chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.08
Sex: M
Vaccine: DTAPH, DTAPHEPBIP, HEPAB, PNC, RV5
Symptoms: Body temperature normal, Ear infection, Irritability, Rash, Upper respiratory tract infection
Clinical narrative: Information has been received from a physician via medical recovered concerning a 2 month old male with exposure to GARDASIL (WAES #0807USA03843) and formula intolerance who on 19-FEB-2008 was vaccinated with the first dose of ROTATEQ (lot #657516/1128U). Concomitant therapy included PREVNAR, VERO, PEDIARIX, TRIHIBIT and TWINRIX. On 04-MAR-2008 office notes indicated that the patient had been trying different formulas to see which one he would tolerate the best however the rash seems to be little worse. He had an upper respiratory infection on approximately 01-MAR-2008 "last week" with some nebulizer treatments and seemed to improve however his riling and wheezing started again on 04-MAR-2008. Mild expiratory wheezes noted especially in the right upper lobe. The notes indicated that they would continue with the breathing treatments and continue to monitor the rash. They will continue to adjust formula until they find one he tolerates a little better. On 13-April-2008 the patient was vaccinated with the second dose of ROTATEQ (lot #660374/0275X). On 08-AUG-2008 the patient was vaccinated with the second dose ROTATEQ (lot #660845/0289X). On 08-AUG-2008 office notes indicated that the patient had a recent ear infection and was treated with AMOXIL BID. Additional information not expected.
Age: 0.08
Sex: M
Vaccine: DTAPH, DTAPHEPBIP, HEPAB, PNC, RV5
Symptoms: Wheezing
Clinical narrative: Information has been received from a physician via medical recovered concerning a 2 month old male with exposure to GARDASIL (WAES #0807USA03843) and formula intolerance who on 19-FEB-2008 was vaccinated with the first dose of ROTATEQ (lot #657516/1128U). Concomitant therapy included PREVNAR, VERO, PEDIARIX, TRIHIBIT and TWINRIX. On 04-MAR-2008 office notes indicated that the patient had been trying different formulas to see which one he would tolerate the best however the rash seems to be little worse. He had an upper respiratory infection on approximately 01-MAR-2008 "last week" with some nebulizer treatments and seemed to improve however his riling and wheezing started again on 04-MAR-2008. Mild expiratory wheezes noted especially in the right upper lobe. The notes indicated that they would continue with the breathing treatments and continue to monitor the rash. They will continue to adjust formula until they find one he tolerates a little better. On 13-April-2008 the patient was vaccinated with the second dose of ROTATEQ (lot #660374/0275X). On 08-AUG-2008 the patient was vaccinated with the second dose ROTATEQ (lot #660845/0289X). On 08-AUG-2008 office notes indicated that the patient had a recent ear infection and was treated with AMOXIL BID. Additional information not expected.
Age: 0.41
Sex: F
Vaccine: RV5
Symptoms: Abdominal pain, Croup infectious, Culture stool positive, Diarrhoea, Ear infection
Clinical narrative: Information has been received from a registered nurse concerning a 12 month old female patient with  pertinent medical history and known drug allergies or reactions who on 10-APR-2008, 01-JUL-2008 and -02-SEP-2008 was vaccinated with the first, second and third PO dose of ROTATEQ (lot # 657980/0106X, 660550/0616X, 660876/0304X) respectively. There was no concomitant medication. On 16-FEB-2009 the patient experienced ear infection and the croup. The patient was treated with Augmentin, Orapred and Albuterol. On 06-MAR-2009 the patient developed rotovirus. The patient experienced fever, diarrhea, yellow stool, no vomiting and abdominal pain. The patient was treated with Tylenol and Motrin for the fever by the mother and recommended to get Donnatal, Mylicon drops and biogaia by the prescriber. The stool culture was performed which showed positive for rotavirus and negative for WBC. On 16-MAR-2009, the patient recovered. Additional information has been requested.
Age: 0.41
Sex: F
Vaccine: RV5
Symptoms: Faeces discoloured, Pyrexia, Rotavirus infection
Clinical narrative: Information has been received from a registered nurse concerning a 12 month old female patient with  pertinent medical history and known drug allergies or reactions who on 10-APR-2008, 01-JUL-2008 and -02-SEP-2008 was vaccinated with the first, second and third PO dose of ROTATEQ (lot # 657980/0106X, 660550/0616X, 660876/0304X) respectively. There was no concomitant medication. On 16-FEB-2009 the patient experienced ear infection and the croup. The patient was treated with Augmentin, Orapred and Albuterol. On 06-MAR-2009 the patient developed rotovirus. The patient experienced fever, diarrhea, yellow stool, no vomiting and abdominal pain. The patient was treated with Tylenol and Motrin for the fever by the mother and recommended to get Donnatal, Mylicon drops and biogaia by the prescriber. The stool culture was performed which showed positive for rotavirus and negative for WBC. On 16-MAR-2009, the patient recovered. Additional information has been requested.
Age: 0.36
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a certified medical assistant (C.M.A.) concerning a 17 week old female who on 22-JAN-2009 was vaccinated orally with a first dose of ROTATEQ "after the 6-12 weeks of age". No adverse effects reported. The patient sought medical attention at physician's office. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Dehydration, Diarrhoea
Clinical narrative: Information has been received from a registered nurse concerning a 9 month old male who on 20-AUG-2008, 20-OCT-2008 and 17-DEC-2008 was vaccinated orally with a first, second and third dose of ROTATEQ (lot # 660376/0019X, 661037/0641X and 662884/1127X, respectively). It was reported that on 04-FEB-2009 the patient was seen by nurse and brought to emergency room and was diagnosed of diarrhea and dehydration. Reporter did not specify if the patient was admitted in the hospital. Emergency room demographics unspecified. On an unknown date, the patient recovered from diarrhea and dehydration. Follow-up information was received from the R.N. on 26-MAR-2009 which reported that the patient was not admitted in hospital. No further information is available.
Age: 0.34
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Diarrhoea, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a certified medical assistant concerning a 16 week old male who on 22-JAN-2009 was vaccinated with the first dose of ROTATEQ (lot # not provided)  On 20-MAR-2009 the patient received the second dose of ROTATEQ twice.  This infant is a twin.  The patient was not experiencing any known symptoms.  Follow up information received on 28-MAY-2009 from a certified medical assistant stated that it was a white patient with mile soy protein intolerance and a history of pulmonary branch stenosis, born at 34 weeks (premature), who on 20-MAR-2009 at 16:15 was vaccinated with two doses of ROTATEQ, orally (lot # 1160X, valid for PREVNAR.  On the same date at 16:15 the patient was also vaccinated with a second dose of poliovirus vaccine inactivated (unspecified) (manufacturer unknown) (lot # A1229-2), intramuscularly into the left thigh, a second dose of DAPTACEL, (lot # C308AA), intramuscularly into the right thigh and a second dose of ACTHIB (lot # DUFS11AA) IM into the left thigh.  Another dose of ACTHIB with lot #VUFU67AA was also listed.  Additional vaccinations received at the same time and date included a second dose of PREVNAR (lot # C7197S), intramuscularly into the right thigh.  On 26-MAR-2009, the patient experienced 5-6 loose watery stools daily; the patient was treated with diet changes and PEDIALYTE SOLUTION).  No laboratories studies performed.  The patient recovered in 1-2 days, date of recovery listed as 27-MAR-2009 to 28-MAR-2009.  No further information is available.
Age: 0.21
Sex: F
Vaccine: HEPA
Symptoms: Aggression, Breath holding, Erythema, Grunting, Inappropriate schedule of drug administration
Clinical narrative: This case was reported by a consumer (the subject's mother) and described the occurrence of off label use in a 2-month-old female subject who was vaccinated with HAVRIX, (GlaxoSmithKline).  A physician or other health care professional has not verified this report.   On an unknown date in 2009 the subject accidentally received 1st dose of HAVRIX (details unknown) at 2 months of age instead of PNEUMOCOCCAL vaccine (wrong vaccine administered).  The subject was younger than the recommended age of administration for HAVRIX (off-label use).  Less than one year after vaccination with HAVRIX, the subject experienced tension in arm, bright red face, breath holding, grunting, pain, change in sleeping pattern and temper tantrums.  After receiving HAVRIX, the reporter noticed her daughter would tense her right arm straight in the air and get frozen in position.  At the same time her daughter's face would get bright red and she would hold her breath and grunt like she was in pain.  The reporter states she can help her daughter relax her arms by stretching her out and then the facial redness goes away after she relaxes.  She also states her sleeping pattern has changed.  Prior to receiving the vaccine she slept well but now she does not sleep well at night or during the day.  She is not sure if she relates the sleeping pattern change to receiving HAVRIX or just her being an infant and having sleeping pattern change all the time.  The physician told her he felt the tensing episodes were the beginning of temper tantrums.  She states at first they noticed these events occurring when she was tired but they have gotten worse and more frequent.  At the time of reporting the events were worse.  At the time of reporting the subject was 4.5 months old.  The reporter did not want to provide any further details at this time.
Age: 0.21
Sex: F
Vaccine: HEPA
Symptoms: Pain, Sleep disorder, Tension, Wrong drug administered
Clinical narrative: This case was reported by a consumer (the subject's mother) and described the occurrence of off label use in a 2-month-old female subject who was vaccinated with HAVRIX, (GlaxoSmithKline).  A physician or other health care professional has not verified this report.   On an unknown date in 2009 the subject accidentally received 1st dose of HAVRIX (details unknown) at 2 months of age instead of PNEUMOCOCCAL vaccine (wrong vaccine administered).  The subject was younger than the recommended age of administration for HAVRIX (off-label use).  Less than one year after vaccination with HAVRIX, the subject experienced tension in arm, bright red face, breath holding, grunting, pain, change in sleeping pattern and temper tantrums.  After receiving HAVRIX, the reporter noticed her daughter would tense her right arm straight in the air and get frozen in position.  At the same time her daughter's face would get bright red and she would hold her breath and grunt like she was in pain.  The reporter states she can help her daughter relax her arms by stretching her out and then the facial redness goes away after she relaxes.  She also states her sleeping pattern has changed.  Prior to receiving the vaccine she slept well but now she does not sleep well at night or during the day.  She is not sure if she relates the sleeping pattern change to receiving HAVRIX or just her being an infant and having sleeping pattern change all the time.  The physician told her he felt the tensing episodes were the beginning of temper tantrums.  She states at first they noticed these events occurring when she was tired but they have gotten worse and more frequent.  At the time of reporting the events were worse.  At the time of reporting the subject was 4.5 months old.  The reporter did not want to provide any further details at this time.
Age: 26.0
Sex: F
Vaccine: HEPA, HPV4, TDAP
Symptoms: Incorrect dose administered, Injection site erythema, Injection site pain, Injection site reaction, Local reaction
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of extra dose administered in a 26-year-old female subject who was vaccinated with HAVRIX, (GlaxoSmithKline), ADACEL.  Concurrent medical conditions included elevated cholesterol.  Previous vaccination included booster 2nd dose of HAVRIX, (GlaxoSmithKline) given 1 year ago in 2008.  Concurrent vaccination included GARDASIL, (non-GSK manufacturer; unknown) given on 28 July 2009.  Concurrent medications included Oral contraceptive.  On 28 July 2009 the subject inadvertently received 3rd dose of HAVRIX (1440 iu, unknown route, left arm) and an extra dose of ADACEL (left arm).  On 29 July 2009, 1 day after vaccination with ADACEL and HAVRIX, the subject experienced localized reaction on the left arm of injection site redness and injection site pain.  There was no fever or shortness of breath.  It was reported that the subject also received extra dose of GARDASIL (administration site unknown).  At the time of reporting the outcome of the events was unspecified.  Follow-up information received on 21 August 2009 indicated that the resolved by 31 July 2009.  The reported felt that the events were probably related to treatment with HAVRIX.
Age: 0.4
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician concerning a 24 weeks old female patient who on approximately 01-DEC-2008 was vaccinated with first dose of ROTATEQ (lot# not reported). On 24-MAR-2009 she received second dose of ROTATEQ (lot# not reported). The child was no experiencing any known symptoms. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a patient who on 09-JAN-2009 was vaccinated with the first dose of ROTATEQ (lot number and route not reported).  On 26-MAR-2009 the patient was in the office to receive the 2nd dose.  No adverse effect reported.  Additional information has been requested.
Age: 0.3
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse (L.P.N.) concerning a 22 week old female who on 31-MAR-2009 was vaccinated with a first dose of ROTATEQ (lot# not reported). The patient sought an unspecified medical attention. No adverse effects noted. Additional information has been requested.
Age: 0.2
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 15 week old patient who on an unspecified date was vaccinated with a first dose of ROTATEQ (lot # not reported).  The patient sought an unspecified medical attention.  No adverse effects noted.  Additional information has been requested.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Constipation, Cough, Erythema, Eye discharge, Eyelid oedema
Clinical narrative: Pediatric medical records has been received from a physician's office concerning a male patient with poor weight gain and a history of premature birth who on 31-OCT-2008 was vaccinated orally with a first dose of ROTATEQ (lot # 660878/0502X) (expiration date November 2009).  Concomitant vaccinations on the same day included a first dose of PEDIARIX (lot # AC21B198BA) (expiration date January 2011) in the left thigh (LT) and a dose of PREVNAR (lot # C99098) (expiration date April 2011) in the right thigh (RT).  On 30-DEC-2008, the patient was vaccinated orally with a second dose of ROTATEQ (lot # 662652/1272X) (expiration date May 2010).  Concomitant vaccinations on the same day included a second dose of PEDIARIX (lot # AC21B198BA) (expiration date January 2011) in the left thigh (LT), a second dose of PREVNAR (lot # C87310) (expiration date April 2011) in the right thigh (RT) and a first dose of ACTHIB (lot # UF519AB) (expiration date August 2010) in the right thigh (RT).  On 19-JAN-2009, the patient experienced low lid swollen/puffy and eye with yellow/green drainage.  The patient was prescribed medication (therapy illegible), gtts QID X 7 days.  On 09-FEB-2009 the patient experienced fever (101) and cough.  It was reported that the fever decreased with TYLENOL.  On approximately 13-FEB-2009, the patient experienced fussy, spitting, constipation, and right drum red and bulging.  The patient was prescribed AMOXIL 1/2 teaspoon PO BID X 10 days, rest and fluids.  At the time of the report, the patient's status was unknown.  On 03-MAR-2009, the patient was vaccinated orally with a third dose of ROTATEQ (lot # 663263/1489X) (expiration date August 2010).  Concomitant vaccinations on the same day included a third dose of PEDIARIX (lot # AC21B198BA) (expiration date March 2011) in the left thigh (LT), a third dose of PREVNAR (lot # D07543) (expiration date May 2011) in the right thigh (RT) and a second dose of ACTHIB (lot # UF547AC) (expiration date November 2010).  Additional information has been requested.  WAES # 0904USA00095 is associated to WAES # 0806USA03426.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Infantile spitting up, Irritability, Pyrexia, Tympanic membrane disorder
Clinical narrative: Pediatric medical records has been received from a physician's office concerning a male patient with poor weight gain and a history of premature birth who on 31-OCT-2008 was vaccinated orally with a first dose of ROTATEQ (lot # 660878/0502X) (expiration date November 2009).  Concomitant vaccinations on the same day included a first dose of PEDIARIX (lot # AC21B198BA) (expiration date January 2011) in the left thigh (LT) and a dose of PREVNAR (lot # C99098) (expiration date April 2011) in the right thigh (RT).  On 30-DEC-2008, the patient was vaccinated orally with a second dose of ROTATEQ (lot # 662652/1272X) (expiration date May 2010).  Concomitant vaccinations on the same day included a second dose of PEDIARIX (lot # AC21B198BA) (expiration date January 2011) in the left thigh (LT), a second dose of PREVNAR (lot # C87310) (expiration date April 2011) in the right thigh (RT) and a first dose of ACTHIB (lot # UF519AB) (expiration date August 2010) in the right thigh (RT).  On 19-JAN-2009, the patient experienced low lid swollen/puffy and eye with yellow/green drainage.  The patient was prescribed medication (therapy illegible), gtts QID X 7 days.  On 09-FEB-2009 the patient experienced fever (101) and cough.  It was reported that the fever decreased with TYLENOL.  On approximately 13-FEB-2009, the patient experienced fussy, spitting, constipation, and right drum red and bulging.  The patient was prescribed AMOXIL 1/2 teaspoon PO BID X 10 days, rest and fluids.  At the time of the report, the patient's status was unknown.  On 03-MAR-2009, the patient was vaccinated orally with a third dose of ROTATEQ (lot # 663263/1489X) (expiration date August 2010).  Concomitant vaccinations on the same day included a third dose of PEDIARIX (lot # AC21B198BA) (expiration date March 2011) in the left thigh (LT), a third dose of PREVNAR (lot # D07543) (expiration date May 2011) in the right thigh (RT) and a second dose of ACTHIB (lot # UF547AC) (expiration date November 2010).  Additional information has been requested.  WAES # 0904USA00095 is associated to WAES # 0806USA03426.
Age: 0.2
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician concerning an 18 week old patient who on 01-APR-2009 was vaccinated with the first PO dose of ROTATEQ.  No adverse symptoms were reported.  It is unknown if the patient sought medical attention.  Additional information has been requested.
Age: 1.04
Sex: F
Vaccine: HEPA, PNC, VARCEL
Symptoms: Joint swelling, Oedema peripheral, Rash, Swelling face
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of facial rash in a 1-year-old female subject who was vaccinated with HAVRIX, GlaxoSmithKline. Concurrent medical conditions included anemia, ear infection and upper respiratory infection. Concurrent vaccination included PREVNAR, Wyeth and VARIVAX, Merck both given on 16 January 2009. Concurrent medications included Amoxicillin and Poly-Vi-Sol. On 16 January 2009 the subject received 1st dose of HAVRIX at 0.5ml in the right thigh. On 17 January 2009, one day after vaccination with HAVRIX, the subject experienced facial rash and arm rash in the morning and had swelling of face, hand swelling and ankle swelling by evening. The subject was seen in the emergency room and was treated with BENADRYL and steroids. At the time of reporting the outcome of the events was unspecified. Follow-up information was received on 24 March 2009 from the reporting nurse. On 19 January 2009, the events resolved. The reporting nurse considered the events were possibly related to vaccination with HAVRIX.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Diarrhoea, Faeces discoloured
Clinical narrative: Information has been received from a nurse practitioner concerning a 6 month old female who was vaccinated with first dose of ROTATEQ.  The patient did not have adverse reaction with the first dose.  The patient was vaccinated with the second 2ml dose of ROTATEQ.  The patient experienced diarrhea and developed green stool after receiving the second dose.  At the time of this report, the patient was recovering.  The patient sought medical attention from a nurse practitioner.  Follow-up information has been received from nurse practitioner concerning the 17 week old white female with no illness at time of vaccination and no pre-existing allergies, birth defects or medical conditions who on 09-DEC-2008, at 14:10, was vaccinated with the first dose of ROTATEQ (lot # 661685/0967X) and on 03-FEB-2009, at 14:41, the patient was vaccinated with the second dose of ROTATEQ (lot #: 660926/0308X).  Other concomitant therapy received at the same date included the first dose of PENTACEL into the left thigh and the first dose of PREVNAR into the right thigh on 09-DEC-2009 and the second dose of PENTACEL into the left thigh and the first dose of PREVNAR into the right thigh on 03-FEB-2009.  It was reported that the patient was vaccinated with the first dose of hepatitis B vaccine, recomb (MSD) on 02-OCT-2008 and the second dose of hepatitis B vaccine, recomb (MSD) into her left thigh at 14:23, on 04-NOV-2008.  On 03-FEB-2009 the patient experienced large watery diarrhea and green stool for two months.  No relevant lab test was performed.  Subsequently, in May 2009, the patient recovered.  On 19-MAY-2009, at 15:13, the patient was vaccinated with the third dose of ROTATEQ (lot #: 663142/1462X).  No further information is available.
Sex: F
Vaccine: DTAPHEPBIP, HEPA, PNC, RV5
Symptoms: Rash, Wrong drug administered
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of rash in a 2-month-old female subject who was vaccinated with HAVRIX, (GlaxoSmithKline), PEDIARIX, ROTATEQ and PREVNAR.  On 26 January 2009 the subject inadvertently received 1st dose of HAVRIX (.5 ml, unknown, left thigh) instead of DTAP (wrong vaccine administered).  On 26 January 2009, the subject also received 1st dose of PEDIARIX, 1st dose of ROTATEQ and 1st dose of PREVNAR.  On 26 January 2009, less than one day after vaccination with HAVRIX, PEDIARIX, PREVNAR and ROTATEQ, the subject experienced rash.  Upon physical examination of the infant after administration of HAVRIX, PEDIARIX, ROTATEQ and PREVNAR, the physician's assistant and the subject's parent noticed a rash on the infant's face.  The infant's mother reported that the rash was not there prior to the administration of the vaccines.  At the time of reporting the rash was unresolved, but did not require medical attention.  The healthcare professional considered the events were possibly related to vaccination with HAVRIX, PEDIARIX, ROTATEQ and PREVNAR.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with the first and second dose of ROTATEQ (Lot numbers not reported) and each time after receiving the vaccine the patient developed diarrhea. The patient had not yet received th third dose. On unspecified dates the patient recovered from the events. Follow up information has been received from a physician concerning a 17 week old female patient (weight 24 lb and height 30 in) with no pertinent medical history and no known drug allergies, who on 04-FEB-2009 was orally vaccinated with the second dose of ROTATEQ (lot: 62953/1652X). On 11-APR-2009, the patient received the third dose of ROTATEQ (Lot: 663711/0107Y) orally. On an unspecified date after the patient received the second dose and third doses the patient experienced diarrhea. Subsequently, the patient recovered from diarrhea one day after each episode. Additional information is not expected.
Age: 0.53
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Rotavirus test positive
Clinical narrative: Information has been received from a physician concerning a 7 month old male who on 02-DEC-2008, 02-FEB-2009 and 09-MAR-2009 was vaccinated orally with first dose (lot number 660682/0574X), second dose (lot number 661736/0690X) and third dose (lot number 663260/1794X) respectively of ROTATEQ. The physician reported that the patient came into the office on 09-APR-2009 for a follow up visit regarding the patient's unspecified congestion; the physician reported that it was unknown if the patient was congested after received any of the ROTATEQ doses. The patient's mother reported to the physician that her son had been experiencing diarrhea. The physician then did a rotavirus test on the patient and the test came positive for rotavirus. The physician reported that the patient's mother was given hydration information and he changed the patient's formula. The physician report that he had not heard back from the mother, so he does not know how the patient is doing. Additional information has been requested.
Age: 0.08
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, Irritability, Vaccination error
Clinical narrative: This case was reported by a physician and described the occurrence of maladministration (asymptomatic/ child too young) in a 1-month-old female subject who was vaccinated with HAVRIX, (GlaxoSmithKline).  There were no concurrent medications.  On 11 February 2009 the subject inadvertently received 1st dose of HAVRIX.  This was considered to be a maladministration (asymptomatic/child too young) as HAVRIX is not indicated for use in subjects under the age of 12 months.  An unspecified amount of time following vaccination with HAVRIX, the subject became fussy.  At the time of reporting the outcome of the events was unspecified.
Sex: F
Vaccine: HEPA
Symptoms: Anaphylactic reaction
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of anaphylactic reaction in a female subject of unspecified age who was vaccinated with HAVRIX (GlaxoSmithKline). On an unspecified date the subject received 2nd dose of HAVRIX (unknown). At an unspecified time after vaccination with HAVRIX, the subject experienced anaphylactic reaction. The healthcare professional considered the event was life threatening. The subject was treated with BENADRYL. At the time of reporting the outcome of the event was unspecified.
Sex: F
Vaccine: HEPA
Symptoms: Incorrect route of drug administration, Injection site pain
Clinical narrative: This case was reported by a pharmacist and described the occurrence of pain during injection in a female subject of unspecified age who was vaccinated with HAVRIX 1440, (GlaxoSmithKline).  On an unspecified date the subject received unspecified dose of HAVRIX 1440 (right arm).  Immediately after vaccination with HAVRIX 1440, the subject experienced pain during injection and intramuscular formulation administered by other route.  A pharmacy student received a call from a subject at the pharmacy  stating that their HAVRIX vaccine had been administered subcutaneously.  It was painful while it was being administered and he believes it has been bothering her since.  At the time of reporting the outcome of the pain during injection was unspecified.
Age: 4.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Accidental overdose, Incorrect dose administered, Injection site haemorrhage
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site bleeding spot in a 4-year-old female subject who was vaccinated with HAVRIX, (GlaxoSmithKline).  Concurrent vaccination included MMR II (Merck) and VARIVAX (Merck) both given on 25 March 2009.  There were no concurrent medications.  On 25 March 2009 at 14:00 the subject inadvertently received an adult dose of HAVRIX in the left arm for the 2nd dose.  On 25 March 2009, at an unspecified time after vaccination with HAVRIX, the subject experienced injection site bleeding spot and an unintentional overdose.  She should have received a pediatric dose of HAVRIX.  At the time of reporting the events were resolved.  Follow-up information was received on 13 April 2009 from the reporting medical assistant.  The events resolved.  The medical assistant considered the events were related to vaccination with HAVRIX.  The medical assistant considered that the events could have been associated with erroneous administration: wrong dose.
Age: 53.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Diarrhoea, Nausea, Toothache, Vomiting
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of diarrhea in a 53-year-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). Concurrent medical conditions included elevated cholesterol and thyroid problem. Previous and/or concurrent vaccination included ADACEL (non-gsk); Sanofi Pasteur given on 23 March 2009. Concurrent medications included Simvastatin, CYTOMEL, SYNTHROID and DIOVAN. On 23 March 2009 the subject received 1st dose of HAVRIX (unknown, left arm). On the morning of 24 March 2009, 1 day after vaccination with HAVRIX, the subject experienced diarrhea, nausea, vomiting and thought he was coming down with the flu. The same morning, he also experienced teeth hurting. At the time of reporting, teeth hurting was resolved; The diarrhea, nausea and vomiting improved; The outcome of possible flu was unspecified. The healthcare professional considered the diarrhea, nausea, vomiting and teeth hurting were possibly related to vaccination with HAVRIX. Follow-up information was received on 13 April 2009 from the reporting medical assistant. The events resolved on 26 March 2009. The medical assistant considered the events were possibly related to vaccination with HAVRIX. The medical assistant considered that the events could have been associated with medical history/concurrrent illness of possible coincidental concurrent viral illness.
Sex: F
Vaccine: HEPA
Symptoms: Antibody test negative, No therapeutic response
Clinical narrative: This case was reported by a physician and described the occurrence of not responding to therapy in a female subject of unspecified age who was vaccinated with HAVRIX, (GlaxoSmithKline).  Concurrent medications included METHOTREXATE.  On an unspecified date, the subject received 1st dose of HAVRIX (unknown).  Three weeks after vaccination with HAVRIX, the subject experienced not responding to therapy.  She experienced a negative antibody titer three weeks after one dose of HAVRIX was administered.  Relevant test results included (laboratory results/hospital investigations).
Age: 67.0
Sex: M
Vaccine: HEPA
Symptoms: Paraesthesia
Clinical narrative: This case was reported by a consumer and described the occurrence of tingling over body in a 67-year-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medications included LIPITOR and SYNTHROID. On 17 August 2009 at 14:00 the subject received 1st dose of HAVRIX (unknown). On 1 September 2009, 15 days after vaccination with HAVRIX, the subject experienced tingling over body. At the time of reporting, the tingling over body was unresolved. The consumer (the subject) reported that approximately two weeks after receiving a HAVRIX injection he experienced body tingling. The subject noted that the tingling was primarily in his arms and legs. The subject reported that he had consulted with a healthcare professional concerning the tingling over his body. At the time of reporting, the subject had not received the second dose of HAVARIX in the series.
Age: 5.0
Sex: M
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: This case was reported by a physician and described the occurrence of hives in a 5-year-old male subject who was vaccinated with HAVRIX, (GlaxoSmithKline).  There were no concurrent medications.  On 27 August 2008 the subject received 1st dose of HAVRIX (unknown).  In September 2008, at an unspecified time after vaccination with HAVRIX, the subject experienced hives.  The subject was treated with BENADRYL on 11 September 2008.  The subject consulted a health care professional regarding the event.  At the time of reporting the outcome of the event was resolved.  On 19 October 2009, a physician reported that a subject experienced hives after receiving HAVRIX.  The subject was not allergic to eggs.  He was given BENADRYL on 11 September 2008.  His hives lasted for one month.  In 2009, the subject received FLUZONE and broke out in hives two days after receiving via a prefilled syringe.  Follow up information was received on 30 October 2009.  The physician did not have any details to add to this case and requested that the case be closed.  Follow up information was received on 16 November 2009 via the reporting physician.  The physician had "nothing else to add".
Sex: F
Vaccine: HEPA
Symptoms: Drug administration error, No therapeutic response, Vaccination error
Clinical narrative: This case was reported by a physician (parent of the subject) and described the occurrence of not responding to therapy in a female subject of unspecified age who was vaccinated with Hepatitis A vaccine, (manufacturer unspecified).  On an unspecified date the subject received unspecified dose of Hepatitis A vaccine (unknown), and experienced not responding to therapy, vaccination error and laboratory error.  The physician reported that his daughter, who had received a Hepatitis A vaccination in the past, had an antibody test performed which showed she needed another dose.  The physician did not know which Hepatitis A vaccine had been given.  The physician wanted information on the accuracy of antibody tests, and wanted to know if additional doses were recommended after vaccination series.  The physician felt "it may have been an administration error on the administration of the vaccine or the antibody detection's testing laboratory error."  The physician was not willing to provide any information, nor did he want to be followed up with.  The physician stated that he did not have any additional information to offer.  This is one of two cases by this physician; see case A0814449A for not responding to therapy for an unknown number of subjects.
Sex: F
Vaccine: HEPA
Symptoms: Gastrointestinal disorder
Clinical narrative: This case was reported by an unknown source and described the occurrence of reaction gastrointestinal in a female subject of unspecified age who was vaccinated with Hepatitis A vaccine, manufacturer unspecified), Hepatitis B vaccine.  Concurrent medical conditions included celiac disease.  On an unspecified date the subject received unspecified dose of Hepatitis A vaccine (unknown), unspecified dose of Hepatitis B vaccine (unknown).  At an unspecified time after vaccination with Hepatitis A vaccine and Hepatitis B vaccine, the subject experienced reaction gastrointestinal.  A female subject with "a kind of" celiac disease reported that she was given Hepatitis A vaccine and Hepatitis B vaccine, which she believed were GSK bran vaccines.  The subject reported that she had some sort of gastrointestinal (GI) reaction.  The subject inquired about GSK vaccines and gluten content.  At the time of reporting the outcome of the reaction gastrointestinal was unspecified.
Sex: U
Vaccine: HEPA
Symptoms: Vaccination failure
Clinical narrative: This case was reported by a physician and described the occurrence of not responding to therapy in an unknown number of subjects of unspecified age and gender who was vaccinated with Hepatitis A vaccine, manufacturer unspecified. On an unspecified date the subjects received unspecified dose of Hepatitis A vaccine (unknown), and experienced not responding to therapy. The physician stated that he knew of other physicians who had done antibody testing on subjects after Hepatitis A vaccinations series where the antibody tests did not show antibodies. This is one of two cases by this physician; see case A0813885A for not responding to therapy, vaccination error and laboratory error in a female subject.
Age: 11.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site nodule, Injection site pain, Scab, Skin lesion
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of bump at injection site in an 11-year-old female subject who was vaccinated with HAVRIX, (GlaxoSmithKline).  On 11 March 2009, at an unspecified time after vaccination with HAVRIX, the subject experienced bump at injection site, pink around injection site, painful to touch and crusted lesion.  At the time of reporting the bump at injection site, pink around injection site, injection site pain and crusted lesion were unresolved.  The healthcare professional considered the bump at injection site, pink around injection site, injection site pain and crusted lesion were probably related to vaccination with HAVRIX.  The lot number was reported as AKAVE140AC.  The healthcare professional reported that an 11 year old subject received her first HAVRIX vaccination on 11 March 2009.  The reporter could not read the subject's medical record, and was unable to determine very much from what was provided to her by the subject's father.  The subject developed a pink bump at the injection site that was painful to the touch and seemed to be crusty on top.  The subject's family denied any drainage from the lesion.  Follow up information was received on 23 November 2009 via the reporting nurse practitioner.  The subject did not use alcohol or tobacco.  Onset date of earliest sign or symptom was reported as an unspecified date in March 2009.  The nurse practitioner did not consider the events to be serious.  The nurse practitioner reported that it was unknown if the events could have been associated with erroneous administration.  A biopsy was not performed.
Age: 69.0
Sex: F
Vaccine: HEPA
Symptoms: Antibody test negative, No therapeutic response
Clinical narrative: This case was reported by a pharmacist and described the occurrence of not responding to therapy in a 71-year-old female subject who was vaccinated with HAVRIX, (GlaxoSmithKline).  Concurrent medical conditions included possible cirrhosis and sulfa allergy.  Concurrent vaccination included RECOMBIVAX, (Sanofi Pasteur MSD) given on an unspecified date.  Concurrent medications included PRAVASTATIN and LIBRAX.  On 5 October 2007 and 20 March 2008 the subject received 1st dose and 2nd dose of HAVRIX (1440 units, unknown route, unknown deltoid).  On an unknown date in 2009 (in the past 2-3 months), the subject experienced negative antibodies (not responding to therapy).  A physician from a liver institute called the reporter to inquire about these results.
Age: 1.07
Sex: F
Vaccine: HEPA
Symptoms: Injection site rash, Injection site reaction
Clinical narrative: This case was reported by a healthcare professional via other manufacturer sales representative and described the occurrence of injection site rash in a child female subject who was vaccinated with HAVRIX, (GlaxoSmithKline).  On 15 December 2008, the subject received 1st dose of HAVRIX (unknown, left thigh).  At an unspecified time after vaccination with HAVRIX, the subject experienced injection site rash.  The subject was treated with steroids.  At the time of reporting the event was resolved.  The nurse in the office reported to a sales representative (Merck) that a subject had an injection site reaction after vaccination with a vaccine manufactured by GSK.  The subject developed a rash over injection site of her left thigh.  She was prescribed topical steroids.
Age: 26.0
Sex: M
Vaccine: HEPA
Symptoms: Tinnitus
Clinical narrative: This case was reported by a consumer and described the occurrence of tinnitus in a 26-year-old male subject who was vaccinated with HAVRIX, (GlaxoSmithKline).  A physician or other health care professional has not verified this report.  On 19 June 2009, the subject received 1st dose of HAVRIX (unknown).  On 19 June 2009 or the next day, at an unspecified time after vaccination with HAVRIX, the subject experienced tinnitus.  At the time of reporting the event was unresolved.  The reporter was calling on behalf of his brother to report the symptoms and did not have the prescriber or office information available during the report.
Age: 0.3
Sex: F
Vaccine: HEPA, MMR, PNC
Symptoms: Accidental exposure, Inappropriate schedule of drug administration, Pyrexia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of fever in a 4-month-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline), rotavirus vaccine (non-gsk), DTaP, haemophilus influenzae type b vaccine (non-gsk), pneumococcal vaccine (non-gsk) and poliomyelitis vaccine inactivated (non-gsk). Previous and/or concurrent vaccination included MMR vaccine (non-gsk); Merck given on 29 June 2009; pneumococcal vaccines (non-gsk); Wyeth Labs; unknown given on 29 June 2009. On an unspecified date the subject received unspecified dose of Rotavirus vaccine (Non-GSK) (unknown). Unspecified dose of DTaP (unknown), unspecified dose of Haemophilus influenzae type b vaccine (Non-GSK) (unknown), unspecified dose of Pneumococcal vaccines (Non-GSK) (unknown), unspecified dose of Poliomyelitis vaccine inactivated (Non-GSK) (unknown). At an unspecified time after vaccination with DTaP and Hib (Non-GSK), PCV (Non-GSK), IPV (Non-GSK) and RV (Non-GSK), the subject experienced fever. The subject became febrile after four month immunization with "RV, DTaP, Hib, PCV and IPV". On 29 June 2009 at 15:45 the subject received 1st dose of HAVRIX (unknown, right thigh) and experienced inadvertent overdose (asymptomatic). Pediatric subject received adult dose of HAVRIX. At the time of reporting the outcome of the fever and inadvertent overdose (asymptomatic) were unspecified.
Age: 8.0
Sex: F
Vaccine: HEPA
Symptoms: Hyperhidrosis, Morphoea, Scleroderma, Skin lesion, Skin odour abnormal
Clinical narrative: This case was reported by a consumer and described the occurrence of morphea in a female subject of unspecified age who was vaccinated with HAVRIX, GlaxoSmithKline, (non-gsk) FLUZONE vaccine. Concurrent medical conditions included seasonal allergy. On 9 August 2005 and 16 august 2006 the subject received 1st dose and 2nd dose of HAVRIX (unknown, left thigh). On 4 September 2007 the subject received unspecified dose of FLUZONE (unknown). At an unspecified time after vaccination with HAVRIX, the subject experienced morphea, and scleroderma. At an unspecified time after vaccination with FLUZONE, the subject experienced sweating profusely, peculiar body odour and lesions nos. The subject's mother first thought that the issue was due to abrasions from the subject's cleats. The subject was diagnosed with scleroderma morphea in 2007, but her mother noticed the lesions before this time. The subject received FLUZONE on 04 September 2007, went to practice and started sweating profusely and developed an unusual body odor that lasted three months. She also broke out in additional scleroderma morphea lesions. At the time of reporting, the scleroderma morphea was unresolved, unusual body odor was resolved, sweating profusely and scleroderma morphea lesions were unspecified.
Age: 17.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Accidental overdose, Feeling abnormal, Headache, Hypoaesthesia, Injection site pain
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of arm numbness in a 17-year-old female subject who was vaccinated with HAVRIX adult, GlaxoSmithKline. There was no relevant medical history. Concurrent vaccination included MENACTRA (non-gsk) ; Sanofi Pasteur MSD given on 13 July 2009. Concurrent medications included Yasmin and Claritin. On 13 July 2009 at 14:45 the subject received 1st dose of HAVRIX (1ml, unknown, left arm). The subject experienced accidental overdose as she received an adult dose by mistake. On 13 July 2009, less than one day after vaccination with HAVRIX adult, the subject experienced left arm numbness from elbow down, strange feeling in hands and palm, injection site soreness and stiffness around injection site and headache. She was seen at the doctor's office at 19:40 hours. At the time of reporting the outcome was unspecified.
Age: 17.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Musculoskeletal stiffness
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of arm numbness in a 17-year-old female subject who was vaccinated with HAVRIX adult, GlaxoSmithKline. There was no relevant medical history. Concurrent vaccination included MENACTRA (non-gsk) ; Sanofi Pasteur MSD given on 13 July 2009. Concurrent medications included Yasmin and Claritin. On 13 July 2009 at 14:45 the subject received 1st dose of HAVRIX (1ml, unknown, left arm). The subject experienced accidental overdose as she received an adult dose by mistake. On 13 July 2009, less than one day after vaccination with HAVRIX adult, the subject experienced left arm numbness from elbow down, strange feeling in hands and palm, injection site soreness and stiffness around injection site and headache. She was seen at the doctor's office at 19:40 hours. At the time of reporting the outcome was unspecified.
Age: 0.1
Sex: M
Vaccine: RV5
Symptoms: Regurgitation
Clinical narrative: Information has been received from a medical assistant concerning an 8 week old male who on an unspecified date was vaccinated with ROTATEQ. It was reported that the patient was given ROTATEQ and regurgitated it and the patient was given another dose of ROTATEQ. At the time of reporting the patient's outcome was not reported. Unspecified medical attention was sought. Follow up information was received on 02-JUN-2009 from the physician's office explaining that they do not have any further information regarding this event. Additional information is not expected.
Age: 1.65
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 19 month old patient who on 09-APR-2009 was vaccinated with a first dose of ROTATEQ (lot # not reported). It was reported that the patient was given the vaccine past 32 weeks of age. No adverse reactions reported.
Age: 0.94
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician concerning an 11 month old (currently 16 month old) male with a history of diaper rash who on 19-NOV-2008 was vaccinated with a third dose of ROTATEQ vaccine (lot # not reported). It was reported that the patient received the vaccination while he was greater than 32 weeks old. It was unknown if there was any relevant laboratory data. As of 13-APR-2009 it was unknown if the child will continue to receive ROTATEQ vaccine and it was unknown if he was experiencing any adverse reactions. Additional information has been requested.