chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US021584 is an initial spontaneous report received from a nurse on 24 Oct 2012 with a follow up information received on 24 Oct 2012. This report refers to an 11-years-old female patient. She was given only Men CYW lyophilized conjugate component of MENVEO (batch number: M11064, expiry date: Dec 2013) intramuscularly on 24 Oct 2012. No adverse event was reported following this administration error (Inappropriate preparation of medication). Follow up information received on 24 Oct 2012: Expiry date of vaccine administered.
Age: 21.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US021619 is an initial spontaneous report received from a nurse on 26 Oct 2012. This report refers to a 21-years-old female patient. It was reported that on 26 Oct 2012 she only received a 0.5 ml intramuscular dose of MenCYW-135 liquid conjugate component of MENVEO (batch number: 123123, expiry date: Jun 2013) instead of being reconstituted with MenA. No adverse reaction was reported.
Age: 65.0
Sex: M
Vaccine: MNQ
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2012US021674 is an initial spontaneous report received from a pharmacist on 24 Oct 2012. This report refers to a 65-years-old male patient. He was vaccinated with MENVEO (batch number: M11073) intramuscularly on 24 Oct 2012. No adverse reaction was reported.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2012US022172 is an initial spontaneous report received from a physician on 06 Nov 2012: This report refers to multiple patients. They were vaccinated with MENVEO (batch number: unknown) intramuscularly on undetermined dates in Jul 2012 and Aug 2012. The un-reconstituted vaccine had reached 31 to 32 degree Fahrenheit temperature multiple times in Jul 2012 and Aug 2012. The vaccine was not frozen. No adverse event was reported.
Age: 27.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Case number PHEH2012US022183 is an initial spontaneous report received from a nurse on 06 Nov 2012. This report refers to a 27-years-old male patient. He was vaccinated with MENVEO (batch number: not reported) intramuscularly on 05 Nov 2012. It was reported that the patient received a partial dose which was less than 0.5 ml of the vaccine. No adverse event was reported following the maladministration.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US022221 is an initial spontaneous report received from a nurse on 07 Nov 2012. This report refers to a 16-years-old male patient. He was vaccinated with only MenCYW-135 liquid conjugate of MENVEO (batch number: M11032) intramuscularly on 06 Nov 2012 and that he did not receive MenA lyophilized conjugate. No adverse event was reported following the maladministration.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Case number PHEH2012US022267 is an initial spontaneous report received from a nurse on 01 Nov 2012. This report refers to a male child. His vaccination history included administration of Dtap (other manufacturer and batch number: unknown) on an unspecified date after which he experienced redness, swelling an itching. He was vaccinated with MENVEO (batch number: A11047 and expiry date: 30 Mar 2014) on 29 Oct 2012. After vaccination his entire upper arm had swelled and was red and itchy. No further information about outcome, seriousness and causality was available.
Age: 22.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US024794 is an initial spontaneous report received from a pharmacist on 12 Dec 2012: This case refers to a 22-years-old male patient. He was received only Men C, Y, W-135 liquid conjugate component of MENVEO vaccine (batch number: X11073), intramuscularly without being reconstituted with Men A component on 12 Dec 2012. No adverse reaction reported following this administration error (inappropriate preparation of medication).
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2012US016177, is an initial spontaneous report received from a health care professional on 14 Aug 2012. This report refers to an 18-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: A10053), intramuscularly on 13 Aug 2012. The patient received only the Men A lyophilized component (powder) of MENVEO reconstituted with sterile water. The patient did not receive the Men C, Y, W-135 liquid conjugate (solvent). No adverse event was reported.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2012US016177, is an initial spontaneous report received from a health care professional on 14 Aug 2012 with a follow up report received from health care professional on 04 Sep 2012. This report refers to an 18-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: A10053), intramuscularly 13 Aug 2012. The patient received only the Men A lyophilized component (powder) of MENVEO which was reconstituted with sterile water. The patient did not received the Men C, Y, W-135 liquid conjugate (solvent). No adverse event was reported. Follow up information received from a health care professional on 04 Sep 2012. Patient demographics were updated.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2012US024673 is an initial spontaneous report received from a nurse on 10 Dec 2012: This report refers to an adolescent female patient. She was vaccinated with MENVEO (batch number: M12009 and expiry date: Feb 2014) intramuscularly at a dose of 0.5 ml on 04 Dec 2012. This vaccine had experienced multiple temperature excursions below 36 degree Fahrenheit (F). On 15 Nov 2012 the temperature reached 34 F, on 29 Nov 2012 and 26 Nov 2012 it was 32 F to 36 F and on 04 Dec 2012 it was 33 F. The excursions happened for unknown time periods. The reporters did not know if the product was frozen at any time. No adverse event was reported following this administration error (incorrect storage of drug).
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2012US016200 is an initial spontaneous report received from a pharmacist on 15 Aug 2012. This case refers to a patient of unspecified age and gender (patient details not available at the time of this report). The pharmacist stated that they found an extra vial of MenCYW-135 liquid conjugate vaccine component of MENVEO in the box. Therefore they believed that a patient may have received only the MenA lyophilized conjugate vaccine component of MENVEO (batch number: unknown, intramuscularly) reconstituted with a sterile diluent and did not receive the MenCYW-135 liquid conjugate component of MENVEO. No adverse event was reported. No other information was available.
Age: 24.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US016122 is an initial spontaneous report received from a nurse on 10 Aug 2012. This case refers to 24-year-old male patient. He was given only with MenCYW-135 liquid conjugate component of MENVEO (batch number: X11051) intramuscularly on 10 Aug 2012. He did not receive the MenA lyophilized conjugate component of MENVEO. No adverse event was reported following this administration error.
Age: 0.51
Sex: M
Vaccine: MNQ
Symptoms: Unevaluable event
Clinical narrative: Case number PHEH2012US020672, is an initial spontaneous report received from a health care professional on 10 Oct 2012 with a follow-up received on 06 Nov 2012: This report refers to a 6 month old male child. He was vaccinated with MENVEO (batch number: A12012, expiry date: May 2013) at a dose of 0.5 ml intramuscularly in to the left anterior thigh on 09 Oct 2012. No adverse event was reported. Follow-up received from the health care professional on 06 Nov 2012: Updated patient demographics, batch number of MENVEO, dose, route and site of administration.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2012US015607 is an initial spontaneous report received from a nurse on 03 Aug 2012 with a follow-up received on 05 Sep 2012: This report refers to a 12-years-old female. Her current condition included exercise induced asthma. It was reported that she received intramuscularly 0.5 ml MenCWY liquid conjugate component of MENVEO (batch number: M11051) inadvertently reconstituted with another MenCWY vial instead of Men A lyophilized component on 03 Aug 2012. She was concomitantly also vaccinated with a booster dose of TDaP (other manufacturer, batch number: C41181AA) intramuscularly in to the left deltoid on 03 Aug 2012. No adverse reaction was reported following the maladministration. Follow-up received from the nurse on 05 Sep 2012: Updated current condition and concomitant vaccination.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Antibody test, Blood glucose increased, Glycosylated haemoglobin increased, Type 1 diabetes mellitus, Weight gain poor
Clinical narrative: At her 04/01/2016 appointment, they sent us for blood work because patient didn't gain that much weight. We went on 04/22 and on 4/25 they called and asked me to come in because her sugar was high. (270). They checked at office and it was (174). I had to go to an endocrinologist the following day. After taking her A1C, which was 6.7, they admitted us to the Hospital to begin treatment for Type 1 Diabetes.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Arthralgia, Fall, Haemorrhage, Joint swelling, Laceration
Clinical narrative: Patient was given vaccine and left on exam room table.  I then walked out of the room to enter immunizations into patient chart to give updated immunization record.  Patients mother also left the room at this time to go to the waiting room to check on another child that was with her at the time.  When returning to the room 3 - 5 minutes later patient was found on exam room for face down.  She was touched and gently shaken and asked if she was okay and no response.  Nursing help was called for.  Patient was rolled onto her back and mom had returned on this time to.  Patient was rolled to her back and proper up by her mother on the floor. Patient was moaning and started to become more responsive.  PA-C was called in to evaluate patient.  It was noted that patient had blood below bottom lip on right side.  Patient must have bit through lip when she fell since tooth marks on inside of lip.  All teeth intake, none broken.  No bumps or bruises on patients head that were visible.  Patient did c/o left ankle pain as well and ankle appeared a little swollen.  Ambulance was called to transport patient to ER for evaluation.  When they arrived patient was able to stand with assistance of two and bare weight to transfer to gurney.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Moaning, Unresponsive to stimuli
Clinical narrative: Patient was given vaccine and left on exam room table.  I then walked out of the room to enter immunizations into patient chart to give updated immunization record.  Patients mother also left the room at this time to go to the waiting room to check on another child that was with her at the time.  When returning to the room 3 - 5 minutes later patient was found on exam room for face down.  She was touched and gently shaken and asked if she was okay and no response.  Nursing help was called for.  Patient was rolled onto her back and mom had returned on this time to.  Patient was rolled to her back and proper up by her mother on the floor. Patient was moaning and started to become more responsive.  PA-C was called in to evaluate patient.  It was noted that patient had blood below bottom lip on right side.  Patient must have bit through lip when she fell since tooth marks on inside of lip.  All teeth intake, none broken.  No bumps or bruises on patients head that were visible.  Patient did c/o left ankle pain as well and ankle appeared a little swollen.  Ambulance was called to transport patient to ER for evaluation.  When they arrived patient was able to stand with assistance of two and bare weight to transfer to gurney.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Pruritus, Tenderness
Clinical narrative: Arm became red and tender to the touch. On exam the arm was described to have erythema, itching soreness, with a slight red streak in the center of the redness.
Age: 16.0
Sex: F
Vaccine: FLUX, MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2012US018688 is an initial spontaneous report received from a health care professional on 05 Sep 2012 with a follow up information received on 16 Oct 2012: This report refers to a 16-year-old female patient whose medical history included allergy to BACTRIM. Her vaccination history included administration of MENVEO (batch number: not reported) on 14 Aug 2007 which was well tolerated. Her concomitant vaccination included administration of 0.5 ml influenza vaccine (manufacturer unknown, batch number: 44531AA) intramuscularly on 31 Aug 2012. She was vaccinated with MENVEO (batch number: M11082 and expiry date: 31 May 2014) intramuscularly on to left arm on 31 Aug 2012. It was reported that the storage refrigerator of the vaccine was affected by a power outage and that the vaccine had reached up to 11 degree Celsius for 30 to 60 minutes. It was also reported that he vaccine was stable and was okay to administer. No adverse event was reported following this administration error. Follow up information received on 16 Oct 2012: Patient demographics (height and weight), medical and vaccination history, concomitant vaccine information route and site of administration of suspect vaccine were updated.
Sex: U
Vaccine: HPVX, MNQ
Symptoms: Rash
Clinical narrative: Case number PHEH2012US015830 is an initial spontaneous report received from a physician on 06 Aug 2012. This case refers to a patient of unspecified age and gender. The patient was vaccinated with MENVEO (batch number: not reported) intramuscularly on an unspecified date. The patient was also vaccinated with HPV vaccine (other manufacturer, batch number: not reported) on the same day. On an unknown date after vaccination the patient developed rashes. The outcome, causality and seriousness of the vent were not reported. No other information was available at the time of this report.
Age: 10.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US014310 is an initial spontaneous report received from a healthcare professional on 17 Jul 2012 with a follow-up received on 20 Aug 2012: This case refers to a 10-year-old female patient. She was given only Men C,Y, W-135 liquid conjugate component of MENVEO vaccine (batch number: M11047), intramuscularly without being reconstituted with Men A component on 16 Jun 2012. No adverse reaction was reported following this administration error. Reporter stated that the family chose not to have the Men A portion of MENVEO administered to the patient. They decided to wait and get the booster dose of meningococcal vaccine since they were not going out of the country. There was no adverse event and patient is doing good. Follow-up received from the health care professional on 20 Aug 2012: Updated information about booster dose of vaccine.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US016068 is an initial spontaneous report received from a medical assistant on 08 Aug 2012. This case refers to an 18-year-old female patient. She was vaccinated with MenCYW-135 liquid conjugate component of MENVEO (batch number: X10062) intramuscularly on 02 Aug 2012. The patient did not receive the MenA lyophilized conjugate component of MENVEO. No adverse event was reported following vaccination. No other information was available.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US014453 is an initial spontaneous report received from a nurse on 20 Jul 2012. This report refers to an 18-year-old female patient. She was vaccinated only with MenCYW-135 component of MENVEO vaccine (batch number: X11032) intramuscularly on 20 Jul 2012. No adverse event was reported.
Age: 12.0
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US015689 is an initial spontaneous report received from a healthcare professional on 07 Aug 2012. This case refers to a 12-year-old patient of unspecified gender. This patient was vaccinated only with MenCWY-135 liquid component of MENVEO (batch number: M11033) without being reconstituted with Men A component of MENVEO 09 May 2012. Thus this patient received only partial dose of MENVEO. No adverse event was reported. No other information was available.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2012US016213 is an initial spontaneous report received from a nurse on 15 Aug 2012. This case refers to an 18-year-old female patient. This patient was vaccinated intramuscularly with MENVEO (batch number: M10131/M11064/M11054A) that had reached 23 degree Fahrenheit and the vaccine was not frozen. No adverse event was reported following vaccination. No other information was available.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US016244 is an initial spontaneous report received from a pharmacist on 15 Aug 2012. This case refers to a patient of unspecified age and gender. The patient was vaccinated only with MenCYW component of MENVEO vaccine (batch number: X11032) intramuscularly on 15 Aug 2012. No adverse event was reported following this drug administration error.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2012US018695 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 a male child. He was vaccinated with MENVEO (batch number: M11053 and expiry date: 28 Feb 2014) intramuscularly into his left arm on 04 Sep 2012. This 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 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 route and site of vaccination, and the reporter's comment on administered MENVEO vaccine.
Age: 8.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Case number PHEH2012US007047 is an initial spontaneous report received from a consumer who was a nurse on 27 Mar 2012 with the follow-up received on 21 May 2012. This report refers to 84-months-old male patient whose medical history, past drugs, current conditions and concomitant medications was unspecified. He was vaccinated with MENVEO (batch number: M10135B) at dose of 0.5 ml, intramuscularly on to unspecified site on 23 Mar 2012. Within 24-hours after vaccination, on 24 Mar 2012, he experienced soreness, swelling and redness at the injection site. He was administered antibiotics and the swelling and pain have resided. The outcome was reported as condition improving for swelling and pain and for redness reported as completely recovered. No other information was provided. Follow-up received on 21 May 2012: Updated patient age (84-months), date of vaccination (23 Mar 2012), date of onset (24 Mar 2012), (dose (0.5 ml) and outcome (completely recovered for redness).
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2012US015774 is an initial spontaneous report received from a medical assistant on 07 Aug 2012: This report refers to an adolescent female patient, she was given only the Men-A powder component of MENVEO vaccine (batch number: X11042) reconstituted with sterile water intramuscularly on 07 Aug 2012. No other adverse reaction was reported following this administration error.
Age: 10.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Vaccination site swelling
Clinical narrative: Case number PHEH2012US009583 is an initial spontaneous report received from a health care professional on 04 May 2012 with a follow-up received on 05 Jun 2012: This report refers to an 11-years-old male patient whose age, medical history, past drugs, current conditions and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: A10135) intramuscularly on 20 Mar 2012. On the same date, he experienced localized swelling and redness in arms as abnormal reaction at vaccination site (out of normal parameters). The outcome of the event was reported as complete recovery on 21 Mar 2012 and the causality was not provided. Follow-up received from a health care professional on 05 Jun 2012: Updated date of vaccination, event description, event onset date and recovery date.
Age: 12.0
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US015694 is an initial spontaneous report received from a healthcare professional on 07 Aug 2012. This case refers to a 12-year-old patient of unspecified gender. This patient was vaccinated only with MenCWY-135 liquid component of MENVEO (batch number: M11033) without being reconstituted with Men A component of MENVEO on 06 Jul 2012. Thus this patient received only partial dose of MENVEO. No adverse event was reported. No other information was available.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Local reaction, Vaccination site swelling
Clinical narrative: Case number PHEH2012US009589 is an initial spontaneous report received from a health care professional on 04 May 2012 with a follow-up received on 05 Jun 2012: This report refers to a 14-years-old male patient whose age, medical history, past drugs, current conditions and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: A10135) intramuscularly on 20 Mar 2012. On the same date, he experienced localized swelling and redness in arms as abnormal reaction at vaccination site (out of normal parameters). The outcome of the event was reported as complete recovery on 21 Mar 2012 and the causality was not provided. Follow-up received from a health care professional on 05 Jun 2012: Updated event description and recovery date.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2012US015768 is an initial spontaneous report received from a nurse on 06 Aug 2012. This case refers to an 11-year-old female patient. On 06 Aug 2012, she was vaccinated intramuscularly only with MenA lyophilized conjugate component of MENVEO (batch number: A11051) reconstituted with a sterile water; she did not receive the MenCYW-135 liquid conjugate vaccine component of MENVEO. No adverse event has occurred following maladministration error.
Sex: U
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site induration, Local reaction, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Case number PHEH2012US013089 is an initial spontaneous report received from a nurse on 28 Jun 2012. This report refers to a patient whose age, gender, medical history, past drugs, current conditions and concomitant medications were not reported. The patient was vaccinated with 0.5 ml MENVEO (batch number: A11071, expiry date: Dec 2013) intramuscularly on to unspecified site on 25 Jun 2012. On an unknown date, the patient experienced localized reactions at vaccination site which was described as red, hard and hot swelling. The outcome was causality of the event was not reported.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site induration, Local reaction, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Case number PHEH2012US013091 is an initial spontaneous report received from a nurse on 28 Jun 2012. This report refers to a female patient whose age, medical history, past drugs, current conditions and concomitant medications were not reported. She was vaccinated with 0.5 ml MENVEO (batch number: A11071, expiry date: Dec 2013) intramuscularly on to unspecified site on 25 Jun 2012. On an unknown date, she experienced localized reactions at vaccination site which was described as red, hard and hot swelling. The outcome and causality of the event was not reported.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Case number PHEH2012US013092 is an initial spontaneous report received form a nurse on 28 Jun 2012: This case refers to 11-years-old male patient. He was vaccinated with MENVEO (batch number: A11071 and expiry date: Dec 2013), at dose 0.5 ml intramuscularly on 25 Jun 2012. On unspecified date after vaccination, he experienced localized reactions at injection site as red swollen, hard and hot. The outcome and causality of the events was not reported.
Age: 26.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US016112 is an initial spontaneous report received from a pharmacist on 09 Aug 2012. This case refers to 26-year-old male patient. He was given only MenCYW-135 liquid conjugate component of MENVEO (batch number: X11041) intramuscularly on 20 Jul 2012. He did not receive the MenA lyophilized conjugate component of MENVEO. No adverse event was reported following administration error. No other information was available.
Age: 11.0
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US015690 is an initial spontaneous report received from a healthcare professional on 07 Aug 2012. This case refers to an 11-year-old patient of unspecified gender. This patient was vaccinated only with MenCWY-135 liquid component of MENVEO (batch number: M10133) 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.
Age: 26.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US016114 is an initial spontaneous report received from a physician on 10 Aug 2012. This case refers to an adult age group male patient. He was given only MenCYW-135 liquid conjugate component of MENVEO (batch number: X10132) intramuscularly on 10 Aug 2012. He did not receive the MenA lyophilized conjugate component of MENVEO. No adverse event was reported following this administration error. No other information was available.
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US016120 is an initial spontaneous report received from a pharmacist on 10 Aug 2012: This case refers to an unknown age group male patient. He was given only MenCYW-135 liquid conjugate component of MENVEO (batch number: unknown) intramuscularly on unspecified date. No adverse event was reported following this administration error.
Sex: U
Vaccine: MNQ
Symptoms: Peripheral swelling
Clinical narrative: Case number PHEH2012US020831, is an initial spontaneous report received from a physician on 10 Oct 2012. This report refers to patient of unknown age and gender. The patient was vaccinated with MENVEO (batch number: unknown) intramuscular into the left arm, on 06 Oct 2012. On the same day has begun swelling in the arm. Event outcome, seriousness and causality assessment was not reported.
Age: 20.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2012US014411 is an initial spontaneous report received from a nurse on 18 Jul 2012. This report refers to a 20-years-old female patient whose medical history, past drugs, current conditions and concomitant medications were not reported. It was reported that she was vaccinated with expired MENVEO (batch number: M10027, expiry date: not reported) intramuscularly on to unspecified site on 16 Jul 2012. No adverse event was reported.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Myalgia, Nausea, Vomiting
Clinical narrative: Case number PHEH2012US021294 is an initial spontaneous report received from a physician on 21 Oct 2012. This report refers to a 19-years-old female patient. She was vaccinated with MENVEO (batch number: unknown) intramuscularly on 19 Oct 2012. Later on that night she experienced muscle pain in her back and neck as well as nausea and vomiting. The events were still ongoing at the time of reporting. No further information about causality and seriousness was provided.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US014371 is an initial spontaneous report received from a medical assistant on 19 Jul 2012. This report refers to a patient whose age, gender, medical history, past drugs and current conditions were not reported. It was reported that the patient inadvertently received a 0.5 ml intramuscular dose of MenCWY liquid conjugate component of MENVEO (batch number: not reported) without being reconstituted with Men A on an unspecified date. No adverse event was reported following the medication error.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Case number PHEH2012US015848 is an initial spontaneous report received from a medical assistant on 30 Jul 2012: This report refers to multiple patients. They were given only the 135-CYW liquid component of MENVEO vaccine (batch number: A11071) on undetermined dates. It was reported that there were two patients that received a partial dose of MENVEO. No other adverse reaction was reported following this administration error.
Age: 11.0
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US015692 is an initial spontaneous report received from a healthcare professional on 07 Aug 2012. This case refers to an 11-year-old patient of unspecified gender. This patient was vaccinated only with MenCWY-135 liquid component of MENVEO (batch number: M11033) without being reconstituted with Men A component of MENVEO on 05 Jul 2012. Thus this patient received only partial dose of MENVEO. No adverse event was reported. No other information was available.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US014340 is an initial spontaneous report received from a medical assistant on 19 Jul 2012. This report refers to an 11-years-old male patient whose medical history, past drugs, current conditions and concomitant medications were not reported. It was reported that he was vaccinated intramuscularly only with the MenCYW-135 component of MENVEO (batch number: M11033) on 19 Jul 2012 and did not receive the Men A lyophilized component. No adverse event was reported following the medication error.
Age: 11.0
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US015693 is an initial spontaneous report received from a healthcare professional on 07 Aug 2012. This case refers to an 11-year-old patient of unspecified gender. This patient was vaccinated only with MenCWY-135 liquid component of MENVEO (batch number: M11033) without being reconstituted with Men A component of MENVEO on 05 Jul 2012. Thus this patient received only partial dose of MENVEO. No adverse event was reported. No other information was available.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2012US024671 is an initial spontaneous report received from a nurse on 10 Dec 2012: This case refers to an 11-years-old male patient. He was vaccinated with MENVEO (batch number: M12009 and expiry date: Feb 2014), at dose of 0.5 ml intramuscularly on 27 Nov 2012. The MENVEO had experienced multiple temperature excursions. On 15 Nov 2012, the temperature reading of 34 F for unknown time, on 19 Nov 2012 and 26 Nov 2012, the temperature reading of 32 F for unknown time and reporter stated that, at 09:00am the temperature reading was 36 F respectively. Reporter stated that, she does not know if the vaccine was frozen at any time. No adverse reaction reported following this administration error (incorrect storage of drug).
Age: 19.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US016136 is an initial spontaneous report received from a nurse on 13 Aug 2012: This case refers to 19-year-old male patient. He was given only MenCYW-135 liquid conjugate component of MENVEO (batch number: X10130) intramuscularly on 13 Aug 2012. He did not receive the MenA lyophilized conjugate component of MENVEO. No adverse event was reported following this administration error.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2013US003047 is an initial spontaneous report received from a healthcare professional on 01 Feb 2013. This report refers to female patient. It was reported that on 30 Nov 2012, she received only 0.5 ml Men CYW-135 liquid conjugate component of MENVEO (batch number: M11081, expiry date: Apr 2014) intramuscularly instead of being reconstituted with Men A lyophilized conjugate. No adverse reactions were reported following the administration error.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product storage
Clinical narrative: Case number PHEH2012US016141, is an initial spontaneous report received from a nurse on 13 Aug 2012. This report refers to an unknown patient (age and gender). The patient received MENVEO (batch number: unknown) intramuscularly on an unknown date. The vaccine was stored at 32 F on two separate dates of 30 Jul 2012 and 31 Jul 2012. The event outcome, seriousness and causality were not reported.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Case number PHEH2012US016142, is an initial spontaneous report received form a pharmacist on 14 Aug 2012. This report refers to a 12-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with two MENVEO (batch number: X11052, Expiry date: Mar 2014; A11052, Expiry date: Apr 2014), injections at different pharmacies on the same date of 14 Aug 2012. No adverse event was reported.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US020068, is an initial spontaneous report received from a medical assistant on 04 Oct 2012. This report refers to 11 year old female patient. She was vaccinated only with the CWY-135 liquid component of MENVEO (batch number: X10130), intramuscular on 04 Oct 2012. No adverse event was reported following this administration error.
Age: 27.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US022813 is an initial spontaneous report received from a medical assistant on 15 Nov 2012 and a follow up received from a medical assistant on 17 Dec 2012: This report refers to a 27-year-old female patient. She was given only MenCYW lyophilized conjugate component of MENVEO (batch number M11071 and expiry date: Dec 2013) intramuscularly into her left deltoid on 13 Nov 2012 without being reconstituted with the MenA component. No adverse event was reported following this administration error. Follow up information received from a medical assistant on 17 Dec 2012: Updated the site of vaccination.
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2012US016148 is an initial spontaneous report received from a medical assistant on 08 Aug 2012: This report refers to a patient of unknown age group and gender. This patient was only given MenA lyophilized conjugate component of MENVEO (batch number: unknown) constituted with normal saline. The patient did not receive the MenCYW-135 liquid conjugate component of MENVEO. No adverse event was reported following this administration error.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case PHEH2012US016150, is an initial spontaneous report received from a health care professional (pharmacy student) on 13 Aug 2012. This report refers to an 18-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: A11052), intramuscularly on 13 Aug 2012. The patient received only the men A lyophilized component (powder) of MENVEO reconstituted with sterile water. The patient did not receive the men C, Y, W-135 liquid conjugate (solvent). No adverse event was reported.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2012US018687 is an initial spontaneous report received from a health care professional on 05 Sep 2012, and with the follow-up received on 16 Oct 2012: This report refers to an 11-year female child. She was vaccinated with MENVEO (batch number: M11082 and expiry date: 31 May 2014) intramuscularly in the left arm on 31 Aug 2012 at 09:58 am. This 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 and time of vaccination.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2012US020829 is an initial spontaneous report received from a physician on 11 Oct 2012. This case refers to a 17-year-old male patient. He was vaccinated only with the MenCYW-135 liquid conjugate component of MENVEO (batch number: M11050)  intramuscularly on 04 Oct 2012. He did not receive MenA lyophilized conjugate component of MENVEO. No adverse event was reported following this drug administration error. No other information was available.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2012US020881 is an initial spontaneous report received from a medical assistant on 16 Oct 2012. This case refers to multiple patients. These patients were vaccinated with MENVEO (batch number: A11076) intramuscularly on unspecified dates. The reporter stated since 22 Jun 2012, the refrigerator that stores un-reconstituted MENVEO vials has reached temperature down to 0 degree C on 15 different occasions. Duration of excursions was not known. It was also not known if the vaccine froze or not. No adverse event was reported following this drug administration error.
Age: 3.0
Sex: M
Vaccine: MNQ
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2012US016020 is an initial spontaneous report received from a nurse on 13 Aug 2012: This report refers to three-year-old male patient. He was vaccinated with MENVEO (batch number: M11053) intramuscularly on 13 Aug 2012. The nurse reported that MENVEO was administered to patient in error. No adverse event was reported following vaccination. No other information was available.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Vaccination site pain, Vaccination site warmth
Clinical narrative: Case number PHEH2012US016490 is an initial spontaneous report received from a medical assistant on 20 Aug 2012 with a follow up information received on 04 Sep 2012: This report refers to 11-year-old male patient whose current condition included Penicillin allergy. He was vaccinated with MENVEO (batch number: A10135 and expiry date: Feb 2013) along with BOOSTRIX (manufacturer and batch number: unknown) intramuscularly in same arm on 13 Jul 2012. On 14 Jul 2012 he experienced symptoms of swelling which was greater than 10 cm, redness, tenderness and warmth at vaccination site. The final outcome of the events was reported as complete recovery with a stop date of 16 Jul 2012. No further information about the seriousness and causality of the event was reported. Follow up information received on 04 Sep 2012: Patient demographics (height and weight), current condition, batch number, event (tenderness), event stop date and outcome updated.
Sex: U
Vaccine: MNQ
Symptoms: Rash
Clinical narrative: Case number PHEH2012US015771 is an initial spontaneous report received from a physician on 06 Aug 2012. This case refers to a patient of unspecified age and gender. The patient was vaccinated with MENVEO (batch number: not reported) intramuscularly on an unspecified date. On an unknown date after vaccination the patient developed rashes. The outcome, causality and seriousness of the event was not reported. No other information was available at the time of this report.
Age: 20.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site warmth, Vaccination site pain, Vaccination site swelling
Clinical narrative: Case number PHEH2012US016496 is an initial spontaneous report received from a medical assistant on 20 Aug 2012 with a follow up information received on 04 Sep 2012: This case refers to 20-year-old female patient whose medical history, past drugs, current conditions and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: A10135 and expiry date: Feb 2013) intramuscularly on to deltoid muscle of left arm on 13 Aug 2012. On same day she experienced symptoms of swelling, tenderness, redness greater than 5 cm and warmth at vaccination site. The final outcome of the events, swelling, redness and tenderness was reported as complete recovery with a stop date of 15 Aug 2012 and that of warmth was not reported. No further information about the seriousness and causality of the event was reported. Follow up information received on 04 Sep 2012: Patient demographics (height and weight), batch number, vaccination site, event (tenderness), event stop date and outcome of swelling, redness and tenderness were updated.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Headache, Pyrexia
Clinical narrative: Case number PHEH2012US015107 is an initial spontaneous report received from a nurse on 01 Aug 2012. This report refers to a 12-year-old female patient. She was vaccinated with MENVEO (batch number: M11075) intramuscularly into her left deltoid muscle on 24 Jul 2012. On the same day she was also vaccinated with TDaP vaccine(other manufacturer, batch number: unknown). The following day she experienced fever up to 104.3 F in addition to headache. She took ibuprofen and TYLENOL for fever and headache. The symptoms lasted for three days. On 28 Jul 2012 she had recovered completely. No other information was available.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Nausea, Pyrexia, Urticaria
Clinical narrative: Case number PHEH2012US018854 is an initial spontaneous report received from a medical assistant on 18 Sep 2012: This report refers to an adolescent female patient. Her medical history included gluten allergy. She was vaccinated with MENVEO (batch number: A11042) intramuscularly on 13 Sep 2012. After vaccination she experienced fever, nausea and hives. This reaction was similar to the reaction that she experienced after consuming gluten. Outcome was reported as condition unchanged as on 18 Sep 2012. No further information about seriousness and causality was available.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Exposure during breast feeding
Clinical narrative: Case number PHEH2012US014501 is an initial spontaneous report received from a nurse on 18 Jul 2012. This case refers to a 19-year-old breastfeeding female patient. She was vaccinated with MENVEO (batch number: A10065) intramuscularly on 18 Jul 2012. No other information was available at the time of this report.
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US018712, is an initial spontaneous report received from a physician on 05 Sep 2012. This report refers to an adult female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: unknown) on unspecified date. The patient was vaccinated with only CYW-135 liquid conjugate, lyophilized A powder component was not received. No adverse event was reported.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Case number PHEH2012US016069 is an initial spontaneous report received from a nurse on 09 Aug 2012. This report refers to a 12-years-old female patient. She was vaccinated with MENVEO vaccine (batch number: A11042) subcutaneously instead of intramuscularly on 09 Aug 2012. No other adverse reaction was reported following this medication error (wrong route of administration).
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Case number PHEH2012US016501 is an initial spontaneous report received from a medical assistant on 20 Aug 2012, and with a follow up received on 04 Sep 2012: This case refers to an adolescent female patient. She was vaccinated with MENVEO (batch number: A10135 and expiry date: Feb 2013) intramuscularly into the right arm along with BOOSTRIX (batch number: AC52BOB5AA, manufacturer unknown) intramuscularly into the right arm on 17 Aug 2012. The medical assistant reported that within 48 hours after vaccination she experienced symptoms of swelling, 5 cm redness, warmth and tenderness at vaccination site. The final outcome of the events was recovered. No further information about the seriousness and causality of the event was reported. Follow up reported received on 04 Sep 2012: Updated batch number and vaccination site of vaccines. Events added.
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Local swelling, Pain
Clinical narrative: Case number PHEH2012US018198 is an initial spontaneous report received from a nurse on 12 Sep 2012: This report refers to a male patient of unknown age group. He was vaccinated with MENVEO (batch number: unknown) intramuscularly on 25 Jun 2012 and experienced swelling, redness and pain from his shoulder to his elbow after vaccination on the same day. No further information about outcome, causality and seriousness was reported.
Age: 26.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US022819, is an initial spontaneous report received from a medical assistant on 15 Nov 2012. This report refers to 26 year old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: M11071, expiry date: Dec 2013) 0.5 ml, intramuscular on 12 Nov 2012.. The patient received Men CWY-135 liquid conjugate component only and did not receive the Men A lyophilized component. No adverse event was reported.