chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Case number PHEH2012US023628, is an initial spontaneous report received from a nurse on 27 Nov 2012 and a follow up report from the nurse received on 17 Dec 2012. This report refers to a male child. He was vaccinated with a 0.5 ml dose of MENVEO (batch number: not reported) intramuscularly into the left deltoid region on 01 Dec 2011. It was reported that he was vaccinated with a second dose of 0.5 ml MENVEO (batch number: A12011) intramuscularly into the right deltoid region on 27 Nov 2012. After vaccine administration, it was realized that the patient had already received vaccine previously. In the follow up, it was confirmed that the patient had no adverse event between the 1st and 2nd dose of the suspect drug. Follow up report from the nurse received on 17 Dec 2012: The patient details, dose and administration route (region) of suspect drug and information related to the patient's condition were updated.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2012US023535 is an initial spontaneous report received from a health care professional on 28 Nov 2012. This report refers to a 15-years-old male patient. On 29 Oct 2012 he was vaccinated intramuscularly with 0.5 ml MENVEO (batch number: A11082, expiry date: May 2014) which had multiple temperature excursions above 46 Fahrenheit (F). The vaccine was stored at 55 F for 1.5 hours, 52 F for 3 hours on 27 Jul 2012 and 08 Sep 2012. It also experienced two temperature excursions: 49 F for 1 hour and 50 F for 2 hours on 09 Sep 2012. No adverse events were reported following this administration error (incorrect storage of drug).
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US013248 is an initial spontaneous report received from a nurse on 02 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 29 Jun 2012. No other adverse reaction was reported following this administration error.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US012688 is an initial spontaneous report received from a medical assistant on 22 Jun 2012: This case refers to 12-years-old male patient. He was received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: X11071), intramuscularly, without being reconstituted with Men A component on 21 Jun 2012. No adverse reaction occurred following this administration error.
Age: 28.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Case number PHEH2012US010165 is an initial spontaneous report received from a healthcare professional on 11 May 2012. This case refers to a 28-year-old male patient. He was vaccinated with expired MENVEO vaccine (batch number and expiration date: Apr 2012) intramuscularly on an unspecified date. No other information was available.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US004482 is a combined initial and follow-up spontaneous report received from a nurse on 14 Feb 2012 and 16 Feb 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: M10129) intramuscularly on an unknown date. No adverse event was reported following this administration error.
Age: 45.0
Sex: F
Vaccine: MNQ
Symptoms: Unevaluable event
Clinical narrative: Case number PHEH2012US010776 is an initial spontaneous report received from pharmacist on 23 May 2012: This case refers to 45 years old female patient. The patient received MENVEO (batch number: 024011) intramuscularly on 22 May 2012. No adverse reactions occurred since administration.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2012US003918 is an initial spontaneous report received from a medical assistant on 15 Feb 2012 with a follow up received on 24 Feb 2012. This case refers to a 16-year-old female patient. She was vaccinated with MENVEO (batch number: A11033/X11033 and expiration date: Jan 2014) at a dose of 0.5ml intramuscularly on 09 Feb 2012. It was reported that the administered MENVEO vaccine before reconstitution was stored in temperature of 32.7F on 01 Feb 2012 and was then at 35.6F at 4:30 pm on the same day. The reporter stated that the vaccine was not frozen. No adverse event was reported following vaccination. Follow up information received from the medical assistant on 24 Feb 2012: Updated patient's age and date of vaccination.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2012US023534 is an initial spontaneous report received from a health care professional on 28 Nov 2012, and with a follow up received on 19 Dec 2012. This report refers to an 18-years-old female patient. On 01 Oct 2012 she was vaccinated intramuscularly with 0.5 ml MENVEO (batch number: A11082, expiry date: May 2014) which had multiple temperature excursions above 46 F. The vaccine was stored at 55 F for 1.5 hours, 52 F for 3 hours on 27 Jul 2012 and 08 Sep 2012. It also experienced two temperature excursions; 49 F for 1 hour and 50 F for 2 hours and 09 Sep 2012. No adverse event was reported. No further information was provided. Non significant follow up received on 19 Dec 2012. No new medical information was provided.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US011964 is an initial spontaneous report received from a health care professional on 11 Jun 2012 and a follow up received from the healthcare professional on 06 Aug 2012. This report refers to a 12-year-old female patient. Her medical history, past drugs, current conditions and concomitant medications were not reported. It was reported that on 06 Jun 2012 she was vaccinated only with 0.5 mL intramuscular dose of MenCWY liquid conjugate component of MENVEO (batch number: X10123) without being reconstituted with Men A lyophilized conjugate into her left deltoid. No adverse event was reported following the maladministration. On 12 Jul 2012, she was vaccinated with full dose of MENVEO (batch number: A10123) which was MenA lyophilized component mixed with MenCYW-135 liquid conjugate component of MENVEO into her right deltoid muscle. She was doing great; no adverse event was reported after vaccination. Follow up information received from the healthcare professional on 06 Aug 2012: Updated patient demographics and the patient was vaccinated with full dose of MENVEO on 12 Jul 2012.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2012US013371 is an initial spontaneous report received from a nurse on 03 Jul 2012: This case refers to 19-years-old female patient. She was vaccinated with expired MENVEO (batch number: 100005) intramuscularly on 28 Jun 2012. No other adverse event was reported following this administration error.
Age: 19.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US010928, is an initial spontaneous report received from a nurse on 25 May 2012 with a follow up information received on 06 Jun 2012. This report refers to 20-year-old male patient. He received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: M11071) intramuscularly, without reconstituting with MenA component on 25 May 2012. No adverse event was reported following this administration error. The patient did not wish to receive Men A portion of the vaccine. No other details were provided. Follow up received on 06 Jun 2012: Age of the patient updated.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US009470 is an initial spontaneous report received from a nurse on 02 May 2012 with the follow-up received from a physician on 21 May 2012. This report refers to 11-years-old male patient whose medical history, past drugs, current conditions and concomitant medications were not specified. It was reported that on 27 Apr 2012 he received only the MenCYW-135 liquid conjugate vaccine component of MENVEO (batch number: A11053) intramuscularly and did not receive the MenA lyophilized conjugate vaccine component. No adverse event was reported following this administration error. The causality was reported as not suspected. Follow-up received from a physician on 21 May 2012: Updated patient demographics (age, height and weight) and causality (not suspected).
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2012US008173, is an initial spontaneous report received from nurse on 09 Apr 2012. This case refers to a 19-year-old female patient. The patient was received only Men A liquid conjugate component of MENVEO vaccine (batch number: M10053) intramuscularly, reconstituted with a sterile diluent instead of MenCYW-135 liquid conjugate vaccine component of MENVEO on 06 Apr 2012. No adverse reaction had occurred following this administration error.
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2012US005575 is an initial spontaneous report received from a nurse on 09 Mar 2012. This report refers to a patient whose age, gender, medical history, past drugs, current conditions and concomitant medications were unspecified. This patient was administered MENVEO MenA lyophilized conjugate component (batch number: M10135B) reconstituted with sterile water intramuscularly on to unspecified site on an unspecified date and did not receive the MenCYW-135 liquid conjugate vaccine component. No adverse reaction was reported following the administration error.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US005886 is an initial spontaneous report received from a nurse on 13 Mar 2012: This report refers to unknown age and gender patient. The patient was received only the Men CYW-135 liquid conjugate component of MENVEO (batch number: M10027) intramuscularly, without reconstituted with Men A lyophilized powder component on an unspecified date in Jan 2012. No adverse reaction was reported following this drug administration error.
Age: 23.0
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Case number PHEH2012US008232 is an initial spontaneous report received from a pharmacist on 11 Apr 2012: This report refers to a 23-year-old male patient. His vaccination history included administration of MENVEO sometime last year. He was re-vaccinated with MENVEO (batch number: A11042) intramuscularly on 11 Apr 2012. No adverse event was reported following this administration error.
Age: 19.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US008937 is an initial spontaneous report received from a nurse on 24 Apr 2012. This report refers to a male patient whose age, medical history, past drugs, current conditions and concomitant medications were unspecified. It was reported that on 24 Apr 2012 he was vaccinated with MenCYW-135 liquid conjugate vaccine component of MENVEO (batch number: X11041) intramuscularly on to unspecified site and did not receive the MenA lyophilized conjugate. No adverse reaction was reported following the maladministration.
Age: 25.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US008936 is an initial spontaneous report received from a consumer on 24 Apr 2012. This report refers to a female patient whose age, medical history, past drugs, current conditions and concomitant medications were unspecified. It was reported that on 24 Apr 2012, she was vaccinated with MenCYW-135 liquid conjugate vaccine component of MENVEO (batch number: X10062) intramuscularly on to unspecified site and did not receive the MenA lyophilized conjugate. No adverse reaction was reported following the maladministration.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US008746 is an initial spontaneous report received from a health care professional on 19 Apr 2012 with a follow up report received on 01 May 2012. This report refers to an 11-years-old female patient whose medical history, past drugs, current conditions and concomitant medications were not specified. It was reported that on 17 Apr 2012 she received only the MenCYW-135 liquid conjugate vaccine component of MENVEO (batch number: X10132) intramuscularly and did not receive the MenA lyophilized conjugate vaccine component. No adverse event was reported. Follow up received on 01 May 2012: Patient demographics updated (age, height and weight).
Age: 22.0
Sex: F
Vaccine: MNQ
Symptoms: Asthenia, Fatigue, Neck pain, Pain in extremity, Pain in jaw
Clinical narrative: Case number PHEH2012US008972 is an initial spontaneous report received from a nurse on 25 Apr 2012 with a follow up information received on 21 May 2012. This report refers to a 22-year-old female patient. Her medical history, concomitant medications and vaccination history were not reported. She was vaccinated with MENVEO vaccine (batch number: A11041, expiry date: 01 Mar 2014) at a dose of 0.5ml intramuscularly on to left deltoid on 24 Apr 2012. Fifteen minutes after vaccination she began to experience pain in her left lateral upper leg that slowly traveled up to her left arm and to left side of neck and jaw. Around this time she also began to experience fatigue and weakness. She was treated with ZYRTEC and BENADRYL along with TYLENOL and ibuprofen for pain. She was asked to return to the clinic if symptoms persisted. The outcome of the event was reported as completed recovery and the causality was assessed as not suspected. No further information was available. Follow up information received on 21 May 2012: Expiry date and treatment drugs updated, Event outcome and causality updated. Weakness was captured as an event.
Sex: F
Vaccine: MNQ
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2012US008739 is an initial spontaneous report received from a nurse on 20 Apr 2012. This report refers to an adult female patient. It was reported that this patient over the age of 55 years but under the age of 65 years was vaccinated with a dose of MENVEO (batch number: not reported) intramuscularly on to unspecified site on an unknown date. No adverse reaction was reported following this maladministration. No further details were provided.
Sex: U
Vaccine: MNQ
Symptoms: Peripheral swelling
Clinical narrative: Case number PHEH2012US009496 is an initial spontaneous report received from a medical assistant on 02 May 2012. This report refers to an unknown age and gender patient. The patient was vaccinated with MENVEO (batch number: unknown) on unspecified date. On unspecified date, the patient experienced swelling in the arm. The outcome and causality of the events was not reported.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2012US008744 is an initial spontaneous report received from a nurse on 17 Apr 2012. This report refers to multiple patients whose details were not provided. It was reported that the patients were vaccinated intramuscularly with MENVEO (batch number: A10016) that was stored below 36 degree F. It was reported that the vaccine was stored at 32 degree F on 16 Mar 2012 and 20 Mar 2012 and 33 degree F on 22 Mar 2012. The reporter stated that the vaccine did not appear to have frozen. No adverse reaction was reported following this medication error. No further details were provided.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US005891, is an initial spontaneous report received from a nurse on 13 Mar 2012: This report refers to unknown age and gender patient. The patient was received only the Men CYW-135 liquid conjugate component of MENVEO (batch number: unknown) intramuscularly, without reconstituted with Men A lyophilized powder component on 12 Mar 2012. No adverse reaction was reported following this drug administration error.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US010783 is an initial spontaneous report received from nurse on 23 May 2012 with a follow-up received on 12 Jun 2012: This case refers to a patient of unknown age and gender. The patient received MENVEO (batch number: A10032) intramuscularly on an unspecified date. The patient received MenCWY liquid conjugate component, without reconstituting with MenA. This was discovered after taking an inventory of refrigerator contents, and discovering one extra MenA lyophilized powder vial. No other adverse events were reported. This patient's parents were notified to revaccinate the patient with correctly reconstituted MENVEO. Follow-up received from the nurse on 12 Jun 2012: Updated comment about revaccination.
Age: 44.0
Sex: F
Vaccine: MNQ
Symptoms: Accidental exposure to product, Exposure via direct contact, Eye irrigation, Eye irritation
Clinical narrative: Case number PHEH2012US009549 is an initial spontaneous report received from a medical assistant on 04 May 2012 with a follow up information received on 16 May 2012: This report refers to a 44-year-old female patient who was a nurse. She accidentally squirted some MENVEO (batch number: M11066) in her eye while administering it to a patient on 04 May 2012. It was reported that any irritation that was present after eye exposure disappeared after irrigation of eye with saline. The outcome of the event was reported as complete recovery. Follow up information received on 16 May 2012: Eye irritation was captured as an event.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US008745 is an initial spontaneous report received from a nurse on 19 Apr 2012. This report refers to four patients whose details were not specified. It was reported that these patients were administered only the MenCYW-135 liquid conjugate vaccine component of MENVEO (batch number: A10124) intramuscularly without being reconstituted with MenA lyophilized conjugate vaccine component on an unspecified date. No adverse reaction was reported following this medication error. No further details were provided.
Age: 21.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2012US009634 is an initial spontaneous report received from a pharmacist on 04 May 2012. This report refers to a male patient whose age, medical history, past drugs, current conditions and concomitant medications were not specified. It was reported that on 04 May 2012, he received only the MenCYW-135 liquid conjugate vaccine component of MENVEO (batch number: A10123) intramuscularly on to unspecified site and did not receive the MenA lyophilized conjugate vaccine component. No adverse event was reported.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site extravasation, No adverse event, Underdose
Clinical narrative: Case number PHEH2012US011418 is an initial spontaneous report received from a nurse on 05 Jun 2012: This case refers to 11-years-old female patient. She was vaccinated with MENVEO (batch number: M11053) at dose of 0.5 ml intramuscularly on 05 Jun 2012. But vaccine came out of the vaccination site during the injection resulting in less than 0.5 ml entering to the patient's deltoid muscle. No adverse event was reported following this administration error.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2012US008927 is an initial spontaneous report received from a consumer on 24 Apr 2012. This report refers to a male patient whose age, medical history, past drugs, current conditions and concomitant medications were unspecified. It was reported that on 18 Apr 2012, he was vaccinated with MenA lyophilized conjugate vaccine component of MENVEO (batch number: A11032) intramuscularly on to unspecified site and did not receive the MenCYW-135 liquid conjugate. No adverse reaction was reported following the maladministration.
Age: 19.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US009094, is an initial spontaneous report received from a medical assistant on 26 Apr 2012: This case refers to an 18-years-old male patient. He was received only Men C, Y, W-135 liquid conjugate component of MENVEO vaccine (batch number: X11053) intramuscularly, without reconstituting with Men A component on 26 Apr 2012. No adverse event was occurred during this administration error.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US009206 is an initial spontaneous report received from a nurse on 27 Apr 2012. This report refers to a male patient whose age, medical history, past drugs, current conditions and concomitant medications were unspecified. It was reported that on 27 Apr 2012, he was vaccinated with MenA lyophilized conjugate vaccine component of MENVEO (batch number: M10126A) intramuscularly on to unspecified site an did not receive the MenCYW-135 liquid conjugate. No adverse reaction was reported following the maladministration.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US005260 is an initial spontaneous report received from a physician on 02 Mar 2012. This report refers to a patient whose age, gender, medical history, past drugs, current conditions and concomitant medications were not provided. This patient was administered MENVEO MenA lyophilized conjugate component (batch number: not reported) diluted with another diluent, without being reconstituted with MenCWY, intramuscularly on to unspecified site on an unspecified date. No adverse reaction was reported after this administration error.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product storage
Clinical narrative: Case number PHEH2012US006788 is an initial incomplete report received from physician on 20 Mar 2012: This case refers to multiple patients (number unknown). The reporter stated that approximately 65 doses of unconstituted MENVEO (batch number: unknown) may had been exposed to 33 F for 30 minutes on 16 Mar 2012 during the afternoon. The reporter stated that 2 out of 3 thermometers indicated that vaccine temperature was in refrigeration range, however 1 thermometer indicated excursion occurred. The reporter did not know whether the vaccine froze. He stated that vaccine doses may had been administered to patients since the excursion, however he was unable to confirm the number of patients that may had been vaccinated. No other additional information was available.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2012US005066, is an initial spontaneous report received from nurse on 27 Feb 2012: This case refers to multiple patients. These patients may have received MENVEO vaccine (batch number: M10031), at dose of 0.5 ml intramuscularly on unspecified date. MENVEO vaccine exposed to temperature between 32 and 34 F over two-month period and vaccine did not freeze. No adverse events were reported.
Age: 14.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2012US023532, is an initial spontaneous report received from a healthcare professional on 28 Nov 2012: This case refers to a 14-year-old female patient. She was vaccinated with MENVEO (batch number: A11082 and expiry date: May 2014), at dose of 0.5 ml intramuscularly on 17 Sep 2012. The MENVEO vaccine was stored at multiple temperature excursions above 46F (on 27 Jul 2012 55 F for 1.5 hours, on 08 Sep 2012, 52 F for 3 hours and on 09 Sept 2012, 49 F for 1 hour and 50 F for 2 hours). No adverse reaction reported following this administration error.
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2012US006070, is an initial spontaneous report received from a medical assistant on 12 Mar 2012: This report refers to an unknown age and gender patient. The patient was received only Men A liquid conjugate component of MENVEO vaccine (batch number: M10135B) intramuscularly, reconstituted with a sterile diluent instead of Men C, Y, W-135 liquid conjugate component on an unspecified date. No adverse reaction had occurred following this administration error.
Sex: U
Vaccine: MNQ
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case number PHEH2012US010027 is an initial spontaneous report received from a pharmacist on 11 May 2012: This case refers to an adult patient of unknown age and gender. This patient was mistakenly received MENVEO (batch number: unknown), two years in a row. No adverse event was reported following this drug administration error.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US009721 is an initial spontaneous report received from a nurse on 07 May 2012. This report refers to a patient whose age, gender, medical history, past drugs, current conditions and concomitant medications were not specified. It was reported that on an unspecified date, the patient was vaccinated with the MenCYW-135 liquid conjugate vaccine component of MENVEO (batch number: not specified) intramuscularly on to unspecified site and did not receive the MenA lyophilized conjugate vaccine component. No adverse event was reported.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2012US004793 is an initial incomplete report received from medical assistant (health care professional) on 28 Feb 2012. This case refers to multiple patients (n = unknown). These patients were vaccinated with MENVEO (batch number: unknown) intramuscularly on an unspecified date. The unreconstituted MENVEO vaccine which was administered reached 31F for 2 days in Dec 2011. The reported stated that he does not believe that vaccine froze. No additional information was reported. No adverse reaction was reported.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Circumstance or information capable of leading to medication error, Incorrect dose administered, No adverse event
Clinical narrative: Case number PHEH2012US004170 is an initial spontaneous report received from nurse on 16 Feb 2012 with a follow up received on 07 Mar 2012. This report refers to 11 years old male patient with a follow up received on 12 Mar 2012. The patient was vaccinated with MENVEO (batch number: 114030AA) intramuscularly on to right deltoid on 15 Feb 2012. The nurse stated that the patient received less than 0.5 ml of MENVEO. During administration, the patient squirmed and only part of the vaccine entered into patient's arm. The patient received a redoes on 06 Mar 2012. In the follow up information it was reported that no adverse events were noted following administration error. Follow up received on 07 Mar 2012: Updated revaccination status of patient. Event recoded to vaccine underdose. Follow up received on 12 Mar 2012: Batch no and site of administration of vaccine updated, patient demographics updated, event recoded to drug administration error as the patient received a redose of MENVEO.
Sex: F
Vaccine: MNQ
Symptoms: Asthenia, Influenza like illness
Clinical narrative: Case number PHEH2012US003969 is an initial spontaneous report received from a pharmacist on 14 Feb 2012, with a follow up received from pharmacist on 29 Feb 2012. This case refers to a female patient (age not reported). She was vaccinated with MENVEO vaccine (batch number: M11042) intramuscularly on 09 Feb 2012. After vaccination she experienced flu-like symptoms which began 2-3 days before the time of this report. She had been feeling weak since the symptoms began. The outcome was not reported at the time of this report. The reporter stated that a direct causal relationship could not be determined since it was at the peak of the flu-season when everyone around seemed to have the flu. However a relationship between the flu-like symptoms and MENVEO could not be denied since the symptoms developed shortly after the patient received the vaccine. No further details are available. Follow up report received on 29 Feb 2012: Updated pharmacist's comment about causality of events.
Age: 22.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2012US010640 is an initial spontaneous report received from a pharmacist on 22 May 2012 with a follow up information received on 31 May 2012 with the follow-up on 11 Jun 2012: This case refers to 23-years-old male patient. It was reported that he received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: M10047 and expiry date: Dec 2012), in the left arm, intramuscularly without reconstituting with Men A component on 28 Apr 2012. He was fine so far. No adverse reaction occurred following this administration error. Follow up received on 31 May 2012: Reporter details and vaccination date updated. Follow-up received on 11 Jun 2012: Updated date of birth, age (23), vaccination date (28 Apr 2012), site (left arm), route (intramuscular).
Age: 35.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2012US011315 is an initial spontaneous report received from a nurse on 01 Jun 2012 and a follow up received from a healthcare professional on 19 Jun 2012: This case refers to a patient of 35-year-old male. He was previously vaccinated with MENVEO which was tolerated well. On 05 Feb 2012 he was vaccinated only with Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: unknown), intramuscularly, without reconstituting with Men A component. It was reported that, later she was received the correct dose of MENVEO. No adverse event was reported following this administration error. Follow up information received from a healthcare professional on 19 Jun 2012: updated patient demographics, vaccination history, and confirmed that no adverse event happened following vaccination.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US010694 is an initial spontaneous report received from a health care professional on 23 May 2012. This report refers to a patient whose age, gender, medical history, past drugs, current conditions and concomitant medications were not reported. It was reported that the patient was vaccinated only with the MenCWY-135 liquid conjugate component of MENVEO (batch number: A1103Z, expiry date: Mar 2014) through unspecified route and site on an unknown date and did not receive the MenA lyophilized conjugate. No adverse event was reported following the maladministration. No other information was provided.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2012US012083 is an initial spontaneous report received from a nurse on 15 Jun 2012. This report refers to a female patient whose age was not reported. Her medical history, past drugs, current conditions and concomitant medications were reported. It was reported that on 15 Jun 2012 she was vaccinated intramuscularly on to unspecified site with expired MENVEO (batch number: 022011, expiry date: Apr 2012). No adverse event was reported following the maladministration.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case number PHEH2012US013458 is an initial spontaneous report received from a nurse on 26 Jun 2012. This report refers to a male patient whose age was not reported. His medical history, past drugs, current conditions and concomitant medications were not specified. His vaccination history included administration of unspecified vaccine in 2007. He was vaccinated with MENACTRA (other manufacturer, batch number: not reported) on an unknown date in Mar 2012. It was reported that without noticing that he had been vaccinated with MENACTRA he was administered 0.5 ml intramuscular dose of MENVEO (batch number: M11073, expiry date: Dec 2013) on 26 Jun 2012. No adverse event was reported.
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2012US013311 is an initial spontaneous report received from a nurse on 03 Jul 2012: This case refers to an unknown age and gender patient. This patient was received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: X10049), intramuscularly without being reconstituted with Men A component, sometime between 31 May 2012 and 11 Jun 2012. No adverse reaction occurred following this administration error.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2012US006673 is an initial spontaneous report received from a nurse on 20 Mar 2012. This case refers to a patient (age and gender not reported). The patient was vaccinated with 0.5ml intramuscular dose of MENVEO (batch number: M100062) intramuscularly on 20 Mar 2012, that had been exposed to temperature up to 53 F for up to 4 hours. Vaccine was not reconstituted during excursion. No adverse event had occurred following vaccination.
Sex: U
Vaccine: MNQ
Symptoms: Erythema, Feeling hot, Peripheral swelling
Clinical narrative: Case number PHEH2012US005259 is an initial spontaneous report received from a consumer on 02 Mar 2012. This report refers to a patient whose age, gender, medical history, past drugs, current conditions and concomitant medications were not reported. This patient received MENVEO (batch number: not specified) though site and route unspecified on an unknown date. On 29 Feb 2012, the patient experienced swollen arm, redness and it was hot. The outcome of the events was not reported.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2012US009829 is an initial spontaneous report received from a medical assistant on 08 May 2012: This report refers to an 11-year-old male patient. He was given only the CYW-15 liquid component of MENVEO (batch number: X10133) intramuscularly on 18 Apr 2012. No adverse event was reported following this administration error.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2012US013840 is an initial spontaneous report received from a medical assistant on 12 Jul 2012: This report refers to an adolescent male patient. He was given only the CYW-135 liquid conjugate component of MENVEO (batch number: X11071) on 11 Jul 2012. No other adverse reaction was reported following this administration error.
Age: 20.0
Sex: F
Vaccine: MNQ, TYP
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US011717 is an initial spontaneous report received from a nurse on 07 Jun 2012 and a follow up received from the nurse on 02 Jul 2012. This report refers to a female patient whose age, medical history, past drugs, current conditions and concomitant medications were not reported. It was reported that she was vaccinated intramuscularly into left deltoid muscle, only with the MenCYW-135 liquid conjugate vaccine component of MENVEO (batch number: X11065) and did not receive the MenA lyophilized conjugate vaccine component on 07 Jun 2012. On the same day concomitantly she was vaccinated with Typhoid vaccine (manufacturer unknown, batch number: G0508-1) intramuscularly into his right deltoid. No adverse event was reported following the maladministration. On 14 Jun 2012, she was vaccinated with the whole dose of MENVEO. No other information was available. Follow up information received from the nurse on 02 Jul 2012: Updated concomitant vaccine given on 07 Jun 2012, and the patient was revaccinated with whole dose of MENVEO on 14 Jun 2012.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2012US003914 is an initial spontaneous report received from a medical assistant on 15 Feb 2012 with a follow up received on 24 Feb 2012. This case refers to a 13-year-old male patient. He was vaccinated with MENVEO (batch number: A11033 and expiration date: Jan 2014) at a dose of 0.5ml intramuscularly on 03 Feb 2012. It was reported that the administered MENVEO vaccine before reconstitution was stored in temperature of 32.7F on 01 Feb 2012 and was then at 35.6F at 4:30 pm on the same day. The reporter stated that the vaccine was not frozen. No adverse event was reported. Follow up information received from the medical assistant on 24 Feb 2012: Updated patient's age.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US006459 is an initial spontaneous report received from a pharmacist on 16 Mar 2012: This report refers to 11-year-old female patient. She was given only the CYW-135 liquid component MENVEO (batch number: unknown) intramuscularly on 16 Mar 2012. No other adverse reaction was reported.
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2012US009413 is an initial spontaneous report received from a health care professional on 01 May 2012. This report refers to a patient whose age, gender, medical history, past drugs, current conditions and concomitant medications were not specified. It was reported that on 30 Apr 2012 the patient received only the MenCYW-135 liquid conjugate vaccine component of MENVEO (batch number: not reported) intramuscularly and did not receive the MenA lyophilized conjugate vaccine component. No adverse event was reported following this medication error.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US009446 is an initial spontaneous report received from a pharmacist on 03 May 2012. This report refers to a 17-years-old female patient. Her medical history, past drugs, current conditions and concomitant medications was unspecified. She received only the MenCWY-135 liquid component of MENVEO (batch number: 090701) intramuscularly on to unspecified site without reconstituting the Men A lyophilized conjugate vaccine component on 07 Jan 2012. No adverse event was reported following this drug administration error.
Age: 54.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2012US009542 is an initial spontaneous report received from a medical assistant on 02 May 2012: This report refers to an adult male patient. He was given only the Men A powder component of MENVEO (batch number: X10129) reconstituted with sterile water instead of Men CYW liquid component on 02 May 2012. No adverse event was reported following this administration error.
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2012US009545 is an initial spontaneous report received from a pharmacist on 03 May 2012: This report refers to a patient of unknown age group and gender. This patient was vaccinated with an expired dose of MENVEO (batch number: unknown and expiry date: 30 Apr 2012) intramuscularly on 02 May 2012. No adverse event was reported following this administration error.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Flushing, Injection site erythema, Injection site oedema, Oedema
Clinical narrative: Case number PHEH2012US006719 is a spontaneous report initially received from a nurse on 21 Mar 2012 with a follow up information received on 06 Apr 2012 and 19 Apr 2012: This case refers to an 18-year-old female patient whose medical history included allergic rhinitis and asthma. She was vaccinated with MENVEO (batch number: 10130) intramuscularly into the left deltoid on 13 Mar 2012. On the same day she experienced edema and redness from shoulder to the elbow. It was described as a flushing redness. Although the site of vaccination was left deltoid she experienced this reaction to the entire arm. She also had edema of both the feet. She was treated with ORAPRED and diphenhydramine. The outcome of the event, flushing redness was reported as ongoing and that of edema was reported as complete recovery. The causality of edema was assessed as suspected to vaccination with MENVEO and that of other events were not reported. No other information was available. Follow up received on 06 Apr 2012: Patient demographics (height and weight) updated, medical history, treatment drugs and events edema and redness added. Follow-up received from the nurse on 19 Apr 2012: Updated event description, site of the vaccination and causality.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US009638 is an initial spontaneous report received from a pharmacist on 04 May 2012. This report refers to a patient whose age, gender, medical history, past drugs, current conditions and concomitant medications were not specified. It was reported that on an unspecified date, a patient was vaccinated only the MenCYW-135 liquid conjugate vaccine component of MENVEO (batch number: M11041) intramuscularly on to unspecified site and did not receive the MenA lyophilized conjugate vaccine component. No adverse event was reported.
Age: 14.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2012US025225, is an initial spontaneous report received from a nurse on 20 Dec 2012. This case refers to a 15-year-old female patient. The medical history and concomitant medication of the patient were not reported. She was vaccinated with MENVEO (batch number: X11041) solution for injection, intramuscularly on 06 Dec 2012. The nurse reported that the patient received only meningococcal CYW-135 on 06 Dec 2012. No adverse event was reported following this mal administration.
Age: 0.69
Sex: M
Vaccine: MNQ
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2012US025217 is an initial spontaneous report received from a nurse on 20 Dec 2012. This case refers to an 8 month old male patient. His medical history and concomitant medications are not reported. The patient was vaccinated with MENVEO (batch number: X11081) on 20 Dec 2012 through intra-muscular route. No side effects are reported. The seriousness, causality and outcome were not reported.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2013US001308, is an initial spontaneous report received from a nurse on 12 Jan 2013. This report refers to an unspecified age and gender patient. The patient medical history and concomitant medication was not reported. The patient received only Men C, Y, W-135 liquid conjugate component of MENVEO vaccine (batch number: not reported), intramuscularly without being reconstituted with Men A component on an unspecified date. No adverse reaction reported following this administration error.
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2013US000864 is an initial spontaneous report received from a nurse on 07 Jan 2013. This report refers to an adult male patient whose age was not reported. It was reported that he was inadvertently vaccinated with an intramuscular dose of Men A lyophilized conjugate component of MENVEO (batch number: M11042) reconstituted with sterile water instead of being reconstituted with MenCYW-135 liquid component on 26 Dec 2012. No adverse reaction was reported following the medication error.
Age: 36.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US025704 is an initial spontaneous report received from a nurse on 31 Dec 2012: This report refers to a 36-year-old female patient. She was given only the CYW-135 liquid component of MENVEO vaccine (batch number: X11032) intramuscularly on 23 Dec 2012, instead of being reconstituted with Men A. No other adverse reaction was reported.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Case number PHEH2012US025324 is an initial spontaneous report received from a nurse on 21 Dec 2012: This report refers to an 11-year-old male child. He was vaccinated with two doses of MENVEO (batch number: M11081) intramuscularly on 11 Dec 2012 and 20 Dec 2012. No adverse event was reported following this administration error (inappropriate schedule of vaccine administered).
Age: 22.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2013US003447 is an initial spontaneous report received from a pharmacist on 05 Feb 2013. This report refers to a female patient whose age was not reported. She was vaccinated with a dose of expired MENVEO (batch number: A10047, expiry date: Dec 2012) intramuscularly on 03 Feb 2013. No adverse reactions were reported following the maladministration.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2013US003319 is an initial spontaneous report received from a nurse on 07 Feb 2013. This report refers to an 11-years-old male patient. It was reported that he received only MenCYW-135 liquid component of MENVEO (batch number: M11077) intramuscularly on 24 Jan 2013 and did not receive MenA lyophilized conjugate. No adverse reactions were reported following the maladministration.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2013US003051 is an initial spontaneous report received from a health care professional on 01 Feb 2013. This report refers to an adult female patient. It was reported that she might have received only 0.5 ml Men CYW-135 liquid component of MENVEO (batch number: M11081, expiry date: Apr 2014) intramuscularly and did not receive MenA lyophilized conjugate on 04 Dec 2012. No adverse reaction was reported. No further information was available.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2013US003022 is an initial spontaneous report received from a health care professional on 01 Feb 2013. This report refers to a 16-years-old female patient. It was reported that on an unknown date she inadvertently received only the MENVEO (batch number: A10132) intramuscularly instead of being reconstituted with Men A lyophilized conjugate. No adverse reactions were reported following the administration error.