chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, No therapeutic response
Clinical narrative: Information has been received from a physician concerning a cluster of six of seven patients who did not develop sufficient titer after vaccinations with RECOMBIVAX HB. 23-NOV-2010, 5 patients were vaccinated with a dose of RECOMBIVAX HB (lot number: 666029/1456Y), thimerosal free (dose and site of administration not reported) and 2 patients were vaccinated with a dose of RECOMBIVAX HB (lot number: 666806/0732Z), thimerosal free (dose and site of administration not reported). On 22-DEC-2010, all 7 patients were vaccinated with a dose of RECOMBIVAX HB (lot number: 666805/0657Z), thimerosal free (dose and site of administration not reported). On 25-MAY-2011, 6 patients were vaccinated with a dose of RECOMBIVAX HB (lot number: 669597/0294AA), thimerosal free (dose and site of administration not reported). On 25-MAY-2011, 1 patient was vaccinated with a dose of RECOMBIVAX HB (lot number: 666809/1631Z), thimerosal free (dose and site of administration not reported). Titers drawn in June 2011 showed that six of seven total patients did not developed sufficient titers. The titers were repeated in July 2011 at a second laboratory. The patients did not seek medical attention. At the time of the report, the patients' outcomes were unknown. This is one of several reports received from the same source. Follow up information has been received from the physician concerning one of several patients who on 23-NOV-2010 was vaccinated with the first dose of RECOMBIVAX HB (dose and route not reported) and lot # 66806/0732Z, expiration date 09-NOV-2012. On 25-MAY-2011, the patient received the third dose of RECOMBIVAX HB (dose and route not reported) and lot# 669597/0294AA and expiration date 07-SEP-2013. On an unspecified date, the patient had a titer result of not reactive (NR) on titer #1 and #2. Follow up information was received from the physician who reported that his office does not treat any pediatric patients, the office only treats adults. The physician reported that the office purchased the pediatric vials "which are cheaper" and dispensed two vials to each patient to provide an adult dose. A standard lot check investigation has been finalized. All in-process quality checks for the lot numbers 66806/0732Z, 666805/0657Z and 669597/0294AA were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 68.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, No therapeutic response
Clinical narrative: Information has been received from an approximately 68 year old female Registered Nurse reporting on herself with diabetes, sleep apnoea, spinal stenosis and no drug reactions or allergies who in 2010 was vaccinated with the first, second and third dose of RECOMBIVAX HB (manufacturer unknown, lot number, dose and route not reported). Sometime in 2010, after receiving all 3 doses, she contacted her physicians, they drew hepatitis B titers and she was informed that she did not develop any antibodies and that she was a non-responder. No treatment was given. At the time of the report the patient's outcome was unknown. No further information is available.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Vaccination failure
Clinical narrative: Information has been received from a registered nurse concerning a female nurse who received a Hep B series 15 to 20 years ago and now her hepatitis B titer was less than 0.1. The nurse did not know the manufacturer or lot number nor did she have any documentation of the hepatitis B series being given other than the patient's word. It was unknown if the patient sought any medical attention. At the time of reporting outcome was unknown. This is one of several reports concerning same patient. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Unevaluable event, Vaccination failure
Clinical narrative: Information has been received from a registered nurse concerning an unknown number of dialysis patients with renal failure who on an unknown dates were intramuscularly vaccinated with 1mL of 3 dose series of RECOMBIVAX HB (lot# was not reported), respectively. The nurse reported that patients have failed to seroconvert after receiving a 3 dose series of RECOMBIVAX HB dialysis formulation. Patients sought unspecified medical attention. At the time of the report patients' present status were not recovered, they had negative antibody titers. This is an amended report. Upon internal review, the LLT and PT of the AE "patient have failed to seroconvert" has been changed from "Anti-HBs antibody negative" and "Hepatitis B surface antibody negative" to "Hepatitis B antibody negative". No further information is available.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Vaccination failure
Clinical narrative: Information has been received from a physician concerning a female patient with no pertinent medical history or drug allergies who on an unspecified date completed full series of RECOMBIVAX HB (manufacturer, lot # and exp unknown) years back, had hepatitis B antibody test done for her job and result came back less than "5" and physician diagnosed patient as sero-negative. There was no concomitant medication. No treatment was given. The patient sought unspecified medical attention. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: HEP
Symptoms: Allergy test positive, Allergy to plants, Food allergy, Urticaria
Clinical narrative: Information has been received from a 63 year old male pharmacist who in September 2011, was vaccinated with the first dose of RECOMBIVAX HB (Lot #, dose and route not reported) and in October 2011, received the second dose of RECOMBIVAX HB (lot #, dose and route not reported). On 01-DEC-2011, the patient developed an allergy to potatoes, tomatoes, coffee and bell peppers and hives all over his body when he ate any of these products event tomatoe sauce. The patient did not know if the allergies were related to RECOMBIVAX HB or not. The patient was seen by the allergist who tested him and the patient was positive for nightshade family of plants. No treatment for the AEs was given. At the time of the report, the patient did not recovered. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B core antibody negative, Hepatitis B surface antibody negative, No therapeutic response
Clinical narrative: Information has been received from a physician assistant concerning a 22 year old female patient with no pertinent medical history and drug allergy who received the three dose series of RECOMBIVAX HB injection (dosage not provided) at another practice as follows: first dose (lot#: 635270/0317K) (Expiration: 10-JAN-2003) on 25-APR-2000, second dose (lot#: 637372/1324K) (Expiration: 18-AUG-2003) on 27-NOV-2000 and the third dose Thimerosal Free (lot#: 640324/0674L) (Expiration: 02-APR-2004) on 18-JUL-2001. There was no concomitant medication. On 04-AUG-2011, a titer "was not 100%". One additional dose of RECOMBIVAX HB 1.0 ml was given on 16-AUG-2011 and she would probably receive another dose now on 20-SEP-2011. The patient sought medical attention in office. At the time of the report, the patient had not recovered. Follow up information has been received from the physician assistant concerning the 11 year old student with no pertinent medical history and drug allergy who were vaccinated intramuscularly with three doses of RECOMBIVAX HB injection (dosage not provided) as follows: first dose (lot#: 635270/0317K) (Expiration: 10-JAN-2003) on 25-APR-2000 in the right arm, second dose (lot#: 637372/1324K) (Expiration: 18-AUG-2003) on 27-NOV-2000 in the left arm and the third dose Thimerosal Free (lot#: 640324/0674L) (Expiration: 02-APR-2004) in the left arm on 18-JUL-2001. It was reported that the patient did not seek medical attention. On 04-AUG-2011, the patient had blood drawn to check for immunity to the previously given hepatitis B series. The results showed that the patient did not have immunity to hepatitis B virus. On the same day, serum hepatitis B surface antibody quantitative test with the result of 7 mIU/ml, and hepatitis B core antibody total test with the result of non-reactive. The patient was not illness at the time of vaccination. At the time of the report, the patient had recovered. No further information is available.
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B core antibody negative, Injection site nodule
Clinical narrative: Information has been received from a licensed practical nurse concerning a 40 year old female patient who in 2006 was administered a series of RECOMBIVAX HB (dose unknown, lot # not provided), and on 15-AUG-2011 the patient was vaccinated with RECOMBIVAX HB, intramuscularly (Lot number 0869AA is an invalid lot number for RECOMBIVAX HB, EXP 01-NOV-2013). The nurse noted this patient "did not develop adequate titers to a previous series of RECOMBIVAX HB in 2006". Nurse reported the patient developed a "pea-sized knot" where RECOMBIVAX HB was administered on 15-AUG-2011. The nurse did not know when this "pea-sized knot" developed. The patient sought unspecified medical attention and had not recovered from "pea-sized knot" at the time of the report. Out come of "did not develop adequate titers to a previous series of RECOMBIVAX HB in 2006" was unknown at the time of reporting. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Fatigue, Headache, Nausea, Tremor
Clinical narrative: Information has been received from a female consumer who on 07-DEC-2011 was vaccinated with a dose of RECOMBIVAX HB (Route, dose and lot number not reported). The patient called to report she experienced extreme fatigue, shaking, headache and nausea after receiving the RECOMBIVAX HB. It was unspecified if the patient had sought any medical attention. At the time of the report, the patient had not recovered. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody positive, Hepatitis B surface antigen
Clinical narrative: Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with a second dose of RECOMBIVAX HB (lot #, dose and route not reported). The physician reported that the patient was found to be HBsAg positive 1-2 weeks after the second dose of RECOMBIVAX HB was administered. The patient sought medical attention at the office. At the time of the report the outcome of the patient was unknown. No further information is available.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, No therapeutic response
Clinical narrative: Information has been received from a licensed practitioner nurse concerning a patient who on unspecified dates received the three doses of RECOMBIVAX HB (route, site, doses and lot numbers not provided). The nurse reported that on an unspecified date the patient was showing no immunity to hepatitis B. At the time of the report, the patient's outcome was unknown. No further information is available.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, No therapeutic response
Clinical narrative: Information has been received from a registered pharmacist concerning a female patient who on an unknown dates, was vaccinated with 2 complete series of RECOMBIVAX HB (dose, route and lot number not reported). On an unknown date, the patient reported that she had undetectable titer levels. The patient sought unspecified medical attention by contacted the pharmacist. At the time of the report the patient had not recovered. Follow up information was received from a doctor of pharmacy who reported that the vaccines were not given at that pharmacy. No further information is available.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative, No therapeutic response
Clinical narrative: Information has been received from a healthcare worker concerning a number of employees at their office (office unspecified) who was vaccinated with the series of HepB. (Manufacturer unknown, route and Lot# not reported). After the patients completed the vaccine series and they had low titers. At the time of the report, outcome was unknown. This is an amended report. The lower level term and preferred term of AE of "low titers" was changed to "hepatitis B surface antibody negative". No further information is available.
Age: 54.0
Sex: F
Vaccine: HEP
Symptoms: Blepharospasm, Headache, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a 54 year old female with no pertinent medical history and no drug reaction/allergies who was vaccinated (approximately 20-SEP-2011) with RECOMBIVAX HB 10 mcg/mL. There was no concomitant medication. The patient reported that following administration of the first dose of RECOMBIVAX HB, on approximately 20-Sep-2011 ("approximately three weeks ago"), she experienced injection site soreness and warmth within hours following the vaccination. The patient also reported that she began to develop headaches approximately two days after receiving the vaccine (on approximately 22-Sep-2011), and a twitch in left lower eyelid approximately one week following the vaccination (on approximately 27-SEP-2011). No lab diagnostics studies were performed. The patient did not seek medical attention. No treatment given for the events. At the time of reporting, the patient was recovering from all reported adverse events. Follow up information has been received from the physician who said this was not one of his patients. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, No adverse event, No therapeutic response
Clinical narrative: Information has been received from a registered nurse concerning an approximately 19 year old male patient who in 1992, was vaccinated with 3 doses of Hep B (manufacturer unknown) (route, dose and lot number not reported). On 28-JUN-2011, the patient had an antibody test which reported failed to seroconvert. It was also reported as no adverse effects. It was unknown if the patient sought medical attention. At the time of the report the patient had not recovered. No further information is available.
Age: 59.0
Sex: M
Vaccine: HEP
Symptoms: Pain, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 59 year old male patient with hypertension and a history of amputation and no drug reactions/allergies who on 30-NOV-2011, was vaccinated with the first dose of RECOMBIVAX HB (lot # 671032/0908AA, expiration date: 05-APR-2014), 0.5 mL, IM. Concomitant therapy included unspecified antihypertensive medication. On 05-DEC-2011, the patient experienced body aches which lasted through 06-DEC-2011. On 07-DEC-2011, the patient developed fever of 101F which lasted for 3 days, to 09-DEC-2011. The patient sought unspecified medical attention. No laboratory diagnostic studies were performed. No treatment was given for the AEs. On 10-DEC-2011, the patient fully recovered from these symptoms. Additional information has been requested.
Age: 0.4
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Irritability, Local swelling
Clinical narrative: Initial report received on 22 September 2011 from a nurse. This case involves one 4-month old patient who is part of a cluster of 3 patients from the same reporter, and with the same vaccines administered. Information regarding the other 2 patient who are also 4 months old have been captured in case number 2011-09210. A 4-month-old male patient (dates of birth unknown) who had no concurrent illnesses, and no known allergies had received a second intramuscular right leg injection of ACTHIB (lot number UH409AA, sanofi pasteur SA lot number G1317-1), and a second intramuscular left leg injection of DAPTACEL (lot number C4002AA), and an intramuscular right leg injection of PREVNAR (Wyeth, lot number 916973) on 20 September 2011 and the following day the patient was brought back to the office with swollen right foot that started the same day of vaccination. The patient required medical evaluation and was advised to take TYLENOL for the swelling and irritability. It was reported "med RX not available for demographics". No relevant diagnostic tests and or laboratory data were performed. Twenty-five gauge, 5/8 inch (15.875 mm) needled were used for the vaccinations. The patient recovered on an unspecified date. Documents held by sender: None.
Age: 0.4
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Initial report received on 22 September 2011 from a nurse. This case involves two 4-month old patient who are part of a cluster of 3 patients from the same reporter, and with the same vaccines administered. Information regarding the other patient who is also 4 months old has been captured in case number 2011-09211. Two 4-month-old male patients who had no concurrent illnesses, and no known allergies had received a second intramuscular right leg injection of ACTHIB (lot number UH209AA, sanofi pasteur SA lot number G1317-1), and a second intramuscular left leg injection of DAPTACEL (lot number C2004AA), and an intramuscular right leg injection of PREVNAR (Wyeth, lot number 916973) and 72 hours after receiving the vaccinations the parent reported both patients had a red rash (described as little bumps) on the left thigh at the DAPTACEL injection site. The patients did not require medical evaluation and no relevant diagnostic tests and or laboratory data were performed. Twenty-five gauge, 5/8 inch (15.875mm) needles were used for the vaccinations. At the time of this report, it was unknown if either of the patients had recovered. Documents held by sender: None.
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Antibody test, Contusion, Headache, Injection site pain, Pyrexia
Clinical narrative: Information has been received from a 52 year old female patient, reporting on herself, with penicillin allergy and a history of seizure from rubella as a child and mitral valve prolapse who on 22-JUN-2011 was vaccinated intramuscularly with a first dose of RECOMBIVAX HB (manufacturer, lot # and dose not provided). There was no concomitant medication. After getting the hepatitis B vaccine on 22-JUN-2011 the patient developed bruise on her back, had a fever, headaches, and tenderness at site of injection. Patient sought unspecified medical attention and no treatment was given. On an unspecified date the patient had a "titer" test done (results not reported). At the time of this report, the patient still had the fever and had not yet recovered (it was also reported that the AE improve after stopping therapy). Follow up information has been received from a physician concerning the 52 year old female patient who in the morning at 10:15 of 22-JUN-2011, was vaccinated with a dose of RECOMBIVAX HB subcutaneously in the left arm (Lot number AHBVC004AA is an invalid lot number for RECOMBIVAX HB. Concomitant therapy included TB-PPD). Follow up information has been received from a physician concerning a 52 year old female patient who in the morning at 10:15 of 22-JUN-2011, was vaccinated with a dose of RECOMBIVAX HB intramuscularly (Lot number AHBVC004AA is an invalid lot number for RECOMBIVAX HB. No further information is available.
Sex: F
Vaccine: HEP
Symptoms: Hypersensitivity, Rhinorrhoea, Sneezing
Clinical narrative: Information has been received from a doctor of pharmacy concerning a female patient who years ago was vaccinated with Hep B (manufacturer unknown) (lot #, dose and route not reported). The pharmacist reported that the patient years ago on an unspecified date had a reaction to a Hepatitis B vaccine. It was reported that she had allergy symptoms post vaccination of running nose and sneezing. The patient recovered from the symptoms. It was unknown if she sought medical attention. No further information is available.
Age: 56.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative, No therapeutic response
Clinical narrative: Information has been received from a medical assistant concerning a 55 year old male patient with elevated liver enzymes, renal insufficiency, 3 liver biopsies and dyslipidaemia who on 15-DEC-2004, was vaccinated with the first dose of RECOMBIVAX HB 0.5 ml, intramuscularly (Lot number ENG5563A4 is an invalid lot number for RECOMBIVAX HB), (Exp: August, 2005). On 10-JAN-2005, the patient was vaccinated with the second dose of RECOMBIVAX HB 1ml, intramuscularly (Lot number ENG5589A4 is an invalid lot number for RECOMBIVAX HB) (Exp: September, 2005). On 09-JUN-2005, the patient was vaccinated with the third dose of RECOMBIVAX HB 1 ml, intramuscularly (Lot number AHBVB125AA is an invalid lot number for RECOMBIVAX HB) (Exp: October, 2006). Concomitant therapy included testosterone, INDOCIN, DIOVAN HCT, prednisone and ANDROGEL. The medical assistant mentioned the patient had not been immune. The patient sought medical attention by office visit. Titers for hepatitis B were performed. There was no treatment for the event. At the time of the report titer showed not immune. Follow-up information has been received a medical assistant concerning a 55 year old male (199 pounds, 75 inches) on 15-DEC-2004, was vaccinated with the first dose of RECOMBIVAX HB in his left arm. On 10-JAN-2005, the patient was vaccinated with the second dose of RECOMBIVAX HB in his right arm. On 09-JUN-2005, the patient was vaccinated with the third dose of RECOMBIVAX HB in his right arm. The medical assistant who reported that the manufacturer of the "Hep B" vaccine was unknown. The patient did not have any illnesses at the time of the vaccinations. On 15-APR-2011, a serum hepatitis B surface antibody screen result was <5 MIU/ml- patient did not have immunity to hepatitis B virus. All available medical records will be provided upon request. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: HEP
Symptoms: Discomfort, Induration, Mass, Pain, Skin warm
Clinical narrative: Information has been received from a physician concerning a 58 year old female patient who on 12-SEP-2011, was vaccinated in the left deltoid with the third dose of RECOMBIVAX HB thimerosal free (lot# 669935/0569AA, expire on 01-NOV-2013). The physician reported that his patient had a delayed reaction to RECOMBIVAX HB after the third dose. The patient experienced "a fair amount discomfort at the time of the injection". Two weeks later "on 26-SEP-2011", the patient had increasing pain, swelling, induration at the shoulder ("6 cm lump"). There was no erythema, the patient was afebrile, but the area was slightly warm to the touch. There was not treatment given to the patient. At the time of the report, the patient had not recovered. The patient sought medical attention. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: HEP
Symptoms: Swelling
Clinical narrative: Information has been received from a physician concerning a 58 year old female patient who on 12-SEP-2011, was vaccinated in the left deltoid with the third dose of RECOMBIVAX HB thimerosal free (lot# 669935/0569AA, expire on 01-NOV-2013). The physician reported that his patient had a delayed reaction to RECOMBIVAX HB after the third dose. The patient experienced "a fair amount discomfort at the time of the injection". Two weeks later "on 26-SEP-2011", the patient had increasing pain, swelling, induration at the shoulder ("6 cm lump"). There was no erythema, the patient was afebrile, but the area was slightly warm to the touch. There was not treatment given to the patient. At the time of the report, the patient had not recovered. The patient sought medical attention. Additional information has been requested.
Age: 0.01
Sex: M
Vaccine: HEP
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a pharmacist informed by the nurses in the hospital concerning an approximately 2 day old male infant with no pertinent medical history and no drug reactions/allergies who in "July 2011, over the weekend", on approximately 02-JUL-2011, was vaccinated intramuscularly with the first dose of RECOMBIVAX HB (Thimerosal Free) (Lot # 668308/0491AA, exp date 30-APR-2013). There was no concomitant medication. It was reported that the patient received his first dose of RECOMBIVAX HB in his "thigh" before leaving the hospital after his birth. Minutes after the vaccination was given, the patient's leg turned completely red, and a few minutes later only the back of the child's leg was red and then only a small circle at the injection site was red and within 20 minutes all the redness disappeared completely. No lab diagnostics studies performed. It was not specified whether the patient sought medical attention. The patient recovered on approximately 02-JUL-2011. Additional information has been requested.
Age: 0.1
Sex: M
Vaccine: HEP
Symptoms: Incorrect dose administered, Injection site pain
Clinical narrative: Information has been received from a registered nurse concerning her approximately 30 day old (currently 8 weeks) infant son with no pertinent medical history and no known drug reactions or allergies who in August 2011, was inadvertently vaccinated intramuscularly with 1 ml of RECOMBIVAX HB (lot # not reported). There was no concomitant medication. Her son experienced slight tenderness at the injection site which did not require treatment (date unspecified). No treatment for the adverse event was given. Laboratory and diagnostics studies were not performed. At the time of the report, the patient had recovered on an unspecified date. No further information is available.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, No therapeutic response
Clinical narrative: Information has been received from a health care worker (also the patient) with no pertinent medical history or drug reaction/allergy who "about 10 years ago" (in approximately 2001) was vaccinated with HepB (lot# and manufacturer unknown). There was no concomitant medication. On an unknown date, the patient did "blood test" and reported that "she did not have a positive titer after receiving the 3 dose series of HepB (manufacturer was unknown)". No treatment was given for the adverse event. The patient did not seek medical attention. At the time of report, the outcome of the adverse event was unknown. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, No therapeutic response
Clinical narrative: Information has been received from a registered nurse concerning her son who is her 20's and who when he was a child on unknown dates, was vaccinated with the complete series of RECOMBIVAX HB (dose, route and lot number not reported). The nurse stated that her son recent had an hepatitis B antibody test that showed his level was less than 4 and he was required to receive additional hepatitis B vaccinations for school. The patient did not sought medical attention. At the time of the report the outcome of the patient was unknown. This is an amended report. The preferred term for the adverse event was changed from "Hepatitis B surface antibody negative" to "Hepatitis B antibody negative". Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, No therapeutic response
Clinical narrative: Information has been received from a registered nurse concerning a now 62 year old female with no pertinent medical history and no drug reactions or allergies who in 2006 was vaccinated with 3 doses of RECOMBIVAX HB (lot #, dose and route not reported). There was no concomitant medication. On an unspecified date, antibody titers for hepatitis B was performed and the patient had "non immune" antibody titers. The patient sought unspecified medical attention. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from a physician concerning a cluster of six of seven patients who did not develop sufficient titer after vaccinations with RECOMBIVAX HB. On 23-NOV-2010, 5 patients were vaccinated with a dose of RECOMBIVAX HB (lot number: 666029/1456Y), thimerosal free (dose and site of administration not reported) and 2 patients were vaccinated with a dose of RECOMBIVAX HB (lot number: 666806/0732Z), thimerosal free (dose and site of administration not reported). On 22-DEC-2010, all 7 patients were vaccinated with a dose of RECOMBIVAX HB (lot number: 666805/0657Z), thimerosal free (dose and site of administration not reported). On 25-MAY-2011, 6 patients were vaccinated with a dose of RECOMBIVAX HB (lot number: 669597/0294AA), thimerosal free (dose and site of administration not reported). On 25-MAY-2011, 1 patient was vaccinated with a dose of RECOMBIVAX HB (lot number: 666809/1631Z), thimerosal free (dose and site of administration not reported). Titers drawn in June 2011 showed that six of seven total patients did not developed sufficient titers. The titers were repeated in July 2011 at a second laboratory. The patients did not seek medical attention. At the time of the report, the patients' outcomes were unknown. All telephone attempts to obtain follow-up information have been unsuccessful. Follow up information has been received from the physician who stated that she did not have time to fill out any of the correspondence that she received, but that she had a spreadsheet with all the patient identifiers that she would fax in. Follow up information was received from the physician who reported that his office did not treat any pediatric patients, the office only treated adults. The physician reported that the office purchased the pediatric vials (0.5 ml vial dose) "which are cheaper" and dispensed two vials to each patient to provide an adult dose. Related WAES#s include: 1107USA03575, 1108USA01425, 1108USA01426, 1108USA01427, 1108USA01428. This is one of several reports received from the same source. A standard lot check investigation has been finalized. All in-process quality checks for the lot numbers 669597/0294AA, 666805/0657Z and 666029/1456Y in question were satisfactory. In addition, an expanded lots check investigation were performed. The testing performed on the batches prior to release met all release specifications. The lots met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 0.22
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a physician concerning an 11 weeks old female patient with no pertinent medical history and no known drug allergies/drug reactions who on 18-JUL-2011 was vaccinated with a dose of RECOMBIVAX HB (Lot #, site and route not reported). Concomitant vaccines given on the same day included a dose of PREVNAR and a dose of PENTACEL. It was reported that the site of injection was red. There were no laboratory tests performed. The patient was given TYLENOL as a treatment of the event. At the time of the report the outcome of the patient was unknown. The patient sought medical attention with a phone call and an office visit. This is one of several reports concerning the same patient (WAES # 1107USA02485). Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from an office administrator concerning a 19 year old male patient who on unspecified date was vaccinated with a dose of 5 mcg/ 0.5 ml RECOMBIVAX HB (Lot number not reported). On an unspecified date the patient had no detectable hepatitis B titers. The patient had visited the office. At the time of reporting, the patient had not recovered. Follow-up information has been received from a physician reporting that they had re-vaccinated the patient on an unspecified date. No further information is available.
Age: 20.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Urticaria
Clinical narrative: Information has been received from a Registered Nurse (R.N) concerning an "about 20-25 years" old male patient who in approximately 1999, "about 10-12 years", was either vaccinated with a dose of RECOMBIVAX HB or a dose of ENGERIX B (Lot #, dose and route not reported). The registered nurse reported that on an unspecified date, the patient developed 2-3 hives on the leg. On an unspecified date, the patient spoke to a physician. It was unspecified if there was given any treatment for the event. On an unspecified date, the patient was recovered. Additional information has been requested.
Age: 1.5
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from the physician concerning a now 20 years old female patient who was vaccinated with two series of RECOMBIVAX HB - three doses of first series were given on 26-Oct-1992 (dose, route and lot # not provided), 09-DEC-1992 (late) and 15-MAY-1993 (late) respectively. Physician reported that the patient had "low immunity" to the first series of RECOMBIVAX HB, so a second series of was given. Three doses of second series were given on 10-AUG-2010 (lot # 666187/1484Y), 24-NOV-2010 (lot # 666029/1456Y) and 28-JAN-2011 (lot # "AHBLOVB868CE", not valid for the vaccine) respectively. All expiration dates were not provided. Physician reported that after receiving the second series, the patient's immunity was "low at 0.26". The patient had blood work, result was not provided. The patient saw the physician to seek medical attention. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from a consumer concerning her daughter with coeliac disease who on an unspecified date, was vaccinated with the second dose of Hep B (manufacturer unknown). Subsequently, on an unspecified date, after being vaccinated twice with Hep B (manufacturer unknown) the patient had failed to developed immunity. The patient's mother stated that "it was not unheard of for people with celiac disease to fail to develop titers when vaccinated for hepatitis B". At the time of the report the patient's outcome was not reported. It was unspecified if the patient sought medical attention. Additional information is not expected.
Sex: F
Vaccine: HEP
Symptoms: Pruritus generalised
Clinical narrative: Information has been received from a registered pharmacist concerning a female patient with no pertinent medical history or drug reactions/allergies who on 24-AUG-2011 was vaccinated with 1ml RECOMBIVAX HB (lot# 671032/1106AA, exp: 05-APR-2014) by intramuscular. There was no concomitant medication. "Within 24-48 hours after the dose of RECOMBIVAX HB", the patient developed "itching all over the body". The patient sought medical attention by calling pharmacy. No lab diagnostics study was performed. The patient self-treated with BENADRYL and AMBIEN. The patient fully recovered on an unspecified date. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from a medical assistant concerning a 29 year old female patient with unknown relevant history, unknown preexisting medical conditions and unknown past drug history who on 09-DEC-2008, was vaccinated with a dose of  ENGERIX-B. On 06-JAN-2009, the patient was vaccinated with a dose of Hep B (lot number, expiration date, dose and site of administration not reported). On unspecified date, the patient had a negative hepatitis B titer. As of 25-JUL-2011, the patient's hepatitis B titer continued to be negative. It was unknown if the patient would be receive any further doses of ENGERIX-B or Hep B. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from a registered nurse concerning a 22 year old female patient with amoxicillin allergy who on unspecified date was vaccinated with the first series of RECOMBIVAX HB (lot number, dose and site of administration not reported) when the patient was a child. On 18-OCT-2011, the patient was vaccinated with a second of RECOMBIVAX HB (lot number, dose and site of administration not reported) on public health clinic. On an unspecified date, the patient had a titer drawn recently and it was low for Hepatitis B. At the time of the report, the patient had not recovered. The patient sought unspecified medical attention. Follow up was received from the registered nurse who stated that the patient had low titer from initial doses received as a child. The patient need it a booster for RECOMBIVAX HB. Additional information is not expected.
Age: 0.75
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative, No adverse event
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 9 month old female patient who on 26-JUN-1992 was vaccinated with her first dose of RECOMBIVAX HB (Lot# unspecified) and completed her series on 27-MAR-1993. The nurse reported that the patient (approximately 19 year old now) had done "HBsAb" test and was then testing negative for titers for HBsAb (date unknown). The patient sought medical attention by medical examination and considered revaccination. The nurse stated that the patient had reported no adverse experience. Additional information has been requested.
Age: 0.33
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from a physician concerning a 9 month old male patient who on 05-JUN-1992, was vaccinated with the first dose of RECOMBIVAX HB (dose and route not reported) (lot number 603483/0585V). On 07-AUG-1992, was vaccinate with the second dose of RECOMBIVAX HB (dose, route and lot number not reported). On 07-JAN-1993, was vaccinated with the third dose of RECOMBIVAX HB (dose, route and lot number not reported). The physician stated that the patient received 3 doses of RECOMBIVAX HB and has no titers. At the time of the report the patient had not recovered. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: HEP
Symptoms: Pyrexia
Clinical narrative: Information has been received from a physician concerning an approximately 12 months old patient, with no known medical history, who on approximately 19-AUG-2011, was vaccinated with a dose of RECOMBIVAX HB Lot number 0596A is an invalid lot number for RECOMBIVAX HB (route not reported) 0.5 ml. Concomitant therapy included PENTACEL. The physician reported that on approximately 19-AUG-2011, the patient experienced a high fever lasting more than 24 hours. The patient did not seek medical attention and was not given any treatment for the event. No laboratory tests were performed. On an unspecified date, the patient was recovered. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, No therapeutic response
Clinical narrative: Information has been received from a physician concerning a pediatric patient with celiac disease who on unspecified date was vaccinated with the series for RECOMBIVAX HB (manufacturer unknown) but was  not seroconvert. It was unspecified if the patient sought medical attention. At the time of reporting the outcome of the patient was unknown. All telephone attempts to obtain follow-up information have been unsuccessful. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B test negative, No therapeutic response
Clinical narrative: Information has been received from a physician concerning a pediatric patient with celiac disease who on unspecified date was vaccinated with the series of Hep B (manufacturer unknown) but was not seroconvert. It was unspecified if the patient sought medical attention. At the time of reporting the outcome of the patient was unknown. All telephone attempts to obtain follow-up information have been unsuccessful. This is one of several reports from the same source. Additional information has been requested.
Age: 0.5
Sex: U
Vaccine: HEP
Symptoms: Pyrexia
Clinical narrative: Information has been received from a physician concerning an approximately 20 week old patient, with no known medical history, who on approximately 19-AUG-2011, was vaccinated with a dose of RECOMBIVAX HB Lot number 0596A is an invalid lot number for RECOMBIVAX HB (route not reported) 0.5ml. Concomitant therapy included PENTACEL. The physician reported that on approximately 19-AUG-2011, the patient experienced a high fever lasting more than 24 hours. The patient did not seek medical attention and was not given any treatment for the event. No laboratory tests were performed. On an unspecified date, the patient was recovered. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from a physician concerning a cluster of six of seven patients who did not develop sufficient titer after vaccinations with RECOMBIVAX HB. On 23-NOV-2010, 5 patients were vaccinated with a dose of RECOMBIVAX HB (lot number: 666029/1456Y), thimerosal free (dose and site of administration not reported) and 2 patients were vaccinated with a dose of RECOMBIVAX HB (lot number: 666806/0732Z), thimerosal free (dose and site of administration not reported). On 22-DEC-2010, all 7 patients were vaccinated with a dose of RECOMBIVAX HB (lot number: 666805/0657Z), thimerosal free (dose and site of administration not reported). On 25-MAY-2011, 1 patient was vaccinated with a dose of RECOMBIVAX HB (lot number: 666809/1631Z), thimerosal free (dose and site of administration not reported). Titers drawn in June 2011 showed that six of seven total patients did not developed sufficient titers. The titers were repeated in July 2011 at a second laboratory. The patients did not seek medical attention. At the time of the report, the patients' outcomes were unknown. Follow up information has been received from the physician who stated that on 23-NOV-2010, on 22-DEC-2010 and on 01-JUN-2011 one of the patients involved was vaccinated with the first, second and third doses respectively of RECOMBIVAX HB thimerosal free (dose and site of administration not reported) (lot numbers: 666806/0732Z, expiring 10-NOV-2010; 666805/0657Z, expiring 09-NOV-2012 and 666809/1631Z, expiring 12-NOV-2012, respectively). The physician reported that on unspecified dates, two titer test were performed (both results: NR). Follow up information was received from the physician who reported that his office does not treat any pediatric patients, the office only treats adults. The physician reported that the office purchased the pediatric vials (0.5 ml vial dose) "which are cheaper" and dispensed two vials to each patient to provide an adult dose. Related WAES#s include: 1107USA03575, 1108USA01425, 1108USA01426, 1108USA10427, 1108USA01429. This is one of several reports received from the same source. A standard lot check investigation has been finalized. All in-process quality checks for the lot numbers 666806/0732Z and 666805/0657Z in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from a physician concerning a patient who "10 years ago" (approximately in June 2001), was vaccinated with the complete series of either RECOMBIVAX HB (dose, route and lot# not reported) or ENGERIX B and "now" (on approximately 30-JUN-2011), the patient had a negative hepatitis B titer. At the time of the report the patient's outcome was unknown. It was unspecified if the patient sought medical attention. Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from a registered nurse concerning unspecified number patients who on unspecified dates were vaccinated with a series of HepB (thimerosal free) (manufacturer unknown) in her office. It was reported that "the patient might have been given RECOMBIVAX HB". The patients "still" had negative titers. It was unspecified if the patients sought medical attention. At the time of reporting, the patients' outcomes were unknown. Follow up information received from the nurse who denied that she made the report stated that she did not know where this report came from. All telephone attempts to obtain follow-up information has been unsuccessful. No further information is available.
Age: 17.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from a nurse practitioner concerning a 17 year old female patient who on unspecified dates was vaccinated with the 3 doses of HepB (manufacturer unknown). The nurse practitioner reported that the patient was administered the HepB (manufacturer unknown) as an infant and now had inconsistent titers for Hepatitis B. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from a physician concerning a pediatric patient with celiac disease who on unspecified date was vaccinated with the series for Hep B (manufacturer unknown) but was not seroconvert. It was unspecified if the patient sought medical attention. At the time of reporting the outcome of the patient was unknown. All telephone attempts to obtain follow-up information have been unsuccessful. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Neck pain
Clinical narrative: Information has been received from a physician concerning a female employee who "about 15 years ago", in approximately 1996, was vaccinated with a dose of RECOMBIVAX HB (Lot # not provided). It was reported the patient who received RECOMBIVAX HB subsequently experienced neck pain on the same side as the injection site "about 15 years ago", in approximately 1996. Whether the patient sought medical attention was not reported. At the time of reporting, the patient's outcome was unknown. Additional information has been requested.
Age: 1.56
Sex: M
Vaccine: DTAP
Symptoms: Abnormal behaviour, Middle insomnia, Psychomotor hyperactivity
Clinical narrative: Initial report was received 24 February 2011 from a consumer, who is the patient's parent. An 18-month-old male patient with an unknown medical history had received a first dose of DTaP vaccine (manufacturer, lot number, route and site of administration unknown) on 15 February 2011 and on the day of vaccination, he became hyperactive, wouldn't let anyone touch him and he was awakening at night. Symptoms persisted until 23 February 2011 at which time they resolved. The event did not require a doctor's visit. The patient had previously received a first dose of Tetanus Toxoid Adsorbed Preservative-free, lot number U3349AA on 10 December 2010 in the ER after sustaining an unspecified injury. According to the reporter, the patient did not experience any of the above symptoms after receiving Tetanus Toxoid Adsorbed Preservative-free vaccination. No additional information was provided at the time of the report. Follow-up information received from a health care professional on 05 April 2011. The patient received on 15 February 2011 a left thigh injection of DAPTACEL, sanofi pasteur lot  number C3577AA (previously reported at DTaP vaccine). Follow-up information received from a health care professional on 05 May 2011. The patient had no past medical history. He had no illness at the time of vaccination and was taking no medications. No treatment was given after vaccination. Documents held by sender: None.