chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 6.0
Sex: F
Vaccine: DTAP, FLU3
Symptoms: Injection site pain, Injection site rash
Clinical narrative: Initial report was received on 04 January 2012 from a consumer who is also the patient's parent. A five year-old female patient with an allergy to OMNICEF and no medical conditions had received on 02 January 2012 a left arm injection of DAPTACEL, lot number C4006AA (route of administration not reported) and a right arm injection of Influenza vaccine (manufacturer, lot number, route, site and date of administration not reported) and an unspecified amount of time later the date of vaccination, experienced a large raised rash at the injection and extends entire length of arm, painful. The patient was treated with BENADRYL with no improvement. No further information was available at the time of vaccination. The patient's outcome was not recovered. Documents held by sender: none.
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, No therapeutic response
Clinical narrative: Information has been received from a public health nurse supervisor concerning an adult male who in the 1980's was vaccinated with 3 doses of Hep B (manufacturer unknown). On unspecified date an antibody test was drawn and showed the patient did not seroconvert. So in 1997 the patient was vaccinated again with a 4th dose of Hep B (lot # not reported) (manufacturer unknown). Again the patient failed to seroconvert. The patient sought unspecified medical attention. The status of the patient was unknown. Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Adverse reaction
Clinical narrative: Information has been received from a registered nurse concerning a child who over a year ago in approximately 2010, was vaccinated with a dose of RECOMBIVAX HB (Lot #, expire date and route not reported). Registered nurse stated that four days later after receiving RECOMBIVAX HB in approximately 2010, the child had an adverse reaction. At the time of the report, 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 patient who on an unspecified date was vaccinated with the third dose of RECOMBIVAX HB (Lot #, expire date and route not reported), 5 mcg. Physician stated that on an unspecified date, antibody titers were measured and patient was found to have low titer. No adverse effect was known. At the time of the report, 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 Nurse Practitioner concerning a patient who on unspecified dates received all 3 doses of RECOMBIVAX HB (lot number not provided). On an unspecified date, the titers were less than 10mlu/ml. The patient did not seek medical attention. No treatment was given. At the time of the report the patient had not recovered. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from a pharmacist concerning a female patient who on an unknown date, was vaccinated with a complete HepB series (manufacturer unspecified). On an unknown date, the patient had a negative hepatitis B antibody titer after having receiving a complete HepB series (manufacturer unspecified). Lab diagnostic studies performed included hepatitis B antibody titer with a negative result. At the time of the report, the outcome was unknown. It was unknown if the patient sought 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. Follow up information has been received from a physician concerning a patient who on 23-NOV-2010 was vaccinated with the first dose of RECOMBIVAX HB (Lot # lot number 666806/0732Z, exp: 10-NOV-2012), on 22-DEC-2010 was vaccinated with the second dose of RECOMBIVAX HB (Lot # lot number: 6666805/0657Z, exp: 09-NOV-2012) and on 25-MAY-2011 was vaccinated with the third dose of RECOMBIVAX HB (Lot # lot number: 669597/0294AA, exp: 07-SEP-2013). 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 vial dose) "which are cheaper" and dispensed two vials to each patient to provide an adult dose. Related WAES#s included: 1107USA03575, 1108USA01426, 1108USA01427, 1108USA01428, 1108USA01429. This is one of several reports from the same source. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process checks for the lot numbers 666806/0732Z, 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: 41.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Unevaluable event
Clinical narrative: Information has been received from a Licensed Visiting Nurse concerning a 41 year old female patient who was vaccinated with her first full Hep B series (route, dose and manufacturer unknown) on 11-OCT-2005, 26-JAN-2006 and 19-APR-2006. The patient had a negative hepatitis B antibody titer after completing her first Hep B series. The patient was vaccinated her second full Hep B (1.0mL) series intramuscularly on 08-JUN-2010, 09-JUL-2010 and 10-JAN-2011. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Anaphylactic reaction
Clinical narrative: Information has been received from a nurse concerning an actually 36 year old female patient with allergy to yeast and bee sting and no pertinent medical history who on an unknown date was vaccinated with a dose of HepB (manufacturer unknown) (Lot# and expiration not reported). There was no concomitant medication. The nurse reported that on an unspecified date the patient had a severe anaphylactic reaction when administered a dose of HepB (manufacturer unknown). The nurse also noted that the anaphylactic reaction was found to be due to the yeast in the HepB (manufacturer unknown). The nurse stated, "This occurred a while ago". No laboratories were performed. It was unknown if the patient sought medical attention. The patient recovered on an unspecified date. No further information is available.
Age: 28.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from a registered pharmacist concerning a 28 year old male patient who about 9 years ago (approximately 2002) had a complete series of hepatitis B vaccinations (product and manufacturer unknown) (lot number and site of administration not reported). A hepatitis B titer last week (approximately 11-MAY-2011) was negative. No treatment was given for the adverse event. The patient contacted to pharmacist and physician. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, HEPA, HPV4, MNQ, TDAP, IPV, MMR
Symptoms: Erythema, Injection site reaction, Oedema peripheral, Type III immune complex mediated reaction
Clinical narrative: Initial report was received from a health care professional on 10 February 2011. An 11 year-old female patient with a history of asthma, eczema, a peanut allergy and environmental allergies had received on 08 February 2011 a first dose intramuscular right deltoid injection of MENACTRA, lot number U3518AA, a first dose intramuscular right deltoid injection of ADACEL, lot number C3489AA, GARDASIL (Merck lot number, route and site of administration not reported) and Hep A (manufacturer, lot number, route and site of administration not reported) and an unspecified amount of time later the same day, experienced a Arthus reaction of swelling and redness of the right upper arm down to the elbow. The patient was evaluated by a physician. Treatments were not reported. Concomitant medications included ADVAIR, Albuterol, FLONASE, CLARITIN and an EPIPEN. According to the reporter the patient had a "similar reaction" after she had received an IPOL and MMR vaccine. The patient also had to be revaccinated after having a DTaP vaccine when she was five year old because it was thought that the vaccine had been "unstable" from being too cold. No further information was available at the time of the report. The patient's outcome was unknown. Documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, HEPA, HPV4, MNQ, TDAP, IPV, MMR
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Oedema peripheral, Type III immune complex mediated reaction
Clinical narrative: Initial report was received from a health care professional on 10 February 2011. An 11 year-old female patient with a history of asthma, eczema, a peanut allergy and environmental allergies had received on 08 February 2011 a first dose intramuscular right deltoid injection of MENACTRA, lot number U3518AA, a first dose intramuscular right deltoid injection of ADACEL, lot number C3489AA, GARDASIL (Merck lot number, route and site of administration not reported) and Hep A (manufacturer, lot number, route and site of administration not reported) and an unspecified amount of time later the same day, experienced a Arthus reaction of swelling and redness of the right upper arm down to the elbow. The patient was evaluated by a physician. Treatments were not reported. Concomitant medications included ADVAIR, Albuterol, FLONASE, CLARITIN and an EPIPEN. According to the reporter the patient had a "similar reaction" after she had received an IPOL and MMR vaccine. The patient also had to be revaccinated after having a DTaP vaccine when she was five year old because it was thought that the vaccine had been "unstable" from being too cold. No further information was available at the time of the report. The patient's outcome was unknown. Documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, HEPA, HPV4, MNQ, TDAP, IPV, MMR
Symptoms: Injection site erythema, Oedema peripheral, Type III immune complex mediated reaction
Clinical narrative: Initial report was received from a health care professional on 10 February 2011. An 11 year-old female patient with a history of asthma, eczema, a peanut allergy and environmental allergies had received on 08 February 2011 a first dose intramuscular right deltoid injection of MENACTRA, lot number U3518AA, a first dose intramuscular right deltoid injection of ADACEL, lot number C3489AA, GARDASIL (Merck lot number, route and site of administration not reported) and Hep A (manufacturer, lot number, route and site of administration not reported) and an unspecified amount of time later the same day, experienced a Arthus reaction of swelling and redness of the right upper arm down to the elbow. The patient was evaluated by a physician. Treatments were not reported. Concomitant medications included ADVAIR, Albuterol, FLONASE, CLARITIN and an EPIPEN. According to the reporter the patient had a "similar reaction" after she had received an IPOL and MMR vaccine. The patient also had to be revaccinated after having a DTaP vaccine when she was five year old because it was thought that the vaccine had been "unstable" from being too cold. No further information was available at the time of the report. The patient's outcome was unknown. Documents held by sender: none.
Sex: F
Vaccine: MNQ
Symptoms: Abdominal discomfort, Arthralgia, Malaise
Clinical narrative: Initial report was received from a health care professional on 22 June 2011. A female patient (age and date of birth not reported) had received MENACTRA (lot number, route and site of administration not reported) on 21 June 2011 and an unspecified amount of time later experienced joint pain, malaise and GI upset. The patient was not evaluated by a physician. No further information was provided at the time of the report. The patient's outcome was not reported. Documents held by sender: none.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Emotional disorder, Malaise, Pain in extremity
Clinical narrative: Initial report received from a consumers' parent on 27 June 2011. An 11-year-old male patient with allergies to egg, corn, sugar, soy, chocolate and peanuts, received an injection (route and site reported as unknown) of MENACTRA, sanofi pasteur lot number reported as unknown, and an injection (route and site reported as unknown) of Tdap, manufacturer and lot number unknown, on 27 June 2011. The patient's concomitant medications included NASONEX and CLARITIN. The patient had no illness at the time of vaccinations and no other adverse event following prior vaccinations. On 27 June 2011, the patient complained of soreness in the arms, not feeling well and emotional following the vaccines. The outcome was not reported. Follow-up information was received from a health care professional on 08 August 2011. The patient received the MENACTRA, sanofi pasteur Inc. lot number U3712AA, in the right arm and the ADACEL, sanofi pasteur Ltd. lot number C3727BA, in the left arm. The outcome was reported as recovered on 01 July 2011. Documents held by sender: None.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Diarrhoea, Oropharyngeal pain, Pain, Pain in extremity, Pyrexia
Clinical narrative: Initial report received from the consumers' parent on 28 June 2011. An 11-year-old male patient with a history of seasonal allergies, received an intramuscular injection (site not reported) of MENACTRA, sanofi pasteur lot number U3839AA, and an injection (route and site not reported) of TUBERSONL 5 TU, sanofi pasteur lot number not reported. The patient had a reaction to ADACEL at age 10 on 10 June 2010. The patient had no illness at the time of vaccination and no other vaccines within 4 weeks of the MENACTRA and TUBERSOL. The patient took no concomitant medications. On 24 June 2011, the patient developed a fever of 1-2 (oral), sore throat and a runny nose with clear drainage. The patient was seen by a physician and tested negative for strep. The outcome was reported as not recovered. Follow-up information was received from a health care professional on 02 August 2011. The patient had received MENACTRA in the left deltoid and TUBERSOL 5 TU, lot number C3373AA in the left forearm. The patient's parent called on 24 June 2011 to report the patient had a fever, sore arm and body aches. It was recommended that the patient take MOTRIN and limit activity. On 27 June 2011, the patient was evaluated and he continued to have a fever, body aches, runny nose and diarrhea. No treatments were prescribed at that time. The patient has not been seen and no calls have been received since 27 June 2011. No further information was provided at the time of the report. The patient's outcome was not reported. Follow-up information received on 09 September 2011 from a health care professional. The reporter has had no further contact from the patient or parent regarding the adverse events. The patient had not been seen in the office for any reason since 27 June 2011. No information regarding the patient's recovery status was provided. Documents held by sender: None.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Rhinorrhoea, Streptococcus test negative
Clinical narrative: Initial report received from the consumers' parent on 28 June 2011. An 11-year-old male patient with a history of seasonal allergies, received an intramuscular injection (site not reported) of MENACTRA, sanofi pasteur lot number U3839AA, and an injection (route and site not reported) of TUBERSONL 5 TU, sanofi pasteur lot number not reported. The patient had a reaction to ADACEL at age 10 on 10 June 2010. The patient had no illness at the time of vaccination and no other vaccines within 4 weeks of the MENACTRA and TUBERSOL. The patient took no concomitant medications. On 24 June 2011, the patient developed a fever of 1-2 (oral), sore throat and a runny nose with clear drainage. The patient was seen by a physician and tested negative for strep. The outcome was reported as not recovered. Follow-up information was received from a health care professional on 02 August 2011. The patient had received MENACTRA in the left deltoid and TUBERSOL 5 TU, lot number C3373AA in the left forearm. The patient's parent called on 24 June 2011 to report the patient had a fever, sore arm and body aches. It was recommended that the patient take MOTRIN and limit activity. On 27 June 2011, the patient was evaluated and he continued to have a fever, body aches, runny nose and diarrhea. No treatments were prescribed at that time. The patient has not been seen and no calls have been received since 27 June 2011. No further information was provided at the time of the report. The patient's outcome was not reported. Follow-up information received on 09 September 2011 from a health care professional. The reporter has had no further contact from the patient or parent regarding the adverse events. The patient had not been seen in the office for any reason since 27 June 2011. No information regarding the patient's recovery status was provided. Documents held by sender: None.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from a registered nurse concerning a patient whom hepatitis B titer was found to be "9" after receiving on an unspecified date a series of RECOMBIVAX HB (lot#'s not reported). At the time of the report, the patient's outcome was unknown. It was unknown if the patient sought medical attention. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Back pain, Musculoskeletal stiffness, Pyrexia, Vomiting
Clinical narrative: Initial report was received on 07 July 2011 from a consumer who is also the patient's parent. A 15 year-old female patient with no reported past medical history had received an intramuscular injection of MENACTRA (lot number and site of administration not reported) on 05 July 2011 and the next morning woke up with a backache, stiff neck, fever and vomiting. According to the reporter, the patient's "problems" were getting worse. The patient was not evaluated by a physician. Treatments were not reported. No further information was available at the time of the report. The patient's outcome was not recovered. Follow-up information was received on 14 September 2011 from a health care professional. On 05 July 2011, the patient had received an intramuscular right deltoid injection of MENACTRA, lot number U4001AA, a dose one left deltoid injection of ADACEL, lot number C3921BA (route of administration not reported) and a second dose right arm deltoid injection of VARIVAX, Merck lot number 0095AA (route of administration not reported). The patient had no illness at the time of vaccination, no concomitant medications and had no history of adverse events following prior vaccinations. The patient had a primary series of Tdap with the "last one 7/19/0" (entire year not reported). The reporter had no additional information to provide at the time of the report. The patient's outcome was recovered (date not reported). Follow-up information was received from a health care professional on 03 November 2011. The patient had been given the fifth dose of Dtap (also reported as Tdap) on 19 July 2000 (previously reported as "0"). The patient had received ADACEL IM (intramuscularly) and VARIVAX SC (subcutaneously). No further information was available at the time of the report. Outcome was recovered. Documents held by sender: none.
Age: 0.33
Sex: M
Vaccine: DTAP, HEP, HIBV, PNC, UNK
Symptoms: Cough, Pyrexia
Clinical narrative: Information has been received from a Medical Assistant concerning a 17 weeks old male patient who was vaccinated with the first, second and third dose of RECOMBIVAX HB, on 21-NOV-2010, 21-DEC-2010 and 18-MAR-2011 respectively (routes and lot #s were not specified). Secondary suspect therapy included a dose of an unknown Hib vaccine (manufacturer unknown) (dose, route and lot# not specified). Concomitant therapy included DTaP, PREVNAR and poliovirus vaccine. It was reported that an unknown Hib vaccine (manufacturer unknown), DTaP, PREVNAR and poliovirus vaccine; were administered to the patient on 18-MAR-2011, "the same office visit as the 3rd vaccination with RECOMBIVAX HB. The Medical assistant reported that on 18-MAR-2011, after the third dose of RECOMIBAX HB, the patient developed a fever and cough. It was reported that on an unspecified date, the patient recovered from fever, but the cough continues. The patient sought medical attention by calling the physician's office. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antigen positive, Hepatitis B virus test positive
Clinical narrative: Information has been received from a Registered Nurse during a temperature excursion call, concerning a "child" patient who in "summer 2009" "within 24 hours of their birth" (approximately June 2009), was vaccinated with a 0.5 ml dose of RECOMBIVAX HB (manufacturer unknown) (route and lot# unspecified). Concomitant therapy included hepatitis B immune globulin. The Nurse reported she was aware of a child who was not diagnosed with hepatitis B antigen positive until around one year of age. They believed the child contracted hepatitis B from her mother prenatally but the child has been hepatitis B immune globulin (HBIG) and a dose of RECOMBIVAX HB (manufacturer unknown) within 24 hours of their birth. The patient was given unspecified treatment for this event. The Nurse was questioning if this might be a vaccine failure or a case of improperly stored vaccine being administered. The patient sought unspecified medical attention. At the time of the report patient's outcome was not reported. Additional information has been requested.
Age: 0.74
Sex: F
Vaccine: HEP
Symptoms: Diarrhoea, Feeling abnormal, Hypersomnia, Immediate post-injection reaction, Pyrexia
Clinical narrative: Information has been received from a father concerning a 8 months old (also reported as "9 months old" by the father) daughter with no pertinent medical history and no allergies who on "last Thursday morning" (03-MAR-2011) was vaccinated with a dose of RECOMBIVAX HB (Expiration date: December 2012). There was no concomitant medication. The patient's father reported that "immediately after the vaccine" on, the patient was not feeling good. She slept for 6 hours after the shot. She was having diarrhea, vomiting and fever that lasted until Sunday, on 06-MAR-2011. The patient sought medical attention and was kept giving milk and treatment of PEDIALYTE. No lab diagnostics studies performed. At "last night" (on 06-MAR-2011), the patient was recovered. Follow up information has been received from a physician concerning the 8 month old female patient with no pre-existing allergies, birth defects, medical conditions and no adverse event following prior vaccination who on 10-JUN-2010 and 14-JUL-2010 was vaccinated with the first and the second dose of RECOMBIVAX HB respectively, and on 03-MAR-2011 was vaccinated IM with the third dose of RECOMBIVAX HB on thigh (Lot number 04822 is an invalid lot number for RECOMBIVAX HB). For 24 hours after vaccination on 03-MAR-2011 the patient experienced diarrhea and vomiting. Hydration status was maintained. No lab diagnostic test was performed. Within 2 days, on approximately 05-MAR-2011, the patient was recovered from vomiting and diarrhea. Additional information is not expected.
Age: 0.74
Sex: F
Vaccine: HEP
Symptoms: Vomiting
Clinical narrative: Information has been received from a father concerning a 8 months old (also reported as "9 months old" by the father) daughter with no pertinent medical history and no allergies who on "last Thursday morning" (03-MAR-2011) was vaccinated with a dose of RECOMBIVAX HB (Expiration date: December 2012). There was no concomitant medication. The patient's father reported that "immediately after the vaccine" on, the patient was not feeling good. She slept for 6 hours after the shot. She was having diarrhea, vomiting and fever that lasted until Sunday, on 06-MAR-2011. The patient sought medical attention and was kept giving milk and treatment of PEDIALYTE. No lab diagnostics studies performed. At "last night" (on 06-MAR-2011), the patient was recovered. Follow up information has been received from a physician concerning the 8 month old female patient with no pre-existing allergies, birth defects, medical conditions and no adverse event following prior vaccination who on 10-JUN-2010 and 14-JUL-2010 was vaccinated with the first and the second dose of RECOMBIVAX HB respectively, and on 03-MAR-2011 was vaccinated IM with the third dose of RECOMBIVAX HB on thigh (Lot number 04822 is an invalid lot number for RECOMBIVAX HB). For 24 hours after vaccination on 03-MAR-2011 the patient experienced diarrhea and vomiting. Hydration status was maintained. No lab diagnostic test was performed. Within 2 days, on approximately 05-MAR-2011, the patient was recovered from vomiting and diarrhea. Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: Information has been received from a pharmacist concerning an unspecified number of hospital employees who on an unknown date, were vaccinated with RECOMBIVAX HB (dose, route and lot # not reported) in the past had negative titers. No adverse reactions were reported. It was unknown if they sought medical attention. At the time of reporting, the outcomes were unknown. All telephone attempts to obtain follow-up information have been unsuccessful. This is an amended report. The lower level term and preferred term of AE of "had negative titers" was changed to "hepatitis B surface antibody negative". Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: HIV antibody, Hepatitis B virus test positive, Laboratory test normal
Clinical narrative: Information has been received from a health care worker concerning an 18 year old female patient, with no pertinent medical history and penicillin and erythromycin allergies reported, who on unspecified dates was vaccinated with "the 3 series" of RECOMBIVAX HB (manufacturer unknown) (lot # not reported). Concomitant therapy included birth control pills. On 20-DEC-2010 the patient had tested positive for hepatitis B. There was no treatment given for the adverse event. An enzyme immunoassay HIV antibody screen test (EIA) was performed (results not provided), and a nucleic acid testing (NAT) was performed. Nucleic acid testing (NAT) test was negative. The patient sought unspecified medical attention. At the time of the report the patient's outcome was not recovered. No further information is available because we can't contact the physician.
Age: 38.0
Sex: M
Vaccine: HEPA
Symptoms: Musculoskeletal stiffness
Clinical narrative: This case was reported by the mother of a consumer and described the occurrence of stiff neck in a 38-year-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included history of Lymes disease. In February 2011 the subject received 2nd dose of HAVRIX (unknown). On the day of HAVRIX vaccination, the subject experienced stiff neck, stiff back and stiffness in shoulder. At the time of reporting the outcome of the events was unspecified.
Age: 35.0
Sex: M
Vaccine: HEPA
Symptoms: Paraesthesia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of paresthesia in a 35-year-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). There were no concurrent medications. In November 2010 the subject received 2nd dose of HAVRIX (unknown). In November 2010, at an unspecified time after vaccination with HAVRIX, the subject experienced paresthesia (all over). At the time of reporting the outcome of the event was unspecified.
Sex: U
Vaccine: HEPA
Symptoms: Alopecia, Eczema
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of eczema in an infant subject of unspecified gender who was vaccinated with HAVRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of HAVRIX (unknown). At an unspecified time after vaccination with HAVRIX, the subject experienced eczema and hair loss. At the time of reporting the outcome of the eczema and hair loss was unspecified. At the time of the report no other information was provided.
Age: 45.0
Sex: M
Vaccine: HEPA
Symptoms: Tendonitis
Clinical narrative: This case was reported by a pharmacist and described the occurrence of tendonitis in a 45-year-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). On 27 July 2011 at 15:45 the subject received 1st dose of HAVRIX (.5 ml, unknown, left arm). At an unspecified time after vaccination with HAVRIX, the subject experienced tendonitis. At the time of reporting the tendonitis was unresolved.
Age: 1.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from a registered nurse concerning a 12 month old female patient with no drug reactions or allergies, who on 20-MAY-1997 was vaccinated with a first dose of RECOMBIVAX HB (Lot # not reported). On 12-JUN-1997 the patient received the second dose of RECOMBIVAX HB (Lot # not reported) and on 14-MAY-1998 received the third dose. The nurse reported that the patient's hepatitis B titer was negative after receiving three doses of RECOMBIVAX HB or other hepatitis B vaccines when the patient was an infant. The patient sought unspecified medical attention. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 0.75
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from an office manager concerning an approximately 16 year old female patient who on 27-JUN-1995 was vaccinated with the first pediatric dose of Hep B (manufacturer unknown) (lot #, expire date and route not reported), 5 mcg/ 0.5 ml. On 31-JUL-1995, the patient was vaccinated with the second pediatric dose of Hep B (manufacturer unknown) (lot #, expire date and route not reported), 5 mcg/ 0.5 ml and on 29-NOV-1995, the patient was vaccinated with the third pediatric dose of Hep B (manufacturer unknown) (lot #, expire date and route not reported), 5 mcg/ 0.5 ml. The office manager stated that the patient was given 3 doses of Hep B (manufacturer unknown) and on an unspecified date, the patient still had negative titers for hepatitis B. It was unknown if the patient sought medical attention. At the time of the report, patient's outcome was unknown. Follow up information has been received from a physician concerning the female student. On an unspecified date, the patient's hepatitis B titers showed non immune 0.56. The patient received the third dose of Hep B (manufacturer unknown) when she was 9 months old. It was reported that the vaccine doses was not given at that office. The patient did not seek medical attention. At the time of the report, the patient recovered on an unspecified date. No further information is available.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Rash
Clinical narrative: Information has been received from a Registered Nurse concerning an approximately 25 year old female patient with a history of seizure when received a "DPT" vaccine as a child, Pertussis, sulfa medications allergy and drug allergy to SEPTRA, who on an unspecified date was vaccinated with the Hep B series (manufacturer unspecified) (lot number not provided). The Nurse mentioned that the patient received "the hepatitis series" and developed a rash. It was unspecified if the patient received any treatment, sought medical attention or if lab diagnostics studies were performed. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Hypersensitivity
Clinical narrative: Information has been received from a nurse practitioner concerning a male infant who on an unspecified date was vaccinated with Hep B (manufacturer unknown). On an unspecified date, the patient experienced an allergic reaction to the "hepatitis B vaccine". It was unknown if the patient sought medical attention. At the time of the reporting, the patient's status was unknown. No further information is available.
Age: 50.0
Sex: M
Vaccine: HEP
Symptoms: Hepatic enzyme increased
Clinical narrative: Information has been received from a Doctor of Pharmacy concerning a 50 year old male with no drug allergies and no medical history who "4-5 months ago", in approximately October 2010, was vaccinated with the third dose of RECOMBIVAX HB (therapy route and lot # not provided). There was no concomitant medication. It was reported that the patient received the three dose series of RECOMBIVAX HB within 6 months as indicated. On 23-FEB-2011 a blood test revealed elevated liver enzymes. No pain noted. Doctor would possibly repeat liver enzyme and possibly a CT, computed tomography, scan of liver. No treatment was given for the adverse event. Patient sought unspecified medical attention. At the time of reporting, the patient had not recovered. Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: HEPA
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of hive in a 9-year-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). On 21 February 2011 the subject received unspecified dose of HAVRIX (unknown). That same month, at an unspecified time after vaccination with HAVRIX, the subject experienced hives. At the time of reporting the hives were worse. Follow-up information was received on 09 March 2011 via healthcare professional who reported on 21 February 2011 the subject received 1st dose of HAVRIX pediatric (.5 ml, intramuscular, left deltoid). The nurse reported the hives experienced by the subject was an allergic reaction. The immunization series was discontinued. The nurse reported the allergic reaction resolved on "29" February 2011.
Age: 25.0
Sex: M
Vaccine: HEPA
Symptoms: Hypersomnia, Influenza like illness
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of flu like symptoms in a 25-year-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). On 19 April 2011 the subject received 1st dose of HAVRIX (unknown, left arm). On 19 April 2011, 2 hours after vaccination with HAVRIX, the subject experienced flu like symptoms. On 19 April 2011, the subject also experienced excessive sleep (slept for 18 hours). On 26 April 2011, flu like symptoms improved. At the time of reporting, excessive sleep was improved.
Age: 21.0
Sex: F
Vaccine: HEPA
Symptoms: Headache, Injection site pain, Underdose
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of vaccine underdose in a 21-year-old female subject who was vaccinated with HAVRIX pediatric (GlaxoSmithKline), HAVRIX. There were no concurrent medications. On 10 February 2011 the subject received 1st dose of HAVRIX (unknown). An unspecified amount of time following vaccination with HAVRIX, the subject developed headache and injection site soreness, which resolved on an unknown date. On 11 August 2011 the adult subject received 2nd dose of HAVRIX pediatric in the left arm. The was a vaccine underdose. No additional details were provided. Follow-up received on 16 September 2011 from the healthcare professional: The healthcare professional reported that no adverse events occurred as a result of the vaccine underdose. The healthcare professional considered that the vaccine underdose may have been associated with pediatric Hep A and adult Hep A being together in refrigerator, and Hep A pediatric dose was grabbed inadvertently. The subject returned to the clinic the following day and received the adult dose of Hep A vaccine.
Age: 30.0
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site warmth, Local reaction
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of possible latex allergic reaction in a 30-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline). Concurrent medical conditions included latex allergy. Concurrent vaccination included FLULAVAL; GlaxoSmithKline; unknown; left deltoid given on 27 September 2011. There was no concurrent medications. On 27 September 2011 at 15:00 the subject received 1st dose of HAVRIX (.5 ml, unknown, left deltoid). On 27 September 2011, two hours after vaccination with HAVRIX, the subject experienced a local reaction that included possible latex allergic reaction, injection site redness, soreness from injection, knot at injection site, fever and hot feeling injection site. The initial reason for the subject's report was due to the latex content of the HAVRIX syringe (58160-826-48) and when it was noted that a possible latex reaction could occur, due to the tip cap containing dry natural latex rubber the subject was identified. The subject received HAVRIX and FLULAVAL in the left deltoid about two inches apart. The subject has received FLULAVAL annually in years past and had no reaction. HAVRIX immunization series was discontinued. At the time of reporting the possible latex allergic reaction, injection site redness, soreness from injection, nodule injection site, fever and hot feeling injection site were unresolved. The healthcare professional considered the injection site redness was probably related to vaccination with HAVIRX. Follow-up received from the healthcare professional on 20 October 2011: The events resolved on an unspecified date after 3 days duration. The healthcare professional confirmed that the events were not considered serious.
Age: 30.0
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Pyrexia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of possible latex allergic reaction in a 30-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline). Concurrent medical conditions included latex allergy. Concurrent vaccination included FLULAVAL; GlaxoSmithKline; unknown; left deltoid given on 27 September 2011. There was no concurrent medications. On 27 September 2011 at 15:00 the subject received 1st dose of HAVRIX (.5 ml, unknown, left deltoid). On 27 September 2011, two hours after vaccination with HAVRIX, the subject experienced a local reaction that included possible latex allergic reaction, injection site redness, soreness from injection, knot at injection site, fever and hot feeling injection site. The initial reason for the subject's report was due to the latex content of the HAVRIX syringe (58160-826-48) and when it was noted that a possible latex reaction could occur, due to the tip cap containing dry natural latex rubber the subject was identified. The subject received HAVRIX and FLULAVAL in the left deltoid about two inches apart. The subject has received FLULAVAL annually in years past and had no reaction. HAVRIX immunization series was discontinued. At the time of reporting the possible latex allergic reaction, injection site redness, soreness from injection, nodule injection site, fever and hot feeling injection site were unresolved. The healthcare professional considered the injection site redness was probably related to vaccination with HAVIRX. Follow-up received from the healthcare professional on 20 October 2011: The events resolved on an unspecified date after 3 days duration. The healthcare professional confirmed that the events were not considered serious.
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Tic
Clinical narrative: This case was reported by a healthcare professional (pharmacy technician who was also the subject's mother) and described the occurrence of motor tic in a 3-year-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). Historic vaccination included HAVRIX; GlaxoSmithKline: unknown; unknown given on an unspecified date when the subject was 2 years 9 months old. On 8 November 2011 at 14:00 the subject received 2nd dose of HAVRIX (unknown route, unknown gluteal). On 8 November 2011, 30 minutes after vaccination with HAVRIX, the subject experienced motor tics in the eyes, feet and hands. The subject's mother took him to the emergency room on the night of 08 November 2011 and was advised to see the regular physician on 09 November 2011. At the time of reporting the event was worse.
Age: 0.39
Sex: F
Vaccine: HEPA
Symptoms: Pyrexia, Wrong drug administered
Clinical narrative: This case was reported by a consumer (the subject's grandmother) and described the occurrence of low grade fever in a 5-month-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 29 November 2011 "before noon" the subject received a dose of HAVRIX (details unknown) and experienced wrong vaccine administered. The subject was supposed to receive ENGERIX B and received HAVRIX by mistake. On 29 November 2011 at 14:00 the same day after vaccination with HAVRIX the subject experienced low grade fever. A healthcare provider was consulted regarding the events. At the time of reporting the fever was unresolved. The consumer also reported events for the subject's fraternal twin who also had low grade fever and wrong vaccine administered (see case ID A0956137A for details).
Age: 9.0
Sex: F
Vaccine: HEPA
Symptoms: Convulsion
Clinical narrative: This case was reported by a physician, via another manufacturer (Merck) and described the occurrence of seizure in a 9-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of HAVRIX (details unknown). At an unspecified time after vaccination with HAVRIX, the subject experienced seizure. A healthcare professional also reported that the seizure had not been diagnosed. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified. Follow-up was received from the healthcare professional on 12 July 2011: The physician's office had no further information as they were unable to identify the subject who this report was pertaining to. Follow-up was received from a healthcare professional on 19 July 2011: The physician's office was again noting they could not provide further information as they were not able to identify who the subject was based on the limited details provided to us with this report.
Age: 15.0
Sex: M
Vaccine: HEPA
Symptoms: Abdominal pain, Dizziness, Headache, Muscle twitching, Nausea
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of abdominal pain in a 15-year-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). Concurrent vaccination included HAVRIX;GlaxoSmithKline; unknown;unknown arm given on 12 December 2011; MENACTRA (non-gsk); non-GSK manufacturer;unknown;unknown given on 20 December 2011. Concurrent medications included clindamycin. On 15 December 2011 the subject received 2nd dose of HAVRIX (.5 ml, unknown route, unknown arm). The subject received a dose of HAVRIX on 12 December 2011 and 15 December 2011 with one dose given in the left arm and one dose given in the right arm. On 20 December 2011, 5 days after vaccination with HAVRIX, the subject experienced abdominal pain, nausea and on 21 December 2011 at 07:00, 6 days after vaccination with HAVRIX, the subject experienced muscle twitching, dizziness and headache. The healthcare provider was not sure if the adverse events were the cause of the appointment, but also reported that headache and nausea were the reason for the office visit. At the time of reporting the events were unresolved.
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Hepatitis B antibody negative, Immediate post-injection reaction, Influenza like illness, No therapeutic response
Clinical narrative: Information has been received from a 50 year old female consumer with an allergy to flowers who was vaccinated with the first dose of RECOMBIVAX HB. She received dose one on 14-OCT-2010 (lot # 1484Y), dose two on 15-Nov-2010 (lot # 1491Y) and dose three on 14-Apr-2011 (lot # 0482Z) at the Health Services department at her work. The initial two doses in the series were recorded as pediatric doses "x 2" in her records. The patient reported receiving only one injection each time. The patient stated she received the full series but a titer taken on 16-May-2011 was non reactive/non immune. After her initial vaccination on 14-Oct-2010, she experienced arm pain and "flu-like symptoms" that persisted for several days then resolved. She also experienced a sensation "like I almost passed out" when the dose was administered. She recovered fully in a few days without treatment from these events. After the second and third dose, she only experienced mild arm pain that resolved the day of the injection without treatment. The expiration date recorded on the chart of the first dose given on 14-Oct-2010 with lot 1484Y was 11-Sep-2010, which the patient believes proves it was expired at the time administered and may be the reason she did not respond. Per OMC the expiration date for lot 1484Y was 11-Sep-2012 so not expired at the time of administration. Unspecified medical attention was sought. No further information is available.
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a 50 year old female consumer with an allergy to flowers who was vaccinated with the first dose of RECOMBIVAX HB. She received dose one on 14-OCT-2010 (lot # 1484Y), dose two on 15-Nov-2010 (lot # 1491Y) and dose three on 14-Apr-2011 (lot # 0482Z) at the Health Services department at her work. The initial two doses in the series were recorded as pediatric doses "x 2" in her records. The patient reported receiving only one injection each time. The patient stated she received the full series but a titer taken on 16-May-2011 was non reactive/non immune. After her initial vaccination on 14-Oct-2010, she experienced arm pain and "flu-like symptoms" that persisted for several days then resolved. She also experienced a sensation "like I almost passed out" when the dose was administered. She recovered fully in a few days without treatment from these events. After the second and third dose, she only experienced mild arm pain that resolved the day of the injection without treatment. The expiration date recorded on the chart of the first dose given on 14-Oct-2010 with lot 1484Y was 11-Sep-2010, which the patient believes proves it was expired at the time administered and may be the reason she did not respond. Per OMC the expiration date for lot 1484Y was 11-Sep-2012 so not expired at the time of administration. Unspecified medical attention was sought. No further information is available.