chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHEH2012US017337 is an initial spontaneous report received from a nurse on 28 Aug 2012 with a follow up information received on 28 Aug 2012. This report refers to an 11-year-old female patient. The patient was vaccinated with MENVEO (batch number: M11082, expiry date: May 2014) 0.5 ml intramuscularly on 25 Aug 2012. On unknown date, the patient experienced tenderness, warmth and redness and swelling of 3 inches diameter at the injection site. The patient recovered from the events on 28 Aug 2012. Follow up information received on 28 Aug 2012: Reporter information updated.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Activities of daily living impaired, Chills, Nausea, Urticaria
Clinical narrative: Developed chills night of vaccine.  Stayed home from school 6/15/16. Possible low grade fever. Nausea. Hives on legs. She has had hives on her legs in the past related to other causes. Instructed to take Benadryl 25mg po x 1 and prn, Calamine and 1% hydrocortisone cream.
Age: 2.0
Sex: M
Vaccine: DTAP, FLU3, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site movement impairment, Injection site pain
Clinical narrative: PAIN IN RIGHT LEG, ACTING LIKE LEG LOCKING UP OR NOT WANTING TO WALK ON IT. GAVE 2 DOSES OF CHILDRENS TYLENOL 6/15/16 AND AT TIME OF REPORT HAS ALREADY GIVEN 2 DOSES.  MOTHER REPORTS THAT CHILD SEEMS TO DO BETTER WITH LEG AFTER TYLENOL ADMINISTRATION.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Blood test normal, Chills, Depression, Fatigue, Injection site swelling
Clinical narrative: 101 Fever, chills, body aches, severe swelling of arm around shot area, depression, fatigue.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pyrexia
Clinical narrative: 101 Fever, chills, body aches, severe swelling of arm around shot area, depression, fatigue.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Redness, pain, swelling since 6-15-16 will see primary md today at 12:30pm.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, RVX
Symptoms: Blood culture, Body temperature increased, CSF culture, Culture urine, Electroencephalogram
Clinical narrative: At or around 7 pm, patient was getting ready to eat so beforehand I checked her temperature it was 101.4 (by ear) at that time I gave her 1.25mg of infants Tylenol and then started feeding her, while feeding her she cut her eyes to the right and wouldn't move them so I wiped her face off and tried to get her to look at me, her eyes went crossed and she wouldn't uncross them and then clenched her mouth shut and balled up both fists out to the sides of her body and got really stiff. Then she seemingly came right out of it.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, RVX
Symptoms: Eye movement disorder, Muscle contractions involuntary, Musculoskeletal stiffness
Clinical narrative: At or around 7 pm, patient was getting ready to eat so beforehand I checked her temperature it was 101.4 (by ear) at that time I gave her 1.25mg of infants Tylenol and then started feeding her, while feeding her she cut her eyes to the right and wouldn't move them so I wiped her face off and tried to get her to look at me, her eyes went crossed and she wouldn't uncross them and then clenched her mouth shut and balled up both fists out to the sides of her body and got really stiff. Then she seemingly came right out of it.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site inflammation, Rash
Clinical narrative: Localized Rash and inflammation at the site of injection.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Confusional state, Cough, Erythema, Laboratory test
Clinical narrative: It started with pain and significant swelling and redness in arm within 24 hours. It progressed to high spiking fevers past 103, confusion, cough and lethargy and physical/muscular pain.  My white blood count plummeted to about 1 and I had to go the the ER twice and have many medical visits.  I was confused and week for about 2 months.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Lethargy, Myalgia, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: It started with pain and significant swelling and redness in arm within 24 hours. It progressed to high spiking fevers past 103, confusion, cough and lethargy and physical/muscular pain.  My white blood count plummeted to about 1 and I had to go the the ER twice and have many medical visits.  I was confused and week for about 2 months.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: White blood cell count decreased
Clinical narrative: It started with pain and significant swelling and redness in arm within 24 hours. It progressed to high spiking fevers past 103, confusion, cough and lethargy and physical/muscular pain.  My white blood count plummeted to about 1 and I had to go the the ER twice and have many medical visits.  I was confused and week for about 2 months.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Biopsy skin, Blister, Chills, Pyrexia
Clinical narrative: Fever, chills, Bullae type blisters formed on both arms, scalp.
Age: 0.86
Sex: M
Vaccine: MNQ
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2012US020627, is an initial spontaneous report received from a nurse on 11 Oct 2012 and a follow up received on 11 Oct 2012. This report refers to 10 month old male patient. He was vaccinated with MENVEO (batch number: M11051, expiration date: 30 Mar 2014), intramuscularly on 11 Oct 2012. No adverse event was reported. Follow up received from the nurse on 11 Oct 2012: updated expiration date of MENVEO vaccine.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US020653 is an initial spontaneous report received from a pharmacist on 12 Oct 2012 with a follow-up received on 06 Nov 2012: This case refers to a 13-year-old female patient. Previous administration of MENVEO in the past was reported to be tolerated well. She was vaccinated intramuscularly only with MenCYW-135 liquid conjugate component of MENVEO (batch number: X10051) without MenA lyophilized conjugate component on 12 Oct 2012. The mother did not want to receive the lyophilized component. No adverse event was reported following this drug administration error. Follow-up received from the pharmacist on 06 Nov 2012: Updated comment from the mother.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US020830 is an initial spontaneous report received from a physician on 11 Oct 2012. This case refers to an 11-year-old female patient. She was vaccinated only with the MenCYW-135 liquid conjugate component of MENVEO (batch number: M11050) intramuscularly on 04 Oct 2012. She did not receive MenA lyophilized conjugate component of MENVEO. No adverse event was reported follow this drug administration error. No other information was available.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US020839 is an initial spontaneous report received from a medical assistant on 06 Nov 2012: This report refers to an 11-year-old male patient. His vaccination profile was up to date. He received only the MenCYW-135 liquid conjugate component of MENVEO vaccine (batch number M11052) intramuscularly in to the left deltoid on 08 Oct 2012. He did not receive the MenA lyophilized conjugate component of MENVEO. He did not plan on leaving country and would be offered the booster dose at 16 year wellness examination. He was concomitantly also vaccinated with GARDASIL (other manufacturer, batch number: 0636AE) intramuscularly in to the right deltoid along with BOOSTRIX (other manufacturer, batch number: AC52B081BA) intramuscularly in to the left deltoid on 08 Oct 2012. No adverse event was reported. The reporter stated that the error was noted in the late afternoon on 08 Oct 2012.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: Case number PHEH2012US012272 is an initial spontaneous report received from a nurse via sales representative on 19 Jun 2012 with a follow-up received on 10 Jul 2012: This report refers to a male child. His medical history included unspecified allergies. He was vaccinated with a dose of MENVEO (batch number: M11071 and A11071, expiry date: Dec 2013) intramuscularly on 15 Jun 2012. On an unspecified date, the patient experienced red firm swelling and itching on injection site. The patient was treated with AUGMENTIN. The outcome of the event was not reported and the causality was not assessed. Follow-up received from the nurse on 10 Jul 2012: Updated patient demographics, medical history and route and date of vaccination with MENVEO.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Headache
Clinical narrative: Case number PHEH2012US012755, is an initial spontaneous report received from a nurse on 25 Jun 2012: This report refers to 13-year-old male patient. He was vaccinated with MENVEO (batch number: M11073), intramuscularly, ten-days ago (unknown date). After vaccination, he experienced headaches. The event outcome and causality was not reported.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Case number PHEH2012US013093 is an initial spontaneous report received from a nurse on 28 Jun 2012: This case refers to 12-years-old male patient. He was vaccinated with MENVEO (batch number: A11071 and expiry date: Dec 2013), at dose 0.5 ml intramuscularly on 25 Jun 2012. On unspecified date after vaccination, he experienced localized reactions at injection site as red swollen, hard and hot. The outcome and causality of the events was not reported.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: Case number PHEH2012US013201 is an initial spontaneous report received from a health care professional on 28 Jun 2012. This report refers to an 11-years-old male patient whose medical history, past drugs, current conditions and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: M10134A) intramuscularly and GARDASIL (other manufacturer, batch number: not reported) through unspecified route in the same arm on 22 Jun 2012. On 23 Jun 2012 he developed redness and blisters at the vaccination site. It was reported that the symptoms were improved on an unspecified date. The final outcome was unknown. No further information was provided.
Age: 27.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, Wrong drug administered
Clinical narrative: Case number PHEH2012US020090 is an initial spontaneous report received from a pharmacist on 05 Oct 2012. This case refers to a 27-year-old male patient. He was vaccinated only with MenCYW-135 liquid conjugate component of MENVEO vaccine (batch number: X10053) intramuscularly on 05 Oct 2012. He did not receive the MenA lyophilized conjugate component of MENVEO vaccine. The pharmacist stated that they did not event intend to administer MENVEO and thought they were administering TDAP (other manufacturer, batch number: not reported). no other information was available.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US020262, is an initial spontaneous report received from a health care professional on 08 Oct 2012. This report refers to a patient (unknown age and gender). The patient was vaccinated with only the Men CYW-135 liquid conjugate component of MENVEO (batch number: 11032) intramuscular, did not receive the MenA lyophilized conjugate on 08 Oct 2012. No adverse event was reported following this medication error.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2012US020587 is an initial spontaneous report received from a nurse on 10 Oct 2012, and with a follow up received on 10 Oct 2012. This case refers to a 16-year-old female patient. She was vaccinated with lyophilized A component of MENVEO vaccine (batch number: M10059, expiry date: Jan 2013) reconstituted with sterile water instead of the MenCYW-135 liquid component of MENVEO on 02 Oct 2012. No adverse event was reported. No other information was available. Follow up report received on 10 Oct 2012. Expiry date of the vaccine updated.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US021210 is an initial spontaneous report received from a pharmacist on 15 Oct 2012: This case refers to an 18-years-old female patient. She was received only Men C, Y, W-135 liquid conjugate component of MENVEO vaccine (batch number: not reported), intramuscularly without being reconstituted with Men A component on an unspecified date in Aug 2012. No adverse reaction reported following this administration error.
Age: 20.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Case number PHEH2012US021203 is an initial spontaneous report received from a pharmacist on 16 Oct 2012: This case refers to a 20-years-old female patient. She was vaccinated with MENVEO vaccine (batch number: not reported), subcutaneously on 15 Oct 2012. No adverse reaction reported following this administration error.
Age: 55.0
Sex: M
Vaccine: MNQ
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2012US019580, is an initial spontaneous report received from a nurse on 03 Oct 2012. This report refers to a 56-year-old male patient. His medical history and concomitant medications were not reported. Nurse reported that she inadvertently administered MENVEO to a 56 year old. He looked young and she did not verify his age before vaccination. No adverse reaction was reported.
Age: 75.0
Sex: M
Vaccine: MNQ
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2012US019901, is an initial spontaneous report received from a physician on 04 Oct 2012 with a follow up information received on 25 Oct 2012. This report refers to a 75 year old male patient. His current condition included chronic lymphocytic leukemia. His vaccination history included unspecified vaccines which were tolerated well in the past. He was inadvertently vaccinated with MENVEO (batch number: A11064) at a dose of 0.5 ml intramuscularly on 03 Oct 2012. No adverse event was reported following administration error. Follow up information received on 25 Oct 2012: Patient demographics (height and weight), medical history, dose and route of MENVEO updated.
Age: 16.0
Sex: F
Vaccine: HPV4, MENB, MNQ
Symptoms: Loss of consciousness, Syncope, Vomiting
Clinical narrative: Pt had syncopal episode following dose #2 of GARDASIL. Took approx 5 mins to fully recover, was out for approx 15 seconds, feet elevated, cool rag to forehead. Vomited x 1. Email sent.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB, FLU3, PNC13, RV5
Symptoms: Abdominal pain, Decreased appetite, Ultrasound abdomen normal
Clinical narrative: Intermittent abdominal pain and loss of appetite for 5 days. Slept all day 6/7/16. Negative ultrasound for intussusception.
Age: 17.0
Sex: F
Vaccine: HPV4, MENB
Symptoms: Chills, Dizziness, Hyperhidrosis, Pain in extremity, Peripheral swelling
Clinical narrative: (R) arm swollen, very painful, dizzy, vomiting, sweating, chills. Better day 2, arm still remains tender to touch.
Age: 17.0
Sex: F
Vaccine: HPV4, MENB
Symptoms: Tenderness, Vomiting
Clinical narrative: (R) arm swollen, very painful, dizzy, vomiting, sweating, chills. Better day 2, arm still remains tender to touch.
Age: 15.0
Sex: M
Vaccine: HPV4, HPV9
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Fever - 102, chills, headache.
Age: 15.0
Sex: M
Vaccine: HPV4, HPV9
Symptoms: Dizziness, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Fever - 102, chills, headache.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Seizure like phenomena, Unresponsive to stimuli
Clinical narrative: After vaccine administration, within minute, brief period of unresponsiveness with seizure like activity, lasted about 10 seconds. Monitored patient 30 min.
Age: 20.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2012US010859 is an initial spontaneous report received from a nurse on 24 May 2012: This case refers to 20-years-old male patient. He was received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: X10053) intramuscularly, without reconstituting with Men A component on 24 May 2012. No adverse reaction had occurred following this administration error.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Erythema, Feeling hot, Flushing, Heart rate increased
Clinical narrative: Feeling faint, hot, red, flushed, high blood pressure, high heart rate, nausea, little tightness in throat, dizzy.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Hypertension, Nausea, Throat tightness
Clinical narrative: Feeling faint, hot, red, flushed, high blood pressure, high heart rate, nausea, little tightness in throat, dizzy.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin warm, Swelling, Tenderness
Clinical narrative: A large bump that is greater than 70mm, warm, and painful to touch.
Age: 58.0
Sex: M
Vaccine: TDAP
Symptoms: Body temperature increased, Erythema, Injection site erythema
Clinical narrative: Patient's arm turned red from injection site down to the fingers. Patient also ran a 101-102 degree temperature.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal pain, Musculoskeletal stiffness, Pain, Pain in extremity, Tenderness
Clinical narrative: Deep, excruciating pain from shoulder to tips of fingers. Could not touch or move arm due to stiffness and pain.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal discomfort, Alopecia, Amnesia, Anaemia, Antinuclear antibody
Clinical narrative: HEADACHES, SEVERE FATIGUE, SKIN DISCOLORATION, MUSCLE WEAKNESS, SEVERE ANEMIA, FACE PUFFINESS, EDEMA, VERTIGO, HAIR LOSS, VISION CHANGES, MEMORY LOSS, SEVERE MOBILITY ISSUES, STOMACH DISCOMFORT, ESOPHAGUS TIGHTENING. GONE THROUGH IMMUNOSUPPRESSANTS, CELLCEPT, PLAQUENIL, RITUXAN TWICE, PLASMAPHERESIS EVER SINCE.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Autoimmune disorder, Fatigue, Full blood count, Headache, Mobility decreased
Clinical narrative: HEADACHES, SEVERE FATIGUE, SKIN DISCOLORATION, MUSCLE WEAKNESS, SEVERE ANEMIA, FACE PUFFINESS, EDEMA, VERTIGO, HAIR LOSS, VISION CHANGES, MEMORY LOSS, SEVERE MOBILITY ISSUES, STOMACH DISCOMFORT, ESOPHAGUS TIGHTENING. GONE THROUGH IMMUNOSUPPRESSANTS, CELLCEPT, PLAQUENIL, RITUXAN TWICE, PLASMAPHERESIS EVER SINCE.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Muscular weakness, Oedema, Plasmapheresis, Scleroderma, Skin discolouration
Clinical narrative: HEADACHES, SEVERE FATIGUE, SKIN DISCOLORATION, MUSCLE WEAKNESS, SEVERE ANEMIA, FACE PUFFINESS, EDEMA, VERTIGO, HAIR LOSS, VISION CHANGES, MEMORY LOSS, SEVERE MOBILITY ISSUES, STOMACH DISCOMFORT, ESOPHAGUS TIGHTENING. GONE THROUGH IMMUNOSUPPRESSANTS, CELLCEPT, PLAQUENIL, RITUXAN TWICE, PLASMAPHERESIS EVER SINCE.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Swelling face, Throat tightness, Thrombotic thrombocytopenic purpura, Vertigo, Visual impairment
Clinical narrative: HEADACHES, SEVERE FATIGUE, SKIN DISCOLORATION, MUSCLE WEAKNESS, SEVERE ANEMIA, FACE PUFFINESS, EDEMA, VERTIGO, HAIR LOSS, VISION CHANGES, MEMORY LOSS, SEVERE MOBILITY ISSUES, STOMACH DISCOMFORT, ESOPHAGUS TIGHTENING. GONE THROUGH IMMUNOSUPPRESSANTS, CELLCEPT, PLAQUENIL, RITUXAN TWICE, PLASMAPHERESIS EVER SINCE.
Age: 32.0
Sex: F
Vaccine: HEP, MNQ, TDAP
Symptoms: Nodule, Pain in extremity, Peripheral swelling
Clinical narrative: ADACEL vaccination given IM into Right upper arm. Patient states the arm has become swollen and continues to hurt. She also states she feels a "knot" under her right arm. Has treated with ibuprofen, massage, and applying localized heat.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: CSF protein, Guillain-Barre syndrome, Hypoaesthesia, Nerve conduction studies, Nuclear magnetic resonance imaging
Clinical narrative: Numbness began in toes an progresses up legs over a week before diagnosis of Guillain-Barre Syndrome at Hospital on June 9, 2016.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysgeusia, Injection site erythema, Throat tightness
Clinical narrative: Less than 1 minute after administration, patient described a metallic taste in the back of her throat.  I asked patient if she felt tightness in her throat and she stated she did not.  I checked her injection site and there was a slight redness at the site, but no more than any other injection site on any of my other patients.  I asked her to remain in the building so I could monitor her.  After 5 minutes or so, the patient stated that she felt as if she had a tightness in her throat as if she had a sore throat from a cold but without the pain.  I again asked if she was having any difficulty swallowing or breathing and she stated she did not, but stated it was just "uncomfortable".  I again asked her to stay close.  The patient stayed with me for another 20 minutes as we discussed topics unrelated to medicine, and she displayed no further symptoms. I again checked the site of administration and there was still only a mild redness at site of injection and no further spreading.  The patient stated she felt much better and i released her to go home with her husband.
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Chills, Erythema, Headache, Hyperhidrosis, Skin warm
Clinical narrative: Swelling, redness, warm to touch, headaches, sweats/chills.
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Swelling
Clinical narrative: Swelling, redness, warm to touch, headaches, sweats/chills.
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives all over body; extremely itchy and persistent. Zyrtec and Benadryl did nothing. Went to PCP 3 days after onset for steroids.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US006804, is an initial spontaneous report received from a nurse on 06 Mar 2012. This report refers to a patient of unknown age and gender. No medical history and concomitant medications were provided. The patient received only MenCYW-135 liquid conjugate vaccine component of MENVEO (batch number: 10005 and expiry date 31 Aug 2011) intramuscularly on an unspecified date. The nurse reported that she did not know which patient received a partial dose of MENVEO or date of vaccine administration. However, she was sure that vaccine was administered sometime prior to the expiration date provided as 31 Aug 2011. No adverse reaction was reported following this administration error.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US006813 is an initial spontaneous report received from a pharmacist on 15 Mar 2012. This case refers to a patient (age and gender not reported). The reporter stated that a patient received only MenA lyophilized conjugate component of MENVEO (batch number: unknown) reconstituted with a sterile diluent on an unspecified date; patient did not receive the MenCYW-135 liquid conjugate vaccine component of MENVEO. The reporter stated that the error was discovered because they had an extra MenCYW-135 liquid conjugate component of MENVEO vial. It was also reported that no patient identifying information was available at the time of this report, because they do not know which patient received a partial dose. No adverse reaction had occurred following this vaccination error.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US006918 is a spontaneous report initially received from a medical assistant on 22 Mar 2012 with a follow-up received on 16 Apr 2012: This case refers to a 16-year-old female patient. She was vaccinated with MENVEO (batch number: A10126A) intramuscularly on 22 Mar 2012. The reporter stated that this patient received only the MENCYW-135 liquid conjugate component of MENVEO; she did not receive the MenA lyophilized conjugate component of MENVEO. No adverse event was reported following this drug administration error. She was revaccinated with the correctly constituted MENVEO on an unknown date. Follow-up received from the medical assistant on 16 Apr 2012: Updated information about revaccination with the correctly reconstituted vaccine and updated patient details.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US006923 is an initial spontaneous report received from a medical assistant on 22 Mar 2012. This case refers to a 17-year-old male patient. He was vaccinated with MENVEO (batch number: X10054) intramuscularly on 28 Feb 2012. The reporter stated that this patient was administered MenCYW -135 liquid conjugate component of MENVEO only, instead of reconstituting with MenA lyophilized conjugate component of MENVEO. No adverse event have occurred since administration.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, Product preparation error
Clinical narrative: Case number PHEH2012US006927 is an initial spontaneous report received from a consumer (parent) on 09 Mar 2012. This case refers to an 18-year-old female patient. She was vaccinated with MENVEO (batch number: unknown) on an unspecified date. The reporter stated that a mistake was done by the healthcare professional who administered the vaccine; the patient was given only the liquid component without reconstituting it with the powder component of MENVEO. The powder was afterwards resolved in salt water and injected. No other information was available at the time of this report.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2012US007061, is an initial spontaneous report received from a physician on 28 Mar 2012: This case refers to 18-years-old female patient. She was received only Men A liquid conjugate component of MENVEO vaccine (batch number: A10061) at dose of 0.5 ml intramuscularly, reconstituted with a sterile water instead of Men C, Y, W-135 liquid conjugate component on 28 Mar 2012. No adverse reaction had occurred following this maladministration error.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2012US007087, is an initial spontaneous report received from medical assistant on 28 Mar 2012 with a follow up received on 16 Apr 2012: This case refers 11-years-old male patient whose medical history, past drugs, current conditions and concomitant medications were unspecified. He was received only partial dose of Men A lyophilized conjugate component of MENVEO (batch number: M11053) intramuscularly on to right arm on 27 Mar 2012, which did not reconstituted well with Men C, Y, W-135 liquid conjugate component and half of powder stuck to the bottom of the vial. No adverse reaction had occurred following this administration error. No other information was provided. Follow up received on 16 Apr 2012: Patient demographics updated (height and weight) and site of vaccine administration.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Product reconstitution issue
Clinical narrative: Case number PHEH2012US007096 is an initial spontaneous report received from a nurse on 22 Mar 2012 with the follow-up received on 30 Apr 2012. This report refers to an 11-years-old female patient. Her medical history, past drugs, current conditions and concomitant medications was unspecified. It was reported that this patient received only the MenCWY-135 liquid component of MENVEO (batch number: not specified) intramuscularly on to unspecified site without reconstituting the Men A lyophilized conjugate vaccine component on 22 Mar 2012. The patient will return to clinic to receive full-dose of MENVEO. No adverse event was reported following this drug administration error. Follow-up received from nurse on 30 Apr 2012: Updated patient demographics (age, gender, date of birth, height and weight).
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2012US007167 is an initial spontaneous report received from a nurse on 28 Mar 2012: This case refers to multiple patients. These patients were vaccinated with MENVEO (batch number: M10132 and M10133) intramuscularly on 20 Mar 2012. MENVEO reached 34.1 F for up to 3-hours on 20 Mar 2012. No adverse event was reported during this administration error.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US007255, is an initial spontaneous report received from a nurse on 23 Mar 2012: This case refers to 15-years-old female patient. She was vaccinated only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: A10062/X10067), at dose of 0.5 ml, without reconstituting with Men A component on 27 Dec 2011. No adverse event was occurred during this administration error.
Age: 31.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US007554, is an initial spontaneous report received from a physician on 02 Apr 2012 with a follow up information received on 16 Apr 2012: This report refers to 31-years-old female patient whose medical history, past drugs and current conditions were not specified. Her concomitant medications included birth control pills. She was received only Men C, Y, W-135 liquid conjugate component of MENVEO vaccine (batch number: A11033), intramuscularly, without reconstituting with Men A lyophilized conjugate on 30 Mar 2012. No adverse event was occurred during this administration error. She was revaccinated with 0.5 ml dose of MENVEO (batch number: M11042, expiry date: 31 Mar 2014) on 02 Apr 2012. No other details were provided. Follow up received on 16 Apr 2012: Concomitant medication added, revaccination details added.
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2012US007900 is an initial spontaneous report received from a nurse on 06 Apr 2012. This case refers to a patient of unspecified age and gender. This patient was vaccinated with MENVEO (batch number: unknown) intramuscularly on an unspecified date. The reporter stated that they recently discovered an extra MENVEO MenCWY liquid conjugate component vial in the fridge and suspected that this patient was only administered a 0.5ml intramuscular dose of MenA reconstituted with an unknown diluent. The patient information and date of administration were not known, since they were investigating who received this dose. No adverse events have been reported since vaccination. No other information was available.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Case number PHEH2012US008036 is an initial spontaneous report received from a nurse on 10 Apr 2012: This case refers to an 11-years-old female patient. Previously she was vaccinated with first dose of MENVEO (batch number: unknown) intramuscularly on 13 Oct 2011. She was also vaccinated with second dose of MENVEO (batch number: A10042) subcutaneously instead of intramuscularly on 10 Apr 2012. No adverse event was occurred following this administration error.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US008119 is an initial spontaneous report received from a nurse on 11 Apr 2012. This report refers to a 12-years-old female patient whose medical history, past drugs, current conditions and concomitant medications were not specified. It was reported that on an unspecified date, she received only the MenCYW liquid conjugate vaccine component of MENVEO (batch number: X10127B) intramuscularly and did not receive the MenA lyophilized conjugate vaccine component. No adverse reaction was reported following this maladministration.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US008130, is an initial spontaneous report received from a nurse on 30 Mar 2012: This case refers to a unknown age and gender. The patient was received only Men C, Y, W-135 liquid conjugate component of MENVEO vaccine (batch number: X10028), intramuscularly, without reconstituting with Men A component on an unspecified date. No adverse event was occurred during this administration error.
Age: 24.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2012US014992 is an initial spontaneous report received from a pharmacist on 27 Jul 2012. This report refers to a 24-year-old male patient. This patient was vaccinated with VARIVAX (other manufacturer, batch number: unknown) lyophilized vaccine component mixed with MenCYW-135 liquid conjugate component of MENVEO (batch number: X11042) intramuscularly on 26 Jul 2012. No adverse event was reported following this drug administration error.
Age: 11.0
Sex: F
Vaccine: FLUN3, MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2012US018681 is an initial spontaneous report received from a health care professional on 05 Sep 2012 with the follow-up received on 16 Oct 2012: This report refers to an 11-year-old female child. She was vaccinated with MENVEO (batch number: M11082 and expiry date: 31 May 2014) intramuscularly in the left arm on 31 Aug 2012 at 13:41 pm. She was also vaccinated with FLUMIST (other manufacture) on 31 Aug 2012. These vaccine had reached up to 11 degree Celsius for 30 to 60 minutes. No adverse event was reported following this administration error. Follow-up received on 16 Oct 2012: Updated patient height and weight, vaccine route of vaccination, site of vaccination, time of vaccination and concomitant vaccine.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site pruritus, Wrong technique in product usage process
Clinical narrative: Case number PHEH2012US016274 is a spontaneous report initially received from a nurse on 16 Aug 2012 with a follow-up received on 27 Aug 2012 and 17 Sep 2012: This report refers to a 16-years-old female patient. Her medical history included allergy to penicillin and cephalosporin. She was given only the MenA lyophilized conjugate vaccine component of MENVEO (batch number: A11046 and expiry date: 20 Apr 2014) reconstituted with sterile water, intramuscularly on 14 Aug 2012. She did not receive the MenCYW-135 liquid conjugate vaccine component. She experienced slight itching at the vaccination site on 14 Aug 2012 and completely recovered from the event on 17 Aug 2012. It was reported that vaccination with correctly reconstituted MENVEO would be repeated later. No further information was provided. Follow-up information received from the nurse on 27 Aug 2012: Updated patient demographic and medical history. Follow-up received from the nurse on 17 Sep 2012: Updated expiry date of MENVEO, start date of itching and information on revaccination with MENVEO.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2012US013858 is an initial spontaneous report received from a nurse on 09 Jul 2012. This case refers to 11-year-old male patient. He was vaccinated with MenA lyophilized conjugate component of MENVEO (batch number: A11071) mixed with sterile water on 09 Jul 2012. He did not receive MENCYW-135 liquid conjugate vaccine component of MENVEO. No adverse event was reported following vaccination.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2012US012262 is a combined initial spontaneous report received from a physician on 14 Jun 2012 with a follow up information received on 20 Jun 2012. This report refers to a male patient whose age, medical history, past drugs, current conditions and concomitant medications were not reported. It was reported that on 18 Nov 2011, he was vaccinated intramuscularly on to unspecified site with MENVEO (batch number: A10029) that was reconstituted and stored in the refrigerator for three to five days. No adverse event was reported following the medication error.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Fatigue, Headache, Paraesthesia, Photophobia, Pyrexia
Clinical narrative: Case number PHEH2012US012969 is an initial spontaneous report received from a nurse on 22 Jun 2012 and a follow up received from the nurse on 16 Jul 2012. This report refers to a 16-years-old female patient whose medical history, past drugs, current conditions and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: A11075) intramuscularly into her left deltoid muscle on 20 Jun 2012. On 21 Jun 2012 she experienced tingling in extremities, headache, fever, mild photophobia and fatigue. On 24 Jun 2012, she had recovered completely from these events. The causality was not reported. Follow up information received from the nurse on 16 Jul 2012: Updated site of vaccination, additional events (fever and photophobia), start date and end date of events, outcome.
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Case number PHEH2012US011087 is an initial spontaneous report received from a pharmacist on 23 May 2012. This case refers to a patient of unspecified age and gender. On 22 May 2012, the patient was inadvertently vaccinated with MENVEO vaccine (batch number: unknown) that got expired in Apr 2012. The pharmacist stated that the physician was trying to determine whether another dose should be administered. No other information was available.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: Case number PHEH2012US010286 is an initial spontaneous report received from medical assistant on 15 May 2012: This report refers to an 11-year-old male patient. He was given only the CYW-135 liquid component of MENVEO (batch number: X10053) intramuscularly on 15 May 2012. No other adverse reaction was reported following this administration error.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Wrong technique in product usage process
Clinical narrative: Case number PHEH2012US009550 is an initial spontaneous report received from a health care professional on 04 May 2012 with a follow up information received on 21 May 2012. This report refers to an 11-years-old male patient whose medical history, past drugs, current conditions and concomitant medications were not specified. It was reported that on 04 May 2012, he received only the MenCYW-135 liquid conjugate vaccine component of MENVEO (batch number: X10135B) intramuscularly on to unspecified site and did not receive the MenA lyophilized conjugate vaccine component. No adverse event was reported. He was scheduled for correct dose at next visit. Follow up information received on 21 May 2012: Patient demographics updated (age, date of birth, height and weight).
Age: 27.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2012US011251 is an initial spontaneous report received from a nurse on 31 May 2012. This case refers to a 27-year-old male patient. He was vaccinated with a complete dose of MENVEO (batch number: 022011) intramuscularly on 30 May 2012. It was reported that the MenA lyophilized conjugate vaccine component of MENVEO had expired in Apr 2012. The MenCYW liquid conjugate component of MENVEO that was administered had an expiration date of Jul 2012. The batch number provided corresponds to MenA lyophilized conjugate component of MENVEO. No adverse reaction was reported following vaccination. No additional information was available.
Age: 53.0
Sex: M
Vaccine: HEPAB, IPV, MMR, MNQ, YF
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US011019 is an initial spontaneous report received from a nurse on 29 May 2012 with a follow-up received on 11 Jun 2012: This case refers to an adult male patient. His concomitant vaccinations included administration of yellow fever vaccine (other manufacturer, batch number: UH258AA) subcutaneously, TWINRIX, (other manufacturer, batch number: AHABB223DA) intramuscularly, inactivated polio vaccine (other manufacturer, batch number: 1330-1) subcutaneously and MMR II (other manufacturer, batch number: 0705AA) subcutaneously on 29 May 2012. He was vaccinated with MENVEO (batch number: X11065) intramuscularly on 29 May 2012. The nurse stated that this patient received only the MenCYW-135 liquid conjugate component of MENVEO; did not receive the Men A lyophilized conjugate component of MENVEO. It was also reported that the patient was vaccinated for the purpose of upcoming international travel. No adverse event was reported following vaccination. The same day he was re-vaccinated with the correctly reconstituted MENVEO. He was scheduled to receive VIVOTIF (batch number 3000009) on 30 May 2012. Follow-up received from a nurse on 11 Jun 2012: Updated patient's demographics, concomitantly administered vaccines and details about revaccination with MENVEO.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2012US005912 is an initial spontaneous report received from consumer on 07 Mar 2012: This case refers to multiple patients (several patients). These patients may have received MENVEO (batch number: unknown), intramuscularly on an unspecified date. The MENVEO vaccine stored at temperature of about 33 Fahrenheit for up to one-month. No adverse events were reported following this administration error.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US012493 is an initial spontaneous report received from a medical assistant on 19 Jun 2012: This case refers to 11-years-old female patient. She was received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: X10130), intramuscularly, without being reconstituted with Men A component on 18 Jun 2012. No adverse reaction occurred following this administration error.
Age: 20.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US012934 is an initial spontaneous report received from a consumer on 26 Jun 2012: This report refers to a 20-year-old male patient. He was given only the CYW-135 liquid component of MENVEO vaccine (batch number: M10126A) intramuscularly on 26 Jun 2012. No adverse reaction was reported following this administration error.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2012US010705 is an initial spontaneous report received from a consumer on 22 May 2012 with a follow-up received on 02 Jul 2012. This report refers to a 12-year-old male child. It was reported that on 10 Apr 2012, he was vaccinated with MenA lyophilized conjugate vaccine component of MENVEO (batch number: A10133) reconstituted with a sterile diluent intramuscularly on to unspecified site and did not receive the MenCYW-135 liquid conjugate. On 12 Apr 2012, he was revaccinated with a full dose of MENVEO. No adverse reaction was reported following the maladministration. Follow-up received from the consumer on 02 Jul 2012: Updated patient details.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US013413 is an initial spontaneous report received from a medical assistant on 03 Jul 2012: This case refers to an 18-years-old female patient. She was received only Men C, Y, W-135 liquid conjugate component of MENVEO vaccine (batch number: M11047), intramuscularly without being reconstituted with Men A component on 02 Jul 2012. No adverse reaction occurred following this administration error.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US011413 is an initial spontaneous report received from a nurse on 05 Jun 2012 with a follow up information received on 25 Jun 2012: This report refers to a 17-years-old female patient. Her vaccination history included up to date administration of school vaccines (unspecified) and her medical history and concomitant medications were not reported. She was given only the CYW-135 liquid component of MENVEO (batch number: X10062, expiry date: Feb 2013) intramuscularly on to right deltoid on 23 May 2012. No other adverse reaction was reported following this administration error. She was readministered MENVEO (batch number: A10062) on 06 Jun 2012. Follow up information received on 25 Jun 2012: Updated information on vaccination history, expiry date and site of administration of suspect vaccine, revaccination details.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2012US011951 is an initial spontaneous report received from a medical assistant on 11 Jun 2012: This report refers to a 12-year-old female patient. She was given only the CYW-135 liquid component MENVEO (batch number: A11075) intramuscularly on 11 Jun 2012. No other adverse reaction was reported.
Age: 18.0
Sex: F
Vaccine: FLUX, MNQ, VARCEL
Symptoms: Induration, Peripheral swelling
Clinical narrative: Case number PHEH2012US024155 is an initial spontaneous report received from a nurse on 03 Dec 2012. This report refers to an 18-years-old female patient. Her medical history was not reported and concomitant vaccinations included influenza vaccine (other manufacturer, batch number: not reported) and chicken pox vaccine (other manufacturer, batch number: not reported) on right arm 17 Oct 2012. She was vaccinated with MENVEO (batch number: A11042) and a tuberculosis skin test (other manufacturer, batch number: not reported) on left arm on 17 Oct 2012. Two weeks after vaccination, she experienced induration in the left arm. It was reported that she experienced an indention in her arm with a pocket of swelling right below it. It was reported that the patient did not notice the reaction and someone else has noticed it on her. The outcome of the event was not reported. No further information was provided.
Age: 19.0
Sex: M
Vaccine: FLU3, MNQ
Symptoms: Pain in extremity, Product quality issue, Pyrexia
Clinical narrative: Case number PHEH2012US023888 is an initial spontaneous report received from a pharmacist on 03 Dec 2012. This report refers to a 19-years-old male patient. He was vaccinated with MENVEO (batch number: not reported) intramuscularly on to arm on an unknown date. He also received FLUVIRIN (batch number: not reported) intramuscularly on to the other arm on the same date (see related case: PHHY2012US112717) as that of MENVEO. After vaccination with MENVEO on 02 Dec 2012, he was up and down all night with fever and the morning when he woke up it was 102 degrees Fahrenheit. The reporter also stated that the arm was sore. The reported stated that MENVEO was cloudy and she said that she did not see junk floating around in it; it looked more like a ZOSTAVAX than being totally clear. MENVEO was stored in the refrigerator prior to administration. It was also reported that she did not wait a long time after reconstitution prior to administration. The event outcome was not reported. No further information was provided.