chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
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 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: 49.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody, Hepatitis B antibody negative
Clinical narrative: Information has been received from a physician concerning a 52 year old male with no drug allergies and a history of renal disorder, type ii diabetes mellitus and hypercholesterolaemia who in approximately July 2004, was vaccinated with a completed series of Recombivax HB (manufacturer unknown). Concomitant therapy included Glipizide, exetimibe (+) simvastatin (MSD), AVANDARYL, PHOSLO, BUMEX, LASIX, LOTREL, vitamins (unspecified), aspirin and iron (unspecified). Subsequently the patient's labs confirmed negative hepatitis b antibody titer on 09-JUN-2007. Unspecified medical attention was sought. No product quality complaint reported. 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 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 several reports received from the same source.
Sex: U
Vaccine: HEPA
Symptoms: No therapeutic response
Clinical narrative: This case was reported by another manufacturer and described the occurrence of not responding to therapy in a subject of unspecicifed age and gender who was vaccinated with HAVRIX (GlaxoSmithKline). In 1999 the subject received unspecified dose of Havrix (unknown). At an unspecified time after vaccination with Havrix, the subject experienced not responding to therapy. At the time of reporting the outcome of the event was unspecified.
Age: 20.0
Sex: F
Vaccine: HEPA
Symptoms: Hepatitis A antibody positive
Clinical narrative: This case was reported by a consumer and described the occurrence of hepatitis A antibody titer positive in a 20-year-old female subject who was vaccinated with Hep A vaccine (manufacturer unspecified).  A physician or other health care professional has not verified this report.  On 16 January 2007 the subject received unspecified dose of Hep A vaccine (unknown).  On 21 February 2007, 36 days after vaccination with Hep A vaccine, the subject experienced hepatitis A antibody titer positive.  At the time of reporting the outcome of the event was unspecified.
Age: 70.0
Sex: U
Vaccine: HEP
Symptoms: 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.
Age: 70.0
Sex: U
Vaccine: HEP
Symptoms: 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.
Age: 70.0
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.
Age: 70.0
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.
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Feeling cold
Clinical narrative: Information has been received from a licensed visiting nurse concerning a 46 year old female housekeeper with no pertinent medical history or drug allergies who on 26-MAY-2007 was vaccinated IM with the first 1.0 ml dose of RECOMBIVAX HB (lot# 655810/1286F) in the left deltoid. Concomitant drug therapy included hormones (unspecified), ZYRTEC-D and LEXAPRO. On 27-MAY-2007 the patient "very cold" the day after vaccination. Symptoms were believed to be resolved in a day. On 27-JUL-2007 the patient was vaccinated IM with second 1.0 ml dose of RECOMBIVAX HB (Lot# 655810/1286F). Unspecified medical attention was sought. There were no labs or diagnostic studies performed. Subsequently the patient recovered. No product quality complaint reported. Additional information has been requested.
Age: 22.0
Sex: M
Vaccine: HEP
Symptoms: Back pain, Body temperature increased, Lymphadenopathy, Oral herpes, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 22 year old male with no known allergies or pertinent medical history who on 17-JUL-2007 was vaccinated intramuscularly with 1 ml second dose of RECOMBIVAX HB (Lot# 652715/0108U). There was no concomitant medication. Subsequently 21-JUL-2007 the patient developed a fever of 102 degrees Fahrenheit, swelling of the glands of his neck, fever blisters on his lips, and back pain. The nurse noted that the patient's brother was experiencing the same symptoms, but had not been vaccinated. Unspecified medical attention was sought. At the time of this report the patient had not recovered. No further information was available. There was no product quality complaint involved. There was no product quality complaint involved. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Rash generalised
Clinical narrative: Information has been received from a medical assistant concerning a 26 year old female nursing student who on "25-MAY-2007" was vaccinated with a dose of RECOMBIVAX HB. Subsequently, on "24-MAY-2007" the patient developed a rash all over her body. Unspecified medical attention was sought. Subsequently, on an unspecified date the patient recovered. No other information was provided. There was no product quality complaint involved. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody, Hepatitis B antibody negative
Clinical narrative: Information has been received from a registered nurse concerning a 14 year old male with no known allergies who on 06-NOV-1992 was vaccinated in the buttock with a first dose of Recombivax HB.  On 20-JUL-1993 (also reported as 26-JUL-1993) he received a second dose of Recombivax HB (Lot#606687/1617V).  On 27-SEP-1993 he received a third dose of Recombivax HB (Lot#606687/1617V).  On 24-JUL-2007 the patient tested negative for titers.  The value was less than 3.0 for the Hepatitis B surface antibody.  It was noted that the patient was in the office on 15-JUL-1993 for a bilateral otitis media and was on a maintenance dose of Lorabid for 3 weeks (at the time of the second dose).  Unspecified medical attention was sought.  There was no further information provided.  There was no product quality complaint involved.  Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Decreased immune responsiveness, Hepatitis B antibody negative
Clinical narrative: Information has been received from a registered nurse concerning a staff worker who in approximately 2000 was vaccinated with a series of Recombivax HB (manufacturer unknown) and was not immunogenic.  Subsequently the patient experienced no adverse symptoms.  It was unknown whether medical attention was sought.  There was no product quality complaint.  Follow-up information indicated that the staff worker did not get her immunizations in the office or by the office.  Titers are rechecked on every employee and she was not immunogenic.  No further information is available.
Sex: U
Vaccine: HEP
Symptoms: Pruritus generalised, Rash
Clinical narrative: Information has been received from a physician concerning a patient who "about one month ago" was vaccinated with a dose of RECOMBIVAX HB. Subsequently the patient developed generalized itching and rash 2 hours after administration of vaccine. Medical attention was sought. There was no respiratory distress. The symptoms resolved spontaneously 2 hours later without treatment. The patient was fully recovered. No product complaint was involved. Follow up information from the physician's office staff reported that the physician does not have any information of the patient involved. Further information is not expected.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from a licensed practical nurse who from between 1987 and 1992 was vaccinated with a primary series of RECOMBIVAX HB (manufacturer unknown).  In June 2007, the patient had a negative level of anti-HBs when tested.  No symptoms were reported.  Unspecified medical attention was sought.  The patient's present status was unknown.  There was no product quality complaint.  Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a male pharmacist (age not reported) who on 06-AUG-2007 was vaccinated with a second dose of RECOMBIVAX HB.  Subsequently the patient reported that his arm became a little bit sore.  At the time of reporting, the patient had not yet recovered.  No further information is available.
Age: 13.0
Sex: F
Vaccine: HEP
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning an approximately 13 year old female who "a few years ago" in approximately 2004 was vaccinated with a dose of RECOMBIVAX HB.  Subsequently the patient fainted after vaccination.  No further information was provided.  The patient's outcome was not reported.  Additional information is not expected.  The patient had a similar experience after vaccination with GARDASIL (MSD) (WAES # 0706USA05225).
Sex: F
Vaccine: HEP
Symptoms: Constipation, Convulsion, Crying, Eructation, Hiccups
Clinical narrative: Information has been received via medical records through a Merck pregnancy registry concerning a premature female infant who on 23-APR-2007 was vaccinated at birth with a dose of RECOMBIVAX HB (lot 654745/0608F). After delivery , the infant had seizures x1 while in intensive care (WAES# 0705USA00475). The infant has seizures x1 with normal MRI, and extensive work-up revealed all normal studies. On 01-MAY-2007, the infant was discharged to home to follow-up at clinic in 1 week. On 07-MAY-2007, the infant presented at the clinic for 2 week well baby check. The family was concerned as the infant was experiencing frequent hiccups. On 30-MAY-2007, office note indicated that the infant was constipated and fussy. On 04-JUN-2007, the infant was seen for 6 week well baby check. The mother stated that the baby started to cry, get fussy, burped, and spit up after feeding. She stated that it occurred mostly at night, and the infant seemed to feed well during the day. It was noted that there was a change in formula from Similac to Enfamil the previous week. The plan was to change back to Similac formula for a few days, and if no improvement may change to soy formula, and also use simethicone drops. Additional information is not expected.
Sex: F
Vaccine: HEP
Symptoms: Infantile spitting up, Irritability, Laboratory test normal, Nuclear magnetic resonance imaging normal
Clinical narrative: Information has been received via medical records through a Merck pregnancy registry concerning a premature female infant who on 23-APR-2007 was vaccinated at birth with a dose of RECOMBIVAX HB (lot 654745/0608F). After delivery , the infant had seizures x1 while in intensive care (WAES# 0705USA00475). The infant has seizures x1 with normal MRI, and extensive work-up revealed all normal studies. On 01-MAY-2007, the infant was discharged to home to follow-up at clinic in 1 week. On 07-MAY-2007, the infant presented at the clinic for 2 week well baby check. The family was concerned as the infant was experiencing frequent hiccups. On 30-MAY-2007, office note indicated that the infant was constipated and fussy. On 04-JUN-2007, the infant was seen for 6 week well baby check. The mother stated that the baby started to cry, get fussy, burped, and spit up after feeding. She stated that it occurred mostly at night, and the infant seemed to feed well during the day. It was noted that there was a change in formula from Similac to Enfamil the previous week. The plan was to change back to Similac formula for a few days, and if no improvement may change to soy formula, and also use simethicone drops. Additional information is not expected.
Age: 5.0
Sex: M
Vaccine: HEPA, MMR
Symptoms: Pain, Pyrexia, Somnolence
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of pain all over in a 5-year-old male subject who was vaccinated with HAVRIX, GlaxoSmithKline.  Concurrent vaccination included the third dose of MMR II, administered on 07 March 2007.  There were no concurrent medications.  The subject's mother stated that it was "normal" for her son to develop a fever following vaccination(s).  On 07 March 2007 the subject received the first dose of HAVRIX (0.5 mL) administered intramuscularly, in the left arm.  At approximately 5:00 a.m. on 8 March 2007, one day after vaccination with HAVRIX, the subject awakened with pain all over and fever.  The subject's mother consulted his health care provider by telephone, who advised treatment with Ibuprofen.  Following administration of Ibuprofen, the subject had been "sleeping most of the day".  At the time of reporting, on 08 March 2007, the fever and pain were resolved.  The event of "sleeping a lot" was unresolved.  Follow-up information received on 28 March 2007 indicated that the events were completely resolved by 09 March 2007.  In the reporter's opinion, the events were not related to treatment with HAVRIX.
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Cold sweat, Feeling cold, Pain, Pyrexia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of pain in a 3-year-old male subject who was vaccinated with Havrix (GlaxoSmithKline). The patient's mother stated that it was "normal" for her son to develop a fever following vaccination(s). The subject received no other vaccinations on 07 March 2007. On 07 March 2007 the subject received the first dose of Havrix (0.5 mL) administered intramuscularly, in the left arm. On 08 March 2007, within one day after vaccination with Havrix, the subject experienced unspecified pain, and became cold and clammy. On 09 March 2007, the events were resolved. In the reporter's opinion, the events were not related to treatment with Havrix.
Age: 36.0
Sex: M
Vaccine: HEPA
Symptoms: Headache
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of headache in a 36-year-old male subject who was vaccinated with Havrix (GlaxoSmithKline). Concurrent medications included Tetanus vaccine. On 14 March 2007 the subject received a dose of Havrix at 1440 elisa units, intramuscularly, in the left deltoid. A short time after vaccination with Havrix, the subject experienced headache. At the time of reporting the event was unresolved.
Sex: U
Vaccine: HEPA
Symptoms: Rash generalised
Clinical narrative: This case was reported by a physician via a representative and described the occurrence of rash in a child subject of unspecified gender who was vaccinated with HAVRIX (GlaxoSmithKline). Concurrent vaccination included live MMR and VARIVAX given on the same day as HAVRIX. On an unspecified date the subject received unspecified dose of HAVRIX (unknown). At an unspecified time after vaccination with HAVRIX, the subject developed a generalized rash. The subject was treated with BENADRYL and was referred to an allergist for evaluation. At the time of reporting the outcome of the event was unspecified.
Sex: U
Vaccine: HEPA
Symptoms: Injection site urticaria, Wrong technique in drug usage process
Clinical narrative: This case was reported by a pharmacist and described the occurrence of welt injection site in a subject of unspecified age and gender who was vaccinated with Havrix (GlaxoSmithKline). The pharmacist reported that "children" experienced welts at the injection site, however a specific number of subjects was not reported. On an unspecified date on or before 26 April 2007, the subject received unspecified dose of Havrix in an unspecified thigh. At an unspecified time after vaccination with Havrix, the subject experienced welt injection site. The pharmacist reported that, "A new nurse's injection technique was evaluated and there was a possibility that the nurse is injecting the subjects subcutaneously instead of intramuscularly "At the time of initial reporting the outcome of the events was unspecified. Follow-up information received on 11 May 2007 indicated that Havrix was administered to the subject subcutaneously. The events resolved and according to the reporter, they were related to administration of Havrix.
Sex: U
Vaccine: HEP
Symptoms: Tachycardia
Clinical narrative: Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with a dose of Recombivax HB. Subsequently the patient developed tachycardia. Unspecified medical attention was sought. Subsequently, the patient recovered without requiring treatment. No further information was provided. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a registered nurse concerning an adult patient, on dialysis, who was vaccinated with the primary series of RECOMBIVAX HB in the past (dates unspecified), and now is showing "negative titers".  Unspecified medical attention was sought.  There was no product quality complaint.  At the time of reporting the patient was not yet recovered.  Attempts are being made to obtain additional identifying information to distinguish the individual patient mentioned in this report.  Additional information will be provided if available.  Follow up information was received from a nurse who reported that no additional information is available.  This is one of several reports received from the same source.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site pruritus
Clinical narrative: Information has been received from a nurse practitioner concerning a 24 year old female who on 09-AUG-2007 was vaccinated with a 0.5ml intramuscular dose of Recombivax HB in the right deltoid. There was no concomitant medication. On 09-AUG-2007 the patient developed a hard, red lump that was tender, swollen and itchy at the injection site after receiving Recombivax HB. The patient reported that the itching is less than it was on 09-AUG-2007, however, the hard lump is still red and tender. The outcome is not recovered. No laboratory or diagnostic testing was done. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Injection site swelling
Clinical narrative: Information has been received from a nurse practitioner concerning a 24 year old female who on 09-AUG-2007 was vaccinated with a 0.5ml intramuscular dose of Recombivax HB in the right deltoid. There was no concomitant medication. On 09-AUG-2007 the patient developed a hard, red lump that was tender, swollen and itchy at the injection site after receiving Recombivax HB. The patient reported that the itching is less than it was on 09-AUG-2007, however, the hard lump is still red and tender. The outcome is not recovered. No laboratory or diagnostic testing was done. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Antibody test negative, Hepatitis B antibody negative
Clinical narrative: Information has been received from a registered nurse concerning a 24 year old female with latex allergy who on 19-DEC-2001, 01-FEB-2002 and 14-JUN-2002 was vaccinated with a three dose series of RECOMBIVAX HB (Manufacturer unknown). On 05-FEB-2007 patient's hepatitis B titer was found to be negative. On 08-FEB-2007 and on 08-MAR-2007 the patient received a two dose series of RECOMBIVAX HB. The titer was done on 11-JUN-2007 was positive. A product quality complaint was not involved. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with RECOMBIVAX HB (manufacturer unknown) and subsequently broke out in hives.  Lot number not provided.  No further information is available.
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Information has been received from a nurse practitioner concerning a female who was vaccinated with a second dose of Recombivax HB. After receiving the second dose of Recombivax HB the patient experienced hives. Unspecified medical attention was sought. Subsequently, the patient recovered from hives. A product quality complaint was not involved. Additional information is expected.
Age: 51.0
Sex: M
Vaccine: HEP
Symptoms: Antibody test negative, Hepatitis B antibody negative, Incorrect dose administered
Clinical narrative: Information has been received from a physician concerning a 51 year old male who on 23-FEB-2006, 07-JUL-2006, 18-DEC-2006, 18-JUN-2007 was vaccinated with the first (Lot# 649260/0848R), second, third (Lot# 654018/0904F) and fourth (Lot# 0042U) 0.5 ml IM dose of RECOMBIVAX HB. On 17-AUG-2007, lab hepatitis titers showed he did not have seroprotection with a level of 3 mIU/ml. Medical attention was sought via the physician's office. The patient's recovery status was unknown. There was no product quality complaint. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Muscle disorder
Clinical narrative: Information has been received from a health professional concerning a 30 year old female who was vaccinated with RECOMBIVAX HB (manufacturer unspecified).  Subsequently the patient developed pulsation in her leg muscle.  No rash involved.  The symptoms developed in the evening on the same day that she was vaccinated.  Nurse thought the patient was vaccinated a month ago but she was not sure because the vaccination took place at the patient's employer.  Medical attention was sought.  The patient's outcome was unknown.  No product quality complaint was involved.  Additional information is not expected.
Age: 40.0
Sex: M
Vaccine: HEP
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a 40 year old male pharmacy technician with no pertinent medical history or drug allergies, who on 22-AuG-2007 was vaccinated with a dose of Recombivax HB. There was no concomitant medication. On 23-AUG-2007 the pharmacy technician developed a red spot at the injection site. No medical attention was sought. No labs or diagnostic studies were performed. Subsequently, the patient recovered. There was no product quality complaint. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from a medical assistant concerning a 17year old white female student who was vaccinated with a three doses of RECOMBIVAX HB (manufacturer unknown) when she was 6 years old. Subsequently the patient's hepatitis b titer came back negative. Medical attention was sought through the doctor. The patient's recovery status was unknown. There was no product quality complaint. Follow-up information ahs been received from a physician's office. The physician and a medical record indicating that the 3 doses of hepatitis B virus vaccine rHBsAg were given at another office, and feel there was no adverse event. On 15-AUG-2007 at 06:40 a hepatitis B screen for the patient's job application revealed a negative result for antibodies. No further information is available.
Sex: F
Vaccine: HEP
Symptoms: Antibody test negative, Hepatitis B antibody negative
Clinical narrative: Information has been received from a licensed visiting nurse concerning a female with no pertinent medical history or drug allergies who on 17-AUG-2007 was vaccinated with the fourth dose of Recombivax HB (lot# 655810/0041U). In 2007 the patient's titers came back negative even after the fourth dose. Medical attention was sought through a physician. The patient's recovery status was unknown. 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 registered nurse concerning a female healthcare worker who in approximately 1997 (about 10 years ago) was vaccinated with RECOMBIVAX HB.  Recently (date not specified) an antibody titer was drawn and showed the patient's titer was low.  The patient sought medical attention via an office visit.  A product quality complaint was not involved.  No further information is available.
Sex: U
Vaccine: HEP
Symptoms: Hypersensitivity, Rash
Clinical narrative: Information has been received from a pharmacist and a physician concerning a patient who in August 2007, was vaccinated with a dose of RECOMBIVAX HB. In approximately August 2007, the patient developed a rash on the trunk and arms 24 to 48 hours after vaccination. The physician was then notified and described the rash as a hypersensitivity rash. The physician did not describe other symptoms or treatment. The patient's recovery status was unknown. There was no product quality complaint. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B, Laboratory test
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with a dose of Recombivax HB. It was reported that the patient was positive for hepatitis B after the patient was already given a vaccine for hepatitis B. The patient was possibly given Recombivax HB before she was found to be positive for hep B. It was also reported that patient might be pregnant. It was unknown whether medical attention was sought. The patient's outcome was unknown. No product quality complaint was involved. Follow-up information has been received from the reporting physician indicating that the 31 year old female state tested nurse aid with no known drug allergies had hepatitis B confirmed by labs (pending). No adverse event was reported. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HEP
Symptoms: Dyspnoea, Urticaria
Clinical narrative: Information has been received from a nurse concerning a 17 year old female daughter of a physician that was vaccinated on 19-SEP-2007, with RECOMBIVAX HB. On 19-SEP-2007, she experienced shortness of breath and hives. She received medical care at the physicians office. Details of the treatment were not provided, but she reportedly fully recovered. The vaccine series was discontinued after the first dose. A product quality complaint was not reported. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: HEP
Symptoms: Injection site nodule
Clinical narrative: Information has been received from a pharmacist concerning her 3 year old daughter who on 18 Sep-2007, was vaccinated with her second dose of RECOMBIVAX HB generic.  Concomitant vaccines included DTaP (unspecified) administered into an alternative site.  On 18-SEP-2007, within several hours of receiving the hepatitis B vaccine, a small, fluid filled nodule developed at the injection site.  The patient's physician office was notified via phone.  No treatment was reported.  The patient was recovering.  "There were no laboratory or diagnostic tests performed."  A product quality complaint was not reported.  No further information was available.  Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Asthenia, Dizziness, Fatigue
Clinical narrative: Information has been received from a nurse concerning her daughter who was vaccinated with a dose of RECOMBIVAX. Subsequently the patient developed an allergy to hepatitis B virus vaccine rHBsAg, symptoms not reported. At the time of the report the patient's outcome was unknown. The patient subsequently experienced weakness, fatigue and dizziness while on therapy with GARDASIL (WAES #0709USA01032). Additional information has been requested.
Age: 0.7
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a medical assistant concerning a 10-week-old male with allergic rhinitis and an allergy to sulfonamides who on 19-AUG-1993 was vaccinated with his first dose of RECOMBIVAX HB (Lot # 608134/0848W). On 14-OCT-1993 he received his second dose (Lot # 608884/1087W) and on 29-APR-1994 the third dose (Lot # "1325B"). Concomitant therapy included SINGULAIR. On 31-AUG-2007 the patient had a negative hepatitis B antibody titer. The patient sought unspecified medical attention. A product quality complaint was not involved. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody positive, Hepatitis B surface antigen positive
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 17-year-old female who on 12-APR-1994, 11-MAY-1994 and 17-NOV-1994 was vaccinated with her first, second and third doses (respectively) of RECOMBIVAX HB (lot# 610111/1414W, 610111/1414W, and 611786/0450A respectively). Concomitant vaccinations given on 11-MAY-1994 included: MMR II, poliovirus vaccine inactivated (unspecified), tetanus toxoid vaccine (unspecified) and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. Subsequently, while hospitalized "for other concerns on 06-AUG-2007" the patient tested positive for hepatitis B surface antigen. It was reported that the patient was Hepatitis B IgM core antibody negative. Unspecified medical attention was sought. Liver function tests were performed and were negative. No outcomes were reported. No product quality complaint was involved. Additional information has been requested
Age: 51.0
Sex: M
Vaccine: HEP
Symptoms: Seroconversion test, Seroconversion test negative
Clinical narrative: Information has been received from a physician concerning a 51 year old male who was vaccinated with "all three doses of RECOMBIVAX HB, twice, (for a total of six doses) and is still borderline seroconverted. There was no product quality complaint. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain, Blood iron decreased, Serum ferritin decreased
Clinical narrative: Information has been received from a physician concerning a female who on 24-JAN-2007 was vaccinated with a dose of RECOMBIVAX HB.  Subsequently the patient experienced severe abdominal pain and low ferritin levels.  The patient was seen by the physician and was then referred to the clinic.  The patient was diagnosed with Dunbar's compression and was being treated for low ferritin levels.  As of 02-Oct-2007, the patient was recovering.  No product quality complaint was involved.  Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Presyncope, Tachycardia
Clinical narrative: Information ahs been received from a female with a history of allergic rhinitis to bee sting and no pertinent medical history who was on an unspecified date vaccinated with a first dos eof RECOMBIVAX HB. There was no concomitant medication. Subsequently the patient developed tachycardia, dizziness and nearly passed out. Medical attention was sought, and she was give OTC BENADRYL. No lab studies were performed. Subsequently, the patient recovered. The vaccine series was discontinued. No further information was provided. There was no product quality complaint involved. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B
Clinical narrative: Information has been received from a consumer regarding a female who was vaccinated with a dose of Recombivax HB (manufacturer unknown). Subsequently the patient developed hepatitis B. It was unknown whether medical attention was sought. The outcome was unknown at the time of this report. There was no product quality complaint. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from a physician's assistant concerning an 18 year old female with obesity and no other pertinent medical history or drug allergies who on 04-MAY-1998 was vaccinated with the first 0.5ml IM dose of Recombivax HB (lot# "2515A2") The patient was also vaccinated with second and third 0.5ml IM doses of Recombivax HB (lot# "2559A2", "2797A2") (dates unknown). There was no concomitant medication. Subsequently after completely the vaccination series, the patient's labs revealed a non-reactive hepatitis b surface antigen test. Unspecified medical attention was sought. The patient's present status was unknown. There was no product quality complaint. Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Antibody test negative, Hepatitis B antibody negative
Clinical narrative: Information has been received from a physician concerning a 42 year old female with a history of diabetes, and no drug reactions or allergies who was vaccinated with three doses of RECOMBIVAX HB on unspecified date. Concomitant therapy included PLAQUENIL, LANTUS, AMARYL, and metformin. Subsequently the patient titer was 0.85. The physician reports that the patient failed to adequately respond to RECOMBIVAX HB after 3 doses, noting that the minimum titer level for protection must be 0.99. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody, Hepatitis B antibody negative
Clinical narrative: Information has been received from a female patient who was vaccinated with first second and third doses of Recombivax HB (manufacturer unknown) in January 1996 (lot # "1744A2"), on 28-JUN-1996 (lot # "206A?K") and on 07-JUL-1997 (lot # "2118A") respectively.  On an unspecified date in 2001 the patient's serum hepatitis B surface antibody screen was negative.  The patient received a booster dose of Recombivax HB (lot # 650006/0448L) on 22-OCT-2001.  On 24-JAN-2002 the patient's serum hepatitis B surface antibody screen was >150.0 indicating immunity to Hepatitis B.  No further information was provided.  Additional information is not expected.  The patient had a similar experience after vaccination with MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3) (WAES # 0701USA03958).
Age: 0.0
Sex: F
Vaccine: HEP
Symptoms: Cough, Lethargy, Rash
Clinical narrative: Information has been received from a nurse practitioner concerning a newborn (1 day old) white female, with no allergies, pertinent medical history or concomitant medications, who prior to her discharge from the hospital on 07-OCT-2007, was vaccinated with RECOMBIVAX HB (lot# 654744/0771F). It was reported that thirty minutes after the vaccination, at home, the mother of the newborn noticed she had developed a rash on her back, chest, and legs. It was reported that the newborn also seemed lethargic and was coughing. The mother brought the newborn back to the hospital where she was seen by the attending physician who indicated that the symptoms may have been related to newborn acne. The rash resolved on 09-OCT-2007. No product quality complaint was reported. NO further information was available. Follow up information received from the nurse practitioner reported that 30 minutes after the vaccine was given, red bumps that looked like fire ants bites developed on the legs, back, and stomach, seemed lethargic, and as if phlegm was in the throat. The patient feed poorly that day. It was reported that the rash lasted for two days and that the patient as of 08-OCT-2007 had recovered. Additional information has been requested.
Age: 46.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Hepatitis B surface antigen negative, Herpes zoster, Measles antibody negative, Mumps antibody test negative
Clinical narrative: Information has been received from a physician concerning a 46 year old male firefighter with a history of renal cell carcinoma (treated with nephrectomy "6-7 years" ago), and hepatitis B exposure (prior to June 2007). It was reported that 10-15 years ago the patient received his initial 3 dose series of hepatitis B vaccine (unspecified manufacturer). Beginning in June 2007, he began his second series of 3 doses of hepatitis B vaccine (unspecified manufacturer). On 10-OCT-2007, he received his seventh dose of RECOMBIVAX HB. He tested negative for hepatitis B after his exposure. He was also tested for titer levels of varicella, measles, mumps, and rubella that were all reported as normal. On 10-OCT-2007, prior to his seventh dose of vaccine, his hepatitis B titer was reported as negative. Current patient status was not reported. A product quality complaint was not reported. No further information was available. Follow up information from a physician reported that the patient finally seroconverted. It was reported that the patient received a total of four doses over four months (dates not reported). Additional information is not expected.
Age: 46.0
Sex: M
Vaccine: HEP
Symptoms: Rubella antibody negative
Clinical narrative: Information has been received from a physician concerning a 46 year old male firefighter with a history of renal cell carcinoma (treated with nephrectomy "6-7 years" ago), and hepatitis B exposure (prior to June 2007). It was reported that 10-15 years ago the patient received his initial 3 dose series of hepatitis B vaccine (unspecified manufacturer). Beginning in June 2007, he began his second series of 3 doses of hepatitis B vaccine (unspecified manufacturer). On 10-OCT-2007, he received his seventh dose of RECOMBIVAX HB. He tested negative for hepatitis B after his exposure. He was also tested for titer levels of varicella, measles, mumps, and rubella that were all reported as normal. On 10-OCT-2007, prior to his seventh dose of vaccine, his hepatitis B titer was reported as negative. Current patient status was not reported. A product quality complaint was not reported. No further information was available. Follow up information from a physician reported that the patient finally seroconverted. It was reported that the patient received a total of four doses over four months (dates not reported). Additional information is not expected.
Sex: F
Vaccine: HEP
Symptoms: Nuclear magnetic resonance imaging normal, Vertigo, Vestibular disorder
Clinical narrative: Information has been received regarding a case in litigation concerning a female who on 13-MAY-1992, was vaccinated with her final dose of three dose series of Recombivax HB (manufacturer unknown).  She had a fourth dose on 03-May-1994, and alleged two other administrations in 1994 (for which she was unable to produce records).  In January 1998 at approximately 61 years old, the patient experienced vestibular dysfunction, where she had 2 attacks of vertigo.  An MRI revealed that there were lesions in her brain that were consistent with Multiple Sclerosis (M.S.), however, they were also consistent with the aging process.  A subsequent interpretation was that the MRI did not show lesions.  Her clinical condition had never reflected MS and her doctors, (although initially posting that she might have MS), backed away from that diagnosis and decided that she had vestibular dysfunction.  The patient felt that vestibular dysfunction was related to therapy with Recombivax HB, however, this was not medically supported.  The outcome was unknown.  No further information is available.
Age: 58.0
Sex: F
Vaccine: HEP
Symptoms: Neck pain
Clinical narrative: Information has been received from a health professional concerning a 58 year old female with fibromyalgia, allergies, and allergies to aspirin, duloxetine (CYMBALTA) and sulfonamides who on 16-AUG-2007, and 18-SEP-2007, received her first and second 1.0 ml intramuscular doses of RECOMBIVAX HB (lot#"0042U").  Concomitant therapy included mometasone furoate (NASONEX), montelukast sodium (MSD), bupropion HC1 (WELLBUTRIN XL), cyclosporine (RESTASIS), estrogens, (PREMPRO), calcium (unspecified), dicyclomine HC1, nefazodone HC1 and clindamycin.  On 23-AUG-2007, and on 25-SEP-2007, (1 week after each vaccine administration), the patient experienced sharp pain in the back of her neck that resolved within 3-5 days without treatment.  The patient sought unspecified medical attention in the physician's office.  There were no laboratory or diagnostic tests performed.  A product quality complaint was not reported.  No further information was available.  Additional information has been requested.
Sex: U
Vaccine: HEP, HEPA
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a health professional concerning a patient who may have inadvertently been vaccinated with Recombivax HB instead of Vaqta (MSD (lot#656680/0010U).  It was reported that if there was an error, it would be staff error only, not product quality complaint.  No other information is available.  Follow up information reported that the patient developed no reaction.  Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Serology negative
Clinical narrative: Information has been received from a physician concerning an 18 or 19 year old female who may have received three doses of Recombivax HB (manufacturer unknown) and per laboratory data has no titers.  It was reported that she sought unspecified medical attention.  Current patient status was not reported.  A product quality complaint was not reported.  No further information was available.  Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Influenza like illness, Musculoskeletal pain
Clinical narrative: Information has been received from a dentist concerning a 38 year old female dental office worker with no pertinent medical history or drug allergies who in 2005 was vaccinated IM with her second 1.0 ml dose of Recombivax HB.  There was no concomitant medication.  In 2005 the patient experienced shoulder pain and flu-like symptoms.  The patient did not see or call a physician when she had the symptoms.  No labs or diagnostic studies were performed.  Subsequently, the patient recovered several days after vaccination.  It was noted that the patient did not have any reaction on her first vaccination.  She also did not receive the third dose.  There was no product quality complaint.  Additional information has been requested.
Age: 46.0
Sex: M
Vaccine: HEP
Symptoms: Facial palsy
Clinical narrative: Information has been received from a health professional concerning a 46 year old male who on 22-AUG-2007 was vaccinated with a dose of RECOMBIVAX HB (lot#654018/0904F). In August 2007, the patient experienced Bells Palsy. The timing of the onset of the Bells Palsy was unknown. The patient did not return to the office to complete the series. Unspecified medical attention was sought. No product quality complaint. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Laboratory test abnormal, Serology negative
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a three dose series of Recombivax HB.  Subsequently the patient's titer was performed which showed negative.  Medical attention was sought in the physician's office.  The patient was not recovered.  There was no product quality complaint.  Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Serology negative
Clinical narrative: Information has been received from a registered nurse concerning an adult patient, on dialysis, who was vaccinated with the primary series of RECOMBIVAX HB in the past (dates unspecified), and now is showing "negative titers".  Unspecified medical attention was sought.  There was no product quality complaint.  At the time of reporting the patient was not yet recovered.  Attempts are being made to obtain additional identifying information to distinguish the individual patient 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.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, PPV
Symptoms: Erythema, Rash, Urticaria
Clinical narrative: This case was reported by a physician, via a representative, and described the occurrence of rash in a 12 month old male subject who was vaccinated with Havrix (GlaxoSmithKline), Proquad vaccine and PCV 7 vaccine. On an unspecified date, the subject received 1st dose of Havrix (720 elisa unit, unknown), 1st dose of Proquad vaccine and 3rd dose of PCV 7 vaccine. Within 24 hours of receiving these vaccinations, the subject developed a red rash described as urticaria over his body. Hives were also reported. The child was taken to the emergency department and treated with oral Benadryl and Prednisolone (30mg over three days). The rash resolved within three hours after receiving Benadryl and Prednisolone in the emergency room. In the physician's opinion, the events were possibly related to treatment with Havrix. It was stated that the child planned to see an allergist prior to administration of next doses of vaccine.
Sex: U
Vaccine: HEP
Symptoms: Laboratory test abnormal, Serology negative
Clinical narrative: Information has been received from a registered nurse concerning an adult patient, on dialysis, who was vaccinated with the primary series of Recombivax HB in the past (dates unspecified), and now is showing "negative titers".  Unspecified medical attention was sought.  There was no product quality complaint.  At the time of reporting the patient was not yet recovered.  Attempts are being made to obtain additional identifying information to distinguish the individual patient 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.
Age: 18.0
Sex: M
Vaccine: HEPA
Symptoms: Dyspnoea, Injection site irritation, Injection site pain, Palpitations
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site pain in an 18-year-old male subject who was vaccinated with Havrix (GlaxoSmithKline).  The reporting nurse is the mother of the patient.  There were no concurrent medications.  On 09 April 2007 the subject received the first dose of Havrix (720 mIU/mL, unknown).  On 09 April 2007, less than one day after vaccination with Havrix, the subject experienced "severe" pain with injection, burning with injection, and shortness of breath.  The subject also experienced racing heartbeat.  At the time of reporting the events were resolved.