chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2014US014051 is an initial spontaneous report from the nurse on 11 Jul 2014. This report refers to a female patient whose age was not reported. Her medical history and concomitant medications were not reported. It was reported that on an unknown date she inadvertently received an intramuscular dose of Men A lyophilized conjugate of MENVEO (batch number: not reported) reconstituted with sterile diluent from Merck instead of MenCYW-135 liquid component. No adverse events were reported following the maladministration.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2014US014997 is an initial spontaneous report from a medical assistant received on 24 Jul 201 with a follow-up from a medical assistant received on 21 Oct 2014. This report refers to an 18-year-old male patient. Past medical history and concomitant medications were not provided. His vaccination status was up-to-date. He was vaccinated with 0.5 ml of expired MENVEO (batch number: M11075) intramuscular into left arm on 07 Jul 2014. No adverse reactions have occurred following this medication error. Repeat dose of vaccine was offered but it was declined. Follow up information received from the medical assistant on 21 Oct 2014: Patient demographics (height and weight) site of vaccination (left arm) and narrative (repeat dose declined) were updated.
Age: 10.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number# PHEH2014US014056, is an initial spontaneous  report from a nurse on 11 Jul 2014 with a follow up report received from the physician on 01 Aug 2014. This report refers to an 10 year old male patient. Historical conditions were not reported. His concomitant medications included TDAP (other manufacturer, batch number: C4472AA) intramuscularly at a dose of 0.5 ml on 11 Jul 2014. He was administered only MenCYW-135 liquid component of MENVEO (batch number: X13057) partial dose without being reconstituted with Men A component intramuscularly on 11 Jul 2014, at 09:30 AM. It was insisted that there was no patient harm involved. No adverse event was reported following the administration error. It was reported that the patient would be re-vaccinated with complete MENVEO vaccine when the patient would come back to the office to get vaccinated. Follow up report was received from the physician on 01 Aug 2014: The patient demographics, age of the patient, time of vaccine administration, the concomitant medications and the physician's comments were updated.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number# PHEH2014US014069, is an initial spontaneous report from a health care professional received on 07 Jul 2014. This report refers to an 11-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. He was vaccinated with MENVEO (batch number: A12132) intramuscularly at a dose of 0.5 ml on 02 Jul 2014, that had a temperature excursion to 9 degrees Celsius for 1.5 hours on 01 Jul 2014. No adverse event was reported following the medication error.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US014071 is an initial spontaneous report received from the medical assistant on 14 Jul 2014. This report refers to a 17 years old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: M13016) intramuscularly on 10 Jul 2014. It was reported that MENVEO was exposed at temperature of 31.8 degree F (-0.11 degree C) up to six hours on 10 Jul 2014. No adverse event reported after the maladministration.
Age: 59.0
Sex: F
Vaccine: MNQ
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US013212 is an initial spontaneous report received from a nurse on 27 Jun 2014 with a follow up report received on 08 Jul 2014. This report refers to a 61 year old female patient. Her past medical history and concomitant medication were not reported. The patient was vaccinated with MENVEO (batch number: M12127) at dose of 0.5 ml intramuscularly on 17 Oct 2013. No adverse event was reported following this administration error. Follow report was received from the nurse on 08 Jul 2014: The initials, gender and date of birth of the patient, batch number and date of vaccination of MENVEO and the date of onset of administration error were updated.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2014US013297 is an initial spontaneous report received from the medical assistant on 02 Jul 2014. This report refers to 18 years old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: X130558) intramuscularly on 17 Jun 2014. It was reported that he was erroneously received a dose of Men A lyophilized conjugate reconstituted with sterile diluent instead of MenCYW-135 liquid conjugate. No adverse event reported after the maladministration.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2014US018879, is an initial spontaneous report received from a nurse on 19 Sep 2014. This report refers to a 16 year old female patient. Past medical history and concomitant medication were not reported. Previous vaccinations were well tolerated. She received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: M14030), intramuscularly without being reconstituted with Men A lyophilized conjugate vaccine component on 18 Sep 2014. No adverse event was reported following this administration error.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case number PHEH2014US013390 is an initial spontaneous report received from a healthcare professional (medical assistant) on 02 Jul 2014. This report refers to a 12 year old female patient. Her medical history and concomitant medication were not reported. She was inadvertently vaccinated with two doses of MENVEO both intramuscularly at a dose of 0.5 ml on 10 Jun 2014 (batch number: A12012) and on 01 Jul 2014 (batch number: A13065). No adverse event was reported following this administration error.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2014US019853 is an initial spontaneous report from the nurse received on 01 Oct 2014. This report refers to a 11-year-old female patient. On 01 Aug 2014, she inadvertently received only Men CYW-135 component of MENVEO (batch number: M14040) intramuscularly without reconstitution with Men A lyophilized component. No adverse event reported following this medication error.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Case number PHEH2014US013404 is an initial spontaneous report received from a pharmacist on 03 Jul 2014. This report refers to an 18-year-old female patient. Her medical history and concomitant medications was not reported. She was vaccinated with MENVEO (batch number: X12104), subcutaneously on 02 Jul 2014. No adverse reaction was reported following this administration error.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2014US013405 is an initial spontaneous report received from a medical assistant on 03 Jul 2014. This report refers tot an 11-year-old female patient. Her medical history and concomitant medications was not reported. She received only Men A lyophilized conjugate component of MENVEO (batch number: M13015), intramuscularly reconstituted with a sterile diluent instead of MenCYW-135 liquid component on 01 Jul 2014. No adverse reaction reported following this administration error.
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2014US013447, is an initial spontaneous report received from a nurse on 27 Jun 2014, with a follow up received from nurse on 23 Jul 2014 and with a follow up information received from the physician on 04 Aug 2014. This report refers to a male patient of unknown age. His medical history and concomitant medications were not reported. He received an initial dose of Men CYW-135 liquid conjugate component of MENVEO (batch number: M13054) intramuscularly without being reconstituted with Men A lyophilized conjugate vaccine component on 27 Jun 2014. No adverse event was reported following this administration error. Upon follow up received from the physician, it was reported that they would re-immune the patient with correct preparation. Non-significant follow up received from nurse on 23 Jul 2014: updated physician contact information and reporter comment (the nurse stated that she would give the follow up form to doctor to fill out. They would have to figure out who was the patient and then would fill out the follow up form). Follow up information received from the physician via 04 Aug 2014: Updated patient demographics (initials and gender) and physician comments.
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2014S013548, is an initial spontaneous report received from a nurse on 02 Jul 2014 with a follow up report received from the nurse on 04 Aug 2014. This report refers to a patient of unknown age and gender. The patient was administered only the Men CYW-135 liquid component of MENVEO (batch number: A12027) intramuscular on an unknown date during the last year fall. No adverse event was reported. No further information was provided. Follow up report received from the nurse on 04 Aug 2014: The patient received the vaccine during last year fall season.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2014US013554 is an initial spontaneous report from the nurse received on 02 Jul 2014 with a follow up report received from nurse on 03 Jul 2014. This report refers to a 16 year old female patient. On 02 Jul 2014, she was inadvertently vaccinated with only the liquid component MenCYW-135 of MENVEO (batch number: not reported) without reconstitution with Men A lyophilized component. No adverse event reported following this medication error (inappropriate preparation of medication). Follow up report was received from a nurse on 03 Jul 2014: The gender of the patient was updated.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2014US013756, is an initial spontaneous report received from a physician on 08 Jul 2014. This report refers to a 16 year old male patient. Physician reported that the patient received only the Men CWY-135 component of MENVEO (batch number: X13066) intramuscular on 03 Jul 2014. No adverse event was reported. No further information was provided.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2014US013795, is an initial spontaneous report received from a medical assistant on 08 Jul 2014 and with a follow up information received from the medical assistant on 04 Aug 2014. This report refers to a 12 year old female patient. Her medical history and concomitant medications were not reported. She received only the Men CYW-135 liquid conjugate component of MENVEO (batch number: M14024, expiry date: Jul 2015), intramuscularly without being reconstituted with Men A lyophilized conjugate vaccine component on 08 Jul 2014 at 1:45 PM. No adverse event was reported. No further information was provided. Follow up information received from the medical assistant on 04 Aug 2014: Updated patient demographics (height and weight), batch number, expiry date of BEXSERO and time of vaccination.
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2014US013874 is an initial spontaneous report received from a nurse on 09 Jul 2014. This report refers to an unknown age and gender patient. Past medical history and concomitant medications was not reported. The patient received only Men A lyophilized conjugate component of MENVEO (batch number: A12125), intramuscularly reconstituted with a sterile diluent instead of MenCYW-135 liquid component on an unknown date in Jun 2014. No adverse reaction reported following this administration error.
Age: 10.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US014078, is an initial spontaneous report from a health care professional received on 07 Jul 2014. This report refers to a 10-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with MENVEO (batch number: A12132) intramuscularly at a dose of 0.5 ml on 02 Jul 2014, that had a temperature excursion to 9 degrees Celsius for 1.5 hours on 01 Jul 2014. No adverse event was reported following the medication error (incorrect storage of drug).
Age: 10.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US014079, is an initial spontaneous report from a health care professional received on 07 Jul 2014. This report refers to a 10-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. He was vaccinated with MENVEO (batch number: A12132) intramuscularly at a dose of 0.5 ml on 02 Jul 2014, that had a temperature excursion to 9 degrees Celsius for 1.5 hours on 01 Jul 2014. No adverse event was reported following the medication error (incorrect storage of drug).
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US014081, is an initial spontaneous report from a health care professional received on 07 Jul 2014. This report refers to a 12-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with MENVEO (batch number: A12132) intramuscularly at a dose of 0.5 ml on 02 Jul 2014, that had a temperature excursion to 9 degrees Celsius for 1.5 hours on 01 Jul 2014. No adverse event was reported following the medication error.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US014082 is an initial spontaneous report received from a medical staff supervisor on 07 Jul 2014. This report refers to a 13 year old female patient. Her past medical history and concomitant medications were not reported. On 01 Jul 2014, she was vaccinated with MENVEO (batch number: A12132) intramuscularly, which was stored at a temperature of 9 C for one and a half hours. No adverse events were reported following this medication error (incorrect storage of drug).
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2014US014US014131 is an initial spontaneous report received from a pharmacist on 11 Jul 2014. This report refers to a 17-year-old female patient. Past medical history and concomitant medications were not reported. On 11 Jul 2014, she was vaccinated intramuscularly with only MenCYW-135, the liquid component of MENVEO. batch number: X12025) and did not received Men A lyophilized conjugate. No adverse event was reported following this administration error (inappropriate preparation of medication).
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2014US014193, is an initial spontaneous report received from a healthcare professional on 14 Jul 2014. This report refers to an 11 year old female patient. Past medical history and concomitant medications were not reported. She received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: X13067), intramuscularly without being reconstituted with Men A lyophilized conjugate vaccine component  on 14 Jul 2014. No adverse event was reported following this administration error.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2014US014257 is an initial spontaneous report received from a nurse on 15 Jul 2014. This report refers to an 18 year old female patient. Her medical history and concomitant medications were not reported. Nurse reported that the patient received only the MenCYW-135 liquid component of MENVEO (batch number: M14040) intramuscularly on 15 Jul 2014 and did not receive MenA lyophilized conjugate. No adverse event was reported following the maladministration. No further information was provided.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2014US014007 is an initial spontaneous report received from a health care professional on 15 Jul 2014. This report refers to a 11-year-old female patient. The patient received only Men CWY liquid conjugate component of MENVEO (batch number: not reported) intramuscularly on 15 Jul 2014. No adverse events were reported following this medication error.
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2014US014303, is an initial spontaneous report received from a medical assistant on 15 Jul 2014 with a follow up information received from health care professional on 04 Aug 2014. This report refers to a patient of unknown age and gender. It was reported that the patient received Men a component of MENVEO (batch number: A14040) reconstituted with a sterile diluent intramuscularly on 14 Jul 2014. The patient did not receive the Men CYW-135 liquid component of MENVEO. No adverse event was reported following the maladministration. Upon follow up information received on 04 Aug 2014, the reporter stated that the patient came back on an unknown date and was re-vaccinated with a full dose of MENVEO. No further information was provided.
Age: 45.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2014US014407 is an initial spontaneous report received from a pharmacist on 16 Jul 2014 with a follow up report received from the pharmacist on 02 Sep 2014. This report refers to a 45 year old female patient. Her medical history and concomitant medication were not reported. Her vaccination history included vaccination with MENVEO (batch number: not reported) in the past which was well tolerated on unknown date. On 15 Jul 2014 at 04:00 pm, she was vaccinated with the liquid component (MenCWY) of MENVEO (batch number: 12104) without being reconstituted with the powder component (Men A) via intramuscular route. Following this error, she was revaccinated with a complete dose of MENVEO (batch number: not reported) on 17 Jul 2014. No adverse event was reported following this administration error (inappropriate preparation of medication).
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2014US014474, is an initial spontaneous report received from a nurse on 17 Jul 2014 with a follow-up received on 18 Aug 2014. This report refers to a male patient of unknown age. Past medical history and concomitant medications was not reported. He received only Men A lyophilized conjugate component of MENVEO (batch number: M14031 and C4565AA), intramuscularly that was reconstituted with a sterile diluent instead of MenCYW-135 liquid component on 15 Jul 2014 at 12:23. No adverse reaction reported following this administration error. Follow-up received from a nurse on 18 Aug 2014: Time of vaccination and batch number of vaccine was updated.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US014479 is an initial spontaneous report received from a nurse on 17 Jul 2014. This report refers to a patient of unknown age and gender. Past medical history and concomitant medications was not reported. The patient inadvertently received an intramuscular dose of MENVEO after the Men A and Men CYW-135 vials (batch number: not reported) reached 9.3 degrees Celsius for approximately 38 minutes and 20 seconds on an unknown date. No adverse reaction reported following this administration error.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2014US014482, is an initial spontaneous report received from a healthcare professional on 17 Jul 2014. This report refers to an unknown age and gender patient. Past medical history and concomitant medications were not reported. 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 lyophilized conjugate vaccine component on an unknown date. 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 PHEH2014US014490 is an initial spontaneous report received from a nurse on 17 Jul 2014. This report refers to an 18 year old male patient. Past medical history and concomitant medications was not reported. He received only Men A lyophilized conjugate component of MENVEO (batch number: M13014), intramuscularly reconstitut4ed with a sterile water instead of MenCYW-135 liquid component on 14 Jul 2014. No adverse reaction reported following this administration error.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2014US014494, is an initial spontaneous report received from a nurse on 17 Jul 2014. This report refers to a 17 year old female patient. Past medical history and concomitant medications were not reported. Inadvertently she received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: M14022), intramuscularly without being reconstituted with Men A lyophilized conjugate vaccine component on 15 Jul 2014 by nurse at her facility. No adverse event was reported following this administration error.
Age: 22.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2014US014714 is an initial spontaneous report from a nurse received on 21 Jul 2014 with a follow up report received from the nurse on 01 Oct 2014. This report refers to a 22 year old male patient. His medical history and concomitant medication was reported. His vaccination history included vaccination with MENVEO (batch number: not reported) in the past which was well tolerated. He was administered inadvertently MenA powder component of MEVNEO (batch number: A13011) reconstituted with sterile water instead of Men-CYW-135 liquid conjugate component intramuscularly into right deltoid on 21 Jul 2014 at 12:15 hours. No adverse event had occurred since the administration error. Follow up report received from the nurse on 01 Oct 2014: Updated patient demographics (height and weight), vaccination history, site of vaccination and time of vaccination.
Age: 17.0
Sex: U
Vaccine: MNQ
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Case number PHEH2014US014727 is an initial spontaneous report from the nurse on 22 Jul 2014. This report refers to a 17 years old patient of unknown gender. The patient's medical history and concomitant medications were not reported. The patient was vaccinated with MENVEO (batch number: A13061) inadvertently administered subcutaneously on 08 Jul 2014. No adverse event reported after the maladministration (wrong route of administration).
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2014US015378 is an initial spontaneous report received from a medical assistant on 30 Jul 2014 with a follow up information received from the medical assistant on 03 Sep 2014. This report refers to an 11 year old male patient. Past medical history and concomitant medications was not reported. He received only Men A lyophilized conjugate component of MENVEO (batch number: M14024), reconstituted with a sterile water instead of MenCYW-135 liquid component at a dose of 0.5 ml intramuscularly in the right arm on 30 Jul 2014 at 16:09 as initial application. No adverse reaction reported following this administration error. He was recommended to have revaccination and hence he was called back to the office and administered another dose of MENVEO on an unknown date. No further information was provided. Follow up information received from the medical assistant on 03 Sep 2014: Patient demographics (height and weight), dose and site of vaccination and revaccination details updated.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2014US015458 is an initial spontaneous report from the health care professional received on 01 Aug 2014. This report refers to a 11 year old male patient. The patient received an expired MENVEO (batch number: M12013) vaccine on 30 Jul 2014, intramuscularly. No adverse event reported following this medication error.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2014US015495 is an initial spontaneous report received from a nurse on 31 Jul 2014, and with a follow up report received from nurse on 04 Sep 2014. This report refers to a 16 year old male patient. His medical history and concomitant medication were not reported. On 30 Jul 2014, he was vaccinated only with the liquid component of MENVEO (batch number: X12024) via intramuscular route instead of being reconstituted with MenA. His mother reported that the vaccination will be repeated in this month. No adverse event was reported following this maladministration error. Follow up report received from nurse on 04 Sep 2014. Updated patient details and mother comments.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2014US015521, is an initial spontaneous report from a nurse received on 30 Jul 2014 and with a follow up information received from a nurse on 05 Sep 2014. This report refers to an 11-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. On 29 Jul 2014, she was administered only Men CYW-135 liquid component of MENVEO (batch number: X13058) without being reconstituted with Men A (see case: PHEH2014US015362). She was administered Men A powder component of MENVEO (batch number: M13058) reconstituted with sterile water instead of Men-CYW-135, intramuscularly in the left deltoid on 30 Jul 2014 at 10:30.  No adverse reaction was reported following this administration error (wrong solution used in drug reconstitution).
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2014US015546 is an initial spontaneous report received from a nurse on 30 Jul 2014. This report refers to a 17 year old female patient. Past medical history and concomitant medications was not reported. She received only Men A lyophilized conjugate component of MENVEO (batch number: A13016), intramuscularly reconstituted with a sterile water instead of MenCYW-135 liquid component on 30 Jul 2014. No adverse reaction reported following this administration error.
Age: 19.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Case number PHEH2014US015548 is an initial spontaneous report received from a pharmacist on 02 Aug 2014. This report refers to a 19 years old male patient. Past medical history and concomitant medications was not reported. He was vaccinated with MENVEO (batch number M13047), subcutaneously instead of intramuscularly on 30 Jul 2014. No adverse reaction reported following this administration error.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2014US015561 is an initial spontaneous report received from a healthcare professional (medical assistance) on 29 Jul 2014. This report refers to a 16 year old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with MENVEO (batch number: M14023) intramuscularly on 25 Jul 2014. It was reported that the MenA powder component was reconstituted with a sterile diluent instead of CYW-135 liquid component. No adverse event was reported following this administration error (wrong solution used in drug reconstitution).
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site extravasation
Clinical narrative: Case number PHEH2014US015634, is an initial spontaneous report received from a pharmacist on 05 Aug 2014. 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: unknown) intramuscular on 04 Aug 2014. It was reported that the vaccine leaked from the injection site once the needle was removed. The outcome of the event was unknown. Seriousness and causality assessment was not reported. No further information was provided.
Age: 12.0
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US015677 is an initial spontaneous report received from a medical assistant on 01 Aug 2014. This report refers to a 12 year old patient of an unspecified gender. The past medical history and concomitant medications of the patient was not reported. On 28 Jul 2014, the patient was vaccinated with MENVEO (batch number: M13030, expiry date: 30 Sep 2014) which had multiple temperature excursion while in storage. The temperature of the vaccine reached a maximum of 47.5 F for one hour and 17 minutes on 18 Jul 2014, a maximum of 47.5 F for 42 minutes on 21 Jul 2014, a maximum of 47.5 for one hour and three minutes on 24 Jul 2014 and a maximum of 47.5 for one hour and three minutes on 31 Jul 2014. No adverse events were reported following this maladministration (incorrect storage of drug).
Age: 11.0
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US015692 is an initial spontaneous report received from a medical assistant on 01 Aug 2014. This report refers to a 11 year old patient of an unspecified gender. The past medical history and concomitant medications of the patients were not reported. On 01 Aug 2014, the patient was vaccinated with MENVEO (batch number: M13030, expiry date: 30 Sep 2014) which had multiple temperature excursions while in storage. The temperature of the vaccine reached a maximum of 47.5 F for one hour and 17 minutes on 18 Jul 2014, a maximum of 47.5 F for 42 minutes on 21 Jul 2014, a maximum of 47.5 for one hour and three minutes on 24 Jul 2014 and a maximum of 47.5 for one hour and three minutes on 31 Jul 2014. No adverse events were reported following this maladministration (incorrect storage of drug).
Age: 12.0
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US015693 is an initial spontaneous report received from a medical assistant on 01 Aug 2014. This report refers to a 12 year old patient of an unspecified gender. The past medical history and concomitant medications of the patients were not reported. On 29 Jul 2014, the patient was vaccinated with MENVEO (batch number: M13030, expiry date: 30 Sep 2014) at a dose of 0.5 ml intramuscularly which had multiple temperature excursions while in storage. The temperature of the vaccine reached a maximum of 47.5 F for one hour and 17 minutes on 18 Jul 2014, a maximum of 47.5 F for 42 minutes on 21 Jul 2014, a maximum of 47.5 for one hour and three minutes on 24 Jul 2014 and a maximum of 47.5 for one hour and three minutes on 31 Jul 2014. No adverse events were reported following this maladministration.
Age: 16.0
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US015694 is an initial spontaneous report received from a medical assistant on 01 Aug 2014. This report refers to a 16 year old patient of an unspecified gender. The past medical history and concomitant medications of the patients were not reported. On 25 Jul 2014, the patient was vaccinated with MENVEO (batch number: M13030, expiry date: 30 Sep 2014) at a dose of 0.5 ml intramuscularly which had multiple temperature excursions while in storage. The temperature of the vaccine reached a maximum of 47.5 for one hour and 17 minutes on 18 Jul 2014, a maximum of 47.5 for 42 minutes on 21 Jul 2014, a maximum of 47.5 for one hour and three minutes on 24 Jul 2014 and a maximum of 47.5 for one hour and three minutes on 31 Jul 2014. No adverse events were reported following this maladministration (incorrect storage of drug).
Age: 11.0
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US015695 is an initial spontaneous report received from a medical assistant on 01 Aug 2014. This report refers to a 11 year old patient of an unspecified gender. The past medical history and concomitant medications of the patients were not reported. On 22 Jul 2014, the patient was vaccinated with MENVEO (batch number: M13030, expiry date: 30 Sep 2014) at a dose of 0.5 ml intramuscularly which had multiple temperature excursions while in storage. The temperature of the vaccine reached a maximum of 47.5 F for one hour and 17 minutes on 18 Jul 2014, a maximum of 47.5 F for 42 minutes on 21 Jul 2014, a maximum of 47.5 for one hour and three minutes on 24 Jul 2014 and a maximum of 47.5 for one hour and three minutes on 31 Jul 2014. No adverse events were reported following this maladministration (incorrect storage of drug).
Age: 11.0
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US015696 is an initial spontaneous report received from a medical assistant on 01 Aug 2014. This report refers to a 11 year old patient of an unspecified gender. The past medical history and concomitant medications of the patients were not reported. On 29 Jul 2014, the patient was vaccinated with MENVEO (batch number: M13030, expiry date: 30 Sep 2014) at a dose of 0.5 ml intramuscularly which had multiple temperature excursions while in storage. The temperature of the vaccine reached a maximum of 47.5 F for one hour and 17 minutes on 18 Jul 2014, a maximum of 47.5 F for 42 minutes on 21 Jul 2014, a maximum of 47.5 for one hour and three minutes on 24 Jul 2014 and a maximum of 47.5 for one hour and three minutes on 31 Jul 2014. No adverse events were reported following this maladministration.
Age: 16.0
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US015697 is an initial spontaneous report received from a medical assistant on 01 Aug 2014. This report refers to a 16 year old patient of an unspecified gender. The past medical history and concomitant medications of the patients were not reported. On 25 Jul 2014, the patient was vaccinated with MENVEO (batch number: M13030, expiry date: 30 Sep 2014) at a dose of 0.5 ml intramuscularly which had multiple temperature excursions while in storage. The temperature of the vaccine reached a maximum of 47.5 for one hour and 17 minutes on 18 Jul 2014, a maximum of 47.5 for 42 minutes on 21 Jul 2014, a maximum of 47.5 for one hour and three minutes on 24 Jul 2014 and a maximum of 47.5 for one hour and three minutes on 31 Jul 2014. No adverse events were reported following this maladministration (incorrect storage of drug).
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Lymphadenopathy
Clinical narrative: Case number PHEH2014US015001 is an initial spontaneous report from a nurse received on 24 Jul 2014. This report refers to an 18-year-old female patient. The patient was an intolerance to gluten. Concomitant medications were not provided. The patient was vaccinated with MENVEO (batch number: unknown) intramuscularly on an unknown date. On unspecified date, the patient experienced swollen lymph nodes down her back. The issue resolved after about three days. The seriousness was not reported. The patient's mother stated that the patient had a possible reaction to MENVEO. Following an internal review on 31 Jul 2014 of the data received on 24 Jul 2014, it was found that the event of intolerance to gluten was erroneously coded as event instead of concurrent condition. Hence correction was performed.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2014US014996 is an initial spontaneous report received from a Healthcare Professional on 24 Jul 2014. This report refers to a 17 year old female patient. She was vaccinated with an expired dose of MENVEO (batch number: M11075) via intramuscular route at a dose of 0.5 ml on 23 Jun 2014. No adverse event was reported following this administration error (expired vaccine used).
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2014US014769, is an initial spontaneous report received from a nurse on 21 Jul 2014. This report refers to a 12 year old female patient. Nurse reported that the patient inadvertently received only the Men CYW-135 liquid component of MENVEO (batch number: M13014) intramuscular on 17 Jul 2014, without being reconstituted with Men A component. 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 PHEH2014US024149 is an initial spontaneous report received from a medical assistant on 02 Dec 2014. This report refers to a 12 years old female patient. Her medical history and concomitant medications were not reported. She received only the MenCYW-135 liquid component of MENVEO (batch number X14025) intramuscularly on 02 Dec 2014 and was not administered the Men A lyophilized conjugate. No adverse events were reported following the maladministration.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US023373 is an initial spontaneous report received from a medical assistant on 19 Nov 2014 with a follow up information received from a medical assistant on 05 Jan 2015. This report refers to a 19 years old female patient. Her medical history and concomitant were not reported. She was vaccinated with 0.5 ml intramuscular MENVEO (batch number: M14040) on 17 Nov 2014. It was reported that the administered vaccine was stored below recommended temperature for a week. Upon follow up received on 05 Jan 2015, the reporter confirmed that no adverse events were reported following the inadvertent administration. No further information was provided. Follow up information received from a medical assistant on 05 Jan 2015: Reporter's comment updated.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US023367 is an initial spontaneous report received from a medical assistant on 19 Nov 2014, and with a follow up report received on 05 Jan 2015. This report refers to an 11 years old female patient. Her medical history and concomitant were not reported.  She was vaccinated with 0.5 ml intramuscular MENVEO (batch number: M14040) on 18 Nov 2014. It was reported that the administered vaccine was stored below recommended temperature for a week. No adverse events were reported following the medication error. Follow up report received on 05 Jan 2015. No adverse event reported.
Age: 36.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2014US023380 is an initial spontaneous report received from a pharmacist on 19 Nov 2014. This report refers to a 36 year old male patient. Past medical history and concomitant medications was not reported. He received only Men A lyophilized conjugate component of MENVEO (batch number: A14030), intramuscularly reconstituted with a sterile water instead of MenCYW-135 liquid component on 08 Sep 2014. No adverse reaction was reported following this administration error (wrong solution used in drug reconstitution).
Age: 21.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2014US023526 is an initial spontaneous report received from a pharmacist on 10 Nov 2014. This case refers to a 21 year old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with an expired dose of MENVEO (batch number: A12014 and expiry date: Sep 2014), on 08 Nov 2014. No adverse event was reported following this administration error.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2014US023990, is an initial spontaneous report from a health care professional (medical assistant) received on 26 Nov 2014. This report refers to a 16-year-old male patient. Medical history and concomitant medications were not reported. The patient received only Men CWY liquid conjugate component of MENVEO (batch number: X13016) without being reconstituted with Men A lyophilized conjugate component intramuscularly on 26 Nov 2014. No adverse reaction reported following this medication error.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Case number PHEH2014US023487, is an initial spontaneous report received from a nurse on 21 Nov 2014, with a follow up report received from the Quality Assurance Department (QA, reference number: 340911) on 07 Jan 2015. This report refers to patient of unknown demographics. Historical condition was not reported. No concomitant medication was reported. On an unknown date, the patient was vaccinated with MENVEO (batch number: M14069) intramuscularly at a dose of 0.4 ml instead of 0.5 ml. It was reported that after MENVEO reconstitution volume of vaccine in the vial was 0.4 ml. No adverse event was reported following this administration error (vaccine underdose). Non-significant follow up report received from the QA department on 07 Jan 2015: Updated QA reference number only.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2014US020245, is an initial spontaneous report from a medical assistant received on 06 Oct 2014. This report refers to a 16-year-old female patient. Past medical history and concomitant medication were not provided. She was vaccinated with an intramuscular dose of expired MENVEO (batch number: A13017) in error on 02 Oct 2014. No adverse reactions have occurred following this medication error (expired vaccine used).
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: Case number PHEH2014US019978 is an initial spontaneous report received from a medical assistant on 03 Oct 2014. This report refers to an 11 years old male patient. His medical history and concomitant medications were not reported. His vaccination history included administration of first dose of MENVEO (batch number: not reported) on 14 Sep 2006. He was vaccinated with a dose of MENVEO (batch number: not reported) on 18 Mar 2014. It was reported that he was accidentally administered this year a second dose of MENVEO (batch number: M14031) intramuscularly on 30 Sep 2014 without any complaints of patient harm after the inadvertent administration. No further information was provided.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2014US020124 is an initial spontaneous report from the nurse on 06 Oct 2014. This report refers to a 16-year-old female patient. She was inadvertently vaccinated with only Men CYW-135 liquid component of MENVEO (batch number: A14044) intramuscularly without reconstitution with Men A lyophilized component on 25 Aug 2014. No adverse event reported following this medication error.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2014US020529, is an initial spontaneous report from a nurse received on 13 Oct 2014, with a follow up information received from the nurse on 11 Nov 2014 and with another follow up received from the nurse on 30 Dec 2014. This report refers to a 13-year-old male patient. Past medical history and concomitant medications were not reported. His current condition included allergy to amoxicillin. The patient received only Men CWY liquid conjugate component of MENVEO (batch number: X14030) without being reconstituted with Men A lyophilized conjugate component intramuscularly in the right arm on 13 Oct 2014 at 11.18 AM. It was also reported that portion of the vaccine was administered without being reconstituted was given. No adverse reaction reported following this medication error (inappropriate preparation of medication). He was not vaccinated on same day. Follow up information received from the nurse on 11 Nov 2014: Updated patient demographics (weight and height), site of vaccination, and time of vaccination. Updated revaccination details in the narrative. Follow up information received from the nurse on 30 Dec 2014: Updated current condition (allergy to amoxicillin) and reporter comment in narrative only.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2014US020477, is an initial spontaneous report received from a nurse on 09 Oct 2014. This report refers to a patient of unknown age and gender. Past medical history and concomitant medication were not reported. 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 lyophilized conjugate vaccine component on 26 Sep 2014. No adverse event was report following this administration error.
Age: 0.76
Sex: F
Vaccine: HIBV, MNQ
Symptoms: Accidental exposure to product, Diarrhoea, Feeling abnormal, Pyrexia, Rash
Clinical narrative: Case number PHEH2014US020253 is an initial spontaneous report received from a Medical Assistant on 06 Oct 2014 and a follow up report from the medical assistant received on 18 Nov 2014. This report refers to a 09 month old female infant. Her medical history and concomitant medication were not reported. She was vaccinated with MENVEO (batch number: A13059) at a dose of 0.5 ml intramuscularly on 19 Sep 2014 (at 09:10 am). On the same date, she also received HIB vaccine (batch number: UH966AB) at a dose of 0.5 ml intramuscularly. It was reported that the MENVEO vaccination was inadvertent as she was not at high risk for meningococcal disease. On 22 Sep 2014, she developed a rash on her buttocks and groin area, felt fuzzy, had fever and diarrhea. Treatment was rendered with nystatin. The outcome of the events reported as recovered on 06 Oct 2014. The seriousness and causality of the events were not reported. Follow up report from the medical assistant received on 18 Nov 2014: Updated MENVEO dose and vaccination time. Added co-suspect HIB vaccine, events (fever, diarrhea and fuzzy) and recovery date of the events. Changed event onset date from 26 Sept 2014 to 22 Sept 2014.