chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: This case was reported by a contact and described the occurrence of vaccine underdose in a adult patient who received ENGERIX B pediatric (batch number ZF2L3, expiry date 19th January 2017). On an unknown date, the patient received ENGERIX B pediatric. On an unknown date, an unknown time after receiving ENGERIX B pediatric, the patient experienced vaccine underdose. On an unknown date, the outcome of the vaccine underdose was unknown. No adverse event reported.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This case was reported by a other health professional via other manufacturer and described the occurrence of incorrect storage of drug in a patient who received ENGERIX B (batch number 995J5, expiry date 6th February 2017). On 24th November 2014, the patient received ENGERIX B. On 24th November 2014, an unknown time after receiving ENGERIX B, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information: This product has been exposed to temperature outside of the required temperature range and the efficacy of this product outside the temperature range had not been established. No adverse events were reported to the office. Per other health professional at office this product has been administered to several patients, ages and genders are unknown at the time of reporting.
Age: 11.0
Sex: F
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This case was reported by a nurse and described the occurrence of inappropriate age at vaccine administration in a 11-year-old female patient who received INFANRIX (batch number 5A425, expiry date 27th February 2017). On an unknown date, the patient received INFANRIX. On an unknown date, an unknown time after receiving INFANRIX, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. Additional information: No adverse event reported.
Age: 16.0
Sex: F
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age, Underdose
Clinical narrative: This case was reported by a nurse and described the occurrence of vaccine underdose in a 16-year-old female patient who received INFANRIX (batch number 75H53, expiry date 22nd September 2016). On an unknown date, the patient received INFANRIX. On an unknown date, an unknown time after receiving INFANRIX, the patient experienced vaccine underdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the vaccine underdose and inappropriate age at vaccine administration were unknown. Additional information: The nurse reports administration of INFANRIX to a 16 year old patient that was supposed to take Tdap.
Age: 19.0
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: This case was reported by a nurse and described the occurrence of vaccine underdose in a 19-year-old female patient who received HAVRIX 720 (batch number 3J9AM, expiry date unknown). On an unknown date, the patient received the 2nd dose of HAVRIX 720. On an unknown date, an unknown time after receiving HAVRIX 720, the patient experienced vaccine underdose. On an unknown date, the outcome of the vaccine underdose was unknown. Additional information: an adult patient was inadvertently given a 720 dose of HAVRIX as her 2nd booster dose.
Age: 0.09
Sex: M
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: This case was reported by a physician and described the occurrence of inappropriate age at vaccine administration in a 1-month-old male patient who received KINRIX (batch number KJ924, expiry date 22nd October 2015). On 15th December 2014, the patient received KINRIX. On 15th December 2014, an unknown time after receiving KINRIX, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown. Additional information: 1-month-old infant received a dose of KINRIX by mistake instead of second dose of Hep B vaccine.
Sex: F
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This case was reported by a other health professional and described the occurrence of inappropriate age at vaccine administration in a adult female patient who received INFANRIX (batch number F37NC, expiry date 13th September 2015). On an unknown date, the patient received INFANRIX. On an unknown date, an unknown time after receiving INFANRIX, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. Additional information: INFANRIX given to an adult instead of Tdap.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2014US001298 is an initial spontaneous report received from a pharmacist on 14 JAN 2014. This report refers to a 15-year-old male patient. His medical history and concomitant medications was not reported. Erroneously he received only Men A  lyophilized conjugate component of MENVEO (batch number A11081), reconstituted with a sterile water instead of MenCYW-135 liquid component intramuscularly on 07 JAN 2014. No adverse reaction reported following this administration error.
Age: 11.0
Sex: F
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: This case was reported by a nurse and described the occurrence of inappropriate age at vaccine administration in a 11-year-old female patient who received INFANRIX (batch number 907CM, expiry date 27th February 2017). On 12th December 2014, the patient received INFANRIX .5 ml. On 12th December 2014, an unknown time after receiving INFANRIX, the patient experienced wrong vaccine administered. On an unknown date, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown. Additional information: INFANRIX mistakenly given to an 11 year old female instead of BOOSTRIX.
Age: 25.0
Sex: F
Vaccine: HEPA, MMR, MNQ, PNC13
Symptoms: Injection site bruising, Injection site erythema, Pain
Clinical narrative: Soreness evening of 2-9-15 site of MMR. Today puffy purple at center and injection red around the purple. Size of a golf ball. She feels sore head.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Pain in extremity
Clinical narrative: Information has been received from a 56 year old female patient concerning herself. The patient's concurrent condition included multiple myeloma and Crohn's disease. VENOFER infusion and iodine gave her hives (drug allergy). On 12-JAN-2015, the patient received PNEUMOVAX 23 (strength, dose, lot#, route not reported) in her left arm. On the same day, the patient developed an injection site reaction and her arm was sore. No treatment was given for adverse events. The patient had not sought medical attention. The outcome of injection site reaction and arm sore was reported as not recovered. Additional information is not expected because the reporter did not allow us to contact the physician.
Age: 1.59
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Seen in office 02/09/15 for 18 mo WCE; pt was behind on imm., total of 4 given in thighs; 2 SQ's given-(1) in each arm. S/s began 02/11/15; Seen in office for eval-> 6 x 8cm area of erythema with induration to (lt0 thigh; afebrile; Tx=supportive ibuprofen of 6-8 hours; warm moist compresses; return if worsens.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US016163, is an initial spontaneous report received from medical assistant on 26 JUL 2013 with a combined follow up information received from medical assistant on 27 AUG 2013 and 29 AUG 2013. This report refers to a 17-years-old female patient. It was reported that the patient received MENVEO (batch number M11071, expiry date: DEC 2013) that had a temperature excursion of 33F for 4-6 hours at a dose of 0.5 ml in the right deltoid on 11 JUL 2013. No adverse event was reported following this maladministration. No further information was provided.   Combined follow up information received on 27 AUG 2013 and 29 AUG 2013. Vaccination site updated.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Pruritus, Skin lesion
Clinical narrative: Developed redness at injection site one day after administration, and continued to have multiple red lesions around area. This area then increased to 8cm x 8cm today. Slight itching; had slight pain under left arm but subsided after 3 days.
Age: 10.0
Sex: F
Vaccine: MNQ
Symptoms: Rash
Clinical narrative: Case number PHEH2013US008331 is an initial spontaneous report received from a medical assistant on 09 APR 2013 with a follow-up0 received on 11 APR 2013. No additional information was added. This report refers to a 10-year-old female patient. She was vaccinated with MENVEO (batch number: unknown) intramuscularly on 06 APR 2013. On the same day after vaccination, she had rash on her arm. The reporter stated that rash was a scattered pattern in the deltoid region only and had resolved on an unspecified date. No additional information about seriousness and causality was provided.  Follow-up received from the medical assistant on 11 APR 2013. Updated patient demographics, description of event and outcome.
Sex: F
Vaccine: MNQ
Symptoms: Headache
Clinical narrative: Case number PHEH2013US008955, is an initial spontaneous report received from a pharmacist on 18 Apr 2013. This report 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) intramuscularly on an unspecified date. Reporter stated that, she was planned to travel out of the country and 10-days later she experienced headache. The physician said that, she was in the emergency department last week. The event occurred 2 to 3-weeks ago. The outcome, seriousness and causality of the event were not reported. No more information was available at this time.
Age: 10.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Case number PHEH2013US009123 is an initial spontaneous report received from a medical assistant on 19 APR 2013. This report refers to an 11-year-old male patient. His medical history and concomitant medication was not reported. He was vaccinated with MENVEO (batch number: M120127 and expiry date: DEC 2014) at dose of 0.5 ml intramuscularly on 02 APR 2013. On the same day after vaccination, he experienced redness and swelling at the injection site on left arm. These symptoms were subsided the next day. The outcome of the events was reported as completely recovered. The seriousness and causality of the events was not reported.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US016314, is an initial spontaneous report received from the pharmacist on 30 JUL 2013. This report refers to an 18 years old female patient. Past medical history and concomitant medication were not reported. She received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number X12097), intramuscularly on 29 JUL 2013. She did not received Men A lyophilized conjugate vaccine component of MENVEO. No adverse event was reported following this administration error.
Age: 4.0
Sex: F
Vaccine: MMR, MNQ
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Case number PHEH2013US016192, is an initial spontaneous report received from the medical assistant on 29 Jul 2013. This report refers to a 4 year old female child. It was reported that someone mistook MENVEO (batch number: M12013) intramuscularly for a MMR (batch number: unknown) and inadvertently administered to the patient on 23 Jul 2013. No adverse reaction was reported.
Age: 16.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US016160 is an initial spontaneous report received from a medical assistant on 26 JUL 2013 and a follow up report from the medical assistant received on 27 AUG 2013. This report refers to a 16-year-old female patient. Her medical history included allergies. Her vaccination history included vaccination with DTap on 27 FEB 1997 on 03 MAR 1997, on 26 JUL 1997, on 19 FEB 1998, 02 FEB 2001 and on 02 DEC 2010, Polio vaccine (unknown manufacturer) on 27 FEB 1997, on 26 JUL 1997, on 19 FEB 1998 and on 02 FEB 2001, MMR vaccine (other manufacturer) on 19 FEB 1998 and on 02 FEB 2001. HIB (other manufacturer) on 27 FEB 1997, 03 MAR 1997, 26 JUL 1997, 19 FEB 1998 and on 02 FEB 2001, Hepatitis B (other manufacturer) on 27 FEB 1997, 03 MAY 1997 and on 26 AUG 1997, VARICELLA (other manufacturer) on 26 NOV 2001 and on 02 DEC 2010, HPV (other manufacturer on 02 DEC 2010 and on 14 JUL 2012, Meningococcal (other manufacturer) on 02 DEC 2013 at a dose of 0.5 ml in the right deltoid intramuscularly on 01 JUL 2013 (at 12:38 PM). It was reported that the vaccine she received had a temperature excursion of 33 F for 4-6 hours. No adverse event was reported following the medication error. She was further vaccinated with another dose of MENVEO which had a temperature excursion (see related case: PHEH2013US016337). She received Pneumococcal (other manufacturer on 02 JUL 2013. It was reported that she needed to receive few more shots of seasonal influenza vaccine. Td and meningococcal vaccine in future.   Follow up report from the medical assistant received on 27 AUG 2013. Vaccination history and  recommended shots of vaccines in future were added. The MENVEO vaccine details (date of vaccination, batch number and site of vaccination were updated.
Age: 16.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US016337 is an initial spontaneous report received from a medical assistant on 26 JUL 2013. This report refers to a 16-years-old female patient. Her medical history and concomitant medications were not reported. Her vaccination history included administration of a dose of MENVEO which experienced temperature excursion (see related case: PHEH2013US016160). She was further vaccinated with second dose of MENVEO (batch number: M11071, expiry date: DEC 2013) at a dose of 0.5 ml intramuscularly on 02 JUL 2013. It was reported that the vaccine she received had experienced a temperature excursion of 33F for 4-6 hours. No adverse event was reported following the medication error.
Age: 37.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2013US016125, is an initial spontaneous report received from a physician on 25 JUL 2013. This report refers to a 37 years old male patient. His medical history and concomitant medication were not reported. He was vaccinated with expired MENVEO (batch number: A10047 and expiry date: DEC 2012), intramuscularly on 24 JUL 2013. No adverse event was reported following this administration error.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2013US016100 is an initial spontaneous report received from a pharmacist on 27 JUL 2013. This report refers to an 18-year-old male patient. This patient was only given the MenCYW-135 component of MENVEO (batch number: X11077) intramuscularly without being reconstituted with MenA, on 27 UUL 2013. No adverse event was reported following this administration error (inappropriate preparation of medication).
Age: 0.5
Sex: U
Vaccine: DTAPIPV
Symptoms: No adverse event, Underdose
Clinical narrative: Initial misuse report received from a healthcare professional on 10 January 2014. A 06-month-old patient (gender unknown) had received a dose of PENTACEL on an unspecified date. It was reported that the patient received only DTaP IPV without ACT-HIB portion. 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 PHEH2014US002353 is an initial spontaneous report from the nurse received on 30 Jan 2014. This report refers to a patient of an unknown age and gender. The patient was accidentally vaccinated with only Men A lyophilized component of MENVEO, (batch number: M13011) which was reconstituted with saline instead of Men CYW-135 liquid component. No adverse event reported following this medication error.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2014US000524 is an initial spontaneous report received from a nurse on 03 JAN 2014. This report refers to an 11-years-old male patient. His medical history and concomitant medications were not reported. It was reported that he was only administered MenCYW-135 liquid component of MENVEO (batch number: M13012, expiry date: Sep 2014) at a dose of 0.5 ml intramuscularly and did not receive MenA lyophilized conjugate on 05 DEC 2013. No adverse reactions were reported following the maladministration.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2014US002356 is an initial spontaneous report from the nurse received on 31 JAN 2014. This report refers to a 16-year-old male patient. He was accidentally vaccinated with only Men CYW-135 liquid component of MENVEO (batch number: M12011) intramuscularly without reconstitution with Men A lyophilized component. No adverse event reported following this medication error.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2014US002608 is an initial spontaneous report from the pharmacist received on 05 FEB 2014. This report refers to a 16-year-old male patient. He was accidentally vaccinated with only MEN CYW-135 liquid component of MENVEO (batch number A12119) intramuscularly and did not receive Men A lyophilized conjugate. It was reported that the patient did not experience any adverse event after the maladministration. No other information was available.
Age: 36.0
Sex: M
Vaccine: MNQ
Symptoms: Exposure via direct contact, No adverse event
Clinical narrative: Case number PHEH2014US002615 is an initial spontaneous report received from a nurse on 04 FEB 2014. This report refers to a 36-years-old male patient. His medical history and concomitant medications were not reported. The reporter stated that while drawing up MENVEO (batch number: M12102) from a vial, the patient accidentally squired himself in the eye with the vaccine on 04 FEB 2014. No adverse event was reported following the maladministration.
Sex: F
Vaccine: MNQ
Symptoms: Accidental exposure to product, Exposure via direct contact, No adverse event, Syringe issue
Clinical narrative: Case number PHEH2014US002828 is an initial spontaneous report received from a health care professional on 06 FEB 2014. This report refers to a female patient whose age was not reported. Her medical history and concomitant medications were not reported. The reporter stated that the doctor while administering MENVEO (batch number: A13058), the needle came off the syringe and splashed back to the doctor's face on 06 FEB 2014. IT was reported that the vaccine almost exploded back to the doctor's face. Some of the vaccine went into her mouth and she spit it out and some went into her eye. No adverse seven was reported following the medication error.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Case number PHEH2014US002860 is an initial spontaneous report received from the nurse on 07 FEB 2014. This report refers to a 19-year-old female patient. Her medical history and concomitant medications were not reported. She was accidentally vaccinated with MENVEO (batch number: 13011) subcutaneously on 07 FEB 2014. No adverse event was reported following this medication error (inappropriate route of vaccination).
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Case number PHEH2014US003129 is an initial spontaneous report from a medical assistant on 11 FEB 2014 with a follow up information received from the medical assistant on 13 FEB 2014. This report refers to a 19-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number A122102) subcutaneously on 20 JAN 2014. It was reported that on the same day her arm became swollen and there was redness on the upper back of the arm. The event outcome, seriousness and causality were not reported. Follow up information received from the medical assistant on 13 FEB 2014. Treating physician details, patient demographics (date of birth, age) and batch number of MENVEO updated.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US003178 is an initial spontaneous report received from a medical assistant on 13 Feb 2014. The case refers to a 17 year old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with one dose of MENVEO (batch number: M11082) intramuscularly on 12 Nov 2013. The unreconstituted MENVEO was reached 51 F for up to 17.5 hours. No adverse event was reported following this administration error.
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2014US000892 is an initial spontaneous report received from a health care professional on 08 Jan 2014. This report refers to a female patient of unknown age. She received only Men A lyophilized conjugate component of MENVEO (batch number: not reported), without reconstituted with MenCYW-135 liquid component, intramuscularly on an unknown date in Oct 2013. No adverse reaction reported following this administration error.
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2014US000898 is an initial spontaneous report received from a health care professional on 08 Jan 2014. This report refers to a female patient of unknown age. She received only Men A lyophilized conjugate component of MENVEO (batch number: not reported), without reconstituted with MenCYW-135 liquid component intramuscularly on an unknown date in Oct 2013. No adverse reaction reported following this administration error.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2014US000526 is an initial spontaneous report received from a nurse on 03 Jan 2014: This report refers to an 11-year-old male child. He was given only MenCYW-135 liquid component of MENVEO (batch number: M13012 and expiry date: Sep 2014) intramuscularly on 31 Dec 2013. No adverse event was reported following this administration error.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2014US000596 is an initial spontaneous report from the health care professional received on 03 Jan 2014. This report refers to a 12-year-old male patient. His medical history was not reported. On an unknown date, the patient was accidentally vaccinated with only Men A lyophilized conjugate of MENVEO (batch number: A13014) which was reconstituted in a sterile diluent instead of Men CYW-135 liquid component. It was reported that the patient did not experience any adverse event after the mal-administration. No other information was available.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2014US000610 is an initial spontaneous report received from a nurse on 02 Jan 2014 and a follow up report received from the nurse on 30 Jan 2014. This report refers to a 14-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated only with 0.5 ml of MenCYW-135 liquid component of MENVEO (batch number: A13014) intramuscularly in the right deltoid and did not receive MenA lyophilized conjugate on 31 Dec 2013 (14:10). No adverse event was reported following the mal administration. Follow up report received from the nurse on 30 Jan 2014: MENVEO batch number and site of vaccination and patient details were updated.
Age: 20.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2013US0325475, is an initial spontaneous report received from a pharmacist on 09 Dec 2013. This report refers to a 20-year-old male patient. He received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: M12097), intramuscularly without being reconstituted with Men A lyophilized conjugate vaccine component on 05 Dec 2013 No adverse event was reported following this administration error.
Age: 56.0
Sex: M
Vaccine: MNQ, TYP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2013US025478 is an initial spontaneous report received from a nurse on 09 Dec 2013 and a follow up report from the nurse received on 09 Jan 2014: This report refers to a 56-year-old male patient. She was allergic to crabs. Concomitant vaccines included TYPHIM VI (batch number: J12011) and TWINRIX (batch number: MF3X3) intramuscularly on 09 Dec 2013. The patient was inadvertently vaccinated with 0.5 ml of MENVEO (batch number: M12100) intramuscularly in the left deltoid on 09 Dec 2013 (09:30 am). No adverse event was reported following this administration error (inappropriate age at vaccine administration). Follow up report from the nurse received on 09 Jan 2014: medical history, concomitant vaccines, MENVEO vaccination site, date and dose were updated.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US025552 is an initial spontaneous report received from a health care professional on 05 Dec 2013. This report refers to an 11-year-old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with MENVEO, (batch number: M12094 and expiry date: 31 Aug 2014) at a dose of 0.5 ml intramuscularly on 28 Oct 2013, which was stored at 0 C for 250 minutes over a period of 63 days. No adverse event was reported following this administration error.
Age: 20.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2013US025763 is an initial spontaneous report received from a nurse on 12 Dec 2013 with a follow-up received on 13 Jan 2014: This report refers to a 20-year-old female patient. She was given only MenCYW-135 liquid component of MENVEO (batch number: M12129) intramuscularly in to the left deltoid on 11 Dec 2013. On the same day she was also vaccinated with GARDASIL (other manufacturer, batch number: unknown) intramuscularly at 0.5 ml. No adverse event was reported following this administration error. Follow-up received from the nurse on 13 Jan 2014: Updated patient demographics, concomitant vaccination and site of application of MENVEO.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US025842 is an initial spontaneous report received from a nurse on 13 Dec 2013: This report refers to a 17-year-old female patient. She was given only MenA powder component of MENVEO (batch number: A13058) mixed with sterile water instead of Men-CYW-135, intramuscularly on 27 Nov 2013. No adverse event was reported following this administration error.
Age: 20.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US025958 is an initial spontaneous report received from a nurse on 16 DEC 2013 with a follow up information received from the physician on 13 JAN 2014. This report refers to a 20-years-old female patient. Her medical history was reported. Her vaccination history included administration of diptheria, tetanus, acellular pertussis (other manufacturer, batch number, not reported). hepatitis A (other manufacturer, batch number: not reported)., hepatitis B (other manufacturer, batch number: not reported), hemophilus influenza type B vaccine (other manufacturer, batch number: not reported; inactivated polio virus vaccine (other manufacturer, batch number: not reported), mumps, measles, rubella vaccine (other manufacturer, batch number: not reported), and varicella virus vaccine (other manufacturer, batch number: not reported. She also received a dose of MENVEO (batch number: not reported) on 26 AUG 2008 which was well tolerated. Her concomitant vaccinations included administration of HAVRIX (other manufacturer, batch number: 5B23A720EL) and GARDASIL (other manufacturer, batch number: J011272); both vaccines administered at a dose  0.5 ml intramuscularly on 16 DEC 2013. It was reported that she was vaccinated intramuscularly with MENA lyophilized powder of MENVEO (batch number: M13050, expiry date 31 MAY 2015) reconstituted with sterile water instead of MenCYW-135 liquid component on 16 DEC 2013 as booster dose. No adverse events were reported following the maladministration.    Follow up information received from the physician on 13 JAN 2014. Patient demographics (weight and height), vaccination history, concomitant vaccinations, vaccination date and expiry date of suspect vaccine updated.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US016949 is an initial spontaneous report received from a nurse on 08 Aug 2013. This report refers to an 11-years-old female patient. her medical history and concomitant medications were not reported. it was reported that she was vaccinated with MenCYW-135 liquid conjugate component of MENVEO (batch number: X12092 intramuscularly on 02 Aug 2013 without being reconstituted with MenA lyophilized conjugate. No adverse reactions were reported following the administration error.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US016946 is an initial spontaneous report received from a pharmacist on 07 Aug 2013. This report refers to a 18-years-old male patient. His medical history and concomitant medications were not reported. It was reported that he was vaccinated only with MenCYW-135 liquid conjugate component of MENVEO (batch number: M12119) intramuscularly on 06 Aug 2013 without being reconstituted with MenA lyophilized conjugate. No adverse reactions were reported following the administration error.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Case number PHEH2013US016944, is an initial spontaneous report received from nurse on 07 Aug 2013. This report refers to an 11 year old female patient. Her medical history and concomitant medication was not reported. Nurse reported that the patient received MENVEO (batch number: X11042/A12013), at a dose of 0.5 ml subcutaneously on 07 Aug 2013. No adverse event was reported. No further information was provided.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2013US016938 is an initial spontaneous report received from a medical assistant on 06 Aug 2013. This report refers to a 12-years-old female patient. Her medical history and concomitant medications were not reported. It was reported that she was vaccinated only with MenCYW-135 liquid conjugate component of MENVEO (batch number: A12097) intramuscularly on 31 Jul 2013 without being reconstituted with MenA lyophilized conjugate. no adverse reactions were reported following the administration error.
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US016819 is an initial spontaneous report from the nurse received on 05 Aug 2013. This report refers to a patient of an unknown age and gender. On an unknown date, the patient was accidentally vaccinated with only MenCYW-135 liquid component of MENVEO (batch number: not reported) and did not receive Men A lyophilized conjugate. No adverse event reported following this medication error. No other information was available.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2013US016749, is an initial spontaneous report received from the nurse on 06 Aug 2013 and a follow up report from the nurse received on 30 Aug 2013. This report refers to an 18 years old male patient. His vaccination history included vaccination with an unspecified vaccine and it was well tolerated. he received only Men C, Y, W-135 liquid conjugate component of MENVEO (Batch number: M12024), intramuscularly in the deltoid at a dose of 0.5 ml without being reconstituted with Men A lyophilized conjugate vaccine component on 02 Aug 2013. No adverse event was reported following this administration error. The patient notified that if they would travel, they would want to get another round of meningitis vaccine. Follow up report from the nurse received on 30 Aug 2013: Vaccination history and the patient's statement regarding meningitis vaccine were added.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case number PHEH2013US016637 is an initial spontaneous report received from a nurse on 02 Aug 2013 with a follow up information received from a nurse on 29 Oct 2013. This report refers to a 12-year-old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with an initial dose of MENVEO (batch number: A11042) intramuscularly in the right deltoid on 18 Jul 2012. She inadvertently received another dose of MENVEO (batch number: A12006) intramuscularly in the left deltoid on 30 Jul 2013. No adverse event was reported following medication error (inappropriate schedule of vaccine administered). Follow up infromation received from a nurse on 29 Oct 2013: Patient demographics 9gender, weight and height), vaccination date of first dose, vaccination sites of both doses updated.
Sex: U
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Case number PHEH2013US016630, is an initial spontaneous report received from the pharmacist on 01 Aug 2013. This report refers to an unspecified age and gender patient. Past medical history and concomitant medication were not reported. From after hours on 01 Aug 2013, pharmacist reported that, a patient was vaccinated with double dose of MENVEO (batch number: not reported), intramuscularly on an unspecified date. No adverse event was reported following this administration error.
Sex: F
Vaccine: MNQ
Symptoms: Injury associated with device, Laceration
Clinical narrative: Case number PHEH2013US016586 is an initial spontaneous report received from a physician on 18 Jul 2013. This report refers to an adult female patient (age was reported as thirties). Her medical history and concomitant medications were not reported. It was reported that one MenCYW-135 vial in the box of MENVEO (batch number: M12129, expiry date: Aug 2014) was broken. On 17 Jul 2013, the nurse opened the box, went to draw up the vaccine and as she was grabbing the base of the vial, she cut her finger. The outcome of the event injury was not reported. The seriousness and causality was not reported. No other information was provided.
Age: 59.0
Sex: M
Vaccine: MNQ
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2013US016542, is an initial spontaneous report received from a health care professional on 01 Aug 2013. This case refers to a 59 years old male patient. His medical history and concomitant medication was not reported. He was vaccinated with MENVEO (batch number: not reported), intramuscularly on 03 Jul 2013. No adverse event was reported following this administration error.
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage
Clinical narrative: Case number PHEH2013US06508, is an incomplete initial report received from a nurse on 02 Aug 2013 with a follow up information received from a nurse on 04 Sep 2013. This case was initially reported as a multiple patient case, but upon follow up receipt both the patients were identified. This report refers to a female patient. Her past medical history and concomitant medication were not reported. She was vaccinated with MENVEO (batch number: A11032), intramuscularly on 30 Jul 2013. MENVEO had experienced a one time temperature excursion of 9.0-9.5 C for maximum time of 18 minutes. No adverse event was reported following this administration error. Follow up information received from a nurse on 04 Sep 2013: Case category changed to spontaneous case the case became valid, patient demographics (patient initial and gender) and vaccination date updated.
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US016402, is an initial spontaneous report received from the pharmacist on 31 JUL 2013. This report refers to an unspecified age and gender patient. Past medical history and concomitant medication were not reported. The patient received only MenCYW-135 liquid conjugate component of MENVEO (batch number: M12129) on an unspecified date. The patient did not receive Men A lyophilized conjugate component of MENVEO. No adverse event was reported following this administration error. No additional information was available.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US017767 is an initial spontaneous report received from a physician on 19 Aug 2013 and a follow up report from the health care professional received on 23 Sep 2013. This report refers to a 11-year-old male patient. His medical history and concomitant medications were not reported. On 07 Aug 2013, he was vaccinated only with an intramuscular dose of MenCYW-135 liquid component of MENVEO (batch number: M12132) at a dose of 0.5 ml in the left deltoid region without being reconstituted with Men A lyophilized conjugate. It was reported that the patient was doing well and he would be re-vaccinated in the next vaccination schedule as there was no plan for a foreign travel at this time. No adverse reactions were reported following the mal-administration. Follow up report received from the health care professional received on 23 Sep 2013: The patient's present condition was updated.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US017763 is an initial spontaneous report received from a physician on 19 Aug 2013, with a follow-up received on 23 Sep 2013: This report refers to an 11-year-old male child. He was given only MenCYW liquid conjugate component of MENVEO (batch number: M12122) intramuscular on 16 Aug 2013, without being re-constituted with the powder component. The physician confirmed that patient would be revaccinated with the correctly constituted vaccine, as per the normal schedule. No adverse event was reported following this administration error. Follow-up received from a health care professional on 23 Sep 2013: Updated patient demographics and information about revaccination.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Immunisation, No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US017751 is an initial spontaneous report received from a nurse on 19 Aug 2013 with a follow-up received on 24 Sep 2013: This report refers to an adult male patient. He was given only MenCYW liquid conjugate component and MENVEO (batch number: M11073) intramuscularly in to the left arm on 16 Aug 2013. No adverse event was reported following this administration error. He was vaccinated with the correctly re-constituted vaccine on 18 Sep 2013. Follow-up received from the nurse on 24 Sep 2013: Updated patient demographics, site of application of MENVEO and information about revaccination with the correctly re-constituted MENVEO.
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US017744 is an initial spontaneous report received from a physician on 19 Aug 2013. This report refers to a patient of unknown age and gender. It was reported that the patient received only Men CWY 135 liquid component of MENVEO (batch number: unknown) intramuscularly without being reconstituted with Men A lyophilized conjugated on an unknown date. Client reported that Men A powder vial was discovered in the refrigerator. No adverse event was reported following this administration error. No further information was provided.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US017740 is an initial spontaneous report received from a nurse on 19 AUG 2013. This report refers to an 11 year old male patient. It was reported that MENVEO (batch number: M11032, expiry date MAR 2014) which reached to a temperature of 31.1 Fahrenheit for a brief but an unknown period of time and on the previous day to a temperature of 32 Fahrenheit for 24 hours was given to the patient via intramuscular  route on 13 AUG 2013. It was reported that no adverse reactions reported following this medication error. No other information was available.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US017737 is an initial report from the nurse received on 19 AUG 2013. This report refers to a 17-year-old male patient. It was reported that MENVEO (batch number: M11032, expiry date: MAR 2014) which reached to a temperature of 31.1 Fahrenheit for a brief but an unknown period of time and on the previous day to a temperature of 32 Fahrenheit for 24 hours was given to the patient via intramuscular route on 13 AUG 2013. It was reported that no adverse reactions reported following this medication error.  No other information was available.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US017649 is an initial spontaneous report received from a nurse on 16 AUG 2013. This report refers to an 18-years-old male patient. His medical history and concomitant medications were not reported. It was reported that on 13 AUG 2013, he received only an intramuscular dose of MenCYW-135 liquid component of MENVEO (batch number: X12092) without being reconstituted with MenA lyophilized conjugate. No adverse event was reported following the maladministration.
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US017646 is an initial spontaneous report received from a pharmacist on 15 AUG 2013. This report refers to a patient whose identifies were not reported. The patient's medical history and concomitant medications were not reported. IT was reported that on 15 AUG 2013, the patient received only an intramuscular dose of MenCYW-135 liquid component of MENVEO (batch number: not reported) without being reconsituted with MenA lyophilized conjugate. No adverse event was reported following the maladministration.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US017531 is an initial spontaneous report received from a nurse on 15 AUG 2013, with a follow-up received on 30 SEP 2013. This report refers to a 12 year old male patient. Nurse reported that the patient received only Men CWY 135  liquid component of MENVEO (batch number: M11065) intramuscularly into right deltoid without being reconstituted with Men A lyophilized conjugate on 12 AUG 2013 (at 3:40 PM). No adverse event was experienced following this administration error.  Follow-up was received on 30 SEP 2013. Patient demographics, vaccination site and vaccination date were updated.
Age: 25.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US017529 is an initial spontaneous report from the pharmacist received on 15 AUG 2013. This report refers to a 25-year-old male patient. His medical history was not reported. On 14 AUG 2013, the patient was accidentally vaccinated with only MenCYW-135 liquid component of Menveo (batch number: M11077) via intramuscular route and did not receive Men A lyophilized conjugate. No adverse event reported following the medication error. No other information was available.
Age: 20.0
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHHY2013US080932 is an initial spontaneous report received from a nurse on 26 JUL 2013. This report refers to a 20-year-old male patient. He was given only the Men A component of MENVEO (batch number A12131) intramuscularly on 26 JUL 2013. MenA was reconstituted with sterile water instead of MenCYW-135. No adverse event was reported following this administration error (wrong solution used in drug reconstitution).
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US017433 is an initial spontaneous report from the nurse received on 14 AUG 2013. This report refers to a 16-year-old male patient. On 14 AUG 2013, the patient was accidentally vaccinated with Men A lyophilized conjugate of MENVEO (batch number: A12092), mixed with a sterile diluent instead of MenCYW-135 liquid component. No adverse reaction reported following this medication error. No other information was available.
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US017431 is an initial spontaneous report from the pharmacist received on 14 AUG 2013. This report refers to a patient of unknown age and gender. On 14 AUG 2013, the patient was accidentally  vaccinated with Men A lyophilized conjugate of MENVEO (batch number: M12009) mixed with sterile diluent instead of MenCYW-135 liquid component. No adverse reaction reported following this medication error. No other information was available.
Age: 0.2
Sex: U
Vaccine: DTAPHEPBIP, DTAPIPVHIB
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 30-Aug-2013. A 02-months-old patient had received both PENTACEL and PEDIARIX were administered at the same time. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Initial misuse report received from a healthcare professional on 22 October 2013. The case was received on 21 March 2014 at GPV. The patient was administered only the ACTHIB component from PENTACEL. No adverse event was reported. List of documents held by sender: none. Addendum: 13 May 2014. Upon second medical examination of case at time of internal review the following has been modified in this case. The event as reported was taken as PENTACEL: States pt was administered only the ACTHIB component which was inadvertently reconstituted with sterile water, no adverse event. The event underdose was deleted from the case. It was reported that the patient was administered only the ACTHIB component which was inadvertently reconstituted with sterile water.