chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product container 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 (explicitly coded as product leakage). On 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 (explicitly coded as product closure issue) 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. On 03-Oct-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252234 and expiry date: 30-Jun-2019] from the leaking vial (explicitly coded as drug administration error). No adverse events were reported after administration of the vaccine. This case 201804829 is cross-linked to the original case 201804823 due to the same reporter. This case was associated with product quality complain, 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 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 (explicitly coded as wrong technique in product usage process). 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 leaking FLUCELVAX MDV of Batch 252234 was due to user or improper handling. Added new event (wrong technique in product usage process) in the event tab. The narrative and case comment was amended accordingly.
Age: 66.0
Sex: F
Vaccine: FLUC4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This non-serious spontaneous case, initially received on 09-Oct-2018, reported by other health care professional (nurse) concerning a 66-year-old, elderly, female patient. On 09-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 2 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252233 and expiry date: 31-May-2019). The nurse reported that, she had given the suspect vaccine 3 times over the amount that she was supposed to give the patient. The patient did not experience any adverse events after vaccination. Update received on 02-Nov-2018: Non-significant case correction (09-Oct-2018)- The sentence in the case comment 'company assessed the causality of the event as not related to the suspect vaccine considering the accidental nature of the event as medication error and the causal role of suspect vaccine was unlikely' was replaced with 'The company assessed the causality of the event as not related to the suspect vaccine considering the accidental nature of the event (medication error).' Non-significant follow up received from the reporter on 01-Nov-2018: The nurse confirmed that the patient had not experience any adverse events after vaccination. The 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 spontaneous case, initially received on 09-Apr-2018, was reported by other health professional and concerns a 3-year-old male patient. The patient historical condition included delayed speech prior to vaccination. The patient was not taking any concomitant medications. On 04-Apr-2018, the patient was administered with FLUCELVAX QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: thigh, batch number: 195236, expiry date: 31-May-2018). A 3-year-old male patient received FLUCELVAX QUADRIVALENT. No adverse effects were noted. The reporter assessed the case as non-serious. Non-significant follow-up received from the on 20-Apr-2018: The reporter confirmed that, the patient experienced delayed speech prior to vaccination and no adverse effects were noted. Amended narrative 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 05-year-old, female child patient. The patient had no medical history. 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 case was cross-linked to case 201801689 from same reporter.
Age: 3.0
Sex: F
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, concerns a 03-year-old, female child patient. On 08-Oct-2018, the patient (less than 4 years of age) 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). At the time of this report, no adverse events were reported. This case was linked to original case 201804369 and 201804369 due to the same reporter. Follow-up report received from the reporter on 12-Nov-2018: The reporter confirmed that the patient had not received partial dose of suspect vaccine. Hence, the event under-dose was deleted. The narrative was amended accordingly.
Age: 37.0
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 37-year-old, adult female pregnant. On 10-Oct-2018, the pregnant patient received expired FLUCELVAX QIVc [batch number: 195215 and expiry date: 30-Apr-2018, dose, route of administration, anatomical location: not reported] (explicitly coded as expired vaccine exposure during pregnancy). At the time of this report, no adverse events were reported. Update received on 02-Nov-2018: Non-significant case correction (IRD: 12-Oct-2018): The case comment was corrected from " The company assessed the causality of the event expired vaccine used due to the accidental nature of the event" to "The company assessed the causality of the event expired vaccine uses as not related to suspect vaccine, due to the accidental nature of the event".
Age: 35.0
Sex: F
Vaccine: FLUC4
Symptoms: Paraesthesia
Clinical narrative: This non-serious spontaneous case, initially received from pharmacist on 29-Mar-2018, concerning a 35-year-old, adult, female patient. The patient's medical history and medication history was not reported. On 15-Mar-2018, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195242 and expiry date: 30-Jun-2018). On the same day, about an hour after vaccination, the patient had pins and needles sensation in her left arm. The patient consulted physician but was referred to contact pharmacist. At the time of this report, the patient had not recovered from the event. The reporter assessed this case as non-serious. Follow-up information received from the pharmacist on 19-Apr-2018: The pharmacist stated that the patient did not receive treatment for event initially and she was not aware of the treatment or resolution of event. She added that, there was no permission to contact the patient and hence this report had been considered lost to follow-up.
Age: 70.0
Sex: M
Vaccine: FLUC4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This is a spontaneous case, initially received from other health professional (nurse) on 23-Oct-2018, concerning a 70-year-old, elderly, male patient. The patient's current condition included chronic lymphocytic leukemia (CLL) (reported as medical history) (diagnosed 7 to 10 years ago, as reported). On 23-Oct-2018, the patient was administered expired FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 195215 and expiry date: 30-Apr-2018]. It was reported that the patient would revaccinate. At the time of this report, no adverse event was reported after vaccination. The reporter assessed this case as non-serious. Non-significant follow-up received from the reporter on 26-Nov-2018: The reporter confirmed that the patient was diagnosed with chronic lymphocytic leukaemia (CLL) 7 to 10 years ago. Also, it was confirmed that no adverse event was reported after the administration of expired vaccine. The narrative was amended accordingly.
Age: 62.0
Sex: F
Vaccine: FLUC4
Symptoms: Incorrect dose administered, Needle issue, No adverse event, Product container issue, Product quality issue
Clinical narrative: This is a spontaneous case, initially received from a pharmacist and follow up received (combinedly processed) on 09-Oct-2018, concerns a 62-year-old, adult female patient. The patient's medical history and concomitant medications were not available. It was reported that the needle was attached tightly but the hub seemed loose and kept rotating on the syringe and the syringe leaked during the shot. The vaccine leaked where it attaches to the ridge of the needle, some leaked down the patient's arm. The pharmacist also had a drop or two leaked. The needle used was BD safety glide 25 and there were no signs of damage on the needle. On 09-Oct-2018, the patient was administered a partial dose of FLUCELVAX QIV (dose: reported as less than 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252380 and expiry date: 31-May-2019). 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 1034035. Based on the QA investigation, it was concluded that very unlikely that a LUER-LOK defect was present throughout the inspection and packaging process. AQL inspection, reclassification results, and Brevetti inspection were all completed per procedure and indicate there were no defects during the inspection and packaging process. There are no relevant deviations to the leaking LUER-LOK. There is no indication that relevant equipment malfunctioned or alarmed during the execution of this batch. There is no indication that the LUER-LOK defect originated during the filling or inspection and packaging processes. Therefore, there is no product impact. No CAPA is required following this complaint. This investigation revealed no evident root cause and batch was manufactured in compliance with all approved internal procedures and GMP requirements. The reporter assessed this case as non-serious. Non-significant follow-up received from the reporter on 07-Nov-2018: It was confirmed that, the patient did not experience any adverse event after the vaccine administration. No changes were made in narrative. Follow up report received from QA department on 20-Nov-2018: Based on the QA investigation report, it was concluded that batch was manufactured in compliance with all approved internal procedures and GMP requirements and no LUER-LOK defect originated during the filling or inspection and packaging processes. Hence, no evidence for the root cause was found. The narrative was amended accordingly. Non-significant case amendment (20-Nov-2018): The statement vaccine leaked where it attaches to the ridge of the needle, some leaked down the patient's arm and the pharmacist also had a drop or two leaked was changed to the vaccine leaked where it attaches to the ridge of the needle, some leaked down the patient's arm. The pharmacist reported a drop or two leaked. The narrative was amended accordingly.
Age: 62.0
Sex: F
Vaccine: FLUC4
Symptoms: Syringe issue
Clinical narrative: This is a spontaneous case, initially received from a pharmacist and follow up received (combinedly processed) on 09-Oct-2018, concerns a 62-year-old, adult female patient. The patient's medical history and concomitant medications were not available. It was reported that the needle was attached tightly but the hub seemed loose and kept rotating on the syringe and the syringe leaked during the shot. The vaccine leaked where it attaches to the ridge of the needle, some leaked down the patient's arm. The pharmacist also had a drop or two leaked. The needle used was BD safety glide 25 and there were no signs of damage on the needle. On 09-Oct-2018, the patient was administered a partial dose of FLUCELVAX QIV (dose: reported as less than 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252380 and expiry date: 31-May-2019). 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 1034035. Based on the QA investigation, it was concluded that very unlikely that a LUER-LOK defect was present throughout the inspection and packaging process. AQL inspection, reclassification results, and Brevetti inspection were all completed per procedure and indicate there were no defects during the inspection and packaging process. There are no relevant deviations to the leaking LUER-LOK. There is no indication that relevant equipment malfunctioned or alarmed during the execution of this batch. There is no indication that the LUER-LOK defect originated during the filling or inspection and packaging processes. Therefore, there is no product impact. No CAPA is required following this complaint. This investigation revealed no evident root cause and batch was manufactured in compliance with all approved internal procedures and GMP requirements. The reporter assessed this case as non-serious. Non-significant follow-up received from the reporter on 07-Nov-2018: It was confirmed that, the patient did not experience any adverse event after the vaccine administration. No changes were made in narrative. Follow up report received from QA department on 20-Nov-2018: Based on the QA investigation report, it was concluded that batch was manufactured in compliance with all approved internal procedures and GMP requirements and no LUER-LOK defect originated during the filling or inspection and packaging processes. Hence, no evidence for the root cause was found. The narrative was amended accordingly. Non-significant case amendment (20-Nov-2018): The statement vaccine leaked where it attaches to the ridge of the needle, some leaked down the patient's arm and the pharmacist also had a drop or two leaked was changed to the vaccine leaked where it attaches to the ridge of the needle, some leaked down the patient's arm. The pharmacist reported a drop or two leaked. The narrative was amended accordingly.
Age: 2.0
Sex: U
Vaccine: FLUC4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous case, initially received from pharmacist on 09-Oct-2018, concerns a 2-year-old, child patient of an unspecified gender. On an unspecified date, the patient (under 4 years of age) was administered FLUCELVAX QIVc [dose, batch number, expiry date, route of administration and anatomical location: not reported]. No adverse event was reported after the vaccine administration. The reporter assessed this case as non-serious. Update received on 25-Oct-2018: Significant case correction (IRD: 09-Oct-2018): The report type of the case was changed from 'invalid' to 'valid'.
Age: 3.0
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous case, initially received from the other health professional (pharmacist) on 10-Oct-2018, concerns a 3-year-old, child female patient. The patient had no relevant medical history. On 06-Oct-2018, the patient (under age of 4 years) was administered FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm deltoid, batch number; 252225 and expiry date: 31-May-2019). At the time of this report, the patient did not report any complaints of side effects or adverse reactions. The reporter assessed the case as non-serious.
Age: 27.0
Sex: F
Vaccine: FLUC4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous case, initially received on 09-Oct-2018, reported by other healthcare professional (nurse), concerns a 27-year-old adult female patient. The patient's medical history and concomitant medications were not reported. On 09-Oct-2018, the patient was administered expired FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 195244 and expiry date: 30-Jun-2018). The patient did not experience any adverse event after the vaccination. The reporter assessed this case as non-serious. Non-significant follow-up received from the nurse on 31-Oct-2018: It was reported that, the patient had not experienced any adverse event after vaccination. No changes were made in the narrative.
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product closure issue, Product container issue, Product quality issue, Wrong technique in product usage process
Clinical narrative: This spontaneous case, initially received from other non-health professional (consumer) 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 (explicitly coded as product leakage). 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 (explicitly coded as product closure issue) where 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. 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 (explicitly coded as drug administration error). 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 investigation performed, it can be 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 follow-up revealed the complainant was adding air to the vial prior to extracting doses and was inverting the vial when drawing the needle from the stopper. It is unknown 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 (explicitly coded as wrong technique in product usage process). The reporter assessed this case as non-serious. This case 201804824 was cross-linked with the original case 201804823 due to the same reporter. 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 the event tab. The narrative was amended accordingly.
Age: 40.0
Sex: F
Vaccine: FLUC4
Symptoms: Muscle spasms, Pain
Clinical narrative: This non-serious spontaneous case, initially received from other healthcare professional (nurse) on 11-Oct-2018, concerning a 40-year-old, adult, female patient. The patient had no medical history and concomitant medications. On 10-Oct-2018, the patient was administered FLUCELVAX QIVc [batch number: 252663, expiry date: 31-May-2019, dose, route of administration and anatomical location: not reported]. On the same day, after vaccination, the patient experienced body aches all the night and nothing helped (as reported), and the patient developed a giant cramp from head to toe which remained still painful. At the time of this report, the patient had not recovered from the events.
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product closure issue, 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. 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 201804825 is cross-linked to the original case 201804823 due to the same reporter. This case was associated with product quality complaint, hence quality assurance investigation (QAI) had been requested and the corresponding product technical complaint (PTC) reference number was 1034101. Based on the investigation performed, 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 follow-up revealed 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 was 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.
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product closure issue, 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 struck 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. On 02-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. This case 201804826 was cross-linked with the original case 201804823 due to the same reporter. 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.
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product closure issue, 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. On 05-Oct-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252234 and expiry date: 30-Jun-2019] from the leaking vial. No adverse events were reported after administration of the vaccine. This case 201804831 is cross-linked to the original case: 201804823, reported by the same reporter. This case was associated with product quality complaint, hence quality assurance investigation (QAI) had been requested and the corresponding PTC reference number was 1034101. This case was associated with product quality complaint, hence quality assurance investigation (QAI) had been requested and the corresponding PTC reference number 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 in the event tab. The narrative and case comment were amended accordingly.
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product closure issue, 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. On 02-Oct-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252234 and expiry date: 30-Jun-2019] from the leaking vial. No adverse events were reported after administration of the vaccine. This case 201804827 is linked to the original case 201804823 due to the same reporter. 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 was 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 the event tab. The narrative was amended accordingly.
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product closure issue, 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 (explicitly coded as product leakage). 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 (explicitly coded as product closure issue) 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. On 03-Oct-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location:deltoid, batch number: 252234 and expiry date: 30-Jun-2019] from the leaking vial (explicitly coded as drug administration error). 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. Bases 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. The 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 (explicitly coded as wrong technique in product usage process). The reporter assessed this case as non-serious. This case is linked to 201804823 due to the same reporter. 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.
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product closure issue, Product container issue, Product quality issue, Wrong technique in product usage process
Clinical narrative: This is a spontaneous case, initially received from other non-health professional on 26-Oct-2018, concerning 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 of 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. On 05-Oct-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252234 and expiry date: 30-Jun-2019] from the leaking vial. No adverse events were reported after administration of the vaccine. This case is linked to 201804823, due to the same reporter. 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 vail and cause leaking. In addition, inverting the vial while trying to extract a dosage can increase 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 and the case comment were amended accordingly.
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product closure issue, Product container issue, Product quality issue, Wrong technique in product usage process
Clinical narrative: This is a spontaneous case, initially received from other non-health professional on 26-Oct-2018, concerning 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 of 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. On 05-Oct-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252234 and expiry date: 30-Jun-2019] from the leaking vial. No adverse events were reported after administration of the vaccine. This case 201804830 is cross-linked to 201804823, due to the same reporter. 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 was 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 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.
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product closure issue, 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. On 05-Oct-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252234 and expiry date: 30-Jun-2019] from the leaking vial. No adverse events were reported after administration of the vaccine. This case: 201804833 is linked to the original case 201804823 due to the same reporter. 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 was 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 the event tab. The narrative was amended accordingly.
Age: 61.0
Sex: M
Vaccine: FLUC4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous case, initially received from other health professional (nurse) on 19-Oct-2018, concerning a 61-year-old, adult male patient. The patient had no relevant medical history and had not received any concomitant medications. On 19-Oct-2018, the patient was administered an expired vaccine FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 195250 and expiry date: 30-Jun-2018]. No adverse events were reported after administration of the vaccine. The reporter assessed this case as non-serious. This case 201804701 was cross-linked with the original case 201804702 due to the same reporter. Non-significant follow up received from other health professional on 03-Nov-2018: The reporter was not aware whether the patient experience any adverse effects or not. No changes were made in the narrative.
Age: 2.0
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This non-serious spontaneous case, initially received on 19-Oct-2018, reported by other health professional (nurse), concerning a 2-year-old, female child patient. On 08-Oct-2018, the patient (less than 4 years of age) 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]. At the time of this report, no adverse events were reported. This case was linked to original case 201804369 and 201804369 due to the same reporter. Follow-up report received from the reporter on 12-Nov-2018: The reporter confirmed that the patient had not received partial dose of suspect vaccine. Hence, the event under-dose was deleted. The narrative was amended accordingly.
Age: 60.0
Sex: F
Vaccine: FLUC4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous case, initially received from other health professional (nurse) on 19-Oct-2018, concerns a 60-year-old, adult female patient. The patient had no relevant medical history. The patient was not taking any medication at the time of vaccination. On 19-Oct-2018, the patient was administered expired FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 195250 and expiry date: 30-Jun-2018). At the time of this report, no adverse events were reported. The reporter assessed this case as non-serious. Non-significant follow up received from other health professional on 03-Nov-2018: The reporter confirmed that the patient did not experience any adverse effects after vaccination. No changes were done in the narrative.
Age: 51.0
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from other health professional on 24-Oct-2018, concerns a 51-year-old, adult female patient. It was reported that due to power outage, there was a first temperature excursion with the FLUCELVAX QIVc and the maximum temperature reached to 56.3F for approximately 2 hours and 52 minutes. On 02-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, batch number: 252227, expiry date: 31-May-2019 and anatomical location: right deltoid] which underwent temperature excursion. It was reported that, the patient did not experience any adverse effects after vaccination. The reporter assessed this case as non-serious. Follow-up received from other health professional on 22-Nov-2018: The reporter confirmed that, the patient didn't experience any additional adverse reactions after administration of the vaccine. The anatomical location was updated from unknown to right deltoid. The narrative was amended accordingly.