chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US009399, is an initial spontaneous report received from medical assistant on 05 May 2014. This report refers to 11 year old female child. She was vaccinated with MENVEO (batch number: M12103, expiry date: Sep 2014) 0.5 ml intramuscular on 05 May 2014. It was reported that the unreconstituted MENVEO reached 33.8 degree Fahrenheit for 8 hours and 31 minutes. No adverse event was reported following this mal administration.
Age: 12.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Product preparation error
Clinical narrative: Case number PHEH2014US007525 is an initial spontaneous report received from a nurse on 14 Apr 2014. This report refers to a 12-year-old male patient. His medical history and concomitant medications were not reported. He inadvertently received an intramuscular dose of MenA lyophilized powder component of MENVEO (batch number: M13059) mixed with MENACTRA (batch number: not reported) on 14 Apr 2014 and did not receive the MenCYW-135 liquid conjugate. The reporter stated that they pulled out a MENVEO powder and MENACTRA since it was accidentally placed in the box with the MENVEO liquid components. The reporter stated that she was sure that maladministration occurred.  No revaccination occurred till the time of reporting.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2014US019856 is an initial spontaneous report from the nurse received on 01 Oct 2014 and a follow up report from a health care professional received on 14 Nov 2014. This report refers to a 16-year-old male patient. On 16 Sep 2014, he inadvertently received only Men CYW-135 component of MENVEO (batch number: M14040) intramuscularly without reconstitution with Men A lyophilized component. No adverse event reported following this medication error. Upon follow up, it was confirmed that the patient did not experience any adverse event and was not traveling to any other place in future. Follow up report from a health care professional received on 14 Nov 2014: Updated confirmation from the health care professional that the patient did not receive any adverse event.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US007559 is an initial spontaneous report received from a nurse on 15 Apr 2014: This report refers to an 11-year-old female patient. She was vaccinated with MENVEO (batch number: M13015) intramuscularly on 14 Apr 2014. This vaccine had reached 22 degree Celsius approximately five hours and four minutes and was subsequently administered. No adverse event was reported following this administration error (incorrect storage of drug).
Age: 22.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2014US007648 is an initial spontaneous report received from a nurse on 15 Apr 2014 with a follow-up received on 09 May 2014. This report refers to a 22 year old female patient. Her medical history was not reported. Concomitant medication included GILDESS FE 1/20 for birth control. Past vaccination included meningococcal vaccine (unknown manufacturer) on 18 May 2006. On 15 Apr 2014, at 10:29 am, she was vaccinated only with the MenCYW-135 liquid conjugate vaccine component of MENVEO (batch number: X13067) into left deltoid via intramuscular route and did not receive the Men A lyophilized conjugate. It was reported that the two vials were not reconstituted for administration of vaccine. She returned for correct administration of MENVEO vaccine on 22 Apr 2014. No adverse event was reported following the administration error (inappropriate preparation of medication). Follow-up received from a nurse on 09 May 2014: Patient's demographics, concomitant medication, past vaccination, site and time of vaccination were updated.
Age: 10.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US011971 is an initial spontaneous report from a nurse received on 12 Jun 2014. This report refers to a 10-year-old female patient. Medical history and concomitant medications of the patient were not reported. On 09 Jun 2014, this patient received MENVEO (batch number: M13017) that experienced a temperature excursion up to 14C for 85 minutes. No adverse event was reported. No additional information was available.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2014US007740 is an initial spontaneous report received from a nurse on 16 Apr 2014 with a follow up information received from a nurse on 05 Jun 2014. This report refers to a 17 year old female patient. Her past medical history and concomitant medications were not reported. Her vaccination history included administration of MENVEO (batch number: not reported) on unknown dates which were well tolerated. The patient received only Men A lyophilized conjugate component of MENVEO (batch number: M12094), reconstituted with a sterile diluent instead of MenCYW 135 liquid component intramuscularly at a dose of 1 cc on 16 Apr 2014. No adverse events were reported following this medication error (wrong solution used in drug reconstitution). Follow up information received from a nurse on 05 Jun 2014: Patient demographics (height and weight) and vaccination history updated.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2014US017091, is an initial spontaneous report received from a nurse on 25 Aug 2014. This report refers to an 18-year-old male patient. Past medical history and concomitant medications were not reported. The patient received only Men CWY liquid conjugate component of MENVEO (batch number: X14024) without reconstitution with Men A lyophilized component intramuscularly on 25 Aug 2014. No adverse event was reported following this medication error.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2014US011746 is an initial spontaneous report received from a nurse on 09 Jun 2014. This report refers to a 11 year old female patient. Her past medical history and concomitant medications were not reported. The patient inadvertently received only Men CWY liquid conjugate component of MENVEO (batch number: M13014) without reconstitution with Men A lyophilized component intramuscularly on 29 May 2014. No adverse events were reported following this medication error.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US017806, is an initial spontaneous report from a nurse received on 04 Sep 2014. This report refers to patient of unknown demographics. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with MENVEO (batch number: not reported) intramuscularly on 04 Sep 2014. It was reported that MENVEO was exposed to temperatures down to 34 F overnight. No adverse reaction was reported since the maladministration (incorrect storage of drug).
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2014US011937, is an initial spontaneous report from a pharmacist received on 12 Jun 2014. This report refers to a 17 year old female patient. Historical conditions were not reported. No concomitant medication was reported. The pharmacist reported that the patient had received only the CYW-135 liquid component of MENVEO (batch number: M13046) intramuscular on 11 Jun 2014. No adverse event was reported.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2014US016995, is an initial spontaneous report received from a healthcare professional on 21 Aug 2014. This report refers to an unknown age and gender patient. The reporter stated that, the patient received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: M14044), intramuscularly without being reconstituted with Men A lyophilized conjugate vaccine component and then administered a correct dose of Men A reconstituted with the Men C, Y, W-135 at dose of 0.5 ml on an unknown date (months ago). No adverse event was reported following this administration error.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Case number PHEH2014US012229, is an initial spontaneous report received from a nurse on 16 Jun 2014. This report refers to a 17 year old male patient. Past medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: A13011), subcutaneously on 16 Jun 2014. No adverse event was reported following this administration error.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US017008 is an initial spontaneous report from a nurse received on 21 Aug 2014 and a follow up report from the nurse received on 03 Oct 2014. This report refers to 17 year old male patient. Past medical history and concomitant medication were not provided. It was reported that the past vaccinations were well tolerated by the patient. He was vaccinated with MENVEO (batch number: M14030) at a dose of 0.5 ml intramuscularly on 20 Aug 2014 (at 01:45 pm), which was stored at 48 F for 5 minutes. No adverse event was reported following this administration error. Follow up report from the nurse received on 03 Oct 2014: Added vaccination history, MENVEO vaccination time and dose.
Age: 22.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Case number PHEH2014US012232, is an initial spontaneous report received from a nurse on 16 Jun 2014, with a follow up received from nurse on 21 Jul 2014. This report refers to a 22 year old female patient. She received MENVEO (batch number: A11052), reconstituted with an expired Men A with MenCYW-135 liquid component intramuscularly at dose of 0.5 ml on 16 Jun 2014. She was revaccinated. The reporter explained that, she was not aware of any reports of adverse reactions due to the maladministration. Follow up received from nurse on 21 Jul 2014: updated patient demographics, dose of MENVEO and other clinically relevant information in the narrative.
Age: 0.39
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Case number PHEH2014US017056, is an initial spontaneous report from a medical assistant received on 21 Aug 2014. This report refers to a 4-month-old male patient. Past medical history and concomitant medications were not reported. He was unintentionally administrated with MENVEO (batch number: A12129) intramuscularly on 21 Aug 2014. No adverse reaction was reported following maladministration (wrong vaccine administered).
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2014US012376, is an initial spontaneous report received from a nurse on 16 Jun 2014. This report refers to an 11 years old male patient. Past medical history and concomitant medications were not reported. He received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: M12102), intramuscularly without being reconstituted with Men A lyophilized conjugate vaccine component on 13 Jun 2014. No adverse event was reported following this administration error.
Sex: M
Vaccine: MEN
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Case number PHEH2014US017089, is an initial spontaneous report received from a pharmacist on 22 Aug 2014. This report refers to a male patient over 65 years old. His medical history included spleen removed. The pharmacist reported that he realized that their protocol for meningococcal vaccination of asplenic patients was out of date. And one of the doctors incorrectly gave this patient MENOMUNE (batch number unknown, other manufacturer) intramuscularly instead of MENVEO (batch number: unknown) on an unknown date. No adverse event was reported. No further information was provided.
Age: 21.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2014US012461 is an initial spontaneous report received from a health care professional on 18 Jun 2014 with a follow-up received on 21 Jul 2014. This report refers to a 21 year old female patient. Her past medical history and concomitant medications were not reported. She was vaccinated with 0.5 ml of MENVEO (batch number: X11032) intramuscularly into left deltoid on 16 Jun 2014 at 11:15 am. However, the Men A lyophilized conjugate component of the vaccine was reconstituted with an expired Men CYW 135 liquid component. No adverse events were reported following the administration of expired vaccine. Follow-up received from a health care professional on 21 Jul 2014: Dose, site and time of vaccination updated.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Case number PHEH2014US017186 is an initial spontaneous report received from the nurse on 21 Aug 2014. This report refers to an 18 years old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: not reported) subcutaneously on 21 Aug 2014. No adverse events reported after the maladministration.
Age: 59.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2014US017244 is an initial spontaneous report received from the pharmacist on 26 Aug 2014. This report refers to 59 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: X11046) intramuscularly on 22 Aug 2014. It was reported that she was vaccinated with expired MENVEO vaccine. No adverse events reported after the maladministration.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Cold sweat, Hypertension, Immediate post-injection reaction, Nausea, Tinnitus
Clinical narrative: Case number PHEH2014US017251 is an initial spontaneous report received from the other health care profession on 26 Aug 2014. This report refers to an 18 years old male patient. He did not have any history of allergy to any vaccination, no history of nervous system disorders and severe illness after vaccination. His concomitant medications were not reported. He was vaccinated with MENVEO (batch number: M12102) intramuscularly on 22 Aug 2014. It was reported that immediately after vaccination he experienced ringing in ears, clammy skin, nausea and high blood pressure. The nurses and EMTs at the clinic elevated his feet and laid his head back. The vitals improved within 10 minutes. He was feeling much better and did not have any complaints for 25 minutes after the leg elevation and laying head back techniques. He was advised to rest before he left the clinic. He was on his feet and left the clinic approximately one hour after MENVEO vaccination. The final outcome of the events was reported as unknown. The seriousness and causality of the events were not reported.
Sex: U
Vaccine: MNQ
Symptoms: Local swelling, Pain
Clinical narrative: Case number PHEH2014US017295 is an initial spontaneous report received from a physician on 26 Aug 2014. This report refers to a patient of unknown age and gender. The patient medical history and concomitant medications were not reported. The patient was vaccinated with MENVEO (batch number: A14044) intramuscularly on 25 Aug 2014. It was reported that on 26 Aug 2014, the patient experienced large painful swollen area. The event outcome was reported as condition unchanged. The seriousness and causality were not reported.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Limb discomfort, Paraesthesia
Clinical narrative: Case number PHEH2014US017308 is an initial spontaneous report from a medical assistant received on 26 Aug 2014. This report refers to a 13-year-old male patient. Past medical history and concomitant medications were not reported. He was vaccinated with 0.5 ml of MENVEO (batch number: M14044) intramuscularly on 25 Aug 2014. On 26 Aug 2014, twenty four hours after vaccination, his arm felt heavy and was tingling. Outcome of the events was reported as condition unchanged. Seriousness and causality of the events was not reported.
Age: 19.0
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Case number PHEH2014US012463 is an initial spontaneous report received from a health care professional on 18 Jun 2014. This report refers to a 19 year old male patient. His past medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: not reported) on 18 Apr 2014. He was accidentally vaccinated with MENVEO (batch number: A12131) again on 18 Jun 2014. No adverse events were reported following this medication error.
Age: 14.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2014US012470 is an initial spontaneous report received from a nurse on 18 Jun 2014. This report refers to a 14 year old female patient. Her past medical history and concomitant medications were not reported. The patient received only Men A lyophilized conjugate component of MENVEO (batch number: A14022), reconstituted with sterile diluent instead of Men-CYW 135 liquid component, intramuscularly on 16 Jun 2014. No adverse events were reported following this medication error (wrong solution used in drug reconstitution).
Age: 21.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2014US018094 is an initial spontaneous report from the pharmacist received on 08 Sep 2014. This report refers to a 21-year-old male patient. He was vaccinated with 0.5 ml of MENVEO (batch number: M11077) intramuscularly on 18 Aug 2014. It was reported that the patient accidentally received an expired MENVEO vaccine. No adverse event reported following this medication error (expired vaccine used).
Age: 0.63
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Case number PHEH2014US012535, is an initial spontaneous report received from a physician on 13 Jun 2014. This report refers to a 7 month old male patient. Physician stated that the 7 month old child received MENVEO (batch number: M13030, expiry date: Sep 2014) on 13 Jun 2014, by mistake when he was supposed to receive the pneumococcal vaccine (manufacturer and batch number: unknown). No adverse reaction reported. No further information was provided.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US018218 is an initial spontaneous report from the health care professional (medical assistant) received on 08 Sep 2014. This report refers to a 17-year-old female patient. She was vaccinated with MENVEO (batch number: not reported) at a dose of 0.5 ml intramuscularly on 29 Aug 2014. It was reported that the vaccine received by the patient had been stored at 47 F for 10 minutes before administration to the patient. No adverse event reported following this medication error (incorrect storage of drug).
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2014US01544 is an initial spontaneous report received from a healthcare professional on 11 Jun 2014. This report refers to a 17-year-old female patient. She received only powder component of MENVEO (batch number: M13014, expiry date: Sep 2014) mixed with sterile diluent instead of Men CYW-135 liquid component on 10 Jun 2014. No adverse event was reported following this medication error.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US012552 is an initial spontaneous report received from a medical assistant on 11 Jun 2014. This report refers to a 12 years old female child. She was vaccinated with MENVEO (batch number: A13047 and expiry date: May 2015) on 10 Jun 2014. This vaccine had reached 51 degree Fahrenheit for two hours. The dose was administered to the patient at 4pm and excursion of MENVEO was discovered at 4.45pm on the same day. No adverse event was reported following this administration error.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US018220 is an initial spontaneous report from the health care professional (medical assistant) received on 09 Sep 2014. This report refers to a 11 year old female patient. She was vaccinated with MENVEO (batch number: not reported) at a dose of 0.5 ml intramuscularly on 29 Aug 2014. It was reported that the vaccine received by the patient had been stored at 47 F for 10 minutes before administration to the patient. No adverse event reported following this medication error (incorrect storage of drug).
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2014US012573 is an initial spontaneous report received from a nurse on 11 Jun 2014. This report refers to a 12 years old male child. He was given only MenA component of MENVEO (batch number: M13013 and expiry date: Sep 2014) reconstituted with sterile water instead of MenCYW-135 on 10 Jun 2014. No adverse event was reported following this administration error.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US018221 is an initial spontaneous report from the health care professional (medical assistant) received on 09 Sep 2014. This report refers to a 11 year old male patient. He was vaccinated with MENVEO (batch number: not reported) at a dose of 0.5 ml intramuscularly on 02 Sep 2014. It was reported that the vaccine received by the patient had been stored at 47 F for 10 minutes before administration to the patient. No adverse event reported following this medication error (incorrect storage of drug).
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2014US012576 is an initial spontaneous  report received from a nurse on 11 Jun 2014. This report refers to a 12 years old male child. He was given only MenA component of MENVEO (batch number: M13013 and expiry date: Sep 2014) reconstituted with sterile water instead of MenCYW-135 on 10 Jun 2014. No adverse event was reported following this administration error.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US018223 is an initial spontaneous report from the health care professional (medical assistant) received on 09 Sep 2014. This report refers to a 16 year old male patient. He was vaccinated with MENVEO (batch number: not reported) at a dose of 0.5 ml intramuscularly on 02 Sep 2014. It was reported that the vaccine received by the patient had been stored at 47 F for 10 minutes before administration to the patient. No adverse event reported following this medication error (incorrect storage of drug).
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US018224, is an initial spontaneous report received from a medical assistant on 09 Sep 2014. This report refers to a 16 years old female patient. Her medical history and concomitant medications were not reported. It was reported that MENVEO vaccine was at 47 F for 10 minutes on 29 Aug 2014. On 02 Sep 2014, the patient was vaccinated with 0.5 ml intramuscular MENVEO (batch number: not reported) which underwent temperature excursion. No adverse event was reported following this administration error.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US018225, is an initial spontaneous report received from a medical assistant on 09 Sep 2014. This report refers to a 12 years old male patient. His medical history and concomitant medications were not reported. It was reported that MENVEO vaccine was at 47 F for 10 minutes on 29 Aug 2014. On 04 Sep 2014, the patient was vaccinated with 0.5 ml intramuscular MENVEO (batch number: not reported) which underwent temperature excursion. No adverse event was reported following this administration error.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2014US012577 is an initial spontaneous report received from a nurse on 11 Jun 2014. This report refers to an 18 years old female patient. She was given only Men A component of MENVEO (batch number: M13013 and expiry date: Sep 2014) reconstituted with sterile water instead of MenCYW-135 on 10 Jun 2014. No adverse event was reported following this administration error.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US018226, is an initial spontaneous report received from a medical assistant on 09 Sep 2014. This report refers to a 17 years old female patient. Her medical history and concomitant medications were not reported. It was reported that MENVEO vaccine was at 47 F for 10 minutes on 29 Aug 2014. On 04 Sep 2014, the patient was vaccinated with 0.5 ml intramuscular MENVEO (batch number: not reported) which underwent temperature excursion. No adverse event was reported following this administration error.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US018227, is an initial spontaneous report from the health care professional (medical assistant) received on 08 Sep 2014. This report refers to a 16-year-old female patient. Past medical history and concomitant medication were not provided. She was vaccinated with 0.5 ml of MENVEO (batch number: unknown) intramuscularly on 05 Sep 2014. It was reported that the MENVEO received by the patient had been at 47 Fahrenheit (F) for 10 minutes on 29 Aug 2014. No adverse event reported following this medication error (incorrect storage of drug). No additional information was available.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2014US012647 is an initial spontaneous report received from a physician on 20 Jun 2014: This report refers to a 17-year-old male patient. He was given only MenA component of MENVEO (batch number: M13059) intramuscularly reconstituted with sterile saline instead of MenCYW-135 on 20 Jun 2014. No adverse event was reported following  this administration error.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US014074 is an initial spontaneous report from a health care professional received on 07 Jul 2014. This report refers to an 11-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. He was vaccinated with MENVEO (batch number: A12132) intramuscularly at a dose of 0.5 ml on 02 Jul 2014, that had a temperature excursion to 9 degrees Celsius for 1.5 hours on 01 Jul 2014. No adverse event was reported following the medication error (incorrect storage of drug).
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US018228, is an initial spontaneous report from the health care professional (medical assistant) received on 08 Sep 2014. This report refers to a male patient of an unknown age. Past medical history and concomitant medication were not provided. He was vaccinated with 0.5 ml of MENVEO (batch number: unknown) intramuscularly on 05 Sep 2014. It was reported that the MENVEO received by the patient had been at 47 Fahrenheit (F) for 10 minutes on 29 Aug 2014. No adverse event reported following this medication error.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2014US015571 is an initial spontaneous report received from a nurse on 30 Jul 2014. This report refers to an 11 year old female patient. Past medical history and concomitant medications was not reported. She received only Men A lyophilized conjugate component of MENVEO (batch number: M13051), intramuscularly reconstituted with a sterile diluent instead of MenCYW-135 liquid component on 29 Jul 2014. No adverse reaction reported following this administration error.
Age: 10.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US012818 is an initial spontaneous report received from a nurse on 24 Jun 2014, with a follow up received from nurse on 21 Jul 2014. This report refers to a 10 year old female patient. Past medical history was none and concomitant medications were not reported. Her vaccination status was up to date (UTD). She was vaccinated with MENVEO (batch number: M13047) intramuscularly into the left deltoid at a dose of 0.5 ml on 23 Jun 2014, which was stored at a temperature of 10 Fahrenheit for two hours out of a 24 hour time period for which the vaccine was stored/exposed to below 36 Fahrenheit low temperature. The reporter stated that the vaccine was not frozen. She also received BOOSTRIX (other manufacturer, batch number: 3T549) into the right deltoid at a dose of 0.5 ml on 23 Jun 2014. No adverse events were reported following this medication error (incorrect storage of drug). Follow up received from nurse on 21 Jul 2014: Updated patient demographics, dose and site of vaccination of MENVEO and concomitant vaccine BOOSTRIX.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US018282 is an initial spontaneous report received from a Medical Assistant on 11 Sep 2014. This report refers to a patient of unknown demographics. Past medical history and concomitant medication were not reported. On an unknown date, the patient was intramuscularly vaccinated with MENVEO (batch number: not reported) which was stored between 30 to 35 degree Fahrenheit for about one and a half day. No adverse event was reported following this medication error.
Age: 14.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2014US012837 is an initial spontaneous report received from a nurse on 24 Jun 2014 and with a follow up information received from a nurse on 20 Aug 2014. This report refers to a 14 year old female patient. Her past medical history and concomitant medications were not reported. She received only Men CWY liquid conjugate component of MENVEO (batch number: X14021) without reconstitution with Men A lyophilized component intramuscularly in the left deltoid on 23 Jun 2014 at 17:20 PM. No adverse events were reported following this medication error (inappropriate preparation of medication). Follow up information received from the nurse on 20 Aug 2014: Updated patient demographics (height and weight), site of vaccination and time of vaccination.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2014US018443 is an initial spontaneous report received from a nurse on 11 Sep 2014 with a follow up information received from the nurse on 10 Dec 2014. This case refers to a 16 year old female patient. Her current conditions included vitamin deficiency, anemia and contraception. Her concomitant medications were vitamin D3 at a dose of 200 IU via oral route daily for vitamin deficiency, ferrous sulphate 325 mg via oral route daily for anemia and DEPO PROVERA 150 mg intramuscularly every three months for contraception. Her vaccinations were updated and vaccination history included a dose of MENVEO (batch number: not reported) which was well tolerated. She was vaccinated with a booster dose of MENVEO (batch number: X12097/A12097) at a dose of 0.5 ml intramuscularly on 11 Sep 2014 at 9:55 am, which was reconstituted with an expired lyophilized vial. No adverse event was reported following this administration error. Follow up information received from the nurse on 10 Dec 2014: Patient demographics (height and weight), vaccination history, current conditions and concomitant medications updated.
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2014US012908 is an initial spontaneous report received from a nurse via sales representative on 25 Jun 2014. This report refers to a male patient of unknown age. Past medical history and concomitant medications were not reported. On 24 Jun 2014, he was vaccinated intramuscularly with only MenCYW-135, the liquid component of MENVEO (batch number: M14021) and did not receive Men A lyophilized conjugate (powder form). No adverse event was reported following this administration error (inappropriate preparation of medication).
Age: 20.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US018546, is an initial spontaneous report from a nurse received on 12 Sep 2014. This report refers to a 20-year-old female patient. Past medical history and concomitant medications were not reported. She was administered an intramuscular dose of MENVEO (batch number: M13015) on 12 Sep 2014. It was reported that the vaccine administered was exposed to 1 degree Celsius four times overnight on 12 Sep 2014. No adverse reactions were reported following the medication error.
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2014US012910 is an initial spontaneous report received from the medical assistant on 25 Jun 2014. This report refers to patient of unknown identifiers. The patient's medical history and concomitant medications were not reported. The patient was vaccinated with MENVEO (batch number: M13047) intramuscularly on an unspecified date. It was reported that the patient erroneously received a dose of Men A lyophilized conjugate reconstituted with sterile diluent instead of MENCYW-135 liquid conjugate. No adverse event reported after the maladministration.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2014US012911 is an initial spontaneous report received from the medical assistant on 25 Jun 2014 with a follow up information received from a medical assistant on 29 Jul 2014. This report refers to a 12 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with a dose of MENVEO (batch number: A13058) intramuscularly in the left arm on 25 Jun 2014 at 1:50 pm. It was reported that she received 0.5 ml MenA lyophilized conjugate of MENVEO was reconstituted with sterile water instead of the Men CYW-135 liquid conjugate. No adverse event reported after the maladministration.Follow up information received from a medical assistant on 29 Jul 2014: Patient demographics (height and weight) and site of vaccination updated.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2014US018793, is an initial spontaneous report from a nurse received on 18 Sep 2014. This report refers to a 14-year-old male patient. Past medical history and concomitant medication was not reported. The patient received only Men CWY liquid conjugate component of MENVEO (batch number: X14031) without being reconstituted with Men A lyophilized conjugate component intramuscularly on 18 Sep 2014. No adverse reaction reported following this medication error (inappropriate preparation of medication).
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2014US012925 is an initial spontaneous report received from the pharmacist on 19 Jun 2014. This report refers to a 17 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: X12004, expiry date: Oct 2014) on 18 Jun 2014. It was reported that she received partial dose of MENVEO from the Men CYW-135 vial alone and she did not receive Men A lyophilized conjugate. No adverse event reported after the maladministration.
Age: 14.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2014US014961 is an initial spontaneous report from the nurse received on 24 Jul 2014. This report refers to a 14 year old male patient. On 03 Jul 2014, he was inadvertently vaccinated with Men A lyophilized component of MENVEO (batch number: M13012) which was reconstituted with sterile water instead of Men CYW liquid component. No adverse event reported following this medication error.
Age: 14.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2014US014962 is an initial spontaneous report received from a nurse on 24 Jul 2014. This report refers to a 14 year old male patient. His past medical history and concomitant medications were not reported. The patient inadvertently received the Men A lyophilized conjugate component of MENVEO (batch number: M13012) intramuscularly which was reconstituted with sterile water instead of Men CWY liquid component on 03 Jul 2014. No adverse events were reported following this medication error (wrong solution used in drug reconstitution).
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a clinical medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and drug reactions/allergies were not reported. Since 21-MAR-2016 the patients were vaccinated with doses of improperly stored ROTATEQ (lot # L020865 with expiration date 09-FEB-2017, dose unknown) orally. The temperature/time frame was 8.5 Celsius degree for 2.5 days (60 hours). No adverse effects were reported. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2014US019262, is an initial spontaneous report received from a pharmacist on 24 Sep 2014. This report refers to an unknown age and gender patient. Past medical history and concomitant medication were not reported. The patient received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: M13066), intramuscularly without being reconstituted with Men A lyophilized conjugate component on an unknown date. No adverse event was reported following this administration error.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US018171 is an initial spontaneous report received from a medical assistant on 08 Sep 2014 with a follow up information received from the medical assistant on 09 Sep 2014. This case was initially reported as a multiple patient case. Upon follow up information, identifiers were reported making this a valid single patient case. This report refers to a 16 years old male patient. His medical history and concomitant medications were not reported. It was reported that MENVEO vaccine had been at 47 F for 10 minutes on 29 Aug 2014. On 03 Sep 2014, the patient was vaccinated with 0.5 ml intramuscular MENVEO (batch number: not reported) which underwent temperature excursion. No adverse event was reported following this administration error. Follow up information received from the medical assistant on 09 Sep 2014: Updated report type, patient demographics (age, date of birth, gender, initials) and vaccination date.
Age: 10.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2014US022757, is an initial spontaneous report from a nurse received on 11 Nov 2014 and with a follow-up from a nurse received on 23 Dec 2014. This report refers to a 9 years old male patient. Past medical history and concomitant medications were not provided. On 04 Nov 2014, the patient received an intramuscular dose of expired MENVEO (batch number: M12002, expiry date: 14 Oct 2014) at a dose of 0.5 ml into right arm in error. No adverse event was reported following this administration error. The patient was revaccination on 13 Nov 2014. Follow-up from a nurse received on 23 Dec 2014: Vaccine details (dose, site and expiry date), patient's demographics (weight and height) and revaccination details were updated.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US022424 is an initial spontaneous report received from a nurse on 07 Nov 2014. This report refers to a 12 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with an intramuscular dose of MENVEO (batch number: 14042) on an unknown date. It was reported that the vaccine administered was exposed to temperature in between 22 F for two hours on 06 Nov 2014. No adverse events were reported following the medication error.
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Case number PHEH2014US019555 is an initial spontaneous report from the health care professional received on 25 Sep 2014. This report refers to a patient of unknown age and gender. The patient was inadvertently vaccinated with only Men A lyophilized component of MENVEO (batch number: not reported) which was reconstituted with another diluent instead of Men CYW liquid component. No adverse event reported following this medication error.
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2014US019456 is an initial spontaneous report received from a nurse on 25 Sep 2014. This report refers to a patient of an unspecified age. Past medical history and concomitant medications of the patient were not reported. The patient received the Men A lyophilized powder component of MENVEO (batch number: M14042) intramuscularly which was reconstituted with another unspecified diluent instead of Men CWY liquid conjugate component on an unspecified date. No adverse events had occurred following this medication error (wrong solution used in drug reconstitution).
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2014US019676 is an initial spontaneous report from the health care professional (allergy technician) received on 26 Sep 2014. This report refers to a 11 year old female patient. She was inadvertently vaccinated with MENVEO (batch number: A14024) upon reconstitution with a sterile diluent instead of MENCYW liquid component, intramuscularly on 25 Sep 2014. No adverse event reported following this medication error (wrong solution used in drug reconstitution).
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: Case number PHEH2014US019250, is an initial spontaneous report received from a nurse on 24 Sep 2014. This report refers to an 11 year old male patient. His medical history and concomitant medication was not reported. He received MENVEO (batch number: A14044) subcutaneously in the side of the leg on 19 Sep 2014. Nurse reported that the decision to administer MENVEO in the leg was because the patient was too young and too skinny to get it into the arm. On 20 Sep 2014, the injection site had a "large, red whelp." On 21 Sep 2014, the size of the "large, red whelp" increased to 4 inches. He was given BENADRYL and DEPO-MEDROL at a dose of 40 mg on 21 Sep 2014 which helped lessen the severity of the adverse event. Outcome of the event was unknown. Seriousness and causality assessment was not reported.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2014US014007 is an initial spontaneous report received from a nurse on 11 Jul 2014. This report refers to a 12-year-old male patient. The patient received only Men CWY liquid conjugate component of MENVEO (batch number: X13030) intramuscularly instead of being reconstituted with Men A lyophilized conjugate component on 03 Jul 2014. No adverse events were reported following this medication error (inappropriate preparation of medication).
Age: 15.0
Sex: F
Vaccine: MMR, MNQ, VARCEL
Symptoms: Breath holding, Product preparation error
Clinical narrative: Case number PHEH2014US016200 is an initial spontaneous report received from the pharmacist on 12 Aug 2014. This report refers to a 15 year old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with MENVEO (batch number: A14041) intramuscularly on 11 Aug 2014. It was reported that the Men A lyophilized component of MENVEO was reconstituted with sterile diluent which was used with MMR (other manufacturer, batch number: not reported) and varicella vaccine (other manufacturer, batch number: not reported) instead of the Men CYW-135 liquid component of vaccine. It was reported that she held her breath immediately after vaccination with MENVEO because it was the last of three vaccinations that she received on the same day. The outcome. seriousness and causality of events were not reported. No further information was provided.
Age: 12.0
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US015698 is an initial spontaneous report received from a medical assistant on 01 Aug 2014. This report refers to a 12 year old patient of an unspecified gender. The past medical history and concomitant medications of the patients were not reported. On 25 Jul 2014, the patient was vaccinated with MENVEO (batch number: M13030, expiry date: 30 Sep 2014) at a dose of 0.5 ml intramuscularly which had multiple temperature excursions while in storage. The temperature of the vaccine reached a maximum of 47.5 F for one hour and 17 minutes on 18 Jul 2014, a maximum of 47.5 F for 42 minutes on 21 Jul 2014, a maximum of 47.5 for one hour and three minutes on 24 Jul 2014 and a maximum of 47.5 for one hour and three minutes on 31 Jul 2014. No adverse events were reported following this maladministration (incorrect storage of drug).
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: Case number PHEH2014US015362, is an initial spontaneous report from a nurse received on 29 Jul 2014 and with a follow up information received from the nurse on 05 Sep 2014. This report refers to an 11-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was administered only MenCYW-135 liquid component of MENVEO (batch number: X13058) without being reconstituted with MenA, intramuscularly in the left deltoid on 29 Jul 2014 at 11.01. No adverse event was reported following the administration error (inappropriate preparation of medication). She was also vaccinated with MenA powder component on MENVEO (batch number: M13058) reconstituted with sterile water instead of Men-CYW-135, intramuscularly in the left deltoid on 30 Jul 2014 at 10.30 (See related case number: PHEH2014US015521). Follow up information received from the nurse on 05 Sep 2014: Updated site of vaccination and time of vaccination. Men A vaccination details were updated only in the narrative.