chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: FLUC4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This non-serious spontaneous case, was initially received on 09-Oct-2017, reported by other non-health professional and concerns a 32-year-old, adult pregnant female patient. Patient's medical history was not reported. The patient's concomitant medication included vitamins. The subject's last menstrual period date was on 15-Sep-2017. There was no evidence of defect or adverse findings from prenatal test. No spontaneous abortion was reported and had no family history (offspring, maternal and paternal) of congenital malformation and no medications were taken by the father prior to conception. On 09-Oct-2017, the patient received FLUCELVAX QIV (dose: 0.5ml, route of administration: intramuscular, batch number: 195243, expiry date: 30-Jun-2018, anatomical location: deltoid). On 09-Oct-2017, the patient received vaccine at three weeks of pregnancy. It was reported that, there was no adverse reactions experienced by fetus. The estimated date of delivery was on 20-Jun-2018. The outcome of the event was not reported. Non-significant case correction received 09-Oct-2017: Batch number (195243) was added on the screen and updated expiry date. The narrative was amended accordingly.
Sex: F
Vaccine: FLUC4
Symptoms: Exposure during pregnancy
Clinical narrative: This non-serious initial spontaneous case was received from consumer on 12-Oct-2017, concerning a female pregnant patient of an unspecified age. On an unspecified date, the patient was administered with FLUCELVAX QIV (dose, batch number, expiry date, route of administration and anatomical location: not reported). The patient received the vaccine during the pregnancy. The patient did not give the permission to enroll in the pregnancy registry.
Age: 29.0
Sex: F
Vaccine: FLUC4
Symptoms: Delivery, Expired product administered, Exposure during pregnancy, No adverse event
Clinical narrative: Case number PHEH2017US003252 is non-serious initial spontaneous report received  from nurse on 27 Jan 2017. This case refers to 29-year-old female patient weighing 152lb with height 5.5 feet. Medical history and no concomitant medication was not reported. On 27-Jan-2017, the pregnant patient was vaccinated with single dose of expired FLUCELVAX QUADRIVALENT (batch number: 173987 (as reported), expiry date: 05-Jan-2016 and anatomical location: not reported) at dose of 0.5 ml intramuscular. No adverse event was reported following the administration of the vaccine. It was reported that the gestational age of the patient was 39.1 weeks (at the time of the report) and there was no evidence of any defect or adverse finding from the prenatal test. The patient had 3 previous pregnancies and had still birth/miscarriage in one of the previous pregnancies, it was reported that there was no spontaneous abortion or still birth. The patient delivered live infant (male) by normal delivery method. It was reported that neither the patient nor the foetus experienced any adverse event. At the time of this report, outcome of the events was not reported. This case was non-serious. Follow up received on 14-Jul-2017: Updated age at vaccination, pregnancy history, pregnancy course and outcome. Narrative was amended accordingly. Significant case correction received on 26-Jul-2017: An additional event "no adverse event" was added and listedness of the event "expired vaccine used" was corrected.
Age: 26.0
Sex: F
Vaccine: FLUC4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This initial spontaneous case, was received on 30-Oct-2017, from a consumer, concerning a 26-year-old adult female pregnant patient of 9 weeks. The patient's medical history, concomitant medications were not reported. The patient's last menstrual period (LMP) was reported as 27-Aug-2017. On an unspecified date in 2017 (reported as 5 weeks ago), was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number:195239, expiry date: Mar-2018). It was reported that, 9 weeks pregnant patient (first pregnancy) was administered with vaccine (explicitly coded as vaccine exposure during pregnancy) and had no adverse event. The EDD (estimated date of delivery) was reported as 02-Jun-2018. The reporter assessed as event as non-serious.
Age: 3.0
Sex: F
Vaccine: FLUC4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2017US002881, is an initial spontaneous report received from a nurse on 25 Jan 2017. This report refers to a 03 years and 1 month old female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 186866) intramuscularly at a dose of 0.5 ml on 21 Nov 2016, when she was 03 years and 01 month old (less than 04 years of age). No adverse reaction was reported following this administration error. The seriousness of the event was reported as non serious.
Sex: U
Vaccine: FLUC4
Symptoms: Device leakage, No adverse event
Clinical narrative: This spontaneous case, initially received on 02-Nov-2017, from other health professional (nurse) and concerning a patient of unspecified age and gender. The patient's medical history and concomitant medications were not reported. On 01-Nov-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left or right deltoid (as reported), batch number: 195128, expiry date: 30-Apr-2018). It was reported that, a dose from a leaking FLUCELVAX Quadrivalent multi-dose vial was administered to a patient (explicitly coded as product leakage and drug administration error). The reporter (nurse) stated that, the vial had been used once but when she was about to administer the second dose from that MDV, she discovered it was leaking and did not give it to the patient. The metal rim around the stopper was slightly lifted in a spot and was very thin. It was reported that, 25-gauze syringe of 1-inch needle was used and packaging was not damaged. No adverse event was reported after the vaccination. As per PTC (product technical complaint) (PTC reference number: 1025735) investigation performed, it was concluded that FLUCELVAX Batch 195128 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified in the manufacturing process. However, a known trend was identified for the FLUCELVAX batches from the 2017/2018 FLUCELVAX Commercial Season for vials leaking at the stopper during dosing due to air being added to the vial. The most likely root cause could be attributed to improper handling by the user. The report was considered as non-serious. Follow up received on 15-Dec-2017: The PTC investigation results were updated. It was reported that, the metal rim around the stopper was slightly lifted in a spot and was very thin, 25-gauze syringe of 1-inch needle was used and packaging was not damaged. The narrative was amended accordingly. Follow up received on 28-Dec-2017. The vaccination date (01-Nov-2017) was updated. The reporter confirmed that, the 0.5 ml dose was administered to the patient. The narrative was amended accordingly.
Age: 35.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This non-serious initial spontaneous case, was received from other health professional via Merck on 30-Oct-2017, concerning a 35-year-old adult female patient. On 27-Sep-2017, at 02:30 pm, the patient was administered with FLUCELVAX TIV (batch number: 195124, dose, anatomical location: left arm, route of administration, expiry date: not reported). It was reported that, patient had no illness at the time of vaccination. On 28-Sep-2017, after 21 hrs 30 min of vaccination, the patient experienced hurts and swelling around injection site. The patient used cold compress and received BENADRYL for the events. At the time of this report, the outcome of the events was not reported.
Age: 3.0
Sex: M
Vaccine: FLUC4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2017US003416, Is an initial spontaneous report received from a nurse on 31 Jan 2017. This report refers to a 03 years old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUCELVAX Quadrivalent (batch number: 185886, Expiry date: 30 Apr 2017) at a dose of 0.5 ml Intramuscularly on 20 Oct 2016. On the same day a 03 year old child patient received treatment with FLUCELVAX Quadrivalent. No adverse event was reported following this administration error (drug administered to patient of inappropriate age).
Age: 41.0
Sex: F
Vaccine: FLUC4
Symptoms: Exposure during pregnancy
Clinical narrative: This initial spontaneous case, was received from other non-health professional on 02-Oct-2017, concerning a 41-year-old, adult, female pregnant patient. The last menstrual period of the patient was 10-Jul-2017, it was reported that, the patient had no significant personal (relevant to pregnancy) or paternal medical history (hereditary disease). On 01-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: Intramuscular, batch number: 195236 (as reported), expiry date: May-2018, anatomical location: right deltoid). It was reported that, this was the first pregnancy of the patient and she received FLUCELVAX QUADRIVALENT when she was 12 weeks pregnant. The estimated date of delivery was reported as 16-Apr-2018. The reporter assessed the event as non-serious. Follow up report received on 20-Oct-2017: The LMP of the patient was added, it was reported that, the patient had no significant personal (relevant to pregnancy) or paternal medical history (hereditary disease). The anatomical location (right deltoid) was added. The batch number was updated from 195235 to 195236. The EDD of the patient was added. The narrative was amended accordingly.
Age: 18.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: Case number PHEH2017US005237, is an initial spontaneous report received from a pharmacist on 16 Feb 2017. This report refers to a 18 years old male patient. Medical history was not reported. Concomitant medication was not reported. The pharmacist reported that, the temperature excursion was occurred in Jan for 10 hours, maximum temperature of 51.8 Fahrenheit and the patient was vaccinated with FLUCELVAX Quadrivalent (batch number: 186867, expiry date: May 2017) at a dose of 0.5 ml, intramuscularly on 05 Feb 2017, following the temperature excursion. No adverse event was reported following this medication error (incorrect storage of drug).
Sex: M
Vaccine: FLUC4
Symptoms: Device leakage
Clinical narrative: This spontaneous case, was initially received on 18-Oct-2017, from other health professional, concerning a patient of unspecified age and gender. On 04-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: full dose (as reported), batch number: 195128, expiry date: Apr-2018, route of administration, anatomical location: not reported). It was reported that, after piercing the vial, when it was turned upside down and upon injecting air, vial was dripping from the rubber seal (explicitly coded as product leakage). The nurse could withdraw only 7 doses from the vial. The patient  was administered with full dose (explicitly considered as drug administration error). There were 2 defective units, but the package was not damaged or wet. The nurse used 23 needle gauge of size 3 cc. The PTC (product technical complaint) number provided for was 1025066. Based on the investigation performed, it can be concluded that FLUCELVAX Batch 195128 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified in the manufacturing process, or relating to the vial or stopper components, and no trends were identified for the batch. However a known trend was identified for the FLUCELVAX batches from the 2017/2018 FLUCELVAX Commercial Season for vials leaking at the stopper during dosing due to air being added to the vial. The most likely root cause can be attributed to improper handling by the user. Follow-up received on 21-Nov-2017: Added PTC number and the QA (quality assurance) report results. New event drug administration error was coded. Narrative amended accordingly. Non-significant case correction received 18-Oct-2017: The verbatim of the event 'product leakage' was corrected.
Sex: M
Vaccine: FLUC4
Symptoms: Device leakage
Clinical narrative: This non-serious spontaneous case, was initially received on 18-Oct-2017 from other health professional (nurse), concerns a patient of an unspecified age and gender. On 04-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: full dose (as reported), batch number: 195128, expiry date: 30-Apr-2018, route of administration, anatomical location: not reported). On 04-Oct-2017, employees were given vaccine from a vial that leaked. It was reported that, after piercing the vial, when it was turned upside down and upon injecting air, vial was dripping from the rubber seal (explicitly coded as product leakage). The nurse could withdraw only 7 doses from the vial. The patient was administered with full doses. There were 2 defective units, but the package was not damaged or wet. The nurse used 23 needle gauge of size 3 cc. The PTC (product technical complaint) number provided for was 1025066. Based on the investigation performed, it can be concluded that FLUCELVAX Batch 195128 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified in the manufacturing process, or relating to the viral or stopper components, and no trends were identified for the batch. However, a known trend was identified for the FLUCELVAX batches from the 2017/2018 FLUCELVAX Commercial Season for vials leaking at the stopper during dosing due to air being added to the vial. The most likely root cause can be attributed to improper handling by the user. Follow-up received on 21-Nov-2017: Added PTC number and the QA (quality assurance) report results. Narrative amended accordingly. Non-significant case correction received 18-Oct-2017: The verbatim of the event 'product leakage' was corrected.
Sex: U
Vaccine: FLUC4
Symptoms: Device leakage, Wrong technique in product usage process
Clinical narrative: This non-serious spontaneous case, was initially received on 18-Oct-2017, from other health professional, concerning a patient of unspecified age and gender. On 04-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: full dose (as reported), batch number: 195128, expiry date: Apr-2018, route of administration, anatomical location: not reported). It was reported that, after piercing the vial, when turned upside down upon injecting air, vial was dripping from the rubber seal. The nurse could withdraw only 7 doses from the vial. The patient was administered with full dose. There were 2 defective units, but the package was not damaged or wet. The nurse used 23 needle gauge of size 3 cc. The PTC (product technical complaint) number provided for was 1025066. Based on the investigation performed, it can be concluded that FLUCELVAX Batch 195128 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified in the manufacturing process, or relating to the vial or stopper components, and no trends were identified for the batch. However a known trend was identified for the FLUCELVAX batches from the 2017/2018 FLUCELVAX Commercial Season for vials leaking at the stopper during dosing due to air being added to the vial. The most likely root cause can be attributed to improper handling by the user. Follow-up received on 21-Nov-2017: Added PTC number and the QA (quality assurance) report results. New event drug administration error was coded. Narrative amended accordingly. Non-significant case correction received with IRD 18-Oct-2017: The verbatim of the event 'product leakage' was corrected.
Sex: U
Vaccine: FLUC4
Symptoms: Device leakage, Wrong technique in product usage process
Clinical narrative: This non-serious spontaneous case, was initially received on 18-Oct-2017 from other health professional (nurse) on 18-Oct-2017, concerns a patient of an unspecified age and gender. On 04-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: full dose (as reported), batch number: 195128, expiry date: 30-Apr-2018, route of administration, anatomical location: not reported). On 04-Oct-2017, employees were given vaccine from a vial that leaked. It was reported that, after piercing the vial, when it was turned upside down and upon injecting air, vial was dripping from the rubber seal (explicitly coded as product leakage). The nurse could withdraw only 7 doses from the vial. The patient was administered with full doses. There were 2 defective units, but the package was not damaged or wet. The nurse used 23 needle gauge of size 3 cc. The PTC (product technical complaint) number provided for was 1025066. Based on the investigation performed, it can be concluded that FLUCELVAX Batch 195128 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified in the manufacturing process, or relating to the vial or stopper components, and no trends were identified for the batch. However, a known trend was identified for the FLUCELVAX batches from the 2017/2018 FLUCELVAX Commercial Season for vials leaking at the stopper during dosing due to air being added to the vial. The most likely root cause can be attributed to improper handling by the user. Follow-up received on 21-Nov-2017: Added PTC number and QA (quality assurance) report results. Narrative amended accordingly. Non-significant case correction received 18-Oct-2017: The verbatim of the event 'product leakage' was corrected.
Sex: M
Vaccine: FLUC4
Symptoms: Device leakage
Clinical narrative: This non-serious spontaneous case, was initially received on 18-Oct-2017, from other health professional (Nurse), concerns a patient of unspecified age and gender. This was 15th out of 31 reports. On 04-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: full dose (as reported), batch number: 195128, expiry date: 30-Apr-2018, route of administration, anatomical location: not reported). On 04-Oct-2017, this employee was given vaccine from a vial that leaked. It was reported that, after piercing the vial, when it was turned upside down and upon injecting air, vial was dripping from the rubber seal. The nurse could withdraw only 7 doses from the vial. The patient was administered with full doses. There were 2 defective units, but the package was not damaged or wet. The nurse used 23 needle gauge of size 3 cc. The PTC (product technical complaint) number provided was 1025066. Based on the investigation performed, it can be concluded that FLUCELVAX Batch 195128 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified in the manufacturing process, or relating to the vial or stopper components, and no trends were identified for the batch. However a known trend was identified for the FLUCELVAX batches from the 2017/2018 FLUCELVAX Commercial Season for vials leaking at the stopper during dosing due to air being added to the vial. The most likely root cause can be attributed to improper handling by the user. Follow-up received on 21-Nov-2017: Added PTC number and the QA (quality assurance) report results. New event drug administration error was coded. Narrative amended accordingly. Non-significant case correction received with IRD 18-Oct-2017: The verbatim of the event 'product leakage' was corrected.
Sex: M
Vaccine: FLUC4
Symptoms: Device leakage
Clinical narrative: This non-serious spontaneous case, was initially received on 18-Oct-2017, from other health professional, concerning a patient of unspecified age and gender. On 04-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: full dose (as reported), batch number: 195128, expiry date: 30-Apr-2018, route of administration, anatomical location: not reported). On 04-Oct-2017, employees were given vaccine from a vial that leaked. It was reported that, after piercing the vial, when turned upside down and upon injecting air, vial was dripping from the rubber seal. The nurse could withdraw only 7 doses from the vial. The patient was administered with full doses. There were 2 defective units, but the package was not damaged or wet. The nurse used 23 needle gauge of size 3 cc. The PTC (product technical complaint) number provided for was 1025066. Based on the investigation performed, it can be concluded that FLUCELVAX Batch 195128 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified in the manufacturing process, or relating to the vial or stopper components, and no trends were identified for the batch. However, a known trend was identified for the FLUCELVAX batches from the 2017/2018 FLUCELVAX Commercial Season for vials leaking at the stopper during dosing due to air being added to the vial. The most likely root cause can be attributed to improper handling by the user. Follow-up received on 21-Nov-2017: Added PTC number and the QA (quality assurance) report results. Narrative amended accordingly. Non-significant case correction received with IRD 18-Oct-2017: The verbatim of the event 'product leakage' was corrected.
Sex: U
Vaccine: FLUC4
Symptoms: Device leakage
Clinical narrative: This non-serious spontaneous case, was initially received on 18-Oct-2017, from other health professional, concerns a patient of unspecified age and gender. On 04-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: full dose (as reported), batch number: 195128, expiry date: 30-Apr-2018, route of administration, anatomical location: not reported). On 04-Oct-2017, employees were given vaccine from a vial that leaked. It was reported that, after piercing the vial, when it was turned upside down and upon injecting air, vial was dripping from the rubber seal. The nurse could withdraw only 7 doses from the vial. The patient was administered with full dose. There were 2 defective units, but the package was not damaged or wet. The nurse used 23 needle gauge of size 3 cc. The PTC (product technical complaint) number provided for was 1025066. Based on the investigation performed, it can be concluded that FLUCELVAX Batch 195128 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified in the manufacturing process, or relating to the vial or stopper components, and no trends were identified for the batch. However, a known trend was identified for the FLUCELVAX batches from the 2017/2018 FLUCELVAX Commercial Season for vials leaking at the stopper during dosing due to air being added to the vial. The most likely root cause can be attributed to improper handling by the user. Follow-up received on 21-Nov-2017: Added PTC number and the QA (quality assurance) report results. Narrative amended accordingly. Non-significant case correction received with IRD 18-Oct-2017: The verbatim of the event 'product leakage' was corrected and the lead sentence in narrative was amended.
Sex: M
Vaccine: FLUC4
Symptoms: Device leakage, Drug administration error
Clinical narrative: This non-serious spontaneous case, was initially received on 18-Oct-2017, from other health professional (nurse), concerns a patient of unspecified age and gender. On 04-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: full dose (as reported), batch number: 195128, expiry date: 30-Apr-2018, route of administration, anatomical location: not reported). On 04-Oct-2017, employees were given vaccine from a vial that leaked. It was reported that, after piercing the vial, when it was turned upside down and upon injecting air, vial was dripping from the rubber seal. The nurse could withdraw only 7 doses from the vial. The patient was administered with full doses. There were 2 defective units, but the package was not damaged or wet. The nurse used 23 needle gauge of size 3 cc. The PTC (product technical complaint) number provided was 1025066. Based on the investigation performed, it can be concluded that FLUCELVAX Batch 195128 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified in the manufacturing process, or relating to the vial or stopper components, and no trends were identified for the batch. However a known trend was identified for the FLUCELVAX batches from the 2017/2018 FLUCELVAX Commercial Season for vials leaking at the stopper during dosing due to air being added to the vial. The most likely root cause can be attributed to improper handling by the user. Follow-up received on 21-Nov-2017: Added PTC number and the QA (quality assurance) report results. New event drug administration error was coded. Narrative amended accordingly. Non-significant case correction received with IRD 18-Oct-2017: The verbatim of the event 'product leakage' was corrected and narrative was amended.
Sex: U
Vaccine: FLUC4
Symptoms: Device leakage
Clinical narrative: This non-serious spontaneous case, was initially received on 18-Oct-2017 from other health professional (nurse), concerns a patient of an unspecified age and gender. On 06-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: full dose (as reported), batch number: 195128, expiry date: 30-Apr-2018, route of administration, anatomical location: not reported). On 06-Oct-2017, employees were given vaccine from a vial that leaked. It was reported that, after piercing the vial, when it was turned upside down and upon injecting air, vial was dripping from the rubber seal. The nurse could withdraw only 7 doses from the vial. The patient was administered with full doses. There were 2 defective units, but the package was not damaged or wet. The nurse used 23 needle gauge of size 3 cc. The PTC (product technical complaint) number provided was 1025066. Based on the investigation performed, it can be concluded that FLUCELVAX Batch 195128 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified in the manufacturing process, or relating to the vial or stopper components, and no trends were identified for the batch. However a known trend was identified for the FLUCELVAX batches from the 2017/2018 FLUCELVAX Commercial Season for vials leaking at the stopper during dosing due to air being added to the vial. The most likely root cause can be attributed to improper handling by the user. Follow-up received and significant case correction received on 21-Nov-2017: Added PTC number and the QA (quality assurance) report results. Narrative amended accordingly. Non-significant case correction received with IRD 18-Oct-2017: The verbatim of the event 'product leakage' was corrected and the lead sentence in narrative was amended.
Sex: M
Vaccine: FLUC4
Symptoms: Device leakage
Clinical narrative: This non-serious spontaneous case, was initially received on 18-Oct-2017 from other health professional (nurse), concerns a patient of unspecified age and gender. This was 23rd out of 31 reports. On 09-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: full dose (as reported), batch number: 195128, expiry date: 30-Apr-2018, route of administration, anatomical location: not reported). On 09-Oct-2017, this employee was given vaccine from a vial that leaked. It was reported that, after piercing the vial, when it was turned upside down and upon injecting air, vial was dripping from the rubber seal. The nurse could withdraw only 7 doses from the vial. The patient was administered with full doses. There were 2 defective units, but the package was not damaged or wet. The nurse used 23 needle gauge of size 3 cc. The PTC (product technical complaint) number provided for was 1025066. Based on the investigation performed, it can be concluded that FLUCELVAX Batch 195128 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified in the manufacturing process, or relating to the vial or stopper components, and no trends were identified for the batch. However, a known trend was identified for the FLUCELVAX batches from the 2017/2018 FLUCELVAX Commercial Season for vials leaking at the stopper during dosing due to air being added to the vial. The most likely root cause can be attributed to improper handling by the user. Follow-up received on 21-Nov-2017: Added PTC number and the QA (quality assurance) report results. Narrative amended accordingly. Non-significant case correction received with IRD 18-Oct-2017: The verbatim of the event 'product leakage' was corrected and the lead sentence in narrative was amended.
Sex: U
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: Case number PHEH2016US031528, is an initial spontaneous report received from a nurse on 29 Nov 2016. This report refers to a patient of unspecified age and gender. Past medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUCELVAX QUADRIVALENT (batch number: not reported) at a dose of 0.5 ml intramuscularly on an unspecified date. The nurse reported that administered vaccine might have been reached 10 degree Celsius for 162 hours. Lot was not available. The nurse did not have further information. No adverse event was reported following this administration error. The case was assessed as non-serious by the nurse.
Sex: M
Vaccine: FLUC4
Symptoms: Device leakage
Clinical narrative: This non-serious spontaneous case, was initially received on 18-Oct-2017 from other health professional (nurse), concerns a patient of an unspecified age and gender. On 09-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: full dose (as reported), batch number: 195128, expiry date: 30-Apr-2018, route of administration, anatomical location: not reported). On 09-Oct-2017, employees were given vaccine from a vial that leaked. It was reported that, after piercing the vial, when it was turned upside down and upon injecting air, vial was dripping from the rubber seal. The nurse could withdraw only 7 doses from the vial. The patient was administered with full doses. There were 2 defective units, but the package was not damaged or wet. The nurse used 23 needle gauge of size 3 cc. The PTC (product technical complaint) number provided for was 1025066. Based on the investigation performed, it can be concluded that FLUCELVAX Batch 195128 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified in the manufacturing process, or relating to the vial or stopper components, and no trends were identified for the batch. However, a known trend was identified for the FLUCELVAX batches from the 2017/2018 FLUCELVAX Commercial Season for vials leaking at the stopper during dosing due to air being added to the vial. The most likely root cause can be attributed to improper handling by the user. Follow-up received on 21-Nov-2017: Added PTC number and the QA (quality assurance) report results. Narrative amended accordingly. Non-significant case correction received with IRD 18-Oct-2017: The verbatim of the event 'product leakage' was corrected and the lead sentence in narrative was amended.
Age: 13.0
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, was initially received on 23-Oct-2017 from a Pharmacist, concerns a 13-year-old adolescent female patient. On 23-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, batch number: 195210A, expiry date: Mar-2018, route of administration: intramuscular and anatomical location: left deltoid). It was reported that vaccine was at a maximum temperature of 55F overnight and it was administered. The pharmacist stated that the refrigerator was 40.6F last night but that morning the temperature was 55F and that was the first-time excursion. It was reported that, the patient did not experience any adverse events after the administration of the vaccine. The reporter did not provide the seriousness assessment. Follow-up report received on 27-Nov-2017: Gender of the patient (female) was added. Routed of administration (intramuscular), anatomical location (left deltoid) was updated. It was reported that, the patient did not experience any adverse events after administration of the vaccine. Amended narrative accordingly. Significant case correction received with IRD 27-Nov-2017: The event 'no adverse event' was deleted.
Sex: M
Vaccine: FLUC4
Symptoms: Device leakage
Clinical narrative: This non-serious spontaneous case, was initially received on 18-Oct-2017 from other health professional (nurse), concerns a patient of an unspecified age and gender. On 09-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: full dose (as reported), batch number: 195128, expiry date: 30-Apr-2018, route of administration, anatomical location: not reported). On 09-Oct-2017, employees were given vaccine from a vial that leaked. It was reported that, after piercing the vial, when it was turned upside down and upon injecting air, vial was dripping from the rubber seal (explicitly coded as product leakage). The nurse could withdraw only 7 doses from the vial. The patient was administered with full doses (explicitly considered as drug administration error). There were 2 defective units, but the package was not damaged or wet. The nurse used 23 needle gauge of size 3 cc. The PTC (product technical complaint) number provided was 1025066. Based on the investigation performed, it can be concluded that FLUCELVAX Batch 195128 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified in the manufacturing process, or relating to the vial or stopper components, and no trends were identified for the batch. However a known trend was identified for the FLUCELVAX batches from the 2017/2018 FLUCELVAX Commercial Season for vials leaking at the stopper during dosing due to air being added to the vial. The most likely root cause can be attributed to improper handling by the user. Follow-up received on 21-Nov-2017: Added PTC number and the QA (quality assurance) report results. New event drug administration error was coded. Narrative amended accordingly. Non-significant case correction received 18-Oct-2017: The verbatim of the event 'product leakage' was corrected and the lead sentence in narrative was amended.
Sex: U
Vaccine: FLUC4
Symptoms: Device leakage, Wrong technique in product usage process
Clinical narrative: This non-serious spontaneous case, was initially received on 18-Oct-2017 from other health professional, concerns a patient of unspecified age and gender. On 10-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: full dose (as reported), batch number: 195128, expiry date: 30-Apr-2018, route of administration, anatomical location: not reported). It was reported that, after piercing the vial, when turned upside down upon injecting air, vial was dripping from the rubber seal (explicitly coded as product leakage). The nurse could withdraw only 7 doses from the vial. The patient was administered with full dose. There were 2 defective units, but the package was not damaged or wet. The nurse used 23 needle gauge of size 3 cc. The PTC (product technical complaint) number provided was 1025066. Based on the investigation performed, it can be concluded that FLUCELVAX Batch 195128 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified in the manufacturing process, or relating to the vial or stopper components, and no trends were identified for the batch. However a known trend was identified for the FLUCELVAX batches from the 2017/2018 FLUCELVAX Commercial Season for vials leaking at the stopper during dosing due to air being added to the vial. The most likely root cause can be attributed to improper handling by the user. Follow-up received on 21-Nov-2017: Added PTC number and the QA (quality assurance) report results. New event drug administration was coded. Narrative amended accordingly. Non-significant case correction received 18-Oct-2017: The verbatim of the event 'product leakage' was corrected and the lead sentence in narrative was amended.
Sex: U
Vaccine: FLUC4
Symptoms: Device leakage, Wrong technique in product usage process
Clinical narrative: This non-serious spontaneous case, was initially received on 18-Oct-2017 from other health professional (nurse), concerns a patient of an unspecified age and gender. On 04-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: full dose (as reported), batch number: 195128, expiry date: 30-Apr-2018, route of administration, anatomical location: not reported). On 04-Oct-2017, the patient was given vaccine from a vial that leaked. It was reported that, after piercing the vial, when it was turned upside down and upon injecting air, vial was dripping from the rubber seal. The nurse could withdraw only 7 doses from the vial. The patient was administered with full dose of vaccine. There were 2 defective units, but the package was not damaged or wet. The nurse used 23 needle gauge of size 3 cc. The PTC (product technical complaint) number provided was 1025066. Based on the investigation performed, it can be concluded that FLUCELVAX Batch 195128 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified in the manufacturing process, or relating to the vial or stopper components, and no trends were identified for the batch. However a known trend was identified for the FLUCELVAX batches from the 2017/2018 FLUCELVAX Commercial Season for vials leaking at the stopper during dosing due to air being added to the vial. The most likely root cause can be attributed to improper handling by the user. Follow-up received on 21-Nov-2017: Added PTC number and the QA (quality assurance) report results. New event drug administration error was coded. Narrative amended accordingly. Non-significant case correction received 18-Oct-2017: The verbatim of the event 'product leakage' was corrected and the lead sentence in narrative was amended.
Age: 55.0
Sex: F
Vaccine: FLUC4
Symptoms: Blood pressure increased, Immediate post-injection reaction, Injection site pain, Pain
Clinical narrative: This initial spontaneous case, received on 30-Oct-2017, reported by other-non health professional, and concerns a 55-year-old female patient. The patient's medication history included PTSD (post-traumatic stress disorder) due to car crash (occurred and resolved on an unspecified date). Current conditions included sprained ankle since an unspecified date. The patient's concomitant medication included AMBIEN, MOTRIN, PAMELOR, NEURONTIN and unspecified steroid injections for sprained ankle. On an unspecified date in mid-October, the patient was administered with FLUCELVAX QIV of 4 strains (dose: 0.5ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: F95225A (as reported), expiry date: not reported). Immediately, after administration of FLUCELVAX QIV, the patient had extreme pain in the left deltoid and it hurts to reach forward. On an unspecified date, the patient went to a doctor and tried a steroid pack and a steroid shot. The pain worsened at first and then got little better. It was reported that, the patient's blood pressure "skyrocketed" after vaccine administration. The pharmacist had a note of patient's blood pressure and she was fine then. It was stated that, the initial injection was very painful. The patient had a continued bad arm pain, it was not easing and got worsened in the mornings. It was reported that, the patient's daughter also experienced the same pain (initial injection was painful). However the daughter's arm pain eased up after a couple of days. The daughter's arm hurt for just over a week and got cured. At the time of this report, the patient continues to have arm pain (not recovered). The outcome of rest of the events were not reported. The reporter considered the case as non-serious and assessed the event hypertension as related to the influenza vaccine. Follow-up report received on 21-Nov-2017: Outcome of the event injection site pain was updated to not recovered from unknown and narrative was amended accordingly with the relevant information.
Age: 50.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Mobility decreased, Pain in extremity, Poor quality sleep, Sleep disorder
Clinical narrative: This initial spontaneous case, received on 31-Oct-2017, reported by other non-health professional concerns a 50-year-old, adult, female patient. Patient's medical history and concomitant medications were not reported. On 26-Oct-2017, the patient received, FLUCELVAX QIV (dose: 0.5 ml, route administration: intramuscular, anatomical location: left arm, batch number, expiry date: not reported). On the same day, after a couple of hours of vaccination, the patient had pain in her arm and was not able to move her hand and grab things. It was reported that, for a couple of days, the patient felt pain in side where she got the shot and was not able to sleep on her left side. The patient stated that, 2 or 3 weeks after the flu shot, the pain in the arm had disappeared and she was able to sleep properly after 10 days of administration of vaccine. At the time of this report, the patient had recovered from the events. The reporter assessed the events as non-serious. Follow-up received on 13-Nov-2017: Added dose of suspect vaccine, route of administration and anatomical location. Added new event sleep unwell. The reporter stated that the events were still ongoing. The patient still felt pain in the side were she got the shot and has not been sleeping well lately. It was reported that she does not have pain as much as she had before but it has not gone away. The narrative was amended accordingly. Follow-up received on 05-Dec-2017: The onset date of the event sleep unwell was added. The outcome of the events was updated. The narrative was amended accordingly.
Age: 49.0
Sex: F
Vaccine: FLUC4
Symptoms: Joint swelling, Lip swelling, Pruritus
Clinical narrative: This spontaneous case, was initially received on 02-Nov-2017 from other-health professional, concerns a 49-year-old adult female patient. Historical condition included hypertension which occurred and resolved on an unspecified date. Concomitant medication included EXFORGE for an unknown indication. On 26-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch no: 195229 and expiry date: May-2018). On 30-Oct-2017, the patient was presented to physician with itching, joint swelling, and lip swelling. On the same day, the patient was prescribed CLARITIN (1 tablet AM) and BENADRYL HS (1 tablet bedtime). On 31-Oct-2017, the patient was prescribed MEDROL (1 tablet per day) dose pack. The physician recommended, the patient should not receive any additional flu vaccine. The outcome of the events was not reported. The reporter considered this case as non-serious. Non-significant follow-up received on 29-NOV-2017: Updated dosage regimen and frequency of treatment drugs. The narrative was amended accordingly. Significant case correction received 02-NOV-2017: The case comment was (changed from not related to related) corrected.
Age: 28.0
Sex: F
Vaccine: FLUC4
Symptoms: Menstruation delayed, Pregnancy test negative
Clinical narrative: This initial spontaneous case, received from pharmacist on 19-Oct-2017, concerns a 28-year-old adult female patient. The patient had no relevant medical history. The patient's concomitant medication included unspecified birth control medication. On 04-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, batch number: 195126, expiry date: Apr-2018 and anatomical location: not reported). After the administration of the vaccine, the patient's period was late by 14 days. It was reported that, the patient underwent a pregnancy test which was negative. No treatment was taken for the event. The reporter assessed the event as non-serious and assessed the causality of the event as related to the vaccine. Follow-up report received on 27-Oct-2017: The patient's period was late by 14 days. It was reported that, the patient underwent a pregnancy test which was negative. Amended narrative accordingly.
Age: 25.0
Sex: F
Vaccine: FLUC4
Symptoms: Insomnia, Mobility decreased, Pain, Paraesthesia
Clinical narrative: Case number PHEH2016US033285, is an initial spontaneous report received from a nurse on 16 Dec 2016. This report refers to an adult female patient. Historical and current conditions were not reported. The concomitant medications included BCP, multivitamins, zinc, Vit D, Fe and probiotics. The patient was vaccinated with one single dose of FLUCELVAX QUADRIVALENT (batch number: 186685) at a dose of 0.5 ml intramuscularly on 02 Nov 2016. It was reported that the patient had experienced symptoms of soreness and difficulty raising her arm. The symptoms began on an unknown date after vaccination but was believed within about a week after vaccination. It was reported that the patient still had the symptoms including difficulty sleeping. On an unknown date, the patient felt little tingling on outside of the arm to fingers and it persist for couple of days. The patient felt soreness while lifting arm and this condition persist for couple of months. The patient went to chiropractor for stretches and felt better. After the administration of the vaccine it was also reported that the vaccine was tolerated by the patient in the past. The events were resolved around the beginning of Feb 2017. The seriousness and causality of the events were not reported. Follow up received from the nurse on 12-Apr-2017: Added concomitant medications (BCP, multivitamins, zinc, Vit D, Fe and probiotics), treatment procedure (chiropractor for stretches), added event (felt little tingling on outside of the arm to fingers and it persist for couple of days), updated outcome of the events tingling in arm and soreness (as recovered) and updated narrative accordingly.
Age: 29.0
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: Case number PHEH2016US032832, is a spontaneous report initially received from a medical assistant on 13 Dec 2016. This report refers to a 29 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUCELVAX QUADRIVALENT (batch number: 185887) at a dose of 0.5 ml, intramuscularly on 12 Dec 2016. It was reported that, the first temperature excursion was reported with FLUCELVAX pre-filled syringe (PFS) as 18.0 degrees Celsius (maximum temperature) for 6.5 hours. One of the pre-filled syringes might have been given after the temperature excursion on 12 Dec 2016. Upon follow up it was reported that, the patient had no adverse reaction following this medication error. The case was assessed as non serious by the medical assistant. Follow up report received from a medical assistant on 10 Jan 2017: Updated reporter's comment.