chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.42
Sex: M
Vaccine: PNC
Symptoms: Vaccination failure
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.
Age: 0.33
Sex: M
Vaccine: PNC
Symptoms: General physical health deterioration, Laboratory test, Pneumococcal sepsis, Vaccination failure
Clinical narrative: Information regarding Prevnar was received from a healthcare professional regarding a 4-month-old male patient who experienced pneumococcal sepsis and drug ineffective. At 4 months of age, the patient received the second dose on an unspecified date. One week after receiving the second dose of Prevnar (date not specified), the patient was hospitalized and diagnosed with pneumococcal sepsis in Jun-2006. Laboratory tests were performed; however, the results were not available. The reporter indicated that the infant is currently hospitalized and "in bad shape." No additional information was available at the time of this report.
Age: 0.8
Sex: F
Vaccine: PNC
Symptoms: Blood culture positive, Lumbar puncture normal, Pneumococcal sepsis, Streptococcal bacteraemia, Vaccination failure
Clinical narrative: Follow-up information pertaining to the recovery status of the patient, changes of concomitant vaccines with administration dates and correction of Prevnar lot number has been received. Information regarding Prevnar was received from a healthcare professional regarding an 11-month-old female patient who developed pneumococcal sepsis. At 10 months of age, the patient received the third dose on 17-Feb-2006. The patient also received a dose of Daptacel and Ipol on 17-Feb-2006. On 08-Apr-2006 the patient was hospitalized with pneumococcal sepsis. Blood cultures revealed Strep pneumococcus; serotyping was not performed. Spinal tap results were negative. The child remained hospitalized until 10-Apr-2006. She was treated with unspecified antibiotics and recovered on an unspecified date in 2006. Blood cultures (results: revealed: Strep pneumococcus) and lumbar puncture (results: negative) were done on 08-Apr-2006.
Age: 1.3
Sex: F
Vaccine: MMR, PNC
Symptoms: Body temperature increased, Pneumococcal infection, Pyrexia, Streptococcal bacteraemia, Streptococcal identification test positive
Clinical narrative: Follow-up information pertaining to the patient's recovery status has been received. Information regarding Prevnar was received from a healthcare professional regarding a female patient who had a positive test result for streptococcal pneumoniae. At 15 months of age, the patient received the fourth dose on 05-Jun-2006. The patient also received the first dose of M-M-R on 05-Jun-2006. On 05-Jun-2006 the patient received her 4th dose of Prevnar. Within 12 hours after vaccination on 06-Jun-2006, the patient was hospitalized with a fever of 103 deg. F. Testing was positive for streptococcal pneumoniae. It was noted that the "test report was sent to the state to see what strain it is". The patient was treated with unspecified intravenous antibiotics. The patient recovered.
Age: 1.3
Sex: F
Vaccine: MMR, PNC
Symptoms: Vaccination failure
Clinical narrative: Follow-up information pertaining to the patient's recovery status has been received. Information regarding Prevnar was received from a healthcare professional regarding a female patient who had a positive test result for streptococcal pneumoniae. At 15 months of age, the patient received the fourth dose on 05-Jun-2006. The patient also received the first dose of M-M-R on 05-Jun-2006. On 05-Jun-2006 the patient received her 4th dose of Prevnar. Within 12 hours after vaccination on 06-Jun-2006, the patient was hospitalized with a fever of 103 deg. F. Testing was positive for streptococcal pneumoniae. It was noted that the "test report was sent to the state to see what strain it is". The patient was treated with unspecified intravenous antibiotics. The patient recovered.
Age: 1.3
Sex: F
Vaccine: DPP, HIBV, PNC
Symptoms: Incorrect route of drug administration, Injection site haemorrhage
Clinical narrative: Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from healthcare professional regarding a 27-month-old female patient who received a dose on 09-Feb-2007, along with a dose of Hib-Titer vaccine and a dose of Diphtheria/Tetanus Toxoids/Acellular Pertussis Vaccine (manufacturer unknown) (diphtheria/tetanus  toxoid/acellular pertussis vaccine. After injection with Prevnar it was reported that the patient experienced more bleeding than usual at the site of injection and it is not certain if Prevnar went directly into the child's vein. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 09-Feb-2007. Dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. On 09-Feb-2007, after injection with Prevnar, it was reported that the patient experienced more bleeding than usual at the site of injection and it is not certain if Prevnar went directly into the child's vein (injection site haemorrhage) (incorrect route of drug administration). The bleeding stopped in the office and the child went home without any further bleeding. No additional information was available at the  time of this report.
Age: 0.02
Sex: F
Vaccine: PNC
Symptoms: Injection site irritation, Injection site pain
Clinical narrative: Information regarding Prevnar (pneumococcal 7-valent conjugate (diphtheria crm197 protein) syringe pre-filled) was received from a consumer regarding a 2-month-old female patient who experienced injection site pain and injection site burning. The patient received a dose on an unspecified date. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day (intramuscular). Concomitant medications were not reported. The patient experienced injection site pain (injection site pain) and injection site burning (injection site irritation) following her 2 month vaccination. See related case(s): HQWYE776421AUG06 (injection site pain and injection site burning following 6 month Prevnar vaccination; non-expedited). No additional information was available at the time of this report.
Age: 1.0
Sex: F
Vaccine: PNC
Symptoms: Drug administered at inappropriate site, Incorrect route of drug administration, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Follow-up information was received that provide additional information on recovery status and emergency room or doctor visit. Information regarding Prevnar was received from a nurse regarding an 11-month-old female patient who received the fourth dose of Prevnar that appeared to be inadvertently administered in tradermally in right forearm but believed to have been administered deeper on 05-Jul-2006. On the same day the child became itchy at the injection site and developed a possible local delayed hypersensitivity reaction or possible reaction to aluminum in the adjuvant characterized by a red lump on the injection site. On 12-Jul-2006, the child became cranky. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 05-Jul-2006. Dose regimen was 1 dose 1 time per day (intradermal). Concomitant medications were not reported. On 05-Jul-2006, the patient received a dose of Prevnar that appeared to be inadvertently administered intradermally in the right forearm (drug administered at inappropriate site) but believed to have been administered deeper (incorrect route of drug administration). The reporter noted that no indruation was immediately observed and could "not even tell the child received a vaccine." Later, on the same day, the child was itchy at the injection site (injection site pruritus). The nurse suggested Tylenol (acetaminophen), Motrin (ibuprofen), Benadryl (diphenhydramine) and hydrocortisone treatment. At 5:00 pm, the child developed a small red bump on the injection site (injection site erythema) (injection site swelling) that grew to 2.5 by 3.0 cm. The reporter noted that these events were the result of a possible local delayed hypersensitivity reaction (type IV hypersensitivity reaction) or possible reaction to aluminum in the Prevnar adjuvant (hypersensitivity). On 12-Jul-2006, the injection site swelling decreased to a size "smaller that a marble" and the child was described as cranky (irritability). The reporter noted that the events required an emergency room or doctor visit. On an unspecified date in 2006, the patient recovered from the events. No additional information was available at the time of this report.
Age: 1.0
Sex: F
Vaccine: PNC
Symptoms: Type IV hypersensitivity reaction
Clinical narrative: Follow-up information was received that provide additional information on recovery status and emergency room or doctor visit. Information regarding Prevnar was received from a nurse regarding an 11-month-old female patient who received the fourth dose of Prevnar that appeared to be inadvertently administered in tradermally in right forearm but believed to have been administered deeper on 05-Jul-2006. On the same day the child became itchy at the injection site and developed a possible local delayed hypersensitivity reaction or possible reaction to aluminum in the adjuvant characterized by a red lump on the injection site. On 12-Jul-2006, the child became cranky. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 05-Jul-2006. Dose regimen was 1 dose 1 time per day (intradermal). Concomitant medications were not reported. On 05-Jul-2006, the patient received a dose of Prevnar that appeared to be inadvertently administered intradermally in the right forearm (drug administered at inappropriate site) but believed to have been administered deeper (incorrect route of drug administration). The reporter noted that no indruation was immediately observed and could "not even tell the child received a vaccine." Later, on the same day, the child was itchy at the injection site (injection site pruritus). The nurse suggested Tylenol (acetaminophen), Motrin (ibuprofen), Benadryl (diphenhydramine) and hydrocortisone treatment. At 5:00 pm, the child developed a small red bump on the injection site (injection site erythema) (injection site swelling) that grew to 2.5 by 3.0 cm. The reporter noted that these events were the result of a possible local delayed hypersensitivity reaction (type IV hypersensitivity reaction) or possible reaction to aluminum in the Prevnar adjuvant (hypersensitivity). On 12-Jul-2006, the injection site swelling decreased to a size "smaller that a marble" and the child was described as cranky (irritability). The reporter noted that the events required an emergency room or doctor visit. On an unspecified date in 2006, the patient recovered from the events. No additional information was available at the time of this report.
Age: 0.2
Sex: M
Vaccine: PNC
Symptoms: Fontanelle bulging, Irritability, Pyrexia
Clinical narrative: Information regarding Prevnar was received from a consumer regarding a 2-month-old male patient who experienced a mild fever for a couple of days, was cranky and developed fontanel swelling on the top of his head. The patient recovered from the fever; the swelling and irritability are resolving. See related cases HQWYE560316AUG06 (adverse event, expedited) and HQWYE638117AUG06 (adverse event, non-expedited). No additional information was available at the time of this report.
Age: 0.4
Sex: M
Vaccine: PNC
Symptoms: Fontanelle bulging, Irritability, Pyrexia
Clinical narrative: Information regarding Prevnar was received from a consumer regarding a 4-month-old male who experienced fontanel swelling on top of head, was cranky and developed a fever for a couple of days. The patient received the second dose on 04-Jan-2005. The patient previously experienced pyrexia, irritability and swelling after receiving his first dose of Prevnar on 02-Nov-2004. 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. After receiving his second dose of Prevnar on 04-Jan-2005, the patient experienced a mild fever for couple days (pyrexia). He was cranky (irritability) and developed fontanel swelling (swelling) on the top of his head. The patient recovered from the fever; the swelling and irritability are resolving. See related cases(s): HQWYE560316AUG06 (adverse event, expedited) and HWWYE638117AUG06 (adverse event, non-expedited). No additional information was available at the time of this report.
Sex: F
Vaccine: PNC
Symptoms: Coxsackie viral infection, Irritability, Rash macular
Clinical narrative: Follow-up information provided event outcome and physician's comments. Information regarding Prevnar vaccine was received from a healthcare professional regarding a 12-month-old female patient who experienced irritable, "pinpoint macular rash on her trunk and some on her extremities" and Coxsackie. The patient received the fourth dose on 01-Sep-2006. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 01-Sep-2006. Dose regimen was 1 dose 1 time per day (intramuscular). Concomitant medications were not reported. The patient received the fourth dose of Prevnar on 01-Sep-2006. On 05-Sep-2006, the patient became irritable (irritability) and developed a "pinpoint macular rash on her trunk and some on her extremities" (rash macular) on 06-Sep-2006, The patient was treated with Benadryl. A few days later the patient developed a few urticarial lesions on her back of the leg, trunk and in her mouth. The patient was diagnosed with Coxsackie (Coxsackie viral infection). The patient recovered. The physician noted that the child was exposed at play groups and that the infection was not related to Prevnar. No additional information was available at the time of this report.
Age: 1.1
Sex: M
Vaccine: MMR, PNC, VARCEL, MMR, PNC, VARCEL
Symptoms: Accidental overdose, Incorrect dose administered, Pyrexia
Clinical narrative: Information regarding Prevnar was received from a consumer regarding a 13-month-old male patient who was inadvertently given a fifth dose of Prevnar and developed a fever. At 13 months of age, the patient received the fifth dose on 03-Apr-2006. The patient also received a dose of Varicella Virus Vaccine, live (manufacturer unknown) and M-M-R (Merck Sharp & Dome) on 03-Apr-2006. Indication for Prevnar was immunization. Product was administered on 03-Apr-2006. Dose regimen was 1 dose 1 time per day (intramuscular). Concomitant medications were not reported. A father reported that his son was inadvertently given a fifth dose of Prevnar (incorrect dose administered) (accidental overdose) on 03-Apr-2006. At this time, the patient also received a dose of Varicella Virus Vaccine, Live and M-M-R ; on 01-Mar-2006, the child had previously received these vaccines along with a 4th dose of Prevnar. On 04-Apr-2006 the patient developed a fever (pyrexia). On an unspecified date, the fever resolved. The family reportedly stated that the patient "still isn't the same" No additional information was available at the time of this report.
Age: 1.1
Sex: M
Vaccine: MMR, PNC, VARCEL, MMR, PNC, VARCEL
Symptoms: Inappropriate schedule of drug administration, Pyrexia
Clinical narrative: Information regarding Prevnar was received from a consumer regarding a 13-month-old male patient who was inadvertently given a fifth dose of Prevnar and developed a fever. At 13 months of age, the patient received the fifth dose on 03-Apr-2006. The patient also received a dose of Varicella Virus Vaccine, live (manufacturer unknown) and M-M-R (Merck Sharp & Dome) on 03-Apr-2006. Indication for Prevnar was immunization. Product was administered on 03-Apr-2006. Dose regimen was 1 dose 1 time per day (intramuscular). Concomitant medications were not reported. A father reported that his son was inadvertently given a fifth dose of Prevnar (incorrect dose administered) (accidental overdose) on 03-Apr-2006. At this time, the patient also received a dose of Varicella Virus Vaccine, Live and M-M-R ; on 01-Mar-2006, the child had previously received these vaccines along with a 4th dose of Prevnar. On 04-Apr-2006 the patient developed a fever (pyrexia). On an unspecified date, the fever resolved. The family reportedly stated that the patient "still isn't the same" No additional information was available at the time of this report.
Sex: U
Vaccine: PPV
Symptoms: Screaming
Clinical narrative: Information regarding Prevnar was received from a healthcare professional regarding an unknown number of children who, since using PFS, are really screaming when given an injection. Dates were not provided. 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 (intramuscular). Concomitant medications were not reported. A physician reported that since using PFS, children are really screaming when given an injection  (screaming) (pharmaceutical product complaint). Dates and outcome were not provided. No additional information was available at the time of this report.
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: Information regarding Prevnar was received from a healthcare professional regarding a 4-month-old female patient who experienced injection site pain and injection site bruising. At 4 months of age, the patient received the second dose of 06-Jul-2006. The patient also received the second dose of Vaccin D.T.C. "Pasteur" (Pasteur Vaccins), the second dose of Act-Hib on 06-Jul-2006. Relevant medical history was not provided. Concomitant therapy included Vaccin D.T.C. "Pasteur", Act-Hib, Polio and None. Four hours after administration, the patient's leg became red and purple from her knee to a little above the injection site. The child was taken to the emergency room but no treatment was given. On 07-Jul-2006, the child visited her physician. The child was no longer in pain and the area appeared black and blue. The physician speculated that a blood vessel was hit during administration. The patient recovered on an unknown date. It was reported that the child experienced no problems following the first dose of Prevnar.
Sex: U
Vaccine: PNC
Symptoms: Blood aluminium increased
Clinical narrative: Information regarding Prevnar was received from a consumer regarding a patient who developed high aluminum blood levels. Data of administration was not provided. 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. On unspecified date, a patient reportedly developed a high aluminum blood level (blood aluminum increased). The outcome is unknown. The reporter indicated that 2 patients experienced this event; however, they are not presently identifiable. No additional information was available at the time of this report.
Age: 0.6
Sex: F
Vaccine: PNC
Symptoms: Injection site irritation, Injection site pain
Clinical narrative: Information regarding Prevnar was received from a consumer regarding a 6-month-old female patient who experienced injection site pain and injection site burning. At 6 months of age. the patient received a dose on an unspecified date. The patient also experienced injection site pain and injection site burning following Prevnar dose at 2 months of age (HQWYE622417AUG06). Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day (intramuscular). Concomitant medication were not reported. The patient experienced injection site pain (injection site pain) and injection site burning (injection site (irritation) following her 6 month Prevnar vaccination. See related case (s): HQWYE622417AUG06 (adverse event, non-expedited). No additional information was available at the time of this report.
Sex: M
Vaccine: PNC, UNK
Symptoms: Injection site erythema, Wrong drug administered
Clinical narrative: Information regarding Prevnar was received from a healthcare professional regarding a male patient who experienced redness near the injection site. The patient received a dose on an unspecified date. Relevant medical history was not reported. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day (intramuscular). Additional suspect medication included unspecified vaccine (unspec). Concomitant medications were not reported. The patient received Prevnar and other vaccines/biologics on the same day and in the same area, and experienced redness near the injection site (injection site erythema). It was reported that the patient was an adult (wrong drug administered). The outcome was unknown. No additional information was available at the time of this report.
Sex: U
Vaccine: PNC
Symptoms: Injection site pain
Clinical narrative: Follow-up information received from the reporter indicated that there were no patient adverse reactions. Information regarding Prevnar was received from a healthcare professional that indicated they were "having a problem getting the last of the air out of the pre-filled syringes" and the "children were reacting as if it is more painful with prefilled syringes". The patient received a dose on an unspecified date. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day. Concomitant medication were not reported. The physician indicated that they were " having a problem getting the last of the air out of the pre-filled syringes" (pharmaceutical product complaint) and the children receiving Prevnar therapy were "reacting as if it is more painful with the prefilled syringe" (injection site pain). Additional notes from the reporter indicated that " there were no patient adverse reactions."
Age: 0.6
Sex: F
Vaccine: HIBV, PNC
Symptoms: Balance disorder, Hypotonia, Irritability, Pyrexia, Speech disorder
Clinical narrative: Information regarding Prevnar was received from a healthcare professional regarding a 7-month-female patient who experienced irritability, low muscle tone/stopped waving, balance was off, tired, stopped babbling and slight fever. The patient received a dose on 24-Jan-2007. Additional suspect vaccine received on the same day included Act-Hib. On 25-Jan-2007, one day post vaccination, the patient's mother called to report her child experienced irritability, low muscle tone/stopped waving, her balance was off, she was tired, stopped babbling and a slight fever. The patient was evaluated by her physician on 29-Jan-2007. The events lasted for two weeks and subsided. The reporter indicated the child appears to be fine now. No additional information was available at the time of this report.
Sex: U
Vaccine: PNC
Symptoms: Crying, Injection site pain
Clinical narrative: Information regarding Prevnar was received from a healthcare professional  regarding an unspecified number of patients who were perceived as crying more and louder with Prevnar versus other vaccines. Additionally, the Prevnar injection seemed to be more painful when given than the other vaccines. Dates were not provided. It was reported that a HCP felt that when giving the Prevnar injection, it seemed to be painful than the other vaccines and that the children were crying more and louder with Prevnar. The reporter did not specify dates, outcomes or the number of patients experiencing these events; additional reports will be generated when identifying information is provided. No additional information was available at the time of this report.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Injection site rash
Clinical narrative: Information regarding Prevnar was received from a nurse regarding a 2-month-old female patient who received the first dose along with a dose of Hib injection (manufacturer unknown) and a dose of Pediarix. On the same day, the patient experienced a local rash on the right leg. On 30-Jun-2006, the patient received a dose of Prevnar along with other childhood vaccines. Immediately after the injection, the child developed a local rash on the right leg that lasted for several hours. The rash "went away" and the patient recovered.  No additional information was available at the time of this report.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Pyrexia, Rash erythematous
Clinical narrative: Follow-up information received from the reporting physician indicated that the patient recovered. Information regarding Prevnar was received from a healthcare professional regarding a 2-month-old male patient who experienced fever and diffuse erythematous rash. At 2 months of age, the patient received the first dose on 15-May-2006. The patient also received the first dose of Act-Hib, the first dose of Rotateq and the first dose of Pediarix on 15-May-2006. On 15-May-2006, the patient developed fever which had resolved. On 18-May-2006, the patient experienced a diffuse erythematous rash. The patient recovered on an unknown date.
Sex: F
Vaccine: PNC
Symptoms: Injection site rash, Urticaria generalised
Clinical narrative: Information regarding Prevnar was received from a healthcare professional regarding a female patient who experienced an injection site eruption followed by a more generalized urticaria eruption. The patient received the third dose in Mar-2006. A physician reported that on an unspecified date in Mar-2006, his daughter developed and injection site urticarial eruption that was followed by a more generalized urticarial eruption. These events occurred in less than 24 hours following the vaccine administration. The outcome is unknown. Additionally, the reporter noted that for this series of immunisations, the vaccines were separated, the first vaccine did not cause any reaction. No additional information was available at the time of this report.
Sex: F
Vaccine: PNC, PNC, UNK, PNC, UNK
Symptoms: Injection site rash, Urticaria generalised
Clinical narrative: Additional information was received that provided patient information, vaccine administration information, dose site and route of administration and recovery status. Information regarding Prevnar vaccine was received from a dermatologist, who is a parent of the patient, regarding a female child who received the third dose on an unspecified date in 2006 and subsequently developed injection site urticarial eruption and generalized urticarial eruption. On an unspecified date in 2006, the patient received the third dose of Prevnar. Less than 24 hours later, the child developed injection site urticarial eruption that was followed by a generalized urticarial eruption. On an unspecified date, the patient recovered from the events. No additional information was available at the time of this report.
Sex: F
Vaccine: PNC, PNC, UNK, PNC, UNK
Symptoms: Body temperature increased, Pyrexia
Clinical narrative: Additional information was received that provided patient information, vaccine administration information, dose site and route of administration and recovery status. Information regarding Prevnar vaccine was received from a dermatologist, who is a parent of the patient, regarding a female child who received the third dose on an unspecified date in 2006 and subsequently developed injection site urticarial eruption and generalized urticarial eruption. On an unspecified date in 2006, the patient received the third dose of Prevnar. Less than 24 hours later, the child developed injection site urticarial eruption that was followed by a generalized urticarial eruption. On an unspecified date, the patient recovered from the events. No additional information was available at the time of this report.
Sex: F
Vaccine: PNC, PNC, UNK, PNC, UNK
Symptoms: Injection site rash, Urticaria generalised
Clinical narrative: Additional information was received that provided patient and vaccine administration information. Information regarding Prevnar was received from a dermatologist, who is a relative of the patient, regarding a female child who received the first dose along with along with other vaccines on an unspecified date and subsequently developed a fever greater than 103 degrees Fahrenheit. On an unspecified date, the patient received the first dose of Prevnar. On an unspecified date, the child developed fever greater than 103 degrees Fahrenheit. It was unknown if the patient recovered from the event. Body temperature  (results: greater than 103 degrees Fahrenheit) was done on an unspecified date. See related case (s): HQWYE493523MAR06 (adverse event, non-expedited) and HQWYE570529MAR06 (adverse event, non-expedited). No additional information was available at the time of this report.
Sex: F
Vaccine: PNC, PNC, UNK, PNC, UNK
Symptoms: Body temperature increased, Pyrexia
Clinical narrative: Additional information was received that provided patient and vaccine administration information. Information regarding Prevnar was received from a dermatologist, who is a relative of the patient, regarding a female child who received the first dose along with along with other vaccines on an unspecified date and subsequently developed a fever greater than 103 degrees Fahrenheit. On an unspecified date, the patient received the first dose of Prevnar. On an unspecified date, the child developed fever greater than 103 degrees Fahrenheit. It was unknown if the patient recovered from the event. Body temperature  (results: greater than 103 degrees Fahrenheit) was done on an unspecified date. See related case (s): HQWYE493523MAR06 (adverse event, non-expedited) and HQWYE570529MAR06 (adverse event, non-expedited). No additional information was available at the time of this report.
Sex: F
Vaccine: PNC, PNC, UNK, PNC, UNK
Symptoms: Injection site rash, Urticaria generalised
Clinical narrative: Additional information was received that provided patient and vaccine administration information. Information regarding Prevnar was received from a dermatologist, who is a relative of the patient, regarding a female child who received the second dose along with other vaccines on an unspecified date and subsequently developed a fever greater than 103 degrees Fahrenheit. On an unspecified date, the patient received the second dose of Prevnar. On an unspecified date, the child developed fever greater than 103 degrees Fahrenheit. It was unknown if the patient recovered from the event. Body temperature (results: greater than 103 degrees Fahrenheit) was done on an unspecified date. See related case (s): HQWYE493523MAR06 (adverse event, non-expedited) and HQWYE570629MAR06 (adverse event, non-expedited). No additional information was available at the time of this report.
Sex: F
Vaccine: PNC, PNC, UNK, PNC, UNK
Symptoms: Body temperature increased, Pyrexia
Clinical narrative: Additional information was received that provided patient and vaccine administration information. Information regarding Prevnar was received from a dermatologist, who is a relative of the patient, regarding a female child who received the second dose along with other vaccines on an unspecified date and subsequently developed a fever greater than 103 degrees Fahrenheit. On an unspecified date, the patient received the second dose of Prevnar. On an unspecified date, the child developed fever greater than 103 degrees Fahrenheit. It was unknown if the patient recovered from the event. Body temperature (results: greater than 103 degrees Fahrenheit) was done on an unspecified date. See related case (s): HQWYE493523MAR06 (adverse event, non-expedited) and HQWYE570629MAR06 (adverse event, non-expedited). No additional information was available at the time of this report.
Age: 0.1
Sex: M
Vaccine: HIBV, PNC
Symptoms: Body temperature increased
Clinical narrative: Follow up information provided birthweight, name if additional suspect vaccine and country where vaccines administered. Information regarding Prevnar was received from a healthcare professional regarding a 2-month-old male patient who experienced a temperature greater than 101^F. At 2 months of age, the patient received the first dose Jan-2006. The patient also received a dose of Act-Hib in Jan-2006. The patient experienced temperature greater than 101^F in Jan-2006. In Jan-2006, the patient developed a temperature of greater than 101^F after receiving his first dose of Prevnar and Act-Hib. The patient's outcome is unknown. See related case: HQWYE221314JUN06 (adverse event, non-expedited).
Sex: F
Vaccine: PNC, UNK
Symptoms: Pyrexia
Clinical narrative: Information regarding Prevnar was received from a healthcare professional regarding a female patient who experienced fever of >103F. The patient received the first dose on an unspecified date. A physician reported that his daughter experienced a fever of >103F on an unspecified date. The outcome is unknown. See related case (s): HQWYE456022MAR06 (adverse event, non-expedited) and HQWYE517724MAR06 (adverse event, non-expedited). No additional information was available at the time of this report.
Sex: F
Vaccine: PNC, UNK
Symptoms: Pyrexia
Clinical narrative: Information regarding Prevnar was received from a healthcare professional regarding a female patient who experienced fever of >103F. The patient received the second dose on an unspecified date. A physician reported that his daughter experienced fever of >103F after receiving her second dose of Prevnar on an unspecified date. The outcome was not reported. See related case (s): HQWYE456022MAR06 (adverse event, non-expedited) and HQWYE517624MAR06 (adverse event, non-expedited).
Age: 0.3
Sex: M
Vaccine: PNC
Symptoms: Body temperature increased, Pyrexia
Clinical narrative: Information regarding Prevnar was received from a healthcare professional regarding a 4-month-old male patient who experienced fever of 100 deg. F. At 4 months of age, the patient received the second dose on 16-Mar-2006. On 26-May-2006, the patient developed fever of 100 deg. F when he arrived to receive his third dose of Prevnar. The reporter noted that the physician did not believe the vaccine was responsible for the fever. The patient's outcome was unknown. Body temperature (results: 100 deg. F.) was done on 26-May-2006.
Sex: U
Vaccine: PNC
Symptoms: Injection site pain
Clinical narrative: Information regarding Prevnar was received from a nurse regarding a patient who received a dose on an unspecified date. The reporter noted that Prevnar injection "hurts" more than other vaccines. On an unspecified date, the patient received a dose of Prevnar. The reporter noted that the Prevnar injection "hurts" more than other vaccines. As of 04-Apr-2006, it was unknown if the patient recovered from the event. 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: U
Vaccine: PNC
Symptoms: Crying, Injection site pain
Clinical narrative: Information regarding Prevnar was received from a healthcare professional regarding an unknown number of patients who experienced pain and crying after receiving an injection. Dates were not provided. It was reported that an unspecified number of patients experienced painful injections with the administration of Prevnar. The outcome is unknown. Additional reports will be generated when identifying information is received. No additional information was available at the time of this report.
Sex: M
Vaccine: IPV, PNC
Symptoms: Body temperature increased, Pyrexia
Clinical narrative: Information regarding Prevnar was received from a nurse regarding a 1-year-old male patient who received a dose of Prevnar and a dose of Ipol on an unspecified date in 2002. The child developed a fever of 104 to 105 degrees Fahrenheit that lasted a week. On an unspecified date in 2002, the patient received a dose of Prevnar  along with another childhood vaccine. After vaccine administration, the patient developed a fever of 104 to 105 degrees Fahrenheit that lasted a week. On an unspecified date, the patient recovered from the event with treatment (not specified). Body temperature (results: 104 to 105 degrees Fahrenheit) was done. No additional information was available at the time of this report.
Sex: M
Vaccine: PNC
Symptoms: Sinusitis, Vaccination failure
Clinical narrative: Information regarding Prevnar was received from a healthcare professional regarding a 3-year-old male patient who experienced sinus infection and had no titers in blood levels. The patient received a dose on an unspecified date. On an unspecified date, the patient experienced a sinus infection and no titers on blood levels. The patient outcome is unknown. No additional information was available at the time of this report.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Barium enema, Culture urine, Diarrhoea, Full blood count normal, Hospitalisation
Clinical narrative: Initial report received on 10 April 2007 from another manufacturer, reference number WAES 0703USA04917. This report is verbatim from the other manufacturer's report: "A 6 month old male who on 15-JAN-2007 was vaccinated with a second PO dose of dose of Rotateq (lot # 654969/1016F). Concomitant vaccination administered that day included a second dose in the left thigh of ActHib (lot # UFD22AA),..." (This is not a valid manufacturer lot number) "a second dose in the right thigh of PEDIARIX (lot # AC21B074AA) (lot # BD8675D). On 25-MAR-2007 the patient developed diarrhea that lasted ten days. Subsequently the patient developed blood per rectum perfuse with clots. He was admitted to the hospital. A barium enema, CBC, BMP and stool tests were performed. The results were not reported. The patient's outcome was unknown."
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Pyrexia, Rectal haemorrhage, Red blood cell count normal, White blood cell count
Clinical narrative: Initial report received on 10 April 2007 from another manufacturer, reference number WAES 0703USA04917. This report is verbatim from the other manufacturer's report: "A 6 month old male who on 15-JAN-2007 was vaccinated with a second PO dose of dose of Rotateq (lot # 654969/1016F). Concomitant vaccination administered that day included a second dose in the left thigh of ActHib (lot # UFD22AA),..." (This is not a valid manufacturer lot number) "a second dose in the right thigh of PEDIARIX (lot # AC21B074AA) (lot # BD8675D). On 25-MAR-2007 the patient developed diarrhea that lasted ten days. Subsequently the patient developed blood per rectum perfuse with clots. He was admitted to the hospital. A barium enema, CBC, BMP and stool tests were performed. The results were not reported. The patient's outcome was unknown."
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Barium enema, Diarrhoea, Full blood count, Metabolic function test, Rectal haemorrhage
Clinical narrative: Initial report received on 10 April 2007 from another manufacturer, reference number WAES 0703USA04917. This report is verbatim from the other manufacturer's report: "A 6 month old male who on 15-JAN-2007 was vaccinated with a second PO dose of dose of Rotateq (lot # 654969/1016F). Concomitant vaccination administered that day included a second dose in the left thigh of ActHib (lot # UFD22AA),..." (This is not a valid manufacturer lot number) "a second dose in the right thigh of PEDIARIX (lot # AC21B074AA) (lot # BD8675D). On 25-MAR-2007 the patient developed diarrhea that lasted ten days. Subsequently the patient developed blood per rectum perfuse with clots. He was admitted to the hospital. A barium enema, CBC, BMP and stool tests were performed. The results were not reported. The patient's outcome was unknown."
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Stool analysis, Thrombosis
Clinical narrative: Initial report received on 10 April 2007 from another manufacturer, reference number WAES 0703USA04917. This report is verbatim from the other manufacturer's report: "A 6 month old male who on 15-JAN-2007 was vaccinated with a second PO dose of dose of Rotateq (lot # 654969/1016F). Concomitant vaccination administered that day included a second dose in the left thigh of ActHib (lot # UFD22AA),..." (This is not a valid manufacturer lot number) "a second dose in the right thigh of PEDIARIX (lot # AC21B074AA) (lot # BD8675D). On 25-MAR-2007 the patient developed diarrhea that lasted ten days. Subsequently the patient developed blood per rectum perfuse with clots. He was admitted to the hospital. A barium enema, CBC, BMP and stool tests were performed. The results were not reported. The patient's outcome was unknown."
Age: 0.52
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, HIBV, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal pain, Haematochezia, Muscle spasms, Surgery, Vomiting
Clinical narrative: Information has bee received from a physician concerning a 6 month old female with no known drug allergies or medical history who on 28-NOV-2006 was vaccinated with the first dose of Rotateq (Lot # 654248/0577F) 2.0 ml. On 01-FEB-2007, the patient was vaccinated with the second dose of Rotateq (Lot # 654422/0607F) 2.0 ml. On 04-APR-2007, the patient was vaccinated with the third dose of Rotateq (Lot # 656192/0022U). There was no concomitant medication. On 05-APR-2007 (also reported as three days after the third dose of Rotateq), the patient experienced intussusception and was hospitalized. The patient was hospitalized for one week and had resection surgery on her bowel ("portion of their colon removed"). Subsequently, the patient recovered from intussusception on 12-APR-2007. Intussusception was considered to be immediately life-threatening, disabling and was an other important medical event. Additional information has been requested.
Age: 0.52
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, HIBV, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Gastroenteritis viral, Haematochezia, Insomnia, Intestinal obstruction, Intestinal resection
Clinical narrative: Information has bee received from a physician concerning a 6 month old female with no known drug allergies or medical history who on 28-NOV-2006 was vaccinated with the first dose of Rotateq (Lot # 654248/0577F) 2.0 ml. On 01-FEB-2007, the patient was vaccinated with the second dose of Rotateq (Lot # 654422/0607F) 2.0 ml. On 04-APR-2007, the patient was vaccinated with the third dose of Rotateq (Lot # 656192/0022U). There was no concomitant medication. On 05-APR-2007 (also reported as three days after the third dose of Rotateq), the patient experienced intussusception and was hospitalized. The patient was hospitalized for one week and had resection surgery on her bowel ("portion of their colon removed"). Subsequently, the patient recovered from intussusception on 12-APR-2007. Intussusception was considered to be immediately life-threatening, disabling and was an other important medical event. Additional information has been requested.
Age: 0.52
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, HIBV, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Intussusception, Sleep disorder, Vomiting, X-ray abnormal
Clinical narrative: Information has bee received from a physician concerning a 6 month old female with no known drug allergies or medical history who on 28-NOV-2006 was vaccinated with the first dose of Rotateq (Lot # 654248/0577F) 2.0 ml. On 01-FEB-2007, the patient was vaccinated with the second dose of Rotateq (Lot # 654422/0607F) 2.0 ml. On 04-APR-2007, the patient was vaccinated with the third dose of Rotateq (Lot # 656192/0022U). There was no concomitant medication. On 05-APR-2007 (also reported as three days after the third dose of Rotateq), the patient experienced intussusception and was hospitalized. The patient was hospitalized for one week and had resection surgery on her bowel ("portion of their colon removed"). Subsequently, the patient recovered from intussusception on 12-APR-2007. Intussusception was considered to be immediately life-threatening, disabling and was an other important medical event. Additional information has been requested.
Age: 0.52
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, HIBV, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Intestinal resection, Intussusception, Surgery
Clinical narrative: Information has bee received from a physician concerning a 6 month old female with no known drug allergies or medical history who on 28-NOV-2006 was vaccinated with the first dose of Rotateq (Lot # 654248/0577F) 2.0 ml. On 01-FEB-2007, the patient was vaccinated with the second dose of Rotateq (Lot # 654422/0607F) 2.0 ml. On 04-APR-2007, the patient was vaccinated with the third dose of Rotateq (Lot # 656192/0022U). There was no concomitant medication. On 05-APR-2007 (also reported as three days after the third dose of Rotateq), the patient experienced intussusception and was hospitalized. The patient was hospitalized for one week and had resection surgery on her bowel ("portion of their colon removed"). Subsequently, the patient recovered from intussusception on 12-APR-2007. Intussusception was considered to be immediately life-threatening, disabling and was an other important medical event. Additional information has been requested.
Age: 32.0
Sex: M
Vaccine: ANTH, SMALL, TYP, SMALL, SMALL
Symptoms: Cardiac enzymes increased, Catheterisation cardiac normal, Chest pain, Echocardiogram abnormal, Electrocardiogram ST segment elevation
Clinical narrative: Taken to ER for chest pain radiating in right arm and ST segment flutations, increase CK, increase Troponin; reveal hypokinetic segment; Treated as Str-Ami; no fibrolytics given secondary to duration of pain, nl came 24 hour later.
Age: 32.0
Sex: M
Vaccine: ANTH, SMALL, TYP, SMALL, SMALL
Symptoms: Electrocardiogram abnormal, Hypokinesia, Injection site inflammation, Myopericarditis, Pericardial effusion
Clinical narrative: Taken to ER for chest pain radiating in right arm and ST segment flutations, increase CK, increase Troponin; reveal hypokinetic segment; Treated as Str-Ami; no fibrolytics given secondary to duration of pain, nl came 24 hour later.
Age: 32.0
Sex: M
Vaccine: ANTH, SMALL, TYP, SMALL, SMALL
Symptoms: Ventricular hypokinesia
Clinical narrative: Taken to ER for chest pain radiating in right arm and ST segment flutations, increase CK, increase Troponin; reveal hypokinetic segment; Treated as Str-Ami; no fibrolytics given secondary to duration of pain, nl came 24 hour later.
Age: 32.0
Sex: M
Vaccine: ANTH, SMALL, TYP, SMALL, SMALL
Symptoms: Blood creatine phosphokinase increased, Chest pain, Electrocardiogram ST segment elevation, Hypokinesia, Troponin increased
Clinical narrative: Taken to ER for chest pain radiating in right arm and ST segment flutations, increase CK, increase Troponin; reveal hypokinetic segment; Treated as Str-Ami; no fibrolytics given secondary to duration of pain, nl came 24 hour later.
Age: 32.0
Sex: M
Vaccine: ANTH, SMALL, TYP, SMALL, SMALL
Symptoms: Ultrasound scan abnormal
Clinical narrative: Taken to ER for chest pain radiating in right arm and ST segment flutations, increase CK, increase Troponin; reveal hypokinetic segment; Treated as Str-Ami; no fibrolytics given secondary to duration of pain, nl came 24 hour later.
Age: 32.0
Sex: M
Vaccine: ANTH, SMALL, TYP, SMALL, SMALL
Symptoms: Catheterisation cardiac, Chest pain, Electrocardiogram, Electrocardiogram ST segment elevation
Clinical narrative: Taken to ER for chest pain radiating in right arm and ST segment flutations, increase CK, increase Troponin; reveal hypokinetic segment; Treated as Str-Ami; no fibrolytics given secondary to duration of pain, nl came 24 hour later.