chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: FLUC4
Symptoms: Exposure via skin contact, No adverse event, Syringe issue
Clinical narrative: This initial spontaneous case was received on 21-Sep-2017 from a pharmacist, concerning a  57-year-old, adult, female patient. The patient's concomitant medication and medical history were not reported. On 21-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: less than 0.5 ml (as reported), route of administration: intramuscular, anatomical location: deltoid, batch number: 195216, expiry date: 30-Apr-2018). It was reported that, the pharmacist administered the vaccine to a patient, when the needle was in the patient arm while pharmacist pushed the plunger, the dose started to leak out from the barrel and leaked down her arm (explicitly coded as under dose) and the issue was with the leaking pre-filled syringe (explicitly coded as syringe leak). The patient had not experienced any adverse reaction after administration of vaccine. As per the PTC (product technical complaint) report, with reference number (1024666), it was reported that, the package condition was good and stored in the original box until use and the needle which used was 25 gauge. The reporter considered the events as non-serious. Follow-up received from the reporter on 27-Sep-2017: The patient's route of administration and anatomical location of the suspect vaccine were updated. Additional event (no adverse reaction) was added and narrative amended accordingly. Follow-up received from the reporter on 13-Oct-2017 and 31-Oct-2017: The event exposure via skin contact was deleted as case correction. Batch number was added in the screen. It was reported that the issue was with the leaking pre-filled syringe. The narrative was amended accordingly. Significant case correction received with IRD 21-Sep-2017: The case 201701660 (deletion case) was identified as duplicate to the case 201701629 (retained case). Hence, all the information from the case 201701660 (deletion case) was merged into the retained case 201701629 and the case 201701660 will be deleted. The PTC (product technical complaint) reported with reference number (1024666) was merged from 201701660 (deleted case) to 201701629 (retained case). The narrative was amended accordingly. Significant follow-up receive on 08-Dec-2017. Based on the investigation performed, it can be concluded that  FLUCELVAX batch 195216 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No definitive root cause was identified in the manufacturing process, or relating to the stopper or syringe components, and  no trends were identified for the batch, or any other batches FLUCELVAX QIV batches from the 2017-2018 FLUCELVAX Commercial season. However, without an inspection of the involved sample, a root cause of user handling could not be ruled out for this PTC. Therefore, no internal root cause could be confirmed and no external/user root cause could be determined.
Age: 3.0
Sex: M
Vaccine: FLUC4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This initial spontaneous case, was received on 26-Sep-2017, from other health professional (nurse), concerning a 3-year-old male child. The concomitant medications of the patient included unspecified multivitamins and minerals. The patient had no relevant medical history. On 25-Sep-2017, the patient was administered with FLUCELVAX QIV (batch number: 195226A, expiry date: Apr-2018, dose: 0.5 ml, route of administration, anatomical location: not reported). It was reported that, the vaccine was inadvertently administered to a person under 4 years of age. No other adverse event was reported. The reporter assessed the events as non-serious. Significant case correction was received with IRD 26-Sep-2017: The event 'no adverse event' was removed.
Age: 19.0
Sex: F
Vaccine: FLUC4
Symptoms: Bursitis, Injected limb mobility decreased, Loss of personal independence in daily activities, Mobility decreased, Tendonitis
Clinical narrative: This initial spontaneous case, was received from other health professional (nurse) on 20-Sep-2017, concerning a 19-year-old, adult female patient. The patient's historical procedures included removal of pancreatic tumor (on an unspecified date in May-2017) and appendectomy (on an unspecified date in Jul-2017). On 28-Aug-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, anatomical location: left deltoid, route of administration, batch number and expiry date: not reported). After 2 weeks of vaccination, the patient complained of bursitis, tendinitis, and difficulty in raising arms, which affected her tasks such as dressing herself and was treated with ice packs, ibuprofen and unspecified steroids. At the time of this report, the outcome of the events was not recovered (ongoing). It was reported that, the patient described that she has no pain when her shoulder was rotated actively but, she has pain when her shoulder was rotated passively. It was also reported that, the physician thought it would be related to muscle as opposed to bursitis or tendinitis. The reporter assessed the report as non-serious. Follow-up received from the reporter on 13-Oct-2017: The patient's age, historical procedure, anatomical location were updated. Narrative amended accordingly. Follow up received on 27-Oct-2017: The onset latency from 1 week to 2 weeks were updated. The narrative was amended accordingly.
Age: 65.0
Sex: F
Vaccine: FLUC4
Symptoms: Expired product administered
Clinical narrative: This non-serious spontaneous case, was initially received from other health professional on 28-Sep-2017, concerning a 65-year-old, elderly female patient. The patient's medical history and concomitant medications were not reported. On 27-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, batch number: 185286, expiry date: 30-Apr-2017, route of administration, anatomical location: not reported). The patient received the expired dose of the product, which was considered as expired vaccine used. The reporter assessed the report as non-serious. Non-significant case correction received 28-Sep-2017: Batch number (185286) was added on the screen and updated expiry date. The narrative was amended accordingly.
Age: 3.0
Sex: M
Vaccine: FLUC4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This non-serious spontaneous case, was initially received on 22-Sep-2017 from other non-health professional, concerning a 38-month-old, male child. The patient's medical history and concomitant medications were not reported. On 21-Sep-2017, the patient was administered with FLUCELVAX QIV (dose, batch number: 195215, expiry date: 30-Apr-2018, route of administration and anatomical location: not reported) (explicitly coded as inappropriate age at vaccination since FLUCELVAX QUADRIVALENT have not been established in children less than 4 years of age). It was reported that, the patient had not experienced any adverse event after the vaccine administration. The outcome of the event was not reported. The reporter considered the events as non-serious. Follow-up received on 13-Oct-2017: The patient's date of birth and age were updated. It was reported that, the patient had not experienced any adverse event after the vaccine administration. Additional event 'no adverse event' was coded. The narrative was amended accordingly. Non-significant case correction received with IRD 22-Sep-2017: Batch number was updated on the screen. Narrative was amended accordingly.
Age: 3.0
Sex: F
Vaccine: FLUC4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This non-serious initial spontaneous case, was received on 23-Sep-2017 from other health professional (pharmacist), concerning a 3-years-old, child (female) patient. The patient's medical history and concomitant medications were not reported. On 23-Sep-2017, the patient was administered with FLUCELVAX QIV (dose, batch number: 195213, expiry date: 31-Mar-2018, route of administration and anatomical location: not reported) which was characterized as inappropriate age at vaccination. As FLUCLEVAX QUADRIVALENT had not been established in children less than 4 years of age. The patient had no adverse event at the time of the report. No treatment medication was received. The outcome of the events was not reported. The reporter considered the events as non-serious. Non-significant follow-up received on 03-Oct-2017. The reporter states that no further information regarding adverse event was available. Non-significant case correction received 23-Sep-2017: Batch number was updated on the screen. Narrative was amended accordingly.
Age: 70.0
Sex: M
Vaccine: FLUC4
Symptoms: Expired product administered
Clinical narrative: This non-serious spontaneous case, was initially received from other health professional on 28-Sep-2017, concerning a 70-year-old, elderly male patient. The patient's medical history and concomitant medications were not reported. On 27-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, batch number: 185286, expiry date: 30-Apr-2017, route of administration, anatomical location: not reported). The patient received the expired dose of the product, which was considered as expired vaccine used. The reporter assessed the report as non-serious. Non-significant case correction received with IRD 28-Sep-2017: Batch number (185286) was added on the screen and updated expiry date. The narrative was amended accordingly.
Age: 8.0
Sex: M
Vaccine: FLUC4
Symptoms: Expired product administered
Clinical narrative: This non-serious spontaneous case, was initially received from other health professional on 28-Sep-2017, concerning a 08-year-old, child, male patient. The patient's medical history and concomitant medications were not reported. On 27-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, batch number: 185286, expiry date: 30-Apr-2017, route of administration, anatomical location: not reported). The patient received the expired dose of the product, which was considered as expired vaccine used. The reporter assessed the report as non-serious. Non-significant case correction received 28-Sep-2017: Batch number (185286) was added on the screen and updated expiry date. The narrative was amended accordingly.
Age: 52.0
Sex: F
Vaccine: FLUC4
Symptoms: Expired product administered
Clinical narrative: This non-serious spontaneous case, was initially received from other health professional on 28-Sep-2017, concerning a 52-year-old, adult female patient. The patient's medical history and concomitant medications were not reported. On 27-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, batch number: 185286, expiry date: 30-Apr-2017, route of administration, anatomical location: not reported). The patient received the expired dose of the product, explicitly coded as expired vaccine used. The reporter assessed the report as non-serious. Non-significant case correction received with IRD 28-Sep-2017: Batch number (185286) was added on the screen and updated expiry date. The narrative was amended accordingly.
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Expired product administered
Clinical narrative: This non-serious spontaneous case, was initially received on 28-Sep-2017 from other health professional concerning a 56-year-old, adult female patient. The patient's medical history and concomitant medications were not reported. On 27-Sep-2017, the patient was administered with expired FLUCELVAX QIV (dose: 0.5 ml, batch number: 185286, expiry date: 30-Apr-2017, route of administration, anatomical location: not reported). It was reported that the patient was administered with last year's FLUCELVAX that expired on Apr-2017. The reporter assessed the report as non-serious. Non-significant case correction received 28-Sep-2017: Batch number (185286) was added on the screen and updated expiry date. The narrative was amended accordingly.
Age: 3.0
Sex: M
Vaccine: FLUC4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This non-serious initial spontaneous case, was received from other non-health professional on 20-Sep-2017, concerning a 3-year-old child male patient. The patient had no medical history and he did not receive any concomitant medications. On 19-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: 195126 (as reported)). The patient administered the vaccine under 4 years of age, which was considered as inappropriate age at vaccine administration. It was reported that, the patient did not experience any side effects after the administration of the vaccine. At the time of this report, the outcome of the events was not reported. Significant follow-up received on 27-Sep-2017: The route of administration (intramuscular) and anatomical location (right deltoid) was updated.
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, was initially received on 14-Sep-2017 from other Health Professional and concerns a male patient of unspecified age. Patient's medical history and concomitant medications were not reported. On an unspecified date in Sep-2017, the vaccine stored FLUCELVAX QIV in a new fridge that reached 29-degree F and later it was displaced to the fridge after it reached 63.96-degree F for less than 24 hours in the previous one. On 14-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, batch number: 195128, expiry date: 30-Apr-2018, route of administration, anatomical location: not reported). It was reported that four administrations took place after second excursion, recommended the vaccines be discarded. It was reported that, no adverse event was experienced by the patient after second excursion of the vaccine administered. The outcome of the events was not reported. The reporter assessed the report as non-serious. Follow up report received on 20-Sep-2017: New event (no adverse event) was added. It was reported that, no adverse event was experienced by the patient after second excursion of the vaccine administered. The narrative was amended accordingly. Non-significant case correction received with IRD 14-Sep-2017: Batch number was added in the screen and updated expiry date. The narrative was amended accordingly.
Age: 47.0
Sex: F
Vaccine: FLUC4
Symptoms: Expired product administered
Clinical narrative: This non-serious spontaneous case, was initially received from other health professional on 28-Sep-2017, concerning a 47-year-old, adult female patient. The patient's medical history and concomitant medications were not reported. On 27-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, batch number: 185286, expiry date: 30-Apr-2017, route of administration, anatomical location: not reported) as expired vaccine used. The reporter assessed the report as non-serious. Non-significant case correction received 28-Sep-2017: Batch number (185286) was added on the screen and updated expiry date. The narrative was amended accordingly.
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case was initially received on 14-Sep-2017 from other Health Professional and concerns a female patient of unspecified age. Patient's medical history and concomitant medications were not reported. On an unspecified date in Sep-2017, the vaccine stored FLUCELVAX QIV in a new fridge that reached 29-degree F and  later it was displaced to the fridge after it reached 63.96-degree F for less than 24 hours in the previous one. On 14-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, batch number: 195128, expiry date: 30-Apr-2018, route of administration, anatomical location: not reported). It was reported that four administrations took place after second excursion, recommended the vaccines be discarded. It was reported that, the patient had not experienced adverse event, after the second excursion of vaccine administered. The outcome of the events was not reported. The reporter assessed the report as non-serious. Non-significant case correction received on 14-Sep-2017: Batch number was added in the screen and updated expiry date. The narrative was amended accordingly. Follow-up report received on 20-Sep-2017: It was reported that, the patient had not experienced any adverse event following the administration of the vaccine, amended narrative accordingly. Non-significant case correction received with IRD 14-Sep-2017: Batch number was added in the screen and updated expiry date. The narrative was amended accordingly.
Age: 54.0
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: This initial non-serious case, was received on 19-Sep-2017, from other health professional concerning a 54-year-old, adult, female patient. The patient had no medical history and had not taken any concomitant medications. On 19-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration, anatomical location, batch number: 195214, expiry date: 30-Apr-2018, PTC number: 1024623). It was reported that, during vaccine administration while pushing the plunger, the entire Luer-Lok came off completely with the needle (25 gauge) was in the patient arm and partial dose was administered. It was reported that, no adverse event occurred following the vaccination. It was stated that, the product was stored in an original packaging in the refrigerator in a good condition. No signs of leakage nor the hub was cracked. No treatment medication was taken. Based on the investigation performed, it can be concluded that FLUCELVAX Batch 195214 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 syringes or stopper components, and no trends were identified for the batch, or any other FLUCELVAX batches from the 2017/2018 FLUCELVAX commercial season for syringes for Luer-Lok separation during administration. The most likely root cause can be attributed to improper handling by the user. The outcome was not reported. The reporter assessed the event as non-serious. Follow-up report received on 20-Sep-2017: PTC (pharmaceutical technical complaint) report was updated. PTC number 1024623 was added. Amended narrative accordingly. Significant case correction received on 11-Oct-2017: Added new event as syringe issue. The narrative was amended accordingly. Follow-up report received on 04-Nov-2017: Based on the investigation performed, it can be concluded that FLUCELVAX Batch 195214 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 syringes or stopper components, and no trends were identified for the batch, or any other FLUCELVAX batches from the 2017/2018 FLUCELVAX commercial season for syringes for Luer-lok separation during administration. The most likely root cause can be attributed to improper handling by the user. Expiry date was updated as 30-Apr-2018. Amended narrative accordingly.
Age: 51.0
Sex: M
Vaccine: FLUC4
Symptoms: Product storage error
Clinical narrative: This non-serious initial spontaneous case, was received on 19-Sep-2017 from Other Health Professional and concerns a 51-years-old male patient. The patient's current condition included: Diabetes, hypercholesterolemia and CAD (coronary artery disease). The patient's concomitant medications included Atorvastatin, GEODON, Tiagabine, Clonazepam, NOVOLOG mix, VICTOZA, Metformin, Ziprasidone, Glipizide, Venlafaxine, Carbamazepine, Vitamin D and Metoprolol succinate for unknown indication. It was reported that MDV (multiple dose vials) (open and unopened) affected by Hurricane, reached unknown temperature (possibly 86F) for more than 24 hours, but exact number of hours without power was not known. On 10-Sep-2017, power went out till 12-Sep-2017. On 18-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, batch number: 195124 (as reported), expiry date: Apr-2018, route of administration, anatomical location: not reported). It was reported that vaccine administered following temperature exposure more than 46F. The outcome of the events was not reported. The reporter assessed the report as non-serious.
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, was initially received on 14-Sep-2017 from other Health Professional and concerns a male patient of unspecified age. Patient's medical history and concomitant medications were not reported. On an unspecified date in Sep-2017, the vaccine stored FLUCELVAX QIV in a new fridge that reached 29-degree F and later it was displaced to the fridge after it reached 63.96-degree F for less than 24 hours in the previous one (temperature excursion). On 14-Sep-2017, the patient was administered with FLUCELVAX QIV (dose:0.5 ml, batch number: 195128, expiry date: 30-Apr-2018, route of administration, anatomical location: not reported). It was reported that four administrations took place after second excursion (explicitly coded as drug administration error) recommended the vaccines to be discarded. No adverse events were reported after the second excursion of vaccine administered. The outcome of the events was not reported. The reporter assessed the report as non-serious. Follow-up report received on 20-Sep-2017: No adverse events were reported after the second excursion of vaccine administered. Amended narrative accordingly. Non-significant case correction received on 14-Sep-2017: Batch number was added in the screen and updated expiry date. The narrative was amended accordingly.
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, was initially received on 14-Sep-2017, from other Health Professional and concerns a female patient of unspecified age. The patient's concomitant medications included FLONASE for unknown indication. On an unspecified date in Sep-2017, the vaccine stored FLUCELVAX QIV in a new fridge that reached 29-degree F and later it was displaced to the fridge after it reached 63.96-degree F for less than 24 hours in the previous one. On 14-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, batch number: 195128, expiry date: 30-Apr-2018, route of administration, anatomical location: not reported). It was reported that four administrations took place after second excursion, recommended the vaccines be discarded. It was reported that, no adverse event was experienced by the patient. The outcome of the events was not reported. The reporter assessed the report as non-serious. Follow up report received on 20-Sep-2017: It was reported that, no adverse event was experienced by the patient. The narrative was amended accordingly. Non-significant case correction received on 14-Sep-2017: Batch number was added in the screen. The narrative was amended accordingly.
Age: 63.0
Sex: M
Vaccine: FLUC4
Symptoms: Expired product administered
Clinical narrative: This non-serious spontaneous case, was initially received from other health professional on 28-Sep-2017, concerning a 63-year-old, adult male patient. The patient's medical history and concomitant medications were not reported. On 27-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, batch number: 185286, expiry date: 30-Apr-2017, route of administration, anatomical location: not reported). The patient received the expired dose of the product, which was considered as expired vaccine used. The reporter assessed the report as non-serious. Non-significant case correction received 28-Sep-2017: Batch number (185286) was added on the screen and updated expiry date. The narrative was amended accordingly.
Age: 43.0
Sex: F
Vaccine: FLUC4
Symptoms: Product storage error
Clinical narrative: This spontaneous case, was initially received from other health professional (nurse) on 06-Oct-2017, concerning a 43-year-old adult female patient. The patient did not receive any concomitant medications. On 02-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, batch number: 195128 (reported as 195198), expiry date: 30-Apr-2018, route of administration: intramuscular, anatomical location: deltoid). The patient received the vaccine after the multiple temperature excursion over a week. It was reported that, the storage temperature of the vaccine fluctuated between 36-degree F and 48.18-degree F, which reached to maximum 49-degree F over a week instead of storing between 36-degree F to 46-degree F and no adverse event was reported. The reporter assessed the report as non-serious. Non-significant case correction received 06-Oct-2017: Batch number (195128) was captured in the case form and narrative was amended accordingly.
Age: 90.0
Sex: F
Vaccine: FLUC4
Symptoms: Contusion, Skin discolouration
Clinical narrative: This spontaneous case, was initially received on 06-Oct-2017 reported by a pharmacist and concerns a 90-year-old, elderly female patient. Patient's medical history was not reported. The patient's concomitant medication included blood thinners. On 10-Mar-2017, FLUCELVAX QIV was administered to the patient (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: 195212, expiry date: 31-Mar-2018). On 10-Mar-2017, after administration of FLUCELVAX QIV, the patient experienced bruising after receiving vaccine, beyond injection site, up and down all the way down to elbow. Color changed to dark purple. The outcome of the event was not recovered. The reporter assessed this case as non-serious. Follow-up received from the reporter on 16-Oct-2017: The patient's route of administration and anatomical location were updated. Narrative amended accordingly. Non-significant case correction received 06-Oct-2017: Batch number (195212) was added on the screen and updated expiry date. The narrative was amended accordingly.
Age: 30.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous case, was initially received from other health professional (nurse) on 03-Oct-2017, concerning a 30-year-old adult female patient. The patient's historical vaccine included unspecified influenza vaccine without any reaction. The patient's concomitant medications were not reported. On 29-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, batch number: 195126, expiry date: 30-Apr-2018, route of administration and anatomical location: not reported). It was reported that, within 24 hours of vaccination, the patient had symptoms of localized redness, swelling and heat at the site of minor intensity, which lasted for 3 days. No treatment was given for the events. At the time of this report, the outcome of the events was recovered. The reporter assessed the report as non-serious. Non-significant case correction received 03-Oct-2017: Batch number (195126) was captured in the case form and narrative was amended accordingly.
Age: 39.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This non-serious spontaneous case, was initially received from other health professional (nurse) on 03-Oct-2017, concerning a 39-year-old adult female patient. The patient's historical vaccine included unspecified influenza vaccine without any reaction. The patient's current condition included occasional reaction to egg, but did not react with an egg based vaccine in the past. The patient's concomitant medications were not reported. On 29-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, batch number: 195126, expiry date: 30-Apr-2018, route of administration and anatomical location: not reported). It was reported that, within 24 hours of vaccination, the patient had symptoms of localized redness, swelling and heat at the site of minor intensity, which lasted for 3 days. No treatment was given for the events. At the time of this report, the outcome of the events was recovered. The reporter assessed the report as non-serious. Non-significant case correction received 03-Oct-2017: Batch number (195126) was added on the screen and updated expiry date. The narrative was amended accordingly.
Age: 28.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: This spontaneous case, was initially received on 28-Sep-2017, from other health professional (pharmacist) concerning a 28-year-old, adult, female patient. The patient's medical history and concomitant medications were not reported. On 27-Sep-2017, the patient was administered with the FLUCELVAX QIV (dose: 0.5 ml, batch number: 195213 (reported as 1925213), expiry date: 31-Mar-2018, anatomical location, route of administration: not reported). On 28-Sep-2017, after 2 days of vaccination, the patient experienced redness, warmth on touching and swelling at the vaccination site. At the time of this report, the patient had not recovered from the events. The reporter assessed the events as non-serious. Non-significant case correction received 28-Sep-2017: Batch number (195213) was captured in the case form and narrative was amended accordingly.
Age: 38.0
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, was initially received from other health professional (nurse) on 05-Oct-2017, concerning a 38-year-old adult female patient. The patient's medical history was not reported. The patient's concomitant medications included: VENTOLIN, NEXPLANON and calcium for unknown indication. On 03-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: 195221 and expiry date: 30-Apr-2018). The patient received vaccine that underwent temperature excursion (less than 32.54 degree F for about 25 hours). It was reported that, after vaccination the patient had not experienced any adverse event. The outcome of the events was not reported. The reporter assessed the events as non-serious. Follow-up received from the reporter on 24-Oct-2017: The route of administration, anatomical location and additional event were added. Narrative amended accordingly. Non-significant case correction received 05-Oct-2017: Batch number (195221) was captured in the case form and narrative was amended accordingly.
Age: 6.0
Sex: F
Vaccine: FLUC4
Symptoms: Tic
Clinical narrative: This initial spontaneous case, received on 13-Oct-2017, was reported by other non-health professional and concerns a 6-year-old female patient. The patient's medical history and concomitant medications were not reported. On 03-Oct-2017, the patient received FLUCELVAX QIV (dose: 0.5ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 195210, expiry date: Mar-2018). On 06-Oct-2017, after administration 4 days of vaccination, the patient had rapidly developed neurological tick. Treatment measures associated with event was neurologist appointment on 16-Oct-2017. It was reported that, tick had not improved, but movements related to tick were changed and frequent. The patient did not receive any treatment medication for the event. As per the reporter, agents such as wheat, unspecified medications and foods could have triggered the event. The outcome of the event was not recovered. The reporter assessed this case as non-serious. Follow up report received on 19-Oct-2017: The outcome of the event from unknown to not recovered was updated. It was reported that, tick had not improved, but movements related to tick were changed and frequent. The patient did not receive any treatment medication for the event. As per the reporter, agents such as wheat, unspecified medications and foods could have triggered the event. The narrative was amended accordingly.
Sex: F
Vaccine: FLUC4
Symptoms: Expired product administered
Clinical narrative: This initial spontaneous case, was received from other health professional on 17-Oct-2017, concerning a patient of unspecified age of gender. The patient's medical history and concomitant medications was not reported. On 17-Oct-2017, the patient received FLUCELVAX QIV (dose: 0.5 ml, route of administration, anatomical location was not reported, batch number: 185745, expiry date: Apr-2017). It was reported that, the patient received expired vaccine dose (explicitly coded as expired vaccine used). The outcome of the events was not reported. The reporter considered this case as non-serious.
Sex: U
Vaccine: FLUC4
Symptoms: Injection site discolouration
Clinical narrative: This spontaneous case, was initially received on 17-Oct-2017 from other health professional, concerns a patient of unspecified age and gender. The patient's medical history and concomitant medications were not reported. On 03-Oct-2017, the patient received FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid (doesn't know which arm), batch number: 195223, expiry date: Apr-2018). On 13-Oct-2017, 10 days, after vaccination, the patient had hyperpigmentation around the injection site. It was reported by the nurse that, she was not the one who administered the vaccine. The outcome of the event was not reported. The reporter considered this case as non-serious. Significant case correction received with 17-OCT-2017: Event causality changed from not reported to related. Narrative amend accordingly. Non-significant case correction received with 17-OCT-2017: The case comment was corrected.
Sex: M
Vaccine: FLUC4
Symptoms: Device leakage
Clinical narrative: This non-serious initial spontaneous case, was received on 18-Oct-2017, from a nurse, concerns a patient of unspecified age and gender. This was 2nd out of 24 reports. 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 (explicitly considered 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 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 18-Oct-2017: The event verbatim for the product leakage was changed.
Age: 30.0
Sex: F
Vaccine: FLUC4
Symptoms: Drug administration error, Product storage error
Clinical narrative: This non-serious initial spontaneous case, was received from nurse on 12-Oct-2017, concerning a 30-year-old adult female patient. The patient's medical history and concomitant medications were not reported. On 11-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number and expiry date: not reported). The patient received frozen vaccine, which was considered as incorrect product storage and drug administration error. It was reported that, frozen vaccine was thawed before the administration. It was reported that, the patient had not experienced any adverse event. Follow up report received on 06-Dec-2017: The patient's age was added. It was reported that, the patient had not experienced any adverse event. The narrative was amended accordingly.
Age: 10.0
Sex: M
Vaccine: FLUC4
Symptoms: Ear infection, Pyrexia, Sinusitis
Clinical narrative: This initial spontaneous case, was received from other non-health professional (consumer) on 09-Oct-2017, concerns a 10-year-old male patient. The patient had no history of sinusitis. On 30-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, expiry date: Mar-2018 and batch no: 195210). On 04-Oct-2017, 05 days after vaccination, the patient started out with a fever for 48 hours, reaching 102.1 (as reported) due to which the patient was consulted to a doctor on 06-Oct-2017 (reported as Friday). Subsequently the patient was diagnosed with sinus infection with double ear infection and was treated with amoxicillin. Outcome of the events was not reported. The reporter assessed the events as non-serious. Follow up received on 09-Nov-2017: It was reported that, the patient had no history of sinusitis. The narrative was amended accordingly.
Age: 63.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: This spontaneous case, was received on 12-Oct-2017 from a pharmacist, concerning a 63-year-old adult male patient. This was a quality complaint report (PTC number: 1025294). The patient's medical history and concomitant medications were not reported. On 12-Oct-2017, the patient was administered FLUCELVAX QIV (dose: less than 0.5 ml, batch number: 195234, expiry date: 31-May-2018, anatomical location: left deltoid, route of administration: intramuscular). It was reported that, on the same day, the patient received less than a 0.5 ml dose of vaccine due to leakage from the PFS (explicitly coded as vaccine under dose and product leakage). It was reported that, part of vaccine leaked between the needle and the syringe where needle tip fastens into the syringe. Although the reporter concedes that it was hard to tell, from where the leaking took place. As per the reporter, she securely fastened the needle tip into the syringe before administration. No defects were identified on syringe or any other syringes in box. Based on the investigation performed, it can be concluded that FLUCELVAX batch 195234 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 syringe or stopper components, and no trends were identified for the batch. However, a trend was identified for the FLUCELVAX batches from the 2017/2018 FLUCELVAX commercial season for leaking syringes due to using the easy point needles, but the needles are not supplied or controlled by Seqirus. The most likely root cause can be attributed to improper handling by the user. It was reported that, no adverse effects were noted. The reporter assessed the events as non-serious. Follow-up received on 16-Oct-2017: Non-significant information received. PTC reference number (1025294) was updated. Follow-up received on 01-Dec-2017: Expiry date: 31-May-2018 was updated. Event "no adverse event" exists no longer. Based on the investigation performed, it can be concluded that FLUCELVAX Batch 195234 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 syringe or stopper components, and no trends were identified for the batch. However, a trend was identified for the FLUCELVAX batches from the 2017/2018 FLUCELVAX Commercial Season for leaking syringes due to using the easy point needles, but the needles are not supplied or controlled by Seqirus. The most likely root cause can be attributed to improper handling by the user. Amended narrative accordingly. Non-significant case correction received with 16-Oct-2017: PTC reference number (1025294) was added.
Age: 31.0
Sex: U
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This spontaneous case, was initially received from other health professional on 10-Oct-2017, concerning a 31-year-old, adult, patient of an unspecified gender. The patient's medical history and concomitant medications were not reported. On 05-Oct-2017, the patient was administered with FLUCELVAX QUADRIVALENT (dose: 0.5 ml, batch number: 195128, expiry date: 30-Apr-2018, route of administration: intramuscular and anatomical location: deltoid). On the same day, 1 hour after vaccination, the patient experienced red, and hot at injection site. On 08-Oct-2017, the patient had recovered from the events (reported as few days). The reporter assessed the events as non-serious. Non-significant case correction received with 10-Oct-2017: Batch number (195128) was captured in the case form and narrative was amended accordingly.
Age: 45.0
Sex: F
Vaccine: FLUC4
Symptoms: Pruritus, Urticaria
Clinical narrative: This initial spontaneous case, was received on 10-Oct-2017, from other health professional, concerning a 45-year-old, adult, female patient. The patient's medical history and concomitant medications were not reported. On 05-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 195128, expiry date: Apr-2018). On the same day, few hours after shot, the patient had a raised, itchy welt. On 06-Oct-2017, the patient recovered from the events. It was reported that, the patient recovered from the events after 72 hours. The reporter assessed the event as non-serious. Significant follow-up received on 26-Oct-2017: The patient details were added (date of birth, age and gender). The event stop date was updated as 06-Oct-2017. Narrative amended accordingly. Significant case correction received 12-OCT-2017: event coding was changed for raised whelped and itchy.
Age: 48.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Injection site pain, Injection site pruritus, Insomnia
Clinical narrative: Pt reports: "I received my flu and pneumonia shots on my left arm, it was excruciating that same day, and has been hurting ever since. Some days don't bother me much at all, but in general it is bothersome all the time. Some days it is just itchy, some days just hurts, sometimes so badly cannot sleep on that side. Says can still feel exactly where the injections were given". Denies redness or swelling at sites.
Age: 0.17
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Body temperature increased
Clinical narrative: Temp to 101.6 No redness of swelling at site of immunization.
Age: 12.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Headache, Nausea
Clinical narrative: Received GARDASIL and flu vaccine. Ate breakfast but no lunch so was given juice before vaccinations. After 15 minutes reported nausea and headache. Was put in lying position temporarily, also given juice and candy. Was sent home at 4:10 pm by provider, reporting symptoms improved. Vitals were monitored, final BP was 105/57 and pulse 66.
Age: 25.0
Sex: F
Vaccine: FLUC4
Symptoms: Drug administration error, Product storage error
Clinical narrative: This non-serious spontaneous case, was initially received on 09-Oct-2017, from Other Health Professional, concerning a 25-year-old, adult female patient. On 09-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: Intramuscular, anatomical location: deltoid, batch number: 195220, expiry date: 30-Apr-2018). It was reported that vaccine was administered that was exposed to 68F for 8 hours/temp excursion above 46F. Non-significant case correction received with IRD 09-Oct-2017: Batch number (195220) was captured in the case form and narrative was amended accordingly.
Age: 55.0
Sex: F
Vaccine: FLUC4
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: This initial spontaneous case, was received from nurse on 10-Oct-2017, concerning a 55-year-old adult female patient. On 05-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, batch number: 195128, expiry date: Apr-2018 route of administration: intramuscular, anatomical location: deltoid). On the same day, immediately after the vaccination, the patient experienced itching, hotness and redness at the injection site. The patient was treated with BENADRYL and applied the ice. On 06-Oct-2017, itching at injection site was resolved in 24 hours, hotness and redness at injection site were resolved in 72 hours (08-Oct-2017) of vaccination. The reporter assessed the report as non-serious. Significant case correction received 10-Oct-2017: duration for redness changed from 4 days to 3 days, during for itching was added. Follow up received on 21-Nov-2017: The gender of the patient (female) and stop date of the event itching at injection site (06-Oct-2017) were updated. The narrative was amended accordingly.
Age: 50.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, was initially received from other health professional (nurse) on 06-Oct-2017, concerning a 50-year-old adult male patient. The patient did not receive any concomitant medications. On 04-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, batch number: 195128 (reported as 195198), expiry date: Apr-2018, route of administration: intramuscular, anatomical location: deltoid). The patient received the vaccine after the multiple temperature excursion over a week. It was reported that, the storage temperature of the vaccine fluctuated between 36-degree F and 48.18-degree F, which reached to maximum 49-degree F over a week instead of storing between 36-degree F to 46-degree F and no adverse event was reported. The reporter assessed the report as non-serious. Non-significant case correction received with IRD 06-Oct-2017: Batch no. (195128) was captured in the case form and narrative was amended accordingly.
Age: 34.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous case was received from other-health professional on 03-Oct-2017, concerning a 34-year-old adult female patient. The patient did not have any relevant medical history. On 03-Oct-2017, the patient was administered with FLUCELVAC QIV (batch number: 195124, expiry date: Apr-2018, route of administration, anatomical location: not reported). On 03-Oct-2017, the same day after vaccination, at night the patient developed red at injection site, swelling, hard, painful, hot to touch. It was reported that, the patient felt arm sore and hard, and get hurts while lifting. On 09-Oct-2017, the patient recovered from the events. The reporter assessed the events as non-serious. Non significant follow up received on 25-Oct-2017 from a nurses: the patient did not have any relevant medical history. Significant case correction received with IRD 03-Oct-2017: Listedness for the event 'injection site swelling was corrected.