chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: M
Vaccine: HEPA
Symptoms: C-reactive protein normal, Fatigue, Full blood count normal, Headache, Malaise
Clinical narrative: This case was reported by a physician and described the occurrence of headache in a 52-year-old male subject who was vaccinated with Havrix, for prophylaxis. The subject's medical history included allergies, asthma, depression, restless legs syndrome, non-smoker and consumption of approximately one alcoholic beverage per week. Concurrent medications included Levoxyl, Effexor. Advair, Astelin, Mirapex and Trazodone. On 18 October 2006, the subject received 1st dose of Havrix. On 19 October 2006, one day after vaccination with Havrix, the subject experienced headache, feeling unwell, fatigue and excessive sleepiness. The subject was seen at a physician's office. The physician considered the events were clinically significant (or requiring intervention) and reported that the subject, "missed several days of work" as a result of the events. The immunization series with Havrix was discontinued. On 23 October 2006, laboratory analyses for complete blood count, metabolic function test, erythrocyte sedimentation rate, and C-reactive protein were all normal. The physician concluded from the laboratory analyses that there were " no obvious indicators of infection." At the time of follow-up reporting, 08 December 2006, the events had improved. The physician considered the events to be related to vaccination with Havrix.
Age: 52.0
Sex: M
Vaccine: HEPA
Symptoms: Metabolic function test normal, Red blood cell sedimentation rate normal, Somnolence
Clinical narrative: This case was reported by a physician and described the occurrence of headache in a 52-year-old male subject who was vaccinated with Havrix, for prophylaxis. The subject's medical history included allergies, asthma, depression, restless legs syndrome, non-smoker and consumption of approximately one alcoholic beverage per week. Concurrent medications included Levoxyl, Effexor. Advair, Astelin, Mirapex and Trazodone. On 18 October 2006, the subject received 1st dose of Havrix. On 19 October 2006, one day after vaccination with Havrix, the subject experienced headache, feeling unwell, fatigue and excessive sleepiness. The subject was seen at a physician's office. The physician considered the events were clinically significant (or requiring intervention) and reported that the subject, "missed several days of work" as a result of the events. The immunization series with Havrix was discontinued. On 23 October 2006, laboratory analyses for complete blood count, metabolic function test, erythrocyte sedimentation rate, and C-reactive protein were all normal. The physician concluded from the laboratory analyses that there were " no obvious indicators of infection." At the time of follow-up reporting, 08 December 2006, the events had improved. The physician considered the events to be related to vaccination with Havrix.
Sex: F
Vaccine: HEPA
Symptoms: Accidental exposure, Exposure to communicable disease
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of occupational exposure to HIV in an adult female subject who was accidentally exposed to Havrix. On 08 November 2006 the subject, a healthcare professional, was injecting a dose of Havrix into an individual who is HIV and hepatitis B positive. During the administration of Havrix, while "the needle was in the individual's arm," the syringe "spurted fluid." The fluid spurted back into the eyes and nose of the healthcare professional. As a result of the fluid spurting, the healthcare professional was exposed to HIV and hepatitis B and also was accidentally exposed to Havrix. The healthcare professional was treated with Kaletra and Truvada for HIV post-exposure prophylaxis. The outcome of the events was not reported.
Sex: F
Vaccine: HEPA
Symptoms: Injury
Clinical narrative: This case was reported by a consumer (who was possibly a health care professional) and described the occurrence of injury in a female subject of unspecified age who was vaccinated with Havrix, for prophylaxis. On an unspecified date the subject received unspecified dose of Havrix. On 1 July 2005, at an unspecified time after vaccination with Havrix, the subject experienced an unspecified injury. At the time of reporting the outcome of the event was unspecified.
Age: 9.0
Sex: F
Vaccine: HEP
Symptoms: Asthma, Urticaria
Clinical narrative: Information has been received from a consumer concerning her approximately 9-year-old daughter with asthma and no allergies who in approximately 1997 or 1998 was vaccinated with a dose of Recombivax HB. There was no concomitant medication. Following vaccination, in 1997 or 1998, the patient developed hives and her asthma was activated. Unspecified medical attention was sought. No diagnostic laboratory tests were performed. A product quality complaint was not involved. No further information is available.
Age: 49.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Tongue black hairy, Vaginal haemorrhage
Clinical narrative: Information has been received from a 49-year-old female with an allergy to "arrythnomyacin" and a history of "toxic build up of mercury", who on 28-DEC-2005 was vaccinated with a dose of Recombivax HB. Concomitant vaccination given on that same day included: a booster dose of Vaqta (lot# 649456/0175R). On 29-DEC-2005, the patient experienced black tongue. It was reported that the patient was post menopausal, however, developed vaginal bleeding "four days ago" (08-JAN-2006). Unspecified medical attention was sought. No laboratory or diagnostic tests were performed. At the time of this report the patient had not recovered. No product quality complaint was involved.  Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Dyspnoea, Flushing, Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a 35-year-old female with a latex allergy, and allergies to vancomycin and Varivax (WAES # 0601USA02315) who on 06-JAN-2006 was vaccinated with a dose of Recombivax HB (Lot # 651852/0304R). Concomitant therapy that day included a dose of MMR II. Subsequently the patient returned to the office with hives to her neck and face, flushed face, and shortness of breath. Her vital signs including blood pressure were stable after observation at the office for 45 minutes. Her symptoms resolved without any medication and she returned home. The patient was directed to call the office if any other problems occur. No further information was available. There was no product quality complaint. Follow up information indicated that after vaccination the patient left the clinic. She then returned that day, 06-JAN-2006, with her mother with complaints of a flushed face, hives, and shortness of breath. Her vitals were stable. The patient was offered epinephrine, however the mother declined, stating that she would take her daughter home and give her medicine. No additional information is expected.
Age: 31.0
Sex: M
Vaccine: HEP
Symptoms: CSF protein increased, Guillain-Barre syndrome, Lumbar puncture, Muscular weakness, Pain in extremity
Clinical narrative: Information has been received from a medical assistant concerning a 31-year-old male with no pertinent medical history, who was vaccinated with a second dose of hepatitis B (lot # 637982/1749K) (date, route and dose unspecified). There was no concomitant medication. In 2001 the patient complained of weakness in both hands, soreness in the biceps and forearms bilaterally; unspecified medical attention was sought. The patient was subsequently diagnosed with a mild case of Guillain-Barre Syndrome and was hospitalized. Pulmonary function tests were performed (results unspecified) and a spinal tap revealed mild elevation in protein. The time frame between the dose of hepatitis B and the onset of the symptoms is unknown. It was reported that the patient recovered. Medication taken by the patient as of 06-FEB-2006 included "baby aspirin" and multivitamins. No product quality complaint was involved. The reporter considered the patient's adverse experience to be life threatening. Additional information has been requested.
Age: 31.0
Sex: M
Vaccine: HEP
Symptoms: Pulmonary function test
Clinical narrative: Information has been received from a medical assistant concerning a 31-year-old male with no pertinent medical history, who was vaccinated with a second dose of hepatitis B (lot # 637982/1749K) (date, route and dose unspecified). There was no concomitant medication. In 2001 the patient complained of weakness in both hands, soreness in the biceps and forearms bilaterally; unspecified medical attention was sought. The patient was subsequently diagnosed with a mild case of Guillain-Barre Syndrome and was hospitalized. Pulmonary function tests were performed (results unspecified) and a spinal tap revealed mild elevation in protein. The time frame between the dose of hepatitis B and the onset of the symptoms is unknown. It was reported that the patient recovered. Medication taken by the patient as of 06-FEB-2006 included "baby aspirin" and multivitamins. No product quality complaint was involved. The reporter considered the patient's adverse experience to be life threatening. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Fatigue, Malaise
Clinical narrative: Information has been received from a health professional concerning a 20 year old female who on 02-FEB-2006 was vaccinated IM with a dose of Recombivax HB (lot # 648211/0864P). Subsequently the patient experienced "not feeling well" and fatigue. Unspecified medical attention was sought. At the time of the report, the patient had not recovered. There was no product quality complaint involved. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Fungal infection
Clinical narrative: Information has been received from a female with many allergies and no pertinent medical history who in 1997 was vaccinated with doses of Recombivax HB. Concomitant therapy included allergy medications. In 1997, "soon after receiving the therapy", the patient experienced a cronic systemic yeast infection, with symptoms similar to lupus. Autoimmune test were performed. Unspecified medical attention was sought. The outcome was not recovered. There was no product quality complaint. Additional information has been requested.
Age: 40.0
Sex: M
Vaccine: HEP
Symptoms: Anti-HBs antibody negative, Back pain, Neck pain, Vaccination failure
Clinical narrative: Information has been received from a pharmacist concerning a male in his 40s, with no medical history and no allergies, who, 15 years ago, in approximately 1991 was vaccinated with a complete series of hepatitis B virus vaccine rHBsAg (yeast). IT was reported that the patient had a "recent" anti-HB titer, in approximately 2006, which was negative. It was noted that the patient was not ill. Unspecified medical attention was sought. No product quality complaint was involved. Follow-up information form a health professional indicated that the patient received one additional dose of hepatitis B virus vaccine rHBsAg (yeast) (Lot # 653364/1121R) on 16-Feb 2006 due to the negative titer. concomitant therapy included fluticasone propionate (+) salmeterol xinafoate (ADVAIR) for an undisclosed condition. It was reported that since 16- Feb 2006 the patient has had neck and back pain. It was noted that he had also shoveled snow during that time and it was not known if the pain was from the vaccination or from the snow. The patient has taken ibuprofen (ADVIL) or ibuprofen (MOTRIN) without relief. NO other information was provided. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: HEP
Symptoms: Expired drug administered, Injection site pruritus
Clinical narrative: Information has been received from a 65 year old female with " stomach problems", a penicillin allergy and a "sulfa" allergy who on 22, Feb 2006 was vaccinated SC with a 0.5 ml first and second dose of hepatitis B virus vaccine rHBsAg (yeast) (Lots #'s 651363/0336R and 646145/0624N) Concomitant therapy included "Chinese herbal supplement." It was reported that lot # 646145/0624N expired on 09, Feb 2006. Subsequently on 22, Feb 2006 the patient developed pruritis at the injection site. Medical attention was not sought. There were no laboratory diagnostic tests performed. At the time of the report the patient had not yet recovered. There was no product quality complaint involved. Follow up information was received from the consumer indicating that she wanted to know if she could sue her physician due to the administration of the expired vaccine. Additional information is not expected.
Age: 18.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B, Hepatitis B antigen positive
Clinical narrative: Information has been received from a physician concerning an 18 year old male who on 15, Aug 1003. 17, Sep 1993  and 24, Feb 1994 was vaccinated with a first, second and third dose of hepatitis B virus vaccine rHBsAg (yeast). "Recently", in approximately February 2006, the patient was treated and found to be positive for hepatitis B. Unspecified medical attention was sought. No product quality complaint was involved. Follow-up information from a nurse in the physicians office indicated that the patient went to donate blood and was told that he tested positive for Hepatitis B. The following lab test findings were reported: Anti HB core positive, HB surface antigen positive, and Anti Hep C negative. The physicians office ordered testing and received the following lab test results: HB surface antigen positive, HB e antibody reactive, HB e antibody negative, and HB e antigen non-reactive. The nurse was unable to provide any details regarding symptoms experienced by the patient as he had not been seen by the office.
Age: 11.0
Sex: F
Vaccine: HEP
Symptoms: Adverse event, Unevaluable event
Clinical narrative: Information has been received from a registered nurse concerning a 11 year old female who in August 2001, was vaccinated with a dose of hepatitis B virus vaccine rHBsAg (yeast). Subsequently the patient experienced a reaction. It was unknown what type of reaction. Unspecified medical attention was sought. The patient's outcome was unknown. There was no product quality complaint involved. Follow-up information form the registered nurse indicated that this was a "possible" event cited by the patient's mother. The possible event took place several years earlier and the mother could not provided specific information regarding the event. The event took place at another clinic. Due to the circumstances the registered nurse was unable to provided any further information.
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Hypersensitivity, Pruritus
Clinical narrative: Information has been received from a nurse concerning a 33 year old white female with a history of yeast and "RECOMBIVAX" who in September 2002, was vaccinated with the first 1ml IM dose in a series of hepatitis B. Subsequently the patient experienced a mild allergic reaction. She became severely itchy for 2 days and the rest of the series was discontinued. It was reported that the symptoms lasted for 2 days and then resolved. The reporter felt the patient's experience was disabling. Additional information is not expected.
Age: 67.0
Sex: M
Vaccine: HEP
Symptoms: Arthralgia, Fatigue, Musculoskeletal pain
Clinical narrative: Information has been received from a registered nurse concerning a 67 year old white male with no known medical history or allergies who on 21 , Mar 2006 was vaccinated IM with a 1 ml dose of hepatitis B virus vaccine rHBsAg (yeast) (Lot # 647982/0446R). Concomitant therapy included simvastatin (MSD). There was no illness at the time of vaccination. Approximately 24 hours later on 22, Mar 2006 (also reported as several hours later, on 21 Mar 2006 The patient experienced fatigue, shoulder pain and knee joint pain, that was described as being a 3-4 on a 10 scale of intensity. The symptoms lasted 3 days. No medical consultation or exam was performed. No laboratory diagnostic tests were performed. The patient's outcome was recovered. It was reported that on 18, Apr 2006 the patient received his second dose of hepatitis B virus vaccine rHBsAg (yeast) and he had no complains at joint pain after this dose. There were no adverse events following prior vaccination. There was o product quality complaint involved.
Sex: M
Vaccine: HEP
Symptoms: Polyneuropathy
Clinical narrative: Information has been received from a healthcare professional concerning a male with rosacea who on 1998 was vaccinated IM with a dose of hepatitis B virus vaccine rHBsAg (yeast) (manufacturer unknown). concomitant therapy included tetracycline hydrochloride. In September 1998, the patient experienced polyneuropathy.
Sex: M
Vaccine: HEP, TYP
Symptoms: Erythema, Flushing, Rash, Swollen tongue
Clinical narrative: Information has been received from a physician concerning an adult male with no pertinent medical history who on 24-FEB-2006 was vaccinated with a dose of Recombivax HB. Concomitant therapy that day included typhoid vaccine (unspecified). Other concomitant therapy on 17-FEB-2006 included hepatitis A vaccine (inactive) and influenza virus vaccine (unspecified). Since vaccination, the patient has reported drinking heavily twice during March 2006. Both times, the patient developed a red flushing rash on his face and extremities, and a slight swelling of his tongue. Unspecified medical attention was sought. The outcome was reported as recovered. No other information was available. There was no lab diagnostic studies performed. There was no product quality complaint. No additional information is expected.
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Myalgia
Clinical narrative: Information has been received from a physician concerning a female in her early 30s with a family history of multiple sclerosis who in the "week of 20-MAR-2006" was vaccinated with a first 1.0ml dose of Recombivax HB. The "week of 20 Mar 2006", within 24 hours of vaccination, the patient experienced myalgia in her lower extremities. She described it as her legs felt like she was walking in water. It was noted that symptoms lasted 1 day. It was also noted that she recovered on 04-APR-2006. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 0.08
Sex: M
Vaccine: HEP
Symptoms: Injection site rash
Clinical narrative: Information has been received from a physician concerning her son with no medical history and no known allergies who in approximately August 2005, at 4 weeks of age, was vaccinated in the thigh with a second dose of Recombivax HB. In approximately August 2005, post vaccination, the patient experienced a rash a the injection site. The child's doctor prescribed oral BENADRYL, but the child did not need to use it. She reported that her child gets a rash at the injection site from all the childhood vaccines he receives and they are trying to rule out an allergy to latex. The child has fully recovered. Medical attention was sought. No product quality complaint was involved. Additional information is not expected.
Sex: M
Vaccine: HEP
Symptoms: Bedridden, Influenza like illness
Clinical narrative: Information has been received from a lawyer concerning a report of a professor's brother who was vaccinated with a dose of Recombivax HB. Subsequently, shortly thereafter he experienced flu-like symptoms. Within a few weeks after the second Recombivax (manufacturer unknown), the patient "was in bed mostly". At the time of this report there was no further information available. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Malaise
Clinical narrative: Information has been received from a lawyer concerning a report of a professor's "worker" who was vaccinated with a dose of Recombivax HB. Subsequently, the worker became ill after vaccination. There was no further information at the time of this report. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Injection site cellulitis, Injection site pain
Clinical narrative: Information has been received from a registered nurse concerning a 20 year old female who in approximately 1986 was vaccinated with a first and second dose of Recombivax (manufacturer unknown). Subsequently, the patient developed injection site cellulitis and pain. The outcome of the event was unknown. The patient also developed injections site cellulitis and pain post vaccination with pneumococcal vaccine (WAES# 0603USA03128). No further information is available.
Age: 59.0
Sex: F
Vaccine: HEP
Symptoms: Blood pressure increased, Culture urine, Dysuria, Fibromyalgia, Influenza
Clinical narrative: Information has been received from a 59 year old female with a sulfonamide allergy and fibromyalgia who on 06-MAR-2006 was vaccinated IM with a dose of Recombivax HB. Concomitant therapy included PREMARIN. On 06-MAR-2006 the patient experienced lethargy, flu symptoms, fatty tumors in left side and under the right arm, pain with urination, "triggered" fibromyalgia, elevated blood pressure, and depression after vaccination. She had cultures done for her bladder. At the time of the report the patient was recovering. It was noted that she also had an adverse reaction while taking EFFEXOR. Other unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: HEP
Symptoms: Lethargy, Neoplasm skin
Clinical narrative: Information has been received from a 59 year old female with a sulfonamide allergy and fibromyalgia who on 06-MAR-2006 was vaccinated IM with a dose of Recombivax HB. Concomitant therapy included PREMARIN. On 06-MAR-2006 the patient experienced lethargy, flu symptoms, fatty tumors in left side and under the right arm, pain with urination, "triggered" fibromyalgia, elevated blood pressure, and depression after vaccination. She had cultures done for her bladder. At the time of the report the patient was recovering. It was noted that she also had an adverse reaction while taking EFFEXOR. Other unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain, Allergy test positive, Breast cancer, Chills, Drug hypersensitivity
Clinical narrative: Information has been received from a 64 year old female who is a nurse with a cashew allergy, dilauid allergy and iodine (IVP) allergy who in 1995 was vaccinated IM with a second dose of Recombivax HB. Concomitant medication included an unspecified thyroid medication and Motrin IB. An allergic reaction was noted of chills, fever, abdominal pain and ill like malaise that lasted a few days. She did not receive the third injection. The series was again tried in 1997 and after the first dose in that series of Recombivax HB the patient just felt tired with no other symptoms. The second dose of that series was followed by chills, fever, abdominal pain and swelling. She did not continue the series. It was noted that she was trying to determine if this brought on all her allergies: amoxil, penicillin, Ceclor (hospitalized for hives), Keflex (red rash), albuterol, dopamine, novocaine with epinephrine, Benadryl, IM, heparin drip, B 12 injection and latex. Allergy tests were done and determined she was allergic to shellfish, wheat, barley, bananas and nuts. It was also reported that she experienced a rash while taking antibiotics, cortisone, IVP dyes, iodine, Keflex, Amoxil, Visine and latex and that Glucophage makes her nauseous. Information received contained the following adverse experiences: polymyalgia and breast cancer. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: HEP
Symptoms: Fatigue, Food allergy, Hypersensitivity, Malaise, Myalgia
Clinical narrative: Information has been received from a 64 year old female who is a nurse with a cashew allergy, dilauid allergy and iodine (IVP) allergy who in 1995 was vaccinated IM with a second dose of Recombivax HB. Concomitant medication included an unspecified thyroid medication and Motrin IB. An allergic reaction was noted of chills, fever, abdominal pain and ill like malaise that lasted a few days. She did not receive the third injection. The series was again tried in 1997 and after the first dose in that series of Recombivax HB the patient just felt tired with no other symptoms. The second dose of that series was followed by chills, fever, abdominal pain and swelling. She did not continue the series. It was noted that she was trying to determine if this brought on all her allergies: amoxil, penicillin, Ceclor (hospitalized for hives), Keflex (red rash), albuterol, dopamine, novocaine with epinephrine, Benadryl, IM, heparin drip, B 12 injection and latex. Allergy tests were done and determined she was allergic to shellfish, wheat, barley, bananas and nuts. It was also reported that she experienced a rash while taking antibiotics, cortisone, IVP dyes, iodine, Keflex, Amoxil, Visine and latex and that Glucophage makes her nauseous. Information received contained the following adverse experiences: polymyalgia and breast cancer. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: HEP
Symptoms: Nausea, Pyrexia, Rash, Rash erythematous, Swelling
Clinical narrative: Information has been received from a 64 year old female who is a nurse with a cashew allergy, dilauid allergy and iodine (IVP) allergy who in 1995 was vaccinated IM with a second dose of Recombivax HB. Concomitant medication included an unspecified thyroid medication and Motrin IB. An allergic reaction was noted of chills, fever, abdominal pain and ill like malaise that lasted a few days. She did not receive the third injection. The series was again tried in 1997 and after the first dose in that series of Recombivax HB the patient just felt tired with no other symptoms. The second dose of that series was followed by chills, fever, abdominal pain and swelling. She did not continue the series. It was noted that she was trying to determine if this brought on all her allergies: amoxil, penicillin, Ceclor (hospitalized for hives), Keflex (red rash), albuterol, dopamine, novocaine with epinephrine, Benadryl, IM, heparin drip, B 12 injection and latex. Allergy tests were done and determined she was allergic to shellfish, wheat, barley, bananas and nuts. It was also reported that she experienced a rash while taking antibiotics, cortisone, IVP dyes, iodine, Keflex, Amoxil, Visine and latex and that Glucophage makes her nauseous. Information received contained the following adverse experiences: polymyalgia and breast cancer. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Information has been received from a 64 year old female who is a nurse with a cashew allergy, dilauid allergy and iodine (IVP) allergy who in 1995 was vaccinated IM with a second dose of Recombivax HB. Concomitant medication included an unspecified thyroid medication and Motrin IB. An allergic reaction was noted of chills, fever, abdominal pain and ill like malaise that lasted a few days. She did not receive the third injection. The series was again tried in 1997 and after the first dose in that series of Recombivax HB the patient just felt tired with no other symptoms. The second dose of that series was followed by chills, fever, abdominal pain and swelling. She did not continue the series. It was noted that she was trying to determine if this brought on all her allergies: amoxil, penicillin, Ceclor (hospitalized for hives), Keflex (red rash), albuterol, dopamine, novocaine with epinephrine, Benadryl, IM, heparin drip, B 12 injection and latex. Allergy tests were done and determined she was allergic to shellfish, wheat, barley, bananas and nuts. It was also reported that she experienced a rash while taking antibiotics, cortisone, IVP dyes, iodine, Keflex, Amoxil, Visine and latex and that Glucophage makes her nauseous. Information received contained the following adverse experiences: polymyalgia and breast cancer. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: HEP
Symptoms: Alopecia
Clinical narrative: Information has been received from a healthcare professional concerning a 44 month old female who was vaccinated with a first and second dose of hepatitis B virus vaccine. On 20-OCT-1993 the patient was vaccinated with a third intramuscular dose of Recombivax. Three days later, on 23-OCT-1993, the patient started to lose her hair. It was reported that a follow up consult with a dermatologist diagnosed it as an adverse reaction to Recombivax HB. It was noted that the patient was now 16 years old and has her hair. The patient was reported as recovered. Unspecified medical attention was sought. No product quality complaint was involved. Follow-up information from a registered nurse indicated that there was no other information to report. Additional information is not expected.
Age: 0.43
Sex: M
Vaccine: HEP
Symptoms: Hypersensitivity, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a registered pharmacist concerning a male, approximately 5 months of age, who on 05-SEP-2002 and 15-NOV-2002 was vaccinated with doses of Recombivax HB (lot# 642924/0304M and 644060/0782M, respectively). The second dose was considered to be an inappropriate schedule of vaccine administration. Subsequently, the patient experienced an allergic reaction post vaccination. No outcome information was reported. No product quality complaint was involved. Additional information was not provided.
Age: 33.0
Sex: M
Vaccine: HEP
Symptoms: Allergy test, Condition aggravated, Eczema
Clinical narrative: Information has been received from a 33 year old male with eczema, and egg allergy and a mild allergy who "sometime in 1989" was vaccinated IM with a second dose of Recombivax HB. Concomitant therapy included WESTCORT ointment. He reported that a worsening of eczema developed after this second shot. He did not receive the third shot. It was noted that allergy testing was done. The patient recovered after a couple of weeks. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 30.0
Sex: M
Vaccine: HEP, HEP, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received form a physician concerning a 30 day old white male who was a premature baby who on 04-Sep- 2002 was vaccinated with a first dose of hepatitis Ba virus vaccine rHBsAg (yeast) (manufacturer unknown). Subsequently the patient experienced swelling and redness at the site. It was also noted that the patient developed adverse events after vaccination with varicella virus vaccine live (Oka/Merk) (MSD) (WAES # 0606USA02200)
Age: 30.0
Sex: M
Vaccine: HEP, HEP, VARCEL
Symptoms: Diarrhoea, Rash, Vomiting
Clinical narrative: Information has been received form a physician concerning a 30 day old white male who was a premature baby who on 04-Sep- 2002 was vaccinated with a first dose of hepatitis Ba virus vaccine rHBsAg (yeast) (manufacturer unknown). Subsequently the patient experienced swelling and redness at the site. It was also noted that the patient developed adverse events after vaccination with varicella virus vaccine live (Oka/Merk) (MSD) (WAES # 0606USA02200)
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Paraesthesia
Clinical narrative: Information has been received from a certified Medical Assistant concerning a female employee in her 30's, with carpal tunnel, who on 28, June 2006 was vaccinated intramuscularly in the left deltoid with a 1ml dose of hepatitis B virus vaccine rHBsAf (yeast) (Lot # 652348/1097R). Subsequently, within 20 minutes she developed tingling of her left hand, which resolved in 2-3 hours. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information form the medical assistant indicated that the patient ; has had this numbness before because she has carpal tunnel.  the patient felt that this numbness was not a reaction to vaccination.
Sex: M
Vaccine: HEP
Symptoms: Facial palsy
Clinical narrative: Information has been received from a physician concerning a male who in September 2005, was vaccinated with a 10mcg first dose of hepatitis B virus vaccine rHBsAg (yeast). The physician was unsure if the vaccine administered was hepatitis B virus vaccine rHBsAg (yeast) or hepatitis B virus vaccine rHBsAg (yeast) (ENGERIX-B). "Sometime after the first dose" the patient developed bells palsy "from the vaccination" Unspecified medical attention was sought. The patient's outcome was unknown. There was no  product quality complaint involved.
Sex: F
Vaccine: HEP
Symptoms: HIV test, Hepatitis B antibody positive, Seroconversion test positive, Unevaluable event
Clinical narrative: Information has been received from a registered nurse concerning a female healthcare worker who on 22, June 1988,  22, July 1998, and 22, Dec 1988 was vaccinated with a first, second, and third dose of hepatitis B virus vaccine rHBsAg (yeast). There was no concomitant medication. It was noted that the patient had previously seroconverted. She had positive tests on 12, Apr 1999 and 07, Jul 2000. On approximately 28, June 2006, the patient had an indeterminate test for hepatitis B. It was noted that the patient also had a rapid HIV test (results not provided) The patient had not contacted hepatitis B or had any problems with the series. Unspecified medical attention was sought. A product quality complaint was not involved.
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, Pain in extremity
Clinical narrative: Information has been received from a 38 year old female consumer with an allergy to sulfa who was vaccinated with "three doses one month apart" of hepatitis B virus vaccine rHBsAg (yeast). She did not experience andy side effects other than a sore arm. Medical attention was sought. No laboratory diagnostic tests were performed. There was no product quality complaint involved.
Sex: U
Vaccine: HEP
Symptoms: Adverse event, Unevaluable event
Clinical narrative: Information has been received regarding a case in litigation concerning a patient who was vaccinated with a dose of hepatitis B virus vaccine rHBsAg (yeast) (Lot # 629874/0211J). Subsequently the patient had an adverse experience.
Age: 5.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Gait disturbance, Pain, Pyrexia, Sinus congestion
Clinical narrative: Information has been received from a registered nurse concerning a 5 year old white female with a drug allergy/reaction to cefaclor (CECLOR) furticarial (also reported as no pre-existing allergies, birth defects, or medical conditions) who on 27, Jan 1993 at 3: 00 PM was vaccinated IM in her right arm with a second dose of hepatitis B virus vaccine rHBsAg (yeast), 0.5 mL. There was no illness at the time of vaccination. There was no concomitant therapy. On 28, Jan 1993 the patient developed a fever of 103 degrees Fahrenheit and felt "achey". She was too weak to walk. Medical intervention for the events included acetaminophen (TYLENOL) and bedrest The symptoms improved over a couple of days and she recovered. She did not experience a reaction to her first dose of hepatitis B virus vaccine rHBsAg (yeast), and subsequently she did not complete the series. Follow-up information indicated that on 26, Jan 1993 at 3:00 PM, the patient experienced a fever of 103 degrees, aches, congestion and was unable to walk. The patient recovered on 30, Jan 1993. There were no relevant diagnostic tests or laboratory data. There were no adverse events following prior vaccinations.
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B e antigen negative, Hepatitis B surface antigen negative, Inappropriate schedule of drug administration, Thyroidectomy
Clinical narrative: Information has been received from a physician's assistant concerning a 31 year old female with an allergy to codeine and hypertension who was vaccinated IM with a first, second and third dose of hepatitis B virus vaccine rHBsAg (yeast) on 20, Jan 2004 (Lot # 643221/0386M) 25, Feb 2004 (Lot # 646999/0999N), and 13, Feb 2006 (Lot # 649259/0833R) respectively. Concomitant therapy included atenolol and hydrochlorothiazide. On 07, Aug 2006 the patient had a hepatitis B titer that was negative. Unspecified medical attention was sought. There was no product quality complaint involved. Information received on 09, Aug 2006 contained the following adverse experiences: partial thyroidectomy (December 2005)
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Anti-HBs antibody negative, Chest X-ray normal, Hepatitis B surface antigen negative, Inappropriate schedule of drug administration, Tuberculosis skin test positive
Clinical narrative: Information has been received from an health professional concerning a 25 year old white female with a positive tuberculin test and no known drug allergies who on 30, Nov 2005 was vaccinated IM with two  pediatric doses of 0.5 mL hepatitis B virus vaccine rHBsAg (yeast (lot # 648240/0812O),  There was no concomitant medication. On 03, Jan 2006 the patient was vaccinated Im with two pediatric doses of 0.5 mL hepatitis B virus vaccine rHBsAg (yeast) (lot# 651494/0458R). On 12, June 2006, the patient was vaccinated IM with tow pediatric doses of 0.5 mL hepatitis B virus vaccine rHBsAg (yeast) (lot # 651494/0458R). On 03, Aug 2006, the patient had blood work which was non reactive for the hepatitis B surface antibody. The chest x-ray was done for positive tuberculosis test and it was normal. Follow-up information from the health professional indicated that the patient was vaccinated with two 0.5 mL pediatric doses of hepatitis B virus vaccine rHBsAg (yeast) on 30, Nov 2005 (lot# 648240/0812P; right deltoid), 03, Jan 2006 (lot#651494/0458R; left deltoid), 12, June 2006 (lot#651494/045BR; right deltoid), 18, Aug (lot# 653268/0202F; left deltoid) and 26, Sep 2006 (lot# 652882/0038F; right deltoid). On 05, Dec 2005 the patient did not receive medication for preventative measures. On 8, Dec 2005 was negative for tuberculosis, with a result of 3mm. On 01, March 2006 the patient had no evidence of pulmonary tuberculosis. On 03, Aug 2006 the patient underwent a hepatitis B surface antibody test that was non reactive. At the time of the report the patients outcome was not known. Follow-up information from the health professional indicated that the patient received a repeat three dose series of RECOMBIVAX HB. Hepatitis surface antibody and hepatitis surface antigen were negative after the six doses. It was reported that the  patient was obese and over 300 pounds. Additional information is not expected.
Age: 59.0
Sex: F
Vaccine: HEP
Symptoms: Burning sensation, Conjunctivitis, Erythema, Full blood count, Liver function test
Clinical narrative: Information has been received from a physician concerning a 59 year old female with no pertinent medical history who in the end of June 2006 was vaccinated with a dose of hepatitis B virus vaccine rHBsAg (Yeast). There was no concomitant medication. A month later, at the end of July 2006, the patient developed conjunctivitis and redness on her neck and shoulder. Unspecified medical attention was sought and the patient recovered from the symptoms. At the time of this report. it was noted that the patient was still experiencing tinnitus and a burning sensation on her face and shoulder. The physician reported that medical attention was sought and laboratory test were performed, including a complete blood cell count and liver function test (no results were reported). The patient's present status was reported as recovering. No product quality complaint was involved.
Age: 59.0
Sex: F
Vaccine: HEP
Symptoms: Tinnitus
Clinical narrative: Information has been received from a physician concerning a 59 year old female with no pertinent medical history who in the end of June 2006 was vaccinated with a dose of hepatitis B virus vaccine rHBsAg (Yeast). There was no concomitant medication. A month later, at the end of July 2006, the patient developed conjunctivitis and redness on her neck and shoulder. Unspecified medical attention was sought and the patient recovered from the symptoms. At the time of this report. it was noted that the patient was still experiencing tinnitus and a burning sensation on her face and shoulder. The physician reported that medical attention was sought and laboratory test were performed, including a complete blood cell count and liver function test (no results were reported). The patient's present status was reported as recovering. No product quality complaint was involved.
Sex: U
Vaccine: HEP
Symptoms: Adverse event, Unevaluable event
Clinical narrative: Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with a dose of Recombivax HB. Subsequently the patient experienced an adverse event. The physician would not provided any further details. There was no product quality complaint involved. No further information is available.
Sex: U
Vaccine: HEP
Symptoms: Adverse event
Clinical narrative: Information has been received regarding a case in litigation concerning a patient who was vaccinated with a dose of Recombivax HB and subsequently developed an adverse event. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Adverse event
Clinical narrative: Information has been received regarding a case in litigation concerning a patient who was vaccinated with a dose of Recombivax HB. Subsequently the patient experienced an adverse event. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Adverse event
Clinical narrative: Information has been received regarding a case in litigation concerning a patient who was vaccinated with a dose of Recombivax HB (Lot #'s 614560/015D; 614817/1405B; and 614567/0280D). Subsequently the patient experienced an adverse event. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Rash
Clinical narrative: Information has been received from a licensed practical nurse concerning an 18 year old female with no known allergies or medical history who, "above five years age," in approximately 2001 was vaccinated with a first dose of Recombivax HB. There was no concomitant medication. Shortly after being vaccinated, in approximately 2001, the patient developed a rash. Therapy with hepatitis B virus vaccine was discontinued. Unspecified medical attention was sought and the patient recovered. A product quality complaint was not involved. Additional information has been received from the nurse who reported that, to date, he was unable to get anymore information due to the patient not returning to the clinic for follow-up.
Sex: F
Vaccine: HEP
Symptoms: Anorexia, Bronchospasm, Incorrect dose administered, Influenza, Overdose
Clinical narrative: Information has been received from a pharmacist concerning a female with asthma and no drug allergies who on 09-AUG-2006 was vaccinated with a 40 mcg IM dose of Recombivax HB. There was no concomitant medication. A few days after vaccination the patient developed bronchospasm and flu symptoms. She also lost her appetite and had not been able to eat well ever since vaccination. It was reported that there were no other symptoms. It was reported that on 08-SEP-2006 the patient still continued to have problems from the overdose with Recombivax HB. The patient continued to have bronchospasms that did not resolve with medication (inhalers). She was referred to a respiratory specialist on 07-SEP-2006. At the time of the report the patient was recovering. There was no product quality complaint involved. Additional information has been requested.
Age: 45.0
Sex: M
Vaccine: HEP
Symptoms: Antibody test positive, Thrombocytopenia
Clinical narrative: Information has been received from a pharmacist concerning a male "between the ages of 40 and 50" with hypertension and a history of a myocardial infarction and no drug reactions/allergies who between 1989 and 1992 was vaccinated with the first, second, and third doses of hepatitis B virus vaccine or hepatitis B virus vaccine plasma-derived (the patient could not remember what vaccine he received). Concomitant therapy included hydrochlorothiazide. Subsequently the patient experienced thrombocytopenia and a positive core antibody. He did not have symptoms at the time of vaccination. Unspecified medical attention was sought. The outcome was reported as not recovered. No additional information was available. There was no product quality complaint. The pharmacist indicated that these events are possibly related to vaccination with hepatitis  virus vaccine rHBsAg (yeast) or hepatitis B virus vaccine plasma-derived. Additional information has been requested.
Age: 0.01
Sex: F
Vaccine: HEP
Symptoms: Rash, Urticaria
Clinical narrative: Information has been received from a physician concerning a 22 day old female with no medical history or allergies who on 05-SEP-2006 was vaccinated with a first "standard" dose via the "standard" route of Recombivax HB. There was no illness at the time of vaccination. There was no concomitant medication. On 6-SEP-2006 (previously reported as 25-SEP-2006) the patient developed a urticarial rash. The patient was treated with BENADRYL. No laboratory tests were performed. Subsequently on 28-SEP-2006 (previously reported as 30-SEP-2006), the patient recovered from urticaria and rash. There was no product quality complaint involved. No laboratory diagnostic tests were performed. The reporter stated that it was suggested Recombivax HB as possible etiology. Additional information is not expected.
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Tenderness
Clinical narrative: Information has been received from a registered nurse concerning a 36 year-old female employee with no allergies who on 29-AUG-2006 was vaccinated intramuscularly in the left deltoid with a 1.0 ml first dose of Recombivax HB. "A few days later", the patient experienced tenderness and soreness of the left elbow. The patient mentioned that she rides a bicycle long distance every day with significant weight-bearing on her arms. No medical attention was sought, no laboratory or diagnostic tests were performed. At the time of this report, the patient has not recovered. No product quality complaint was involved. No further information is available.
Age: 0.29
Sex: M
Vaccine: HEP, HIBV
Symptoms: Haematochezia
Clinical narrative: Information has been received from a physician concerning a 3 month old male with no medical history or allergies who was vaccinated with a first and second dose of Hib conj vaccine on 29-JUN-2006 and 13-OCT-2006 (lot # 652711/1191R). Suspect vaccination administered 13-OCT-2006 included a dose of ACTHIB. There was no illness at the time of vaccination. On 16-OCT-2006 at 9PM he developed blood in stool/diaper and daily since then. Medical attention was sought. A stool hematocrit test was positive. At the time of the report the patient had not recovered. The patient had no adverse events following prior vaccination. There was no product quality complaint involved. The patient's sibling (WAES#0610USA12053) experienced a similar reaction after vaccination with hepatitis B virus vaccine rHBsAg (yeast) (manufacturer unknown) and Hib conj vaccine (manufacturer unknown).
Sex: F
Vaccine: HEP
Symptoms: Body temperature increased, Pyrexia, Rash
Clinical narrative: Information has been received a nurse practitioner concerning an adult female who "several years ago" was vaccinated with a third dose of Recombivax HB (manufacturer unknown). Subsequently over a 48 hour period the patient developed a faint rash on her stomach and a low grade fever of 99 degrees F. The outcome was recovered. It was not know if medical attention was sought. There was no product quality complaint involved. Follow-up information indicated that additional details were not available.