chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.2
Sex: M
Vaccine: HIBV, PNC
Symptoms: Blood culture negative, Body temperature increased, Culture urine negative, Eosinophil count normal, Granulocyte count decreased
Clinical narrative: Follow-up information was received that upgraded this case to serious and provided vaccine information, event onset date, additional event of rash, outcome, and laboratory tests. Information regarding PREVNAR was received from a healthcare professional regarding a 2-month-old male patient who received the first dose on 31-Jul-2007 along with the first dose of ACT-HIB (Aventis) and spiked a very high temperature and developed a rash. Relevant medical was not provided. Indication for PREVNAR was immunization. Product was administration on 31-Jul-2007. Dose regimen was 1 dose 1 time per day. Additional suspect medication included ACT-HIB. Concomitant medications were not reported. On 31-Jul-2007, the patient received the first dose of PREVNAR along with another childhood vaccine. On 02-Aug-2007, the child spiked a very high temperature (pyrexia) and developed a rash. The patient was hospitalized to rule out sepsis, and a blood culture revealed no growth. After three days a of hospitalization, the patient was discharged from the hospital. Both events resolved. See 'Relevant Tests/Laboratory Data" below. No additional information was available at the time of this report.
Age: 0.2
Sex: M
Vaccine: HIBV, PNC
Symptoms: Lymphocyte count normal, Monocyte count normal, Rash, Streptococcal identification test negative, White blood cell count decreased
Clinical narrative: Follow-up information was received that upgraded this case to serious and provided vaccine information, event onset date, additional event of rash, outcome, and laboratory tests. Information regarding PREVNAR was received from a healthcare professional regarding a 2-month-old male patient who received the first dose on 31-Jul-2007 along with the first dose of ACT-HIB (Aventis) and spiked a very high temperature and developed a rash. Relevant medical was not provided. Indication for PREVNAR was immunization. Product was administration on 31-Jul-2007. Dose regimen was 1 dose 1 time per day. Additional suspect medication included ACT-HIB. Concomitant medications were not reported. On 31-Jul-2007, the patient received the first dose of PREVNAR along with another childhood vaccine. On 02-Aug-2007, the child spiked a very high temperature (pyrexia) and developed a rash. The patient was hospitalized to rule out sepsis, and a blood culture revealed no growth. After three days a of hospitalization, the patient was discharged from the hospital. Both events resolved. See 'Relevant Tests/Laboratory Data" below. No additional information was available at the time of this report.
Sex: M
Vaccine: PNC
Symptoms: Culture, Pneumonia pneumococcal, Vaccination failure
Clinical narrative: Information regarding PREVNAR was received from a consumer regarding a 3-year-old male patient who experienced pneumococcal pneumonia. The patient received a dose of an unspecified date. Relevant medical history was not provided. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. On an unspecified date in Apr-2007, the patient was hospitalized with pneumococcal pneumonia. The patient's mother questioned the length of PREVNAR immunity (drug ineffective). She did not known if the patient had 3 or 4 injections of PREVNAR or if a specific serotype of pneumococcal infection had been determined. Caller declined to provide any further details stating that the child has a doctor's appointment on 19-Apr-2007. The patient's outcome is unknown. No additional information was available at the time of this report.
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Diarrhoea, Erythema multiforme, Irritability, Rash, Skin lesion
Clinical narrative: This case was considered medically important. Information regarding PREVNAR was received from a healthcare professional regarding a 3-month-old male patient who experienced erythema multiforme, diarrhea and irritability. The patient received the first dose in 2007. Relevant medical history was not provided. Indication for PREVNAR was immunisation. Product was administration in 2007. Dose regimen was 1 dose 1 time per day. Additional suspect vaccine included PEDIARIX and Hib vaccine (manufacturer unknown). Concomitant medication were not reported. After vaccination on an unspecified date in 2007, the patient developed a rash and lesions and was subsequently diagnosed with erythema multiforme. He was also experienced diarrhea and irritability. The outcome is unknown. The reporter considered the events probably related to vaccination with PEDIARIX, PREVNAR and Hib.
Age: 0.2
Sex: F
Vaccine: PNC
Symptoms: Pneumonia staphylococcal
Clinical narrative: This case was considered medically important. Information regarding PREVNAR was received from a physician regarding a 3-month-old female patient who experienced "Staph pneumonia." At 2 months of age, the patient received a dose in Jul-2007. Relevant medical history was not provided. Indication for PREVNAR was immunisation. Product was administered in Jul-2007. Dose regimen was 0.5 mL 1 time per day (intramuscular). Concomitant medications were not reported. The patient experienced "Staph pneumonia" (drug ineffective) in Aug-2007. Staphylococcal pneumonia resolved. No additional information was available at the time of this report.
Age: 0.2
Sex: M
Vaccine: PNC
Symptoms: Meningitis pneumococcal, Serology test, Vaccination failure
Clinical narrative: Information regarding PREVNAR was received from a pediatrician regarding a male patient who received the fist dose on an unspecified date at the age of 2 months. At the age of 3.5 months, the patient was hospitalized for pneumococcal meningitis. Relevant medical history was not provided. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. On an unspecified date, at the age of 2 months, the patient received the first dose of PREVNAR. At the age of 3.5 months, the patient was hospitalized for pneumococcal meningitis (drug ineffective). On an unspecified date, the patient recovered. Serology test (results: unknown) was done on an unspecified date. No additional information was available at the time of this report.
Age: 1.6
Sex: M
Vaccine: PNC
Symptoms: Body temperature increased, Electroencephalogram normal, Febrile convulsion, Pyrexia
Clinical narrative: Follow-up information was received that provided additional event details, outcome, illness at time of vaccination and laboratory test. This case was considered medically important. Information regarding PREVNAR was received from a pediatrician regarding an 18-month-old male patient who received a dose on 18-Jun-2007 and experienced febrile seizure. The patient's concurrent illness includes rhinorrhoea (mild). The patient's twin sister experienced fever of 103 to 104 degrees Fahrenheit with PREVNAR on the same day (case HQWYE727221JUN07). Product was administered on 18-Jun-2007. Dose regimen was 1 dose 1 time per day (intramuscular). Concomitant medications were not reported. On 18-Jun-2007, the patient received a dose of PREVNAR. Six hours after administration, the child experienced febrile seizure with a body temperature of 105 degrees Fahrenheit. The patient was taken to the Emergency room. The patient continued to have two to three subsequent febrile seizures. On an unspecified date, the patient recovered from the event. Body temperature (results: 105 deg. F.) was done on 18-Jan-2007. Electroencephalogram (results: negative focus seizure activity) was done in 2007. No additional information was available at the time of this report.
Age: 0.5
Sex: M
Vaccine: PNC
Symptoms: Laboratory test abnormal, Pneumococcal bacteraemia, Vaccination failure
Clinical narrative: Additional information has been received pertaining to the addition of the serious criteria of hospitalization, age change for patient at receipt of third dose of vaccine and deletion of concomitant therapy medication. Information regarding PREVNAR was received from a healthcare professional regarding a 19-month-old male patient who experienced drug ineffective and pneumococcal bacteremia. At 6 months of age, the patient received the third dose on 23-Dec-2005. The second dose was received on 10-Oct-2005. The first dose was received on 11-Aug-2005. The patient's concurrent illness included asthma (diagnosed on Jan-2007), convulsion (diagnosed at 9 months) and ear infection (ear tubes due to recurrent ear infections). Product was administered on 23-Dec-2005. Dose regimen was 1 dose 1 time per day (intramuscular). Concomitant therapy was not reported. On 27-Jan-2007, the patient developed pneumococcal bacteremia (drug ineffective), after receiving, a series of three doses. The child did not receive the 12-month dose of PREVNAR. The patient was hospitalized for 4 days. On 28-Feb-2007, titer levels were drawn on 15 serotypes. On an unspecified date, the pneumococcal bacteremia resolved. Laboratory test (results: pneumococcal titers- for 15 serotypes all were less than 0.2 except for 19F Igg) was done on 28-Feb-2007. No additional information was available at the time of this report.
Sex: M
Vaccine: PNC
Symptoms: Bacteraemia, Vaccination failure
Clinical narrative: Information was considered medically important. Information regarding PREVNAR was received from a pediatrician regarding a male patient (under the age of 5 years) who experienced bacteremia from invasive pneumococcal disease - drug ineffective. The patient received the first dose, second dose, third dose and fourth dose of unspecified dates. Relevant medical history was not provided. It was reported that the 4 doses of product had been administered on unknown dates. Each dose was 1 dose 1 time per day (intramuscular). Concomitant medications were not reported. The patient experienced bacteremia from invasive pneumococcal disease (drug ineffective) on an unknown date in 2007. The serotype was unknown. The patient's parents stated that the child's immunizations were current. However, the physician explained that the patient had been previously cared for by an Health Services Hospital, therefore he could not confirm that the patient had received all 4 doses of PREVNAR. It was unknown if bacteremia was resolved. No additional information was available at the time of this report.
Sex: U
Vaccine: PNC
Symptoms: Bacteraemia, Vaccination failure
Clinical narrative: This case was considered medically important. Information regarding PREVNAR (unspec) was received from a healthcare professional regarding a patient (age and gender unknown) who experienced drug ineffective and bacteremia. The patient received the fourth dose on an unspecified date. Relevant medical history was not provided. Product was administration on an unspecified date. Dose regimen was not provided. Concomitant medications were not reported. On an unspecified date after receiving the fourth dose of PREVNAR therapy, the patient presented with bacteremia and (drug ineffective). Treatment consisted of 2 shots of ROCEPHIN and patient was sent home with oral antibiotics. Serotype was not specified at time of the report. Patient was since made a full recovery. No additional information was available at the time of this report.
Sex: U
Vaccine: PNC
Symptoms: Meningitis pneumococcal, Vaccination failure
Clinical narrative: This case was considered medically important. Information regarding PREVNAR (unspec) was received from a pediatrician regarding a patient who experienced Streptococcus pneumonia meningitis. The patient received the fourth dose on an unspecified date. Relevant medical history was not provided. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day. Additional suspect medication included PREVNAR. Concomitant medications were not reported. The child who was fully immunized, experienced Streptococcus pneumoniae meningitis (drug ineffective). It was found that meningitis was caused by a serotype not contained in the vaccine. The outcome of pneumococcal meningitis was unknown. No additional information was available at the time of this report.
Sex: U
Vaccine: PNC
Symptoms: Streptococcal infection, Vaccination failure
Clinical narrative: This case was considered medially important. Information regarding PREVNAR (unspec) was received from a healthcare professional regarding a patient who developed a pneumococcal infection. The patient received a dose in 2007. Relevant medical history was not provided. Product was administered on an unspecified date in 2007. Dose regimen was 1 dose 1 time per day. Concomitant medication were not reported. On an unspecified date 2007, the patient developed a "strep infection" (drug ineffective). The outcome is unknown. No additional information was available at the time of this report.
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Lethargy, Vaccination failure
Clinical narrative: This case was considered medically important. Information regarding PREVNAR (unspec) was received from a healthcare professional regarding a 3-year-old female patient who developed lethargy and possible bacteremia. The patient received the fourth dose on an unspecified date. Relevant medical history was not provided. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day (intramuscular). Additional suspect medication included Diphtheria/Tetanus Toxoids/Acellular Pertussis Vaccine and Hib-Titer Vaccine. Concomitant medications were not reported. On 04-nov-2007, the developed lethargy and possible bacteremia (drug ineffective). The patient recovered on an unknown date in Nov-2007. No additional information was available at the time of this report.
Age: 0.2
Sex: U
Vaccine: PNC
Symptoms: Febrile convulsion
Clinical narrative: This case was considered medically important. Information regarding PREVNAR was received from a physician, who is a neighbor of the 2-month-old patient who experienced possible febrile seizure. At 2 months of age, the patient received the first dose on an date. Relevant medical history was not provided. Product was administered on an unspecified date.  Dose regimen was 1 dose 1 time per day (intramuscular). Concomitant medications included several unspecified vaccines. The patient experienced possible febrile seizure on an unknown date. Several unspecified vaccines were administered on the same day. The outcome is unknown. No additional information is anticipated. See related case: US-WYE-H01608207 (adverse event, expedited).
Age: 0.4
Sex: U
Vaccine: PNC
Symptoms: Febrile convulsion
Clinical narrative: This case was considered medically important. Information regarding PREVNAR was received from a physician, who is the neighbor of a 4-month-old patient who experienced possible febrile seizure. At 4 months of age, the patient received the second dose on an unspecified date. The patient previously experienced febrile convulsion while PREVNAR at 2 months of age (see case # US-WYE-H01604507). Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day (intramuscular). Concomitant medications included several unspecified vaccines. The patient experienced possible febrile seizure on an unknown date. Several unspecified vaccines were administered on the same day. The outcome is unknown. No additional information is anticipated. See related case (s): US-WYE-H0160507 (adverse event, expedited).
Sex: F
Vaccine: PNC
Symptoms: Blood culture positive, Chest X-ray abnormal, Pneumonia streptococcal, Sepsis, Vaccination failure
Clinical narrative: Information regarding PREVNAR was received from a healthcare professional regarding a 2-year-old female patient who developed general septicemia and streptococcal pneumonia. The patient received the fourth dose in Dec-2006. Healthy child. Product was administered in Dec-2006. Dose regimen was 1 dose 1 time per day (intramuscular). Concomitant medications were not reported. On 05-Dec-2007 the patient was hospitalized with general septicemia and streptococcal pneumonia (drug ineffective). The patient was treated with unspecified IV antibiotics; hospital discharge was tentative for 12-Dec-2007. The patient has not yet recovered. Blood culture (results: positive) and chest x-ray (results: pneumonia) were done in Dec-2007. No additional information was available at the time of this report.
Sex: M
Vaccine: PNC
Symptoms: Blood culture positive, Drug ineffective, Pneumococcal bacteraemia, Pneumococcal infection, Vaccination failure
Clinical narrative: Information regarding PREVNAR was received from a healthcare professional regarding a patient between 12 and 18 months of age (gender not provided) who experienced pneumococcal bacteremia. The patient received the fourth dose on an unspecified date. Relevant medical history was not provided. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day (intramuscular). Concomitant medications were not reported. On 01-Jan-2008, the patient experienced life threatening pneumococcal bacteremia (drug ineffective) and was hospitalized. Testing revealed a blood culture positive for pneumococcus. Information regarding treatment was not provided. On an unspecified date, the patient recovered. Blood culture (results: positive for pneumococcus) was done on 01-Jan-2008. See related case(s): US-WYE-H02022008 (adverse event, expedited). No additional information was available at the time of this report. Additional information was received from the pediatrician which updated patient details, product details and event details. Information regarding PREVNAR was received from a healthcare professional regarding a 11-month-old, male patient who experienced pneumococcal bacteremia. The patient received the third dose of 01-Aug-2007. On 30-Dec-2007, the patient experienced life threatening pneumococcal bacteremia and was hospitalized. Testing revealed a blood culture positive for pneumococcus. Information regarding treatment was not provided. On an unspecified date, the patient recovered.
Sex: U
Vaccine: PNC
Symptoms: Blood culture positive, Pneumococcal bacteraemia, Vaccination failure
Clinical narrative: Information regarding PREVNAR was received from a healthcare professional regarding a patient between 12 and 18 months of age (gender not provided) who experienced pneumococcal bacteremia.  The patient received the fourth dose on an unspecified date.  Relevant medical history was not provided.  Product was administered on an unspecified date.  Dose regimen was 1 dose 1 time per day (intramuscular).  Concomitant medications were not reported.  On 01-Jan-2008, the patient experienced life threatening pneumococcal bacteremia (drug ineffective) and was hospitalized.  Testing revealed a blood culture positive for pneumococcus.  Information regarding treatment was not provided.  On an unspecified date, the patient recovered.  Blood culture (results: positive for pneumococcus) was done on 01-Jan-2008.  See related case(s): US-WYE-H02014208 (adverse event, expedited).  No additional information was available at the time of this report.
Age: 1.3
Sex: F
Vaccine: PNC
Symptoms: Bacteraemia, Pneumonia
Clinical narrative: Information regarding PREVNAR was received from a healthcare professional regarding a 19-month-old female patient who experienced bacteremic pneumonia.  The patient received the fourth dose in Sep-2007.  Relevant medical history was not provided.  Product was administered in Sep-2007.  Additional suspect medication included PREVNAR, PREVNAR and PREVNAR.  Concomitant medications were not reported.  The patient experienced bacteremic pneumonia on 12-Jan-2008.  The patient was hospitalized.  Outcome was reported as recovered (Jan-2008).  No additional information was available at the time of this report.
Age: 34.0
Sex: M
Vaccine: HEPAB, TDAP
Symptoms: Hypoaesthesia
Clinical narrative: Patient received TWINRIX and TDaP on 3-18-08.  Soon after that, he noticed right upper arm became numb only at night.  No tingling, no color change.  Arm recovers in AM.
Age: 0.6
Sex: M
Vaccine: PNC
Symptoms: Blood culture positive, Pneumococcal bacteraemia, Vaccination failure, White blood cell count increased
Clinical narrative: This case was considered medically important. Information regarding PREVNAR was received from a pediatrician regarding a male patient who received the third dose at 6 months of age and experienced pneumococcal bacteremia at 11 months of age. Relevant medical history was not provided. Product was administered in 2007. Dose regimen was 1 dose 1 time per day (intramuscular). Concomitant medications were not reported. In 2007, the patient had received three doses of PREVNAR at 2, 4 and 6 months of age. During the first week of Feb-2008, the patient developed pneumococcal bacteremia (drug ineffective) with fever, irritability, a blood culture positive for penicillin-sensitive Streptococcus pneumoniae and a white blood cell count of 30,000. Treatment included ROCEPHIN, followed by levofloxacin. On an unspecified date in Feb-2008, the patient recovered. Blood culture (results: penicillin-sensitive Streptococcus pneumoniae) and white blood cell count (results: 30,000) were done in Feb-2008. No additional information was available at the time of this report.
Sex: U
Vaccine: PNC
Symptoms: Injection site atrophy
Clinical narrative: This case was considered medically important. Information regarding PREVNAR vaccine was received from a healthcare professional regarding a patient who experienced received vaccine subcutaneously instead of intramuscularly and subcutaneous atropy secondary to vaccination. The patient received a dose on an unspecified date. Relevant medical history was not provided.  Concomitant medications were not reported. On an unspecified date, the patient received the vaccination subcutaneously instead of intramuscularly. The child did not have redness or swelling but had an indentation at injection site which was diagnosed as subcutaneous atrophy secondary to vaccination. The outcome if the event is unknown. No additional information was available at the time of this report.
Sex: U
Vaccine: PNC
Symptoms: Incorrect route of drug administration, Injection site atrophy
Clinical narrative: Information regarding PREVNAR was received from a healthcare professional regarding a patient who received PREVNAR subcutaneously instead of IM and was diagnosed with subcutaneous atrophy secondary to vaccination. The patient received a dose on an unspecified date. On an unspecified date, the patient was diagnosed with subcutaneous atrophy secondary to vaccination. The patient received PREVNAR subcutaneously instead of IM. The outcome is unknown. No additional information was available at the time of this report.
Sex: M
Vaccine: PNC
Symptoms: Injection site abscess sterile
Clinical narrative: Information regarding Prevnar was received from a healthcare professional regarding a 5-month-old male patient who experienced two sterile abscesses at the injection sites. The patient received a dose in 2007. Healthy infant. Concomitant medications were not reported. On 06-May-2007, the patient developed two sterile abscesses on each anterior thigh after receiving "vaccines". Reporters stated that there were surgical intervention but did not know the extent. An allergies saw the patient on 07-May and noted that the "injection sites" are healing. No additional information was available at the time of this report.
Age: 3.0
Sex: M
Vaccine: PNC
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Information regarding PREVNAR was received from a healthcare professional regarding a 3-year-old male patient who experienced 40% of right lateral thigh was red and swollen.  At 3 years of age, the patient received the fourth dose on 08-Mar-2006.  Relevant medical history was not provided.  Product was administered on 08-Mar-2006.  Concomitant therapy included Hep A.  On 08-Mar-2006 40% of the patient's right lateral thigh became red and swollen after he received his 4th dose of PREVNAR.  The patient recovered without treatment.  No additional information was available at the time of this report.
Age: 7.0
Sex: F
Vaccine: PNC
Symptoms: Antibody test abnormal, Malaise
Clinical narrative: Information regarding PREVNAR was received from a healthcare professional regarding a 7-year-old female patient who experienced pneumococcal titer levels all very low except for 23F.  The patient received the second dose in 2001.  Relevant medical history was not provided.  Product was administered in 2001.  Dose regimen was 1 dose 1 time per day (intramuscular).  Concomitant medications were not reported.  On unspecified dates in or around 2001, the patient received a dose of PREVNAR at 13 months and 15 months of age.  On an unspecified date in or around 2007, at 7 years of age, the patient's pnuemococcal titer levels revealed that all but 23F were very low (antibody test abnormal).  The reporter noted the patient is 'continually ill' (malaise).  The patient's outcome is unknown.  Antibody test (results: pneumococcal titer levels all very low except 23F) was done in 2007.  No additional information was available at the time of this report.
Sex: U
Vaccine: PNC
Symptoms: Medication error, No adverse event
Clinical narrative: Information regarding Prevnar was received from a healthcare professional regarding a patient who received dose of Prevnar that was exposed to out of temperature range on an unspecified date. Relevant medical history was not provided. Concomitant medications were not reported. On an unspecified date, the patient received a dose of PREVNAR that was exposed to out of temperature range due to a power outage. No adverse event was reported. The reporter was unable to specify the number of patients who received this vaccine. No additional information was available at the time of this report.
Age: 23.0
Sex: F
Vaccine: PNC
Symptoms: Injection site swelling, Injection site warmth, Musculoskeletal stiffness, Wrong drug administered
Clinical narrative: Follow-up information included recovery status.  Information regarding PREVNAR was received from a healthcare professional regarding a 23-year-old female patient who administered the PREVNAR instead of PPV23.  She experienced heat at injection site, stiffness in left arm and injection site swelling.  The patient received a dose on 04-Jun-2007.  The patient's concurrent illness includes diabetes mellitus (Borderline).  Product was administered on 04-Jun-2007.  Concomitant medications were not reported.  The patient was administered the PREVNAR instead of PPV23 on 04-Jun-2007.  The following day, 05-Jun-2007, she experienced heat at injection site, stiffness in left arm and injection site swelling.  The patient recovered.  No additional information was available at the time of this report.
Sex: M
Vaccine: PNC
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Information regarding Prevnar was received from healthcare professional regarding a male patient who experienced redness and swelling of the arm, had not eat on two days and redness and swelling of the arm. The patient received vaccine. Relevant medical history was not provided. Concomitant medications were not reported. The patient experienced redness and swelling of the arm and had not eaten in two days. Outcome was unknown. No additional information was available at the time of this report.
Sex: F
Vaccine: PNC
Symptoms: Pharmaceutical product complaint, Skin laceration
Clinical narrative: Follow-up information provided outcome. Information regarding PREVNAR was received from a healthcare professional regarding a nurse who sustained a cut on her thumb when the PREVNAR prefilled syringe broke. Relevant medical history was not provided. Product was administered on an unspecified date. Dose regimen was 1 dose. Concomitant medications were not reported. The nurse sustained a cut on her thumb when the PREVNAR prefilled syringe broke (pharmaceutical product complaint). No injury to patient was noted. The nurse recovered. No additional information was available at the time of this report.
Sex: U
Vaccine: PNC
Symptoms: Antibody test abnormal
Clinical narrative: Information regarding PREVNAR (unspec) was received from a healthcare professional regarding a patient who experienced non-responsive titer levels to PREVNAR. The patient received a dose on an unspecified date. Relevant medical history was not provided. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. On an unspecified date, the patient received a dose of PREVNAR (date unspecified) and subsequently experienced a non-responsive titer level to PREVNAR (antibody test abnormal). The patient's outcome is unknown. No additional information was available at the time of this report.
Age: 1.0
Sex: M
Vaccine: PNC
Symptoms: Anorexia, Irritability, Pharyngolaryngeal pain, Wheezing
Clinical narrative: Information regarding PREVNAR was received from a consumer regarding a 12-month-old male patient who experienced wheezing, sore throat, loss of appetite and irritability. The patient recovered a dose on 14-Jun-2007. Relevant medical history was not provided. Concomitant medications were not reported. On 15-Jun-2007, the patient experienced wheezing, sore throat, loss of appetite and irritability. The patient was treated with Motrin, Tylenol, and Nebulizer. The outcome of the events is unknown. No additional information was available at the time of this report.
Sex: U
Vaccine: PNC
Symptoms: Medication error
Clinical narrative: Information regarding PREVNAR was received from a healthcare professional regarding a patient who received a dose of PREVNAR exposed to 1 degree Centigrade for a period of nine days on an unspecified date.  Relevant medical history was not provided.  Product was administered on an unspecified date.  Dose regimen was 1 dose 1 time per day.  Concomitant medications were not reported.  In Mar-2006, PREVNAR was exposed to 1 degree Centigrade for a period of nine days (medication error).  On an unspecified date, the patient received a dose of that incorrectly stored PREVNAR.  No adverse event was reported.  The reporter was unable to specify the number of patients who experienced this event.  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: Immune system disorder, Overdose, Sinus disorder
Clinical narrative: Information regarding PREVNAR was received from a Pediatrician regarding a female patient who received 7 doses of PREVNAR. The reporter noted the patient "possibly has immune response issues and had constant sinus problems. The patient received the seventh dose on an unspecified date. Child has no history of meningitis or bacteremia. Concomitant vaccine included Pneumococcal Polysaccharide Vaccine. On unspecified dates, the patient received 7 doses of PREVNAR. The reporter indicated the patient also received approximately 3 doses of a "pneumococcal polysaccharide vaccine". Additionally, the reporter noted the patient "possibly had immune response issues and had constant sinus problems (dates unspecified). As of 03-May-2007, the patient's outcome was unknown. No additional information was available at the time of this report.
Sex: U
Vaccine: PNC
Symptoms: Medication error
Clinical narrative: Information regarding PREVNAR was received from a healthcare professional regarding a patient who received a dose of PREVNAR exposed to "too cold" temperatures on an unspecified date. On an unspecified date, the patient received a dose of PREVNAR that was exposed to "too cold" temperatures. No adverse event was reported. The reporter was unable to specify the number of patients who experienced this event. The out-of-range variances in the temperature occurred over the past three years. Additional reports will be generated when identifying information is provided. No additional information was available at the time of this report.
Age: 0.8
Sex: F
Vaccine: PNC
Symptoms: Accidental overdose, Incorrect dose administered, Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: Information regarding PREVNAR was received from a consumer regarding a 9-month-old female patient who received a second and third dose of PREVNAR on 22-Jun-2007.  On the same day, she experienced irritability and her right thigh was red, swollen and a hard lump formed at the injection site on her right thigh.  The patient's concurrent illness includes premature baby (one month premature).  No previous adverse event occurred with the patient's first injection of PREVNAR administered on 19-Dec-2006.  Concomitant medications were not reported.  On 22-Jun-2007, the patient's mother reported that PREVNAR was administered to her daughter twice in one day.  She received one dose in her left thigh with no reaction reported, and one injection in her right thigh.  On the same day the patient's right thigh was red, swollen and a hard lump formed at the injection site.  She also experienced irritability.  The patient's outcome is unknown.  No additional information was available at the time of this report.
Age: 0.8
Sex: F
Vaccine: PNC
Symptoms: Injection site swelling, Irritability, No reaction on previous exposure to drug
Clinical narrative: Information regarding PREVNAR was received from a consumer regarding a 9-month-old female patient who received a second and third dose of PREVNAR on 22-Jun-2007.  On the same day, she experienced irritability and her right thigh was red, swollen and a hard lump formed at the injection site on her right thigh.  The patient's concurrent illness includes premature baby (one month premature).  No previous adverse event occurred with the patient's first injection of PREVNAR administered on 19-Dec-2006.  Concomitant medications were not reported.  On 22-Jun-2007, the patient's mother reported that PREVNAR was administered to her daughter twice in one day.  She received one dose in her left thigh with no reaction reported, and one injection in her right thigh.  On the same day the patient's right thigh was red, swollen and a hard lump formed at the injection site.  She also experienced irritability.  The patient's outcome is unknown.  No additional information was available at the time of this report.
Sex: U
Vaccine: PNC, PPV
Symptoms: Medication error
Clinical narrative: Information regarding PREVNAR was received from a healthcare professional regarding an unspecified number of patients who were administered the vaccine that was exposed to a temperature of 1 degree C. for 2 days. The patients received a dose on an unspecified date. Relevant medical history was not provided. Product was administered on an unspecified date. Dose regimen was 1 dose. Concomitant medications were not reported. An unspecified number of patients were administered the vaccine that was exposed to a temperature of 1 degree C. for 2 days (medication error). No additional information was available at the time of this report.
Sex: U
Vaccine: PNC
Symptoms: Medication error
Clinical narrative: Information regarding PREVNAR was received from a healthcare professional regarding a patient who experienced stored at 32 degrees Fahrenheit for a few days.  The patient received a dose on an unspecified date.  Relevant medical history was not provided.  Product was administered on an unspecified date.  Concomitant medications were not reported.  Approximately 5 patients received the PREVNAR vaccine the was stored at 32 degrees Fahrenheit for a few days.  No adverse events were reported at this time.  No additional information was available at the time of this report.
Age: 1.9
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Follow-up provided additional concomitant medication, event outcome and patient demographics. Information regarding PREVNAR was received from a healthcare professional regarding a 23-month-old male patient who experienced localized reaction to vaccination (red, firm, warm, tender to touch, 7-8 cm long by 5 cm wide, and slightly raised). At 23 months of age, the patient received the fourth dose on 25-Apr-2007. The patient also received the first dose of MMR Vax, the first dose of HAVRIX and the third dose of PEDVAXHIB on 25-Apr-2007. On 26-Apr-2007, the mother reported to the physicians office an exaggerated reaction to vaccination, "orange size, red, hot spot". On 27-Apr-2007, the patient was taken to the ER and was diagnosed with a localized reaction to vaccination (red, firm, warm, tender to touch, 7-8 cm long by 5 cm wide, and slightly raised). The patient was treated with ice pack and MOTRIN. The patient recovered. No additional information was available at the time of this report.
Sex: U
Vaccine: PNC
Symptoms: Decreased immune responsiveness
Clinical narrative: Information regarding PREVNAR was received from a consumer regarding a patient who experienced a low immune response. The patient received a dose of PREVNAR on an unspecified date. Relevant medical history was not provided. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. On an unspecified date, the patient experienced low response. "Caller declined to provide complete AE report." The outcome of the event was unknown. No additional information was available at the time of this report.
Sex: U
Vaccine: PNC
Symptoms: Medical device complication, Skin laceration
Clinical narrative: Information regarding PREVNAR was received from a healthcare professional regarding a healthcare professional who cut her finger as a result of the syringe breaking at the finger grip while administering the vaccine. The patient received a dose on an unspecified date. Relevant medical history was not provided. Concomitant medications were not reported. A healthcare professional cut her finger as a result of the syringe breaking at the finger grip while administering the vaccine. No additional information was available at the time of this report. The plant has reviewed all investigations associated with this batch from a manufacturing and techinical perspective and investigations were appropriately clsoed and addressed prior to batch release. No quality issues were identified in review of batch records, release test records or inspection of retained samples. Retained samples meet the product description and the product. No product was returned for examination.
Sex: U
Vaccine: PNC
Symptoms: No therapeutic response
Clinical narrative: Information regarding PREVNAR was received from a physician regarding 6 Down's patients who have not responded, even after 5, 6 or 7 doses of PREVNAR.  The patients received doses on unspecified dates.  The patient's concurrent condition includes trisomy 21.  Product was administered on an unspecified date.  Concomitant medications were not reported.  Six Down's patients have not responded even after 5, 7 or 7 doses of PREVNAR.  The outcome is unknown.  No additional information was available at the time of this report.
Age: 0.2
Sex: F
Vaccine: PNC
Symptoms: Injection site induration, Oedema peripheral
Clinical narrative: Information regarding PREVNAR was received from a healthcare professional regarding a 2-month-old female patient who experienced one inch diameter globule at the injection site and entire leg was swollen after PREVNAR administration. At 2 months of age, the patient received the first dose on 16-Jan-2008. The patient experienced one inch diameter globule at the injection site and entire leg was swollen after PREVNAR administration on 16-Jan-2008. The patient was recovering from the leg swelling. The outcome of the injection site induration was unknown. No additional information was available at the time of this report.
Age: 0.28
Sex: F
Vaccine: PNC
Symptoms: Anorexia, Irritability, Pyrexia
Clinical narrative: Information regarding PREVNAR was received from a consumer regarding a 3-month-old female patient who experienced low grade fever, fussy and did not have appetite.  At 3 months of age, the patient received a dose on 07-Feb-2008.  The patient's concurrent illness includes nasopharyngitis.  Product was administered on 07-Feb-2008.  Concomitant medications were not reported.  The patient experienced low grade fever, was fussy and did not have appetite on 07-Feb-2008.  Outcome of the events of pyrexia and irritability was unknown.  The patient was considered not recovered from the anorexia.  No additional information was available at the time of this report. Follow-up the patient recovered (2008).
Sex: M
Vaccine: PNC, PNC, PNC, PNC, PNC
Symptoms: Otitis media
Clinical narrative: Additional information provided information regarding PREVNAR was  from a healthcare professional regarding a male patient who experienced otitis media. The patient completed his primary series, having received a fourth dose on 29-Oct-2003.
Sex: M
Vaccine: PNC, PNC, PNC, PNC, PNC
Symptoms: Condition aggravated, Otitis media
Clinical narrative: Additional information provided information regarding PREVNAR was  from a healthcare professional regarding a male patient who experienced otitis media. The patient completed his primary series, having received a fourth dose on 29-Oct-2003.
Sex: M
Vaccine: PNC, PNC, PNC, PNC, PNC
Symptoms: Antibody test abnormal, Blood immunoglobulin A normal, Blood immunoglobulin G normal, Blood immunoglobulin M normal, Complement factor normal
Clinical narrative: Additional information provided information regarding PREVNAR was  from a healthcare professional regarding a male patient who experienced otitis media. The patient completed his primary series, having received a fourth dose on 29-Oct-2003.
Sex: M
Vaccine: PNC, PNC, PNC, PNC, PNC
Symptoms: No therapeutic response, Otitis media, Platelet count increased, Therapeutic response decreased
Clinical narrative: Additional information provided information regarding PREVNAR was  from a healthcare professional regarding a male patient who experienced otitis media. The patient completed his primary series, having received a fourth dose on 29-Oct-2003.
Sex: M
Vaccine: PNC, PNC, PNC, PNC, PNC
Symptoms: Otitis media
Clinical narrative: Information regarding PREVNAR was received from a healthcare professional regarding a male patient who experienced otitis media. The patient completed his primary series, having received a fourth dose on 29-Oct-2003. On 29-Oct-2003, the patient received a fourth dose of PREVNAR completing his primary series. In Jan-2006, the patient experienced otitis media. On an unspecified date, the patient recovered. No additional information was available at the time of this report.
Sex: M
Vaccine: PNC, PNC, PNC, PNC, PNC
Symptoms: Condition aggravated, Otitis media
Clinical narrative: Information regarding PREVNAR was received from a healthcare professional regarding a male patient who experienced otitis media. The patient completed his primary series, having received a fourth dose on 29-Oct-2003. On 29-Oct-2003, the patient received a fourth dose of PREVNAR completing his primary series. In Jan-2006, the patient experienced otitis media. On an unspecified date, the patient recovered. No additional information was available at the time of this report.
Sex: M
Vaccine: PNC, PNC, PNC, PNC, PNC
Symptoms: Antibody test abnormal, Blood immunoglobulin A normal, Blood immunoglobulin G normal, Blood immunoglobulin M normal, Complement factor normal
Clinical narrative: Information regarding PREVNAR was received from a healthcare professional regarding a male patient who experienced otitis media. The patient completed his primary series, having received a fourth dose on 29-Oct-2003. On 29-Oct-2003, the patient received a fourth dose of PREVNAR completing his primary series. In Jan-2006, the patient experienced otitis media. On an unspecified date, the patient recovered. No additional information was available at the time of this report.
Sex: M
Vaccine: PNC, PNC, PNC, PNC, PNC
Symptoms: No therapeutic response, Otitis media, Platelet count increased, Therapeutic response decreased
Clinical narrative: Information regarding PREVNAR was received from a healthcare professional regarding a male patient who experienced otitis media. The patient completed his primary series, having received a fourth dose on 29-Oct-2003. On 29-Oct-2003, the patient received a fourth dose of PREVNAR completing his primary series. In Jan-2006, the patient experienced otitis media. On an unspecified date, the patient recovered. No additional information was available at the time of this report.
Sex: M
Vaccine: PNC, PNC, PNC, PNC, PNC
Symptoms: Otitis media
Clinical narrative: Information regarding PREVNAR was received from a healthcare professional regarding a male patient who experienced otitis media.  The patient completed his primary series, having received a fourth dose on 29-Oct-2003.  The patient has a past history of otitis media (Nov-2004, Apr-2005, Nov-2005 and Jan-2006 (recovered)).  See related cases HQWYE105409MAY07, HQWYE105509MAY07, HQWYE105609MAY07 and HQWYE105709MAY07).  Product was administered on 29-Oct-2003.  Concomitant medications were not reported.  On 29-Oct-2003, the patient received a fourth dose of PREVNAR completing his primary series.  In Feb-2006, the patient experienced otitis media.  On an unspecified date, the patient recovered.  See related case(s): HQWYE062008MAY07 (adverse event, expedited); HQWYE105409MAY07 (adverse event, non-expedited); HQWYE105509MAY07 (adverse event, expedited); HQWYE105609MAY07 (adverse event, expedited); and HQWYE105709MAY07 (adverse event, expedited).  No additional information was available at the time of this report.
Sex: M
Vaccine: PNC, PNC, PNC, PNC, PNC
Symptoms: Condition aggravated, Otitis media
Clinical narrative: Information regarding PREVNAR was received from a healthcare professional regarding a male patient who experienced otitis media.  The patient completed his primary series, having received a fourth dose on 29-Oct-2003.  The patient has a past history of otitis media (Nov-2004, Apr-2005, Nov-2005 and Jan-2006 (recovered)).  See related cases HQWYE105409MAY07, HQWYE105509MAY07, HQWYE105609MAY07 and HQWYE105709MAY07).  Product was administered on 29-Oct-2003.  Concomitant medications were not reported.  On 29-Oct-2003, the patient received a fourth dose of PREVNAR completing his primary series.  In Feb-2006, the patient experienced otitis media.  On an unspecified date, the patient recovered.  See related case(s): HQWYE062008MAY07 (adverse event, expedited); HQWYE105409MAY07 (adverse event, non-expedited); HQWYE105509MAY07 (adverse event, expedited); HQWYE105609MAY07 (adverse event, expedited); and HQWYE105709MAY07 (adverse event, expedited).  No additional information was available at the time of this report.
Sex: M
Vaccine: PNC, PNC, PNC, PNC, PNC
Symptoms: Antibody test abnormal, Blood immunoglobulin A normal, Blood immunoglobulin G normal, Blood immunoglobulin M normal, Complement factor normal
Clinical narrative: Information regarding PREVNAR was received from a healthcare professional regarding a male patient who experienced otitis media.  The patient completed his primary series, having received a fourth dose on 29-Oct-2003.  The patient has a past history of otitis media (Nov-2004, Apr-2005, Nov-2005 and Jan-2006 (recovered)).  See related cases HQWYE105409MAY07, HQWYE105509MAY07, HQWYE105609MAY07 and HQWYE105709MAY07).  Product was administered on 29-Oct-2003.  Concomitant medications were not reported.  On 29-Oct-2003, the patient received a fourth dose of PREVNAR completing his primary series.  In Feb-2006, the patient experienced otitis media.  On an unspecified date, the patient recovered.  See related case(s): HQWYE062008MAY07 (adverse event, expedited); HQWYE105409MAY07 (adverse event, non-expedited); HQWYE105509MAY07 (adverse event, expedited); HQWYE105609MAY07 (adverse event, expedited); and HQWYE105709MAY07 (adverse event, expedited).  No additional information was available at the time of this report.