chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US003148 is an initial spontaneous report from a nurse received on 10 Feb 2015. This report refers to a 11 year old patient of an unknown gender. The patient was vaccinated with MENVEO (batch number: M14071, expiry date: Nov 2015) at a dose of 0.5 ml intramuscularly on 03 Feb 2015. It was reported that the vaccine which was given to the patient was frozen with excursions at 0.4 Celsius for 1 hour 16 minutes on 14 Jan 2015, at 0.8 Celsius for 36 minutes on 24 Jan 2015 and at 0.6 Celsius for 35 minutes on 31 Jan 2015. No adverse event reported following this medication error.
Age: 11.0
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US003149, is an initial spontaneous report from a nurse received on 10 Feb 2015. This report refers to an 11 year old patient of an unknown gender. The patient was vaccinated with MENVEO (batch number: M14071, expiry date: Nov 2015) intramuscularly on 19 Jan 2015. It was reported that the vaccine was frozen with excursion of 0.4 Celsius for 1 hour 16 minutes on 14 Jan 2015, 0.8 C for 36 minutes on 24 Jan 2015 and 0.6 C for 35 minutes on 31 Jan 2015. No adverse event reported following this medication error (incorrect storage of drug).
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US002937, is an initial spontaneous report received from a nurse on 09 Feb 2015. This report refers to a 17-year-old female patient. Historical condition and concomitant medication were not reported. The patient was vaccinated with MENVEO (batch number M14030) intramuscularly at a dose of 0.5 ml on 24 Nov 2014. It was reported that before administration, the MENVEO was stored at a temperature greater than 45 degree Fahrenheit for a total of 35 hours. On 17 Nov 2014, it was stored at 55.1 degree Fahrenheit for unknown period of time. No adverse event was reported following this administration error.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US002940, is an initial spontaneous report received from a nurse on 09 Feb 2015. This report refers to a 17-years-old female patient. Historical condition and concomitant medication were not reported. It was reported that before administration, MENVEO (batch number: M14030) was stored at a temperature greater than 45 degree Fahrenheit for a total of 35 hours. On 17 Nov 2014, MENVEO was stored at 55.1 degree Fahrenheit for unknown period of time and the patient was vaccinated on 18 Nov 2014 intramuscularly at a dose of 0.5 ml with this vaccine which was stored outside recommended storing temperature. No adverse event was reported following this administration error (incorrect storage of drug).
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case number PHEH2015US003113, is an initial spontaneous report received from a nurse on 10 Feb 2015. This report refers to a 15 year old female patient. Historical condition and concomitant medication were not reported. On an unknown date, the patient was vaccinated with MENVEO for the first time when her age was 11 years. She was again vaccinated with another dose of MENVEO (batch number: X14071) intramuscularly on 04 Feb 2015 when she was 15 year old. No adverse event was reported following this administration error (inappropriate schedule of vaccine administered).
Age: 0.5
Sex: M
Vaccine: MNQ
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case number PHEH2015US003117, is an initial spontaneous report received from a medical assistant on 10 Feb 2015. This report refers to a 6 month old male patient. Historical condition and concomitant medication were not reported. By mistake, the patient was vaccinated with MENVEO (batch number: A14071) intramuscularly on 05 Feb 2015 instead of the schedule date of 07 Feb 2015. No adverse event was reported following this administration error (inappropriate schedule of vaccine administered).
Age: 15.0
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US003118, is an initial spontaneous report received from a nurse on 10 Feb 2015. This report refers to a 15 year old patient of unknown gender. Historical condition and concomitant medication were not reported. On 28 Jan 2015, the patient was vaccinated with MENVEO (batch number: M14071, expiry date: Nov 2015) intramuscularly at a dose of 0.5 ml. The reporter stated that, before vaccination the MENVEO had a temperature excursion. On 14 Jan 2015, it was stored at 0.4 degree Celsius for 16 hours and on 24 Jan 2015, it was stored at 0.8 degree C for 36 minutes. No adverse event was reported following this administration error (incorrect storage of drug).
Age: 15.0
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US003124, is an initial spontaneous report received from a nurse on 10 Feb 2015. This report refers to a 15 year old patient of unknown gender. Historical condition and concomitant medication were not reported. On 30 Jan 2015, the patient was vaccinated with MENVEO (batch number: M14071, expiry date: Nov 2015) intramuscularly at a dose of 0.5 ml. The reporter stated that, before vaccination the MENVEO had a temperature excursion. On 14 Jan 2015, it was stored at 0.4 degree Celsius for 16 hours and on 24 Jan 2015, it was stored at 0.8 degree C for 36 minutes. No adverse event was reported following this administration error (incorrect storage of drug).
Age: 16.0
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This report refers to a 16 year old patient of unknown gender. Historical condition and concomitant medication were not reported. On 05 Feb 2015, the patient was vaccinated with MENVEO (batch number: M14071, expiry date: Nov 2015) intramuscularly at a dose of 0.5 ml. The reporter stated that, before vaccination the MENVEO had a temperature excursion. On 14 Jan 2015, it was stored at 0.4 degree Celsius for 16 hours; on 24 Jan 2015, it was stored at 0.8 degree C for 36 minutes and on 31 Jan 2015, it was stored at 0.6 degree C for 35 minutes. No adverse event was reported following this administration error.
Age: 16.0
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US003126, is an initial spontaneous report from a nurse received on 10 Feb 2015. This report refers to a 16 years old patient of an unknown gender. The patient was vaccinated with MENVEO (batch number: M14071, expiry date: Nov 2015) at a dose of 0.5 ml intramuscularly on 04 Feb 2015. It was reported that the vaccine which was given to the patient was frozen with excursion at 0.4 Celsius for 1 hour 16 minutes on 14 Jan 2015, at 0.8 Celsius for 36 minutes on 24 Jan 2015 and at 0.6 Celsius for 35 minutes on 31 Jan 2015. No adverse event reported following this medication error (incorrect storage of drug).
Age: 59.0
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Blood test, Chills, Computerised tomogram, Dehydration
Clinical narrative: Severe headache, chills, vomiting, blurry vision, stiff, weak, dehydrated.
Age: 59.0
Sex: M
Vaccine: TDAP
Symptoms: Electrocardiogram, Headache, Lumbar puncture, Musculoskeletal stiffness, Vision blurred
Clinical narrative: Severe headache, chills, vomiting, blurry vision, stiff, weak, dehydrated.
Age: 59.0
Sex: M
Vaccine: TDAP
Symptoms: Vomiting
Clinical narrative: Severe headache, chills, vomiting, blurry vision, stiff, weak, dehydrated.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site inflammation, Injection site pain, Injection site warmth
Clinical narrative: Headache started 5/18/16 in the evening; then on 5/19/16 her left lateral upper arm became inflamed, warm, painful, red. She also developed severe nausea and vomiting.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Vomiting
Clinical narrative: Headache started 5/18/16 in the evening; then on 5/19/16 her left lateral upper arm became inflamed, warm, painful, red. She also developed severe nausea and vomiting.
Age: 17.0
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US03127, is an initial spontaneous report from a nurse received on 10 Feb 2015. This report refers to a 17 years old patient of an unknown gender. The patient was vaccinated with MENVEO (batch number: M14071, expiry date: Nov 2015) at a dose of 0.5 ml intramuscularly on 06 Feb 2015. It was reported that the vaccine which was given to the patient was frozen with excursions at 0.4 Celsius for 1 hour 16 minutes on 14 Jan 2015, at 0.8 Celsius for 36 minutes on 24 Jan 2015 and at 0.6 Celsius for 35 minutes on 31 Jan 2015. No adverse event reported following this medication error.
Age: 17.0
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US003128, is an initial spontaneous report from a nurse received on 10 Feb 20155. This report refers to a 17 years old patient of an unknown gender. The patient was vaccinated with MENVEO (batch number: M14071, expiry date: Nov 2015) at a dose of 0.5 ml intramuscularly on 03 Feb 2015. It was reported that the vaccine which was given to the patient was frozen with excursions at 0.4 Celsius for 1 hour 16 minutes on 14 Jan 2015, at 0.8 Celsius for 36 minutes on 24 Jan 2015 and at 0.6 Celsius for 35 minutes on 31 Jan 2015. No adverse event reported following this medication error.
Age: 17.0
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US003129 is an initial spontaneous report from a nurse received on 10 Feb 2015. This report refers to a 17 year old patient of an unknown gender. The patient was vaccinated with MENVEO (batch number: M14071, expiry date: Nov 2015) at a dose of 0.5 ml intramuscularly on 26 Jan 2015. It was reported that the vaccine which was given to the patient was frozen with excursion at 0.4 Celsius for 1 hour and 16 minutes on 14 Jan 2015 and at 0.8 Celsius for 36 minutes on 24 Jan 2015. No adverse event reported following this medication error (incorrect storage of drug).
Age: 18.0
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US003131, is an initial spontaneous report from a nurse received on 10 Feb 2015. This report refers to a 18 year old patient of an unknown gender. The patient was vaccinated with MENVEO (batch number: M14071, expiry date: Nov 2015) at a dose of 0.5 ml intramuscularly on 26 Jan 2015. It was reported that the vaccine which was given to the patient was frozen with excursions at 0.4 Celsius for 1 hour 16 minutes on 14 Jan 2015 and at 0.8 Celsius for 36 minutes on 24 Jan 2015. No adverse event reported following this medication error.
Age: 10.0
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US003134 is an initial spontaneous report received from a nurse on 10 Feb 2015. This report refers to a 10 years old patient whose gender was not reported. The patient's medical history and concomitant medications were not reported. On 14 Jan 2015, MENVEO (batch number: M14071, expiry date: Nov 2015) was at 0.4 degree Celsius for 1 hour and 16 minutes and the patient received 0.5 ml intramuscular dose of this frozen vaccine with excursion on 20 Jan 2015. The vaccine had two more other excursion as follows: on 24 Jan 2015, the vaccine was at 0.8 degree Celsius for 36 minutes and on 31 Jan 2015 the vaccine was at 0.6 degree Celsius for 35 minutes. No adverse events were reported following the maladministration.
Age: 11.0
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US003135 is an initial spontaneous report received from a nurse on 10 Feb 2015. This report refers to an 11 years old patient whose gender was not reported. The patient's medical history and concomitant medications were not reported. On 14 Jan 2015, MENVEO (batch number: M14071, expiry date: Nov 2015) was at 0.4 degree Celsius for 1 hour and 16 minutes and the patient received 0.5 ml intramuscular dose of this frozen vaccine with excursion on 02 Feb 2015. The vaccine had two more other excursion as follows: on 24 Jan 2015, the vaccine was at 0.8 degree Celsius for 36 minutes and on 31 Jan 2015 the vaccine was at 0.6 degree Celsius for 35 minutes. No adverse events were reported following the maladministration.
Age: 10.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US001318, is an initial spontaneous report from a medical assistant received on 14 Jan 2015. This report refers to an 11-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. He was vaccinated with MENVEO (batch number: M14070) intramuscularly at a dos of 0.5 ml on 09 Jan 2015. It was reported that patient may have received MENVEO that reached 32 F for 16 hours. The reporter stated that the vaccine did not freeze. The backup thermometers in the refrigerator did not identify the temperature excursion and the thermometer that identified excursion was faulty. Therefore the reporter was not sure if the excursion had occurred at all. No adverse event was reported following this medication error.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2015US001398, is an initial spontaneous report from a pharmacist received on 15 Jan 2015. This report refers to a 19-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was administered only MenCYW-135 liquid component of MENVEO (batch number: X14089) without being reconstituted with MenA intramuscularly on 15 Jan 2015. No adverse event was reported following the administration error (inappropriate preparation of medication).
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2015US001686, is an initial spontaneous report from a nurse received on 21 Jan 2015. This report refers to a 11-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was administered only MenCYW-135 liquid component of MENVEO (batch number: X14082) without being reconstituted with MenA intramuscularly on 19 Jan 2015. No adverse event was reported following the administration error.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2015US002051, is an initial spontaneous report from a medical assistant (MA) received on 27 Jan 2015 and with a follow up report received on 23 Mar 2015. This report refers to a 16-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. Her vaccination history included administration of MENVEO (batch number: not reported), on 24 Mar 20101 which was well tolerated. She was administered incorrectly with only MenA powder component of MENVEO (batch number: M14044) reconstituted with sterile solution instead of Men-CYW-135 intramuscularly on 12 Jan 2015. No adverse event was reported following the administered errors.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2015US002052, is an initial spontaneous report from a medical assistant (MA) received on 27 Jan 2015 and with a follow up report received on 23 Mar 2015. This report refers to an 11-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was administered MenCYW-135 liquid component of MENVEO (batch number: M14044) without being reconstituted with MenA, intramuscularly on 19 Jan 2015. No adverse event was reported following the administration error (inappropriate preparation of medication). Follow up report received from MA on 23 Mar 2015: Added patient demographic details.
Age: 16.0
Sex: F
Vaccine: MEN, MNQ
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Case number PHEH2015US002315, is an initial spontaneous report received from physician on 29 Jan 2015. This report received 16 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENOMUNE (batch number: UH532AA) instead of MENVEO (batch number: not reported) on 28 Jan 2015. The reporter was intended to administer MENVEO. No adverse events reported after the maladministration.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2015US002320, is an initial spontaneous report received from a physician on 30 Jan 2015. This report refers to a 14 year old male patient. Medical history and concomitant medication was not reported. He was vaccinated with expired MENVEO (batch number: M13014) intramuscular on 30 Jan 2015. No adverse event was reported. No further information was provided.
Age: 49.0
Sex: M
Vaccine: HEP
Symptoms: Dizziness, Dyspnoea, Palpitations
Clinical narrative: Heart racing,difficulty breathing, dizzy. It passed after about 15 minutes with no treatment.
Age: 58.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Headache, Myalgia, Pyrexia
Clinical narrative: Patient reported feeling weakness, muscle aches, a slight fever and headache a few days after the vaccine was administered. Patient will follow up with PCP if symptoms persist.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Muscle twitching
Clinical narrative: Felt muscle twitching all around his body. Not treated.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, warmth, pain at injections site of right deltoid.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: REDNESS AROUND INJECTION SITE AND MILD ITCHING. NO PAIN OR SORENESS REPORTED.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pruritus, Skin lesion
Clinical narrative: Itchy, painful lesions all over trunk and upper arms.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Chest discomfort, Headache, Rash, Rash pruritic, Urticaria
Clinical narrative: Itchy, hive-like rash on both arms; mild headache; chest tightness.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient presented to ER with C/O Pain, swelling and warmth to injection site. Pneumonia Vaccine administered today approximately 1100 by PCP office, unknown administrator/Lot/Exp date as it is not charted in system at this time. Patient to be seen by ER Physician for further treatment Care at this time. Patient did NOT take TYLENOL/IBUPROFEN PTA.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Lymphadenopathy
Clinical narrative: PATIENT WAS GIVEN HUMIRA FROM ANOTHER PHARMACY ON 5/12/16. THE NEXT MORNING THE PATIENT WOKE UP WITH AN EGG SIZED RAISED RED AREA ON THE SAME ARM IN THE SAME AREA WHERE HERE PREVNAR AND TWINRIX VACCINES WERE PREVIOUSLY ADMINISTERED.  SHE ALSO HAD WHAT SHE THOUGHT WAS A BASEBALL SIZED ENLARGED LYMPH NODE UNDER THE LEFT ARM.
Age: 37.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2015US000726, is an initial spontaneous report from a physician received on 06 Jan 2015. This report refers to a 37-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. He was administered only MenCYW-135 liquid component of MENVEO (batch number: M14044) without being reconstituted with MenA, intramuscularly on 01 Jan 2015. No adverse event was reported following the administration error.
Age: 7.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2015US00652, is an initial spontaneous report received from a nurse on 05 Jan 2015. This report refers to a 07 years old female patient. Past medical history and concomitant medication were not reported. She received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: X14030), intramuscularly without being reconstituted with Men A lyophilized conjugate vaccine component on 22 Dec 2014. No adverse event was reported following this administration error (inappropriate preparation of medication).
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from the patient's daughter, who was also a company representative and refers to a 69 year old female patient. The patient's medical history and drug reactions or allergies were not reported. The patient's concurrent conditions included diabetes. In approximately 2013 (reported as 3 or 4 years before the onset of shingles), the patient was vaccinated with a dose of ZOSTAVAX injection, route of administration reported as '"injection" (site of administration, dose, lot number and expiration date were not reported). Other suspect therapies included JANUMET oral tablet (strength, dose, frequency, indication, lot number and expiration date were not reported). Concomitant drugs included unspecified medications. In May 2016 (reported as last week), the patient had surgery on shoulder. On 10-MAY-2016, the patient developed shingles. The patient sought medical attention as she spoke with physician. It was not reported if any lab diagnostic studies were performed. The event of shingles was treated with NEURONTIN and ZOVIRAX. The outcome of surgery on shoulder was not reported. The outcome of shingles was reported as not recovered. The relatedness between the events and the therapy with ZOSTAVAX and JANUMET was not reported. Upon internal review, surgery on shoulder was determined to be medically significant. Additional information is not expected as no consent for follow up was provided.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2015US000723, is an initial spontaneous report from a nurse received on 06 Jan 2015 and with follow-up information received from a nurse received on 09 Mar 2015. This report refers to an 11-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. Concomitant vaccinations included VARIVAX (batch number: unknown, other manufacturer) and BOOSTRIX (batch number: unknown, other manufacturer). She was administered only MenCYW-135 liquid component of MENVEO (batch number: M14021, X14021) without being reconstituted with MenA, intramuscularly into right arm on 30 Dec 2014. No adverse event was reported following this administration error. Follow-up received from a nurse received on 09 Mar 2015: Concomitant vaccinations (VARIVAX and BOOSTRIX), batch number of MENVEO (M14021) and site of vaccination (right arm) were updated.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2015US001208 is an initial spontaneous report from a nurse received on 13 Jan 2015. This report refers to a patient of an unknown age and gender. The patient was vaccinated with only Men CYW-135 liquid component of MENVEO (batch number: M14042) intramuscularly without reconstitution with the lyophilized Men A component on 17 Dec 2014. No adverse event reported following this medication error (inappropriate preparation of medication).
Age: 46.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2014US023378 is an initial spontaneous report received from a pharmacist on 19 Nov 2014. This report refers to a 46 year old male patient. Past medical history and concomitant medications was not reported. He received only Men A lyophilized conjugate component of MENVEO (batch number: A14030), intramuscularly reconstituted with a sterile water instead of MenCYW-135 liquid component on 21 Aug 2014. No adverse reaction was reported following this administration error.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2015US000753, is an initial spontaneous report from a nurse received on 07 Jan 2015. This report refers to a 16-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. He was administered incorrectly with MenA powder component of MENVEO (batch number: A14069) reconstituted with sterile diluent instead of Men-CYW-135, intramuscularly on 29 Dec 2014. No adverse event was reported following the maladministration.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Inappropriate schedule of drug administration, Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US000738, is an initial spontaneous report received from a nurse on 05 Jan 2015 and combined follow up report received from the nurse on 19 Mar 2015. This report refers to a 11-year-old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with MENVEO (batch number: M14068), intramuscularly on 05 Jan 2014, which had a temperature excursion of 1 degree Celsius for 20 hours. No adverse event was reported following this administration error. The patient was contacted, waited for 60 days and then the patient received a repeated dose of MENVEO on 11 Mar 2015 due to possible non-viability. The patient was doing fine. No adverse event was reported following this administration error. Combined follow up report received from the nurse on 19 Mar 2015: Report type changed from other to spontaneous, patient's demographics and new event inappropriate schedule of vaccine administered was added.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2014US026193, is an initial spontaneous report received from a nurse on 31 Dec 2014. This report refers to a 16 years old female patient. Past medical history and concomitant medication were not reported. She received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: M14056), intramuscularly without being reconstituted with Men A lyophilized conjugate vaccine component on 24 Dec 2014. No adverse event was reported following this administration error.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2015US001090 is an initial combined spontaneous report received from a health care professional on 12 Jan 2015 with a follow up information received from a physician on 13 Jan 2015 This report refers to an 11 years old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MenCYW-135 liquid component of MENVEO (batch number: X140711) intramuscularly on 12 Jan 2015 in error without reconstituting with Men A lyophilized powder conjugate. The physician reported that the patient either received one vial of the MenCYW-135 liquid component or two vials of MenCYW-135 liquid component on 12 Jan 2015. No adverse event was reported following the maladministration.
Age: 18.0
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US003133 is an initial spontaneous report received from a nurse on 10 Feb 2015. This report refers to an 18 years old patient whose gender was not reported. The patient's medical history and concomitant medications were not reported. On 14 Jan 2015, MENVEO (batch number: M14071, expiry date: Nov 2015) was at 0.4 degree Celsius for 1 hour and 16 minutes and the patient received 0.5 ml intramuscular dose of this frozen vaccine with excursion on 19 Jan 2015. The vaccine had two more other excursion as follows: On 26 Jan 2015, the vaccine was at 0.8 degree Celsius for 36 minutes and on 31 Jan 2015 the vaccine was at 0.6 degree Celsius for 35 minutes. No adverse events were reported following the maladministration.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US024163 is an initial spontaneous report received from a health care professional on 01 Dec 2014. 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: A13046) intramuscularly at a dose of 0.5 ml on 13 Nov 2014. It was reported that the vaccine reached 0 to 1 degree C sporadically for 3 days when it was not reconstituted and was subsequently administered to the patient. The reporter stated that the vaccine did not freeze and it was the first occurrence. No adverse events were reported following the maladministration.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case number PHEH2015US000979, is an initial spontaneous report received from a medical assistant on 12 Jan 2015, and with a follow up report received from medical assistant on 02 Feb 2015. This report refers to a 12 year old male patient. Historical condition and concomitant medication were not reported. He was vaccinated with two doses of meningococcal ACWY vaccine (manufacturer and batch number: not reported) 0.5 ml intramuscular on 05 Dec 2008 (at 11 year of age) and on 15 Aug 2010 (at 12 year of age). These were given at another providers office, details are not available. Unsure whether the vaccine was MENACTRA (other manufacturer, batch number: not reported) or MENVEO (batch number: unknown). No adverse event was reported following this administration error. No further information was provided. Follow up report received from medical assistant on 02 Feb 2015. Updated vaccination details.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US001317, is an initial spontaneous report from a medical assistant received on 14 Jan 2015. This report refers to a 12-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. He was vaccinated with MENVEO (batch number: M14070) intramuscularly at a dose of 0.5 ml on 08 Jan 2015. It was reported that patient may have received the MENVEO that reached 32 F for 16 hours. The reporter stated that the vaccine did not freeze. The backup thermometers in the refrigerator did not identify the temperature excursion and the thermometer that identified excursion was faulty. Therefore the reporter was not sure if the excursion had occurred at all. No adverse event was reported following this medication error.
Age: 23.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2015US001210, is an initial spontaneous report from a nurse received on 14 Jan 2015 with a follow up information received from the nurse on 18 Feb 2015. This report refers to a 23 years old female patient. She had unspecified medical history. No concomitant medication was reported. Her vaccination history included administration of previous doses of MENVEO (batch number: not reported) which was well tolerated. It was reported that the vaccine mixing was incorrect and she was administered only 0.5 ml MenCYW-135 liquid component of MENVEO (batch number: M14080) intramuscularly without being reconstituted with MenA lyophilized conjugate on 09 Jan 2015 at 10:00 (booster dose). No adverse event was reported following the administration error. Follow up information received from the nurse on 18 Feb 2015: Updated vaccination history and narrative.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US024162, is an initial spontaneous report from a health care professional received on 01 Dec 2014. This report refers to an 11-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. He was vaccinated with MENVEO (batch number: A13046) intramuscularly at a dose of 0.5 ml on 12 Nov 2014. It was reported that the vaccine reached 0 to 1 degree C sporadically for 3 days when it was not reconstituted and was subsequently administered to the patient. The reporter stated that the vaccine did not freeze and it was the first occurrence. No adverse events were reported following the maladministration.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US024437, is an initial spontaneous report received from a nurse on 04 Dec 2014 and with follow-up received from a nurse on 21 Jan 2015. This report refers to a 17 year old female patient. Concurrent conditions included smoking and occasional alcohol use. All previous vaccinations were well tolerated. The patient received MENVEO (batch number: M14030) at a dose of 0.5 ml into right deltoid intramuscularly on 05 Nov 2014 at 08:56. It was reported that the patient received MENVEO which had 27 temperature excursions more than 46 degree F with the temperature excursions lasting 30 minutes each time. No adverse event was reported. No further information was provided. Follow-up received from a nurse received on 21 Jan 2015: Patients demographics (height and weight), concurrent conditions, vaccine details (dose, site, date and time) were updated.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US024633, is an initial spontaneous report from a health care professional (medical assistant) received on 04 Nov 2014. This report refers to a 17-year-old male patient. Past medical history and concomitant medications were not reported. On 26 Oct 2016, he was vaccinated with intramuscular dose of MENVEO (batch number: M14068) that was at 20.11 F for 49 hours (did not freeze). No adverse event was reported following this medication error (incorrect storage of drug).
Age: 60.0
Sex: F
Vaccine: MNQ
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2015US001175, is an initial spontaneous report from a pharmacist received on 14 Jan 2015. This report refers to a 60-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with MENVEO (batch number: M14024) intramuscularly on 13 Jan 2015. No adverse event was reported following the maladministration.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2014US024629 is an initial spontaneous report received from a nurse on 05 Dec 2014. This report refers to a patient of an unknown age and gender. The patient was inadvertently vaccinated with only Men CYW liquid component of MENVEO (batch number: not reported) intramuscularly without reconstitution with Men A lyophilized component on 21 Nov 2014. No adverse event reported following this medication error.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2014US019861 is an initial spontaneous report from a medical assistant received on 01 Oct 2014 with a follow up information received from a medical assistant on 24 Nov 2014 and a follow up report from the medical assistant received on 12 Jan 2015. This report refers to an 11-year-old female patient. Historical conditions were not reported. Her vaccination status was up to date. Concomitant vaccination included 0.5 ml of BOOSTRIX (batch number: LF444) and 0.5 ml of GARDASIL (batch number: J009788, other manufacturer) intramuscularly on 16 Sep 2014. She was administered only MenCYW-135 liquid component of MENVEO (batch number: M14067) initial dose without being reconstituted with MenA intramuscularly in the right arm on 16 Sep 2014. No adverse event was reported following the administration error. Follow up information received from a medical assistant on 24 Nov 2014: Patient demographics (height and weight), vaccination status and concomitant vaccination updated. Follow up report from the medical assistant received on 12 Jan 2015: Updated concomitant drug (GARDASIL), batch number of BOOSTRIX and vaccination site of MENVEO.
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2014US025229 is an initial spontaneous report received from a nurse on 11 Dec 2014. This report refers to a patient of unknown age and gender. Past medical history and concomitant medications was not reported. The patient received only Men A lyophilized conjugate component of MENVEO (batch number: not reported), intramuscularly reconstituted wit a sterile water instead of MenCYW-135 liquid component on 10 Dec 2014. No adverse reaction was reported following this administration error.
Age: 61.0
Sex: M
Vaccine: MNQ
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US024686, is an initial spontaneous report received from a nurse on 08 Dec 2014. This report refers to a 61 year old male patient. His medical history and concomitant medication was not reported. He was vaccinated with MENVEO (batch number: unknown) on 08 Dec 2014. No adverse reaction was reported. No further information was provided.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US025544, is an initial spontaneous report received from a medical assistant on 12 Dec 2014. This report refers to a patient of unknown age and gender. Past medical history and concomitant medication were not reported. The patient was vaccinated with MENVEO (batch number: unknown), on an unknown date, which was at 49.2 F for 3.5 hours on 29 Nov 2014. No adverse event was reported following this administration error.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2014US025837 is an initial spontaneous report received from a nurse on 23 Dec 2014. This case refers to a 16 year old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with an expired dose of MENVEO (batch number: A12104, expiry date: Sep 2014) intramuscularly on 23 Dec 2014. 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 PHEH2014US025902, is an initial spontaneous report from a nurse (patient mother) received on 23 Dec 2014. This report refers to an 11-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was administered only MenCYW-135 liquid component of MENVEO (batch number: 14031) without being reconstituted with MenA, intramuscularly on 11 Nov 2014. No adverse event was reported following the administration error.
Age: 67.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2014US024788, is an initial spontaneous report received from a medical assistant on 09 Dec 2014, with a follow up report received from the medical assistant on 09 Feb 2015. This report refers to a 67-year-old female patient. Historical condition was not reported. Concurrent conditions included diabetes, hypercholesterolemia and hypothyroidism. No concomitant medication was reported. She was vaccinated only with the MenCYW-135 liquid component of MENVEO (batch number: X14041) without being reconstituted with MenA, intramuscularly in left deltoid on 09 Dec 2014 at around 1:30 PM. Patient did not experience any adverse event following this administration error. Follow up report received from the medical assistant on 09 Feb 2015: Updated patient demographics, vaccination details and reporter's statement in the narrative.
Age: 19.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2015US001244, is an initial spontaneous report from a health care professional received on 13 Jan 2015. This report refers to a 19-years-old male patient. Historical conditions were not reported. No concomitant medication was reported. He was administered only MenCYW-135 liquid component of MENVEO (batch number: X14023) without being reconstituted with MenA lyophilized conjugate intramuscularly on 09 Jan 2015. No adverse event was reported following the administration error.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2014US026183 is an initial spontaneous report received from a medical assistant on 31 Dec 2014. This case refers to a 12 year old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with MENVEO (batch number: A13016) intramuscularly on 31 Dec 2014. It was reported that, Men CYW liquid component vial which expires on Dec 2015 and Men A lyophilized component vial which expired on Sep 2014. No adverse event was reported following this administration error.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2014US023269, is an initial spontaneous report from a physician received on 18 Nov 2014 with a follow up information received from a physician on 13 Jan 2015. This report refers to an 11-year-old male patient. His current conditions included morbid obesity, allergic rhinitis and multiple food allergies. His concomitant medications were not reported. His vaccination status was up to date. The patient received an initial 0.5 ml intramuscular dose of MENVEO (batch number: A13012/X13012) on 03 Nov 2014 at 9:53 am. His concomitant vaccination included a booster dose of BOOSTRIX (other manufacturer, batch number: N4277) at a dose of 0.5 ml intramuscularly on the same date. It was reported that the patient received Men A lyophilized powder component which was expired in Sep 2014. No adverse event was reported following this medication error. Follow up information received from a physician on 13 Jan 2015: Updated patient demographics (height and weight), vaccination status, current conditions and concomitant vaccination.
Age: 14.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US023371 is an initial spontaneous report received from a medical assistant on 19 Nov 2014. This report refers to a 14 years old female patient. Her medical history and concomitant were not reported. She was vaccinated with 0.5 ml intramuscular MENVEO (batch number: M14040) on 19 Nov 2014. It was reported that the administered vaccine was stored below recommended temperature for a week. No adverse events were reported following the medication error.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US002563 is an initial spontaneous report received from a health care professional (office manager) on 02 Feb 2015 and with a follow up report received from physician on 17 Mar 2015. This report refers to a 16 year old female patient. The patient was vaccinated with MENVEO (batch number: unknown) into the left deltoid at a dose of 0.5 ml on 21 Oct 2014. The patient received the vaccine that had a temperature excursion of 30 degree Fahrenheit for 17 hours. The vaccine was not frozen. The reporter stated that the dose of MENVEO was reconstituted and pre-drawn into a syringe and then administered after the temperature excursion. No adverse event was reported. No further information was provided. Follow up report received from physician on 17 Mar 2015: updated patient demographics, date of vaccination and site of vaccination.
Age: 16.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2014US020241 is an initial spontaneous report from a nurse received on 08 Oct 2014 with a follow up information received from a nurse on 04 Nov 2014. This report refers to a 16 years old male patient. His medical history was not reported. His vaccination status was not up to date and records were missing. His vaccination history included administration of MENVEO (batch number: not reported) on 02 Oct 2009 which was well tolerated. Concomitant vaccination included GARDASIL (batch number: K004205) at a dose of 0.5 ml intramuscularly in the left deltoid on 29 Sep 2014. The patient was inadvertently vaccinated with only Men CYW-135 liquid component of MENVEO (batch number: M14030) intramuscularly at a dose of 0.5 ml in the right deltoid on 29 Sep 2014 without reconstituting with Men A lyophilized component. No adverse event reported following this medication error. Follow up information received from a nurse on 04 Nov 2014: Patient demographics (date of birth age, height and weight), concomitant vaccination, vaccination history, batch number and site of administration of suspect vaccination updated.
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2015US002764, is an initial spontaneous report received from a nurse on 04 Feb 2015. This report refers to a patient of unknown age and gender. The patient's medical history and concomitant medications were not reported. The patient was vaccinated with only diluent (liquid component) of MENVEO (batch number: not reported) without reconstituting with lyophilized component on unspecified date. No adverse events reported after the maladministration.
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2014US022834, is a combined initial and follow up spontaneous report received from a nurse on 11 Nov 2014 and on 14 Nov 2014, with a follow up received from a nurse on 22 Dec 2014. This report refers to a patient of unknown demographics. Past medical history and concomitant medication were not reported. On an unknown date between Aug 2014 and 10 Nov 2014, the patient was vaccinated only with the liquid component (MenCYW) of MENVEO (batch number: A14025) without being reconstituted with MenA powder via intramuscular route into the deltoid. No adverse reaction was reported following this administration error. Follow up received form a nurse on 22 Dec 2014: updated site of vaccination and reporter comments.
Age: 27.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2014US023522 is an initial spontaneous report received from a pharmacist on 10 Nov 2014. This case refers to a 27 year old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with an expired dose of MENVEO (batch number: A12014 and expiry date: Sep 2014), on 08 Nov 2014. No adverse event was reported following this administration error.
Age: 17.0
Sex: M
Vaccine: FLU3, HPV4, MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2014US020250 is an initial spontaneous report from the nurse received on 08 Oct 2014 with a follow up report received from the nurse on 04 Nov 2014. This report refers to a 17 year old male patient. His past medical history was not reported. His concomitant vaccinations included GARDASIL (other manufacturer, batch number: J009788) at a dose of 0.5 ml intramuscularly and FLUVIRIN (batch number: 145204) at a dose of 0.5 ml intramuscularly on 06 Oct 2014. On 06 Oct 2014, at 11:06 AM, he was inadvertently vaccinated with a dose of MENVEO (batch number: M13015) of which the Men A lyophilised component was expired, at a dose of 0.5 ml intramuscularly into his left deltoid. No adverse event reported following this medication error. Follow up report was received from the nurse on 04 Nov 2014: Updated height and weight of the patient, concomitant vaccinations, event details, dose of MENVEO and anatomical site of vaccination of MENVEO.