chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HEP
Symptoms: Rash, Upper respiratory tract infection
Clinical narrative: Information has been received from a medical records via of a health professional concerning a 1 day old male who on 27-APR-2008 was vaccinated with the first dose of RECOMBIVAX HB.  On 27-MAY-2008, the patient was vaccinated with a second dose of RECOMBIVAX HB.  Secondary suspect therapy included the first dose of ROTAVIRUS on 27-JUN-2008 and the second dose on 28-AUG-2008, and, the first dose of HIB CONJ vaccine (OMPC) on 27-JUN-2008 and the second dose on 28-AUG-2008.  Concomitant therapy included PNEUMOCOCCAL vaccine (unspecified), POLIOVIRUS vaccine and DIPHTHERIA TOXOID (+) PERTUSSIS vaccine (unspecified) (+) TETANUS TOXOID.  On 30-APR-2008 the baby had a routine exam and the physician reported that the baby had mildly icteric to shoulders (not noted in the hospital) and had gained excellent weight.  On 11-JUN-2008, it was reported that the baby had experienced rash on face for 1 week, red in ears and neck going onto chest.  No fever.  The mother was instructed to call the physician if baby had fever over 101, if child became worse or rash didn't go way in 1-3 weeks.  On 18-SEP-2008, the baby developed ear infections, built of wax in ears, was pulling at ears, congested, didn't sleep well and was fussy.  Wax was removed bilaterally and both tympanic membranes cleared and mobile.  The baby was diagnosed with upper respiratory infection and otalgia.  This is one of two reports from the same source.  Additional information has been requested.
Sex: F
Vaccine: DTAPHEPBIP, HEP, HIBV, RV5
Symptoms: Cough, Nasopharyngitis, Pigmentation disorder, Rash papular, Upper respiratory tract congestion
Clinical narrative: Information has been received from a physician concerning a 2 day old, 6 pound 12 ounce black infant female.  On 11-JUL-2008 she was vaccinated with the first dose of RECOMBIVAX HB (manufacturer unknown).  Concomitant therapy included ROTATEQ given orally and PREVNAR given intramuscularly (manufacturer unknown).   Other concomitant therapy included ACTHIB, given intramuscularly and PEDIARIX, given intramuscularly.  On 11-SEP-2008 the patient experienced a papular rash on her face with mild hypopigmentation.  She was treated with hydrocortisone cream mixed with AVEENO.  On 21-OCT-2008 the patient presented at the office with the complaint of a new common cold.  The onset of symptoms had been gradual.  The course had been constant.  The symptoms were described as mild.  There had been associated cough and congestion, while there had been no fever.  The infant was diagnosed with an upper respiratory infection.  No treatment information was provided.  Follow-up information was received from the physician.  The physician reported that this immunization was not given at their office in hospital after check.  The physician also reported that on 11-SEP-2008 this child received PEDIARIX in their office with no adverse reaction.  Additional information has been requested.
Sex: F
Vaccine: DTAPHEPBIP, HEP, HIBV, RV5
Symptoms: Upper respiratory tract infection
Clinical narrative: Information has been received from a physician concerning a 2 day old, 6 pound 12 ounce black infant female.  On 11-JUL-2008 she was vaccinated with the first dose of RECOMBIVAX HB (manufacturer unknown).  Concomitant therapy included ROTATEQ given orally and PREVNAR given intramuscularly (manufacturer unknown).   Other concomitant therapy included ACTHIB, given intramuscularly and PEDIARIX, given intramuscularly.  On 11-SEP-2008 the patient experienced a papular rash on her face with mild hypopigmentation.  She was treated with hydrocortisone cream mixed with AVEENO.  On 21-OCT-2008 the patient presented at the office with the complaint of a new common cold.  The onset of symptoms had been gradual.  The course had been constant.  The symptoms were described as mild.  There had been associated cough and congestion, while there had been no fever.  The infant was diagnosed with an upper respiratory infection.  No treatment information was provided.  Follow-up information was received from the physician.  The physician reported that this immunization was not given at their office in hospital after check.  The physician also reported that on 11-SEP-2008 this child received PEDIARIX in their office with no adverse reaction.  Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Injection site irritation, Injection site swelling
Clinical narrative: Information has been received from a medical assistant concerning a 35 year old female with no pertinent medical history or drug reactions/allergies who on 30-SEP-2008 was vaccinated with a first dose of RECOMBIVAX HB (lot # 653786/0185F) 1.0 ml IM in the left arm. There was no concomitant medication. On 2-OCT-2008 the patient experienced developed swelling and burning sensation at the injection site, 2 days after administration of the first dose of RECOMBIVAX HB. The patient was examined in the office on 17-OCT-2008 but it was not known if the treatment was prescribed. No further information was provided. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a 25 year old female with PENICILLIN allergy who on 25-SEP-2008 was vaccinated with a third dose of 0.5mL RECOMBIVAX HB (lot# 660951/0398X).  Concomitant therapy included hormonal contraceptives (unspecified).  On 28-SEP-2008 the patient developed pain at injection site.  The pain later moved up her arm into her shoulder.  The patient described it as "arthritis pain".  Medical attention was sought.  The patient went to the emergency room but was not admitted to the hospital.  The patient was treated with ALEVE.  The patient did not report an adverse event after either of the first two shots.  The adverse events improved after stopping therapy.  At the time of reporting the patient was recovering.  Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Acoustic stimulation tests normal, Choking, Impaired gastric emptying, Irritability, Jaundice
Clinical narrative: Information has been received from a physician through medical records concerning a 1 day old, 3345 gram, white male who on 02-JUL-2008 was vaccinated with the first dose of RECOMBIVAX HB (manufacturer unknown).  There was no concomitant medication.  On 08-JUL-2008 the infant was seen for a routine visit.  He was noted to weigh 7 pounds and 4 ounces.  It was reported that the infant had mild jaundice and doesn't burp well, he has some spitting.  It was also noted that the infant had passed a newborn hearing screen on an unspecified date.  The child was reported to have appropriate growth and development.  On 27-AUG-2008 the child was seen for a routine visit.  His weight was reported to be 11 pounds, 8 ounces.  It was noted that the child had experienced a gagging and choking episode that started a couple of weeks prior, and had been taken once to the emergency room due to "choking on his spit."  No treatment or outcome information was provided.  It was also noted that the child spits up and is sometimes fussy.  At this visit, the infant was reported to have GE reflux and the formula was changed.  The infant was to be seen for follow-up in 2 months.  On 27-AUG-2008 the child was vaccinated with the first dose of ROTAVIRUS, by mouth; ACTHIB; PREVNAR; and PEDIARIX.  Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Retching, Vomiting
Clinical narrative: Information has been received from a physician through medical records concerning a 1 day old, 3345 gram, white male who on 02-JUL-2008 was vaccinated with the first dose of RECOMBIVAX HB (manufacturer unknown).  There was no concomitant medication.  On 08-JUL-2008 the infant was seen for a routine visit.  He was noted to weigh 7 pounds and 4 ounces.  It was reported that the infant had mild jaundice and doesn't burp well, he has some spitting.  It was also noted that the infant had passed a newborn hearing screen on an unspecified date.  The child was reported to have appropriate growth and development.  On 27-AUG-2008 the child was seen for a routine visit.  His weight was reported to be 11 pounds, 8 ounces.  It was noted that the child had experienced a gagging and choking episode that started a couple of weeks prior, and had been taken once to the emergency room due to "choking on his spit."  No treatment or outcome information was provided.  It was also noted that the child spits up and is sometimes fussy.  At this visit, the infant was reported to have GE reflux and the formula was changed.  The infant was to be seen for follow-up in 2 months.  On 27-AUG-2008 the child was vaccinated with the first dose of ROTAVIRUS, by mouth; ACTHIB; PREVNAR; and PEDIARIX.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HEP
Symptoms: Pyrexia
Clinical narrative: Information has been received from a nurse practitioner concerning a female who at the age of 13 (approximately 1996) was vaccinated with a first dose of RECOMBIVAX HB (manufacturer unknown) and developed a fever of 104 degrees F.  No additional information was available.  Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Basophil count increased, Body temperature increased, Condition aggravated, Dermatitis diaper, Diarrhoea
Clinical narrative: Information has been received from pediatric medical records and a physician concerning a 15 week old female with diaper rash who on RECOMBIVAX HB (manufacturer unknown).  Concomitant therapy included ROTATEQ (manufacturer unknown), PEDVAXHIB (manufacturer unknown), POLIOVIRUS vaccine, DTAP-IPV and PREVNAR.  On 20-AUG-2008, the patient went to the emergency room (ER) because of diarrhea and diaper rash.  It was reported that the patient was having diarrhea movements approximately 5 per day, very watery in nature.  The patient has been on her regular formula plus occasionally some solid food.  The patient has had no vomiting and was also noted to have a diaper rash for which she had been using NYSTATIN cream.  Her physical examination was normal except for the noted diaper rash on her perineum.  Laboratory diagnostic studies performed include: white blood cell count 14,200, hemoglobin 12.9, hematocrit 36.8, lymphocyte count 46, segs 42, monocyte 9, eosinophils 2 and basophils 2.  The infant was diagnosed with gastroenteritis and diaper rash.  She was instructed to continue with the NYSTATIN and to air dry her bottom as much as possible.  She was also switched to clear liquids for 1.5 days, 2 oz s. every 1 hour while awake.  On 04-SEP-2008 the patient was seen in the physician's office for a rash.  The patient was still using NYSTATIN twice a day until clear.  Her physical examination was normal except for the rash that was noted on her skin.  It was reported to be negative for acne.  It was described as no impressive skin lesions, erythematous macular and red in color and it appeared on the patient's right neck.  The patient was diagnosed with candidiasis of skin and nails.  At the time of this report, the patient's outcome was unknown.  Follow-up information was received from the physician's office.  The reporter stated that "we have no records on file of the patient having an adverse reaction to RECOMBIVAX HB (manufacturer unknown) and no relevance to the immunization was ever addressed".  Additional information has been requested.  All pediatric medical records are available upon request.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Eosinophil count normal, Gastroenteritis, Haematocrit normal, Haemoglobin normal, Heart rate increased
Clinical narrative: Information has been received from pediatric medical records and a physician concerning a 15 week old female with diaper rash who on RECOMBIVAX HB (manufacturer unknown).  Concomitant therapy included ROTATEQ (manufacturer unknown), PEDVAXHIB (manufacturer unknown), POLIOVIRUS vaccine, DTAP-IPV and PREVNAR.  On 20-AUG-2008, the patient went to the emergency room (ER) because of diarrhea and diaper rash.  It was reported that the patient was having diarrhea movements approximately 5 per day, very watery in nature.  The patient has been on her regular formula plus occasionally some solid food.  The patient has had no vomiting and was also noted to have a diaper rash for which she had been using NYSTATIN cream.  Her physical examination was normal except for the noted diaper rash on her perineum.  Laboratory diagnostic studies performed include: white blood cell count 14,200, hemoglobin 12.9, hematocrit 36.8, lymphocyte count 46, segs 42, monocyte 9, eosinophils 2 and basophils 2.  The infant was diagnosed with gastroenteritis and diaper rash.  She was instructed to continue with the NYSTATIN and to air dry her bottom as much as possible.  She was also switched to clear liquids for 1.5 days, 2 oz s. every 1 hour while awake.  On 04-SEP-2008 the patient was seen in the physician's office for a rash.  The patient was still using NYSTATIN twice a day until clear.  Her physical examination was normal except for the rash that was noted on her skin.  It was reported to be negative for acne.  It was described as no impressive skin lesions, erythematous macular and red in color and it appeared on the patient's right neck.  The patient was diagnosed with candidiasis of skin and nails.  At the time of this report, the patient's outcome was unknown.  Follow-up information was received from the physician's office.  The reporter stated that "we have no records on file of the patient having an adverse reaction to RECOMBIVAX HB (manufacturer unknown) and no relevance to the immunization was ever addressed".  Additional information has been requested.  All pediatric medical records are available upon request.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Lymphocyte count increased, Monocyte count increased, Neutrophil percentage decreased, Rash erythematous, Rash macular
Clinical narrative: Information has been received from pediatric medical records and a physician concerning a 15 week old female with diaper rash who on RECOMBIVAX HB (manufacturer unknown).  Concomitant therapy included ROTATEQ (manufacturer unknown), PEDVAXHIB (manufacturer unknown), POLIOVIRUS vaccine, DTAP-IPV and PREVNAR.  On 20-AUG-2008, the patient went to the emergency room (ER) because of diarrhea and diaper rash.  It was reported that the patient was having diarrhea movements approximately 5 per day, very watery in nature.  The patient has been on her regular formula plus occasionally some solid food.  The patient has had no vomiting and was also noted to have a diaper rash for which she had been using NYSTATIN cream.  Her physical examination was normal except for the noted diaper rash on her perineum.  Laboratory diagnostic studies performed include: white blood cell count 14,200, hemoglobin 12.9, hematocrit 36.8, lymphocyte count 46, segs 42, monocyte 9, eosinophils 2 and basophils 2.  The infant was diagnosed with gastroenteritis and diaper rash.  She was instructed to continue with the NYSTATIN and to air dry her bottom as much as possible.  She was also switched to clear liquids for 1.5 days, 2 oz s. every 1 hour while awake.  On 04-SEP-2008 the patient was seen in the physician's office for a rash.  The patient was still using NYSTATIN twice a day until clear.  Her physical examination was normal except for the rash that was noted on her skin.  It was reported to be negative for acne.  It was described as no impressive skin lesions, erythematous macular and red in color and it appeared on the patient's right neck.  The patient was diagnosed with candidiasis of skin and nails.  At the time of this report, the patient's outcome was unknown.  Follow-up information was received from the physician's office.  The reporter stated that "we have no records on file of the patient having an adverse reaction to RECOMBIVAX HB (manufacturer unknown) and no relevance to the immunization was ever addressed".  Additional information has been requested.  All pediatric medical records are available upon request.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Respiration abnormal, Skin candida, White blood cell count normal
Clinical narrative: Information has been received from pediatric medical records and a physician concerning a 15 week old female with diaper rash who on RECOMBIVAX HB (manufacturer unknown).  Concomitant therapy included ROTATEQ (manufacturer unknown), PEDVAXHIB (manufacturer unknown), POLIOVIRUS vaccine, DTAP-IPV and PREVNAR.  On 20-AUG-2008, the patient went to the emergency room (ER) because of diarrhea and diaper rash.  It was reported that the patient was having diarrhea movements approximately 5 per day, very watery in nature.  The patient has been on her regular formula plus occasionally some solid food.  The patient has had no vomiting and was also noted to have a diaper rash for which she had been using NYSTATIN cream.  Her physical examination was normal except for the noted diaper rash on her perineum.  Laboratory diagnostic studies performed include: white blood cell count 14,200, hemoglobin 12.9, hematocrit 36.8, lymphocyte count 46, segs 42, monocyte 9, eosinophils 2 and basophils 2.  The infant was diagnosed with gastroenteritis and diaper rash.  She was instructed to continue with the NYSTATIN and to air dry her bottom as much as possible.  She was also switched to clear liquids for 1.5 days, 2 oz s. every 1 hour while awake.  On 04-SEP-2008 the patient was seen in the physician's office for a rash.  The patient was still using NYSTATIN twice a day until clear.  Her physical examination was normal except for the rash that was noted on her skin.  It was reported to be negative for acne.  It was described as no impressive skin lesions, erythematous macular and red in color and it appeared on the patient's right neck.  The patient was diagnosed with candidiasis of skin and nails.  At the time of this report, the patient's outcome was unknown.  Follow-up information was received from the physician's office.  The reporter stated that "we have no records on file of the patient having an adverse reaction to RECOMBIVAX HB (manufacturer unknown) and no relevance to the immunization was ever addressed".  Additional information has been requested.  All pediatric medical records are available upon request.
Sex: M
Vaccine: HEP
Symptoms: Acoustic stimulation tests normal, Diarrhoea, Erythema, Frequent bowel movements, Irritability
Clinical narrative: Information has been received from a physician through medical records concerning a 1 day old, 3608 gram, 21.5 inch, white male with a head circumference of 36.5 cm, who on 12-JUN-2008 was vaccinated with the first dose of RECOMBIVAX HB, 0.5 ml intramuscularly.  Concomitant medications on 12-JUN-2008 included phytonadione (MSD), 1 mg intramuscularly; and erythromycin eye ointment to both eyes.  On 13-JUN-2008 the infant was noted to be not nursing well.  His weight was noted to be 7 pounds, 11 ounces, down 3.2 %.  The child was also circumcised.  The infant was given a hearing screen and was noted to have passed the right ear.  On 14-JUN-2008 the patient was noted to have experienced some fussiness.  Also noted were approximately three to four lesions with an erythematous base and whitish center consistent with erythema toxicum.  The infants weight was noted to be 3380 grams, down 6 %.  Hearing screen was passed to the left ear.  The baby was discharged on this date.  On 16-JUN-2008 the patient was seen for a follow-up visit for weight and bilirubin.  He was initially breast fed, but did not do well, and he was changed to bottle feeding.  The parents noted that the baby was not fussy, but he wanted to eat all the time.  He experienced frequent stools.  His weight was 8 pounds.  He had gained 8 ounces in two days.  His circumcision site was noted to be healing and his skin was free of rash.  He was reported to be a healthy baby.  It was noted that his feeding pattern would need to be watched.  On 25-JUN-2008 the infant was seen for follow-up.  He continued on formula feedings.  Stools were reported to be slightly loose and slightly frequent.  The baby's exam was reported to be excellent.  There was a small umbilical granuloma noted, that was treated with silver nitrate stick.  On 12-AUG-2008 the patient was seen for a two month check up.  He was noted to be sleeping well, was on formula feedings and had no problems.  He was vaccinated with DAPTACEL (lot # C2952BA); ACTHIB or OMNI-HIB (lot #UF401AA); IPV (lot # A0805); PREVNAR (lot #C45721E); and ROTAVIRUS (lot #0209X).  Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Skin lesion, Toxic skin eruption, Umbilical granuloma, Weight
Clinical narrative: Information has been received from a physician through medical records concerning a 1 day old, 3608 gram, 21.5 inch, white male with a head circumference of 36.5 cm, who on 12-JUN-2008 was vaccinated with the first dose of RECOMBIVAX HB, 0.5 ml intramuscularly.  Concomitant medications on 12-JUN-2008 included phytonadione (MSD), 1 mg intramuscularly; and erythromycin eye ointment to both eyes.  On 13-JUN-2008 the infant was noted to be not nursing well.  His weight was noted to be 7 pounds, 11 ounces, down 3.2 %.  The child was also circumcised.  The infant was given a hearing screen and was noted to have passed the right ear.  On 14-JUN-2008 the patient was noted to have experienced some fussiness.  Also noted were approximately three to four lesions with an erythematous base and whitish center consistent with erythema toxicum.  The infants weight was noted to be 3380 grams, down 6 %.  Hearing screen was passed to the left ear.  The baby was discharged on this date.  On 16-JUN-2008 the patient was seen for a follow-up visit for weight and bilirubin.  He was initially breast fed, but did not do well, and he was changed to bottle feeding.  The parents noted that the baby was not fussy, but he wanted to eat all the time.  He experienced frequent stools.  His weight was 8 pounds.  He had gained 8 ounces in two days.  His circumcision site was noted to be healing and his skin was free of rash.  He was reported to be a healthy baby.  It was noted that his feeding pattern would need to be watched.  On 25-JUN-2008 the infant was seen for follow-up.  He continued on formula feedings.  Stools were reported to be slightly loose and slightly frequent.  The baby's exam was reported to be excellent.  There was a small umbilical granuloma noted, that was treated with silver nitrate stick.  On 12-AUG-2008 the patient was seen for a two month check up.  He was noted to be sleeping well, was on formula feedings and had no problems.  He was vaccinated with DAPTACEL (lot # C2952BA); ACTHIB or OMNI-HIB (lot #UF401AA); IPV (lot # A0805); PREVNAR (lot #C45721E); and ROTAVIRUS (lot #0209X).  Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: Information has been received from a certified medical assistant concerning a patient who "years ago" was vaccinated with RECOMBIVAX HB (manufacturer unknown) and experienced "severe allergic reaction with hives from head to toe". The patient only received 2 of the 3 recommended vaccinations as a result. Subsequently, years ago, the patient recovered from "severe allergic reaction with hives from head to toe". Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Hypersensitivity
Clinical narrative: Information has been received from a certified medical assistant concerning a 34 year old female patient who 20+ years ago (approximately 1988) was vaccinated with RECOMBIVAX HB (lot # not reported).  The medical assistant reported that on a medical form that was completed in 2002, the patient listed that she experienced severe hypersensitivity reaction to RECOMBIVAX HB.  There was no information available about the dates, symptoms or treatment.  The medical assistant also reported that the patient recovered on an unspecified date.  No other information was available.  Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Flushing, Induration, Influenza like illness, Oedema peripheral
Clinical narrative: Initial and follow up information has been received from a Registered Nurse (R.N.) concerning a 26 year old (also reported as 24 year old) female with no known allergy and Paroxysmal supraventricular tachycardia who on 29-AUG-2008 was vaccinated IM with a first dose of RECOMBIVAX HB vaccine 0.5 ML lot# 660951/0399X. On 29-SEP-2008 the patient received IM at 10:30 AM into left deltoid her second dose of RECOMBIVAX HB vaccine lot # 660951/0399X. Concomitant therapy included digoxin. In follow up report from the doctor's office it was reported that on 01-OCT-2008 (previously reported as on 30-SEP-2008) at 10:00 AM the patient developed flu-like symptoms after getting the second vaccination. Her upper left arm became swollen, red, hard, and warm. She also had pain at left deltoid site few days after the vaccination. She also experienced facial flushing. On 04-OCT-2008 patient recovered. No additional information was provided.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Pain in extremity, Skin warm
Clinical narrative: Initial and follow up information has been received from a Registered Nurse (R.N.) concerning a 26 year old (also reported as 24 year old) female with no known allergy and Paroxysmal supraventricular tachycardia who on 29-AUG-2008 was vaccinated IM with a first dose of RECOMBIVAX HB vaccine 0.5 ML lot# 660951/0399X. On 29-SEP-2008 the patient received IM at 10:30 AM into left deltoid her second dose of RECOMBIVAX HB vaccine lot # 660951/0399X. Concomitant therapy included digoxin. In follow up report from the doctor's office it was reported that on 01-OCT-2008 (previously reported as on 30-SEP-2008) at 10:00 AM the patient developed flu-like symptoms after getting the second vaccination. Her upper left arm became swollen, red, hard, and warm. She also had pain at left deltoid site few days after the vaccination. She also experienced facial flushing. On 04-OCT-2008 patient recovered. No additional information was provided.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Adverse reaction, Hypersensitivity
Clinical narrative: Information has been received from a medical assistant concerning a 22 year old female who was vaccinated with a dose of RECOMBIVAX HB, on an unspecified date. Subsequently the patient experienced an unspecified severe reaction to RECOMBIVAX HB (manufacturer unknown). The patient sought unspecified medical attention. She was subsequently determined to be allergic to yeast and she fully recovered after unspecified treatment. No further information is available.
Age: 43.0
Sex: U
Vaccine: HEP
Symptoms: Arthralgia, Fibromyalgia, Intervertebral disc degeneration, Myalgia, Pain in extremity
Clinical narrative: Information has been received from a lawyer from a case in litigation concerning a 43 year old patient who on 20-JUN-2003 was vaccinated with a first dose of RECOMBIVAX HB. Subsequently the patient developed myalgia and fibromyalgia, experienced itching on her arms and pain in her knees but did not report to her physician. On 28-JUL-2003 the patient had a second vaccination with RECOMBIVAX HB. The patient developed itching and "an odd tingling sensation" in her fingers. Then she developed more significant problems such as pain in her fingers which would travel up her left arm and shoulder to her posterior neck causing sharp pain. The treating physicians diagnosed the patient as having a degenerative disc disease from a review of an MRI. No further information available.
Age: 43.0
Sex: U
Vaccine: HEP
Symptoms: Paraesthesia, Pruritus
Clinical narrative: Information has been received from a lawyer from a case in litigation concerning a 43 year old patient who on 20-JUN-2003 was vaccinated with a first dose of RECOMBIVAX HB. Subsequently the patient developed myalgia and fibromyalgia, experienced itching on her arms and pain in her knees but did not report to her physician. On 28-JUL-2003 the patient had a second vaccination with RECOMBIVAX HB. The patient developed itching and "an odd tingling sensation" in her fingers. Then she developed more significant problems such as pain in her fingers which would travel up her left arm and shoulder to her posterior neck causing sharp pain. The treating physicians diagnosed the patient as having a degenerative disc disease from a review of an MRI. No further information available.
Sex: U
Vaccine: HEP
Symptoms: Anaphylactic reaction
Clinical narrative: Information has been received from a pharmacist concerning a patient (age and gender unspecified) who was vaccinated on an unspecified date with a dose of RECOMBIVAX HB. Subsequently, on an unspecified date, the patient experienced an anaphylactic reaction. It was unspecified if the patient sought medical treatment. The patient was reported to be recovered from anaphylactic reaction. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Convulsion
Clinical narrative: Initial information has been received from a vaccine nurse and follow-up information was received from the physician, concerning a patient who in 2007, "over a year ago", was vaccinated with RECOMBIVAX HB. Subsequently the patients developed seizure. The patient was not hospitalized. The patient recovered and left the office approximately 30 minutes after the seizure. It was reported that this happened over a year ago. It was not specified if the patient sought medical attention or not. Upon internal review, seizure was considered to be other important medical event. This is one of several reports received from the same source. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HEP
Symptoms: Pyrexia
Clinical narrative: Information has been received from a nurse practitioner concerning an 11 year old female who was vaccinated with RECOMBIVAX HB (manufacturer unknown). Subsequently the patient experienced a severe fever post vaccination and was hospitalized at the time. Subsequently, the patient recovered. Additional information has been requested.
Age: 32.0
Sex: M
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a 32 year old male with sulfonamide and penicillin allergy who on 12-NOV-2007 at 1300 was vaccinated intramuscularly into the right deltoid with his first dose of RECOMBIVAX HB (lot# 0762U). There was no concomitant medication and no illness at the time of vaccination. Thirty minutes after vaccination, the patient experienced diffuse hives. Medical attention was sought by the patient, and he was treated with 50 mg of BENADRYL. Subsequently, the patient recovered from diffuse hives on 12-NOV-2007. The nurse considered the patient's diffuse hives to be an other important medical event. No further information is expected.
Age: 49.0
Sex: F
Vaccine: HEP
Symptoms: Injection site abscess, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 49 year old female with thyroid papillary carcinoma, asthma and drug hypersensitivity to procaine and a history of renal cyst who on 25-JUL-2008 was vaccinated with RECOMBIVAX HB.  Concomitant therapy included levothyroxine Na, LEXAPRO, WELLBUTRIN, and ADVAIR DISKUS.  On 03-SEP-2008 the patient was vaccinated with a second dose of RECOMBIVAX HB (lot # 659670/0475X) and developed redness, pain, swelling and itching on her left arm at the injection site a few days after receiving her second dose of RECOMBIVAX HB.  Medical attention was sought.  The patient was diagnosed with a sterile abscess at the injection site.  No other information was available.  Additional information has been requested.
Age: 0.1
Sex: F
Vaccine: HEP
Symptoms: Acne infantile, Ear infection, Ear pain, Laboratory test, Otitis media
Clinical narrative: Initial information has been received from the physician's office via medical records concerning a baby girl with a history of neonatal jaundice, mongolian spots and torticollis after maternal exposure to GARDASIL (MSD WAES # 0708USA00006) who on 28-FEB-2007 was vaccinated with a first dose of RECOMBIVAX HB (manufacturer unknown).  On 13-MAR-2008 the baby came in for a well child visit at 15 days old.  There were no complaint or concerns at this time.  The baby recovered from neonatal jaundice.  The following lab results for the baby was negative: newborn screen amino acid D/O, Fatty Acis D/O, Organic Acid D/O, Galactosemia, Biotinidase deficiency, Endocrine D/O and Hemoglobinopathy.  A venipuncture was also performed.  Follow-up was scheduled for 2 weeks.  On 31-MAR-2008 the baby came in for a well child visit at one month and 3 days old.  The baby had a rash on her shoulder and back (acne neonatorum).  The baby was also administered DAPTACEL (Lot # C2951BA) IM 0.5 cc in the left thigh, ACTHIB (Lot # UF253AD) 0.5 cc on the right thigh, IPOL (Lot # A0490-2) IM 0.5 cc administered on the left thigh, ROTATEQ (lot # 660291/1829U) 2 mL administered orally and PREVNAR (lot # C45153) 0.5 cc administered on the right thigh.  Follow-up was scheduled for 2 months.  On 16-JUL-2008 the baby came in for a well child visit at 4 months and 18 days.  The baby holds her neck to the right side and still had craddle cap.  The baby was also administered DAPTACEL (C2934AA) IM 0.5 cc in the right thigh, ACTHIB (UF260AB) 0.5 cc on the left thigh, IPOL (Lot # A0492-2) IM 0.5 cc administered on the right thigh, ROTATEQ (Lot # 660600/0281X) 2 mL administered orally and PREVNAR (C65928) 0.5 cc administered on the left thigh.  Follow-up was scheduled for 2 months.  On 31-JUL-2008 the baby was 5 months 3 days and complained of a possible ear infection.  The baby was pulling at the left ear, dry on ear lobe- not sure if it was drainage.  Denies fever.  ENT/respiratory examination revealed throat moist membranes, post nasal drip seen, tonsils erythematous, no exudates, auditory canals normal, no wax, tympanic membranes erythema and fluid, dull appearing, bulging, nasal mucosa boggy nasal mucosa, yellowish rhinorrhea.  Assessment was otitis media, acute and otalgia nos.  The baby was given OMNICEF powder for reconstitution 125mg/ml, drops every four to six hours prn for pain and MOTRIN three to four times daily.  Follow-up was scheduled for 2 weeks.  On 28-AUG-2008 the baby came in for a well child visit at 6 months.  There were no complaints at this time.  The baby was also administered DAPTACEL IM 0.5 cc in the right thigh, ACTHIB 0.5 cc on the left thigh, RECOMBIVAX HB 0.5 cc on the right thigh, IPOL IM 0.5 cc administered on the right thigh, ROTATEQ 2 mL administered orally and PREVNAR 0.5 cc administered on the left thigh.  Follow-up was scheduled for 3 months.  Additional information is not expected.
Age: 0.1
Sex: F
Vaccine: HEP
Symptoms: Postnasal drip, Rhinorrhoea, Tonsillar inflammation, Ultrasound scan, Venipuncture
Clinical narrative: Initial information has been received from the physician's office via medical records concerning a baby girl with a history of neonatal jaundice, mongolian spots and torticollis after maternal exposure to GARDASIL (MSD WAES # 0708USA00006) who on 28-FEB-2007 was vaccinated with a first dose of RECOMBIVAX HB (manufacturer unknown).  On 13-MAR-2008 the baby came in for a well child visit at 15 days old.  There were no complaint or concerns at this time.  The baby recovered from neonatal jaundice.  The following lab results for the baby was negative: newborn screen amino acid D/O, Fatty Acis D/O, Organic Acid D/O, Galactosemia, Biotinidase deficiency, Endocrine D/O and Hemoglobinopathy.  A venipuncture was also performed.  Follow-up was scheduled for 2 weeks.  On 31-MAR-2008 the baby came in for a well child visit at one month and 3 days old.  The baby had a rash on her shoulder and back (acne neonatorum).  The baby was also administered DAPTACEL (Lot # C2951BA) IM 0.5 cc in the left thigh, ACTHIB (Lot # UF253AD) 0.5 cc on the right thigh, IPOL (Lot # A0490-2) IM 0.5 cc administered on the left thigh, ROTATEQ (lot # 660291/1829U) 2 mL administered orally and PREVNAR (lot # C45153) 0.5 cc administered on the right thigh.  Follow-up was scheduled for 2 months.  On 16-JUL-2008 the baby came in for a well child visit at 4 months and 18 days.  The baby holds her neck to the right side and still had craddle cap.  The baby was also administered DAPTACEL (C2934AA) IM 0.5 cc in the right thigh, ACTHIB (UF260AB) 0.5 cc on the left thigh, IPOL (Lot # A0492-2) IM 0.5 cc administered on the right thigh, ROTATEQ (Lot # 660600/0281X) 2 mL administered orally and PREVNAR (C65928) 0.5 cc administered on the left thigh.  Follow-up was scheduled for 2 months.  On 31-JUL-2008 the baby was 5 months 3 days and complained of a possible ear infection.  The baby was pulling at the left ear, dry on ear lobe- not sure if it was drainage.  Denies fever.  ENT/respiratory examination revealed throat moist membranes, post nasal drip seen, tonsils erythematous, no exudates, auditory canals normal, no wax, tympanic membranes erythema and fluid, dull appearing, bulging, nasal mucosa boggy nasal mucosa, yellowish rhinorrhea.  Assessment was otitis media, acute and otalgia nos.  The baby was given OMNICEF powder for reconstitution 125mg/ml, drops every four to six hours prn for pain and MOTRIN three to four times daily.  Follow-up was scheduled for 2 weeks.  On 28-AUG-2008 the baby came in for a well child visit at 6 months.  There were no complaints at this time.  The baby was also administered DAPTACEL IM 0.5 cc in the right thigh, ACTHIB 0.5 cc on the left thigh, RECOMBIVAX HB 0.5 cc on the right thigh, IPOL IM 0.5 cc administered on the right thigh, ROTATEQ 2 mL administered orally and PREVNAR 0.5 cc administered on the left thigh.  Follow-up was scheduled for 3 months.  Additional information is not expected.
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain, Eczema, Erythema, Insomnia, Respiratory tract congestion
Clinical narrative: Information has been received from a pediatrician concerning a 14 day old female baby with a history of exposure to GARDASIL while in uterus (approximately on 14-MAR-2007) (refer to WAES # 0705USA00917) and with neonatal jaundice and no known allergies who on 20-NOV-2007 was vaccinated with a first dose of RECOMBIVAX HB (manufacture unknown). On 27-NOV-2007 the baby had a well baby check-up which revealed the neonatal jaundice was improved and the "levels" were starting to decrease. On 03-DEC-2007 the baby had an office check-up and the mother reported the baby had nasal congestion, sneezing, green nasal drainage and no fever. On 04-DEC-2008 the baby was diagnosed with upper respiratory infection and treated with saline suction. On 03-JAN-2008 the baby was seen for well check up  and the mother reported that the baby had bellyache, screaming, "colicky symptoms" and not sleeping well. The baby was diagnosed with colic and treated with ENFAMIL NUTRAMIGEN. On 14-JAN-2008, the baby had a well baby check-up which revealed the colic was improved. The baby also received the following vaccinations that day: RECOMBIVAX HB (manufacturer unknown), ROTATEQ, PEDIARIX and PREVNAR. On 18-Feb-2008 the baby was seen for well check up and the mother reported that the baby had green-yellow nasal drainage, temperature 100.3. The baby was noted to have red cheeks. The baby was diagnosed with upper respiratory infection and eczema and treated with "saline bulb, "propping" and EUCERIN. On 21-FEB-2007 the baby was prescribed nystatin (reason not reported). On 01-APR-2008, the baby was seen for well check up and the mother reported that the baby had sneezing for 1 week and had no fever. The baby was diagnosed with upper respiratory infection and treated with saline. The baby also received the following vaccinations that day: RECOMBIVAX HB (manufacturer unknown), ROTATEQ, PEDIARIX and PREVNAR. On 10-APR-2008, the baby was seen for well check up and the mother reported that the baby had seen spitting up and had constipation. The baby was diagnosed with gastroesophageal reflux disease and treated with "propping" and rice cereal in all bottles. The baby's outcome was unknown for the URIs, eczema and GERD. No further information is available.
Sex: F
Vaccine: HEP
Symptoms: Rhinorrhoea, Screaming, Sneezing
Clinical narrative: Information has been received from a pediatrician concerning a 14 day old female baby with a history of exposure to GARDASIL while in uterus (approximately on 14-MAR-2007) (refer to WAES # 0705USA00917) and with neonatal jaundice and no known allergies who on 20-NOV-2007 was vaccinated with a first dose of RECOMBIVAX HB (manufacture unknown). On 27-NOV-2007 the baby had a well baby check-up which revealed the neonatal jaundice was improved and the "levels" were starting to decrease. On 03-DEC-2007 the baby had an office check-up and the mother reported the baby had nasal congestion, sneezing, green nasal drainage and no fever. On 04-DEC-2008 the baby was diagnosed with upper respiratory infection and treated with saline suction. On 03-JAN-2008 the baby was seen for well check up  and the mother reported that the baby had bellyache, screaming, "colicky symptoms" and not sleeping well. The baby was diagnosed with colic and treated with ENFAMIL NUTRAMIGEN. On 14-JAN-2008, the baby had a well baby check-up which revealed the colic was improved. The baby also received the following vaccinations that day: RECOMBIVAX HB (manufacturer unknown), ROTATEQ, PEDIARIX and PREVNAR. On 18-Feb-2008 the baby was seen for well check up and the mother reported that the baby had green-yellow nasal drainage, temperature 100.3. The baby was noted to have red cheeks. The baby was diagnosed with upper respiratory infection and eczema and treated with "saline bulb, "propping" and EUCERIN. On 21-FEB-2007 the baby was prescribed nystatin (reason not reported). On 01-APR-2008, the baby was seen for well check up and the mother reported that the baby had sneezing for 1 week and had no fever. The baby was diagnosed with upper respiratory infection and treated with saline. The baby also received the following vaccinations that day: RECOMBIVAX HB (manufacturer unknown), ROTATEQ, PEDIARIX and PREVNAR. On 10-APR-2008, the baby was seen for well check up and the mother reported that the baby had seen spitting up and had constipation. The baby was diagnosed with gastroesophageal reflux disease and treated with "propping" and rice cereal in all bottles. The baby's outcome was unknown for the URIs, eczema and GERD. No further information is available.
Sex: F
Vaccine: HEP
Symptoms: Blood bilirubin increased, Blood bilirubin unconjugated increased, Diarrhoea, Flatulence, Jaundice
Clinical narrative: Information has been received from certified physician assistant (PAC) concerning a 3 day old, 7 pounds, 5 ounce, 19.75 inch, female with a history of jaundice who on 09-APR-2008 was vaccinated with RECOMBIVAX HB (manufacturer unknown).  There was no concomitant medication.  On approximately 12-APR-2008 the patient was seen by the (PAC) for jaundice.  There was no reported history of mom/baby incomparability per the parents.  It was reported that the infant was a healthy appearing, alert, normally nourished, well hydrated child in no acute distress.  The infant had skin symptoms of jaundice to the hips.  Bilirubin levels were drawn and were as follows: neonatal bilirubin was high at 12.3; and indirect bilirubin was high at 12.0.  The infant was seen in follow-up the following day 13-APR-2008.  Neonatal bilirub was high at 13.3; and indirect bilirubin was high at 12.9.  On 14-APR-2008 the mom reported that the child "looks less yellow today."  The physician assistant reported the jaundice to be improved.  On 23-APR-2008 at a follow-up visit, the baby was reported to be "doing well presently without any significant abnormalities identified on exam."  On 12-MAY-2008 at a well exam, it was reported that the patient experienced gas and explosive stools with similac.  The infants weight was noted to be 8 pounds and 12 ounces, and height was 22 inches.  The patient was to continue with routine immunizations.  Additional information has been requested.
Age: 0.1
Sex: M
Vaccine: HEP
Symptoms: Infantile spitting up, Plagiocephaly
Clinical narrative: Pediatric medical records were received and received concerning an 6 week old male with cleft lip and a history of jaundice, spitting up and blood bilirubin abnormal (WAES # 0708USA01488) who on 29-APR-2008 was vaccinated with ROCOMBIVAX HB.  On 09-APR-2008 a 2 weeks male infant with no with no known allergies was examined.  The weight was 7 pounds 9 ounces, the length 20 3/4 inches, head circumference 14 1/4 inch, temperature 98.4 degrees F, pulse 158, respiratory frequency 40.  The infant was well.  It was noted that the patient spit up when nursing assessment: well child.  On 29-APR-2008 the 4 weeks male infant with no with no known allergies was examined.  The weight was 9 pounds 6 ounces, the length 21 inches, head circumference 14 3/4 inch, temperature 99.2 degrees F, pulse 120, respiratory frequency 32.  The baby was vaccinated with RECOMBIVAX HB IM in left thigh.  The infant was well.  On 19-MAY-2008 plagiocephaly was noted.  On 27-MAY-2008 an 8 weeks male infant with no known allergies was examined.  The weight was 11 pounds 4.5 ounces, the length 22 1/2 inches, head circumference 15 1/2 inch, temperature 99 degrees F, pulse 128, respiratory frequency 30.  Feeding problems reported as "spit up".  The infant was well.  The baby was vaccinated on this same day with:  PREVNAR (C80901) IM in right thigh.  ROTAVIRUS (660596/0211X) PO.  ACTHIB (UF352AA) IM in left thigh.  On 26-JUN-2008 the patient was vaccinated with: TRIPEDIA (C2934AA) IM in left thigh.  IPOL (A0492) SC/IM in right thigh.  On 27-AUG-2008, the patient had an upper respiratory infection.  (WAES # 0809USA02064) No additional information is expected.
Sex: F
Vaccine: HEP
Symptoms: Optic neuritis, Vision blurred, Visual impairment
Clinical narrative: Information has been received from a female pharmacist concerning herself who in earlier 2008 was vaccinated with a first and second dose of RECOMBIVAX HB.  The reporter reported that she had been experiencing some visual disturbances after she received her RECOMBIVAX HB vaccine.  She started to have blurred visions on her left eye.  She went to see an ophthalmologist and was diagnosed with optic neuritis.  No further information was available.  The patient had not recovered.  Additional information has been requested.
Sex: M
Vaccine: HEP, HEP
Symptoms: Malaise
Clinical narrative: Information has been received from an office manager concerning a male who on unspecified dates was vaccinated with three doses of RECOMBIVAX HB (lot numbers: 654745/0608F and 655149/0006U (unspecified for which doses).  The office manager reported that the patient have not seroconverted after 3 doses of RECOMBIVAX HB were given.  The reporter also indicated that the patient was feeling "sick".  No further information was available.  This is one of several reports received from the same source.  A standard lot check investigation was performed.  All in-process quality checks for the lot number (654745/0608F) in question were satisfactory.  In addition, an expanded lot check investigation was performed.  The testing performed on the batch prior to release met all release specifications.  The lot met the requirements of the Centers for Biologics Evaluation and Research and was released.  Supplemental lot information of 03-FEB-2009 reported that a standard lot check investigation was performed.  All in-process quality checks for the lot number (655149/0006U) in question were satisfactory.  In addition, an expanded lot check investigation was performed.  The testing performed on the batch prior to release met all release specifications.  The lot met the requirements of the Center for Biologics Evaluation and Research and was released.  Additional information has been requested.