chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, Injection site pain, Pyrexia
Clinical narrative: Case number PHEH2013US002744, is an initial spontaneous report received from a pharmacist on 29 Jan 2013 and a follow up received from the pharmacist on 13 Feb 2013. This report refers to 66-year-old male patient. His medical history included of blood pressure and allergy to penicillin. He was inadvertently vaccinated with intramuscular dose of expired MENVEO (batch number: X10047, expiration date: 31 Dec 2012) at a dose of 0.5 ml intramuscularly in his left deltoid on 29 Jan 2013. The same day afternoon he was followed up on phone and found that he was fine. The next day he was follow up and found that he experienced soreness at the injection site of arm and felt feverish that night. He felt better after taking Aspirin. No other adverse reaction was reported. The final outcome was reported as completely recovered on 30 Jan 2013. The reporter considered these events as non-serious. The causality was not reported. Follow up information received from the pharmacist on 13 Feb 2013: Updated medical history, adverse events (soreness at the injection site, feverish), expiration date of MENVEO, treatment medication and outcome.
Age: 40.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2013US002664 is an initial spontaneous report received from a nurse practitioner on 28 Jan 2013, and with a follow up received on 15 Feb 2013. This case refers to a 40-year-old female patient. She was vaccinated only with Men CYW-135 component of MENVEO vaccine (batch number: M11042) at a dose of 0.5 ml intramuscularly into the left deltoid on 14 Jan 2013. No adverse event was reported following this drug administration error. Follow up report received on 15 Feb 2013. Updated patient initials, vaccination details.
Age: 1.03
Sex: F
Vaccine: MNQ
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2013US002371, is a spontaneous report initially received from a nurse on 12 Jan 2013 with a follow-up received on 12 Feb 2013: This report refers to a 1-year-old female patient (infant). Her medical history and concomitant medication were not reported. She was vaccinated with MENVEO (batch number: A11078/X11078) intramuscularly at a dose of 0.05 ml on 22 Jan 2013. No adverse event was reported, following this medication error (inappropriate age at vaccine administration). Follow-up received from the nurse on 12 Feb 2013: Updated patient demographics, batch number and dose for MENVEO and event (vaccine underdose).
Age: 54.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2013US02279 is an initial spontaneous report received from a pharmacist on 22 Jan 2013: This case refers to a 54-years-old female patient. She was received only MEN C, Y, W-135 liquid conjugate component of MENVEO (batch number: X11064), intramuscularly without being reconstituted with Men A component on 22 Jan 2013. No adverse reaction reported following this administration error.
Age: 6.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2013US002018 is an initial spontaneous report received from a nurse on 18 Jan 2013: This case refers to a 06-years-old male patient. He received only Men A lyophilized conjugate component of MENVEO vaccine (batch number: M11052) reconstituted with sterile water intramuscularly on 17 Jan 2013. He did not receive the Men C, Y, W liquid conjugate component of MENVEO. No adverse reaction reported following this maladministration error.
Age: 20.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2013US001917 is an initial spontaneous report from the nurse received on 18 Jan 2013. This report refers to a 20-year-old female patient. It was reported that on 15 Jan 2013, she received only the Men, C, Y, W-135 liquid component of MENVEO (batch number: A10123) intramuscularly without reconstituting it with MenA lyophilized conjugate. No other adverse event was reported following the inadvertent administration. No other information was available.
Age: 26.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Case number PHEH2013US001616, is an initial spontaneous report received from a nurse on 15 Jan 2013, and with a follow up report received on 05 Feb 2013. This report refers to a 26 year old female patient. The patient received MENVEO (batch number: A12024) at a dose of 0.5 ml subcutaneous route on 11 Jan 2013 at 10:30. After vaccination, the patient developed a site reaction, which appeared similar to any site reaction from a vaccine with erythema and slight induration on 11 Jan 2013. As per nurse, the patient had no constitutional symptoms. The outcome of the events was recovered as on 18 Jan 2013. Seriousness and causality of the event were not reported. Follow up report received on 05 Feb 2013. Patient demographics, vaccination details, onset and outcome of the event updated.
Age: 37.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2013US003756 is an initial spontaneous report received from a pharmacist on 08 Feb 2013. This case refers to a 37-year-old male patient. He was vaccinated with an expired MENVEO (batch number: M10053, expiration date: 31 Jan 2013) intramuscularly on 05 Feb 2013. No adverse event was reported following vaccination.
Age: 65.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Case number PHEH2013US003647, is an initial spontaneous report received from a nurse on 08 Feb 2013. This report refers to 65-year-old male patient. He was vaccinated with MENVEO (batch number: unknown) subcutaneously on 06 Feb 2013. No adverse event was reported.
Age: 29.0
Sex: F
Vaccine: MNQ
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Case number PHEH2011US011840 is an initial spontaneous report received from a nurse on 15 Dec 2011: This report refers to a 29-year-old pregnant female patient. She was vaccinated (during pregnancy) with MENVEO vaccine (batch number: M10124) intramuscularly on 15 Dec 2011. No other adverse event was reported. 20 Nov 2012: Multiple attempts have been made to obtain follow-up information and outcome of pregnancy event without success. This case is considered lost to follow-up.
Age: 19.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US019090 is an initial spontaneous report received from a pharmacist on 20 Sep 2012 with a follow-up received on 28 Nov 2012: This case refers to a 20-years-old male patient. He was given only Men A component of MENVEO vaccine (batch number: unknown) reconstituted with sterile diluent, intramuscularly on 19 Sep 2012. No adverse reaction reported following this administration error. He was vaccinated with a correctly re-constituted MENVEO on 24 Sep 2012. Follow-up received from the pharmacist on 28 Nov 2012: Updated patient demographics, date of vaccination and information about re-vaccination.
Age: 19.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2012US019090 is an initial spontaneous report received from a pharmacist on 20 Sep 2012 with a follow-up received on 28 Nov 2012: This case refers to a 20-years-old male patient. He was given only Men A component of MENVEO vaccine (batch number: unknown) reconstituted with sterile diluent, intramuscularly on 19 Sep 2012. No adverse reaction reported following this administration error. He was vaccinated with a correctly re-constituted MENVEO on 24 Sep 2012. Follow-up received from the pharmacist on 28 Nov 2012: Updated patient demographics, date of vaccination and information about re-vaccination.
Sex: U
Vaccine: MNQ, MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US019090 is an initial spontaneous report received from a pharmacist on 20 Sep 2012: This case refers to an unspecified age and gender patient. The patient was received only Men A component of MENVEO (batch number: unknown) reconstituted with sterile diluent, intramuscularly on an unspecified date. No adverse reaction reported following this administration error.
Sex: U
Vaccine: MNQ, MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2012US019090 is an initial spontaneous report received from a pharmacist on 20 Sep 2012: This case refers to an unspecified age and gender patient. The patient was received only Men A component of MENVEO (batch number: unknown) reconstituted with sterile diluent, intramuscularly on an unspecified date. No adverse reaction reported following this administration error.
Age: 18.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Case number PHEH2012US019089 is an initial spontaneous report received from a pharmacist on 20 Sep 2012 with the follow-up received on 19 Nov 2012: This report refers to an 18-years-old adult male patient.  He was vaccinated with MENVEO (batch number: X11032 (liquid) and A11032 (powder)) at dose of 0.5 ml subcutaneously on 19 Sep 2012. No adverse event was reported following this administration error. Follow-up received on 19 Nov 2012: Updated patient age, batch numbers and vaccine dose.
Age: 18.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Case number PHEH2012US019089 is an initial spontaneous report received from a pharmacist on 20 Sep 2012: This report refers to an adult male patient. He was vaccinated with MENVEO (batch number: 11032) subcutaneously on 19 Sep 2012. No adverse event was reported following this administration error.
Age: 27.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2012US022821, is an initial spontaneous report received from a medical assistant on 15 Nov 2012 with the follow-up received from a healthcare professional on 17 Dec 2012. This report refers to 27 year old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: X11071, expiry date: Dec 2013) 0.5 ml, in the left deltoid intramuscular on 07 Nov 2012 at 12:33 PM. The patient received Men CWY-135 liquid conjugate component only and did not receive the Men A lyophilized component. No adverse event was reported. Follow-up received on 17 Dec 2012: Updated batch number, time of vaccination and site of vaccination.
Age: 23.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2012US022820, is an initial spontaneous report received from a medical assistant on 15 Nov 2012 with the follow-up received from other healthcare professional on 17 Dec 2012. This report refers to 23 year old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: X11071, expiry date: Dec 2013) in the left arm at a dose of 0.5 ml, intramuscular on 05 Nov 2012 at 11:56AM. The patient received Men CWY-135 liquid conjugate component only and did not receive the Men A lyophilized component. No adverse event was reported. Follow-up received on 17 Dec 2012: Updated vaccine batch number, site of vaccination and time of vaccination.
Age: 29.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2012US022817, is an initial spontaneous report received from a medical assistant on 15 Nov 2012 and a follow up report from the health care professional received on 17 Dec 2012. This report refers to 29 year old female patient. Her medical history and concomitant medications were not reported. She was vaccinated intramuscularly with MENVEO (batch number: M11071, expiry date: Dec 2013) and received only Men CYW-135 liquid component on 14 Nov 2012 at a dose of 0.5 ml into the left deltoid region. No adverse event was reported following the maladministration. Follow up report from the health care professional received on 17 Dec 2012. The patient details, dose of the suspect drug and region of vaccination were updated.
Age: 28.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2012US023115 is an initial spontaneous report received from a nurse on 15 Nov 2012. This report refers to a 28-years-old female patient. It was reported that she received only the MenCYQ-135 liquid conjugate of MENVEO (batch number: X11082) intramuscularly and did not receive Men A lyophilized conjugate on 07 Nov 2012. No adverse reactions were reported.
Age: 71.0
Sex: U
Vaccine: MNQ
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Case number PHEH2012US023053, is an initial spontaneous report received from a pharmacist on 15 Nov 2012. This report refers to 71 year old patient of unknown gender. The patient was vaccinated with MENVEO (batch number: unknown) on an unspecified date. No further information was reported.
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2012US023031 is an initial spontaneous report received from a nurse on 20 Nov 2012: This report  refers to a patient whose identifiers were not reported. It was reported that the patient received only the MenCYW-135 liquid component of MENVEO vaccine (batch number: not reported) intramuscularly without being reconstituted with MenA lyophilized conjugate on 16 Nov 2012. No other adverse reaction was reported following this administration error.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2012US023530 is an initial spontaneous report received from a healthcare professional on 28 Nov 2012: This case refers to an 18-years-old female patient. She was vaccinated with MENVEO vaccine (batch number: A11082 and expiry date: May 2014), at dose of 0.5 ml intramuscularly on 13 Sep 2012. The MENVEO vaccine was stored at multiple temperatures excursion above 46F (on 27 Jul 2012 55 F for 1.5 hours, on 08 Sep 2012, 52 F for 3-hours and on 09 Sep 2012, 49 F for 1-hour (two separate times during these dates, total 3-separate occurrences on 09 Sep 2012). No adverse reaction reported following this administration error.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2012US023201 is an initial spontaneous report received from a medical assistant on 21 Nov 2012 with the follow-up received on 21 Nov 2012: This case refers to an 11-years-old female patient. She was received only Men C, Y, W-135 liquid conjugate component of MENVEO vaccine (batch number: A11051 and expiry date: 01 Apr 2014), intramuscularly without being reconstituted with Men A component on 19 Nov 2012. No adverse reaction reported following this administration error. Follow-up received on 21 Nov 2012; Updated vaccine expiry date (01 Apr 2014).
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US018215 is an initial spontaneous report received from a nurse on 13 Sep 2012. This report refers to an 11-years-old male patient whose medical history and concomitant medications were not reported. It was reported that he only received the MenCYW-135 liquid conjugate vaccine component of MENVEO (batch number X110077) intramuscularly and did not receive Men A lyophilized conjugate vaccine component on 13 Sep 2012. No adverse reaction was reported.
Age: 40.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered
Clinical narrative: Case number PHEH2012US018053 is an initial spontaneous report received from a pharmacist on 09 Sep 2012. This case refers to a 40-year-old female patient. She was vaccinated only with the MenCYW-135 component of MENVEO vaccine (batch number: not reported) intramuscularly on 09 Sep 2012. No other information was available at the time of this report.
Age: 16.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2012US022478 is an initial spontaneous report received from a nurse on 12 Nov 2012 and a follow up received from a physician on 10 Dec 2012: This case refers to a 17-year-old female patient. Her concurrent condition included of chronic stomachache. She received only Men A component of MENVEO vaccine (batch number: A12013) intramuscularly into left deltoid, reconstituted with sterile water on 31 Oct2012. She did not receive Men C, Y W-135 liquid conjugate component of MENVEO. No adverse reaction was occurred following this administration error. She was revaccinated with MENVEO on 16 Nov 2012. No other information was available. Follow up information received from the physician on 10 Dec 2012: Updated concurrent condition, batch number, site of vaccination, revaccination date.
Age: 16.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2012US022478 is an initial spontaneous report received from a nurse on 12 Nov 2012: This case refers to a 17-years-old female patient. She received only Men A component of MENVEO (batch number: unknown) intramuscularly, reconstituted with sterile water on 31 Oct2012. She did not receive Men C, Y, W-135 liquid conjugate component of MENVEO. No adverse reaction was occurred following this administration error.
Age: 26.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect route of drug administration, Local reaction
Clinical narrative: Case number PHEH2012US016350 is an initial spontaneous report received from a medical assistant on 17 Aug 2012 with a follow-up received on 11 Sep 2012: This report refers to 26-year-old female patient. Her medical history included asthma and pneumonia. Her vaccination history was unknown. She was vaccinated with MENVEO (batch number: A11071) subcutaneously in to left arm on 15 Aug 2012 following which she experienced a localized reaction. The outcome of the event was reported as complete recovery. The seriousness and causality were not reported. No additional information was available. Follow up information received from the medical assistant on 11 Sep 2012: Patient demographics, vaccinated arm, relevant medical history, outcome updated.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2012US019569 is an initial spontaneous report received from a nurse on 30 Sep 2012. This report refers to a 12-years-old female patient whose medical history and concomitant medications were not reported. It was reported that she received only the MenA lyophilized conjugate vaccine component of MENVEO (batch number: 11042) reconstituted with sterile water intramuscularly and did not receive MenCYW-135 liquid conjugate component on 30 Sep 2012. No adverse reaction was reported.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US019118 is an initial spontaneous report received from a nurse on 21 Sep 2012: This report refers to a 16-year-old female patient. She was given only CYW-135 liquid component of MENVEO (batch number: X11052) intramuscularly on 21 Sep 2012. No other adverse reaction was reported following the administration error.
Age: 11.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2012US018882 is an initial spontaneous report received from a physician on 05 Sep 2012. This report refers to a male patient whose medical history, past drugs, current conditions and concomitant medications were not repotted. It was reported that he received a dose of MenA lyophilized conjugate vaccine component of MENVEO (batch number: A10033, expiry date: Sep 2012) reconstituted with MENACTRA on 04 Sep 2012. No adverse reaction was reported.
Sex: U
Vaccine: MNQ
Symptoms: Wrong technique in product usage process
Clinical narrative: Case number PHEH2012US017094 is an initial spontaneous report received from a nurse on 27 Aug 2012. This case refers to a patient of unspecified age and gender. The patient was vaccinated with only MenCYW liquid conjugate component of MENVEO vaccine (batch number: Unknown) on an unspecified date. No other information was available.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US016709 is an initial spontaneous report received from a nurse on 21 Aug 2012 with the follow-up received on 17 Sep 2012: This report refers to an 18-year-old female patient. She was given only the CYW-135 liquid component of MENVEO (batch number: M10047) intramuscularly on 21 Aug 2012. She was revaccinated with full dose of MENVEO (batch number: M11082) at dose of 0.5 ml intramuscularly on 23 Aug 2012. No other adverse reaction was reported following this administration error. Follow-up received on 17 Sep 2012: Updated patient initials, weight and height and revaccinated details (MENVEO).
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2012US016632 is an initial spontaneous report received from a nurse on 22 Aug 2012: This report refers to an 11-year-old male child. He was given only the CYW-135 liquid component of MENVEO (batch number: M10075) intramuscularly on 22 Aug 2012. No other adverse reaction 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 PHEH2012US016528 is an initial spontaneous report received from a pharmacist on 20 Aug 2012, and with a follow up received on 17 Aug 2012. This case refers to an 18-year-old male patient. This patient was vaccinated only with MenCYW component of MENVEO (batch number: X10051) 0.5 ml intramuscularly, in right deltoid on 11 Jul 2012. The liquid component was not mixed with lyophilized A powder component. No adverse event was reported. Follow up report received on 17 Sep 2012. Vaccination site and dose was updated. No adverse event was reported.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US016524 is an initial spontaneous report received from a nurse on 16 Aug 2012 with a follow up information received on 07 Sep 2012: This report refers to a 17-year-old male patient. He was accidentally given only the CYW-135 liquid component of MENVEO (batch number: X10054) intramuscularly on 16 Aug 2012. No other adverse reaction was reported following this administration error. Follow up information received on 07 Sep 2012: Patient demographics captured (age, height and weight) updated.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US017416 is an initial spontaneous report received from a consumer on 30 Aug 2012. This report refers to a 19-years-old female patient whose medical history, past drugs, current conditions and concomitant medications were not reported. It was reported that she was vaccinated only with the MenCYW-135 liquid conjugate vaccine component of MENVEO (batch number: 10047) intramuscularly on to unspecified site and did not receive the Men A lyophilized conjugate on 24 Aug 2012. No adverse event was reported following the maladministration.
Age: 1.1
Sex: M
Vaccine: MNQ
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Case number PHEH2012US017186 is an initial spontaneous report received from a medical assistant on 29 Aug 2012. This case refers to a 1-year-old male infant. The reporter stated that this infant might have been vaccinated with MENVEO (batch number: A10132) intramuscularly on 22 Aug 2012. The reporter also stated that it is also possible the patient might have received Hepatitis vaccination and not MENVEO. This information was documented in patient's chart. No other information was available.
Age: 49.0
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2012US017153, is an initial spontaneous report received from a health care professional on 28 Aug 2012. This report refers to a 49 year old patient (unknown gender). The patient was vaccinated with MENVEO (batch number: M10047), intramuscularly on 27 Aug 2012. The patient had difficulty in withdrawing a full dose of MENVEO from two different vials after reconstitution; therefore they mixed MENVEO from two different vials after reconstitution to administer a 0.5 ml dose to the patient. No adverse event was reported.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product storage
Clinical narrative: Case number PHEH2012US018046 is an initial spontaneous report received from a healthcare professional on 07 Sep 2012. This case refers to multiple patients. These patients were vaccinated with MENVEO (batch number: M11082) intramuscularly on unspecified dates. The reporter stated that this batch of MENVEO reached 34 F for one hour on 23 Aug 2012 before reconstitution and were subsequently administered. It was also reported that MENVEO was not frozen after temperature excursion. No other information was available.
Age: 20.0
Sex: F
Vaccine: MNQ
Symptoms: Exposure during pregnancy, Skin warm
Clinical narrative: Case number PHEH2011US011818 is an initial spontaneous report received from a pharmacist on 14 Dec 2011 with a follow-up received from a physician on 29 Dec 2011: This report refers to a 20-year-old pregnant female patient. She was vaccinated (vaccine given during pregnancy) with MENVEO vaccine (batch number: M10135B) intramuscularly on 14 Dec 2011. She was warm and was transferred to a patient registry. Physician stated that it was all right for the patient to have the MENVEO vaccine but was not the one who administered the vaccine. Reporter did not know where the patient received MENVEO vaccine and the patient did not report any reactions to their office. No additional information was provided. Follow-up received from a physician on 29 Dec 2011: Updated seriousness. 22 Oct 2012: Multiple attempts were made to obtain outcome of events without success. This case is considered lost to follow-up.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US016273 is an initial spontaneous report received from a medical assistant on 15 Aug 2012. This case refers to a child patient (age and gender not reported). This patient received only the MenCYW-135 liquid conjugate component of MENVEO (batch number: A10054) intramuscularly on 04 Aug 2012, and did not receive the MenA lyophilized conjugate component of MENVEO. The reporter stated that few children were vaccinated 04 Aug 2012, and they could not tell which child received only the partial dose. No adverse event was reported following vaccination.
Age: 24.0
Sex: M
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: Case number PHEH2012US015346 is an initial spontaneous report received from a nurse on 31 Jul 2012 and a follow up received on 27 Aug 2012: This report refers to a 24-year-old male patient. His medical history included of gastro esophageal reflux disease and allergy to penicillin. He was given only the MenA powder component of MENVEO vaccine (batch number: A10134) reconstituted with the sterile water instead of MENVEO diluent, intramuscularly on 31 Jul 2012. No other adverse reaction was reported following this administration error. The patient was asked to return on an unspecified date for revaccination. Follow up received from the nurse on 27 Aug 2012: Updated that the diluent used was sterile water (not the sterile diluent from mumps rubella vaccine as previously reported), medical history and allergy history.
Age: 25.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US015201 is an initial spontaneous report received from a pharmacist on 02 Aug 2012, and with a follow up received on 04 Oct 2012: This report refers to 25 year old male patient. He was given only the CYW-135 liquid component of MENVEO vaccine (batch number: X11042) intramuscularly on 31 Jul 2012. No other adverse reaction was reported following this administration error. Follow up report received on 04 Oct 2012. Vaccination date updated.
Age: 25.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US015201 is an initial spontaneous report received from a pharmacist on 02 Aug 2012: This report refers to an adult male patient. He was given only the CYW-135 liquid component of MENVEO vaccine (batch number: X11042) intramuscularly on 01 Aug 2012. No other adverse reaction was reported following this administration error.
Age: 11.0
Sex: F
Vaccine: FLU3, MNQ, TDAP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2012US018699 is an initial spontaneous report received from a health care professional on 05 Sep 2012, and with a follow up received on 16 Oct 2012: This report refers to a 11 year old female child. Her medical history included asthma, gastrooesophageal reflux disease and appendicitis on 20 Mar 2012. She was vaccinated with MENVEO (batch number: M11082 and expiry date: 31 May 2014) into the right arm, intramuscular, on 31 Aug 2012 at 10 am. This vaccine had reached up to 11 degree Celsius for 30 to 60 minutes due to power outage. Vaccine was stable and okay to administer. No adverse event was reported following this administration error (incorrect storage of drug). Follow up received on 16 Oct 2012: Updated patient details, vaccination site, medical history and concomitant medications.
Age: 18.0
Sex: M
Vaccine: FLUN3, MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2012US018691 is an initial spontaneous report received from a health care professional on 05 Sep 2012, and a follow up received on 16 Oct 2012: This report refers to an 18-year-old male patient. He was vaccinated with MENVEO (batch number: M11082 and expiry date: 31 May 2014) intramuscularly into his left arm on 31 Aug 2012. Concomitantly on the same day he also received intranasal FLUMIST (other manufacturer, batch number: A52108). This MENVEO had reached up to 11 degree Celsius for 30 to 60 minutes due to power outage. It was reported that vaccine was stable and was okay to administer. No adverse event was reported following this administration error (incorrect storage of drug). Follow up information received from a healthcare professional on 16 Oct 2012: Updated concomitant vaccine administered and the reporter's comment on administered MENVEO vaccine.
Age: 16.0
Sex: F
Vaccine: FLUX, MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2012US018689 is an initial spontaneous report received from a health care professional on 05 Sep 2012, and with a follow up received on 16 Oct 2012: This report refers to a 16-year-old female patient. Her medical history included allergies to BACTRIM, SUPRAX, penicillin and latex. She was vaccinated with MENVEO (batch number: M11082 and expiry date: 31 May 2014) into the right arm on 31 Aug 2012 at 10 am. This vaccine had reached up to 11 degree Celsius for 30 to 60 minutes due to power outage. Vaccine was stable and okay to administer. Concomitant medication included influenza vaccine (batch number: M531AA) intramuscular, on 31 Aug 2012. No adverse event was reported following this administration error (incorrect storage of drug). Follow up report received on 16 Oct 2012: Updated patient demographics (height and weight), medical history, concomitant medication and vaccination site.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Incorrect product storage
Clinical narrative: Case number PHEH2012US018686 is an initial spontaneous report received from a health care professional on 05 Sep 2012: This report refers to an 11-year-old female child. Her medical history included of asthma. She was vaccinated with MENVEO (batch number: M11082 and expiry date: 31 May 2014) intramuscularly in right arm on 04 Sep 2012. Concomitantly she was also vaccinated with Hepatitis A vaccine (manufacturer: not reported, batch number: AHAVB646AA) and Tdap (other manufacturer, batch number: AC52B085BA) intramuscularly on 04 Sep 2012. It was reported that MENVEO vaccine had reached up to 11 degree Celsius for 30 to 60 minutes due to power outage. It was reported that vaccine was stable and was okay to administer. No adverse event was reported following this administration error (incorrect storage of drug). Follow up information received from the healthcare professional on 16 Oct 2012: Updated site of vaccination of MENVEO, concomitant vaccines administered and medical history.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2012US018685 is an initial spontaneous report received from a health care professional on 05 Sep 2012 with the follow-up received on 16 Oct 2012: This report refers to an 11-year-old female child. She was vaccinated with MENVEO (batch number: M11082 and expiry date: 31 May 2014) intramuscularly in the right arm on 04 Sep 2012 at 15:00 pm. Concomitantly, she was also vaccinated with BOOSTRIX (other manufacturer, batch number: AC52B085BA) intramuscularly on 04 Sep 2012. The MENVEO vaccine had reached up to 11 degree Celsius for 30 to 60 minutes. No adverse event was reported following this administration error (incorrect storage of drug). Follow-up received on 16 Oct 2012: Updated patient height and weight, vaccine route of vaccination, site of vaccination, time of vaccination and concomitant vaccine.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2012US018683 is an initial spontaneous report received from a health care professional on 05 Sep 2012 with the follow-up received on 16 Oct 2012: This report refers to an 11-year-old female child. Her medical history included allergic to Amox and OMNICEF. She was vaccinated with MENVEO (batch number: M11082 and expiry date: 31 May 2014) intramuscularly in the right arm on 31 Aug 2012 at 15:15 pm. Concomitantly, she was also vaccinated with BOOSTRIX (other manufacturer, batch number: AC52B085BA) intramuscularly on 31 Aug 2012. The MENVEO vaccine had reached up to 11 degree Celsius for 30 to 60 minutes. No adverse event was reported following this administration error (incorrect storage of drug). Follow-up received on 16 Oct 2012: Updated patient height and weight, medical history, vaccine route of vaccination, site of vaccination, time of vaccination and concomitant vaccine.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Case number PHEH2012US021289 is an initial spontaneous report received from a nurse on 19 Oct 2012 with a follow up information received on 19 Oct 2012. This report refers to an 11-years-old female patient. She was vaccinated with MENVEO (batch number: M12013, expiry date: Feb 2014) intramuscularly on to right arm on 16 Oct 2012. It was reported that she was presented to the clinic with a raised swollen, sore, reddened area on her right arm around the vaccination site that measures 12 cm by 15 cm on 18 Oct 2012. The physician prescribed her topical hydrocortisone and KEFLEX. The outcome of the event was reported as condition unchanged. No further information was available. Follow up information received on 19 Oct 2012: Expiry date of vaccine updated.
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Case number PHEH2012US017342 is an initial spontaneous report received from a nurse on 28 Aug 2012 with a follow up information received on 28 Aug 2012. This report refers to a male patient of unspecified age. He was vaccinated with MENVEO (batch number: M11082, expiry date: May 2014) 0.5 ml intramuscularly on 20 Aug 2012. On 21 Aug 2012, he experienced tenderness, redness and warmth at the injection site. The patient recovered from the events on 28 Aug 2012. No further information was available. Follow up information received on 28 Aug 2012: Reporter details updated.
Sex: U
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Case number PHEH2012US017120 is an initial spontaneous report received from a nurse on 29 Aug 2012. This report refers to three unidentified patients. They were vaccinated with MENVEO (batch number: A11052, and expiry date: Mar 2014) 0.5 ml intramuscularly on unspecified date between 20 Aug 2012 and 24 Aug 2012. On unspecified date they had injection site reaction. The injection site was raised, hard, sore, red and swollen. The outcome was not reported.
Age: 13.0
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US015691 is an initial spontaneous report received from a healthcare professional on 07 Aug 2012. This case refers to an 13-year-old patient of unspecified gender. This patient was vaccinated only with MenCYW-135 liquid component of MENVEO (batch number M11033) without being reconstituted with Men A component of MENVEO on 29 Jun 2012. Thus this patient received only partial dose of MENVEO. No adverse event was reported. No other information was available.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US014605 is an initial spontaneous report received from a health care professional on 19 Jul 2012: This report refers to a patient of unknown age group and gender. This patient was given only the CYW-135 liquid component of MENVEO vaccine (batch number: unknown) intramuscularly on 19 Jul 2012. No other adverse reaction was reported following this administration error.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US016072 is an initial spontaneous report received from a nurse on 09 Aug 2012. This report refers to an unknown age group and gender. This patient was given only the CYW-135 liquid component of MENVEO vaccine (batch number: unknown) intramuscularly on 09 Aug 2012. No other adverse reaction was reported following this administration error.
Age: 11.0
Sex: M
Vaccine: HEP, HPV9, MMR
Symptoms: Electrocardiogram normal, Presyncope, Syncope
Clinical narrative: Less than 1 minute after receiving vaccines, RECOMBIVAX HB, MMR and GARDASIL 9, pt fainted. Cardiac - Vasovagal.
Age: 21.0
Sex: M
Vaccine: HPV4, TDAP
Symptoms: Blood glucose normal, Hyperhidrosis, Laboratory test, Musculoskeletal stiffness, Nervousness
Clinical narrative: Patient tolerated immunization and blood draw well. As PPD implant occurred, approximately 10 minutes after immunization, patient had a generalized seizure (completely stiff arms and legs, briefly unresponsive) for approximately 30 seconds. Patient was supported by staff. Patient was immediately afterwards able to respond to his name, identify location, time, and date. Initially diaphoretic. Immediate neuro exam was non focal, with good strength. Vitals taken within one minute. BP 110/70, glucose 117, HR initially 48 with return to 62 within 30 seconds of monitoring, O2 99%. Able to hold conversation and discuss events clearly and coherently without confusion. Patient monitored for 20 minutes in clinic, given an apple and water. Patient reported that he felt well enough, though nervous about what had happened, as he had never had a seizure previously. Reported that he was aware of what was happening throughout episode, but saw flashing lights and heard staff's voices in the distance. Discussed ER-however, patient was immediately medically stable. Labs sent for STAT report to lab. Urgent neurology consult requested. Patient to rest today and check back to clinic. Mother is at home to monitor him. Previously worked up for tremors and ? Parkinson's several years ago. Denies history of absence seizures. Denies recent use of any medications or drugs. Neurological.
Age: 21.0
Sex: M
Vaccine: HPV4, TDAP
Symptoms: Neurological examination normal, Photopsia, Seizure, Unresponsive to stimuli
Clinical narrative: Patient tolerated immunization and blood draw well. As PPD implant occurred, approximately 10 minutes after immunization, patient had a generalized seizure (completely stiff arms and legs, briefly unresponsive) for approximately 30 seconds. Patient was supported by staff. Patient was immediately afterwards able to respond to his name, identify location, time, and date. Initially diaphoretic. Immediate neuro exam was non focal, with good strength. Vitals taken within one minute. BP 110/70, glucose 117, HR initially 48 with return to 62 within 30 seconds of monitoring, O2 99%. Able to hold conversation and discuss events clearly and coherently without confusion. Patient monitored for 20 minutes in clinic, given an apple and water. Patient reported that he felt well enough, though nervous about what had happened, as he had never had a seizure previously. Reported that he was aware of what was happening throughout episode, but saw flashing lights and heard staff's voices in the distance. Discussed ER-however, patient was immediately medically stable. Labs sent for STAT report to lab. Urgent neurology consult requested. Patient to rest today and check back to clinic. Mother is at home to monitor him. Previously worked up for tremors and ? Parkinson's several years ago. Denies history of absence seizures. Denies recent use of any medications or drugs. Neurological.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying
Clinical narrative: Parent called now 03/23/2016 7:30 pm stating baby has continuous crying after vaccines were administered. I explained to parent that child might need to go to ER if not feeding properly because of continuous crying. I also explained that continuous crying is a reason to avoid vaccine for DTAP in the future.
Age: 18.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Rash
Clinical narrative: Rash noticed on right side of face on 6/9/16.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US015198 is an initial spontaneous report received from a physician on 29 Jul 2012: This report refers to a patient of unknown age group and gender. This patient given only the CYW-135 liquid component of MENVEO vaccine (batch number: unknown) on unspecified date. No other adverse reaction was reported following this administration error.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2012US015141 is an initial spontaneous report received from a nurse on 30 Jul 2012. This report refers to multiple patients whose identifiers were not reported. It was reported that on an unknown date the patients were intramuscularly vaccinated with MENVEO (batch number: not reported) that reached 31F for less than eight hours in Mat 2011. No adverse events were reported.
Age: 30.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2012US015123 is an initial spontaneous report received from a pharmacist on 31 Jul 2012. This case refers to a 30-year-old female patient. She was vaccinated with MENVEO vaccine (batch number: A10047) intramuscularly on 31 Jul 2012. It was reported that MenA lyophilized conjugate component of MENVEO was reconstituted with sterile water instead of being reconstituted with MenCYW liquid conjugate component of MENVEO. No adverse event was reported following vaccination.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US014996 is an initial spontaneous report received from a nurse on 30 Jul 2012. This case refers to two patients (patient identifiers not reported). These patients were vaccinated with MENVEO (batch number: M10126A) intramuscularly on unspecified dates between Jun 2012 and Jul 2012. It was reported that these patients were administered only MenCYW liquid conjugate component, instead of being reconstituted with MenA component of MENVEO. No adverse event had occurred since vaccination.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2012US014989 is an initial spontaneous report received from a nurse on 27 Jul 2012: This report refers to an 11-year-old female patient. She was given only the CYW-135 liquid component of MENVEO vaccine (batch number: X11046) intramuscularly on 27 Jul 2012. No other adverse reaction was reported following this administration error.
Sex: U
Vaccine: MNQ
Symptoms: Erythema, Induration, Peripheral swelling, Skin warm
Clinical narrative: Case number PHEH2012US014959 is an initial spontaneous report received from a nurse on 26 Jul 2012: This report refers to a patient of unknown gender and age group. This patient was vaccinated with MENVEO (batch number: M11051 and expiry date: Mar 2014) on an undetermined date. After vaccination this patient experienced firm swelling on the arm, the arm was warm, red and swollen. These events were treated with unspecified steroids, TYLENOL along with MOTRIN and ice. No further information about causality and outcome of the events was reported.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Case number PHEH2012US014957 is an initial spontaneous report received from a pharmacist on 26 Jul 2012: This report refers to an 18-year-old female patient. She was vaccinated with MENVEO (batch number: A10051) subcutaneously on 25 Jul 2012. No adverse event was reported following this medication error.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2012US014893 is an initial spontaneous report received from a medical assistant on 24 Jul 2012. This report refers to a 12-years-old male patient whose medical history, past drugs, current conditions and concomitant medications were not reported. It was reported that he received only the MenCYW-135 liquid component of MENVEO (batch number: X10065) through unspecified route and site on 23 Jul 2012 and did not receive the Men A lyophilized component. No adverse event was reported.
Sex: M
Vaccine: MNQ
Symptoms: Incorrect route of drug administration
Clinical narrative: Case number PHEH2012US014308 is an initial spontaneous report received from a pharmacist on 16 Jul 2012: This report refers to a male patient of unknown age group. He was vaccinated with MENVEO (batch number: A10047) subcutaneously on 15 Jul 2012. No other adverse reaction was reported following this administration error.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2012US014290 is an initial spontaneous report received from a nurse on 16 Jul 2012: This report refers to a 19-year-old male patient. He was given only the CYW-135 liquid component of MENVEO vaccine (batch number: M11073) without being constituted with MenA, intramuscularly on 14 Jul 2012. No other adverse reaction was reported following this administration error.