chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product administered at inappropriate site
Clinical narrative: This spontaneous case, initially received from other non-health professional on 01-Oct-2018, concerns a 42-year-old, adult female patient. The patient had no relevant medical history. The patient had not received any concomitant medications. On 10-Oct-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: subcutaneous, anatomical location: arm, batch number and expiry date: not reported]. The patient felt that the vaccine was administered in the back of the arm and not in the deltoid region. No adverse events were reported after administration of the vaccine. The reporter assessed this case as non-serious. Follow up received from other non-health professional on 30-Oct-2018: The dose (0.5 ml) of the suspect vaccine was added. The narrative was amended accordingly.
Sex: F
Vaccine: FLUC4
Symptoms: Product storage error
Clinical narrative: This spontaneous case, initially received from other health professional (nurse) on 02-Oct-2018, concerning a female patient of an unknown age. The patient had not medical history. The patient did not receive any concomitant medications. Since an unspecified date, an opened multi dose vial (MDV) of FLUCELVAX QIV vaccine was left out of the refrigerator overnight and was exposed to room temperature of 73F for 16 hours, which was first excursion (explicitly coded as incorrect product storage). On 02-Oct-2018, the patient was administered FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, batch number: 252229, expiry date: 31-May-2019 and anatomical location: not reported) which underwent temperature excursion (explicitly coded as drug administration error). The reporter assessed the case as non-serious.
Age: 1.25
Sex: F
Vaccine: FLUC4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: This non-serious spontaneous case, initially received on 01-Oct-2018, reported by a pharmacist, concerning a 1-year-old, female infant patient. On 01-Oct-2018, the patient (under age of 4 years) was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, batch number: 252381, expiry date: 31-May-2019 and anatomical location: not reported).
Age: 61.0
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initial and follow up version are being processed together on 02-Nov-2018 received from other health professional, concerns a 61-year-old, adult female patient. On 28-Sep-2018, FLUCELVAX QIVc was exposed to 9.5 degree Celsius for 2 hours and 43 minutes which was a first-time excursion of the product. The maximum temperature (Tmax) was 9.5 Celsius for 2 hours and 48 minutes. On the same day, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252235, expiry date: 30-Jun-2019] that underwent temperature excursion. No adverse events were reported after the vaccination. Follow-up received from other health professional on 19-Nov-2018: The dose (0.5 ml), route of administration (intramuscular), anatomical location (deltoid) were added in the product tab. The date of vaccination and temperature excursion date (29-Sep-2018) were added in the event tab. The narrative was amended accordingly.
Age: 0.5
Sex: M
Vaccine: FLUC4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: This non-serious spontaneous case, initially received on 29-Nov-2017 from other health professional, concerning a 6 months old male infant patient. The patient's concomitant vaccinations included PEDIARIX, ACTHIB, PREVNAR 13, ROTATEQ and OTC (over-the-counter) gas drops for an unknown indication. On 28-Nov-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left thigh, batch number: 195248, expiry date: 30-Jun-2018). The reporter assessed the event as non-serious. Non-significant case correction received with IRD 29-Nov-2017: The expiry date of the suspect product was changed from Jun-2018 to 30-Jun-2018. Narrative was amended accordingly.
Age: 3.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This non-serious spontaneous case, initially received from other health professional (nurse) on 08-Oct-2018, concerning a 03-year-old male child patient. On 08-Oct-2018, the patient (under age of 4 years) was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 252230 and expiry date: 31-May-2019] (explicitly coded as inappropriate age at vaccine administration). The patient did not experience any adverse events after administration of the vaccine. Follow up received from other health professional (nurse) on 19-Oct-2018: Added patient's gender (male) and date of birth in the patient's tab. Added start date 08-Oct-2018, dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 252230 and expiry date: 31-May-2019 of the product in the product tab. Added onset date 08-Oc-2018 of the event inappropriate age at vaccine administration in the event tab. The narrative and case comment were amended accordingly. Non-significant follow up received from reporter on 12-Nov-2018: No new information was received. Hence, no changes were made in narrative.
Age: 41.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from a pharmacist on 24-Sep-2018, concerning a 41-year-old, elderly patient of an unspecified gender. The patient's medical history and concomitant medications were not available. Since 03-Sep-2018, the refrigerator's temperature fluctuated above 47F and FLUCELVAX QIVc vaccine exposed to temperatures in the range of 47F to 50.9F. On 12-Sep-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number and expiry date: not reported) which underwent temperature excursion. The patient did not experience any adverse drug reaction after the vaccination. The reporter assessed this case as non-serious. This case 201804094 cross-linked to original case 201804076 due to the same reporter. Non-significant follow-up received from the reporter on 14-Nov-2018: Med info number (SEQ18-04086) was updated in the additional information tab. No changes were made in the narrative.
Age: 79.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from a pharmacist on 24-Sep-2018, concerning a 79-year-old, elderly patient of an unspecified gender. The patient's medical history and concomitant medications were not available. Since 03-Sep-2018, the refrigerator's temperature fluctuated above 47F and FLUCELVAX QIVc vaccine exposed to temperatures in the range of 47F to 50.9F. On 07-Sep-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number and expiry date: not reported) which underwent temperature excursion. The patient did not experience any adverse drug reaction after the vaccination. The reporter assessed this case as non-serious. This case 201804089 cross-linked to original case 201804076 due to the same reporter. Non-significant follow-up received from the reporter on 14-Nov-2018: Added Med info number (SEQ18-04086) in the additional information tab. No changes were made in the narrative.
Age: 51.0
Sex: U
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from a pharmacist on 24-Sep-2018, concerning a 51-year-old, adult patient of an unspecified gender. The patient's medical history and concomitant medications were not available. Since 03-Sep-2018, the refrigerator's temperature fluctuated above 47F and FLUCELVAX QIVc vaccine exposed to temperatures in the range of 47F to 50.9F. On 13-Sep-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number and expiry date: not reported] which underwent temperature excursion. The patient did not experience any adverse drug reaction after the vaccination. The reporter assessed the case as non-serious. This case 201804099 cross-linked to original case 201804076 due to the same reporter. Non-significant follow-up received from the reporter on 14-Nov-2018: Added info number (SEQ18-04086) in the additional information tab. No changes were made in the narrative.
Age: 61.0
Sex: F
Vaccine: FLUC4
Symptoms: Product storage error
Clinical narrative: This is a spontaneous case, initially received from other health care professional (nurse) on 28-Sep-2018, concerns a 61-year-old adult, female patient. The patient's medical history and concomitant medications were unknown. Since 27-Sep-2018, 09:00 am to 28-Sep-18, 09:00 am, the one dose of open multi-dose vial (MDV) of vaccine was left out of the refrigerator and room temperature was 20-degree Celsius (explicitly coded as incorrect product storage). On 28-Sep-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, batch no: 252234, expiry date: 30-Jun-2019 and anatomical location: not reported) which underwent temperature excursion (explicitly coded as drug administration error). The nurse inquired that, whether she should revaccinate the patient again, since previous dose of the vaccine had been exposed to temperature excursion. The reporter assessed this case as non-serious.
Sex: F
Vaccine: FLUC4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous case, initially received from other healthcare professional on 27-Sep-2018, concerns a female patient of an unspecified age. On 27-Sep-2018, the patient was administered FLUCELVAX QIVc (dose: 6 ml, route of administration: intramuscular, anatomical location: deltoid, batch number; 252226 and expiry date: 31-May-2019). No adverse event was reported. The reporter assessed the case as non-serious. This case: 201804160 was cross-linked to the case: 201804158 reported by the same reporter. Non-significant follow-up received from the reporter on 03-Nov-2018: No new information was available regarding the patient's age and adverse events. Hence, no changes were done in the narrative.
Sex: F
Vaccine: FLUC4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous case, initially received from other health professional on 27-Sep-2018, concerns a female patient of unspecified age. On 27-Sep-2018, the patient was administered FLUCELVAX QIVc (dose: 1 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252226 and expiry date: 31-May-2019) (explicitly coded as overdose). No adverse event was reported. The reporter assessed the case as non-serious. This case (201804159) was linked to case: 201804158 reported by same reporter. Non-significant follow-up received from the reporter on 03-Nov-2018: No new information was available regarding the patient's age and adverse events. Hence, no changes were done in the narrative.
Age: 44.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received on 31-Aug-2018, from a pharmacist (reporting on himself), 44-year-old, adult male patient. On an unspecified date, the vaccine, FLUCELVAX QIVc underwent temperature excursion (50 F) for 6 hours. On 30-Aug-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, batch number: 252380, expiry date: 31-May-2019, frequency, route of administration and anatomical site: not reported), that underwent temperature excursion. The Seqirus confirmed that, the reported batch number (252380) was of FLUCELVAX QIV PFS NH 18-19. No adverse event was noted. Non-significant follow up received from the reporter on 18-Sep-2018: The reporter confirmed that, the patient was administered with the suspect vaccine on 30-Aug-2018.
Age: 0.5
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous case, initially received on 30-Aug-2018, reported by other health professional (nurse), concerning a 6-months-old, female infant patient. The patient had no medical history. The patient did not receive any concomitant medications. On 29-Aug-2018, the patient (under age of 4 years) was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right vastus lateralis (thigh), batch number: 252380 (reported as 255380) and expiry date: 31-May-2019). It was reported that, there were no complaints of any side effects. The reporter assessed the case as non-serious. Follow-up received from other health professional on 13-Sep-2018: Added route of administration: intramuscular, anatomical location: right vastus lateralis (thigh) and expiry date: 31-May-2019 of suspect vaccine in product tab. The reported batch number (255380) was added in narrative. The narrative was amended accordingly. Update received on 02-Oct-2018: Significant case correction (IRD: 13-Sep-2018): The batch number: 252380 was added in the product tab. The narrative was amended accordingly.
Age: 41.0
Sex: M
Vaccine: FLUC4
Symptoms: Incorrect dose administered
Clinical narrative: This spontaneous case, initially received from other healthcare professional on 05-Sep-2018, concerning a 41-year-old adult male patient. The patient's current conditions included high cholesterol, stroke, hypertension and renal failure (reported as medical history). The patient's concomitant medications included furosemide, MEROPEX, azathioprine, lisinopril, metoprolol, felodipine, amlodipine, calcium, baclofen, hydrazine and Aspirin for unknown indications. On 05-Sep-2018, the patient was accidentally administered with 1.5 ml instead of 0.5 ml dose of FLUCELVAX QIV (expiry date: 31-May-2019, batch number: 252227, route of administration, anatomical location: not reported). The Seqirus confirmed that, the batch number (252227) was a valid FLUCELVAX NH1819 QIV MDV 1X10 batch number. It was reported that, the details of adverse event experienced by the patient after vaccination was not known. The reporter assessed this case as non-serious.
Age: 63.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous case, initially received on 07-Sep-2018, reported by a pharmacist and concerns a 63-year-old adult female patient. The patient's medical history and concomitant medications were not reported. On 07-Sep-2018, the patient received the suspect vaccine FLUCELVAX QIV (dose: 0.5 ml, batch number: 195124, expiry date: 30-Apr-2018, route of administration and anatomical location: not reported). On the same day, the patient also received  the non-company suspect ZOSTAVAX ([reported as SHINGRIX] (dose, route of administration, anatomical location, batch number, expiry date: not reported). It was reported that, the patient was observed for 10 minutes and did not experience any adverse events. This case '201803758' was linked to '201803759' reported by the same reporter. The reporter assessed the case as non-serious.
Age: 44.0
Sex: M
Vaccine: FLUC4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous case, initially received from other health professional (pharmacist), on 12-Oct-2018, concerns a 44-year-old, adult male patient. On 12-Oct-2018, the patient received expired FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 195245 and expiry date: 30-Jun-2018]. No adverse events were reported by the patient after the vaccination. The reporter assessed the case as non-serious. This case '201804447' was linked to case '201804445' due to same reporter. Follow-up received from the pharmacist on 31-Oct-2018: The patient's date of birth and age (44 years) was added in the patient's tab. The batch number (195245) of the product was added in the product tab. The narrative and case comment were amended accordingly.
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous case, initially received from a pharmacist on 12-Oct-2018, concerns a 59-year-old, adult female patient. On 12-Oct-2018, the patient was administered expired suspect vaccine FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 195245 and expiry date: 30-Jun-2018]. No adverse effects were reported by the patient after vaccination. The reporter assessed the case as non-serious. Follow up received from the pharmacist on 31-Oct-2018: Updated patient's date of birth and age (59 years) in the patient's tab. Added batch number (195245) in the product's tab. The narrative was amended accordingly.
Age: 29.0
Sex: F
Vaccine: FLUC4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This non-serious spontaneous case, initially received from other health professional (nurse), on 12-Oct-2018, concerns a 29-year-old, adult female pregnancy patient. On 10-Oct-2018, the pregnant patient was administered an expired suspect vaccine FLUCELVAX QIVc [batch number: 195215, expiry date: 30-Apr-2018, dose, route of administration and anatomical location: not reported]. At the time of this report, no adverse events were reported. This case was linked to case 201804438 due to the same reporter.
Age: 55.0
Sex: M
Vaccine: FLUC4
Symptoms: Needle issue, Underdose
Clinical narrative: This is a spontaneous case, initially received from other health professional on 11-Sep-2018, concerning a 55-year-old, adult, male patient. The patient's medical history and concomitant medication were not available. On 10-Sep-2018, the patient was administered FLUCELVAX QIVc (dose: partial dose, route of administration, anatomical location, batch number, expiry date: not reported). It was reported that, at the moment of administration of vaccine from multi dose vial (MDV), the medical assistant removed the cap, inserted the syringe, pressed the plunger and administered the flu shot, therefore, a part of the vaccine had reached the patient's muscular tissue. Then, with the pressure, the needle was detached and separated from the syringe, and the residual vaccine was lost. The reporter assessed this case as non-serious.
Age: 17.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-spontaneous case, initially received on 19-Mar-2018, was reported by other health professional and concerns a 17-year-old adolescent patient of unspecified gender. It was reported that, on an unspecified date, the temperature of the refrigerator in which vaccine was stored dropped to 32 F and was out of range for a total of 1 hour and continued for 2 weeks. On 08-Feb-2018, the patient was administered FLUCELVAX QIV (dose, route of administration: intramuscular, anatomical location: left deltoid, batch number: 195236, expiry date: 30-May-2018) that was stored out of recommended temperature for an unknown indication. The patient had no adverse reactions from the suspect vaccine that underwent temperature excursion. Non-significant follow-up received on 07-May-2018: Upon internal review, it was realised that the expiry date was incorrect. Hence, the expiry date was changed from 31-May-2018 to 30-May-2018 in the product tab. The reporter confirmed that, the patient had no adverse reactions from the suspect vaccine that underwent temperature excursion. Narrative was amended accordingly.
Age: 11.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received on 19-Mar-2018, was reported by other health professional and concerns a 11-year-old child of an unspecified gender. It was reported that, on an unspecified date, the temperature of the refrigerator in which vaccine was stored dropped to 32 F and was out of range for a total of 1 hour off and on for 2 weeks. On 19-Feb-2018, the patient was administered with FLUCELVAX QIV (dose, route of administration: intramuscular, anatomical location: left deltoid, batch number: 195236, expiry date: 31-May-2018) that was stored out of recommended temperature. The patient had no adverse reactions from the suspect vaccine that underwent temperature excursion. Non-significant follow-up received on 07-May-2018: The reporter confirmed that, the patient had no adverse reactions from the suspect vaccine that underwent temperature excursion. Narrative was amended accordingly. Non-significant case correction received with IRD 19-Mar-2018: The expiry date was changed from 31-May-2018 to 30-May-2018 in the product tab. The narrative was amended accordingly.
Age: 5.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received on 19-Mar-2018, was reported by other health professional and concerns a 05-year-old, child of an unspecified gender. It was reported that, on an unspecified date, the temperature of the refrigerator in which vaccine was stored dropped to 32 F and was out of range for a total of 1 hour off and on for 2 weeks. On 14-Feb-2018, the patient was administered with FLUCELVAX QIV (dose, route of administration: intramuscular, anatomical location: left deltoid, batch number: 195236, expiry date: 30-May-2018) that was stored out of recommended temperature. The patient had no adverse reactions from the suspect vaccine that underwent temperature excursion. Non-significant follow-up received on 07-May-2018: Upon internal review, it was realised that the expiry date was incorrect. Hence, the expiry date was changed from 31-May-2018 to 30-May-2018 in the product tab. The reporter confirmed that, the patient had no adverse reactions from the suspect vaccine that underwent temperature excursion. Narrative was amended accordingly.
Age: 5.0
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from other health professional (nurse) on 30-Apr-2018, concerning a 04-year-old, female child patient. The patient historical condition included anaemia. The patient did not receive any concomitant medications. It was reported that, on 15-Mar-2018, the vaccine underwent temperature excursion of 34.3-degree F for 820 minutes, which was the first temperature excursion. On 18-Apr-2018, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, batch number: 195244, expiry date: 30-Jun-2018 and anatomical location: not reported) which underwent temperature excursion of 34.3 degree F for 820 minutes. It was reported that, patient did not experience any adverse events after the vaccination. The reporter assessed the events as non-serious. This report was cross-linked to case 201801690 reported from the same reporter. Update 08-Jun-2018: Non-significant case correction was performed with IRD 30-Apr-2018: 'Accidental nature of the event' was removed from the case comment and case comment was corrected accordingly.
Age: 7.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received on 19-Mar-2018, was reported by other health professional, concerning a 07-year-old child of unspecified gender. It was reported that, on an unspecified date, the temperature of the refrigerator in which vaccine was stored dropped to 32 F and was out of range for a total of 1 hour off and on for 2 weeks. On 01-Feb-2018, the patient was administered with FLUCELVAX QIV that was stored out of recommended temperature (route of administration: intramuscular, anatomical location: right deltoid, batch number: 195236, expiry date: 30-May-2018, dose: not reported). It was reported that, the patient did not experience any adverse event. Non-significant follow-up received on 07-May-2018: Upon internal review, it was realized that the expiry date was incorrect. Hence, the expiry date was changed from 31-May-2018 to 30-May-2018 in the product tab. The reporter confirmed that, the patient had no adverse reactions from the suspect vaccine that underwent temperature excursion. Narrative was amended accordingly.
Age: 2.0
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous case, initially received from a physician on 22-Oct-2018, concerns a 02-year-old, child female patient. The patient had no relevant medical history. The patient was not taking any medication at the time of vaccination. On 06-Oct-2018, the patient (under age of 4 years) was administered FLUCELVAX QIVc (route of administration: intramuscular, anatomical location: left thigh, batch number: 252664, dose and expiry date: not reported). No treatment measure was taken. At the time of this report, no adverse event was reported after the vaccine administration. The reporter assessed this case as non-serious.
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This is a spontaneous case, initially received from other non-health professional on 26-Oct-2018, concerns a female patient of an unspecified age. On 16-Oct-2018 (reported as last week), the vaccine FLUCELVAX Quadrivalent touched 50F for about 90 minutes. It was the first temperature excursion. On an unspecified date in Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252674 and expiry date: 30-Jun-2019) which had undergone temperature excursion. No adverse event was reported. The reporter assessed the case as non-serious. Follow-up received from the reporter on 13-Nov-2018: The reporter refused to provide the patient's initials. The batch number (252674) and expiry date (30-Jun-2019) was confirmed. The onset date of the event incorrect product storage was updated as 16-Oct-2018. The reporter confirmed that, the patient did not experience any adverse events after vaccination. The narrative was amended accordingly.
Age: 12.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received on 19-Mar-2018, was reported by other health professional and concerns a 12-year-old adolescent child of an unspecified gender. It was reported that, on an unspecified date, the temperature of the refrigerator in which the vaccines were stored, dropped to 32 F and was out of range for a total of 1 hour and on for 2 weeks. On 01-Feb-2018, the patient was administered with FLUCELVAX QIV (route of administration: intramuscular, anatomical location: right deltoid, batch number: 195236, expiry date: 30-May-2018, dose: not reported) that was stored out of recommended temperature. The patient had no adverse reactions from the suspect vaccine that underwent temperature excursion. Non-significant follow-up received on 07-May-2018: Upon internal review, it was realised that the expiry date was incorrect. Hence, the expiry date was changed from 31-May-2018 to 30-May-2018 in the product tab. The reporter confirmed that, the patient had no adverse reactions from the suspect vaccine that underwent temperature excursion. Narrative was amended accordingly.
Age: 0.75
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous case, initially received on 28-Mar-2018 reported by a Pharmacist and concerns a 9-month old infant female patient. Patient's medical history was not reported. On 28-Mar-2018, the patient was administered with FLUCELVAX QIV (dose: 0.5ml, Batch number: 195241, expiry date: 30-Jun-2018, route of administration: intramuscular). The patient was administered with FLUCELVAX QIV inadvertently. No adverse events were noted.
Age: 5.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received on 19-Mar-2018, was reported by other health professional and concerns a 05-year-old child patient of unspecified gender. On an unspecified date, the temperature of the refrigerator in which vaccine was stored dropped to 32 F and was out of range for a total of 1 hour off and on for 2 weeks. On 01-Feb-2018, the patient was administered with FLUCELVAX QIV (route of administration: intramuscular, batch number: 195236, expiry date: 30-May-2018 and anatomical location: right deltoid and dose: not reported) which was stored out of recommended temperature. The reporter was not aware of any adverse event after the vaccination. Non-significant follow-up received on 07-May-2018: Upon internal review, it was realised that the expiry date was incorrect. Hence, the expiry date was changed from 31-May-2018 to 30-May-2018 in the product tab. The reporter confirmed that, the patient had no adverse reactions from the suspect vaccine that underwent temperature excursion. Narrative was amended accordingly.
Age: 4.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received on 19-Mar-2018, was reported by other health professional and concerns a 04-year-old child of an unspecified gender. It was reported that, on an unspecified date, the temperature of the refrigerator in which vaccine was stored dropped to 32 F and was out of range for a total of 1 hour and it continued for 2 weeks (explicitly coded as incorrect product storage). On 05-Feb-2018, the patient was administered with FLUCELVAX QIV (dose, route of administration: intramuscular, anatomical location: left deltoid, batch number: 195236, expiry date: 30-May-2018) that was stored out of recommended temperature for an unknown indication (explicitly coded as drug administration error). The patient had no adverse reactions from the suspect vaccine that underwent temperature excursion. Non-significant follow-up received on 07-May-2018: Upon internal review, it was realized that the expiry date was incorrect. Hence, the expiry date was changed from 31-May-2018 to 30-May-2018 in the product tab. The reporter confirmed that, the patient had no adverse reactions from the suspect vaccine that underwent temperature excursion. Narrative was amended accordingly.
Age: 3.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received on 19-Mar-2018, was reported by other health professional and concerns a 03-year-old, child of unspecified gender. It was reported that, on an unspecified date, the temperature of the refrigerator in which vaccine was stored dropped to 32 F and was out of range for a total of 1 hour off and on for 2 weeks. On 07-Feb-2018, the patient was administered with FLUCELVAX QIV (dose, route of administration: intramuscular, anatomical location: right deltoid, batch number: 195236, expiry date: 31-May-2018) that was stored out of recommended temperature for an unknown indication. No adverse event was reported. Non-significant follow-up received from the reporter on 07-May-2018: The reporter confirmed that, the patient had no adverse reactions from the suspect vaccine that underwent temperature excursion. Narrative was amended accordingly.
Age: 13.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received on 19-Mar-2018, reported by other health professional, concerning a 13-year-old, adolescent patient of unspecified gender. It was reported that, on an unspecified date, the temperature of the refrigerator in which vaccine was stored dropped to 32 F and was out of range for a total of 1 hour off and on for 2 weeks. On 08-Feb-2018, the patient was administered with FLUCELVAX QIV that was stored out of recommended temperature (route of administration: intramuscular, anatomical location: right deltoid, batch number: 195236, expiry date: 30-May-2018, dose: not reported). The patient had no adverse reactions from the suspect vaccine that underwent temperature excursion. Non-significant follow-up received on 07-May-2018: Upon internal review, it was realised that the expiry date was incorrect. Hence, the expiry date was changed from 31-May-2018 to 30-May-2018 in the product tab. The reporter confirmed that, the patient had no adverse reactions from the suspect vaccine that underwent temperature excursion. Narrative was amended accordingly.
Age: 7.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received on 19-Mar-2018, was reported by other health professional and concerns a 07-year-old child of an unspecified gender. It was reported that, on an unspecified date, the temperature of the refrigerator in which vaccine was stored dropped to 32 F and was out of range for a total of 1 hour off and on for 2 weeks. On 08-Feb-2018, the patient was administered with FLUCELVAX QIV (route of administration: intramuscular, anatomical location: right deltoid, batch number: 195236, expiry date: 30-May-2018, dose: not reported) that was stored out of recommended temperature for an unknown indication. The patient had no adverse reactions from the suspect vaccine that underwent temperature excursion. Non-significant follow-up received on 07-May-2018: Upon internal review, it was realized that the expiry date was incorrect. Hence, the expiry date was changed from 31-May-2018 to 30-May-2018 in the product tab. The reporter confirmed that, the patient had no adverse reactions from the suspect vaccine that underwent temperature excursion. Narrative was amended accordingly.
Age: 8.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received on 19-Mar-2018, was reported by other health professional and concerns a 08-year-old child patient of unspecified gender. It was reported that, on an unspecified date, the temperature of the refrigerator in which vaccine was stored dropped to 32 F and was out of range for a total of 1 hour and continued for 2 weeks (explicitly coded as incorrect product storage). On 08-Feb-2018, the patient was administered with FLUCELVAX QIV (route of administration: intramuscular, batch number 195236, expiry date: 30-May-2018 and anatomical location: right deltoid and dose: not reported) which was stored out of recommended temperature (explicitly coded as drug administration error). The patient had no adverse reactions from the suspect vaccine that underwent temperature excursion. Non-significant follow-up received on 07-May-2018: Upon internal review, it was realized that the expiry date was incorrect. Hence, the expiry date was changed from 31-May-2018 to 30-May-2018 in the product tab. The reporter confirmed that, the patient had no adverse reactions from the suspect vaccine that underwent temperature excursion. Narrative was amended accordingly.
Age: 7.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received on 19-Mar-2018, was reported by other health professional and concerns a 07-year-old child of an unspecified gender. It was reported that, on an unspecified date, the temperature of the refrigerator in which the vaccine were stored, dropped to 32 F and was out of range for a total of 1 hour off and on for 2 weeks. On 14-Feb-2018, the patient was administered with FLUCELVAX QIV (dose, route of administration: intramuscular, anatomical location: left deltoid, batch number: 195236, expiry date: 30-May-2018) that was stored out of recommended temperature. The patient had no adverse reactions from the suspect vaccine that underwent temperature excursion. Non-significant follow-up received on 07-May-2018: Upon internal review, it was realised that the expiry date was incorrect. Hence, the expiry date was changed from 31-May-2018 to 30-May-2018 in the product tab. The reporter confirmed that, the patient had no adverse reactions from the suspect vaccine that underwent temperature excursion. Narrative was amended accordingly.
Age: 9.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received on 19-Mar-2018, was reported by other health professional and concerns a 9-year-old, child of an unspecified gender. It was reported that, on an unspecified date, the temperature of the refrigerator in which vaccine was stored dropped to 32F and was out of range for a total of 1 hour off and on for 2 weeks (explicitly coded as incorrect product storage). On 15-Feb-2018, the patient was administered with FLUCELVAX QIV (route of administration: intramuscular, anatomical location: right deltoid, batch number: 195236 expiry date: 30-May-2018, dose: not reported) that was stored out of recommended temperature for an unknown indication (explicitly coded as drug administration error). The patient had no adverse reaction from the suspect vaccine that underwent temperature excursion. Non-significant follow-up received on 07-May-2018: Upon internal review, it was realized that the expiry date was incorrect. Hence, the expiry date was changed from 31-May-2018 to 30-May-2018 in the product tab. The reporter confirmed that, the patient had no adverse reactions from the suspect vaccine that underwent temperature excursion. Narrative was amended accordingly.
Age: 13.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received on 19-Mar-2018, reported by other health professional, concerning a 13-year-old, adolescent patient of an unspecified gender. It was reported that, on an unspecified date, the temperature of the refrigerator in which vaccine was stored dropped to 32 F and was out of range for a total of 1 hour and continued for 2 weeks. On 15-Feb-2018, the patient was administered with FLUCELVAX QIV that was stored out of recommended temperature (route of administration: intramuscular, anatomical location: right deltoid, batch number: 195236, expiry date: 30-May-2018, dose: not reported). The patient had no adverse reactions from the suspect vaccine that underwent temperature excursion. Non-significant follow-up received on 07-May-2018: Upon internal review, it was realised that the expiry date was incorrect. Hence, the expiry date was changed from 31-May-2018 to 30-May-2018 in the product tab. The reporter confirmed that, the patient had no adverse reactions from the suspect vaccine that underwent temperature excursion. Narrative was amended accordingly.
Age: 6.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received on 19-Mar-2018, was reported by other health professional and concerns a 06-year-old child of an unspecified gender. On an unspecified date, the temperature of the refrigerator in which vaccine was stored dropped to 32 F and was out of range for a total of 1 hour and it continued for 2 weeks (explicitly coded as incorrect product storage). On 19-Feb-2018, the patient was administered with FLUCELVAX QIV (dose: not reported, route of administration: intramuscular, anatomical location: right deltoid, batch number: 195236, expiry date: 30-May-2018 that was stored out of recommended temperature for an unknown indication (explicitly coded as drug administration error). The patient had no adverse reactions from the suspect vaccine that underwent temperature excursion. Non-significant follow-up received on 07-May-2018: Upon internal review, it was realized that the expiry date was incorrect. Hence, the expiry date was changed from 31-May-2018 to 30-May-2018 in the product tab. The reporter confirmed that, the patient had no adverse reactions from the suspect vaccine that underwent temperature excursion. Narrative was amended accordingly.
Sex: F
Vaccine: FLUC4
Symptoms: Exposure during pregnancy, Product storage error
Clinical narrative: This spontaneous case, received initially on 19-Mar-2018 was reported by other health professional and concerns a female pregnant patient of unspecified age. The patient's medical history was not reported. On an unspecified date, the patient was administered with FLUCELVAX QIV (dose: 0.5ml, batch number: 195232, expiry date: 31-May-2018, route of administration, anatomical location not reported). It was reported that, the vaccine underwent two temperature excursions, one was at 48F for 15 hours maximum and minimum temperature reached was 35F for 30hours. Possible vaccines were administered. Follow up report received on 09-Apr-2018: Follow-up for this case is not being sought as information is not available". Hence this case is considered as lost to follow up.
Age: 6.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other healthcare professional (nurse) on 27-Mar-2018, concerning a 06-year-old, child, male patient. The patient's medical history and concomitant medications were not reported. On an unspecified date, refrigerator was out of range for about 45 minutes and reached a maximum temperature of 48.6F and vaccine also underwent second temperature excursion. On 22-Mar-2018, the patient was administered with FLUCELVAX QIV (dose: 0.5ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 195235, expiry date: 31-May-2018), which was exposed to 2 temperature excursions. It was reported that, no adverse effects were noted after the vaccination. The report was linked to case 201801298. Follow up report received on 24-Apr-2018: The dose (0.5ml), route of administration (intramuscular), anatomical location (deltoid) of suspect vaccine was added. The narrative was amended accordingly.
Age: 7.0
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received on 27-Mar-2018, was reported by other healthcare professional (nurse) and concerns a 07-year-old, male child. On an unspecified date, refrigerator was out of range for about 45 minutes and reached a maximum temperature of 48.6F. On an unspecified date, vaccine also underwent second temperature excursion (explicitly coded as incorrect product storage). On 22-Mary-2018, the patient was administered with FLUCELVAX QIV (does: 0.5ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 195235, expiry date: 31-May-2018), which underwent temperature excursions twice (explicitly coded as drug administration error). No adverse effects were noted after the vaccination. This report was linked to case 201801297. Non-significant case correction received with IRD 27-Mar-2018: Repetition of narrative was corrected. Follow up report received on 24-Apr-2018: The dose (0.5ml), route of administration (intramuscular), anatomical location (deltoid) of suspect vaccine was added. The narrative was amended accordingly.
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product container issue, Product quality issue, Wrong technique in product usage process
Clinical narrative: This spontaneous case, initially received from other non-health professional on 26-Oct-2018, concerns a female patient of an unspecified age. It was reported that whenever flu vaccine was drawn up, it leaked out from the rubber stopper. One of the nurses noticed when they popped the secured lock off the vial the rubber stopper was dented in and off a little. The nurses advised when they removed the hard cap and stuck the needle in the middle, there was a corner on the top where the rubber stopper was dented in causing a hole where the medication would leak. About 5 doses were drawn out of 10 doses in the vial. The vials leaked and only 4 vials were leaking so far. The doses from the 4 affected MDV that were leaking were administered. On 01-Oct-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252234, expiry date: 30-Jun-2019] from the leaking vial. No adverse events were reported after administration of the vaccine. This case was associated with product quality complaint, hence quality assurance investigation (QAI) had been requested and the corresponding PTC reference number was 1034101. Based on the QA investigation report, it was concluded that FLUCELVAX Batch 252234 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. A known trend was identified for the FLUCELVAX batches from the 2018/2019, FLUCELVAX commercial season for vials leaking at the stopper during dosing. A review revealed that the complainant was adding air to the vial prior to extracting doses and was inverting the vial when withdrawing the needle from the stopper. It is known that the addition of air to the vial can over pressurize the vial and cause leaking. In addition, inverting the vial while trying to extract a dosage can increase the potential for the vial to leak. The root cause for this investigation was found to be user-improper handling. The reporter assessed this case as non-serious. Follow up report received from QA department on 19-Nov-2018: The QA investigation report stated that, the root cause for the leaking FLUCELVAX MDV of Batch 252234 was due to user or improper handling. Added new event (wrong technique in product usage process) in event tab. The narrative was amended accordingly.