chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: FLUC4
Symptoms: Device leakage, Product closure issue, Wrong technique in product usage process
Clinical narrative: This is a spontaneous case, initially received from other non-health professional on 14-Nov-2018, concerning a male patient of unspecified age. It was reported that, whenever the flu vaccine was withdrawn, the vaccine leaked out from the rubber stopper (explicitly coded as product leakage). As the secured lock was popped off the vial the rubber stopper was dented in and off a little (explicitly coded as product closure issue). It was reported that, when the nurses 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 leaked. On 01-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 leaked vial (explicitly coded as drug administration error). There were only 5 doses left out of the 10 doses in the vial. It was reported that sample vials were available in which they had one opened vial and 46 left. The package was not damaged, but the rubber stopper was damaged. From the withdrawal of first vaccine, the leakage was observed. The needle used was 25-guage needle and the syringe were 3 ml syringe. The user had added air to the vial from the syringe. At the time of this report, no adverse event was reported. 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 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 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 the 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: Exposure during pregnancy
Clinical narrative: This is a non-serious spontaneous case, initially received from other non-health professional (reporting on herself) on 12-Jan-2018, concerning a 14 weeks 5 days pregnant female patient of unspecified age. The patient's medical history and concomitant medication was not reported. On an unspecified date, the pregnant female patient was administered with FLUCELVAX QIV (dose, route of administration, anatomical location, batch number and expiry date: not reported). The outcome of the event was not reported.
Age: 71.0
Sex: U
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 71-year-old, elderly patient of an unspecified gender. it was reported that, the FLUCELVAX QIVc vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 16-Oct-2018, the patient was administered FLUCELVAX QIVc [route of administration: intramuscular, anatomical location: left deltoid, batch number: 252230, expiry date: 31-May-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805466 was crossed linked to original case 201804863 due to same reporter.
Age: 69.0
Sex: F
Vaccine: FLUC4
Symptoms: Hypoaesthesia, Pain in extremity, Skin discolouration, Vomiting
Clinical narrative: This is a spontaneous case initially received from the other non-health professional (consumer) on 13-Nov-2018, concerning a 69-year-old, elderly female patient. The patient's current conditions included thyroid, reflux, high blood pressure which was under control and allergy to thiomersal (reported as medical history). The patient's concomitant medication included Propranolol, lisinopril, diazepam, Levothyroxine, omeprazole, Vitamin D and baclofen for unknown indications. On 19-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252656 and expiry date: 31-May-2019). On the same day after vaccination, the patient started vomiting profusely. The patient had to take a bag to her room as she could not even make it through the bathroom. The patient administered suppository of promethazine, which did not help much. On 20-Oct-2018, one day after the vaccination, the patient experience soreness and numbness (reported as sore and numb) in arm. The patient when had a look to it, she had a huge black mark (not black blue, but black). The patient developed a tiny mark (it was not even symmetrical, dark coloured pink). The outcome of the event vomiting was recovered on 21-Oct-2018. The outcome of the event sore and numb arm was not reported. The outcome of the event skin discoloration was not recovered. The reporter assessed the case as non-serious.
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This is a non-serious spontaneous case, initially received from a physician on 30-Oct-2018, concerning a male patient of unspecified age. On an unspecified date, the FLUCELVAX QIVc (multi dose vial) MDV vaccine underwent first temperature excursion for 2 hours, reaching a minimum temperature of 34-degree Fahrenheit. On an unspecified date, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252225 and expiry date: 31-May-2019] which underwent temperature excursion. The patient did not experience any adverse events after the vaccination.
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 14-Nov-2018, concerning a female patient of unspecified age. On an unspecified date, the FLUCELVAX QIVc vaccine underwent first temperature excursion with maximum temperature (Tmax) 8.2 degree Celsius for 4 minutes. On 22-Oct-2018, vaccine underwent second temperature excursion with Tmax 9.8 degree Celsius for 23 minutes. On an unspecified date, two temperature excursions were identified after an audit. On 26-Oct-2018, the patient was inadvertently administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: 252672 and expiry date:30-Jun-2019) which underwent temperature excursion. The patient did not experience any adverse effect after the vaccination. This case is linked to 201805262 (same reporter).
Age: 35.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This is a spontaneous case, initially received from the other health professional (nurse) on 07-Nov-2018, concerning a 35-year-old, adult, male patient. On an unspecified date, the vaccines were stored in the refrigerator and eventually a temperature drop was noted for a moment up to plus 0.3 Celsius for less than 115 minutes, which was considered as first temperature excursion. It was reported that the vaccines were moved immediately. On 26-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, batch number: 252227, expiry date: 31-May-2019, route of administration: intramuscular and anatomical location: left deltoid) which underwent temperature excursion The patient did not experience any adverse reactions. This case is linked to case 201805327 owing to same reporter. The reporter assessed this case as non-serious. Follow-up report received from other health profession on 28-Nov-2018: The patient's age (35-year-old) was added. The route of administration (intramuscular) and anatomical location (left deltoid) of suspect vaccine were added in the product tab. The reporter confirmed that, the patient did not experience any adverse reactions. The narrative and case comment were amended accordingly.
Age: 2.0
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This is a spontaneous case, initially received from other health professional on 09-Nov-2018, concerning a 02-year-old, female child. The patient had no medical history and did not take any other vaccine or medication at the time of vaccination. On 04-Oct-2018, the patient (under the age of 4 years) was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular and anatomical location: deltoid, batch number: 252235, expiry date: 30-Jun-2019). At the time of this report, no adverse event was reported, but the patient was being monitored. This case is linked to case: 201805300 (same reporter). The reporter assessed the case as non-serious.
Age: 78.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 78-year-old, elderly patient of an unspecified gender. It was reported that, the FLUCELVAX QIVc vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degrees Celsius. On 22-Oct-2018, the patient was administered FLUCELVAX QIVc [route of administration: intramuscular, anatomical location: left deltoid, batch number 252230, expiry date: 31-May-2018 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805432 was crossed linked to original cases 201804863 due to same reporter.
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 14-Nov-2018, concerning a female patient of unspecified age. On an unspecified date, the FLUCELVAX QIVc vaccine underwent first temperature excursion with maximum temperature (Tmax) 8.2 degree Celsius for 4 minutes. On 22-Oct-2018, vaccine underwent second temperature excursion with Tmax 9.8 degree Celsius for 23 minutes. On an unspecified date, two temperature excursions were identified after an audit. On 24-Oct-2018, the patient was inadvertently administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 252672 and expiry date: 30-Jun-2019) which underwent temperature excursion. The patient did not experience any adverse effect after the vaccination. This case is linked to 201805262 (same reporter).
Age: 75.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 75-year-old, elderly patient of an unspecified gender. It was reported that, the FLUCELVAX QIVc vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours it reached 11.6 degree Celsius. On 16-Oct-2018, the patient was administered FLUCELVAX QIVc [route of administration: intramuscular, anatomical location: right deltoid, batch number: 252230, expiry date: 31-May-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805468 was crossed linked to original cases 201804863 due to same reporter.
Age: 58.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This is a spontaneous case, initially received from other health professional on 14-Nov-2018, concerning a 58-year-old, adult, male patient. The patient had no medical history. The patient did not receive any concomitant medications or vaccines. On an unspecified date, the FLUCELVAX QIVc underwent first temperature excursion with maximum temperature (Tmax) 72 Fahrenheit for up to 11 hours. On 14-Nov-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252676 and expiry date: 30-Jun-2019) which underwent temperature excursion. It was reported that, the patient was monitored. At the time of this report, no adverse event was reported. The reporter assessed the case as non-serious.
Age: 70.0
Sex: U
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 70-year-old, elderly patient of an unspecified gender. It was reported that, FLUCELVAX QIVc vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 15-Oct-2018, the patient was administered FLUCELVAX QIVc [route of administration: intramuscular, anatomical location: left deltoid, batch number: 252230, expiry date: 31-May-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805478 was crossed linked to original case 201804863 due to same reporter.
Age: 75.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 75-year-old, elderly patient of an unspecified gender. It was reported that, the FLUCELVAX QIVc vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 23-Oct-2018, the patient was administered FLUCELVAX QIVc [route of administration: intramuscular, anatomical location: left deltoid, batch number: 252230, expiry date: 30-Apr-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805411 was crossed linked to original cases 201804863 due to same reporter.
Age: 30.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This is a spontaneous case, initially received from the other health professional (nurse), concerns a 30-year-old, adult male patient. On an unspecified date, the vaccines were stored in the refrigerator and eventually a temperature drop was noted for a moment up to plus 0.3 Celsius for less than 115 minutes, which was considered as first temperature excursion. It was reported that the vaccines were moved immediately. On 26-Oct-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: 2227 and expiry date: 31-May-2019] which underwent temperature excursion. The patient did not experience any adverse reactions after vaccination. The reporter assessed this case as non-serious. This case (201805346) was cross-linked to case 201805327 due to same reporter. Follow-up report received from reporter on 28-Nov-2018: The age of the patient, route of administration (intramuscular), anatomical location (right deltoid) were added. The reporter confirmed that the patient did not experience any adverse reactions. The narrative and case comment were amended accordingly.
Age: 3.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This is a spontaneous case, initially received from other health professional (nurse) on 06-Nov-2018, concerning a 46-month-old (reported as 3 years 10 months), male child. The patient's current condition included allergies. The patient's concomitant medication included ZYRTEC for an unknown indication. On 05-Nov-2018, the patient (under 4 years) was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, batch number: 252680, expiry date: 30-Jun-2019 and anatomical location: not reported). At the time of this report, the patient had not reported any adverse events and was being monitored for side-effects and adverse effects. The reporter assessed the case as non-serious.
Age: 60.0
Sex: F
Vaccine: FLUC4
Symptoms: Butterfly rash, Immediate post-injection reaction, Rash
Clinical narrative: This is a spontaneous case initially received from the pharmacist on 08-Nov-2018, concerning a 60-year-old, adult female patient. On 03-Nov-2018, the patient 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). On the same day after the vaccination, the patient experienced rash in the middle of her face in the nose area which was radiating from the nose in the shape of a butterfly, one to two inches. The patient's husband noticed it immediately after the shot. The patient did not receive any treatment measure associated with the event. At the time of this report, the patient had not recovered from the event (reported as ongoing). The reporter assessed the case as non-serious.
Age: 1.83
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This is a spontaneous case, initially received from other health professional (nurse) on 06-Nov-2018, concerning a 22-months-old, male infant. The patient's current condition included asthma. The patient's concomitant medication included SINGULAR for an unknown indication. On 05-Nov-2018, the patient (under 4 years) was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: thigh, batch number: 252680, expiry date: 30-Jun-2019). At the time of this report, the patient had not reported any adverse events and was being monitored for side-effects and adverse effects. This case is linked to 201805283, due to same reporter. The reporter assessed this case as non-serious.
Age: 2.0
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This is a spontaneous case, initially received from other non-health professional on 08-Nov-2018, concerning a 34-months-old, female child. The patient had no medical history and did not receive any concomitant medications. On 31-Oct-2018, the patient (under 4 years of age) was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252232 and expiry date: 31-May-2019). At the time of this report, the patient did not experience any adverse events. The reporter assessed the case as non-serious.
Sex: M
Vaccine: FLUC4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This is a non-serious spontaneous case, initially received from other health professional (nurse) on 09-Nov-2018, concerning a patient of unspecified age and gender. On 09-Nov-2018, the patient was administered expired FLUCELVAX QIVc [batch number: 195129, expiry date: 31-May-2018, dose, route of administration and expiry date: not reported]. At the time of this report, no adverse event was reported.
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-Nov-2018, concerning a 3-year-old, child patient of unspecified gender. On an unspecified date, the patient (under age of 4 years) was administered FLUCELVAX QIVc (dose, route of administration, anatomical location, batch number and expiry date: not reported). At the time of this report, no adverse event was reported.
Age: 63.0
Sex: F
Vaccine: FLUC4
Symptoms: Asthenia, Diarrhoea, Nausea, Pyrexia, Vomiting
Clinical narrative: This is a spontaneous case initially received from the other health professional on 07-Nov-2018, concerning a 63-year-old, adult female patient. The patient was allergic to mold and reacts to PPD. The patient did not receive any concomitant medications. On 05-Nov-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252678 and expiry date: 30-Jun-2019). On an unspecified date in Nov-2018 (started approximately 60 hours), the patient experienced diarrhoea, weakness, nausea, vomiting and fever over 100-degree Fahrenheit. The patient had already lost 4 pounds. The patient did not receive any treatment for the events. On an unspecified date, the patient made an emergency room visit. On an unspecified date in Nov-2018, the patient had recovered from the events diarrhoea (stopped at 6 am), nausea, vomiting (last time at 4:30 am) and fever. The patient had not recovered from the event weakness. The outcome of the event weight decreased was not reported. The reporter assessed the case as non-serious.
Age: 63.0
Sex: F
Vaccine: FLUC4
Symptoms: Weight decreased
Clinical narrative: This is a spontaneous case initially received from the other health professional on 07-Nov-2018, concerning a 63-year-old, adult female patient. The patient was allergic to mold and reacts to PPD. The patient did not receive any concomitant medications. On 05-Nov-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252678 and expiry date: 30-Jun-2019). On an unspecified date in Nov-2018 (started approximately 60 hours), the patient experienced diarrhoea, weakness, nausea, vomiting and fever over 100-degree Fahrenheit. The patient had already lost 4 pounds. The patient did not receive any treatment for the events. On an unspecified date, the patient made an emergency room visit. On an unspecified date in Nov-2018, the patient had recovered from the events diarrhoea (stopped at 6 am), nausea, vomiting (last time at 4:30 am) and fever. The patient had not recovered from the event weakness. The outcome of the event weight decreased was not reported. The reporter assessed the case as non-serious.
Age: 37.0
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case received, initially received from the other health professional (nurse) on 07-Nov-2018, concerns a 37-year-old, adult female patient. On an unspecified date, the vaccines were stored in the refrigerator and eventually a temperature drop was noted for a moment up to plus 0.3 Celsius for less than 115 minutes, which was considered as first temperature excursion. It was reported that the vaccines were moved immediately. On 26-Oct-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 252227 and expiry date: 31-May-2019] which underwent temperature excursion. The patient did not experience any adverse reactions after the vaccination. The reporter assessed this case as non-serious. Follow-up report received from other health professional on 28-Nov-2018: The age of the patient (37-year-old), route of administration (intramuscular), anatomical location (left deltoid) of suspect vaccine were added. The reporter confirmed that, the patient did not experience any adverse reactions. The narrative and case comment was amended accordingly.
Age: 39.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case received, initially received from the other health professional (nurse) on 07-Nov-2018, concerns a 39-year-old, adult, male patient. On an unspecified date, the vaccines were stored in the refrigerator and eventually a temperature drop was noted for a moment up to plus 0.3 Celsius for less than 115 minutes, which was considered as first temperature excursion. It was reported that the vaccines were moved immediately. On 26-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 252227 and expiry date: 31-May-2019) which underwent temperature excursion. No adverse events were reported after the vaccine administration. The reporter assessed this case as non-serious. Follow-up report received from other health profession on 28-Nov-2018: The patient's age (39-year-old) was added. The route of administration (intramuscular) and anatomical location (left deltoid) of suspect vaccine were added in the product tab. The reporter confirmed that, the patient did not experience any adverse reactions. The narrative and case comment were amended accordingly.
Age: 34.0
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from the other health professional (nurse) on 07-Nov-2018, concerns a 34-year-old adult female patient. On an unspecified date, the vaccines were stored in the refrigerator and eventually a temperature drop was noted for a moment up to plus 0.3 Celsius for less than 115 minutes, which was considered as first temperature excursion. It was reported that the vaccines were moved immediately. On 26-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 252227 and expiry date: 31-May-2019) which underwent temperature excursion. No adverse events were reported after the vaccine administration. The reporter assessed this case as non-serious. This case 201805330 was cross linked to source case 201805327 due to same reporter. Follow-up report received from other health profession on 28-Nov-2018: The patient's age (34-year-old) was added. The route of administration (intramuscular) and anatomical location (left deltoid) of suspect vaccine were added in the product tab. The reporter confirmed that the patient did not experience any adverse reactions. The narrative and case comment were amended accordingly.
Age: 62.0
Sex: M
Vaccine: FLUC4, FLUC4, FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from the other health professional (nurse) on 07-Nov-2018, concerns a 62-year-old, adult male patient. On an unspecified date, the vaccines were stored in the refrigerator and eventually a temperature drop was noted for a moment up to plus 0.3 Celsius for less than 115 minutes, which was considered as first temperature excursion. It was reported that the vaccines were moved immediately. On 26-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 252227 and expiry date: 31-May-2019) which underwent temperature excursion. The patient did not experience any adverse reactions after the vaccination. The reporter assessed this case as non-serious. This case 201805331 is cross linked to source case 201805327 due to same reporter. Follow-up report received from other health profession on 28-Nov-2018: The patient's age (62-year-old) was added. The route of administration (intramuscular) and anatomical location (left deltoid) of suspect vaccine were added in the product tab. The reporter confirmed that, the patient did not experience any adverse reactions. The narrative and case comment were amended accordingly.
Age: 62.0
Sex: M
Vaccine: FLUC4, FLUC4, FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This is a spontaneous case, initially received from the other health professional (nurse) on 07-Nov-2018, concerning a 62-year-old, adult, male patient. On an unspecified date, the vaccines were stored in the refrigerator and eventually a temperature drop was noted for a moment up to plus 0.3 Celsius for less than 115 minutes, which was considered as first temperature excursion. It was reported that the vaccines were moved immediately. On 26-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, batch number: 252227, expiry date: 31-May-2019, route of administration: intramuscular and anatomical location: left deltoid) which underwent temperature excursion. The patient did not experience any adverse reactions after the vaccination. The reporter assessed this case as non-serious. This case is linked to case 201805327 owing to same reporter. Follow-up report received from other health profession on 28-Nov-2018: The patient's age (62-year-old) was added. The route of administration (intramuscular) and anatomical location (left deltoid) of suspect vaccine were added in the product tab. The reporter confirmed that, the patient did not experience any adverse reactions. The narrative and case comment were amended accordingly.
Age: 62.0
Sex: M
Vaccine: FLUC4, FLUC4, FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This is a spontaneous case, initially received from the other health professional (nurse) on 07-Nov-2018, concerns a 62-year-old, adult male patient. On an unspecified date, the vaccines were stored in the refrigerator and eventually a temperature drop was noted for a moment up to plus 0.3 Celsius for less than 115 minutes, which was considered as first temperature excursion. It was reported that the vaccines were moved immediately. On 26-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 252227 and expiry date: 31-May-2019) which underwent temperature excursion. The patient did not experience any adverse reactions. The reporter assessed this case as non-serious. This case (201805335) was cross-linked to original case 201805327 due to same reporter. Follow-up report received from other health profession on 28-Nov-2018: The patient's age (62-year-old) was added. The route of administration (intramuscular) and anatomical location (left deltoid) of suspect vaccine were added in the product tab. The reporter confirmed that, the patient did not experience any adverse reactions. The narrative and case comment were amended accordingly.
Age: 66.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 66-year-old, elderly patient of an unspecified gender. It was reported that, the FLUCELVAX QIVc vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6-degree Celsius. On 23-Oct-2018, the patient was administered FLUCELVAX QIVc [route of administration: intramuscular, anatomical location: left deltoid, batch number: 252230, expiry date: 31-May-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805412 was crossed linked to original cases 201804863 due to same reporter.
Age: 47.0
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from the other health professional (nurse) on 07-Nov-2018, concerns a 47-year-old adult female patient. On an unspecified date, the vaccines were stored in the refrigerator and eventually a temperature drop was noted for a moment up to plus 0.3 Celsius for less than 115 minutes, which was considered as first temperature excursion. It was reported that the vaccines were moved immediately. On 26-Oct-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 252227 and expiry date: 31-May-2019] which underwent temperature excursion. The patient did not experience any adverse reactions after vaccination. The reporter assessed this case as non-serious. This case (201805333) was cross-linked to case 201805327 due to same reporter. Follow-up report received from other health profession on 28-Nov-2018: The patient's age (47-year-old adult) was added. The route of administration (intramuscular) and anatomical location (left deltoid) of suspect vaccine were added in the product tab. The reporter confirmed that, the patient did not experience any adverse reactions. The narrative and case comment were amended accordingly.
Age: 70.0
Sex: U
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 70-year-old, elderly patient of an unspecified gender. It was reported that, the FLUCELVAX QIVc vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6-degree Celsius. On 16-Oct-2018, the patient was administered FLUCELVAX QIVc [route of administration: intramuscular, anatomical location: left deltoid, batch number: 252230, expiry date: 31-May-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805461 was crossed linked to the original cases 201804863 due to same reporter.
Age: 46.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case received, initially received from the other health professional (nurse) on 07-Nov-2018, concerns a 46-year-old, adult, male patient. On an unspecified date, the vaccines were stored in the refrigerator and eventually a temperature drop was noted for a moment up to plus 0.3 Celsius for less than 115 minutes, which was considered as first temperature excursion. It was reported that the vaccines were moved immediately. On 26-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, batch number: 252227, expiry date: 31-May-2019, route of administration: intramuscular and anatomical location: left deltoid) which underwent temperature excursion. The patient did not experience any adverse reactions after the vaccination. The reporter assessed this case as non-serious. This case (201805334) was cross-linked to case 201805327 due to same reporter. Follow-up report received from other health profession on 28-Nov-2018: The patient's age (46-year-old) was added. The route of administration (intramuscular) and anatomical location (left deltoid) of suspect vaccine were added in the product tab. The reporter confirmed that, the patient did not experience any adverse reactions. The narrative and case comment were amended accordingly.
Age: 51.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 51-year-old, adult patient of an unspecified gender. It was reported that, the FLUCELVAX QIVc vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 17-Oct-2018, the patient was administered FLUCELVAX QIVc [route of administration: intramuscular, anatomical location: left deltoid, batch number: 252230, expiry date: 31-May-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805452 was cross linked to original case 201804863 due to same reporter.
Age: 51.0
Sex: U
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from the other health professional (nurse) on 07-Nov-2018, concerns a 51-year-old, adult patient of unspecified gender. On an unspecified date, the vaccines were stored in the refrigerator and eventually a temperature drop was noted for a moment up to plus 0.3 Celsius for less than 115 minutes, which was considered as first temperature excursion. It was reported that the vaccines were moved immediately. On 26-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: 252227 and expiry date: 31-May-2019) which underwent temperature excursion. The patient did not experience any adverse reactions after vaccination. The reporter assessed this case as non-serious. This case (201805336) was cross-linked to original case 201805327 due to same reporter. Follow-up report received from other health profession on 28-Nov-2018: The patient's age (51-year-old) was added. The route of administration (intramuscular) and anatomical location (right deltoid) of suspect vaccine were added in the product tab. The reporter confirmed that, the patient did not experience any adverse reactions. The narrative and case comment were amended accordingly.
Age: 36.0
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This is a spontaneous case, initially received from the other health professional (nurse) on 07-Nov-2018, concerns a 36-year-old, adult female patient. On an unspecified date, the vaccines were stored in the refrigerator and eventually a temperature drop was noted for a moment up to plus 0.3 Celsius for less than 115 minutes, which was considered as first temperature excursion. It was reported that the vaccines were moved immediately. On 26-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 252227 and expiry date: 31-May-2019) which underwent temperature excursion. The patient did not experience any adverse reactions after vaccination. The reporter assessed this case as non-serious. This case (201805338) was cross-linked to the original case 201805327 reported by the same reporter. Follow-up report received from other health profession on 28-Nov-2018: The patient's age (36-year-old) was added. The route of administration (intramuscular) and anatomical location (left deltoid) of suspect vaccine were added in the product tab. The reporter confirmed that the patient did not experience any adverse reactions. The narrative and case comment were amended accordingly.
Age: 44.0
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This is a spontaneous case, initially received on 07-Nov-2018 from the other health professional (nurse), concerning a 44-year-old, adult female patient. On an unspecified date, the vaccines were stored in the refrigerator and eventually a temperature drop was noted for a moment up to plus 0.3 Celsius for less than 115 minutes, which was considered as first temperature excursion. It was reported that the vaccines were moved immediately. On 26-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, batch number: 252227, expiry date: 31-May-2019, route of administration: intramuscular, anatomical location: left deltoid) which underwent temperature excursion. At the time of this report, no adverse events were reported. This case is linked to case 201805327 due to same reporter. The reporter assessed this case as non-serious. Follow-up report received from the reporter on 28-Nov-2018: Age, route of administration and anatomical location was updated. The reporter confirmed that no adverse events were reported after vaccination. The narrative was amended accordingly.
Age: 23.0
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from the other health professional (nurse) on 07-Nov-2018, concerns a 23-year-old, adult, female patient. On an unspecified date, the vaccines were stored in the refrigerator and eventually a temperature drop was noted for a moment up to plus 0.3 Celsius for less than 115 minutes, which was considered as first temperature excursion. It was reported that the vaccines were moved immediately. On 26-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 252227 and expiry date: 31-May-2019) which underwent temperature excursion. The patient did not experience any adverse event after the vaccination. This case (201805342) was cross-linked to the original case 201805327 reported by the same reporter. The reporter assessed this case as non-serious. Follow-up received from the nurse on 28-Nov-2018: Age of the patient was added in the patient tab. Route of administration and anatomical location was added in the product tab. It was reported that the patient had not experienced any adverse event after the vaccination. Narrative and case comment were amended accordingly.
Age: 59.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case received, initially received from the other health professional (nurse) on 07-Nov-2018, concerns a 59-year-old, adult male patient. On an unspecified date, the vaccines were stored in the refrigerator and eventually a temperature drop was noted for a moment up to plus 0.3 Celsius for less than 115 minutes, which was considered as first temperature excursion. It was reported that the vaccines were moved immediately. On 26-Oct-2018, the patent was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 252227 and expiry date: 31-May-2019] which underwent temperature excursion. The patient did not experience any adverse reactions after the vaccination. The reporter assessed this case as non-serious. This case (201805341) was cross-linked to the source case: 201805327 reported by the same reporter. Follow-up report received from other health profession on 28-Nov-2018: The patient's age (59-year-old) was added. The route of administration (intramuscular) and anatomical location (left deltoid) of suspect vaccine were added in the product tab. The reporter confirmed that, the patient did not experience any adverse reactions. The narrative and case comment were amended accordingly.
Age: 26.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received on 07-Nov-2018 from other health professional (nurse), concerns a 26-year-old adult male patient. On an unspecified date, the vaccines were stored in the refrigerator and eventually a temperature drop was noted for a moment up to plus 0.3 Celsius for less than 115 minutes, which was considered as first temperature excursion. It was reported that the vaccines were moved immediately. On 26-Oct-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: 252227 and expiry date: 31-May-2019] which underwent temperature excursion. The patient did not experience any adverse reactions after the vaccination. The reporter assessed this case as non-serious. This case (201805343) was cross-linked to case 201805327 due to same reporter. Follow-up report received from other health profession on 28-Nov-2018: The patient's age (26-year-old) was added. The route of administration (intramuscular) and anatomical location (right deltoid) of suspect vaccine were added in the product tab. The reporter confirmed that, the patient did not experience any adverse reactions. The narrative and case comment were amended accordingly.
Age: 58.0
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received on 07-Nov-2018 from other health professional (nurse), concerns a 58-year-old, adult, female patient. On an unspecified date, the vaccines were stored in the refrigerator and eventually a temperature drop was noted for a moment up to plus 0.3 Celsius for less than 115 minutes, which was considered as first temperature excursion. It was reported that the vaccines were moved immediately. On 26-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 252227 and expiry date: 31-May-2019) which underwent temperature excursion. The patient experienced no adverse event after the vaccination. This case (201805344) was cross-linked to the source case 201805327 due to same reporter. The reporter assessed this case as non-serious. Follow-up received from the nurse on 28-Nov-2018: Age of the patient was added in the patient tab. Route of administration and anatomical location was added in the product tab. It was reported that the patient had not experienced any adverse event after the vaccination. Narrative and case comment were amended accordingly.
Age: 69.0
Sex: U
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 69-year-old, elderly patient of an unspecified gender. It was reported that, the FLUCELVAX QIVc vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 10-Oct-2018, the patient was administered FLUCELVAX QIVc [route of administration: intramuscular, anatomical location: left deltoid, batch number: 252230, expiry date: 31-May-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805502 was crossed linked to original case 201804863 due to same reporter.
Age: 45.0
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Syringe issue
Clinical narrative: This is a spontaneous case, initially received from other non-health professional on 12-Nov-2018 and follow-up received on 22-Nov-2018 (being processed together), concerning a 45-year-old, adult, female patient. On 09-Nov-2018, the patient was administered FLUCELVAX QIVc [route of administration: intramuscular, anatomical location: deltoid, dose: 0.5 ml, batch number: 195250 and expiry date: 01-Jun-2019 (as reported)]. It was reported that while administering the vaccine, the plunger was stuck while the needle was in the patient's arm. The patient did not have any discomfort or pain and was not harmed in any way. The product technical complaint (PTC) of batch 195250 was provided as 1035617. The reporter assessed this case as non-serious.
Age: 60.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 60-year-old, adult patient of an unspecified gender. It was reported that, the FLUCELVAX QIVc vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 22-Oct-2018, the patient was administered FLUCELVAX QIVc [route of administration: intramuscular, anatomical location: right deltoid, batch number: 252230, expiry date: 31-May-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805436 was crossed linked to original cases 201804863 due to same reporter.