chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Syringe issue
Clinical narrative: Case number PHEH2013US009217 is an initial combined report received from a nurse on 18 APR 2013 with a follow up information received from quality assurance department (QA reference number: 224311) on 22 APR 2013. This report refers to a male patient whose age was not reported. It was reported that during administration of an intramuscular dose of MENVEO (batch number: A12025, expiry date: DEC 2014) to him on 18 APR 2013, some of the vaccine splashed back on to the vaccine administrator's face because the syringe had a slip tip and needle popped off. The reporter stated that the patient received the majority of the vaccine. No adverse reactions were reported. The quality assurance department registered a complaint with reference number 224311. No further information was provided.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US009465, is an initial spontaneous report received from a nurse on 24 APR 2013, and with a follow up received on 16 MAY 2013. This report refers to a 19-year-old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with MENVEO (batch  number: M11042) at a dose of 0.5 ml, intramuscularly into left arm, on 24 APR 2013 at 9:20 AM. Nurse reported that the patient received MENVEO injection which had experienced multiple temperature excursions down to 1.9 C, but not frozen (dates of temperature excursions: 14 APR 2013; 21 APR 2013 and 23 APR 2013). No adverse was reported following this medication error (incorrect storage of drug).   Follow up report received on 16 MAY 2013. Updated dose and site of vaccination.
Sex: F
Vaccine: MNQ
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Case number PHEH2013US004936, is an initial spontaneous report received from a pharmacist on 26 Feb 2013: This case refers to a female patient of unspecified age. Her medical history and concomitant medication was not reported. She was vaccinated with MENVEO (batch number: not reported), subcutaneously on 24 Feb 2013. No adverse reaction reported following this administration error.
Age: 28.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US005049, is an initial spontaneous report received from a nurse on 27 FEB 2013. This report refers to a 28-year-old female patient. Her medical history and concomitant medications was not reported. On 02 JAN 2013, she was vaccinated with MENVEO, batch number: M12009) which was inadvertently stored at an unknown temperature above 46F for 4.75 hours on 03 DEC 2012. No adverse event was reported following this administration error.
Age: 1.88
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2013US005087, is an initial spontaneous report receivd from nurse on 27 Feb 2013. This report refers to a 22-month-old female infant patient. Her medical history and concomitant medication were not reported. She was vaccinated with expired MENVEO, (batch number: M10054A) intramuscularly on 27 Feb 2013. No adverse event was reported following this administration error.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US005293 is an initial spontaneous report received from a medical assistant on 28 FEB 2013 and a follow up received on 25 MAR 2013. This report   refers to an adult male patient. He was vaccinated with MENVEO (batch numberM12006 and expiry date: 31 OCT 2014) intramuscularly at a dose of 0.5 ml on 30 JAN 2013. This vaccine had undergone temperature excursions. The first temperature excursion took place on 23 JAN 2013 and the vaccine reached 54 degree Fahrenheit for less than four hours. MENVEO was not re-constituted at the time of excursion. Reporter stated that the MENVEO had a temperature excursion but the patient did not experience any adverse events as a result of the temperature excursion. It was reported that the patient will be revaccinated.   Follow up information received on 25 MAR 2013: Confirmed that the patient did not experience any adverse event and will be revaccinated.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US005298 is an initial spontaneous report received from a medical assistant on 28 FEB 2013 with the follow-up received on 25 MAR 2013. This report refers to a 16-year-old male patient. He was vaccinated with MENVEO (batch number: M11051 and expiry date: 31 MAR 2014) intramuscularly at a dose of 0.5 ml on 24 JAN 2013. This vaccine had undergone temperature excursion. The first temperature excursion took place on 23 JAN 2013 and the vaccine reached 54 degree Fahrenheit for less than four hours. MENVEO was not re-constituted at the time of excursion. Reporter stated that MENVEO had a temperature excursion. The patient did not experience any adverse events as a result of the temperature excursion. IT was reported that the patient will be revaccinated.   Follow up information received on 25 MAR 2013. Confirmed that the patient did not experience any adverse event and will be revaccinated.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US005300 is an initial spontaneous report received from a medical assistant on 28 FEB 2013 with a follow up received on 25 MARCH 2013. This report refers to a 16-year-old female patient. She was vaccinated with MENVEO (batch number: M11051 and expiry date: 31 MAR 2014) intramuscularly at a dose of 0.5 ml on 07 FEB 2013. This vaccine had  undergone temperature excursion. This first temperature excursion took place on 23 JAN 2013 and the vaccine reached 54 degree Fahrenheit for less than four hours. MENVEO was not re-constituted at the time of excursion. Reporter stated that, the MENVEO had a temperature excursion. She did not experience any adverse events as a result of the temperature excursion. She would be revaccinated. No further information was reported.   Follow up received on 25 MARCH 2013. Updated reporter comments.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US005302 is an initial spontaneous report received from a medical assistant on 28 FEB 2013 with a follow up information received on 25 MAR 2013. This report refers to a 15-year-old female patient. She was vaccinated with MENVEO (batch number M11051 and expiry date: 31 MAR 2014) intramuscularly at a dose of 0.5 ml on 15 FEB 2013. This vaccine had undergone temperature excursion. The first temperature excursion took place on 23 JAN 2013 and the vaccine reached 54 degree Fahrenheit for less than four hours. MENVEO was not re-constituted at the time of excursion. The reporter confirmed that the patient did not experience any adverse events as a result of temperature excursion. The patient would be re-vaccinated. No further information was reported.   Follow up information received on 25 MAR 2013: Reporter's comment updated.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US005305 is an initial spontaneous report received from a medical assistant on 25 Feb 2013 with a follow up information received on 25 Mar 2013. This report refers to an adult male patient. it was reported that he was vaccinated intramuscularly with 0.5 ml of MENVEO (batch number: M 11051, expiry date: 31 Mar 2014) that experienced temperature excursion on 25 Feb 2013. The first temperature excursion happened on 23 Jan 2013 and the vaccine was in a temperature of 54 F for less than 4 hours. It was reported that MENVEO was not reconstituted at the time of excursion. The reporter confirmed that the patient did not experience any adverse events as a result of temperature excursion. The patient would be re-vaccinated. No further information was reported. Follow up information received on 25 mar 2013: Reporter's comment updated.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US005306 is an initial spontaneous report received from a medical assistant on 25 Feb 2013 with the follow-up received on 25 mar 2013. This report refers to a 15-year-old female patient. it was reported that she was vaccinated intramuscularly with 0.5 ml of MENVEO (batch number: M12013, expiry date: 28 Feb 2014) that experienced temperature excursion on 25 Feb 2013. The first temperature excursion happened on 23 Jan 2013 and the vaccine was in a temperature of 54 F for less than 4 hours. it was reported that MENVEO had a temperature excursion. She did not experience any adverse events as a result of the temperature excursion. She would be revaccinated. No further information was reported. Follow-up received on 25 Mar 2013: Updated reporter comments.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US005309 is an initial spontaneous report received from a medical assistant on 28 Feb 2013 with the follow-up received on 25 Mar 2013. This report refers to a 19-years-old female patient. It was reported that she was vaccinated intramuscularly with 0.5 ml of MENVEO (batch number: M11051, expiry date: 31 Mar 2014) that experienced temperature excursion on 25 Feb 2013. The first temperature excursion happened on 22 Jan 2013 and the vaccine was in a temperature of 54 F for less than 4 hours. It was reported that MENVEO was not reconstituted at the time of excursion. No adverse events were reported following the medication error. Reporter stated that, the MENVEO had a temperature excursion. She did not experience any adverse events as a result of the temperature excursion. She would be revaccinated. No further information was reported. Follow-up received on 25 Mar 2013. Updated reporter comments.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2013US005335 is an initial spontaneous report received from a medical assistant on 03 Mar 2013. This report refers to a patient whose identifiers were not reported. It was reported that the patient received intramuscularly only the MENVEO (batch number; not reported) without being reconstituted with MenA lyophilized conjugate. No adverse reactions were reported following the maladministration.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Circumstance or information capable of leading to medication error, Incorrect route of drug administration, No adverse event
Clinical narrative: Case number PHEH2013US005883, is an initial spontaneous report received from a healthcare professional on 11 Mar 2013. This report refers to a 17-year-old male patient. His medical history and concomitant medications was not reported. He was vaccinated with MENVEO (batch number: A102024) on 11 Mar 2013. During intramuscular administration of vaccine he moved and some vaccine went into the subcutaneous tissue. No adverse event was reported due to this administration error.
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US006012 is an initial spontaneous report received from a pharmacist on 12 Mar 2013. This report refers to a patient whose identifiers were not reported. It was reported that on an unknown date, the MenCYW-135 component was found in the refrigerator and the patient was suspected to be vaccinated intramuscularly only with MenA lyophilized component of MENVEO (batch number: not reported) reconstituted with another diluent. No adverse event was reported following the maladministration.
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2013US006260, is an initial spontaneous report received from a nurse on 15 Mar 2013. This report refers to a 14 to 15-years-old female patient. Her medical history and concomitant medication was not reported. She was vaccinated with expired MENVEO (batch number: not reported) intramuscularly on 05 Mar 2013. No adverse event was reported following this administration error.
Age: 44.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2013US006547 is an initial spontaneous report received from a pharmacist on 20 Mar 2013: This report refers to a 44-year-old male patient. he was vaccinated with an expired dose of MENVEO (batch number: A10051 and expiry date: Jan 2013) intramuscularly on 19 mar 2013. No revaccination had occurred. No adverse event was reported following this administration error.
Age: 16.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US006553, is an initial spontaneous report received from a nurse on 18 Mar 2013, and with a follow up report received from nurse on 09 Apr 2013, with a follow up received from a nurse on 30 Apr 2013: This case refers to a 16-years-old female patient. Her medical history was not reported. Concomitant medications included BOOSTRIX (batch number: ACZ0BZ64AA) and HAVRIX (batch number: AHAVB90BA) both at a dose of 0.5 ml intramuscularly on 09 Mar 2013.She was inadvertently given only Men C, Y, W-135 liquid conjugate component of MENVEO vaccine (batch number: X12010), intramuscularly without being reconstituted with Men A component on 09 Mar 2013 by a nurse, who was unfamiliar to the practice. The patient's parents informed of need for revaccination. No adverse reaction reported following this administration error. Follow up report received from nurse on 09 Apr 2013. Updated patient demographics, concomitant medications updated. Follow up received from a nurse on 30 Apr 2013: Updated reporter comment.
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US006564, is an initial spontaneous report received from a medical assistant on 18 Mar 2013. This report refers to a patient of unknown age and gender. The patient was vaccinated with MENVEO (batch number: A 12024) intramuscularly and did not receive Men A lyophilized conjugate in Mar 2013. No adverse event was reported.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2013US006903, is an initial spontaneous report received from a nurse on 22 mar 2013 and a follow up information received from the nurse on 28 May 2013: This case refers to a 12-years-old female patient. She received only Men C, Y, W-135 liquid conjugate component of MENVEO vaccine (batch number: M11052), intramuscularly without being reconstituted with Men A component on 21 mar 2013. This was her initial application of MENVEO vaccine. No adverse reaction reported following this administration error. Follow up information received from the nurse on 28 may 2013: Updated patient demographic details.
Age: 18.0
Sex: M
Vaccine: FLU3, HEP, MNQ, TYP
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Case number PHEH2013US006920 is an initial spontaneous report received from a nurse on 21 Mar 2013 and a follow up report from the nurse received on 23 Apr 2013. This case refers to a 18-year-old male patient. Concomitant vaccinations included Oral Typhoid (batch number: 3000326), Hepatitis B (batch number: AHBVC142AA) and influenza vaccine (batch number: U4545EF) on 21 Mar 2013. On the same date, he was vaccinated with MENVEO (batch number: M12026) via subcutaneous route. No adverse event was reported following this maladministration. The nurse inquired whether to repeat the vaccine and due to information found on CDC general recommendations under non standard vaccine practices, the MENVEO vaccine was not repeated. No other information was available. Follow up report from a nurse received on 23 Apr 2013: The age of the patient was changed from 88 years to 18 years (deleted the event inappropriate age of vaccine administration). Concomitant vaccines were added and information from nurse related to the immunisation was updated.
Age: 20.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2013US007936 is an initial spontaneous report from the pharmacist received on 05 Apr 2013. This report refers to a 20-year-old female patient. She was vaccinated with an expired MENVEO (batch number: M10053) intramuscularly on 05 Apr 2013. It was reported that, no adverse reactions have occurred since this administration. No other information was available.
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2013US006963 is an initial spontaneous report received from a pharmacist on 22 Mar 2013. This report refers to a female patient whose age was not reported. She was vaccinated intramuscularly with a dose of MenA lyophilized conjugate of MENVEO, (batch number: not reported) which was reconstituted with sterile water instead of liquid component on 11 Mar 2013. No adverse events were reported following the maladministration.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US007858 is an initial spontaneous report received from a healthcare professional on 03 Apr 2013. This case refers to a 11-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: A12009, expiration date: Feb 2014) at a dose of 0.5ml intramuscularly on 06 Mar 2013. This reporter stated that the administered MENVEO was stored at 34 F for 12 hours, but was not frozen. No adverse event was reported following this drug administration error.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US007866 is an initial spontaneous report received from a health care professional on 03 Apr 2013. This report refers to an 11-years-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: A12009, expiry date: Feb 2014) at a dose of 0.5 ml intramuscularly on 28 Mar 2013. It was reported that the MENVEO she had received had been at 34 F for 12 hours and the vaccine was reported as not frozen. No adverse events were reported.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2013US007536, is an initial spontaneous report received from a medical assistant on 25 Mar 2013: This case refers to a 12-years-old female patient. She received only Men C, Y, W-135 liquid conjugate component of MENVEO vaccine, (batch number: X11050), subcutaneously without being reconstituted with Men A component on 28 Mar 2013. No adverse reaction reported following this administration error.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US007864 is an initial spontaneous report received from a healthcare professional on 03 Apr 2013. This report refers to a female patient. Her medical history and concomitant medications were not reported. She was vaccianted with MENVEO (batch number: A12009, expiry date: Feb 2014) at a dose of 0.5 ml intramuscualrly on 07 mar 2013. it was reported that the MENVEO she had received had been at 34 F for 12 hours and the vaccine was reported as not frozen. No adverse events were reported.
Sex: U
Vaccine: MNQ
Symptoms: Immunisation, No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US007828 is an initial spontaneous report from the nurse received on 04 Apr 2013. This report refers to a patient of an unknown age and gender. On an unknown date, the patient was accidentally vaccinated with only the MenCYW-135 liquid component of MENVEO (batch number: not reported) intramuscularly and did not receive Men A lyophilized conjugate. The nurse again gave a correctly reconstituted dose of MENVEO to the patient. It was reported that the patient did not experience any adverse event after these mal-administrations. No other information was available.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US008326 is an initial spontaneous report received from a nurse on 10 Apr 2013, with a follow-up received on 26 Apr 2013: This report refers to an 11-year-old female patient. She was given only Men CYW liquid conjugate component of MENVEO (batch number: X12025) intramuscularly on 08 Apr 2013 (at 3.48 pm). The liquid was not re-constituted with MenA powder component (she received only diluent portion of MENVEO vaccine). It was reported that she would be receiving full vaccine dose in next two months. No adverse event was reported following this administration error. Follow-up was received from a nurse on 26 Apr 2013: Patient gender (changed from male to female), vaccination time and information about revaccination schedule were updated.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: case number PHEH2013US007861 is an initial spontaneous report received from a healthcare professional on 03 Apr 2013. This case refers to a 15-yer-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: A 12009, expiration date: Feb 2014) at a dose of 0.5ml intramuscularly on 20 Mar 2013. The reporter stated that the administered MENVEO was stored at 34 F for 12 hours, but was not frozen. No adverse event was reported following this drug administration error.
Age: 39.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2013US007281 is an initial spontaneous report received from a pharmacist on 26 Mar 2013. This case refers to a 38-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with an expired MENVEO vaccine (batch number: A10133, expiration date: Feb 2013 for MenA and Sep 2013 for MenCYW-135) intramuscularly on 26 Mar 2013. No adverse events were reported following this administration error. No other information was available.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US007860 is an initial spontaneous report received from a healthcare professional on 03 Apr 2013. This case refers to 12-yer-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: A12009, expiration date: Feb 2014) at a dose of 0.5ml intramuscularly on 18 Mar 2013. The reporter stated that the administered MENVEO was stored at 34 F for 12 hours, but was not frozen. No adverse event was reported following this drug administration error.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 02 October 2013. The patient had received only DTaP/IPV/HIB vaccine. No adverse event was reported. List of documents held by sender: none.
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US006982 is an initial spontaneous report received from a consumer on 25 Mar 2013 with a follow up information received from a nurse on 16 Apr 2013. This report refers to male adult patient of unspecified age. He was vaccinated with MENVEO (batch number: not reported) on unspecified date. Reporter stated that, the vaccine had a temperature excursion. The nurse confirmed that the patient did not experience any adverse events as a result of the temperature excursion. It was stated that they were repeating the dose of MENVEO due to the temperature excursion to the vaccine. No further information was reported. Follow up information received from a nurse on 16 Apr 2013: Reporter details updated: Nurse confirmed that there were no adverse event and revaccination details updated.
Sex: U
Vaccine: DTAPIPV
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial misuse report reported from a healthcare professional on 11 June 2013. ACTHIB component from PENTACEL was reconstituted with sterile diluent not the DTAP/IPV. No information was provided regarding the patient. No adverse event was reported. List of documents held by sender: none.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Blood pressure decreased, Dark circles under eyes, Dizziness, Immediate post-injection reaction
Clinical narrative: Case number PHEH2013US007327 is an initial spontaneous report received from a medical assistant on 27 Mar 2013, with a follow-up received on 27 Mar 2013. This case refers to an 11-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: A12004, expiry date: Sep 2014) intramuscularly on 26 Mar 2013. On the same day immediately after vaccination, he experienced dizziness, decreased blood pressure and dark circles under his eyes. The reporter stated that the patient was kept in the office for 30 minutes after vaccination and his symptoms resolved, and then he was discharged from the office. The seriousness and causality were not reported. No other information was available. Follow-up was received on 27 March 2013: Expiry date of MENVEO was updated.
Age: 29.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US007526, is an initial spontaneous report received from a nurse on 01 Apr 2013 and a follow up report from the nurse received on 23 Apr 2013: This case refers to a 29-year-old male patient. His medical history and concomitant medication were not reported. He was inadvertently vaccinated with expired MENVEO (batch number: A10053 and expiry date: not reported) intramuscularly at the left deltoid at a dose of 0.5 ml on 01 Apr 2013. It was reported that the vaccine was 2 months outdated but was properly stored and temperature was monitored. No adverse reaction was reported following the administration error. No other information was available. Follow up report from the nurse received on 23 Apr 2013: The information related to the storage, batch number and route of administration of MENVEO vaccine were updated.
Age: 21.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US008218, is an initial spontaneous report received from a nurse on 08 Apr 2013: This case refers to a 21-years-old female patient. She received only Men C,Y, W-135 liquid conjugate component of MENVEO (batch number: 12013), intramuscularly without being reconstituted with Men A component on 05 Apr 2013. She was not re-vaccinated. No adverse reaction reported following this administration error.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US08337 is an initial spontaneous report received from a nurse on 10 Apr 2013. This report refers to an 18-year-old male patient His medical history and concomitant medication was not reported. He was vaccinated with MENVEO (batch number: X12013 and expiry date: Oct 2014) at 0.5 ml intramuscularly on 18 Mar 2013. MENVEO was stored at 33-36 F for 19 days and vaccine was not frozen. No adverse event was reported following this administration error.
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US008330, is an initial spontaneous report received from a pharmacist on 09 APR 2013. This report refers to an unspecified age and gender patient. The patient received only Men C, Y, W-135 liquid conjugate component of MENVEO, batch number: not reported) intramuscularly  without being reconstituted with Men A on an unspecified date. It is reported that an extra Men A lyophilized powder vial is left out in the refrigerator, which led them to conclude that a medication error occurred. No adverse event was occurred following this administration error.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US008343, is an initial spontaneous report received from a nurse on 10 Apr 2013. This report refers to a 17-year-old male patient. His medical history and concomitant medication was not reported. He was vaccinated with MENVEO (conjugated-M102006 and expiry date: Oct 2014), batch number: X12013), at dose of 0.5 ml intramuscularly on 01 Mar 2013. MENVEO vaccine was stored at 33-36 F for 19 days and vaccine was not frozen. No adverse event was reported following this administration error.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US008346, is an initial spontaneous report received from a nurse on 10 APR 2013. This report refers to a 14-years-old male patient. His medical history and concomitant medication was not reported. He was vaccinated with MENVEO (batch number: M102006 and expiry date: OCT 2014), at dose of 0.5 ml intramuscularly on 14 MAR 2013. MENVEO vaccine was stored at 33-36 F for 19 days and vaccine was not frozen. No adverse event was reported following this administration error.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial misuse report received from a nurse on 11 November 2013. The patient had received only DTaP/IPV component of PENTACEL. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered
Clinical narrative: Initial medication error report received on 04 October 2013 from a medical assistant. A patients whose gender, age, medical history and concomitant medications were not reported, received a dose of PENTACEL (route, lot number and site of vaccination was not reported) on an unspecified date. Medical assistant reported that I gave the dtap/ipv without reconstituting the hib. From a medical standpoint, it is fine to give the ACTHIB alone if they gave DTAP-IPV alone. Because the child was not given the ACTHIB component of PENTACEL, he/she needs to be given a separate injection of ACTHIB reconstituted with saline diluent (0.4% sodium chloride). List of documents held by sender: none.
Age: 0.45
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Crying
Clinical narrative: Initial information received from a healthcare professional on 18 November 2013. A 6-month-old male patient who had no medical history had received a dose of PENTACEL (batch number: C4485AA) intramuscularly in the right thigh, a dose of PREVENAR (batch number: G63308) intramuscularly in left thigh and ROTATEQ (batch number: J009050) orally on 01 August 2013. The patient had no illness at the time of vaccination. On 01 August 2013, the patient had high pitched inconsolable crying for 2 hours. Lab investigations and treatment medications were not reported. At the time of this report, the patient had recovered. List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPV
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 01 October 2013. The patient had received PENTACEL. Nurse reported that gave DTAP / IPV portion to patient. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Age: 9.0
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Initial misuse report received from a healthcare professional on 05 August 2013. A 09-year-old patient was administered PENTACEL vaccine instead of Td vaccine. No other information was provided. No adverse event was reported. Documents held by sender: none.
Sex: U
Vaccine: DTAPIPV
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 12 September 2013. It was reported that DTaP-IPV from the PENTACEL vaccine was administered to a child without ACT-HIB. No adverse event was reported. List of documents held by sender: none.
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2013US004119 is an initial spontaneous report received from a nurse on 13 Feb 2013. This case refers to a female patient of unspecified age. She was vaccinated only with the liquid CYW-135 component of MENVEO vaccine (batch number: X10133) intramuscularly on 13 Feb 2013. No adverse event was reported following this drug administration error.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial report received from a healthcare professional on 07 November 2013. A patient received PENTACEL and some squirted during administration of first dose. (No information was provided regarding the patient). No adverse event was reported.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Drug administration error, No adverse event
Clinical narrative: Initial misuse report received from a physician on 12 November 2013. The patient had administered the DTaP-IPV part of PENTACEL. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 14 November 2013. The patient had received Merck diluent instead of the DTaP/IPV and adm as PENTACEL. Patient used Merck diluent instead of the DTaP IPV and adm as PENTACEL. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US004187 is an initial spontaneous report received from a consumer on 15 Feb 2013 with the follow-up received on 15 Feb 2013. This report refers to a patient of an unknown gender and age. The medical history and concomitant medication of the patient were not reported. The patient received only Men A lyophilized powder of MENVEO (batch number: M11042 and expiry date: Mar 2014) intramuscularly, reconstituted with something (solvent) other than Men CWY liquid conjugate component. It was reported that during a routine inventory, it was discovered that one MenA vial was missing. No adverse event was reported following this administration error. Follow-up received on 15 Feb 2013: Updated vaccine expiry date.
Sex: U
Vaccine: DTAPIPV
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 08 August 2013. It was reported that a child received only DTaP/IPV component of PENTACEL. No information was provided regarding the patient. No adverse event was reported. List of documents held by sender: none.
Age: 0.1
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Initial report received from a report on 07-Oct-2013. A 1-month-old patient (gender unknown) had received PENTACEL vaccine (batch number: unknown, dose number and site of administration not reported) on an unknown date. The patient's medical history was unknown. The patient had no illness at the time of vaccination and concomitant medications. PENTACEL vaccine was administered to 1 month old neonate. No laboratory tests were performed and corrective treatments were not reported. List of documents held by sender: None.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial misuse report received on 08-Oct-2013 from a health care professional. A patients whose gender, age, medical history and concomitant medications were not reported, received a dose of PENTACEL (lot number, route and site of vaccination was not reported) on an unspecified date. It was reported patient have received expired PENTACEL. As of 08-Oct-2013, Patient did not have any adverse events. List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPV, FLU3
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 01 October 2013. The patient had received FLUZONE HD. Nurse reported that gave only the DTAP/IPV portion to patient. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Age: 5.0
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 30 July 2013. It was reported that a dose of PENTACEL was administered to a 5-year-old patient. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPV
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 30 July 2013. A child had only received DTaP/IPV component of PENTACEL and did not receive ActHIB component. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered
Clinical narrative: Initial medication error report received on 12 November 2013 from a pharmacist. A patients whose, gender, age, medical history and concomitant medications were not reported, received a dose of PENTACEL (route, lot and site of vaccination was not reported) on an unspecified date. She thinks they gave 1 of 2 patients 4 months old liquids in the same syringe as 1 injection and no Acthib. List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPV
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 07 November 2013. This is an invalid case as individual patient identifiers are missing. It was reported that out of the PENTACEL only the DTAP/IPV was given and the ACTHIB was not given. No adverse event was reported. List of documents held by sender: none.
Age: 0.79
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Asthenia, Decreased appetite, Glassy eyes, Injection site rash, Injection site warmth
Clinical narrative: Initial report received from a consumer on 09 Dec 2013: A 9-months-old male patient, whose medical history included allergic to cows milk and intolerance to wheat and concomitant medications were not reported, had received a dose of PENTACEL (Lot number, expiration date and route were not reported) on leg, 06 March 2013. On 06 March 2013, after receiving vaccine the patient experienced fever over a week and would not move for 3 days, lower energy for three months, glassy eyed. The patient gets a fever every month since then. The patient lost appetite for two weeks. The patient had rash on his leg at the injection site, hot to touch which lasted a week. Corrective treatment was not reported. At the time of this report the outcome of all adverse events was not recovered. Documents held by sender: none.
Age: 0.79
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Mobility decreased, Pyrexia
Clinical narrative: Initial report received from a consumer on 09 Dec 2013: A 9-months-old male patient, whose medical history included allergic to cows milk and intolerance to wheat and concomitant medications were not reported, had received a dose of PENTACEL (Lot number, expiration date and route were not reported) on leg, 06 March 2013. On 06 March 2013, after receiving vaccine the patient experienced fever over a week and would not move for 3 days, lower energy for three months, glassy eyed. The patient gets a fever every month since then. The patient lost appetite for two weeks. The patient had rash on his leg at the injection site, hot to touch which lasted a week. Corrective treatment was not reported. At the time of this report the outcome of all adverse events was not recovered. Documents held by sender: none.
Sex: U
Vaccine: DTAPIPV
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 09 August 2013. A child was administered only DTaP/IPV component of PENTACEL vaccine without ACTHIB component. No more information was provided. No adverse event was reported. List of documents held by sender: none.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Urticaria
Clinical narrative: Initial case was received from a health care professional on 14 October 2013. A 06 months female patient had no medical history reported, received a dose PENTACEL vaccine on an unspecified date (route, dose, site and batch number not reported). Patient had no reported concomitant medication. It was reported that on an unspecified date patients had hives after the vaccine. No corrective treatment was reported. At the time of report the outcome of event was unknown.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Poor quality drug administered
Clinical narrative: Initial misuse report received on 09 December 2013 from a health care professional. A patients whose gender, age, medical history and concomitant medications were not reported, received a dose of PENTACEL (lot number, route and site of vaccination was not reported) on an unspecified date which was potentially unstable and was advised to repeat the dose. List of documents held by sender: none.
Age: 0.1
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 07 October 2013. The 01-month-old patient had received PENTACEL vaccine. It's an inappropriate schedule of vaccine administered. No adverse event was reported. List of documents held by sender: none.
Age: 0.16
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Initial report received from a healthcare professional on 22 November 2013. An unknown age patient received dose of PENTACEL at left deltoid on 19-Oct-2013. On 22 October 2013, pain and swelling injections. It was reported that when she abducts the arm the area around the injection site pulls. Patient had swelling at left deltoid and slight indurated area. Event was not resolved at the time of report. List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered
Clinical narrative: Initial medication error report received on 04 October 2013 from a medical assistant. A patients whose gender, age, medical history and concomitant medications were not reported, received a dose of PENTACEL (route was intravenous, lot number and site of vaccination was not reported) on an unspecified date. Medical assistant gave the DTAP/IPV portion to the patient. List of documents held by sender none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Initial medication error report received from a healthcare professional on 14 October 2013. The patient had received unstable dose of PENTACEL (Lot# unknown) on an unspecified date. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Initial misuse report received on 07 October 2013 from a health care professional. A patient, whose medical history and concomitant medications were not reported, received a dose of PENTACEL (lot number, Expiry date and site of vaccination were not reported). It was reported that the patient was administered with unstable dose. No reaction was reported. List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 04 September 2013. A child (date of birth and gender was not reported) had received DTaP/IPV component of PENTACEL vaccine reconstituted with sterile water and ActHIB was not administered. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 04 September 2013. This is an invalid case as individual patient identifiers are not reported. It was reported that DTAP-IPV was given from PENTACEL vaccine without ACT-HIB. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPV
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 01 August 2013. A child was administered only the DTaP/IPV component from PENTACEL vaccine without the ACTHIB component. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPV
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial misuse report received from a Healthcare professional on 07 August 2013. A child was administered only the DTaP/IPV component of PENTACEL. No other information was provided. No adverse event was reported. List of documents held by sender: none.
Age: 5.0
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 09 August 2013. It was reported that PENTACEL was administered to a 5 year old patient. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPV
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 12 June 2013. One child received only a portion of DTaP-IPV from PENTACEL. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 22 July 2013. A patient had received ACT-HIB component of PENTACEL vaccine inadvertently reconstituted with sterile water. The patient did not received DTAP/IPV component of PENTACEL. No information was provided regarding the patient. No adverse event was reported. Documents held by sender: None.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC
Symptoms: Crying, Immediate post-injection reaction, Injection site erythema
Clinical narrative: Initial report received from a healthcare professional on 13 August 2013 and follow up information received on 15 August 2013. A 02-month-old female patient had received intramuscular first dose of PENTACEL vaccine (lot number: C4485AB) in the left thigh, a dose of PREVNAR vaccine from Pfizer (lot number G57196 and route of administration was not reported) in the right thigh and intramuscular dose of Hepatitis B vaccine from other manufacturer (lot number J005078) in the left deltoid on 12 August 2013. The patient was well and had no illness at time of vaccination. On 12 August 2013, the patient developed large area of redness that spread to the entire left thigh (front and back) to the knee and up to hip and leg immediately after vaccination and the patient was crying immediately after vaccination. Laboratory investigations and corrective treatments were not reported. As of 13 August 2013, the outcome of the events was unknown. List of documents held by the sender: None.