chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Abasia, Injection site induration, Injection site pain, Pyrexia
Clinical narrative: This case was reported by a physician and described the occurrence of fever in a 2-year-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). On 15 April 2011 the subject received unspecified dose of HAVRIX (unknown). At an unspecified time after vaccination with HAVRIX (days later), the subject experienced fever (102 degrees F). At the time of reporting the outcome of the event was unspecified. Follow-up information was received via the subject's physician on 06 June 2011. It was reported that HAVRIX was given on 14 April 2011 in the left thigh. The following day, on 15 April 2011, the subject developed a fever. On 20 April 2011, the subject experienced induration of the left thigh, egg sized with tenderness. The subject was unable to walk. Fever and induration were worse at the time of reporting. Attribution of the events to HAVRIX was unknown.
Age: 21.0
Sex: M
Vaccine: HEPA, TYP
Symptoms: Nausea, Vomiting
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of nausea in a 21-year-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). Concurrent vaccination included Typhoid vaccine (manufacturer unspecified) given on 21 January 2011. On 21 January 2010 the subject received 1st dose of HAVRIX at 1.0 ml in the right arm. On 23 January 2010, 2 days after vaccination with HAVRIX (approximately 36 hours after dose), the subject experienced nausea and vomiting. The events lasted for 36 hours and then resolved.
Age: 7.0
Sex: F
Vaccine: HEPA
Symptoms: Mass, Oedema peripheral, Pain in extremity, Urticaria
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of an unspecified adverse event in a subject of unspecified age and gender who was vaccinated with HAVRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of HAVRIX (unknown). At an unspecified time after HAVRIX, the subject experienced an unspecified adverse event. At the time of reporting the outcome of the event was unspecified. Follow-up received from healthcare professional on 20 April 2011: The subject was a 7-year-old female. On 25 March 2011 the subject received a booster dose of HAVRIX pediatric (intramuscular). On 25 March 2011 within several hours after vaccination with HAVRIX, the subject experienced urticaria with hives, and pain and swelling of her hands and feet. The subject was seen at the healthcare professional's office 48 hours after vaccination with ongoing hives and also a lump on the bottom of her right heel. The events resolved on an unspecified date. The subject had received HAVRIX previously with no adverse reaction.
Sex: U
Vaccine: HEPA
Symptoms: Immediate post-injection reaction, Nausea
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of nausea in an adult subject of unspecified gender who was vaccinated with HAVRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of HAVRIX at 1.0 ml in an unknown arm. Immediately after vaccination with HAVRIX, the subject experienced nausea. At the time of reporting the outcome of the event was unspecified. In the reporter's opinion nausea was probably related to treatment with HAVRIX. It was noted that the occurrence of nausea following administration of HAVRIX happened with three different subjects. The reporter requested replacement of three packs of vaccine (ndc 58160-826-48). All three vaccinations in question had the same lot number and expiration date. Linked cases include A0931343A and A0931347A. According to information received on 09 August 2011 via GSK Quality Assurance, this report involved an adverse event only (no product complaint).
Age: 17.0
Sex: F
Vaccine: MNQ, PPV
Symptoms: Musculoskeletal pain, Neck pain
Clinical narrative: Initial case received from a healthcare professional on 26 July 2011. A 17-year-old female patient, with a history of asthma and ovarian cysts, received intramuscular right deltoid injections of MENACTRA (lot number U3844AA) and PNEUMOVAX (Merck, lot number 056AA) on 25 July 2011. The evening of vaccination, she complained of neck and shoulder pain on the right side. The pain was reported as constant, and was ongoing at the time of the report. The patient was seen by her physician due to the event. Concomitant vaccination included SINGULAIR, methotrexate, folic acid, "Apprgy" birth control, and ondansetron. The patient was not ill at the time of vaccination.
Sex: U
Vaccine: HEPA
Symptoms: Immediate post-injection reaction, Nausea
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of nausea in an adult subject of unspecified gender who was vaccinated with HAVRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of HAVRIX at 1.0 ml in an unknown arm. Immediately after vaccination with HAVRIX, the subject experienced nausea. At the time of reporting the outcome of the event was unspecified. In the reporter's opinion nausea was probably related to treatment with HAVRIX. It was noted that the occurrence of nausea following administration of HAVRIX happened with three different subjects. The reporter requested replacement of three packs of vaccine (ndc 5816-826-48). All three vaccinations in question had the same lot number and expiration date. Linked cases include A0931343A and A0931346A. According to information received on 09 August 2011 via GSK Quality Assurance, this report involved an adverse event only (no product complaint).
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Dysphagia, Erythema, Migraine, Muscular weakness, Oedema peripheral
Clinical narrative: Initial report was received from a consumer, who was also the patient's parent, on 30-December-2011. A 16-year-old male patient had received an intramuscular injection in the right deltoid of MENACTRA, sanofi pasteur Inc., lot number U4040AA, in the morning on 01 December 2011. On the evening of the vaccination, the patient became sluggish. The next day, by the afternoon, the patient could not get up off the couch, all extremities were weakened, the patient had a migraine, difficulty swallowing and redness, swelling and pain from the shoulder to the elbow on the left arm. The symptoms were gone by Sunday, except for redness and swelling of arm. The patient was seen by a pediatrician and was diagnosed with reaction to vaccine. No further information was available at the time of the report. The patient's outcome was reported as recovered. Documents held by sender: none.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Pain in extremity, Sluggishness, Vaccination complication
Clinical narrative: Initial report was received from a consumer, who was also the patient's parent, on 30-December-2011. A 16-year-old male patient had received an intramuscular injection in the right deltoid of MENACTRA, sanofi pasteur Inc., lot number U4040AA, in the morning on 01 December 2011. On the evening of the vaccination, the patient became sluggish. The next day, by the afternoon, the patient could not get up off the couch, all extremities were weakened, the patient had a migraine, difficulty swallowing and redness, swelling and pain from the shoulder to the elbow on the left arm. The symptoms were gone by Sunday, except for redness and swelling of arm. The patient was seen by a pediatrician and was diagnosed with reaction to vaccine. No further information was available at the time of the report. The patient's outcome was reported as recovered. Documents held by sender: none.
Age: 25.0
Sex: F
Vaccine: MNQ
Symptoms: Lymphadenopathy
Clinical narrative: Initial report was received 25 October 2011 from a health care professional. A 25-year-old female patient had received an intramuscular left deltoid injection of MENACTRA, lot number U4073BA on 21 October 2011 at 3:24 pm and three days later on 24 October 2011 AM, she developed a swollen lymph node under her left arm. The patient had no past medical history or concomitant medications, and she had not received any other vaccines during the four weeks prior. The event did not require a doctor's visit. At the time of the report, outcome was unknown. Documents held by sender: None.
Age: 7.0
Sex: F
Vaccine: HEPA
Symptoms: Convulsion
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of convulsion in a 7-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline). The subject's medical history included tracheo-oesophageal fistula post surgery. Concurrent medical conditions included craniosynostosis. Concurrent medications included ZYRTEC. On 7 July 2011 at 16:45 the subject received 1st dose of HAVRIX (.5 ml, unknown route, right arm). On 7 July 2011, 3 minutes after vaccination with HAVRIX, the subject experienced convulsion. This case was assessed as medically serious by GSK. On 7 July 2011, the event was resolved. The healthcare professional considered the event was probably related to vaccination with HAVRIX.
Age: 47.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Antinuclear antibody, Arthralgia, Borrelia test negative, Full blood count, Musculoskeletal pain
Clinical narrative: Initial report was received from a health care professional on 02 September 2011. A 47 year-old female patient had received on 01 August 2011 at 10:15 a second dose intramuscularly right deltoid injection of MENACTRA, lot number U3849AA and second dose intramuscular left deltoid injection of ADACEL, lot number U3561CA (sanofi pasteur LTD lot number C3726) and 13 days later on 14 August 2011, the patient experienced stiffness, pain in the neck and shoulders and generalized joint pain. Laboratory tests included: lyme test negative and a CBC sed rate, ANA and rheumatoid arthritis work-up (results not reported). The patient has a history of "E-myon", hypothyroidism, asthma and depression. She was recently diagnosed with right carpal tunnel and was evaluated on 22 September 2011 by a rheumatologist (results not reported). Concomitant medications included SYNTHROID, SINGULAIR, LEXAPRO, ADVAIR and NAPROSYN. Illness at the time of vaccination was denied. No further information was available at the time of the report. The patient's outcome was not reported. Follow-up information received from a health care professional on 10 November 2011 reported that no additional information was available at this time. Documents held by sender: none.
Age: 47.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Musculoskeletal stiffness, Neck pain, Red blood cell sedimentation rate, Rheumatoid factor
Clinical narrative: Initial report was received from a health care professional on 02 September 2011. A 47 year-old female patient had received on 01 August 2011 at 10:15 a second dose intramuscularly right deltoid injection of MENACTRA, lot number U3849AA and second dose intramuscular left deltoid injection of ADACEL, lot number U3561CA (sanofi pasteur LTD lot number C3726) and 13 days later on 14 August 2011, the patient experienced stiffness, pain in the neck and shoulders and generalized joint pain. Laboratory tests included: lyme test negative and a CBC sed rate, ANA and rheumatoid arthritis work-up (results not reported). The patient has a history of "E-myon", hypothyroidism, asthma and depression. She was recently diagnosed with right carpal tunnel and was evaluated on 22 September 2011 by a rheumatologist (results not reported). Concomitant medications included SYNTHROID, SINGULAIR, LEXAPRO, ADVAIR and NAPROSYN. Illness at the time of vaccination was denied. No further information was available at the time of the report. The patient's outcome was not reported. Follow-up information received from a health care professional on 10 November 2011 reported that no additional information was available at this time. Documents held by sender: none.
Age: 70.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Vitamin B12 increased
Clinical narrative: This case was reported by a consumer and described the occurrence of elevated vitamin B12 level in a 70-year-old male subject who was vaccinated with HAVRIX 1440 (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included benign prostate hypertrophy, high blood pressure, high cholesterol, lung cancer and lung neoplasm surgery. Previous and/or concurrent vaccination included tdap vaccine (non-gsk); Sanofi Aventis;unknown;unknown given on 10 February 2011. Concurrent medications included verapamil ER, trandolapril, tamsulosin, simvastatin, bisoprolol HCTZ, levothyroxine, multivitamin, NIACIN, vitamin D3, folic acid, Co Q10, pantethine, 'Lutein' (unknown), fish oil, magnesium, vitamin E and vitamin B12. On 10 February 2011 at 1:00 the subject received 1st dose of HAVRIX 1440 (unknown, right arm). On 11 February 2011, 1 day after vaccination with HAVRIX 1440, the subject experienced elevated vitamin B12 level. The subject reported that he had a HAVRIX injection on 10 February 2011, blood work performed on 11 February 2011 and his vitamin B12 level was elevated to 1200. The subject planned to continue follow-up with his physician on an unknown date. At the time of reporting the elevated vitamin B12 level was unresolved.
Age: 6.0
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from a physician concerning a 6 year old patient who on 03-AUG-1993, 15-SEP-1993 and 27-SEP-1999, was vaccinated with the first, second and third dose of RECOMBIVAX HB (manufacturer unknown) (routes, expiration dates and lot numbers not reported). The physician reported that the patient received the three doses of RECOMBIVAX HB (manufacturer unknown), but still did not show immunity to hepatitis B. It was noted that the physician did not know certainly which vaccine for Hepatitis B was given to the patient since this was given in another office. The patient sought medical attention called to the office. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B virus test positive, Maternal exposure during pregnancy
Clinical narrative: Information has been received from a pediatrician for the unborn child concerning a female who on an unspecified date was vaccinated with her third dose of 10 mcg/ml RECOMBIVAXHB (lot # not reported) (manufacturer unknown) while pregnant. The patient was still pregnant and a recent hepatitis B titer was positive for hepatitis B. The physician did not know if this was surface or core antibodies. The patient had not recovered from hepatitis B titer positive for hepatitis B. The patient sought unspecified medical attention. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: Information has been received from a medical assistant concerning a patient who four years ago, in 2007, before got married was vaccinated with the three doses of RECOMBIVAX HB (Lot number not reported). The medical assistant reported that "now", in May 2011, the patient had serum hepatitis B surface antibody screen which showed less than 5 mIU/ml for the anti-HB concentration. She was uncertain what the dates were for the administration of the three doses, since they were administered at another health care provider's office. No other adverse experiences were reported. At the time of the report, the patient's outcome was unknown. This is an amended report. The vaccinated at and vaccine purchased with fields now read unknown instead of being blank. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: Information has been received from a physician concerning a female patient who in approximately 2007 ("about 4 years ago") was vaccinated with a full series of RECOMBIVAX HB (dose, route and lot # not reported). The physician reported that in approximately 2009 and ("about 1 and 1/2 years ago") last titers were taken. The patient's HBs titers were under 10. It was unspecified if the patient sought medical attention. At the time of reporting, the patient's status was unknown. No further information is available.
Age: 1.87
Sex: F
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of hive in a 22-month-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline). Concurrent medications included BENADRYL, ZYRTEC and ORAPRED. On 28 March 2011 at 16:00 the subject received 1st dose of HAVRIX at 0.5 ml in the left thigh. On 29 March 2011, 1 day after vaccination with HAVRIX, the subject experienced hive. She was taken to the director's office and was started on steroids. The nurse was going to follow-up with the mother to see how the subject was doing. No additional details were reported. The outcome of the event was not known. Follow-up information was received via the reporter on 27 April 2011. It was reported that the child experienced hives and urticaria one day following administration of HAVRIX on 29 March 2011. The events resolved and were considered to be possibly related to treatment with HAVRIX.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, VARCEL
Symptoms: Gait disturbance, Oropharyngeal pain, Pain in extremity, Pharyngitis
Clinical narrative: Initial report was received 15 August 2011 from a health care professional. A 15-year-old female patient had received a first dose intramuscular right deltoid injection of MENACTRA, lot number U3780AA, and a first dose intramuscular right deltoid injection of VAQTA (manufacturer Merck), lot number 0627AA, and a first dose intramuscular left deltoid injection of GARDASIL (manufacturer Merck), lot number 0636AA, and a second dose subcutaneous left deltoid injection of VARIVAX (manufacturer Merck), lot number 1704Z on 01 August 2011. One to two days later, the patient complained of pain and difficulty walking in both legs which lasted approximately three days. These symptoms resolved (date not reported) and did not require a doctor's visit. On 12 August 2011, the patient was seen by her physician with complaints of a sore throat and she was subsequently diagnosed with acute pharyngitis. The patient denied any concurrent illness or pre-existing medical conditions and she had not been taking any concomitant medications. It was unknown if the patient experienced any adverse events following prior vaccinations. Outcome for the event of pharyngitis was unknown at the time of the report. Documents held by sender: None.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from a physician reporting on herself who "years ago when in medical school", was vaccinated with three-dose series of RECOMBIVAX HB (dose, route and lot # not reported). The physician noted that she did not develop antibodies to her three-dose series of RECOMBIVAX HB (manufacturer unknown). The physician sought unspecified medical attention. No treatment was given for the adverse event. At the time of reporting, the patient's status was unknown. 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 patient who on an unknown date was vaccinated with 10 mcg/mL of a dose of RECOMBIVAX HB (manufacturer unknown) (lot # and expiration not reported) and their titers are low. It was unspecified if the patient sought medical attention. Antibody level was testes and was low. At the time of reporting the patient's outcome was unknown. Additional information has been requested.
Age: 21.0
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 her 21 year old son who on an unspecified date was vaccinated with a 0.5 ml second dose of RECOMBIVAX HB (lot # not reported). The nurse stated her son needed the RECOMBIVAX HB due to he was attending school and his titer showed he failed to seroconvert to a previously administered hepatitis B vaccine (Manufacturer unknown). No adverse events reported. the patient did not seek medical attention. Upon the time of the report, the patient's present status was unknown. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Information has been received from a female consumer, reporting on herself, who in September 2010, was vaccinated with a dose of RECOMBIVAX HB (Lot # and route not reported), 40mcg/ml. The consumer reported that 12 hours later she experienced vomiting and diarrhea. Consumer reported that she received a second dose of RECOMBIVAX HB 40mcg/ml, in October 2010 with no known adverse effect. No treatment was given for the events. The patient sought unspecified medical attention. At the time of the report, the patient's outcome was recovered. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from a registered nurse concerning an approximately 72 year old female patient with no drug allergies and no medical history who in the 1980's on an unspecified date was vaccinated with a hepatitis B series (manufacturer unknown) (lot # not reported). On an unspecified date, blood work results revealed that the patient had no protective hepatitis B titers. Then on an unspecified date, the patient received a booster dose of a hepatitis B vaccine (manufacturer unknown) (lot # not reported). After the booster dose, the patient's blood work also revealed the patient had no protective hepatitis B titers. The patient had sought unspecified medical attention. At the time of reporting, the patient's outcome was unknown. Follow up information has been received from the registered nurse who reported that the patient thought she received the hepatitis B series (manufacture MSD or GSK) in later 1980s - early 1990s. The patient stated that previous blood work revealed that she had no protective hepatitis B titers since she had declined hepatitis B vaccine. Additional information is not expected.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative, Inappropriate schedule of drug administration, No therapeutic response
Clinical narrative: Information has been received from a medical assistant concerning a 30 year old female patient with no known drug allergies and no pertinent medical history who on 21-FEB-2011 (it was also reported that therapy started on 21-APR-2011, dose reported as 0.5 mL), was vaccinated with the first dose of RECOMBIVAX HB (route and lot number not reported). On 21-MAR-2001, the patient was vaccinated with the second dose of RECOMBIVAX HB (route and lot number not reported). On 23-AUG-2001, the patient was vaccinated with the third dose of RECOMBIVAX HB (route and lot number not reported). There was no concomitant medication. On 20-MAY-2011, the patient came into the office and the physician did blood work. The test and results were "Hepatitis B surface antibody and result was nonreactive and a Hepatitis Fab and results was 5.48 mIU/mL". The medical assistant stated that on 09-JUN-2011, the patient was vaccinated with a fourth dose of RECOMBIVAX HB (route and lot number not reported). At the time of the report the patient had not recovered. Follow-up information received on 18-JUL-2011 from a Registered Nurse who stated that the physician had nothing further to add and did not want to provide more information. No further information is available.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from a nurse concerning an unknown number of children who on unspecified dates was vaccinated with hepatitis B virus vaccine (lot # not reported). Subsequently the patients were failing to show antibody levels to hepatitis B after finishing the vaccination series. The practice had 7 offices and nurse reported that they routinely tests for antibody levels and children were not responding. No active cases of hepatitis B to their knowledge. It was unspecified if the patients had sought medical attention. At the time of reporting, the patients' outcomes were unknown. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Age: 16.0
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from a nurse concerning a 16 year old patient who on unspecified date was vaccinated with 3 dose series of RECOMBIVAX HB and failed to elicit a positive titer. It was unknown if the patient sought medical attention. At the time of the report, the outcome of the event was not reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 52.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B surface antigen positive
Clinical narrative: Information has been received from a physician concerning a dialysis male patient who had received three dose series of hepatitis B virus vaccine (lot # not reported) on unspecified dates. Subsequently the patient was found to be hepatitis B antigen positive. The patient had sought medical attention by dialysis on schedule. At the time of this report, the patient's outcome was unknown. Follow up information has been received from a registered nurse who provided the list of dates the patient was vaccinated and clarification of which vaccine the patient was given, along with dates, lot #'s and expiration dates as below: ENGERIX-B was given on 29-OCT-2009 (lot # AHBVB719AA, expiration date 04-NOV-2011), 01-DEC-2009 (lot # AHBVB632AA, expiration date 13-APR-2011), 29-APR-2010 (lot # AHBV834BA, expiration date 02-JUN-2012), 12-JUN-2010 (lot # not reported) ("same as above by looking at consent") and 15-JUL-2010 (lot # AHBVB798AA, expiration date 27-APR-2012), respectively. Hepatitis B virus vaccine (lot # 669001/1064Z, expiration date 15-APR-2013) was given on 05-APR-2011. Follow up information has been received on 23-JUN-2011 from a physician and medical records concerning a 52 year old male with end stage renal disease (ESRD) at the time of vaccination. The patient was vaccinated with ENGERIX-B was given on 29-OCT-2009 (lot # AHBVB719AA, expiration date 04-NOV-2011), 01-DEC-2009 (lot # AHBVB632AA, expiration date 13-APR-2011), 29-APR-2010 (lot # AHBV834BA, expiration date 02-JUN-2012), 12-JUN-2010 (lot # not reported) and 15-JUL-2010 (lot # AHBVB798AA, expiration date 27-APR-2012), respectively. Hepatitis B virus vaccine (lot # 669001/1064Z, expiration date 15-APR-2013) was given on 05-APR-2011. It was noted that the patient's results of monthly hepatitis 15-APR-2013) was given on 05-APR-2011. It was noted that the patient's results of monthly hepatitis 15-APR-2013) was given on 05-APR-2011. It was noted that the patient's results of montly hepatitis B surface antigen test from 07-JAN-2010 to 10-MAR-2011 were non reactive. On 07-APR-2011, the patient's hepatitis B surface antigen result had been reported as reactive. The patient had persistent positive hepatitis B surface antigen results on 19-APR-2011, 26-APR-2011, 05-MAY-2011 and 31-MAY-2011. On 28-APR-2011 and 09-JUN-2011, the patient's results of HBV DNA were <29 IU/ml and the results of HBV DNA QT were <169 copies/ml. The physician reported the patient had persistent positive hepatitis B surface antigen after the last dose of Hepatitis B virus vaccine. All avilable medical records will be provided upon request. No further information is available.
Age: 1.6
Sex: M
Vaccine: HEP
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning an 18 month old male who in August 2010, was vaccinated with the first dose of RECOMBIVAX HB (Lot number not reported). In August 2010, after receiving the first dose of RECOMBIVAX HB, the patient developed a rash on his back. It was not reported whether the patient sought medical attention. The patient's physician had not decided whether the series would be continued. No treatment was given for this event. The event improved after stopping therapy. On an unspecified date, the patient recovered. No further information is available.
Age: 3.0
Sex: M
Vaccine: HEP
Symptoms: Contusion, Oedema peripheral, Urticaria
Clinical narrative: Information has been received from a consumer concerning on her son 36 month old (also reported as 3 years old) with allergic reaction to antibiotics (unspecified) and "omnisaph" who on June 9th (year unspecified) was vaccinated with RECOMBIVAX HB (lot number, dose and site of administration not reported). On unspecified date after having the vaccination the consumer also started on amoxicillin. On 21-JUN-2011, the consumer broke out in hives very severely from the back of his head to his feet, his limbs swelled up, and he had bruising on his joints. The consumer was taking Amoxicillin at the the time of the adverse event. Also, it was reported that the consumer had been to see his pediatrician, who stated that the reaction seems to be "caused by the amoxicillin". The consumer also had appointments to see and allergist as well. When asked if the consumer's condition had improved his mother stated that" he was not fully recovered; he continued to get a little better, slowly". Unspecified treatment was given for the treatment of the adverse events. Blood test was performed (results not provided). At the time of the report, the patient was recovering. 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 physician concerning a patient who on an unspecified date was vaccinated IM with a dose of RECOMBIVAX HB (lot # not reported). The patient did not convert after receiving the vaccine. The outcome of not convert after vaccination was unknown at the time of reporting. It was unknown if the patient sought medical attention. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Liver function test abnormal
Clinical narrative: Information has been received from a physician concerning her 14 year old daughter with a history of cystinuria who in 1997 was vaccinated with three 0.5ml doses series of RECOMBIVAX HB (route and lot # not reported). The physician reported that in 2010 ("within the past year") she noted that her daughter did not develop antibodies to her three-dose series of RECOMBIVAX HB (manufacturer unknown). No treatment was given for the adverse event. In 2010 ("in the past year") lab diagnostics studies revealed her daughter had elevated liver function test results. At the time of reporting, the patient's status was unknown. 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, Hepatitis B test negative
Clinical narrative: Information has been received from a registered nurse concerning a patient who in 2006, report as "5 years ago", was vaccinated with 3 dose series of hepatitis B virus vaccine, and on an unspecified date in 2009, bloodwork showed no hepatitis B antibodies. On an unspecified date in 2009 the patient starting a second series of hepatitis B virus vaccine, and finishing in January 2010. On an unspecified date in 2011, the patient's quantitative hepatitis panel done and was negative for hepatitis B antibodies. It was unknown if the patient sought medical attention. At the time of report, the patient's outcome was unknown. No further information is available.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Incorrect dose administered
Clinical narrative: Information has been received from a certified medical assistant concerning a female in her 30's who in approximately 2006, reported as "5 years earlier", was vaccinated with hepatitis B vaccine. Titers were drawn in 2010 but came back negative. On 23-MAR-2011, the patient was vaccinated with, 0.5ml (lot no. 668061/1632Z, expiration date 30-MAR-2013) again, but only received one pediatric dose instead of 2. The patient did not seek medical attention. No adverse effect seen. Additional information has been requested.
Age: 0.01
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered, Lethargy, Somnolence
Clinical narrative: Information has been received from a consumer reporting on one of his 3 day old ("recently born") twin daughters with no pertinent medical history and no drug reaction or allergies who on 01-MAY-2011 was vaccinated with two doses of RECOMBIVAX HB (thimerosal-free) (lot # 669600/0230AA, expiration: 22-OCT-2013) (route, and dose not reported). There was no concomitant medication. The consumer reported that he suspected one of his twin daughters received two injections of RECOMBIVAX HB. The consumer suspected this because the nurse noticed two injection marks on the baby's arm. The consumer reported that the baby seemed "lethargic and drowsy", but had since recovered. The consumer was concerned of there would be any further effects if in fact the baby did receive two injections. No treatment was given for the adverse events and no lab diagnostics studies were performed. The patient sought unspecified medical attention. No further information is available.
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from a physician concerning a 47 year old female patient with gastrooesophageal reflux disease and depression who on unknown dates was vaccinated with two complete series of RECOMBIVAX HB, 10 microgram per milliliter (route and lot # were not reported). The physician reported that the patient continued to have low hepatitis B antibody titers. Laboratory diagnostics studies included "hepatitis B titers". The patient was seen by the physician. At the time of reporting the patient had not recovered. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Blood bilirubin increased, Cough, Dermatitis atopic, Faeces discoloured, Infantile spitting up
Clinical narrative: Information has been received from a physician and medical records concerning a 3 day old male patient who on 05-OCT-2010 was vaccinated with the first dose of RECOMBIVAX HB (lot number not provided). Secondary suspect therapy given on 23-DEC-2010 included the first dose of ROTATEQ (manufacturer unknown) and the second dose of ROTATEQ (manufacturer unknown) given on 12-DEC-2011. Concomitant vaccination included the first dose of PENTACEL and the first dose of PCV-13 given on 12-DEC-2010 and the second dose of PENTACEL and PCV-13 given on 12-FEB-2011. It was reported that on 08-OCT-2010 laboratory tests were performed which included: white blood cell count: 8.4; mean corpuscular volume (MCV): 102.5; mean corpuscular hemoglobin concentration (NCHC): 35.4; red cell distribution width test (RDW): 17.0; reticulocyte count: 3.4. On 08-OCT-2010 mild jaundice was noted and body temperature was 98.5. A bilirubin test was performed: 15.7, 16.5. On 09-OCT-2010 the mother was advised to continue breast feeding. The patient was seen by the doctor 2 or 3 days later. On 11-OCT-2010 the patient still experienced jaundice. breastfeeding was good. On 20-OCT-2010 the patient presented yellow stools, it was also reported that the patient was spitting up a lot. The patient was switched to amino acids (unspecified) (+) arachidonic acid (+) carbohydrates (unspecified) (+) docosahexaenoic acid (+) fat (unspecified) (+) linoleic acid (+) minerals (unspecified) (+) protein (unspecified) (+) vitamins (unspecified) GENTLEAZE 4 ounces each 2-3 hours and seemed better. On 18-FEB-2011 the patient presented papular rash on arms and back and body temperature of 98.1. The patient also presented with atopic dermatitis. On 12-MAR-2011 the patient complained of cough and stuffy nose, the patient was treated with nasal saline. At the time of the report the patient's outcome was unknown. No further information is available.
Sex: M
Vaccine: HEP
Symptoms: Jaundice neonatal, Mean cell haemoglobin concentration increased, Mean cell volume normal, Nasal congestion, Rash
Clinical narrative: Information has been received from a physician and medical records concerning a 3 day old male patient who on 05-OCT-2010 was vaccinated with the first dose of RECOMBIVAX HB (lot number not provided). Secondary suspect therapy given on 23-DEC-2010 included the first dose of ROTATEQ (manufacturer unknown) and the second dose of ROTATEQ (manufacturer unknown) given on 12-DEC-2011. Concomitant vaccination included the first dose of PENTACEL and the first dose of PCV-13 given on 12-DEC-2010 and the second dose of PENTACEL and PCV-13 given on 12-FEB-2011. It was reported that on 08-OCT-2010 laboratory tests were performed which included: white blood cell count: 8.4; mean corpuscular volume (MCV): 102.5; mean corpuscular hemoglobin concentration (NCHC): 35.4; red cell distribution width test (RDW): 17.0; reticulocyte count: 3.4. On 08-OCT-2010 mild jaundice was noted and body temperature was 98.5. A bilirubin test was performed: 15.7, 16.5. On 09-OCT-2010 the mother was advised to continue breast feeding. The patient was seen by the doctor 2 or 3 days later. On 11-OCT-2010 the patient still experienced jaundice. breastfeeding was good. On 20-OCT-2010 the patient presented yellow stools, it was also reported that the patient was spitting up a lot. The patient was switched to amino acids (unspecified) (+) arachidonic acid (+) carbohydrates (unspecified) (+) docosahexaenoic acid (+) fat (unspecified) (+) linoleic acid (+) minerals (unspecified) (+) protein (unspecified) (+) vitamins (unspecified) GENTLEAZE 4 ounces each 2-3 hours and seemed better. On 18-FEB-2011 the patient presented papular rash on arms and back and body temperature of 98.1. The patient also presented with atopic dermatitis. On 12-MAR-2011 the patient complained of cough and stuffy nose, the patient was treated with nasal saline. At the time of the report the patient's outcome was unknown. No further information is available.
Sex: M
Vaccine: HEP
Symptoms: Rash papular, Red cell distribution width increased, Reticulocyte percentage normal, White blood cell count decreased
Clinical narrative: Information has been received from a physician and medical records concerning a 3 day old male patient who on 05-OCT-2010 was vaccinated with the first dose of RECOMBIVAX HB (lot number not provided). Secondary suspect therapy given on 23-DEC-2010 included the first dose of ROTATEQ (manufacturer unknown) and the second dose of ROTATEQ (manufacturer unknown) given on 12-DEC-2011. Concomitant vaccination included the first dose of PENTACEL and the first dose of PCV-13 given on 12-DEC-2010 and the second dose of PENTACEL and PCV-13 given on 12-FEB-2011. It was reported that on 08-OCT-2010 laboratory tests were performed which included: white blood cell count: 8.4; mean corpuscular volume (MCV): 102.5; mean corpuscular hemoglobin concentration (NCHC): 35.4; red cell distribution width test (RDW): 17.0; reticulocyte count: 3.4. On 08-OCT-2010 mild jaundice was noted and body temperature was 98.5. A bilirubin test was performed: 15.7, 16.5. On 09-OCT-2010 the mother was advised to continue breast feeding. The patient was seen by the doctor 2 or 3 days later. On 11-OCT-2010 the patient still experienced jaundice. breastfeeding was good. On 20-OCT-2010 the patient presented yellow stools, it was also reported that the patient was spitting up a lot. The patient was switched to amino acids (unspecified) (+) arachidonic acid (+) carbohydrates (unspecified) (+) docosahexaenoic acid (+) fat (unspecified) (+) linoleic acid (+) minerals (unspecified) (+) protein (unspecified) (+) vitamins (unspecified) GENTLEAZE 4 ounces each 2-3 hours and seemed better. On 18-FEB-2011 the patient presented papular rash on arms and back and body temperature of 98.1. The patient also presented with atopic dermatitis. On 12-MAR-2011 the patient complained of cough and stuffy nose, the patient was treated with nasal saline. At the time of the report the patient's outcome was unknown. No further information is available.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Asthenia, Chills, Myalgia, Nausea
Clinical narrative: Fever that rose throughout the day and into the night peaking at 102 degrees and resulting in violent chills and nausea, but no vomiting. Also experienced terrible muscle/joint soreness and weakness.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Fever that rose throughout the day and into the night peaking at 102 degrees and resulting in violent chills and nausea, but no vomiting. Also experienced terrible muscle/joint soreness and weakness.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site oedema, Injection site warmth
Clinical narrative: Significant edema, firmness, warm to the touch for several days --area around injection site--3x5 inches. Resolved in 7 days.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Local reaction
Clinical narrative: Large local reaction OTC cetirizine.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt stated the injection site got extremely red and swollen. It did not hurt - but pt got flu shot in opposite arm and did not have any reaction to that vaccine.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Antimitochondrial antibody positive, Asthenia, Blood test, Burning sensation, Hypoaesthesia
Clinical narrative: (L) arm pain, numbness, weakness, tingling, burning, body aches, ringing in ears, seeing "floaters", have seen two doctors & a rheumatologist, as well as blood work & MRI. Very expensive & still not well! Awaiting neurology appt. & further follow ups too. (Currently treated w/muscle relaxers, pain pills & anxiety pills).
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Nuclear magnetic resonance imaging, Pain, Pain in extremity, Paraesthesia
Clinical narrative: (L) arm pain, numbness, weakness, tingling, burning, body aches, ringing in ears, seeing "floaters", have seen two doctors & a rheumatologist, as well as blood work & MRI. Very expensive & still not well! Awaiting neurology appt. & further follow ups too. (Currently treated w/muscle relaxers, pain pills & anxiety pills).
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Tinnitus, Vitreous floaters
Clinical narrative: (L) arm pain, numbness, weakness, tingling, burning, body aches, ringing in ears, seeing "floaters", have seen two doctors & a rheumatologist, as well as blood work & MRI. Very expensive & still not well! Awaiting neurology appt. & further follow ups too. (Currently treated w/muscle relaxers, pain pills & anxiety pills).
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Skin ulcer
Clinical narrative: Rash with small sores on left side of face, slightly itchy.
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal distension, Computerised tomogram normal, Dyspepsia, Endoscopy normal, Ultrasound scan normal
Clinical narrative: My stomach became bloated, and hard, and indigestion.  No heartburn.  And months, my stomach, after misc tests, seem not to be much better.  I just want to know if others had this same side effect, and will it subside with time.
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: X-ray normal
Clinical narrative: My stomach became bloated, and hard, and indigestion.  No heartburn.  And months, my stomach, after misc tests, seem not to be much better.  I just want to know if others had this same side effect, and will it subside with time.
Age: 26.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Haemorrhage, Premature labour
Clinical narrative: Preterm labor/hemorrhage. Went into labor at 28 weeks.
Age: 1.0
Sex: F
Vaccine: DTAPIPVHIB, MMR, PNC13, VARCEL
Symptoms: Rash generalised, Rash papular
Clinical narrative: Erythematous papular rash gen. over body. No itching, afebrile. Seen by Dr on 3/09/2012; to give Benadryl prn.
Age: 1.09
Sex: M
Vaccine: PNC13
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: High fever 102-103, severe diarrhea lasting 3+ days.
Age: 62.0
Sex: F
Vaccine: TYP
Symptoms: Headache, Immunisation reaction, Pyrexia, Rash generalised, Rash papular
Clinical narrative: Fever of 103 F, papular rash over my entire body, headache, this lasted until 02/10/12 when I realized I was having a post typhoid immunization reaction and started Cipro.  My fevers came down within 48 hours.
Age: 1.05
Sex: F
Vaccine: MMRV, RVX
Symptoms: Injection site induration, Injection site rash, Injection site warmth, Pyrexia
Clinical narrative: 100.0 fever, rash at injection site the size of a dollar coin. The rash feels firm and warm.
Age: 21.0
Sex: F
Vaccine: FLU3, HEPA, MNQ, PPV, TDAP
Symptoms: Chills, Local reaction, Myalgia, Pyrexia
Clinical narrative: Had large local reaction to Pneumovax as well as fevers, rigors, myalgias present on 3/11/2012. Had hep A, influenza, Menactra same day other arm; had Adacel same day same arm.
Age: 48.0
Sex: F
Vaccine: MMR
Symptoms: Flushing, Pruritus, Rash, Rash macular
Clinical narrative: Rash on face, neck, upper trunk started 7 p.m. 3/7/12. Itching and facial flushing, blotches a.m. 3/8/12. By 3/9/12 itching, rash and blotchiness lessened.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Computerised tomogram, Dandy-Walker syndrome, Device malfunction, Eye movement disorder, Head circumference abnormal
Clinical narrative: Initial report was received on 26 September 2011 from another manufacturer, report number WAES1109USA01131. The initial reporter to this manufacturer had been a consumer who is the parent of the patient. Verbatim from the report: "Information has been received from a consumer concerning her 2 month old daughter with no known drug allergies who in approximately OCT-2010 was vaccinated with ROTATEQ (dose, date unspecified) and ACTHIB (dose, date and route unspecified) and dose of DTAP (dose, date, manufacturer unspecified). On 29-DEC-2010 the patient was diagnosed with Dandy Walker Syndrome which caused the patient to experience hydrocephaly and she was hospitalized. While hospitalized the consumer reported her daughter had surgery to place a ventricular-peritoneal shunt. The consumer reported that her daughter was hospitalized a second time to have a new shunt placed because the first shunt malfunctioned. The consumer reported that her daughter was currently recovering and was stable. The primary reporter considered the Dandy Walker Syndrome to be an other important medical event as well as immediately life-threatening. MRI and CAT scan were performed (results not reported). Follow up information has been received from a physician concerned an 18 weeks old female patient who on 14-OCT-2010 was vaccinated with the first dose of ROTATEQ (lot number: 668036/0594Z) (route of administration not reported). On 14-DEC-2010, the patient was vaccinated with the second dose of ROTATEQ (Lot number: 668036/0549Z) (route of administration not reported). On 14-FEB-2011, the patient was vaccinated with the third dose of ROTATEQ (lot number: 668264/0854Z) (route of administration not reported). The patient was not vaccinated with ACTHIB and DAPTACEL (dates not provided). The events were not related to the vaccines; condition was congenital. Symptoms of Dandy Walker Syndrome: increased head circumference, hydrocephalus, vomiting, and sun-setting. On 30-DEC-2010, the first surgery was performed. On unspecified date, approximately one to two months later, after the first shunt failed, patient had another surgery. Events were disabling and life threatening at the time. Other vaccines were given after the adverse event onset. On 01-MAR-2011, the patient was vaccinated with the first dose of ACTHIB (lot number: 666187/1484Y) thimerosal free, (dose and site of administration not reported). On 16-MAY-2011, the patient was vaccinated with the second dose of ACTHIB (lot number: 668635/1520Z) (dose and site of administration not reported). At the time of the report, the patient was indeed recovering and in fact had "advance development for her age." No further information is available." Documents held by sender: none.