chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number: PHEH2013US017345 is an initial spontaneous report received from a nurse on 13 AUG 2013, with a follow-up received on 27 SEP 2013. This report refers to a 13-year-old male patient. His medical history was not reported and his concomitant medication included BOOSTRIX (batch number: YJ475) received on 13 AUG 2013. He received only MenCYW-135 liquid component of MENVEO (batch number: M12092) intramuscularly at a dose of 0.5 ml on 13 AUG 2013 (at 11:15AM) without being reconstituted with Men A. No adverse event was reported following medication error (inappropriate preparation of medication).  Follow-up was received on 27 SEP 2013. Concomitant medication, vaccination dose and vaccination site were updated.
Age: 57.0
Sex: M
Vaccine: MNQ
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2013US017332, is an initial spontaneous report received from nurse on 12 AUG 2013. This report refers to a 57 year old male patient. His medical history and concomitant medication was not reported. Nurse reported that 57 year old male was inadvertently administered MENVEO (batch number: M12092) intramuscular on 12 AUG 2013. No adverse event was reported. No further information was provided.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US017323 is initial report received from a health care professional on 13 AUG 2013. This report refers to an 18-year-old male patient. He was given only the Men A component of MENVEO (batch number: M12123) intramuscularly on 09 AUG 2013. MenA was reconstituted with diluent instead of MenCYW-135. No adverse event was reported following the administration error (wrong solution used in drug reconstitution). Doctor planned to re-vaccinate the patient with properly reconstituted MENVEO.
Age: 24.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US017317, is a combined initial and follow up spontaneous report received from nurse on 12 AUG 2013 and on 14 AUG 2013, with a follow-up received on 17 SEP 2013. This report refers to 24 year old male patient. His medical history an concomitant medication were not reported. Nurse reported that the patient received only Men CWY135 liquid conjugate of MENVEO (batch number: M12092/X12092) intramuscularly at a dose of 0.5 ml into left deltoid without being reconstituted with Men A lyophilized conjugate on 12 AUG 2013. No adverse event was reported. No further information was provided. Follow-up was received on 17 SEP 2013. Patient demographics, vaccination site and vaccination dose were updated.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US017313, is an initial spontaneous report received from a medical assistant on 13 AUG 2013. This report refers to a 15 year old male patient. His medical history and concomitant medications was not reported. Medical assistant reported that the patient received Men A component of MENVEO (batch number: M12092) intramuscular that was reconstituted with Merck diluent reported as sterile water on 13 AUG 2013. No adverse event was reported. No further information was provided.
Sex: U
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHEH2013US017248 is an initial spontaneous report received from a health care professional on 12 AUG 2013. This report refers to a patient of unknown age and gender. This patient medical history and concomitant medications were not reported. This patient was vaccinated with MENVEO (batch number: M12129) on an unspecified date. On 25 JUL 2013, after vaccination, this patient experienced scratchy throat. Outcome was reported as complete recovery on 28 JUN 2013. No further information was provided.  Following an internal review of the data received on 12 AUG 2013. It was observed that the event  "scratchy throat" was erroneously captured as sore throat; therefore it was correctly coded to throat irritation in the case.
Sex: U
Vaccine: MNQ
Symptoms: Throat irritation
Clinical narrative: Case number PHEH2013US017248 is an initial spontaneous report received from a health care professional on 12 AUG 2013. This report refers to a patient of unknown age and gender. This patient medical history and concomitant medications were not reported. This patient was vaccinated with MENVEO (batch number: M12129) on an unspecified date. On 25 JUL 2013, after vaccination, this patient experienced scratchy throat. Outcome was reported as complete recovery on 28 JUN 2013. No further information was provided.  Following an internal review of the data received on 12 AUG 2013. It was observed that the event  "scratchy throat" was erroneously captured as sore throat; therefore it was correctly coded to throat irritation in the case.
Age: 30.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US017178 is an initial spontaneous report received from a pharmacist on 12 AUG 2013. This report refers to an adult female patient. She was given only the CYW135 liquid component of MENVEO (batch number: M12026) intramuscularly without being reconstituted with MenA component on 10 AUG 2013. No adverse event was reported following this administration error.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US018640, is an initial spontaneous report received from a medical assistant on 03 Sep 2013, with a follow up report from nurse received on 17 Oct 2013. This case refers to a 18-year-old female patient. She received only Men A lyophilized conjugate component of MENVEO, (batch number: not reported) reconstituted with sterile diluent intramuscularly on 27 Aug 2013. She did not received Men C, Y, W-135 liquid conjugate component of MENVEO vaccine. Patient had no adverse reaction however it was noted that she would not receive complete immunity to all her strains of the meningitis. It was recommended to re-boost in six months to provide the coverage. The nurse stated that the patient would re-boost in Feb 2014. Follow up report from nurse received on 17 Oct 2013: Updated information on re-boost of vaccine.
Age: 10.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2013US018597, is an initial spontaneous report received from a medical assistant on 29 AUG 2013 with the follow up received on 28 AUG 2013. This case refers to a 10 years old male patient. He was vaccinated with expired MENVEO, batch number: A10133 and expiry date: FEB 2013, intramuscularly on 28 MAR 2013. No adverse reaction was reported following this administration error.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US18580, is an initial spontaneous report received from a medical assistant on 30 AUG 2013, with a follow-up received on 30 AUG 2013. This case refers to an 11 years old female patient. She received only Men A lyophilized conjugate component of MENVEO (batch number M12124, expiry date: AUG 2014), reconstituted with diluent from Merck, intramuscularly on 30 AUG 2013. No adverse reaction was reported following this administration error. Medical assistant inquired whether the patient should revaccinate. Follow-up was received on 30 AUG 2013. Expiry date of vaccine was updated.
Sex: F
Vaccine: MNQ
Symptoms: Feeling hot, Pruritus, Swelling
Clinical narrative: Case number PHEH2013US018511 is an initial spontaneous report received from a medical assistant on 30 AUG 2013. This report refers to a female patient whose age was not reported. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: M12124) intramuscularly on unspecified date. She experienced intense swelling of 2 inch radius, warmth and itching on 23 AUG 2013. The outcome of the event was reported as condition unchanged. The seriousness and causality was not reported.
Sex: U
Vaccine: DTAPIPV
Symptoms: No adverse event, Underdose
Clinical narrative: Initial medication error report received on 09 December 2013 from reporter. A child whose age, gender, medical history and concomitant medications were not reported, received a dose of PENTACEL (route, lot number and site of vaccination was not reported) on an unknown date. Patient received only the DTaP/IPV part without the ACTHIB. Patient did not have any adverse events. List of documents held by sender: none.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case number PHEH2013US018488 is an initial spontaneous report received from a physician on 28 AUG 2013. This report refers to an 18-years-old male patient. His medical history and concomitant medications were not reported. It was reported that he received two doses of MENVEO (batch number: A12004) intramuscularly on 06 JUN 2013 and on unknown date, within 2-months of each other. No adverse events were reported following the inadvertent administration.
Sex: U
Vaccine: DTAPIPV
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 26 September 2013 and at agency on 21 March 2014. The patient had only received DTaP/IPV component from PENTACEL. No adverse event was reported. List of documents held by sender: none.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US018409, is an initial spontaneous report received from a healthcare professional on 28 AUG 2013, with a follow-up received on 13 NOV 2013. This case refers to a 13 years old female patient. She received only Men A lyophilized conjugate component of MENVEO (batch number: A12092), reconstituted with sterile diluent at a dose of 0.5 ml intramuscularly into left deltoid on 26 AUG 2013 (at 3:30 PM). No adverse reaction was reported following this administration error.  Follow-up was received on 13 NOV 2013. Patient demographics, vaccination site, vaccination time and changed batch number (A12092) was updated.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Underdose
Clinical narrative: Initial misuse report received from a healthcare professional on 11 February 2014. A patient had received only the ACTHIB portion of PENTACEL reconstituted with ACTHIB diluent. It's an underdose of vaccine administered. No adverse event was reported. List of documents held by sender: None.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Inappropriate schedule of drug administration, No adverse event, Wrong drug administered
Clinical narrative: Case number PHEH2013US018379 is an initial spontaneous report received from a health care professional on 26 AUG 2013, with a follow-up received on 01 OCT 2013. This report refers to a 14-year-old male patient. He was vaccinated with MENVEO (batch number: unknown) on 22 APR 2011 and was well tolerated. He was inadvertently vaccinated with another dose of MENVEO (batch number: A12128/X12128) intramuscularly on 07 AUG 2013 instead of receiving GARDASIL (other manufacturer, batch number: unknown) on 07 AUG 2013. It was reported that the patient had no adverse reaction but received meningococcal shot too early. Now he was only 14 and need the booster dose at 16. Follow-up was received on 01 OCT 2013, patient demographics, vaccination history, and MENVEO vaccination date with batch number was updated.
Sex: U
Vaccine: DTAPIPV
Symptoms: No adverse event, Underdose
Clinical narrative: The cases were received on 21 March 2014 at agency. Initial misuse report received from a healthcare professional on 20 September 2013. A medical assistant only administered the DTaP-IPV portion of PENTACEL. It was a vaccine underdose. No adverse event was reported. List of documents held by sender: none.
Age: 23.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US018368, is an initial spontaneous report received from a pharmacist on 27 AUG 2013 and a follow up report from the pharmacist received on 08 OCT 2013. This report refers to a 23 years old female patient. She received only Men CYW-135 liquid component of MENVEO (batch number: X12097), intramuscularly without being reconstituted with Men A lyophilized conjugate component on 11 AUG 2013. On 28 AUG 2013, the patient returned to the clinic to receive new MENVEO. No adverse event reported following this administration error. Follow up report from the pharmacist received on 08 OCT 2013. The patient's present condition was updated.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2013US018287, is an initial spontaneous report from a physician on 27 Aug 2013. This report refers to an 11 years old female patient. She received only Men C, Y, W-135 liquid conjugate component of MENVEO, batch number: not reported), intramuscularly without being reconstituted with Men A lyophilized conjugate vaccine component on 21 Aug 2013, No adverse event was reported following this administration error.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Initial misuse report received from a healthcare professional on 30-Aug-2013. The case was received on 21-Mar-2014 at agency. This is an invalid case as individual patient identifiers are not reported. A patient had received a dose of PENTACEL on an unknown date. The nurse called last night after hours and is calling back to report change that now that the MA mixed the ACTHIB powder with sterile water instead of what was previously reported as DTaP/IPV mixed with sterile water. No adverse event was reported. (No information was provided regarding the patients). List of documents held by sender: none.
Age: 22.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2013US018222, is an initial spontaneous report received from a medical assistant on 27 Aug 2013, with a follow-up received on 17 Sep 2013 and a follow up report from the health are professional received on 24 Sep 2013: This case refers to a 22-year-old male patient. He received only 0.5 ml of Men A lyophilized conjugate component of MENVEO (batch number: A11066), reconstituted with sterile diluent intramuscularly in the right deltoid region on 08 Aug 2013 (2:30 pm). Reporter stated that patient did not experience any adverse event following this medication error. Follow-up was received on 17 Sep 2013: Information that patient did not experience any event was updated. Follow up report from the health care professional received on 24 Sep 2013: The vaccination site was updated.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2013US018209, is an initial spontaneous report received from a medical assistant on 26 Aug 2013. This report refers to a 17 years old male patient. He received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: not reported), intramuscularly without being reconstituted with Men A lyophilized conjugate vaccine component on 24 Aug 2013. No adverse event was reported following this administration error.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2013US018029, is an initial spontaneous report received from a nurse on 22 Aug 2013, with a follow-up received on 17 Sep 2013. This report refers to an unspecified age and gender patient. The patient received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: M12126), intramuscularly at a dose of 0.5 ml into deltoid, without being reconstituted with Men A lyophilized conjugate vaccine component on 20 Aug 2013. No adverse event was reported following this administration error. Follow-up was received on 17 Sep 2013: Vaccination site and dose were updated.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2013US018020, is an initial spontaneous report received from a nurse on 23 Aug 2013: This case refers to an 11 years old male patient. He received only Men A lyophilized conjugate component of MENVEO (batch number: M12098) reconstituted with sterile diluent intramuscularly on 22 Aug 2013: No adverse reaction was reported following this administration error.
Age: 24.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2013US018018, is an initial spontaneous report received from a pharmacist on 22 Aug 2013. This report refers to a 24 years old female patient. She received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: X12009), intramuscularly without being reconstituted with Men A lyophilized conjugated vaccine component on 14 Aug 2013. No adverse event was reported following this administration error.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2013US017944, is an initial spontaneous report received from a nurse on 22 Aug 2013. This report refers to an 11 years old female patient. She received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: X12120), intramuscularly without being reconstituted with Men A lyophilized conjugate vaccine component on 16 Aug 2013. No adverse event was reported following this administration error.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Needle issue, No adverse event
Clinical narrative: Case number PHEH2013US017940, is an initial spontaneous report received from a nurse on 20 Aug 2013. This report refers to a 12 years old male patient. Past medical history and concomitant medication was not reported. He was vaccinated with MENVEO (batch number: not reported) on 20 Aug 2013. Reporter stated that, a nurse administering MENVEO lost about half the dose, when the needle came out during administration. No adverse event was reported following this administration error.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2013US017916, is an initial spontaneous report received from a pharmacist on 20 Aug 2013. This report refers to a 19 year old female patient. Past medical history and concomitant medication was not reported. She was vaccinated with expired MENVEO (batch numbers: A10133 and expiry date: Feb 2013) intramuscularly on 20 Aug 2013. No adverse event was reported following this administration error.
Age: 22.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US017910, is an initial spontaneous report received from a nurse on 21 Aug 2013. This report refers to a 22 years old female patient. Past medical history and concomitant medication was not reported. She was vaccinated with MENVEO (batch number: X13012 and expiry date: 21 Aug 2013) at dose of 0.5 ml, intramuscularly on 21 Aug 2013. The MENVEO was frozen overnight and then administered. No adverse event was reported following this administration error.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US017909, is an initial spontaneous report received from a nurse on 21 Aug 2013. This report refers to an 18 years old female patient. Past medical history and concomitant medication was not reported. She was vaccinated with MENVEO (batch number: X13012 and expiry date: 21 Aug 2013) at dose of 0.5 ml, intramuscularly on 21 Aug 2013. The MENVEO was frozen overnight and then adminsitered. No adverse event was reported following this administration error.
Age: 65.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2013US019069, is an initial spontaneous report received from a pharmacist on 09 Sep 2013. This report refers to a 65 years old female patient. She received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: A 10042), intramuscularly without being reconstituted with Men A lyophilized conjugate vaccine component on 05 Sep 2013. 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 PHEH2013US018995 is an initial spontaneous report received from a nurse on 05 Sep 2013 and a follow up report from the nurse received on 10 Oct 2013. This report refers to a 17-year-old male patient. His medical history and concomitant medication were not reported. His vaccination history included MENVEO vaccine on 27 Aug 2008, which was well tolerated. He was vaccinated with MENVEO (batch number: A12009, expiry date: 28 Feb 2014) at a dose of 0.5 ml intramuscularly in the right deltoid on 12 Aug 2013 (2:15). It was reported that MENVEO which reached 31 Fahrenheit for 3 days was subsequently administered to the patient. No adverse event was reported following this medication error. Follow up report from the nurse received on 10 Oct 2013: The vaccination history and vaccination site were added.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US018994 is an initial spontaneous report received from a nurse on 05 Sep 2013, with a follow up received from a nurse on 10 Oct 2013. This report refers to an 18-year-old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with MENVEO (batch number: unknown) at a dose of 0.5 ml intramuscularly on 01 Aug 2013 at 01:30 pm. It was reported that MENVEO which reached 31 Fahrenheit for 3 days was subsequently administered to the patient. No adverse event was reported following this medication error. Follow up was received on 10 Oct 2013: Updated patient demographics and time of vaccination.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US018993 is an initial spontaneous report received from a nurse on 05 Sep 2013, with a follow up received from a nurse on 10 Oct 2013. This report refers to an 18-year-old female patient. Her medical history and concomitant medication were not reported. Her vaccination history included administration of meningococcal vaccine (manufacturer and batch number: unknown) on 09 May 2006, which was well tolerated. She was vaccinated with MENVEO (batch number: A11077, expiry date: 01 Apr 2014) in the left deltoid at a dose of 0.5 ml intramuscularly on 08 Jul 2013 at 01:45 pm. It was reported that MENVEO which reached 31 Fahrenheit for 3 days was subsequently administered to the patient. No adverse event was reported following this medication error. Follow-up was received on 10 Oct 2013: Updated vaccination history, site and time of vaccination.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US18987 is an initial spontaneous report received from a nurse on 05 Sep 2013 and a follow up report from the nurse received on 10 Oct 2013. This report refers to a 19-year-old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with MENVEO (batch number: A11077, expiry date: 01 Apr 2014) at a dose of 0.5 ml intramuscularly in the left deltoid on 09 Aug 2013 (09:15). It was reported that MENVEO which reached 31 Fahrenheit for 3 days was subsequently administered to the patient. No adverse event was reported following this medication error. Follow up report from the nurse received on 10 Oct 2013: The vaccination site was updated.
Age: 22.0
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US018985 is an initial spontaneous report received from a nurse on 05 Sep 2013, with a follow up received from a nurse on 10 Oct 2013. This report refers to a 22-year-old male patient. His medical history and concomitant medication were not reported. His vaccination history included administration of meningococcal vaccine (manufacturer and batch number unknown) on 20 Jun 2005, which was well tolerated. He was vaccinated with MENVEO (batch number: A12009, expiry date: 28 Feb 2014) in the right deltoid at a dose of 0.5 ml intramuscularly on 13 Aug 2013 at 01:00 pm. It was reported that MENVEO which reached 31 Fahrenheit for 3 days was subsequently administered to the patient. No adverse event was reported following this medication error. Follow up was received on 10 Oct 2013: Updated patient demographics, vaccination history, site and time of vaccination.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US018983 is an initial spontaneous report received from a nurse on 05 Sep 2013, with a follow up received from a nurse on 10 Oct 2013. This report refers to a 19-year-old female patient. Her medical history and concomitant medication were not reported. Her vaccination history included administration of meningococcal vaccine (manufacturer and batch number unknown) on 11 Oct 2005, which was well tolerated. She was vaccinated with MENVEO (batch number: X11077, expiry date: 01 Jun 2014) in the right deltoid at a dose of 0.5 ml intramuscularly on 07 Aug 2013 at 02:15 pm. It was reported that MENVEO which reached 31 Fahrenheit for 3 days was subsequently administered to the patient. No adverse event was reported following this medication error. Follow-up was received on 10 Oct 2013: Updated patient demographics, vaccination history, site and time of vaccination.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US018981 is an initial spontaneous report received from a nurse on 05 Sep 2013, with a follow up received on 10 Oct 2013. This report refers to a 17-year-old female patient. Her medical history and concomitant medication were not reported. Her vaccination history included administration of meningococcal vaccine (manufacturer and batch number unknown) on 19 Jun 2008, which she was well tolerated. She was further vaccinated with MENVEO (batch number: A11077, expiry date: 30 Apr 2013) in the right deltoid at a dose of 0.5 ml intramuscularly on 18 Jul 2013 at 01:00 pm. It was reported that MENVEO which reached 31 Fahrenheit for 3 days was subsequently administered to the patient. No adverse event was reported following these medication errors. Follow up received from a nurse on 10 Oct 2013: Updated patient demographics, vaccination history, site and time of vaccination.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US018977 is an initial spontaneous report received from a nurse on 05 Sep 2013, with a follow up received on 10 Oct 2013. This report refers to an 18-year-old female patient. Her medical history and concomitant medication were not reported. Her vaccination history include administration of meningococcal vaccine (manufacturer and batch number unknown) on 13 Nov 2007, which she was well tolerated. She was vaccinated with MENVEO (batch number: A12009, expiry date: 28 Feb 2014) in the left deltoid at a dose of 0.5 ml intramuscularly on 15 Aug 2013 at 01:00 pm. It was reported that MENVEO which reached 31 Fahrenheit for 3 das was subsequently administered to the patient. No adverse event was reported following this medication error. Follow up was received from nurse on 10 Oct 2013: Updated patient demographics, vaccination history, site and time of vaccination.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US018949, is an initial spontaneous report received from a medical assistant on 06 Sep 2013: This case refers to an 11 years old female patient. She received only Men A lyophilized conjugate component of MENVEO (batch number: A12092), reconstituted with sterile diluent from Merck, intramuscularly on 03 Sep 2013. No adverse reaction was reported following this administration error.
Age: 10.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2013US018855, is an initial spontaneous report received from a medical assistant on 29 Aug 2013: This case refers to a 10 years old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with expired MENVEO, batch number: A10133 and expiry date: Feb 2013) on 11 Mar 2013. No adverse reaction reported following this administration error.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2013US018853, is an initial spontaneous report received from a medical assistant on 29 Aug 2013: This case refers to a 12 years old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with expired MENVEO (batch number: A10054 and expiry date: Jan 2013) on 17 Jun 2013. No adverse reaction was reported following this administration error.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2013US018851, is an initial spontaneous report received from a medical assistant on 29 Aug 2013: This case refers to an 11 years old male patient. Past medical history and concomitant medicaton were not reported. He was vaccinated with expired MENVEO (batch number: A10054 and expiry date: Jan 2013) on 13 Jun 2013. No adverse reaction was reported following this administration error.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US018849, is an initial spontaneous report received from a pharmacist on 05 Sep 2013, with a follow-up received on 04 Nov 2013. This report refers to an 18 years old male patient. He received only Men C, Y, W-135 liquid conjugated component of MENVEO (batch number: X12009), intramuscularly into left deltoid without being reconstituted with Men A lyophilized conjugated vaccine component on 14 Aug 2013 at 11:45 am. No adverse event was reported following this administration error. He was not returned to the hospital for revaccination. Follow-up was received on 04 Nov 2013: Vaccination site, vaccination time and information that patient not returned for revaccination were updated.
Age: 10.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2013US018843, is an initial spontaneous report received from a medical assistant on 29 Aug 2013: This case refers to a 10 years old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with expired MENVEO (batch number: A10054 and expiry date: Jan 2013) on 11 Jun 2013. No adverse reaction reported following this administration error.
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US018831, is an initial spontaneous report received from a physician on 05 SEP 2013. This report refers to an 11-years-old male patient. He received only Men C,Y, W-135 liquid conjugate component of MENVEO (batch number: A12123), without being reconstituted with Men A lyophilized conjugate component on 27 AUG 2013. No adverse event was reported following the administration error.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US020254, is an initial spontaneous report received from a nurse on 25 SEP 2013. This report refers to an 11-year-old male patient. He received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch  number: not reported), intramuscularly without being r4econsititut4ed with Men A lyophilized conjugate component on 16 SEP 2013. No adverse event was reported following this administration error.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Immediate post-injection reaction, Incorrect route of drug administration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Case number PHEH2013US020253 is an initial spontaneous report received from a consumer on 26 Sep 2013. This report refers to an 18-years-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: not reported) in the upper arm on 23 Sep 2013. It was reported that the injection was given under the skin, underneath the fatty part instead of intramuscular administration. On 23 Sep 2013, she experienced swelling, redness and pain in site immediately after vaccination. She went to the physician on 25 Sep 2013 and the physician confirmed that MENVEO was adminsitered in the wrong place. The physician did not do anything to treat the symptoms and stated that the symptoms would eventually go away. The patient was instructed that she could put ice on the area or take ibuprofen. The outcome of the event was unknown. No further information was provided.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: C-reactive protein normal, Dizziness, Fatigue, Full blood count normal, Headache
Clinical narrative: Case number PHEH2013US020199 is an initial combined spontaneous report received from a nurse via sales representative on 25 SEP 2013, with a follow-up received from a physician on 25 OCT 2013. This report refers to a 16-years-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number A12118, expiry date: 30 AUG 2014) at a dose of 0.5 ml subcutaneously into left upper arm on 13 JUN 2013 at 11:54 AM. It was reported that two days after injection, he started complaining of nausea, fatigue, dizziness and headache that lasted for three to four days. He also had flu like symptoms and neck swelling. The patient consulted physician on 15 JUN 2013. It was reported that on 01 JUL 2013, he had sore throat with swelling in right side of neck which became more of an issue and received some injection (unspecified). On 03 JUL 2013, the physician called him back to the office and it was reported that the patient looked better during the visit, but he had fatigue and dizziness at that visit. The patient's mother did not report any other serious event. Blood tests like erythrocyte sedimentation rate, complete blood count and C-reactive protein were done at the end of JUL 2013 and the results were reported as normal. His mother stated that he was fine now and outcome of th4e events was completed recovered. The physician did not believe  that the event was due to the vaccine, but was concerned as the administere4d MENVEO lot number was recalled after the vaccination.  follow up was received on 25 OCT 2013. Patient demographics, vaccination date, vaccination route (wrong route of vaccine administration), vaccination dose and outcome of the events were updated.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect route of drug administration, Influenza like illness, Local swelling, Nausea, Oropharyngeal pain
Clinical narrative: Case number PHEH2013US020199 is an initial combined spontaneous report received from a nurse via sales representative on 25 SEP 2013, with a follow-up received from a physician on 25 OCT 2013. This report refers to a 16-years-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number A12118, expiry date: 30 AUG 2014) at a dose of 0.5 ml subcutaneously into left upper arm on 13 JUN 2013 at 11:54 AM. It was reported that two days after injection, he started complaining of nausea, fatigue, dizziness and headache that lasted for three to four days. He also had flu like symptoms and neck swelling. The patient consulted physician on 15 JUN 2013. It was reported that on 01 JUL 2013, he had sore throat with swelling in right side of neck which became more of an issue and received some injection (unspecified). On 03 JUL 2013, the physician called him back to the office and it was reported that the patient looked better during the visit, but he had fatigue and dizziness at that visit. The patient's mother did not report any other serious event. Blood tests like erythrocyte sedimentation rate, complete blood count and C-reactive protein were done at the end of JUL 2013 and the results were reported as normal. His mother stated that he was fine now and outcome of th4e events was completed recovered. The physician did not believe  that the event was due to the vaccine, but was concerned as the administere4d MENVEO lot number was recalled after the vaccination.  follow up was received on 25 OCT 2013. Patient demographics, vaccination date, vaccination route (wrong route of vaccine administration), vaccination dose and outcome of the events were updated.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Product quality issue, Red blood cell sedimentation rate normal
Clinical narrative: Case number PHEH2013US020199 is an initial combined spontaneous report received from a nurse via sales representative on 25 SEP 2013, with a follow-up received from a physician on 25 OCT 2013. This report refers to a 16-years-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number A12118, expiry date: 30 AUG 2014) at a dose of 0.5 ml subcutaneously into left upper arm on 13 JUN 2013 at 11:54 AM. It was reported that two days after injection, he started complaining of nausea, fatigue, dizziness and headache that lasted for three to four days. He also had flu like symptoms and neck swelling. The patient consulted physician on 15 JUN 2013. It was reported that on 01 JUL 2013, he had sore throat with swelling in right side of neck which became more of an issue and received some injection (unspecified). On 03 JUL 2013, the physician called him back to the office and it was reported that the patient looked better during the visit, but he had fatigue and dizziness at that visit. The patient's mother did not report any other serious event. Blood tests like erythrocyte sedimentation rate, complete blood count and C-reactive protein were done at the end of JUL 2013 and the results were reported as normal. His mother stated that he was fine now and outcome of th4e events was completed recovered. The physician did not believe  that the event was due to the vaccine, but was concerned as the administere4d MENVEO lot number was recalled after the vaccination.  follow up was received on 25 OCT 2013. Patient demographics, vaccination date, vaccination route (wrong route of vaccine administration), vaccination dose and outcome of the events were updated.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2013US020141 is an initial spontaneous report received from a practice manager on 24 SEP 2013. This report refers to a patient of an unknown age and gender. The patient received only Men CYW-135 liquid component MENVEO (batch number unknown) intramuscularly on 02 SEP 2013, without being reconstituted with Men A. Patient was revaccinated on an unknown date. No adverse event was reported following medication error.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2013US019971, is an initial spontaneous report received from a nurse on 20 SEP 2013 with a follow-up received from the nurse on 24 OCT 2013. This report refers to an 11-year-old male patient. He received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: M12120), intramuscularly without being reconstituted with men A lyophilized conjugate vaccine component on 13 SEP 2013. No adverse event was reported following this administration error. The patient was re-called on an undetermined date and was given correctly re-constituted MENVEO vaccine. Follow-up received from the nurse on 24 OCT 2013. Updated information about re-vaccination.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US019963, is an initial spontaneous report received from a medical assistant on 20 SEP 2013. This report refers to a 15-year-old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with MENVEO (batch number: M12092), intramuscularly on an unspecified date, which was exposed to temperature up to 51F for a time of 90 minutes on 19 SEP 2013. No adverse event was reported following this administration error.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2013US019878, is an initial spontaneous report received from a pharmacist on 19 SEP 2013. This report refers to an unspecified age and gender patient. The patient received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number not reported), intramuscularly without being reconstituted with Men A lyophilized conjugate vaccine component on 18 SEP 2013. No adverse event was reported following this administration error.
Age: 39.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Product container issue
Clinical narrative: Case number PHEH2013US019869 is an initial spontaneous report received from a physician on 19 SEP 2013. This report refers to a 39-year-old female patient (was a nurse). Her medical history and concomitant medications were not reported. The physician reported that on 05 SEP 2013, the nurse had MENVEO (batch number: M12098) leaked on to her hands from a Men CYW-135 vial that was cracked and leaking sometime around. No adverse events were reported following the maladministration.
Sex: U
Vaccine: DTAPIPVHIB, HIBV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Initial misuse report received from a healthcare professional on 26 September 2013 and the case was received on 21 March 2014 at agency. A patient (date of birth and gender was not reported) had received PENTACEL and ACTHIB (batch number and anatomical site of administration was not reported) on an unspecified date. It was reported that the infant received PENTACEL and instead of Hep B vaccine received ACTHIB. No adverse event was reported. List of documents held by sender: none.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US019090, is an initial spontaneous report received from a healthcare professional on 09 Sep 2013. This report refers to an 11 years old male patient. He received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: A12092), intramuscularly without being reconstituted with Men A lyophilized conjugate vaccine component on 29 Aug 2013. No adverse event was reported following this administration error.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US019142 is an initial spontaneous report from the medical assistant received on 11 Sep 2013 with a follow-up received on 03 Oct 2013. This report refers to a 17-year-old female patient. Her vaccination status was up to date and she was healthy. On 09 Sep 2013, the patient was accidentally administered with Men A powder vial of MENVEO (batch number: M12130) mixed with a sterile diluent of MMR. The solution was injected intramuscularly in to the left arm. The reporter wanted to confirm whether to wait for certain time to again administer the correct dose of MENVEO or it can be administered. The nurse stated that the patient would be vaccinated with the correctly re-constituted vaccine. No adverse event reported following this medication error. Follow-up received from the nurse on 03 Oct 2013: Updated patient demographics, batch number of MENVEO, confirmation on the diluent used from MMR vaccine and information about re-vaccination.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2013US019150 is an initial spontaneous report received from a pharmacist on 10 Sep 2013. This report refers to a patient whose identifiers were not reported. The patient's medical history and concomitant medications were not reported. It was reported that the patient was vaccinated with MENVEO (batch number: M11042) intramuscularly on an unknown date. It was reported that the patient only received MenA lyophilized conjugate reconstituted with sterile water and did not receive MenCYW-135 liquid conjugate. No adverse event was reported following the maladministration. No further information was provided.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2013US019472 is an initial spontaneous report received from a nurse on 13 Sep 2013. This report refers to an adult (in between 20-29 years) male patient. He received only MenCYW liquid conjugate component of MENVEO (batch number: M12024) intramuscularly, without being reconstituted with MenA on 12 Sep 2013. No adverse event was reported following medication error.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2013US019556, is an initial spontaneous report received from a nurse on 16 Sep 2013, with a follow-up received on 25 Oct 2013. This report refers to a 15-year-old female patient. She received only Men A lyophilized conjugate component of MENVEO (batch number: M12104/4434AA) reconstituted with sterile water intramuscularly at a dose of 0.5 ml into left deltoid on 13 Sep 2013. She did not receive the Men C, Y, W-135 liquid conjugate component of MENVEO. Patient had no adverse event following medication error. Follow-up was received on 25 Oct 2013: Patient demographics, vaccination site, batch number and information that no adverse event was experienced were updated.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2013US019599 is an initial spontaneous report received from a nurse on 16 Sep 2013 with follow up information received from a nurse on 07 Nov 2013. This report refers to a 12 years old male patient. He had tolerated the vaccine well in the past. He received only Men CYW-135 liquid conjugate component of MENVEO (lot number: A12098) without being reconstituted with Men A lyophilized conjugate vaccine component intramuscularly in the upper arm on 13 Sep 2013. He also received a booster dose of Tdap (other manufacturer, batch number: not reported) 0.5 ml intramuscularly on the same date. He was vaccinated with Tdap and liquid component of MENVEO on separate arms. About 1 week ago patient came back and was re-vaccinated with the full dose of MENVEO because they were waiting for the vaccine to arrive. No adverse event was reported following this administration error. Follow-up was received from a nurse on 07 Nov 2013: Patient demographics (height, weight) dose, site and route of administration, lot number of MENVEO, concomitant medications and re-vaccination information were updated.