chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PNC
Symptoms: Bacterial infection, Drug ineffective, Pneumonia
Clinical narrative: This case was considered medically important (OMIC). Follow up information stated that on 7/1/04, the peds doc indicated that this case did not meet the criteria for vaccine failure. Information regarding Prevnar was received from a healthcare professional regarding a patient who experienced invasive pneumococcal pneumonia. The patient received a dose on an unspecified date. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose. Concomitant medications were not reported. The patient experienced invasive pneumococcal pneumonia. The reporter indicated that 3 children experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying information is received.
Sex: U
Vaccine: PNC
Symptoms: Bacterial infection, Drug ineffective, Pyrexia, Sepsis
Clinical narrative: Information regarding Prevnar was received from a pediatrician regarding a patient who received a third dose on an unspecified date and in December 2004 developed pneumococcal bacteremia. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was not provided. Concomitant medications were not reported. The patient received a third dose of Prevnar on an unspecified date. In December 2004, a blood culture was performed which was positive for Streptococcus pnuemoniae. On an unspecified date the infant was hospitalized with a diagnosis of pneumococcal bacteremia. After approximately two days of hospitalization, when the fever subsided, the patient was discharged. Treatment included 10 days of antibiotic therapy. The reporter indicated that the infant recovered. The reporter stated 1 or 2 infants experienced this event Additional reports will be generated when identifying information is provided. No additional information was available at the time of this report.
Age: 0.37
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Bacterial infection, Drug ineffective, Sepsis, White blood cell count increased
Clinical narrative: Follow up information received provided concomitant vaccination information. Information regarding Prevnar was received from a nurse regarding a 5 month old male patient who experienced pneumococcal septicemia. At 4 months of age, the patient received the second dose on 1/9/04. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 1/9/04. Dose regimen was 1 dose (IM). Concomitant vaccines included Tripedia, Comvax, and IPOL. On 2/18/04, the infant was hospitalized for pneumococcal septicemia. A blood culture was performed; Streptococcus pneumoniae was isolated. Laboratory tests performed on an unspecified date revealed a white blood cell count of 15,000 and a C-reactive protein of 6.9. The infant received a three-day course of unspecified IV antibiotics. On 2/21/04, he was discharged from the hospital on unspecified oral medications. He recovered. No additional information was available at the time of this report.
Age: 0.16
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Somnolence
Clinical narrative: Information regarding Prevnar was received from a consumer, the mother of an 8 week old male patient who received a first dose on 6/17/03. The patient also received a first dose of Tripedia, Act-HIB, and Polio vaccine on the same day, and was reported to have slept a lot post vaccination. The patient's concurrent illness includes haematochezia (suspected diary product allergy). Indication for Prevnar was immunization. Product was administered on 6/17/03. Dose regimen was 0.5ml 1 time per day (IM). Patient was not taking concomitant therapy. On 6/17/03, an 8 week old male patient received his first dose of Prevnar, Tripedia, Act-HIB, and IPOL. His mother reported that the slept a lot for a day or so following his first shot. Information regarding this event has been forwarded to the manufacturer of the concomitantly administered vaccines. No additional information was available at the time of this report.
Age: 0.16
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Abnormal behaviour, Crying, Grand mal convulsion, Pyrexia, Screaming
Clinical narrative: Information regarding Prevnar was received from a consumer, the mother of an 8 week old male patient who received a first dose on 6/17/03. The patient also received a first dose of Tripedia, Act-HIB, and Polio vaccine on the same day, and was reported to have slept a lot post vaccination. The patient's concurrent illness includes haematochezia (suspected diary product allergy). Indication for Prevnar was immunization. Product was administered on 6/17/03. Dose regimen was 0.5ml 1 time per day (IM). Patient was not taking concomitant therapy. On 6/17/03, an 8 week old male patient received his first dose of Prevnar, Tripedia, Act-HIB, and IPOL. His mother reported that the slept a lot for a day or so following his first shot. Information regarding this event has been forwarded to the manufacturer of the concomitantly administered vaccines. No additional information was available at the time of this report.
Age: 0.16
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Sleep disorder, Speech disorder
Clinical narrative: Information regarding Prevnar was received from a consumer, the mother of an 8 week old male patient who received a first dose on 6/17/03. The patient also received a first dose of Tripedia, Act-HIB, and Polio vaccine on the same day, and was reported to have slept a lot post vaccination. The patient's concurrent illness includes haematochezia (suspected diary product allergy). Indication for Prevnar was immunization. Product was administered on 6/17/03. Dose regimen was 0.5ml 1 time per day (IM). Patient was not taking concomitant therapy. On 6/17/03, an 8 week old male patient received his first dose of Prevnar, Tripedia, Act-HIB, and IPOL. His mother reported that the slept a lot for a day or so following his first shot. Information regarding this event has been forwarded to the manufacturer of the concomitantly administered vaccines. No additional information was available at the time of this report.
Age: 0.31
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Somnolence
Clinical narrative: Follow up information received from the infant's pediatrician provided lot numbers and sites of administration. Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a consumer, the mother of a male pt who at 16 weeks received a second dose on 11Aug03. The pt also received second doses of Tripedia (diphtheria/tetanus toxoid/acellular pertussis) vaccine, Acthib (haemophilus B conjugate (tetanus) vaccine and polio vaccine (poliomyelitis vaccine inactivated) on the same day and subsequently developed a fever and exhibited seizure activity and behavior changes. The pt's concurrent illnesses include Haematochezia and hypersensitivity (suspected allergy to dairy products). Indication for Prevnar, Tripedia, Acthib and polio was immunization. Products were administered on 11Aug03. Dose regimen was 1 dose. Pt was not taking concomitant therapy. On 11Aug03, a 16 week old male received a second dose of Prevnar and other childhood vaccines, and shortly after, developing a boiling fever (temp unk). The fever resolved with fever drops (possibly Tylenol). The reporter indicated that the child slept constantly for an unspecified amount of time. On 20Aug03, he experienced a seizure. On 21Aug03 the pt experienced a grand mal seizure and was evaluated in the ER. An electroencephalogram performed on 22Aug03 yielded normal results. On 23Aug03, the pt experienced another seizure and was admitted to the hospital overnight. A computerized tomogram was performed yielding normal results and a low dose of phenobarbital was initiated. The reporter indicated that when the child came home from the hospital, she noticed a dramatic change in pt experienced sleep problems and screamed a lot; he stopped cooing and appeared to have continuing language problems. An MRI performed in Oct2003 revealed normal results. After five months of treatment, the pt was weaned off of phenobarbital. The reporter indicated that the pt immediately exhibited pointing behavior and became sensitive to sound. The pt had not had another seizure since Aug 2003. On 03Sep04, he is scheduled to be evaluated for autism. Information regarding these events has been forwarded to manf, manf of the concomitantly administered vaccines.  Electroencephalogram (results: normal) was done on 22Aug03. Computerized tomogram (results: normal) was done on 23Aug03. Nuclear magnetic resonance imaging (results: normal) was done in Oct2003. See related case: HQWYE519218JUN04. No additional information was available at the time of this report.
Age: 0.31
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Abnormal behaviour, Crying, Grand mal convulsion, Pyrexia, Screaming
Clinical narrative: Follow up information received from the infant's pediatrician provided lot numbers and sites of administration. Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a consumer, the mother of a male pt who at 16 weeks received a second dose on 11Aug03. The pt also received second doses of Tripedia (diphtheria/tetanus toxoid/acellular pertussis) vaccine, Acthib (haemophilus B conjugate (tetanus) vaccine and polio vaccine (poliomyelitis vaccine inactivated) on the same day and subsequently developed a fever and exhibited seizure activity and behavior changes. The pt's concurrent illnesses include Haematochezia and hypersensitivity (suspected allergy to dairy products). Indication for Prevnar, Tripedia, Acthib and polio was immunization. Products were administered on 11Aug03. Dose regimen was 1 dose. Pt was not taking concomitant therapy. On 11Aug03, a 16 week old male received a second dose of Prevnar and other childhood vaccines, and shortly after, developing a boiling fever (temp unk). The fever resolved with fever drops (possibly Tylenol). The reporter indicated that the child slept constantly for an unspecified amount of time. On 20Aug03, he experienced a seizure. On 21Aug03 the pt experienced a grand mal seizure and was evaluated in the ER. An electroencephalogram performed on 22Aug03 yielded normal results. On 23Aug03, the pt experienced another seizure and was admitted to the hospital overnight. A computerized tomogram was performed yielding normal results and a low dose of phenobarbital was initiated. The reporter indicated that when the child came home from the hospital, she noticed a dramatic change in pt experienced sleep problems and screamed a lot; he stopped cooing and appeared to have continuing language problems. An MRI performed in Oct2003 revealed normal results. After five months of treatment, the pt was weaned off of phenobarbital. The reporter indicated that the pt immediately exhibited pointing behavior and became sensitive to sound. The pt had not had another seizure since Aug 2003. On 03Sep04, he is scheduled to be evaluated for autism. Information regarding these events has been forwarded to manf, manf of the concomitantly administered vaccines.  Electroencephalogram (results: normal) was done on 22Aug03. Computerized tomogram (results: normal) was done on 23Aug03. Nuclear magnetic resonance imaging (results: normal) was done in Oct2003. See related case: HQWYE519218JUN04. No additional information was available at the time of this report.
Age: 0.31
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Sleep disorder, Speech disorder
Clinical narrative: Follow up information received from the infant's pediatrician provided lot numbers and sites of administration. Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a consumer, the mother of a male pt who at 16 weeks received a second dose on 11Aug03. The pt also received second doses of Tripedia (diphtheria/tetanus toxoid/acellular pertussis) vaccine, Acthib (haemophilus B conjugate (tetanus) vaccine and polio vaccine (poliomyelitis vaccine inactivated) on the same day and subsequently developed a fever and exhibited seizure activity and behavior changes. The pt's concurrent illnesses include Haematochezia and hypersensitivity (suspected allergy to dairy products). Indication for Prevnar, Tripedia, Acthib and polio was immunization. Products were administered on 11Aug03. Dose regimen was 1 dose. Pt was not taking concomitant therapy. On 11Aug03, a 16 week old male received a second dose of Prevnar and other childhood vaccines, and shortly after, developing a boiling fever (temp unk). The fever resolved with fever drops (possibly Tylenol). The reporter indicated that the child slept constantly for an unspecified amount of time. On 20Aug03, he experienced a seizure. On 21Aug03 the pt experienced a grand mal seizure and was evaluated in the ER. An electroencephalogram performed on 22Aug03 yielded normal results. On 23Aug03, the pt experienced another seizure and was admitted to the hospital overnight. A computerized tomogram was performed yielding normal results and a low dose of phenobarbital was initiated. The reporter indicated that when the child came home from the hospital, she noticed a dramatic change in pt experienced sleep problems and screamed a lot; he stopped cooing and appeared to have continuing language problems. An MRI performed in Oct2003 revealed normal results. After five months of treatment, the pt was weaned off of phenobarbital. The reporter indicated that the pt immediately exhibited pointing behavior and became sensitive to sound. The pt had not had another seizure since Aug 2003. On 03Sep04, he is scheduled to be evaluated for autism. Information regarding these events has been forwarded to manf, manf of the concomitantly administered vaccines.  Electroencephalogram (results: normal) was done on 22Aug03. Computerized tomogram (results: normal) was done on 23Aug03. Nuclear magnetic resonance imaging (results: normal) was done in Oct2003. See related case: HQWYE519218JUN04. No additional information was available at the time of this report.
Sex: U
Vaccine: PNC
Symptoms: Bacterial infection, Drug ineffective
Clinical narrative: This case was considered medically important (OMIC). Information regarding Prevnar was received from a pediatrician regarding a patient who received two doses on unspecified dates and developed invasive Pneumococcal Disease. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on unspecified dates. Dose regimen was 1 dose (IM). Concomitant medications were not reported. A pediatrician reported that a patient received 2 doses of Prevnar, administered at 2 and 4 months of age (dates unspecified) and after several doses, developed invasive Pneumococcal Disease during an unspecified period of time. The reporter indicated that the patient recovered. No additional information was available at the time of this report.
Age: 0.62
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Bacterial infection, Convulsion, Drug ineffective, Pyrexia, Sepsis
Clinical narrative: Follow up information pertaining to the recovery status of the pt was received from the reporter. Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding a 21 month old male pt who experienced bacteremia, fever and convulsion. At 7 months of age, the pt received the second dose on 09Jan03. The pt also received the second dose of Polio vaccine (poliomyelitis vaccine inactivated), the second dose of Diphtheria/tetanus toxoids/acellular pertussis vaccine and the second dose of Comvax (haemophilus b conjugate vaccine/hep b vaccine) on 09Jan03. Pt has no birth defects; was a well baby at time of second Prevnar injection. Indication for Prevnar was immunization. Product was administered on 09Jan03. Dose regimen was 1 dose. Concomitant medications were not reported. On 07Mar04 the pt experienced a seizure with fever and was taken to the ER. The pt was subsequently hospitalized with bacteremia. Blood culture results were positive for Streptococcus pneumoniae, serotype 19F. The pt recovered and was discharged on 08May04. No additional information was available at the time of this report.
Age: 1.03
Sex: F
Vaccine: HIBV, MMR, PNC
Symptoms: Rash
Clinical narrative: Mom states that when pt woke up she had a rash around the hairline which progressed down her face and neck. When she woke from her nap the rash had spread down her back and abdomin.
Age: 13.0
Sex: M
Vaccine: TD, VARCEL
Symptoms: Erythema, Feeling hot, Injection site erythema, Pain
Clinical narrative: On 3/18/05, student received 1st varicella vaccine.  On 3/19/05, student returned to health service with redness of right arm from elbow to deltoid, which was hot and painful.  Area was treated with warm soaks and hydrocortisone cream and resolved.  Student was given 2nd dose of Varivax (Merck,lot # 0284P, SC, LA) on 04/18/05.  Student was given 50 mg of Benadryl prior to 2nd dose and developed approximately 1 cm of erythema around site the day after being vaccinated.
Age: 3.0
Sex: F
Vaccine: PNC
Symptoms: Rash
Clinical narrative: RASH STARTED 4-21-05, IS SPREADING. STARTED ON BACK. FAMILY QUESTIONED ABOUT ANYTHING NEW INTRODUCED TO CHILD FAMILY JUST STATED SHOT ON 4-18-05.
Sex: M
Vaccine: PNC
Symptoms: Drug ineffective, Sepsis
Clinical narrative: A nurse reported that a male patient received an injection of Prevnar vaccine and developed overwhelming sepsis. The patient received a dose on an unspecified date. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose. The reporter stated that the patient received at least one dose of Prevnar, maybe two. Concomitant medications were not reported. At the end of January 2004, a male patient developed overwhelming sepsis and was hospitalized. On an unspecified date, blood cultures were performed; results were positive. As of 3/8/04, the patient recovered. No additional information was available at the time of this report.
Age: 0.99
Sex: M
Vaccine: PNC, VARCEL
Symptoms: Bacterial infection, Drug ineffective, Meningitis
Clinical narrative: Follow up provided information regarding serotyping. Information regarding Prevnar was received from a healthcare professional regarding a 3 year old male who experienced pneumococcal meningitis. At 11 months of age, the patient received the fourth dose on 1/28/02. The patient had no relevant medical history. Indication for Prevnar was immunization. Product was administered on 1/28/02. Dose regimen was 1 dose (IM). Concomitant therapy included Varivax. In October 2004, the patient was hospitalized for pneumococcal meningitis. An unspecified culture revealed streptococcus pneumoniae. The patient was discharged after 5 days and continued treatment with Rocephin for a total of 14 days. The patient recovered. The reporter indicated that there is no information pertaining to the serotype of streptococcus pneumoniae in the patient's chart. The reporter did not believe serotyping was performed. The reporter considered this event to be life-threatening.
Age: 1.07
Sex: M
Vaccine: PNC
Symptoms: Bacterial infection, Drug ineffective, Sepsis
Clinical narrative: Follow up received from the physician provided information regarding serotyping. Information regarding Prevnar was received from a physician regarding a 4 year old male patient who developed pneumococcal bacteremia. At 12 months of age, the patient received the fourth dose on 6/11/01. The patient has no relevant medical history. Indication for Prevnar was immunization. Product was administered on 6/11/01. Dose regimen was 1 dose. Patient was not taking concomitant therapy. On 5/20/04, a 4 year old male patient developed pneumococcal bacteremia and was hospitalized. He was discharged from the hospital on 5/23/04. The reporter indicated that the patient has recovered. The reporter indicated that he has been unable to obtain serotype information for this patient. The reporter stated that the hospital worked with the local health department to forward isolates to the CDC. However, whenever the reporter calls the local health department, they have no information to provide him. No additional information was available at the time of this report.
Sex: U
Vaccine: PNC
Symptoms: Drug ineffective, Pneumonia
Clinical narrative: This case was considered medically important (OMIC). Information regarding Prevnar was received from a healthcare professional regarding a patient who experienced pneumonia and drug ineffective. The patient received the vaccine. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was not provided. Concomitant medications were not reported. The patient developed pneumonia on an unspecified date. The reporter stated that 16 patients in 19 days had been diagnosed with pneumonia from his clinic. All were under 2 years of age, and it was not known if each child had received doses of Prevnar. The reporter indicated that 16 children experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided. No additional information was available at the time of this report.
Sex: F
Vaccine: PNC
Symptoms: Bacterial infection, Drug ineffective, Meningitis
Clinical narrative: Information regarding Prevnar was received from a pediatrician regarding a 5 month old female patient who received a first dose of vaccine in 2004 and developed pneumococcal meningitis approximately March 2004. Relevant medical history was not reported. Indication for Prevnar was immunization. Product was administered in 2004. Dose regimen was 1 dose (IM). Concomitant medications were not reported. The patient was hospitalized in March 2004. A non-specific culture was performed; the results were positive for Streptococcus pneumoniae. A diagnosis of pneumococcal meningitis was made. The infant was treated with a 10 to 14 day IV regimen of unspecified antibiotics. As of 5/10/04, the reporter indicated that the infant now looks normal but is still under observation. No additional information was available at the time of this report.
Age: 1.26
Sex: M
Vaccine: HIBV, PNC, VARCEL
Symptoms: Bacterial infection, Drug ineffective, Lethargy, Meningitis, Pyrexia
Clinical narrative: Follow up information provided patient's recovery status and number of days hospitalized. Information regarding Prevnar was received from a medical assistant regarding a 15 month old male patient who received a first dose on 12/03/04 and developed pneumococcal meningitis. On the same day, the patient also received a second dose of Act-HIB and a first dose of Varivax. The patient had no relevant medical history. Indication for Prevnar was immunization. Product was administered on 12/3/04. Dose regimen was 0.5ml 1 time per day (IM). Concomitant vaccines included Act-HIB and Varivax administered on 12/3/04. The patient was not taking any concomitant medications. On 12/5/04, the patient experienced an episode of vomiting, lethargy, and developed a temperature of 103 degrees F. On 12/6/04, the patient was evaluated at the doctor's office; his temperature at that time was 103.6 degrees F. On the same day, he was admitted to the hospital and later that night was diagnosed with pneumococcal meningitis. The patient remained in the hospital 14 days. On 1/10/05, the reporter indicated that the patient recovered.
Age: 1.26
Sex: M
Vaccine: HIBV, PNC, VARCEL
Symptoms: Vomiting
Clinical narrative: Follow up information provided patient's recovery status and number of days hospitalized. Information regarding Prevnar was received from a medical assistant regarding a 15 month old male patient who received a first dose on 12/03/04 and developed pneumococcal meningitis. On the same day, the patient also received a second dose of Act-HIB and a first dose of Varivax. The patient had no relevant medical history. Indication for Prevnar was immunization. Product was administered on 12/3/04. Dose regimen was 0.5ml 1 time per day (IM). Concomitant vaccines included Act-HIB and Varivax administered on 12/3/04. The patient was not taking any concomitant medications. On 12/5/04, the patient experienced an episode of vomiting, lethargy, and developed a temperature of 103 degrees F. On 12/6/04, the patient was evaluated at the doctor's office; his temperature at that time was 103.6 degrees F. On the same day, he was admitted to the hospital and later that night was diagnosed with pneumococcal meningitis. The patient remained in the hospital 14 days. On 1/10/05, the reporter indicated that the patient recovered.
Age: 2.0
Sex: M
Vaccine: PNC
Symptoms: Bacterial infection, Drug ineffective
Clinical narrative: Follow up received from the physician provided information regarding serotyping. Information regarding Prevnar was received from a physician regarding a 26 month old male patient who developed pneumococcal bacteremia. At 24 months of age, the patient received the fourth dose on 7/16/04. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 7/16/04. Dose regimen was 1 dose. Concomitant medications were not reported. On 8/24/04, a 26 month old male patient developed pneumococcal bacteremia and was hospitalized. He was discharged from the hospital on 8/26/04. The reporter indicated that the patient has recovered. The reporter indicated that he has been unable to obtain serotype information for this patient. The reporter stated that the hospital worked with the local health department to forward isolates to the CDC. However, whenever the reporter calls the local health department, they have no information to provide him. The reporter indicated that this patient has returned to his office several times for infectious illnesses. The patient was worked up for immune deficiencies, however, nothing was found. No additional information was available at the time of this report.
Age: 1.01
Sex: F
Vaccine: PNC
Symptoms: Bacterial infection, Drug ineffective, Sepsis
Clinical narrative: Follow up information received from the physician provided patient identifiers, immunization dates, event onset date and revised serious criteria. Information regarding Prevnar was received from a healthcare professional regarding an 18 month old female who developed bacteremia. At 12 months of age, the patient received the fourth dose on 8/9/03. The child had no relevant medical history. Indication for Prevnar was immunization. Product was administered on 8/9/03. Dose regimen was 1 dose. The child was not taking concomitant therapy. On 2/27/04, the child developed pneumococcal bacteremia. The child was hospitalized for 2 days before fully recovering. The reporter indicated that the isolate was going to be sent to the CDC for typing.
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Bacterial infection, Meningitis, Sepsis
Clinical narrative: A nurse reported that a 7 month old female pt received an injection of Prevnar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) vaccine and developed pneumococcal meningitis. The pt received the third dose on 19Jan04. Relevant medical history was not provided.  Indication for Prevnar was immunization. Product was administered on 19Jan04. Dose regimen was 1 dose. Concomitant medications were not reported.  Concomitant vaccines administered on 19Jan04 included the third dose of diphtheria and tetanus toxoids and pertussis (manf unk) and the third dose of haemophilus influenzae b (manf unk). On 03Mar2004, a female pt developed pneumococcal meningitis. On the same day a blood culture was performed; results were not available. The following day, she was hospitalized. A CSF culture was performed; the results were not provided. The reporter indicated that the pt survived. No additional information was available at the time of this report. See related case(s): HQWYE652709MAR04 (adverse event, expedited).
Sex: M
Vaccine: PNC
Symptoms: Agitation, Diarrhoea, Medication error, Vomiting
Clinical narrative: Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine( diphtheria crml97 protein) injection) was received from a healthcare professional regarding a 9 month old male patinet who experienced agitation, diarrhea, vomiting. At 9 months of age, the pt received the fourth dose on 01/22/05 only 2 months after receipt of the third dose. Event Details: The patient was inadvertently administered a fourth dose only 2 months after receipt of the 3rd dose. He experienced agitation, diarrhea, and vomiting on 01/22/05. He was taken to the ER by his mother. He was given Rocephin and his vomiting worsened. The child's mother stated that he had received Rocephin before without complications. The child was released the same day.
Sex: F
Vaccine: PNC
Symptoms: Medication error, Rash
Clinical narrative: Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diphtheria crml97 protein) injection) was received from a healthcare professional regarding a 6 month old female patient who received possibly improperly stored Prevnar, and developed a rash on her chest and neck. The patient received the 3rd dose on 12/10/2004. Event Details: On 12/13/2004- 3 days post- immunization, the patient developed a rash on her chest and neck. The nurse stated that the Prevnar vaccine that was administered, was possibly improperly stored, as it had "arrived later than expected, and was stored at unknown temperatures before it was received on ice" The pt was prescribed Benadryl as needed for the symptoms. As of 12/13/04, there had been no change in the pt's condition. No additional information was available at the time of this report.
Age: 0.35
Sex: F
Vaccine: DTAP, PNC
Symptoms: Injection site haemorrhage, Injection site mass, Injection site reaction, Urticaria
Clinical narrative: Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine) was received from a healthcare professional regarding a 16 month old female pt who experienced an injection site reaction characterized by a lump, ithcing, and bleeding. The patinet received a dose on 05/01/03. Event Details: On 05/01/03- at an unspecified time post immunization, the pt developed an injection site reaction characterized by a lump, ithcing, and bleeding. The pt was examined at a physician's office. The events were unresolved at the time of reporting. No additional information was available at the time of this report.
Sex: M
Vaccine: PNC
Symptoms: Angioneurotic oedema, Dry skin, Hypersensitivity, Skin exfoliation
Clinical narrative: Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diphtheria crml97 protein) injection) was received from a nurse practitioner, the mother of a 6 month old male patient who received his first dose of Prevnar in the spring of 2000, and developed an allergic reaction characterized by " a hive at the injeciton site", covered from head to toe with "1 large hive" and dry scaly skin over a large area of his body. Mediacal History: the pt concurrent illness includes thrombocytopenia (with normal count of 70,000 to 80,0000) and a past medical history of hypersensitivity (mother reported that pt outgrew allergy to strawberries). The reporter indicated that there were no other allergies. Event Details: The pt received his first dose of Prevnar in the spring of 2000. One hour post-vaccination, he developed a large allergic reaction characterized by " a hive at the injection site" one inch in diameter. Five hours post vaccination, the pt was covered  from head to toe with "one large hive" The reporter stated " the hive lasted 3 days even though the child was treated with Benadryl elixer (dose unknown). Two days post vaccination the "hive" had occurred. The pt recovery status is unknown. No additonal information was available at the time of this report.
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Crying, Pyrexia
Clinical narrative: Follow up information received from a health care professional provided patient demographics and additional vaccine details. Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine(diphtheria crml97 protein) injection) was received form a healthcare professional regarding a 4 month old patient who developed a temp of 100.3 degrees Fahrenheit and was screaming. At 4 months of age, the pt received the 2nd dose on 07/19/2004. The pt also received the 2nd dose of Pediarix (DTaP/ HepB/ polio virus inactivated) (GSK) and the 2nd dose of ActHib (Haemophilus B conjugate vaccine (tetanus) ) (Aventis) on 07/19/2004. Event Details: on 07/20/2004, one day post immunization, a 4 month old female pt developed a temp of 100.3 degrees Fahrenheit. The pt's mother reported that her daughter had been screaming for one hour. Treatment consisted of Motrin "60mg Q 6H". This report was received from Merck. No additional information was available at the time of this report.
Age: 1.52
Sex: M
Vaccine: PNC
Symptoms: Injection site erythema, Injection site oedema, Injection site reaction, Injection site warmth, Pyrexia
Clinical narrative: Additional information was received from the reporter via Merck. Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diphtheria crml97 protein) injection) was received from a mother regarding her 18 month old son who developed a mild fever of 101 degrees F, a "prickly heat" rash on his back, and an injection site reaction characterized by redness, warmth, and swelling. The patinet received the fourth dose on 12/15/04.  Medical History: The pt was reported to have no medical history. The pt experienced a mild fever-101 degrees F, and injection site swelling (described as the size of a quarter) after receiving his 1st, 2nd and 3rd dose of Prevnar. Event Details: On 12/15/2004, post immunization, the child developed a mild fever-101 degrees F, a "prickly heat rash" on his back, and an injection site reaction characterized by redness, warmth, and swelling. The swelling was described as "covering an area 3"x 4". The child's mother stated that " here son's left thigh was much more swollen at the injection site, than what had occured with previous Prevnar vaccinations". The fever and injection site swelling were treated with Tylenol, and the rash was treated topically with Lubriderm Cream. The fever and injection site swelling resolved after 4 days. Related Cases: It has been determined that HQWYE598812JAN05 is a duplicate report of HQWYE173023DEC04. Therefore, the reports are being consolidated into HQWYE173023DEC04, which will remain the official case of record. See related cases HQWYE279829DEC04, HQWYE279929DEC04, and HQWYE280029DEC04.
Age: 1.52
Sex: M
Vaccine: PNC
Symptoms: Rash
Clinical narrative: Additional information was received from the reporter via Merck. Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diphtheria crml97 protein) injection) was received from a mother regarding her 18 month old son who developed a mild fever of 101 degrees F, a "prickly heat" rash on his back, and an injection site reaction characterized by redness, warmth, and swelling. The patinet received the fourth dose on 12/15/04.  Medical History: The pt was reported to have no medical history. The pt experienced a mild fever-101 degrees F, and injection site swelling (described as the size of a quarter) after receiving his 1st, 2nd and 3rd dose of Prevnar. Event Details: On 12/15/2004, post immunization, the child developed a mild fever-101 degrees F, a "prickly heat rash" on his back, and an injection site reaction characterized by redness, warmth, and swelling. The swelling was described as "covering an area 3"x 4". The child's mother stated that " here son's left thigh was much more swollen at the injection site, than what had occured with previous Prevnar vaccinations". The fever and injection site swelling were treated with Tylenol, and the rash was treated topically with Lubriderm Cream. The fever and injection site swelling resolved after 4 days. Related Cases: It has been determined that HQWYE598812JAN05 is a duplicate report of HQWYE173023DEC04. Therefore, the reports are being consolidated into HQWYE173023DEC04, which will remain the official case of record. See related cases HQWYE279829DEC04, HQWYE279929DEC04, and HQWYE280029DEC04.
Age: 1.54
Sex: F
Vaccine: HIBV, PNC
Symptoms: Drug effect decreased
Clinical narrative: Follow up information received from the reporter on 05/03/04 provided updated patient demographics, medical history, additional vaccine, lot numbers, and name of patient's physician. Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diphtheria crml97 protein) injection) was received from a pediatrician regarding a 3 year old pt who, at the age of 18 months, completed her primary series on 06/04/2002. On 03/25/04, the child experienced low titers. The child also received a dose of hib titer vaccine on 06/04/2002. Event Details: On 03/25/04, a pediatrician reported that a 3 year old pt having completed her primary series of Prevnar on 06/04/02 at 18 months of age, had titer test done which showed "low titers". Test Results: Antibody test (results : low titers) was done on an unspecified date.
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Crying, Pyrexia, Tremor
Clinical narrative: Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine ( diphtheria crml97 protein) injection) was received from a consumer regarding a 6 month old female pt who received a dose of Prevnar on 07/06/04. On the same day, she also received a dose of  haemophilus B conjugate vaccine (manufacturer unknown) and Pediarix (GSK) and developed  a fever, crying and body shakes post immunization. Event Details:  A 6 month old female pt received a dose of Prevnar, Haemophilus B conjugate vaccine and Pediarix on 07/06/2004. At an unspecified time on the same day, the pt developed a fever of 105 degrees F, crying, and body shakes. The pt was treated with Motrin. The events resolved in 24 hours. This report was received from GSK (report # A0517527A) The reporter declined to provide additional info in order to perform follow up.
Sex: U
Vaccine: PNC
Symptoms: Contusion, Injection site erythema, Injection site oedema
Clinical narrative: Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diphtheria crml97 protein) injection) was received from a healthcare professional regarding a 6 month old pt who experienced injection site redness, injection site swelling and injection site bruise. The pt received a dose on an unspecified date. Event Details: On 08/20/2004, the pt developed a severe local reaction characterized by redness,  and swelling. As of 09/21/04, the pt still had a bruise. No additional information was available at the time of this report.
Age: 4.0
Sex: F
Vaccine: PNC
Symptoms: Cellulitis, Injection site oedema, Oedema peripheral
Clinical narrative: Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diphtheria crml97 protein) injection was received from a physician regarding a 3 year old female patient who developed redness, swelling, and a red streak going up the side of her thigh. At 3 years of age, the patient received the fourth dose on 11/03/2004. Medical History: The reporter indicated that the patient is a "well baby, no birth defects, no allergies". Product details: Indication for Prevnar was immunization. Product was administered on 11/03/2004. Dose regimen was 1 dose intramuscularly. Concomitant Therapy: Concomitant medications were not reported. Event Details: On 11/05/2004, a 3 year old female patient developed swelling, redness, and red streak going up the side of her thigh ( erythema) after receiveing an injection of Prevnar. The child's parent contacted the physician: treatment was not administered. No additional information was available at the time of this report. Manufacturers Comment: This is one of 2 patients from this facility who experienced this event following receipt of Prevnar lot No. A083578E/ See related case HQWYE334710NOV04.
Sex: M
Vaccine: PNC
Symptoms: Cellulitis, Erythema, Injection site erythema, Injection site oedema
Clinical narrative: Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diphtheria crml97 protein) injection) was received from a physician regarding a 2 month old male patient who developed redness, swelling and a red streak going up the side of his thigh. At 2 months of age, the pt received a dose on 10/26/2004. Event Details: On 10/27/2004, A 2 month old male pt developed swelling, redness, and a red streak going up the side of his thigh. (erythema) after receiving an injection of Prevnar. The child was examined by a physician: treatment was not administered. No additional information was available at the time of this report. Manufacturers Comment: This is one of 2 patients from this facility who experienced this event following receipt of Prevnar lot No. A83578E. See related HQWYE334610NOV04.
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Crying, Erythema, Rash macular, Rash maculo-papular, Rash papular
Clinical narrative: Follow up information received from the physician provovided a revised dose number and concomitant vaccine information. Information regarding Prevnar (pneumococcal 7-valent conjugate) was received from a pharmacist regarding a 4 month old female pt who experienced crying, screaming and a rash on right arm. At 4 months of age, the pt received the second dose on 03/29/04. The pt also received the 2nd dose of IPOL (AVENTIS) and the 2nd dose of DAPTACEL (AVENTIS), and the second dose of ACT HIB (AVENTIS) on 03/29/2004. Event details: On the evening of 03/31/2004, following receipt of her 2nd dose of Prevnar, a pharmacist reported that his daughter developed a rash on her right arm and was crying. The rash was characterized as a "red splotchy" patches. The reporter indicated "if the skin was pulled tight, there was a white mark in the center of the patches" After the child had been bathed and had slept for one hour, she woke up screaming. She had a similar "rash on her back" and the skin over the patches felt warm. According to the reporter, the " rash on her arm" did not reappear. The child remained afebrile during both events. The reporter stated that there were no adverse events at the site of injections on either thigh. The childs physician on follow up that he was unaware that this event occurred.
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Screaming
Clinical narrative: Follow up information received from the physician provovided a revised dose number and concomitant vaccine information. Information regarding Prevnar (pneumococcal 7-valent conjugate) was received from a pharmacist regarding a 4 month old female pt who experienced crying, screaming and a rash on right arm. At 4 months of age, the pt received the second dose on 03/29/04. The pt also received the 2nd dose of IPOL (AVENTIS) and the 2nd dose of DAPTACEL (AVENTIS), and the second dose of ACT HIB (AVENTIS) on 03/29/2004. Event details: On the evening of 03/31/2004, following receipt of her 2nd dose of Prevnar, a pharmacist reported that his daughter developed a rash on her right arm and was crying. The rash was characterized as a "red splotchy" patches. The reporter indicated "if the skin was pulled tight, there was a white mark in the center of the patches" After the child had been bathed and had slept for one hour, she woke up screaming. She had a similar "rash on her back" and the skin over the patches felt warm. According to the reporter, the " rash on her arm" did not reappear. The child remained afebrile during both events. The reporter stated that there were no adverse events at the site of injections on either thigh. The childs physician on follow up that he was unaware that this event occurred.
Sex: U
Vaccine: PNC
Symptoms: Crying, Discomfort
Clinical narrative: Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diphtheria crml97 protein) injection) was received from a  healthcare professional regarding a  patient who experienced cry so much and vaccine cause much discomfort. The patient received a  dose on an unspecified date. Event details, the nurse reported that regardless of lot number and injection technique, when babies are administered  Prevnar in her office they cry more, and experience much discomfort. No additional information was available at the time of this report. Manufacturer Comments: The reporter was unable to specify the number of pt;s who experienced the events. Additional reports will be generated when identifying information is received.
Sex: M
Vaccine: PNC
Symptoms: Erythema nodosum
Clinical narrative: Information regarding Prevnar (pnemococcal 7-valent conjugate vaccine (diphtheria crml97 protein) injection) was received form a pharmacist regarding a  male pt who experienced erythema nosodum. The pt received the first dose on an unspecified date. Event Details: The reportere stated that the pt developed erythema nodosum , after receiving his first dose of Prevnar. The child is now 2 years old and received Prevnar "sometime within the first year" The adverse event was treated and resolved" No additonal information was available at the time of this report.
Sex: M
Vaccine: DT, HIBV, IPV, PNC
Symptoms: Erythema, Medication error, Oedema
Clinical narrative: Follow up information providing adverse events and recovery status was received from the reporter. Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diphtheria crml97 protein) injection) was received from a healthcare professional regarding a 5 month old male patient who was inadvertently given Prevnar  SQ in the RA and experienced mild redness and swelling at the injection site. The pt received a second dose of Act Hib (Aventis) (haemophilus b conjugate vaccine (tetanus)), the second dose of polio vaccine (Aventis) (poliomyelitis vaccine inactivated) and the second dose of diphtheria/tetanus toxoids/ acellular pertussis vaccine (Aventis) on 04/12/2004. Event Details: The pt was inadvertently given a dose of Prevnar SQ in his right arm. The pt experienced mild swelling and redness at the injection site which resolved in 2 days.
Sex: M
Vaccine: PNC
Symptoms: Child maltreatment syndrome
Clinical narrative: Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diphtheria crml97 protein) injection) was received from an attorney regarding a 4 month old male pt who experienced alleged shaken baby syndrome. The pt received the vaccine on an unspecified date. Event Details: The reporter stated that the defendants "may claim Prevnar(which was given to the baby) cause the alleged shaken baby syndrome in this 4 month old infant. This event occurred in December 2001. No additonal information was available at the time of this report.
Sex: F
Vaccine: PNC
Symptoms: Anorexia, Nasal congestion, Restlessness, Rhinorrhoea, Sleep disorder
Clinical narrative: Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diphtheria crml97 protein) injection) was received form a mother regarding her 21 month old female daughter who experienced irritability post vaccination, loss of appetite, restless sleeping, and significant congestion with runny nose, the pt received the third dose on 08/13/2004. Event Details: within 3 days of administration, the child experienced irritability, loss of appetite, and restless sleeping, which has continued for the last 11 days. The pt is a fraternal twin,  her twin sister experienced a similar reaction including a fever of 103.8 degrees Fahrenheit. which lasted for 3 days (see case ID HQWYE510024AUG04). The mother also reported that  one twin during this period of time, developed significant congestion (nasal) with a runny nose. No addiotonal information was available at the time of this report.