chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective, Weight decreased
Clinical narrative: Information has been received from a RN concerning a 52 year old white non-smoking female pt with no known allergies, no chronic illness and no illness at time of vaccination who on 07/19/00 was vaccinated with a first dose of hepatitis B vaccine recombinant (yeast) in the left deltoid (Lot # 635178/0473K), a second dose on 08/23/00 in the left deltoid (Lot # 635178/0473K), a third dose on 01/26/01 in the right deltoid (Lot # 636021/0839K).  On 06/27/02, anti-hbs titer was negative.  A booster series was administered-first booster dose on 07/09/02 (Lot # 642096/0069M), a second booster dose on 09/10/02 in the left deltoid (Lot # 642096/0069M), and a third booster dose on 01/13/03 in the left deltoid (Lot # 644078/0940M).  On 06/27/02 and 02/18/03, the pt failed to respond to the vaccine (had not converted to immunity after 6 hepatitis B injections).  Concomitant therapy included hydrochlorothiazide (manufacturer unknown) indicated for fluid retention.  It was also noted that the pt developed a 100lb weight loss in the 3 years that she received injections and that her weight was 300lbs.  On 05/21/00 and on 05/05/02 her weight was 200lbs.  The outcome was unknown.  Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Nausea, Vomiting
Clinical narrative: Information has been received from a Doctor of Pharmacy concerning a female pt who was vaccinated with a dose of hepatitis B vaccine recombinant (yeast).  Concomitant therapy included levothyroxine Na (Levoxyl).  The pt developed "nausea and vomiting within one to two days of receipt".  It was reported that the pt stopped levthyroxine Na (Levoxyl) therapy at the time she received the vaccine.  Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: HEP
Symptoms: Abnormal behaviour, Psychomotor hyperactivity
Clinical narrative: Information has been received from a physician concerning a 5 year old male with allergic rhinitis who in August 2002, was vaccinated with the first dose of hepatitis B vaccine recombinant (yeast).  The pt was vaccinated with the second dose (Lot # 643683/0705M) in the left deltoid on 10/29/02.  there was no concomitant medication.  There was no illness at the time of vaccinations.  The physician reported that, according to the pt's parents, the pt subsequently developed behavioral changes after the first and second doses of the vaccine.  The pt was noted to be more hyperactive and had more temper tantrums.  During school, the pt would not pay attention to the teacher and would often pull the hair of his classmates.  Unspecified medical attention was sought.  On 05/14/03 it was reported that these symptoms are "much improved now".  No product quality complaint was noted.  No further information is expected.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Asthenia, Muscular weakness, Musculoskeletal stiffness, Pain
Clinical narrative: Information has been received from a RN concerning a 30 year old white female with allergies to codeine, aspartame, and bee stings, and history of three week duration of muscle stiffness and pain at age 21 following a tetanus toxoid vaccination, who on 2/12/03 at 16:00 pm was vaccinated by IM injection in her right deltoid with a first dose of hep B vaccine (641694/1534L). It was noted a few minutes later (also reported as immediately after injection at 1600), the pt began feeling a tingling sensation in the right arm that radiated down into her forearm and then into all five fingers. It was noted she also developed some weakness in the right hand and right arm which lasted six hours. It was reported that she was still able to hold a pen and write, but her strength was not the same in both hands. At the time of this report on 2/13/03, the reporter noted the pt still has some tingling in the arm, and "all of her joints ache." Follow up info from a RN noted that 12 hrs after the injection (04:00 02/13/03) the pt developed stiffness, ache in arms, and she reported all "joints ache." The reporter noted the pt's ache in her arms, and joint ache in her shoulders and wrists lasted six hours. The joint ache in the pt's hips resolved after eight hours, knees resolved after 11 hrs, and ankles resolved after 14 hrs. It was noted that no laboratory or diagnostic tests were performed, and the pt had no illness at the time of vaccination. It was reported the pt recovered. No additional info is expected.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Paraesthesia
Clinical narrative: Information has been received from a RN concerning a 30 year old white female with allergies to codeine, aspartame, and bee stings, and history of three week duration of muscle stiffness and pain at age 21 following a tetanus toxoid vaccination, who on 2/12/03 at 16:00 pm was vaccinated by IM injection in her right deltoid with a first dose of hep B vaccine (641694/1534L). It was noted a few minutes later (also reported as immediately after injection at 1600), the pt began feeling a tingling sensation in the right arm that radiated down into her forearm and then into all five fingers. It was noted she also developed some weakness in the right hand and right arm which lasted six hours. It was reported that she was still able to hold a pen and write, but her strength was not the same in both hands. At the time of this report on 2/13/03, the reporter noted the pt still has some tingling in the arm, and "all of her joints ache." Follow up info from a RN noted that 12 hrs after the injection (04:00 02/13/03) the pt developed stiffness, ache in arms, and she reported all "joints ache." The reporter noted the pt's ache in her arms, and joint ache in her shoulders and wrists lasted six hours. The joint ache in the pt's hips resolved after eight hours, knees resolved after 11 hrs, and ankles resolved after 14 hrs. It was noted that no laboratory or diagnostic tests were performed, and the pt had no illness at the time of vaccination. It was reported the pt recovered. No additional info is expected.
Age: 15.0
Sex: M
Vaccine: HEP
Symptoms: Blood bilirubin increased, Chills, Dysuria, Headache, Malaise
Clinical narrative: Information has been received from a consumer concerning a 5 year old male patient with a reaction to sulfa and no past medical history who in September 2002, was vaccinated with a dose of hepatitis B vaccine recombinant. There was no concomitant medication. Shortly after vaccination in approximately September 2002, the patient began to experience severe pain, bouts of sickness, headaches, chills, candidiasis, trouble with urination and his bilirubin level elevated. Unspecified medical attention was sought and the patient had CAT scans. As of 2/14/03, the patient was suffering from occasional GI pain, diarrhea, he continued to experience severe pain and he was gong to be taken to a hematologist. Due to the sicknessess, the patient was unable to participate in the basketball season. Upon internal review, severe pain was considered to be an other important medical event (OMIC). Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HEP
Symptoms: Pain
Clinical narrative: Information has been received from a consumer concerning a 5 year old male patient with a reaction to sulfa and no past medical history who in September 2002, was vaccinated with a dose of hepatitis B vaccine recombinant. There was no concomitant medication. Shortly after vaccination in approximately September 2002, the patient began to experience severe pain, bouts of sickness, headaches, chills, candidiasis, trouble with urination and his bilirubin level elevated. Unspecified medical attention was sought and the patient had CAT scans. As of 2/14/03, the patient was suffering from occasional GI pain, diarrhea, he continued to experience severe pain and he was gong to be taken to a hematologist. Due to the sicknessess, the patient was unable to participate in the basketball season. Upon internal review, severe pain was considered to be an other important medical event (OMIC). Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Face oedema, Flushing, Headache, Paraesthesia, Pruritus
Clinical narrative: Information has been received from a RN concerning a 45 year old female employee with no known drug allergies and no known food allergies who on 2/22/03 was vaccinated with a first dose of hep B vaccine (644388/1018M) SC in the right deltoid. Subsequently, thirty minutes later the pt developed itching on upper chest and both arms, light diffuse rash, lips tingling, face flushed, lips slightly swollen and a mild headache. The pt was treated with epinephrine (.4cc) SC, prednisone (60mg) po, and Benadryl (50mg) IM. The pt was not hospitalized. It was reported that the pt recovered. Additional info has been requested.
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Rash
Clinical narrative: Information has been received from a RN concerning a 45 year old female employee with no known drug allergies and no known food allergies who on 2/22/03 was vaccinated with a first dose of hep B vaccine (644388/1018M) SC in the right deltoid. Subsequently, thirty minutes later the pt developed itching on upper chest and both arms, light diffuse rash, lips tingling, face flushed, lips slightly swollen and a mild headache. The pt was treated with epinephrine (.4cc) SC, prednisone (60mg) po, and Benadryl (50mg) IM. The pt was not hospitalized. It was reported that the pt recovered. Additional info has been requested.
Age: 24.0
Sex: M
Vaccine: HEP
Symptoms: Dizziness, Nausea
Clinical narrative: Information has been received from a RN concerning a 24 year old male who was vaccinated with a second dose of hep B vaccine. Two hours after receiving the vaccine the pt reported being lightheaded and nauseated and had to go home from work. The pt responded to rest and Tylenol and returned back to work the next day. No medical attention was sought. Additional info has been requested.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Hot flush
Clinical narrative: Information has been received from a RN concerning a 22 year old female with no past medical history and no known drug allergies who on 3/4/03 at 10 am was vaccinated in the right deltoid with the second dose of hep B vaccine (644848/1060M). The pt was vaccinated with the first dose of hep B vaccine recombinant on 1/17/03. There were no concomitant medications. There was no illness at the time of vaccination. On 3/4/03 at 10 am, immediately after the vaccination, the pt developed an immediate reaction a reddened arm. The reporter indicated that she then felt flushed and hot. No other symptoms or complaints were noted. The physician indicated that she does not believe that this is an allergic reaction. There were no events following prior vaccinations, and there were no relevant diagnostic tests or lab data reported. Follow up info received from a RN indicated that on 3/4/03 the pt recovered. No further info is expected.
Age: 11.0
Sex: F
Vaccine: HEP
Symptoms: Oedema peripheral, Pain
Clinical narrative: Information has been received from a licensed practical nurse concerning an 11 year old female with eczema, reactive airway disease, mild mitral valve prolapse/ regurgitation, multiple food allergies: honeydew, Brazil nuts, lentils, chick peas (severe reaction-per mother), and subacute bacterial endocarditis. On 1/21/03 and on 3/3/03 the pt was vaccinated with a first and second dose of hep B vaccine (642923/0159M).There was no concomitant therapy or illness at the time of vaccination. On 3/4/03 the mother contacted the doctor's office to report that the pt's fingers had swollen slightly on the right hand and pt complained of pain. There were no markings at the injection site. There was no fever or other systemic symptoms. The physician recommended to try anti-inflammatories and call back in a few days. The physician "does not feel this was related to the hep B vaccine administration," but was reporting on the mother's request. It was noted that the pt "had no problems" after the first dose of hep B vaccine. Follow-up reported that on 3/5/03 the pt had "history of swelling of arm and shoulder." There were no relevant diagnostic tests or lab data. Additional info has been requested.
Age: 19.0
Sex: M
Vaccine: HEP
Symptoms: Pharyngitis
Clinical narrative: PHARYNGITIS. Information has been received on 05-MAR-2003 from a nurse practitioner concerning an 18 to 20 year old male in the recent past was vaccinated with hepatitis B vaccine recombinant (yeast) (1.0ml)(IM). The patient subsequently developed pharyngitis. The patient sought unspecified medical attention.
Sex: M
Vaccine: HEP
Symptoms: Dyskinesia, Muscular weakness
Clinical narrative: Information has been received from a RN concerning a male pt who is receiving dialysis who on 3/10/03 was vaccinated with a 40mcg dose of hep B vaccine (644028/1017M). On 3/12/03 hte pt presented for dialysis and complained of muscle "jerking" and weakness in the upper extremities, including the shoulders, neck and both arms. It was reported that these symptoms began on the 3/12/03. The condition worsens when the pt lifts his arms or tries to lift something. Unspecified medical attention was sought. Additional info has been requested.
Sex: F
Vaccine: HEP
Symptoms: Chills, Pyrexia, Vomiting
Clinical narrative: Information has been received from a RN concerning a female pt who on 4/19/02 and 5/31/02 was vaccinated with the first and second doses of hep B vaccine. On 4/20/02, the day after the first vaccination, the pt developed a fever, chills, and vomiting. It was reported that she went to her family doctor and the symptoms were treated as the flu. On 6/1/02, the day after the second vaccination, the pt developed the same symptoms and her fever was reported as being 101 deg. "The family doctor then said the pt should no longer" get the vaccine. Unspecified medical attention was sought. No further info is expected.
Age: 43.0
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Information has been received from a health professional concerning a 43 year old female pt who on an unknown date was vaccinated with a first dose of hep B vaccine. The reporter stated, the pt provided info that she "broke out in hives" after receiving the first dose of hep B vaccine. The reporter noted that the pt could not remember when she received the vaccination. The reporter noted it was unknown whether a prescription drug was required. Unspecified medial attention was sought. Additional info has been requested.
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Hyperhidrosis, Migraine, Musculoskeletal stiffness, Sinusitis
Clinical narrative: Information has been received from a RN concerning a 39 year old female with no known allergies and no relevant medical history who on 3/27/03 was vaccinated at 13:00 IM in the left deltoid with a first dose of hep B vaccine (643395/0429M).There was no illness at the time of vaccination. On 3/27/03, within a few hours after vaccination, the pt developed a severe headache described as pain on the right side of her head that started at 15:00 and "continued through the night into the next morning and afternoon," stiff neck and sweating of the entire body. There was no relevant diagnostic lab data. On 3/8/03, the pt was seen in the ER and was diagnosed with possible sinus infection vs. migraine. The pt was treated with Keflex and a cough medicine. By 3/29/03, the conditions had resolved. It was noted that the pt forgot to tell the ER that she had received the vaccine. It was reported that the pt "was advised by her private physician not receive any more doses of hep B." Prescription drug treatment was required. No further info is expected.
Age: 0.25
Sex: M
Vaccine: HEP
Symptoms: Rash, Rash papular
Clinical narrative: Information has been received from a RN concerning a 12 week old male pt who on 3/5/03 was vaccinated with a dose of hep B vaccine (643641/0894M). "Three days ago," on 3/30/03, the child developed a "papular, acrodermatitis rash," on the extensor surface of the legs and arms and presented to the office on 4/2/03. Unspecified medical attention was sought.
Age: 14.0
Sex: U
Vaccine: HEP
Symptoms: Anaphylactoid reaction, Dizziness, Dry mouth, Hypersensitivity, Pyrexia
Clinical narrative: Information has been received from a RN concerning a 14 year old pt who was vaccinated with a dose of hep B virus vaccine. Subsequently, the pt developed an allergic type reaction that included a fever 2 to 3 hrs after vaccination and lasted 24 hrs. The pt also developed dizziness, dry mouth, and a swollen tongue. It was reported on 4/3/03 that "presently" the pt was "fine," however,  the doctor was concerned with the tongue swelling and wanted to see how to possibly prevent a future anaphylactoid reaction. Unspecified medical attention was sought. On 4/15/03, it was reported that the pt was not vaccinated at this allergist's office but at a pediatrician's office. No further info is expected.
Age: 14.0
Sex: U
Vaccine: HEP
Symptoms: Tongue oedema
Clinical narrative: Information has been received from a RN concerning a 14 year old pt who was vaccinated with a dose of hep B virus vaccine. Subsequently, the pt developed an allergic type reaction that included a fever 2 to 3 hrs after vaccination and lasted 24 hrs. The pt also developed dizziness, dry mouth, and a swollen tongue. It was reported on 4/3/03 that "presently" the pt was "fine," however,  the doctor was concerned with the tongue swelling and wanted to see how to possibly prevent a future anaphylactoid reaction. Unspecified medical attention was sought. On 4/15/03, it was reported that the pt was not vaccinated at this allergist's office but at a pediatrician's office. No further info is expected.
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Musculoskeletal stiffness, Nausea, Pyrexia, Swelling
Clinical narrative: Information has been received from a RN concerning a 44 year old female with no known allergies and no relevant medical history who on 3/27/03 was vaccinated at 13:00 in the left deltoid with an IM first dose of hep B vaccine (643395/0429M). There was no illness at the time of vaccination. On 3/27/03, within a few hours after vaccination, the pt developed a severe headache, stiff neck ("I could bearly hold my head up"), sweating of the entire body, nausea, vomiting and fever. There was no relevant diagnostic lab data. The pt was seen in ER on 3/27/03 and was released the same day. it was reported that the pt recovered. It was also noted the pt forgot to tell the ER that she received the vaccine and treatment info was not available at this time. Prescription drug treatment was required. No further info is expected.
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Vomiting
Clinical narrative: Information has been received from a RN concerning a 44 year old female with no known allergies and no relevant medical history who on 3/27/03 was vaccinated at 13:00 in the left deltoid with an IM first dose of hep B vaccine (643395/0429M). There was no illness at the time of vaccination. On 3/27/03, within a few hours after vaccination, the pt developed a severe headache, stiff neck ("I could bearly hold my head up"), sweating of the entire body, nausea, vomiting and fever. There was no relevant diagnostic lab data. The pt was seen in ER on 3/27/03 and was released the same day. it was reported that the pt recovered. It was also noted the pt forgot to tell the ER that she received the vaccine and treatment info was not available at this time. Prescription drug treatment was required. No further info is expected.
Age: 49.0
Sex: F
Vaccine: HEP
Symptoms: Acne, Arthralgia, Hypoaesthesia, Pyrexia
Clinical narrative: Information has been received from a RN concerning a 49 year old obese female with dyslipidemia who on approximately 3/9/03, "a little over a month ago," was vaccinated with a dose of hep B vaccine. There was no concomitant medication. On approximately 3/14/03, in the weeks after the vaccination, the pt developed a fever, joint aches (especially in her shoulders and knees), pimples on her face, and a numb forehead. Unspecified medical attention was sought. Additional info has been requested.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Pyrexia, Rash
Clinical narrative: Information has been received from a pharmacist concerning a 26 year old female who in August 2002 was vaccinated with a first dose of hep B virus vaccine. Within 24 hrs of receiving the vaccination, the client developed a "rash, joint pain, arthralgia, fever." The reporter indicated that the client received the second dose of hep B virus vaccine one month later and did not develop any apparent side effects. Unspecified medical attention was sought. Additional info has been requested.
Age: 16.0
Sex: F
Vaccine: HEP
Symptoms: Rash
Clinical narrative: Information has been received from a health professional concerning a 16 year old female pt who in November 2002, was vaccinated with a dose of hep B virus vaccine (642248/0003M) and was subsequently vaccinated again in November 2002 with a dose of hep B virus vaccine (8388M). Several weeks later in approximately December 2002, the pt "broke out" with a rash. Unspecified medical attention was sought. Additional info has been requested.
Sex: F
Vaccine: HEP
Symptoms: Liver function test abnormal
Clinical narrative: Information has been received from a female RN who in September 2002 and October 2002 was vaccinated with the first and second dose of hep B virus vaccine. The reporter indicated the after the second dose, slightly elevated LFT's were noted in her lab work. No prescription drug was required. Unspecified medical attention was sought. Additional info has been requested.
Age: 35.0
Sex: U
Vaccine: HEP
Symptoms: Platelet count decreased, Thrombocytopenia
Clinical narrative: Information has been received from a physician concerning a 35 year old pt who was vaccinated with a dose of hep B virus vaccine. The reporter indicated that the pt may have developed a thrombocytopenia and noted that "the pt's platelet count of one year ago was approximately 160K while this year was a few thousand below our lab's normal of 150K." It was noted that the pt is otherwise unremarkable. Unspecified medical attention. Additional info has been requested.
Age: 34.0
Sex: M
Vaccine: HEP
Symptoms: Ageusia, Dysgeusia
Clinical narrative: Dysgeusia; Aguesia, Ageusia; Dysgeusia. Information has been received from a registered nurse concerning a 34 year old white male with no allergies or medical conditions who in the a.m. of 26-FEB-2003 was vaccinated IM in the left deltoid with a first dose of hepatitis B virus vaccine rHBsAg (yeast) (lot #644199/0835M). After the first dose of vaccine, the patient noted a "metal" taste and could not taste food as long as the metallic taste was present. It persisted for four to five days. On 26-MAR-2003 at 9:00 a.m. the patient was vaccinated IM in the right deltoid with a second dose of hepatitis B virus vaccine rHBsAg (yeast) (lot # 644099/0835M). There was no illness at the time of vaccination. The reporter indicated that on 26-MAR-2003 at 9:00 p.m., about 12 hours after the vaccine was given, the patient noted a "metal" taste and could not taste food as long as the metallic taste was present. Unspecified medical attention was sought. There was no diagnostic tests or laboratory results available. No further information is expected.
Age: 6.0
Sex: F
Vaccine: HEP
Symptoms: Decreased appetite, Fatigue, Hypersensitivity, Insomnia, Malaise
Clinical narrative: Rash NOS; Appetite Decreased NOS; Fatigue; Hypersensitivity NOS; Insomnia; Malaise. Information has been received from the mother of a 6 year old female with no known allergies who on 31-MAR-2003 was vaccinated with a third dose of hepatitis B virus vaccine rHBsAg (yeast) (lot #643169/0355M). On 31-MAR-2003, within 24 hours of the vaccination, the child developed malaise, fatigue, diminished appetite and a white rash on her tummy and the back of her shoulders The mother stated that the child frequently wakes up at night and is not sleeping well. She stated that some symptoms resolved somewhat, but that the rash remained Medical attention was sought and the mother stated that the child's doctor told her that her daughter had an allergic reaciton to the vaccine and that oral diphenhydramine hydrochloride (BENADRYL) could be given for treatment, but the mother said it was not needed. It was also reported that on 20-SEP-2002 and 24-JAN-2003, the child was vaccinated with a first and second dose of hepatitis B vaccine recombant (ENGERIX-B) (lot # ENG5353B2 and #ENG5368A2) respectively. On 02-JUN-2003 the patient's father reported that his daughter still had not fully recovered from her adverse experience. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: HEP
Symptoms: Rash
Clinical narrative: Rash NOS; Appetite Decreased NOS; Fatigue; Hypersensitivity NOS; Insomnia; Malaise. Information has been received from the mother of a 6 year old female with no known allergies who on 31-MAR-2003 was vaccinated with a third dose of hepatitis B virus vaccine rHBsAg (yeast) (lot #643169/0355M). On 31-MAR-2003, within 24 hours of the vaccination, the child developed malaise, fatigue, diminished appetite and a white rash on her tummy and the back of her shoulders The mother stated that the child frequently wakes up at night and is not sleeping well. She stated that some symptoms resolved somewhat, but that the rash remained Medical attention was sought and the mother stated that the child's doctor told her that her daughter had an allergic reaciton to the vaccine and that oral diphenhydramine hydrochloride (BENADRYL) could be given for treatment, but the mother said it was not needed. It was also reported that on 20-SEP-2002 and 24-JAN-2003, the child was vaccinated with a first and second dose of hepatitis B vaccine recombant (ENGERIX-B) (lot # ENG5353B2 and #ENG5368A2) respectively. On 02-JUN-2003 the patient's father reported that his daughter still had not fully recovered from her adverse experience. Additional information has been requested.
Sex: U
Vaccine: HEP, MMR
Symptoms: Headache, Photosensitivity reaction
Clinical narrative: HEACHE; PHOTOSENSITIVITY REACTION NOS. Information has been received concerning a patient who was vaccinated with a dose of hepatitis B virus vaccine rHBsAg (yeast). Concomitant therapy that day included a dose of measles-mumps-rubella vaccine (MSD). Subsequently, the patient developed a headache and light sensitivity. Unspecified medical attention was sought. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Back pain, Discomfort, Pain
Clinical narrative: LIMB DISCOMFORT NOS; ARTHRALGIA; BACK PAIN. Information has been received from a registered nurse concerning a 36 year old female CMA employee with no medical history and no allergies who on 23-APR-2003 at a nursing home was vaccinated intramuscularly in the left arm with a second dose of hepatitis B virus vaccine rHBsAg (yeast) (lot #15360). There was no illness at the time of vaccination. On the afternoon of 25-APR-2003 the patient developed achiness in the knees, back and arm. Unspecified medical attention was sought. On 28-APR-2003, the patient recovered. It was reported on 13-JUN-2003 that the employee has since quit the nursing home. No product quality complaint was involved. No further information is expected.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Rash pruritic
Clinical narrative: RASH PRURITIC. Information has been received from a registered nurse concerning a 34-year old white female with no allergies or medical history who on 26-SEP-1988 (also reported as 27-SEP-1998) was vaccinated with a second dose of hepatitis B virus vaccine rHBsAg (yeast) (lot # 2044N) (reported as a multidose vial). There was no illness at the time of vaccination. On 26-AUG-1998 (also reported as 26-AUG-1998) the patient was vaccinated with a first dose of hepatitis B virus vaccine rHBsAg (yeast) (lot #2044N). On 27-SEP-1988, about seven hours following the second vaccination, the patient experienced a sunburn-like rash that was itchy. It was noted that a third dose of hepatitis B virus vaccine rHBsAg (yeast) was never administered. Unspecified medical attention was sought. The patient subsequently recovered on 27-SEP-1988. A product quality complaint was not involved. No further information is expected.
Sex: M
Vaccine: HEP, HEPA
Symptoms: Body temperature increased, Cough, Drug level increased, Drug toxicity, Headache
Clinical narrative: DRUG SCREEN POSITIVE; INFLUENZA LIKE ILLNESS; HEADACHE; BODY TEMPERATURE INCREASED; PRODUCTIVE COUGH. Information has been received from an incarcerated male consumer with hepatitis C since approximately 1982 and who does not smoke, drink, "do drugs" or eat pork who was vaccinated with a dose of hepatitis B virus vaccine rHBsAg (yeast) (manufacturer unknown) and a dose of hepatitis A virus vaccine inactivated (manufacturer unknown). Subsequently, the consumer reported that he "keeps testing positive for marijuana and that he didn't test positive until he was vaccinated for Hepatitis A and B". The consumer questioned if here was anything in the vaccine that could give him a "cross-reaction". He also reported that he had flu-like symptoms, a high fever and was coughing up phlegm that looked like "gossamer". He reported that he gets headaches but "before" he didn't. The consumer noted that he had never been sick until the vaccination. Additional information has been requested.
Sex: M
Vaccine: HEP, HEPA
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: DRUG SCREEN POSITIVE; INFLUENZA LIKE ILLNESS; HEADACHE; BODY TEMPERATURE INCREASED; PRODUCTIVE COUGH. Information has been received from an incarcerated male consumer with hepatitis C since approximately 1982 and who does not smoke, drink, "do drugs" or eat pork who was vaccinated with a dose of hepatitis B virus vaccine rHBsAg (yeast) (manufacturer unknown) and a dose of hepatitis A virus vaccine inactivated (manufacturer unknown). Subsequently, the consumer reported that he "keeps testing positive for marijuana and that he didn't test positive until he was vaccinated for Hepatitis A and B". The consumer questioned if here was anything in the vaccine that could give him a "cross-reaction". He also reported that he had flu-like symptoms, a high fever and was coughing up phlegm that looked like "gossamer". He reported that he gets headaches but "before" he didn't. The consumer noted that he had never been sick until the vaccination. Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective, Leukopenia
Clinical narrative: ANTI-HBS ANTIBODY NEGATIVE; WHITE BLOOD CELL COUNT DECREASED. Information has been received from a registered nurse concerning a 42 year old white female non smoker with no known allergies who on 05-NOV-1998, 08-DEC-1998, 07-JUN-1999 and 13-MAY-2003 at 09:00 was vaccinated intramuscularly in the left arm with a first, second, third and a fourth booster dose of hepatitis B virus vaccne rHBsAg (yeast), (lot number 624329/1225E and 623395/0429M), respectively. There was no illness at the time of vaccination. In May, 2003, "routine labwork" revealed the patient had a negative titer, also reported as "no immune titer" and a "low WBC count". Additional information is requested.
Age: 14.0
Sex: M
Vaccine: HEP
Symptoms: Dizziness, Headache, Hypokinesia, Neck pain, Pain
Clinical narrative: HEADACHE; DIZZINESS; PYREXIA; NECK PAIN; MOBILITY DECREASED; PAIN NOS. Information has been received from a registered nurse and a physician concerning a 14 year old male student with a history of Lyme disease (1998 currently resolved) who on 08-jan-2003 at 15:00 was vaccinated in the left deltoid with a first dose of hepatitis B virus vaccine rHBsAg (yeast) (lot # 643757/0781M). There was no illness at the time of vaccination and there were no adverse events following prior vaccinations. On 11-Jan-2003, the patient developed a severe headache, severe neck pain, body aches, a fever to 103 F dizziness and he "couldn't get out of bed". No local reaction was noted and the "arm site was fine". The patient sought medical attention and was treated with acetaminophen (TYLENOL) or ibuprofen (ADVIL). It was noted that the patient was not brought into the office. No other laboratory tests were performed. The symptoms lasted approximately 3 days. Subsequently, the symptoms resolved and the patient recovered. It was noted that a product quality complaint was not involved.
Age: 14.0
Sex: M
Vaccine: HEP
Symptoms: Pyrexia
Clinical narrative: HEADACHE; DIZZINESS; PYREXIA; NECK PAIN; MOBILITY DECREASED; PAIN NOS. Information has been received from a registered nurse and a physician concerning a 14 year old male student with a history of Lyme disease (1998 currently resolved) who on 08-jan-2003 at 15:00 was vaccinated in the left deltoid with a first dose of hepatitis B virus vaccine rHBsAg (yeast) (lot # 643757/0781M). There was no illness at the time of vaccination and there were no adverse events following prior vaccinations. On 11-Jan-2003, the patient developed a severe headache, severe neck pain, body aches, a fever to 103 F dizziness and he "couldn't get out of bed". No local reaction was noted and the "arm site was fine". The patient sought medical attention and was treated with acetaminophen (TYLENOL) or ibuprofen (ADVIL). It was noted that the patient was not brought into the office. No other laboratory tests were performed. The symptoms lasted approximately 3 days. Subsequently, the symptoms resolved and the patient recovered. It was noted that a product quality complaint was not involved.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Hypoaesthesia
Clinical narrative: HYPOAESTHESIA; DIZZINESS. Information has been receiving from a physician concerning a 30 year-old white female patient with "no history of previous drug reactions" who on 07-Apr-2003 and 07-MAY-2003 was vaccinated with a first and second dose of hepatitis B virus vaccine rHBsAg (yeast) intramuscularly in the right deltoid with 1 ml (lot number 642096/0069M), respectively. There was no concomitant therapy. On 07-May-2003, "within a couple of minutes", also reported as "around 10 minutes after vaccination", the patient developed "numbness in her opposing arm", (the left arm) with a duration of 2 hours. It was noted that "observation was done at first but with failure to improve' and the patient began with "lightheadedness" with a duration of 15 minutes. It was also noted that there was no previous history of similar problems, "BP, pulse and respirations remained constant, she had full range of motion in the arms and digits, her reflexes were intact and symmetrical, and she was able to distinguish "sensation sharp" but no light touch sensations. The patient received 50 mg of dipehnhydramine HCL (Benadryl) IM and symptoms resolved within 30 minutes (also reported as 1 hour later) and she was discharged. There were no prescription drug treatments required. Medical attention was sought. On 07-May-2003, the patient recovered and on the "following day she was doing well without residual complaints".
Sex: U
Vaccine: HEP
Symptoms: Injection site mass, Injection site reaction, Pruritus
Clinical narrative: INJECTION SITE MASS; INJECTION SITE PRURITUS. Information has been received from a registered nurse concerning a patient who on 15-May-2003 was vaccinated with a dose of hepatitis B virus vaccine rHBsAg (yeast )(lot # 643165/0217M). Subsequently the patient developed a 'welt', about the size of a 50 cent piece, raised and itching". The patient sought unspecified medical attention. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Erythema, Nausea, Oedema peripheral, Pain
Clinical narrative: PAIN IN EXTREMITY; DIZZINESS; ERYTHEMA; OEDEMA PERIPHERAL; SKIN WARM; NAUSEA. Information has been received from a registered nurse concerning a 23 year old Caucasian female patient who on 13-May-2003 at 10:00 AM was vaccinated with a first dose of hepatitis B virus vaccine rHBsAg (yeast) (lot # 643165/0217M), in the left deltoid. On that same day, the patient received a TB test in the opposite arm. On 19-may-2003 at 4:00 PM the patient complained of "pain in arm while trying to turn on light." The patient developed "a band of redness encircling her arm and her arm hurts so much that she cannot raise the arm." There was also swelling noted below deltoid area left inner arm. The patient also reportedly had "red warm area 2 in. wide by 4 in. long." The patient also complained of nausea and was lightheaded. The patient sought unspecified medical attention. It was reported that the "symptoms were gone a week later." The patient recovered on 27-may-2003. It was also noted that the patient received a second dose of hepatitis b virus vaccine rHBsAg (yeast) on 20-Jun-2003 with "no adverse effects." It was also reported that another patient had similar symptoms (WAES0305USA02041). Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Skin warm
Clinical narrative: PAIN IN EXTREMITY; DIZZINESS; ERYTHEMA; OEDEMA PERIPHERAL; SKIN WARM; NAUSEA. Information has been received from a registered nurse concerning a 23 year old Caucasian female patient who on 13-May-2003 at 10:00 AM was vaccinated with a first dose of hepatitis B virus vaccine rHBsAg (yeast) (lot # 643165/0217M), in the left deltoid. On that same day, the patient received a TB test in the opposite arm. On 19-may-2003 at 4:00 PM the patient complained of "pain in arm while trying to turn on light." The patient developed "a band of redness encircling her arm and her arm hurts so much that she cannot raise the arm." There was also swelling noted below deltoid area left inner arm. The patient also reportedly had "red warm area 2 in. wide by 4 in. long." The patient also complained of nausea and was lightheaded. The patient sought unspecified medical attention. It was reported that the "symptoms were gone a week later." The patient recovered on 27-may-2003. It was also noted that the patient received a second dose of hepatitis b virus vaccine rHBsAg (yeast) on 20-Jun-2003 with "no adverse effects." It was also reported that another patient had similar symptoms (WAES0305USA02041). Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Oedema peripheral
Clinical narrative: OEDEMA PERIPHERAL. Information has been received on 19-may-2003 from a licensed practical nurse concerning a male dialysis patient who was vaccinated with a first dose of hepatitis b virus vaccine rHBsAg (yeast). Subsequently the patient's "arm became swollen." It was noted that "no further injections were administered to the patient." The patient sought unspecified medical attention.
Age: 15.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Fibromyalgia, Muscular weakness, Neck pain
Clinical narrative: Information has bee received from a registered nurse and a physician concerning a 15 year old female with no yeast allergy who in February 2003 was vaccinated with a second dose of hepatitis B virus vaccine. The reporter indicated that about a week to two weeks later the patient complained of muscle weakness, arthralgia, and pain in and around her neck area. It was noted that these events have been weaning and waning since that time. The patient visited an emergency room and a rheumatologist and the tests were negative. The reporter stated that the rheumatologist thought that the patient was experiencing fibromyalgia. The patient also saw an allergist ad it was determined that she was not allergic to yeast. The patient has not been going to school recently because of the pain. It was indicated that a prescription drug was required to treat the event. The event has not abated and the patient has not recovered. The reporter noted that it was unknown if the patient was pregnant. Muscle weakness, arthralgia and pain in and around the neck area were considered disabling. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus
Clinical narrative: PRURITUS. Information has been received from a registered nurse concerning a 13 year old female with an unknown medical history who on 20-MAY-2003 was vaccinated with a first dose of hepatitis B virus vaccine rHBsAg (yeast). It was unknown if the patient was on concomitant medication. It was reported that at the time of vaccination the patient also "got a sunburn earlier in the week so the child already had redness". On 22-may-2003 the patient developed pruritus on her face. There was no rash or peeling. It was unknown if diagnostic studies were performed. Unspecified medical attention was sought. No additional patient information was provided. No product quality complaint was noted. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Pruritus
Clinical narrative: PRURITIS. Information has been received from a registered nurse concerning a female with a history of seasonal allergies who on 07-APR-2003 was vaccinated with hepatitis B virus vaccine rHBsAg (yeast) (0.5ml) (IM). Concomitant therapy included antihistamines. Subsequently, the patient "had itching with no rash the following day." The patient sought unspecified medical attention. Additional information has been requested.
Age: 86.0
Sex: F
Vaccine: HEP
Symptoms: Chills, Flushing, Hypotension, Medication error, Pyrexia
Clinical narrative: Information has been received from a pharmacist concerning an 86 year old female on outpatient hemodialysis who on 5/27/03 was inadvertently vaccinated IV instead of IM with a dose of hepatitis B virus vaccine. On 5/27/03 the patient developed hypotension, chills, fever, and flushing. On 5/27/03 it was reported that the patient was stabilized at the dialysis unit and that the physician recommended that the patient go to the emergency room. It was also noted that the patient might be admitted. On 5/30/03 the pharmacist reported that she did not have any further information on this patient. She noted that the patient was not at her facility but that she was at another outpatient facility. She reported that she did not know if the patient was admitted to the hospital but did know that the patient did not want to go to the hospital because she reported to the doctor that she felt fine. Upon internal review, hypotension was determined to be an other important medical event (OMIC). No further information is available.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pain, Joint range of motion decreased, Pain
Clinical narrative: INJECTION SITE PAIN; PAIN IN EXTREMITY. Information has been received on 29-may-2003 from a nurse practitioner concerning a 35 year old female who vaccinated 4 weeks prior with a third dose of hepatitis b virus vaccine rHBsAg (yeast) (lot# 643395/0429M). On 29-may-2003 the patient called the physician's office to ask why her arm still hurt at the site of her shot. The patient reported no swelling, redness, itchiness or any other symptoms but that she was sore on range of motion. Unspecified medical attention was sought and no treatment was required. At the time of report, 29-may -2003, the patient had not recovered. No product quality complaint was involved.
Age: 64.0
Sex: F
Vaccine: HEP
Symptoms: Drug ineffective, Hepatitis, Laboratory test abnormal
Clinical narrative: HEPATITIS B SURFACE ANTIGEN POSITIVE. Information has been received from a registered nurse concerning a 64 year old female dialysis patient with a complicated medical history who on 19-may-2003 was vaccinated with a second dose of hepatitis B virus vaccine rHBsAg (yeast) 40 mcg. On 21-may-2003, a lab test was drawn and revealed the patient was "hepatitis surface antigen positive, HBsAG". It was noted that the nurse did not know if the patient was core positive, and that she did not think the test was done for core". It was also noted that no treatment was required. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Liver function test abnormal
Clinical narrative: ANTI-HBS ANTIBODY NEGATIVE; LIVER FUNCTION TEST ABNORMAL. Information has been received from a nurse and nurse practitioner concerning a 23 year old female patient with no past medical history except for the flu in 2002, who on 13DEC2001 was vaccinated with a third dose of hepatitis b  virus vaccine rHBsAg (yeast) (Lot# 640830/1067L). It was noted that she had received a first dose of hepatitis b virus vaccine rHBsAg (yeast) (Lot #631558/1188K) on 13JUN2001, and a second dose (Lot 631558/1188K) on 11JUL2001. On 12JUL2002, reported as one year later, the patient had titers done as a condition of employment. It was noted the patient had a negative titer. Her hepatitis b surface antibody result was "3", and the nurse reported that "10" equaled immunity. The nurse practitioner reported he patient was then given two more doses of "another company's" hepatitis vaccine. Additional information received from a different nurse also reported the patient was given two additional doses, however indicated the two doses were hepatitis b virus vaccine rHBsAg (yeast); one dose was administered on 30-OCT-2002 (lot #ENG 5366 A2) and another was administered on 29NOV2002 (lot #ENG5366 A2). The nurse laboratory values were reported. It was noted the patient was due for a third dose and she had called the physician office to ask if it was OK to receive the third dose with elevated liver enzymes. The nurse noted the patient had been due for the third dose on 30APR2003. The nurse reported there was no additional information regarding the patient at this time, as she was being seen by her primary care provider. There was no product quality complaint involved.
Sex: M
Vaccine: HEP
Symptoms: Laboratory test abnormal
Clinical narrative: DRUG SCREEN POSITIVE. Information has received from a paralegal concerning her male coworker who was vaccinated with a dose of hepatitis b virus vaccine rHBsAg (yeast). Subsequently the patient tested positive for marijuana in a urine test. The reporter indicated that her client denies using marijuana, and "said that it may be a false positive because he recently received" a dose of hepatitis b virus vaccine rHBsAg (yeast). No medical attention was sought. There was no product quality complaint. No further information is expected.
Age: 32.0
Sex: M
Vaccine: HEP
Symptoms: Influenza like illness, Nausea, Vomiting
Clinical narrative: VOMITING NOS; INFLUENZA LIKE ILLNESS; NAUSEA. Information has been received from a registered nurse concerning a 32 year old white male a history of a rash from penicillin and no other listed past medical history or known drug allergies who on 13-JUN-2003 at 09:00 Am was vaccinated IM in the right deltoid with a first 0.5ml dose of hepatitis b virus vaccine rHBsAg (yeast) (Lot #:644384/ D986M). There was no listed illness at the time of the vaccination. Concomitant therapy included venlafaxine HCl (EFFEXOR). On 13JUN2003, a few hours after vaccination, the patient developed nausea and vomiting and "had to leave work". The reporter indicated that several other people were vaccinated with a dose of hepatitis b virus vaccine rHBsAg (yeast) (lot # 644384/0986M) and "they did not report any problems". No lab diagnostics studies were performed. Unspecified medical attention was sought. There was no product quality complaint. There were no relevant diagnostic tests or laboratory data reported. Follow up information indicated that the patient received the vaccination per employer requirement. Approximately 2 hours after injection, on 13JUN03 at "9AM" the patient complained of nausea and vomiting. The patient was excused from work and he did not seek further medical treatment. The patient reported that the next day he felt he had the "flu", as other members of his family had been ill with signs and symptoms of the flue. The patient has since received the second doe of the vaccination without any adverse reaction. The outcome was reported as recovered. No further information is expected.