chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Dizziness, Muscle twitching, Seizure
Clinical narrative: Case number PHHY2014US171146, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 543919) website on 29 Dec 2014 and with the follow-up information received from Quality Assurance Department (reference number: 346029) on 11 Feb 2015. This report refers to a 13 year old male patient. His medical history and concomitant medication were none. The patient was vaccinated with MENVEO (batch number: M14055 and expiry date: Aug 2015) intramuscularly in right arm, GARDASIL (other manufacturer, batch number: K009202) intramuscularly in left arm, ADACEL (other manufacturer, batch number: U4902BA) intramuscularly in left arm and VARIVAX (other manufacturer, batch number: K001391) subcutaneously in right arm on 16 Sep 2014. On the same day after vaccination, he experienced seizure and felt dizzy. His hands were twitching (as his mother mentioned). The patient was taken to emergency room. He was alert and oriented. Final outcome of these events was reported as complete recovery. Events were reported as non-serious. Seriousness assessment of seizure was upgraded to serious (medically significant) based on the information available in the source document. Causality of these events was not reported. Based on the investigation performed, the QA department stated that, MENVEO vaccine (batch number: M14055) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow up information received from the quality assurance department (reference number: 346029) on 13 Jan 2015: Updated QA reference number. Non-significant follow-up information received from the Quality Assurance Department (reference number: 346029) on 11 Feb 2015: Updated MENVEO vaccine batch review report.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Syncope
Clinical narrative: Case number PHHY2014US169279, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 544216) website on 29 Dec 2014. This report refers to a 18-year-old female patient. She was vaccinated with MENVEO (batch number: A14041) in the left arm on 17 Sep 2014. On the same date, after vaccination she experienced vasovagal syncope episode. She was laid down on the floor, was fully covered with blanket and provided water little by little when she was able to upright her position. She was alert all the time and did not hit any place. The outcome of the event reported as recovered. The event was reported as non-serious. Seriousness assessment of the event (syncope) was upgraded based on available information in the source document. The causality of the event was not reported.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Anaphylactic reaction, Angioedema, Dyspnoea
Clinical narrative: Case number PHHY2014US170222, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 545718) website on 29 Dec 2014. This report refers to an 11 year old female patient. Medical history and concomitant medication were not reported. Concurrent conditions included asthma. She was vaccinated with MENVEO (batch number: A13059) in right arm and BOOSTRIX (other manufacturer, batch number: F62P2) in left arm both on 26 Apr 2014. On 27 Apr 2014, the patient experienced difficulty breathing, angioedema and anaphylaxis. She was taken to emergency room and then hospitalized for the event. Final outcome of the events was reported as complete recovery. Causality of these events was not reported.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Headache, Pyrexia, Vomiting
Clinical narrative: Case number PHHY2014US171454 is an initial spontaneous report received from a health care professional via the Vaccine Adverse Event Reporting System (VAERS ID: 545837) website on 29 Dec 2014. This report refers to a 17 year old male patient. His past medical history and concomitant medications were not reported. On 18 Aug 2014, he was vaccinated with MENVEO (batch number: A13054) intramuscularly into his left arm. On 19 Aug 2014, he complained of fever with a body temperature of 105, vomiting and headache. The patient completely recovered from vomiting and headache after three days of onset and from fever after five days of onset with supportive care at home. The final outcome of the events was complete recovery. The events were reported as non serious but the seriousness of fever with body temperature of 105 was upgraded based on the information available in the source documents. The causality of events was not reported.
Age: 26.0
Sex: F
Vaccine: MNQ
Symptoms: Chest discomfort, Dyspnoea, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Case number PHHY2015US001297 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS ID: 546401) on 06 Jan 2015. This report refers to a 26 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with meningococcal ACYW-135 vaccine (manufacturer and batch number: not reported) on 16 may 2014. On 16 May 2014 after vaccination, she experienced shortness of breath, chest tightness and vaccination site reactions which were further described as warm to touch and swelling. She went to emergency room. The events outcome was reported as complete recovery. The events were reported as non-serious, but the events dyspnea and chest tightness were upgraded as medically significant based on the information available in  the source documents. The causality of the events was not reported.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, IPV, MMR, MNQ, TDAP
Symptoms: Anxiety, Asthenia, Crying, Dyspnoea, Hypoaesthesia
Clinical narrative: Case number PHHY2014US170482, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 548142) website on 29 Dec 2014. This report refers to a 12-year-old female patient. Her vital signs were normal prior to vaccinations. She was vaccinated with MENVEO (batch number: M14055) intramuscularly in the right arm on 29 Sep 2014. On the same date, she also received HAVRIX (other manufacturer, batch number: 9H9R4) intramuscularly in left arm, IPOL (other manufacturer, batch number: J13821) via subcutaneous route in left arm, ADACEL (other manufacturer, batch number: U4875AA) intramuscularly in the left arm, MMR II (other manufacturer, batch number: J005846) via subcutaneous route in right arm and GARDASIL (other manufacturer, batch number: J015378) intramuscularly in the right arm. On the same date, 10 minutes after vaccinations she experienced numbness and decreased strength in hands which moved to legs, had nausea, throat fullness, trouble breathing, anxiety and crying. She received epinephrine and BENADRYL as treatment drugs. The patient recovered from the events. The events reported as non-serious. Seriousness assessment of the events (numbness and decreased strength in hands, nausea, throat fullness, trouble breathing, anxiety and crying) was upgraded based on the available information in the source document. The causality of the events was not reported.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, IPV, MMR, MNQ, TDAP
Symptoms: Muscular weakness, Nausea, Throat tightness
Clinical narrative: Case number PHHY2014US170482, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 548142) website on 29 Dec 2014. This report refers to a 12-year-old female patient. Her vital signs were normal prior to vaccinations. She was vaccinated with MENVEO (batch number: M14055) intramuscularly in the right arm on 29 Sep 2014. On the same date, she also received HAVRIX (other manufacturer, batch number: 9H9R4) intramuscularly in left arm, IPOL (other manufacturer, batch number: J13821) via subcutaneous route in left arm, ADACEL (other manufacturer, batch number: U4875AA) intramuscularly in the left arm, MMR II (other manufacturer, batch number: J005846) via subcutaneous route in right arm and GARDASIL (other manufacturer, batch number: J015378) intramuscularly in the right arm. On the same date, 10 minutes after vaccinations she experienced numbness and decreased strength in hands which moved to legs, had nausea, throat fullness, trouble breathing, anxiety and crying. She received epinephrine and BENADRYL as treatment drugs. The patient recovered from the events. The events reported as non-serious. Seriousness assessment of the events (numbness and decreased strength in hands, nausea, throat fullness, trouble breathing, anxiety and crying) was upgraded based on the available information in the source document. The causality of the events was not reported.
Age: 11.0
Sex: F
Vaccine: FLUN4, HPV4, MNQ, TDAP
Symptoms: Asthenia, Blood glucose normal, Dyspnoea, Haemoglobin normal, Immediate post-injection reaction
Clinical narrative: Case number PHHY2015US014502, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 548598) web site on 03 Feb 2015. This report refers to an 11 year old female patient. Her medical history included anemia. Concomitant medication was not reported. On 16 Oct 2014, she was vaccinated with MENVEO (Batch number M14023) intramuscular into left arm. On the same day she also received GARDASIL (batch number J011272, other manufacturer) intramuscular into right arm, FLUMIST (batch number: CJ2006, other manufacturer) intranasal and BOOSTRIX (batch number: LF444, other manufacturer) intramuscular into left arm. Immediately after receiving all vaccines, the patient became weak, lethargic, pale and continued to nod off. Symptoms continued for 30 minutes. After 30 minutes she stated she felt better but it was hard to breathe. All vital signs normal, glucose 124, hemoglobin 13.1, orientated (3). Recommended ER via ambulance and her mother refused transportation to paramedics and stated would follow up with primary provider immediately. Final outcome of the events was unknown. Events were reported as non-serious. Seriousness assessment of hard to breathe was upgraded based on information available in the source documents. Causality assessment was not reported.
Age: 11.0
Sex: F
Vaccine: FLUN4, HPV4, MNQ, TDAP
Symptoms: Lethargy, Pallor, Somnolence
Clinical narrative: Case number PHHY2015US014502, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 548598) web site on 03 Feb 2015. This report refers to an 11 year old female patient. Her medical history included anemia. Concomitant medication was not reported. On 16 Oct 2014, she was vaccinated with MENVEO (Batch number M14023) intramuscular into left arm. On the same day she also received GARDASIL (batch number J011272, other manufacturer) intramuscular into right arm, FLUMIST (batch number: CJ2006, other manufacturer) intranasal and BOOSTRIX (batch number: LF444, other manufacturer) intramuscular into left arm. Immediately after receiving all vaccines, the patient became weak, lethargic, pale and continued to nod off. Symptoms continued for 30 minutes. After 30 minutes she stated she felt better but it was hard to breathe. All vital signs normal, glucose 124, hemoglobin 13.1, orientated (3). Recommended ER via ambulance and her mother refused transportation to paramedics and stated would follow up with primary provider immediately. Final outcome of the events was unknown. Events were reported as non-serious. Seriousness assessment of hard to breathe was upgraded based on information available in the source documents. Causality assessment was not reported.
Age: 16.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Cold sweat, Hypotension, Immediate post-injection reaction, Pallor, Syncope
Clinical narrative: Case number PHHY2015US017486, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 553281) website on 03 Feb 2015. This report refers to a 16 years old female patient. Concurrent condition included hypothyroidism. Concomitant medication included LETROX. She was vaccinated with MENVEO (batch number: M14056) into left arm on 20 Oct 2014. On the same day, she was vaccinated with BOOSTRIX (batch number: 5DM3Y, other manufacturer) and VARIVAX (batch number: K006134, other manufacturer): both into left arm. On the same day, immediately after vaccinations, the patient experienced an episode of syncope. Blood pressure was 72/50 mmHg and pulse rate was 54 per minute. The patient was clammy and had a pale skin. The patient legs were elevated and cool cloth was applied. It was reported that the patient previously had a fainting after administration of unknown vaccine. Outcome of the events was recovered. Events were reported as non-serious. Seriousness assessment of syncope was upgraded based on the source document. Causality assessment was not reported.
Age: 11.0
Sex: F
Vaccine: FLUX, MNQ, TDAP
Symptoms: Crying, Headache, Immediate post-injection reaction, Malaise, Myalgia
Clinical narrative: Case number PHEH2014US022478 is an initial spontaneous report received from a physician on 06 Nov 2014 with a follow up information received from a nurse on 29 Dec 2014. This report refers to an 11 years old female patient. Her medical history and concomitant medication was not reported. Her vaccination status was up to date. She received an initial dose of MENVEO (batch number: G14041/X14041) intramuscularly at a dose of 0.5 ml in the left deltoid on 29 Oct 2014. She also received influenza virus vaccine (other manufacturer, batch number: U189AE) and tetanus, diphtheria, acellular pertussis vaccine (other manufacturer, batch number: 04963AA); both vaccines at a dose of 0.5 ml intramuscularly on 29 Oct 2014. On the same day immediately after vaccination the patient began inconsolably crying (4 times) for a few hours. A few days after vaccination she experienced headache and myalgia. The patient had on and off fever. The patient also experienced an extreme sore throat a few days later. The sore throat had caused the patient to lose weight because it hurt for her to eat. She also had malaise. Headache, fever and sore throat persisted for a week. The outcome of the events was reported as complete recovery. The seriousness and causality assessment of the events was not reported. Follow up information received from a nurse on 29 Dec 2014: Updated patent's demographics (height and weight), co-suspect vaccines, outcome of sore throat, event (malaise added).
Age: 11.0
Sex: F
Vaccine: FLUX, MNQ, TDAP
Symptoms: Oropharyngeal pain, Pyrexia, Weight decreased
Clinical narrative: Case number PHEH2014US022478 is an initial spontaneous report received from a physician on 06 Nov 2014 with a follow up information received from a nurse on 29 Dec 2014. This report refers to an 11 years old female patient. Her medical history and concomitant medication was not reported. Her vaccination status was up to date. She received an initial dose of MENVEO (batch number: G14041/X14041) intramuscularly at a dose of 0.5 ml in the left deltoid on 29 Oct 2014. She also received influenza virus vaccine (other manufacturer, batch number: U189AE) and tetanus, diphtheria, acellular pertussis vaccine (other manufacturer, batch number: 04963AA); both vaccines at a dose of 0.5 ml intramuscularly on 29 Oct 2014. On the same day immediately after vaccination the patient began inconsolably crying (4 times) for a few hours. A few days after vaccination she experienced headache and myalgia. The patient had on and off fever. The patient also experienced an extreme sore throat a few days later. The sore throat had caused the patient to lose weight because it hurt for her to eat. She also had malaise. Headache, fever and sore throat persisted for a week. The outcome of the events was reported as complete recovery. The seriousness and causality assessment of the events was not reported. Follow up information received from a nurse on 29 Dec 2014: Updated patent's demographics (height and weight), co-suspect vaccines, outcome of sore throat, event (malaise added).
Age: 56.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Guillain-Barre syndrome, Intensive care
Clinical narrative: Skin irritation, itchy. (+) G.B.S tingling/cold hands and feet. Feverish. Felt unstable.
Age: 56.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Feeling abnormal, Guillain-Barre syndrome, Laboratory test abnormal, Mechanical ventilation, Paraesthesia
Clinical narrative: Skin irritation, itchy. (+) G.B.S tingling/cold hands and feet. Feverish. Felt unstable.
Age: 56.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Peripheral coldness, Pruritus, Pyrexia, Skin irritation
Clinical narrative: Skin irritation, itchy. (+) G.B.S tingling/cold hands and feet. Feverish. Felt unstable.
Sex: U
Vaccine: HPVX
Symptoms: Death
Clinical narrative: This spontaneous unconfirmed report was received from a healthcare worker via a company representative and refers to a patient of unknown age and gender. The reporter read about this information on the internet (unspecified website). No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On an unknown date, the patient was vaccinated with a dose of unidentified Merck HPV vaccine (name, strength, dose, route of administration, anatomical location, lot # and expiration date were not provided). Reporter could not confirm whether the product was GARDASIL or GARDASIL 9. On an unknown date, 36 hours after receiving a dose of unidentified Merck HPV vaccine, the patient died of an unspecified cause. The relatedness between the patient's death and unidentified Merck HPV vaccine was not reported. Upon internal review, the event of death was considered to be medically significant. Additional information is not expected as the reporter did not have any additional information and did not wish to be contacted regarding this report.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised
Clinical narrative: Broke out into a full body rash. Went to ER.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Angiogram normal, Asthma, Body temperature decreased, Computerised tomogram normal, Condition aggravated
Clinical narrative: Extreme fatigue two hours post immunization, day two: achy low grade temperature. Day three: heart palpitations, asthma exacerbation. Day four: asthma worse, seen by PCP, given nebulizer treatment. Day five migraine headache, passed out taken to ED with slurred speech and right hemiparesis. Negative MRA and CT scan.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Dysarthria, Fatigue, Hemiparesis, Loss of consciousness, Migraine
Clinical narrative: Extreme fatigue two hours post immunization, day two: achy low grade temperature. Day three: heart palpitations, asthma exacerbation. Day four: asthma worse, seen by PCP, given nebulizer treatment. Day five migraine headache, passed out taken to ED with slurred speech and right hemiparesis. Negative MRA and CT scan.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Palpitations
Clinical narrative: Extreme fatigue two hours post immunization, day two: achy low grade temperature. Day three: heart palpitations, asthma exacerbation. Day four: asthma worse, seen by PCP, given nebulizer treatment. Day five migraine headache, passed out taken to ED with slurred speech and right hemiparesis. Negative MRA and CT scan.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 08-APR-2016, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) injection, lot # L044058, expiration date 02-MAY-2017 (dose and route were not reported). Concomitant therapies were not provided. According to the reporter, the vaccine was stored at a temperature of 9.9 degrees Fahrenheit for 163 hours and 30 minutes. There was no previous temperature excursion reported. No adverse effect was reported. No product quality complain (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Case number PHEH2014US011235 is an initial spontaneous report received from a physician on 02 Jun 2014. This report refers to a 04 year old male patient. His medical history and concomitant medication were not reported. He was vaccinate with a dose of MENVEO (batch number: not reported) via subcutaneous route on an unknown date in May 2014. Vaccination was performed using 5/8 inch needle. No adverse event was reported following this medication error.
Age: 47.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2014US011247 is an initial spontaneous report from the nurse received on 02 Jun 2014. This report refers to a 47-year-old male patient. His medical history included splenectomy. On 02 Jun 2014, he was inadvertently vaccinated with only Men CYW-135 liquid component of MENVEO (batch number: X13014) without reconstitution with Men A lyophilized component. No adverse event reported following this medication error (inappropriate preparation of vaccine).
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2014US011536, is an initial spontaneous report received from a medical assistant on 06 Jun 2014. This report refers to a 11 year old female patient. Past medical history and concomitant medications were not reported. She received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: M13017), without being reconstituted with Men A lyophilized conjugate vaccine component on 29 MAY 2014. No adverse event was reported following this administration error.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Case number PHEH2014US011539 is an initial spontaneous report from the nurse received on 05 Jun 2014 with a follow up information received from a nurse on 11 Jul 2014. This report refers to a 16 years old female patient. Her medical history included bipolar disorder. Her concomitant medications included LAMICTAL, RISPERDAL and Birth Control Pills (BCP). Her vaccination history included administration of MENVEO in the past which was well tolerated. On 05 Jun 2014, she was inadvertently vaccinated with a booster dose of MENVEO (batch number: M12098) via subcutaneous route in the left arm post laterally. No adverse event reported following this medication error (wrong route of vaccination).  Follow up information received from a nurse on 11 Jul 2014: Patient demographics (initials, date of birth, age and gender), medical history, concomitant medications, vaccination history, vaccination date and site updated.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2014US011545, is an initial spontaneous report received form a nurse on 05 Jun 2014. This report refers to an unknown age and gender patient. Past medical history and concomitant medications were not reported. The patient received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: not reported), without being reconstituted with Men A lyophilized conjugate vaccine component on an unknown date and few days later received full dose of MENVEO. No adverse event was reported following this administration error.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2014US011628 is an initial spontaneous report  from a physician received on 06 Jun 2014 with a follow up information received from a physician on 17 Jul 2014. This report refers to a 12 year old male patient. His medical history included Hodgkin's Lymphoma in remission and his concomitant medication included PERIACTIN for appetite stimulation at a dose of 5 ml thrice daily via oral route since 22 Aug 2012. On 05 Jul 2014 at 11 am, the patient received intramuscularly lyophilized Men A powder vial of MENVEO (batch number: M13017) mixed with a BOOSTRIX (other manufacturer, batch number unknown) vial. Later on the same day the patient received the MenCYW 135 liquid component of MENVEO alone. No adverse event was reported following these medication errors. Follow up information received from a physician on 17 Jul 2014: Updated patient demographics (height and weight), medical history, concomitant medication and cosuspect vaccine.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2014US011731 is an initial spontaneous report received from a nurse on 09 Jun 2014 with a follow-up received on 10 Jul 2014. This report refers to a 17 year old female patient. Her past medical history and concomitant medications were not reported. The patient received only Men CWY liquid conjugate component of MENVEO (batch number: M12121) without reconstitution with Men A lyophilized component intramuscularly into left deltoid on 09 Jun 2014 at 13:54. The patient was notified and informed about the CDC recommendation. No adverse events were reported following this medication error (inappropriate preparation of medication). Follow-up received from a nurse on 10 Jul 2014: Site and time of vaccination was updated. Batch number was amended.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US009493 is an initial spontaneous report received from a medical assistant on 08 May 2014: This report refers to an 11 years old female child. She was vaccinated with MENVEO (batch number: M13017) intramuscularly on 07 May 2014. This vaccine was stored at 33.8 degree Fahrenheit for 8.5 hours. No adverse event was reported following this administration error.
Age: 11.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: MOP states the patients arm is swollen from the Shoulder to the elbow and warm to the touch, started approx. 24 hours after injection.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2014US009509 is an initial spontaneous report receive from a pharmacist on 08 May 2014: This report refers to a patient od unknown age and gender. She was given only the liquid component of MENVEO (batch number: unknown) without being reconstituted with MenA component, on an undetermined date. No adverse event was reported following this administration error.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2014US009861 is an initial spontaneous report from the nurse received on 09 May 2014 with a follow-up received on 09 May 2014 with a follow-up received on 17 Jun 2014. This report refers to a 14-year-old male patient. On 09 May 2014, the patient was accidentally vaccinated with only 0.5 ml of Men CYW-135 liquid component of MENVEO (batch number: M12131) intramuscularly without reconstitution with the lyophilized Men A component. No adverse event reported following the medication error (inappropriate preparation of medication). Follow-up received from a nurse on 17 Jun 2014: Batch number amended.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect route of drug administration
Clinical narrative: Case number PHEH2014US009946 is an initial spontaneous report received from a health care professional via sales representative on 12 May 2014. This repot refers to a patient unknown age and gender. It was reported that the patient received MENVEO (batch number: unknown) subcutaneous on 09 May 2014. Outcome of the event, seriousness and causality assessment was not reported. No further information was provided.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2014US009951, is an initial spontaneous report from the health care profession on 13 May 2014, and with a follow up report received on 28 Jul 2014. This report refers to a 11-year-old male patient. Concomitant vaccine included BOOSTRIX (batch number: 3T549, other manufacturer) at a dose of 0.5 ml intramuscular into right deltoid on 08 May 2014. On 08 May 2014, he was vaccinated with an intramuscular dose of Men A lyophilized component of MENVEO (batch number: A13015) reconstituted with sterile water instead of being reconstituted with MenCYW-135 liquid component. He was advised to re-immunize with full dose of MENVEO. The child had received full dose of MENVEO (batch number: unknown) on 08 Jul 2014 with no complaints. No adverse event reported following this medication error (wrong solution used in drug reconstitution). No further details provided. Follow up report received on 28 Jul 2014. Updated the vaccination details.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2014US009974 is an initial spontaneous report received from a nurse on 13 May 2014 with a follow up report received from the nurse on 08 Sep 2014. This report refers to a 12 years old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with an expired dose of MENVEO (batch number: X11033 and A11033) intramuscularly at a dose of 0.5 ml into left deltoid on 12 may 2014 at 04:10 pm. It was her initial MENVEO vaccination. On the same day, she was concomitantly vaccinated with ADACEL (other manufacturer, batch number: not reported) intramuscularly at a dose of 0.5 ml and varicella vaccine (other manufacturer, batch number: not reported) subcutaneously at a dose of 0.5 ml. She did not experience any adverse event following this administration error (expired vaccine used). Follow up report received from the nurse on 08 Sep 2014: Updated patient demographics (height and weight), suspect vaccine description (time of vaccination, dose and site), added concomitant vaccines, concomitant vaccination details and reports statement (no event).
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Abdominal pain, Erythema, Oxygen saturation decreased, Vomiting
Clinical narrative: Patient had PROQUAD and KINRIX, came back into office 30 min later with redness on face, abdominal pain and vomiting, HR 120, low blood O2, EPIPEN Jr given.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2014US010040 is an initial spontaneous report from a nurse received on 12 May 2014. This report refers to a patient of an unknown gender. The patient intramuscularly received only powder component of MENVEO (batch number: unknown) mixed with bacteriostatic saline instead of Men CYW-135 liquid component. No adverse event reported following this medication error.
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2014US010042, is an initial spontaneous report received from a nurse on 14 May 2014. This report refers to a patient of unknown age and gender. Nurse reported that a patient was administered with MENVEO (batch number: unknown) intramuscular after the Men A lyophilized component was reconstituted with a sterile diluent that was for live vaccines. No adverse event was reported. No further information was provided.
Age: 85.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Induration, Injected limb mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable office supervisor, then from a medical assistant on behalf of a doctor's office, and from a contactable Other HCP (Supervisor). These contactable reporters reported similar events for 3 patients. This is the 3rd of 3 reports. An 85-year-old male patient received PREVNAR 13 (lot M51192, expiry date 31May2017) in left deltoid at 0.5 ml single on 16Feb2016 at 09:00. Medical history and concomitant medications were not reported. Illness at time of vaccination: none. No other vaccines given on same date along with suspect vaccine. No other vaccinations within 4 weeks prior to date of vaccination. On 17Feb2016 the patient experienced swollen arm, hot to the touch, red, hard lump and could not move left arm and on unknown date "he has still persistent pain in left arm". All the events had not yet been resolved and resulted worsened at the time of report. The patient was in the office seeing the doctor on 18Feb2016. The reporter considered the events were related to vaccination. The contactable Other HCP (Supervisor) stated that the patient provided to him/her information regarding the reported adverse events with the use of the suspect vaccine. The contactable Other HCP (Supervisor) considered there was a reasonable possibility that the event is related to suspect product. The contactable Other HCP (Supervisor) was willing to be contacted again by Pfizer on the reported adverse events. Follow-up attempts completed. No further information expected. Follow-up (14-APR-2016): Follow-up attempts are completed. No further information is expected. Follow-up (22Apr2016): Additional information received from medical assistant includes: pain in arm added as adverse event. Follow-up (13May2016): New information reported from a contactable Other HCP (Supervisor) included:  event "still has pain in arm" changed to "still has pain persistent in arm/pain left arm" serious; No other vaccines given on same date not other vaccinations within 4 weeks prior to date of vaccination; outcome of AEs swollen arm, hot to the touch and red confirmed as ongoing; reporter informed regarding the adverse events; reporter event causality assessment; reporter further contactability.
Age: 85.0
Sex: M
Vaccine: PNC13
Symptoms: Skin warm, Upper extremity mass
Clinical narrative: This is a spontaneous report from a contactable office supervisor, then from a medical assistant on behalf of a doctor's office, and from a contactable Other HCP (Supervisor). These contactable reporters reported similar events for 3 patients. This is the 3rd of 3 reports. An 85-year-old male patient received PREVNAR 13 (lot M51192, expiry date 31May2017) in left deltoid at 0.5 ml single on 16Feb2016 at 09:00. Medical history and concomitant medications were not reported. Illness at time of vaccination: none. No other vaccines given on same date along with suspect vaccine. No other vaccinations within 4 weeks prior to date of vaccination. On 17Feb2016 the patient experienced swollen arm, hot to the touch, red, hard lump and could not move left arm and on unknown date "he has still persistent pain in left arm". All the events had not yet been resolved and resulted worsened at the time of report. The patient was in the office seeing the doctor on 18Feb2016. The reporter considered the events were related to vaccination. The contactable Other HCP (Supervisor) stated that the patient provided to him/her information regarding the reported adverse events with the use of the suspect vaccine. The contactable Other HCP (Supervisor) considered there was a reasonable possibility that the event is related to suspect product. The contactable Other HCP (Supervisor) was willing to be contacted again by Pfizer on the reported adverse events. Follow-up attempts completed. No further information expected. Follow-up (14-APR-2016): Follow-up attempts are completed. No further information is expected. Follow-up (22Apr2016): Additional information received from medical assistant includes: pain in arm added as adverse event. Follow-up (13May2016): New information reported from a contactable Other HCP (Supervisor) included:  event "still has pain in arm" changed to "still has pain persistent in arm/pain left arm" serious; No other vaccines given on same date not other vaccinations within 4 weeks prior to date of vaccination; outcome of AEs swollen arm, hot to the touch and red confirmed as ongoing; reporter informed regarding the adverse events; reporter event causality assessment; reporter further contactability.
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2014US010044 is an initial spontaneous report received from a pharmacist on 14 May 2014. This report refers to a patient of unknown demographics. Past medical history and concomitant medication were not reported. On 12 May 2014, the patient was vaccinated with an expired dose of MENVEO (batch number: M11081, expiry date: 30 Apr 2014) intramuscularly. No adverse event was reported following this administration error.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US010188, is an initial spontaneous report received from a nurse on 15 May 2014 with a follow-up received on 24 June 2014. This report refers to 13 year old male patient. He was not taking any concomitant medications. He was vaccinated with initial application of MENVEO (batch number: A12094) intramuscularly in to the right deltoid at 5:00 pm on 08 May 2014. Seven days later the vaccine was noted to have been stored out of temperature range for a 2.5 hour period prior to administration. Temperature maximum of 21 degree Celsius was reached. No adverse event was reported following this mal administration (incorrect storage of drug). Follow-up received from the nurse on 24 June 2014: Updated patient demographics, site and time of application, vaccination history and comment from reporter.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2014US010189 is an initial spontaneous report from the pharmacist received on 16 May 2014 with a follow up report received on 20 Jun 2014. This report refers to a 17 year old female patient. She was vaccinated with MENVEO (batch number: A13059) on 23 May 2014 at 12:00 hour. It was reported that the Men A lyophilized component was inadvertently reconstituted with sterile diluent that comes with MMR vaccination instead of Men CYW liquid conjugate. No adverse event reported following this medication error (wrong solution used in drug reconstitution). Follow up report received on 20 Jun 2014: Changed patient gender (male to female), update patient demographics (date of birth, height and weight), changed vaccination date (from 16 May 2014 to 23 May 2014) and batch number (M13059 to A13059).
Sex: F
Vaccine: MNQ
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Case number PHEH2014US016219, is an initial spontaneous report from a health care professional received on 11 Aug 2014. This report refers to an 18-year-old female patient. Past medical history and concomitant medication were not provided. The patient was vaccinated with first dose of MENVEO (batch number: unknown) in 2007, second dose in 2012 and third dose in 2014.  It was reported that the patient received a total of three doses. No adverse event was reported following this medication error.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US010196 is an initial spontaneous report from the medical assistant (other health care professional) received on 16 May 2014. This report refers to a 13-year-old male patient. The patient was vaccinated with MENVEO (batch number: M13015) intramuscularly on 13 May 2014. It was reported that the MENVEO vaccine administered to the patient was exposed to the temperatures between 33 F and 44 F for up to seven days before vaccination. No adverse event reported following this medication error (incorrect storage of drug).
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2014US015056 is an initial spontaneous report received from the physician on 25 Jul 3024. This report refers to a patient of unknown identifiers. The patient's medical history and concomitant medication were not reported. The patient was vaccinated with a dose of MENVEO (batch number: not reported) intramuscularly on unspecified date. it was reported that Men A lyophilized conjugate was reconstituted with saline instead of the Men CYW-135 liquid conjugate. No adverse events were reported after the maladministration.
Age: 22.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2014US010361, is an initial spontaneous report received from a pharmacist on 19 May 2014. This report refers to a 22 year old male patient. He received Men CWY liquid conjugate component of MENVEO (batch number: X13011) without being reconstituted with Men A lyophilized component on 16 May 2014. No adverse event was reported.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2014US010430, is an initial spontaneous report received from a pharmacist on 20 May 2014. This report refers to a patient of unknown age and gender. It was reported that the patient received only the Men CYW-135 liquid component of MENVEO (batch number: unknown) on 17 May 2014. No adverse event was reported. No further information was provided.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Case number PHEH2014US015252 is an initial spontaneous report received from healthcare professional on 29 Jul 2014. This report refers to a 12 year old male patient. His medical history and concomitant medication were not reported. He was vaccinated with MENVEO (batch number: A13059) via subcutaneous route on 29 Jul 2014. No adverse event was reported following this administration error.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2014US010437 is an initial spontaneous report from the pharmacist received on 21 May 2014, with a follow up received from nurse on 17 Jun 2014. This report refers to a 19-year-old female patient. She was inadvertently vaccinated with an expired MENVEO (batch number: A11081) intramuscularly on 19 May 2014. No adverse event reported following this medication error (expired vaccine used). The reporter stated that she does not belong to their practice. She used to be their patient many years ago, but was no longer their patient and they have no records of her. So they cannot provide any additional information. Follow-up received form nurse on 17 Jun 2014: Updated reporter comment.
Age: 26.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2014US010527, is an initial spontaneous report received from a pharmacist on 21 May 2014. This report refers to a 26 year old female patient. Pharmacist reported that she administered an expired dose of MENVEO (batch number: A11064, expiry date: Dec 2013), intramuscular to the patient on 21 May 2014. No adverse reaction was reported. No further information was provided.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2014US016193, is an initial spontaneous report from a nurse received on 11 Aug 2014. This report refers to a 17-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. He was administered MenA powder component of MENVEO (batch number: A14023) reconstituted with sterile water instead of Men-CYW-135, intramuscularly on 11 Aug 2014. No adverse event was reported following the administration error (wrong solution used in drug reconstitution).
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Product preparation error
Clinical narrative: Case number PHEH2014US010648 is an initial spontaneous report received from a nurse on 22 May 2014 with a follow up report received on 19 Jun 2014. This report refers to a 13-year-old female patient. She received only the powder component of MENVEO (batch number: A12102) mixed with sterile diluent instead of MenCYW-135 liquid component, intramuscularly into left deltoid, on 17 Apr 2014 at 10:58 am. The reporter believed that the sterile diluent was normal saline but she was not sure. Reporter insisted that the patient did not experience any adverse event following this medication error. Follow up reported on 19 Jun 2014: Updated patient demographics (height and weight), vaccination details (left deltoid at 10:58 am) and changed batch number (M12102 to A12102).
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Product reconstitution issue
Clinical narrative: Case number PHEH2014US010666 is a combined initial spontaneous report from a nurse received on 22 May 2014 and a follow-up received on 27 May 2014 with a follow-up received on 27 Jun 2014. This report refers to an 18-year-old female patient. She received only the Men CYW-135 liquid conjugate component of MENVEO (batch number: X13051) into right deltoid on 25 Apr 2014 at 11:30. It was reported that the past vaccination with MENVEO which was given on 24 Jan 2008 was well tolerated. No adverse reaction has been reported following this medication error (inappropriate preparation of medication). Follow-up received on 27 Jun 2014: Site of vaccination, past vaccination, patient's demographics and reporter details were updated.
Age: 59.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Product reconstitution issue
Clinical narrative: Case number PHEH2014US010743 is an initial spontaneous report from a health care professional received on 23 May 2014 with a follow up report received from the health care professional on 07 Jul 2014. This report refers to a 59 year old female patient. She was inadvertently vaccinated with only Men CYW-135 liquid conjugate component of MENVEO (batch number: X12024) intramuscularly into her right deltoid without reconstituting with Men A lyophilized component on 08 May 2014 at 05:30 PM. No adverse event reported following this medication error (inappropriate preparation of vaccine). Follow up report received from the health care professional on 07 Jul 2014: The patient's demographics, anatomical site of administration and the time of administration of MENVEO were updated.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2014US010817 is an initial spontaneous report received from a nurse on 27 May 2014. This report refers to a 12 year old male patient. His medical history and concomitant medication were not reported. On an unknown date, he was vaccinated with MENVEO (batch number: M13014) via intramuscular route. It was reported that, before administration the vaccine was stored under 02 degree Celsius (between 33 to 36 degree Fahrenheit) for 28 hours on 05 May 2014. No adverse event was reported following this medication error.
Age: 20.0
Sex: M
Vaccine: HEP, HEPA, IPV, MMR, MNQ, TDAP, TYP
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Case number PHEH2014US010846 is an initial spontaneous report received from a nurse on 27 May 2014 with a follow-up received on 30 Jun 2014. This report refers to a 20 year old male patient. Concurrent condition included seasonal allergies. Concomitant vaccinations included TYPHIM, IPOL, Hepa-B, MMR, Tdap and Hep A. the patient received only the liquid component (MenCYW) of MENVEO (batch number: X13059) intramuscular into left deltoid on 24 May 2014 at 2:20 pm. The patient notified to return to clinic for revaccination with full MENVEO dose (both components). No adverse event was reported following this drug administration error (inappropriate preparation of medication). Follow-up received on 30 Jun 2014: Site of vaccination, time of vaccination, concomitant vaccinations, concurrent condition and patient's demographics were updated. Batch number was amended.