chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.19
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a 10 week old male with no pertinent medical history or drug allergies who on 17-FEB-2009 was vaccinated with the second dose of RECOMBIVAX HB (lot #: 662421/1040X) and the first dose of ROTATEQ (lot #: 661358/1522X). On 18-FEB-2009 the patient developed rash at injection site. It was reported that some lesions were papular and others resembled hives. The patient was seen in the office on 24-FEB-2009, the rash was not recovered at that time. It was reported that the patient received his first dose of RECOMBIVAX HB in the hospital after birth. Follow up information was received from a registered nurse (R.N.) and medical records reported that the patient was a 10 weeks old male with no pre-existing allergies, birth defects, medical conditions who on 10-DEC-2008 and 17-FEB-2009 was vaccinated intramuscularly in his right upper thigh with a first and second dose of RECOMBIVAX HB (lot# 662421/1040X). Secondary suspect vaccination included a first dose of ROTATEQ (lot# 661358/1522X) given orally on 17-FEB-2009. Concomitant therapy included a first dose of PREVNAR (lot# D07543) vaccinated intramuscularly in his left lower thigh and a first dose of PENTACEL (lot# C3186AA) vaccinated intramuscularly in his left upper thigh on 17-FEB-2009. There was no illness at the time of vaccination. On 18-FEB-2009 the patient developed whole body rash which was possibly erythema multiforme. On 04-MAR-2009 the patient went to ER accompanied by his parents, with a chief complaint of fever. The patient was in H until that day at noon, when FOC felt he was warmer than normal. His temperature was 100.4. The patient was more fussy at that day than before, only additional associated symptom was rash which was discrete, erythematous lesions, initially on face and all four extremities, it was only found on extremities at that day. No central clearing, almost urticarial in appearance. No evidence of super infection. The patient appeared alert and interactive, grossly nonfocal. Urine analysis and urine culture were performed but the results were pending. The diagnosis was fever. The patient's parents insisted on leaving despite discussion of risk of possible underlying urine infection. At the time of reporting, the events persisted. Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal discomfort, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a medical assistant concerning a 38 year old female patient who on 23-JAN-2009 was vaccinated with the first dose of RECOMBIVAX HB and on 23-FEB-2009 received IM the second 0.5 mL dose of RECOMBIVAX HB (LOT # 662115/1263X thimerosal free). Approximately two hours after receiving the second dose of hepatitis B vaccine, the patient experienced stomach upset. The patient was seen by the physician. It is unknown if the patient recovered. It was also reported that on the same date two other patients were vaccinated and experienced the same adverse event. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal discomfort
Clinical narrative: Information has been received from a medical assistant concerning a 27 year old female patient who on 23-JAN-2009 was vaccinated with the first dose of RECOMBIVAX HB and on 23-FEB-2009 received IM the second 0.5 mL dose of RECOMBIVAX HB (LOT # 662115/1263X thimerosal free). Approximately two hours after receiving the second dose of hepatitis B vaccine, the patient experienced stomach upset. The patient was seen by the physician. It is unknown if the patient recovered. It was also reported that on the same date two other patients were vaccinated and experienced the same adverse event. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Hypotonia, Inappropriate schedule of drug administration, Muscle disorder
Clinical narrative: Information has been received from a registered nurse concerning her approximately 1 day old son with many unspecified allergies and no previous medical history reported, who "the day after birth", on 30-DEC-1998 was vaccinated with the first dose of RECOMBIVAX HB along with the other routine vaccines. Then a month later, on approximately 30-JAN-1999, the patient received the second dose of RECOMBIVAX HB and then received the third dose, two months later, on approximately 20-MAR-1999 and after each dose the patient started to get worse. Then after many different test's, the patient was diagnosed with a muscle disorder called hypotania, and has been going through therapy to help his condition. The mother reported that the patient has been doing better because of therapy. On unspecified date, the patient had various tests done (unspecified and results not provided). The patient sought physician's medical attention. No further information is available.
Sex: F
Vaccine: HEP
Symptoms: Constipation, Respiratory tract congestion, Upper respiratory tract infection
Clinical narrative: Information has been received from a physician via medical records concerning an 16 day old female patient who on 23-APR-2008 was vaccinated with first dose of Hepatitis B vaccine (manufacturer unknown). On approximately 08-SEP-2008 the baby had some constipation, well child care PRN was suggested. On 30-Oct-2008 the patient was vaccinated with a second dose of Hepatitis B vaccine (manufacturer unknown). Concomitant therapy included a dose of (CRM197) PREVNAR and a dose of PENTACEL. On 01-JAN-2009 the patient experienced congested. On 05-JAN-2009 the patient was taken to visit the physician and was diagnosed with upper respiratory tract infection which persisted at that time. At the same date, the baby was vaccinated with a dose of PENTACEL, PREVENAR. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Arthritis, Connective tissue disorder, Neck pain, Pyrexia
Clinical narrative: Information has been received from a lawyer regarding a case in litigation which was reported, concerning a 43 year old female with pharyngitis streptococcal and had a generic background to develop autoimmunity who on 08-MAY-1998 was vaccinated with a third dose of RECOMBIVAX HB (manufacturer unknown). It was reported that one month later the patient received the vaccine, she complained of pain in the right knee and neck, a rash and a low-grade fever and saw the physician. Three theories were reported by the physician in this case to describe patient's autoimmune process to explain the reaction to the vaccine. The physician reported that the vaccine whose purpose was to enhance the immune reaction but, in this case, overstimulated it, and failed to develop antibodies to the vaccine but still reacted to the shot. The physician's preferred diagnosis for the patient was nonspecific arthritis, an undefined connective tissue disease, He also mentioned that patient had seronegative rheumatoid arthritis because of the absence of positive rheumatoid factor, or "epitope spreading" where the immune system developed autoantibodies or antibodies toward a part of molecule in the vaccine that was similar to the individual's own body, in this case the enzyme polymerase. The special master reported that all of those mentioned theories by the physician were plausible. Another physician reported that patient had elevated white blood count (WBC) but was not sure of the significance of the elevated WBC. The patient's outcome was unknown. No other information is available.
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Rash, Rheumatoid arthritis, Rheumatoid factor negative, White blood cell count increased
Clinical narrative: Information has been received from a lawyer regarding a case in litigation which was reported, concerning a 43 year old female with pharyngitis streptococcal and had a generic background to develop autoimmunity who on 08-MAY-1998 was vaccinated with a third dose of RECOMBIVAX HB (manufacturer unknown). It was reported that one month later the patient received the vaccine, she complained of pain in the right knee and neck, a rash and a low-grade fever and saw the physician. Three theories were reported by the physician in this case to describe patient's autoimmune process to explain the reaction to the vaccine. The physician reported that the vaccine whose purpose was to enhance the immune reaction but, in this case, overstimulated it, and failed to develop antibodies to the vaccine but still reacted to the shot. The physician's preferred diagnosis for the patient was nonspecific arthritis, an undefined connective tissue disease, He also mentioned that patient had seronegative rheumatoid arthritis because of the absence of positive rheumatoid factor, or "epitope spreading" where the immune system developed autoantibodies or antibodies toward a part of molecule in the vaccine that was similar to the individual's own body, in this case the enzyme polymerase. The special master reported that all of those mentioned theories by the physician were plausible. Another physician reported that patient had elevated white blood count (WBC) but was not sure of the significance of the elevated WBC. The patient's outcome was unknown. No other information is available.
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Nervous system disorder, No reaction on previous exposure to drug, Pain in extremity
Clinical narrative: Information has been received from a registered nurse concerning a 52 year old female with LISINOPRIL (WAES#: 0903USA02280) and PENICILLIN allergy and dialysis who on 24-JAN-2009 was vaccinated IM with a 40mcg dose of HEP B vaccine into the left deltoid. 1 week later, the patient developed a sore arm. The patient went to her physician to have it examined and the physician stated the patient had a "nerve spasm" possibly related to the HEP B vaccine that she was given. The nurse stated "the physician informed the patient that the HEP B vaccine may have crystallized in the vial and then it was given to the patient." The nurse stated she did not see any crystallization in the vaccine vial when it was administered. Nurse also reported that this was not the first time this patient was given HEP B vaccine and she has never had a reaction in the past. As of 11-MAR-2009 the patient's nerve spasm was not recovered. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Chills, Syncope
Clinical narrative: Information has been received from a pharmacy student concerning a patient who on an unknown date was vaccinated with RECOMBIVAX HB. It was reported that the patient experienced syncope and shivering after administration of RECOMBIVAX HB. No further information is available.
Age: 0.08
Sex: M
Vaccine: HEP
Symptoms: Candidiasis, Conjunctivitis, Constipation, Cough, Crying
Clinical narrative: Information has been received from a physician via pediatric medical records concerning a 2 month old male (birth weight 6 pounds 7 ounces) with no known drug allergies who on 10-JUL-2008 (1 month old) was vaccinated with the first dose of RECOMBIVAX HB (lot # 655871/057OU). On 11-AUG-2009 the patient was in the office for well child check. The physician's impression was thrush, constipation with lots of crying and irritability. Nystatin, 100,000/dose, 2 dose daily PO was prescribed. Formula changed and guided stools for 3 times. On 11-AUG-2008, the patient was vaccinated with TRIPEDIA (lot # C2935AA) and IPOL (lot #A0127) into the right thigh; the first dose of PREVNAR (lot #C80884) into the left thigh; the first dose of ROTATEQ (lot #660289/1888U) PO. On 29-SEP-2008 the patient was in the office with complaint with increased irritability, decreased appetite, cranking, fever (temp 101 degree), running nose and cough. The patient was fed Tylenol. The physician's impression was upper respiratory infection (URI).  Treatment with Tylenol, 100/package every 4 hours and Amoxicillin, 250/package, 1 package BID for 5 days was prescribed. On 10-OCT-2008 the 4 month old patient was in the office and was noted teething, drooling, a rash on head and scalp with several erythematous patches. On 10-OCT-2008, the patient was vaccinated with the first dose of PEDIARIX (lot #AC21B150AA) IM into the right thigh; the second dose of ACTHIB (lot # UF454AA) and the second dose of PREVENAR (lot# C65046) IM into the left thigh; the second dose of RECOMBIVAX HB (lot # 660880/0923X) PO. On 17-NOV-2008 the patient was in office with complaint with coughing for 3 days and irritability. The physician's impression was cough and probably teething. Tylenol was prescribed as necessary. On 14-JAN-2009 the patient was in office with complaint with discharge from left eye for 5 days. pulling left ear and no fever. The physician's impression was conjunctivitis. The physician prescribed Amoxicillin suspension, 250mg/5ml, 3ml q12h PO for 10 days and Tylenol PRN. On 24-FEB-2009 the patient was in office and vaccinated with the second dose of PEDIARIX (lot #AC21B150AA) and the third dose of PREVENAR (lot # D03124) IM into the right thigh; the third dose of ACTHIB (lot # UF505AB) IM into the left thigh; the third dose of ROTATEQ (lot # 661579/0899X) PO. It was reported previously that when the patient's mother was pregnant, she was vaccinated with HPV (WAES # 0711USA02981). Additional information is not expected.
Age: 0.08
Sex: M
Vaccine: HEP
Symptoms: Decreased appetite, Drooling, Drug exposure during pregnancy, Ear discomfort, Eye discharge
Clinical narrative: Information has been received from a physician via pediatric medical records concerning a 2 month old male (birth weight 6 pounds 7 ounces) with no known drug allergies who on 10-JUL-2008 (1 month old) was vaccinated with the first dose of RECOMBIVAX HB (lot # 655871/057OU). On 11-AUG-2009 the patient was in the office for well child check. The physician's impression was thrush, constipation with lots of crying and irritability. Nystatin, 100,000/dose, 2 dose daily PO was prescribed. Formula changed and guided stools for 3 times. On 11-AUG-2008, the patient was vaccinated with TRIPEDIA (lot # C2935AA) and IPOL (lot #A0127) into the right thigh; the first dose of PREVNAR (lot #C80884) into the left thigh; the first dose of ROTATEQ (lot #660289/1888U) PO. On 29-SEP-2008 the patient was in the office with complaint with increased irritability, decreased appetite, cranking, fever (temp 101 degree), running nose and cough. The patient was fed Tylenol. The physician's impression was upper respiratory infection (URI).  Treatment with Tylenol, 100/package every 4 hours and Amoxicillin, 250/package, 1 package BID for 5 days was prescribed. On 10-OCT-2008 the 4 month old patient was in the office and was noted teething, drooling, a rash on head and scalp with several erythematous patches. On 10-OCT-2008, the patient was vaccinated with the first dose of PEDIARIX (lot #AC21B150AA) IM into the right thigh; the second dose of ACTHIB (lot # UF454AA) and the second dose of PREVENAR (lot# C65046) IM into the left thigh; the second dose of RECOMBIVAX HB (lot # 660880/0923X) PO. On 17-NOV-2008 the patient was in office with complaint with coughing for 3 days and irritability. The physician's impression was cough and probably teething. Tylenol was prescribed as necessary. On 14-JAN-2009 the patient was in office with complaint with discharge from left eye for 5 days. pulling left ear and no fever. The physician's impression was conjunctivitis. The physician prescribed Amoxicillin suspension, 250mg/5ml, 3ml q12h PO for 10 days and Tylenol PRN. On 24-FEB-2009 the patient was in office and vaccinated with the second dose of PEDIARIX (lot #AC21B150AA) and the third dose of PREVENAR (lot # D03124) IM into the right thigh; the third dose of ACTHIB (lot # UF505AB) IM into the left thigh; the third dose of ROTATEQ (lot # 661579/0899X) PO. It was reported previously that when the patient's mother was pregnant, she was vaccinated with HPV (WAES # 0711USA02981). Additional information is not expected.
Age: 0.08
Sex: M
Vaccine: HEP
Symptoms: Irritability, Pyrexia, Rash erythematous, Rhinorrhoea, Teething
Clinical narrative: Information has been received from a physician via pediatric medical records concerning a 2 month old male (birth weight 6 pounds 7 ounces) with no known drug allergies who on 10-JUL-2008 (1 month old) was vaccinated with the first dose of RECOMBIVAX HB (lot # 655871/057OU). On 11-AUG-2009 the patient was in the office for well child check. The physician's impression was thrush, constipation with lots of crying and irritability. Nystatin, 100,000/dose, 2 dose daily PO was prescribed. Formula changed and guided stools for 3 times. On 11-AUG-2008, the patient was vaccinated with TRIPEDIA (lot # C2935AA) and IPOL (lot #A0127) into the right thigh; the first dose of PREVNAR (lot #C80884) into the left thigh; the first dose of ROTATEQ (lot #660289/1888U) PO. On 29-SEP-2008 the patient was in the office with complaint with increased irritability, decreased appetite, cranking, fever (temp 101 degree), running nose and cough. The patient was fed Tylenol. The physician's impression was upper respiratory infection (URI).  Treatment with Tylenol, 100/package every 4 hours and Amoxicillin, 250/package, 1 package BID for 5 days was prescribed. On 10-OCT-2008 the 4 month old patient was in the office and was noted teething, drooling, a rash on head and scalp with several erythematous patches. On 10-OCT-2008, the patient was vaccinated with the first dose of PEDIARIX (lot #AC21B150AA) IM into the right thigh; the second dose of ACTHIB (lot # UF454AA) and the second dose of PREVENAR (lot# C65046) IM into the left thigh; the second dose of RECOMBIVAX HB (lot # 660880/0923X) PO. On 17-NOV-2008 the patient was in office with complaint with coughing for 3 days and irritability. The physician's impression was cough and probably teething. Tylenol was prescribed as necessary. On 14-JAN-2009 the patient was in office with complaint with discharge from left eye for 5 days. pulling left ear and no fever. The physician's impression was conjunctivitis. The physician prescribed Amoxicillin suspension, 250mg/5ml, 3ml q12h PO for 10 days and Tylenol PRN. On 24-FEB-2009 the patient was in office and vaccinated with the second dose of PEDIARIX (lot #AC21B150AA) and the third dose of PREVENAR (lot # D03124) IM into the right thigh; the third dose of ACTHIB (lot # UF505AB) IM into the left thigh; the third dose of ROTATEQ (lot # 661579/0899X) PO. It was reported previously that when the patient's mother was pregnant, she was vaccinated with HPV (WAES # 0711USA02981). Additional information is not expected.
Age: 0.08
Sex: M
Vaccine: HEP
Symptoms: Upper respiratory tract infection
Clinical narrative: Information has been received from a physician via pediatric medical records concerning a 2 month old male (birth weight 6 pounds 7 ounces) with no known drug allergies who on 10-JUL-2008 (1 month old) was vaccinated with the first dose of RECOMBIVAX HB (lot # 655871/057OU). On 11-AUG-2009 the patient was in the office for well child check. The physician's impression was thrush, constipation with lots of crying and irritability. Nystatin, 100,000/dose, 2 dose daily PO was prescribed. Formula changed and guided stools for 3 times. On 11-AUG-2008, the patient was vaccinated with TRIPEDIA (lot # C2935AA) and IPOL (lot #A0127) into the right thigh; the first dose of PREVNAR (lot #C80884) into the left thigh; the first dose of ROTATEQ (lot #660289/1888U) PO. On 29-SEP-2008 the patient was in the office with complaint with increased irritability, decreased appetite, cranking, fever (temp 101 degree), running nose and cough. The patient was fed Tylenol. The physician's impression was upper respiratory infection (URI).  Treatment with Tylenol, 100/package every 4 hours and Amoxicillin, 250/package, 1 package BID for 5 days was prescribed. On 10-OCT-2008 the 4 month old patient was in the office and was noted teething, drooling, a rash on head and scalp with several erythematous patches. On 10-OCT-2008, the patient was vaccinated with the first dose of PEDIARIX (lot #AC21B150AA) IM into the right thigh; the second dose of ACTHIB (lot # UF454AA) and the second dose of PREVENAR (lot# C65046) IM into the left thigh; the second dose of RECOMBIVAX HB (lot # 660880/0923X) PO. On 17-NOV-2008 the patient was in office with complaint with coughing for 3 days and irritability. The physician's impression was cough and probably teething. Tylenol was prescribed as necessary. On 14-JAN-2009 the patient was in office with complaint with discharge from left eye for 5 days. pulling left ear and no fever. The physician's impression was conjunctivitis. The physician prescribed Amoxicillin suspension, 250mg/5ml, 3ml q12h PO for 10 days and Tylenol PRN. On 24-FEB-2009 the patient was in office and vaccinated with the second dose of PEDIARIX (lot #AC21B150AA) and the third dose of PREVENAR (lot # D03124) IM into the right thigh; the third dose of ACTHIB (lot # UF505AB) IM into the left thigh; the third dose of ROTATEQ (lot # 661579/0899X) PO. It was reported previously that when the patient's mother was pregnant, she was vaccinated with HPV (WAES # 0711USA02981). Additional information is not expected.
Sex: F
Vaccine: BCG, HEP
Symptoms: Inappropriate schedule of drug administration, Rash
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated on 05-MAR-2009 with an unspecified dose RECOMBIVAX HB intramuscularly. On 17-MAR-2009, The patient was inadvertently given an other dose of RECOMBIVAX HB. The patient developed a rash on her arms on 17-MAR-2009. The patient sought medical attention at the office. No labs were performed. On 18-MAR-2009, the patient recovered from rash on her arms. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning up to 7-8 children who were intramuscularly vaccinated with RECOMBIVAX HB (Lot no. 654436/1106F) 0.5 ml, during the period of 03-FEB-2009 to 20-MAR-2009. The nurse reported that RECOMBIVAX HB had expired on 02-FEB-2009. No adverse effect was reported. Attempts are being made to obtain additional identifying information
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a female was vaccinated with two doses of RECOMBIVAX HB (manufacturer unknown). Subsequently the patient experienced developed hives on two occasions after the both doses. The patient was seen by a physician. The patient recovered on an unspecified date. Additional information has been requested.
Age: 1.3
Sex: M
Vaccine: HEP
Symptoms: Rash
Clinical narrative: Information has been received from a consumer concerning her 15 month old son with no pertinent medical history and no known drug allergies or reactions who in January 2008, June 2008, and October 2008 was vaccinated with the first, second and third dose of HEP B vaccine respectively (manufacturer unknown, lot # not provided). There was no concomitant medication. In October 2008 ("the next day after receiving the third shot"), the patient experienced bad rashes and the rashes lasted for four to five months. The patient was brought to a dermatologist and the dermatologist considered the rashes were linked to HEP B vaccine. No lab diagnostics studies were performed. At the time of reporting, the patient was recovering. No further information is available.
Sex: M
Vaccine: HEP
Symptoms: Abdominal pain, Autism, Frequent bowel movements, Insomnia, Lactose intolerance
Clinical narrative: Information has been received from a consumer concerning her son who on an unspecified date was vaccinated with RECOMBIVAX HB (the name and manufacturer was unspecified). After receiving the vaccination, the patient was very colicky, could not tolerate milk, had a lot of bowel movements and could only sleep for a couple of hours. The outcome was unknown. It was not specified if the patient sought medical attention or not. The mother also reported that on an unspecified date, after the patient received diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid (manufacturer unspecified), he spiked a 104 degree fever. The mother also reported that the patient was diagnosed with autism after received MMR II (WAES # 0903USA05205). This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Pyrexia
Clinical narrative: Information has been received from a consumer concerning her son who on an unspecified date was vaccinated with RECOMBIVAX HB (the name and manufacturer was unspecified). After receiving the vaccination, the patient was very colicky, could not tolerate milk, had a lot of bowel movements and could only sleep for a couple of hours. The outcome was unknown. It was not specified if the patient sought medical attention or not. The mother also reported that on an unspecified date, after the patient received diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid (manufacturer unspecified), he spiked a 104 degree fever. The mother also reported that the patient was diagnosed with autism after received MMR II (WAES # 0903USA05205). This is one of several reports received from the same source. Additional information has been requested.
Age: 0.01
Sex: M
Vaccine: HEP
Symptoms: Breath sounds abnormal, Cough, Crying, Decreased appetite, Irritability
Clinical narrative: Information has been received from medical records concerning a 3 weeks old male with a history of serotonin syndrome (SSRI) and jaundice neonatal who on 21-NOV-2008 was vaccinated with a first dose of hepatitis B virus vaccine(manufacturer unknown). On approximately 08-DEC-2008 the patient was taken to the clinic by parents for evaluation because of a 12-24 hour history of slight cough and runny nose. They reported that he had been a little fussy, but feeding. The physician's physical exam showed that the lung was clear to auscultation without rales, rhonchi, or wheeze. Respiratory rate was 40-50 and unlabored. Impression was a 3-week newborn with an upper respiratory infection. Recommendation was bulb syringe for removing secretions and to follow up if symptoms did not improve in 3-5 days or if fever developed. On 02-JAN-2009, the baby was brought in by the mother to see the physician with primary complaints about a bad cough, rattling in his chest that started 3-4 days prior. He might have had a slight fever initially but none for the past 3-4 days. She reported that his appetite might have been a little decreased. The physicians' examination showed clear tympanic membranes, nares slightly congested, oropharynx with good moist mucus membranes, lungs clear to auscultation without rales, rhonchi or wheeze. Respiratory rate was 40-50 and unlabored. Impression was upper respiratory infection and cough in a 6-week old infant. Recommendation was that parent was to continue to monitor him and could use TYLENOL for comfort. Also discussed use of a humidifier or a vicks vaporizer and to follow up if no improvement in 1-2 weeks. On 15-JAN-2009, the baby was vaccinated with a first dose of ROTATEQ PO, PEDIARIX in left thigh, PREVNAR IM in right thigh and ACTHIB IM in right thigh. On 11-FEB-2009 the baby was brought to clinic by father who said the baby had red cheeks, crying and had a temperature of 100 axillary. Physical exam was normal. Impression was acute fever, and rule out strep infection. A rapid Streptococcus group A test was done and was negative. Plan was to continue checks, TYLENOL BID, observe behavior and call for temp>101, dry diaper for 6 hrs, vomiting or respiratory distress. On 17-APR-2009 the patient was brought in for a clinic visit with complaints of cold. He was pulling his right ear and had no fever. He was congested for 4 days. On examination his ears and tympanic membranes were abnormal. The abnormal findings were that his tympanic membranes was dull and bulging. The physicians' impression was right otitis media. The plan was to put the baby on AMOXIL 125/5 and to use humidifier. Additional information is not expected. Medical records will be provided upon request.
Age: 0.01
Sex: M
Vaccine: HEP
Symptoms: Nasal congestion, Nasopharyngitis, Otitis media acute, Pyrexia, Respiratory tract congestion
Clinical narrative: Information has been received from medical records concerning a 3 weeks old male with a history of serotonin syndrome (SSRI) and jaundice neonatal who on 21-NOV-2008 was vaccinated with a first dose of hepatitis B virus vaccine(manufacturer unknown). On approximately 08-DEC-2008 the patient was taken to the clinic by parents for evaluation because of a 12-24 hour history of slight cough and runny nose. They reported that he had been a little fussy, but feeding. The physician's physical exam showed that the lung was clear to auscultation without rales, rhonchi, or wheeze. Respiratory rate was 40-50 and unlabored. Impression was a 3-week newborn with an upper respiratory infection. Recommendation was bulb syringe for removing secretions and to follow up if symptoms did not improve in 3-5 days or if fever developed. On 02-JAN-2009, the baby was brought in by the mother to see the physician with primary complaints about a bad cough, rattling in his chest that started 3-4 days prior. He might have had a slight fever initially but none for the past 3-4 days. She reported that his appetite might have been a little decreased. The physicians' examination showed clear tympanic membranes, nares slightly congested, oropharynx with good moist mucus membranes, lungs clear to auscultation without rales, rhonchi or wheeze. Respiratory rate was 40-50 and unlabored. Impression was upper respiratory infection and cough in a 6-week old infant. Recommendation was that parent was to continue to monitor him and could use TYLENOL for comfort. Also discussed use of a humidifier or a vicks vaporizer and to follow up if no improvement in 1-2 weeks. On 15-JAN-2009, the baby was vaccinated with a first dose of ROTATEQ PO, PEDIARIX in left thigh, PREVNAR IM in right thigh and ACTHIB IM in right thigh. On 11-FEB-2009 the baby was brought to clinic by father who said the baby had red cheeks, crying and had a temperature of 100 axillary. Physical exam was normal. Impression was acute fever, and rule out strep infection. A rapid Streptococcus group A test was done and was negative. Plan was to continue checks, TYLENOL BID, observe behavior and call for temp>101, dry diaper for 6 hrs, vomiting or respiratory distress. On 17-APR-2009 the patient was brought in for a clinic visit with complaints of cold. He was pulling his right ear and had no fever. He was congested for 4 days. On examination his ears and tympanic membranes were abnormal. The abnormal findings were that his tympanic membranes was dull and bulging. The physicians' impression was right otitis media. The plan was to put the baby on AMOXIL 125/5 and to use humidifier. Additional information is not expected. Medical records will be provided upon request.
Age: 0.01
Sex: M
Vaccine: HEP
Symptoms: Rhinorrhoea, Streptococcus test, Streptococcus test negative, Tympanic membrane disorder, Upper respiratory tract infection
Clinical narrative: Information has been received from medical records concerning a 3 weeks old male with a history of serotonin syndrome (SSRI) and jaundice neonatal who on 21-NOV-2008 was vaccinated with a first dose of hepatitis B virus vaccine(manufacturer unknown). On approximately 08-DEC-2008 the patient was taken to the clinic by parents for evaluation because of a 12-24 hour history of slight cough and runny nose. They reported that he had been a little fussy, but feeding. The physician's physical exam showed that the lung was clear to auscultation without rales, rhonchi, or wheeze. Respiratory rate was 40-50 and unlabored. Impression was a 3-week newborn with an upper respiratory infection. Recommendation was bulb syringe for removing secretions and to follow up if symptoms did not improve in 3-5 days or if fever developed. On 02-JAN-2009, the baby was brought in by the mother to see the physician with primary complaints about a bad cough, rattling in his chest that started 3-4 days prior. He might have had a slight fever initially but none for the past 3-4 days. She reported that his appetite might have been a little decreased. The physicians' examination showed clear tympanic membranes, nares slightly congested, oropharynx with good moist mucus membranes, lungs clear to auscultation without rales, rhonchi or wheeze. Respiratory rate was 40-50 and unlabored. Impression was upper respiratory infection and cough in a 6-week old infant. Recommendation was that parent was to continue to monitor him and could use TYLENOL for comfort. Also discussed use of a humidifier or a vicks vaporizer and to follow up if no improvement in 1-2 weeks. On 15-JAN-2009, the baby was vaccinated with a first dose of ROTATEQ PO, PEDIARIX in left thigh, PREVNAR IM in right thigh and ACTHIB IM in right thigh. On 11-FEB-2009 the baby was brought to clinic by father who said the baby had red cheeks, crying and had a temperature of 100 axillary. Physical exam was normal. Impression was acute fever, and rule out strep infection. A rapid Streptococcus group A test was done and was negative. Plan was to continue checks, TYLENOL BID, observe behavior and call for temp>101, dry diaper for 6 hrs, vomiting or respiratory distress. On 17-APR-2009 the patient was brought in for a clinic visit with complaints of cold. He was pulling his right ear and had no fever. He was congested for 4 days. On examination his ears and tympanic membranes were abnormal. The abnormal findings were that his tympanic membranes was dull and bulging. The physicians' impression was right otitis media. The plan was to put the baby on AMOXIL 125/5 and to use humidifier. Additional information is not expected. Medical records will be provided upon request.
Age: 9.0
Sex: F
Vaccine: HEP
Symptoms: Body temperature normal, Oropharyngeal pain, Pyrexia
Clinical narrative: Information has been received from a consumer concerning his daughter, a 9 year old female, who on 10-JUN-2009 was vaccinated with one dose of RECOMBIVAX HB.  There was no concomitant medication.  On 10-JUN-2009 the patient experienced fever of 100 degrees Fahrenheit and sore throat, however no injection site reaction.  The patient did not seek medical attention.  At the report time the patient had not recovered.  No further information is available.
Age: 0.02
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antigen positive
Clinical narrative: Information has been received from a physician concerning a 7 day old patient who was vaccinated with a dose of RECOMBIVAX HB. There was no concomitant medication. The patient had a positive Hepatitis B surface antigen after RECOMBIVAX HB was given. The physician stated the patient's mother was negative. It was unknown if the patient sought medical attention. At the time of report, the patient had not recovered. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: HEP
Symptoms: Chills, Cough, Pain, Pyrexia
Clinical narrative: Information has been received from a Registered Nurse concerning a 59 year old female patient who on 08-Jun-2009 was vaccinated with the first 0.1 mL dose of RECOMBIVAX HB (Lot # 662115/1647X) intramuscularly. It was reported that on 08-Jun-2009, the patient experienced chills, feverish sensations, achiness and cough after receiving her first doe of RECOMBIVAX HB. The patient sought medical attention via telephone call. There were no laboratory diagnostic tests performed. It was reported that the patient would feel better each morning, but each afternoon the symptoms would return. It was reported that on 16-Jun-2009 the symptoms resolved. Additional information has been requested.
Age: 0.01
Sex: F
Vaccine: HEP
Symptoms: Acne, Constipation, Diet refusal, Enema administration, Flatulence
Clinical narrative: Information has been received from a physician via medical records concerning an 18 day old female with clicking hip, and a history of breast lump, band neutrophil count increased, jaundice, and group B betahaemolytic streptococcal positive (all reported in WAES 0806USA02242) who on 27-JAN-2009 was vaccinated with a dose of RECOMBIVAX HB (manufacturer unknown). On 26-FEB-2009 the patient was vaccinated IM with a third dose of pediatric RECOMBIVAX HB (manufacturer unknown). The patient's sister was diagnosed with diabetes at age 4.  On 09-FEB-2009, the patient was seen by the physician for 2 week hearth care. It was reported that the baby stopped breast feeding "last night". She was fussy with breast milk. She had no major spitting up. Physical examination showed no abnormality. The doctor stated that she might use hydrocortisone cream 1% to face twice a day for 5 days. The patient was to be followed up in 2 weeks. On 25-FEB-2009, the baby was taken for an office visit by her parents. The parents had concerns about rash on her face behind ears and spreading to scalp which lasted 2 weeks. Physical examination showed acne in face, neck and scalp. The patient was diagnosed with acne. The doctor suggested to keep face clean with soap and water. On 26-FEB-2009, the baby presented to the office for 1 month well baby visit. Physical examination revealed pustules in scalp, Lactose intolerance was diagnosed during the visit. On 04-MAR-2009, the mother called to report that the child had chronic constipation. She had been using infant fleets enema. A nurse advised to stop and use karos syrup, 1-2 tsp in bottle once to twice a day. ON 24-MAR-2009, the patient was taken to the office by her parents for well baby visit. The parents had questions regarding formula. The patient was still very gassy, constipation. She used Miralax every two days. The parents wanted to start rice cereal at night. Physical examination showed no abnormailty. During this visit, the patient was vaccinated with a dose of PENTACEL, ROTATEQ oral, PREVENAR IM. The baby would be followed up in 2 months if age 4 months for well baby check. The patient experienced upper respiratory infection (WAES #0908USA00001) after being vaccinated with ROTATEQ. This is one of several reports concerning the same patient. Additional information is not expected.
Age: 0.01
Sex: F
Vaccine: HEP
Symptoms: Irritability, Lactose intolerance, Rash, Rash pustular, Upper respiratory tract infection
Clinical narrative: Information has been received from a physician via medical records concerning an 18 day old female with clicking hip, and a history of breast lump, band neutrophil count increased, jaundice, and group B betahaemolytic streptococcal positive (all reported in WAES 0806USA02242) who on 27-JAN-2009 was vaccinated with a dose of RECOMBIVAX HB (manufacturer unknown). On 26-FEB-2009 the patient was vaccinated IM with a third dose of pediatric RECOMBIVAX HB (manufacturer unknown). The patient's sister was diagnosed with diabetes at age 4.  On 09-FEB-2009, the patient was seen by the physician for 2 week hearth care. It was reported that the baby stopped breast feeding "last night". She was fussy with breast milk. She had no major spitting up. Physical examination showed no abnormality. The doctor stated that she might use hydrocortisone cream 1% to face twice a day for 5 days. The patient was to be followed up in 2 weeks. On 25-FEB-2009, the baby was taken for an office visit by her parents. The parents had concerns about rash on her face behind ears and spreading to scalp which lasted 2 weeks. Physical examination showed acne in face, neck and scalp. The patient was diagnosed with acne. The doctor suggested to keep face clean with soap and water. On 26-FEB-2009, the baby presented to the office for 1 month well baby visit. Physical examination revealed pustules in scalp, Lactose intolerance was diagnosed during the visit. On 04-MAR-2009, the mother called to report that the child had chronic constipation. She had been using infant fleets enema. A nurse advised to stop and use karos syrup, 1-2 tsp in bottle once to twice a day. ON 24-MAR-2009, the patient was taken to the office by her parents for well baby visit. The parents had questions regarding formula. The patient was still very gassy, constipation. She used Miralax every two days. The parents wanted to start rice cereal at night. Physical examination showed no abnormailty. During this visit, the patient was vaccinated with a dose of PENTACEL, ROTATEQ oral, PREVENAR IM. The baby would be followed up in 2 months if age 4 months for well baby check. The patient experienced upper respiratory infection (WAES #0908USA00001) after being vaccinated with ROTATEQ. This is one of several reports concerning the same patient. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: HEP
Symptoms: Hepatic enzyme increased, Liver function test
Clinical narrative: Information has been received from a Medical Assistant concerning a 60 year old female patient with no pertinent medical history and no known drug allergies/drug reactions who on an unspecified date was vaccinated with a dose of RECOMBIVAX HB (manufacturer unknown). Concomitant therapy included "unspecified cholesterol medication". It was reported that on an unspecified date the patient had increased liver enzyme levels. The patient sought unspecified medical attention. It was reported that the patient had elevated liver enzymes at the time of the report. Additional information has been requested.
Age: 0.8
Sex: M
Vaccine: HEP
Symptoms: Speech disorder
Clinical narrative: Information has been received from a Medical Assistant concerning a 12 month old male patient with no pertinent medical history who on an unspecified dated was vaccinated with 0.5 mL dose of RECOMBIVAX HB. It was reported that eh patient's mother noticed after her child received RECOMBIVAX HB at 9 months of age the child did not "talk" again for two weeks. It was reported that the child received hepatitis B as a part of a combination vaccine (name and manufacturer unknown) for the initial two doses in the series. It was reported that this lasted for two weeks then the child began to speak again. The patient sought medical attention at the office. Follow-up information was received from an unknown reporter who stated that he had no knowledge of this reaction. The reporter also stated that the patient was not his. No further information is available.
Sex: F
Vaccine: HEP
Symptoms: Administration related reaction
Clinical narrative: Information has been received from a registered nurse concerning a female patient who on 09-JUL-2009 was vaccinated with a second 1ml dose of RECOMBIVAX HB (lot#0438Y thimerosal-free) intramuscular. On 09-JUL-2009, the patient complained that the injection was painful. The patient had sought medical attention in the office. At the time of report, the patient's outcome was not reported.
Age: 49.0
Sex: M
Vaccine: HEP
Symptoms: Condition aggravated, Impaired work ability, Migraine
Clinical narrative: Information has been received from a 50 year old male patient with allergy to yeast and history of Hodgkin's lymphoma in 2006, fine now, who on 12-JUN-2009 was vaccinated with the first dose of RECOMBIVAX HB. There was no concomitant medication reported. It was reported that on 02-JUL-2009 the patient experienced a migraine. The patient received the second dose of RECOMBIVAX on 13-JUL-2009 despite continued migraine. It was reported that he still had a migraine " for the past 18 days, which had never gone away." The patient was treated with Imitrex 100 mg and on 19-JUL-2009 received an injection of Imitrex and was also started on Dexamethesone. There were no laboratory diagnostic test performed. He reported a history of migraines for approximately 30 years and noted that when drinking beer he experienced migraines. It was reported that he stopped drinking beer 10 years ago and he had not had a migraine in the past few years. It was reported that he had missed 16 hours of work since receiving the vaccine. The patient sought unspecified medical attention. The patient had not recovered at the time of the report.  Additional information had not been requested.
Age: 11.0
Sex: M
Vaccine: HEP
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a medical assistant concerning a 11 year old male patient who on 15-MAY-2008, was vaccinated with a dose of RECOMBIVAX HB (lot #657461/1610U) by accident. The patient was given an order of VARIVAX (Merck) by the physician but was given a dose of RECOMBIVAX HB. The patient received the series in 1997. The error was found when the medical assistant called to confirm which vaccine was associated with a particular lot number. The patient was not experiencing any known symptoms. Follow-up information was received from the physician who reported that the patient was healthy. The physician considered that hepatitis A virus vaccine and RECOMBIVAX HB was given by mistake. No adverse reactions was recorded or noted by either parent or physician. No further information is available.
Sex: M
Vaccine: HEP
Symptoms: Dermatitis, Dermatitis diaper, Diarrhoea, Neonatal candida infection, Rash erythematous
Clinical narrative: Information has been received from a physician via medical records concerning a 14 day old with a history of circumcision premature (reported in WAES0707USA01443) male who on 30-Aug-2007 was vaccinated with RECOMBIVAX (Lot # 655565/0007U) in the left vast lateralis. On 13-Sep-2007 the baby was taken to the physician with concerns of diaper area being very raw looking. Genitourinary examination showed erythematous. The baby was diagnosed with candial dermatitis and was treated with nystatin cream, four times a day for 14 days. On Sep-2007, the baby was seen by the doctor again. No abnormality was found. The baby recovered from candial dermatitis. On 07-Nov-2007 the baby was seen by the doctor with concerns of diarrhea for 3 to 4 days. Physical examination did not show any abnormality. There was no documented treatment. The patient subsequently developed adverse events after vaccination with OMPC (WAES # 0908USA00771) and adverse events after vaccination with RECOMBIVAX (WAES # 0908USA00772). Additional information is not expected.
Sex: M
Vaccine: HEP
Symptoms: Acne, Crying, Decreased appetite, Erythema toxicum neonatorum, Hypersomnia
Clinical narrative: Information has been received from a physician via medical record concerning an 11 day old male with right congenital clubfoot who on 27-APR-2009 was vaccinated with a dose of RECOMBIVAX HB (manufacturer unknown). On 06-MAY-2009 the baby was taken to the emergency department by his mother. His mom described that the he had a "normal baby rash" in the nursery over his abdomen and face. Before his bath that day, mom took off onesie and noted increased erythema of the rash, with spread to arms as well. Mom described rash as red, and looking pimples, no blisters. Initially mom thought baby had heat rash as he had an onesie, sleeper and blanket on, but did not have tactile temperatures. No fever, congestion, cough, emesis or diarrhea. No one else with similar rash, no sick contacts. The baby had some increased crying that day, and took a longer nap than usual (4 hrs) but mom sometimes had to wake him for feeds and stated that she forgot to wake him that day. Otherwise, taking breast milk and formula supplementation (1-1.5 oz) q2h, wet diapers 7/day, BMs 2/day. The baby was an ex-39 weeker, 7 lb 15 oz, NSVD, normal pregnancy and home with mom. Physical exam showed that erythematous, maculopapular rash over chest, abdomen, decreased on arms and back. No rash on legs. The physician's impression was erythema toxicum neonatorum. The condition was stable. The baby was disposed to home and recommended to return to the ED if symptoms worsen or change, and follow up PCP. The physician reported the baby improved with the therapy. On 19-JUN-2009 at 15:21 the patient's mom called the office to report that the patient did not eat much that day and had not had a wet diaper since 09:00. She was advised to take the patient to the ER. It was not reported if the patient was taken to the ER. On 23-JUN-2009 the baby was vaccinated with a dose of RECOMBIVAX HB (manufacturer unknown), a dose of PREVNAR, a dose of ROTATEQ, a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, a dose of Hib conj vaccine (unspecified carrier) and a dose of poliovirus vaccine inactivated (unspecified). Additional information is not expected.