chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HEP
Symptoms: Candidiasis, Conjunctivitis, Rash, Upper respiratory tract infection
Clinical narrative: Information has been received from a physician, concerning a 1 day old Caucasian male infant (a normal 9 lb 0.2 oz, male infant with no abnormalities or anomalies), who on 10-DEC-2007 was vaccinated with the first dose of RECOMBIVAX HB (manufacturer not specified).  On 21-DEC-2007 the infant was seen for a 2 week check up, and had a nonspecific rash.  On 08-JAN-2008 the infant was seen for a 4 week check up with no findings noted, and was vaccinated with the second dose of RECOMBIVAX HB (manufacturer no specified).  On 21-JAN-2008, the infant, whose brother had an upper respiratory infection (URI) was seen by the physician; his mother expressed concern about his wheezing, and reported "cough, rhinorrhea, congestion for 3 days."  There was no fever.  The physician assessed an upper respiratory infection, and prescribed treatment with a cool mist machine for coughing and saline nasal suction.  On 11-FEB-2008, the infant was seen by the physician for a 2 month check up.  At this visit, the infant was vaccinated with the first dose of ROTATEQ, the first dose of DTAP (manufacturer not specified), the first doe of IPOL (manufacturer not specified), the first dose of PEDVAXHIB (manufacturer not specified), and the first dose of PREVNAR (manufacturer not specified).  On 03-MAR-2008, the infant was seen by the physician, who noted the infant's brother had conjunctivitis; the infant was diagnosed with blepharo conjunctivitis (symptom onset documented as 2 days prior to visit), and thrush.  Treatment included nystatin and sulfacefamide 1.0 % ophthalmic drops.  The outcome of the individual events was not specified.  Additional information is not expected.
Sex: F
Vaccine: HEP, IPV
Symptoms: Candidiasis, Conjunctivitis, Cough, Dermatitis diaper, Dry skin
Clinical narrative: Information has been received from medical records and a health professional concerning a 4 week old female infant with small heart murmur and varicella disease.  The infant's father used tobacco outside not at home.  On 23-OCT-2007 the infant was vaccinated with RECOMBIVAX HB.  Concomitant therapy included PREVNAR, PEDIARIX.  On 23-NOV-2007 patient was seen in the doctor's office for check ups.  The patient had diaper rash and upper respiratory tract infection (URI).  Mother used cod liver oil + DESITIN ointment for rash and it made it worse.  She was prescribed BACTROBAN ointment 30 grams to apply to rash four times a day.  The baby also had mild cough for last three to four days and her skin was dry. Nasal saline gtts with bulb syringe PRN was prescribed for URI.  Patient was to get follow up when she will be two months old.  On 26-DEC-2007 the infant came to doctor's office for check up and she had thrush.  She was prescribed NYSTATINS "BID".  The baby came for her three month check up on 17-JAN-2008.  She had URI and conjunctivitis.  She was treated with CILOXAN two gtts each eye TID for seven days.  Nasal saline gtts with bulb syringe was prescribed for URI.  She was also prescribed RONDEC DMD "30 ml" 0.25 ml PO Q 6 hours PRN.  She was to follow up as needed.  The patient's outcome was unknown.  Additional information has been requested.
Sex: F
Vaccine: HEP, IPV
Symptoms: Upper respiratory tract infection
Clinical narrative: Information has been received from medical records and a health professional concerning a 4 week old female infant with small heart murmur and varicella disease.  The infant's father used tobacco outside not at home.  On 23-OCT-2007 the infant was vaccinated with RECOMBIVAX HB.  Concomitant therapy included PREVNAR, PEDIARIX.  On 23-NOV-2007 patient was seen in the doctor's office for check ups.  The patient had diaper rash and upper respiratory tract infection (URI).  Mother used cod liver oil + DESITIN ointment for rash and it made it worse.  She was prescribed BACTROBAN ointment 30 grams to apply to rash four times a day.  The baby also had mild cough for last three to four days and her skin was dry. Nasal saline gtts with bulb syringe PRN was prescribed for URI.  Patient was to get follow up when she will be two months old.  On 26-DEC-2007 the infant came to doctor's office for check up and she had thrush.  She was prescribed NYSTATINS "BID".  The baby came for her three month check up on 17-JAN-2008.  She had URI and conjunctivitis.  She was treated with CILOXAN two gtts each eye TID for seven days.  Nasal saline gtts with bulb syringe was prescribed for URI.  She was also prescribed RONDEC DMD "30 ml" 0.25 ml PO Q 6 hours PRN.  She was to follow up as needed.  The patient's outcome was unknown.  Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Multiple sclerosis, Paraesthesia
Clinical narrative: Information has been received from a case in litigation concerning a female physician who on 03-SEP-1996, 11-NOV-1996 and 03-APR-1997 was vaccinated with a dose of RECOMBIVAX HB (manufacturer unknown). It was reported that in 1997 the patient experienced an "electric-like shock sensation going down (the) center of (her) back into both feet." The patient's symptoms continued to progress. In 1998 the patient was seen by a neurologist and subsequently was diagnosed with multiple sclerosis. The patient's outcome was not reported. Upon internal review multiple sclerosis is considered to be an other medical event. No further information was available. Follow-up information was received and stated that although the electric-shock sensation occurred in 1997 at the time it was not clear that the patient had multiple sclerosis. As the symptoms continued to progress it became clear that the symptoms that she was suffering from were a result of the disease. The petitioner argued that the statute of limitations should not be applied to her until after her diagnosis in 2003. The special master, however held that "the Act provides a window of three years from 'the first symptoms or manifestation of onset' to file a vaccine related claim" and that because the electric-shock sensation was proven to be a statutory manifestation, her petition, falls outside the realm of the statute of limitations. Upon internal review multiple sclerosis is considered to be an other medical event. No further information was available.
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Hypoaesthesia, Multiple sclerosis
Clinical narrative: Information has been received regarding a case in litigation which was reported in Litigation Report concerning a 48 year old female who in November 1992, was vaccinated with the first dose of RECOMBIVAX HB and received the second dose on 16-DEC-1992. Concomitant medication was not reported. In approximately December 1992, after the second vaccination with RECOMBIVAX HB, the patient sought medical attention for left body and leg numbness. The reporter concluded that "the RECOMBIVAX HB caused the patient's multiple sclerosis." The outcome of the event was not reported. Upon internal review, multiple sclerosis was considered to be an other important medical event. No further information is available.
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Multiple sclerosis
Clinical narrative: Information has been received regarding a case in litigation concerning a 43 year old female with carpal tunnel syndrome and numbness in hand (both at 15 years of age) who on 12-AUG-1992 was vaccinated with the first dose of RECOMBIVAX HB, a second dose was received but date was not specified. Concomitant medication was not reported. Subsequently on an unspecified date, after the second vaccination with RECOMBIVAX HB, the patient developed multiple sclerosis. The reporter concluded that a "biologically plausible theory connected the vaccine with her injury, a logical sequence of cause and effect, and there was a medically appropriate time frame between vaccination and onset." The outcome of the event was not reported. 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: Arthralgia, Movement disorder, Myalgia, Pain in extremity
Clinical narrative: Information has been received from a Nurse Practioner (N.P) concerning a 49 year old female patient with sulfonamide allergy who on 13-MAR-2008 was vaccinated into right deltoid with a first dose of RECOMBIVAX HB (lot # 656876/0874U).  Concomitant therapy included DEPAKOTE.  The reporter reported that patient developed arthalgia in right shoulder after she received the first injection.  The patient continued to have arthalgia one month first injection.  The second injection was not given.  The nurse practioner also reported that patient had myalgia in addition to arthralgia.  The patient called and stated that she had this adverse event for "the last six weeks".  She explained that if she kept her arm stationary, the pain she felt "like a tooth ache".  She needed to move her arm to relieve the apin.  She reported that the pain had decreased.  The event made it painful for her to lie down and to sit still.  She felt pain when she got dressed and performed tasks required for her landscaping job.  Her pain had not decreased when she did her activities.  She had full movements of her arm but pain made some movements prohibitive.  The patient had not recovered.  Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: HEP
Symptoms: Adverse drug reaction
Clinical narrative: Information has been received from a pharmacist concerning a 66 year old female patient who in 1997 or 1998 was vaccinated with a dose of RECOMBIVAX HB. The reporter reported that patient had a reaction to RECOMBIVAX HB and she did not know what the reaction was. She did not have any other information on the patient and the event. The outcome was unknown. Additional information hs been requested.
Sex: U
Vaccine: HEP
Symptoms: Malaise
Clinical narrative: Information has been received from a patient who was vaccinated with a dose of RECOMBIVAX HB.  Subsequently, the patient reported that she fell sick.  She did not know the name of the vaccine.  At the time of this report, the patient's outcome was unknown.  No product quality complaint was involved.  Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Morphoea
Clinical narrative: Information has been received from a mother concerning her daughter who in August 1993, was vaccinated with a first dose of RECOMBIVAX HB (manufacturer unknown).  In January 1994, she was vaccinated with a second dose of RECOMBIVAX HB (manufacturer unknown).  In approximately 1994, several months after the second dose she developed a skin disorder (MORPHIA).  No other symptoms or treatment were reported.  At the time of the report, the outcome was unknown.  This is one of two reports received from the same source.  Additional information has been requested.
Age: 21.0
Sex: M
Vaccine: HEP
Symptoms: Condition aggravated, Hypersensitivity
Clinical narrative: Information has been received from a registered nurse concerning a 21 year old male with a history of yeast of allergy who stated that he had an "allergic reaction" to the yeast in a hepatitis B virus vaccine that he received when he was about 6 years old. The manufacturer of the vaccine is unknown, but the nurse assumed it was hepatitis B virus vaccine. Additional information has been requested.
Age: 27.0
Sex: M
Vaccine: HEP
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood uric acid increased, Gilbert's syndrome, Heart rate increased
Clinical narrative: Initial and follow up information has been received from a physician and from medical records concerning a 27 year old white male physician with gilbert's syndrome, steatosis, hypertension, hyperuricaemia (uric acid: 9.6), hypercholesterolaemia, with a history of hyperuricemian, allergic reaction to RECOMBIVAX HB who in November 1996, December 1996 and May 1997 while in high school was vaccinated with RECOMBIVAX HB (manufacturer unknown).  Concomitant therapy included LISINOPRIL (manufacturer unknown) 10 mg daily, aspirin 81 mg daily, and omega-3 marine triglycerides (fish oil) 1000mg twice daily.  In 2006, his RECOMBIVAX HB titer was done and came back as low.  On 05-MAY-2006 (also reported as 05-MAY-2008) the patient was vaccinated intramuscularly with one dose of RECOMBIVAX HB (lot # 647274/0205P), and within 24-48 hours developed a generalized itchy rash.  There was no illness at time of vaccination.  On 07-MAY-2008 the patient was seen by a physician, for swelling of his right ankle, which was determined to be due to an effusion and an inflammatory process about the tibialis anterior tendon.  An MRI was done on the same date, which showed a tear of the anterior talofibular tendon, and ankle effusion.  He was treated with a CAM walker boot, to be worn as directed as was given a prescription for PERCOCET for pain.  He has improved.  On 22-MAY-2008 the patient had a recheck of his hepatitis B surface antibody which was 1.01, which was just within the immune range that begins at 1.00, other laboratory tests included serum aspartate aminotransferase test (AST): 31, and serum alanine aminotransferase test (ALT) : 85.  The physician reported that the patient was seen on 28-May-2008 for follow up.  The patient denies chest pain, shortness of breath, gastrointestinal (GI) or genito-urinary (GU) complaints.  Physical examination showed a pulse: 88, respirations: 10, blood pressure: 134/90 x2, weigh: 209 pounds, and increase of 2 pounds since April 2008.  Extremities demonstrated a mild effusion of the right ankle.  The physician's impression included: hypertension (uncontrolled) treated with LISINOPRIL (manufacturer unknown) which was increased to 20 mg daily, elevated transaminases (improved) secondary to steatosis; gilbert's syndrome.  The physician reported that a T B skin test (PPD) (manufacturer unknown) was applied to the patient's arm.  The physician's plan was for the patient to have a basic metabolic panel (BMP), lipid profile and liver function tests done in November, when he had his blood pressure rechecked.  The outcome was not reported.  No other information was available.  Additional information is not expected.
Age: 27.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Hypertension, Joint swelling, Nuclear magnetic resonance imaging abnormal, Rash generalised
Clinical narrative: Initial and follow up information has been received from a physician and from medical records concerning a 27 year old white male physician with gilbert's syndrome, steatosis, hypertension, hyperuricaemia (uric acid: 9.6), hypercholesterolaemia, with a history of hyperuricemian, allergic reaction to RECOMBIVAX HB who in November 1996, December 1996 and May 1997 while in high school was vaccinated with RECOMBIVAX HB (manufacturer unknown).  Concomitant therapy included LISINOPRIL (manufacturer unknown) 10 mg daily, aspirin 81 mg daily, and omega-3 marine triglycerides (fish oil) 1000mg twice daily.  In 2006, his RECOMBIVAX HB titer was done and came back as low.  On 05-MAY-2006 (also reported as 05-MAY-2008) the patient was vaccinated intramuscularly with one dose of RECOMBIVAX HB (lot # 647274/0205P), and within 24-48 hours developed a generalized itchy rash.  There was no illness at time of vaccination.  On 07-MAY-2008 the patient was seen by a physician, for swelling of his right ankle, which was determined to be due to an effusion and an inflammatory process about the tibialis anterior tendon.  An MRI was done on the same date, which showed a tear of the anterior talofibular tendon, and ankle effusion.  He was treated with a CAM walker boot, to be worn as directed as was given a prescription for PERCOCET for pain.  He has improved.  On 22-MAY-2008 the patient had a recheck of his hepatitis B surface antibody which was 1.01, which was just within the immune range that begins at 1.00, other laboratory tests included serum aspartate aminotransferase test (AST): 31, and serum alanine aminotransferase test (ALT) : 85.  The physician reported that the patient was seen on 28-May-2008 for follow up.  The patient denies chest pain, shortness of breath, gastrointestinal (GI) or genito-urinary (GU) complaints.  Physical examination showed a pulse: 88, respirations: 10, blood pressure: 134/90 x2, weigh: 209 pounds, and increase of 2 pounds since April 2008.  Extremities demonstrated a mild effusion of the right ankle.  The physician's impression included: hypertension (uncontrolled) treated with LISINOPRIL (manufacturer unknown) which was increased to 20 mg daily, elevated transaminases (improved) secondary to steatosis; gilbert's syndrome.  The physician reported that a T B skin test (PPD) (manufacturer unknown) was applied to the patient's arm.  The physician's plan was for the patient to have a basic metabolic panel (BMP), lipid profile and liver function tests done in November, when he had his blood pressure rechecked.  The outcome was not reported.  No other information was available.  Additional information is not expected.
Age: 27.0
Sex: M
Vaccine: HEP
Symptoms: Rash pruritic, Respiratory rate decreased, Transaminases increased
Clinical narrative: Initial and follow up information has been received from a physician and from medical records concerning a 27 year old white male physician with gilbert's syndrome, steatosis, hypertension, hyperuricaemia (uric acid: 9.6), hypercholesterolaemia, with a history of hyperuricemian, allergic reaction to RECOMBIVAX HB who in November 1996, December 1996 and May 1997 while in high school was vaccinated with RECOMBIVAX HB (manufacturer unknown).  Concomitant therapy included LISINOPRIL (manufacturer unknown) 10 mg daily, aspirin 81 mg daily, and omega-3 marine triglycerides (fish oil) 1000mg twice daily.  In 2006, his RECOMBIVAX HB titer was done and came back as low.  On 05-MAY-2006 (also reported as 05-MAY-2008) the patient was vaccinated intramuscularly with one dose of RECOMBIVAX HB (lot # 647274/0205P), and within 24-48 hours developed a generalized itchy rash.  There was no illness at time of vaccination.  On 07-MAY-2008 the patient was seen by a physician, for swelling of his right ankle, which was determined to be due to an effusion and an inflammatory process about the tibialis anterior tendon.  An MRI was done on the same date, which showed a tear of the anterior talofibular tendon, and ankle effusion.  He was treated with a CAM walker boot, to be worn as directed as was given a prescription for PERCOCET for pain.  He has improved.  On 22-MAY-2008 the patient had a recheck of his hepatitis B surface antibody which was 1.01, which was just within the immune range that begins at 1.00, other laboratory tests included serum aspartate aminotransferase test (AST): 31, and serum alanine aminotransferase test (ALT) : 85.  The physician reported that the patient was seen on 28-May-2008 for follow up.  The patient denies chest pain, shortness of breath, gastrointestinal (GI) or genito-urinary (GU) complaints.  Physical examination showed a pulse: 88, respirations: 10, blood pressure: 134/90 x2, weigh: 209 pounds, and increase of 2 pounds since April 2008.  Extremities demonstrated a mild effusion of the right ankle.  The physician's impression included: hypertension (uncontrolled) treated with LISINOPRIL (manufacturer unknown) which was increased to 20 mg daily, elevated transaminases (improved) secondary to steatosis; gilbert's syndrome.  The physician reported that a T B skin test (PPD) (manufacturer unknown) was applied to the patient's arm.  The physician's plan was for the patient to have a basic metabolic panel (BMP), lipid profile and liver function tests done in November, when he had his blood pressure rechecked.  The outcome was not reported.  No other information was available.  Additional information is not expected.
Sex: M
Vaccine: HEP
Symptoms: Rheumatoid arthritis
Clinical narrative: Information has been received from a mother concerning her son who was vaccinated with a second dose (date unspecified) of RECOMBIVAX HB (manufacturer unknown).  He developed symptoms of rheumatoid arthritis several weeks after the second dose.  No other symptoms or treatment were reported.  At the time of the report, the outcome was unknown.  This is one of two reports received from the same source.  Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Blister, Wrong technique in drug usage process
Clinical narrative: Information has been received from a registered nurse concerning a patient (age and gender unknown), who on 24-JUN-2008 was vaccinated with a dose of RECOMBIVAX HB. The patient was administered one half of an adult dose intramuscularly and one half intradermally. It was reported that the injection met resistance from scar tissue as the vaccine was administered. An unspecified portion of the vaccine surfaced as an intradermal bubble. It was reported that there were no adverse symptoms. At the time of the report, the outcome of the patient was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 52.0
Sex: M
Vaccine: HEP
Symptoms: Disturbance in attention, Irritability, Lethargy
Clinical narrative: Information has been received from a 52 year old male physician who in 1998 was vaccinated IM with a second 0.5 ml dose of RECOMBIVAX HB and became lethargic, irritated, and could not concentrate for one day after the vaccination.  There was no concomitant medication.  The physician stated he did not received the third dose.  He sought unspecified medical attention.  The physician recovered on an unknown date.  Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Cough, Lip swelling, Swelling face
Clinical narrative: Information has been received from pharmacist concerning a patient who on unspecified date was vaccinated with the third dose of RECOMBIVAX HB (Lot number not reported). It was reported that on 2-JUL-2008, the patient experienced coughing and swelling of the face and lips. The patient did not experience any problems with previous RECOMBIVAX vaccinations. The patient sought unspecified medical attention by seeing the physician. At the time of reporting, the patient was recovering. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: HEPA
Symptoms: Dizziness, Electrocardiogram, Fatigue
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of dizziness in a 28-year-old female subject who was vaccinated with HAVRIX. Concurrent medications included oral contraceptives and concurrent vaccination included ADACEL given on 21 August 2007. On 21 August 2007 the subject received 1st dose of HAVRIX at 1 cc in the right deltoid. On 22 August 2007, 1 day after vaccination with HAVRIX (the following morning), the subject experienced dizziness while in the shower. The event resolved the same day with no treatment. The subject did go to her primary care physician regarding the dizziness. An EKG was performed, but was negative. On 4 March 2008 at 09:08, the subject received 2nd dose of HAVRIX at 1cc in the left arm. Six hours after vaccination with the 2nd dose of HAVRIX, at 15:00 on 4 March 2008, the subject developed severe fatigue that improved without treatment. The event had resolved by 5 March 2008. Both event s of dizziness and fatigue were systemic reactions. The healthcare professional considered the events were possibly related to vaccination with HAVRIX.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Blood creatine phosphokinase normal, Chest X-ray normal, Computerised tomogram normal, Electrocardiogram normal, Full blood count normal
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of near fainting in a 13-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline), GARDASIL. The subject's medical history included MRSA infection of the skin. On 2 February 2008 at 09:30 the subject received 2nd dose of HAVRIX (.5 ml, left arm) and the 1st dose of GARDASIL. On 2 February 2008, 12 hours after vaccination with GARDASIL and HAVRIX, the subject experienced near fainting, low blood pressure and rapid heartbeat. The subject was seen in the emergency room. At the time of reporting the outcome of the events were unspecified. On 28 February 2008 follow-up was received via the healthcare professional. She reported that on 02 February 2008, the subject experienced near fainting, low blood pressure and rapid heartbeat. The events resolved on 08 February 2008. On 11 February 2008, diagnostic test for influenza, CBC, ESR and CPK were normal. A CT scan of the head, chest x-ray and EKG were also normal. She considered that the events were not serious and she considered that the events were possibly related to the use of HAVRIX. She also stated that she was unsure which product were suspect.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Heart rate increased, Hypotension, Influenza serology negative, Metabolic function test normal, Mononucleosis heterophile test negative
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of near fainting in a 13-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline), GARDASIL. The subject's medical history included MRSA infection of the skin. On 2 February 2008 at 09:30 the subject received 2nd dose of HAVRIX (.5 ml, left arm) and the 1st dose of GARDASIL. On 2 February 2008, 12 hours after vaccination with GARDASIL and HAVRIX, the subject experienced near fainting, low blood pressure and rapid heartbeat. The subject was seen in the emergency room. At the time of reporting the outcome of the events were unspecified. On 28 February 2008 follow-up was received via the healthcare professional. She reported that on 02 February 2008, the subject experienced near fainting, low blood pressure and rapid heartbeat. The events resolved on 08 February 2008. On 11 February 2008, diagnostic test for influenza, CBC, ESR and CPK were normal. A CT scan of the head, chest x-ray and EKG were also normal. She considered that the events were not serious and she considered that the events were possibly related to the use of HAVRIX. She also stated that she was unsure which product were suspect.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Presyncope, Red blood cell sedimentation rate normal
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of near fainting in a 13-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline), GARDASIL. The subject's medical history included MRSA infection of the skin. On 2 February 2008 at 09:30 the subject received 2nd dose of HAVRIX (.5 ml, left arm) and the 1st dose of GARDASIL. On 2 February 2008, 12 hours after vaccination with GARDASIL and HAVRIX, the subject experienced near fainting, low blood pressure and rapid heartbeat. The subject was seen in the emergency room. At the time of reporting the outcome of the events were unspecified. On 28 February 2008 follow-up was received via the healthcare professional. She reported that on 02 February 2008, the subject experienced near fainting, low blood pressure and rapid heartbeat. The events resolved on 08 February 2008. On 11 February 2008, diagnostic test for influenza, CBC, ESR and CPK were normal. A CT scan of the head, chest x-ray and EKG were also normal. She considered that the events were not serious and she considered that the events were possibly related to the use of HAVRIX. She also stated that she was unsure which product were suspect.
Age: 1.3
Sex: M
Vaccine: DTIPV, HEPA
Symptoms: Injection site urticaria, Rash, Skin test negative, Urticaria, Viral infection
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of rash in a 15-month-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). Concurrent medical conditions included otitis media. Previous and/or concurrent vaccination included DT and IPV; manufacturer unspecified given on an unspecified date. Concurrent medications included TRIPEDIA and Amoxicillin trihydrate (Amoxicillin). On 24 February 2008, the subject received 1st dose of HAVRIX (intramuscular, right thigh). On 26 January 2008, at an unspecified time after vaccination with HAVRIX, the subject experienced rash on his groin, trunk and legs. The subject was seen in the emergency department but not treated. The subject was treated with BENADRYL after consulting his physician. At the time of reporting, the outcome of the event was unspecified. The healthcare professional considered the event was possibly related to vaccination with HAVRIX. Follow-up information received via the original reporter and an allergist on 22 April 2008 indicated that the events may have started within one day of receiving HAVRIX and DT and IPV. The dates still reveal a two day onset. The child was an allergist on 28 March 2008 at the age of 17 months following the onset of generalized urticaria and hives beginning at the injection sites on both sides and spreading to cover his entire body on 26 January 2008. He did not have systemic symptoms and the hives resolved with BENADRYL treatment after about three days. Since that time, the child remained well. A skin test with DPT, DT and tetanus toxoid and the hepatitis A vaccine performed on 28 March 2008 gave negative reactions by prick and intradermal testing with a good positive histamine control. There was no evidence of an allergic reaction to any of the vaccine components. The subject has just finished a course of amoxicillin (date not specified) just before he received his vaccines and it was suggested that the events may have been a delayed reaction to the amoxicillin. It was also suggested that the events my have been the result of a viral infection. The events remained resolved at the time of reporting.
Sex: M
Vaccine: HEPA
Symptoms: Lethargy, Liver disorder, Lung disorder, Pyrexia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of high fever in an adult male subject who was vaccinated with HAVRIX (GlaxoSmithKline).  On 5 February 2008 the subject received unspecified dose of HAVRIX (unknown).  At an unspecified time after vaccination with HAVRIX, the subject experienced high fever (103), lethargy, a liver disorder and a lung disorder (the physician felt that the vaccine attacked the subject's liver and lungs).  At the time of reporting, the subject was still off of work.  The outcome of the events was unspecified.  Limited follow-up information indicated that additional information concerning this report will be provided pending lab results (unspecified).
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Body temperature increased, Pyrexia, Sleep terror, Vaccination complication
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of night terrors in a 2-year-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline).  Concurrent medications included ZITHROMAX.  The subject has a history of reactive airway disease/asthma and AMOXICILLIN allergy.  The subject had sinusitis just prior to 1st vaccination with HAVRIX and the 1st night terror.  On 22 February 2007 at 10:00 the subject received 1st dose of HAVRIX at 0.5 ml in the left arm.  That night, on 22 February 2007, less than one day after vaccination with HAVRIX, the subject experienced night terror which resolved the same day.  On 27 February 2008 at 10:00 the subject received 2nd dose of HAVRIX at 0.5 ml in the left arm.  That night, on 27 February 2008, less than one day after vaccination with 2nd dose of HAVRIX, the subject experienced night terror and a fever of 103.6 degrees F.  The subject was given TYLENOL and the fever resolved the next morning on 28 February 2008.  The night of 28 February 2008, the subject experienced a 2nd night terror.  They then resolved.  Follow-up information was received on 04 April 2008 from the nurse.  Diagnosis was vaccine reaction.  The vaccine reaction, night terrors, and fever resolved on 29 February 2008.  The nurse considered the events were possibly related to vaccination with HAVRIX.  The nurse did not believe the events could have been associated with medical history/concurrent illness, lack of efficacy, erroneous administration, suspected transmission of an infectious agent via a medicinal product, or any other unspecified reason.
Age: 1.2
Sex: F
Vaccine: HEPA
Symptoms: Pyrexia, Rash
Clinical narrative: This case was reported by a physician via a sales represented and a health care professional and described the occurrence of rash in a 15-month-old  female subject who was vaccinated with HAVRIX (GlaxoSmithKline). There were no concurrent medications. On the morning of 14 May 2008 the subject received 1st dose of HAVRIX at 0.5ml (720 elisa units) in the left thigh. There hours after vaccination with HAVRIX, the subject experienced rash on her stomach and legs. The subject also developed a fever of 99.1 the subject was treated with  Benadryl. At the time of reporting the outcome of the events was unspecified. Follow-up information received on 09 June 2008 indicated that the events of rash and fever resolved. In the reporter's opinion, the events were possibly related to treatment with HAVRIX.
Age: 18.0
Sex: F
Vaccine: HEPA
Symptoms: Neck pain, Pain, Product quality issue
Clinical narrative: This case was reported by a consumer (also the subject) and described the occurrence of shooting pain up the neck in a 18-year-old female subject who was vaccinated with HEPATITIS A vaccine (manufacturer unspecified).  A physician or other health care professional has not verified this report.  Co-suspect medication included Cyanocobalamin (Vitamin B 12).  On 6 May 2008 at 13:15 the subject received 2nd dose of HEPATITIS A vaccine in the left arm.  During the injection with HEPATITIS A vaccine, the subject experienced a shooting pain up her neck that lasted for a little while after the injection, but resolved the same day.  The subject experienced a systemic reaction.  The reporter was concerned about the red coloring of the injectable.  This was considered to be a product complaint.  At the time of reporting the outcome of the events was unspecified.  Additional information provided on 09 May 2008 indicated that the injection that was red in color may have actually been the vitamin B12 injection and not the HEPATITIS A injection.  The events may have been in response to the vitamin B12 injection.  Follow-up information was received on 28 MAY 2008 via a consumer (also the subject), who reported that she now realizes that the shooting pain she experienced was due to a Vitamin B 12 injection, not the HEPATITIS A vaccine.  The consumer/subject stated that she was able to identify the injection which caused the pain by the color of the vaccine.  The subject indicated that she did not contact her physician about the event, and did not provide any physician contact information.
Age: 41.0
Sex: F
Vaccine: HEPA
Symptoms: Headache, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: This case was reported by a healthcare professional, via a sale representative, and described the occurrence of swollen gland in a 41-year-old female subject who was vaccinated with HAVRIX 1440 for prophylaxis. On 30 April 2008 the subject received 1st dose of HAVRIX 1440 (unknown). On 3 May 2008, three days after vaccination with HAVRIX 1440, the subject experienced swollen glands, headache, body pain and low grade fever. The subject was vaccinated at a travel clinic. The reporting travel clinic nurse recommended that the subject be seen at a physician's office. At the time of reporting, the events were unresolved.
Age: 47.0
Sex: M
Vaccine: HEPA, TDAP, TYP
Symptoms: Injection site erythema, Injection site irritation, Injection site pruritus
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site redness in a 47-year-old male subject who was vaccinated with HAVRIX 1440 (GlaxoSmithKline), ADACEL.  Concurrent medical conditions included motion sickness.  Previous and/or concurrent vaccination included TYPHIM VI vaccine given on 7 January 2008.  On 7 January 2008 at 17:00 the subject received 1st dose of HAVRIX 1440 (unknown, right arm), On 7 January 2008 the subject received unspecified dose of ADACEL (unknown, anterior portion of right arm).  On 7 January 2008, 29 days after vaccination with HAVRIX 1440 and ADACEL, the subject experienced injection site redness with a dime sized area of irritation around it.  On 31 March 2008, it was quarter sized with redness and itching.  At the time of reporting the outcome of the events were unspecified.  Follow-up information received on 26 June 2008 indicated that the outcome of the vents was unknown.  The reporter felt that the events were related to treatment with HAVRIX.  The onset date of the events was not known, however, the events were reported on 05-February 2008.  Havrix and concurrent TYPHIM VI were administered intramuscularly and the dose of each was 0.5 ml.  Adacel was also given intramuscularly.
Age: 45.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Diarrhoea, Fatigue, Somnolence
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of diarrhea in a 45-year-old female subject who was vaccinated with HAVRIX for prophylaxis. Concurrent vaccination given on 15 February 2008 included the 2nd dose of RECOMBIVAX. Previous vaccinations given on 4 January 2008 included the 1st dose of HAVRIX; and the 1st dose of RECOMBIVAX. On 15 February 2008, the subject received 2nd dose of HAVRIX (unknown). At an unspecified time after vaccination with HAVRIX, the subject experienced diarrhea, drowsiness and tiredness. Per the reporting nurse, the subject contacted her and inquired what she could do for drowsiness and tiredness, and how long the symptoms would last. The reporting nurse had no documentation of the vaccinations, as the subject did not received the vaccines at her facility. At the time of reporting, the diarrhea was resolved, but the drowsiness and tiredness were unresolved. Follow-up information was received on 29 May 2008 via a nurse, who reported that she referred the subject back to her physician for follow-up. No further information was received on 29 May 2008 via a nurse, who reported that she referred the subject back to her physician for follow-up. No further information was provided.
Age: 45.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Breath odour, Diarrhoea, Dizziness, Fatigue, Inappropriate schedule of drug administration
Clinical narrative: This case was reported by a consumer and described the occurrence of dizziness in a 45-year-old female subject who was vaccinated with HAVRIX, (GlaxoSmithKline).  A physician or other health care professional has not verified this report.  Concurrent vaccination included RECOMBIVAX HB (manufacturer unspecified) given on 8 February 2008.  There were no concurrent medications.  On 8 February 2008 the subject received 2nd dose of HAVRIX at 1.0 ml in an unknown arm.  This was considered to be an inappropriate schedule of drug administration as the 2nd dose of HAVRIX was administered earlier than recommended.  One day after vaccination with HAVRIX, on the morning of 8 February 2008, the subject experienced dizziness, diarrhea, tiredness and noted that her urine had an odor, similar to when she takes penicillin.  The dizziness resolved two weeks later, diarrhea improved and tiredness worsened.  On the day of reporting, 3 April 2008 the subject noted a funny smell while brushing her teeth.  The outcome of the urine odor and funny smell while brushing teeth was not reported.
Age: 45.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Urine odour abnormal
Clinical narrative: This case was reported by a consumer and described the occurrence of dizziness in a 45-year-old female subject who was vaccinated with HAVRIX, (GlaxoSmithKline).  A physician or other health care professional has not verified this report.  Concurrent vaccination included RECOMBIVAX HB (manufacturer unspecified) given on 8 February 2008.  There were no concurrent medications.  On 8 February 2008 the subject received 2nd dose of HAVRIX at 1.0 ml in an unknown arm.  This was considered to be an inappropriate schedule of drug administration as the 2nd dose of HAVRIX was administered earlier than recommended.  One day after vaccination with HAVRIX, on the morning of 8 February 2008, the subject experienced dizziness, diarrhea, tiredness and noted that her urine had an odor, similar to when she takes penicillin.  The dizziness resolved two weeks later, diarrhea improved and tiredness worsened.  On the day of reporting, 3 April 2008 the subject noted a funny smell while brushing her teeth.  The outcome of the urine odor and funny smell while brushing teeth was not reported.
Age: 29.0
Sex: F
Vaccine: HEPA
Symptoms: HIV test positive, Laboratory test interference
Clinical narrative: This case was reported by a physician and described the occurrence of laboratory test interference in a female subject in her late 20's who was vaccinated with HAVRIX, (GlaxoSmithKline).  On an unspecified date the subject received unspecified dose of HAVRIX (1 ml, unknown).  It was unknown if other vaccinations were given on the same day as HAVRIX.  Three weeks after vaccination with HAVRIX, the subject tested positive for HIV.  The physician was concerned about any possible laboratory test interference on the HIV test due to the HAVRIX vaccination.  At the time of reporting the possible laboratory interference was unresolved.  The outcome of testing positive for HIV was unspecified.  The physician considered the possible laboratory interference was possibly related to vaccination with HAVRIX.  The causality for testing positive for HIV was unspecified.
Age: 27.0
Sex: F
Vaccine: HEPA
Symptoms: HIV test negative, Laboratory test abnormal
Clinical narrative: This case was reported by a consumer and described the occurrence of abnormal laboratory test value in a 27-year-old female subject who was vaccinated with HAVRIX for prophylaxis. A physician or other health care professional has not verified this report. The reported was the subject's mother. At the end of January 2008 the subject received 2nd dose of HAVRIX (unknown). The pharmacy told the subject that she had received HAVRIX. At an unspecified time after vaccination with HAVRIX, the subject "recently" took a HIV test and it "came up inconclusive". At the time of reporting the outcome of the event was unspecified.
Age: 1.2
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Anorexia, Incorrect dose administered, Pyrexia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of low grade fever in a 1-year-old female subject who was vaccinated with HAVRIX 1440, (GlaxoSmithKline), MMR vaccine, VARICELLA vaccine, PREVNAR.  There were no concurrent medications.  On 19 March 2008 the subject received 1st dose of HAVRIX 1440 (unknown, left arm), 1st dose of MMR vaccine (unknown, left arm), 1st dose of VARICELLA vaccine (unknown), 4th dose of PREVNAR (unknown).  On 19 March 2008, in the afternoon, the subject experienced inappropriate dose of vaccine administered since the child received an adult dose of HAVRIX.  On an unspecified date, at an unspecified time after vaccination with HAVRIX 1440, MMR vaccine, PREVNAR and VARICELLA vaccine, the subject experienced low grade fever and loss of appetite.  The low grade fever was diagnosed by touch not by thermometer.  Medical attention was in the form of a phone conversation with a nurse.  At the time of reporting the outcome of the events of low grade fever and loss of appetite was unspecified.  The healthcare professional considered the events of low grade fever and loss of appetite were possibly related to vaccination with HAVRIX 1440, MMR vaccine, VARICELLA vaccine and PREVNAR.  Follow-up information received on 29 April 2008, via healthcare professional, who reported the outcome of the events continued to be unknown.
Age: 20.0
Sex: F
Vaccine: HEPA, TTOX
Symptoms: Hyperhidrosis
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of sweating in a 20-year-old female subject who was vaccinated with HAVRIX 1440 for prophylaxis. Previous and/or concurrent vaccination included diphtheria and tetanus toxoids adsorbed; unknown given on 20 March 2008. Subject reported that her skin always feels sweaty when she does not eat or drink. On 20 March 2008 at 12:45 the subject received 1st dose of HAVRIX 1440 (unknown, right arm). On 20 March 2008, immediately after vaccination with HAVRIX 1440, the subject's skin was sweaty. She was given something to eat and drink and she was fine. On 20 March 2008, the event was resolved. Follow-up information received on 15 April 2008 indicated that the event was considered by the reporter to be possibly related to treatment with HAVRIX.
Age: 65.0
Sex: M
Vaccine: DT, HEPA
Symptoms: Injection site reaction, Rash papular, Rash pruritic
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of pruritic papular rash in a 65-year-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). The subject's medical history included allergy to morphine. Concurrent medical conditions included gastroesophageal reflux disease, high blood pressure, high cholesterol. Previous and/or concurrent vaccination included DECAVAC; Sanofi; unknown; left arm given on 28 February 2008. Concurrent medications included Atenolol, LIPITOR and PROTONIX. On 28 February 2008 the subject received 1st dose of HAVRIX (1 ml, intramuscular, left deltoid). On 9 March 2008, 10 days after vaccination with HAVRIX, the subject experienced pruritic papular rash. The subject received HAVRIX and DECAVAC injections one inch apart in the same arm. The subject was treated with BENADRYL. At the time of reporting, the injection site reaction was improved. The healthcare professional considered the injection site reaction as probably related to vaccination with HAVRIX since this was his first hepatitis A vaccine and the injection had never experienced a reaction with the tetanus vaccine. Follow-up information was received on 21 April 2008, via nurse, who reported the injection site reaction resolved on 13 March 2008. The reporting nurse considered the event possibly related to vaccination with HAVRIX.
Sex: F
Vaccine: HEPA
Symptoms: Paraesthesia
Clinical narrative: This case was reported by a consumer and described the occurrence of tingling feet in an adult female subject who was vaccinated with HAVRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of HAVRIX (unknown). At an unspecified time after vaccination with HAVRIX, the subject experienced tingling feet. At the time of reporting the outcome of the event was unspecified. The consumer reported that she did not know if it was related to taking the vaccine. Additional information was provided regarding this case on 26 March 2008. The actual Hepatitis A vaccine received by the subject was not known (manufacturer unspecified). The subject was given Hepatitis A vaccine and experienced problems with her feet approximately 5 to 6 weeks later. She indicated that her doctor did not know the cause of her symptoms and she was not sure it was vaccine related. No additional details were provided.