chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.02
Sex: F
Vaccine: HEP
Symptoms: Cyanosis
Clinical narrative: CYANOSIS NOS. Information has been received from a pharmacist concerning a 6 or 7 day old female who on approximately 12JUN2003 was vaccinated with a dose of hepatitis b virus vaccine rHBsAg (yeast) (Lot #643366/C054N). Subsequently the patient is having episodes of cyanosis. The reporter indicated that "the doctors are trying to rule out GERD or GI Reflux Disease but are not sure if there is a link" to the vaccine. Date of administration, current medications and other patient information was not available at the time of the report. Unspecified medical attention was sought. the outcome was reported as not recovered. There was no product quality complaint. Follow up information indicated that no other information is available. No further information is expected.
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Hypokinesia, Injection site pain
Clinical narrative: INJECTION SITE PAIN; MOBILITY DECREASED. This report was received from GlaxoSmithKline for hepatitis B vaccine recombinant (ENGERIX-B) and was assigned manufacturer report number A0392993A. This was originally report by a physician's assistant concerning a 29-year old female who in October 2001, was vaccinated with the second dose of hepatitis b virus vaccine rHBsAg (yeast). Subsequently the patient experienced "mild", persistent, left arm pain. The pain was exacerbated by palpation and "specific movement of the arm." Concurrent conditions and current medications were unknown. In May 2002, the patient received the third dose of hepatitis b vaccine recombinant (ENGERIX-B) (lot #ENG5216A2) administered into the left deltoid. Subsequently, the patient experienced increased pain at the injection site. The patient was seen in the clinic. The pain was not located in the shoulder joint and the subject had full range of motion. However, the patient reported difficulty reaching into the back seat of her car. The pain persisted as of 14APR2003. The reporter considered the injection site pain to be possibly related to "scar tissue from injection". No further information is expected.
Sex: F
Vaccine: HEP
Symptoms: Photosensitivity reaction
Clinical narrative: PHOTOSENSITIVE RASH. Information has been received from a registered nurse (RN) concerning a female who was vaccinated with hepatitis B virus vaccine rHBsAg (yeast). The RN reported that 48 to 72 hours after being vaccinated the patient developed a sun rash. It was unknown if medical attention was sought. At the time of this report, the outcome was unknown. Additional information has been requested.
Age: 35.0
Sex: M
Vaccine: HEP
Symptoms: Laboratory test abnormal, Liver function test abnormal
Clinical narrative: LIVER FUNCTION TEST ABNORMAL; ASPARTATE AMINOTRANSFERASE INCREASED. Information has been received from a dentist concerning himself, a 35 year old male with an allergy to penicillin, and no other medical history who in 1987, was vaccinated with an initial three dose series of hepatitis b  virus vaccine rHBsAg (yeast)(lot numbers not available). Concomitant therapy included atenolol (TENORMIN) (dates, dose, indication not reported). He reported that when he had the initial three dose series of hepatitis b virus vaccine rHBsAg (yeast) in 1987, he experienced an elevation in liver enzymes, which eventually returned to normal. He also mentioned that he received a booster dose of hepatitis b virus vaccine rHBsAg (yeast) in February 2003. Subsequently, three months later (approximately May 2003), after the booster dose a routine screening was conductd and he was found to have an elevated aspartate aminotransferase (AST). His AST was 54 (normal 0-40). There was no additional information provided. Unspecified medical attention was sought. Additional information has been requested.
Age: 42.0
Sex: M
Vaccine: HEP
Symptoms: Oedema, Urticaria
Clinical narrative: URTICARIA NOS; URTICARIA NOS; OEDEMA NOS; URTICARIA NOS. Information has been received from a registered nurse concerning a 42 year old white male with no past medical history and no known drug allergies who on 13JAN2003 in the PM was vaccinated IM in the left deltoid with the first dose of hepatitis B virus vaccine rHBsAg (Yeast)(lot # 644388/1038M). Ps: 11-FEB-2003 in the PM (lot #644388/1018M) given IM in the left deltoid; P3:09JUL2003 at 1:50PM (lot #643543/0233N) given in the left deltoid. There was no illness at the time of vaccination. After each vaccine in the series, the patient broke out in hives a few days after the vaccine. After the first and second doses of he vaccine, the reporter indicated that the doctor said the hives were "probably not" related to the vaccine. The hive resolved after a few days and the patient took fexofenadine hydrochloride (ALLEGRA) during the day and diphenhydramine hydrochloride (BENADRYL) at night. After the third dose on 09-JUL-2003, the hives came only 2 days after the vaccine on 11-JUL-2003. At the time of the report, on 14JUL2003, the patient had hives and was being treated with fexofenadine hydrochloride (ALLEGRA) and diphenhydramine hydrochloride (BENADRYL). No further details were given. The outcome was reported as not recovered. There was no product quality complaint No laboratory data or diagnostic tests were reported. Follow-up information indicated that the adverse experience onset was on 13JAN2003. Three days after vaccination, the patient returned to the office with a mild rash on the upper extremeties that changed locations from right to left during the day. This lasted approximately 3 days. After the second vaccination, the patient had a mild rash of the upper expremities with +1edema. He went to his personal doctor and was given an antihistamine. This lasted approximately 4 to 5 days. In both instances, the reaction to the vaccination was not suspected. After the third vaccination, a rash appeared on the upper extremeties and between his fingers and toes and at his armpits. The patient recovered  approximately 3-7 days after each vaccination.
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Chills, Depression, Hyperhidrosis, Influenza like illness
Clinical narrative: Information has been received from manufacturer for hep B virus vaccine. This was originally reported by a RN concerning a 41 year old female with no past medical history and no known drug allergies who on 4/18/03 was vaccinated in the right arm with a first 20mcg dose of hep B virus vaccine (645173/1210M). Prior vaccination included the first series of hep B virus vaccine completed in 1995. The pt did not have antibodies when tested later so they decided to give another series. Concomitant therapy included Xanaflex, amitriptyline hydrochloride and a dose of tetanus toxoid administered on 4/9/03. On 4/19/03, the day after vaccination, the pt reportably began experiencing flu-like symptoms, described as general malaise, profuse sweating and chills, and joint pain. The pt also developed a rash on an unknown date that lasted about a week. The pt noted that the symptoms (other than the rash) lasted the whole month and were present on 5/21/03, when she received her fifth dose of the second series of hep B virus vaccine (637001/1032K). After receiving the second dose of the series, the symptoms" seemed to get a little worse." In late May, the pt saw her family doctor and was prescribed Wellbutrin for a diagnosis of "viral type illness and depression." After she started the Wellbutrin, the nurse practitioner stated that the symptoms went away. However, she also noted that the pt made a trip to the ER in early June for neck and joint pains. A workup at time only showed minimal lab abnormalities. The nurse noted that the pt is now "fine." The outcome of the flu-like symptoms and the rash are recovered. There were no adverse events following previous vaccinations. Information was received which pertained to events which occurred approximately 1 month after vaccination with hep B virus vaccine. This info contained the following adverse experience: viral type illness (late May) and depression (late May). Additional info is not expected.
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Laboratory test abnormal, Malaise, Neck pain, Rash, Viral infection
Clinical narrative: Information has been received from manufacturer for hep B virus vaccine. This was originally reported by a RN concerning a 41 year old female with no past medical history and no known drug allergies who on 4/18/03 was vaccinated in the right arm with a first 20mcg dose of hep B virus vaccine (645173/1210M). Prior vaccination included the first series of hep B virus vaccine completed in 1995. The pt did not have antibodies when tested later so they decided to give another series. Concomitant therapy included Xanaflex, amitriptyline hydrochloride and a dose of tetanus toxoid administered on 4/9/03. On 4/19/03, the day after vaccination, the pt reportably began experiencing flu-like symptoms, described as general malaise, profuse sweating and chills, and joint pain. The pt also developed a rash on an unknown date that lasted about a week. The pt noted that the symptoms (other than the rash) lasted the whole month and were present on 5/21/03, when she received her fifth dose of the second series of hep B virus vaccine (637001/1032K). After receiving the second dose of the series, the symptoms" seemed to get a little worse." In late May, the pt saw her family doctor and was prescribed Wellbutrin for a diagnosis of "viral type illness and depression." After she started the Wellbutrin, the nurse practitioner stated that the symptoms went away. However, she also noted that the pt made a trip to the ER in early June for neck and joint pains. A workup at time only showed minimal lab abnormalities. The nurse noted that the pt is now "fine." The outcome of the flu-like symptoms and the rash are recovered. There were no adverse events following previous vaccinations. Information was received which pertained to events which occurred approximately 1 month after vaccination with hep B virus vaccine. This info contained the following adverse experience: viral type illness (late May) and depression (late May). Additional info is not expected.
Age: 0.2
Sex: M
Vaccine: HEP
Symptoms: Contusion, Injection site atrophy, Injection site erythema, Injection site induration, Pigmentation disorder
Clinical narrative: INJECTION SITE BRUISING; INJECTIN SITE DISCOLORATION; INJECTION SITE ERYTHEMA; INJECTION SITE PIGMENTTION CHANGES; INJECTION SITE INDURATION. Information has been received from a licensed practical nurse concerning an 8 week old male patient who on 28-APR-2003 was vaccinated in the left lateral thigh with a first dose of hepatitis B virus vaccine rHBsAg (yeast) (Lot #645174/1208M). On 28-MAY-2003, the patient was vaccinated in the left medial thigh with a second dose of hepatitis B virus vaccine rHBsAg (yeast)(Lot#645174/1208M). There was no site reaction with the second dose. On 26-JUN-2003, the patient presented to the medical office for his two month old visit. The reporter noted the patient was healthy at this time. At this visit, the patient's parents complained to the doctor that the patient had a bruise "at first injection site at lateral thigh". The reporter was told by the doctor and a nurse colleague that the injection site looked indurated and the center was pale with a cirumferance around it that was purplish and red. The reporter noted that it was, "almost like subcutaneous atrophy at site". At the time of the report, the patient had not recovered. Additonal information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Multiple sclerosis
Clinical narrative: Information has been received concerning a male patient who was vaccinated with hepatitis B virus vaccine, and subsequently developed multiple sclerosis following receipt of the hepatitis B virus vaccine. This report was originally reported by a consumer, the patient's brother, who declined to provide any additional information, and stated his brother would report the information directly. Upon internal review, multiple sclerosis was determined to be an other important medical event (OMIC). Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: HEP
Symptoms: Rash
Clinical narrative: RASH NOS. Information has been received from a registered nurse concerning a 54 year old female on dialysis who on 21-JUL-2003 was vaccinated with a 40mcg dose of hepatitis B virus vaccine rhBsAg (yeast) (lot # 644599/1111M). It was unknown if the patient was on concomitant medications. By the evening of 24-JUL-2003, the patient had developed a rash on both legs. Unspecified medical attention was sought and it was unknown what treatment was required. It was reported that the rash had resolved. No product quality complaint was involved. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HEP
Symptoms: Thrombocytopenia
Clinical narrative: Information has been received from a consumer concerning his 12 year old grandson who in approximately August 2003, was vaccinated with a second dose of hepatitis B virus vaccine rHBsAg (yeast).  The reporter noted that the first two doses of hepatitis B virus vaccine rHBsAg (yeast) were administered over the last five weeks.  On 08/05/03, a physical exam was done that included blood work that showed thrombocytopenia.  On 08/06/03 and on 08/07/03, the pt was re-tested and each test showed a further decrease in blood platelets.  Unspecified medical attention was sought.  A product quality complaint was not involved.  Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Convulsion, Dyskinesia, Insomnia
Clinical narrative: Information has been received from the mother of a female infant with no known allergies who was vaccinated with a dose of hepatitis B virus vaccine. There was no concomitant medication reports. Subsequently the patient developed a seizure. The outcome of the patient's seizure was unknown. Upon internal review, it has been determined that the patient's seizure was considered an other important medical event (OMIC). Additional information has been requested. The mother also reported that the patient, at the age of 13 months, developed insomnia and involuntary movements of the arms and torso while on therapy with famotidine.
Age: 11.0
Sex: M
Vaccine: HEP
Symptoms: Migraine
Clinical narrative: Information has been received from the mother of an 11 year old male with no medical history and no allergies who on 4/2/02 was vaccinated with a second dose of hepatitis B virus vaccine. There was no concomitant medication. Three weeks later, on approximately 4/23/02, the patient developed acute and chronic migraine headaches. He was given topiramate and ergotamine tartrate which did not help. In July 2002, the patient went to the emergency room and was given dexamethasone, ketorolac tromethamine IV, and promethazine HCl. From August 2002 to April 2003 he was given these drugs IV two to three times per week. On 2/17/03 and on 4/22/03 he was hospitalized. In April 2003 he was switched to nortriptyline HCl. Subsequently, he finally recovered. The mother reported that her son missed 43 days of school and that both his parents lost their jobs because of the time needed for his medical care. No product quality complaint was involved. Acute and chronic migraine headaches were considered to be disabling. Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Rash papular
Clinical narrative: Information has been received from a physician's assistant (PA) concerning a 39 year old Hispanic female with no medical history who on 08/05/03 was vaccinated IM in the left deltoid with the first dose (0.5mL) of hepatitis B virus vaccine rHBsAg (yeast)(Lot # 645620/0218N).  There was no concomitant therapy or illness at the time of vaccination.  The PA reported that on 08/06/03, the pt developed an allergic skin rash on the left side of her neck.  On 08/15/03, the pt presented to the clinic with erythematous papules on the lateral part of her neck.  The pt was treated with 25-50 mg of diphenhydramine HC1 (Benadryl) twice daily as needed.  On 08/17/03, the pt was placed on oral prednisone and a topical cream.  No lab/diagnostic tests were performed.  Subsequently, the pt recovered.  On 10/01/03, the pt presented to the clinic.  At that time, no further symptoms were noted.  The PA did not believe the pt's events were caused by Hepatitis B virus vaccine rHBsAg (yeast).  No further information is available.
Age: 18.0
Sex: F
Vaccine: HEP, TTOX
Symptoms: Erythema multiforme
Clinical narrative: Information has been received from a RN concerning her 18 year old daughter with no known allergies who on 08/17/03 was vaccinated with a 0.5mg dose of hepatitis B virus vaccine rHBsAg (yeast)(Lot # 644386/0946M).  Concomitant therapy that day included a dose of tetanus toxoid.  On approximately 08/28/03, about 1 and 1/2 weeks later, the pt experienced erythema multiforme.  It was reported that the pt was not hospitalized and is not pregnant. Unspecified medical attention was sought.  No additional information was provided.  There was no product quality complaint.  Additional information is expected.
Age: 30.0
Sex: M
Vaccine: HEP
Symptoms: Brain oedema, Guillain-Barre syndrome, Paraesthesia
Clinical narrative: Information has been received from a physician concerning the father of a patient in their practice a male while in his 30's, with seasonal allergies, no known drug allergies and no medical history who many years ago was vaccinated with a first dose of a yeast based hepatitis B virus vaccine. There was no concomitant medication. Within 5 hours of the vaccination, the patient developed a loss of feeling in his feet and hands with the paresthesia moving upward to the legs and arms. Over the next few days it continued upward. The patient stated he had swelling of the medulla. The patient was diagnosed with Guillain Barre. It was reported that the patient was hospitalized and treatment and prescription drugs were required. No information was available on the treatment and the duration in the hospital. The patient was with another physician at that time. The symptoms resolved after one week. Subsequently, the patient recovered. No product quality complaint was involved. Follow up information received on 12/8/03 noted that the patient's child was not given a dose of hepatitis B virus vaccine and did not have an adverse reaction. No further information is expected.
Age: 75.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site mass, Urticaria
Clinical narrative: Information has been received from a RN concerning a 75 year old white retired female with chronic renal failure, no acute illnesses and an allergy to erythromycin who on the evenings of 05/21/03 and 06/18/03 was vaccinated IM in the right deltoid with a first and second dose of the dialysis form of hepatitis B virus vaccine rHBsAg (yeast)(Lot # 644028/1017M).  After the first vaccination, the pt developed localized erythema with injection site swelling and redness and a hard lump developed at the injection site.  On the afternoon of 06/18/03, after the second injection, the pt developed generalized hives.  The pt took oral diphenhydramine (Benadryl) at home "which helped).  On 06/19/03 the pt recovered.  It was reported that the third vaccination would not be given.  It was also reported that the pt stated that she has reactions to all vaccines.  Unspecified medical attention was sought.  No diagnostic studies were performed.  No product quality complaint was involved.  No further information is expected.
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a 51 year old female who in the beginning of August 2003, was vaccinated IM with a dose of hepatitis B virus vaccine rHBsAg (yeast).  The physician reported that in August 2003, within 24 hours of being vaccinated, the pt developed hives.  Unspecified medical attention was sought.  Subsequently, the pt recovered from the hives.  Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Liver disorder
Clinical narrative: Information has been received from a medical technologist concerning a middle aged female who was vaccinated with a dose of hepatitis B virus vaccine rHBsAg (yeast).  The reporter indicated that the pt complained of a "funny feeling" in the liver after vaccination.  The reporter noted that the pt had negative titers for hepatitis B virus and hepatitis C virus.  Unspecified medical attention was sought.  A product quality complaint was not involved.  Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a 35 year old female pt who in "spring" of 2003 was vaccinated with a first and second dose of hepatitis B virus vaccine rHBsAg (yeast).  Just after the second dose, the pt began to develop a rash on her arms and legs that appears about 2 hours each day then resolves.  No product quality complaint was involved.  Unspecified medical attention was sought.  Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Hepatic steatosis, Liver function test abnormal
Clinical narrative: Information has been received from an approximately 45 year old licensed practical nurse who in 1991 was vaccinated with the first, second and third doses of hepatitis B virus vaccine rHBsAg (yeast)(manufacturer unknown)("probably Recombivax HB).  The pt received the fourth, fifth and sixth doses of hepatitis B virus vaccine rHBsAg (yeast)(manufactuer unknown) in 2000.  The pt has "now developed" elevated LFT's and steatosis (per CT scan).  The pt is negative for hepatitis.  Unspecified medical attention was sought.  There was no product quality complaint.  Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Information has been received from a health professional concerning a 53 year old female who in 1998 was vaccinated with a three dose series of hepatitis B virus vaccine rHBsAg (yeast).  "Now" when her titer was checked it was negative.  After the first dose the pt experienced redness and swelling at the injection site.  No additional information was available at this time.  Unspecified medical attention was sought.  Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Laboratory test abnormal
Clinical narrative: Information has been received from a physician concerning an adult male who on 09/21/03 was vaccinated with a dose of hepatitis B virus vaccine rHBsAg (yeast).  The physician reported that in approximately October 2003, the pt's urine drug screen was positive for cocaine.  It was noted that the pt felt his vaccination with hepatitis B virus vaccine rHBsAg (yeast) may have caused the positive cocaine result.  Unspecified medical attention was sought, but no treatment was required.  Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Laboratory test abnormal
Clinical narrative: Information has been received from a male consumer, who was vaccinated with hepatitis B virus vaccine rHBsAg (yeast).  The caller reported he received three hepatitis B virus vaccine rHBsAg (yeast) vaccinations, the first in July 2002, the second in August 2002, and the third in March 2003.  He reported, "a recent Hep B titer showed a positive core".  The consumer questioned, "why did my core come back positive?"  It was noted the consumer did not provide any other information.  There was no product quality complaint reported.  Unspecified medical attention was sought.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HEP
Symptoms: Fatigue, Injection site pain, Urticaria
Clinical narrative: Information has been received from a NP and a physician concerning a 16 year old Caucasian female with no past medical history who on 10/13/03 at 11:30AM was vaccinated with a first dose of hepatitis B virus vaccine rHBsAg (yeast)(Lot # 646144/0469N)(IM)(0.5mL), in the left arm.  There was no illness at the time of vaccination.  On 10/13/03 at 7:00PM the pt developed "hives on her abdomen, soreness at the injection site and tiredness."  The mother described the hives as "approximately 3" in diameter on daughter's abdomen."  The pt also had complained of a sore arm on the day after vaccination.  It was also reported that she "developed a sore arm and extreme fatigue".  There were no other symptoms reported.  The pt was not hospitalized.  There were no relevant diagnostic tests or laboratory data.  There were no adverse events following prior vaccinations.  The pt sought medical attention.  The pt was treated with diphenhydramine HC1 (Benadryl).  There was no product quality complaint involved.  The pt recovered on 10/14/03.  No further information is expected.
Age: 49.0
Sex: M
Vaccine: HEP
Symptoms: Liver function test abnormal
Clinical narrative: LIVER FUNCTION TEST ABNORMAL. Information has been received from a physician concerning a 49 year old male with medical history of no known allergies, hypopituitarism, osteopenia, and a hip fracture who between February 2003 and August 2003 was vaccinated with a first, second and third dose of hepatitis B virus vaccine rHBsAg (yeast) (manufacturer unknown), respectively. Concomitant therapy included levothyroxin Na (LEVOTHROD), somatropin (growth horomone), testosterone injection (therapy unspecified), alendronate sodium (MSD) 70 mg not consistently taken every week (WAES 0310USA02073) and atovastatin calcium (LIPITOR) (discontinued). In August 2003, after the third dose, the patient developed an increase in LFT's. It was noted that the patient "felt well" throughout the LFT elevations. Prescription drug treatment was not required. laboratory diagnostic tests performed in August, 2003 were "alkPhos" 351, "AST"257; "ALT" 587; "GGTP"2099 and "tbili" 0.7. On 08-Oct-2003, laboratory tests were "Alkphos" 99; "AST" 32; "ALT" 43 and "tbili" 0.4. Laboratory diagnostic studies performed were MRI, CT scan and an ultrasound (results not reported). Subsequently, the patient recovered. Medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Alopecia, Blood iron decreased, Depression, Hypertension, Laboratory test abnormal
Clinical narrative: BLOOD IRON DECREASED; ALOPECIA; STRESS SYMPTOMS; DEPRESSION. Information has been received from a health professional concerning a 35 year old white female patient care assistant with asthma and no known drug allergies who on 19-JUN-2003 and 31-JUL-2003 was vaccinated with the first and second doses of hepatitis B virus vaccine rHBsAg (yeast) (lOT 643395/0429m). There was no illness at the time of vaccination. Concomitant vaccinations on 06-JUN-2003 included a dose of tetanus toxoid. After the second dose of hepatitis B virus vaccine rHBsAg (yeast), the patient experienced alopecia the size of a half dollar and it has increased to a gold ball size. The patient was seen by her physician, and the physician "does not feel it is associated with the vaccination". Unspecified medical attention was sought. There was no product quality complaint. Follow up information from the patient indicated that she was stressed over losing a job in May 2003, and start4ed a new job in June 2003. On 06AUG2003, the patient's hairstylist noted hair loss on the patient. The hair loss continued to become bigger and more noticeable. On 26SEP2003 the patient presented to the physician's office with complaints of being stressed and depressed, and also complained of a bald spot on the right side of her head. Labs were drawn and the iron count was low at 11.1. All other laboratory data are listed below. The patient was prescribed alprazolan (XANAX)(0.5mg q12h), iron supplements, an injection of B6/B12 every 2 weeks, and a multivitamin. The outcome was reported as not recovered. No additional information is expected.
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Hepatitis, Therapeutic response decreased
Clinical narrative: ARTHRALGIA; THERAPEUTIC RESPONSE DECREASED. Information has been received from a woman in a physician's office concerning an adult female patient with no allergies or medical history who 20 to 30 years ago, in approximately 1983, was vaccine rHBsAg (yeast) (manufacturer unknown). There was no concomitant medication. It was noted that the patient had a positive titer at that time. Subsequently, the patient experienced achy joints and was told that "it was from the live virus in the vaccine." A toter on 13-OCT-2003 was negative. Unspecified medical attention was sought and a prescription drug was not required. A product quality was not involved. Additional information was received from the physician's office which indicated "patient no longer here." No further information is expected.
Sex: U
Vaccine: HEP
Symptoms: Blood pressure decreased, Pneumonia, Pyrexia, Sepsis
Clinical narrative: PNEUMONIA. Information has been received form a registered nurse concerning a dialysis patient who on 20-OCT-2003 was vaccinated intramuscularly with a first dose of hepatitis B virus vaccine rHBsAg (yeast)(40mcg/ml) (lot 644028/1017M or 645647/0527N). Subsequently the patient presented to the clinic with a fever, low blood pressure and generally not feeling well. The patient had a positive blood culture for gram positive blood culture for gram positive cocci. It was noted that the patient also had other issues such as catheters or other frequent needle sticks so causality of the infection had not been determined. The patient received antibiotic therapy. The patient was later diagnosed with pneumonia and subsequently recovered. It was reported that these events were reported "prematurely and thought that the symptoms may have had something to do with the (hepatitis B virus vaccine rHBsAg (yeast)) vaccine that the patients received, since the symptoms of fever and generally not feeling well began within 48 hours of the vaccination." It was noted that the diagnosis was not caused by the hepatitis B virus vaccine rHBsAg (yeast). It was also reported that another patient had a similar experience (WEAES0311USA00987), however was hospitalized with an infected vascular catheter. It was also noted that these were two of fifteen patients who were vaccinated on the same day at the same facility. Additional information has been requested.
Age: 0.25
Sex: F
Vaccine: HEP
Symptoms: Irritability, Medication error
Clinical narrative: IRRITABILITY; MEDICATION ERROR. Information has been received from a registered nurse concerning a healthy 12 week old female infant with no past medical history and no known drug allergies who at birth, in July 2003, was vaccinated with a first dose of hepatitis B virus vaccine rHBsAg (yeast). There was no concomitant medication. Subsequently, the patient received a second dose of the vaccine 2 weeks later at a physician's office. The infant was fussy for a day or two after the second injection. No further information or lot number was available at this time. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 24.0
Sex: M
Vaccine: HEP
Symptoms: Lymphadenopathy
Clinical narrative: LYMPHADENOPATHY; LYMPHADENOPATHY. Information has been received from a registered nurse concerning a 24 year old male clerk who on 23-SEP-2003 had a hepatitis B surface antibody titer of <2.0. On 01-OCT-2003 the patient was vaccinated intramuscularly in the left deltoid with a second dose of hepatitis B virus vaccine rHBsAg (yeast) and on 05-NOV-2003 was vaccinated intramuscularly in the right deltoid with a third dose of hepatitis B virus vaccine rHBsAg (yeast) (lot # for 644394/0154N). On 03-OCT-2003, 48 hours post-vaccination, the patient "noticed" a left axillary adenopathy that was on-tender. It was also reported that the patient had a similar event after the third vaccination with right axillary adenopathy. The adenopathy has now resolved. It was also reported that "several years ago" the patient had received a first dose of hepatitis B virus vaccine rHBsAg (yeast)(manufacturer unknown) without problems. Unspecified medical attention was sought. There was no product quality complaint involved. No further information is expected.
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Injection site pain, Muscular weakness, Myalgia, Throat tightness
Clinical narrative: THROAT TIGHTNESS; GRIP STRENGTH DECREASED; INJECTION SITE PAIN; ASTHENIA; MYALGIA. Information has been received from a nurse concerning a 37 year old white female with no reported allergies or medical history who on 09OCT2003 was vaccinated in the right deltoid with a first dose of hepatitis B virus vaccine rHBsAg (yeast) (lot 646157/0529N). There was no illness at the time of vaccination. The reporter indicated that the patient had tightness in the throat that lasted a few seconds. She also had soreness at the injection site and deltoid muscle which she still has even through the injection was six weeks ago. She also reported difficulty gripping things in the right arm, which is the arm in which she received the vaccination. Unspecified medical attention was sought and it was unknown if a prescription drug was required. A product quality complaint was not involved. Follow-up information was received from the nurse which indicated that on 09-OCT-2003 the patient experienced a momentary tightness sensation to the throat immediately after the shot was given. The patient complained of weakness and an inability to grasp items with the right arm for one month following injection. No diagnostic laboratory tests were performed. The patient subsequently recovered from the tightness in her throat, right arm weakness and difficulty gripping things in the right arm. It was noted that the patient had no adverse events following prior vaccination. Additional information has been requested. Follow up 03/16/05: Additionla follow up received from the registered nurse reported that the patient is not fully recovered. The weakness to her right arm is improved, and she still continues to have aching in the right shoulder which was reported as "more in the joint" than in the muscle. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis
Clinical narrative: HEPATITIS B SURFACE ANTIGEN POSTIVE. Information has been received from a physician concerning an adult female who in 2002, "one year ago", was vaccinated with a dose of hepatitis B virus vaccine rHBsAg (yeast) (manufacturer unknown) and tested positive for hepatitis surface antigen. Unspecified medical attention was sought. There was no product quality complaint involved. Follow-up information from the physician indicated that no adverse reaction was reported.
Age: 50.0
Sex: M
Vaccine: HEP
Symptoms: Injection site nodule
Clinical narrative: INJECTION SITE NODULE. Information has been received from a registered nurse concerning an "otherwise healthy" 50 year old black male who on 18JUN2003 and 23JUL2003 was vaccinated with a first and second dose of hepatitis B virus vaccine rHBsAg (yeast)(1st dose lot #644099/0835M; 2nd dose lot #1018N), respectively. After receipt of the second vaccination in his right arm, the patient developed a nodule at the injection site. It was not red, inflammed or painful for the patient. It was reported that this was discovered upon the patient's return for a third vaccination. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Laboratory test abnormal, Pseudo lymphoma
Clinical narrative: PSEUDO LYMPHOMA. Information has been received from the patient's mother concerning her daughter with no pertinent medical history who was vaccinated IM with a dose of hepatitis B virus vaccine rHBsAg (yeast). There was no concomitant medication. It was noted by the mother that the patient developed Rosai-Dorfan syndrome after being administered hepatitis B virus vaccine rHBsAg (yeast). The patient was being treated with prednisone. It was noted that a variety of tests were done to identify autoimmune disorders. It was also noted that the patient had not recovered at the time of the report. No product quality complaint was involved. Additional information has been requested.
Age: 0.25
Sex: M
Vaccine: HEP
Symptoms: Angioneurotic oedema, Pyrexia
Clinical narrative: ANGIONEUROTIC OEDEMA; PYREXIA. Information has been received from a health professional concerning a 13 week old male with no allergies and no medical history who on 18-DEC-2003 was vaccinated with a second dose of hepatitis B viurs vaccine rHBsAg(yeast)(thimerosal free) (lot #645479/0215N). There was no concomitant medication. It was reported that there was no adverse symtoms with the first vaccination. ON 18-DEC-2003, in the evening, the patient experienced angioedema with his face swollen and a low grade fever. He was seen by a physician on 19DEC2003 and mild swelling was noted. No treatment was given. No product quality complaint was involved. Additional information from a health professional indicated that concomitant vaccines on 11/19/2003 included a first dose IM in the right thigh of diphtheria toxoid (+) pertussis acellular biken vaccine (+) tetanus toxoid (Tripedia) (lot 01606AA), a first dose dose IM in the left thigh of poliovirus vaccine inactivated (Vero) (IPOL) (lot X0148), a first dose IM in the right thigh of Hib conj vaccine (tet toxoid) (ACTHIB) (lot UE064AA) and a first dose IM in the left thigh of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (Prevnar) (lot 492-388).  There were no other concomitant medications.  There was no illness at the time of vaccination.  It was reported that "on 12/19/2003, at 7:00 AM," the patient experienced angioedema of the left side of the face.  He recovered on 12/21/2003. Additional information is not expected.
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Injection site reaction, Pain
Clinical narrative: PAIN IN EXTREMITY. Information has been received from an emergency medical technician concerning a patient, age late 30s to 40s, who during the week of 29-DEC-2003 was vaccinated with a third dose of hepatitis B virus vaccine rHBsAg (yeast) (Lot #644694/1048M). Within five minutes post vaccination on approximately 29-DEC-2003, the patient experienced a shooting pain in the arm, which was described as a site reaction. Unspecified medical attention was sought, but treatment was not required. The pain lasted for 30 minutes and then resolved. A product quality complaint was not involved. The reporter also mentioned another patient who had an experience post vaccination with hepatitis B virus vaccine rHBsAg (yeast) (Lot #644694/1048M) (WAES 0401USA00543). Additional information has been requested. Follow up report received 03/16/2005: Unspecified medical attention was sought, but treatment was not required and laboratory testes were not performed.  On 01/10/2004, the patient recovered.  Additional information is not expected.
Age: 33.0
Sex: M
Vaccine: HEP
Symptoms: Musculoskeletal stiffness
Clinical narrative: MUSCULOSKELETAL STIFFNESS. Information has been received from an emergency medical technician concerning a 34 year old patient who on 04-JAN-2004 was vaccinated with a third dose of hepatitis B virus vaccine rHBsAg (yeast) (Lot # 644694/1048M). Subsequently 04-JAN-2004, the patient developed stiffness of the upper arm to the neck and back, which was described as a site reaction. Unspecified medical attention was sought, but treatment was not required. The stiffness lasted into a second day, 05-JAN-2004, and then resolved. A product quality complaint was not involved. The reporter also mentioned another patient who had an experience post vaccination with hepatitis b virus vaccine rHBsAg (yeast) (Lot #644694/1048M) (WAES #0401USA00224). Additional information has been requested. Follow up report received on 03/16/2005:  Approximately 2 hours after vaccination on 01/04/2004, the patient began getting pain in his tricep area.  As the day went on, the pain traveled up the patient's arm into the back of his neck.  On 01/04/2004, the patient also developed stiffness of the upper arm to the neck and back, which was described as a site reaction.  The patient had what felt like a stiff neck for two days.  Unspecified medical attention was sought, but treatment was not required.  The patient was not seen by a doctor.  The stiffness lasted into a second day, 01/05/2004, and then resolved.  It was noted that the patient recovered.  A product quality complaint was not involved.  The reporter also mentioned another patient who had an experience post vaccination wtih Hepatitis B virus vaccine rHBAg (yeast) (lot # 644694/104EM) (WAES # 0401USA00224).  Additional information is not expected.
Age: 33.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site reaction, Rash erythematous, Rash macular, Skin hyperpigmentation
Clinical narrative: Patient developed rash at 16 days after smallpox vaccination.  Rash was erythematous macules coalesced in groin, axilla, palms, less on chest and shoulders.  Lesion blanch, nontender, nonscaling, appeared to be dermal.  Smallpox site with scab, no surrounding erythema.  On day 4 of rash, was placed on Prednisone.  Within next couple days, rash resolved except small areas of hyperpigmentation current today.  No causes of rash found.
Age: 34.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site infection, Injection site pain, Injection site reaction, Subcutaneous nodule
Clinical narrative: After my 3rd Anthrax shot, which was one year ago. I developed an infection at the injection site that was very sore and irratated. I kept a gauze over the affected area until it had healed. Now I have a permanent nodule on my left shoulder that is 9mm in width.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Amblyopia, Asthenia, Blood cholesterol increased, Guillain-Barre syndrome, Headache
Clinical narrative: Tingling in hands and feet, ascended to elbow and waist.  Weakness in arms, legs.  Hospitalized x 1 day.  Still have residual tingling in hands and feel.  Diagnosed with Guillian Barre Syndrome.  Still with continual tingling hands and feet. The medical records received on 4/5/04 states headache, blurred vision, palpitation, and sweaty palms. discharge summary states viral infection. msv
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Hyperhidrosis, Palpitations, Paraesthesia, Viral infection
Clinical narrative: Tingling in hands and feet, ascended to elbow and waist.  Weakness in arms, legs.  Hospitalized x 1 day.  Still have residual tingling in hands and feel.  Diagnosed with Guillian Barre Syndrome.  Still with continual tingling hands and feet. The medical records received on 4/5/04 states headache, blurred vision, palpitation, and sweaty palms. discharge summary states viral infection. msv
Age: 36.0
Sex: M
Vaccine: SMALL
Symptoms: Cellulitis
Clinical narrative: S/P SMALLPOX VACC, POSS LUE CELLULITIS
Age: 57.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Influenza like illness, Injection site mass, Pruritus, Pyrexia, Rash
Clinical narrative: CC:  "Itchy red rash x 3 weeks"-started 1 week after smallpox, anthrax, and typhoid vaccination.  Patient received smallpox vaccine (Revaccinee), Anthrax #1, and Typhoid on 2/6/04.  No complaints on this date.  On 2/10/04, he developed mild flu-like symptoms with fever around 100 F.  Was evaluated and treated with Sudafed, throat lozenges, and anti-pyretics.  On 2/13/04, Service member noted flat red rash on bilateral arms.  Described it as "mildly itchy" and started taking Claritin QAM and Benadryl QPM.  Denies fever, headache, shortness of breath, chest pain, or abdominal pain.  Flu-like symptoms resolving.  Over the next few days, similar lesions increased on bilateral upper extremities, lower back, inner thigh, and around ankle and lower legs.  No oral lesions, interdigital lesions, or lesions on palms or soles.    He received anthrax #2 on 2/24/04.  He developed a knot in right deltoid area at site of vaccination and had persistent rash but otherwise felt fine.  On 3/4/04, he was referred to Vaccine Healthcare Center.  He reports that the rash appears to be getting better.  He continues to experience mild itching that is controlled on the Claritin QAM and Benadryl QPM.  He states that he feels fine and is eagerly awaiting his upcoming deployment on 3/7/04.  Of note, service member has been residing in a local hotel and reports that he has noted small black bugs in the sheets.  He does not recall being bitten by the bugs.  He also has been using different soaps, detergents, and shampoo while staying at the hotel.  Diagnosis: (ICD 782.1)Non-specific Skin Eruption that occurred after receipt of Smallpox, Anthrax, and Typhoid vaccination.  Unresolved but improving at this time.  The appearance is not compatible with the classic presentation of Non-viral Pustulosis or Erythema Multiforme.  Differential Diagnosis includes Benign Lesions resulting from SPV, Contact Dermatitis, or Arthropod Reaction.  Treatment:  Continue with antihistamine.  Kenalog 0.1% cream-apply TID x 1-2 weeks.    Consulted with Dermatology and they concurred that rash is consistent with arthropod reaction versus Pseudo-Erythema Multiforme.  Lesions started resolving on 3/6/04 and have continued improving.
Age: 36.0
Sex: F
Vaccine: ANTH, FLU3, HEPA, IPV, MEN, MMR, TTOX, TYP, YF, ANTH, FLU3, HEPA, IPV, MEN, MMR, YF
Symptoms: Condition aggravated, Fatigue, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: 2-3 days after immunizations went to sick-call with a migraine, was started on pain reliever. Area of AVA injection swelled and was very itchy for several days, no redness noted, firm tender nodule approx 1/4 in diam developed. Per annual follow up report, Continued with increased migraine headaches, chronic fatigue 03/23/2005.
Age: 36.0
Sex: F
Vaccine: ANTH, FLU3, HEPA, IPV, MEN, MMR, TTOX, TYP, YF, ANTH, FLU3, HEPA, IPV, MEN, MMR, YF
Symptoms: Migraine, Pruritus
Clinical narrative: 2-3 days after immunizations went to sick-call with a migraine, was started on pain reliever. Area of AVA injection swelled and was very itchy for several days, no redness noted, firm tender nodule approx 1/4 in diam developed. Per annual follow up report, Continued with increased migraine headaches, chronic fatigue 03/23/2005.
Age: 36.0
Sex: F
Vaccine: ANTH, FLU3, HEPA, IPV, MEN, MMR, TTOX, TYP, YF, ANTH, FLU3, HEPA, IPV, MEN, MMR, YF
Symptoms: Condition aggravated, Migraine
Clinical narrative: 2-3 days after immunizations went to sick-call with a migraine, was started on pain reliever. Area of AVA injection swelled and was very itchy for several days, no redness noted, firm tender nodule approx 1/4 in diam developed. Per annual follow up report, Continued with increased migraine headaches, chronic fatigue 03/23/2005.
Age: 19.0
Sex: M
Vaccine: HEPA
Symptoms: Medication error
Clinical narrative: PT RECEIVED PEDIATRIC DOSE OF VAQTA (HEP. A) VACCINE O.5CC INSTEAD OF ADULT DOSE.
Age: 11.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Asthenia, Difficulty in walking, Disturbance in attention, Dizziness, Dyspnoea
Clinical narrative: My son is diagnosed with chronic fatigue syndrome which started acutely after after he recived HepB vaccine dose. He is profoundly disabled, he can't attend school or perform any age appropriate activites such as playing, reading, playing sports.Often he can't walk by himself and at times he even can't breath without difficulty. He is in a constant state of fatigue, maldie and brain fog. he requires around the clock care since the onset of his illness. Prior to the vaccination he was absolutely healthy, happy and bright little boy. His illness devastated the entire family physically, financially and morally. I am a mother and looking at my son suffer like he is suffering is riping my heart apart.No amount of medical intervention could provide cure or at least some relief.  Nurse follow up on 08/05/04 states: "Physician states in his progress note that Hep B was not necessary based on their office records. This would indicate that the Hep B in Box 13 was at least the 4th dose. However, a titer drawn on 2/28/2002, nearly 4 months s/p vaccination, was non-reactive. ADD: weakness; dizziness; vomiting ; vestibular neuronitis ; febrile illness ; pharyngitis-tonsillitis."