chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Urticaria
Clinical narrative: 33 year old female nurse with hypothalamic hypothyroidism who in approximately 1990 in the AM was vaccinated in the deltoid with a first dose of Hepatitis B virus vaccine.  There was no illness at the time of vaccination.  In approximately 1990, within 30 minutes of receiving the vaccine, the patient broke out in hives.  At the time, she was told that it was probably a reaction to the preservative used in the vaccine which she thought was thimerosal.  Medical attention was sought and she was treated with antihistamines at that time and the hives resolved that same day.  The reaction was caused her not to complete the recommended series of vaccination.  A product quality complaint was not involved.  Follow up information was received from the registered nurse who reported that she had a reaction to the vaccine in approximately 1990 which consisted of itching and hives.  She had no adverse events following prior vaccination.  No further information is expected.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Bite, Hepatitis B antibody negative, Injury
Clinical narrative: Female, health worker, in her late 20s or early 30s, who in 1997 or 1987, was vaccinated with a full series of hepatitis B virus vaccine, and subsequently had a negative titer.  It was reported that the patient was bit by a student with an unknown HBV vaccination status.  Unspecified medical attention was sought.  No product quality complaint was involved.  Follow-up information from a health professional indicated that the patient was bit by a child, and when checked she was found to have a negative titer. It was reported that the patient was revaccinated.  Additional ifnromation is not excpected.
Sex: F
Vaccine: HEP
Symptoms: Hypersensitivity
Clinical narrative: Female patient who was vaccinated with a dose of hepatitis B virus vaccine.  It was reported that several years ago the patient had an allergic reaction to the vaccine.  It was noted that the brand of the vaccine was unknown and it was not known that component the patient was allergic to.  Unspecified medical attention was sought.  No product quality complaint was involved.  Additional information is not expected.
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Back pain, Pharyngolaryngeal pain
Clinical narrative: Information has been received from a registered nurse concerning a 36 year old female patient with allergy symptoms who on 05/02/2005 was vaccinated intramuscularly with a fist dose of hepatitis B virus vaccine.  Concomitant therapy included Allegra, 180 mg daily indicated for allergy symptoms, started 4 months ago.  On 05/03/2005, the patient began to feel lower back pain and a sore throat developing.  She described the lower back pain as muscular, as though she had lifted heavy boxes using only her back.  Her back pain resolved on 05/20/2005, however the sore throat developed into a cold.  It was reported that the patient felt that the cold symptoms seemed to be resolving at the time of this report, on 05/10/2005.  The patients outcome is recovering.  No additional information regarding the adverse event was provided.  There was no product quality complaint reported.  Unspecified medical attention was sought by the patient.  Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Injection site reaction
Clinical narrative: 28 year old female patient, who about 10 years ago, in approximately 1995, was vaccinated with a first dose of hepatitis B virus vaccine.  After the vaccination in approximately 1995, she developed an injection site reaction that has since resolved completely.  It was reported that the patient never received the last 2 doses to complete the series.  No other information regarding the adverse event was provided.  There was no product quality complaint reported.  The patient sought unspecified medical attention. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Decreased appetite, Fatigue, Insomnia, Irritability, Lymphadenopathy
Clinical narrative: 30 year old white female with hepatitis A and a history of gastritis who on 05/07/2005 was vaccinated intramuscularly in the left deltoid with a first dose of hepatitis B virus vaccine.  On 05/10/2005, 3 days later, the patient developed pharyngitis, low grade fever, swollen lymph nodes, decrease in appetite, irritability, and insomnia.  She was treated with Benadryl.  The symptoms were noted to be gradually resolving.  Unspecified medical attention was sought.  There was no product quality complaint. Follow up information received from the physician indicated that on 05/10/2005, the patient developed fatigue, mild pharyngitis, sensation of warmth, neck pain, axillary lymphadenopathy, disturbed sleep, irritability, and decreased appetite.  The patient was recommended to take Benadryl, Tylenol, and Buspar.  Relevant diagnostic tests and laboratory data included: lead, CBC, and chem 18 = normal results; alk phosphatase = decreased; and urinalysis = positive ketones and glucose.  The patient was feeling better on 05/25/2005, and then left for another country.  Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Neck pain, Pharyngitis, Pyrexia
Clinical narrative: 30 year old white female with hepatitis A and a history of gastritis who on 05/07/2005 was vaccinated intramuscularly in the left deltoid with a first dose of hepatitis B virus vaccine.  On 05/10/2005, 3 days later, the patient developed pharyngitis, low grade fever, swollen lymph nodes, decrease in appetite, irritability, and insomnia.  She was treated with Benadryl.  The symptoms were noted to be gradually resolving.  Unspecified medical attention was sought.  There was no product quality complaint. Follow up information received from the physician indicated that on 05/10/2005, the patient developed fatigue, mild pharyngitis, sensation of warmth, neck pain, axillary lymphadenopathy, disturbed sleep, irritability, and decreased appetite.  The patient was recommended to take Benadryl, Tylenol, and Buspar.  Relevant diagnostic tests and laboratory data included: lead, CBC, and chem 18 = normal results; alk phosphatase = decreased; and urinalysis = positive ketones and glucose.  The patient was feeling better on 05/25/2005, and then left for another country.  Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Malaise
Clinical narrative: Female patient on 05/18/2005 was vaccinated with a fourth dose of hepatitis B virus vaccine.  It was reported that the series was completed many years ago.  Subsequently, on 05/18/2005, the patient said she felt sick.  Unspecified medical attention was sought.  There was no product quality complaint involved.  Additional information has been requested.
Age: 0.16
Sex: F
Vaccine: HEP
Symptoms: Pyrexia, Urticaria
Clinical narrative: Information has been received from a RN concerning a 58 day old female who was vaccinated with a first, second, third and fourth dose of hepatitis B virus vaccine rHBsAg (yeast) on 13Sep04, 10Nov04, 18Jan05 and 11May05 (lot645506/0309N), respectively. On 12May05 the pt developed a fever of 103F and hives. Unspecified medical attention was sought. At the time of the report the pt was recovering. There was no product quality complaint involved. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective, Hepatic neoplasm malignant, Hepatitis, Viral infection
Clinical narrative: Information has been received from a physician concerning a 14  year old male who was vaccinated as a child with a dose of hepatitis B virus vaccine rHBsAg (yeast). Subsequently, the pt developed hepatitis B and metastatic liver cancer "as a result of vaccine failure". Unspecified medical attention was sought. At the time of this report the pt had not recovered. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a mother concerning her child who was vaccinated with a dose of hepatitis B virus vaccine rHBsAg (yeast). Concomitant vaccine included a dose of diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid. It was reported that the child was having medical issues. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: DT, HEP, HIBV
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a 36 month old pt from another country with no pertinent medical history and no allergies, who "recently" (approx June 2005), was vaccinated with a first dose of hepatitis B virus vaccine rHBsAg (yeast). Other concomitant vaccine therapy administered at the same time included a first dose of Hib conj vaccine and a fourth dose of diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid. There was no other concomitant medication. Within 8-10 hrs of receiving the vaccines the pt experienced hives. It was reported that diphenhydramine (Benadryl) was given and the pt's symptoms resolved in a few hrs. The pt's outcome is recovered. There were no lab studies performed. There was no product quality complaint reported. The pt sought unspecified medical attention. Additional information has been requested.
Sex: M
Vaccine: HEP, MMR
Symptoms: Arthralgia
Clinical narrative: Information has been received from a physician concerning a male pt who eight years ago, in approx 1997, was vaccinated with a dose of hepatitis B virus vaccine rHBsAg (yeast). Suspect vaccination at the same time included a dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD). Eight years ago, in approx 1997, the pt experienced severe arthralgia.   Unspecified medical attention was sought.  Subsequently, the pt recovered.  A product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning an adult pt who was recently vaccinated with a dose of hepatitis B virus vaccine rHBsAg (yeast) (lot 647985/0061R or 647354/0254P). Subsequently, the pt developed a rash that covered their torso. Unspecified medical attention was sought. The physician reported that the pt recovered. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a physician concerning his niece who was vaccinated  with a dose of hepatitis B virus vaccine rHBsAg (yeast). Subsequently the pt experienced an event. The reporter refused to disclose what the event was. It was unknown if medical attention was sought. There was no product quality complaint. No additional information is expected.
Sex: U
Vaccine: HEP
Symptoms: Dyspnoea, Urticaria
Clinical narrative: Information has been received from a pharmacist concerning a pt who was vaccinated with a dose of hepatitis B virus vaccine rHBsAg (yeast).  The pharmacist reported that, several years ago, the pt subsequently developed hives and had trouble breathing after being vaccinated. Medical attention was not sought. Subsequently, the pt recovered from the hives and trouble breathing. No further information is available.
Age: 11.0
Sex: M
Vaccine: HEP
Symptoms: Hallucination, Malaise, Pyrexia
Clinical narrative: Information has been received from a physician concerning an approximately 11 year old male who, about 4 years ago, in approx 2001 was vaccinated with a single 1ml IM dose of hep B virus vaccine rHBsAg (yeast). It was reported that within several hours he developed a fever of 104F, general malaise and hallucinations. Subsequently the pt recovered. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: In August 2005, the patient had a titer drawn that came back as inconclusive.  No further information is available regarding the event or patient's outcome.  There was no product quality complaint reported.  Follow up information received on 09/01/2005 reported that the health facility is changing their policy to include information on equivocal lab results after three doses of vaccine to determine antibody status.  It was reported that no adverse reaction occurred.  The patient sought unspecified medical attention.  No additional information is expected.
Age: 30.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Fatigue, Headache, Myalgia, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: 30 year old male with a history of drug reaction to Tedrol who 10 weeks ago, on approximately 05/31/2005, was vaccinated with a dose of Hepatitis B virus vaccine.  Concomitant vaccination that day included a dose of Hepatitis A vaccine.  About 8 weeks ago, on approximately 06/14/2005, the patient developed a sore throat, fatigue, rash, fever of 101.4 degrees, headache, and muscle pain.  He was still having transient pain in hands and top of feet at ten weeks post vaccination.  It was reported that he had viral syndrome and will be seeing an infectious disease physician soon.  The patient was seen in urgent care on 07/29/2005, strep was negative, and was sent home.  Other laboratory diagnostic tests included:  UA - normal, CBC - normal, Sed rate - normal, Alt-slightly elevated and AST slightly elevated.  At the time of the report the patient was not recovered.  There was no product quality complaint involved.  Additional information has been requested.
Age: 30.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Rash, Viral infection
Clinical narrative: 30 year old male with a history of drug reaction to Tedrol who 10 weeks ago, on approximately 05/31/2005, was vaccinated with a dose of Hepatitis B virus vaccine.  Concomitant vaccination that day included a dose of Hepatitis A vaccine.  About 8 weeks ago, on approximately 06/14/2005, the patient developed a sore throat, fatigue, rash, fever of 101.4 degrees, headache, and muscle pain.  He was still having transient pain in hands and top of feet at ten weeks post vaccination.  It was reported that he had viral syndrome and will be seeing an infectious disease physician soon.  The patient was seen in urgent care on 07/29/2005, strep was negative, and was sent home.  Other laboratory diagnostic tests included:  UA - normal, CBC - normal, Sed rate - normal, Alt-slightly elevated and AST slightly elevated.  At the time of the report the patient was not recovered.  There was no product quality complaint involved.  Additional information has been requested.
Age: 42.0
Sex: M
Vaccine: HEP
Symptoms: Asthenia, Pain
Clinical narrative: 42 year old male who on 08/11/2005 was vaccinated intramuscularly in the left deltoid with a 1 ml dose of Hepatitis B virus vaccine.  On 08/15/2005 the patient experienced soreness and weakness in the left arm and wrist and each has remained to the present.  The patient is not recovered.  Unspecified medical attention was sought.  No product quality complaint was involved.  Additional information has been requested.
Sex: M
Vaccine: HIBV
Symptoms: Erythema, Pruritus
Clinical narrative: male in his early twenties with no allergies and no pertinent medical history, who on an unspecified date in February 2005 was vaccinated intramuscularly with a second 1ml dose of Hepatitis B virus vaccine.  There was no concomitant medication.  It was noted that 10 minutes after the vaccination, the patient arms, from his elbows to his hands, turned bright red and started itching.  The patient sought unspecified medical attention.  The reaction fully resolved in one hour and the patient recovered.  There were no laboratory studies performed.  No further information was available.  There was no product quality complaint reported.  Followup information received on 09/12/2005 indicated that the vaccine given to the patient was not Recombivax HB.  There was no information regarding what company's vaccine it was.  There is no further information.
Sex: U
Vaccine: HEP
Symptoms: Neurodevelopmental disorder
Clinical narrative: Information has been received from a physician concerning a patient who 4 years ago was vaccinated with 3 shots of Hepatitis B virus vaccine.  Subsequently, the patient now has experienced developmental delays.  No further information was available.  Additional information has been requested.
Age: 51.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Pain
Clinical narrative: Information has been received from a physician concerning a 51 year old male who had his gallbladder removed years ago and who has no allergies, who on 09/02/2005 was vaccinated with a dose of Hepatitis B virus.  Concomitant vaccine administered on the same day included a dose of Hepatitis A vaccine.  On 09/04/2005, 36 hours later, the patient developed right upper quadrant pain.  It was noted that there was no fever and no loss of appetite.  The liver did not appear to be enlarged.  The patient had pain when he took a deep breath.  At the time of the report the patient had not recovered.  Unspecified medical attention was sought.  No product quality complaint was involved.  Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Fatigue, Pyrexia
Clinical narrative: Information has been received from a 53 year old female with a penicillin allergy who on 09/06/2005 was vaccinated with a 1.0ml third dose of Hepatitis B virus vaccine.  There was no concomitant medication.  On 09/08/2005 the patient experienced fever, fatigue and weakness.  Medical attention was not sought.  No laboratory diagnostic test were performed.  At the time of the report the patient was recovering.  There was no product quality complaint involved.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: Information has been received from a 34 yr old female with asthma and no allergies who on 09Sep05 was vaccinated with the third 1.0 mL dose of hepatitis B virus vaccine rHBsAg (yeast) (lot 651362/0192R). Concomitant therapy included levothyroxine Na (Synthroid) and hormonal contraceptives (unspecified). The pt reported that on 09Sep05, she experienced fever, headache and nausea. Medical attention was not sought and no lab/diagnostic tests were performed. At the time of this report, the pt was recovering from the fever, headache and nausea. No further information is available.
Sex: F
Vaccine: MMR
Symptoms: Injection site rash, Malaise, Nausea, Vomiting
Clinical narrative: Information has been received from a pharmacist concerning a female who was vaccinated with a dose of hep B virus vaccine rHBsAg (yeast). The pharmacist reported that the pt subsequently developed nausea, vomiting, rash and was deathly ill. Unspecified medical attention was sought and the pt subsequently recovered from her events. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: HEP
Symptoms: Difficulty in walking, Injection site reaction, Pain
Clinical narrative: Information has been received from a physician concerning a 5 yr old male who in approx 1993 was vaccinated IM with a 0.5ml dose of hep B virus vaccine rHBsAg (yeast). At that time, the pt experienced leg pain and couldn't walk for a few days. It was noted that the pt developed a local thigh reaction and would not bear weight on his leg. Unspecified medical attention was sought. Subsequently, the pt recovered. It was reported that the pt is now an adolescent. There were no product quality complaint. Follow up information indicated that the pt's mother thought her son was vaccinated (at another doctor's office) with a dose of hepatitis B virus vaccine rHBsAg (yeast) and subsequently had a reaction. The current physician's office had no record, but he has only been a pt since 2002. It was reported that the office called for possible help as to a plan for starting again. They had no actual evidence of any reaction. It was reported that they were only trying to use precaution. Additional information has been requested. This is a consolidation of two reports concerning the same pt.
Age: 27.0
Sex: M
Vaccine: HEP
Symptoms: Pericarditis
Clinical narrative: Information has bee received from a pharmacist concerning a 27 year old male who was vaccinated with a dose of hep b virus vaccine rHBsAg (yeast). Subsequently the pt experienced pericarditis. Unspecified medical attention was sought. No product quality complaint was involved. No further information was available. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Chest discomfort, Heart rate increased, Hyperhidrosis, Throat tightness, Tremor
Clinical narrative: Information has been received from a health professional concerning a white female LPN with no known allergies who on 19Oct05 was vaccinated IM in the right upper arm with a third 1.0 cc dose hepatitis B virus vaccine rHBsAg (yeast) (lot 647274/0426P). There was no illness at the time of vaccination. Concomitant therapy included hormonal contraceptives (unspecified). On 19Oct05, 2 1/2 hours after vaccination, the pt experienced diaphoresis, an elevated pulse and feeling shaky. The pt went back to see the nurse and was offered diphenhydramine hc1 (Benadryl), but she refused it. Her vital signs were monitored and she was sent home when they had turned out normal. The next morning, on 20Oct05, the pt complained of throat tightness and chest tightness. She was seen by the nurse practitioner in the afternoon. Unspecified lab work was done. It was noted that the pt was out of work for 2 days at the direction of the nurse practitioner. No product quality complaint was involved. No additional information was provided. Follow up information indicated that the pt came into the office about 2-2 1/2 hours after receiving the vaccine and stated that she did not feel good. Her vital signs were wnl expect her pulse which was increased to 120 for about 45 minutes. There were no other complaints. Her color was good and was usual for her. Her right upper arm site was free of redness or swelling or heat. Pulse was regular and steady at a rate of approx 120. Respiration were easy and there was no respiratory distress. There were no complaints of a sore throat. No swelling was noted. Speech was normal and she was alert and oriented. Other than the increased pulse rate there were no abnormalities noted. It was recommended that she call her physician and consider diphenhydramine hcl (Benadryl), but the pt didn't want to take medication. The pt reported that if she did not feel better tomorrow she would call her doctor. She was discouraged from waiting. After approx 45 minutes her heart rate was wnl at 88. It was reported that the pt recovered. Conflicting information reported that the pt's third dose was given on 24Oct05 (lot 647974/1118P). No additional information is expected.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Dizziness, Malaise, Myalgia, Nausea
Clinical narrative: Information has been received from a health professional concerning an approximately 27 year old female registered nurse, with a tissue plasminogen activator (TPA) deficiency, who in 1990, was vaccinated with a single dose of hep B virus vaccine rHBsAg (yeast). Concomitant therapy included warfarin sodium (Coumadin). Subsequently the pt developed malaise and muscle aches. It was reported that the pt recovered. There were no laboratory or diagnostic tests performed. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Follow up information from the RN indication that she received an injection and was sick with extreme weakness, nausea and vomiting for the next 4 days. She noted that she could not get out of bed with feeling light headed and severe muscle aches. It was also noted that she did not receive another injection. Additional information is not expected. Additional follow up information from an approximately 27 year old female registered niurse with a morphine allergy indicated that her flu-like symptoms which included having been bed ridden for 4 days, faintness, extreme weakness and body aches had developed within 24 hours of her first dose of HEPATITIS B. Subsequently the patient recovered. These events were not reported to the physician.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Pain, Vomiting
Clinical narrative: Information has been received from a health professional concerning an approximately 27 year old female registered nurse, with a tissue plasminogen activator (TPA) deficiency, who in 1990, was vaccinated with a single dose of hep B virus vaccine rHBsAg (yeast). Concomitant therapy included warfarin sodium (Coumadin). Subsequently the pt developed malaise and muscle aches. It was reported that the pt recovered. There were no laboratory or diagnostic tests performed. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Follow up information from the RN indication that she received an injection and was sick with extreme weakness, nausea and vomiting for the next 4 days. She noted that she could not get out of bed with feeling light headed and severe muscle aches. It was also noted that she did not receive another injection. Additional information is not expected. Additional follow up information from an approximately 27 year old female registered niurse with a morphine allergy indicated that her flu-like symptoms which included having been bed ridden for 4 days, faintness, extreme weakness and body aches had developed within 24 hours of her first dose of HEPATITIS B. Subsequently the patient recovered. These events were not reported to the physician.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Hypotension, Syncope, Tinnitus
Clinical narrative: Information has been received from a 34 yr old female with no known medical history or allergies who on 02Nov05 was vaccinated IM with a dose of hep B virus vaccine rHBsAg (yeast) (manf unk) (lot AHBVB135AA). There was no concomitant medication. Immediately after vaccination the pt fainted. Once revived, she stated that she had low blood pressure and tinnitus but had since recovered. Unspecified medical attention was sought. No laboratory diagnostic tests were performed. It was unk if the pt was hospitalized. The pt's status was recovered, date not specified. There was no product quality complaint involved. No further information is available.
Sex: M
Vaccine: HEP
Symptoms: Rash
Clinical narrative: Information has been received from a male who was vaccinated with a dose of hep B virus vaccine rHBsAg (yeast). The pt reported that he subsequently developed a facial rash. It was unk if medical attention was sought. Subsequently, the pt's rash resolved. No further information is available.
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective, Neoplasm malignant
Clinical narrative: Information has been received from a female health professional who was vaccinated with a series of hep B virus vaccine rHBsAg (yeast). She was tested after completing the series and was immune. Last year, in 2004, she had her titers checked and they came back not immune to Hep B. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Information received on 16Nov05 contained the following adverse event: breast cancer (approx 1996; chemotherapy). Additional information has been requested.
Age: 23.0
Sex: M
Vaccine: HEP
Symptoms: Asthenia, Hepatitis B, Hyperhidrosis, Nausea
Clinical narrative: Information has been received from a RN concerning a 23 yr old male pt with no allergies, no birth defects or medical conditions, who on 28Nov05 at 15:00 was vaccinated in the right deltoid with a first dose of hep B virus vaccine rHBsAg (yeast) (lot 651362/0192R). It was noted that he was not ill at the time of vaccination. It was reported that he experienced nausea weakness and sweating for 30 minutes on 28Nov05, one hour after the vaccination. The pt recovered on 28Nov05. It was noted that the pt did not have adverse events following prior vaccinations. It was noted that on 04Oct05 prior to vaccination the pt had a hep b surface antibody lab study performed and the results showed less than 5 MIU/ML, which did not indicate immunity according to current guidelines. There was no product quality complaint reported. The pt sought unspecified medical attention. No additional information has been requested.  This is in follow-up to report (s) previously submitted on 3/7/2006.  Follow information was received on 18-JAN-2006 which reported that the patient did not require medical treatment and that he recovered at a later time on the day he received the vaccination.  The patient sought unspecified medical attention.  No additional information has been requested.
Age: 0.25
Sex: M
Vaccine: HEP
Symptoms: Constipation, Decreased appetite, Ear disorder, Irritability, Medication error
Clinical narrative: Information has been received from medical records concerning a 9 week old male pt, whose mother was vaccinated with VARIVAX during pregnancy (WAES0405USA00271). He was born at 39 weeks, a normal live male infant weighing 280 grams, had no congenital anomalies, no feature of congenital varicella zoster syndrome and no other complications. It was noted that he was vaccinated with a first dose of RECOMBIVAX HB (manf unk), on an unspecified date in July 2004. During an office visit at seven days old the infants umbilical stump was present and the circumcised area was healing nicely. On 23Sep04 the pt presented for a 2 month old well child check and two month injections. He showed good development. On examination he had several white bumps on his face and an erythematous macular rash that diffusely spread over his body. The pt was assessed to have cutis marmorata and milia on his face. The plan was to reassure and have him return to the clinic in two months for a well child check. The following 2 month vaccinations were administered a first dose of hep B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (Lot 647595/0027P) in the right leg, first dose of Infanrix (lot 632A2) in the left leg, first dose of Ipol (lot X0771) in the left leg and a first dose of Prevnar (lot 495222) in the right leg. The medical records report that the pt also received the following other vaccinations: 18Nov04 a second dose of COMVAX (lot 647905/0240P) administered IM in the left leg, a second dose of Infanrix (lot 634A2) administered IM in the left leg, second dose of Ipol (lot X0771) administered SC in the left arm, and a second dose of Prevnar (lotA67185) administered in the left thigh on 13Oct05 a third dose of COMVAX (lot 0160R) administered IM in the right leg, poliovirus vaccine inactivated (unspecified) (lotY0298) SC in the left leg and Infanrix (lot AC14AA) IM in the left leg. Information received on 26Oct05 contained the following adverse experiences: feverish on and off for one week (22Jun05); constipation (29Jun05); viral upper respiratory infection (19Jul05); pulling his ears (19Jul05; not eating good (19Jul05); cranky (19Jul05); mild viral upper respiratory infection (13Oct05). Additional information is expected.
Age: 0.25
Sex: M
Vaccine: HEP
Symptoms: Pyrexia, Rash erythematous, Rash macular, Upper respiratory tract infection
Clinical narrative: Information has been received from medical records concerning a 9 week old male pt, whose mother was vaccinated with VARIVAX during pregnancy (WAES0405USA00271). He was born at 39 weeks, a normal live male infant weighing 280 grams, had no congenital anomalies, no feature of congenital varicella zoster syndrome and no other complications. It was noted that he was vaccinated with a first dose of RECOMBIVAX HB (manf unk), on an unspecified date in July 2004. During an office visit at seven days old the infants umbilical stump was present and the circumcised area was healing nicely. On 23Sep04 the pt presented for a 2 month old well child check and two month injections. He showed good development. On examination he had several white bumps on his face and an erythematous macular rash that diffusely spread over his body. The pt was assessed to have cutis marmorata and milia on his face. The plan was to reassure and have him return to the clinic in two months for a well child check. The following 2 month vaccinations were administered a first dose of hep B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (Lot 647595/0027P) in the right leg, first dose of Infanrix (lot 632A2) in the left leg, first dose of Ipol (lot X0771) in the left leg and a first dose of Prevnar (lot 495222) in the right leg. The medical records report that the pt also received the following other vaccinations: 18Nov04 a second dose of COMVAX (lot 647905/0240P) administered IM in the left leg, a second dose of Infanrix (lot 634A2) administered IM in the left leg, second dose of Ipol (lot X0771) administered SC in the left arm, and a second dose of Prevnar (lotA67185) administered in the left thigh on 13Oct05 a third dose of COMVAX (lot 0160R) administered IM in the right leg, poliovirus vaccine inactivated (unspecified) (lotY0298) SC in the left leg and Infanrix (lot AC14AA) IM in the left leg. Information received on 26Oct05 contained the following adverse experiences: feverish on and off for one week (22Jun05); constipation (29Jun05); viral upper respiratory infection (19Jul05); pulling his ears (19Jul05; not eating good (19Jul05); cranky (19Jul05); mild viral upper respiratory infection (13Oct05). Additional information is expected.
Age: 14.0
Sex: F
Vaccine: HEP
Symptoms: Muscle twitching, Tremor
Clinical narrative: Information has been received from a certified medical assistant concerning a 14 year old female pt with no allergies and no pertinent medical history, who on 03jan06 was vaccinated with 10 micrograms of hep B virus vaccine rHBsAg (yeast). There was no concomitant medication. On 03Jan06, reported as today, shortly after the pt received the vaccine, she began to twitch and shake. There were no laboratory studies performed. The adverse events did not improve and the pt's outcome is not recovered. There was no product quality complaint reported. The pt sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: HEPA
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a female physician in her 40's who did not respond to the hep A vaccine inactivated (Havrix) for prophylaxis. On 01Dec04 the pt received the 1st dose of Havrix. Subsequently, on 12Jan05, a hep A antibody titer was negative.
Age: 40.0
Sex: M
Vaccine: HEPA
Symptoms: Back pain, Pain
Clinical narrative: This case was reported by a nurse and described the occurrence of pain in the lumbar region in a 39 year old pt who received hep A vaccine inactivated (Havrix). The pt past medical history included diabetes type I. Concurrent medications included Insulin for type I diabetes and Inderal and HCTZ for unspecified medical conditions. On 04Feb2005, the pt received an injection of Tetanus and diphtheria toxoids adsorbed (adult formulation) in the left deltoid. On 07Feb05, the pt received the first dose of Havrix (lot VHA802B6) at 1440 EU in the right deltoid. Approx one day after receipt of Havrix, on 08Feb05, the pt experienced left leg pain and lower back pain. The pt resolved on 10Feb05. In the nurse's opinion, the events were unrelated to vaccination with Havrix.
Sex: F
Vaccine: HEPA
Symptoms: Medication error, Pain
Clinical narrative: This case was reported by a nurse and described a female pt in her mid thirties who accidentally had hep A vaccine inactivated (Havrix) sprayed into her eye. On 24Feb05, the pt's child received a dose of Havrix (dose number not provided; lot VHA814A2). During the vaccination, the vaccine inadvertently sprayed into the pt's left eye. The nurse reported that she had the pt rinse her eye out. On 25Feb05, the nurse contacted the pt who informed her that she had rinsed her eye out for an additional 15 minutes at home. The pt stated that her eye stung at the time, but reported no difficulties afterwards. The event resolved. In the nurse's opinion, the event was unrelated to vaccination with Havrix.
Age: 19.0
Sex: M
Vaccine: HEPA
Symptoms: Injection site rash, Urticaria
Clinical narrative: This case was reported by a nurse to a sales rep and described the occurrence of injection site hives in a 19 year old male subject who was vaccinated with hep A vaccine (Havrix) for prophylaxis. The subject had no known allergies. On an unspecified date on or after 23Dec04 and on or before 03May05, the subject received the second dose of Havrix. The site of the injection of Havrix was not provided. At an unspecified time following the second dose of Havrix, on an unspecified date on or after 23Dec04 and on or before 03May05, the subject experienced a hive-like rash at the injection site. The injection site hives resolved on an unspecified date on or after 23Dec04 and on or before 03May05.
Age: 35.0
Sex: M
Vaccine: HEPA
Symptoms: Antinuclear antibody positive, Joint swelling, Myalgia
Clinical narrative: This case was reported by a nurse and described the occurrence of joint swelling in a 34 year old male subject who was vaccinated with hep A vaccine inactivated (Havrix) for prophylaxis. The nurse reported that on the day of vaccination, 01Apr05, the subject had a head and chest cold. The nurse also reported that on an unspecified date before 01Apr05, the subject was antinuclear antibody positive and was referred to a rheumatologist; antinuclear antibody was negative upon his review. Concurrent medications included Azithromycin (Z pack) to treat the head and chest cold and multivitamins. On 01Apr05, the subject received 1st dose of Havrix in the left arm (lot AHAVB021AA). On 02Apr05, 1 day after vaccination with Havrix, the subject experienced joint swelling, ankle swelling and diffuse muscular pain. The pt was seen at a physician's office; however, information on physical examination of swollen joints, warm joints or fluid from joints was not provided. The vaccination course with Havrix was discontinued. On an unspecified date, diagnostic tests performed for arthritis included sedimentation rate (ESR), rheumatoid factor (RF), anti nuclear antibodies (ANA), and C reactive protein (CRP); however, no results were provided. As of 27May05, the events remained unresolved. In the nurse's opinion, the events were unrelated to the use of Havrix and may have been associated with the pt's medical history and/or concurrent illness.
Age: 56.0
Sex: F
Vaccine: HEPA
Symptoms: Rash, Upper respiratory tract infection
Clinical narrative: This case was reported by a nurse and described the occurrence of upper respiratory infection in a 55 year old female subject who was vaccinated with hep A vaccine inactivated (Havrix) for prophylaxis. The reporter is the pt. Concurrent medical conditions included seasonal allergy and possible viral illness. There were no concurrent medications. On 16May05 the subject received 1st dose of Havrix in the right arm. On 19May05, 3 days after vaccination with Havrix, the subject experienced an upper respiratory infection. On 23May05, approx 7 days after vaccination with Havrix, the subject experienced a rash on her arms and trunk. On, 24May05, the subject was seen by a physician, who felt the rash was viral in nature and not related to vaccination with Havrix. As of 09June05, the outcome of the events was unk.
Age: 15.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site pain, Medication error
Clinical narrative: This case was reported by a healthcare professional and described a 14 yr old female subject who was vaccinated with hep A vaccine inactivated (Havrix) for prophylaxis. There were no concurrent medications. On 07Jun05 the subject inadvertently received the adult dose of Havrix (lot AHAVA031BB) for the 2nd dose in the immunization series. At an unspecified time after the administration of Havrix, the subject experienced soreness at the injection which resolved in one day. The adult dose of Havrix is recommended for immunizing individuals older than 18 yrs of age. In the reporters opinion, the event were unrelated to vaccination with Havrix.
Age: 1.08
Sex: F
Vaccine: DTAPHEPBIP, HEPA, MMR, PNC, VARCEL
Symptoms: Pyrexia
Clinical narrative: This case was reported by a nurse and described a 13 month old female pt who inadvertently received hep A vaccine inactivated (Havrix). On 09Jun05, the pt received an injection of Havrix (lot AHAVA018BA). On the same day, the pt also received injections of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix), measles, mumps and rubella virus vaccine (MMRII), varicella virus vaccine (Varivax) and 7-valent pneumococcal conjugate vaccine (Prevnar). Havrix is only recommended for children and adolescents 2 to 18 years of age. The nurse stated the pt developed a slight fever after administration of the vaccines. The fever resolved at an unspecified time later.
Age: 43.0
Sex: F
Vaccine: HEPA, IPV, RUB, TYP, HEPA, IPV, RUB, TYP
Symptoms: Back pain, Feeling hot, Headache, Hypokinesia, Injection site erythema
Clinical narrative: This case was reported by a nurse to a sales rep and described the occurrence of headache in a 43 year old female subject who was vaccinated with hep A vaccine inactivated (Havrix) for prophylaxis. On 21Jun05 the subject received a dose of Havrix in the left arm (dose number not provided). On 21Jun05 the subject also received injections of rubella virus vaccine (Meruvax II) in the right deltoid, typhoid vaccine (unk manf) in the right deltoid, and inactivated poliomyelitis virus vaccine (Ipol) in the left deltoid. At an unspecified time following the receipt of the immunizations on 21Jun05, the subject experienced headache, back and neck pain, and injection site redness, pain and swelling. The site of the injection reaction was not specified to Havrix or Ipol. On 22Jun05, the subject experienced swelling, redness, and pain in the upper left arm. On 23Jun05, the subject experienced a decreased range of motion of the left arm and injection site warmth. The events were ongoing at the time of initial reporting, 23Jun05.
Age: 43.0
Sex: F
Vaccine: HEPA, IPV, RUB, TYP, HEPA, IPV, RUB, TYP
Symptoms: Injection site oedema, Injection site pain, Neck pain
Clinical narrative: This case was reported by a nurse to a sales rep and described the occurrence of headache in a 43 year old female subject who was vaccinated with hep A vaccine inactivated (Havrix) for prophylaxis. On 21Jun05 the subject received a dose of Havrix in the left arm (dose number not provided). On 21Jun05 the subject also received injections of rubella virus vaccine (Meruvax II) in the right deltoid, typhoid vaccine (unk manf) in the right deltoid, and inactivated poliomyelitis virus vaccine (Ipol) in the left deltoid. At an unspecified time following the receipt of the immunizations on 21Jun05, the subject experienced headache, back and neck pain, and injection site redness, pain and swelling. The site of the injection reaction was not specified to Havrix or Ipol. On 22Jun05, the subject experienced swelling, redness, and pain in the upper left arm. On 23Jun05, the subject experienced a decreased range of motion of the left arm and injection site warmth. The events were ongoing at the time of initial reporting, 23Jun05.
Age: 43.0
Sex: F
Vaccine: HEPA, IPV, RUB, TYP, HEPA, IPV, RUB, TYP
Symptoms: Back pain, Feeling hot, Headache, Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a nurse to a sales rep and described the occurrence of headache in a 43 year old female subject who was vaccinated with hep A vaccine inactivated (Havrix) for prophylaxis. On 21Jun05 the subject received a dose of Havrix in the left arm (dose number not provided). On 21Jun05 the subject also received injections of rubella virus vaccine (Meruvax II) in the right deltoid, typhoid vaccine (unk manf) in the right deltoid, and inactivated poliomyelitis virus vaccine (Ipol) in the left deltoid. At an unspecified time following the receipt of the immunizations on 21Jun05, the subject experienced headache, back and neck pain, and injection site redness, pain and swelling. The site of the injection reaction was not specified to Havrix or Ipol. On 22Jun05, the subject experienced swelling, redness, and pain in the upper left arm. On 23Jun05, the subject experienced a decreased range of motion of the left arm and injection site warmth. The events were ongoing at the time of initial reporting, 23Jun05.
Age: 43.0
Sex: F
Vaccine: HEPA, IPV, RUB, TYP, HEPA, IPV, RUB, TYP
Symptoms: Injection site swelling, Movement disorder, Neck pain
Clinical narrative: This case was reported by a nurse to a sales rep and described the occurrence of headache in a 43 year old female subject who was vaccinated with hep A vaccine inactivated (Havrix) for prophylaxis. On 21Jun05 the subject received a dose of Havrix in the left arm (dose number not provided). On 21Jun05 the subject also received injections of rubella virus vaccine (Meruvax II) in the right deltoid, typhoid vaccine (unk manf) in the right deltoid, and inactivated poliomyelitis virus vaccine (Ipol) in the left deltoid. At an unspecified time following the receipt of the immunizations on 21Jun05, the subject experienced headache, back and neck pain, and injection site redness, pain and swelling. The site of the injection reaction was not specified to Havrix or Ipol. On 22Jun05, the subject experienced swelling, redness, and pain in the upper left arm. On 23Jun05, the subject experienced a decreased range of motion of the left arm and injection site warmth. The events were ongoing at the time of initial reporting, 23Jun05.
Age: 33.0
Sex: M
Vaccine: HEPA
Symptoms: Chills, Fatigue, Nausea
Clinical narrative: This case was reported by a nurse practitioner and described the occurrence of fatigue in a 32 yr old male subject who was vaccinated with hep A vaccine inactivated (Havrix) for prophylaxis. Concurrent medical conditions included codeine allergy. Concurrent medications included Bupropion hydrochloride (Wellbutrin) and Semisodium valproate (Depakote) for unspecified indications. On 15July05 the subject received 1st dose of Havrix (AHAVB021AA). Approx 3 hours after vaccination with Havrix on 15Jul05, the subject experienced fatigue, chills and nausea. The events resolved on 15Jul05. The nurse practitioner considered the events to possibly be related to vaccination with Havrix.
Age: 58.0
Sex: M
Vaccine: DTAP, HEP, HEPA, IPV, MMR
Symptoms: Dry mouth, Lip ulceration, Mouth ulceration, Oral pain, Rash
Clinical narrative: This case was reported by a consumer and described the occurrence of mouth ulcer in a 58 year old male subject who was vaccinated with hep A vaccine (Havrix) hepatitis B vaccine (Engerix B) for prophylaxis. A physician or other health care professional has not verified this report. The subject reported no relevant medical history and no concurrent medications. On 08Jul05 the subject received 1st dose of Havrix (lot number not specified) and the 1st dose of Engerix B (lot number not specified). Concurrently the pt also received injections of diphtheria, tetanus and acellular pertussis vaccine (manf unspecified), inactivated poliomyelitis virus vaccine (Ipol); measles, mumps and rubella virus vaccine (MMRII); and a tuberculin test. On 12Jul05 4 days after vaccination with Engerix B and Havrix, the subject developed ulcers in his mouth and inside of his lips after biting his tongue a couple of times as well as dry cracked, sore lips. Approx 8 days later, on 20Jul05, he developed a rash on his right knee. Three days later on 23Jul05, he developed a rash on both elbows and up his arms a little. At the time of reporting, on 25Jul05, the mouth ulcers and the dry cracked, sore lips and improved. The outcome of the rash was unspecified.