chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Skin reaction
Clinical narrative: 4-17-07 Pt received Pneumonia vaccine. LDIM. Arm began hurting that night. Redness and swelling developed. Painful at site. Pt to see on or 4-20-2007. Told pt that it was localized reaction. Have doctor report to us if any further diagnosis.
Age: 35.0
Sex: F
Vaccine: HEP, HEPA, TD
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 1 hr after vaccine-red and sore at site and swelling at site into upper arm and neck. Today arm sore, swollen and tender to use.
Age: 5.0
Sex: M
Vaccine: IPV
Symptoms: Body temperature increased, Decreased appetite, Hyperhidrosis, Pyrexia
Clinical narrative: Had IPV vaccination that evening patient had a fever 104 deg per mom at 6pm 1 episode of sweats at midnight. temperature increased to 101 deg had decreased appetite. Given Tylenol the next am-patient feel better.
Age: 1.5
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema
Clinical narrative: 3 in x 3 in redness to site of vaccination.
Age: 1.0
Sex: M
Vaccine: DTAPH, HEPA
Symptoms: Injection site erythema
Clinical narrative: Left thigh with 10 x 7 cm raised erythema
Age: 19.0
Sex: M
Vaccine: ANTH
Symptoms: Lymphadenopathy, Pain in extremity
Clinical narrative: Swollen left axillary lymph nodes and painful ROM left arm.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Chicken pox
Sex: M
Vaccine: PNC
Symptoms: Febrile convulsion
Clinical narrative: This case was considered medically important. Additional information has been received regarding Prevnar lot number and physician comments. Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding a 2-year old male patient who experienced a febrile convulsion. The patient received the fifth dose on 11-Aug-2005. The patient has a past history of ear infection. The patient received 4 doses of Prevnar vaccine in the past. Indication for Prevnar was immunization. Product was administered on 11-Aug-2005. Dose regimen was 1 dose 1 time per day (intramuscular). concomitant medications were not reported. The patient experienced a febrile convulsion (febrile convulsion) on 01-Jan-2005. The reporter commented that the patient was symptomatic in the emergency room. the outcome was not specified. See related case(s): HQWYE550225JAN07 (non-expedited and HQWYE024230JAN07 (expedited). No additional information was available at the time of this report. OMIC
Sex: M
Vaccine: PNC
Symptoms: Convulsion, Electroencephalogram
Clinical narrative: This case was considered medically important. Additional information has been received regarding Prevnar lot number. laboratory testing and onset date change of event. Information regarding Prevnar was received from a healthcare professional regarding a 2-year-old male patient who experienced an afebrile convulsion. The patient received the fifth dose on 11-Aug-2005. The patient has a history of ear infection. The patient received 4 doses of Prevenar vaccine doses in past. Concomitant medications were not reported. The patient experienced an afebrile convulsion on 30-May-2006. The patient was referred to a neurologist; an electroencephalogram (EEG) was performed (results unknown). The patient's outcome was not specified. See related case (s): HQWYE550225JAN07 (non-expedited) and HQWYE024130JAN07 (expedited). No additional information was available at the time of this report.
Sex: M
Vaccine: PNC
Symptoms: Antibody test abnormal
Clinical narrative: Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding a 3-year-old male patient who developed non-satisfactory titers. The patient received a dose on an unspecified date. The patient's concurrent illness includes periodic fever disorder. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day ( intramuscular). Concomitant medications were not reported. On an unspecified date. the patient developed non-satisfactory titers (antibody test abnormal) and was being readministered Prevnar. The outcome is unknown. No additional information was available at the time of this report.
Age: 0.6
Sex: F
Vaccine: HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Blood culture, Pneumococcal bacteraemia, Pneumonia streptococcal, Vaccination failure
Clinical narrative: This case was considered medically important. Follow-up information pertaining to patient demographics, additional concomitant vaccines and recovery status has been received. Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding a 9-month-old female patient who developed pneumococcal bacteremia. The patient received the third dose on 14-Aug-2006. The patient also received the third dose of Act-Hib (Aventis) (haemophilus b conjugate vaccine (tetanus)), the third dose of Tripacel (Avesntis-Pasteur) diphtheria/tetanus toxoid/acellular pertussis vaccine) and the second dose of Ipol (Adventis-Pasteur (poliovirus vaccine inactivated) on 14-Aug-2006. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 14-Aug-2006, Dose regimen was 1 dose 1 time per day (intramuscular). Concomitant medications were not reported. On 24-Sep-2006, the patient developed pneumococcal bacteremia (pneumococcal bacteraemia) (drug ineffective). The patient was not hospitalized. Treatment was administered at the time a blood culture was performed; the patient recovered on an unspecified date. Blood culture (results: revealed Streptococcus pneumoniae; not serotyped) was done on 25-Sep-2006. OMIC
Age: 0.6
Sex: F
Vaccine: HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Blood culture positive, Nasal mucosal discolouration, Nasopharyngitis, Pneumococcal bacteraemia, Rhinorrhoea
Clinical narrative: This case was considered medically important. Follow-up information pertaining to patient demographics, additional concomitant vaccines and recovery status has been received. Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding a 9-month-old female patient who developed pneumococcal bacteremia. The patient received the third dose on 14-Aug-2006. The patient also received the third dose of Act-Hib (Aventis) (haemophilus b conjugate vaccine (tetanus)), the third dose of Tripacel (Avesntis-Pasteur) diphtheria/tetanus toxoid/acellular pertussis vaccine) and the second dose of Ipol (Adventis-Pasteur (poliovirus vaccine inactivated) on 14-Aug-2006. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 14-Aug-2006, Dose regimen was 1 dose 1 time per day (intramuscular). Concomitant medications were not reported. On 24-Sep-2006, the patient developed pneumococcal bacteremia (pneumococcal bacteraemia) (drug ineffective). The patient was not hospitalized. Treatment was administered at the time a blood culture was performed; the patient recovered on an unspecified date. Blood culture (results: revealed Streptococcus pneumoniae; not serotyped) was done on 25-Sep-2006. OMIC
Age: 0.6
Sex: F
Vaccine: HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Streptococcal identification test positive, Vaccination failure
Clinical narrative: This case was considered medically important. Follow-up information pertaining to patient demographics, additional concomitant vaccines and recovery status has been received. Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding a 9-month-old female patient who developed pneumococcal bacteremia. The patient received the third dose on 14-Aug-2006. The patient also received the third dose of Act-Hib (Aventis) (haemophilus b conjugate vaccine (tetanus)), the third dose of Tripacel (Avesntis-Pasteur) diphtheria/tetanus toxoid/acellular pertussis vaccine) and the second dose of Ipol (Adventis-Pasteur (poliovirus vaccine inactivated) on 14-Aug-2006. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 14-Aug-2006, Dose regimen was 1 dose 1 time per day (intramuscular). Concomitant medications were not reported. On 24-Sep-2006, the patient developed pneumococcal bacteremia (pneumococcal bacteraemia) (drug ineffective). The patient was not hospitalized. Treatment was administered at the time a blood culture was performed; the patient recovered on an unspecified date. Blood culture (results: revealed Streptococcus pneumoniae; not serotyped) was done on 25-Sep-2006. OMIC
Age: 0.5
Sex: F
Vaccine: HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Blood culture, Pneumococcal bacteraemia, Pneumonia streptococcal, Vaccination failure
Clinical narrative: This case was considered medically important. Information regarding Prevnar was received from a healthcare professional regarding an 8-month-old female patient who experienced pneumococcal bacteraemia and drug ineffective. At 6 months of age, the patient received the third dose of Prevnar on 14-Aug-2006. The patient  also received the third dose of Act-Hib, the second dose of DTaP (manufacturer unknown) and the second dose of IPOL on 14-Aug-2006.  No underlying medication conditions, child was well at each visit. Concomitant therpay included: Hepatitis V Vaccine, Act-Hib. Act-Hib, Ipol, DTaP. On 24-Sep-2006, the patient experienced pneumococcal bacteremia drug ineffective. At the date of this report, it is not known if the child was hospitalized. On 25-Sep-2005, the child was seen in the physician's office. She had just finished the course of Ampicillin and the physician then put her on another oral antibiotic (not specified). The physician follow-up weekly, via telephone, regarding the status of the child's health. The child's mother stated that on 05-Oct-2006, her daughter developed a runny nose. As of 11-Oct-2006, the child's mother noted that the nasal drippings are "slightly green in color, probably a new cold." No additional information was available at the time of this report.
Age: 0.5
Sex: F
Vaccine: HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Blood culture positive, Nasal mucosal discolouration, Nasopharyngitis, Pneumococcal bacteraemia, Rhinorrhoea
Clinical narrative: This case was considered medically important. Information regarding Prevnar was received from a healthcare professional regarding an 8-month-old female patient who experienced pneumococcal bacteraemia and drug ineffective. At 6 months of age, the patient received the third dose of Prevnar on 14-Aug-2006. The patient  also received the third dose of Act-Hib, the second dose of DTaP (manufacturer unknown) and the second dose of IPOL on 14-Aug-2006.  No underlying medication conditions, child was well at each visit. Concomitant therpay included: Hepatitis V Vaccine, Act-Hib. Act-Hib, Ipol, DTaP. On 24-Sep-2006, the patient experienced pneumococcal bacteremia drug ineffective. At the date of this report, it is not known if the child was hospitalized. On 25-Sep-2005, the child was seen in the physician's office. She had just finished the course of Ampicillin and the physician then put her on another oral antibiotic (not specified). The physician follow-up weekly, via telephone, regarding the status of the child's health. The child's mother stated that on 05-Oct-2006, her daughter developed a runny nose. As of 11-Oct-2006, the child's mother noted that the nasal drippings are "slightly green in color, probably a new cold." No additional information was available at the time of this report.
Age: 0.5
Sex: F
Vaccine: HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Streptococcal identification test positive, Vaccination failure
Clinical narrative: This case was considered medically important. Information regarding Prevnar was received from a healthcare professional regarding an 8-month-old female patient who experienced pneumococcal bacteraemia and drug ineffective. At 6 months of age, the patient received the third dose of Prevnar on 14-Aug-2006. The patient  also received the third dose of Act-Hib, the second dose of DTaP (manufacturer unknown) and the second dose of IPOL on 14-Aug-2006.  No underlying medication conditions, child was well at each visit. Concomitant therpay included: Hepatitis V Vaccine, Act-Hib. Act-Hib, Ipol, DTaP. On 24-Sep-2006, the patient experienced pneumococcal bacteremia drug ineffective. At the date of this report, it is not known if the child was hospitalized. On 25-Sep-2005, the child was seen in the physician's office. She had just finished the course of Ampicillin and the physician then put her on another oral antibiotic (not specified). The physician follow-up weekly, via telephone, regarding the status of the child's health. The child's mother stated that on 05-Oct-2006, her daughter developed a runny nose. As of 11-Oct-2006, the child's mother noted that the nasal drippings are "slightly green in color, probably a new cold." No additional information was available at the time of this report.
Age: 1.3
Sex: M
Vaccine: IPV, PNC
Symptoms: Accidental overdose, Cough, Dyspnoea, Wheezing
Clinical narrative: Information regarding Prevnar injection was received from a mother of a 15-month-old male patient who received a fifth injection of Prevnar by accident on 17-Jul-2006 along with a dose of Poliomyelitis vaccine Inactivated (manufacturer unknown). On the same day, the child developed labored breathing, wheezing and deep, dry barking cough. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 17-July-2006. Dose regimen was 1 dose 1 time per day. Additional suspect vaccine included Poliomyelitis Vaccine Inactivated. Concomitant medications were not reported. On 17-Jul-2006, the patient received a fifth injection of Prevnar by accident (accidental overdose) (incorrect dose administered), along with another childhood vaccine. On the same day, the child developed labored breathing (dyspnoea), wheezing (wheezing) and deep, dry barking cough (cough). On 18-Jyl-2006, the child had no wheezing or dyspnea. As of 18-Jul-2006, the child had not recovered from the cough. No additional information was available at the time of this report.
Sex: M
Vaccine: PNC
Symptoms: Meningitis, Vaccination failure
Clinical narrative: This case was considered medically important. Information regarding Prevnar vaccine unspecified was received from an attorney who alleged that a male patient received a dose of Prevnar on an unspecified date and experienced meningitis. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. It is alleged that as a result of having not been given a dose of Prevnar during his doctor visit in March/May 2005, the patient developed meningitis (meningitis) (drug ineffective). The attorney noted that according to the CDC website, "there was a product shortage in 2004 and it said to decrease the number of doses given. "The patient's outcome is unknown. No additional information was available at the time of this report. OMIC. Case cancelled: Upon receipt of addiitonal information, it was discovered that the patient did not receive PREVNAR vaccine. This case was considered medically important.
Age: 1.0
Sex: F
Vaccine: PNC
Symptoms: Hepatic enzyme increased, Petechiae
Clinical narrative: Information regarding Prevnar vaccine injection was received from a consumer regarding a 12-month-old patient who experienced petechiae all over her body and elevated liver enzymes. At 12 months of age, the patient received the first dose in Nov-2005. The patient's concurrent illnesses includes von Willebrand's disease. She was adopted (from China); there are no known allergies, no history of abnormal blood work prior to adoption and no history of blood transfusions. Indication for Prevnar was immunization. Product was administered in Nov-2005. Dose regimen was 1 dose 1 time per day (intramuscular). Concomitant medication were not reported. The patient's mother reported that the patient developed generalized petechiae (petechiae) after receiving her first dose of Prevnar in Nov-2005. She also noted that the child's liver enzymes elevated (hepatic enzyme increased) after this dose. The petechiae resolved; the outcome of the increased liver, enzymes is unknown. See related case(s): HQWYE166406MAR06 (adverse event, expedited). No additional information was available at the time of this report.
Age: 1.3
Sex: F
Vaccine: PNC, UNK
Symptoms: Convulsion, Febrile convulsion, Hypotonia, Injection site erythema, Injection site mass
Clinical narrative: This case was considered medically important for the event of febrile seizure. Information regarding Prevnar was received from a consumer regarding a 15 month old female patient who experienced a febrile seizure, hypotonia, injection site swelling, erythema, and mass; the patient additionally developed a stiff and sore leg. At 15 months of age, the patient received the fourth dose on 19 Jun 2006 in her right thigh. The patient also received a dose of an unspecified vaccine on 19 Jun 2006 in the opposite leg. The patient has a past history of febrile convulsion (occurred in January and February 2006). No previous injection site reactions to Prevnar. Indication for Prevnar was immunization. Product was administered on 19 Jun 2006. Dose regimen was 1 dose 1 time per day (intramuscular). Concomitant therapy included unspecified vaccine. After receiving the fourth dose of Prevnar in her right thigh on 19 Jun 2006, the patient woke up at 5 AM the next day with a quarter sized red spot (injection site erythema) and  pea sized bump (injection site mass) at the injection site; her leg was also swollen at the site (injection site swelling). The patient developed a temperature of 99 degrees (pyrexia) and was treated with Motrin; the temperature returned to normal. At 1 pm the child spiked a high fever between 101 and 102. Minutes later the patient experienced a seizure (febrile convulsion) which lasted 2.5 minutes. She did not loose consciousness. Muscle tone was lost for about 10 minutes (hypotonia); the child then slept for a couple of hours. The red spot was now 3 to 4 inches in diameter and the bump was now the size of a golf ball. It was noted that the mother spoke with a neurologist but a physician did not see the child.  As of 21 Jun 2006, the child still has swelling and redness in her leg and continues taking Motrin.  The redness is now half dollar size and the lump has not gone down in size. Her leg is stiff and sore, she appears to be slowed down and is favoring one leg. No additional information was available at the time of this report.
Age: 1.3
Sex: F
Vaccine: PNC, UNK
Symptoms: Injection site swelling, Laboratory test normal, Musculoskeletal stiffness, Pain in extremity, Pyrexia
Clinical narrative: This case was considered medically important for the event of febrile seizure. Information regarding Prevnar was received from a consumer regarding a 15 month old female patient who experienced a febrile seizure, hypotonia, injection site swelling, erythema, and mass; the patient additionally developed a stiff and sore leg. At 15 months of age, the patient received the fourth dose on 19 Jun 2006 in her right thigh. The patient also received a dose of an unspecified vaccine on 19 Jun 2006 in the opposite leg. The patient has a past history of febrile convulsion (occurred in January and February 2006). No previous injection site reactions to Prevnar. Indication for Prevnar was immunization. Product was administered on 19 Jun 2006. Dose regimen was 1 dose 1 time per day (intramuscular). Concomitant therapy included unspecified vaccine. After receiving the fourth dose of Prevnar in her right thigh on 19 Jun 2006, the patient woke up at 5 AM the next day with a quarter sized red spot (injection site erythema) and  pea sized bump (injection site mass) at the injection site; her leg was also swollen at the site (injection site swelling). The patient developed a temperature of 99 degrees (pyrexia) and was treated with Motrin; the temperature returned to normal. At 1 pm the child spiked a high fever between 101 and 102. Minutes later the patient experienced a seizure (febrile convulsion) which lasted 2.5 minutes. She did not loose consciousness. Muscle tone was lost for about 10 minutes (hypotonia); the child then slept for a couple of hours. The red spot was now 3 to 4 inches in diameter and the bump was now the size of a golf ball. It was noted that the mother spoke with a neurologist but a physician did not see the child.  As of 21 Jun 2006, the child still has swelling and redness in her leg and continues taking Motrin.  The redness is now half dollar size and the lump has not gone down in size. Her leg is stiff and sore, she appears to be slowed down and is favoring one leg. No additional information was available at the time of this report.
Sex: F
Vaccine: PNC
Symptoms: Culture, Pneumococcal sepsis, Pneumonia pneumococcal, Vaccination failure
Clinical narrative: This case was considered medically important. Information regarding Prevnar was received from a healthcare professional regarding a 3 year old female patient who developed pneumococcal sepsis and pneumococcal pneumonia. The patient received the third dose on an unspecified date. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day (intramuscular). On 09 Mar 2004 the patient developed pneumococcal sepsis and pneumococcal pneumonia. She was treated with intravenous Rocephin. On an unspecified date, the patient recovered. Results of a culture performed on an unspecified date revealed "serotype 9A, subtype 19A." No additional information was available at the time of this report.
Sex: U
Vaccine: PNC
Symptoms: Injection site erythema, Injection site warmth, Wrong drug administered
Clinical narrative: Information regarding Prevnar vaccine was received from a healthcare professional regarding a patient who was administered Prevnar intradermally instead of the Tine Test; the injection site was very red and warm. The patient received a dose in 2006. On an unknown date in 2006, the patient was administered Prevnar instead of a Tine Test. The vaccine was given intradermally. The injection site was very red and warm. The outcome is unknown. No additional information was available at the time of this report.
Sex: F
Vaccine: PNC
Symptoms: Drug dispensing error, Limb injury
Clinical narrative: Follow-up information was received that provided the recovery status of the nurse. Information regarding Prevnar was received from a healthcare professional regarding a female nurse who cut her hand when the syringe cracked and broke at the blue flange during administration to a patient 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 1 time per day. Concomitant medications were not reported. Event Details: On an unspecified date, a Prevnar syringe cracked and broke at the blue flange during administration to a patient (pharmaceutical product complaint). Subsequently, the nurse cut her hand (limb injury). No cracks were noted prior to administration. The reporter noted that the patient was not injured. On an unspecified date, the nurse recovered from the event although the cut did not heal completely. No additional information was available at the time of this report.
Sex: M
Vaccine: PNC
Symptoms: Blood test, Convulsion, Disturbance in attention, Febrile convulsion, Loss of consciousness
Clinical narrative: This case was considered medically important for the event of febrile seizure. Information regarding Prevnar was received from the father of a male child who received a dose on an unspecified date in 2002 or 2003. Within one month after receiving his last dose of Prevnar, the patient experienced febrile seizure. In 2006, the child began to experience trouble focusing. "No relevant history; no seizure prior to Prevnar; no family history of seizure." The patient's father reported that past vaccine therapies received by the patient included: "all recommended" vaccines, "according to schedule" (dates unspecified.) Indication for Prevnar was immunization. Product was administered on an unspecified date in 2002 or 2003. Dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. On an unspecified date in 2002 or 2003, the patient received the last dose of Prevnar. Within one month after receiving Prevnar, the patient developed a "high" fever and lost consciousness (date unspecified). On the way to the emergency room, the patient regained consciousness. The patient was observed in the emergency room and had blood work done. The emergency room could not find a cause for the loss of consciousness and released the child. At a follow-up visit to the pediatrician, on an unspecified date, the child was diagnosed with febrile seizure (febrile convulsion). Approximately one month later, the patient experienced a second febrile seizure with loss of consciousness.  A neurologist evaluated the child and found no cause for the loss of consciousness, agreeing with the diagnosis of febrile seizure. On an unspecified date in 2003, the patient began Trileptal (oxcarbazepine) therapy. Between Nov 2004 and Jan 2006, the patient did not experience any seizures. On an unspecified date in Jan 2006, Trileptal was discontinued. On an unspecified date in Mar 2006, the patient experienced a seizure with loss of consciousness. According to the reporter, since the first seizure, the patient experienced approximately ten similar episodes. In 2006, the child started school and his teachers reported that the patient had "trouble focusing" (disturbance in attention). The reporter noted that the child does not follow "simple directions." As of 27 Mar 2006, the patient had not recovered from the events.
Sex: M
Vaccine: PNC
Symptoms: Neurological examination
Clinical narrative: This case was considered medically important for the event of febrile seizure. Information regarding Prevnar was received from the father of a male child who received a dose on an unspecified date in 2002 or 2003. Within one month after receiving his last dose of Prevnar, the patient experienced febrile seizure. In 2006, the child began to experience trouble focusing. "No relevant history; no seizure prior to Prevnar; no family history of seizure." The patient's father reported that past vaccine therapies received by the patient included: "all recommended" vaccines, "according to schedule" (dates unspecified.) Indication for Prevnar was immunization. Product was administered on an unspecified date in 2002 or 2003. Dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. On an unspecified date in 2002 or 2003, the patient received the last dose of Prevnar. Within one month after receiving Prevnar, the patient developed a "high" fever and lost consciousness (date unspecified). On the way to the emergency room, the patient regained consciousness. The patient was observed in the emergency room and had blood work done. The emergency room could not find a cause for the loss of consciousness and released the child. At a follow-up visit to the pediatrician, on an unspecified date, the child was diagnosed with febrile seizure (febrile convulsion). Approximately one month later, the patient experienced a second febrile seizure with loss of consciousness.  A neurologist evaluated the child and found no cause for the loss of consciousness, agreeing with the diagnosis of febrile seizure. On an unspecified date in 2003, the patient began Trileptal (oxcarbazepine) therapy. Between Nov 2004 and Jan 2006, the patient did not experience any seizures. On an unspecified date in Jan 2006, Trileptal was discontinued. On an unspecified date in Mar 2006, the patient experienced a seizure with loss of consciousness. According to the reporter, since the first seizure, the patient experienced approximately ten similar episodes. In 2006, the child started school and his teachers reported that the patient had "trouble focusing" (disturbance in attention). The reporter noted that the child does not follow "simple directions." As of 27 Mar 2006, the patient had not recovered from the events.
Age: 0.83
Sex: M
Vaccine: DTAP, PNC
Symptoms: Accidental overdose, Body temperature increased, Incorrect dose administered, Pyrexia
Clinical narrative: Follow-up information was received that provided adverse event of pyrexia, vaccination information and recovery status of medication error. Information regarding Prevnar vaccine was received from a nurse regarding a 10 month old male patient who inadvertently received two doses of Prevnar in the same right leg at the same office visit and received two doses of Prevnar in the same right leg at the same office visit on 15 Jun 2006. On the same day, the patient received the third dose of DTap vaccine. On 16 Jun 2006, the child developed a fever of 101.5 degrees Fahrenheit.  Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 15 Jun 2006. Dose regimen was two doses on the same day (intramuscular). Concomitant vaccine included DTap. On 15 Jun 2006, the patient received two doses of Prevnar in the same right leg at the same office visit (incorrect dose administered) (accidental overdose), when the child was supposed to receive only the third dose in the Prevenar series. On 16 Jun 2006, the patient developed a fever of 101.5 degrees Fahrenheit (pyrexia). It was unknown if the patient recovered from the pyrexia. No additional information was available at the time of this report. Follow-up information was received that provided information, concomitnat vaccination information, treatment and recovery status. Information regarding PREVNAR vaccinw was received from a nurese regarding a 10-month-old male patient who  inadvertently received two doses of PREVNAR in the same right leg at the same office visit on 15-Jun-2006. On the same day, the patient received the third dose of INFANRIX (Glaxosmithkline) DTAP. On 16-Jun-2006, the child developed a fever of 101.5 degrees Fahrenheit. On 15-Jun-2006, the patient received two doses of PREVNAR in the same right leg at the same office visit. When the child was supposed to received only the third dose in the PREVNAR series, along with another childhood vaccine. On 16-Jun-2006, the patient developed a fever of 101.5 degrees Fahrenheit. Treatment included TYLENOL. On 21-Jun-2006, the patient recovered from the pyrexia
Age: 0.3
Sex: M
Vaccine: IPV, PNC
Symptoms: Blood culture negative, Body temperature increased, Chest X-ray normal, Culture urine negative, Full blood count normal
Clinical narrative: Information regarding Prevnar was received from a healthcare professional regarding a 3 month old male patient who received a first dose on 13 Jul 2006, along with a first dose of Ipol. On 14 Jul 2006 the patient developed a fever, increased white blood cell count of (23,000( and possible injection site cellulitis. Medical history reported as none. Indication for Prevnar was immunization. Product was administered on 13 Jul 2006. Dose regimen was 0.5 ml 1 time per day (intramuscular). Concomitant medications were not reported. On 13 Jul 2006, the patient received a dose of Prevnar along with a dose of Ipol. On 14 Jul 2006, the patient developed a fever (pyrexia) of 103 degrees Fahrenheit at home, was given Tylenol by the patient's mother, and taken to the physician's office for evaluation. At the doctor's visit, a white blood cell count was obtained which was noted as "spiked" at 23,000 c/mm (white blood cell count increased). The fever was noted to be 101 degrees Fahrenheit. The patient was sent to the emergency room and a complete blood count, blood culture, urine culture and chest x-ray were performed. Results were reported as normal. Patient was not admitted. On an unspecified date in Jul 2006, the physician noted the patient possibly had an injection site cellulitis (injection site cellulitis). Treatment included Augumentin. As of 28 Jul 2006, the patient had recovered from all events and was scheduled for a follow-up office visit. A repeat white blood cell count is planned.
Age: 0.3
Sex: M
Vaccine: IPV, PNC
Symptoms: Injection site cellulitis, Pyrexia, White blood cell count increased
Clinical narrative: Information regarding Prevnar was received from a healthcare professional regarding a 3 month old male patient who received a first dose on 13 Jul 2006, along with a first dose of Ipol. On 14 Jul 2006 the patient developed a fever, increased white blood cell count of (23,000( and possible injection site cellulitis. Medical history reported as none. Indication for Prevnar was immunization. Product was administered on 13 Jul 2006. Dose regimen was 0.5 ml 1 time per day (intramuscular). Concomitant medications were not reported. On 13 Jul 2006, the patient received a dose of Prevnar along with a dose of Ipol. On 14 Jul 2006, the patient developed a fever (pyrexia) of 103 degrees Fahrenheit at home, was given Tylenol by the patient's mother, and taken to the physician's office for evaluation. At the doctor's visit, a white blood cell count was obtained which was noted as "spiked" at 23,000 c/mm (white blood cell count increased). The fever was noted to be 101 degrees Fahrenheit. The patient was sent to the emergency room and a complete blood count, blood culture, urine culture and chest x-ray were performed. Results were reported as normal. Patient was not admitted. On an unspecified date in Jul 2006, the physician noted the patient possibly had an injection site cellulitis (injection site cellulitis). Treatment included Augumentin. As of 28 Jul 2006, the patient had recovered from all events and was scheduled for a follow-up office visit. A repeat white blood cell count is planned.
Age: 19.0
Sex: U
Vaccine: PNC
Symptoms: Unevaluable event, Wrong drug administered
Clinical narrative: Information regarding Prevnar was received from a healthcare professional regarding a 19 year old patient who was inadvertently given Prevnar instead of PPV23 and developed a reaction, the nature of which is unknown. The patient received a dose on 31 Aug 2006. Medical history-The patient has past history of splenectomy. Indication for Prevnar was immunization. Product was administered on 31 Aug 2006. Dose regimen was 1 dose 1 time per day. Patient was not taking concomitant therapy. Event Details: A physician reported that on 31 Aug 2006, the patient was inadvertently given Prevnar instead of PPV23 (wrong drug administered). The patient experienced a reaction, the description of which is unknown (unevaluable event). The outcome is unknown. No additional information was available at the time of this report.
Age: 1.3
Sex: M
Vaccine: DTAP, PNC
Symptoms: Accidental overdose, Diarrhoea, Pyrexia, Wrong drug administered
Clinical narrative: Information regarding Prevnar was received from a consumer regarding a 15 month old male patient who inadvertently received a fifth dose of Prevnar instead of MMR vaccine along with the fourth dose of DTap (manufacturer unknown) on 26 Jan 2007 and experienced mild fever and diarrhea. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 26 Jan 2007. Additional suspect vaccine included Dtap. Concomitant medications were not reported. Event Details: on 26 Jan 2007, the patient inadvertently received a fifth dose of Prevnar (accidental overdose) (incorrect dose administered) instead of MMR vaccine (wrong drug administered) along with another childhood vaccine. On 27 2007, the child developed a mild fever (pyrexia). It was unknown if the patient recovered from the pyrexia. On 28 Jan 2007, the patient experienced diarrhea. As of 31 Jan 2007, the patient had not recovered from the diarrhea. The consumer noted that the physician informed her that the diarrhea is "not but to the Prevnar." No additional information was available at the time of this report. Information regarding PREVNAR was received from a consumer regarding a 15-monthold male patient who inadvertently received a fifth dose of PREVNAR instead of MMR vaccine along with the fourth dose of DTAP vaccine (manufacturer unknown) and experienced mild fever and diarrhea. On 26-Jan-2007, the patient inadvertently received a fifth dose of PREVNAR instead of MMR vaccine along with another childhood vaccine. On 27-Jan-7, the child developed a mild fever. It was unknown if the patient recovered from the pyresia. On 28-Jan-2007, the patient experienced diarrhea. As of 31-Jan-2007, the patient had not recovered from the diarrhea. The consumer noted that the physician informed her that the diarrhea is "not due to the PREVNAR". No additional information was available at the time of this report.
Age: 0.2
Sex: F
Vaccine: PNC
Symptoms: Lethargy
Clinical narrative: Follow-up information was received that provided patient information, date of vaccination, concomitant vaccine and hospital of vaccine administration. Information regarding Prevnar was received from a nurse regarding a 2 month old female patient who received the first dose on 29 Aug 2006 and became lethargic. The patient has a past history of being a premature baby. Indication for Prevnar was immunization. Product was administered on 29 Aug 2006. Dose regimen was 1 dose 1 time per day. Concomitant vaccine included Poliomyelitis vaccine inactivated. On 29 Aug 2006, the child received the first dose of Prevnar. Following the injection, the patient became lethargic (lethargy). It was unknown if the patient recovered from the event. No additional information was available at the time of this report. Follow-up information was received that provided patient information, date of vaccination, concomitant vaccine and hospital vaccine administration. Information regarding PREVNAR was received from a nurse regarding a 2-month-old female patient who received the first dose on 29-Aug-2006 and became lethargic. On 29-Aug-2006, the child received the first dose of PREVNAR. Following the injection, the patient became lethargic. It was unknown if the patient recovered from the event. No additional information was available at the time of this report.
Age: 0.5
Sex: M
Vaccine: PNC, UNK
Symptoms: Convulsion
Clinical narrative: This case was considered medically important. Information regarding Prevnar was received from a nurse regarding a 3 year old Hispanic male patient who received the third dose on an unspecified date at 6 months of age. Between the ages of 6 to 9 months, the patient began to experience seizures. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was 0.5mL 1 time per day (intramuscular). Concomitant vaccines included unspecified vaccines. Event Details: At the age of 6 months, the patient received the third dose of Prevnar. The reporter noted that the child received "routine immunizations" on unspecified dates. At the of approximately 6 to 9 months, the patient began to experience seizures (convulsions). As of 13 April 2006, it was unknown if the patient recovered from the event. No additional information was available at the time of this report.
Age: 0.2
Sex: F
Vaccine: HBHEPB, IPV, PNC
Symptoms: Incorrect dose administered, Wrong technique in drug usage process
Clinical narrative: Information regarding Prevnar vaccine was received from a healthcare professional regarding a 2 month old female patient who experienced injection site bleeding. At 2 months of age, the patient received a dose on 27 Jun 2006. The patient also received a dose of Comvax and a dose of Polio (manufacturer unknown) on 27 Jun 2006. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 27 Jun 2006. Dose regimen was 1 dose 1 time per day (intramuscular).  Concomitant therapy included Polio Inactivated, Comvax and none. Event Details: It was reported that after Prevnar administration there was blood on the syringe and the patient experienced injection site bleeding (injection site hemorrhage). The reporter noted that the nurse may have nicked a vein during administration (wrong technique in drug usage process). Additional information has been requested.
Sex: U
Vaccine: PNC
Symptoms: Infection, Laboratory test, Vaccination failure
Clinical narrative: This case was considered medically important. Information regarding Prevnar was received from a healthcare professional regarding a 2-year-old patient who experienced recurrent infections and "vaccine failure". Dates of vaccine administered were not provided. Relevant medical history was not provided. Concomitant medications were not reported. A physician reported that a patient experienced recurrent infections and "vaccine failure". A "panel" performed revealed a low value of -5 of 7. The patient's outcome is unknown. No additional information was available at the time of this report.
Sex: M
Vaccine: PNC
Symptoms: Blood culture positive, CSF culture positive, Meningitis pneumococcal, Vaccination failure
Clinical narrative: Information regarding Prevnar was received from a healthcare professional regarding a 5-month-old male patient who experienced pneumococcal meningitis and drug ineffective. The patient received the second dose approximately in October, 2006 at 4 months of age and the first dose was administered approximately in August, 2006 at 2 months of age. Blood culture (results: identified pneumococcal meningitis (serotype 7F) and CSF culture (results: identified pneumococcal meningitis (serotype 7F) were done in 2006. On 29-Nov-2006, the infant experienced pneumococcal meningitis. He was hospitalized. A spinal tap and blood culture showed pneumococcal meningitis, serotype 7F (not including among the Prevnar serotypes). The infant was visiting at the time of the event and was subsequently air lifted to a hospital closer to his home for the insertion if a PICC line 9date unknown) to complete the anti-infective therapy. He was not admitted to the hospital. Upon leaving the hospital, the physician noted that the infant was stable and the mother recently wrote to the physician and stated that her son was doing very well. No additional information was available at the time of this report.
Sex: M
Vaccine: PNC
Symptoms: Antibody test abnormal, Bacteraemia, Vaccination failure
Clinical narrative: Information regarding Prevnar was received from a healthcare professional regarding a 9-month-old male patient who developed bacteremia and experienced titers less than 1 mcg/ml for serotypes 6B and 23F. The patient received the third dose on an unspecified date. The patient was hospitalized on 07-Feb-2007 with bacteremia. Antibody tests performed revealed less than 1 mcg/ml for serotype 6B and 23F. The child was discharged in stable condition.
Age: 0.2
Sex: M
Vaccine: PNC
Symptoms: Bacteria urine identified, Pneumonia pneumococcal, Pneumonia respiratory syncytial viral, Pneumonia streptococcal, Pneumonitis
Clinical narrative: This case was considered medically important. Information regarding Prevnar was received from a physician regarding a male patient who developed a pneumonia due to respiratory syncytial virus and a possible pneumococcal pneumonia. The patient received the first dose in Oct-2006. In Oct-2006, at approximately 2 months of age, the patient received a first dose of Prevnar. On 06-Dec-2006, the patient was hospitalized with respiratory syncytial (RSV) pneumonitis and pneumonia. A 'urine test' done on the same day of admission, identified Streptococcus pneumoniae antigen. The patient was treated with Rocephin and Zithromax for a possible pneumococcal pneumonia as the reporter noted no 11-Dec-2006, the patient was reported as recovering. Bacteria urine (results: urine antigen for Streptococcus pneumonia identified) was done on 06-Dec-2006. No additional information was available at the time of this report.
Age: 0.2
Sex: M
Vaccine: PNC
Symptoms: Vaccination failure
Clinical narrative: This case was considered medically important. Information regarding Prevnar was received from a physician regarding a male patient who developed a pneumonia due to respiratory syncytial virus and a possible pneumococcal pneumonia. The patient received the first dose in Oct-2006. In Oct-2006, at approximately 2 months of age, the patient received a first dose of Prevnar. On 06-Dec-2006, the patient was hospitalized with respiratory syncytial (RSV) pneumonitis and pneumonia. A 'urine test' done on the same day of admission, identified Streptococcus pneumoniae antigen. The patient was treated with Rocephin and Zithromax for a possible pneumococcal pneumonia as the reporter noted no 11-Dec-2006, the patient was reported as recovering. Bacteria urine (results: urine antigen for Streptococcus pneumonia identified) was done on 06-Dec-2006. No additional information was available at the time of this report.
Age: 5.0
Sex: M
Vaccine: PNC
Symptoms: Blood culture, Blood immunoglobulin G decreased, Coordination abnormal, Meningitis pneumococcal, Neurological symptom
Clinical narrative: Information regarding Prevnar was received from a healthcare professional regarding a 5-year-old male patient who developed pneumococcal meningitis. The patient received the fourth dose on an unspecified date. In Aug-2006, the patient was hospitalized with pneumococcal meningitis, which was considered by the reporter to be a vaccine failure. The child was initially treated with unspecified intravenous antibiotics and then continued on oral therapy. He reportedly recovered "fully" with very little neurological damage and with some ataxia. Reporter was unaware of the serotype that caused the infection and noted that the patient's IGG levels were "low". No additional information was available at the time of this report.
Age: 5.0
Sex: M
Vaccine: PNC
Symptoms: Vaccination failure
Clinical narrative: Information regarding Prevnar was received from a healthcare professional regarding a 5-year-old male patient who developed pneumococcal meningitis. The patient received the fourth dose on an unspecified date. In Aug-2006, the patient was hospitalized with pneumococcal meningitis, which was considered by the reporter to be a vaccine failure. The child was initially treated with unspecified intravenous antibiotics and then continued on oral therapy. He reportedly recovered "fully" with very little neurological damage and with some ataxia. Reporter was unaware of the serotype that caused the infection and noted that the patient's IGG levels were "low". No additional information was available at the time of this report.
Age: 0.42
Sex: M
Vaccine: PNC
Symptoms: Blood culture positive, Oxygen saturation decreased, Pneumococcal bacteraemia, Pyrexia, Streptococcal bacteraemia
Clinical narrative: Information regarding Prevnar was received from a healthcare professional regarding a 12-month-old male patient who experienced pneumococcal bacteremia and drug ineffective. At 5 months of age, the patient received the third dose on 12-Aug-2005. Relevant medical history was not provided. Concomitant medications were not reported. The patient was hospitalized for a high fever (not specified) and oxygen saturation was 72%. A blood culture was performed which indicated S. pneumoniae. He was diagnosed with pneumococcal bacteremia on 02-Mar-2006. The serotype is pending. The child was treated with Ceftin (strength and frequency unknown). He recovered and was discharged from the hospital on either 11 or 12-Mar-2006. No additional information was available at the time of this report.