chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: MNQ
Symptoms: Chills, Headache, Hyperhidrosis, Injection site erythema, Injection site pruritus
Clinical narrative: Case number PHEH2013US019704 is an intimal spontaneous report from the pharmacist received on 18 Sep 2013 with a follow up information received from a pharmacist on 03 Dec 2013. This report refers to a 26-year-old female patient. She was vaccinated with MENVEO (batch number: M11041) at a dose of 0.5 ml intramuscularly in the left deltoid on 13 Sep 2013. On 14 Sep 2013, she had headache. The patient recovered from the event headache on 15 Sep 2013. She felt chills on an unknown date (reported as on all the weekend). It was reported that she had headache and chills within 24-48 hours after vaccination. She took TYLENOL or ibuprofen and had sweating when she woke up and she no longer had a fever. On 17 Sep 2013, 4 days after vaccination, she experienced itching at the injection site, from which she recovered on 18 Sep 2013, but there was 2x3 cm redness around the injection site. The redness went away 6 to 7 days after vaccination. It was reported that the patient has not seen her physician. The event was reported as non-serious. The causality of the events was not reported. Follow up information received from a pharmacist on 03 Dec 2013: Dose and site of vaccination, outcome of redness and reported seriousness of the events updated.
Age: 26.0
Sex: F
Vaccine: MNQ
Symptoms: Pyrexia
Clinical narrative: Case number PHEH2013US019704 is an intimal spontaneous report from the pharmacist received on 18 Sep 2013 with a follow up information received from a pharmacist on 03 Dec 2013. This report refers to a 26-year-old female patient. She was vaccinated with MENVEO (batch number: M11041) at a dose of 0.5 ml intramuscularly in the left deltoid on 13 Sep 2013. On 14 Sep 2013, she had headache. The patient recovered from the event headache on 15 Sep 2013. She felt chills on an unknown date (reported as on all the weekend). It was reported that she had headache and chills within 24-48 hours after vaccination. She took TYLENOL or ibuprofen and had sweating when she woke up and she no longer had a fever. On 17 Sep 2013, 4 days after vaccination, she experienced itching at the injection site, from which she recovered on 18 Sep 2013, but there was 2x3 cm redness around the injection site. The redness went away 6 to 7 days after vaccination. It was reported that the patient has not seen her physician. The event was reported as non-serious. The causality of the events was not reported. Follow up information received from a pharmacist on 03 Dec 2013: Dose and site of vaccination, outcome of redness and reported seriousness of the events updated.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US021723, is an initial spontaneous report received from a nurse on 16 OCT 2013. This report refers to 11-year-old female patient. She was vaccinated with MENVEO (batch number A11082) at a dose of 0.5 ml intramuscularly into left deltoid on 13 MAY 2013 (16:00). The reporter stated that MENVEO was stored in refrigerator that dropped to 32.6 F for less than one hour on 19 APR 2013 (vaccine compromised due to refrigeration malfunction). He was re-vaccinated with another dose on 26 AUG 2013. No adverse reaction was following this administration error.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US021740 is an initial spontaneous report received from a health care professional on 16 Oct 2013. This report refers to a 17-year-old female patient. She was vaccinated with an initial dose of MENVEO (batch number: A11082) at a dose of 0.5 ml intramuscularly in to right deltoid on 01 May 2013 (at 14:00). It was reported that the patient received vaccine which was compromised due to refrigeration malfunction. No adverse event was reported following the medication error. Her mother declined to revaccinate with MENVEO.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Immunisation, No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US021726 is an initial spontaneous report from the health care professional received on 16 OCT 2013 with a follow up information received from a health care professional on 17 JAN 2014. This report refers to a 17-years-old female patient. Her medical history was not reported. Her concomitant vaccinations included Varicella virus vaccine (other manufacturer, batch number H006539) tetanus, diphtheria, acellular pertussis (other manufacturer,batch   number: 44325AB) and human papilloma virus vaccine (other manufacturer, batch number 1495AA) all the vaccines administered intramuscularly at a dose of 0.5 ml on 23 SEP 2013. She was accidentally vaccinated with only Men CYW liquid component of MENVEO (batch number A13013) intramuscularly in the right deltoid on 23 SEP 2013 and she did not receive MenA lyophilized conjugate. It was reported that she did not experience any adverse event after the mal-administration. She was re-vaccinated with MENVEO (batch number: not reported) on 23 OCT 2013 without any incident. No other information was available.   Follow up information received from a health care professional on 17 JAN 2014. Patient demographics (initials, date of birth, age, gender, height and weight), concomitant vaccinations, suspect vaccine batch number, vaccination date and site of vaccination and re-vaccination information updated.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US021741 is an initial spontaneous report received from a health care professional on 16 Oct 2013. This report refers to a an 11-year-old male patient. He was vaccinated with an initial dose of MENVEO (batch number: A11082) at a dose of 0.5 ml intramuscularly in to right deltoid on 14 May 2013 (at 15:00). It was reported that the patient received vaccine which was compromised due to refrigeration malfunction. No adverse event was reported following the medication error. He had an appointment to received HPV vaccine therefore he will be receiving MENVEO at the same time.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US021734 is an initial spontaneous report received from a health care professional on 16 Oct 2013. This reports refers to a 15-year-old female patient. She was vaccinated with an initial dose of MENVEO (batch number: A11082) at a dose of 0.5 ml intramuscularly in to right deltoid on 01 May 2013 (14:00). It was reported that the vaccine administered was compromised due to refrigeration malfunction. No adverse event was reported following the medication error. Her parents declined to revaccinate with MENVEO.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US021736 is an initial spontaneous report received from a health care professional on 16 Oct 2013. This report refers to a 16-year-old female patient. Her vaccination history included administration of MENVEO (batch number: unknown) on 23 May 2007, which was well tolerated. She was further vaccinated with MENVEO (batch number: A11082) at a dose of 0.5 ml intramuscularly in to left deltoid on 15 May 2013 at 13:45. It was reported that the patient administered the vaccine that was compromised due to refrigeration malfunction. No adverse event was reported following the medication error. Revaccination will be done at next appointment.
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US021744, is an initial spontaneous report received from the health care professional on 16 OCT 2013. This report refers to a child female patient. Her medical history and concomitant mediations was not reported. She was vaccinated with initial application of MENVEO (batch number: A11082) in the left deltoid at a dose of 0.5 ml intramuscularly on 31 MAY 2013 at 15:30 PM. TI was reported that the vaccine was compromised due to refrigeration malfunction (temperature error). She was revaccinated on 30 AUG 2013. No adverse event was reported following this administration error (incorrect storage of drug).
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US021746 is an initial spontaneous report received from the health care professional on 16 OCT 2013. This report refers to an 11-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with initial dose of MENVEO (batch number: A11082) at a dose of 0.5 ml, intramuscularly in the left deltoid on 31 MAY 2013 at 09:15 AM. It was reported that the patient received vaccine which was compromised due to refrigeration malfunction (temperature error). She was re-vaccinated on 10 SEP 2013. No adverse event was reported following this administration error (incorrect storage of drug).
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US021748 is an initial spontaneous report received from the health care professional on 16 OCT 2013. This report refers to an 11-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with initial dose of MENVEO (batch number: A11082) at a dose of 0.5 ml intramuscularly in the right deltoid on 10 MAY 2013 at 09:15 AM. It was reported that the patient received vaccine which was compromised due to refrigeration malfunction (temperature error). He was re-vaccinated on 16  AUG 2013. No  adverse event was experienced following this a administration error (incorrect storage of drug).
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US021749 is an initial spontaneous report received from a health care professional on 16 Oct 2013. This report refers to an 11-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with an initial dose of MENVEO (batch number: A11082) at a dose of 0.5 ml intramuscularly in the left deltoid on 17 May 2013. It was reported that the vaccine administered was compromised due to refrigeration error. No adverse event was reported following the medication error. The patient was re-vaccinated on 27 Aug 2013. No further information was provided.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US021859 is an initial spontaneous report received from a nurse on 16 Oct 2013. This report refers to an 11-year-old female patient. Her medical history included seasonal allergies and allergy to amoxicillin. Her concomitant medications were not reported. She was vaccinated with an initial dose of MENVEO (batch number: A11082) at a dose of 0.5 ml intramuscularly in the left deltoid on 31 May 2013. It was reported that the vaccine adminsitered was compromised due to refrigeration error. No adverse event was reported following the medication error. The patient was re-vaccinated on 30 Aug 2013. No further information was provided.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US021860 is an initial spontaneous report received from a nurse on 16 Oct 2013. This report refers to a 17-year-old female patient. Her medical history included SUDAFED allergy and concomitant medications were not reported. Her vaccination history included administration of MENVEO (batch number: not reported) in 04 Nov 2007 which was well tolerated. She was vaccinated with a dose of MENVEO (batch number: A11082) at a dose of 0.5 ml intramuscularly in the left deltoid on 31 May 2013. It was reported that the vaccine administered was compromised due to refrigeration error. No adverse event was reported following the medication error. The patient was notified to schedule for administration of re-vaccination. No further information was provided.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Case number PHEH2013US021979 is an initial spontaneous report from nurse received on 21 Oct 2013. This case refers to a patient of an unknown age. The patient received MENVEO (batch number: A12099) 0.4 ml intramuscularly on 16 Oct 2013. The nurse only drew up 0.4 ml and administered the patient. No adverse event was reported due to this medication error.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2013US022215, is an initial spontaneous report received from a pharmacist on 18 Oct 2013 and follow up report from the pharmacist received on 22 Nov 2013. This report refers to a 12-year-old male patient. On 10 Oct 2013, the patient was accidentally vaccinated with only 0.5 ml MenCYW-135 liquid component of MENVEO (batch number: A11078) intramuscularly and did not receive Men A lyophilized conjugate. It was reported that the patient did not experience any adverse event after the mal-administration. No other information was available. Follow up report from the pharmacist received on 22 Nov 2013: The report type changed from other to spontaneous. The patient details and MENVEO details were updated. The event changed from wrong solution used in drug reconstitution to inappropriate preparation of medication.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US022291, is an initial spontaneous report received from the health care professional on 22 Oct 2013. This report refers to an 11-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: A12119) intramuscularly on 24 Sep 2013. It was reported that before administration, the vaccine was stored at 31.2 F for 12 hours. No adverse event was experienced following this mal-administration.
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US022396 is an initial spontaneous report from a health care professional received on 23 Oct 2013. This case refers to a patient of unknown age and gender. This patient was given only MenCYW-135 liquid component of MENVEO (batch number: unknown) intramuscularly on an undetermined date. MenA component was not administered to the patient. No adverse event was reported following this administration error.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US022539 is an initial spontaneous report received from a medical assistant on 24 Oct 2013. This report refers to a 13-years-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated intramuscularly only with Men A lyophilized powder component of MENVEO (batch number: X12127) reconstituted with sterile water and did not receive MenCYW-135 liquid conjugate on 16 Oct 2013. No adverse event were reported following the administration error.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US020801 is an initial spontaneous report from the nurse received on 02 OCT 2013 with a follow-up received on 15 NOV 2013. This report refers to a 17-year-old female patient. Her medical history was not reported. ON 24 SEP 2013, the patient was accidentally given only MenCYW-135 liquid component of MENVEO (batch number: A11082) intramuscularly in to the left arm, and did not receive Men A lyophilized conjugate. It was reported that the patient did not experience any adverse event after the mal-administration. This was the second administration of MENVEO. No other information was available. Follow-up received from the nurse on 15 NOV 2013. Updated patient demographics, route and site of administration of MENVEO and batch number of MENVEO.
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US0205834 is an initial spontaneous report from nurse received on 02 OCT 2013 and a follow up report from the nurse received on 18 NOV 2013. This report refers to a patient of an unknown age and gender. On an unknown date, the patient was accidentally vaccinated with only MenCYW-135 liquid component of MENVEO (batch number: not reported) intramuscularly and did not receive Men A lyophilized conjugate. It was reported that the patient did not experience any adverse event after the mal-administration . No other information was available. Follow up report from the nurse received on 18 NOV 2013. The patient's condition was updated.
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US020838 is an initial spontaneous report received from a nurse on 02 OCT 2013. This report refers to a patient of unknown age and gender. The patient was given only the Men A component of MENVEO (batch number: unknown) intramuscularly on an unknown date. MenA was reconstituted with water instead of MenCYW-135. No adverse event was reported following this administration error (wrong solution used in drug reconstitution).
Age: 12.0
Sex: M
Vaccine: FLU3, MNQ
Symptoms: Abdominal pain, Decreased appetite, Dizziness, Nausea, Pallor
Clinical narrative: Case number PHEH2013US020959 is an initial spontaneous report received from the medical assistant on 04 OCT 2013 with a follow-up information received from the medical assistant on 05 NOV 2013. This report refers to male child patient whose age was about 11-12 years. He did not have any history of recent injury or illness or allergies. His concomitant medications were not reported. His vaccination history included administration of IPV (manufacturer and batch number not reported) in 22 DEC 2001, DTap (other manufacturer, batch number not reported) in 23 FEB 2002, MMR (other manufacturer, batch number, not reported), IPV (manufacturer and batch number not reported), DTaP (other manufacturer, batch number, not reported) and hepatitis B and HIB (other manufacturer, batch number: not reported) in 21 MAR 2003, Varicella  in 05 SEP 2003, seasonal influenza in 12 NOV 2005, MMR (other manufacturer, batch number not reported), IPV (manufacturer and batch number not reported), DTaP (other manufacturer, batch number, not reported) in 28 AUG 2007 and hepatitis A (manufacturer and batch number not reported) in 18 FEB 2008. He was vaccinated with 0.5 ml of MENVEO (batch number A12114, expiry date 31 AUG 2014) on 03 OCT 2013. ON an unknown date after vaccination, he experienced paleness and severe generalized diffuse abdominal pain for about 30 minutes, nausea, decreased appetite and was light headed. He was afebrile. His vital signs were normal. Physicol examinations were done and were normal. He denied fever, chills malaise, weight loss or gain and he was sleeping well. There were no red eyes, eye drainage, runny nose, nasal congestion, sore throat, post nasal drip, ear pain, mouth ulcers, swallowing difficulty, day time or night tine cough, sleep disturbance, chest pain, vomiting, cramping, diarrhea, heart burn, radiating pain to shoulder or back, joint pain, swelling, redness, rashes and dry skin. There were no signs of appendicitis or obstruction. He was prescribed ZOFRAN 4 mg thrice daily on 04 OCT 2013. He was also advised to increase fluids, avoid spicy foods and to call if the symptoms would not get better. The events outcome was reported as complete recovery. The seriousness and causality were not reported. No additional information was available.   Follow up information received on 05 NOV 2013. Updated vaccination history, suspect drug, site of vaccination, events (nausea, decreased appetite and lightheadedness), physical examination details, treatment and outcome of the event.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US021239 is an initial spontaneous report received from a registered nurse on 09 OCT 2013 with a follow up received on 05 NOV 2013. This report refers to a 16-year-old female patient. She was given only MenCYW-135 liquid component of MENVEO (batch number: M12102) intramuscularly in to the left deltoid on 01 OCT 2013. No adverse event was reported following this administration error (inappropriate preparation of medication). Follow-up received from the nurse on 05 NOV 2013. Updated patient demographics and site and date of administration of MENVEO.
Age: 11.0
Sex: F
Vaccine: FLUN4, HEPA, MNQ, TDAP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US021314, is an initial spontaneous report received from the medical assistant on 10 OCT 2013 and a follow up report from the medical assistant received on 09 DEC 2013. This case refers to an 11 years old female patient. Past medical history was not reported. Concomitant vaccines included TDaP (other manufacturer, batch number AC52B676BA) and hepatitis A (other manufacturer, batch number: AHAVB703AA) and FLUMIST (other manufacturer, batch number M11081 and expiry date: 30 APR 2014) at a dose of 0.5 ml in the right arm intramuscularly on 07 OCT 2013, which had temperature excursion below 2 degree Celsius (two separate temperature excursions). On 04 SEP 2013, the temperature excursion was 0 degree Celsius for may be 10-15 minutes and on 09 SEP 2013, the temperature excursion was 0.5 degree Celsius for many be 10-15 minutes. Reporter stated that, she does not know if the vaccine was frozen. No adverse event was reported following this administration error.   Follow up report from the medical assistant received on 09 DEC 2013. The site of vaccination and concomitant vaccines were added.
Age: 17.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US021321, is an initial spontaneous report received from the medical assistant on 10 OCT 2013 and a follow up report from the medical assistant received on 09 DEC 2013. This case refers to a 17 years old male patient. Past medical history and concomitant medication were not reported. Concomitant vaccine included Tdap (batch number: A652B076BA, other manufacturer) on 25 SEP 2013. He was vaccinated with MENVEO (batch number: M11081 and expiry date: 30 APR 2014), at a dose of 0.5 ml intramuscularly on 25 SEP 2013, which had temperature excursion below 2 degree Celsius (two separate temperature excursions). On 04 SEP 2013, the temperature excursion was 0 degree Celsius for may be 10-15 minutes and on 09 SEP 2013, the temperature excursion was 0.5 degree Celsius for may be 10-15 minutes. Reporter stated that, she does not know if the vaccine was frozen. No adverse event was reported following this administration error. Follow up report from the medical assistant received on 09 DEC 2013. Concomitant vaccine was added.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL, HEPA, HPV4, MNQ, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US021323, is an initial spontaneous report received from the medical assistant on 10 OCT 2013 and a follow up report from the medical assistant received on 09 DEC 2013. This case refers to a 17 years old female patient. Past medical history was not reported. Concomitant vaccines included hepatitis A (other manufacturer and batch number: AHAVB703WAH06), GARDASIL (other manufacturer and batch number: J008423), Varicella virus vaccine (other manufacturer and batch number H000639) and TDap (other manufacturer and batch number: AC52B026BA) on 17 SEP 2013. She was vaccinated with MENVEO (batch number: M11081 and expiry date 30-APR-2014) at a dose of 0.5 ml in the right arm intramuscularly on 17 SEP 2013, which had temperature excursion below 2 degree Celsius (two separate temperature excursions). On 04 SEP 2013, the temperature excursions was 0 degree Celsius for may be 10-15 minutes and on 08 SEP 2013, the temperature excursion was 0.5 degree Celsius for may be 10-15 minutes. Reporter stated that she does not know if the vaccine was frozen. No adverse event was reported following this administration error.  Follow up report frm the medical assistant received on 09 DEC 2013: Site of vaccination and concomitant vaccines were added.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL, HEPA, HPV4, MNQ, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US021326, is an initial spontaneous report received from the medical assistant on 10 OCT 2013 with a follow up information received from a medical assistant on 08 DEC 2013. This case refers to a 17-years old female patient. Past medical history and concomitant medications was not reported. Her vaccination status was up to date. She was vaccinated with an initial dose of MENVEO (batch number: M11081, expiry date: 30 APR 2014) at a dose of 0.5 ml intramuscularly in the right arm on 17 SEP 2013 which had temperature excursion below 2 degree. She was also concomitantly administered HepA (other manufacturer, batch number: AHAVB703AA) intramuscularly, GARDASIL (other manufacturer, batch number J008423) intramuscularly and Varicella virus vaccine (other manufacturer, batch number: H009639) subcutaneously; all vaccines administered at a dose of 0.5 ml on 17 SEP 2013. Reporter stated that she does not know if the MENVEO vaccine was frozen. No adverse event was reported following this administration  error.  Follow up information received from a medical assistant on 09 DEC 2013. Patient demographics initials, date of birth, age, weight and height), site of vaccination and vaccination date and concomitant vaccinations updated.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US021327, is an initial spontaneous report received from the medical assistant on 10 OCT 2013 and a follow up report from the medical assistant received on 09 DEC 2013. This case refers to an 11 years old male patient. Past medical history was not reported. Concomitant vaccines included Tdap (other manufacturer, batch  number: AC52B076BA) and GARDASIL (other manufacturer and batch number: H621608) on 03 SEP 2013. He was vaccinated with MENVEO (batch number: M11081 and expiry date: 30 APR 2014), at a dose of 0.5 ml in the right arm intramuscularly on 04 SEP 2013, which had temperature excursion below 2 degree Celsius. Reporter stated that, she does not know if the vaccine was frozen. No adverse event was reported following this administration error.  Follow up report  from the medical assistant received on 09 DEC 2013. The site of vaccination and concomitant vaccines were added.
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US021459 is an initial spontaneous report from the medical assistant received on 11 OCT 2013. This report refers to a patient of an unknown age and gender. The patient accidentally received 0.5 ml intramuscular dose of Men A lyophilized component of MENVEO (batch number: X12100) after reconstitution in a sterile diluent instead of Men CYW-135 liquid component. No adverse event reported following this medication error.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US021607 is an initial spontaneous report received from a nurse on 15 OCT 2013 with a follow up information received from a nurse on 15 OCT 2013. This report refers to an 18-year-old male patient. He was vaccinated intramuscularly with MenA lyophilized powder of MENVEO (batch number: A12100, expiry date: SEP 2014) reconstituted with sterile water instead of MenCYW-135 liquid conjugate on 14 OCT 2013. No adverse event was reported following the maladministration. Follow up information received from a nurse on 15 OCT 2013. Expiry date of vaccine and DOB and age updated. The event inappropriate age at vaccine administration was deleted.
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, Injection site erythema, Injection site hypersensitivity, Vaccination site induration, Vaccination site warmth
Clinical narrative: Case number PHEH2013US02159 is an initial spontaneous report received from a health care professional on 11 OCT 2013. This report refers to an 11-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: A1214/A1105, expiry date: 30 AUG 2014/30 APR 2014) at a dose of 0.5 ml intramuscularly in the left deltoid on 09 AUG 2013. It was reported that he was vaccinated with MENVEO vial that had a temperature excursion of 32F on two occasions. Crystallization of vaccine might have occurred which destroyed it and the vaccine was not good. The reporter believed that the patient should be revaccinated. During the call back, it was identified that the patient had a local allergic reaction of left deltoid characterized by firmness, redness, and warmth at the vaccination site. The vaccination site reactions were reported to be resolved.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US021722, is an initial spontaneous report received from a nurse on 16 OCT 2013 with a follow-up received on 03 DEC 2013. This report refers to a 12-year-old female patient. She did not have any relevant medical history. Her vaccination status was up to date as per  her records. She was vaccinated with MENVEO (batch number: A11082) at a dose of 0.5 ml into left deltoid arm on 17 MAY 2013 (09:30). The reporter stated that MENVEO was compromised due to refrigeration malfunction. She was revaccinated with MENVEO on 25 NOV 2013. No adverse reaction was reported following this administration error. Follow-up received from the nurse on 30 DEC 2013. Updated information on medical  history, vaccination history and revaccination with MENVEO.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US022558 is an initial spontaneous report received from a nurse on 25 OCT 2013. This report refers to a 12-year-old male child. He was vaccinated with MENVEO (batch number: X12120) intramuscularly at 0.5 ml on 17 SEP 2013. MENVEO had undergone an excursion to zero degree Celsius for 16 hours; however the vaccine was not frozen. 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 PHEH2013US022563 is an initial spontaneous report received from a nurse on 25 OCT 2013. This report refers to a 11-year-old female child. She was vaccinated with MENVEO (batch number: X12120) intramuscularly at 0.5 ml on 19 SEP 2013. MENVEO had undergone an excursion to zero degree Celsius for 16 hours; however the vaccine was not frozen. No adverse event was reported following this administration error.
Age: 21.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US023934 is an initial spontaneous report received from a health care professional on 13 NOV 2013. This case refers to a 21 years old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with MENVEO (batch number: A11076 and expiry date: APR 2014) at a dose of 0.5 ml intramuscularly on 08 NOV 2013, which was reached 0 C for about 1.5 hours on 06 NOV 2013. No adverse event was reported following this administration error.
Age: 34.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US022624 is an initial spontaneous report received from a nurse on 25 OCT 2013. This report refers to a 34-year-old male patient. He was given only MenCYW-135 liquid component of MENVEO (batch number: M12024) intramuscularly on 25 OCT 2013. No adverse event was reported following this administration error (inappropriate preparation of medication).
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US024394, is an initial spontaneous report received from a medical assistant on19 Nov 2013 and a combined follow up report from the medical assistant received on 10 Dec 2013 and 16 Dec 2013. This report refers to a 20 months old male patient. His medical history included frequent infections and allergy (unspecified). He erroneously received only MENVEO, (batch number: M13014/X13014), without being reconstituted with Men A lyophilized conjugate vaccine component on 19 Nov 2013, intramuscularly in the left arm. No adverse event was reported following this administration error. Combined follow up report from the medical assistant received on 10 Dec 2013 and 16 Dec 2013: Medical history and site of vaccination were updated.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US022636 is an initial spontaneous report received from a health care professional on 25 OCT 2013. This report refers to a 13-year-old female patient. She was given only MenCYW-135 liquid component of MENVEO (batch number: X12026) intramuscularly on 25 OCT 2013. No adverse event was reported following this administration error (inappropriate preparation of medication).
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US022709, is a combined initial and follow up spontaneous report from a pharmacist received on 29 Oct 2013 and on 05 Nov 2013 and a follow up report received from the nurse on 26 Nov 2013. This report refers to a 17-year-old female patient. Her medical history included amoxicillin allergy. No concomitant medication was reported. On 24 Oct 2013, she was accidentally vaccinated with 0.5 ml of Men A lyophilized conjugate of MENVEO, (batch number: X12098) which was reconstituted in a sterile water instead of MenCYW-135 liquid component. It was reported that she did not experienced any adverse event (no reaction) after the mal-administration. No other information was available. Follow-up report from the nurse received on 26 Nov 2013: Updated patient demographics and medical history.
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US024403 is an initial spontaneous report received from a nurse on 19 NOV 2013. This report refers to a patient of unknown age and gender. The patient received only Men A lyophilized conjugate component of MENVEO (batch number: M12126), reconstituted with sterile water instead of MenCYW-135 liquid component  intramuscularly on 19 NOV 2013. No adverse reaction reported following this administration error.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Case number PHEH2013US022747 is an initial spontaneous report from the health care professional received on 28 Oct 2013. This report refers to a 11-year-old female patient. She was vaccinated with MENVEO, (batch number: A12119) subcutaneously on 25 Oct 2013. On 28 Oct 2013, she experienced redness and swelling at the injected area. The outcome of the events reported as condition unchanged. The seriousness and causality of the events were not reported.
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US024422, is an initial spontaneous report received from a medical assistant on 19 NOV 2013. This report refers to a patient of unknown age and gender. The patient erroneously received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number, M12130), without being reconstituted with Men A lyophilized conjugate component intramuscularly in the first week of NOV 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 PHEH20143US024518 is an initial spontaneous report received from a medical assistant on 20 NOV 2013 and a follow up information received from a medical assistant on 02 JAN 2014. This report refers to a 17-year-old female patient. On 14 NOV 2013, she received only Men A lyophilized conjugate component of MENVEO (batch number: M12121) reconstituted with sterile water instead of Men CYW-135 liquid component intramuscularly in the left arm at a dose of 0.5 ml. No adverse reaction was reported following this administration error as of 14 NOV 2013.  Follow up information received from a medical assistant on 02 JAN 2014: Patient demographics (height and weight) and vaccination details (site and time) were updated.
Age: 21.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US024756, is an initial spontaneous report received from a pharmacist on 22 NOV 2013. This report refers to a 21-year-old female patient. She received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: X12025), without being reconstituted with Men A lyophilized conjugate vaccine component on 19 NOV 2013. No adverse event was reported following this administration error.
Age: 76.0
Sex: M
Vaccine: MNQ
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2013US024849, is an initial spontaneous report received from a pharmacist on 25 NOV 2013. This report refers to a 76-year-old male patient. Past medical history and concomitant medication were not reported. He was inadvertently vaccinated with MENVEO (batch number: A11077 and expiry date: APR 2014), at a dose of 0.5 ml intramuscularly on 24 NOV 2013. No adverse event was reported following this administration error.
Age: 76.0
Sex: F
Vaccine: MNQ
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2013US024850, is an initial spontaneous report received from a pharmacist on 25 NOV 2013. This report refers to a 76-year-old female patient. Past medical history and concomitant medication were not reported. She was inadvertently vaccinated with MENVEO (batch number: A11077 and expiry date: APR 2014), at a dose of 0.5 ml intramuscularly on 24 NOV 2013. No adverse event was reported following this administration error.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US019795, is an initial spontaneous report received from a nurse on 17 SEP 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: A102002) without being reconstituted with Men A lyophilized conjugate vaccine component on 16 SEP 2013. No adverse event was reported following this administration error.
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US025374 is an initial spontaneous report received from a nurse on 06 DEC 2013. This report refers to a patient of unknown age and gender. This patient was given only Men A component of MENVEO (batch number: unknown) intramuscularly, reconstituted with sterile water instead of Men CYW component on an undetermined date. No adverse event was reported following this administration error (wrong solution used in drug reconstitution).
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2013US025049 is an initial spontaneous report received from a nurse on 27 NOV 2013. This report refers to a female patient of unknown age. Past medical history and concomitant medication were not reported. On 25 NOV 2013, she was vaccinated with MENVEO (batch number: M11053) intramuscularly, which was stored at 47F for 48 hours before administration. No adverse event was reported following this administration error.
Age: 59.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US025310, is a spontaneous initial report received from a physician on 05 DEC 2013 with a follow up  received on 18 FEB 2014. This report refers to a 59-year-old female patient. Her medical history and concomitant medications were not reported. She had no prior vaccinations. It was reported that she was inadvertently administered only MenCYW-135 liquid (batch number X12104) intramuscularly into the right deltoid on 04 DEC 2013 and did not receive Men A lyophilized conjugate. The reporter stated that she did not experience any adverse event due to the maladministration (inappropriate preparation of medication). Two weeks later she was vaccinated with full MENVEO (batch number not reported). Follow  up received from physician on 18 FEB 2014. Updated patient demographics (date of birth and age), site of application of MENVEO and reporter comment.
Age: 14.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Case number PHEH2013US025308 is an initial spontaneous report from a nurse received on 04 DEC 2013. This report refers to a 14-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: A13012/X13012) subcutaneously on 04 DEC 2013. No adverse event was reported following this administration error.  No other information was available.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US026252 is an initial spontaneous report received from a medical assistant on 20 Dec 2013 with a follow-up received on 31 Jan 2014. This report refers to an 11-year-old male patient. Examination showed that he was a well-child. His concomitant medications were not reported. He received only Men A lyophilized conjugate component of MENVEO, (batch number: M12127), reconstituted with a sterile diluent instead of MenCYW-135 liquid component intramuscularly in to the left deltoid on 17 Dec 2013. No adverse reaction reported following this administration error. Follow-up received from the medical assistant on 31 Jan 2014: Updated patient demographics (weight and height), medical history and site of MENVEO application.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US026270, is an initial spontaneous report received from the nurse on 20 DEC 2013. This report refers to a 14-year-old male patient. His medical history  and concomitant medications were not reported. He received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: M13015, expiry date: SEP 2014), intramuscularly without being reconstituted with Men A lyophilized conjugate vaccine component on 10 DEC 2013. No adverse event was reported following this administration error.
Age: 17.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US025304 is an initial spontaneous report received from a nurse on 04 Dec 2013 and a follow up report from the nurse received on 31 Dec 2013: This report refers to a 17-year-old male patient. His previous vaccinations included DTaP on 05 Dec 1996, 06 Feb 1997, 24 Apr 1997, 23 Jul 1999, 21 Aug 2000, 15 Aug 2001 and 08 Nov 2011, Polio vaccine (unknown manufacturer) on 05 Dec 1996, 06 Feb 1997, 23 Jul 1999 and 15 Aug 2001, MMR (other manufacturer) on 23 Jul 1999 and 15 Aug 2001, Hib on 05 Dec 1996, 06 Feb 1997 and 21 Aug 2000, hepatitis B vaccine on 10 Oct 1996, 05 Dec 1996 and 26 Apr 1997, Varicella vaccine on 08 Nov 2011 and 10 Jan 2012. HPV on 10 Jan 2012, seasonal influenza vaccine on 06 Nov 2009, 08 Nov 2011 and on 20 Sep 2013, meningococcal conjugate on 08 Nov 2011 and H1N1 influenza vaccine on 06 Nov 2009. Concomitant vaccine included GARDASIL (other manufacturer, batch number: J008423) received on 02 Dec 2013. He was given only MenCYW liquid component of MENVEO (batch number: X12124) mixed with sterile water, intramuscularly on 02 Dec 2013 (at 4:30 pm). No adverse event was reported following this administration error. Follow up report from the nurse received on 31 Dec 2013: Vaccination history and concomitant vaccine were added. Updated vaccination site and time.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US025173, is an initial spontaneous report received from a physician on 03 DEC 2013. This report refers to a 16-year-old female patient. She received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: M12104), intramuscularly without being reconstituted with Men A lyophilized conjugate vaccine component on 21 NOV 2013. No adverse event was reported following this administration error.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US025072 is an initial spontaneous report from a medical assistant received on 26 NOV 2013. This report refers to a 12-years-old male patient. His medical history and concomitant medications were not reported. It was reported that he received only Men CYW-135 liquid conjugate of MENVEO (batch number: X13016) intramuscularly on 21 OCT 2013 and did not receive Men A lyophilized conjugate. No adverse events  were reported following the maladministration.
Age: 21.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Lymphadenopathy, Pyrexia, Sluggishness, Vaccination site pain
Clinical narrative: Case number PHEH2013US026642 is an initial spontaneous report received from a pharmacist on 30 DEC 2013. This case refers to a 21 years old female patient. Her medical history, past drugs, current conditions and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: X12011), intramuscularly on 26 DEC 2013. On 27 DEC 2013, she experienced a large, painful red spot at the vaccination site that was about 5-6 inches in diameter. She also experienced sluggishness, fever and swollen lymph nodes. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events were not reported.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Case number PHEH2013US026272, is an initial spontaneous report received from the nurse on 20 Dec 2013. This report refers to a 17-year-old female patient. Her medical history and concomitant medications were not reported. She received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: M13015, expiry date: Sep 2014), intramuscularly without being reconstituted with Men A lyophilized conjugate vaccine component on 10 Dec 2013. No adverse event was reported following this administration error.
Sex: U
Vaccine: MNQ
Symptoms: Accidental exposure to product, Product packaging issue
Clinical narrative: Case number PHEH2013US026603 is an initial spontaneous report received from a nurse on 26 Dec 2013. This report refers to a doctor of unknown age and gender. On 26 Dec 2013, when the doctor pulled out MENVEO (batch number: M13051, expiry date: 31 May 2015) from the box, the vial containing the powder broke off and the powder spilled out all over the box and on to the fingers of the doctor. No dose was injected to the patient. No adverse event was reported.
Sex: U
Vaccine: MNQ
Symptoms: Accidental exposure to product, No adverse event, Product packaging issue
Clinical narrative: Case number PHEH2013US026605 is an initial spontaneous report received from a nurse on 26 Dec 2013. This report refers to a nurse of an unknown age and gender. On 26 Dec 2013, when the doctor pulled out MENVEO (batch number. M13051, expiry date: 31 May 2015) the vial containing the powder broke off and the powder spilled out all over the box and on to the fingers of the nurse. No adverse event was reported.