chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of "29 patients received expired FLUMIST" was received from a physician in the concerning a 36-month-old female.  The patient's medical history included no history of asthma.  Concomitant medications were not available.  On 06-Jan-2009, twenty nine patients (26 children & 3 adults) were vaccinated at a military base and administered expired FLUMIST; the product was expired by 11 days (expiration date: 26-Dec-2008).  The reporting physician was concerned regarding efficacy and loss of potency due to the expired product.  Since the facility only administered the immunizations and dose not care for the patients, they had limited medical history information (i.e. screening questions to confirm history of asthma, no detailed medical history to included all their concomitant medications).  There were no adverse events associated with these medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the events are considered resolved.  This case is being submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.  On 05-Feb-2009, the physician confirmed that there were no adverse events associated with the medication error. 02/05/09 Follow-up received 31-Mar-2009: added product complaint investigation results.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of "29 patients received expired FLUMIST" was received from a physician concerning a 36-month-old female.  The patient's medical history included no history of asthma.  Concomitant medications were not available.  On 06-Jan-2009, twenty nine patients (26 children & 3 adults) were vaccinated at a military base and administered expired FLUMIST; the product was expired by 11 days (expiration date: 26-Dec-2008).  The reporting physician was concerned regarding efficacy and loss of potency due to the expired product.  Since the facility only administered the immunizations and does not care for the patients, they had limited medical history information (i.e. screening questions to confirm history of asthma, no detailed medical history to include all their concomitant medications).  There were no adverse events associated with these medications errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the events are considered resolved.  This case is being submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.  On 05-Feb-2009, the physician confirmed that there were no adverse events associated with the medication error. Based on th results of the investigation, the root cause for the medication errors were caused by 1) customers nto discarding product from the previous season 2) product expiring diuring the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 05-Feb-2009 and incorporated into the narrative, physician confirmed that there were no adverse events associated with the medication error. Additional information was received on 31-Mar-2009 and incorporated into the narrative product complaint investigation results.
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of "29 patients received expired FLUMIST" was received from a physician concerning a three-year-old male.  The patient's medical history included no history of asthma.  Concomitant medications were not available.  On 06-Jan-2009, twenty nine patients (26 children & 3 adults) were vaccinated at a military base and administered expired FLUMIST; the product was expired by 11 days (expiration date: 26-Dec-2008).  The reporting physician was concerned regarding efficacy and loss of potency due to the expired product.  Since the facility only administered the immunization and does not care for the patients, they had limited medical history information (i.e. screening questions to confirm history of asthma, no detailed medical history to include all their concomitant medications).  There were no adverse events associated with theses medication errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the events are considered resolved.  This case is being submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.  On 05-Feb-2009, the physician confirmed that there were no adverse events associated with the medication error.  Additional information was received on 05-Feb-2009 and incorporated into the narrative: gender and age; confirmation that there were no adverse events. Additional information was received on 31-Mar-2009 and incorporated into the narrative product complaint investigation results.
Sex: F
Vaccine: FLUN3
Symptoms: Drug administration error
Clinical narrative: A non-serious, spontaneous report of administration of full dose in one nostril was received from a nurse concerning a female child of unknown age subsequent to FLUMIST. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Additional information was received on 17-Feb-2009 and incorporated into the narrative: No adverse event reported.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of expired product was received from a nurse practitioner concerning a four year-old male, which occurred after receiving expired FLUMIST.  There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Based on the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the Flu season resulting in some medication errors that occurred shortly after the product expired. Follow up information was received on 06-Mar-2009 and incorporated into the narrative: confirmed that there were no adverse events associated with the medication error. Additional information was received on 09-Apr-2009: product complaint investigation results.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of administration of expired product was received from a nurse practitioner concerning a 41-month-old female, who received FLUMIST.  There was no adverse event associated with this medication error;  therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  This case is submitted in accordance with agency's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Follow up information was received on 06-Mar-2009 and incorporated into the narrative, confirmed thate there were no adverse events associated with the medication error.
Age: 63.0
Sex: F
Vaccine: HEP
Symptoms: Multiple sclerosis, Nuclear magnetic resonance imaging brain abnormal, Optic neuritis, Visual acuity reduced
Clinical narrative: Information has been received from a case in litigation via a case report concerning a 63 year old female with pre-diagnosis and pre-vaccination medical problems who in 1990 was vaccinated with RECOMBIVAX HB vaccine (manufacturer unknown). Subsequently, "a few days later the patient experienced optic neuritis. A special master said the patient had "deteriorating vision in her right eye and was treated with steroids. In 1994, she had a brain MRI and multiple sclerosis was diagnosed for the first time." A Vaccine Court Special master has ordered compensation for a woman who alleged that the RECOMBIVAX HB (manufacturer unknown) caused or aggravated MS, saying the respondent could not demonstrate no other challenge to the patient's immune system at the time of vaccination. "If petitioner had a pre-vaccination onset of MS, rather than chemotherapy-induced polyneuropathy, then RECOMBIVAX HB vaccine significantly aggravated it." A Special Master said "if the patient did not have a pre-vaccination onset of MS but experienced the onset of her MS with her optic neuritis post-vaccination, then the vaccine caused it." It was noted that this case was complicated by a variety of pre-diagnosis and pre-vaccination medical problems that the patient had. Upon internal review, multiple sclerosis was considered to be an other important medical event. No further information is available.
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Multiple sclerosis, Nuclear magnetic resonance imaging brain abnormal, Optic atrophy, Optic neuritis
Clinical narrative: Information has been received from a case in litigation via a case report concerning a 48 year old female who on 12-NOV-1992, 18-DEC-1992 and 25-MAY-1993 was vaccinated with a first, second and third dose of RECOMBIVAX HB (manufacturer unknown) respectively. Subsequently, the petitioner developed multiple sclerosis. A Vaccine Court special master has ruled that a woman who developed multiple sclerosis after RECOMBIVAX HB (manufacturer unknown) was entitled to compensation. It was noted that on 28-JUN-1993, the petitioner was seen by a retina specialist for the appearance of sparks or flashes and film that she had noticed in her right eye the previous week. The petitioner continued to experience visual problems, which were joined later in 1993 by pain and weakness. A special master said "on 14-OCT-1993, the petitioner underwent a brain MRI, which was abnormal due to increased T2 signal in the posterior parietal white matter bilaterally and in the medial left brachium points." "The primary consideration would be MS." "Optic neuritis is frequently a hallmark for MS" said a special master. The special master said "since the petitioner's onset of right optic neuritis was within a month of her third RECOMBIVAX HB (manufacturer unknown) the onset is medically appropriate for causation." The government's contention that visual problems in the immediate aftermath of the petitioner's third RECOMBIVAX HB (manufacturer unknown) in May 1993 was something other than optic neuritis "seems an extraordinary stretch," although optic neuritis was not diagnosed at the time, said a special master. "The tie-breaker in this case must be the opinion of the petitioner's treating neurologist, who in 1999, when the petitioner came to him complaining of undisputed optic neuritis in her left eye, diagnosed her with having had optic neuritis in her right eye in 1993 after he examined her eyes and found pallor in her right optic nerve," a special master said. "The symptoms about which she complained in June 1993 to another physician, although consistent with a retinal problem, are also consistent with optic neuritis." Upon internal review, multiple sclerosis was considered an other important medical event. No further information is available.
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Pain, Photopsia, Visual impairment
Clinical narrative: Information has been received from a case in litigation via a case report concerning a 48 year old female who on 12-NOV-1992, 18-DEC-1992 and 25-MAY-1993 was vaccinated with a first, second and third dose of RECOMBIVAX HB (manufacturer unknown) respectively. Subsequently, the petitioner developed multiple sclerosis. A Vaccine Court special master has ruled that a woman who developed multiple sclerosis after RECOMBIVAX HB (manufacturer unknown) was entitled to compensation. It was noted that on 28-JUN-1993, the petitioner was seen by a retina specialist for the appearance of sparks or flashes and film that she had noticed in her right eye the previous week. The petitioner continued to experience visual problems, which were joined later in 1993 by pain and weakness. A special master said "on 14-OCT-1993, the petitioner underwent a brain MRI, which was abnormal due to increased T2 signal in the posterior parietal white matter bilaterally and in the medial left brachium points." "The primary consideration would be MS." "Optic neuritis is frequently a hallmark for MS" said a special master. The special master said "since the petitioner's onset of right optic neuritis was within a month of her third RECOMBIVAX HB (manufacturer unknown) the onset is medically appropriate for causation." The government's contention that visual problems in the immediate aftermath of the petitioner's third RECOMBIVAX HB (manufacturer unknown) in May 1993 was something other than optic neuritis "seems an extraordinary stretch," although optic neuritis was not diagnosed at the time, said a special master. "The tie-breaker in this case must be the opinion of the petitioner's treating neurologist, who in 1999, when the petitioner came to him complaining of undisputed optic neuritis in her left eye, diagnosed her with having had optic neuritis in her right eye in 1993 after he examined her eyes and found pallor in her right optic nerve," a special master said. "The symptoms about which she complained in June 1993 to another physician, although consistent with a retinal problem, are also consistent with optic neuritis." Upon internal review, multiple sclerosis was considered an other important medical event. No further information is available.
Sex: F
Vaccine: HEP
Symptoms: Burning sensation, Demyelination, Hypoaesthesia, Multiple sclerosis, Muscle contractions involuntary
Clinical narrative: Information has been received from a case in litigation via a case report concerning a female who on 29-MAR-1999 was vaccinated with a dose of RECOMBIVAX HB (manufacturer unknown). On 12-APR-1999, a special master said that the patient was seen by a neurologist with complaints of tingling in both legs, numbness and weakness of her left arm and unusual abdominal muscle contractions. The patient said her problems began with her legs around 19-NOV-1998. She reported weakness and burning sensation in both feet and legs. The special master, based on the testimony of the treating physician ruled that existing neurological symptoms when the patient had a 1999 RECOMBIVAX HB (manufacturer unknown) were due to structural spinal injuries from a 1995 accident. That represented a deviation from the patient's original petition, which asserted aggravation, and from the special master's 2006 order to show cause, which found that the patient's neurological condition had gradually deteriorated beginning well before the 29-MAR-1999, administration of the RECOMBIVAX HB (manufacturer unknown). A Vaccine Court special master has reversed her earlier skepticism that the RECOMBIVAX HB (manufacturer unknown) caused the petitioner's transverse myelitis and eventual multiple sclerosis and ruled that compensation should be paid. This is the rare case in which the experts from both sides agreed that the petitioner's medical theory is biologically plausible, a Special Master said "Petitioner has proved a logical sequence of cause and effect, and appropriate temporal interval between vaccination and onset." The special master said the physician testifying for the respondent, said that three days between the vaccination and onset of symptoms was too soon for a demyelinating injury to develop but another physician said that if the petitioner had been "primed" by some earlier exposure, the onset can be faster. Moreover, a special Master said, a neuroimmunologist testified at an omnibus hepatitis b proceeding that he would expect a reaction in humans from three to 30 days after vaccination. Upon internal review, transverse myelitis and multiple sclerosis were found to be other important medical events. No further information is available.
Sex: F
Vaccine: HEP
Symptoms: Muscular weakness, Myelitis transverse, Paraesthesia
Clinical narrative: Information has been received from a case in litigation via a case report concerning a female who on 29-MAR-1999 was vaccinated with a dose of RECOMBIVAX HB (manufacturer unknown). On 12-APR-1999, a special master said that the patient was seen by a neurologist with complaints of tingling in both legs, numbness and weakness of her left arm and unusual abdominal muscle contractions. The patient said her problems began with her legs around 19-NOV-1998. She reported weakness and burning sensation in both feet and legs. The special master, based on the testimony of the treating physician ruled that existing neurological symptoms when the patient had a 1999 RECOMBIVAX HB (manufacturer unknown) were due to structural spinal injuries from a 1995 accident. That represented a deviation from the patient's original petition, which asserted aggravation, and from the special master's 2006 order to show cause, which found that the patient's neurological condition had gradually deteriorated beginning well before the 29-MAR-1999, administration of the RECOMBIVAX HB (manufacturer unknown). A Vaccine Court special master has reversed her earlier skepticism that the RECOMBIVAX HB (manufacturer unknown) caused the petitioner's transverse myelitis and eventual multiple sclerosis and ruled that compensation should be paid. This is the rare case in which the experts from both sides agreed that the petitioner's medical theory is biologically plausible, a Special Master said "Petitioner has proved a logical sequence of cause and effect, and appropriate temporal interval between vaccination and onset." The special master said the physician testifying for the respondent, said that three days between the vaccination and onset of symptoms was too soon for a demyelinating injury to develop but another physician said that if the petitioner had been "primed" by some earlier exposure, the onset can be faster. Moreover, a special Master said, a neuroimmunologist testified at an omnibus hepatitis b proceeding that he would expect a reaction in humans from three to 30 days after vaccination. Upon internal review, transverse myelitis and multiple sclerosis were found to be other important medical events. No further information is available.
Sex: F
Vaccine: HEP
Symptoms: Anaphylactic reaction
Clinical narrative: Information has been received from a female who in 1994 or 1995 was vaccinated with RECOMBIVAX HB (manufacturer unknown). In 1994 or 1995, the patient experienced an anaphylactic reaction. No further information is available.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Asthma, Hypersensitivity
Clinical narrative: Information has been received from a registered nurse concerning a 21 year old female patient who on an unspecified date as a child was vaccinated with a dose of RECOMBIVAX HB (manufacturer unknown).  It was reported that the patient had an asthmatic allergic reaction after vaccination and had to be taken to the emergency room.  Subsequently, the patient recovered from asthmatic allergic reaction on an unspecified date. There was no product quality complaint involved.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 3/6/2009. Follow up information was received from the R.N. who reported that was not a medication they gave in their office. She was unaware of any the details about this patient. Additional information is not expected.
Age: 0.2
Sex: M
Vaccine: HEP
Symptoms: Anaemia, Feeding disorder, Gross motor delay, Head lag, Hypertonia
Clinical narrative: Information has been received from a physician concerning a 12 weeks old female with no known drug allergies and born with vocal cord paralysis, hypotonia, laryngomalacia lung disorder (requiring tracheostomy) and malaise after placental exposure to GARDASIL (WAES080USA01055) who on 10-Jun-2008 was vaccinated with the first dose of RECOMBIVAX HB and on 17-Aug-2008 was vaccinated with the second dose of RECOMBIVAX HB. Other vaccination included Polio, DTaP, PREVNAR and Hib conj vaccine (unspecified carrier). On 10-Sep-2008, the patient presented for a scheduled 3 month visit. The patient had severe laryngomalacia and a tracheostomy with a trach tube in place. The patient was on PREVACID twice a day and REGLAN three times a day. The patient's vocal cord paralysis was closely being followed by his ear, nose and throat (ENT) physician. The patient had feeding difficulties and mismanagement. The patient was currently on 24 Kcal carnation and was taking oral feeds well per his mother. A follow-up appointment was scheduled in October with the feeding clinic. The patient also had anemia and was on an iron supplement. On 15-Oct-2008, the patient presented for a scheduled 4 month visit. The patient had a gross motor delay. Respiratory pattern was unremarkable and had a trach in place. The patient had a significant head lag and slightly increased tone in his lower extremities. The patient's vocal cord paralysis was continued closely followed by his ENT physician. The physician advised the patient's mother to mismanagement. An early intervention plan (EIP) evaluation was scheduled on 21-Oct-2008 for gross motor delay. The patient continued to take SYNAGIS, PREVACID and REGLAN. The patient's symptoms persisted. Additional information has been requested. All available medical records will be provided upon request. All available medical records will be provided upon request.
Sex: M
Vaccine: HEP
Symptoms: Attention deficit/hyperactivity disorder, Impulsive behaviour
Clinical narrative: Information has been received from a case in litigation via a case report concerning a male who in 1997, received the usual infant vaccinations that year and in early 1998. Beginning in 1998, the patient was treated five times in the emergency room for a variety of accidents that a respondent's expert said were the results of impulsive behavior and thus evidence of ADHD. A Special Masters ruled a petition alleging that thimerosal in vaccines, including the RECOMBIVAX vaccine (manufacturer unknown), caused attention deficit hyperactivity disorder (ADHD), saying symptoms that may not have been recognized at the time still trigger the Vaccine Act's 36-month statue of limitations. A Chief Special Master said that the experts agreed that the "first symptoms of manifestations" of the patient's ADHD was at the latest by 03-Nov-2001 when he was 4 years and 6 months old, which required a filing by 03-Nov-2004, under the statue. The Chief Special Master noted that the binding decision regarding onset timing, allows "retrospective" analysis even when such analysis identifies as the "first symptoms or manifestations" some innocuous episode in a child's health. The chief special master pointed out, the manifestation was "blinking." The undersigned disagrees with the petitioner's interpretation and finds that the correct reading is that the critical determination is focused solely upon when the first symptoms or manifestation of onset occurred. Chief Special Master said "whether this determination can be made contemporaneously with the symptoms first occurred or in hindsight utilizing the injured's complete medical record is irrelevant, as long as the determination was made utilizing the 'recognized standards of the medical profession at large. No further information is available.
Age: 5.0
Sex: M
Vaccine: HEP, MMR, VARCEL
Symptoms: Attention deficit/hyperactivity disorder
Clinical narrative: Information has been received from a consumer concerning her approximately 5 year old son with no known allergies or pertinent medical history who on unspecified dates was vaccinated with a first and second dose of RECOMBIVAX HB (lot numbers reported as "4027K" and 638081/1667X or "1669K"). It was noted that the patient also received a dose of VARIVAX (lot # 635450/1142K) (date unspecified) and a first and second dose of MMR II (lot numbers reported as "1407K" and 646738/0819N or "0819D" (dates unspecified). It was noted that the patient received the vaccinations when "whatever the standard schedule for infants was. "There was no concomitant medication. It was reported that the patient was diagnosed with attention deficit hyperactivity disorder when he started kindergarten. Unspecified medical attention was sought. There were no lab studies performed. At the time of the report, the patient had not recovered. There was no product quality complaint involved.
Age: 0.1
Sex: M
Vaccine: HEP
Symptoms: Infantile spitting up, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a physician concerning an 8 week old male with no known drug allergies and a history of circumcision and family history of cancer (maternal grandfather) who on 30-APR-2008 was vaccinated with the first dose of RECOMBIVAX HB vaccine and on 29-MAY-2008 was vaccinated IM with the second 0.5 ml dose in the left thigh of RECOMBIVAX HB vaccine. There was no concomitant medications. On 30-JUN-2008, the patient was at a well baby visit and the parents expressed concerns about the baby spitting up after each feeding and not seeming satisfied after feeding. It was reported that the parents tried to increase amount of formula but spits up more and have tried adding cereal to the bottle with little improvement. Informed to delay solids until 4 to 6 months. Feeding issues were reviewed with the patient's parents, not specified. Physical exam revealed no abnormalities. Parents reported no problems with previous immunizations.  On 30-JUN-2008, at the 2 month visit the patient received the following vaccines a dose of DTaP 0.5 ml IM in the left thigh, a dose of ACTHIB 0.5 ml IM in the left thigh, a dose of PREVNAR 0.5 ml IM in the right thigh, a dose of poliovirus vaccine inactivated (unspecified) 0.5 ml SQ in the right thigh and a dose of ROTATEQ (MSD) PO (dose not reported). The patient was to follow-up with the physician in two months. No further information is available.
Sex: F
Vaccine: HEP
Symptoms: Anaphylactic reaction, Apparent life threatening event
Clinical narrative: Information has been received from a registered nurse concerning a female child who on an unspecified date was vaccinated with RECOMBIVAX HB. Subsequently, the patient had an anaphylactic reaction. It was reported that the patient was taken to the hospital, but it was unknown if the patient was admitted. It was noted that the patient "almost died," but did recover. There was no product quality complaint involved. "Almost died" was considered life threatening. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HEP
Symptoms: Adverse reaction
Clinical narrative: Information has been received from a physician concerning a 16 year old male with no pertinent medical history who was vaccinated with a dose of RECOMBIVAX HB. The physician reported that the patient had a reaction to the RECOMBIVAX HB. The patient also had an adverse reaction after vaccination with VARIVAX (WAES# 0811USA00949). No further information is available.
Age: 50.0
Sex: F
Vaccine: FLUX, HEP
Symptoms: Biopsy skin, Hypoaesthesia, Rash pruritic
Clinical narrative: Information has been received from a pharmacist concerning a 50 year old female with hypertension and no history of drug reactions/allergies, who on 1-OCT-2008, was vaccinated with HEPTAVAX. Concomitant therapy included influenza virus vaccine (unspecified), BENICAR, furosemide and ATIVAN. On 2-OCT-2008 the patient developed an itchy rash from her neck to her knees. The patient had been treated with unspecified steroids and antihistamines but the rash persisted. A skin biopsy, performed by an unspecified dermatologist, revealed "possible drug reaction". The patient also developed numbness of the fingers of her left hand. At the time of reporting, the patient has not yet recovered. The patient sought medical attention with an office visit. No product quality complaint involved. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a pharmacist concerning a 1 day old male infant who on 19-NOV-2008 was inadvertently vaccinated SQ with RECOMBIVAX HB.  It was noted that the patient was intended to be administered LIDOCAINE as a nerve block, but was inadvertently administered an unspecified amount of ROCOMBIVAX HB subcutaneously in the groin area prior to circumcision.  There were no adverse symptoms reported.  At the time of the report, the patient's status was unknown.  The pharmacist confirmed that this was human error and not product confusion.  Follow-up information has been received from the pharmacist who confirmed that a male patient was inadvertently vaccinated with ROCOMBIVAX HB.  The pharmacist mentioned that a nurse had pulled a vial of ROCOMBIVAX HB early because she had some students that day.  The nurse attached the vial to the front of the chart and told the nurse that was going to be present for the circumcision that the vial had been pulled.  At the time of circumcision the doctor asked the nurse for the LIDOCAINE and the nurse pulled the vial off the chart without looking at the vial and drew up the syringe and handed it to the doctor.  The pharmacist confirmed that this was not a case of product confusion, but a nursing error.  The pharmacist stated that the vials don't look the same.  Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Constipation, Gastrointestinal disorder, Upper respiratory tract infection
Clinical narrative: Information had been received from a physician via pediatric medical records concerning a 40 day old female who on 30-JUL-2008 was vaccinated with RECOMBIVAX HB.  Secondary suspect therapy included HIB CONJ vaccine (OMPC) (manufacturer unknown) and ROTAVIRUS (manufacturer unknown).  Other concomitant therapy included PREVNAR.  On 04-AUG-2008 record indicated "well infant".  On 08-SEP-2008 the patient was seen and experienced gastrocolonic response (GCR) versus formula intolerance.  Plan was to change to soy formula.  On 11-SEP-2008 the patient was noted to be with complaints of constipation.  Plan was to go back to Enfamil.  On 22-SEP-2008 the physician diagnosed an upper respiratory infection (URI).  At the time of reporting, the outcomes were unknown.  This is one of several reports received from the same source.  Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Chest discomfort, Lip swelling, Oedema mouth, Pharyngeal oedema, Pruritus generalised
Clinical narrative: Information has been received from a physician assistant concerning a 30 year old female patient with no pertinent medical history and no known drug allergies who on 13-NOV-2008 was vaccinated IM with a second 1 ml dose of RECOMBIVAX HB (lot # 660951/0398X).  The patient was vaccinated with the first dose of RECOMBIVAX HB (lot # 660951/0398X) on 13-OCT-2008.  There was no concomitant medication.  On 17-NOV-2008 the patient experienced swelling of her lips, mouth and throat. It was reported that the patient felt generalized pruritus and a feeling of heaviness in her chest.  She also felt her throat was closing.  The patient was examined in the emergency room on the same day.  The patient was not admitted and there were no lab studies performed.  The patient was prescribed PREDNISONE 40 mg once daily for 5 days.  The patient stated that her symptoms were "merely annoying."  At the time of the report, the Patient's status was unknown.  There was no product quality complaint involved.  Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Throat tightness
Clinical narrative: Information has been received from a physician assistant concerning a 30 year old female patient with no pertinent medical history and no known drug allergies who on 13-NOV-2008 was vaccinated IM with a second 1 ml dose of RECOMBIVAX HB (lot # 660951/0398X).  The patient was vaccinated with the first dose of RECOMBIVAX HB (lot # 660951/0398X) on 13-OCT-2008.  There was no concomitant medication.  On 17-NOV-2008 the patient experienced swelling of her lips, mouth and throat. It was reported that the patient felt generalized pruritus and a feeling of heaviness in her chest.  She also felt her throat was closing.  The patient was examined in the emergency room on the same day.  The patient was not admitted and there were no lab studies performed.  The patient was prescribed PREDNISONE 40 mg once daily for 5 days.  The patient stated that her symptoms were "merely annoying."  At the time of the report, the Patient's status was unknown.  There was no product quality complaint involved.  Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect route of drug administration, Injection site vesicles
Clinical narrative: Information has been received from a physician concerning an adolescent patient (exact age not provided) who on an unspecified date was vaccinated with an "adolescent" 0.5 ml single dose of RECOMBIVAX HB. It was reported that about two to three days after vaccination the patient developed a 3 mm blister at the injection site that lasted for two weeks. It was noted that a 5/8 inch needle was used instead of a 1 inch needle. It was believed that the vaccine was administered subcutaneously instead of intramuscularly. Unspecified medical attention was sought. It was unspecified if lab studies were performed. At the time of the report, the patient's status was unknown. There was no product quality complaint involved. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Dermatitis diaper, Flatulence, Irritability
Clinical narrative: Information has been received from a physician via medical records concerning a 51 day old white female infant with bottle feeding and a history of clinical sepsis of newborn (WAES 0712USA07860), premature atrial contractions and arrhythmia's who on approximately 22-AUG-2008, when she was in hospital for clinical sepsis, was vaccinated with a first dose of RECOMBIVAX HB. On 11-OCT-2008 the infant was taken to office by her mother for follow-up visit. The mother reported some gassy and fussiness. Physical examination showed the infant had a little bit of diaper rash. She was treated with MYCOLOG cream for her diaper rash. On 23-OCT-2008, while the baby was seen by physician again, she was found to be playful and having no complaints. Her diaper rash also resolved. This is one of several reports from the same source. Additional information is not expected.
Sex: F
Vaccine: HEP
Symptoms: Barium swallow, Bilirubin conjugated, Blood bilirubin increased, Candidiasis, Dermatitis diaper
Clinical narrative: Information has been received from a physician via pediatric medical records concerning a 10 day old female with no known drug allergies who on 13-JUN-2008 was vaccinated with the first dose of RECOMBIVAX HB vaccine and on 13-AUG-2008 was vaccinated with the second dose of RECOMBIVAX HB vaccine. On 13-AUG-2008, the patient was also vaccinated with diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, pneumococcal vaccine (unspecified), poliovirus vaccine inactivated (unspecified) and rotavirus G1 G2 G3 P1 reassortant vaccine live (human-bovine) (manufacturer unknown). On 29-OCT-2008 the patient was vaccinated with diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, pneumococcal vaccine (unspecified), Hib conj vaccine (CMPC) (manufacturer unknown), poliovirus vaccine inactivated (unspecified) and rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine) (manufacturer unknown). On 16-JUN-2008 the patient's total bilirubin was noted to be 1.7 mg/dL which was considered high. Office notes of 23-JUN-2008 reported the patient experienced trembling while sleeping and dry skin. On 22-JUL-2008 the patient underwent a barium swallow. The patient was administered barium contrast orally. There was free flow of contrast through the esophagus and into the stomach. No abnormal strictures or abnormal extrinsic impression on the esophagus was seen. There was no gastroesophageal reflux seen during fluoroscopic examination. The stomach appeared normal. Duodenojejunal was in normal location without evidence for malrotation. On 22-AUG-2008 physician's notes reported a diaper rash x 1 week and noted the patient was spitting up formula. The patient was on an unspecified medication for gastroesophageal reflux disease (GERD). The physician's assessment was acute gastroenteritis. The physician treated the patient with NYSTATIN. On 08-SEP-2008 the patient was seen for follow up of the diarrhea and rash and was asymptomatic. The patient was noted to be on no medications. On 08-OCT-2008 the patient experienced rash over body/rash buttock/groin, times 1 week. The physician assessment was diaper rash that was probable Candida. NYSTATIN treatment was prescribed for the diaper area. At the time of reporting, the outcomes were unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Diagnostic procedure, Diarrhoea, Dry skin, Gastroenteritis, Gastrooesophageal reflux disease
Clinical narrative: Information has been received from a physician via pediatric medical records concerning a 10 day old female with no known drug allergies who on 13-JUN-2008 was vaccinated with the first dose of RECOMBIVAX HB vaccine and on 13-AUG-2008 was vaccinated with the second dose of RECOMBIVAX HB vaccine. On 13-AUG-2008, the patient was also vaccinated with diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, pneumococcal vaccine (unspecified), poliovirus vaccine inactivated (unspecified) and rotavirus G1 G2 G3 P1 reassortant vaccine live (human-bovine) (manufacturer unknown). On 29-OCT-2008 the patient was vaccinated with diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, pneumococcal vaccine (unspecified), Hib conj vaccine (CMPC) (manufacturer unknown), poliovirus vaccine inactivated (unspecified) and rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine) (manufacturer unknown). On 16-JUN-2008 the patient's total bilirubin was noted to be 1.7 mg/dL which was considered high. Office notes of 23-JUN-2008 reported the patient experienced trembling while sleeping and dry skin. On 22-JUL-2008 the patient underwent a barium swallow. The patient was administered barium contrast orally. There was free flow of contrast through the esophagus and into the stomach. No abnormal strictures or abnormal extrinsic impression on the esophagus was seen. There was no gastroesophageal reflux seen during fluoroscopic examination. The stomach appeared normal. Duodenojejunal was in normal location without evidence for malrotation. On 22-AUG-2008 physician's notes reported a diaper rash x 1 week and noted the patient was spitting up formula. The patient was on an unspecified medication for gastroesophageal reflux disease (GERD). The physician's assessment was acute gastroenteritis. The physician treated the patient with NYSTATIN. On 08-SEP-2008 the patient was seen for follow up of the diarrhea and rash and was asymptomatic. The patient was noted to be on no medications. On 08-OCT-2008 the patient experienced rash over body/rash buttock/groin, times 1 week. The physician assessment was diaper rash that was probable Candida. NYSTATIN treatment was prescribed for the diaper area. At the time of reporting, the outcomes were unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Infantile spitting up, Rash generalised, Tremor
Clinical narrative: Information has been received from a physician via pediatric medical records concerning a 10 day old female with no known drug allergies who on 13-JUN-2008 was vaccinated with the first dose of RECOMBIVAX HB vaccine and on 13-AUG-2008 was vaccinated with the second dose of RECOMBIVAX HB vaccine. On 13-AUG-2008, the patient was also vaccinated with diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, pneumococcal vaccine (unspecified), poliovirus vaccine inactivated (unspecified) and rotavirus G1 G2 G3 P1 reassortant vaccine live (human-bovine) (manufacturer unknown). On 29-OCT-2008 the patient was vaccinated with diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, pneumococcal vaccine (unspecified), Hib conj vaccine (CMPC) (manufacturer unknown), poliovirus vaccine inactivated (unspecified) and rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine) (manufacturer unknown). On 16-JUN-2008 the patient's total bilirubin was noted to be 1.7 mg/dL which was considered high. Office notes of 23-JUN-2008 reported the patient experienced trembling while sleeping and dry skin. On 22-JUL-2008 the patient underwent a barium swallow. The patient was administered barium contrast orally. There was free flow of contrast through the esophagus and into the stomach. No abnormal strictures or abnormal extrinsic impression on the esophagus was seen. There was no gastroesophageal reflux seen during fluoroscopic examination. The stomach appeared normal. Duodenojejunal was in normal location without evidence for malrotation. On 22-AUG-2008 physician's notes reported a diaper rash x 1 week and noted the patient was spitting up formula. The patient was on an unspecified medication for gastroesophageal reflux disease (GERD). The physician's assessment was acute gastroenteritis. The physician treated the patient with NYSTATIN. On 08-SEP-2008 the patient was seen for follow up of the diarrhea and rash and was asymptomatic. The patient was noted to be on no medications. On 08-OCT-2008 the patient experienced rash over body/rash buttock/groin, times 1 week. The physician assessment was diaper rash that was probable Candida. NYSTATIN treatment was prescribed for the diaper area. At the time of reporting, the outcomes were unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Pruritus generalised, Urticaria
Clinical narrative: Information has been received from a pharmacist, with no medical history of allergies, 43 year old female, who on 11-NOV-2008 was intramuscularly vaccinated with dose 1 of RECOMBIVAX HB.  Concomitant therapy included multivitamin.  On 12-NOV-2008 the patient experienced itchy all over her body.  She also had redness and hives.  She treated herself with BENADRYL at night but has not had improvement.  At the time of reporting she did not recover.  The pharmacist tried to contact her physician for medical attention but did not reach the physician.  Follow-up information has been received from a 43 year old asian pharmacist with no known allergies or pertinent medical history who on 11-NOV-2008 was vaccinated IM with a first dose of RECOMBIVAX HB at 15:00.  There was no illness at the time of vaccination.  Subsequently, on 12-NOV-2008 in the afternoon the patient experienced redness, hives and itchy all over her body.  Medical attention was sought, the patient had a doctor's visit.  There were no lab studies performed.  At the time of the report, it was noted that the patient recovered ten days later (21-NOV-2008).  Additional information is not expected.
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Autoimmune hepatitis
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a 39 year old female with variety of ailments (general symptoms) who on unspecified date was vaccinated with a dose of RECOMBIVAX HB.  It was reported that subsequently the patient experienced autoimmune hepatitis.  The patient alleged that the hepatitis B vaccine had caused the autoimmune hepatitis.  The ruling was that "a preponderance of the evidence established that the hepatitis B virus does not cause autoimmune hepatitis."  The patient's physician withdrew the molecular mimicry theory primarily because no evidence showed a homology between parts of the hepatitis B vaccine and liver cells that were attacked by autoimmune hepatitis.  In follow up it was reported that patient had a variety of ailments that predated her hepatitis B vaccinations.  The reporter felt autoimmune hepatitis was not related to therapy with RECOMBIVAX HB.  This is one of several reports received from the same source.  No further information is available.
Sex: F
Vaccine: HEP
Symptoms: Autoimmune hepatitis, Laboratory test abnormal, Liver disorder
Clinical narrative: Information has been received for a case in litigation from information obtained from a published article concerning a female with acne who was vaccinated with a dose of RECOMBIVAX HB. Concomitant therapy included minocycline. Subsequently the patient experienced autoimmune hepatitis. It was reported that the patient had been taking minocycline for approximately 13 months before having an abnormal liver test in August 1997, when she was 40 years old. The reporter felt that autoimmune hepatitis was not related to therapy with RECOMBIVAX HB. It was also reported that "minocycline is know to cause autoimmune hepatitis". This is one of 4 reports from the same source. No further information is available.
Sex: M
Vaccine: HEP
Symptoms: Cerumen impaction, Ear infection, Ear pain, Insomnia, Irritability
Clinical narrative: Information has been received from a medical records via of a health professional concerning a 1 day old male who on 27-APR-2008 was vaccinated with the first dose of RECOMBIVAX HB.  On 27-MAY-2008, the patient was vaccinated with a second dose of RECOMBIVAX HB.  Secondary suspect therapy included the first dose of ROTAVIRUS on 27-JUN-2008 and the second dose on 28-AUG-2008, and, the first dose of HIB CONJ vaccine (OMPC) on 27-JUN-2008 and the second dose on 28-AUG-2008.  Concomitant therapy included PNEUMOCOCCAL vaccine (unspecified), POLIOVIRUS vaccine and DIPHTHERIA TOXOID (+) PERTUSSIS vaccine (unspecified) (+) TETANUS TOXOID.  On 30-APR-2008 the baby had a routine exam and the physician reported that the baby had mildly icteric to shoulders (not noted in the hospital) and had gained excellent weight.  On 11-JUN-2008, it was reported that the baby had experienced rash on face for 1 week, red in ears and neck going onto chest.  No fever.  The mother was instructed to call the physician if baby had fever over 101, if child became worse or rash didn't go way in 1-3 weeks.  On 18-SEP-2008, the baby developed ear infections, built of wax in ears, was pulling at ears, congested, didn't sleep well and was fussy.  Wax was removed bilaterally and both tympanic membranes cleared and mobile.  The baby was diagnosed with upper respiratory infection and otalgia.  This is one of two reports from the same source.  Additional information has been requested.