from a physician concerning a female who," in the past" was vaccinated with RECOMBIVAX HB manufacturer unknown, and experienced an allergic reaction. The physician reports it was not an anaphylactic reaction, and is not certain it was a Merck product or another company's product. The patient did not complete the series. It is unknown if medical attention was sought. There was no product quality complaint. No further information is available.
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Rash generalised
Clinical narrative: Information has been received from a registered nurse concerning a 33 year female with a sulfonamide allergy who in 2005 was vaccinated with her first dose of RECOMBIVAX HB, and developed a rash over her entire body. It is unknown if the patient will receive the second dose of RECOMBIVAX HB. Unspecified medical attention was sought. The patient was considered recovered at the time of this report. There was no product quality complaint. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Platelet count decreased, Platelet transfusion, Thrombocytopenia
Clinical narrative: Information has been received from a registered nurse (RN) concerning a female with an allergy to erythromycin who was vaccinated with a second dose of Recombivax HB at a hospital in January of 2007. Concomitant therapy included folic acid, prednisone and FIORICET TABLETS. Subsequently, the patient experienced thrombocytopenia. It was reported that the patient has received two doses of Recombivax HB so far but it was unknown if the thrombocytopenia occurred with dose 1 or dose 2 or with both. Unspecified medical attention was sought, "bloodwork showed that patient's levels went down to 20,000". The patient was treated with steroids and her thrombocytopenia had only slightly improved. It was reported that the patient will not be given dose 3. As of 23-Mar-2007, the patient's status was unknown. No product quality complaint was involved. Follow-up information was received on 07-JUN-2007 indicating that the patient was hospitalized as a result of thrombocytopenia. A platelet transfusion was performed and the patient was treated with IVIG. At the time of this report the patient was "still being treated". It was indicated that the patient's thrombocytopenia occurred in March 2007 after receiving his second dose of Recombivax HB in January 2007. Additional information has been requested.
Age: 0.1
Sex: M
Vaccine: HEP
Symptoms: Hypersomnia, Lethargy
Clinical narrative: Information has been received from a physician concerning a 37 day old male with no medical history or allergies who was vaccinated with a 0.5ml intramuscular first and second dose of RECOMBIVAX HB (652403/0040F) on 25-May-2006 and 24-Jun-2006, respectively. There were no concomitant medications. On 24-JUN-2006 the experienced "extreme lethergy". He slept all day after leaving the office, woke up for 1/2 hour and went back to sleep.
Age: 57.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody, Hepatitis B core antigen positive, No adverse event, Vaccination failure
Clinical narrative: Information has been received from a physician concerning a 57 year old female with an allergy to penicillin and a history of mitral valve prolapse who was vaccinated with three doses of RECOMBIVAX HB over five years ago. There was no concomitant medication. The patient now has a positive hepatitis B core antibody test. The results of her hepatitis B surface antibody test indeterminate. The patient was asymptomatic. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 0.1
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Lethargy
Clinical narrative: Information has been received from a physician concerning a 28 day old female who on 06-JUN-2006 was vaccinated with first dose of RECOMBIVAX HB (LOT # 652403/0040F). There was no concomitant medication or medical history). On 06-JUN-2006 the patient was "extremely lethargic" and less energetic for most of that day. Subsequently, the patient recovered. The patient sought unspecified medical attention. Additional information has been requested.
Age: 44.0
Sex: M
Vaccine: HEP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a licensed practical nurse concerning a 44 year old male, with no pertinent medical history, drug reactions or allergies, who on 31-JAN-2007 was vaccinated with 10mcg, his first dose RECOMBIVAX HB. There was no concomitant medication. On 31-JAN-2007 the patient experienced pain, redness and swelling at injection site (Lot # 655810/1160F). On 05-MAR-2007 the patient received a second dose of RECOMBIVAX HB, (Lot # 655810/1160F) that may have been improperly stored. No reaction was reported with this vaccination. Unspecified medical attention was sought. There were no lab diagnostic studies performed. The patient was considered recovered at the time of this report. There was no product quality complaint. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Vaccination failure
Clinical narrative: Information has been received from a nurse concerning a patient who was vaccinated with RECOMBIVAX HB on an unspecified date. Subsequently the patient now has a negative hepatitis b surface antibody titer. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B test negative, Seroconversion test negative, Vaccination failure
Clinical narrative: Information has been received from a nurse concerning a female who in approximately 1995 was vaccinated with RECOMBIVAX HB series of three. Subsequently, a titer showed the patient did not seroconvert. In approximately March 2005 the patient underwent a second series of vaccination with RECOMBIVAX HB and again she never seroconverted. Additional information has been requested.
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Facial palsy
Clinical narrative: Information has been received from a physician concerning a 47 year old female, with a history of drug reaction or allergy to an unspecified antibiotic, who on 30-JAN-2007 was vaccinated with Recombivax HB. On 01-FEB-2007, two days after receiving Recombivax HB, the patient developed Bells Palsy. The patient went to the emergency room, but was not admitted. At the time of this report the patient had not yet recovered, and the Bells Palsy persisted. The event of Bells Palsy was considered to be disabling. There was no product quality complaint. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: HEP
Symptoms: Blood alkaline phosphatase increased, Blood thyroid stimulating hormone decreased, Carbon dioxide decreased, Culture urine positive, Headache
Clinical narrative: Information has been received from a physician concerning a 49 year old female with allergies to iodine/betadine, quinolones, penicillins, nitrofurantoin (Macrodantin), albuterol sulfate (Proventil), morphine and sulfa and history of cervical cancer, hysterectomy and kidney stones who on 27-FEB-2007 was vaccinated with the first dose of RECOMBIVAX HB IM into the left deltoid (Lot # 654018/ 0904F). It was noted by the reporting physician that the patient had urinary tract infection "coming on' at the time of vaccination. On 30 MAR 2007 a urine culture was collected, which noted >100,000 CFU/mL Escherichia coli. A second dose of RECOMBIVAX HB was administered on 26-MAR-2007. Concomitant therapy included UROCIT-K, SYNTHROID and ACTONEL. On 29-MAR-2007 the patient experienced fever that ranged from 100.5 to 101 degrees, and headache. The physician instructed the patient to take Tylenol. The patient recovered on 03 APR 2007. Additional information is not expected.
Age: 49.0
Sex: F
Vaccine: HEP
Symptoms: Pyrexia
Clinical narrative: Information has been received from a physician concerning a 49 year old female with allergies to iodine/betadine, quinolones, penicillins, nitrofurantoin (Macrodantin), albuterol sulfate (Proventil), morphine and sulfa and history of cervical cancer, hysterectomy and kidney stones who on 27-FEB-2007 was vaccinated with the first dose of RECOMBIVAX HB IM into the left deltoid (Lot # 654018/ 0904F). It was noted by the reporting physician that the patient had urinary tract infection "coming on' at the time of vaccination. On 30 MAR 2007 a urine culture was collected, which noted >100,000 CFU/mL Escherichia coli. A second dose of RECOMBIVAX HB was administered on 26-MAR-2007. Concomitant therapy included UROCIT-K, SYNTHROID and ACTONEL. On 29-MAR-2007 the patient experienced fever that ranged from 100.5 to 101 degrees, and headache. The physician instructed the patient to take Tylenol. The patient recovered on 03 APR 2007. Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Nuclear magnetic resonance imaging normal, Ophthalmological examination, Optic neuritis, Skin warm
Clinical narrative: Initial and follow-up information has been received from a 26 year old female pharmacist with coeliac disease who in the spring of 2004, was vaccinated with a dose of RECOMBIVAX HB. On a Sunday in June of 2006, the patient started to have distinct pain behind her left eye, this climaxed at 2 weeks. The patient lost 50% of her vision and had cloudy vision. This subsided in 4 weeks. The patient stated that a neuropathologist determined she had optic neuritis with no brain lesions. The patient stated that she did not develop numbness or tingling on her left side (previously reported as she did). At the time of the report the patient still had a "hot spot" on her left foot that "comes and goes periodically" but she considered herself recovered after therapy. Unspecified medical attention was sought, and MRI was performed and showed no multiple sclerosis lesions on her brain, eye exams with dilation and visual field tests were also performed. There was no product quality complaint involved. No further informtion was provided. No further information is expected.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from a pharmacist concerning a nurse who was vaccinated with RECOMBIVAX HB, "a while ago". The nurse recently had a titer drawn and failed to seroconvert. Her physician wants her to receive a booster dose of RECOMBIVAX HB. No other information was provided. Unspecified medical attention was sought. There was no product quality complaint. 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 child with no pertinent medical history or allergies, who was vaccinated 3 times with RECOMBIVAX HB and did not seroconvert. Unspecified medical attention was sought. No product quality complaint was involved. This patient also had adverse experiences after therapy with measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine (Wistar RA 27/3) (manufacturer unknown) (WAES # 0703USA00615). Additional information has been requested.
Age: 26.0
Sex: M
Vaccine: HEP
Symptoms: Antibody test negative, Hepatitis B antibody negative, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a nurse and from a physician concerning his 26 year old son with no pertinent medical history or drug allergy who on 16-FEB-2003, January 2004 (considered inappropriate dosing schedule) and June 2004 was vaccinated with a total of three series of RECOMBIVAX HB, 10 mcg. There was no concomitant medication. On 24-JUL-2004, titer for hepatitis B was 235 (units not provided). On 07-APR-2007 the patient had a hepatitis B titer of 5.6, which is considered not immune. Subsequently, in April 2007, another titer was performed and it was also 5.6. The patient's no immunity after vaccination persisted. Additional information has been requested.
Age: 0.9
Sex: U
Vaccine: HEP
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a physician concerning a 9 month old patient whose mother is hepatitis B positive, who approximately one year ago, in approximately 2006 was vaccinated with RECOMBIVAX HB (total number of doses not reported). Subsequently, in approximately 2006 the patient did not seroconvert after being administered the hepatitis B vaccine. The child had unspecified medical attention. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from a registered nurse concerning a 22 year old female healthcare worker with no known history who in 1999 - 2000 was vaccinated with a first, second and third dose of RECOMBIVAX HB. Concomitant therapy included hormonal contraceptives (unspecified). Subsequently "now" in 2007 the patient has a negative hepatitis B antibody titer. Unspecified medical attention was sought. No other adverse experiences were related to this event. There was no product quality complaint involved. Additional information has been requested.
Age: 21.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from a nurse concerning a 21 year old male with no known allergies and autism and a history of previous hepatitis B vaccination series (manufacturer unknown) and previous nonreactive hepatitis B antibody test who on July 2006, August 2006 (Lot#652712/0039F) (2nd dose), January 2007 (Lot#652881/0105F) (3rd dose)was vaccinated with RECOMBIVAX HB. Subsequently the patient again tested nonreactive. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from an approximately 30-year-old medical assistant who was vaccinated with a three dose series of RECOMBIVAX HB "about eight plus years ago", in approximately 1999, at another facility. An antibody titer was drawn "recently", in approximately 2007, with a result of 3.0; her paperwork showed that anything less than 9.0 is inconclusive for hepatitis immunity. Unspecified medical attention was sought. No additional information is available at this time. No product quality complaint was involved. Additional information is not expected.
Age: 55.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from a physician concerning a male who was in his mind 50s was vaccinated with a 3 dose series of RECOMBIVAX HB. Because the patient works at a local jail a titer was done but it was 3. One booster dose of RECOMBIVAX HB was given 6 months later. The titer after that dose was 4.9. Medical attention was sought. As of 19-Apr-2007 it was reported that the patient was not recovered. No product quality complaint was involved. Additional information has been requested.
Age: 27.0
Sex: M
Vaccine: HEP
Symptoms: Cough
Clinical narrative: Information has been received via Schering-Plough Research Institute and assigned manufacturer number 2007SP003351, from a mother concerning her 27 year old son who was vaccinated with RECOMBIVAX HB. Subsequently the patient experienced a year long coughing reaction. The patient's outcome was not reported. No further information is available.
Age: 18.0
Sex: M
Vaccine: HEP
Symptoms: Paraesthesia oral, Swollen tongue, Throat tightness, Wheezing
Clinical narrative: Information has been received from a licensed practical nurse (L.P.N.) concerning an 18-year-old male with allergies to CEFTIN, AUGMENTIN and codeine who thirteen years ago, in "1994", received his first dose of RECOMBIVAX HB, lot number (606566/1552V). Subsequently he developed swelling and tingling of the tongue, wheezing and throat tightness. The patient's mother administered epinephrine and an oral corticosteroid with improvement of symptoms. It it unspecified if medical attention was sought. Subsequently, on an unspecified date, it is reported that the patient recovered. There is no product quality complaint involved. No more information is expected at this time.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Information was received from a pharmacist concerning a 22 year old female who in "1992 when she was 5 years old", was vaccinated with a dose of RECOMBIVAX HB, manufacturer unknown. Subsequently, she developed hives. It was reported that the patient recovered. No quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hypersensitivity
Clinical narrative: Information has been received from a registered nurse concerning a patient who was vaccinated with a last dose of RECOMBIVAX HB.  It was reported that the patient developed an unspecified allergic reaction.  No further information on the patient or the reaction was available at the time of this report.  There was no other information to report.  Unspecified medical attention was sought.  No product quality complaint was involved.  Additional information has been requested.  Follow-up information from a registered nurse stated that she could not identify the patient and has no further information available to report on this event.  Additional information is not expected.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Injection site pain
Clinical narrative: Information has been received from a female consumer with no medical history or allergies who in 1997 was vaccinated with three 1.0 ml dose series of Recombivax HB.  Hepatitis antibody titer in 1997 was positive.  There was no concomitant medication.  In 1997 the patient experienced muscle soreness at injection site for "a day or so".  In December 2006, the patient had anti hepatitis antibody negative.  At the time of report, the patient did not recover.  Unspecified medical attention was sought.  Laboratory diagnostic test of serum hepatitis B surface antibody screen was undertaken in December 2006.  A product quality complaint was not involved.  Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from a registered pharmacist concerning a 52 year old female patient with type II diabetes mellitus and a history of Guillain-Barre syndrome, depression who was vaccinated with two 3-dose series of RECOMBIVAX HB. Concomitant therapy included AVANDAMET, WELLBUTRIN and AVALIDE. The patient has not responded to the vaccine. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been received which stated that patient was vaccinated with 4 doses of RECOMBIVAX HB (previously reported as 5 doses) on 31-JUL-2006 (Lot # "9510701"), 05-SEP-2006 (Lot # 653786/0185F), 21-FEB-2007 (Lot # "AUBVB287AA") and 26-APR-2007 (Lot # "AHBVB287AA"). It was also reported that patient had negative titers on 20-APR-2007 and 25-JUN-2007. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Anti-HBc antibody negative
Clinical narrative: Information has been received from a health professional concerning a 50 year old female with a history of depression who "ten years ago", month approximate 1997, was vaccinated with a first, second and third dose of RECOMBIVAX HB (manufacturer unknown).  Concomitant therapy included duloxetine hydrochloride (CYMBALTA).  Subsequently, she was told by her physician that her "hepatitis titer was low".  The reporter has not experienced any symptoms.  No product quality complaint was involved.  Additional information has been requested.
Age: 1.7
Sex: M
Vaccine: DTAP, HEP, HIBV, OPV
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a health professional concerning a patient who on 1-MAY-2007 was vaccinated with a dose of Recombivax HB (lot number 652882/0106F).  It was reported that the patient received the vaccine accidentally, the child was supposed to have receive Hep A (MSD).  Concomitant therapy also given on 01-MAY-2007 included ActHIB (SANOFI PASTEUR) (lot# UF072AA), DTaP (AVENTIS PASTEUR) (lot# AC14B047AA) and OPV (AVENTIS PASTEUR) (lot # Z0421).  It was reported that the nurse who administered the vaccine thought the child was to get Recombivax HB.  There was no product confusion.  The patient had already completed the Recombivax HB series on 22-MAY-2006.  It was reported that the childs parents have not reported any difficulties since the injection.  No medical attention was sought.  The child's status is unknown.  No product quality complaint was involved.  Follow up information was received.  Other vaccines administered on 01-MAY-2007 were added to the report.  There was no adverse event reported.  No further information is available.
Age: 4.0
Sex: F
Vaccine: HEP
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a physician concerning a 4 year old female patient who was vaccinated with RECOMBIVAX HB (total number of doses not reported).  Subsequently, the patient did not seroconvert after being administered the RECOMBIVAX HB vaccine.  Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Anti-HBc antibody negative, Serology negative
Clinical narrative: Information has been received from an approximately 23 year old emergency medical technician (EMT) with no allergies and no medical history who in January 1991, was vaccinated with a single vial intramuscular dose of RECOMBIVAX HB in the deltoid (manufacturer unknown).  It was noted that it may have been possibly RECOMBIVAX HB  (MSD).  Concomitant therapy included birth control.  Sometime in 1991, after the series of vaccinations, the patient had negative titers and believed that the vaccine did not absorb properly as it may not have been administered deep enough.  The EMT completed the series and blood work revealed negative titers.  The EMT had 2 additional vaccinations of RECOMBIVAX HB.  Another titer was done with negative results.  It was reported that at the time of the report the patient had not recovered.  No further information is available.  Unspecified medical attention was sought.  No product quality complaint was involved.  Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Nervous system disorder
Clinical narrative: Information has been received from a physician concerning "many patients", with an unknown medical history, were vaccinated with a dose of Recombivax HB (manufacturer unknown).  It was reported that many patients who received the vaccine developed nervous system disorders.  It was unknown if medical attention was sought.  The patients' status is unknown.  No product quality complaint was involved.  In follow-up, the office manager reported that the physician confirmed that this report only concerned one patient. The event happened eight years ago.  The consumer is no longer the physician's patient.  No further information was available.
Sex: F
Vaccine: HEP
Symptoms: Antibody test negative, Laboratory test normal
Clinical narrative: Information has been received from a physician's assistant concerning a female with seafood allergy and no pertinent medical history who in approximately 1997 was vaccinated with the three dose series of RECOMBIVAX HB. There were no concomitant medications. In approximately 2002, the patient had a negative titer. The three dose series was repeated again in approximately 2002, and a titer after that series was again negative. The outcome was not recovered. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 47.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Seroconversion test negative, Vaccination failure
Clinical narrative: Information has been received from a physician concerning a 47 year old male firefighter who in June 2005, August 2005, and December 2005 was vaccinated with the first, second, and third 0.5ml IM doses respectively of Recombivax HB.  Lab titers confirmed that he had not seroconverted and a second series of Recombivax HB on June 2006, July 2006, and December 2006 was initiated.  In May 2007 titers showed he had not seroconverted.  Unspecified medication attention was sought and the patient's recovery status was not recovered.  No product quality complaint reported.  Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: FLU3, HEP, HEPA, TD, TYP, YF
Symptoms: Dizziness, Inner ear disorder, Vertigo
Clinical narrative: Information has been received from a registered nurse concerning a 65 year old female with hypothyroidism, osteoporosis and a history of headaches from antihistamines who on 27-APR-2007 was vaccinated with Recombivax HB.  On that same day, the patient was also vaccinated with Td (MSD), Fluvirin (unspecified), YF-Vax, typhoid vaccine live oral (Ty21a).  Concomitant therapy included thyroid medication and EVISTA.  On 29-MAY-2007, the patient had a follow-up doctor visit  and stated that on approximately 04-MAY-2007 she experienced dizziness and vertigo.  The patient was referred for follow-up to an ear, nose and throat physician and eye doctor.  Subsequently, the patient recovered from dizziness and vertigo.  Additional information has been requested.  Follow-up information has been received from a registered nurse concerning a 66 year old female with hypothyroidism, osteoporosis and a history of headaches from antihistamines who on 27-APR-2007 was vaccinated with her first IM dose of Recombivax HB (Lot# 655810/1022F) at 11:00 in the left deltoid.  Concomitant vaccinations administered on that same day at 11:00 included first dose of IM Td (Lot# TD-165) in the right deltoid, the first dose of IM Vaqta (MSD) (Lot# 652507/0886R) in the right deltoid, the first dose of Fluvirin (unspecified) (Lot# 71213) in the left deltoid, the first dose of SC YF-Vax (Lot# UF044AA) in the right deltoid, and 4 capsules of typhoid vaccine live oral (Ty21a) (Lot# 3001173).  Other concomitant drug therapy included thyroid medication and EVISTA.  On 04-MAY-2007 the patient felt like the room would spin while lying down.  The patient was referred for follow-up to an ear, nose and throat physician.  Subsequently, the patient recovered.  On 02-JUN-2007, the patient reported that she was found to have "an inner ear problem."  On 02-JUN-2007 the patient was administered her second dose of Recombivax HB.  No problems were reported.  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 a 41 day old male who on 19-APR-2006 was vaccinated with RECOMBIVAX HB and given a dose of Hepatitis B Immune Globulin at the time of birth. There was no concomitant medication. The physician indicated that the patient's mother is HBsAg-positive. On 22-MAY-2006, the patient received his 2nd dose of RECOMBIVAX HB (lot #651495/0505R) and his 3rd dose on 01-NOV-2006 (lot #651495/0505R). The physician reported that the patient did not seroconvert after receiving 3 doses of RECOMBIVAX HB. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Feeling hot, Injection site pain
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 26-year-old female employee with no medical history and no allergies, who on 23-MAY-2007 was vaccinated with her third dose of a 1 milliliter intramuscular injection in the left deltoid of RECOMBIVAX HB (lot# 655810/1160F).  No concomitant medications were given.  On 31-MAY-2007 the patient experienced soreness at the injection site.  Medical attention was sought and no laboratory or diagnostic tests were performed.  The R.N. estimated that the patient had a 60 millimeter induration which was not red, but sore and painful.  The patient was recommended to use a heating pad and take Ibuprofen.  It is reported that 8 days later it still had not resolved.  No product quality complaint was involved.  Follow-up information has been received from the RN stating the patient was white who did not have any birth defects or medical conditions and did not have any illnesses at the time of vaccination.  A 60 mm induration at the injection site occurred on 02-Jun-2007, 10 days post-vaccination (previously reported as 31-May-2007).  The site was red, warm and sore.  The patient recovered on an unspecified date.  It was reported that the patient and her siblings have not had any adverse events following prior vaccinations.  Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Antibody test negative, Hepatitis B antibody negative
Clinical narrative: Information has been received from a registered nurse concerning an adult dialysis patient between the age of 60-80 years who was vaccinated with a three dose series of RECOMBIVAX HB. It was reported that the patient had antibody titer that was less than 10 mIU/ml. A product quality complaint was not involved. Additional information has been requested. This is one of the several reports received from the same source.
Sex: F
Vaccine: HEP
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a health professional concerning a female who was vaccinated with RECOMBIVAX HB. Subsequently the patient experienced anti-hbs antibody negative. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Hyperhidrosis, Injection site erythema
Clinical narrative: Information has been received from a physician concerning a 23 year old female with yeast allergy who was vaccinated with a dose of RECOMBIVAX HB.  It was reported that the patient had sweaty palms and redness at the site of injection.  The physician stated that it was a different physician that administered the vaccine.  Unspecified medical attention was sought.  A product quality complaint was not involved.  Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: HEP
Symptoms: Erythema multiforme
Clinical narrative: Information has been received from a licensed practical nurse concerning a 3 month old patient who on an unspecified date was vaccinated with RECOMBIVAX HB. Subsequently, the patient developed erythema multiforme "from RECOMBIVAX HB". Unspecified medical attention was sought. At the time of this report the patient's status was not reported. No further information was provided. There was no product quality complaint involved. Follow up information indicated that another doctor's office called the primary reporter of this report for advice about this case. This was not a patient of their office. They had no information about the patient or physician. Additional informtion is not expected.
Age: 34.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a physician's assistant concerning a 34 year old male nurse with no pertinent medical history, drug reactions or allergies who was vaccinated with a series of RECOMBIVAX HB and VAQTA inactivated and failed to seroconvert.  The nurse reported that he received the vaccinations while in the military, and was not certain who the manufacturer was.  The nurse is not experiencing any known symptoms.  Unspecified medical attention was sought.  There was no product quality complaint.  Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: HEP
Symptoms: Convulsion
Clinical narrative: Initial and follow-up information has been received from a nurse and a office employee concerning a 9 year old female (granddaughter of the office employee) experienced a seizure after her first vaccination with RECOMBIVAX HB (manufacturer unknown).  At the time of the report, the patient's outcome was unknown.  Upon internal review, seizure was determined to be an other important medical event.  Subsequently, she was vaccinated with a first dose of GARDASIL concomitantly with a second dose of hepatitis A virus vaccine inactivated (manufacturer unspecified) and a second dose of RECOMBIVAX HB (manufacturer unknown) and experienced a "small seizure."  (MSD WAES# 0705USA02215).  Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Antibody test negative, Hepatitis B antibody negative
Clinical narrative: Information has been received from a physician concerning 5 to 8 patients who in the past 6 to 12 moths were vaccinated with RECOMBIVAX HB three dose series but did not seroconvert. Their titers are negative. The patient sought unspecified medical attention. A product quality complaint was not involved. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Rash generalised
Clinical narrative: Information has been received from a licensed practical nurse concerning a female who was vaccinated with RECOMBIVAX HB many years ago. Subsequently, the patient experienced rash all over the body. Subsequently, the patient recovered from rash all over the body. The patient sought unspecified medical attention. Additional information has been requested.
Age: 37.0
Sex: M
Vaccine: HEP
Symptoms: Anti-HBs antibody negative, Serology negative
Clinical narrative: Information has been received from a registered nurse concerning a 37 year old male who in approximately 2000 was vaccinated with RECOMBIVAX HB (manufacturer unknown).  On an unspecified date the patient had a negative titer after the series completion.  In approximately 2001, the patient was administered 2 more doses of RECOMBIVAX HB (manufacturer unknown).  On 07-JUN-2007 lab diagnostics studies confirmed that the patient negative anti-hbs test less than 3.0.  No problems reported.  There was no product quality complaint.  Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from a licensed practical nurse concerning a patient who was vaccinated with a three dose series of RECOMBIVAX HB. It was reported that the patient had a negative antibody titer. A product quality complaint was not involved. Additional information has been requested. This is one of several reports received from the same source.
Age: 9.0
Sex: M
Vaccine: HEP
Symptoms: Varicella
Clinical narrative: Information has been received from a company representative concerning her 9 year old son with no drug reactions or allergies, and a history of pharyngitis streptococcal who in "1999" was vaccinated subcutaneously with 0.5ml of RECOMBIVAX HB. Concomitant therapy included amoxicillin (+) clavulanate potassium. On 18-JUN-2007, the patient developed a breakthrough of varicella. The break out consisted of at least 150 lesions. Unspecified medical attention was sought. There were no lab diagnostic studies performed. There was no product quality complaint. Additional information has been requested.
Age: 2.0
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a licensed practical nurse concerning a 30 month old patient who on 22-DEC-2006 was vaccinated with RECOMBIVAX HB (Lot #651854/0306R), rather than hepatitis A virus vaccine inactivated. The patient had previously completed the hepatitis B series. No product confusion was reported, "just an administration error". There were no problems reported. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a 39 year old white female with no history of prior drug reactions or allergies, who was vaccinated at 13:15 on 30 JAN 2007, intramuscularly into the left deltoid with a first dose of RECOMBIVAX HB (Lot # 654018/0904F). There was no reported illness at the time of vaccination. On 30-JAN-2007 at 13:45, about one half post-vaccination, the patient broke out in hives on the left arm, but not at the injection site. At the time of reporting the patient was not yet recovered. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Heart rate increased
Clinical narrative: Information has been received from a registered nurse concerning a 35 year old white female with sulfonamide allergy who on 03-MAY-2007, at 1:15 pm, was vaccinated intramuscularly into the left deltoid with a first dose of hepatitis B virus vaccine rHBsAg (yeast) (Lot 656680/0010u). There was no illness at the time of vaccination.  On 03-MAY-2007, at 2:15 pm, one hour post vaccination, the patient reported experiencing a rapid heart beat, which lasted about one half hour. The patient did not report this at the time she was experiencing it. No treatment was sought or given. Subsequently, the patient recovered from the rapid heart beat. There was no product quality complaint. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from a licensed practical nurse concerning a 46 year old female employee who on 09-Oct-2006, 06-Nov-2006 and 06-Apr-2007 was vaccinated IM with a first, second and third 10 mcg dose of RECOMBIVAX HB. It was reported that the patient received the 3 vaccine doses and failed to seroconvert. A hepatitis B antibody titer was negative. Unspecified medical attention was sought. At the time of the report the patient's status was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from a 45 year old female a licensed practical nurse who in 1995 was vaccinated with 3 doses of RECOMBIVAX HB. It was reported that after 3 doses of RECOMBIVAX HB she did not seroconvert. She received one additional dose and then seroconverted. Unspecified medical attention was sought. Hepatitis B antibody titers were performed. No product quality complaint was involved. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a 25 month old female patient with peanut, almond and egg allergy and no medical history on 22-MAY-2007 was vaccinated IM with a 0.5 ml dose of RECOMBIVAX HB (Lot # 654747/0039U). There was no concomitant medication. On 19-JUN-2007, 28 days after vaccination the patient developed widespread hives with slight itchiness. On 21-JUN-2007 the patient was seen by the physician who prescribed oral BENADRYL. At the time of report the patient had not recovered. No diagnostic laboratory test were undertaken. A product quality complaint was not involved. Additional information has been requested. Additional information was received from a registered nurse regarding the 25 month old female patient who developed hives and slight itchiness 28 days after being vaccinated with RECOMBIVAX HB indicating that on approximately 21-Jun-2007 the patient recovered from widespread hives with slight itchiness.
Age: 33.0
Sex: M
Vaccine: HEP
Symptoms: Antibody test negative, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician concerning her husband, an approximately 35 years old male with a history of smoking, and no drug reactions/allergies who on 23-OCT-2004 was vaccinated intramuscular with the first dose of RECOMBIVAX HB (lot number 647274/0426P). Concomitant therapy included NEUROTIN, CYMBALTA and EXELON. On 24-MAR-2005, the patient received a second dose of RECOMBIVAX HB (lot number "0325P"). On 31-OCT-2006 was vaccinated with a third dose of RECOMBIVAX HB (lot number 653363/1063R). Six months after the completion of series, a test showed that her husband did not seroconvert. NO other symptoms have been reported. No further information is information is available. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Injection site induration, Pruritus, Skin warm, Swelling
Clinical narrative: Information has been received from a registered nurse concerning her daughter, possible allergy to aluminum, with was vaccination with hepatitis b vaccine (manufacturer unknown). Subsequently the patient experienced "knot in her arm around the injection site", swollen and warm to the touch and extreme pruritis. The patient's outcome was unknown.
Sex: U
Vaccine: HEP, TDAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a healthcare professional concerning a patient who was inadvertently vaccinated with a dose of RECOMBIVAX HB instead of ADACEL. The error was not due to product confusion. The patient is not experiencing any known symptoms. No further information is available.
Age: 10.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a registered nurse concerning a 19 year old black male with a past medical history of hernia repair who on 27-SEP-1996 was vaccinated with the first dose of RECOMBIVAX HB 0.5 ml. On 26-OCT-1996, was vaccinated with second dose of RECOMBIVAX HB 0.5 ml. On 28-NOV-1998 the patient was vaccinated with the third dose of RECOMBIVAX HB 0.5ml. Concomitant therapy included ALLEGRA. Subsequently on 18-JUN-2007, when the patient was tested for college admission for hepatitis B immunity (Hepatitis B surface antibody), the patient showed no immunity to hepatitis B virus. The lot numbers of the initial vaccinations are not available. The patient did not seek medical attention. No product quality complaint was involved. The patient was revaccinated on 03-JUL-2007 with RECOMBIVAX HB 1.0 ml IM. On 03-AUG-2007, the patient was again revaccinated with RECOMBIVAX HB 0.5 ml IM (also reported as an adult dose). Anti-HBs titer will be done in the future. 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 was vaccinated IM with RECOMBIVAX HB. Subsequently the patient had a negative hepatitis B virus (HBV) antibody titers/ had not seroconverted. The patient's outcome was not reported. Follow up information indicated that the patient did not seroconvert following vaccination. There was no patient information to provide. No additional information is expected. This is one of several 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 registered nurse concerning a patient who was vaccinated IM with Recombivax HB (manufacturer unknown).  Subsequently the patient had negative hepatitis B virus (HBV) antibody titers/had not seroconverted.  The patient's outcome was not reported.  Follow up information indicated that the patient did not seroconvert following vaccination.  There was no patient information to provide.  No additional information is expected.  This is one of several reports received from the same source.