chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: LYME
Symptoms: Immune system disorder, Influenza like illness, Joint swelling, Nervous system disorder, Sleep disorder
Clinical narrative: This case was reported by a lawyer and described the occurrence of pain, swelling and burning of the joints in a female subject of unspecified age who was vaccinated with Lyme disease vaccine recombinant Lymerix, for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Lymerix (unknown). On an unspecified date after vaccination with Lymerix, the subject experienced pain, swelling and burning in her joints, fatigue, flu like symptoms, coordination and balance problems, asthma, allergies, cognitive problems, sleep disturbances, gastrointestinal problems, hypothyroidism, possible neurological injuries, possible autoimmune disease and decreased activities of daily life. This case was assesses as medically serious by manufacturer (OMIC). At the time of reporting the outcome of the events was unspecified. This information was received via a statement of injuries.
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Bone pain, Chills, Cognitive disorder, Fatigue
Clinical narrative: This case was reported by a lawyer and described the occurrence of hearing los sin a male subject of unspecified age who was vaccinated with Lyme disease vaccine recombinant OSPA Lymerix, for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Lymerix (unknown). An unspecified time after vaccination with Lymerix, the subject experienced hearing loss, arthralgia, fatigue, headache, visual problem, tingling sensation, rash, sinus problems, swollen joint, gastrointestinal disorder, burning sensation, nerve injury, myalgia, fever, chills, nausea, bone pain,m rheumatological symptoms, neurological impairment, cognitive impairment, autoimmune disease, decreased ability to perform daily activities and decreased ability to participate in recreational activities. This case was assessed as medically serious by manufacturer (OMIC). At the time of reporting the outcome of the events was unspecified. This information was received via a statement of injuries.
Sex: M
Vaccine: LYME
Symptoms: Gastrointestinal disorder, Headache, Hypoacusis, Immune system disorder, Joint swelling
Clinical narrative: This case was reported by a lawyer and described the occurrence of hearing los sin a male subject of unspecified age who was vaccinated with Lyme disease vaccine recombinant OSPA Lymerix, for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Lymerix (unknown). An unspecified time after vaccination with Lymerix, the subject experienced hearing loss, arthralgia, fatigue, headache, visual problem, tingling sensation, rash, sinus problems, swollen joint, gastrointestinal disorder, burning sensation, nerve injury, myalgia, fever, chills, nausea, bone pain,m rheumatological symptoms, neurological impairment, cognitive impairment, autoimmune disease, decreased ability to perform daily activities and decreased ability to participate in recreational activities. This case was assessed as medically serious by manufacturer (OMIC). At the time of reporting the outcome of the events was unspecified. This information was received via a statement of injuries.
Sex: M
Vaccine: LYME
Symptoms: Myalgia, Nausea, Nerve injury, Nervous system disorder, Paraesthesia
Clinical narrative: This case was reported by a lawyer and described the occurrence of hearing los sin a male subject of unspecified age who was vaccinated with Lyme disease vaccine recombinant OSPA Lymerix, for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Lymerix (unknown). An unspecified time after vaccination with Lymerix, the subject experienced hearing loss, arthralgia, fatigue, headache, visual problem, tingling sensation, rash, sinus problems, swollen joint, gastrointestinal disorder, burning sensation, nerve injury, myalgia, fever, chills, nausea, bone pain,m rheumatological symptoms, neurological impairment, cognitive impairment, autoimmune disease, decreased ability to perform daily activities and decreased ability to participate in recreational activities. This case was assessed as medically serious by manufacturer (OMIC). At the time of reporting the outcome of the events was unspecified. This information was received via a statement of injuries.
Sex: M
Vaccine: LYME
Symptoms: Pyrexia, Rash, Sensory disturbance, Sinusitis, Thermal burn
Clinical narrative: This case was reported by a lawyer and described the occurrence of hearing los sin a male subject of unspecified age who was vaccinated with Lyme disease vaccine recombinant OSPA Lymerix, for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Lymerix (unknown). An unspecified time after vaccination with Lymerix, the subject experienced hearing loss, arthralgia, fatigue, headache, visual problem, tingling sensation, rash, sinus problems, swollen joint, gastrointestinal disorder, burning sensation, nerve injury, myalgia, fever, chills, nausea, bone pain,m rheumatological symptoms, neurological impairment, cognitive impairment, autoimmune disease, decreased ability to perform daily activities and decreased ability to participate in recreational activities. This case was assessed as medically serious by manufacturer (OMIC). At the time of reporting the outcome of the events was unspecified. This information was received via a statement of injuries.
Sex: M
Vaccine: LYME
Symptoms: Visual disturbance
Clinical narrative: This case was reported by a lawyer and described the occurrence of hearing los sin a male subject of unspecified age who was vaccinated with Lyme disease vaccine recombinant OSPA Lymerix, for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Lymerix (unknown). An unspecified time after vaccination with Lymerix, the subject experienced hearing loss, arthralgia, fatigue, headache, visual problem, tingling sensation, rash, sinus problems, swollen joint, gastrointestinal disorder, burning sensation, nerve injury, myalgia, fever, chills, nausea, bone pain,m rheumatological symptoms, neurological impairment, cognitive impairment, autoimmune disease, decreased ability to perform daily activities and decreased ability to participate in recreational activities. This case was assessed as medically serious by manufacturer (OMIC). At the time of reporting the outcome of the events was unspecified. This information was received via a statement of injuries.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Discomfort, Injection site hypersensitivity, Injection site warmth, Pyrexia, Urticaria
Clinical narrative: Left upper arm is red, and hot to touch with a welt at the injection site, temperature has been between 100 and 100.6 (oral). Client is taking Tylenol for fever and discomfort, cool compress to injection site.
Age: 42.0
Sex: F
Vaccine: TD
Symptoms: Pain
Clinical narrative: Right shoulder severe pain at Subac. fossa increased with ROM.
Age: 1.66
Sex: M
Vaccine: DTAP
Symptoms: Feeling hot, Injection site erythema, Injection site oedema
Clinical narrative: Pt's left thigh became red, warm and swollen on 4/5/06 when pt awakened in AM. Gradually worsened. On 04/06/06 10x6cm red warm, swollen area. Pt came back to our office for exam. Zyrtec 1 tsp q/2 if size increases ABTS.
Age: 1.04
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Erythema, Eye discharge, Eye oedema, Injection site nodule
Clinical narrative: This morning her eyes were full of mucous and right was filled and it was shut. Mother got her ready for daycare and noticed a big red bump (3) swollen in left leg upper thigh area. Mom called Dr and took her into school. They called back after message was left. Over the phone they told mom to give her Tylenol if she runs a fever, give Benadryl if she scratches it and put Calamine lotion on spots and keep her home until it crusts over. Then mom picked her up immediately. She didn't give her daughter anything
Age: 8.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Swelling and pain at site of injection about 24 hours afterwards. Heating pad helped with pain now resolved 48 hours post. Edema improving, mild erythema, no fevers no warmth, prescribed ice and Ibuprofen.
Age: 17.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Fatigue, Headache, Muscular weakness, Paraesthesia
Clinical narrative: A 17 year old female patient had received an intramuscular, right arm injection of Menactra, on 02/23/2006.  Within 11 hours post-vaccination, she experienced headache, weakness in her legs, fatigue and a tingling across her body.  A flu rapid test was negative.  The patient was not hospitalized.  Recovery status was not reported.
Age: 17.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Asthenia, Fatigue, Headache, Paraesthesia
Clinical narrative: A 17 year old female patient had received an intramuscular, right arm injection of Menactra, on 02/23/2006.  Within 11 hours post-vaccination, she experienced headache, weakness in her legs, fatigue and a tingling across her body.  A flu rapid test was negative.  The patient was not hospitalized.  Recovery status was not reported.
Age: 18.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: A 17 year old male patient with a history of peanut allergy and acne, had received his first intramuscular injection of Menactra, in the right deltoid on 03/21/2006 at 09:15.  That evening, the patient developed a fever of 102.8 degrees, nausea, vomiting, and his throat and chest felt tight.  His blood pressure was 149/93 and his heart rate was 120.  He vomited 4 times in the first 24 hours post-vaccination.  Per the reporter, there was no shortness of breath.  The symptoms were still persisting at the time of this report.
Age: 18.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Chest discomfort, Nausea, Pyrexia, Throat tightness, Vomiting
Clinical narrative: A 17 year old male patient with a history of peanut allergy and acne, had received his first intramuscular injection of Menactra, in the right deltoid on 03/21/2006 at 09:15.  That evening, the patient developed a fever of 102.8 degrees, nausea, vomiting, and his throat and chest felt tight.  His blood pressure was 149/93 and his heart rate was 120.  He vomited 4 times in the first 24 hours post-vaccination.  Per the reporter, there was no shortness of breath.  The symptoms were still persisting at the time of this report.
Age: 0.38
Sex: F
Vaccine: DTAP, DTAP, HBHEPB, IPV, PNC
Symptoms: Apnoea, Cardio-respiratory arrest
Clinical narrative: As per mother's history on the following day after baby's immunization, baby vomited x one diarrhea x one, baby worsened, grandmother called 911, they arrived and took baby to Hospital, they pronounced baby's death.
Age: 0.38
Sex: F
Vaccine: DTAP, DTAP, HBHEPB, IPV, PNC
Symptoms: Diarrhoea, Vomiting
Clinical narrative: As per mother's history on the following day after baby's immunization, baby vomited x one diarrhea x one, baby worsened, grandmother called 911, they arrived and took baby to Hospital, they pronounced baby's death.
Age: 1.37
Sex: M
Vaccine: DTAP, FLU3, PNC
Symptoms: Erythema, Irritability, Pyrexia, Rash, Rash macular
Clinical narrative: 2/15/06 - child slept through the night,8:00 am woke up with Blotchy, Red, Swollen, hive like areas on body with systemic rash. No respiratory distress. Decreased eating habits throughout entire time frame of reaction. Temp. ranging from 99.9-100.6 for several days. No complaints of pain. Mom states he was fussy, but not itching. 10AM on 2/16/06 seen local physician. Had been receiving amoxicillin (10 day dosage) for week prior to vaccination for ear inf. Only given Tylenol for reaction symptoms. No other tx. given. Mom states it did take until Friday for rash to begin disappearing. At this point, rash felt very sandpapery. Redness/blotch/swelling was down, but redness would continue if he got too hot or if he cried. Complete recovery with appetite returned to normal.
Age: 1.37
Sex: M
Vaccine: DTAP, FLU3, PNC
Symptoms: Swelling, Urticaria
Clinical narrative: 2/15/06 - child slept through the night,8:00 am woke up with Blotchy, Red, Swollen, hive like areas on body with systemic rash. No respiratory distress. Decreased eating habits throughout entire time frame of reaction. Temp. ranging from 99.9-100.6 for several days. No complaints of pain. Mom states he was fussy, but not itching. 10AM on 2/16/06 seen local physician. Had been receiving amoxicillin (10 day dosage) for week prior to vaccination for ear inf. Only given Tylenol for reaction symptoms. No other tx. given. Mom states it did take until Friday for rash to begin disappearing. At this point, rash felt very sandpapery. Redness/blotch/swelling was down, but redness would continue if he got too hot or if he cried. Complete recovery with appetite returned to normal.
Age: 34.0
Sex: F
Vaccine: ANTH
Symptoms: Arthralgia, Fatigue, Gastrooesophageal reflux disease, Headache, Injection site inflammation
Clinical narrative: Severe local inflammation to include entire left arm and fingers after receiving 2nd Anthrax shot, followed by 2 years ongoing chronic, episodic musculo-skeletal and physical symptoms. Patient claims she came back on 14 Jul 04 (next day after Shot #2) to discuss reaction to the shot, but no documentation is in her medical record of a VAERS form, and the person who gave her the 2nd shot, states that no severe reaction was present. Patient recieved a 3rd Anthrax shot on 27 Jul 04. Headaches, joint pain, and fatigue still persists since 3rd Anthrax shot.
Age: 34.0
Sex: F
Vaccine: ANTH
Symptoms: Laryngitis
Clinical narrative: Severe local inflammation to include entire left arm and fingers after receiving 2nd Anthrax shot, followed by 2 years ongoing chronic, episodic musculo-skeletal and physical symptoms. Patient claims she came back on 14 Jul 04 (next day after Shot #2) to discuss reaction to the shot, but no documentation is in her medical record of a VAERS form, and the person who gave her the 2nd shot, states that no severe reaction was present. Patient recieved a 3rd Anthrax shot on 27 Jul 04. Headaches, joint pain, and fatigue still persists since 3rd Anthrax shot.
Age: 1.03
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Irritability, Urticaria
Clinical narrative: 2-3 days after administration of MMR, PCV, Hep A, and varicalla vaccines, pt developed diffuse hives and irritability.
Age: 1.02
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Agitation, Cough, Crying, Hyperventilation, Insomnia
Clinical narrative: Patient presents to clinic, Mom reports decreased sleep, increased crying, breathing hard with slight wheezing, coughing, fussy and runny nose.  He was observed as being agitated and restless, with decreased bilateral breath sounds and tachypneic with tachycardia.  He was given a Nebulizer treatment with Accuneb 0.63mg.  After treatment he continued to be restless, bilateral breath sounds wre heard with wheezing noted.  He was admitted to the hospital for observation, placed under a mist tent with nebulizer treatment every 4 hour.  Patient is doing well.
Age: 1.02
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Irritability, Restlessness, Rhinorrhoea, Tachycardia, Tachypnoea
Clinical narrative: Patient presents to clinic, Mom reports decreased sleep, increased crying, breathing hard with slight wheezing, coughing, fussy and runny nose.  He was observed as being agitated and restless, with decreased bilateral breath sounds and tachypneic with tachycardia.  He was given a Nebulizer treatment with Accuneb 0.63mg.  After treatment he continued to be restless, bilateral breath sounds wre heard with wheezing noted.  He was admitted to the hospital for observation, placed under a mist tent with nebulizer treatment every 4 hour.  Patient is doing well.
Age: 1.02
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Wheezing
Clinical narrative: Patient presents to clinic, Mom reports decreased sleep, increased crying, breathing hard with slight wheezing, coughing, fussy and runny nose.  He was observed as being agitated and restless, with decreased bilateral breath sounds and tachypneic with tachycardia.  He was given a Nebulizer treatment with Accuneb 0.63mg.  After treatment he continued to be restless, bilateral breath sounds wre heard with wheezing noted.  He was admitted to the hospital for observation, placed under a mist tent with nebulizer treatment every 4 hour.  Patient is doing well.
Age: 1.16
Sex: M
Vaccine: DTAP, HIBV, MMRV, PNC, VARCEL
Symptoms: Irritability, Pruritus, Rash
Clinical narrative: Child received 12 month old vaccines (DTaP, HIB, PCV, MMR, Varicella) at approximately 2:00 pm.  Mom went to grocery store next to clinic and came back approximately 10 minutes later complaining her child was breaking out in a rash.  Child was itching his head and seemed irritable.  At this time the nurses in the clinic evaluated child and agreed child be seen by a physician assistant.  PA assessed child and instructed to give Benadryl 2.5 mg/ml to equal a total of 10 mg per mom's verbal weight given of 24.2 lbs (11 kg).  Child was monitored for 20 minutes after dosage of oral Benadryl and showed no further reaction.  Mom instructed to monitor child, if he started having difficulty with breathing or the rash presented more rapidly to take child to nearest emergency room.  Verbal Understanding by mom noted.
Age: 1.12
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Diarrhoea, Erythema, Irritability, Rash morbilliform, Rhinorrhoea
Clinical narrative: Vomiting, diarrhea, clear runny nose, fussy, morbiliform red color weight loss of 17 ounces. Treatment includes symptomatic treatment, tylenol motrin, phenergan for vomitting, clear fluids.
Age: 1.12
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Vomiting, Weight decreased
Clinical narrative: Vomiting, diarrhea, clear runny nose, fussy, morbiliform red color weight loss of 17 ounces. Treatment includes symptomatic treatment, tylenol motrin, phenergan for vomitting, clear fluids.
Age: 5.0
Sex: M
Vaccine: DTAPHEPBIP, HEPA
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: PEDIARIX PLACED ON LEFT DELTOID, AREA RED, SWOLLEN, HOT TO TOUCH.  CHILD HAS NO PAIN PER MOTHER.
Age: 1.2
Sex: F
Vaccine: PNC
Symptoms: Bacterial infection, Dehydration, Dyspnoea, Hypoxia, Multi-organ failure
Clinical narrative: Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a nurse regarding a female patient who on 3/3/2004 at 14 months, received a fourth dose of Prevnar. on 3/8/2006, at 3 years of age, the child developed respiratory syncytial virus and sinusitis. On 3/13/2006, the patient developed overwhelming streptococcus pneumoniae sepsis and subsequently died. No know allergies, no previous drug reactions. Indication for Prevnar was immunization. Product was administered on 3/3/2004. Dose regimen was 0.5ml 1 time per day intramuscular. Concomitant medications were not reported. On 3/3/2004, the patient received a fourth dose of Prevnar. On 3/8/2006, the patient developed respiratory syncytial virus (respiratory syncytial virus infection) and sinusitis. Treatment included breathing treatments. On 3/13/2006, the child was vomiting and the patients conditions worsened. The child was evaluated at the doctors office and a blood culture revealed streptococcus pneumoniae. No serotype testing was performed. On the same day, the patient was hospitalized for pneumoniae sepsis (pneumococcal sepsis) (drug ineffective). The pneumococcal sepsis resulted in multi system organ failure and the patient subsequently died on the same day. The cause of death was reported as overwhelming streptococcus pneumoniae sepsis resulting in multi system organ failure. Blood culture (results streptococcus pneumoniae) was done on 3/13/2006. No additional information was available at the time of this report. 6/19/06 Received hospital medical records which revealed patient experienced overwhelming septic shock from streptococcus pneumoniae causing multisystem organ failure.  Hospitalized & expired on 3/13/06.   DC summary indicates patient had URI for several days which had gotten progressively worse.  6/19/06 Received medical records from hospital which reveal transferred in on 3/13/06 with a diagnosis of overwhelming septic shock from streptococcus pneumoniae causing multisystem organ failure.  Patient had progressively worsening respiratory infection w/dry nonproductive cough for approx 10 days prior to admit.  Patient expired 3/13/06 after coding x 2.  A CXR showed left pleural effusion vs empyema w/near whiteout of left lung field.  Aspiration of the left pleural space revealed approx 30 ml of purulent dark colored fluid.  C/S of the pleural fluid revealed strep pneumoniae heavy growth.  She was unable to be resuscitated after the second code.  1/25/08 Reviewed death certificate which states COD as multiorgan system failure with septic shock, streptococcal pneumoniae empyema & sepsis & recent RSV infection as contributing causes.
Age: 1.2
Sex: F
Vaccine: PNC
Symptoms: Respiratory distress, Sepsis, Sinusitis, Vomiting
Clinical narrative: Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a nurse regarding a female patient who on 3/3/2004 at 14 months, received a fourth dose of Prevnar. on 3/8/2006, at 3 years of age, the child developed respiratory syncytial virus and sinusitis. On 3/13/2006, the patient developed overwhelming streptococcus pneumoniae sepsis and subsequently died. No know allergies, no previous drug reactions. Indication for Prevnar was immunization. Product was administered on 3/3/2004. Dose regimen was 0.5ml 1 time per day intramuscular. Concomitant medications were not reported. On 3/3/2004, the patient received a fourth dose of Prevnar. On 3/8/2006, the patient developed respiratory syncytial virus (respiratory syncytial virus infection) and sinusitis. Treatment included breathing treatments. On 3/13/2006, the child was vomiting and the patients conditions worsened. The child was evaluated at the doctors office and a blood culture revealed streptococcus pneumoniae. No serotype testing was performed. On the same day, the patient was hospitalized for pneumoniae sepsis (pneumococcal sepsis) (drug ineffective). The pneumococcal sepsis resulted in multi system organ failure and the patient subsequently died on the same day. The cause of death was reported as overwhelming streptococcus pneumoniae sepsis resulting in multi system organ failure. Blood culture (results streptococcus pneumoniae) was done on 3/13/2006. No additional information was available at the time of this report. 6/19/06 Received hospital medical records which revealed patient experienced overwhelming septic shock from streptococcus pneumoniae causing multisystem organ failure.  Hospitalized & expired on 3/13/06.   DC summary indicates patient had URI for several days which had gotten progressively worse.  6/19/06 Received medical records from hospital which reveal transferred in on 3/13/06 with a diagnosis of overwhelming septic shock from streptococcus pneumoniae causing multisystem organ failure.  Patient had progressively worsening respiratory infection w/dry nonproductive cough for approx 10 days prior to admit.  Patient expired 3/13/06 after coding x 2.  A CXR showed left pleural effusion vs empyema w/near whiteout of left lung field.  Aspiration of the left pleural space revealed approx 30 ml of purulent dark colored fluid.  C/S of the pleural fluid revealed strep pneumoniae heavy growth.  She was unable to be resuscitated after the second code.  1/25/08 Reviewed death certificate which states COD as multiorgan system failure with septic shock, streptococcal pneumoniae empyema & sepsis & recent RSV infection as contributing causes.
Age: 51.0
Sex: F
Vaccine: IPV
Symptoms: Tongue disorder
Clinical narrative: Initial report received on 3/23/2006 from a health care provider. A 52 year old female patient had received a subcutaneous injection of IPOL, lot number Y0824-2, in the right deltoid on 3/20/2006 at 8:45. 30 minutes later, she developed what felt like a lump on her tongue. She was seen by her primary care physician and treated with Claritin, Singular and prednisone. Her symptoms resolved forty five minutes later. When she stopped taken the prescribed medications the symptoms returned. At the time of this report the patient had not recovered from this event.
Sex: F
Vaccine: PNC
Symptoms: Bacterial infection, Sepsis, Shock
Clinical narrative: Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding a 5 year old female patient who received a fourth dose of Prevnar on 12/31/2001. On 3/23/2006 the patient developed pneumococcal sepsis and septic shock. The patients concurrent illness included asplenia. Indication for Prevnar was immunization. Product was administered on 12/31/2001. Dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. On 12/31/2001, the patient received a fourth dose of Prevnar. On 3/23/2006, the patient was admitted to the pediatric intensive care unit with septic shock. On the same day, a blood culture was preformed which was positive fore streptococcus pneumoniae and the patient was diagnosed with pneumococcal sepsis. Treatment included Ceftriaxone, Vancomycin, Dopamine and other medications. As of 4/4/2006, the patient remained hospitalized and was reported to be improving, with discharge scheduled for 4/5/2006. The reporter also stated that the patients physician felt that this was not a case of the vaccine being ineffective, but rather attributed the events to the patients underlying history of asplenia. Serotyping was requested and results are pending. Blood culture (positive for streptococcus pneumoniae) was done on 3/23/2006. No additional information was available at the time of this report.
Sex: M
Vaccine: FLUX, PPV
Symptoms: Rash, Rash macular
Clinical narrative: Information has been received from a male consumer regarding a case in litigation who in 11/1996, was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included a dos of influenza virus vaccine (unspecified). Within 24 hours, the patient was in the ER with saucer size blotches on his torso, thighs, arms, and sides. Prednisone was prescribed (in descending amounts) along with clobetasol propionate (Temovate) and was ineffective. Two months later, it erupted again with the same results from treatment. The consumer stated he has been undergoing this cycle 4 to 5 times a year and dermatologist have been unable to stop the eruptions. The consumer noted that his quality of life has been damaged. At the time of this report, the patient has not recovered. Saucer sized blotches on his torso, thighs, arms, and sides was considered to be disabling. Additional information has been requested.
Age: 1.3
Sex: M
Vaccine: MMR
Symptoms: Drug ineffective, Kawasaki's disease, Pyrexia
Clinical narrative: Information has been received from a physician concerning a male who in 1999, age 15 months, was vaccinated SC with a 0.5ml, first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live. Subsequently, four days after immunization, the patient was hospitalized with a temperature of 105.0 degrees, and was diagnosed with Kawaski's disease. The child was treated with immunoglobulin and aspirin, and was discharged from the hospital 3 days later. In approximately March 2006, the child had titers for measles, mumps, and rubella drawn, and was found to have no immunity. The child was then given his second dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live, and developed a temperature of 101.0 after immunization. The child is now recovered. No other information was available at the time of the report. Kawaski's disease was considered to be disabling. No additional information is expected.
Sex: F
Vaccine: LYME
Symptoms: Abnormal behaviour, Arthralgia, Cognitive disorder, Disturbance in attention, Dizziness
Clinical narrative: This case was reported by a lawyer and described the occurrence of mental fog in a female subject of unspecified age who was vaccinated with a Lyme disease vaccine recombinant (Lymerix) for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Lymerix (unk). On an unspecified date after vaccination with Lymerix, the subject experienced mental fog, fatigue, headaches, gastrointestinal problems, lightheadedness, memory problems, arthralgias, body aches, cognitive difficulty, poor concentration, tinnitus, vision problems, numbness, myalgias, rheumatologic, neurologic and/or cognitive impairment of an autoimmune, immune medicated or other mechanism, decreased activities of daily life and decreased ability to participate in recreational activities. At the time of reporting the outcome of the events was unspecified. This case was assessed as medically serious by manf. (OMIC). This information was received via a statement of injuries.
Sex: F
Vaccine: LYME
Symptoms: Fatigue, Gastrointestinal disorder, Headache, Hypoaesthesia, Immune system disorder
Clinical narrative: This case was reported by a lawyer and described the occurrence of mental fog in a female subject of unspecified age who was vaccinated with a Lyme disease vaccine recombinant (Lymerix) for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Lymerix (unk). On an unspecified date after vaccination with Lymerix, the subject experienced mental fog, fatigue, headaches, gastrointestinal problems, lightheadedness, memory problems, arthralgias, body aches, cognitive difficulty, poor concentration, tinnitus, vision problems, numbness, myalgias, rheumatologic, neurologic and/or cognitive impairment of an autoimmune, immune medicated or other mechanism, decreased activities of daily life and decreased ability to participate in recreational activities. At the time of reporting the outcome of the events was unspecified. This case was assessed as medically serious by manf. (OMIC). This information was received via a statement of injuries.
Sex: F
Vaccine: LYME
Symptoms: Memory impairment, Myalgia, Nervous system disorder, Pain, Rheumatoid arthritis
Clinical narrative: This case was reported by a lawyer and described the occurrence of mental fog in a female subject of unspecified age who was vaccinated with a Lyme disease vaccine recombinant (Lymerix) for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Lymerix (unk). On an unspecified date after vaccination with Lymerix, the subject experienced mental fog, fatigue, headaches, gastrointestinal problems, lightheadedness, memory problems, arthralgias, body aches, cognitive difficulty, poor concentration, tinnitus, vision problems, numbness, myalgias, rheumatologic, neurologic and/or cognitive impairment of an autoimmune, immune medicated or other mechanism, decreased activities of daily life and decreased ability to participate in recreational activities. At the time of reporting the outcome of the events was unspecified. This case was assessed as medically serious by manf. (OMIC). This information was received via a statement of injuries.
Sex: F
Vaccine: LYME
Symptoms: Tinnitus, Visual disturbance
Clinical narrative: This case was reported by a lawyer and described the occurrence of mental fog in a female subject of unspecified age who was vaccinated with a Lyme disease vaccine recombinant (Lymerix) for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Lymerix (unk). On an unspecified date after vaccination with Lymerix, the subject experienced mental fog, fatigue, headaches, gastrointestinal problems, lightheadedness, memory problems, arthralgias, body aches, cognitive difficulty, poor concentration, tinnitus, vision problems, numbness, myalgias, rheumatologic, neurologic and/or cognitive impairment of an autoimmune, immune medicated or other mechanism, decreased activities of daily life and decreased ability to participate in recreational activities. At the time of reporting the outcome of the events was unspecified. This case was assessed as medically serious by manf. (OMIC). This information was received via a statement of injuries.
Sex: M
Vaccine: LYME
Symptoms: Abnormal behaviour, Arthralgia, Cognitive disorder, Disturbance in attention, Dizziness
Clinical narrative: This case was reported by a lawyer and described the occurrence of arthralgia in a male subject of unspecified age who was vaccinated with Lyme disease vaccine recombinant (Lymerix) for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Lymerix (unknown). At an unknown time after vaccination with Lymerix, the subject experienced, arthralgia, fatigue, rash, sinus problems, gastrointestinal problems, memory problem, body pain, eye problems, headache, mental fog, dizziness, autoimmune disease, rheumatological symptoms, cognitive impairment, decreased ability to perform activities and decreased activity level. This case was assessed as medically serious by manufacturer (OMIC). At the time of reporting the outcome of the event were was unspecified.
Sex: M
Vaccine: LYME
Symptoms: Eye disorder, Fatigue, Gastrointestinal disorder, Headache, Immune system disorder
Clinical narrative: This case was reported by a lawyer and described the occurrence of arthralgia in a male subject of unspecified age who was vaccinated with Lyme disease vaccine recombinant (Lymerix) for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Lymerix (unknown). At an unknown time after vaccination with Lymerix, the subject experienced, arthralgia, fatigue, rash, sinus problems, gastrointestinal problems, memory problem, body pain, eye problems, headache, mental fog, dizziness, autoimmune disease, rheumatological symptoms, cognitive impairment, decreased ability to perform activities and decreased activity level. This case was assessed as medically serious by manufacturer (OMIC). At the time of reporting the outcome of the event were was unspecified.
Sex: M
Vaccine: LYME
Symptoms: Memory impairment, Pain, Rash, Rheumatoid arthritis, Sinusitis
Clinical narrative: This case was reported by a lawyer and described the occurrence of arthralgia in a male subject of unspecified age who was vaccinated with Lyme disease vaccine recombinant (Lymerix) for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Lymerix (unknown). At an unknown time after vaccination with Lymerix, the subject experienced, arthralgia, fatigue, rash, sinus problems, gastrointestinal problems, memory problem, body pain, eye problems, headache, mental fog, dizziness, autoimmune disease, rheumatological symptoms, cognitive impairment, decreased ability to perform activities and decreased activity level. This case was assessed as medically serious by manufacturer (OMIC). At the time of reporting the outcome of the event were was unspecified.
Sex: F
Vaccine: LYME
Symptoms: Abnormal behaviour, Amnesia, Arthralgia, Asthenia, Cognitive disorder
Clinical narrative: This case was reported by lawyer and described the occurrence of drooping in right side off face in a female subject of unspecified age who was vaccinated with Lyme disease vaccine recombinant Lymerix for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Lymerix unknown. At an unspecified time after vaccination with Lymerix, the subject experienced pain and swelling in her joints, muscle pain and weakness, drooping in right side of face, numbness, severe headaches, tingling, visual disturbances, memory loss, cogni9tive problems, neurological injuries, possible autoimmune disease, and decreased activities of daily life. At the time of reporting the outcome of the events were unspecified. This case was assessed as medically serious by manufacturer (OMIC). This information was received via a statement of injuries.
Sex: F
Vaccine: LYME
Symptoms: Facial palsy, Headache, Hypoaesthesia, Immune system disorder, Joint swelling
Clinical narrative: This case was reported by lawyer and described the occurrence of drooping in right side off face in a female subject of unspecified age who was vaccinated with Lyme disease vaccine recombinant Lymerix for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Lymerix unknown. At an unspecified time after vaccination with Lymerix, the subject experienced pain and swelling in her joints, muscle pain and weakness, drooping in right side of face, numbness, severe headaches, tingling, visual disturbances, memory loss, cogni9tive problems, neurological injuries, possible autoimmune disease, and decreased activities of daily life. At the time of reporting the outcome of the events were unspecified. This case was assessed as medically serious by manufacturer (OMIC). This information was received via a statement of injuries.
Sex: F
Vaccine: LYME
Symptoms: Myalgia, Nervous system disorder, Paraesthesia, Visual disturbance
Clinical narrative: This case was reported by lawyer and described the occurrence of drooping in right side off face in a female subject of unspecified age who was vaccinated with Lyme disease vaccine recombinant Lymerix for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Lymerix unknown. At an unspecified time after vaccination with Lymerix, the subject experienced pain and swelling in her joints, muscle pain and weakness, drooping in right side of face, numbness, severe headaches, tingling, visual disturbances, memory loss, cogni9tive problems, neurological injuries, possible autoimmune disease, and decreased activities of daily life. At the time of reporting the outcome of the events were unspecified. This case was assessed as medically serious by manufacturer (OMIC). This information was received via a statement of injuries.
Sex: F
Vaccine: LYME
Symptoms: Abnormal behaviour, Anaemia, Arthralgia, Fatigue, Immune system disorder
Clinical narrative: This case was reported by a lawyer and described the occurrence of anemia in a female subject of unspecified age who was vaccinated with Lyme disease vaccine recombinant Lymerix for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Lymerix unknown. At an unspecified time after vaccination with Lymerix, the subject experienced pain and swelling in her joints, fatigue, anemia, possible neurological injuries, possible autoimmune disease, and decreased activities of daily life. At the time of reporting the outcome of the events were was unspecified. This case was assessed as medically serious by manufacturer (OMIC). This information was received via a statement of injuries.
Sex: F
Vaccine: LYME
Symptoms: Joint swelling, Nervous system disorder
Clinical narrative: This case was reported by a lawyer and described the occurrence of anemia in a female subject of unspecified age who was vaccinated with Lyme disease vaccine recombinant Lymerix for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Lymerix unknown. At an unspecified time after vaccination with Lymerix, the subject experienced pain and swelling in her joints, fatigue, anemia, possible neurological injuries, possible autoimmune disease, and decreased activities of daily life. At the time of reporting the outcome of the events were was unspecified. This case was assessed as medically serious by manufacturer (OMIC). This information was received via a statement of injuries.
Sex: F
Vaccine: LYME
Symptoms: Abnormal behaviour, Anaemia, Arthralgia, Autoimmune disorder, Blood glucose increased
Clinical narrative: This case was reported by a lawyer and described the occurrence of seizures in a female subject of unspecified age who was vaccinated with Lyme disease vaccine (Lymerix) for prophylaxis. A physician or other health care professional has not verified this report. On on unspecified date the subject received unspecified dose of Lymerix (unk). At an unspecified time after vaccination with Lymerix, the subject experienced pain and swelling in her joints, fatigue, rashes, gastrointestinal problems,  This case was reported by a lawyer and described the occurrence of anemia in a female subject of unspecified age who was vaccinated with a Lyme disease vaccine recombinant (Lymerix) for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Lymerix (unk). At an unspecified time after vaccination with Lymerix, the subject experienced pain and swelling in her joints, fatigue, rashes ,gastrointestinal problems, blood sugar problems, vertigo, seizure, possible neurological injuries, possible autoimmune disease, and decreased activities of daily life. At the time of reporting the outcome of the events were unspecified. This case was assessed as medically serious by manf. (OMIC) This information was received via a statement of injuries.
Sex: F
Vaccine: LYME
Symptoms: Convulsion, Fatigue, Gastrointestinal disorder, Joint swelling, Nervous system disorder
Clinical narrative: This case was reported by a lawyer and described the occurrence of seizures in a female subject of unspecified age who was vaccinated with Lyme disease vaccine (Lymerix) for prophylaxis. A physician or other health care professional has not verified this report. On on unspecified date the subject received unspecified dose of Lymerix (unk). At an unspecified time after vaccination with Lymerix, the subject experienced pain and swelling in her joints, fatigue, rashes, gastrointestinal problems,  This case was reported by a lawyer and described the occurrence of anemia in a female subject of unspecified age who was vaccinated with a Lyme disease vaccine recombinant (Lymerix) for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Lymerix (unk). At an unspecified time after vaccination with Lymerix, the subject experienced pain and swelling in her joints, fatigue, rashes ,gastrointestinal problems, blood sugar problems, vertigo, seizure, possible neurological injuries, possible autoimmune disease, and decreased activities of daily life. At the time of reporting the outcome of the events were unspecified. This case was assessed as medically serious by manf. (OMIC) This information was received via a statement of injuries.
Sex: F
Vaccine: LYME
Symptoms: Rash, Vertigo
Clinical narrative: This case was reported by a lawyer and described the occurrence of seizures in a female subject of unspecified age who was vaccinated with Lyme disease vaccine (Lymerix) for prophylaxis. A physician or other health care professional has not verified this report. On on unspecified date the subject received unspecified dose of Lymerix (unk). At an unspecified time after vaccination with Lymerix, the subject experienced pain and swelling in her joints, fatigue, rashes, gastrointestinal problems,  This case was reported by a lawyer and described the occurrence of anemia in a female subject of unspecified age who was vaccinated with a Lyme disease vaccine recombinant (Lymerix) for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Lymerix (unk). At an unspecified time after vaccination with Lymerix, the subject experienced pain and swelling in her joints, fatigue, rashes ,gastrointestinal problems, blood sugar problems, vertigo, seizure, possible neurological injuries, possible autoimmune disease, and decreased activities of daily life. At the time of reporting the outcome of the events were unspecified. This case was assessed as medically serious by manf. (OMIC) This information was received via a statement of injuries.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Flushing, Visual disturbance
Clinical narrative: Lightheadedness, paleness, light focus in vision field.  Provided lollipop, animal crackers, water.  Patient recovered within seconds; patient had not eaten breakfast.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Flushing, Visual disturbance
Clinical narrative: Lightheadedness, paleness, light fluctuates in vision field.  Provided patient with lollipop, animal crackers, and water.  Patient recovered within seconds.  Patient had not eaten any breakfast.
Age: 1.69
Sex: M
Vaccine: IPV
Symptoms: Urticaria
Clinical narrative: Mom called office on 03/30/2006 and said that child had broke out in hives after his last shot on 03/22/2006.  Child broke out in hives, Mom said she talked to ER and they told her to give him Benadryl.
Age: 0.16
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Pyrexia
Clinical narrative: Woke up early this am with 105 temperature.  Mom took her to ER, but by the time Mom got there temperature was 100.  Given Tylenol and Mom reports at 3:45PM today that baby is doing good.
Age: 1.25
Sex: F
Vaccine: DTAP, MMR
Symptoms: Rash
Clinical narrative: Fine papular rash on trunk.
Age: 28.0
Sex: F
Vaccine: TTOX
Symptoms: Abdominal pain, Cellulitis, Nausea, Pyrexia, Vomiting
Clinical narrative: Cellulitis.  Treating with Keflex.  Fever, abdominal pain, nausea/vomiting.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Injection site induration, Injection site rash, Pyrexia
Clinical narrative: 03/22/2006 complained of fever and rash at vaccine sites.  Had fever 103 last night.  Left deltoid with induration, red, warm 7x5cm and 2x5.5 cm.
Age: 53.0
Sex: M
Vaccine: HEP
Symptoms: Asthenia, Chills, Cough, Pain, Tremor
Clinical narrative: Cough 1 day, extreme chills, bed shaking 2 hours extreme weakness, couldn't hardly get to bathroom and back to bed, this lasted 8-9 hours, pain in back of legs, left very weak for 2-3 after the onset.
Age: 1.03
Sex: M
Vaccine: MMR
Symptoms: Injection site erythema, Rash, Rash papular
Clinical narrative: ?MMR rash on 3/31/2006, IZ shot given on 3/31/2006 a few spots around shot small papules with erythema.
Age: 1.16
Sex: M
Vaccine: DTAP, HIBV, IPV, MMR
Symptoms: Drug ineffective, Rash
Clinical narrative: varicella rash on 03/24/2006, documentation in chart from previously having the varivax vaccine on 08/30/2000.
Age: 1.02
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Patient had varicella vaccine 01/23/2003 but today has obvious clinical varicella.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Oedema peripheral, Pain, Pruritus
Clinical narrative: Left arm on site of injection swollen red, hot, itchy, and painful.
Age: 7.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Swelling
Clinical narrative: 8-10cm erythema, swollen area.  Prescribed steroids and Augmentin.
Age: 1.97
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MMRV, PNC
Symptoms: Lymphadenopathy, Pyrexia, Rash
Clinical narrative: On Thursday 03/30/2006 sent from day care with temperature of 102 degrees.  Friday 100.5 degrees, Sunday 102 degrees.  Developed rash on cheeks, Sunday some on abdomen, back, and legs, lymph glands swollen.
Age: 3.0
Sex: F
Vaccine: DTAP, IPV, PNC
Symptoms: Feeling hot, Injection site erythema, Injection site oedema
Clinical narrative: Left leg are red, edema, warm to touch.