chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Influenza, Pyrexia
Clinical narrative: This initial spontaneous case was received on 05-Jun-2017, from other non-health professional and concerns a female patient of unspecified age. On an unspecified date in 2012, the patient was administered with FLUVIRIN (dosage: 0.5 ml, lot number: 1204201, expiry date, anatomical location: not reported, route of administration: intramuscular). On an unspecified date in 2012, after administration of influenza vaccine, the patient experienced flu symptoms associated with fever and lingering cough for one and half weeks. The patient was treated with TYLENOL for fever. At the time of this report, outcome of the event influenza like illness was recovered. The reporter did not provide the causality between event and in influenza vaccine. The reporter did not provide the causality between event and influenza vaccine. The report was not serious.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: This initial non-serious spontaneous case, received on 01-Sep-2017, reported by a pharmacist, concerning a 51 year-old male patient. Patient's medical history was not reported. On 01-Sep-2017, the patient received FLUVIRIN THIOMERSAL (dose: 0.5ml, route of administration: intramuscular, anatomical location was not reported, batch number: 1720801 as reported, expiry date: unspecified date in Apr-2018). It was reported that, the administered multi dose vial was opened and exposed to 51F for 13 hours, temp excursion above 46F (explicitly captured as incorrect product storage, drug administration error). However, no adverse effect was noted after administration. The outcome of the events was not reported.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Case number PHEH2017US003197, is an initial spontaneous report received from a nurse on 24 Jan 2017. This report refers to a 48 year old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1619701, expiration date: May 2017) at a dose of 3.0 ml intramuscularly on 24 Jan 2017. On 24 Jan 2017, patient received 3.0 ml dose in error instead of the intended 0.5 ml dose. It was reported that the patient did not have any symptoms. No adverse event was reported following this administration error (incorrect dose administered).
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: Case number PHEH2016US030704, is an initial spontaneous report received from a pharmacist on 18 Nov 2016. This report refers to a male patient. Medical history and concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1618621, expiry date: Apr 2017) from 18 Nov 2016, at one single dose of 0.5ml, intramuscularly. It was reported that the patient was administered with FLUVIRIN after a temperature excursion at 50F for less than 24 hours/had inadvertent exposure to vaccine. No adverse event was reported following this administration error (Incorrect product storage). The case was assessed as non serious by the pharmacist.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: Case number PHEH2017US003256 is initial spontaneous case received from pharmacist on 30 Jan 2017. This report refers to 80 year old male patient. Medical history was not reported current condition included diabetes, high cholesterol and high blood pressure. Concomitant medication included: metformin hydrochloride, simvastatin and lisinopril and hydrochlorothiazide. Past vaccination history included: Influenza vaccine 2013, 2013 and 2015 and well tolerated. The patient was vaccinated with FLUVIRIN (batch number: 169003, expiry date: May 2017) at dose of 0.5 ml intramuscular on 28 Jan 2017 at 3.30. Temperature excursion was reported with FLUVIRIN pre filled syringe (PFS). The maximum temperature reached was 51.44 degree F for 2 hours 30 minutes. This was the first excursion and vaccine was given to one patient. No adverse event was reported following this medication error. Follow up information was received from pharmacist on 28 Feb 2017. The patient current condition added (diabetes, high cholesterol and high blood pressure) concomitant drug added (metformin hydrochloride, simvastatin and lisinopril and hydrochlorothiazide) vaccination time and anatomical site added 3.30, left arm and past vaccination history added. And updated narrative accordingly.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: This initial spontaneous case received from a pharmacist on 23-Aug-2017, concerning a 55-year-old male patient. The patient's medical history was not reported and he did not receive any concomitant medications. On 22-Aug-2017, around 2:00 pm, the patient received FLUVIRIN (dose: 0.5ml, route of administration: intramuscular, anatomical location: not reported, batch number: 1720801, expiration date: Apr-18, trade name and manufacturer: not reported). It was reported that, the vaccine was shipped without a track of temperature. However, the pharmacist took the vaccine out of package and put right into the refrigerator, before administering the vaccine. The pharmacist wanted to know, if the vaccine was fine to use. No event occurred and no hospitalisation took place. The outcome of the events (incorrect product storage, drug administration error and no adverse event) were not reported. The health care professional reported this case as non-serious.
Sex: F
Vaccine: FLUX, PPV
Symptoms: No adverse event
Clinical narrative: This spontaneous case, initially received on 08-Dec-2016, was reported by a health authority and concerns a(n) female patient. Weight: not provided; Height: not provided. Concomitant medication: refer to appropriate report section. Administration of company suspect drug(s): The patient received Influenza Virus Vaccine (INN) for Indication not reported from 2015 to 2015. Dose regimen: Not reported, Route of administration: Not reported. Batch number: Not reported. Non-company suspect drugs: Pneumococcal Vaccine, Indication: Indication not reported. Special circumstances: Drug administration error without adverse event. It was reported that the patient received pneumonia and flu shot in the same arm.
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious initial spontaneous case was received on 11-Sep-2017 from pharmacist, concerning a male patient of an unspecified age. On an unspecified date, the patient was administered with FLUVIRIN THIOMERSAL (dose: 0.5 ml, batch number: 1720801 (as reported), expiry date: Apr-2018, route of administration: intramuscular and anatomical location: not reported). The administered vaccine reached 64.9-dgeree F instead of storing at 36-46-degree F for up to 12 hours, which was considered as incorrect product storage and drug administration error. It was reported that, no adverse reactions were observed. The outcome of the events was not reported. The reporter assessed the report as non-serious.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Case number PHEH2016US029994, is an initial spontaneous report from a pharmacist on 11 Nov 2016. This report refers to a female patient. Past medical history and concomitant medication were not reported. She was vaccinated with a single dose of FLUVIRIN (batch number: 168805, Expiry: Apr 2017) at a dose of 0.5 ml intramuscularly on 20 Oct 2016. After vaccination, on the same day, she experienced arm pain and pain in shoulder upon lifting and when driving. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events were not reported.
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Underdose
Clinical narrative: Case number PHEH2016US029916, is an initial spontaneous report from a pharmacist received on 11 Nov 2016. This report refers to an unknown age of female patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: not reported) at a dose of 0.25 ml, intramuscularly on 07 Nov 2016. Pharmacist reported that, a patient stopped by and told him that a 1/2 dose of FLUVIRIN was administered at another pharmacy 04 days ago on Mon 07 Nov 2016 to see if the person would have an allergic reaction. Now, the patient wants him to administered the other half on 11 Nov 2016. No adverse event reported following this medication error (underdose). The case was assessed as non serious by the pharmacist.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure via skin contact, No adverse event, Product container issue
Clinical narrative: Case number PHEH2016US030405, is a report initially received from a nurse on 17 Nov 2016. This report refers to a 37-years-old patient. Past medical history and concomitant medications were not reported. The patient inadvertently vaccinated with FLUVIRIN (batch number: 1620201) on 10 Nov 2016. On the same day a nurse found that FLUVIRIN vial was leaking and some of the vaccine got on her hand. She washed her hands at the time. No problems or symptoms occurred. No adverse event was reported following this administration error. Batch review report reference number [1017976] received from quality assurance department on 05 Jan 2017. Based on the document review, it was stated that the concerned FLUVIRIN batch number [1620201] was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up information received from Quality assurance department of 05 Jan 2017: Added QA reference number (1017976) and  investigation summary.
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Incorrect route of drug administration, Injection site swelling
Clinical narrative: Case number PHEH2017US006056, is an initial spontaneous report received from a nurse on 24 Feb 2017. This report refers to a female patient of unknown age. Medical history and concomitant medications were not reported. The patient was vaccinated with one single dose of FLUVIRIN (batch number: 1418501, Expiry date: Apr 2017) at a dose of 0.5 ml intradermally into right arm on 24 Feb 2017 at 9:30 AM. It was reported that, the patient received FLUVIRIN vaccine which might have been inadvertently administered as a PPD (purified protein derivative) and was given intradermally in the lower portion of the inside of arm where the tuberculin test is usually given. The patient experienced local site reaction of swelling to inner aspect of right forearm. It was resolved in 7 to days. The case was assessed as non serious by the nurse. Causality of the events was not reported. Follow up information was received from a nurse on 23 Mar 2017. Event swelling of arm, Batch number, anatomical site of vaccination was added. Updated narrative accordingly.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: The non-serious initial spontaneous case, was received on 06-Sep-2017 from pharmacist, concerning a 54-year-old adult female patient. The patient's medical history and concomitant medication were not reported. On 04-Sep-2017, the patient administered with FLUVIRIN THIOMERSAL (dose: 0.5 ml, batch number: 1720801 (as reported), expiry date: Apr-2018, dose, route of administration: intramuscular and anatomical location: not reported). On an unspecified date, the vaccine was exposed to temperatures possibly above 25 degree Celsius (77 degree F) for no more than 24 hours, which was considered as incorrect product storage. On 04-Sep-2017, the patient was administered with vaccine which was exposed to temperatures possibly above 25 degree Celsius (77 degree F) instead of storing at 36-46F (2-8 degree Celsius), which was considered as drug administration error. The outcome of the events was not reported. The reporter assessed the report as non-serious.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, received from a pharmacist on 23-Aug-2017, concerning a 53-year-old female patient. The patient's medical history was not reported and he did not received any concomitant medications. On 22-Aug-2017, around 2:00 pm, the patient received FLUVIRIN (dose: 0.5ml, route of administration: intramuscular, anatomical location: not reported, batch number: 1720801, expiration date: unspecified date in Apr-18). It was reported that, the vaccine was shipped without a track of temperature. However, the pharmacist took the vaccine out of package and put right into the refrigerator, before administering the vaccine. The pharmacist wanted to know, if the vaccine was fine to use. No event occurred and no hospitalisation took place. The outcome of the events was not reported. The health care professional reported this case as non-serious.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Case number PHEH2017US004505, is an initial spontaneous report received from a nurse on 09 Feb 2017. This report refers to a 72 year old female patient. Medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number and expiry date: not reported) at a dose of 0.5 ml intramuscularly on 05 Oct 2016. Further she was vaccinated with FLUVIRIN (batch number: 168904, Expiry date: 31 May 2017) on 02 Dec 2016. No adverse event was reported following this medication error.
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: Case number PHEH2017US002900 is an initial spontaneous report received from pharmacist on 24 Jan 2017. This report refers to unknown demographics patient. Medical history and concomitant medication was not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number not reported) at a dose of 0.5 ml intramuscular on an unknown date. A temperature excursion was reported with FLUVIRIN multi dose vial (MDVs). Some may had been opened and some may had been unopened. The minimum temperature reached was 32 degrees Fahrenheit (F). The maximum length of excursion was 12 hours. Pharmacist did not know if patients had received the vaccine after the temperature excursion. No adverse event was reported following this medication error.
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Product container issue
Clinical narrative: Case number PHEH2016US030414, is an initial spontaneous report received from a health care professional on 16 Nov 2016. This report refers to a patient of unknown age and gender. Past medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUVIRIN (batch number: 1618401, expiry date: Apr 2017) intramuscularly on an unspecified date. On the same day the healthcare professional noticed leakage when piercing the vial to draw up vaccine. The product was administered. No adverse event was reported following these administration errors. Batch review report reference number [1017943] received from quality assurance department on 23 Dec 2016. Based on the document review, it was stated that the concerned FLUVIRIN batch number [1618401] was manufactured in accordance with approved internal procedures and it was in compliance with current good manufacturing practices (cGMP) requirements. Non-significant follow up information received from Quality assurance department on 23 Dec 2016: Added QA reference number (1017943) and investigation summary.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: This initial spontaneous case was received on 03-Oct-2017, from other health professional, concerning a 67-year-old, elderly, female patient. The patient's medical history and medication history were not reported. On 03-Oct-2017, the patient was administered with FLUVIRIN (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid muscle of upper arm, batch number: 160301, expiry date: May-2017, trade name, manufacturer: not reported). It was reported that previous year's FLUVIRIN was administered to the patient (explicitly coded as expired vaccine used) and patient had not experienced any adverse effects. The reporter assessed the events as non-serious. Follow-up received on 12-Oct-2017: The reporter stated that, the vaccine was administered intramuscularly in the deltoid muscle of upper arm and reported that, the patient had not experienced any adverse effects. Non-significant case correction received with IRD 03-OCT-2017: The narrative was corrected.
Age: 1.25
Sex: F
Vaccine: DTAP, FLU4, PNC13
Symptoms: Blood test, Catheter placement, Disorientation, Febrile convulsion, Lumbar puncture
Clinical narrative: Seizure febrile, 2-3 days in hospital, fever very disoriented > signs, 930/1000 pm on 10/31/17 > time course. My daughter had her 15 month shots on 10/31/17 at around 930/1000 am and also a flu shot.... exactly 12 hrs later around 930/1000 pm at night she had a seizure and almost died in my arms!!!
Age: 1.25
Sex: F
Vaccine: DTAP, FLU4, PNC13
Symptoms: Pyrexia
Clinical narrative: Seizure febrile, 2-3 days in hospital, fever very disoriented > signs, 930/1000 pm on 10/31/17 > time course. My daughter had her 15 month shots on 10/31/17 at around 930/1000 am and also a flu shot.... exactly 12 hrs later around 930/1000 pm at night she had a seizure and almost died in my arms!!!
Sex: M
Vaccine: FLU3
Symptoms: Drug hypersensitivity, Hypersensitivity
Clinical narrative: This initial non-serious spontaneous case, was initially received from a physician on 13-Jul-2017 and concerns a patient  of unspecified age. The concomitant medication taken by the patient was not reported. The patient's risk factor included tobacco abuse. On an unspecified date, the patient was administered with FLUVIRIN (dose, route of administration, anatomical location, batch number, expiry date: not reported) for an unknown indication. On an unspecified date, after administering the FLUVIRIN vaccine the patient developed allergy. The outcome of the event drug allergy was not reported. Reporter's comment: The reporter considered this report as non-serious and the causality of the event drug allergy was related to the FLUVIRIN vaccine.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous case was received on 04-Oct-2017, from other-health professional, concerns a 29-year-old female patient. On 04-Oct-2017, the patient was administered with FLUVIRIN Thiomersal (dose 0.5 ml, batch number: 1618621 (as reported), expiry date: Apr-2017, route of administration, anatomical location: not reported). It was reported that the patient was administered with the vaccine that had expired in the month of April-2017 (explicitly coded as expired vaccine used). No adverse effect were reported. Revaccination with the current season was advised. The reporter assessed the event as non-serious. Follow-up received on 18-Oct-2017: Age and gender of the patient was updated. Narrative amended accordingly. Non-significant case correction received with IRD 04-Oct-2017: Corrected narrative (vaccine that had expired in the month of April-2017).
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Back pain, Dyspnoea, Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Per verbal phone conversation with mom on 1/11/18-on the evening of 1/9/18, child states at 11pm-she had ringing in the ears, felt shortness of breath and fainted. Today, mom states patient is complaining of significant arm, shoulder, and back pain and cannot lift arm.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Syncope, Tinnitus
Clinical narrative: Per verbal phone conversation with mom on 1/11/18-on the evening of 1/9/18, child states at 11pm-she had ringing in the ears, felt shortness of breath and fainted. Today, mom states patient is complaining of significant arm, shoulder, and back pain and cannot lift arm.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Vomiting
Clinical narrative: The initial spontaneous case, was received from other health professional on 15-Oct-2017, concerning a 39-year-old female patient. The patient's medical history and concomitant medications were not reported. On 02-Oct-2017, the patient was administered with FLUVIRIN (dose: 0.5ml, route of administration: intramuscular, anatomical location: deltoid, batch number: XT59305 (as reported), expiry date: 17-May-2018). On 03-Oct-2017, one day after vaccination, the patient had nausea and vomiting. It was reported that, the patient had not taken any treatment medications for the events. At the time of this report, the patient recovered completely from the events. The reporter assessed the events as non-serious. Non-significant follow up received on 23-Oct-2017: It was reported that, the patient had not taken any treatment medications for the events.
Age: 22.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: Case number PHEH2017US002861, is an initial spontaneous report received from a consumer on 25 Jan 2017. This report refers to a 22 years old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUVIRIN (seasonal, batch number: not reported) at a dose of 0.5 ml, intramuscularly on 13 Dec 2016. It was reported that, patient felt that the dose was administered a little bit higher up on his arm on 13 Dec 2016. On 14 Dec 2016, a day after receiving the vaccine, patient had a little pain at the injection site, but stated that the pain was getting worse and worse. Patient stated that the injection site was still tender to the touch on 15 Dec 2016. Patient characterizes the pain in his arm as a sharp pain that comes and goes. When patient was not using his arm, there was no a lot of pain, but otherwise the pain persists when he tries to lift, move, or put pressure on his arm on 15 Dec 2016. Pain persists to date. The outcome of the events was reported as condition unchanged. The seriousness of the events was reported as non serious. The causality of the events was not reported.
Age: 12.0
Sex: M
Vaccine: FLU3
Symptoms: Circumstance or information capable of leading to medication error, No adverse event, Underdose
Clinical narrative: Case number PHEH2016US030428, is an initial spontaneous report received from a pharmacist on 16 Nov 2016. This report refers to a 12-years-old male patient. Medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUVIRIN (batch number: 1620501) intramuscularly on 15 Nov 2016. On the same day when administering FLUVIRIN, the child (patient) jerked away and only received a partial dose. No adverse event was reported following this administration error.
Age: 20.0
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, Immunisation, No adverse event
Clinical narrative: This non-serious initial spontaneous case was received from other health professional on 04-Oct-2017, concerning a 20-year-old, adult, patient of an unspecified gender. The patient's medical history and concomitant medications were not reported. On 04-Oct-2017, the patient was administered with FLUVIRIN THIOMERSAL (dose: 0.5 ml, batch number: 1618621 (as reported), expiry date: Apr-2017, route of administration: intramuscular and anatomical location: deltoid). The patient was administered with expired vaccine and no adverse effect was experienced by the patient. It was reported that, the patient had to revaccinate with current season vaccine. The reporter assessed the event as non-serious. Follow-up received on 12-Oct-2017: The age of the patient was updated. The route of administration of the vaccine and anatomical location were added. Narrative amended accordingly.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous case was received on 04-Oct-2017, from other-health professional, concerns a 22-year-old, a female patient. On 04-Oct-2017, the patient was administered with FLUVIRIN THIOMERSAL (dose: 0.5 ml, batch number: 1618621 (as reported), expiry date: Apr-2017, route of administration: intramuscular and anatomical location: deltoid). It was reported that the patient was administered with the vaccine that had expired in the month of April of that year. No adverse effects were reported. Revaccination with the current season was advised. The reporter assessed the events as non-serious. Follow-up received on 18-Oct-2017: Age and gender of the patient was updated. Route of administration and anatomical location was updated to intramuscular and deltoid respectively. Amended narrative accordingly.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious initial spontaneous case was received on 13-Sep-2017 from a pharmacist, concerning a 58-year-old adult female patient. On 13-Sep-2017, the patient was administered with FLUVIRIN (dose: 0.5 ml, batch number: 179603P (as reported), expiry date: Apr-2018, route of administration: intramuscular and anatomical location: not reported). The administered vaccine reached 60-degree F for no longer than 24 hours instead of storing at 36-46-degree F, which was considered as incorrect product storage and drug administration error. It was reported that, power went for about 24 hours, FLUVIIRN was in the refrigerator and "they did not have a temperature that it reached". It was reported that, no adverse event was occurred after the administration of vaccine. At the time of this report, the outcome of the events was not reported. The reporter assessed the report as non-serious. Follow up received on 18-Sep-2017: It was reported that, no adverse event was occurred after the administration of vaccine. Route of administration of vaccine was updated. Batch number was confirmed by the reporter. The narrative was amended accordingly.
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity
Clinical narrative: This non-serious initial spontaneous case was received on 25-Sep-2017, from other health professional, concerning a female patient of an unspecified age. The patient's medical and concomitant medications were not reported. On 25-Sep-2017, the patient was administered with FLUVIRIN Thiomersal (dose: 0.5 ml, batch number: 1720801 (as reported), expiry date: April-2018, route of administration and anatomical location: not reported. On the same day, the patient had Allergic reaction, which might be itchiness and was treated with BENADRYL. On an unspecified date, the patient got better. At the time of this report, the outcome of the event was recovering. The reporter assessed the report as non-serious.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: This non-serious initial spontaneous case was received from other health professional on 04-Oct-2017, concerning a patient of 43 year old and gender. The patient's medical history and concomitant medications were not reported. On 04-Oct-2017, the patient was administered expired vaccine that expired in April of this year FLUVIRIN THIOMERSAL (dose: 0.5 ml, batch number: 1618621, expiry date: Apr-2017, route of administration: intramuscular, anatomical location: deltoid). No adverse effect was noted. It was reported that the patient had revaccination with the current season. The reporter assessed the report as non-serious. Follow-up received on 12-Oct-2017: Reporter stated that, the age of the patient was 43 years, vaccine was administered intramuscularly in the deltoid and confirmed that, the patient did not experience adverse event.
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: Case number PHEH2016US029147, is an initial spontaneous report received from a healthcare professional on 03 Nov 2016 and 09 2016 (combined report). This report refers to a female patient of unknown age. Past medical history and concomitant medications were not reported. The patient was vaccinated with a FLUVIRIN (batch number: 1618401) on an unknown date. On 13 Oct 2016, the patient experienced soreness in arm from movement that was not cleared up. The outcome of the event was reported as condition improving. The seriousness of the event was reported as non serious. The causality of the event was not reported.
Age: 40.0
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: This initial non-serious spontaneous case, was received on 04-Oct-2017, from other health professional, concerning a 40-year-old adult patient of unspecified gender. The patient's medical history and concomitant medications were not reported. On 04-Oct-2017, the patient was administered with FLUVIRIN THIOMERSAL (dose: 0.5 ml, batch number: 1618621, expiry date: Apr-2017, route of administration: intramuscularly, anatomical location: deltoid). It was reported that the patient was administered with the vaccine that had expired in the month of April of that year (explicitly coded as expired vaccine used). No adverse effects were reported. Revaccination with the current season was advised. The reporter assessed the events as non-serious. Follow-up received on 12-Oct-2017: Reporter stated that, the age of the patient was 40 years, vaccine was administered intramuscularly in the deltoid and confirmed that, the patient did not experience adverse event. Non-significant case correction received 04-Oct-2017: Added no adverse events noted verbatim in description as reported of the event no adverse effect and narrative was corrected.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2016US029710, is an initial spontaneous report received from a pharmacist on 09 Nov 2016. This report refers to a male patient of an unknown age. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: 158302 and expiry date: Jun 2016) at a dose of 0.5 ml, intramuscularly on 13 Oct 2016 at 09:08 AM. On the same day, the patient was vaccinated with last year vaccine it was given two staff members. It was reported that, patient given prior season vaccine. No adverse event was reported following this medication error. Follow up report received from a pharmacist on 07 Feb 2017: Added suspect drug information (vaccination time) and reporter comment.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This non-serious initial Spontaneous case, was received on 03-Oct-2017, concerning a 27-year-old adult female pregnant patient. The patient had no maternal medical history relevant to pregnancy and no paternal medical history. There were no evidence of a defect/adverse finding from a prenatal test. The patient's concomitant medication included: Prenatal multi-vitamin for unknown indication. The patient had not used any contraceptives. The patient's last menstrual period (LMP) date was on 13-Jan-2017. On 03-Oct-2017, the patient was administered with FLUVIRIN THIOMERSAL (dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number, expiry date: not reported). It was reported that FLUVIRIN vaccine was administered to the pregnant woman (explicitly coded as vaccine exposure during pregnancy) and everything was fine with her. The estimated date of delivery of the patient was on 20-Oct-2017. The outcome of the event was not reported. The reporter assessed the event as not related.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Insomnia, Pain
Clinical narrative: This spontaneous case, was received on 11-Oct-2017, from other-non-health professional, concerning a 44-year-old adult female patient. The patient's medical history was not reported and the concomitant medications included trazadone, clozapine, LAMICTAL for unknown indications. On 30-Sep-2017, the patient was administered with FLUVIRIN (dose: 0.5 ml, route of administration: intramuscular, anatomical site: right arm, deltoid, batch number, expiration date: not reported). On the same day, the patient experienced constant pain after vaccination. The patient could not sleep due to pain while rolling on right side. The pain intensity was reported as 7/10. At the time of the report, the patient had not recovered. The reporter considered the report as non-serious. Significant case correction received 11-Oct-2017: Coding of the event "[When rolling on right side] she cannot sleep" was corrected to sleep difficult from sleep disturbance.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site extravasation, No adverse event, Underdose
Clinical narrative: Case number PHEH2016US026202, is an initial spontaneous report received from pharmacist on 07 Oct 2016. This report refers to a patient of unknown age and gender. Medical history and concomitant medication were not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: 1615401) at dose of 0.5 ml intramuscularly on 06 Oct 2016. The pharmacist stated that, after administration of FLUVIRIN dose, part of vaccine came back out of injection site. No adverse event was reported following this administration error. The pharmacist assessed the case as non serious. Follow up information was received from a physician on 04 Jan 2017. Batch number and reporter comment updated.
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Case number PHEH2016US030018 is an initial spontaneous report received from pharmacist on 11 Nov 2016. This report refers to 63 years old female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: 168805, expiry date: Apr 2017) at a dose of 0.5 ml intramuscular on 04 Oct 2016. On the same day, the patient experienced pain in upper arm and deltoid arm which had been ongoing for weeks. The outcome of the event was reported as condition unchanged. The seriousness and causality of the events was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: This spontaneous case initially received on 12-Jan-2017, was reported by a health authority and concerns a female patient. Weight: not provided; Height: not provided. Concomitant medication: not reported. Administration of company suspect drug(s): On an unknown date, the patient received Influenza Virus Vaccine (INN). Dose regimen: Not reported. Route of Administration: Not Reported. Batch number: Not reported. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the patient experienced increased fever (outcome: not reported). Linked Case ID(s): US-BEH-2017077450 (same patient). 06-Mar-2017 (System Update): Linked Case ID(s): 2017077450 (Patient Link).
Age: 1.08
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2016US029216, is an initial spontaneous report received from a physician on 04 Nov 2016. This report refers to a 13-months old male patient. Medical history and concomitant medication were not reported. This 13 months male patient was inadvertently vaccinated with FLUVIRIN (batch number: 1618621) at a dose of 0.5 ml intramuscularly, on 01 Nov 2016. No adverse event was reported following this administration error (drug administered to patient of inappropriate age). The case was assessed as non-serious by the physician.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This non-serious initial spontaneous case, was received on 26-Sep-2017 from a physician, concerning a 03-year-old male child. The patient's medical history and concomitant medications were not reported. On 25-Sep-2017, the patient was administered with FLUVIRIN (dose: 0.5 ml, batch number: 179602P (as reported), expiry date: 30-Apr-2018, route of administration, anatomical location: not reported), explicitly coded as inappropriate age at vaccine administration. The outcome of the events was not reported. The reporter assessed the events as non-serious.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: Case number PHEH2016US024015, is a spontaneous report initially received from pharmacist on 15 Sep 2016. This case refers to 67 years old female patient. Medical history and concomitant medication were not reported. The patient was vaccinated with a single dose of FLUVIRIN (batch number: 168723, expiry date: not reported) at a dose of 0.5 ml, intramuscularly on 13 Sep 2016. On the same day after vaccination, the patient was dizzy. The patient did not state when the dizziness began only stated since she got the shot. On an unknown date, the patient again felt dizziness. The outcome of the event was reported as unknown. The seriousness and causality of the event were not reported. Follow up information was received from a pharmacist on 15 Sep 2016: Event (patient is dizzy) verbatim and coding were updated.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Insomnia, Musculoskeletal pain, Pain in extremity, Swelling
Clinical narrative: My shoulder got swollen hurts a lot and can't sleep at night because my left arm hurts a lot and still does at this time.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: The initial spontaneous case, was received from other health professional on 11-Oct-2017, concerning a female, patient of 3-year-old. It was reported that FLUVIRIN is an inactivated influenza virus vaccine indicted for active immunization of persons 4 years of age and older against influenza virus disease caused by influenza virus subtypes A and type B contained in the vaccine. On 10-Oct-2017, the patient was administered with FLUVIRIN (dose: 0.5 ml, batch: 179701P, expiry date: on an unspecified date in May-2018, route of administration: intramuscular, anatomical location: left vastus lateralis). As the patient was below 4 years, considered as inappropriate age at vaccination. It was reported that, the patient did not experience any adverse event after the administration of the vaccine. The reporter considered the case as non-serious. Follow up received on 27-Oct-2017: The route of administration: intramuscular and anatomical location: left vastus lateralis were updated. New event (no adverse event) was added. It was reported that, the patient did not experience any adverse event after the administration of the vaccine. The narrative was amended accordingly.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Redness, swelling, warm to touch. Given BENADRYL. Cool compresses.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Decreased appetite, Influenza virus test, Microscopy, Pyrexia, Urine analysis
Clinical narrative: Patient developed a fever about 6 days after receiving vaccines, fever got as high as 104 along with decreased appetite.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Influenza like illness, Influenza virus test negative, Injection site swelling, Pain in extremity, Polymerase chain reaction
Clinical narrative: (L) arm pain, swelling (site of injection). Mild wheezing noted. Flu like symptoms, fever x 24 hours.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Wheezing
Clinical narrative: (L) arm pain, swelling (site of injection). Mild wheezing noted. Flu like symptoms, fever x 24 hours.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: Given LA SQ. Hives at the site and redness only at the site. Hive size of dime.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous case, received on 10-Oct-2017, reported by a pharmacist, concerns 69-year-old female patient. On 09-Oct-2017, the patient received a second dose of FLUVIRIN (dose: 0.5ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: 1720701, expiry date: Apr-2018). It was reported that, the patient was administered two flu shots within the same year, with a month apart (explicitly coded as inappropriate schedule of vaccine administered). The reporter assessed this case as non-serious. Follow-up received on 19-Oct-2017: As per the reporter, at the time of report, the patient did not experience any adverse event (reported as the patient was fine).
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Body temperature increased, Irritability
Clinical narrative: Temp. to 101.8 rectally after imms. Increased fussiness noted. No further complaints.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 12 x 17 cm area of erythema and warmth (L) deltoid.
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case initially received on 06-Apr-2017 00:00 was reported by other non-health professional. Company suspect drug: FLUVIRIN (batch number: 1620301 and 1619701 with expiry date: 30-May-2017) (dose: 0.5 ml, unknown frequency, unknown duration, route of administration: unknown). Adverse reactions/events and outcomes: It was reported that there was a temperature excursion with FLUVIRIN product storage (characterized an Incorrect product storage) (Seriousness criteria: Non-Serious event), (Outcome-Unknown). Other non-health care professional reported that during the storage of vaccine the storage temperature reached minimum at 33.8 degrees F and maximum at 63.1 degrees F and there was a total of 6 excursions over a period of 7 days 17 hours and 10 minutes. He reported that an investigation was going on to determine whether the vaccine was given and there were no events been reported. Action taken with FLUVIRIN was not reported and outcome of the event was unknown. Reporter's Assessment: The other non-health care professional did not provide causality assessment for the event with FLUVIRIN. This case report was non-serious.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, No adverse event, Underdose
Clinical narrative: This spontaneous case initially received on 12-Apr-2017 was reported by other non-health professional and concerns a 50 years old female patient. Administration of Company suspect drug: On 12-Apr-2017, the patient was administered with FLUVIRIN  dose: 0.1 ml, batch no: 1618401) via intradermal route. Adverse reactions/events and outcomes: On 12-Apr-2017, the patient was administered with FLUVIRIN 0.1 ml (incorrect dose administered) via intradermal route (inappropriate route of vaccination) with no reaction. Action taken with vaccine was not reported. The outcome of the events was not reported. Reporter's Assessment: The reporter did not provide the causality between FLUVIRIN and events. This report was not serious.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous case was received on 09-Oct-2017, from other health professional, concerning a 25-year-old female pregnant patient with 31 weeks of pregnancy. The patient had a history of preeclampsia and 6 pregnancies and 4 miscarriages. The patient had no spontaneous abortion or still births or no contraceptives were used. The patient's son has haemophilia. The patient's current conditions included hypertension, with previous pregnancy and haemophilia carrier. The concomitant medications included labetalol, amlodipine,  DICLEGIS, UNISOM, pyridoxine, prenatal vitamins. The LMP (last menstrual period) was reported as 04-Mar-2017. On 09-Oct-2017, the patient was administered with FLUVIRIN (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: 1618621, expiry date: Apr-2017). It was reported that expired FLUVIRIN was administered to the patient during 31 week of pregnancy. No adverse events occurred. The patient wanted to know whether to get revaccinated or not. The reporter assessed the report as non-serious. The EDD (estimated date of delivery) was reported as 10-Dec-2017. Significant case correction received with IRD 09-OCT-2017: Preeclampsia previously changed from current condition to historical condition and narrative was amended.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Accidental exposure to product, Exposure via eye contact, No adverse event
Clinical narrative: Case number PHEH2016US029397, is an initial spontaneous report received from a nurse on 07 Nov 2016. This report refers to a 23 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUVIRIN (batch number: 1619021) at a dose of 0.5 ml intramuscularly, on 07 Nov 2016. The nurse accidentally got FLUVIRIN in an employee's (patients) eye while administration. The nurse immediately flushed the eye with water. No adverse event was reported following this administration error (accidental exposure to product). The case was assessed as lost to follow up.
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2016US029744, is an initial spontaneous report received from a pharmacist on 09 Nov 2016. This report refers to a female patient of unknown age. Past medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUVIRIN (batch number: 158302, Expiry date: Jun 2016) at a dose of 0.5 ml, intramuscularly on 13 Oct 2016. On same day the patient was vaccinated with last years formulation of FLUVIRIN vaccine. The pharmacist stated that, last years FLUVIRIN vaccine was given to two staff members. The pharmacist inquired that if they should received this years dose of the vaccine or not and when they should be revaccinated. No adverse event was reported following this medication error (expired product administered).
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, Immunisation, No adverse event
Clinical narrative: This initial spontaneous case, was received from a Pharmacist on 18-Oct-2017, concerns 8-year-old male patient. This report was 1st out of 03 reports. On 16-Oct-2017, the patient was administered with FLUVIRIN (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch no: 1618701, and expiry date: Apr-2017). On 16-Oct-2017, the patient was administered with influenza vaccine which was explicitly coded as expired vaccine used. The patient did not experience any adverse event later. It was reported that, the patient was revaccinated. The reporter considered the case as non-serious. Non-significant follow up received on 30-Oct-2017: It was reported that, the patient did not experience any adverse event later and was revaccinated.
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: This initial spontaneous case was received from Other Health Professional (nurse) on 06-Nov-2017, concerning a patient of unspecified gender and age. This case refers to 13th out of 18 reports. The patient's medical history and concomitant medications were not reported. It was reported that most of the patients received the vaccine on 09-Oct-17 (as reported), the patient was administered with FLUVIRIN (dose, route of administration, anatomical location, batch number, expiry date: not reported). It was reported that, the patient had no reaction/had not experienced any adverse event after vaccination. The reporter assessed the events as non-serious.
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: This initial spontaneous case, was received from other health professional (nurse) on 06-Nov-2017, concerning a patient of unspecified gender and age. This case refers to 08 out of 18 reports. The patient's medical history and concomitant medications were not reported. It was reported that most of the patients received the vaccine on 09-Oct-17 (as reported), the patient was administered with FLUVIRIN (dose, route of administration, anatomical location, batch number, expiry date: not reported) (explicitly coded to expired vaccine used). It was reported that, the patient had no reaction/had not experienced any adverse event after vaccination. The reporter assessed the events as non-serious.