chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain
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.
Sex: M
Vaccine: FLUC4
Symptoms: Product storage error
Clinical narrative: This spontaneous case, was initially received on 28-Sep-2017 from Other Health Professional, concerning a male patient of unspecified age. The patient was administered with FLUCELVAX QIV (between 06-Sep-2017 to 26-Sep-2017: as reported) (dose: 0.5 ml, batch number: 195214, expiry date: Apr-2018, dose: 0.5 ml, route of administration, anatomical location: not reported). Multiple temperature excursions were occurred on 08-Sep-2017, vaccine was stored at 33F (1st excursion), on 11-Sep-2017, vaccine was stored at 33 F (2nd excursion), on 12-Sep-2017, vaccine was stored at 33 F (3rd excursion), on 13-Sep-2017, vaccine was stored at 33 F (4th excursion) (explicitly coded as incorrect product storage). The patient was administered with vaccine which was stored at 33 F (explicitly coded as drug administration error). The outcome of the events was not reported. The reporter assessed the events as non-serious. Non-significant case correction received with 28-Sep-2017: Batch no. (195214) was captured in the case form and narrative amended accordingly.
Sex: U
Vaccine: FLUC4
Symptoms: Expired product administered
Clinical narrative: This initial spontaneous case, was received from other health professional on 29-Sep-2017, concerning a patient of unknown age and gender. The patient's medical history and concomitant medications were not reported. On unspecified date in Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, batch number: 186866, expiry date: May-2017, route of administration and anatomical location: not reported). The patient received the expired vaccine (explicitly as expired vaccine used). The reporter assessed  the report as non-serious.
Age: 29.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous case, was initially received on 03-Oct-2017, from other health professional and concerning a 29-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 26-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, batch number: 195126 (reported as 195106), expiry date: Apr-2018, route of administration, anatomical location: not reported). On an unspecified date, within 24 hours of vaccination, the patient had experienced symptoms of localized redness, swelling and heat at the site, which were lasted for 2 to 3 days. The events were lasted for 3 days and the patient was recovered from the events. The reporter assessed this case as non-serious. Non-significant case correction received with IRD 03-Oct-2017: Batch no. (195126) was captured in the case form and the narrative was amended accordingly.
Age: 12.0
Sex: F
Vaccine: FLUC4
Symptoms: Exposure via skin contact, No adverse event, Syringe issue, Underdose
Clinical narrative: This initial spontaneous case, received on 03-Oct-2017, reported by a pharmacist and concerns a 12-year-old adolescent female patient. The patient's medical history was not reported. On 03-Oct-2017, FLUCELVAX QIV was administered (dose: less than 0.5 ml, batch number: 195227 and expiry date: 31-May-2018, route of administration: intramuscular, anatomical location: left deltoid). On 03-Oct-2017, while administrating FLUCELVAX QIV, when the needle of the syringe was screwed to give the shot the Lori lock came apart, the needle and Lori lock ends up stuck in the patient's arm and it sprayed all over the skin (explicitly coded as syringe issue). The patient received partial dose (explicitly coded as under dose). It was reported that, there was no damage in the package condition or in the syringe (25 gauge, no signs of leakage), but broke when needle was inserted as the hub was loose. It was reported that, the product was stored in the original box until used and placed in a refrigerator. It was reported that, no adverse event was experienced by the patient. Based on the PTC (product technical complaint) (PTC reference number: 1025025) investigation performed, it was concluded that, FLUCELVAX with batch number: 195227 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 lock separation during administration. The most likely root cause could be attributed to improper handling by the user. The reporter assessed the case as non-serious. Follow up report received on 13-Oct-2017: It was reported that, no adverse event was experienced by the patient. The route of administration and anatomical location was added. The narrative was amended accordingly. Follow up report received on 16-Nov-2017: The PTC Investigation results were updated. The narrative was amending accordingly.
Age: 60.0
Sex: F
Vaccine: FLUC4
Symptoms: Documented hypersensitivity to administered product, No adverse event
Clinical narrative: This non-serious initial spontaneous case, was received on 05-Oct-2017, from other non-health professional, concerning a female patient of unspecified age. The patient's historical conditions included diabetes and asthma. It was reported that, the patient was allergy to eggs. The patient's concomitant medications included insulin for an unknown indication, blood pressure medication, cholesterol medication and inhaler for asthma. On an unspecified date in Oct 2016, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, batch number, expiry date, route of administration, anatomical location: not reported). On an unspecified date, FLUCELVAX QUADRIVALENT was administered to the patient with an egg allergy. It was reported that, after receiving the vaccine everything was fine. The outcome of the event was not reported. The reporter assessed the events as non-serious.
Age: 38.0
Sex: M
Vaccine: FLUC4
Symptoms: 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 male patient. The patient's medical history was not reported. The patient did not receive any concomitant medications. On 03-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, batch number: 195221, expiry date: Apr-2018, route of administration and anatomical location: not reported). The patient received the vaccine, which underwent temperature excursion (less than 32.54-degree F for about 25 hours) (explicitly coded as incorrect product storage and drug administration error). The reporter assessed the events as non-serious. Non-significant case correction received 05-Oct-2017: Batch number (195221) was captured in the case form and narrative was amended accordingly.
Age: 60.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This initial spontaneous case, was received from other health professional (nurse) on 05-Oct-2017, concerning a 60-year-old adult male patient. The patient's medical history was not reported. The patient concomitant medication included Lisinopril and APRISO for an unknown indication. On 03-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, batch number: 195221, expiry date: Apr-2018, route of administration: intramuscular and anatomical location: right deltoid). The patient received vaccine that underwent temperature excursion (less than 32.54-degree F for about 25 hours) (explicitly coded as incorrect product storage and drug administration error). It was reported that, the patient did not experience any adverse effects after the administration of the vaccine. The reporter assessed the events as non-serious. Follow-up report received on 24-Oct-2017: The route of administration (intramuscular) and anatomical location (right deltoid) were updated. It was reported that, the patient did not experience any adverse effects after the administration of the vaccine. The narrative was amended accordingly.
Sex: M
Vaccine: FLUC4
Symptoms: Exposure via skin contact, Syringe issue, Underdose
Clinical narrative: This non-serious initial spontaneous case, was received from other health professional (pharmacist) on 03-Oct-2017, concerning a patient of an unspecified age and gender. The patient's medical history and concomitant medications were not reported. On 28-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: less than 0.5 ml (as reported), batch number: 195227 and expiry date: 31-May 2018, PTC number: 1025025, route of administration and anatomical location: not reported). On 28-Sep-2017, while administrating the vaccine, the needle of the syringe was screwed to give the shot the Lori lock came apart, the needle and Lori lock ends up stuck in the patient's arm and it sprayed all over the skin (explicitly considered as syringe issue). The patient received partial dose (explicitly considered as under dose). As per the PTC (product technical complaint) report, no damage was in the package condition or in the syringe (25 gauge, no signs of leakage), but broke when needle was inserted as the hub was loose. It was reported that, the product was stored in the original box until use and placed in a refrigerator. Based on the investigation performed, it can be concluded that FLUCELVAX Batch 195227 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 lock separation during administration. The most likely root cause can be attributed to improper handling by the user. The reporter assessed this case as non-serious. non-significant case correction received on 03-Oct-2017: The PTC (product technical complaint) reference number (1025025) was updated. Follow-up report received from QA investigation on 16-Nov-2017: Based on the investigation performed, it can be concluded that FLUCELVAX Batch 195227 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 lock separation during administration. The most likely root cause can be attributed to improper handling by the user. Expiry date was updated to 31-may-2018. Amended narrative accordingly.
Age: 41.0
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 41-year-old adult male patient. The patient's current condition included pre-hypertension. The patient did not receive any concomitant medications. On 29-Sep-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 multiple temperature excursions 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 of 49-degree F over a week period of time 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: 43.0
Sex: F
Vaccine: FLUC4
Symptoms: Paraesthesia oral
Clinical narrative: This spontaneous case, was initially received from other health professional (Pharmacist) on 04-Oct-2017, concerning a 43-year-old adult female patient. The patient's historical conditions included hypothyroidism, anxiety, HSV (Herpes simplex virus) 1 and 2, blood clotting disorder-factor 5 leiden and bacterial vaginosis. The patient's concomitant medications included VALTREX, Levothyroxine, Duloxetine, FLAGYL for an unknown indication. On 04-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, batch number: 195239, expiry date: May-2018, route of administration, anatomical location: not reported). On the same day after receiving the vaccine, the patient experienced tingling of her lips and then about 2 hours later her tongue started tingling. At the time of this report, the outcome of the event was not recovered. The reporter assessed the report as non-serious. Non-significant case correction received 04-Oct-2017: Batch number (195239) was captured in the case form and narrative was amended accordingly.
Age: 14.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, was received from other-health professional (nurse) on 05-Oct-2017, concerning a 14-year-old adolescent male patient. The patient concomitant medication included Acetylsalicylic acid for an 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: Apr-2018). The patient received vaccine that underwent temperature excursion (less than 32.54-degree F for about 25 hours). The reporter assessed the events as non-serious. Follow-up received on 24-Oct-2017: Route of administration and anatomical location was updated to intramuscular and right deltoid. As per reporter, there were no any adverse events reported after vaccination. Narrative amended accordingly.
Sex: U
Vaccine: FLUC4
Symptoms: Device leakage
Clinical narrative: This initial non-serious spontaneous case, was 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 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.
Age: 37.0
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This initial spontaneous case, was received on 05-Oct-2017, from a nurse, concerning a 37-year-old adult female patient. The patient's medical history was not reported and the concomitant medications included, ZOLOFT, Ursodiol, temazepam, QVAR, propranolol, PROAIR, omeprazole, cycloserine, levothyroxine, IMITREX, ADDERALL, gabapentin, hydrocodone-acetaminophen for unknown indications. 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, expiry date: Apr-2018). It was reported that the vaccine was stored at a temperature reduced to 32.54 F for about 25 hours (incorrect product storage) and was administered to the patient. No adverse effects were reported after administration of the vaccine. The reporter assessed the event as non-serious. Significant follow-up received on 24-Oct-2017: It was reported that, the patient did not experience any adverse effects after administration of the vaccine. Narrative was amended accordingly. Significant case correction received 24-Oct-2017: Event "no adverse effect" was assessed and labeling was done. Amended narrative accordingly. Significant case correction received 24-Oct-2017: Added route of administration and anatomical location in the field. No adverse event was deleted from the event tab and classification was added as special case with no AE. Narrative was amended accordingly.
Age: 69.0
Sex: F
Vaccine: FLUC4
Symptoms: Accidental exposure to product, Exposure via skin contact, Needle issue
Clinical narrative: This non-serious initial spontaneous case was received on 14-Sep-2017, from other health professional (nurse), concerning a 69-year-old, elderly, female patient. The historical condition of the patient included polio at the age of 2. The current conditions included fibromyalgia, asthma, sleep disorder, thyroid disease, depression to fibromyalgia since unspecified dates. The concomitant medications included,  AMBIEN, ALLEGRA, Piroxicam, CYTOMEL, BUTRIN, ALBUTEROL when needed, SINGULAIR for unknown indications. On 14-Sep-2017, the patient (nurse) had administered FLUCELVAX QIV (batch number 195128, expiry date: Apr-2018, dose, route of administration, anatomical location: not reported). It was reported that, the patient withdrew 6 full doses of injections successfully. Upon the withdrawal of the seventh dose, the vaccine leaked around the metal collar and the patient was exposed to the vaccine. It was reported that, vaccine started to leak out of the metal stopper upon administration of the product. Reporter stated that, the package was in good condition and there was no damage in the carton and leaflet or PIL was wet or appeared as water damaged. It was reported that, the leaking was coming around the stopper and the needle used was 23 gauges and 1 inch. The syringe was set to 1/2 cc and injected that air into the vial. The PTC reference number was 1024513. 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, or any other FLUCELVAX batches from the 2017/2018 FLUCELVAX Commercial Season for vials leaking at the stopper. The most likely root cause can be attributed to improper handling by the user. The patient had washed her hand after the exposure. The outcome of the event was not reported. The reporter assessed the event as non-serious. The causality between the vaccine and the event was not reported. Follow up report received from QA investigation on 31-Oct-2017: Based on the investigation performed, it can be concluded that FLUCELVAX Batch 195128 was manufactured incompliance 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, or any other FLUCELVAX batches form the 2017/2018 FLUCELVAX Commercial Season for vials leaking at the stopper. The most likely root cause can be attributed to improper handling by the user.
Sex: M
Vaccine: FLUC4
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Feeling abnormal, Headache
Clinical narrative: This spontaneous case, was received from Other-Non Health Professional on 05-Oct-2017, concerning a 44-year-old, adult, male patient. The patient's concomitant medications included: Metoprolol. Patient's medical history included: fatty liver, chemotherapy in 2006 and hypoglycaemia. On 09-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: upper arm (reported as upper muscle arm), batch number, expiry date: not reported). On the same day, the patient experienced malaise a few minutes after receiving the vaccine. On 28-Sep-2017, patient experienced collapsing, shivering, fever, loose stools, stomach pain, headache and felt like his head was going to explode. At the time of this report, the patient had not yet recovered from the event (patient feels "kind of funny", symptoms come and go). The reporter assessed the events as non-serious. Follow-up received on 18-Oct-2017: Age of the patient was updated to 44-year. Anatomical location and route of administration was updated. At the time of this report, the patient had not yet recovered from the events (reported as symptoms come and go). Narrative amended accordingly. Significant case correction received 05-Oct-2017: The company causality of the event 'diarrhoea' was corrected from not reported to not related. Significant case correction received 05-Oct-2017: As Determined Listedness of the event headache was changed from unlisted to listed flu vaccine cell subunit NVD.
Sex: M
Vaccine: FLUC4
Symptoms: Malaise, Pyrexia, Syncope
Clinical narrative: This spontaneous case, was received from Other-Non Health Professional on 05-Oct-2017, concerning a 44-year-old, adult, male patient. The patient's concomitant medications included: Metoprolol. Patient's medical history included: fatty liver, chemotherapy in 2006 and hypoglycaemia. On 09-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: upper arm (reported as upper muscle arm), batch number, expiry date: not reported). On the same day, the patient experienced malaise a few minutes after receiving the vaccine. On 28-Sep-2017, patient experienced collapsing, shivering, fever, loose stools, stomach pain, headache and felt like his head was going to explode. At the time of this report, the patient had not yet recovered from the event (patient feels "kind of funny", symptoms come and go). The reporter assessed the events as non-serious. Follow-up received on 18-Oct-2017: Age of the patient was updated to 44-year. Anatomical location and route of administration was updated. At the time of this report, the patient had not yet recovered from the events (reported as symptoms come and go). Narrative amended accordingly. Significant case correction received 05-Oct-2017: The company causality of the event 'diarrhoea' was corrected from not reported to not related. Significant case correction received 05-Oct-2017: As Determined Listedness of the event headache was changed from unlisted to listed flu vaccine cell subunit NVD.
Sex: M
Vaccine: FLUC4
Symptoms: Device leakage
Clinical narrative: This non-serious spontaneous case, was received on 18-Oct-2017, from other health professional, concerning 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 and expiry date: 30-Apr, 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 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 on 21-Nov-2017: Added PTC number and the QA (quality assurance) report results. Narrative amended accordingly. Non-significant case correction was received 18-Oct-2017: The verbatim of the events "The vial is dripping from the rubber seal/vaccine from a vial that leaked/after piercing the vial, turn it upside down, injected air and it started leaking" and 'employees were given vaccine from a vial that leaked' were corrected and labeling, causality assessment was done.
Age: 33.0
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This initial non-serious spontaneous case, received from a nurse on 05-Oct-2017 concerning a 33-year-old female patient. The patient's concomitant medications included Levothyroxine, colestyramine, omeprazole; XYZAL and NASONEX. On 04-Oct-2017, the patient received FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 195216 and expiry date: Apr-2018). It was reported that, FLUCELVAX was stored at the back of the refrigerator and one of the vials of FLUCELVAX was frozen. On an unspecified date, patient received frozen vaccine. It was reported that, the nurse wanted to know what has been tossed out and left over 8 vials were still ok to use. It was reported that, FLUCELVAX should be stored and protected from light (in the original carton) and refrigerated between 36 degrees F and 46 degrees F (2 degrees C and 8 degrees C). On an unspecified date, it was reported that the patient did not experience any adverse events after vaccination. The outcome of the events was not reported. The reporter assessed the event as non-serious. Follow-up report received on 18-Oct-2017: No adverse events were experienced after vaccination, the same have been updated and amended narrative accordingly.
Age: 41.0
Sex: F
Vaccine: FLUC4
Symptoms: Diarrhoea, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous case was initially received from other-heath professional on 03-Oct-2017, concerning a 41-year-old, adult female patient. The patient had no relevant medical history. On 03-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, batch number: 195124, expiry date: 30-A0r-2018, route of administration, anatomical location: not reported). On the same day in the night, the patient developed redness, swelling, hard, painful, hot to touch at injection site. It was reported that, the patient still felt redness, warmth at injection site and diarrhea. On 09-Oct-2017, the patient recovered from the events. The reporter assessed the events as non-serious. Follow up report received on 11-Oct-2017: The outcome of the events from not recovered to recovered on 09-Oct-2017 was updated. The reporter confirmed the onset of the events as 03-Oct-2017. Non-significant follow up received on 25-OCT-2017 from nurse: The patient had no relevant medical history. Significant case correction received on IRD 03-Oct-2017: Listedness of the events were corrected. Significant case correction received with IRD with 03-Oct-2017: As Determined Listedness of the event checked the listedness and for the event injection site swelling was changed from, listed to unlisted in flu vaccine cell subunit. Non-significant case correction received with IRD 03-Oct-2017: Batch number (195124) was added on the screen and updated expiry date. The narrative was amended accordingly.
Age: 41.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site warmth
Clinical narrative: This spontaneous case was initially received from other-heath professional on 03-Oct-2017, concerning a 41-year-old, adult female patient. The patient had no relevant medical history. On 03-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, batch number: 195124, expiry date: 30-A0r-2018, route of administration, anatomical location: not reported). On the same day in the night, the patient developed redness, swelling, hard, painful, hot to touch at injection site. It was reported that, the patient still felt redness, warmth at injection site and diarrhea. On 09-Oct-2017, the patient recovered from the events. The reporter assessed the events as non-serious. Follow up report received on 11-Oct-2017: The outcome of the events from not recovered to recovered on 09-Oct-2017 was updated. The reporter confirmed the onset of the events as 03-Oct-2017. Non-significant follow up received on 25-OCT-2017 from nurse: The patient had no relevant medical history. Significant case correction received on IRD 03-Oct-2017: Listedness of the events were corrected. Significant case correction received with IRD with 03-Oct-2017: As Determined Listedness of the event checked the listedness and for the event injection site swelling was changed from, listed to unlisted in flu vaccine cell subunit. Non-significant case correction received with IRD 03-Oct-2017: Batch number (195124) was added on the screen and updated expiry date. The narrative was amended accordingly.
Age: 29.0
Sex: F
Vaccine: FLUC4
Symptoms: Diarrhoea, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: This initial spontaneous case, was received from other health professional on 03-Oct-2017, concerning a 29-year-old adult female patient. The patient's medical history and concomitant medications were not reported. On 03-Oct-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). On the same day in the night, the patient developed red at injection site, swelling, hard, painful, hot to touch and continuously hurt. It was reported that, the patient still felt redness, warmth at injection site, diarrhoea and sore throat. On 09-Oct-2017, the patient recovered from the events. The reporter assessed the events as non-serious. Follow-up received on 16-Oct-2017: The event onset date was confirmed as 03-Oct-2017. On 09-Oct-2017, the patient recovered from the events. Narrative was amended accordingly. Nonsignificant follow up received on 25-Oct-2017 from a nurse: It was reported that the patient had no relevant medical history. Significant case correction received 03-Oct-2017: The listedness of the event 'Injection site swelling' in CORE flu vaccine cell subunit was corrected from listed to unlisted. The listedness of the event 'sore throat' in flu vaccine cell subunit was corrected from listed to unlisted. The listedness of the event 'diarrhoea' in CORE flu vaccine cell subunit was corrected from unlisted to listed.
Age: 29.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site warmth, Oropharyngeal pain
Clinical narrative: This initial spontaneous case, was received from other health professional on 03-Oct-2017, concerning a 29-year-old adult female patient. The patient's medical history and concomitant medications were not reported. On 03-Oct-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). On the same day in the night, the patient developed red at injection site, swelling, hard, painful, hot to touch and continuously hurt. It was reported that, the patient still felt redness, warmth at injection site, diarrhoea and sore throat. On 09-Oct-2017, the patient recovered from the events. The reporter assessed the events as non-serious. Follow-up received on 16-Oct-2017: The event onset date was confirmed as 03-Oct-2017. On 09-Oct-2017, the patient recovered from the events. Narrative was amended accordingly. Nonsignificant follow up received on 25-Oct-2017 from a nurse: It was reported that the patient had no relevant medical history. Significant case correction received 03-Oct-2017: The listedness of the event 'Injection site swelling' in CORE flu vaccine cell subunit was corrected from listed to unlisted. The listedness of the event 'sore throat' in flu vaccine cell subunit was corrected from listed to unlisted. The listedness of the event 'diarrhoea' in CORE flu vaccine cell subunit was corrected from unlisted to listed.
Age: 29.0
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 29-year-old adult female patient. The patient did not have relevant medical history. On 03-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, batch number: 195124, expiry date: Apr-2018, route of administration: intramuscular, anatomical location: right deltoid). On the same day, at night, the patient developed injection site as red, swollen, hard, painful, hot to touch and complained that it hurts. The patient felt there was no redness at the vaccination site but was lifted. On 09-Oct-2017, the patient was recovered from the events. The reporter assessed the events as non-serious. Follow up report received on 11-Oct-2017: The route of administration (intramuscular), anatomical location (right deltoid) of the vaccine and outcome of the events from not recovered to recovered on 09-Oct-2017 were updated. Non-significant follow up received on 25-Oct-2017 from reporter (nurse): the patient did not have relevant medical history. Significant case correction received with IRD 03-Oct-2017: Listedness of the event injection site swelling was corrected.
Age: 24.0
Sex: F
Vaccine: FLUC4
Symptoms: Cough, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: This initial spontaneous case, was received on 03-Oct-2017, from other health professional and concerning a 24-year-2017, adult, female patient. The patient had no relevant medical history. On 03-Oct 2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 195124, expiry date: Apr-2018: not reported). On the same day, at night after vaccination, the patient had experienced injection site redness swollen, hard, pain and hot to the touch. The patient also had symptoms of sore and hot at that area. The patient also had cough. On 09-Oct-2017, the patient was recovered from the events. 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. Follow up received from health care professional on 25-Oct-2017: The outcome of the events was changed from not recovered to recovered. Significant case correction received 03-Oct-2017: The event 'sensation of heat' was deleted. The verbatim (description as reported) for 'injection site warmth' was corrected to 'Described injection site as [red, swollen, hard, painful and] hot to the touch'. The event coding for the verbatim 'Patient described injection site as [red,] swollen,] hard[, painful and hot to the touch] was correct from 'injection site lump' to 'injection site induration' and labeling was corrected accordingly. The listedness of the event 'cough' was corrected. The listedness of the event 'injection site swelling' was corrected.
Age: 24.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site warmth
Clinical narrative: This initial spontaneous case, was received on 03-Oct-2017, from other health professional and concerning a 24-year-2017, adult, female patient. The patient had no relevant medical history. On 03-Oct 2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 195124, expiry date: Apr-2018: not reported). On the same day, at night after vaccination, the patient had experienced injection site redness swollen, hard, pain and hot to the touch. The patient also had symptoms of sore and hot at that area. The patient also had cough. On 09-Oct-2017, the patient was recovered from the events. 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. Follow up received from health care professional on 25-Oct-2017: The outcome of the events was changed from not recovered to recovered. Significant case correction received 03-Oct-2017: The event 'sensation of heat' was deleted. The verbatim (description as reported) for 'injection site warmth' was corrected to 'Described injection site as [red, swollen, hard, painful and] hot to the touch'. The event coding for the verbatim 'Patient described injection site as [red,] swollen,] hard[, painful and hot to the touch] was correct from 'injection site lump' to 'injection site induration' and labeling was corrected accordingly. The listedness of the event 'cough' was corrected. The listedness of the event 'injection site swelling' was corrected.
Age: 61.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This non-serious initial spontaneous case, was received from other health professional (nurse) on 03-Oct-2017, concerning a 61-year-old adult female patient. The patient had no relevant medical history. On 03-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, batch number: 195124 (as reported), expiry date: Apr-2018, route of administration and anatomical location: not reported). On the same day (in night) (as reported), the patient experienced injection site redness, swelling, hardness, pain, which were hot to the touch. It was reported that, the patient felt redness and hotness of arm. O9-Oct-2017, the patient recovered from the events. The reporter assessed the report as non-serious. Follow  up received from reporter (nurse) on 25-Oct-2017: The outcome of the events was changed from not recovered to recovered on 09-Oct-2017. Amended narrative accordingly. Significant case correction received with IRD 03-Oct-2017: The event coding was corrected from 'injection site lump' to 'injection site induration for the event verbatim 'injection site as [red], swollen,] hard[, painful and hot to the touch]'. Labelling and causality of the event 'injection site induration' was updated accordingly. Listedness of the event 'injection site swelling' was corrected from listed to unlisted in CORE flu vaccine cell subunit NVD. Significant case correction received with IRD 03-Oct-2017: The event coding of the verbatim 'injection site as [red,] swollen,] hard [,painful and hot to the touch]' was corrected from 'injection site lump' to 'injection site induration' and labeling was corrected accordingly. The listedness of the event 'injection site swelling' was corrected.
Age: 31.0
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious initial spontaneous case was received on 09-Oct-2017, from other Health Professional, concerning a 31-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: Apr-2018). It was reported that the vaccine which was exposed to 68F for 8 hours/ temp excursion above 46F was administered and the patient had no adverse effect. The outcome of the events was not reported. Follow-up received on 13-Nov-2017: It was reported that the patient  had no adverse effect. Narrative amended accordingly.
Age: 51.0
Sex: U
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: This spontaneous case, was initially received from other health professional on 10-Oct-2017, concerning a 51-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, the patient experienced redness, warm and itchy at the injection site. on 08-Oct-2017, the patient had recovered from the events (red, warm and itchy). The reporter assessed the events as non-serious. Follow up report received on 18-Oct-2017: The outcome of the event injection site itching was changed from not reported to recovered. The narrative was amended accordingly. Non-significant case correction received 10-Oct-2017: Batch number (195128) was captured in the case form and narrative was amended accordingly.
Age: 20.0
Sex: F
Vaccine: FLUC4
Symptoms: Exposure during pregnancy, Pain in extremity
Clinical narrative: This initial spontaneous case, was received from consumer on 10-Oct-2017, concerning a 20-year-old adult female pregnant patient. The patient had no medical history and had no previous pregnancy. The patient did not receive any concomitant medications prior and during the pregnancy and no medications received by the father prior to conception. The patient had no maternal medical history relevant to pregnancy and paternal medical history for hereditary disease. The patient had not use any contraceptive method. The patient's last menstrual period date was 20-Jan-2017 and had first pregnancy. There was no evidence of any defect/adverse finding from a prenatal test and no birth defect or congenital anomaly, during pregnancy. The gestational period of the fetus was 37 weeks (third trimester) and gender of the fetus was female. The patient gave the permission to enroll in the pregnancy registry. On 09-Oct-2017, at 37 weeks of gestation period (third trimester), the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, batch number, route of administration, anatomical location: not reported). On 10-Oct-2017, after 2 days of vaccination, the patient experienced the soreness in arm and no adverse event was reported in the fetus. On the same day, the patient recovered from the event. The estimated date of delivery was reported as 27-Oct-2017. The reporter assessed the events as non-serious. Significant case correction received with IRD 10-Oct-2017: narrative was amended.
Age: 47.0
Sex: F
Vaccine: FLUC4
Symptoms: Drug administered at inappropriate site, Injected limb mobility decreased, Loss of personal independence in daily activities, Musculoskeletal pain
Clinical narrative: This spontaneous case, was initially received on 09-Oct-2017, reported by other non-health professional and concerns a 47-year-old female patient. Patient's medical history was not reported. The patient's concomitant medications included trazodone. On 19-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, anatomical location: deltoid, left arm, route of administration: intramuscular, batch number: 195218, expiry date: 30-Apr-2018). It was reported that, administration by nurse was too high up reaching tendon (as stated by patient's physician). A week after receiving vaccine (FLUCELVAX QIV) the patient had a limited range of motion, was unable to lift arm and described pain in upper shoulder. The patient's treatment medications included ALEVE, naproxen. It was reported that, the patient was still struggling with shoulder arm issues in the left arm, despite consulting many doctors. An MRI (magnetic resonance imaging) was scheduled on 23-Oct-17, the patient was on physical therapy. It was stated that, it has been very challenging for her, the pain was quite intense and her range of motion was limited. She struggled with day to day activities such as clothing herself and even to put on socks she has to take help of her son. She was not able to carry heavy objects. The patient felt constant probing pain in shoulder and cannot easily get out of the bathtub. The outcome of the events was not recovered. The reporter assessed this case as non-serious. Follow-up report received on 20-Oct-2017: It was reported that, the patient was still struggling with shoulder arm issues in the left arm, despite consulting many doctors. An MRI (magnetic resonance imaging) was scheduled on 23-Oct-17, the patient was on physical therapy. It was stated that, it has been very challenging for her, the pain was quite intense and her range of motion was limited. She struggled with day to day activities such as clothing herself and even to put on socks she has to take help of her son. She was not able to carry heavy objects. The patient felt constant probing pain in shoulder and cannot easily get out of the bathtub. Event "activities of daily living impaired" was added. Amended narrative accordingly. Non-significant case correction received with IRD 09-Oct-2017: Batch number (195218) was captured in the case form and narrative was amended accordingly.
Age: 9.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This initial spontaneous case was received on 10-Oct-2017, from other health professional, concerning a 09-year-old child. The patient's medical history and concomitant medications were not reported. On 08-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, the patient experienced injection site redness, pain and warm. The patient was treated with BENADRYL oral, applied ice and hydrocortisone cream. It was reported that, the events resolved after 2 days. The reporter assessed the event as non-serious. Follow-up received on 26-Oct-2017: The injection site reaction was reported as raised, red, hot, size of coke can. The patient applied hydrocortisone cream and the events resolved after 2 days. Narrative amended accordingly.