chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Vaccination complication
Clinical narrative: Right shoulder pain and limited range of motion immediately after a "too high" influenza vaccine injection.  Pain has improved but is still present 7 months later. Diagnosis is Shoulder Injury Related to Vaccine Administration (SIRVA)
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Dyspnoea, Feeling hot, Palpitations, Tremor
Clinical narrative: Patient, Pharmacist, received Boostrix (Tetanus-diphtheria-acellular-pertussis) on 5/20 around 4:45pm. She was administered the vaccine via intramuscularly route in her right arm by pharmacist. About 5-10 minutes after receiving vaccine, patient states difficulty breathing, heat sensation to head, and heart pounding ie...palpitations. Her hands begin to shake and she ask pharmacist to give her Benadryl liquid per immunization kit in pharmacy. Pharmacist assist patient with receiving 1&1/2 teaspoonful of Benadryl liquid. Patient continues to complain of heat sensation to head and heart pounding in chest. Pharmacist and Technican call 911 and paramedics arrive within 15 minutes of phone call to store pharmacy. Pharmacist alerts, Management for further information and to alert spouse of patient. Patient, Pharmacist, is assisted by paramedics to hospital. She later contacts Pharmacist and states to alert pharmacy team she is feeling much better after leaving emergency room.
Age: 29.0
Sex: F
Vaccine: MMR, TD, VARCEL, MMR, TD, VARCEL
Symptoms: Pyrexia, Rash generalised, Rash pruritic, Varicella post vaccine
Clinical narrative: Fever of 102 the following morning after receiving vaccine. The following day itchy chicken pox rash started and spread from head to toe- consistent with varicella illness.
Age: 29.0
Sex: F
Vaccine: MMR, TD, VARCEL, MMR, TD, VARCEL
Symptoms: Pyrexia, Rash, Rash generalised, Scab, Skin lesion
Clinical narrative: Fever of 102 the following morning after receiving vaccine. The following day itchy chicken pox rash started and spread from head to toe- consistent with varicella illness.
Age: 52.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Crying, Injection site pain, Malaise, Mobility decreased, Pain
Clinical narrative: Pharmacy came to Elementary to give vaccine.  Shortly after vaccine, the injection site became extremely painful.  Could not lift arm.  I had trouble starting my car with hurt arm.  Drove myself to doctors office crying uncontrollably due to pain. Once home I needed to call EMS and was taken into the ER due to extreme pain and ill feeling. Arm and shoulder never healed properly. I deal with pain daily.
Age: 52.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Pain in extremity
Clinical narrative: Pharmacy came to Elementary to give vaccine.  Shortly after vaccine, the injection site became extremely painful.  Could not lift arm.  I had trouble starting my car with hurt arm.  Drove myself to doctors office crying uncontrollably due to pain. Once home I needed to call EMS and was taken into the ER due to extreme pain and ill feeling. Arm and shoulder never healed properly. I deal with pain daily.
Age: 52.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Crying, Injected limb mobility decreased, Malaise, Pain in extremity, Vaccination site pain
Clinical narrative: Pharmacy came to Elementary to give vaccine.  Shortly after vaccine, the injection site became extremely painful.  Could not lift arm.  I had trouble starting my car with hurt arm.  Drove myself to doctors office crying uncontrollably due to pain. Once home I needed to call EMS and was taken into the ER due to extreme pain and ill feeling. Arm and shoulder never healed properly. I deal with pain daily.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US006400 is an initial spontaneous report received from a pharmacist on 28 Mar 2014. This report refers to an 11 year old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with MENVEO (batch number: M13017 and expiry date: 30 Sep 2014), at dose of 0.5 ml intramuscularly on 26 Mar 2014. The MENVEO reached 32 to 34 F for  up to 25 hours (at different time increments) within 8 day period and was subsequently administered to patient. Reporter does not believe that the vaccine was frozen. No adverse event reported following this administration error.
Age: 15.0
Sex: U
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Case number PHEH2014US005824 is an initial spontaneous report from a nurse received on 13 Mar 2014. This report refers to a patient of unknown demographics. Past medical history and concomitant medication were not provided. The patient was vaccinated with first dose of MENVEO (batch number: unknown) intramuscularly at age of 13 years old and second dose at age of 15 yrs and 10 months. No adverse event was reported following this medication error (inappropriate schedule of vaccine administered).
Age: 62.0
Sex: F
Vaccine: MNQ
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003780 is an initial spontaneous report from the pharmacist received on 21 Feb 2014. This report refers to a 62-year-old female patient who was accidentally vaccinated with MENVEO (batch number: A11077, expiry date: Apr 2014) at a dose of 0.5 ml intramuscularly on 11 Jan 2014. No adverse event occurred to the patient following this medication error (inappropriate age of vaccine administration).
Age: 34.0
Sex: M
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: Case number PHEH2014US004461, is an initial spontaneous report from a consumer (physician himself) received on 03 Mar 2014. This report refers to a 34-year-old male patient. Past medical history and concomitant medications were not reported. He was administered only MenA powder component of MENVEO (batch number: not provided) reconstituted with sterile water instead of Men-CYW-135, intramuscularly on 26 Feb 2014. He did not complain any adverse reaction following the administration error (wrong solution used in drug reconstitution).
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product reconstitution issue
Clinical narrative: Case number PHEH2014US004803 is an initial spontaneous report received from a medical assistant on 06 Mar 2014: This report refers to an adolescent male patient. He was given only the MenCYW-135 component of MENVEO (batch number: X13051) intramuscularly without being reconstituted with MenA on 04 Mar 2014. No adverse event was reported following this administration error (inappropriate preparation of medication).
Age: 18.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2014US004816 is an initial spontaneous report received from a practice manager on 06 Mar 2014 with a follow up report received from a physician on 28 Mar 2014. This report refers to an 18 year old male patient. His medical history and concomitant medication were not reported. His vaccination history included vaccination with MENVEO (batch number: not reported) and VARIVAX (other manufacturer, batch number: not reported) on 18 Jun 2008. On 06 Mar 2014 at 10:00 am, he was vaccinated with MENVEO (batch number: M13051/A13051) intramuscularly at a dose of 0.5 ml into right arm. It was reported that before administration, the MENVEO was erroneously mixed with the diluent of VARIVAX (batch number: J014066). He was also concomitantly vaccinated with GARDASIL (other manufacturer, batch number: C4461AA) at a dose of 0.5 ml into right arm on 7 Mar 2014. The reporter was unaware of any adverse reactions to the vaccine after this medication error. Follow up report received from a physician on 28 Mar 2014: Updated patient demographics (height and weight), vaccination history, concomitant vaccination, vaccine batch numbers and dose.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2014US004936 is an initial spontaneous report received from a nurse on 06 Mar 2014 with a follow up report received from the nurse on 27 Mar 2014. The report refers to 16 year old male patient. His current condition included allergy to 'ASA' and sulfonamide. His vaccination history included vaccination with MENVEO (batch number: not reported) which was well tolerated on an unknown date. It was reported that his vaccination status was up to date. On 06 Mar 2014 at 09:08 am, he was vaccinated with an expired dose of MENVEO (batch number: M11071, expiry date: 30 Dec 2013) intramuscularly at a dose of 0.5 ml into left deltoid. No adverse event was reporting following this administration error. Follow up report receive from the nurse on 07 mar 2014: Updated patient demographics (height and weight), current condition (allergy to sulfonamide and 'ASA'), vaccination history (MENVEO) and vaccination details (expiry date, time, site and dose).
Age: 66.0
Sex: M
Vaccine: MNQ
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003649 is an initial spontaneous report from the pharmacist received on 21 Feb 2014. This report refers to a 67-year-old male patient who was accidentally vaccinated with MENVEO (batch number: A11051) intramuscularly on 01 Jun 2013. No adverse event occurred to the patient following this medication error.
Age: 67.0
Sex: F
Vaccine: MNQ, PPV
Symptoms: Drug administered to patient of inappropriate age, Product preparation error
Clinical narrative: Case number PHEH2014US005003, is an initial spontaneous report from a nurse received on 10 Mar 2014, with a follow up received on 02 Apr 2014. This report refers to a 67-year-old female patient. Past medical history included spleen removal and immunocompromised. Concomitant medications were not reported. She was administered incorrectly with only MenA powder component of MENVEO (batch number: M13011) reconstituted with incorrect diluent (unspecified diluent) instead of Men-CWY-135, intramuscularly into the left arm on 20 Feb 2014. On the same day, she also administered PNEUMOVAX 23 (other manufacturer, batch number: H017759) intramuscularly. Also on an undetermined date, she was administered Hib vaccine (manufacturer and batch number: not reported) incorrectly. So the physician requested to administer ACT-HIB (other manufacturer, batch number: UH629AA) intramuscularly on 18 Mar 2014. She did not experience any adverse reactions due to the maladministration (wrong solution used in drug reconstitution and inappropriate age at vaccine administration). Follow up received on 02 Apr 2014: Updated medical history, concomitant medication, vaccination site, new event (wrong solution used in drug reconstitution) and deleted event (inappropriate preparation of medication).
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US006396 is an initial spontaneous report received from a pharmacist on 28 Mar 2014. This report refers to a 12 year old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with MENVEO (batch number: M13017 and expiry date: 30 Sep 2014) intramuscularly on 25 Mar 2014. The MENVEO reached 32 to34 F for up to 25 hours within 8 day period and was subsequently administered to patient. No adverse event reported following this administration error.
Age: 10.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product reconstitution issue
Clinical narrative: Case number PHEH2014US005188, is an initial spontaneous report received from a nurse on 12 Mar 2014. This report refers to a 10 years old male patient. He received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: X13011), intramuscularly without being reconstituted with Men A lyophilized conjugate vaccine  component on 10 Mar 2014. No adverse event was reported following this administration error.
Age: 68.0
Sex: M
Vaccine: MNQ
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003632 is an initial spontaneous report received from a pharmacist on 21 Feb 2014: This report refers to a 68-year-old male patient who was inadvertently vaccinated with MENVEO (batch number: unknown) intramuscularly at a dose 0.5ml on 25 Jan 2014. No adverse event was reported following this administration error (inappropriate age at vaccine administration).
Age: 64.0
Sex: F
Vaccine: MNQ
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003794 is an initial spontaneous report received from a pharmacist on 21 Feb 2014 with follow-up received on 24 Mar 2014. This report refers to a 64-year-old female patient. The patient's medical history and concomitant medications were not reported. It was reported that this patient over 55-years of age was vaccinated with a dose of MENVEO (batch number: A11052) intramuscularly into left deltoid at a dose of 0.5 ml on 21 Sep 2013 at 12:15. No adverse event was reported following the maladministration.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Product reconstitution issue
Clinical narrative: Case number PHEH2014US005295, is an initial spontaneous report received from a medical assistant on 12 Mar 2014. This report refers to an 11 years old female patient. She received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: X13014), intramuscularly without being reconstituted with Men A lyophilized conjugate vaccine component on 10 Mar 2014. No adverse event was reported following this administration error.
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Product reconstitution issue
Clinical narrative: Case number PHEH2014US005388, is an initial spontaneous report received from a health care professional on 14 Mar 2014. This report refers to an unknown age and gender patient. The patient received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: not reported), intramuscularly without being reconstituted with Men A lyophilized conjugate vaccine component on an unknown date (six or months ago). No adverse event was reported following this administration error.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Case number PHEH2014US005392 is an initial spontaneous report received from a physician on 14 Mar 2014. This report refers to a 17-years-old male patient. His medical history and concomitant medications were not reported. His vaccination history included administration of two doses of MENVEO (batch number: not reported) on Jul 2007 and Dec 2012 respectively. It was reported that he was inadvertently vaccinated with third dose of MENVEO (batch number: M13051) intramuscularly on 11 Mar 2014. No adverse events were reported following the maladministration.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US005596 is an initial spontaneous report received from a physician on 19 Mar 2014. This report refers to a patient of unknown age and gender. This patient was vaccinated with MENVEO (batch number: unknown) intramuscularly on an undetermined date. It was reported that the refrigerator at an off-site clinic was faulty for over a month causing the vaccine to reach above recommended temperatures. Temperature readings showed that the vaccine may have remained around 48 to 50 degree Fahrenheit (F) for several hours intermittently during the month with a maximum temperature of 57.2 degree F. No adverse event was reported following this administration error.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US005623 is an initial spontaneous report received from a health care professional on 18 Mar 2014 and with a follow up information received on 11 Apr 2014. This case was initially reported as a multiple patient case, but upon follow up receipt the identifiers were reported. This case refers to 12 year old male child patient. His medical history and concomitant medications were not reported. He received meningococcal polyvalent vaccine (unknown manufacturer, batch number: not reported), influenza vaccine (unknown manufacturer, batch number: not reported), hepatitis A vaccine (unknown manufacturer, batch number: not reported) and HPV vaccine (unknown manufacturer, batch number: not reported) on unknown dates. He was vaccinated with first dose of MENVEO (batch number: M12100) intramuscularly in right deltoid on 06 Mar 2014 at 8:30. It was reported that MENVEO had been stored below the recommended temperature at 1.9 degrees Celsius approximately for two hours (vaccine not frozen or not reconstituted). No adverse event was reported following this administration error. The patient was called for revaccination. Follow up information from the other health care professional on 11 Apr 2014: Reporter type, reporter information, patient identifiers, vaccination history, vaccination date and time, anatomical site of vaccination, temperature of storage of vaccine was updated.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product reconstitution issue
Clinical narrative: Case number PHEH2014US005805 is an initial spontaneous report received from the nurse on 20 Mar 2014 with a follow up information received from a nurse on 29 Apr 2014. This report refers to a 15 years old male patient. He received only 0.5 ml Men CYW-135 liquid component of MENVEO (batch number: M11076) intramuscularly in the left deltoid without reconstitution with Men A lyophilized component on 20 Mar 2014. No adverse event reported following this medication error. It was reported that he went back next week and received the full dose. Follow up information received from a nurse on 29 Apr 2014: Patient demographics (initials, date of birth, age), batch number, dose and site of vaccination and revaccination details updated.
Age: 11.0
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US005900, is an initial spontaneous report from a pharmacist received on 20 mar 2014. This report refers to an 11-year old patient of unknown gender. Past medical history and concomitant medications were not reported. The patient was vaccinated with MENVEO (batch number: M12100, expiry date: Sep 2014) intramuscularly at a dose of 0.5 ml that reached 34 Fahrenheit (1.1 degrees Celsius) for up to 24 hours on 30 Dec 2013. No adverse event was reported following the maladministration (incorrect storage of drug).
Age: 14.0
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US005902, is an initial spontaneous report from a pharmacist received on 20 Mar 2014. This report refers to a 14-year-old patient of unknown gender. Past medical history and concomitant medications were not reported. The patient was vaccinated with MENVEO (batch number: M12100, expiry date: Sep 2014) intramuscularly at a dose of 0.5 ml that reached 34 Fahrenheit (1.1 degrees Celsius) for up to 24 hours on 16 Jan 2014. No adverse event was reported following the maladministration (incorrect storage of drug).
Age: 15.0
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US005904, is an initial spontaneous report from a pharmacist received on 20 Mar 2014. This report refers to a 15-year-old patient of unknown gender. Past medical history and concomitant medications were not reported. The patient was vaccinated with MENVEO (batch number: M12100, expiry date: Sep 2014) intramuscularly at a dose of 0.5 ml that reached 34 Fahrenheit (1.1 degree Celsius) for up to 24 hours on 16 Jan 2014. No adverse even was reported following the maladministration.
Age: 17.0
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US005905, is an initial spontaneous report from a pharmacist received on 20 Mar 2014. This report refers to a 17-year-old patient of unknown gender. Past medical history and concomitant medications were not reported. The patient was vaccinated with MENVEO (batch number: M12127, expiry date: Aug 2014) intramuscularly at a dose of 0.5 ml that reached 34 Fahrenheit (1.1 degrees Celsius) for up to 24 hours on24 Feb 2014. No adverse event was reported following the maladministration.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2014US005907 is an initial spontaneous report received from a nurse on 21 Mar 2014. This report refers to an 11 year old female patient. She inadvertently received only Men C, Y, W-135 liquid component of MENVEO (batch number: A13016) intramuscularly, without reconstitution with Men A lyophilized component on 21 mar 2014. No adverse event reported following this medication error.
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Product reconstitution issue
Clinical narrative: Case number PHEH2014US005913 is an initial spontaneous report received from a health care professional on 21 Mar 2014. This report refers to a patient of unknown age and gender. The patient inadvertently received only Men C, Y, W-135 liquid component of MENVEO (batch number: M13014) intramuscularly, without reconstitution with Men A lyophilized component on an unknown date. No adverse event reported following this administration error.
Age: 45.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2014US006165, is an initial spontaneous report from a nurse received on 26 Mar 2014 with a follow-up received on 15 Apr 2014. This report refers to a 45-year-old female patient. She had her spleen removed and was advised to get a meningococcal vaccination by her doctor. Her concomitant medications included Amlodipine 5mg for hypertension and Citalopram 20 mg for depression. She was vaccinated with expired MENVEO (batch number: M12009) intramuscularly in to the right arm deltoid at a dose of 0.5ml on 26 Mar 2014 at 2:30pm. This was the initial application of MENVEO. No adverse event was reported following the maladministration. Follow-up received from the nurse on 15 Apr 2014: Updated medical history, concomitant medications and dosage, site and time of vaccination with MENVEO.
Age: 61.0
Sex: M
Vaccine: MNQ
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003798 is an initial spontaneous report received from a pharmacist on 21 Feb 2014 with a follow up report received from the pharmacist on 24 mar 2014. This report refers to a 61 years old male patient. His past medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: not reported) in the past which was tolerated well. It was reported that this patient, over 55 years of age, was vaccinated with a dose of MENVEO (batch number: A11052, expiry date: Sep 2014) intramuscularly into his left deltoid at a dose of 0.5 ml on 21 Sep 2013 at 12:15. No adverse events were reported following the maladministration (inappropriate age at vaccine administration). Follow up report was received from the pharmacist on 24 Mar 2014. The patient demographics, vaccination history, batch number of MENVEO, anatomical site of vaccination and time of vaccination were updated.
Age: 83.0
Sex: F
Vaccine: MNQ
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003827 is an initial spontaneous report received from a pharmacist on 24 Feb 2014: This report refers to an 84-year-old female patient who was inadvertently vaccinated with MENVEO (batch number: unknown) intramuscularly at a dose of 0.5 ml on 07 May 2013. No adverse event was reported following this administration error (inappropriate age at vaccine administration).
Age: 84.0
Sex: M
Vaccine: MNQ
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003828 is an initial spontaneous report received from a pharmacist on 24 Feb 20: This report refers to an 85-year-old male patient who was inadvertently vaccinated with MENVEO (batch number: unknown) intramuscularly at a dose of 0.5 ml on 07 May 2013. No adverse event was reported following this administration error.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Pt had injection of vaccine in left deltoid on 5-18-16. Yesterday 24 hours later arm soreness 3 red bumps with swelling inside left arm.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Extra dose administered, Interchange of vaccine products
Clinical narrative: GARDASIL 9 given in error 5/20/16. Patient had been given GARDASIL 4 on 5/12/15, 6/16/15, and 11/17/15. Pt has received #4 GARDASILS - extra dose.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Feeling hot, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Pt felt hot all over then chilled. Injection area red, warm, hard.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Pruritus, Rash
Clinical narrative: Rash on arms, legs, shoulder, neck and legs. Took antihistamine to reduce itching.
Sex: U
Vaccine: MNQ
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003830, is an initial spontaneous report from a pharmacist received on 21 Feb 2014. This report refers to a patient of unknown gender and older than 55 years of age. Past medical history and concomitant medications were not reported. The patient was inadvertently vaccinated with MENVEO (batch number: not reported) intramuscularly on undetermined date. No adverse reaction was reported following the maladministration.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2014US003838, is an initial spontaneous report from a medical assistant received on 24 Feb 2014. This report refers to an 11-year-old male patient. Past medical history and concomitant medications were not reported. He was administered only MenCYW-135 liquid component of MENVEO (batch number: A13013) without being reconstituted with MenA, intramuscularly on 11 Feb 2014. No adverse event was reported following the administration error (inappropriate preparation of medication).
Sex: U
Vaccine: MNQ
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003763 is an initial spontaneous report received from a pharmacist on 20 Feb 2014. This report refers to a patient whose age was not reported. The patient's medical history and concomitant medications were not reported. This patient over 55-years of age was vaccinated with a dose of MENVEO (batch number: not reported) intramuscularly on an unknown date. No adverse events were reported following the maladministration.
Age: 62.0
Sex: F
Vaccine: MNQ
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003637 is an initial spontaneous report received from a pharmacist on 21 Feb 2014. This report refers to a 62-years-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: not reported) intramuscularly on an unknown date. No adverse events were reported following the maladministration.
Age: 57.0
Sex: M
Vaccine: MNQ
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003842 is an initial spontaneous report received from a pharmacist on 21 Feb 2014: This report refers to a 57-year-old male patient who was inadvertently vaccinated with MENVEO (batch number: M11078) intramuscularly on 29 Jan 2014. No adverse event was reported following this administration error (inappropriate age at vaccine administration).
Age: 60.0
Sex: F
Vaccine: MNQ
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003648 is an initial spontaneous report from the pharmacist received on 21 Feb 2014. This report refers to a 60-year-old female patient who was accidentally vaccinated with MENVEO (batch number: not reported) intramuscularly on 31 Oct 2013. No adverse event reported following this medication error (inappropriate age of vaccine administration).
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product reconstitution issue
Clinical narrative: Case number PHEH2014US004175 is an initial spontaneous report from the nurse received on 26 Feb 2014. This report refers to an 11-years-old male child. Past medical history and concomitant medications were not reported. On 11 Feb 2014, the child was vaccinated intramuscularly with only MenCYW-135, the liquid component of MENVEO (batch number: M13013) and did not receive Men A lyophilized conjugate. It was reported that the child did not experience any adverse event following this administration error (inappropriate preparation of medication).
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2014US004179 is an initial spontaneous report received from the nurse on 26 Feb 2014 with the follow-up received on 21 Mar 2014. This report refers to an 18-years-old male patient. Past medical history and concomitant medications were not reported. On 03 Jan 2014 at 3:30, he was vaccinated with intramuscularly with only a partial dose of MENVEO (batch number: A13011) where Men A lyophilized component on MENVEO was reconstituted with an unknown diluent instead of Men CYW-135 liquid component. No adverse event was reported following this maladministration error. Follow-up received from a nurse on 21 Mar 2014: Patient's demographics and time of vaccination updated.
Age: 70.0
Sex: M
Vaccine: MNQ
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003788 is an initial spontaneous report from the pharmacist received on 21 Feb 2014. This report refers to a 70-year-old male patient who was accidentally vaccinated with MENVEO (batch number: A11077, expiry date: Apr 2014) at a dose of 0.5 ml intramuscularly on 11 Jan 2014. No adverse event occurred to the patient following this medication error (inappropriate age of vaccine administration).
Age: 67.0
Sex: M
Vaccine: MNQ
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003673 is an initial spontaneous report from the pharmacist received on 21 Feb 2014. This report refers to a 67-year-old female patient who was accidentally vaccinated with MENVEO (batch number: not reported) intramuscularly on an unknown date in Mar 2013. No adverse event occurred to the patient following this medication error (inappropriate age of vaccine administration).
Age: 69.0
Sex: F
Vaccine: MNQ
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003640 is an initial spontaneous report received from a pharmacist on 20 Feb 2014. This report refers to a 69-years-old female patient. Her medical history and concomitant medications were not reported. It was reported that this patient over 55-years of age was vaccinated with MENVEO (batch number: not reported) intramuscularly on 10 Jan 2013. No adverse events were reported following the maladministration.
Age: 35.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2014US004303 is an initial spontaneous report received from a pharmacist on 27 Feb 2014. This report refers to a 35-year-old male patient. Past medical history and concomitant medications was not reported. He was inadvertently administered only Men A lyophilized conjugate component of MENVEO (batch number: A12098), reconstituted with a sterile diluent instead of MenCYW-135 liquid component, intramuscularly on 27 Feb 2013. Reported stated that, the patient is a physician, who will be traveling. No adverse reaction was reported following this administration error.
Age: 71.0
Sex: M
Vaccine: MNQ
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003629 is an initial spontaneous report received from a pharmacist on 21 Feb 2014: This report refers to a 71-year-old male patient who was inadvertently vaccinated with MENVEO (batch number: unknown) intramuscularly at a dose of 0.5ml on 08 Jan 2014. No adverse event was reported following  this administration error (inappropriate age at vaccine administration).
Age: 20.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Product reconstitution issue
Clinical narrative: Case number PHEH2014US004437, is a spontaneous initial report from a nurse received on 03 Mar 2014, with a follow up received on 10 Mar 2014. This report refers to a 20-year-old female patient. Past medical history and concomitant medications were not reported. She was administered only MenCYW-135 liquid component of MENVEO (batch number: not reported) without being reconstituted with MenA, intramuscularly on 18 Dec 2013. No adverse event was reported following the administration error. Follow up received from nurse on 10 Mar 2014: Updated patient demographics (date of birth, age and gender) and date of vaccine administration.
Age: 64.0
Sex: M
Vaccine: MNQ
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003792 is an initial spontaneous report from the pharmacist received on 21 Feb 2014 with follow-up received on 24 Mar 2014. This report refers to a 64-year-old male patient. The patient was vaccinated with MENVEO (batch number: A11052) at a dose of 0.5 ml intramuscularly into left deltoid on 28 Sep 2013 at 13:43. No adverse event occurred to the patient following this medication error (inappropriate age of vaccine administration). Follow-up received from a pharmacist on 24 Mar 2014: Patient's demographics, site and time of vaccination updated. Batch number was amended.
Sex: F
Vaccine: MNQ
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2014US003797 is an initial spontaneous report received from a pharmacist on 21 Feb 2014 with a follow-up received on 24 Mar 2014. This report refers to an adult female patient. The patient's medical history and concomitant medications were not reported. It was reported that this patient over 55-years of age was vaccinated with a dose of MENVEO (batch number: A11052) intramuscularly into left deltoid at a dose of 0.5 ml on 28 Sep 2013 at 13:43. No adverse events were reported following the maladministration. Follow-up received from a pharmacist on 24 Mar 2014: Patient's demographics, site and time of vaccination updated. Batch number was amended.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US006399 is an initial spontaneous report received from a pharmacist on 28 Mar 2014. This report refers to an 11 year old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with MENVEO (batch number: M13017 and expiry date: 30 Sep 2014), at a dose of 0.5 ml intramuscularly on 26 Mar 2014. The MENVEO reached 32 to 34 F for up to 25 hours (at different time increments) within 8 day period and was subsequently administered to patient. Reporter does not believe vaccine was frozen. No adverse event was reported following this administration error.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US006398 is an initial spontaneous report received from a pharmacist on 29 Mar 2014. This report refers to a 16 year old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with MENVEO (batch number: M13017 and expiry date: 30 Sep 2014), at dose of 0.5 ml intramuscularly on 25 Mar 2014. The MENVEO reached 32 to34 F for up to 25 hours (at different time increments) within 8 day period and was subsequently administered to patient. Reporter does not believe vaccine was frozen. No adverse event reported following this administration error.
Age: 22.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2014US006575 is an initial spontaneous report received from a pharmacist on 01 Apr 2014. This case refers to a 22-year-old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with expired MENVEO (batch number: A11032 and expiry date: Mar 2014) intramuscularly on 01 Apr 2014. No adverse event was reporting following this administration error.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Pain, Peripheral swelling
Clinical narrative: Case number PHEH2014US006659 is an initial spontaneous report from a physician on 02 Apr 2014. This report refers to an 11-years-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: J008423) at a dose of 0.5 ml intramuscularly on 18 Feb 2014. It was reported that on the same day after vaccination, his arm was swollen and he required prednisone, BENADRYL and MOTRIN. It was reported that he also had pain. Pain and swelling resolved 3 days after the initial injection. The seriousness and causality were not reported.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Product reconstitution issue
Clinical narrative: Case number PHEH2014US006389 is an initial spontaneous report received from a nurse on 28 Mar 2014. This report refers to an 18 year old female patient. The patient's past medical history and concomitant medications were not reported. The patient received only Men CWY liquid conjugate component of MENVEO (batch number: X11076) without reconstitution with Men A lyophilized component intramuscularly on 28 Mar 2014. No adverse events were reported following this medication error (inappropriate preparation of medication).
Sex: F
Vaccine: MNQ
Symptoms: Peripheral swelling
Clinical narrative: Case number PHEH214US006660 is an initial spontaneous report from the physician received on 02 Apr 2014. This report refers to a female of an unknown age. She was vaccinated with MENVEO (batch number: J008423) at a dose of 0.5 ml intramuscularly on an unknown date. On an unknown date, after vaccination her arm became swollen. The final outcome of the event was unknown. The seriousness and causality of the event was not reported.
Age: 14.0
Sex: F
Vaccine: MNQ
Symptoms: Circumstance or information capable of leading to medication error, Incorrect dose administered, No adverse event
Clinical narrative: Case number PHEH2014US006796 is an initial spontaneous report received from a health care professional on 04 Apr 2014 and a follow up report from the health care professional on 20 May 2014: This report refers to a 14-year-old adolescent female patient. She was vaccinated with MENVEO (batch number: A13047) intramuscularly on 03 Apr 2014 (at 04:40 pm). During the vaccination, she moved and as a consequence she received a dose less than 0.5 ml. No adverse event was reported following this medication error. Follow up report from the health care professional on 20 May 2014: Updated patient details and vaccination time of MENVEO.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US006171 is an initial spontaneous report received from a health care professional on 26 Mar 2014. This report refers to an unspecified age and gender patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with MENVEO (batch number: not reported) intramuscularly on an unspecified date, which was stored at a temperature of -1 C for approximately 35 minutes. The reporter thought the vaccine did not freeze. No adverse events were reported following this medication error. No additional information was available.
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2014US006190 is an initial spontaneous report received from a nurse on 26 Mar 2014. This report refers to a male patient whose age was not reported. His medical history and concomitant medications were not reported. It was reported that he received an intramuscular dose of MENVEO (batch number: not reported) powder component reconstituted with ZOSTAVAX (other manufacturer, batch number: not reported) diluent on 25 Mar 2014. No adverse event was reported following the maladministration.
Age: 61.0
Sex: M
Vaccine: MNQ
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product reconstitution issue
Clinical narrative: Case number PHEH2014US006925 is an initial spontaneous report received from a nurse on 04 Sep 2014 with a follow-up received on 02 May 2014. This report refers to a 61 year old male patient. His concurrent conditions diabetic and immunodeficiency (HIV positive-undetectable His vaccination status was reported as up to date. He received only Men C, Y, W-135 liquid component of MENVEO (batch number: X12025, A12025) intramuscularly, without reconstitution with Men A lyophilized component on 04 Apr 2014 at 2:00 pm. The patient reported that he was feeling fine and had no complaints. No adverse event was reported following this administration error. Follow-up received from a health care professional on 02 May 2014: Concurrent conditions, batch number, time of vaccination and reporter's details were updated. Non significant follow up received on 07 May 2014: No new medical information added.
Age: 20.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2014US006300 is an initial spontaneous report received from the nurse on 28 mar 2014 and a follow up information was received from a consumer on 25 Apr 2014. This report refers to a 20-year-old male patient. His medical history and concomitant medications were not reported. On 26 Mar 2014 at 14:30 pm, he was vaccinated an intramuscular dose of MENVEO (batch number: M13051) in the arm, where MenA lyophilized conjugated component reconstituted with a sterile diluent (instead of Men CYW-135 liquid component). No adverse event was reported following this administration error (wrong solution used in drug reconstitution). Follow up information was received from a consumer on 25 Apr 2014: Updated vaccination time and site. Reporter information was also updated.
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2014US006182 is an initial spontaneous report received from a nurse on 26 Mar 2014. This report refers to a patient of an unspecified age and gender. The patient's past medical history and concomitant medications were not reported. The patient received only Men A lyophilized conjugate component of MENVEO (batch number: not reported), reconstituted with a sterol water instead of MenCYW 135 liquid component intramuscularly on an unspecified date. No adverse events were reported following this medication error.
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US007332 is an initial spontaneous report received from a health care professional on 11 Apr 2014. This case refers to a female patient of an unknown age. She was vaccinated with MENVEO (batch number: M12100) which had been stored below the recommended temperature at 1.9 degrees Celsius for two hours on an unknown date. She was recalled for revaccination. No adverse event was reported following this administration error.
Age: 21.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product reconstitution issue, Wrong drug administered
Clinical narrative: Case number PHEH2014US006287 is an initial spontaneous report received from a nurse on 28 Mar 2014. This report refers to a 21-years-old male patient. His medical history and concomitant medications were not reported. The nurse reported that the patient came for Tdap vaccine (other manufacturer, batch number: not reported) and he was inadvertently administered the MenCYW-135 liquid component of MENVEO (batch number: not reported) intramuscularly on an unknown date in Mar 2014. The nurse thought that she was administering Tdap vaccine and did not reconstitute the MENVEO vaccine. No adverse reactions were reported following the maladministration.
Age: 54.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Case number PHEH2014US007021 is an initial spontaneous report received from a nurse on 04 Apr 2014. This report refers to a 54-year-old male patient. His medical history and concomitant medications were not reported. On 24 Mar 2014, he was vaccinated with MENVEO (batch number: A12002) by subcutaneous route. No adverse event was reported following this maladministration.
Age: 0.62
Sex: M
Vaccine: MNQ, PNC13
Symptoms: Wrong drug administered
Clinical narrative: Case number PHEH2014US007034 an initial spontaneous report received from a health care professional on 03 Apr 2014, with a follow up received on 29 Apr 2014. This report refers to a 7-months old male patient. His medical history and concomitant medications were not reported. His vaccination history included administration of two doses of PENTACEL (other manufacturer, batch number: not reported) at 4-months of age and 6 months of age and the doses were well tolerated, DTAP (other manufacturer, batch number: not reported), pneumococcal conjugate vaccine (other manufacturer, batch number: not reported), IPV (unknown manufacturer, batch number: not reported) and hepatitis B vaccine (other manufacturer, batch number: not reported). It was reported that he was inadvertently administered an intramuscular dose of MENVEO (batch number: M12094) on 28 Mar 2014 at 13:00 into the left thigh and the intended vaccine was third dose of PENTACEL (other manufacturer, batch number: not reported). On the same day, he was also vaccinated with pneumococcal conjugate vaccine (other manufacturer, batch number: not reported) intramuscularly into the right thigh. The reporter stated that they discovered the error when they conducted inventory and found that they had one extra dose of PENTACEL and one MENVEO dose was missing. The reporter stated that patient was behind on PENTACEL shot. It was reported that he was vaccinated with MENVEO though he had no high risk conditions. The dose of MENVEO, he received was not an off label dose of his age. He did experience any adverse events due to the maladministration (wrong vaccine administered). Follow up received from health care professional on 29 Apr 2014: Updated time and site of vaccination of MENVEO, concomitant vaccine and vaccination history.
Sex: U
Vaccine: MNQ
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case number PHEH2014US006290 is an initial spontaneous report received from a physician's assistant on 26 Mar 2014: This report refers to a patient of unknown age and gender. It was reported that the patient was vaccinated with the booster dose of MENVEO (batch number: unknown) intramuscularly on an undetermined date. The dose was administered too early. No adverse event was reported following this medication error (inappropriate schedule of vaccine administered).