chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Laboratory test normal, Malaise, Swelling, Weight fluctuation
Clinical narrative: Information has been received from a nurse practitioner concerning a 34 year old, unemployed, female patient with depression and a history of hepatitis C, with no illnesses at time of vaccination, who on 10-JUL-2008, was vaccinated with a first dose of RECOMBIVAX HB, (lot # 660951/0399X) intramuscularly to the right deltoid.  On 31-JUL-2008, the patient experienced body swelling, joint pain, malaise and weight fluctuations.  The patient had gained 12 pounds since her last visit.  Unspecified medical attention was sought.  The nurse practitioner reported that weight fluctuated by 10 pounds.  At the time of this report, it was unknown if the patient had recovered.  No product quality complaint was involved.  On 26-AUG-2008, the patient was vaccinated with the second dose of RECOMBIVAX HB, lot # 653363/1283F) intramuscularly to the right deltoid.  Additional information had been requested.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Allergy to vaccine, Pharyngeal oedema
Clinical narrative: Initial and follow up information has been received from a nurse practitioner concerning a 20 year old female who on an unspecified date was vaccinated with a second dose of RECOMBIVAX HB (manufacturer unknown).  The nurse practitioner reported that the patient was told she was "allergic" to RECOMBIVAX HB (manufacturer unknown).  The nurse practitioner also reported that the patient's throat became swollen 2-3 days after her second dose of RECOMBIVAX HB (manufacturer unknown).  In follow up the nurse practitioner reported that she had no additional details as the vaccine was not administered at "our" site.  She reported that the patient stated the information in response to the question "have you ever had an adverse reaction to an immunization?" GARDASIL was not administered due to the answer.  Additional information is not expected.
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Joint stiffness, Musculoskeletal stiffness, Neck pain
Clinical narrative: Information has been received from a registered nurse concerning a 46 year old female with a history of knee problems and an allergy to band aids, who on 02-JUL-2008 was vaccinated IM in the left deltoid with a 10mcg first dose of RECOMBIVAX HB (Lot # 660951/0398X).  Concomitant therapy included PERCOCET, LEXAPRO and ALEVE.  Subsequently, on an unspecified date, the patient experienced neck stiffness on the left side.  The patient recovered from neck stiffness on an unspecified date.  On 12-AUG-2008 the patient was vaccinated IM in the left deltoid with a second dose of RECOMBIVAX HB (Lot # 660951/0398X).  There were no illnesses at the time of the vaccination.  On 13-AUG-2008 the patient experienced stiffness and soreness of her neck and left shoulder that lasted approximately two weeks.  The second time was more pronounced than the first time.  The patient sought unspecified medical attention.  No laboratory diagnostics were performed.  The patient recovered on 27-AUG-2008.  No product quality complaint was involved.  Additional information had been requested.
Sex: F
Vaccine: HEP
Symptoms: Back pain, Liver function test abnormal, Multiple sclerosis, Myelitis transverse, Pain
Clinical narrative: Initial and follow-up information has been received regarding a case in litigation from information obtained from a published article concerning a female who on 09-JAN-2002 was vaccinated with a dose of RECOMBIVAX HB (manufacturer unknown). Three days post vaccination a routine examination showed elevated liver enzymes attributed to the vaccination. It was reported that the patient alleged that the vaccination caused her to experience an onset of pain on 16-MAR-2002. On 17-MAR-2002 the patient was admitted to the hospital for "severe stabbing back pain radiating to both legs for five days." The patient's liver enzymes were five to six times the normal limit. On 22-MAR-2002 the patient was diagnosed with transverse myelitis. On 24-MAY-2004 the patient was diagnosed with multiple sclerosis. The patient also had prominent pain syndrome. The patient's outcome was unknown. The multiple sclerosis, transverse myelitis, and elevated liver enzymes were considered to be related to the vaccination. Upon internal review, the multiple sclerosis was determined to be an other important medical event. No further information is available.
Sex: F
Vaccine: HEP
Symptoms: Convulsion
Clinical narrative: Information has been received from a nurse practitioner via the patient's mother concerning her daughter with a history of bulimia who about 9 years ago, was vaccinated with a second dose of RECOMBIVAX HB (manufacturer unspecified) and experienced a seizure (date unspecified). No other symptoms were reported. The patient recovered on an unspecified date. Upon internal review, the seizure was determined to be an other important medical event. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HEP
Symptoms: Hypersensitivity
Clinical narrative: Information has been received from a medical assistant concerning a 20 year old female who was vaccinated with RECOMBIVAX HB.  Concomitant therapy included MENINGOCOCCAL vaccine (unspecified).  Subsequently the patient experienced an unspecified allergic reaction when she received her first dose of RECOMBIVAX HB.  The patient received the vaccine by her primary care physician when she was in the 7th grade.  The patient was no longer under the care of the same physician therefore there was no additional AE information available.  Subsequently, the patient recovered from unspecified allergic reaction.  Follow-up information was received from the physician's office.  The healthcare professional stated that the "patient did not have the GARDASIL vaccine due to an apparent allergy to aluminum, had reaction after receiving RECOMBIVAX HB and MENINGOCOCCAL vaccine series was done.  Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Information has been received from a nurse practitioner concerning a 14 year old female who was vaccinated with the first dose of RECOMBIVAX HB and experienced hives. The patient received the vaccine at another facility. It was reported that the patient recovered from hives on an unknown date. Unspecified medical attention was sought. No product quality complaint involved. Additional information is not expected.
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Chest discomfort, Pericarditis, Pyrexia
Clinical narrative: Information has been received from a 50 year old female registered nurse with hypothyroidism and allergy to non-steroidal anti-inflammatory medications, who on 08-JAN-2008 was vaccinated with a first dose of RECOMBIVAX HB, 1 ml intramuscularly.  On 28-FEB-2008 was vaccinated with a second dose of RECOMBIVAX HB (Lot # 656879/1148U) and on 02-JUL-2008 was vaccinated with a third dose of RECOMBIVAX HB (Lot # 660951/0398X).  Concomitant therapy included SYNTHROID and TAPAZOLE.  On 13-JUL-2008 the patient developed chest discomfort on inspiration and low-grade fever.  On 20-JUL-2008, she was examined in a local emergency room and had an electrocardiogram, chest X-ray, unspecified blood work, and computerized tomography of the chest.  A diagnosis of pericarditis was made, and the patient was prescribed a four day course of prednosone 40 mg daily.  The symptoms resolved.  On 29-JUL-2008 the chest discomfort returned and the patient was scheduled to see her physician.  There was no product quality complaint.  No further information is available.
Sex: F
Vaccine: HEP
Symptoms: Hyperventilation
Clinical narrative: Information has been received from a registered nurse concerning her daughter who sometime in 1998 was vaccinated with a dose of RECOMBIVAX HB.  Her daughter hyperventilated after the administration of the vaccine.  She sought unspecified medical attention.  At the time of the report the patient's outcome was unknown.  No product quality complaint was involved.  No further information is available.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B
Clinical narrative: Information has been received from a nurse concerning a dialysis patient who was vaccinated with five doses RECOMBIVAX HB (dates of vaccination were 8-AUG-2006 (40 mcg/ml), 16-SEP-2006, 17-FEB-2007, 19-JAN-2008, and 19-FEB-2008). On an unspecified date the patient became positive for Hepatitis B. Patient outcome was not provided. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Hypersensitivity
Clinical narrative: Information has been received from a nurse practitioner who heard that a female who was vaccinated with a dose of hepatitis B virus vaccine (manufacturer unknown) and had an unspecified "allergic reaction". At the time of the report, the patient had recovered. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Information has been received from a consumer concerning her friend's son who in 2008 (also reported as 2001) was vaccinated with one dose of RECOMBIVAX HB (lot # not reported).  In 2008 the patient developed hives.  On an unspecified date, the patient recovered from hives.  The reporter noted that the patient did not receive the second dose of RECOMBIVAX HB.  No further information was available.  Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Adverse event
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with RECOMBIVAX HB. Subsequently the patient experienced an adverse event. No further information is available. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Abdominal distension, Inappropriate schedule of drug administration, Jaundice, Overdose
Clinical narrative: Information has been received from a consumer concerning her daughter who in 1995 was vaccinated with RECOMBIVAX HB.  In 1995 the patient was born and in hospital she was given RECOMBIVAX HB, but the nurse who given the injection did not write that the injection was given and when the next nurse came in she gave another dose of RECOMBIVAX HB to the patient.  It was reported that the patient Subsequently developed jaundice and her mother stated that she did not breast feed her daughter, and believed the jaundice was from getting two dose of RECOMBIVAX HB.  In 2008 the mother stated that her daughter's liver was positioned the area was harder and bigger and she was bloated.  At the time of this report, the outcome was unknown.  The reporter felt that jaundice was related to therapy with RECOMBIVAX HB.  No product quality complaint was involved.  No further information is available.
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Flushing, Hypoaesthesia, Nausea, Paraesthesia, Paraesthesia oral
Clinical narrative: Information has been received from a registered nurse concerning a 32 year old female with a history of migraine headaches, PENICILLIN allergy, hypersensitivity to "quinones" and SULFONAMIDE allergy who on 06-JUN-2008 was vaccinated IM with the first dose of RECOMBIVAX HB (lot# 656680/0218U) (site not reported).  Concomitant therapy included RELPAX and KLONOPIN.  On 06-JUN-2008, the nurse reported that the patient experienced numbness and tingling of her face and tongue, a flushed feeling and nausea within 20 minutes of her vaccination.  There was no swelling or shortness of breath.  The patient sought medical attention at the office.  The patient recovered within 6 hours of the onset of symptoms without requiring treatment.  No further information is available.  Follow-up information was received on 04-AUG-2008 by the caller stating that she had received a second letter from product safety.  The caller has filled out the first letter and has no additional information to report.  The caller does not want to be contacted further.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Back pain, Computerised tomogram normal, Headache, Laboratory test
Clinical narrative: Information has been received from a nurse practitioner concerning an approximate 35-year-old female with a history of motor vehicle accident that resulted in a back injury (according to the patient her back pain is not a chronic issue) who on 20-NOV-2007 and 21-DEC-2007 was vaccinated with her first and second dose of RECOMBIVAX HB.  On 22-NOV-2007, 2 days post vaccination, the patient experienced "body aches" that lasted for one week.  On 24-DEC-2007, 3 days post vaccination, the patient experienced "severe body aches".  The "body aches" have not resolved.  The discomfort is reported to be mostly in her hips and lower back.  The patient stated to the nurse that her "pain and headache were so bad last night that she was seen at the emergency room".  On 07-JAN-2007 the patient had blood work and a CT scan of the head performed in the emergency room.  The nurse practitioner reported that all of the patient's test and labs were negative.  The patient will be following up with her primary care physician.  At the time of the report the patient's status was not recovered.  A product quality complaint was not involved.  No further information is available.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Pain
Clinical narrative: Information has been received from a nurse practitioner concerning an approximate 35-year-old female with a history of motor vehicle accident that resulted in a back injury (according to the patient her back pain is not a chronic issue) who on 20-NOV-2007 and 21-DEC-2007 was vaccinated with her first and second dose of RECOMBIVAX HB.  On 22-NOV-2007, 2 days post vaccination, the patient experienced "body aches" that lasted for one week.  On 24-DEC-2007, 3 days post vaccination, the patient experienced "severe body aches".  The "body aches" have not resolved.  The discomfort is reported to be mostly in her hips and lower back.  The patient stated to the nurse that her "pain and headache were so bad last night that she was seen at the emergency room".  On 07-JAN-2007 the patient had blood work and a CT scan of the head performed in the emergency room.  The nurse practitioner reported that all of the patient's test and labs were negative.  The patient will be following up with her primary care physician.  At the time of the report the patient's status was not recovered.  A product quality complaint was not involved.  No further information is available.
Age: 30.0
Sex: U
Vaccine: HEP
Symptoms: Pain, Rash
Clinical narrative: Information has been received regarding a case in litigation from a physician concerning a 30-year-old patient who was vaccinated with a second dose of RECOMBIVAX HB.  On an unspecified date, following the second dose of RECOMBIVAX HB, the patient developed a rash and pain.  A third dose of RECOMBIVAX HB was not given.  The patient sought unspecified medical attention.  At the time of the report the patient's status was unknown.  A product quality complaint was not involved.  Additional information has been requested.
Age: 53.0
Sex: M
Vaccine: HEP
Symptoms: Myelitis transverse, Paraesthesia
Clinical narrative: Information has been received from a case in litigation via a case report concerning a 53-year-old male who on 04-NOV-2000 was vaccinated with a second dose of RECOMBIVAX HB.  At the time of vaccination he had symptoms of cough and congestion that had started the day before (03-NOV-2000).  On 01-DEC-2000, he returned to his physician complaining of tingling in his feet, going up his legs and some tingling in his fingers that began on 30-NOV-2000.  The patient was diagnosed with transverse myelitis (TM).  Three physicians considered the TM to be post-vaccinal with upper respiratory infection as a likely or possible contributing factor.  Follow-up information received from a case in litigation via a case report indicated that a Special Masters has awarded benefits to a man who alleged that RECOMBIVAX HB in conjunction with an upper respiratory infection (URI) at the time of his vaccination brought on transverse myelitis (TM).  It was noted "in this case, two factors, RECOMBIVAX HB vaccination and an upper respiratory infection, can both be substantial factors in causing the patient's transverse myelitis.  Upon internal review, transverse myelitis was determined to be an other important medical event.  No further information is available.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 22 year old female with no medical history or allergies who on 15-JAN-2008 was vaccinated IM with a first 1.0 ml dose of RECOMBIVAX HB (Lot # 655566/0659U). There was no concomitant medication. On 16-JAN-2008, one day after vaccination developed a fever of 102 F. The patient self-treated with TYLENOL and the fever resolved on 17-JAN-2008. At the time of report the patient was fully recovered. A product quality complaint was not involved. No further information is available.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B core antigen positive, Surgery
Clinical narrative: Information has been received from a pharmacist concerning a 23 year old female with a history of unspecified surgery and contemplated blood donation (December 2007) who in 1995 was vaccinated with 'a standard dose' intramuscular of Hepatitis B core antibody with no evidence of current infection. The pharmacist reported that the patient had donated blood shortly after receiving RECOMBIVAX HB series in 1995 and was told that her blood tested positive for Hepatitis B core antibody. It was indicated that testing was not done prior to vaccination so her status was unknown at that time. It was indicated that the patient had mentioned that she had unspecified surgery and pre-surgery laboratory studies did not show a positive Hepatitis B core antibody (unspecified date). It was indicated that the patient had not been experiencing any symptoms and was told that she was not contagious. Medical attention was sought by "contacting" a physician and pharmacist. At the time of this report, the patient had recovered. A product quality complaint was not reported. No further information is available.
Sex: F
Vaccine: HEP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning a female in approximately her mid 40's with no allergy to yeast (any other allergies unknown) who on 06-FEB-2008 was vaccinated IM with her third 1.0 ml dose of RECOMBIVAX HB (lot # 656876/0874U) in the left deltoid. On 07-FEB-2008 the patient developed severe cellulitis of the left arm from the injection site down to the end. The left arm was hot to touch, swollen and painful. The patient sought unspecified medical attention. The patient was treated with KEFLEX 500mg times a day and possibly BENADRYL. The redness had resolved and swelling decreased since starting on treatment. The patient continued to have left axillary lymph node pain that "felt tight but better." It was also noted that the patient failed to seroconvert after the past first and second completed series of RECOMBIVAX HB. The nurse mentioned that the patient was not currently taking any type of immunocompromising agents. There was no product quality complaint. In follow up information from the doctor's office it was reported that no further changes noted. Issue resolved. Additional information is not expected.
Sex: F
Vaccine: HEP
Symptoms: Laboratory test abnormal, Lymph node pain, No therapeutic response
Clinical narrative: Information has been received from a registered nurse concerning a female in approximately her mid 40's with no allergy to yeast (any other allergies unknown) who on 06-FEB-2008 was vaccinated IM with her third 1.0 ml dose of RECOMBIVAX HB (lot # 656876/0874U) in the left deltoid. On 07-FEB-2008 the patient developed severe cellulitis of the left arm from the injection site down to the end. The left arm was hot to touch, swollen and painful. The patient sought unspecified medical attention. The patient was treated with KEFLEX 500mg times a day and possibly BENADRYL. The redness had resolved and swelling decreased since starting on treatment. The patient continued to have left axillary lymph node pain that "felt tight but better." It was also noted that the patient failed to seroconvert after the past first and second completed series of RECOMBIVAX HB. The nurse mentioned that the patient was not currently taking any type of immunocompromising agents. There was no product quality complaint. In follow up information from the doctor's office it was reported that no further changes noted. Issue resolved. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: HEP
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase decreased, Blood cholesterol increased, Blood triglycerides increased, Hepatic enzyme increased
Clinical narrative: Information has been received from a registered nurse concerning a Caucasian female with allergies to CODEINE, METHANOL and PENICILLIN who on 21-FEB-2007 was vaccinated with a dose of RECOMBIVAX HB (654018/0904F).  Concomitant therapy included LIPITOR, fexofenadine hydrochloride, fluticasone propionate and PATANOL.  A nurse mentioned a patient completed the RECOMBIVAX HB series and the titer was found to be "0" from labs drawn on 31-Oct-2007 and results drawn in the beginning of Dec-2007.  The patient also had a "cold" on Dec-2007 and was "not feeling well".  The patient was found to have elevated liver enzymes from labs drawn on 15-Jan-2008 (AST- 80, ALT- 128).  The patient was taking atorvastatin calcium 20 mg prior to receiving RECOMBIVAX HB and because of the elevated liver enzymes, was told to cut the dose of atorvastatin calcium in half.  The patient had labs drawn on 12-Feb-2008 and liver enzymes were elevated again (AST - 92, ALT - 151).  The nurse also noted that the patient's cholesterol went up from 110 to 141, triglycerides went from 46 to 90, LDL went from 53 to 70, and HDL went from 40 to 50.  The patient received 1st dose of RECOMBIVAX HB on 21-Feb-2007, 2nd dose of RECOMBIVAX HB on 21-Mar-2007 and 3rd dose of RECOMBIVAX HB on 28-Aug-2007.  All doses were given as 1 ml, IM in the left deltoid.  Liver enzymes prior to starting RECOMBIVAX HB series was unknown.  It was not reported if the patient recovered.  Regards to medical attention, the patient called the nurse.  Follow up information and laboratory results received from the RN, indicated that the patient had a medical history of increased lipids.  There was no illness at the time of vaccination.  On 04-MAR-2008, the patient was considered recovered from the increased liver function tests, as AST and ALT had "dropped to near normal" (AST, 41 U/L; ALT 76 U/L).  In March of 2008, following the labs, the patient restarted (LIPITOR), but on 23-MAR-2008 it was discontinued, and QUESTRAN Light was initiated.  On 21-APR-2008, the AST had increased to 107 U/L, and ALT to 187 U/L, with all of the following lab results within normal rang; triglycerides, cholesterol, LDL cholesterol, VLDL cholesterol, HDL cholesterol.  The nurse indicated the physician had been advised to "hold on second hepatitis B series for present time."  Additional labs were planned for June.  Additional information is not expected.  Medical records provided upon request.
Age: 60.0
Sex: F
Vaccine: HEP
Symptoms: High density lipoprotein increased, Laboratory test normal, Low density lipoprotein increased, Malaise
Clinical narrative: Information has been received from a registered nurse concerning a Caucasian female with allergies to CODEINE, METHANOL and PENICILLIN who on 21-FEB-2007 was vaccinated with a dose of RECOMBIVAX HB (654018/0904F).  Concomitant therapy included LIPITOR, fexofenadine hydrochloride, fluticasone propionate and PATANOL.  A nurse mentioned a patient completed the RECOMBIVAX HB series and the titer was found to be "0" from labs drawn on 31-Oct-2007 and results drawn in the beginning of Dec-2007.  The patient also had a "cold" on Dec-2007 and was "not feeling well".  The patient was found to have elevated liver enzymes from labs drawn on 15-Jan-2008 (AST- 80, ALT- 128).  The patient was taking atorvastatin calcium 20 mg prior to receiving RECOMBIVAX HB and because of the elevated liver enzymes, was told to cut the dose of atorvastatin calcium in half.  The patient had labs drawn on 12-Feb-2008 and liver enzymes were elevated again (AST - 92, ALT - 151).  The nurse also noted that the patient's cholesterol went up from 110 to 141, triglycerides went from 46 to 90, LDL went from 53 to 70, and HDL went from 40 to 50.  The patient received 1st dose of RECOMBIVAX HB on 21-Feb-2007, 2nd dose of RECOMBIVAX HB on 21-Mar-2007 and 3rd dose of RECOMBIVAX HB on 28-Aug-2007.  All doses were given as 1 ml, IM in the left deltoid.  Liver enzymes prior to starting RECOMBIVAX HB series was unknown.  It was not reported if the patient recovered.  Regards to medical attention, the patient called the nurse.  Follow up information and laboratory results received from the RN, indicated that the patient had a medical history of increased lipids.  There was no illness at the time of vaccination.  On 04-MAR-2008, the patient was considered recovered from the increased liver function tests, as AST and ALT had "dropped to near normal" (AST, 41 U/L; ALT 76 U/L).  In March of 2008, following the labs, the patient restarted (LIPITOR), but on 23-MAR-2008 it was discontinued, and QUESTRAN Light was initiated.  On 21-APR-2008, the AST had increased to 107 U/L, and ALT to 187 U/L, with all of the following lab results within normal rang; triglycerides, cholesterol, LDL cholesterol, VLDL cholesterol, HDL cholesterol.  The nurse indicated the physician had been advised to "hold on second hepatitis B series for present time."  Additional labs were planned for June.  Additional information is not expected.  Medical records provided upon request.
Sex: F
Vaccine: HEP
Symptoms: Hypersensitivity
Clinical narrative: Information has been received from a nurse practitioner concerning a female who was vaccinated with a nurse practitioner concerning a female who was vaccinated with a dose of RECOMBIVAX HB (lot # not provided) (manufacturer unknown).  Subsequently the patient experienced an allergic reaction.  The patient sought unspecified medical attention.  Therapy with RECOMBIVAX HB was discontinued.  Subsequently, the patient recovered.  There was no product quality complaint.  No further information is available.
Age: 1.2
Sex: F
Vaccine: DTAP, HEP, PNC
Symptoms: Inappropriate schedule of drug administration, Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a 14 month old female patient with no pertinent medical history or drug allergies who on 17-MAR-2008 was vaccinated intramuscularly into the left thigh with her third of 0.5 ml dose of RECOMBIVAX HB (lot# 656876/0874U). Concomitant therapy included DTAP (Lot # AC14B069AA) and PREVNAR (Lot # C56540). On 08-DEC-2006 and 28-FEB-2008 she received her first and second dose of RECOMBIVAX HB. It was reported that she did not have any difficulties with either of the first or second dose. On 17-MAR-2008 in the evening after vaccination, the patient experienced hives on her left leg. No labs or diagnostic studies were performed. The patient was given BENADRYL as per the physician's request when he spoke with the patient's mother that evening. The patient recovered on 18-MAR-2008. It was also noted that the patient's twin sister was vaccinated with doses of RECOMBIVAX HB and did not have any difficulties. There was no product quality complaint. No further information is available.
Sex: F
Vaccine: HEP
Symptoms: Auricular swelling, Candidiasis, Constipation, Crying, Dehydration
Clinical narrative: Information has been received from medical records concerning a female infant (full term normal baby girl weighing 7 pounds 8.4 ounces with a length of 19.9 inches, apgar 8/9) who on 17-SEP-2007 was vaccinated with RECOMBIVAX HB (manufacturer unknown). On 29-SEP-2007, the patient's baby was seen by a pediatrician due to constant crying. There was no fever and no cough, but some congestion. The baby was also spitting up 2-3 times per day after feeding about 20-30 minutes. On 28-SEP-2007 the baby had projectile vomiting but no diarrhea. There was no blood in emesis or stools. The patient was passing gas frequently. The physician assessed as questionable colic. On 16-OCT-2007 the baby was seen again for gas and having spit up. The physician recorded "maybe early VS or maybe normal bowel". On 11-DEC-2007 the baby was seen for a two week history of spitting up, being fussy, screaming before feeding and bed and with projectile vomiting times one in the am. There was no diarrhea, and stools were pasty-hard pebbles. The baby had a clear runny nose and congestion. The baby was assessed for GERD vs cow's milk/soy protein intolerance and constipation. On 21-DEC-2007, the baby had no vomiting on soy and no reflux was noted. 21-DEC-2007 the baby was vaccinated with ROTATEQ, DTAP (unspecified), POLIO (unspecified), HIB (unspecified carrier), PNEUMO (unspecified), RECOMBIVAX HB (manufacturer unknown). On 22-JAN-2008 the baby was seen by a pediatrician due to concerns from the mother of "raspy breathing/questionable wheeze" which started on 20-JAN-2008. Upon assessment, the baby's lungs were clear. On 22-JAN-2008 was vaccinated with ROTATEQ, DTAP (unspecified), POLIO (unspecified), HIB (unspecified carrier), PNEUMO (unspecified), RECOMBIVAX HB (manufacturer unknown). On 30-JAN-2008 the patient's baby was noted to have thrush on the lips and was treated with nystatin. On 28-FEB-2008 the baby was seen by a pediatrician for complaints of a questionable earache. The baby was noted to have an erythematous dry skin on both cheeks with a dry patch that had been enlarging and behind the left ear. Treatment with vaseline did not help. Dry skin was also noted on the trunk and extremities. The baby also had a cough and swelling in the left ear. The baby was diagnosed with a mild upper respiratory infection, eczema and dehydration and treated with nasal suctioning, TYLENOL, EUCERIN. At the time of this report, the outcome of the infant's events was unknown. No further information is available.
Sex: F
Vaccine: HEP
Symptoms: Dry skin, Ear pain, Eczema, Faeces hard, Flatulence
Clinical narrative: Information has been received from medical records concerning a female infant (full term normal baby girl weighing 7 pounds 8.4 ounces with a length of 19.9 inches, apgar 8/9) who on 17-SEP-2007 was vaccinated with RECOMBIVAX HB (manufacturer unknown). On 29-SEP-2007, the patient's baby was seen by a pediatrician due to constant crying. There was no fever and no cough, but some congestion. The baby was also spitting up 2-3 times per day after feeding about 20-30 minutes. On 28-SEP-2007 the baby had projectile vomiting but no diarrhea. There was no blood in emesis or stools. The patient was passing gas frequently. The physician assessed as questionable colic. On 16-OCT-2007 the baby was seen again for gas and having spit up. The physician recorded "maybe early VS or maybe normal bowel". On 11-DEC-2007 the baby was seen for a two week history of spitting up, being fussy, screaming before feeding and bed and with projectile vomiting times one in the am. There was no diarrhea, and stools were pasty-hard pebbles. The baby had a clear runny nose and congestion. The baby was assessed for GERD vs cow's milk/soy protein intolerance and constipation. On 21-DEC-2007, the baby had no vomiting on soy and no reflux was noted. 21-DEC-2007 the baby was vaccinated with ROTATEQ, DTAP (unspecified), POLIO (unspecified), HIB (unspecified carrier), PNEUMO (unspecified), RECOMBIVAX HB (manufacturer unknown). On 22-JAN-2008 the baby was seen by a pediatrician due to concerns from the mother of "raspy breathing/questionable wheeze" which started on 20-JAN-2008. Upon assessment, the baby's lungs were clear. On 22-JAN-2008 was vaccinated with ROTATEQ, DTAP (unspecified), POLIO (unspecified), HIB (unspecified carrier), PNEUMO (unspecified), RECOMBIVAX HB (manufacturer unknown). On 30-JAN-2008 the patient's baby was noted to have thrush on the lips and was treated with nystatin. On 28-FEB-2008 the baby was seen by a pediatrician for complaints of a questionable earache. The baby was noted to have an erythematous dry skin on both cheeks with a dry patch that had been enlarging and behind the left ear. Treatment with vaseline did not help. Dry skin was also noted on the trunk and extremities. The baby also had a cough and swelling in the left ear. The baby was diagnosed with a mild upper respiratory infection, eczema and dehydration and treated with nasal suctioning, TYLENOL, EUCERIN. At the time of this report, the outcome of the infant's events was unknown. No further information is available.
Sex: F
Vaccine: HEP
Symptoms: Gastrooesophageal reflux disease, Infantile spitting up, Irritability, Milk allergy, Rash erythematous
Clinical narrative: Information has been received from medical records concerning a female infant (full term normal baby girl weighing 7 pounds 8.4 ounces with a length of 19.9 inches, apgar 8/9) who on 17-SEP-2007 was vaccinated with RECOMBIVAX HB (manufacturer unknown). On 29-SEP-2007, the patient's baby was seen by a pediatrician due to constant crying. There was no fever and no cough, but some congestion. The baby was also spitting up 2-3 times per day after feeding about 20-30 minutes. On 28-SEP-2007 the baby had projectile vomiting but no diarrhea. There was no blood in emesis or stools. The patient was passing gas frequently. The physician assessed as questionable colic. On 16-OCT-2007 the baby was seen again for gas and having spit up. The physician recorded "maybe early VS or maybe normal bowel". On 11-DEC-2007 the baby was seen for a two week history of spitting up, being fussy, screaming before feeding and bed and with projectile vomiting times one in the am. There was no diarrhea, and stools were pasty-hard pebbles. The baby had a clear runny nose and congestion. The baby was assessed for GERD vs cow's milk/soy protein intolerance and constipation. On 21-DEC-2007, the baby had no vomiting on soy and no reflux was noted. 21-DEC-2007 the baby was vaccinated with ROTATEQ, DTAP (unspecified), POLIO (unspecified), HIB (unspecified carrier), PNEUMO (unspecified), RECOMBIVAX HB (manufacturer unknown). On 22-JAN-2008 the baby was seen by a pediatrician due to concerns from the mother of "raspy breathing/questionable wheeze" which started on 20-JAN-2008. Upon assessment, the baby's lungs were clear. On 22-JAN-2008 was vaccinated with ROTATEQ, DTAP (unspecified), POLIO (unspecified), HIB (unspecified carrier), PNEUMO (unspecified), RECOMBIVAX HB (manufacturer unknown). On 30-JAN-2008 the patient's baby was noted to have thrush on the lips and was treated with nystatin. On 28-FEB-2008 the baby was seen by a pediatrician for complaints of a questionable earache. The baby was noted to have an erythematous dry skin on both cheeks with a dry patch that had been enlarging and behind the left ear. Treatment with vaseline did not help. Dry skin was also noted on the trunk and extremities. The baby also had a cough and swelling in the left ear. The baby was diagnosed with a mild upper respiratory infection, eczema and dehydration and treated with nasal suctioning, TYLENOL, EUCERIN. At the time of this report, the outcome of the infant's events was unknown. No further information is available.
Sex: F
Vaccine: HEP
Symptoms: Respiratory tract congestion, Rhinorrhoea, Screaming, Vomiting projectile
Clinical narrative: Information has been received from medical records concerning a female infant (full term normal baby girl weighing 7 pounds 8.4 ounces with a length of 19.9 inches, apgar 8/9) who on 17-SEP-2007 was vaccinated with RECOMBIVAX HB (manufacturer unknown). On 29-SEP-2007, the patient's baby was seen by a pediatrician due to constant crying. There was no fever and no cough, but some congestion. The baby was also spitting up 2-3 times per day after feeding about 20-30 minutes. On 28-SEP-2007 the baby had projectile vomiting but no diarrhea. There was no blood in emesis or stools. The patient was passing gas frequently. The physician assessed as questionable colic. On 16-OCT-2007 the baby was seen again for gas and having spit up. The physician recorded "maybe early VS or maybe normal bowel". On 11-DEC-2007 the baby was seen for a two week history of spitting up, being fussy, screaming before feeding and bed and with projectile vomiting times one in the am. There was no diarrhea, and stools were pasty-hard pebbles. The baby had a clear runny nose and congestion. The baby was assessed for GERD vs cow's milk/soy protein intolerance and constipation. On 21-DEC-2007, the baby had no vomiting on soy and no reflux was noted. 21-DEC-2007 the baby was vaccinated with ROTATEQ, DTAP (unspecified), POLIO (unspecified), HIB (unspecified carrier), PNEUMO (unspecified), RECOMBIVAX HB (manufacturer unknown). On 22-JAN-2008 the baby was seen by a pediatrician due to concerns from the mother of "raspy breathing/questionable wheeze" which started on 20-JAN-2008. Upon assessment, the baby's lungs were clear. On 22-JAN-2008 was vaccinated with ROTATEQ, DTAP (unspecified), POLIO (unspecified), HIB (unspecified carrier), PNEUMO (unspecified), RECOMBIVAX HB (manufacturer unknown). On 30-JAN-2008 the patient's baby was noted to have thrush on the lips and was treated with nystatin. On 28-FEB-2008 the baby was seen by a pediatrician for complaints of a questionable earache. The baby was noted to have an erythematous dry skin on both cheeks with a dry patch that had been enlarging and behind the left ear. Treatment with vaseline did not help. Dry skin was also noted on the trunk and extremities. The baby also had a cough and swelling in the left ear. The baby was diagnosed with a mild upper respiratory infection, eczema and dehydration and treated with nasal suctioning, TYLENOL, EUCERIN. At the time of this report, the outcome of the infant's events was unknown. No further information is available.
Age: 65.0
Sex: F
Vaccine: HEP
Symptoms: Coeliac disease, Oedema peripheral
Clinical narrative: Information has been received from a nurse practitioner concerning a 65 year old female with allergies to DEMEROL, codeine, and "DARVIN", and a history of celiac disease who in 1992, received a first and second dose, and in 1993, received a third dose of RECOMBIVAX HB (specific dates not reported).  It was indicated that after the first two doses in 1992 (specific dates not reported) of RECOMBIVAX HB her feet swelled.  After the third dose in 1993 (specific dates not reported), it was indicated that all of her joints swelled and the reaction lasted for 8 months.  The nurse practitioner indicated that the patient was monitored by her health care provider, but no treatment was reported.  On unspecified dates, she recovered from the events.  A product quality complaint was not reported.  Other medical events included: Celiac disease (diagnosed after the vaccine events (date not reported); also reported as medical history).  Additional information is not expected.
Sex: F
Vaccine: HEP
Symptoms: Body temperature fluctuation, Body temperature increased, Cough, Dehydration, Haematocrit decreased
Clinical narrative: Information has been received from a physician concerning an 8 month old black female with no known drug allergies, who on 02-AUG-2007 was vaccinated with a dose of RECOMBIVAX HB (manufacturer unknown).  Concomitant suspect vaccinations included ROTATEQ.  Concomitant vaccinations included PEDIARIX, ACTHIB, and PREVNAR.  On 22-OCT-2007 the patient was seen in the office at 2 months old with complaints of cough, fever, and throwing up for four days.  It was reported that the patient was breast fed and formula fed.  The patient had wet diapers and post tussive was decreasing.  The patient was vomiting small amounts, there was no projectile vomiting and no sick contacts.  The signs and symptoms of dehydration were reviewed and to follow-up with the physician.  The patient was diagnosed with viral syndrome.  On 02-JAN-2008 the patient was brought to the clinic by her mother.  The patient experienced vomiting and cough.  It was reported that the patient would throw up after coughing or feeding.  It was reported that the patient was alert, active, afebrile, not in acute respiratory distress, and no dehydrated.  The patient was diagnosed with an upper respiratory infection.  The instructions were to increase oral fluids kept at room temperature 68-72 degrees F and to follow-up at next appointment on 08-JAN-2008.  The patient was also prescribed CARDEC DM, 0.5 CC by mouth four times a day for 3-5 days, and PEDIALYTE.  On 28-JAN-2008 the patient was brought in by her mother with complaints of cough and cold.  The patient was diagnosed with an upper respiratory infection and phyaryngistis.  The patient was treated with amoxicillin 125mg/5mL by mouth three times a day for 10 days, nasal saline drops, and infant TYLENOL (8mg/0.8mL) 0.8mL by mouth every 6 hours as needed.  The patient was instructed to return to the clinic in 2 weeks.  On 08-FEB-2008 the patient returned to the clinic with her mother with complaints of cold, cough, and fever.  the patient experienced a fever for two days, nasal drip, cough, and post tussive.  The instructions given to the patient were to increase humidification, "VRO", increase fluids, use ball suction with saline, use drops 3 to four times, and return to the clinic in 1 to 2 weeks for physical examination.  On 15-FEB-2007 the patient returned to the clinic and it was noted that the coughing had decreased and the patient had not experienced a fever since the previous weekend.  At the time of the report, the outcome of the patient was unknown.  Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Nasopharyngitis, Pharyngitis, Pyrexia, Upper respiratory tract infection, Viral infection
Clinical narrative: Information has been received from a physician concerning an 8 month old black female with no known drug allergies, who on 02-AUG-2007 was vaccinated with a dose of RECOMBIVAX HB (manufacturer unknown).  Concomitant suspect vaccinations included ROTATEQ.  Concomitant vaccinations included PEDIARIX, ACTHIB, and PREVNAR.  On 22-OCT-2007 the patient was seen in the office at 2 months old with complaints of cough, fever, and throwing up for four days.  It was reported that the patient was breast fed and formula fed.  The patient had wet diapers and post tussive was decreasing.  The patient was vomiting small amounts, there was no projectile vomiting and no sick contacts.  The signs and symptoms of dehydration were reviewed and to follow-up with the physician.  The patient was diagnosed with viral syndrome.  On 02-JAN-2008 the patient was brought to the clinic by her mother.  The patient experienced vomiting and cough.  It was reported that the patient would throw up after coughing or feeding.  It was reported that the patient was alert, active, afebrile, not in acute respiratory distress, and no dehydrated.  The patient was diagnosed with an upper respiratory infection.  The instructions were to increase oral fluids kept at room temperature 68-72 degrees F and to follow-up at next appointment on 08-JAN-2008.  The patient was also prescribed CARDEC DM, 0.5 CC by mouth four times a day for 3-5 days, and PEDIALYTE.  On 28-JAN-2008 the patient was brought in by her mother with complaints of cough and cold.  The patient was diagnosed with an upper respiratory infection and phyaryngistis.  The patient was treated with amoxicillin 125mg/5mL by mouth three times a day for 10 days, nasal saline drops, and infant TYLENOL (8mg/0.8mL) 0.8mL by mouth every 6 hours as needed.  The patient was instructed to return to the clinic in 2 weeks.  On 08-FEB-2008 the patient returned to the clinic with her mother with complaints of cold, cough, and fever.  the patient experienced a fever for two days, nasal drip, cough, and post tussive.  The instructions given to the patient were to increase humidification, "VRO", increase fluids, use ball suction with saline, use drops 3 to four times, and return to the clinic in 1 to 2 weeks for physical examination.  On 15-FEB-2007 the patient returned to the clinic and it was noted that the coughing had decreased and the patient had not experienced a fever since the previous weekend.  At the time of the report, the outcome of the patient was unknown.  Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Vomiting, Weight fluctuation
Clinical narrative: Information has been received from a physician concerning an 8 month old black female with no known drug allergies, who on 02-AUG-2007 was vaccinated with a dose of RECOMBIVAX HB (manufacturer unknown).  Concomitant suspect vaccinations included ROTATEQ.  Concomitant vaccinations included PEDIARIX, ACTHIB, and PREVNAR.  On 22-OCT-2007 the patient was seen in the office at 2 months old with complaints of cough, fever, and throwing up for four days.  It was reported that the patient was breast fed and formula fed.  The patient had wet diapers and post tussive was decreasing.  The patient was vomiting small amounts, there was no projectile vomiting and no sick contacts.  The signs and symptoms of dehydration were reviewed and to follow-up with the physician.  The patient was diagnosed with viral syndrome.  On 02-JAN-2008 the patient was brought to the clinic by her mother.  The patient experienced vomiting and cough.  It was reported that the patient would throw up after coughing or feeding.  It was reported that the patient was alert, active, afebrile, not in acute respiratory distress, and no dehydrated.  The patient was diagnosed with an upper respiratory infection.  The instructions were to increase oral fluids kept at room temperature 68-72 degrees F and to follow-up at next appointment on 08-JAN-2008.  The patient was also prescribed CARDEC DM, 0.5 CC by mouth four times a day for 3-5 days, and PEDIALYTE.  On 28-JAN-2008 the patient was brought in by her mother with complaints of cough and cold.  The patient was diagnosed with an upper respiratory infection and phyaryngistis.  The patient was treated with amoxicillin 125mg/5mL by mouth three times a day for 10 days, nasal saline drops, and infant TYLENOL (8mg/0.8mL) 0.8mL by mouth every 6 hours as needed.  The patient was instructed to return to the clinic in 2 weeks.  On 08-FEB-2008 the patient returned to the clinic with her mother with complaints of cold, cough, and fever.  the patient experienced a fever for two days, nasal drip, cough, and post tussive.  The instructions given to the patient were to increase humidification, "VRO", increase fluids, use ball suction with saline, use drops 3 to four times, and return to the clinic in 1 to 2 weeks for physical examination.  On 15-FEB-2007 the patient returned to the clinic and it was noted that the coughing had decreased and the patient had not experienced a fever since the previous weekend.  At the time of the report, the outcome of the patient was unknown.  Additional information has been requested.