chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: RAB
Symptoms: Pityriasis rosea, Pruritus, Rash, Rash erythematous
Clinical narrative: A 16 year old female patient receiving a RabAvert post-exposure series, developed a rash. She was exposed to a rabid raccoon and received her first injection of RabAvert on 5/12/02. The patient received her fourth shot on 5/26/02 and developed some rashes on her back on 5/27/02. These rashes were dot size in the beginning and grew larger. They were raised, scaly, itchy, and not migrating. In the physician's opinion they were not hives. The patient had an existing dermatologic condition: pityriasis rosea, to which the physician suspected this incident is related. The physician wanted to rule out the possibility of an allergic reaction with RabAvert. The patient had no significant prior medical history and was not on any other medications. The physician assessed the events as possibly related to the RabAvert treatment. Follow-up information received 6/10/02: The physician confirmed that the event was not urticaria. There were no lab tests performed to rule out the possibility of an allergic reaction. The rash on the patient's back was considered to be pityriasis rosea. Benadryl was given for this reaction with little help except a decrease in itching. The patient did have a fifth dose of RabAvert without any problem. Follow-up information received 6/14/02: The physician confirmed that the event was pityriasis rosea, not related to RabAvert vaccine.
Age: 35.0
Sex: M
Vaccine: RAB
Symptoms: Back pain, Injection site erythema, Injection site induration, Injection site swelling, Muscle spasms
Clinical narrative: This 35 year old male patient experienced injection site reaction, muscle twitching and back spasm during post exposure RabAvert therapy. After the second injection, the patient experienced injection site reaction with induration, swelling and redness at the site injection. Following the third injection, he experienced back pain and muscle twitching for a short period of time after the injection. No further information is available.
Age: 35.0
Sex: M
Vaccine: RAB
Symptoms: Muscle twitching
Clinical narrative: This 35 year old male patient experienced injection site reaction, muscle twitching and back spasm during post exposure RabAvert therapy. After the second injection, the patient experienced injection site reaction with induration, swelling and redness at the site injection. Following the third injection, he experienced back pain and muscle twitching for a short period of time after the injection. No further information is available.
Age: 61.0
Sex: M
Vaccine: RAB, RAB
Symptoms: Chest discomfort, Pain, Pericarditis
Clinical narrative: A 61 year old male was exposed to a flying bat in the house while sleeping on 8/11/02. He had received post-exposure therapy following exposure to rabies. Following doses of Imovax and RabAvert, he experienced mediastinum pain and ache (pericarditis) after each dose of vaccine (Imovax and RabAvert). He had already received 4 doses of rabies vaccine. He is 12 years post atrial septal defect repair. Further information is pending. Additional information received on 9/17/02: The patient had used the word pericarditis for chest discomfort. This was not the diagnosis of the treating physician. There was no evidence of pericarditis as per this physician.
Age: 34.0
Sex: F
Vaccine: RAB
Symptoms: Arthralgia, Headache, Influenza like illness, Pyrexia
Clinical narrative: A 34 year old female patient developed severe flu-like symptoms, fever, joint pain, and headache following her second dose with RabAvert for pre-exposure prophylaxis. The patient received the first dose of RabAvert on 1/31/02. She also received 1 dose of Hepatitis B vaccine and a PPD injection at the same time. The patient received her second dose of RabAvert on 2/5/02, and had developed these adverse events. She had no past medical history, and the nurse didn't know of concurrent meds. The patient's symptoms were relieved with ibuprofen around the clock. The patient also took ibuprofen prior to the third RabAvert dose and throughout the day with minimal reaction.
Age: 52.0
Sex: M
Vaccine: RAB
Symptoms: Blister, Influenza like illness, Myalgia, Oral mucosal blistering, Swelling
Clinical narrative: A 52 year old male patient, who was bitten in the calf area by a dog, received treatment for post-exposure Rabies. He began his series one month ago (approximately 3/7/02). The patient experienced flu like symptoms following his first treatment. These symptoms subsided fairly quickly. Following the second treatment, the patient developed blisters on his gums and the roof of his mouth. His gums were also swollen. He developed a quarter sized blister on his forehead that had been progressing in size. He also experienced muscle pain. The patient was treated with a tetanus shot, Zithromax Z pack, and hydrocortisone for these symptoms. No other information is available. The events were assessed as possibly related to RabAvert, but not serious.
Age: 65.0
Sex: F
Vaccine: RAB
Symptoms: Headache, Malaise
Clinical narrative: A 65 year old female, who was scratched by a stray cat, received RabAvert, 1ml IM, and Human Rabies Immunoglobulin (HRIG) on 4/12/02 and 4/15/02. The patient developed severe headache and malaise after the second dose of the regimen. She had no significant past medical history. No other details were reported. The treating physician assessed the events as possibly related to the drugs administered.
Age: 31.0
Sex: F
Vaccine: RAB
Symptoms: Disturbance in attention, Headache
Clinical narrative: This 31 year old female patient experienced headache and concentration disorders after RabAvert injections for post exposure therapy. The patient was bit on the back of the neck by a bat and received RabAvert. The headache occurred 4 hours after the first injection. The patient's physician stated that this may be related to the HRIG (human rabies immunoglobulin) injected close to the skull area. The headache and concentration impaired reoccurred 17 hours after the second injection. No further information is available.
Age: 34.0
Sex: F
Vaccine: RAB
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Malaise
Clinical narrative: This 34 year old female patient experienced injection site reaction and malaise during post exposure RabAvert therapy. She received 4 injection of RabAvert. After each injection, the patient experienced injection site reaction with induration, swelling and redness at the site of injection associated with malaise preventing her to go to work. No further information is available.
Sex: U
Vaccine: PNC
Symptoms: Infection, Sepsis
Clinical narrative: A pediatrician reported that a child who received an injection of Prevnar developed pneumococcal sepsis two days post-immunization and subsequently died. No further info was available at the date of this report. *F/UP report on 3/31/03: Add'l info received on 1/14/03 from an MD provided further info about the event. Upon contacting the MD, the MD said that "he heard this story from a PT anecdotally." He had no info about the PT and indicated that he doesn't even know if this is a true story. The MD advised to disregard this report. No further info was available at the date of this report.
Age: 26.0
Sex: F
Vaccine: ANTH
Symptoms: Erythema, Pain, Pruritus
Clinical narrative: Anthrax dose number 4 10x10 cm erythema with 3-4 cm nodularity with pruritis and pain.  Treated with Allegra and Triamcinolone 0.1% topically per military protocol.  VAERS filed per protocol for LR4 reaction.
Age: 41.0
Sex: F
Vaccine: TD, TD
Symptoms: Erythema, Muscular weakness, Musculoskeletal stiffness, Oedema, Pain
Clinical narrative: Deep aching joints, hands and elbows. Red, swollen feet and ankles. Diagnosed at ER as Vasculitis. Reg. Dr. Said it was a severe reaction to the shot. I have residual weakness in my leg muscles and a frozen shoulder from where the shot was administered. One of the warning of the toxoid for tetanus hsould be if allergic to horses DO NOT take this shot.
Age: 41.0
Sex: F
Vaccine: TD, TD
Symptoms: Vasculitis
Clinical narrative: Deep aching joints, hands and elbows. Red, swollen feet and ankles. Diagnosed at ER as Vasculitis. Reg. Dr. Said it was a severe reaction to the shot. I have residual weakness in my leg muscles and a frozen shoulder from where the shot was administered. One of the warning of the toxoid for tetanus hsould be if allergic to horses DO NOT take this shot.
Age: 41.0
Sex: F
Vaccine: TD, TD
Symptoms: Arthralgia, Oedema, Pruritus, Rash, Serum sickness
Clinical narrative: Deep aching joints, hands and elbows. Red, swollen feet and ankles. Diagnosed at ER as Vasculitis. Reg. Dr. Said it was a severe reaction to the shot. I have residual weakness in my leg muscles and a frozen shoulder from where the shot was administered. One of the warning of the toxoid for tetanus hsould be if allergic to horses DO NOT take this shot.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Erythema, Feeling hot, Oedema, Pyrexia
Clinical narrative: Mother reports that child had fever on evening of 12/17 and swelling and redness of arm on 12/18.  Child was seen by doctor at Medical Center on 12/18 and Tylenol plus another medication (unknown) was prescribed.  Child was seen by vaccine provider on 12/19; left upper arm was markedly swollen, reddened and warm to touch.
Age: 0.5
Sex: M
Vaccine: DTAP, HEP, HIBV, PNC, DTAP, HEP, HIBV, PNC
Symptoms: Drug ineffective, Febrile convulsion, Sepsis
Clinical narrative: Additional information received on 10/22/02, from the reporting physician provided patient information, patient's date of birth, revised reporter's information, concomitant vaccine information, and past medical history. Information has been received from a pediatrician concerning a 21 month old male with a history of failure to thrive and a mild immune deficiency (he failed to develop hepatitis B antibodies after 3 doses). On 4/25/01, at 6 months of age, he received his third dose of Prevnar along with Hepatitis B (manufacturer unknown), DTaP (manufacturer unknown) and Hib (manufacturer unknown) vaccines. On 7/22/02, he experienced a febrile seizure. A culture was positive for Streptococcus pneumoniae, serotype 19F. He recovered.
Age: 0.5
Sex: M
Vaccine: DTAP, HEP, HIBV, PNC, DTAP, HEP, HIBV, PNC
Symptoms: Bacterial infection, Convulsion, Drug ineffective, Immune system disorder
Clinical narrative: Additional information received on 10/22/02, from the reporting physician provided patient information, patient's date of birth, revised reporter's information, concomitant vaccine information, and past medical history. Information has been received from a pediatrician concerning a 21 month old male with a history of failure to thrive and a mild immune deficiency (he failed to develop hepatitis B antibodies after 3 doses). On 4/25/01, at 6 months of age, he received his third dose of Prevnar along with Hepatitis B (manufacturer unknown), DTaP (manufacturer unknown) and Hib (manufacturer unknown) vaccines. On 7/22/02, he experienced a febrile seizure. A culture was positive for Streptococcus pneumoniae, serotype 19F. He recovered.
Age: 56.0
Sex: F
Vaccine: HEPAB, MEN, HEPAB, MEN
Symptoms: Cough, Dysphonia, Dyspnoea, Pruritus, Throat tightness
Clinical narrative: Started itching at approx 6pm 11/26. Developed hives soon after difficulty breathing, cough, wheezing, hoarseness, tightness in throat. Took 25mg Benadryl at 11pm 50mg Benadryl at 3am 11/27. Saw NP on 11/27 (7:30pm). No longer had hives, lungs clear.
Age: 56.0
Sex: F
Vaccine: HEPAB, MEN, HEPAB, MEN
Symptoms: Urticaria, Wheezing
Clinical narrative: Started itching at approx 6pm 11/26. Developed hives soon after difficulty breathing, cough, wheezing, hoarseness, tightness in throat. Took 25mg Benadryl at 11pm 50mg Benadryl at 3am 11/27. Saw NP on 11/27 (7:30pm). No longer had hives, lungs clear.
Age: 49.0
Sex: F
Vaccine: IPV
Symptoms: Drug toxicity, Dyspnoea, Lung disorder
Clinical narrative: Information has been received regarding a case in litigation concerning a 49 year old female with a history of toxic effect of asbestos who sometime in the 1980s was vaccinated with the poliovirus vaccine (site and route not reported). It was noted that from approximately 1967 to approximately 2001, the patient used a blow dryer to dry her hair at least twice a week. The patient was exposed to asbestos, asbestos containing products and the SV-40 virus. The patient felt these exposures caused severe and permanent injury, including but not limited to breathing difficulties, asbestosis, lung and/or other cancer, mesothelioma and or lung damage and death. In approximately 5/00 the patient was diagnosed with mesothelioma and subsequently died on 3/24/01 from mesothelioma, a condition related to exposure to asbestos and asbestos containing products and the SV-40 virus. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: DTAP
Symptoms: Rash, Stevens-Johnson syndrome
Clinical narrative: A physician reported the occurrence of Stevens Johnson syndrome in a 6 month old female who was vaccinated with Infanrix for prophylaxis. The subject's medical history and concurrent conditions were not reported. The subject began a 7 day course of Amoxil therapy for an unspecified indication 10 days prior to Infanrix administration. On 12/3/02, the subject received an injection of Infanrix; it was not known if the subject had received previous injections of Infanrix. later that day, the subject developed skin rashes. She was seen by the physician, who made a diagnosis of Stevens Johnson syndrome. As of 12/9/02, the event persisted. The reporting physician considered the event to be possibly realted to both Infanrix and amoxil administration. Stevens Johnson syndrome is considered medically serious (OMIC).
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Abortion spontaneous, Blood gonadotrophin increased
Clinical narrative: This report was received from a nurse and prospectively described a 24 year old  female who was vaccinated with hep B vaccine recombinant (Engerix B) for prophylaxis during the first trimester of pregnancy. The subject's medical history included allergy to Zyban. Concurrent medications were unknown. She experienced no adverse events following previous immunizations. On 11/6/02, the subject received her second injection of Engerix B (lot 5291A4). Unknown to the vaccine administor, the subject was pregnant at the time. Her last menstrual period was on 9/26/02. Additonal info was received on 12/10/02. On 11/16/02, the subject experienced a miscarriage at a gestatonal age of 5 weeks. The beta human chorionic gonadotrpin concentration was "never above 40 (units and reference range unspecified)." An ultrasound performed on 11/12/02 was "without fetal pole." The reporting nurse stated that the miscarriage was "probably not related" to Engerix B adminsistration because "cramping started before injection." Miscarriage is considered medically serious (OMIC). Therefore, this report has been reclassified as serious.
Age: 3.0
Sex: F
Vaccine: FLUX, VARCEL
Symptoms: Asthenia, Cough, Difficulty in walking, Sleep disorder
Clinical narrative: Information has been received from the mother of a 3 year old female patient who on approximately 11/26/02 was vaccinated with a dose of varicella virus vaccine live. That same day, approximately 11/26/02, the patient was concomitantly vaccinated with a dose of influenza virus vaccine. No other concomitant medications or concurrent conditions were noted. Subsequently, the patient was losing her ability to walk, had weakness on the right side of the body, was unable to sleep at night, developed some coughing and was digging at her ear as if she had pain. Unspecified medical attention was sought. According to the mother, the patient was getting worse. At the time of this report, the patient was to be seen by a neurologist. Upon internal review, the patient's abasia was considered an other medical event (OMIC). Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: VARCEL
Symptoms: Autism, Bacterial infection, Gastrointestinal disorder, Speech disorder
Clinical narrative: Information has been received from a consumer concerning a male child with no allergies, who in 04 May 2001 at one year of age, was vaccinated with a dose of varicella virus vaccine. On 8/6/01, the patient was vaccinated with a dose of MMR II. It was noted that the child also received other routine childhood vaccinations. Although it was reported that the child had no past medical history, it was also indicated that in approximately 11/00 at six to nine months of age, the patient began to develop the symptoms of autism. Additional information indicated an onset of symptoms od autism as Sept 2002. Unspecified medical attention was sought. On 12/3/02 at the age of approximately 31 months, the reporter indicated that the patient's current medical conditions included intestinal issues, gastrointestinal yeast infections and does not speak. Upon internal review, symptoms of autism were considered to be an other important medical event (OMIC) Additional information has been requested.
Sex: M
Vaccine: HEP, DTPHIB, HEP
Symptoms: Drug toxicity, Nervous system disorder
Clinical narrative: Information has been received regarding a case in litigation concerning a male child who was injected with vaccinations containing the toxic mercury based preservative thimerosal from 4/99 through at least 10/00. The alleged result of these vaccinations is that the patient suffers from and in the future will continue to suffer the toxic neurological effects of mercury poisoning. Immunization information reported that the patient was vaccinated with hepatitis B vaccine recombinant (yeast) (lot numbers not reported) on 6/18/99 and approximately 12/16/99. Other immunizations included hepatitis B vaccine, recombinant (ENGERIX B)(lot 3ENG2712A2) on 4/19/99; diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid and HIB conjugate vaccine on 6/18/99; diphtheria toxoid (+) haemophilus B conjugate vaccine (+) pertussis vaccine (+) tetanus toxoid (TETRAMUNE VACCINE) on 8/17/99; diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid and HIB conjugate vaccine on 10/18/1999; HIB conjugate vaccine on 4/18/00; and diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid on 10/18/00. Upon internal review, mercury poisoning and neurological disorder were considered to be other important medical events (OMIC). No further information is available.
Sex: M
Vaccine: HEP, DTPHIB, HEP
Symptoms: Drug toxicity, Nervous system disorder
Clinical narrative: Information has been received regarding a case in litigation concerning a male child who was injected with vaccinations containing the toxic mercury-based preservative thimerosal from March 1998 through at least June 1999. The alleged result of these vaccinations is that the pt suffers from and in the future will continue to suffer the toxic neurological effects of mercury poisoning. Immunization info reported that the pt was vaccinated with the hep B vaccine recombinant (lot number not reported) on 9/14/98. Other immunizations included hep b vaccine, recombinant (Engerix B) (lot 2499A2) on 3/9/98; diphtheria toxoid+pertussis vaccine+tetanus toxoid on 5/8/98; diphtheria toxoid+pertussis vaccine+tetanus toxoid on 7/8/98; diphtheria toxoid+haemophilus b conjugate vaccine+pertussis vaccine+tetanus toxoid (Tetramune vaccine) on 9/14/98; diphtheria toxoid+pertussis vaccine+tetanus toxoid and Hib conjugate vaccine on 6/18/99. Upon internal review, mercury poisoning and neurological disorder were considered to be other important medical events (OMIC). No further info is available.
Sex: M
Vaccine: DTAP, HEP, HIBV
Symptoms: Drug toxicity, Nervous system disorder
Clinical narrative: Information has been received regarding a case in litigation concerning a male child who was injected with vaccinations containing the toxic mercury-based preservative thimerosal from August 1984 through at least September 1999. The alleged result of these vaccinations is that the patient suffers from and in the future will continue to suffer the toxic neurological effects of mercury poisoning. Immunization information reported that the patient was vaccinated with hepatitis B vaccine recombinant (yeast) (lot number not reported) on 8/8/94 and 9/27/94. Other vaccinations included diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid and HIB conjugate vaccine on 9/27/94, 12/6/94, 3/3/95 and 12/13/95; diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid on 12/9/99. Upon internal review, mercury poisoning and neurological disorder were considered to be other important medical events (OMIC). No further information is available.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Fatigue, Lymphadenopathy, Mucous membrane disorder, Neck pain
Clinical narrative: Pt states was "out of it" for three days post flu vaccine. States was tired and not up to par. Started after that had thick throat with swollen glands, back and neck pain, dry membranes x 1 month. Has not been to MD. Pt states has had previous flu vaccines without any problems.
Age: 91.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Decreased appetite, Dry throat, Myalgia, Pyrexia
Clinical narrative: Fever, chills, muscle aches, scartchy throat, poor appetitie x 2 weeks.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site oedema, Injection site swelling
Clinical narrative: Large (3 1/2x3inches) raised red swollen red area surrounding injection site.
Age: 2.75
Sex: F
Vaccine: DTAPH, FLU3
Symptoms: Agitation, Cellulitis, Injection site erythema, Injection site mass, Injection site oedema
Clinical narrative: 10/11/02 woke up from sleep crying. L arm red, swollen with lump. Taken to instacare, dx. cellulitis. Rx with Cephalexis.
Age: 2.75
Sex: F
Vaccine: DTAPH, FLU3
Symptoms: Injection site reaction
Clinical narrative: 10/11/02 woke up from sleep crying. L arm red, swollen with lump. Taken to instacare, dx. cellulitis. Rx with Cephalexis.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site hypersensitivity, Pruritus
Clinical narrative: Pt had a flu shot at a community clinic 11/7/02. On 12/19/02 pt's wife called that pt developed itching at site on day following flu shot. Has seen family doctor on 2 occasions since, still itching. Will see dermatologist 12/20/02 as itching now involves much of bout.
Age: 0.8
Sex: M
Vaccine: PNC
Symptoms: Agitation, Crying, Pyrexia
Clinical narrative: Fever to 102 deg, crying, screaming every hour occurring two days after vaccination.
Age: 2.0
Sex: M
Vaccine: HIBV
Symptoms: Injection site oedema
Clinical narrative: L arm was swollen, very swollen x 5 days. Pt got better after the 5th day.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Vaccines given to L deltoid, 12/18/02 . On 12/19/02 teacher noted swollen, redness, warm L deltoid area. No improvement and symptom with cool compresses and Tylenol 12/20/02 L deltoid extremely swollen, redness to L elbow and L anterior shoulder, no prescribed antibio, tx.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: 12/6/02 at 3:15pm presented to window left arm red and swollen. Child denied pain. Advised to go to ER dept.
Age: 21.0
Sex: F
Vaccine: MMR
Symptoms: Difficulty in walking, Erythema nodosum
Clinical narrative: "Huge Massive" bumps on legs below both knees-3 on left side, 2 on right side, hard to walk. Pt had treatment at a hospital-not student health. Bumps still present. Dx "erythema nodosum."
Age: 69.0
Sex: F
Vaccine: TD
Symptoms: Injection site pain
Clinical narrative: Achy, severe local reaction in left deltoid area. Rx cool compresses, Allegra.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Crying, Irritability, Pyrexia, Screaming
Clinical narrative: Right after the injection he fussed, then approximately 3 hrs post injection-lasting 3 hours with child screamed ran a temp 101 for four days.
Age: 0.4
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Rash erythematous, Urticaria
Clinical narrative: Intermittent hives and erythematous rash x two day.
Age: 1.25
Sex: F
Vaccine: HIBV, MMR, PNC
Symptoms: Apnoea, Febrile convulsion, Pyrexia
Clinical narrative: Patient has a history of a febrile seizure at 10 months old. Developed fever for 9 days after MMR. Had a prolonged seizure with apnea. Was demonstrating decerebrate posturing following posticital phase.
Age: 1.0
Sex: M
Vaccine: IPV, PNC, VARCEL, IPV, PNC, VARCEL
Symptoms: Bacterial infection, Drug ineffective
Clinical narrative: Follow up information received 10/14/02 from physician contained dates of Prevnar immunization and complete vaccination record of patient. A physician reported that a 2 year old male child received a 4th dose of Prevnar (pneumococcal 7-valent conjugate vaccine), 1st dose of Varivax, 3rd dose of Polio vaccine on 3/19/01, when he was 12 months old. On 8/23/02, the child's blood culture was positive for Streptotoccal pneumoniae. He was treated with IM ceftriaxone sodium and high doses of amoxicillin. The organism was penicillin sensitive. A serotype is pending. The patient's experience was considered to be life-threatening. On 12/3/01, the patient also had positive blood cultures for Streptococcal pneumoniae. See case HQ4203613SEP2002. No additional information was available as of the date of this report. Follow-up information received 04Mar2003 from physician stated that serotyping was not done following child's first episode of invasive pneumococcal disease. Serotyping performed by CDC following second episode of invasive pneumococcal disease identified serotype 23B (not a Prevnar serotype. Follow-up received 02Dec2002 contained quality control results (satisfactory) for Prevnar lot numbers. Follow-up information received 14Oct2002 from physician contained dates of Prevnar immunization and complete vaccine record of patient.
Age: 1.0
Sex: M
Vaccine: IPV, PNC, VARCEL, IPV, PNC, VARCEL
Symptoms: Infection, Sepsis
Clinical narrative: Follow up information received 10/14/02 from physician contained dates of Prevnar immunization and complete vaccination record of patient. A physician reported that a 2 year old male child received a 4th dose of Prevnar (pneumococcal 7-valent conjugate vaccine), 1st dose of Varivax, 3rd dose of Polio vaccine on 3/19/01, when he was 12 months old. On 8/23/02, the child's blood culture was positive for Streptotoccal pneumoniae. He was treated with IM ceftriaxone sodium and high doses of amoxicillin. The organism was penicillin sensitive. A serotype is pending. The patient's experience was considered to be life-threatening. On 12/3/01, the patient also had positive blood cultures for Streptococcal pneumoniae. See case HQ4203613SEP2002. No additional information was available as of the date of this report. Follow-up information received 04Mar2003 from physician stated that serotyping was not done following child's first episode of invasive pneumococcal disease. Serotyping performed by CDC following second episode of invasive pneumococcal disease identified serotype 23B (not a Prevnar serotype. Follow-up received 02Dec2002 contained quality control results (satisfactory) for Prevnar lot numbers. Follow-up information received 14Oct2002 from physician contained dates of Prevnar immunization and complete vaccine record of patient.
Age: 1.0
Sex: M
Vaccine: IPV, PNC, VARCEL, IPV, PNC, VARCEL
Symptoms: Bacterial infection, Drug ineffective
Clinical narrative: Follow-up info received 10/14/02 contained dates of Prevnar immunizations, copy of vaccine record, and pt's birth weight. A physician reported that a 2 year old male child received a 4th dose of Prevnar, 3rd dose of Polio vaccine and 1st dose of Varivax vaccines on 3/19/01, when he was 12 months old. On 12/3/01, the child's blood cultures was positive for Streptococcal pneumoniae. The pt's experience was considered to be life-threatening. On 8/23/02, the pt again had positive blood cultures for Streptococcal pneumoniae. See case HQ4165511SEP2002. No additional info was available as of the date of this report.
Age: 1.0
Sex: M
Vaccine: IPV, PNC, VARCEL, IPV, PNC, VARCEL
Symptoms: Infection, Sepsis
Clinical narrative: Follow-up info received 10/14/02 contained dates of Prevnar immunizations, copy of vaccine record, and pt's birth weight. A physician reported that a 2 year old male child received a 4th dose of Prevnar, 3rd dose of Polio vaccine and 1st dose of Varivax vaccines on 3/19/01, when he was 12 months old. On 12/3/01, the child's blood cultures was positive for Streptococcal pneumoniae. The pt's experience was considered to be life-threatening. On 8/23/02, the pt again had positive blood cultures for Streptococcal pneumoniae. See case HQ4165511SEP2002. No additional info was available as of the date of this report.
Age: 1.25
Sex: M
Vaccine: PNC
Symptoms: Convulsion
Clinical narrative: Additional info received on 10/17/02, provided quality assurance lab results. A pediatrician reported that a 15 month old male recieved his fourth dose of Prevnar on 9/6/02. He also received Haemophilus influenzae B (manuf unk) vaccine within four weeks of Prevnar. On 9/7/02, he experienceda seizure. This event is considered medically important (OMIC).
Age: 1.4
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Infection, Laboratory test abnormal, Pyrexia, Sepsis
Clinical narrative: Follow-up info received 10/9/02 from physician reported patient's birth weight and recovery status. Follow up info received 10/4/02 from physician. The isolate from this pt is type 38 (not a Prevnar serotype). Additional info received 9/25/02 from physician. Information contained lot numbers and dates of Prevnar immunizations, additional immunizations received, pt age and gender, laboratory data and treatment medications. A physician reported that a 22 month old male received a 4th dose of Prevnar, HibTiter, and a firt dose of MMR II vaccine vaccines on 4/11/02 when he was 17 months old. The child presented at the physician's office with a fever of 104 deg F. On 9/17/02, a blood culture was performed and Strep. pnumonia was isolated. Laboratory data include: platelet count of 275,000 white blood cell count of 16.4, poly of 71, B of 3, hemoglobin of 11.4, mnocyte count of 8, lymphocyte count of 18 and haematocrit of 33. He was treated with Omnicef. He recovered. An infectious disease physician has the isolate on a slant and is willing to ship it where ever needed. No additional info was available as of the date of this report.
Age: 0.5
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Coma, Diarrhoea, Infection, Pharyngitis, Pyrexia
Clinical narrative: Follow-up info received from the physician on 10/23/02 provided serotype. A physician reported that a 6 month old male received his third dose of Prevnar on 7/16/02. Concomitant therapy included Act-Hib, Tripedia, IPOL and Recombivax-HB. On 9/15/02, at 8 months of age, he developed a fever. On 9/17/02, he was seen by the physician; he had a one week history of a cold and presented with vomiting, diarrhea, and a fever of 103.5 deg F. He was treated with acetaminophen. On the morning of 9/18/02, he was found unresponsive. He was taken to the ER and admitted to the ICU. His temperature ranged from 102.2 to 104 deg F. A white blood cell count was 2000. A spinal tap revealed open pressure, blew tube and stopped at 40cm, turbid fluid, protein 250, glucose 20, 8 white blood cells. A blood cultures and cerebrospinal fluid culture revealed Streptococcus pneumoniae serotype 19A. Serotype results are pending. Later that same day, he died.
Age: 0.5
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Rhinitis, Sepsis, Vomiting
Clinical narrative: Follow-up info received from the physician on 10/23/02 provided serotype. A physician reported that a 6 month old male received his third dose of Prevnar on 7/16/02. Concomitant therapy included Act-Hib, Tripedia, IPOL and Recombivax-HB. On 9/15/02, at 8 months of age, he developed a fever. On 9/17/02, he was seen by the physician; he had a one week history of a cold and presented with vomiting, diarrhea, and a fever of 103.5 deg F. He was treated with acetaminophen. On the morning of 9/18/02, he was found unresponsive. He was taken to the ER and admitted to the ICU. His temperature ranged from 102.2 to 104 deg F. A white blood cell count was 2000. A spinal tap revealed open pressure, blew tube and stopped at 40cm, turbid fluid, protein 250, glucose 20, 8 white blood cells. A blood cultures and cerebrospinal fluid culture revealed Streptococcus pneumoniae serotype 19A. Serotype results are pending. Later that same day, he died.
Age: 0.5
Sex: M
Vaccine: PNC
Symptoms: Bacterial infection, Drug ineffective, Laboratory test abnormal, Meningitis, Pyrexia
Clinical narrative: Follow up information provided results of laboratory tests, treatment, and an additional event. A physician reported that a 6 month old male received his third injection of Prevnar on 6/25/02. On 10/3/02, at 9 months of age, the infant developed a fever and vomiting. At that time, laboratory results showed a white blood cell count of 59,000 and a diagnosis of meningitis was made. The following day, the infant was hospitalized where blood and CSF cultures were positive for Streptococcus pneumoniae, serotype 19F. Results of a lumbar puncture revealed a WBC count of 2240, glucose level of 11, and protein level of 111. A CSF fluid gram stain showed many WBC's and gram positive diplococci. Treatment included ceftriaxone, vancomycin, and rifampin. He was discharged on 10/10/02.
Age: 0.5
Sex: M
Vaccine: PNC
Symptoms: Vomiting, White blood cell count increased
Clinical narrative: Follow up information provided results of laboratory tests, treatment, and an additional event. A physician reported that a 6 month old male received his third injection of Prevnar on 6/25/02. On 10/3/02, at 9 months of age, the infant developed a fever and vomiting. At that time, laboratory results showed a white blood cell count of 59,000 and a diagnosis of meningitis was made. The following day, the infant was hospitalized where blood and CSF cultures were positive for Streptococcus pneumoniae, serotype 19F. Results of a lumbar puncture revealed a WBC count of 2240, glucose level of 11, and protein level of 111. A CSF fluid gram stain showed many WBC's and gram positive diplococci. Treatment included ceftriaxone, vancomycin, and rifampin. He was discharged on 10/10/02.
Sex: U
Vaccine: PNC
Symptoms: Meningitis
Clinical narrative: A physician reported that an infant received a dose of Prevnar on an unknown date. At 18 months of age, the infant developed pneumococcal meningitis. No further information was available at the date of this report.
Sex: U
Vaccine: PNC
Symptoms: Infection
Clinical narrative: The patient's experience was considered medically important. Information has been received from a physician via a company representative concerning a child (age and gender unspecified) who received a dose of Prevnar on an unspecified date. The child subsequently developed a pneumococcal infection. Laboratory/diagnostic test results were not provided.
Age: 1.5
Sex: F
Vaccine: PNC
Symptoms: Cyanosis, Difficulty in walking, Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: A pediatrician reported that an 18 month old female received her fourth injection of Prevnar on 8/6/02 and developed a fever and an injection site reaction characterized by *redness and swelling 2.5 hrs post vax.* The reporter stated that the fever persisted for 2 days, and, the leg that was injected swelled to two times the size of the child's other leg, was non-tender, and had a bluish hue within 2 days. The child reportedly refused to walk for 2 days, then started walking again. *She recovered. No further info was available at the date of this report.*
Age: 1.5
Sex: F
Vaccine: PNC
Symptoms: Peripheral vascular disorder, Pyrexia
Clinical narrative: A pediatrician reported that an 18 month old female received her fourth injection of Prevnar on 8/6/02 and developed a fever and an injection site reaction characterized by *redness and swelling 2.5 hrs post vax.* The reporter stated that the fever persisted for 2 days, and, the leg that was injected swelled to two times the size of the child's other leg, was non-tender, and had a bluish hue within 2 days. The child reportedly refused to walk for 2 days, then started walking again. *She recovered. No further info was available at the date of this report.*
Age: 4.0
Sex: F
Vaccine: PNC
Symptoms: Oedema peripheral, Urticaria
Clinical narrative: A nurse reported that a 4 year old female received a dose of Prevnar vaccine on 9/27/02. The child has a cochlear implant and received Prevnar to decrease the risk of meningitis. On 10/3/02, she developed hives covering her body, swollen hands and feet. Additional information received from the reporter on 10/28/02, changed the date of event onset, gender and provided clarifying information about event. The reporter stated that urticaria was generalized but was more evident at the injection site.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, PPV
Symptoms: Injection site reaction, Pyrexia
Clinical narrative: A healthcare professional reported that a 4 month old male received a dose of Hib-TITER, Pneumovax 23, DTaP, and IPV vaccines on 10/14/02. That same day, the patient developed a fever and an unspecified injection site reaction. The events were managed with Motrin (ibuprofen), Tylenol (acetaminophen), and cold compresses. It was also noted that the child was inadvertently administered Pneumovax 23 instead of Prevnar.
Age: 1.5
Sex: M
Vaccine: DTAP, PNC
Symptoms: Erythema multiforme, Injection site erythema, Injection site reaction, Injection site swelling, Pyrexia
Clinical narrative: A nurse reported that an 18 month old male received an injection of Prevnar (pneumococcal 7-valent conjugate vaccine) in the leg on 10/25/02. Concomitant therapy included DTaP in the opposite leg. On 10/27/02, he developed a fever and injection site reactions characterized by redness, swelling, and tenderness at both sites on the legs. On that same day, the child was returned to the physician's office. On 10/28/02, the child developed a red rash and blotches the size of a small fingernail on the torso. He was examined by a physician and treated for his symptoms. On 10/29/02, the reporter indicated that the temperature was fine and the rash was worse. On 10/29/02, a diagnosis of erythema multiforme was made. The physician noted that the event was related to the herpes infection of the mouth and not related to the administration of the vaccines. The child was referred to a pediatrician. He recovered.
Age: 1.5
Sex: M
Vaccine: DTAP, PNC
Symptoms: Rash, Rash macular
Clinical narrative: A nurse reported that an 18 month old male received an injection of Prevnar (pneumococcal 7-valent conjugate vaccine) in the leg on 10/25/02. Concomitant therapy included DTaP in the opposite leg. On 10/27/02, he developed a fever and injection site reactions characterized by redness, swelling, and tenderness at both sites on the legs. On that same day, the child was returned to the physician's office. On 10/28/02, the child developed a red rash and blotches the size of a small fingernail on the torso. He was examined by a physician and treated for his symptoms. On 10/29/02, the reporter indicated that the temperature was fine and the rash was worse. On 10/29/02, a diagnosis of erythema multiforme was made. The physician noted that the event was related to the herpes infection of the mouth and not related to the administration of the vaccines. The child was referred to a pediatrician. He recovered.
Age: 1.3
Sex: F
Vaccine: PNC
Symptoms: Eye swelling, Urticaria
Clinical narrative: A nurse practitioner reported that a 16 month old female received a 3rd dose of Prevnar (pneumococcal 7-valent conjugate vaccine) on 11/19/02 in her left thigh. Within 4-5 hours of administration, the child developed hives on the opposite leg, which spread to the other leg and her trunk. She also developed swelling around the eyes. *F/UP report on 3/31/03: The urticaria resolved w/in 24 hrs of exam and the child recovered.*
Sex: U
Vaccine: HIBV, PNC
Symptoms: Injection site oedema
Clinical narrative: A nurse reported that a child received injections of Hib-Titer vaccine (haemophilus b conjugate vaccine) and Prevnar (pneumococcal 7-valent conjugate vaccine) and subsequently developed a swollen leg from the site of injection to the ankle. Both Prevnar and Hib-Titer were injected into the leg. As of the date this was reported, no further information was available.
Age: 4.0
Sex: F
Vaccine: PNC
Symptoms: Urticaria, Viral infection
Clinical narrative: A nurse reported that a 4 year old female received a first dose of Prevnar (pneumococcal 7-valent conjugate vaccine) on 9/27/02. Medical history included congenital cytomegalovirus and cochlear implants in 11/00. On 10/4/02, the child developed hives. The child has recovered.
Age: 0.6
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Retching, Vomiting
Clinical narrative: A physician reported that a 7 month old male received his firt doses of Prevnar, HibTiter, and Infanrix vaccines on 8/12/02. Approximately 24 hrs post-vaccination, the infant developed *"severe"* vomiting and retching. *The infant recovered.* This child also developed vomiting and retching following receipt of a subsequent dose of prevnar.
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Agitation, Injection site erythema, Injection site oedema, Injection site reaction
Clinical narrative: A mother reported that her son received doses of Prevnar, HibTiter, DTaP (manuf unk) and IPV (manuf unk) vaccines. Subsequent to administration, her son developed injection site reactions characterized by redness and swelling and also experienced inconsolable crying. No further info was available at the date of the report.
Age: 0.75
Sex: M
Vaccine: HEP, PNC
Symptoms: Retching, Vomiting
Clinical narrative: A physician reported that a 9 month old male received his second doses of Prevnar and Engerix B vaccines on 10/22/02. Concomitant therapy included Amoxicillin. Approximately 24 hours post vaccination, the infant developed vomiting and retching. This child also developed vomiting and retching following receipt of a previous dose of Prevnar. See HQ4818225OCT2002. Information regarding this event has been forwarded to manufacturer of Engerix B.
Age: 2.0
Sex: F
Vaccine: PNC
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Irritability
Clinical narrative: A nurse reported that a 2 year old female received a dose of Prevnar on 11/12/02. On 11/13/02, the child's mother called to report that there was a "red, hard and sore area" around her child's injection site. On 11/14/02, the mother reported that the area was slightly larger "4 inches in diameter," and the child was "fussy." *The child recovered.* This is one of two children from this facility who experienced a similar reaction following receipt of Prevnar lot 485-989 on the same day.
Age: 1.5
Sex: F
Vaccine: PNC
Symptoms: Injection site erythema, Injection site pain, Irritability, Pyrexia
Clinical narrative: A nurse reported that an 18 month old female received an injection of Prevnar on 11/12/02 in the right deltoid. On 11/13/02, the child developed a fever to 102.4 deg F, fussiness, and an injection site reaction characterized by a "2 inch" area of redness and soreness. On 11/14/02, the mother indicated that the child's temperature was 99 deg F. *She recovered* This is one of two patients from the same facility who experienced this event following the receipt of Prevnar lot 485-989.
Age: 41.0
Sex: F
Vaccine: TD, TD
Symptoms: Erythema, Muscular weakness, Musculoskeletal stiffness, Oedema, Pain
Clinical narrative: Itching and swelling of feet and ankles. Joint pain in shoulders, wrists, fingers, hips, knees, ankles, and feet. A Red rash. Serum sickness.
Age: 41.0
Sex: F
Vaccine: TD, TD
Symptoms: Vasculitis
Clinical narrative: Itching and swelling of feet and ankles. Joint pain in shoulders, wrists, fingers, hips, knees, ankles, and feet. A Red rash. Serum sickness.
Age: 41.0
Sex: F
Vaccine: TD, TD
Symptoms: Arthralgia, Oedema, Pruritus, Rash, Serum sickness
Clinical narrative: Itching and swelling of feet and ankles. Joint pain in shoulders, wrists, fingers, hips, knees, ankles, and feet. A Red rash. Serum sickness.
Age: 4.0
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Agitation, Dyskinesia, Pyrexia, Screaming, Staring
Clinical narrative: Mother reports tht child cried for 4 hrs straight, had staring of eyes, jerking of hands, fever and protruding of her tongue.
Age: 42.0
Sex: M
Vaccine: SMALL
Symptoms: Aplastic anaemia, Fatigue, Injection site erythema, Injection site hypersensitivity, Injection site oedema
Clinical narrative: Petechiae and fatigue led to CBC subsequent evaluation revealed aplastic anemia. 6/28, 7/1, and 7/5 vesicle (blister), swelling vaccine site. 7/2 and 7/3 muscle pain, itching on body. 7/11 scab vaccine site. 7/1 and 7/5 redness. 7/16 scab fell off. 7/1 itching vaccine site.  Per 60 ay follow up pt has not recovered. On treatment with anti ? globulin and cyclospaule with improvement in aplastic anemia. An annual follow up report received 01/13/2004 adds: Not recovered. We do not believe that the aplastic anemia is related to vaccine, but cannot exclude. Aplastic anemia has not resolved.
Age: 42.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site reaction, Injection site vesicles, Myalgia, Petechiae, Pruritus
Clinical narrative: Petechiae and fatigue led to CBC subsequent evaluation revealed aplastic anemia. 6/28, 7/1, and 7/5 vesicle (blister), swelling vaccine site. 7/2 and 7/3 muscle pain, itching on body. 7/11 scab vaccine site. 7/1 and 7/5 redness. 7/16 scab fell off. 7/1 itching vaccine site.  Per 60 ay follow up pt has not recovered. On treatment with anti ? globulin and cyclospaule with improvement in aplastic anemia. An annual follow up report received 01/13/2004 adds: Not recovered. We do not believe that the aplastic anemia is related to vaccine, but cannot exclude. Aplastic anemia has not resolved.
Age: 39.0
Sex: F
Vaccine: ANTH
Symptoms: Erythema, Oedema, Pruritus
Clinical narrative: left upper extremity red swollen, itchy
Age: 0.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema
Clinical narrative: Local erythema
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza
Clinical narrative: Patient received vaccine for Influenza A/B on 11/5/2002.  Upon recent admission, respiratory culture was obtained and came back positive for Influenza A by FA.
Age: 28.0
Sex: F
Vaccine: ANTH
Symptoms: Unintended pregnancy
Clinical narrative: Pt had a negative HCG the day she received the vaccine.  However, 5 days later, her HCG was positive and she had pregnant for 2 weeks prior.
Age: 21.0
Sex: M
Vaccine: HEPA, YF
Symptoms: Dyspnoea, Heart rate increased, Throat tightness, Urticaria
Clinical narrative: About 30 minutes after Yellow Fever and Hepatitis A vaccines administered, patient developed throat tightening, increased heart rate. Went on to develop SOB and hives.
Age: 20.0
Sex: F
Vaccine: YF
Symptoms: Erythema, Rash, Skin burning sensation
Clinical narrative: Slightly red, slightly flaky 5mmx5mm red patches x2 to eyes and border of upper lip; slight burning sensation.
Age: 24.0
Sex: M
Vaccine: ANTH
Symptoms: Pruritus, Urticaria
Clinical narrative: Welps appearing on legs, back, chest, sides and arms that are extremely itchy.  Symptoms have continued since 1 week after vaccination.  Itching is so severe that it interferes with sleep.  I get maybe 2 hours of sleep a night.
Age: 25.0
Sex: F
Vaccine: ANTH
Symptoms: Anorexia, Anxiety, Migraine, Muscle spasms, Nausea
Clinical narrative: Day 1-2: Nausea, tricep (Lateral head) cramp, bicep spasm, loss of appetite After 1st week: loss of appetite, migrain headaches, altered homeostasis, decrease energy levels, anxiety attacks Currently: loss of appetite, migrain headaches, decrease mood/energy, anxiety, irritability
Age: 40.0
Sex: M
Vaccine: ANTH
Symptoms: Rash
Clinical narrative: Rash appeared on patient's upper torso right and left, underarms and on arms on 23 December 2002.  Patient received shot 21 Dec 2002.  Patient was seen by doctor and he recommended Allegra for possible histamine reaction.
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain, Lymphadenopathy, Musculoskeletal stiffness, Pharyngolaryngeal pain
Clinical narrative: PAIN/STIFFNESS IN RIGHT ARM, SHOULDER AND NECK WITH LYNPHADENOPATHY AND SORE THROAT ON RIGHT SIDE.  TREAT IN AN OCCUPATIONAL HEALTH CLINIC WITH INJECTION OF CORTISONE AND PO MEDICATION