chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Erythema, Gout, Oedema peripheral
Clinical narrative: This case was reported by a nurse practitioner and described the occurrence of gout in a 35-year-old male subject who was vaccinated with Engerix-B plus a separate injection of hepatitis A vaccine inactivated  (Havrix). The subject's medical history included high blood pressure, penicillin allergy and seasonal allergy. Medical history also included "slightly elevated uric acid levels' on 23 October 2003 at 7.5 mg/dl and on 25 August 2005 at 8.3 mg/dl (normal range 2.7 to 8.2). Concurrent medications included Losarten potassium (Cozaar). On 09 March 2006 at 09:20 am, the subject received 1st dose of Engerix-B in the left deltoid (lot AHBVB135AA). On 09 March 2006 the subject also received 2nd dose of Havrix in the right deltoid (lot AHAVB078AJ). On 10 March 2006, 1 day after vaccination with Engerix-B and Havrix, the subject experienced "redness and swelling in the metatarsal and phylargneal area of toes 3, 4, and 5 in the left foot". The subject was seen at a physician's office and was treated with ibuprofen (Advil). He was subsequently diagnosed with gout and treated with allopurinol and nabumetone (Relafen). The events resolved on 22 March 2006. The nurse practitioner considered the events to not be related to vaccination with Engerix-B or Havrix.
Age: 12.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antigen, Hepatitis B surface antigen negative, Inappropriate schedule of drug administration
Clinical narrative: This case was reported by a nurse and described a 12-year-old female subject who did not respond to immunization to the Engerix-B vaccination series. On 24 February 1994, the subject received 1st dose of Engerix-B. This is longer than the recommended interval of one month between the 1st and 2nd doses of Engerix-B. On 26 July 1994, the subject received the 3rd dose of Engerix-B. This is shorter than the recommended interval of six months between the 1st and 3rd doses of Engerix-B. On 10 March 2006, 11 years after the 3rd dose of Engerix-B, a hepatitis B surface antibody titer was negative.
Age: 80.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antigen, Hepatitis B surface antigen positive
Clinical narrative: Hepatitis B surface antigen positive  This case was reported by a nurse and described the occurrence of hepatitis B surface antigen positive in an 80-year-old female subject who was vaccinated with hepatitis B vaccine recombinant (Engerix-B, GlaxoSmithKline) for prophylaxis.  Medical history included renal failure (cause not specified) requiring hemodialysis.  On 08 March 2006 the subject received 2nd dose of Energix-B (lot AHBVB166AA).  On 10 March 2006, 2 days after vaccination with Energix-B, "a lab test demonstrated a positive hepatitis B surface antigen." On 13 March 2006, a hepatitis B viral DNA assay was negative.  The subject was negative for hepatitis B surface antigen when she was retested on 27 March 2006.  The nurse considered the event to not be related to vaccination with Twinrix.
Sex: M
Vaccine: HEP
Symptoms: Abdominal discomfort, Dizziness, Fatigue, Feeling abnormal, Muscular weakness
Clinical narrative: Nausea, Dizziness, Abdominal discomfort, Muscular weakness, Vomiting, Fatigue, Paraesthesia, Feeling abnormal  This case was reported by a nurse and described the occurrence of nausea in an adult male subject who was vaccinated with hepatitis B vaccine recombinant (Engerix-B, GlaxoSmithKline) for prophylaxis.  There was concurrent medications. On 13 February 2006 the subject received 1st dose of Energix-B (lot AHBVB229AA).  Approximately 2 weeks after vaccination with Engerix-B, on an unspecified date after 13 February 2006 and before 14 March 2006, the subject experienced nausea, muscle weakness, "felt weird," and had "abnormal skin sensations like pins and needles while having unprotected sex." The subject "did go to a sexually transmitted disease clinic to be tested for any possible sexually transmitted diseases." The results of these test were not provided.  The events resolved on an unspecified date before 14 March 2006, the subject received the 2nd dose of Engerix-B (lot AHBVB256AA).  "Immediately" following the receipt of the 2nd dose of Engerix-B, on 14 March 2006, the subject again experienced nausea and dizziness.  The events resolved after "a few minutes." On 15 March 2006, the subject again experienced nausea, gastrointestinal distress, and dizziness.  on 16 March 2006, the subject experienced muscle weakness, vomiting and fatigue.  The subject was unable to "work out in the gym due to these side effects." On 17 March 2006, the events improved, but the subject experienced a "pins and needles sensation" on his skin.  The events resolved on 20 March 2006.  The nurse considered the events to possibly be related to vaccination with Engerix-B and also possibly due to sexual disease exposure.
Sex: M
Vaccine: HEP
Symptoms: Nausea, Paraesthesia, Vomiting
Clinical narrative: Nausea, Dizziness, Abdominal discomfort, Muscular weakness, Vomiting, Fatigue, Paraesthesia, Feeling abnormal  This case was reported by a nurse and described the occurrence of nausea in an adult male subject who was vaccinated with hepatitis B vaccine recombinant (Engerix-B, GlaxoSmithKline) for prophylaxis.  There was concurrent medications. On 13 February 2006 the subject received 1st dose of Energix-B (lot AHBVB229AA).  Approximately 2 weeks after vaccination with Engerix-B, on an unspecified date after 13 February 2006 and before 14 March 2006, the subject experienced nausea, muscle weakness, "felt weird," and had "abnormal skin sensations like pins and needles while having unprotected sex." The subject "did go to a sexually transmitted disease clinic to be tested for any possible sexually transmitted diseases." The results of these test were not provided.  The events resolved on an unspecified date before 14 March 2006, the subject received the 2nd dose of Engerix-B (lot AHBVB256AA).  "Immediately" following the receipt of the 2nd dose of Engerix-B, on 14 March 2006, the subject again experienced nausea and dizziness.  The events resolved after "a few minutes." On 15 March 2006, the subject again experienced nausea, gastrointestinal distress, and dizziness.  on 16 March 2006, the subject experienced muscle weakness, vomiting and fatigue.  The subject was unable to "work out in the gym due to these side effects." On 17 March 2006, the events improved, but the subject experienced a "pins and needles sensation" on his skin.  The events resolved on 20 March 2006.  The nurse considered the events to possibly be related to vaccination with Engerix-B and also possibly due to sexual disease exposure.
Age: 59.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Injection site pain, Injection site swelling, Injection site erythema  This case was reported by a nurse and described the occurrence of injection site pain in a 50-year-old female subject who was vaccinated with hepatitis B vaccine recombinant (Engerix-B, GlaxoSmithKline) for prophylaxis.  The nurse reported that, "several other patients" experienced injection site reactions following immunization with Engerix-B, however, a specific number of subjects was not provided.  On an unspecified date in February 2006 the subject received 3rd dose of Engerix-B in the left arm. Approximately 3 to 4 days after vaccination with Engerix-B, on an unspecified date in February 2006, the subject experienced injection site pain, swelling injection site and injection site redness. The subject was seen at a physician's office. The events resolved "the next day."
Sex: M
Vaccine: HEP
Symptoms: Dysgeusia, Prophylaxis
Clinical narrative: Dysgeusia  This case was reported by a pharmacist and described the occurrence of taste alteration in a male subject of unspecified age who was vaccinated with hepatitis B vaccine recombinant. (Engerix-B, GlaxoSmithKline) for prophylaxis.  On an unspecified date on or before 02 March 2006, the subject received a dose of Engerix-B (dose number and lot number not provided). At an unspecified time after vaccination with Engerix-B, on an unspecified date on or before 02 March 2006, the subject experienced "an altered taste of almonds."  The outcome of the event was not reported.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antigen positive
Clinical narrative: This case was reported by a nurse and described an adult female subject who was vaccinated with Engerix-B and subsequently tested positive for hepatitis B surface antigen. Medical history included renal failure (cause not specified) requiring lot number not provided). On 10 February 2006 and 17 February 2006, the subject " was negative for hepatitis B surface antigen". On 24 February 2006, 21 days after vaccination with Engerix-B, the subject "was positive for hepatitis B antigen ". The nurse considered the event to possibly be related to vaccination with Engerix-B.
Age: 58.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a nurse and described a 58-year-old female subject who did not respond to immunization to the Engerix-B series. The subject's medical history included diabetes and smoker. Concurrent medications included Venlafaxine hydrochloride (Effexor), Carvedilol (Coreg), Simvastatin (Zocor), Metformin hydrochloride (Metformin), Human Insulin (Lantus), Oestradiol (Estradiol) and Diltiazem hydrochloride (Diltiazem xr). On 12 December 2005 the subject received 3rd dose of Engerix-B. On 17 February 2006, 67 days after vaccination with Engerix-B, a hepatitis B surface antibody titer was low at 3 mUI/ml.
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: Therapy non-responder  This case was reported by a nurse and described a female subject of unspecified age who did not respond to immunization to separate injections of hepatitis B vaccine (manufacturer unspecified) and hepatitis A vaccine (manufacturer unspecified).  On an unspecified date the subject received a dose of hepatitis B vaccine (dose number and lot number not provided). On an unspecified date, the subject received a dose of hepatitis A vaccine (dose number and lot number not provided).  On an unspecified date in 2005, at an  unspecified time after vaccination with hepatitis B vaccine and hepatitis A vaccine, titers for hepatitis B surface antibody and hepatitis A antibody were negative.
Age: 75.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antigen positive
Clinical narrative: This case was reported by a nurse and described a 75-year-old female subject who was vaccinated with Engerix-B and subsequently tested positive for hepatitis B surface antigen. Medical history included renal failure (cause not specified) requiring hemodialysis. Concurrent medications included Enalapril, Nephro caps (Nephro cap), Biotin, Tramadol hydrochloride (Ultram), Amitriptyline hydrochloride (Elavil), Lansoprazole (Prevacid),  Diltiazem hydrochloride (Elavil), Lansoprazole (Prevacid), Diltiazem hydrochloride (Cardizem), Amiodarone hydrochloride (Cordarone), Aspirin (ASA), Thyroxine sodium (Synthyroid) and Psyllium husk (Regulan). On 04 February 2006 the subject received 1st dose of Engerix-B (lot AHBVB194AA). On 09 February 2006, 25 days after vaccination with Engerix-B, the subject "had lab work done" that was positive for hepatitis B surface antigen. The event resolved on an unspecified date on or before 22 February 20006. The nurse considered the event to probably be related to vaccination with Engerix-B.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antigen positive
Clinical narrative: Hepatitis B antigen positive  This case was reported by a nurse to a sales representative and described a neonate subject of unspecified gender who was vaccinated with hepatitis B vaccine recombinant (Engerix-B, GlaxoSmithKline) and subsequently tested positive for hepatitis B antigen.  On 07 February 2006 the subject received a dose of Engerix-B (dose number and lot number not provided). "Approximately one or two hours later," on 07 February 2006, the subject "tested positive" for hepatitis B antigen. At the time of initial reporting, 08 February 2006, the event was improved.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Incorrect dose administered, Myalgia
Clinical narrative: Headache, Myalgia, Incorrect dose administered  This case was reported by a nurse and described the occurrence of headache in a 35-year-old female subject who was vaccinated with hepatitis B vaccine recombinant (Engerix-B, GlaxoSmithKline) for prophylaxis.  The subject had no pre-existing medical conditions.  There were no concurrent medications.  On 11 January 2006 the subject received 1st dose of Engerix-B in the left arm (lot AHBVB125AA). The subject received the .5 mL, pediatric dose of Engerix-B.  The .5 mL, pediatric dose is recommended for immunizing individuals 19 years of age and younger. On 12 January 2006, "24 hours" after vaccination with Engerix-B, the subject experienced headache and muscle pain. The muscle aches resolved on an unspecified date on or before 10 February 2006. At the time of initial reporting, 10 February 2006, the headache was ongoing. The nurse considered the headache and muscle aches to probably be related to vaccination with Engerix-B.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: This case was reported by a nurse and described an adult female subject who did not respond to immunization to Engerix-B for prophylaxis.  The nurse reported that, "several years" prior to January 2005, the subject, "had the full hepatitis B (unknown manufacturer) series." On 25 January 2005, the subject, "had a needle stick injury" and subsequently received the 4th "booster" dose of Engerix-B (lot AHBVB004AA). On an unspecified date is July 2005, approximately 5 months after vaccination with the 4th dose of Engerix-B, a hepatitis B surface antibody titer was negative.
Age: 84.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Rash, Rash generalised
Clinical narrative: This case was reported by a nurse and described the occurrence of rash in an 84 year old female subject who was vaccinated with Engerix-B for prophylaxis. Medical history included renal failure (cause not specified) requiring hemodialysis. On 01 December 2005, the subject received the 1st dose of Engerix-B (20 mcg; lot AHBVB190AA). On 03 December 2005 the subject received another dose of Engerix-B (20 mgc; lot AHBVB190AA) as the completion of the 1st 40 mcg dose of Engerix-B. The recommended schedule for administering 40 mcg Engerix-B from a 20 mcg dose is two 20 mcg doses on the same day. On 03 December 2005, less than one day after vaccination with the 2nd 20 mcg dose of Engerix-B, the subject experienced itching and "a rash that started on her trunk and spread to the entire body." The subject was seen at a physician's office and was treated with Benadryl. The rash and itching resolved on 13 December 2005. The nurse considered the rash and itching to probably be related to vaccination with Engerix-B.
Sex: F
Vaccine: HEP
Symptoms: Feeling abnormal
Clinical narrative: This case was reported by a consumer and described the occurrence of strange symptoms in an adult female subject who was vaccinated with Engerix-B for prophylaxis. The reporter is the subject. A physician or other health care professional has not verified this report. On 15 April 2005 the subject received the 1st dose of Engerix-B (lot AHBVB030AA). Less than one month following the 1st dose of Engerix-B, on an unspecified date on or after 15 April 2005 and on or before 15 May 2005, the subject experienced "strange symptoms." On 15 May 2005 the subject received 2nd dose of Engerix-B (lot AHBVB030AA). On 15 September 2005, the subject received the 3rd dose of Engerix-B (lot AHBVB076AA). This is sooner than the recommended interval of 6 months between the 1st and 3rd doses of Engerix-B. The subject reported that, "now that I have had all three shots, the symptoms are worse." The subject was seen at a physician's office. The subject reported that she is "losing her job because she can not get a definitive answer from a doctor and I can't work with the symptoms I have."
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody, No therapeutic response
Clinical narrative: This case was reported by a nurse and described a 42 year old female subject who did not respond to immunization with Engerix-B for prophylaxis. Medical history included "moderate tobacco use." On 07 November 2003 and 12 December 2003 the subject received the 1st and 2nd doses of Engerix-B (lot ENG5305B6). On 14 May 2004, the subject received the 3rd dose of Engerix-B (lot ENG5562B6). On an unspecified date in 2005, on or before 20 May 2005, approximately 1 year after vaccination with the 3rd dose of Engerix-B, a hepatitis B surface antibody titer indicated "no measurable titer level." The nurse considered the non-response to therapy to be related to vaccination with Engerix-B.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody, No therapeutic response
Clinical narrative: This case was reported by a pharmacist and described a subject of unspecified age and gender who did not respond to immunization with Engerix-B for prophylaxis. On an unspecified date before 21 December 2005, the subject received 4th dose of Engerix-B. At an unspecified time following the 4th dose of Engerix-B, on an unspecified date on or before 21 December 2005, a hepatitis B surface antibody titer indicated "no response."
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Rash
Clinical narrative: This case was reported by a nurse and described the occurrence of rash on lower leg in a 43 year old female subject who was vaccinated with Engerix-B for prophylaxis. The subject had no pre-existing medical conditions. There were no concurrent medications. On 08 December 2005 the subject received 1st dose of Engerix-B in an unspecified arm (lot AHBVB166AA). On 08 December 2005, the subject also received a "tuberculin skin test" at an unspecified site of administration (unknown manufacturer). On an unspecified date in December 2005, on or after 08 December 2005 and on or before 19 December 2005, less than one month after vaccination with Engerix-B, the subject experienced a rash on lower leg. The rash on lower leg resolved on an unspecified date on or after 08 December 2005 and on or before 19 December 2005. Follow up to this case was received on 06 March 2006. The nurse reported on follow up that, on 23 January 2006, the subject received the 2nd dose of Engerix-B. This is longer than the recommended interval of one month between the 1st and 2nd doses of Engerix-B. The nurse reported that the subjec, "has not had any problems" following receipt of the 2nd dose of Engerix-B. The nurse considered the rash on lower leg to not be related to vaccination with Engerix-B.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antigen
Clinical narrative: This case was reported by a physician assistant to a sales representative and described an adult subject of unspecified gender who did not respond to immunization to the Engerix-B immunization series. On an unspecified date on or before 09 December 2005, the subject received 3rd dose of Engerix-B. The physician assistant reported to the sales representative that the subject was administered "two pediatric (10 mcg) doses to equal one adult (20 mcg) dose." Approximately 6 weeks after vaccination with the 3rd dose of Engerix-B, on an unspecified date on or before 09 December 2005, a hepatitis B surface antibody titer indicated that the subject was non-immune.
Age: 13.0
Sex: M
Vaccine: HEP
Symptoms: Diarrhoea, Injection site induration, Injection site pain, Malaise, Rash
Clinical narrative: This case was reported by a physician assistant and described the occurrence of malaise in a 12 year old male subject who was vaccinated with Engerix-B for prophylaxis. The subject's medical history included vomiting with Biaxin, "rash with sulfa" and diarrhea with erythromycin. There were no concurrent medications. On an unspecified date before 08 December 2005, the subject received a dose of Recombivax. The reporter stated that the subject received Recombivax "without any problems." On 08 December 2005 the subject received a dose of Engerix-B in his left arm as the 2nd dose in the hepatitis B vaccination series (lot AHBVB172AA). On 09 December 2005, 1 day after vaccination with Engerix-B, the subject experienced malaise, injection site induration, injection site tenderness and hardening injection site. On 10 December 2005, the subject was seen at a physician's office. The reporter stated that, " the indurated area at the injection site was about 5 inches around." The subject was treated with Keflex. The subject was seen by the reporter again on 12 December 2005. The reporter stated that the subject "is improved." The physician assistant considered the events to probably be related to vaccination with Engerix-B.
Age: 13.0
Sex: M
Vaccine: HEP
Symptoms: Vomiting
Clinical narrative: This case was reported by a physician assistant and described the occurrence of malaise in a 12 year old male subject who was vaccinated with Engerix-B for prophylaxis. The subject's medical history included vomiting with Biaxin, "rash with sulfa" and diarrhea with erythromycin. There were no concurrent medications. On an unspecified date before 08 December 2005, the subject received a dose of Recombivax. The reporter stated that the subject received Recombivax "without any problems." On 08 December 2005 the subject received a dose of Engerix-B in his left arm as the 2nd dose in the hepatitis B vaccination series (lot AHBVB172AA). On 09 December 2005, 1 day after vaccination with Engerix-B, the subject experienced malaise, injection site induration, injection site tenderness and hardening injection site. On 10 December 2005, the subject was seen at a physician's office. The reporter stated that, " the indurated area at the injection site was about 5 inches around." The subject was treated with Keflex. The subject was seen by the reporter again on 12 December 2005. The reporter stated that the subject "is improved." The physician assistant considered the events to probably be related to vaccination with Engerix-B.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Dysgeusia
Clinical narrative: This case was reported by a nurse and described the occurrence of metallic taste in mouth in an 18 year old female subject who was vaccinated with Engerix-B for prophylaxis. There were no concurrent medications. On 11 May 2205, the subject received the 1st dose of Engergix-B in the left deltoid (lot AHBVB004AA). On 17 June 2005 the subject received 2nd dose of Engerix-B in the left deltoid (lot AHBVB004AA). This is longer than the recommended interval of one month between the 1st and 2nd doses of Engerix-B. On 17 June 2005, 10 minutes after vaccination with Engerix-B, the subject experienced metallic taste in mouth. The event resolved on 17 June 2005. The subject told the reporter that the metallic taste in her mouth, "did not last long." On follow-up received 23 December 2005, the nurse reported that the patient received the third dose of Engerix-B (lot number not specified) and approximately two minutes after the injections experienced a metallic taste in her mouth, lasting approximately ten minutes. In the reporting nurse's opinion, the event was related to vaccination with Engerix-B.
Age: 38.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B surface antigen, Therapeutic response decreased
Clinical narrative: This case was reported by a nurse and described a 38 year old male subject who had decreased response to vaccination with Engerix-B. The subject's medical history included non-smoker and non-drinker. On 03 February 2005, the subject received the third dose of Engerix-B (lot AHBVA077AB). On 28 November 2005, a hepatitis B surface antibody test revealed a titer "below five." The nurse considered the decreased therapeutic response to be related to vaccination with Engerix-B.
Age: 39.0
Sex: M
Vaccine: HEP
Symptoms: Chills, Injection site pain
Clinical narrative: This case was reported by a nurse and described the occurrence of injection site soreness in a 39 year old male subject who was vaccinated with Engerix-B for prophylaxis. The subject had no known allergies. There were no concurrent medications. On 28 November 2005 the subject received 2nd dose of Engerix-B in the left arm (lot AHBVB144BA). On 28 November 2005, 5 hours after vaccination with Engerix-B, the subject experienced "soreness from shoulder to elbow of the injected arm" and chills. The subject was treated with Tylenol on 28 November 2005. At the time of initial reporting, 29 November 2005, the events had improved. The nurse considered the events to possibly be related to vaccination with Engerix-B.
Age: 40.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody, Therapeutic response decreased
Clinical narrative: This case was reported by a nurse and described a 40 year old male subject who had a decreased response to vaccination with Engerix-B. The subject's medical history included non-smoker. On 02 February 2005, the subject received the third dose of Engerix-B (lot AHBVA077AB). On 17 November 2005, a hepatitis B surface antibody test revealed a titer "below five." The nurse considered the decreased therapeutic response to be related to vaccination with Engerix-B.
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody, Therapeutic response decreased
Clinical narrative: This case was reported by a nurse and described a 44 year old female subject who had a decreased response to vaccination with Engerix-B. The subject's medical history included non smoker. On 08 August 2005, the subject received the third dose of Engerix-B (lot AHBVA077AB). On 14 November 2005, a hepatitis B surface antibody test revealed a titer "below five." The nurse considered the decreased therapeutic response to be related to vaccination with Engerix-B.
Age: 46.0
Sex: M
Vaccine: HEP
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a nurse and described a 46 year old male subject who had a decreased response to vaccination with Engergix-B. The subject's medical history included non smoker and non drinker. On 04 August 2005, the subject received the third dose of Engerix-B (lot AHBVA077AB). On 21 October 2005, a hepatitis B surface antibody test revealed a titer "below two." The nurse considered the decreased therapeutic response to be related to vaccination with Engerix-B.
Age: 56.0
Sex: F
Vaccine: HEP
Symptoms: Rash
Clinical narrative: This case was reported by a consumer and described the occurrence of raised rash in a 55 year old female subject who was vaccinated with Engerix-B for prophylaxis. The reporter is the subject. A physician or other health care professional has not verified this report. The subject's medical history included "eczema resulting from food allergies, specifically to bread products," and renal failure due to chronic kidney disease, requiring hemodialysis. The subject stated that she received "several other (concurrent) medications," however, specific medications and indications were not provided. On an unspecified date before 24 June 2005, the subject received the 1st dose of Engerix-B. The subject reported that she, "had no reactions or problems after that dose." On 24 June 2005 the subject received 2nd dose of Engerix-B. On 27 June 2005, 3 days after vaccination with Engerix-B, the subject experienced "a bumpy, itchy rash" on her chest, arms and abdomen. The subject treated the rash with "topical powder." The subject reported that, "the rash lasted for about 3 weeks and then cleared" and that she, "did not consult a physician regarding the rash." The date that the rash resolved was not reported.
Sex: M
Vaccine: HEP
Symptoms: Asthenia, Candidiasis, Somnolence, Tooth loss
Clinical narrative: This case was reported by a consumer and described the occurrence of thrush in an adult male subject who was vaccinated with Engerix-B for prophylaxis. The reporter is the subject. A physician or other health care professional has not been verified this report. Medical history included "exposure to someone who had hepatitis C". There were no concurrent medications. In "the spring of 2005" the subject received 3rd dose of Engerix-B. At an unspecified time following th e3rd dose of Engerix-B, on an unspecified date in June 2005, the subject experienced thrush. The subject stated that , on an unspecified date in October 2005, his, "teeth were coming loose in his gums with one breaking off" when he "pulled it out with a string". The subject reported that, on an unspecified date in November 2005, on or before 18 November 2005, he "has a lack of energy and sleeps a lot". The subject was seen at a physician's office and was treated with fluconazole for the thrush. At the time of initial reporting, 18 November 2005, the events were ongoing.
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody, No therapeutic response
Clinical narrative: This case was reported by a nurse and described a 40-year-old female subject who did not repond to immunization with HepB (manufacturer unspecified). On an unspecified date in 1993, the subject received 3rd dose of HepB (manufacturer unspecified). Approximately 12 years later, on 07 November 2005, a hepatitis B surface antibody titer indicated that the subject was "not immune."
Age: 49.0
Sex: M
Vaccine: HEPA, TYP
Symptoms: Injection site pain
Clinical narrative: A 48 year old male patient received an initial dose of Typhim Vi, lot number Z0572-2, administered intra-muscularly in the left deltoid and an initial dose of Hepatitis A Vaccine (lot number AHAVB106AA, administered intra-muscularly in the right deltoid. Later that same day (exact latency not reported), the patient experienced pain at the Typhim Vi injection site. The pain radiated to the collarbone and mid upper arm. As per the reporter, a 23 gauge one inch safety syringe was used to administer the Typhim Vi product. At the time of this report the patient had not recovered from the events. Follow up information received on 27 October 2006. Per the reporter, the patient received the vaccination at the worksite. The employee followed up with his personal doctor. The contact information for the personal physician was provided. No other medical information was provided.
Sex: F
Vaccine: TYP
Symptoms: Injury
Clinical narrative: Initiail report received on 30 Nov 2005 from a patient in USA. A female patient with no reported age and medical history had a minute puncture at the tip of the right index finger when rim of the back of the plunger crashed and broke off after pushing to give typhoid vaccine (Typhim VI), lot no: X0300-2 on 30 NOve 2005. It was reported that, applied pressure and no medical treatment required. The patient recovered at the time of the report.
Age: 3.0
Sex: M
Vaccine: TDAP, DTAP, HEP
Symptoms: Autism, Autism spectrum disorder
Clinical narrative: Developmental delay  This case was reported by a healthcare professional and described the occurrence of developmental delay in an 4 year-old male subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine (Infanrix) for prophylaxis and hepatitis B vaccine recombinant (Engerix-B).  Concurrent vaccinations given at the same time included Ipol, pneumococcal, Varivax, ActHIB/Engerix-B. On 08 March 2002 the subject received the first dose of Infanrix (lot number DTaP538A2). The nurse reported that the subject received 2 other additional doses of Infanrix on 06 May 2002 and 25 July 2002. He received the first vaccination of Engerix-B on 20 July 2003 and the third dose on 07 May 2004.  The second dose (unspecified manufacturer) was given on an unspecified date.  Approximately three years later (after the first dose of Infanrix) on an unspecified date in June 2005, the subject experienced developmental disorders and autism was being ruled out.  According to the mother of the subject, he experienced "austism and PDD (pervasive developemental disorder)." At the time of reporting, on 21 July 2006, the events were resolved.
Sex: M
Vaccine: DTP, HEP
Symptoms: Asthenia, Hepatitis B, Muscle contracture, Myalgia, Myofascitis
Clinical narrative: Myalgia, Asthenia, Vocal cord disorder, Myofascitis, Eye movement disorder, Tendon pain, Muscle contracture  This case was reported by a french regional center of pharmacovigilance, via another manufacturer (Sanofi Pasteur MSD) and described the occurrence of muscle pain in an adult male subject who was vaccinated with hepatitis B vaccine (Engerix B adult, GlaxoSmithKline) and tetanus and diphtheria toxoids absorbed and inactivated poliomyelitis virus vaccine (Dt polio, Sanofi Aventis MSD) for prophylaxis.  At an unspecified date, the subject received an unspecified dose of Engerix B adult (20 mcg, batch number ENG5116A6 , expired in October 2003) and an unspecified dose of Dt polio (batch number US205-3, expired in April 2002). Within an unspecified delay after vaccination with Dt polio and Engerix B adult, the subject developed muscle and tendon pain without joint pain.  The subject was treated with non-steroidal anti-inflammatory, tramadol hydrochloride and clonazepam (Rivotril), with efficacy.  As well, he presented with variable asthenia, systemically after a physical stress.  The subject experienced muscle contracture and decreased of mobility of vocal cords and ocular muscle. On 29 August 2006, muscle biopsy showed lesions of macrophagic myofascitis.  At the time of reporting, the outcome of the events was unknown.  The reporter's causality assessment was unknown.  On 29 August 2006, muscle biopsy showed lesions of macrophagic myofascitis.   LABORATORY TEST NAME, TEST DATE, TEST RESULT, LOW NORMAL, HIGH NORMAL Biopsy muscle, 29Aug2006, Abnormal
Sex: M
Vaccine: DTP, HEP
Symptoms: Tendon pain, Vocal cord disorder
Clinical narrative: Myalgia, Asthenia, Vocal cord disorder, Myofascitis, Eye movement disorder, Tendon pain, Muscle contracture  This case was reported by a french regional center of pharmacovigilance, via another manufacturer (Sanofi Pasteur MSD) and described the occurrence of muscle pain in an adult male subject who was vaccinated with hepatitis B vaccine (Engerix B adult, GlaxoSmithKline) and tetanus and diphtheria toxoids absorbed and inactivated poliomyelitis virus vaccine (Dt polio, Sanofi Aventis MSD) for prophylaxis.  At an unspecified date, the subject received an unspecified dose of Engerix B adult (20 mcg, batch number ENG5116A6 , expired in October 2003) and an unspecified dose of Dt polio (batch number US205-3, expired in April 2002). Within an unspecified delay after vaccination with Dt polio and Engerix B adult, the subject developed muscle and tendon pain without joint pain.  The subject was treated with non-steroidal anti-inflammatory, tramadol hydrochloride and clonazepam (Rivotril), with efficacy.  As well, he presented with variable asthenia, systemically after a physical stress.  The subject experienced muscle contracture and decreased of mobility of vocal cords and ocular muscle. On 29 August 2006, muscle biopsy showed lesions of macrophagic myofascitis.  At the time of reporting, the outcome of the events was unknown.  The reporter's causality assessment was unknown.  On 29 August 2006, muscle biopsy showed lesions of macrophagic myofascitis.   LABORATORY TEST NAME, TEST DATE, TEST RESULT, LOW NORMAL, HIGH NORMAL Biopsy muscle, 29Aug2006, Abnormal
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Arthritis, Asthenia, Carpal tunnel syndrome, Hepatitis B
Clinical narrative: Myalgia, Hypertonia, Arthritis, Arthalgia, Paraesthesia, Carpal tunnel syndrome, Myofascitis  This case was reported by french regional center of pharmacovigilance, via another manufacturer (Sanofi Pasteur MSD) and described the occurrence of muscle pain in a 34-year-old female subject who was vaccinated with hepatitis B vaccine (manufacturer unspecified) for prophylaxis.  The subject belongs to the EMMM association number 235.  In 1999, the subject received an unspecified dose of hepatitis B vaccine (batch number not available).  Since October 2003, three years after vaccination with hepatitis B vaccine, the subject developed muscle pain an dhypertonia at the four limbs level, joint inflammation with incapacity to carry a weight, bilateral hip pain.  The subject presented with difficulty to stay sitting down and laying down.  As well, she had tingling in limbs, joint pain, carpal tunnel pain (more painful at the right side).  On 16 December 2005, fascia biopsy showed lesions of macrophagic myofascitis.  Left deltoid muscle biopsy was normal.  At the time of reporting the outcome of the events were was unspecified.  The reporter's causality assessment was unknown.  On 16 December 2005, fascia biopsy showed lesions of macrophagic myofascitis.  Left deltoid muscle biopsy was normal.   LABORATORY TEST NAME, TEST DATE, TEST RESULT, LOW NORMAL, HIGH NORMAL Biopsy muscle, 16Dec2005, Abnormal
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Hypertonia, Musculoskeletal discomfort, Myalgia, Myofascitis, Paraesthesia
Clinical narrative: Myalgia, Hypertonia, Arthritis, Arthalgia, Paraesthesia, Carpal tunnel syndrome, Myofascitis  This case was reported by french regional center of pharmacovigilance, via another manufacturer (Sanofi Pasteur MSD) and described the occurrence of muscle pain in a 34-year-old female subject who was vaccinated with hepatitis B vaccine (manufacturer unspecified) for prophylaxis.  The subject belongs to the EMMM association number 235.  In 1999, the subject received an unspecified dose of hepatitis B vaccine (batch number not available).  Since October 2003, three years after vaccination with hepatitis B vaccine, the subject developed muscle pain an dhypertonia at the four limbs level, joint inflammation with incapacity to carry a weight, bilateral hip pain.  The subject presented with difficulty to stay sitting down and laying down.  As well, she had tingling in limbs, joint pain, carpal tunnel pain (more painful at the right side).  On 16 December 2005, fascia biopsy showed lesions of macrophagic myofascitis.  Left deltoid muscle biopsy was normal.  At the time of reporting the outcome of the events were was unspecified.  The reporter's causality assessment was unknown.  On 16 December 2005, fascia biopsy showed lesions of macrophagic myofascitis.  Left deltoid muscle biopsy was normal.   LABORATORY TEST NAME, TEST DATE, TEST RESULT, LOW NORMAL, HIGH NORMAL Biopsy muscle, 16Dec2005, Abnormal
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Biopsy muscle, Dysphagia, Hearing impaired, Muscle fatigue
Clinical narrative: This case was reported by a physician from regional center of pharmacovigilance of patient and described the occurrence of macrophagic myofascitis in a female subject who was vaccinated with Engerix B for prophylaxis. The subject belonged to the EMMM association under reference 228. From 1970 to 1990, the subject received several injections of DTP vaccine (unspecified batch reference). On 01 July 1991, 01 August 1991, 30 September 1991, 12 May 1993, 10 November 1995, 14 August 1997 and 17 September 1997, the subject received seven doses of Engerix B vaccine (unspecified batch reference). On 17 September 1997, she received a firs injection of 14 August 1997 Havrix (unspecified batch reference). On 27 September 1997 and 08 January 2003, she received an injection of typhim (unspecified batch reference). On 21 February, 21 March and 21 April 1998, the subject received three doses of GenHevac B vaccine (unspecified batch reference). On 06 November 1997, the subject received the eighth dose of Engerix B (unspecified batch reference). In unspecified date, within an unspecified delay after the eighth dose of Engerix B, the subject complained of diffuse myalgia, asthenia, muscular fatigue at the upper and lower limbs, rachis pains, sensitivity, auditory and visual disorders and deglutition and sleep disorder. On 10 November 2005, a biopsy of the left deltoid revealed fibers with same diameter and with a good differenciation. No glycogenic overload was noted. A macrophagic myofascitis was then diagnosed. At the time of the report, the outcome of the events was unknown. On 10 October 2005: Biopsy of the left deltoid: Fibers with good differenciation, no glycogenic overload. Macrophagic myofascitis was diagnosed.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Myalgia, Myofascitis, Pain, Sleep disorder, Visual disturbance
Clinical narrative: This case was reported by a physician from regional center of pharmacovigilance of patient and described the occurrence of macrophagic myofascitis in a female subject who was vaccinated with Engerix B for prophylaxis. The subject belonged to the EMMM association under reference 228. From 1970 to 1990, the subject received several injections of DTP vaccine (unspecified batch reference). On 01 July 1991, 01 August 1991, 30 September 1991, 12 May 1993, 10 November 1995, 14 August 1997 and 17 September 1997, the subject received seven doses of Engerix B vaccine (unspecified batch reference). On 17 September 1997, she received a firs injection of 14 August 1997 Havrix (unspecified batch reference). On 27 September 1997 and 08 January 2003, she received an injection of typhim (unspecified batch reference). On 21 February, 21 March and 21 April 1998, the subject received three doses of GenHevac B vaccine (unspecified batch reference). On 06 November 1997, the subject received the eighth dose of Engerix B (unspecified batch reference). In unspecified date, within an unspecified delay after the eighth dose of Engerix B, the subject complained of diffuse myalgia, asthenia, muscular fatigue at the upper and lower limbs, rachis pains, sensitivity, auditory and visual disorders and deglutition and sleep disorder. On 10 November 2005, a biopsy of the left deltoid revealed fibers with same diameter and with a good differenciation. No glycogenic overload was noted. A macrophagic myofascitis was then diagnosed. At the time of the report, the outcome of the events was unknown. On 10 October 2005: Biopsy of the left deltoid: Fibers with good differenciation, no glycogenic overload. Macrophagic myofascitis was diagnosed.
Age: 0.08
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Haematochezia, Occult blood positive
Clinical narrative: Seriousness criteria other medically significant. Initial report received on 05 January 2007 from another manufacturer, report number WAES0621USA03245. Verbatim from the reporter, "Information has been received concerning a one month old male who on 06 September 2006 was vaccinated with a first dose of rotavirus vaccine (lot #654970/0777F). Concomitant vaccines included a dose of Dtap, a dose of Hib conj-Hepatitis B vaccine, a dose of IPOL and a dose of Prevnar. It was reported that on 07 September 2006 the patients parents noticed what appeared to be blood in stool. On 09 September 2006 there was a positive hemoccult in the office. It was noted that the patient was exclusively breast fed. The physician and mother were to monitor the conditions at the time of the report. The patient's mom was to monitor her dairy intake in case of milk allergy. Upon internal review, blood in stool was considered to be an other important medical event. Additional information is not expected.
Age: 0.42
Sex: M
Vaccine: RV5, DTAP, HBHEPB, IPV, PNC
Symptoms: Gastrointestinal necrosis, Intussusception, Lethargy, Vomiting
Clinical narrative: Initial information received on 05 January 2007 from another manufacturer (reference number WAES0612USA03233). Information has been received concerning a 5 month old male who on 12 November 2006, at 9:30am, was vaccinated with a first oral dose of Rotavirus vaccine (lot number 655174/0848F). Concomitant vaccines (administered on 02 November 2006) included a first intramuscular dose in the left thigh of Hib conj-Hepatitis B vaccine (lot number 654424/0268F), a first intramuscular dose in the right thigh of Tripedia (lot number C2490AA), a first intramuscular dose in the right thigh of Ipol (lot number Y0991) and a first intramuscular dose in the left thigh of Prevnar (Lot number B08681F). There were no other concomitant medications. There was no illness at the time of vaccination. On 08 December 2006 the patient experienced vomiting and lethargy. The patient was diagnosed with intussusception, which required surgery for resection of a necrotic bowel, and was hospitalized for five days. The patient had a KUB X ray and barium enema. It was reported that the patient recovered.
Age: 0.42
Sex: M
Vaccine: RV5, DTAP, HBHEPB, IPV, PNC
Symptoms: Barium enema, Gastrointestinal necrosis, Intussusception, Lethargy, Surgery
Clinical narrative: Initial information received on 05 January 2007 from another manufacturer (reference number WAES0612USA03233). Information has been received concerning a 5 month old male who on 12 November 2006, at 9:30am, was vaccinated with a first oral dose of Rotavirus vaccine (lot number 655174/0848F). Concomitant vaccines (administered on 02 November 2006) included a first intramuscular dose in the left thigh of Hib conj-Hepatitis B vaccine (lot number 654424/0268F), a first intramuscular dose in the right thigh of Tripedia (lot number C2490AA), a first intramuscular dose in the right thigh of Ipol (lot number Y0991) and a first intramuscular dose in the left thigh of Prevnar (Lot number B08681F). There were no other concomitant medications. There was no illness at the time of vaccination. On 08 December 2006 the patient experienced vomiting and lethargy. The patient was diagnosed with intussusception, which required surgery for resection of a necrotic bowel, and was hospitalized for five days. The patient had a KUB X ray and barium enema. It was reported that the patient recovered.
Age: 0.42
Sex: M
Vaccine: RV5, DTAP, HBHEPB, IPV, PNC
Symptoms: Urinary system X-ray, Vomiting
Clinical narrative: Initial information received on 05 January 2007 from another manufacturer (reference number WAES0612USA03233). Information has been received concerning a 5 month old male who on 12 November 2006, at 9:30am, was vaccinated with a first oral dose of Rotavirus vaccine (lot number 655174/0848F). Concomitant vaccines (administered on 02 November 2006) included a first intramuscular dose in the left thigh of Hib conj-Hepatitis B vaccine (lot number 654424/0268F), a first intramuscular dose in the right thigh of Tripedia (lot number C2490AA), a first intramuscular dose in the right thigh of Ipol (lot number Y0991) and a first intramuscular dose in the left thigh of Prevnar (Lot number B08681F). There were no other concomitant medications. There was no illness at the time of vaccination. On 08 December 2006 the patient experienced vomiting and lethargy. The patient was diagnosed with intussusception, which required surgery for resection of a necrotic bowel, and was hospitalized for five days. The patient had a KUB X ray and barium enema. It was reported that the patient recovered.