chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Vision blurred
Clinical narrative: This case was reported by a healthcare professional (a nurse) and described the occurrence of headache in a 37-year-old female subject (also a nurse) who was vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent medical conditions included allergy to CYMBALTA. On 6 August 2013 at 10:50 the subject received 3rd dose of ENGERIX B (20 mcg, unknown route, left arm). On 6 August 2013, 2 hours after vaccination with ENGERIX B, the subject experienced headache, dizziness, feeling hot, felt sweaty, muscle pain, fatigue and feeling of confusion. The events were reported as a systemic reaction. The events of headache, dizziness, feeling hot, felt sweaty, muscle pain and feeling of confusion resolved on 7 August 2013. At the time of reporting the event of fatigue was unresolved. Follow up was received from nurse on 17 September 2013. The nurse reported that on 6 August 2013, within the same month as vaccination with ENGERIX B, the subject experienced flushing, tingling in the arms and hands, blurred vision, and lack of concentration. The nurse noted that on 6 August 2013, at 19:20 the symptoms had resolved with sequelae and noted "though very tired." The nurse did not consider this case to be serious. The nurse noted that the following could have been associated with the events: allergy to CYMBALTA of "heart palpitations", frequent "hormonal" headaches, and current medications. Concurrent medical conditions included drug allergy and noted an allergy to ENGERIX B with onset of 6 August 2013 and a resolved outcome of 8 August 2013. Concurrent medications included Butalbital + acetaminophen + caffeine, LOESTRIN, Hydrocodone + acetaminophen, TYLENOL, TUMS and Multivitamins. The nurse reported subject used alcohol "1-2 per week." The nurse reported that the subject quit smoking in March 1996 after smoking "three-fourths of a pack for 15 years." The lot number was originally reported as AHDVC142AA, and, on follow up, the nurse corrected this to be AHBVC142AA.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, Injection site inflammation, Injection site pain
Clinical narrative: This case was reported by a physician and described the occurrence of injection site pain in an unknown number of subjects of unspecified age and gender who were vaccinated with ENGERIX B (GlaxoSmithKline). Historic vaccination included hepatitis B vaccine recombinant; GlaxoSmithKline; unknown; unknown given on an unspecified date. On an unspecified date the subject received 4th dose of ENGERIX B (1 cc, unknown details) and experienced off label use. The physician stated that he had "been vaccinating patients with ENGERIX on a 0, 7, 21 to 30 days, 1 year schedule. He estimated 5 to 10 patients per year for 5 to 10 years." This dosing schedule is not an indicated dosing schedule for ENGERIX B. At an unspecified time after vaccination with ENGERIX B, the subject(s) experienced injection site pain, injection site inflammation. Per the physician, he had "not heard of adverse reactions, other than pain or inflammation in some patients." The physician did not have specific subject information. At the time of reporting the outcome of the events were unspecified.
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antigen positive, Serology negative
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of hepatitis B surface antigen positive in a 40-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent medical conditions included dialysis and kidney disease. On an unspecified date the subject received 1st dose of ENGERIX B (40 mcg, intramuscular, unknown details). Three days after vaccination with ENGERIX B, the subject experienced hepatitis B surface antigen positive. There were multiple discrepancies in the original report. The reporter stated that ENGERIX B was the first dose on the series; however, "serology done which came up negative." The subject was given ENGERIX B; however, the date provided for the vaccine administration was 19 April 2013 which was the day after reported to GSK. The reporter then stated that "3 days later tested again and results showed hepatitis B surface antigen." Attempts were made to clarify the dates of administration, dates of testing and lot number. The lot number was documented as AHBUC039AA which is not a valid GSK lot number for ENGERIX B. Clarification with the original reporter was attempted. Relevant diagnostic tests included serology testing. "Serology [was] done which came negative." The subject was tested again 3 days after administration of ENGERIX B. "Results showed hepatitis b surface antigen." At the time of reporting the outcome of the event was unspecified. Follow up was received from Quality Assurance on 10 June 2013. The lot number provided from the reporter, AHBUC039AA, was incorrect. The corrected lot number based on sales data was found to be AHBVC039AA.
Age: 0.22
Sex: M
Vaccine: DTP, HEP, HIBV, IPV
Symptoms: Hepatitis B antibody negative, Inappropriate schedule of drug administration, No therapeutic response
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of not responding to therapy in a 17-year-old male subject who was vaccinated with Hepatitis B vaccine (manufacturer unspecified). Concurrent vaccination included Haemophilus influenzae type b vaccine; manufacturer unspecified; unknown; unknown given in October 1995; combined diphtheria, tetanus, pertussis (A or W not known) vaccine; manufacturer unspecified; unknown; unknown given in October 1995; inactivated poliomyelitis virus vaccine; manufacturer unspecified; unknown; unknown given on October 1995, 12 December 1995 and April 1996. On October 1995, 12 December 1995 and April 1996 the subject received 1st dose, 2nd dose and 3rd dose of Hepatitis B vaccine (unknown details) and experienced drug dose administration interval too long between the 1st and 2nd dose of hepatitis B. The 2nd dose is indicated to be given 1 month after the first dose. The nurse documented that she obtained the dosing information from school records which were not very detailed. On 6 march 2013, 18 years after vaccination with dose 1 of Hepatitis B vaccine, 18 years after vaccination with dose 2 of Hepatitis B vaccine, and 17 years after vaccination with dose 3 of Hepatitis B vaccine, the subject experienced not responding to therapy. Relevant test results included a negative hepatitis B titer drawn on 6 March 2013. At the time of reporting the outcome of the events was unspecified. The nurse stated that the subject was considering repeating the hepatitis B series.
Age: 0.06
Sex: M
Vaccine: HEP
Symptoms: Incorrect dose administered, Irritability, Nasopharyngitis, Pyrexia
Clinical narrative: This case was reported by a consumer (subject's mother) and described the occurrence of fussy in a 3-week-old male subject who was vaccinated with ENGERIX B adult (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 7 February 2013 at 10:30 the subject received 1st dose of ENGERIX B adult (unknown details, unknown thigh) and experienced overdose. The subject was younger than indicated for the ENGERIX B adult dose. On 7 February 2013, 6 hours after vaccination with ENGERIX B adult (at approximately 16:00 to 17:00), the subject experienced fussy. The subject was treated with TYLNEOL after the vaccination on 7 February 2013. On 8 February 2013, the subject's mother reported that the adverse event of fussy had resolved. On 17 February 2013, the subject's mother reported that the subject experienced fever, fussiness and cold. The subject's mother stated that "fever on 17 February 2013 and fussiness due to cold." At the time of reporting, the outcome of the adverse events of fever, fussiness and cold were unknown. The subject's mother stated that the immunisation series was not discontinued or delayed. The subject's mother also reported another case. See case A1013506A for details on the other case. Follow up information was received from a nurse (subject's grandfather) on 20 February 2013. The overdose has now been medically confirmed. The nurse stated that the subject received 20 mcg, 1mL dose of ENGERIX B adult. He also stated that there were "no problems he knows of with child having this" dose of ENGERIX B adult.
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Eye pruritus, Eye swelling, Eyelid oedema, Joint swelling, Lacrimation increased
Clinical narrative: This case was reported by a healthcare professional (nurse practitioner) and described the occurrence of eye puffiness in a 37-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). On 24 April 2013 at 09:10 the subject received 1st dose of ENGERIX B (1 ml, unknown details). On the morning of 25 April 2013, 1 day after vaccination with ENGERIX B, the subject experienced eye puffiness, eye pruritus, and watery eye. The nurse practitioner reported that the right eye was puffy, itchy and watery. On 26 April 2013, 2 days after vaccination with ENGERIX B, the subject experienced facial rash, pruritus of knees, swollen knee and hive on eye. The nurse practitioner reported that the subject had a "rash on right knee, itchy and swollen." The subject also experienced "a small amount of swelling in the left eye" and the lower eyelid "had a little hive." The subject was seen in the emergency room but was not kept overnight. The subject was treated with BENADRYL "after symptoms". At the time of reporting the outcome of the events were improved. The nurse practitioner stated that the subject "showed improvement by Monday [29 April 2013]". The vaccination course with ENGERIX B was discontinued. Per the nurse practitioner, the subject's doctor directed the subject "not to continue with the second and third doses" of ENGERIX B. The healthcare professional considered the events were probably related to vaccination with ENGERIX B. "Symptoms were probably related to the ENERGIX B as reported by the emergency room doctor."
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: This case was reported by a healthcare professional (nurse practitioner) and described the occurrence of eye puffiness in a 37-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). On 24 April 2013 at 09:10 the subject received 1st dose of ENGERIX B (1 ml, unknown details). On the morning of 25 April 2013, 1 day after vaccination with ENGERIX B, the subject experienced eye puffiness, eye pruritus, and watery eye. The nurse practitioner reported that the right eye was puffy, itchy and watery. On 26 April 2013, 2 days after vaccination with ENGERIX B, the subject experienced facial rash, pruritus of knees, swollen knee and hive on eye. The nurse practitioner reported that the subject had a "rash on right knee, itchy and swollen." The subject also experienced "a small amount of swelling in the left eye" and the lower eyelid "had a little hive." The subject was seen in the emergency room but was not kept overnight. The subject was treated with BENADRYL "after symptoms". At the time of reporting the outcome of the events were improved. The nurse practitioner stated that the subject "showed improvement by Monday [29 April 2013]". The vaccination course with ENGERIX B was discontinued. Per the nurse practitioner, the subject's doctor directed the subject "not to continue with the second and third doses" of ENGERIX B. The healthcare professional considered the events were probably related to vaccination with ENGERIX B. "Symptoms were probably related to the ENERGIX B as reported by the emergency room doctor."
Sex: M
Vaccine: HEP
Symptoms: Pruritus generalised
Clinical narrative: This case was reported by a pharmacist and described the occurrence of generalized itching (no specific area recorded) in a male subject of unspecified age who was vaccinated with ENGERIX B (GlaxoSmithKline). On 15 January 2013 the subject received 1st dose of ENGERIX B (intramuscular, left deltoid). On 15 January 2013, within hours of vaccination with ENGERIX B, the subject experienced generalized itching (no specific area recorded). At the time of reporting the event was resolved. Per the reporter, the subject stated the generalized itching "went away after a few days." The subject consulted his physician and did not require intervention at the physician's office. The vaccination course with ENGERIX B was discontinued. The physician "decided that the patient is not going to receive the other dose series" of ENGERIX B. The pharmacist reported two cases with ENGERIX B. See case A1013166A for details on the other case.
Sex: F
Vaccine: HEP
Symptoms: Eye swelling
Clinical narrative: This case was reported by a pharmacist and described the occurrence of eye swelling in a female subject of unspecified age who was vaccinated with ENGERIX B (GlaxoSmithKline). Historic vaccination included ENGERIX B; GlaxoSmithKline; unknown; unknown given on an unspecified date. Concurrent vaccination included ENGERIX B; GlaxoSmithKline; unknown; unknown given on an unspecified date. On an unspecified date the subject received 3rd dose of ENGERIX B (intramuscular, left deltoid). Within "a few hours" of vaccination with ENGERIX B, the subject experienced eye swelling. At the time of reporting the event was resolved. Per the reporter, the subject stated the swelling "went away after a few days." To the reporter's knowledge, the subject did visit her physician. According to the pharmacist, the subject's "physician said that it was a reaction to the vaccine" but the subject did not receive any intervention. The pharmacist reported two cases with ENGERIX B. See case A1013284A for details on the other case.
Age: 27.0
Sex: M
Vaccine: HEP
Symptoms: Anxiety, Benign neoplasm of bladder, Injection site pain, Irritable bowel syndrome, Panic attack
Clinical narrative: This case was reported by a consumer and described the occurrence of panic attack in an approximately 27 year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject's medical history included surgery for benign neoplasm of the bladder. Concurrent vaccination included hepatitis B vaccine recombinant; manufacturer unspecified; unknown; unknown given on an unspecified date. In 1994 the subject received 2nd dose of ENGERIX B (unknown details). In 1994, less than one year after vaccination with ENGERIX B, the subject experienced panic attack, anxiety attack and injection site soreness. In 1996, 2 years after vaccination with ENGERIX B, the subject experienced irritable bowel syndrome. In 1997, 3 years after vaccination with ENGERIX B, the subject experienced benign neoplasm of bladder. The subject described the panic and anxiety attacks as "almost debilitating." The subject reported that he did consult a healthcare professional regarding the events. The subject reported that his immunization series was not delayed or discontinued. He also reported that symptoms recurred following subsequent administration. No further information was provided about the symptoms recurrence. At the time of reporting the events of panic attack and anxiety attack were unresolved. The subject reported that he "has been suffering from this issue for years." At the time of reporting, the injection site soreness resolved in 1994. The subject reported that the irritable bowel syndrome was improved. The subject reported that in 1997 he underwent surgery for the "benign bladder tumor" and stated that this event has resolved.
Sex: F
Vaccine: HEP
Symptoms: Contusion
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of bruising of leg in a female subject of unspecified age who was vaccinated with ENGERIX B (GlaxoSmithKline). On an unspecified date the subject received 1st dose of ENGERIX B (20 mcg, unknown details). At an unspecified time after vaccination with ENGERIX B, the subject experienced bruising of leg. At the time of reporting the event was resolved. The healthcare professional considered the event was related to vaccination with ENGERIX B.
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Body temperature increased, Chills, Diplopia, Gastroenteritis viral, Hypersensitivity
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of double vision in a 33-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). On 17 October 2012 at 13:00 the subject received 1st dose of ENGERIX B (unknown route, right deltoid). On 17 October 2012, 15 minutes after vaccination with ENGERIX B, the subject experienced double vision, flu-like symptoms (diagnosis unknown) ("flu to the 10th power"), feels like a stomach virus, fever, and chills. The nurse reported that the subject fell "asleep and woke up five hours later, her temperature was better but still shaking and felt nauseous." Relevant test results included elevated body temperature of 103 degrees Fahrenheit. On 18 October 2012, the events were resolved. "The patient went to work the next day [18 October 2012]." Per the nurse, "the second dose in the series was scheduled to be administered"; however, "due to the patient's response" the nurse was debating on continuation of the series. Follow-up information was received on 18 December 2012 via healthcare professional who reported that subject received 20mcg of ENGERIX B intramuscularly on 17 October 2012. The subject was diagnosed with an allergic/adverse reaction. The onset date was 17 October 2012 and resolved on 18 October 2012. The immunization series with ENGERIX B was discontinued until the subject could follow-up with their primary care physician for instructions. The events were not associated with lack of efficacy, erroneous administration or suspect transmission of the infectious agent via medicinal product. Medical history / concurrent illness were not known. The reporting healthcare professional considered the events probably related to vaccination with ENGERIX B. The reporting healthcare professional did not consider the events serious.
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Influenza like illness, Nausea, Pyrexia, Tremor
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of double vision in a 33-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). On 17 October 2012 at 13:00 the subject received 1st dose of ENGERIX B (unknown route, right deltoid). On 17 October 2012, 15 minutes after vaccination with ENGERIX B, the subject experienced double vision, flu-like symptoms (diagnosis unknown) ("flu to the 10th power"), feels like a stomach virus, fever, and chills. The nurse reported that the subject fell "asleep and woke up five hours later, her temperature was better but still shaking and felt nauseous." Relevant test results included elevated body temperature of 103 degrees Fahrenheit. On 18 October 2012, the events were resolved. "The patient went to work the next day [18 October 2012]." Per the nurse, "the second dose in the series was scheduled to be administered"; however, "due to the patient's response" the nurse was debating on continuation of the series. Follow-up information was received on 18 December 2012 via healthcare professional who reported that subject received 20mcg of ENGERIX B intramuscularly on 17 October 2012. The subject was diagnosed with an allergic/adverse reaction. The onset date was 17 October 2012 and resolved on 18 October 2012. The immunization series with ENGERIX B was discontinued until the subject could follow-up with their primary care physician for instructions. The events were not associated with lack of efficacy, erroneous administration or suspect transmission of the infectious agent via medicinal product. Medical history / concurrent illness were not known. The reporting healthcare professional considered the events probably related to vaccination with ENGERIX B. The reporting healthcare professional did not consider the events serious.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Chest pain, Dyspnoea, Headache, Heart rate increased
Clinical narrative: This case was reported by a consumer (also the subject) and described the occurrence of nausea in a 30-year-old female subject who was vaccinated with Hepatitis B vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. Concurrent vaccination included hepatitis B vaccine recombinant ;manufacturer unspecified;unknown;right arm given in 1983. In 1983 or 1984 the subject received 3rd dose of Hepatitis B vaccine (unknown route, right arm). In 1983 or 1984, 1 month after vaccination with the 3rd dose of Hepatitis B vaccine, the subject experienced nausea, headache, muscle pain, vertigo, eye sensitive to light, shortness of breath, chest pain, irregular heartbeat, rapid heartbeat, weakness, sweating and at an unknown time after vaccination with the 3rd dose of Hepatitis B vaccine, the subject experienced hepatitis b antibody abnormal. The subject reported that she received the Hepatitis B vaccine series in 1983 or 1984 as a requirement for work. She did not know the manufacturer of the vaccine. She reported that her "symptoms resolved, but it took 20 years". She explained that the events occurred approximately one month after the third dose in series. She stated that she treated the events with "massage and chiropractic care and nutritional help". She indicated that she had a titer done and the "normal was supposed to be less than 10 and hers was 200" (hepatitis b antibody abnormal). The subject explained that the physician screened her for a hepatitis infection, but "there was none and no explanation as to why the titers were so high". At the time of reporting the events were resolved. The subject explained that the symptoms resolved, but "came back with a vengeance" when she received FLUARIX. See case A1002560A for details regarding the events with FLUARIX.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Heart rate irregular, Hepatitis B antibody abnormal, Hyperhidrosis, Myalgia, Nausea
Clinical narrative: This case was reported by a consumer (also the subject) and described the occurrence of nausea in a 30-year-old female subject who was vaccinated with Hepatitis B vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. Concurrent vaccination included hepatitis B vaccine recombinant ;manufacturer unspecified;unknown;right arm given in 1983. In 1983 or 1984 the subject received 3rd dose of Hepatitis B vaccine (unknown route, right arm). In 1983 or 1984, 1 month after vaccination with the 3rd dose of Hepatitis B vaccine, the subject experienced nausea, headache, muscle pain, vertigo, eye sensitive to light, shortness of breath, chest pain, irregular heartbeat, rapid heartbeat, weakness, sweating and at an unknown time after vaccination with the 3rd dose of Hepatitis B vaccine, the subject experienced hepatitis b antibody abnormal. The subject reported that she received the Hepatitis B vaccine series in 1983 or 1984 as a requirement for work. She did not know the manufacturer of the vaccine. She reported that her "symptoms resolved, but it took 20 years". She explained that the events occurred approximately one month after the third dose in series. She stated that she treated the events with "massage and chiropractic care and nutritional help". She indicated that she had a titer done and the "normal was supposed to be less than 10 and hers was 200" (hepatitis b antibody abnormal). The subject explained that the physician screened her for a hepatitis infection, but "there was none and no explanation as to why the titers were so high". At the time of reporting the events were resolved. The subject explained that the symptoms resolved, but "came back with a vengeance" when she received FLUARIX. See case A1002560A for details regarding the events with FLUARIX.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Photophobia, Vertigo
Clinical narrative: This case was reported by a consumer (also the subject) and described the occurrence of nausea in a 30-year-old female subject who was vaccinated with Hepatitis B vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. Concurrent vaccination included hepatitis B vaccine recombinant ;manufacturer unspecified;unknown;right arm given in 1983. In 1983 or 1984 the subject received 3rd dose of Hepatitis B vaccine (unknown route, right arm). In 1983 or 1984, 1 month after vaccination with the 3rd dose of Hepatitis B vaccine, the subject experienced nausea, headache, muscle pain, vertigo, eye sensitive to light, shortness of breath, chest pain, irregular heartbeat, rapid heartbeat, weakness, sweating and at an unknown time after vaccination with the 3rd dose of Hepatitis B vaccine, the subject experienced hepatitis b antibody abnormal. The subject reported that she received the Hepatitis B vaccine series in 1983 or 1984 as a requirement for work. She did not know the manufacturer of the vaccine. She reported that her "symptoms resolved, but it took 20 years". She explained that the events occurred approximately one month after the third dose in series. She stated that she treated the events with "massage and chiropractic care and nutritional help". She indicated that she had a titer done and the "normal was supposed to be less than 10 and hers was 200" (hepatitis b antibody abnormal). The subject explained that the physician screened her for a hepatitis infection, but "there was none and no explanation as to why the titers were so high". At the time of reporting the events were resolved. The subject explained that the symptoms resolved, but "came back with a vengeance" when she received FLUARIX. See case A1002560A for details regarding the events with FLUARIX.
Age: 62.0
Sex: F
Vaccine: HEP
Symptoms: Immediate post-injection reaction, Incorrect dose administered, Injection site pain
Clinical narrative: This case was reported by a physician (spouse of subject) and via a patient assistance program described the occurrence of injection site pain in a 62-year-old female subject who was vaccinated with ENGERIX B adult (GlaxoSmithKline). On 21 May 2013, 2005, 2000, and 1995 the subject received 7th dose, 6th dose, 5th dose, 4th dose of ENGERIX B adult (unknown details) and experienced extra dose administered and off label use. The physician "was advised that an additional dose was required every 5 years." In 1990, the subject received 3rd dose, 2nd dose and 1st dose of ENGERIX B adult (unknown details). On 21 May 2013, immediately after vaccination with the 7th dose of ENGERIX B adult, the subject experienced injection site pain. The physician stated there was "no redness or swelling noted." At an unspecified time after vaccination with 6th, 5th, 4th, 3rd, 2nd, and 1st doses of ENGERIX B adult, the subject experienced injection site soreness (described as "some soreness"). In 2013, the subject was treated with CIPRO, ADVIL, ALEVE, BACTRIM and Fluconazole. The physician stated that the treatments did not relieve the injection site pain. At the time of reporting the outcome of the event of injection site pain following the 7th dose of ENGERIX B vaccine was improved and still present. The physician stated that the soreness following previous ENGERIX B injections lasted for a few days. The physician considered the event of injection site pain with the 7th dose of ENGERIX B was probably related to vaccination with ENGERIX B adult; however, he did not specify relationship with the previous doses of ENGERIX B.
Age: 29.0
Sex: M
Vaccine: HEP
Symptoms: No therapeutic response
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of not responding to therapy in a currently 29-year-old male subject who was vaccinated with hepatitis B (unknown manufacturer). Concurrent medical conditions included Crohn's disease. Concurrent medications included PRAVACHOL, Metformin and Unknown for the treatment of Crohn's disease. On unspecified dates the subject received 1st dose, 2nd dose and 3rd dose of hepatitis B vaccine (unknown details). At an unspecified time after vaccination with hepatitis B vaccine, the subject experienced not responding to therapy. The nurse reported that a subject "with Crohn's Disease did not respond to first series of hepatitis B." The subject was treated with ENGERIX B administered on 13 June 2013. Per the nurse, this dose was the "first of 2nd series".
Age: 58.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Hepatitis B surface antibody negative, Inappropriate schedule of drug administration, No therapeutic response
Clinical narrative: This case was reported by a healthcare professional (medical assistant) and described the occurrence of not responding to therapy in a 59-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Historic vaccination included hepatitis A vaccine inactivated; GlaxoSmithKline; unknown; unknown given on December 2011 and June 2012. In December 2011, June 2012 and 21 January 2013 the subject received 1st dose, 2nd dose and 3rd dose of ENGERIX B (unknown details). The dose administered on 21 January 2013 was 1ml administered into the left arm. In June 2012 and 21 January 2013 the subject experienced drug dose administration interval too long. In April 2013, 3 months after vaccination with ENGERIX B, the subject experienced not responding to therapy. Relevant test results included a hepatitis b surface antibody test in April 2013 and "the test was 'non-reactive'". At the time of reporting, the outcome of not responding to therapy was unknown.
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Diarrhoea, Headache, Nausea, Pyrexia, Vomiting
Clinical narrative: This case was reported by a physician and described the occurrence of headache in a 39-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline), influenza. Concurrent medical conditions included high blood pressure and seasonal allergy. Concurrent vaccination included hepatitis B vaccine recombinant;GlaxoSmithKline;unknown;unknown given on an unspecified date. Concurrent medications included Vitamins, VONTROL and clonidine. On 3 May 2013 at 16:00 the subject received 2nd dose of ENGERIX B (1 cc, unknown route, left deltoid). On an unspecified date the subject received a dose of influenza vaccine (unspecified) (unknown details). On 3 May 2013, 7 hours after vaccination with ENGERIX B (also described as 21:00 and "that evening", the subject experienced headache, nausea, vomiting, and diarrhea. At an unspecified time after vaccination with Influenza vaccine (unspecified), the subject experienced headache, nausea, vomiting, diarrhea and fever. At the time of reporting the outcome of the events were unspecified.
Age: 26.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative, Inappropriate schedule of drug administration, No therapeutic response
Clinical narrative: This case was reported by a healthcare professional (nurse practitioner) and described the occurrence of not responding to therapy in a 26-year-old male subject who was vaccinated with Hepatitis B vaccine (manufacturer unspecified). On an unspecified date, the subject received the 4th dose of hepatitis B vaccine (details unknown) and experienced extra dose administered. On 26 November 2010, 18 November 2010, the subject received 3rd dose and 2nd dose of hepatitis B vaccine (unknown details) and experienced drug dose administration level too short. On 12 November 2010 the subject received 1st dose of Hepatitis B vaccine (unknown details). Around March 2011, months after vaccination with 4th dose of Hepatitis B vaccine and 4 months after vaccination with 3rd, 2nd, and 1st doses of hepatitis B vaccine, the subject experienced not responding to therapy. The subject had hepatitis B serology titer testing performed around March 2011 and the results showed no detectable titers following 4 doses of hepatitis B vaccination. Relevant test results included Hepatitis B surface antibody test performed around March 2011 with results showing negative.
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Injection site bruising, Injection site movement impairment, Injection site pain
Clinical narrative: This case was reported by a healthcare professional (nurse practitioner) and described the occurrence of bruise injection site in a 31-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent medical conditions included allergy to amoxicillin and heavy menstruation. Concurrent medications included Birth control pill. On 14 December 2012 at 11:00 the subject received 1st dose of ENGERIX B ("entire dose", unknown route, left arm). On 1 January 2013, 18 days after the vaccination with ENGERIX B, the subject experienced bruise injection site, injection site movement impairment and injection site pain. The nurse practitioner reported that heat applied to the injection site was helpful to the subject. At the time of reporting the events were improved. At the time of reporting, it was unknown if the immunization series was delayed or discontinued.
Age: 29.0
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, Jaundice
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of jaundice in a 29-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent vaccination included ENGERIX B; GlaxoSmithKline; unknown; unknown given on 11 April 2013. On an unspecified date, the subject possibly received 3rd dose of ENGERIX B (unknown details) and possibly experienced drug dose administration interval too long. On 22 May 2013 the subject received 2nd dose of ENGERIX B (20 mcg, unknown route, left arm) and experienced drug dose administration interval too long. In June 2013, 3 weeks after vaccination with ENGERIX B, the subject experienced jaundice. At the time of reporting the event was resolved. The nurse did not report when the jaundice resolved. It was unknown if the immunization series was delayed or discontinued. It was unknown if the subject sought medical attention for the event. The healthcare professional considered the event was unrelated to vaccination with ENGERIX B. The nurse and the subject's healthcare provider "do not believe the jaundice is related to ENGERIX-B."
Sex: F
Vaccine: HEP
Symptoms: Activities of daily living impaired, Impaired work ability, Joint stiffness, Myalgia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of myalgia in a female subject of unspecified age who was vaccinated with Hepatitis B vaccine (GlaxoSmithKline). On 3 June 2013 the subject received 1st dose of Hepatitis B vaccine (unknown details). In 2013, within months of vaccination "since the vaccination" with Hepatitis B vaccine, the subject experienced myalgia, joint stiffness, and decreased ability to perform daily activities. The reporter described the myalgias as "significant" and reported that the joint stiffness was "in her upper and lower extremities." The reporter also documented that the events have caused "her difficulty with her job and limiting her activities." The reporter stated that she had "screened for other causes and feel this may be a vaccine side effect." The reporter was considering how to proceed with additional doses of hepatitis B vaccination series. At the time of reporting the outcome of the events were unspecified. The healthcare professional considered the events were possibly related to vaccination with Hepatitis B vaccine.
Sex: U
Vaccine: HEP
Symptoms: Hypersensitivity
Clinical narrative: This case was reported by a pharmacist via another manufacturer and described the occurrence of allergic reaction in a subject of unspecified age and gender who was vaccinated with ENGERIX B (GlaxoSmithKline). On an unspecified date the subject received a dose of ENGERIX B (unknown details). At an unspecified time after vaccination with ENGERIX B, the subject experienced allergic reaction (described as "unspecified allergic"). No additional details were provided. At the time of reporting the outcome of the event was unspecified.
Age: 65.0
Sex: M
Vaccine: HEP
Symptoms: No therapeutic response
Clinical narrative: This case was reported by a consumer (subject) and described the occurrence of not responding to therapy in a 65-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included hepatitis C and liver cirrhosis. On an unspecified dates the subject received 1st dose, 2nd dose and 3rd dose of ENGERIX B (unknown details) and experienced not responding to therapy. The subject stated that he "has received the GSK hepatitis vaccine 7 times and it never worked. Half the time he develops antibodies, but 2 months later they are gone." The subject did not provide additional details.
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, No therapeutic response
Clinical narrative: This case was reported by a pharmacist and described the occurrence of not responding to therapy in a male subject of unspecified age who was vaccinated with ENGERIX B (GlaxoSmithKline). On an unspecified date the subject received 1st dose, 2nd dose and 3rd dose of ENGERIX B (20 mcg, unknown details). Per the healthcare professional, the subject received the doses on a 0, 1, and 6 month schedule. On an unknown date, at an unknown amount of time after vaccination with ENGERIX B, the subject experienced not responding to therapy. Relevant test results included: Per the healthcare professional, titers were drawn (on an unknown date) after a subject received 3 doses of ENGERIX B and the results "were not considered protective" against hepatitis B.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No therapeutic response
Clinical narrative: This case was reported by a pharmacist and described the occurrence of not responding to therapy in a currently 18-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline), Hepatitis B vaccine. In July 2013 the subject received 4th dose of ENGERIX B (unknown details) and experienced extra dose administered. The ENGERIX B series is indicated for 3 doses. In February 1996 and December 1995 the subject received the 3rd and 2nd doses of hepatitis B vaccine (unknown details) and experienced drug administration interval too long. In May 1995 the subject received 1st dose of Hepatitis B vaccine (unknown details). In 2013, 17 years after vaccination with 3rd dose of Hepatitis B vaccine, 18 years after vaccination with 2nd and 1st dose of Hepatitis B vaccine, the subject experienced not responding to therapy. The pharmacist reported that the subject was "not seroprotected."
Age: 3.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative, Inappropriate schedule of drug administration, No therapeutic response
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a 23-year-old female subject who was vaccinated with ENGERIX B (SmithKline Beecham). Concurrent vaccination included DTP-Hib (non-gsk); unknown given on an unspecified date; OPV (non-gsk); non-GSK manufacturer; oral given on an unspecified date. Concurrent medications included TB skin test. On 11 August 1993, 18 October 1993 and 24 July 1996 the subject received 1st dose, 2nd dose and 3rd dose of ENGERIX B (unknown details). When the 3rd dose was administered on 24 July 1996, the subject experienced drug dose administration interval too long. The healthcare professional was unsure if the second dose was given on 18 October 1993 as it was administered at another facility. On 3 September 2013, 20 years after vaccination with 1st and 2nd dose of ENGERIX B, 17 years after vaccination with the 3rd dose of ENGERIX B, the subject experienced not responding to therapy. Relevant diagnostic results included a "titer drawn and on 3 September 2013 was told that the levels in her body were inconsistent with immunity for hepatitis B." At the time of reporting the outcome of the events was unspecified. Follow up was received from the office manager on 29 October 2013. The office manager reported that the subject was a 20 year old female rather than a 23 year old as previously reported. On 3 September 2013, the subject received a hepatitis B surface antibody test with results of "non-reactive." The definition of non-reactive per the laboratory was 'inconsistent with immunity, less than 10 mIU per milliliter." The physical also documented that the 1st and 2nd doses of hepatitis B vaccine were by an unknown manufacturer as they were given by a previous doctor's office. Per the physician the immunization series was not discontinued or delayed and symptoms did not recur following subsequent administration. The subject had not experienced adverse events following previous vaccinations. Concurrent vaccinations included DTP-Hib (non-gsk); non-GSK manufacturer; unknown given on 11 August 1993 and 18 October 1993; OPV (non-gsk); non-GSK manufacturer; oral given on 11 August 1993 and 18 October 1993. Concurrent medications included TB skin test administered on 24 July 1996.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: No therapeutic response
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a 30-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). On unspecified date, the subject received 1st dose and 2nd dose of ENGERIX B (details unknown). On 8 July 2013 the subject received 3rd dose of ENGERIX B (20 mcg, unknown route, left arm). The subject experienced not responding to therapy. At an unspecified time after completing the ENGERIX B series, the subject was found to have no response to the vaccination.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, No therapeutic response
Clinical narrative: This case was reported by a healthcare professional (pharmacy student) and described the occurrence of not responding to therapy in a subject of unspecified age and gender who was vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent medical conditions included human immunodeficiency virus. On an unspecified date the subject received 3rd dose, 2nd dose and 1st dose of ENGERIX B (unknown details). On an unknown date, at an unspecified time after vaccination with ENGERIX B series, the subject experienced not responding to therapy. The pharmacy student stated that the subject "failed" the series. A second ENGERIX B series was administered. Per the pharmacy student, the subject was "low responder HIV patient' and "had low titers post 2 sets of series with ENGERIX B" and "failed both times". Since the pharmacist student was reporting based on a "question from an infectious disease physician," the reporter did not have any subject specified details. Follow up was received from Merck on 30 August 2013. The reporter, documented as a pharmacist, contacted Merck and provided that the HIV positive subject was an adult who "was vaccinated with 6 doses of ENGERIX and failed to seroconvert". Per the report from Merck, hepatitis B "antibody testing was negative." No additional details were available.
Age: 49.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of pain during injection in a 49-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). On 23 July 2013 at 15:15 the subject received 3rd dose of ENGERIX B (1 ml, unknown route, left deltoid). On 23 July 2013, during vaccination with ENGERIX B, the subject experienced pain during injection. On 24 July 2013, the subject experienced injection site tenderness and bump at injection site. On 25 July 2013, the subject experienced injection site redness and low grade fever. The reporter also stated that the subject experienced "swelling, redness, and low grade fever." At the time of reporting the outcome of the events were unspecified. Follow up was received from nurse on 27 August 2013. The nurse stated that some information was unavailable as the subject lived "in another state." The nurse documented that all adverse events had resolved. The nurse did not consider the events to be serious. The nurse documented that she did not consider the events to involve severe or permanent disability. Medical history, alcohol use and tobacco use were all unknown. Per the injury report, the subject reported the events on 25 July 2013. The subject mentioned that "when she received the vaccine it did hurt but did not have any symptoms other than the pain." On the date of the injury report, the subject reported her pain was 7 out of 10. Per the report, the subject was evaluated by a physician for another unknown reason and asked the physician to look at it. The subject was evaluated another doctor on an unknown date. Per the nurses correspondence, the doctor told the subject that "she was having an allergic reaction." The subject was instructed to "treat with BENADRYL and to go to the hospital if it got worse for a BENADRYL IV." Also per the nurse's correspondence, the reaction was "getting much better. The doctor said to expect it to take about a week to clear so she [the subject] is on track with that."
Age: 18.0
Sex: F
Vaccine: HEP, MNQ
Symptoms: Dizziness, Eyelid oedema, Fatigue, Rash
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of fatigue in a 18-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent vaccination included MENVEO (non-gsk); Novartis; unknown; unknown given on 31 May 2013. On 31 May 2013 the subject received 2nd dose of ENGERIX B (10 mcg, unknown route, right arm). On 18 July 2013, the subject received 3rd dose of ENGERIX B (unknown details) and experienced drug dose administration interval too short. On 31 May 2013, the same date as vaccination with 2nd dose of ENGERIX B, the subject experienced widespread rash. The subject was evaluated by the doctor's office for the rash. The nurse noted that "the rash had no itch or swelling to it." On 19 July 2013, one day after vaccination with the 3rd dose of ENGERIX B, the subject experienced fatigue, puffy eyes, dizziness. Per the nurse, the subject has not required medical attention for the fatigue, puffy eyes and dizziness at the time of reporting. At the time of reporting the outcome of the events of rash were resolved. The nurse reported that the rash "resolved approximately 7 days post immunization" in June 2013. At the time of reporting the outcome of the events of fatigue, puffy eyes, and dizziness were unspecified. The healthcare professional considered the event of rash was possibly related to vaccination with ENGERIX B. The nurse did not comment on the relationship of the other events. The lot number was reported as AHBVC88AA; however, based on a safety lot number review received 11 September 2013, the lot number was updated to AHBVC188AA.
Age: 61.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Local swelling, Pruritus
Clinical narrative: Received ZOSTAVAX on 11-22-2013. Seen in Dr's office 11-25-2013 for (R) arm swelling, itchy, "there is erythematous area extending in circle around injection site size of baseball sl indurated, warm to touch, no regional adenopathy no streaking".