chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Headache, Injection site pruritus, Injection site warmth
Clinical narrative: This initial spontaneous case, was received from nurse on 10-Oct-2017, concerning a 25-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, batch number: 195128, expiry date: Apr-2018, route of administration: intramuscular, anatomical location: deltoid). On the same day, within an hour of vaccination, the patient had headache, dizziness, warmth and itchiness at injection site. The patient received BENADRYL for the events. The outcome of all the events was reported as recovered. The reporter assessed the events as non-serious. Follow up received on 21-Nov-2017: The gender of the patient (female) and outcome of all the events from not reported to recovered were updated. The narrative was amended accordingly.
Sex: M
Vaccine: FLUC4
Symptoms: Drug administration error, Underdose
Clinical narrative: This spontaneous case, was initially received from a Pharmacist on 09-Oct-2017, concerning a male patient of an unspecified age. On 09-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: less than full 0.5 ml, batch number: 195239, expiry date: 31-May 2018, route of administration: intramuscular, anatomical location: left deltoid) (explicitly coded to Incomplete dose administered). It was reported that the patient felt a mist from the vaccine, as though he wasn't getting the full dose. The reporter was wondering if/when he should be revaccinated (explicitly coded to drug administration error). The reporter assessed the report as non-serious. Follow-up received on 17-oct-2017: Route of administration and anatomical location was updated to Intramuscular and left deltoid respectively. Narrative was amended accordingly. Non-significant case correction received 09-Oct-2017: Batch number (195239) was captured in the case form and narrative was amended accordingly.
Age: 37.0
Sex: M
Vaccine: FLUC4
Symptoms: Pain in jaw
Clinical narrative: This spontaneous case, was initially received from other health professional on 11-Oct-2017, concerning a 37-year-old, adult, male patient. The patient had no medical history and had not received any concomitant medications. On 06-Oct-2017, the patient was administered with FLUCELVAX QUADRIVALENT (dose: 0.5 ml, batch number: 195212, expiry date: 30-Mar-2018, route of administration: intramuscular and anatomical location: left deltoid). On 08-Oct-2017 (reported as 2 days after receiving the vaccine), the patient experienced increasing soreness in jaw. It was reported that, the soreness had aggravated. The patient had not consulted any physician. It was also reported that, the patient had no other associated symptoms or other adverse event. At the time of this report, the patient had recovered from the event jaw pain. The reporter assessed the event as non-serious. Follow-up received on 18-Oct-2017: It was reported that the patient had no other associated symptoms and the outcome was changed from not recovered to recovering. Narrative amended accordingly. Follow-up report received on 24-Oct-2017: The outcome of the event was updated from recovering to recovered. It was reported that, the patient had no other adverse event. The narrative was amended accordingly. Significant case correction received with IRD 24-Oct-2017: No adverse event was deleted.
Age: 9.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This initial spontaneous case, was received from a pharmacist on 11-Oct-2017, concerning a 9-year-old, male child. This refers to 01 out of 04 reports. On 10-Oct 2017, the patient was administered with FLUCELVAX QIV (influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch no: 195216 and expiry date: Apr-2018). It was reported that the Influenza vaccine was left out of the refrigerator for a couple of days and temperature had reached maximum of 72F to 90 hours (explicitly considered as incorrect product storage). The same vaccine was administered to the patient (explicitly considered as drug administration error). It was reported that, the patient did not experience any adverse effects after vaccination. The reporter assessed the case as non-serious. Follow-up received from the reporter on 20-Oct-2017: This case was updated from invalid to valid due to reported identifiable age of the individual patients. The patient's age was updated and narrative amended accordingly. Follow-up received from the reporter on 26-Oct-2017: It was reported that, the patient did not experience any adverse effects after vaccination. Narrative amended accordingly. Significant case correction received 20-OCT-2017: The onset date of the event incorrect product storage was removed. The event 'no adverse event' was removed from events tab.
Sex: U
Vaccine: FLUC4
Symptoms: Incorrect dose administered
Clinical narrative: This initial spontaneous case, was received on 10-Oct-2017, by a pharmacist, concerning a patient of unspecified age and gender. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was administered with FLUCELVAX QIV (dose: 1 ml (instead of 0.5 ml), route of administration, anatomical location, batch number, expiry date was not reported). The outcome of the event was not reported. The reporter assessed the event as non-serious.
Age: 41.0
Sex: F
Vaccine: FLUC4
Symptoms: Blister, Pain, Scar, Skin burning sensation, Skin discolouration
Clinical narrative: This initial spontaneous case, was received on 11-Oct-2017, by other non-health professional, concerning a 41-year-old, adult, female patient. The patient's historical conditions included disc bulging, anxiety disorder, COPD (chronic obstructive pulmonary disease), migraine, depression, seizures. The patient's current condition included latex allergy. The patient's concomitant medications included KEPPRA, hydroxyzine, PROVENTIL, SEROQUEL, KLONOPIN, omeprazole, FLONASE, oxycodone, promethazine. On 14-Sep-2017, the patient received FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid of left arm, batch number: 195216, expiry date: Apr-2018). On 15-Sep-2017, next day of vaccination, the patient woke up with blisters all over body, with skin felt as if it were on fire. In the meantime, of her healing, all the color has come out of her tattoos. It was reported that, the patient received FLUCELVAX QUADRIVALENT for the first time, but had other products in past with no issues. The patient was in treatment with lidocaine cream for pain. The patient recovered from the events blister (but it left scars) and burning sensation of the skin. It was reported that, the color had drained from tattoos. The reporter assessed the event as non-serious. Follow-up received on 24-Oct-2017: The outcome of the event was changed from not recovered to recovered, but was left with scars. It was reported that, the color had drained from tattoos. Narrative was amended accordingly. Follow-up received on 08-Nov-2017: Outcome for the event 'burning sensation skin' was updated from not recovered to recovered. Amended narrative accordingly.
Age: 53.0
Sex: F
Vaccine: FLUC4
Symptoms: Fatigue, Influenza like illness, Pain in extremity
Clinical narrative: This initial spontaneous case, was received from other non-health professional on 12-Oct-2017, concerning a 53-year-old adult female patient. The patient current conditions included HTN (hypertension) and hot flashes since an unspecified date. The patient's concomitant medications included lisinopril, EFFEXOR SR and PRILOSEC for an unknown indication. On 29-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number, expiry date, manufacturer and trade name: not reported). On 30-Sep-2017, after 2 days of vaccination, the patient had sore arm, flu like symptoms and fatigue. It was reported that, the patient was recovered within 24 hours. The reporter assessed the events as non-serious. Follow-up received on 20-Oct-2017: Non-significant information received (no new information). Significant case correction received with IRD 12-Oct-2017: Causality was changed from 'not reported to related'.
Age: 28.0
Sex: M
Vaccine: FLUC4
Symptoms: Syringe issue, Underdose
Clinical narrative: This initial non-serious spontaneous case, was received on 13-Oct-2017, from a pharmacist, concerning a 28-year-old adult male patient. The patient had no medical history and took no concomitant medications. On 04-Oct-2017, the patient was administered with the FLUCELVAX QIV (dose: less than 0.5 ml (as reported), route of administration: intramuscular, anatomical location: left deltoid, batch number: 195227, expiry date: May-2018). It was reported that the patient was administered with a dose less than 0.5 ml, as some dose came out through the lock attached. The pharmacist wore gloves and hence, was not exposed to the vaccine. The patient was administered with a second dose of vaccine. No adverse events had occurred. It was reported that the defect was discovered during the use. Hence, full dose of vaccine was not administered. The location of the leak was from the bottom where the lure lock attaches. There were no signs of damage on the syringe. The model of the needle used was BD/25 gauge/1 inch. The needle appeared tightly attached. As per PTC (product technical complaint) (PTC number: 1025258) investigation, it was concluded that FLUCELVAX Batch 195227 was manufactured in compliance with 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 leaking syringes. The most likely root cause could be attributed to no internal root cause could be confirmed and no external/user root cause could be determined. Significant case correction received with IRD 13-Oct-2017: Event 'drug administration error' was removed from the event field. PTC (PTC reference number: 1025258) report received on 13-Oct-2017: It was reported that the defect was discovered during use. Hence, full dose of vaccine was not administered. The location of the leak was from the bottom where the lure lock attaches. There were no signs of damage on the syringe. The model of the needle used was BD/25 gauge/1 inch. The needle appeared tightly attached. The narrative was amended accordingly. Significant case correction received with IRD 13-Oct-2017: Event 'drug administration error' was removed from the event field. Follow up received on 01-Dec-2017: The PTC investigation results were updated. The event "no adverse event" was deleted from the screen. The narrative was amended accordingly.
Age: 26.0
Sex: M
Vaccine: FLUC4
Symptoms: Back pain, Injection site pain
Clinical narrative: This initial spontaneous case, was received on 16-Oct-2017 from a pharmacist, concerning a 26-year-old adult male patient. The patient's medical history and concomitant medications were reported as none. On 11-Oct-2017, the patient was administered with FLUCELVAX QIV (dose:0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number, expiry date: not reported). On 14-Oct-2017, 3 days after the vaccination, the patient experienced severe back pain and pain at the injection site. The patient was treated with TYLENOL. The outcome of the event injection site pain was recovered and outcome of the event severe back pain was ongoing. The reporter assessed the events as non-serious.
Sex: M
Vaccine: FLUC4
Symptoms: Device leakage
Clinical narrative: This non-serious initial spontaneous case was received from other health professional (nurse) on 18-Oct-2017, concerns a patient of an unspecified age and gender. This is 3 out of 24 reports. On 04-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: full dose (as reported), batch number: 195128, expiry date: 30-Apr-2018, route of administration, anatomical location: not reported). On 04-Oct-2017, 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, via was dripping from the rubber seal. The nurse could withdraw only 7 doses from the vial. The patient was administered with full doses. There were 2 defective units, but the package was not damaged or wet. The nurse used 23 needle gauge of size 3 cc. The PTC (product technical complaint) number provided was 1025066. Based on the investigation performed, it can be conclude that FLUCELVAX Batch 195128 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified in the manufacturing process, or relating to the vial or stopper components, and no trends were identified for the batch. However a known trend was identified for the FLUCELVAX batches from the 2017/2018 FLUCELVAX Commercial Season for vials leaking at the stopper during dosing due to air being added to the vial. The most likely root cause can be attributed to improper handling by the user. Follow-up received and significant case correction received on 21-Nov-2017: added PTC number and the QA (quality assurance) report results. Narrative amended accordingly. Non-significant case correction received with IRD 18-Oct-2017: The verbatim of the event 'product leakage' was corrected.
Sex: U
Vaccine: FLUC4
Symptoms: Device leakage, Wrong technique in product usage process
Clinical narrative: This non-serious initial spontaneous case, was received from other health professional (nurse) on 18-Oct-2017, concerns a patient of an unspecified age and gender. This refers to 6 out of 24 reports. On 04-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: full dose (as reported), batch number: 195128, expiry date: Apr-2018, route of administration, anatomical location: not reported). 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. New event drug administration error was coded. Narrative amended accordingly. Non-significant case correction received with IRD 18-Oct-2017: The verbatim of the event 'product leakage' was corrected.
Sex: M
Vaccine: FLUC4
Symptoms: Device leakage, Wrong technique in product usage process
Clinical narrative: This non-serious initial spontaneous case, was received from other health professional (Nurse) on 18-Oct-2017, concerns a patient of unspecified age and gender. This was 7th out of 31 reports. On 04-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: full dose (as reported), batch number: 195128, expiry date: 30-Apr-2018, route of administration, anatomical location: not reported). On 04-Oct-2017, this employee was given vaccine from a vial that leaked. It was reported that, after piercing the vial, when it was turned upside down and upon injecting air, vial was dripping from the rubber seal. The nurse could withdraw only 7 doses from the vial. The patient was administered with full doses. There were 2 defective units, but the package was not damaged or wet. The nurse used 23 needle gauge of size 3 cc. The PTC (product technical complaint) number provided for was 1025066. Based on the investigation performed, it can be concluded that FLUCELVAX Batch 195128 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified in the manufacturing process, or relating to the vial or stopper components, and no trends were identified for the batch. However a known trend was identified for the FLUCELVAX batches from the 2017/2018 FLUCELVAX Commercial Season for vials leaking at the stopper during dosing due to air being added to the vial. The most likely root cause can be attributed to improper handling by the user. Follow-up received on 21-Nov-2017: Added PTC number and the QA (quality assurance) report results. Narrative amended accordingly. Non-significant case correction received with IRD 18-Oct-2017: The verbatim of the event 'product leakage' was corrected.
Age: 44.0
Sex: F
Vaccine: FLUC4
Symptoms: Product storage error
Clinical narrative: This non-serious spontaneous case, was initially received on 23-Oct-2017 from a Pharmacist, concerns a 44-year-old adult female patient. On 23-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, batch no: 195210A, expiry date: Mar-2018, route of administration: intramuscular and anatomical location: left deltoid). It was reported that vaccine was at a maximum temperature of 55F overnight and it was administered. The pharmacist stated that the refrigerator was 40.6F last night but that morning the temperature was 55F and that was a first-time excursion. It was reported that, the patient did not experience any adverse event after the administration of the vaccine. The reporter did not provide the seriousness assessment. Follow-up report received on 27-Nov-2017: Gender of the patient (female) was added. Route of administration (intramuscular), anatomical location: left deltoid was updated. Amended narrative accordingly. Significant case correction received with IRD 27-Nov-2017: The event 'no adverse event' was deleted.
Age: 19.0
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This initial spontaneous case, was received from a pharmacist on 20-Oct-2017, concerns a 19-year-old, adult, female patient. This was fourth out of 04 reports. On 10-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch no: 195216 and expiry date: Apr-2018). On 10-Oct-2017, the patient was administered with influenza vaccine that reached 72F for up to 90 hours and had no adverse effects. It was reported that, the FLUCELVAX was left out of the refrigerator for a couple of days. The reporter assessed the case as non-serious. Follow-up received up on 26-Oct-2017: It was reported that, the patient had no adverse effect after the vaccination. Narrative amended accordingly.
Age: 14.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, was initially received on 23-Oct-2017 from the pharmacist, concerns a 14-year-old adolescent male patient. The subject had no relevant medical history and concomitant medications. On 23-Oct-2017, the patient administered with FLUCELVAX QIV (dose: 0.5 ml, batch number: 195210A, expiry date: Mar-2018, route of administration: intramuscular, anatomical location: left deltoid). It was reported that, the patient received the vaccine, which undergone the maximum temperature excursion of 55-degree F overnight. It was reported that, the patient did not experience any adverse events after the administration of the vaccine. Follow-up report received on 27-Nov-2017: Gender of the patient (male) was added. Route of administration (intramuscular), anatomical location (left deltoid) was updated. It was reported that, the patient did not experience any adverse events after administration of the vaccine. Amended narrative accordingly. Significant case correction received 27-Nov-2017: The event 'no adverse event' was deleted.
Age: 28.0
Sex: F
Vaccine: FLUC4
Symptoms: Menstruation delayed, Pregnancy test negative
Clinical narrative: This initial spontaneous case, received from pharmacist on 19-Oct-2017, concerning a 28-year-old, adult, female patient. This refers to 02 out of 04 reports. The patient had no relevant medical history. The patient's concomitant medication included unspecified birth control medication. On 04-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, batch number: 195126, expiry date: Apr-2018 and anatomical location: not reported). After the administration of the vaccine, it was reported that, the patient's period was late by 13 days. The patient underwent a pregnancy test which was negative. No treatment was taken for the event. The reporter considered the causality as related. The reporter assessed the event as non-serious. Follow-up report received on 27-Oct-2017: The patient's period was late by 13 days. It was reported that, the patient underwent a pregnancy test which was negative. Amended narrative accordingly.
Age: 27.0
Sex: F
Vaccine: FLUC4
Symptoms: Menstruation delayed, Pregnancy test negative
Clinical narrative: This initial spontaneous case, received from pharmacist on 19-Oct-2017, concerning an adult, female patient of unspecified age. This refers to fourth of 04 reports. The patient had no relevant medical history. The patient's concomitant medication included unspecified birth control medication. On 04-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, batch number: 195126, expiry date: Apr-2018 and anatomical location: not reported). On an unspecified date, after the administration of the vaccine. It was reported that the patient's period was late by 13 days. She underwent pregnancy test and the result was negative. No treatment was taken for the event. The reporter assessed the event as non-serious. Follow-up received on 30-Oct-2017: It was reported that the patient's period was late by 13 days. She underwent pregnancy test and the result was negative. The narrative was amended accordingly.
Age: 42.0
Sex: F
Vaccine: FLUC4
Symptoms: Product storage error
Clinical narrative: This spontaneous case, was initially received on 23-Oct-2017 from a pharmacist, concerning a 42-year-old, adult, female patient. This refers to 06 out of 06 reports. The patient had no relevant medical history and concomitant medications. On 23-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, batch number: 195210A, expiry date: Mar-2018, route of administration: intramuscular, anatomical location: right deltoid). It was reported that the refrigerator was 40.6F at last night but next morning the temperature was 55F, it was first-time excursion. Overnight the vaccine was at a maximum temperature 55F and it was administered. Follow-up received on 27-Nov-2017: Added gender of the patient, route of administration and anatomical location. The narrative was amended accordingly. Non-significant case correction received with IRD 23-Oct-2017: The narrative was amended accordingly.
Sex: U
Vaccine: FLUC4
Symptoms: Device leakage, Wrong technique in product usage process
Clinical narrative: This non-serious spontaneous case, was initially received on 18-Oct-2017 from other health professional (nurse), concerns a patient of an unspecified age and gender. On 04-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: full dose (as reported), batch number: 195128, expiry date:30-Apr-2018, route of administration, anatomical location: not reported). On 04-Oct-2017, 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 injection air, vial was dripping from the rubber seal. The nurse could withdraw only 7 doses from the vial. The patient was administered with full doses. There were 2 defective units, but the package was not damaged or wet. The nurse used 23 needle gauge of size 3 cc. The PTC (product technical complaint) number provided for was 1025066. Based on the investigation performed, it can be concluded that FLUCELVAX Batch 195128 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified in the manufacturing process, or relating to the vial or stopper components, and no trends were identified for the batch. However, a known trend was identified for the FLUCELVAX batches from the 2017/2018 FLUCELVAX Commercial Season for vials leaking at the stopper during dosing due to air being added to the vial. The most likely root cause can be attributed to improper handling by the user. Follow-up received on 21-Nov-2017: Added PTC number and the QA (quality assurance) report results. Narrative amended accordingly. Non-significant case correction received 18-Oct-2017: The verbatim of the event 'product leakage' was corrected and the lead sentence in narrative was amended.
Sex: U
Vaccine: FLUC4
Symptoms: Device leakage
Clinical narrative: This non-serious spontaneous case, was initially received on 18-Oct-2017 from other health professional, concerns a patient of unspecified age and gender. On 04-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: full dose (as reported), batch number: 195128, expiry date: 30-Apr-2018, route of administration, anatomical location: not reported). It was reported that, after piercing the vial, when it was turned upside down and upon injecting air, vial was dripping from the rubber seal. The nurse could withdraw only 7 doses from the vial. The patient was administered with full dose. There were 2 defective units, but the package was not damaged or wet. The nurse used 23 needle gauge of size 3 cc. The PTC (product technical complaint) number provided for was 1025066. Based on the investigation performed, it can be concluded that FLUCELVAX Batch 195128 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified in the manufacturing process, or relating to the vial or stopper components, and no trends were identified for the batch. However a known trend was identified for the FLUCELVAX batches from the 2017/2018 FLUCELVAX Commercial Season for vials leaking at the stopper during dosing due to air being added to the vial. The most likely root cause can be attributed to improper handling by the user. Follow-up received on 21-Nov-2017: Added PTC number and the QA (quality assurance) report results. New event drug administration error was coded. Narrative amended accordingly. Non-significant case correction received with IRD 18-Oct-2017: The verbatim of the event 'product leakage' was corrected and the lead sentence in narrative was amended.
Age: 33.0
Sex: F
Vaccine: FLUC4
Symptoms: Menstruation delayed, Pregnancy test negative
Clinical narrative: This initial spontaneous case, received from pharmacist on 19-Oct-2017, concerns a 33-year-old, adult, female patient. The patient had no relevant medical history. The patient's concomitant medication included unspecified birth control medication. On 04-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, batch number: 195126, expiry date: Apr-2018 and anatomical location: not reported). On an unspecified date, after the administration of the vaccine, it was reported that, the patient's period was late by 14 days. No treatment was taken for the event. At the time of this report, the outcome of the event was not reported. The reporter assessed the event as non-serious. Follow-up report received on 27-Oct-2017: The patient's initials were updated. The patient's period was late by 14 days. It was reported that, the patient underwent a pregnancy test which was negative. Amended narrative accordingly.
Age: 6.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, was received on 20-Oct-2017 from a pharmacist, concerns a 06-year-old, male child. This refers to 03 out of 04 reports. On 10-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch no: 195216 and expiry date: Apr-2018). It was reported that, the influenza vaccine was left out of the refrigerator for a couple of days and temperature had reached maximum of 72F to 90 hours. The same vaccine was administered to the patient. It was reported that, the patient did not experience any adverse effects after the administration of the vaccine. The reporter assessed the case as non-serious. Significant case correction received on 20-Oct-2017: The event inappropriate age at vaccine administration was deleted. Narrative amended accordingly. Follow up received on 26-Oct-2017: New event (no adverse event) was added. It was reported that, the patient did not experience any adverse effects after the administration of the vaccine. The narrative was amended accordingly. Significant case correction received with IRD 26-Oct-2017: The event 'no adverse event' was deleted.
Sex: U
Vaccine: FLUC4
Symptoms: Device leakage
Clinical narrative: This non-serious spontaneous case, was initially received on 18-Oct-2017 from other health professional (nurse), concerns a patient of an unspecified age and gender. On 09-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: full dose (as reported), batch number: 195128, expiry date: 30-Apr-2018, route of administration, anatomical location: not reported). On 09-Oct-2017, the patient was given vaccine from a vial that leaked. It was reported that, after piercing the vial, when it was turned upside down and upon injection air, vial was dripping from the rubber seal. The nurse could withdraw only 7 doses from the vial. The patient was administered with full dose of vaccine. There were 2 defective units, but the package was not damaged or wet. The nurse used 23 needle gauge of size 3cc. 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 know trend was identified for the FLUCELVAX batches from the 2017/2018 FLUCELVAX Commercial Season for vials leaking at the stopper during dosing due to air being added to the vial. The most likely root cause can be attributed to improper handling by the user. Follow-up received on 21-Nov-2017: Added PTC number and the QA (quality assurance) report results. Narrative amended accordingly. Non-significant case correction received 18-Oct-2017: The verbatim of the event 'product leakage' was corrected and the lead sentence in narrative was amended.
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: This initial spontaneous case, received on 30-Oct-2017, reported by other non-health professional and concerns a female patient of unspecified age. On an unspecified date in mid-October (reported as third week after), the patient was administered with FLUCELVAX QIV(dose: 0.5ml, route of administration: intramuscular, anatomical location: deltoid, batch number: F95225A (as reported), expiry date: not reported). Immediately, after administration of FLUCELVAX QIV, the patient experienced the pain (initial injection was very painful). It was reported that, pain eased up after a couple of days. Reporter stated that, the patient's arm hurt for just over a week and got cured. The outcome of the event was reported as recovered. The reporter assessed the case as non-serious.
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case, initially received on 12-Jan-2017, was reported by a health authority and concerns a female patient. Weight: not provided; Height: not provided. Concomitant medication: not reported. Administration of company suspect drug(s): On an unknown date, the patient received Influenza Virus Vaccine (INN). Dose regimen: Not reported. Route of administration: Not reported. Batch number: Not reported. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the patient experienced right arm pain (outcome: not reported). Linked Case ID(s): US-BEH-2017077575 (same patient). 8-MAR-2017 (System Update): Linked Case ID(s):2017077575 (Patient Link).
Age: 18.0
Sex: F
Vaccine: FLUC4
Symptoms: Asthenia, Immediate post-injection reaction, Nausea
Clinical narrative: The spontaneous case, was initially received on 17-Oct-2017 reported by other non-health professional, concerning a 18-year-old, adult female patient. On 16-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 195212, expiry date: 31-Mar-2018). On the same day, immediately after vaccination, the patient experienced nausea and weakness. The patient went to ER (emergency room) and was treated with IV fluids and unspecified shot. The patient stated that, the reaction was due formaldehyde in the flu vaccine. The outcome of the events was not reported. The reporter assessed this case as non-serious. Significant follow-up received on 30-Oct-2017: The age of the patient was confirmed as 18. The treatment included IV fluids and unspecified shot. Narrative was amended accordingly. Significant case correction received 17-Oct-2017: The listedness of the event nausea was corrected to listed from unlisted.
Sex: M
Vaccine: FLUC4
Symptoms: Product storage error
Clinical narrative: This initial spontaneous case, was received from a other health professional on 17-Nov-2017, concerning a patient of an unspecified age and gender. On 16-Nov-2017, the patient was administrated with FLUCELVAX (TIV) (batch number: 195235, expiry date: May-2018, route of administration, anatomical location: not reported). It was reported that the vaccine reached minimum temperature at 1C for 15 minutes and one vaccine was administered that was stored outside the recommended range (explicitly coded as incorrect product storage and drug administration error). The reporter assessed the events as non-serious.
Age: 78.0
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: Case number PHEH2016US029309 is a spontaneous report initially received from a nurse on 07 Nov 2016. This report refers to 78 year old female patient. Medical history and concomitant medication was not reported. The nurse stated that first temperature excursion of FLUCELVAX QUADRIVALENT on 18 Oct 2016 at 52 Fahrenheit (F) for 1 hour, second excursion of FLUCELVAX QUADRIVALENT on 23 Oct 2016 dropped low 6 times to 34 Fahrenheit (F) and lasted 30 minutes each time. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 186866) at a dose of 0.5 ml in to deltoid, intramuscularly on 25 Oct 2016. Third time excursion on 02 Nov 2016 down to 32 Fahrenheit (F) 3 times over the course of 12 hour. It was unknown if vaccine was frozen. Nurse did not know which lot was given to which patient. Upon follow up it was reported that, the patient was not revaccinated. The excursion occurred at night when the clinic closed. No adverse event was reported from the vaccine following this administration error. The seriousness of the event was reported as non serious. Follow up report received from a nurse on 07 Dec 2016: Added batch number (186866) and vaccination site as deltoid of FLUCELVAX QUADRIVALENT and patient demographics (height, weight), updated seriousness as non serious and reporter's comment.
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This initial spontaneous case, was received from other health professional on 10-Nov-2017, concerning a 59-year-old adult female patient. The patient's medical history and concomitant medications were not reported. On 10-Nov-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: 195129 and expiry date: 01-May-2018). It was reported that, the patient received 2 flu shots in a row, 1st on 09-Nov-2017 (but was not sure) and 2nd on 10-Nov-2017 and no adverse event was reported after the vaccination. The reporter assessed the event as non-serious.
Age: 35.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain in extremity, Pruritus
Clinical narrative: This non-serious initial spontaneous case was received from other Non-health professional on 13-Nov-2017, concerning a 35-year-old, adult, female patient. On an unspecified date in Oct-2017, the patient was administered with FLUCELVAX QIV (dose, route of administration, anatomical location, batch number and expiry date: not reported). On 15-Oct-2017, the patient experienced pain in whole arms down to her wrists. It was reported that the pain lasted for 20 minutes. On the following day, her arms were little bit itchy. The outcome of the events was not reported.
Age: 5.0
Sex: F
Vaccine: FLUC4
Symptoms: Vomiting
Clinical narrative: This initial spontaneous case, was received on 07-Nov-2017, from a consumer, concerning a 05-year-old female child. On 06-Nov-2017, at 17:00 hrs (05:00 pm), the patient was administered with FLUCELVAX QIV (dose: 0.5ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: 195240A and expiry date: unspecified date in Jun 2018). On the same day of vaccination, the patient vomited profusely overnight. On 07-Nov-2017, patient had completely recovered from the event. The reporter assessed this case as non-serious. The causality was assessed as related between the vaccine and event. Follow up report received on 11-Dec-2017: Batch number and expiry date was added. The narrative was amended accordingly.
Age: 41.0
Sex: F
Vaccine: FLUC4
Symptoms: Hypoaesthesia oral
Clinical narrative: This initial spontaneous case, was received from other health professional on 14-Nov-2017, concerning a 41-year-old adult female patient. The patient's medical history and concomitant medications were not reported. On 07-Nov-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, batch number: 195242, expiry date: 01-Jun-2018 and anatomical location: left deltoid). On the same day, after 2 hours of vaccination, the patient experienced numbness in her lips and gums and no treatment was received. At the time of this report, the patient had not yet recovered from the event. The reporter assessed the event as non-serious.
Age: 35.0
Sex: M
Vaccine: FLUC4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This initial spontaneous case, was received from a physician on 07-Nov-2017, concerning a 35-year-old male adult patient. The current conditions included ADD (attention deficit disorder), high blood pressure controlled with diet. The concomitant medications included, ibuprofen and trazodone 50 mg (as reported) for unknown indications. On 07-Nov-2017, the patient administered with FLUCELVAX QIV (dose: 1.5 ml (as reported), route of administration: intramuscular, anatomical location: left deltoid, batch number: 195128, expiry date: Apr-2018) (explicitly coded as extra dose administered). No adverse event was reported. The reporter assessed this case as non-serious.
Age: 31.0
Sex: M
Vaccine: FLUC4
Symptoms: Loss of personal independence in daily activities, Rash generalised
Clinical narrative: This initial spontaneous case was received on 07-Nov-2017, from a consumer, concerning a 31-year-old adult, male patient. The medical history included, the administration of unspecified flu vaccine and development of similar type of rash, 2 years ago. The concomitant medication included multivitamins for an unknown indication. On 17-Nov-2017, at 11:00 hrs, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195250, expiry date: Jun-2018). After 7 to 10 days of administration of vaccine the patient developed full body rash, which has changed the daily life. The patient was treated with CLARITIN after consultation with primary physician. At the time of the report, the patient was recovering from the event. The reporter assessed the event as non-serious and the causality as related.
Age: 33.0
Sex: F
Vaccine: FLUC4
Symptoms: Dysuria, Vulvovaginal swelling
Clinical narrative: This non-serious initial spontaneous case, was received from a Pharmacist on 06-Nov-2017, concerning a 33-year-old, adult female patient. On 31-Oct-2017, the patient was administered with FLUCELVAX QIV (dose:0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 195243, expiry date: Jun-2018). On 01-Nov-2017, after 1 day of vaccination, the patient experienced burning while urination and swelling on one side of her labia. It was reported that, the patient used unspecified medications (not antibiotics) for urinary pain. At the time of this report, the outcome of events was not recovered (still ongoing) and not sure of her recovery (as reported). The reporter assessed the case as non-serious and causality as related to the suspect vaccine. Follow-up report received on 28-Nov-2017: It was reported that, the patient was using unspecified medications (not antibiotics) for urinary pain and not sure of her recovery. Amended narrative accordingly.
Age: 61.0
Sex: M
Vaccine: FLUC4
Symptoms: Dry skin, Hypersensitivity, Injection site bruising, Injection site mass, Rash
Clinical narrative: This initial spontaneous case, was received from other health care professional on 02-Nov-2017, concerning a 61-year-old adult male patient. The patient's medical history and concomitant medications were not reported. On 31-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, anatomical location: left deltoid, route of administration: intramuscular, batch number: 195250, expiry date: 30-Jun-2018). On the same day, after vaccination, patient had an allergic reaction to FLUCELVAX, few minutes later developed a large lump in the area. On 02-Nov-2017, the patient developed bruise where vaccine was administered, rash all over the left side of his body (down left side from left shoulder to left hip as reported). The reporter stated that the lump and bruise was due to hitting an artery there, she did not think that was related to the vaccine. From the symptoms, it was considered as allergic reaction due to the vaccine. The patient was on cold compression as a treatment approximately for 40 minutes for initial lump at the site of injection. From the symptoms, it was considered as allergic reaction due to the vaccine. The rash resolved within one week, but the patient had dry scaly skin where the rash was. The patient was doing fine now. The lump and bruise had also gone away. The reporter considered the causality of the events lump and bruise as not related. The reporter assessed this case as non-serious. Follow up received from the reporter on 29-Nov-2017: Updated outcome of the events injection site lump, bruise and rash generalized, added reporter's comment. Accordingly, updated narrative.
Age: 61.0
Sex: M
Vaccine: FLUC4
Symptoms: Skin exfoliation
Clinical narrative: This initial spontaneous case, was received from other health care professional on 02-Nov-2017, concerning a 61-year-old adult male patient. The patient's medical history and concomitant medications were not reported. On 31-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, anatomical location: left deltoid, route of administration: intramuscular, batch number: 195250, expiry date: 30-Jun-2018). On the same day, after vaccination, patient had an allergic reaction to FLUCELVAX, few minutes later developed a large lump in the area. On 02-Nov-2017, the patient developed bruise where vaccine was administered, rash all over the left side of his body (down left side from left shoulder to left hip as reported). The reporter stated that the lump and bruise was due to hitting an artery there, she did not think that was related to the vaccine. From the symptoms, it was considered as allergic reaction due to the vaccine. The patient was on cold compression as a treatment approximately for 40 minutes for initial lump at the site of injection. From the symptoms, it was considered as allergic reaction due to the vaccine. The rash resolved within one week, but the patient had dry scaly skin where the rash was. The patient was doing fine now. The lump and bruise had also gone away. The reporter considered the causality of the events lump and bruise as not related. The reporter assessed this case as non-serious. Follow up received from the reporter on 29-Nov-2017: Updated outcome of the events injection site lump, bruise and rash generalized, added reporter's comment. Accordingly, updated narrative.
Age: 32.0
Sex: F
Vaccine: FLUC4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This initial non-serious spontaneous case, was received on 18-Oct-2017, from a consumer, concerning 32-year-old adult female patient of 14 weeks pregnancy. The patient had no concomitant medications. On 18-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: Intramuscular, anatomical location, batch number, expiry date: not reported). It was reported that, patient was 14 weeks pregnant and received FLUCELVAX vaccine. The patient had no adverse event. The estimated date of delivery was reported as 17-Apr-2018.
Age: 25.0
Sex: F
Vaccine: FLUC4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This initial spontaneous case received from other non-health professional on 13-Oct-2017, concerning a 25-year-old female pregnant patient. The patient had not significant medical history and concomitant medications were not reported. The subject's last menstrual period date was not reported. The gestation age of the patient was 16 weeks and there was no evidence of defect of adverse findings from prenatal test. No spontaneous abortion/still birth was reported and had no family history or congenital anomaly, as it was the first pregnancy of the patient. It was reported that, the patient did not use any contraceptives. No medications were taken by the patient prior or during the pregnancy. On 13-Oct-2017, at 16 weeks of the gestation age (second trimester) the subject was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number and expiry date: not reported). It was reported that, the patient did not experience any adverse event after receiving the vaccine. The outcome of the event was not reported. It was reported that, the patient was interested to get enrolled in the pregnancy registry. She gave explicit permission for an agent to contact her via phone  or email to enroll in the study and for additional information regarding the registry. The estimated date of delivery was on 30-Mar-2018. It was reported that, there were no adverse reactions experienced by fetus. The reporter assessed this case as non-serious.
Sex: F
Vaccine: FLUC4
Symptoms: Exposure during breast feeding
Clinical narrative: This initial non-serious spontaneous case, received on 09-Oct-2017, reported by other health professional and concerns a female patient of unknown age. Patient's medical history was not reported. On 05-Oct-2017, breast feeding patient received FLUCELVAX QIV (dose: 0.5 ml, expiry date, batch number, route of administration, anatomical location, trade name, manufacturer: not reported). The outcome of the event was not reported.