chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This 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 Tmax 8.2 degree centigrade for 4 minutes. On 22-Oct-2018, vaccine underwent temperature excursion with Tmax 9.8 degree centigrade for 23 minutes (explicitly coded as incorrect product storage). On an unspecified date, the two temperature excursions were identified after an audit. On 07-Nov-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 (explicitly coded as drug administration error). The patient did not experience any adverse events after administration. This case is linked to (201805262) due to same reporter.
Age: 23.0
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 16-Nov-2018, concerning a 23-year-old, adult male patient. On an unspecified date, vaccine was exposed to 56 Fahrenheit for 3 hours and 20 minutes which was considered as first-time excursion. On 15-Nov-2018, the patient was administered FLUCELVAX QIVc which underwent temperature excursion (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252678 and expiry date: 30-Jun-2019). The patient did not experience adverse effects. The reporter assessed the case as non-serious.
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site rash
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 16-Nov-2017, concerns a 59-year-old, adult, female patient. On 13-Nov-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, batch number: 195243, expiry date: 30-Jun-2018, anatomical location: upper left arm and route of administration: not reported). On an unspecified date, the patient had a injection site rash on her upper left arm. At the time of this report, the outcome of the event was not reported. Non-significant follow up received on 18-Dec-2017: The medical communication reference number (SEQ17-5799) was updated in the additional information.
Age: 75.0
Sex: F
Vaccine: FLUC4
Symptoms: Cough, Fatigue, Myalgia, Rash
Clinical narrative: This non-serious initial spontaneous case, was received from other non-health professional, concerning a 75-year-old elderly female patient. On 30-Oct-2017, the patient was administered with FLUCELVAX QIV (dose, route of administration, anatomical location, batch number, expiry date: not reported). On an unspecified date, after the vaccination, patient complained of muscle aches and coughing, which were ongoing since one month. She also complained of rash on her face and tiredness. She consulted the doctor and took unspecified antibiotics, bout cough had not stopped. The outcome of the events muscle aches, cough was not recovered and rash on her face, tiredness was not reported. The reporter considered the causality of the events as related.
Age: 29.0
Sex: F
Vaccine: FLUC4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous case, was initially received from a pharmacist on 24-Jan-2018, concerning a 29-year-old adult female pregnant patient. The patient's maternal and paternal (hereditary disease only) medical history, including previous pregnancies, birth defect or congenital anomaly occurred during pregnancy was not reported. The patient did not have spontaneous abortion or still birth in the past. It was unknown whether the patient was taking any medications prior, during pregnancy and received by the father prior to conception. The patient's last menstrual period (LMP), estimated date of delivery (EDD) was unknown. On 24-Jan-2018, the pregnant woman was administered with FLUCELVAX QIV (dose: 0.5 ml, batch number: 195242, route of administration: intramuscular, anatomical location: left deltoid) (explicitly coded as vaccine exposure during pregnancy). The reporter assessed the event vaccine exposure during pregnancy as non-serious. Non-significant follow-up received from the reporter on 09-Mar-2018: The reporter informed that the patient neither had any adverse event nor any details of LMP, EDD, medical history. Narrative was amended accordingly.
Age: 34.0
Sex: F
Vaccine: FLUC4
Symptoms: Exposure during pregnancy
Clinical narrative: This is a spontaneous case, initially received from other non-health professional on 12-Jan-2018, concerning a 34-year-old adult female pregnant patient. The patient had a history of 2 pregnancies. The patient's last menstruation date was 30-Jun-2017. No history of miscarriage in previous pregnancies. The patient had no history of major congenital anomalies and birth defects in previous pregnancies. The patient had no relevant maternal medical history relevant to pregnancy. The patient had no relevant paternal medical history. On 11-Jan-2018, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number and expiry date: not reported) at 28 weeks of pregnancy. The EDD (estimated date of delivery) on 06-Apr-2018. The reporter considered this case as non-serious.
Age: 39.0
Sex: F
Vaccine: FLUC4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This is a spontaneous case, initially received from other non-health professional on 15-Feb-2018, concerning a 39-year-old adult female pregnant patient. The patient had no medical history. The patient's concomitant medication included prenatal vitamin for an unknown indication. The patient had no maternal or paternal medical history (hereditary disease) relevant to pregnancy. The patient had 2 previous pregnancies. The patient had no still birth, miscarriage, birth defect or congenital anomaly occurred in previous pregnancy. The patient did not use any contraceptive method. The patient had not received any medications prior to pregnancy and no medication taken by the fetus's father prior to conception. The patient's LMP (last menstrual period) date was 28-Dec-2017. It was reported that, there was no evidence of defect or adverse finding from a prenatal test. On 14-Feb-2018, the pregnant patient at gestation age of 7 weeks (first trimester) was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number and expiry date: not reported) (explicitly coded vaccine exposure during pregnancy). It was stated that, the patient did not experience any adverse effect after the vaccination. The patient's EDD (estimated date of delivery) was 04-Oct-2018. The reporter assessed the event as non-serious.
Age: 25.0
Sex: F
Vaccine: FLUC4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This non-serious spontaneous case, reported by a nurse on 28-Mar-2018, concerning a 25-year-old adult pregnant female patient. It was unknown whether, patient used any contraceptive methods. On 28-Mar-2018, pregnant patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number and expiry date: not reported). The patient had provided the permission to be contacted by the research for pregnancy registry. It was reported that, patient's fetus did not experience any adverse event after the vaccination. The patient's estimated delivery date was 11-Apr-2018.
Age: 64.0
Sex: F
Vaccine: FLUC4
Symptoms: Hypersensitivity, Swelling
Clinical narrative: This spontaneous case, initially received on 07-Sep-2018, reported by a pharmacist and concerns a 64-year-old, adult, female patient. The patient's medical history and concomitant medications were unknown. On an unspecified date in 2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: unknown, expiry date: not reported). After vaccination, within 24 hours, the patient experienced allergic reaction and developed swelling all over. It was reported that, the patient had a visit to primary care physician. At the time of this report, the patient had recovered from the events (swelling and allergic reaction). The reporter assessed the case as non-serious.
Age: 34.0
Sex: F
Vaccine: FLUC4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This is a spontaneous case, initially received on 20-Sep-2018, reported by other non-health professional (consumer), concerning a 34-year-adult, female pregnant patient. The patient had 1 previous pregnancy and had no history of still birth/miscarriage or birth defect/congenital anomaly in previous pregnancy. The patient had no paternal medical history (hereditary disease). The patient's husband received unspecified medication prior to conception. The patient's historical drugs included allergy medications for grass allergy and oral contraceptives for an unknown indication. The patient's current condition included grass allergy. The concomitant medication included prenatal vitamins for an unknown indication. The patient's last menstrual period (LMP) date was 05-May-2018. It was reported that, it was patient's second pregnancy. The gender of the infant was reported as female. There was no defect or adverse finding from the prenatal test. On 20-Sep-2018, at 19 gestational weeks, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252661, expiry date: 31-May-2019) (explicitly coded as vaccine exposure during pregnancy). At the time of this report, the patient and foetus had not experienced any adverse events. The patient's estimated delivery date (EDD) was reported as Feb-2019. The reporter assessed the case as non-serious. Follow-up received from other non-health professional on 25-Oct-2018: The reporter refused to provide the requested information. Hence, this case was considered as lost to follow-up.
Age: 36.0
Sex: F
Vaccine: FLUC4
Symptoms: Exposure during pregnancy, No adverse event, Prenatal screening test
Clinical narrative: This spontaneous case, initially received on 19-Sep-2018 from other non-health professional (consumer), concerns a 36-year-old, adult, female pregnant patient. The patient had no maternal medical history relevant to pregnancy and paternal medical history (hereditary disease). The patient had 2 previous pregnancies and had a stillbirth/miscarriage. There was no birth defect or congenital anomaly occurred during any previous pregnancy. The patient's contraceptive method was not reported. The patient's medications taken prior to pregnancy and during pregnancy were not reported. The medications taken by father prior to conception were not reported. The patient's concomitant medications were not reported. The patient's last menstrual period (LMP) date was not reported. On 17-Sep-2018, at gestational age of 18-weeks (second trimester) the patient was administered with FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number and expiry date: not reported). No adverse events were reported in pregnant patient and fetus after the vaccination. There was no evidence of a defect or adverse finding from a prenatal test. The patient's estimated delivery date (EDD) was reported as 19-Feb-2019. The reporter assessed this case as non-serious.
Sex: F
Vaccine: FLUC4
Symptoms: Rash
Clinical narrative: This spontaneous case, initially received from a pharmacist on 11-Sep-2018, concerns a female patient of unspecified age. The patient's medical history and concomitant medications were unknown. On 10-Sep-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number and expiry date: not reported). On an unspecified date in Sep-2018 after vaccination, the patient developed a rash. The patient was given 2 1/2 percent hydrocortisone cream and the rash resolved within 1 to 2 days (recovered). The reporter assessed the causality of the event as related to the suspect vaccine. Follow up received on 04-Oct-2018: the outcome of the event 'rash' was changed from unknown to recovered. It was reported that, the patient was given 2 1/2 percent hydrocortisone cream. Narrative and case comment were amended accordingly. Update received on 02-Nov-2018: Non-significant case correction (IRD: 04-Oct-2018): The date in the case comment was removed and the cases comment was amended.
Sex: F
Vaccine: FLUC4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 25-Sep-2018, concerns a pregnant female patient of an unspecified age. On an unspecified date, the pregnant patient was administered FLUCELVAX QIVc [dose, route of administration, anatomical location, batch number and expiry date: not reported]. At the time of the report, no adverse event was reported.
Sex: F
Vaccine: FLUC4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This non-serious spontaneous case, initially received from other health professional on 26-Sep-2018, concerns an adult, pregnant, female pregnant patient of unspecified age. On an unspecified date, the pregnant patient was administered FLUCELVAX QIVc (batch number: 252659, expiry date: 31-May-2019, dose, route of administration and anatomical location: not reported). No adverse event was reported.
Age: 32.0
Sex: F
Vaccine: FLUC4
Symptoms: Exposure during pregnancy, No adverse event, Prenatal screening test
Clinical narrative: This spontaneous case, initially received from other health professional, concerns a 32-year-old, adult pregnant female patient. The patient had four previous pregnancies, out of which miscarriage occurred in two pregnancies. The patient had no relevant maternal and paternal medical history. The patient did not use any contraceptive method. The patient had no history of birth defects and congenital anomalies in the previous pregnancies. The patient did not use any medications prior to pregnancy. The patient's husband did not use any medications prior to conception. The patient's concomitant medications included prenatal vitamins and folic acid for unknown indications. On 26-Sep-2018, the pregnant patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, batch number: 252659, expiry date: 31-May-2019 and anatomical location: not reported). It was reported that, after vaccine administration, the patient did not experience any adverse event. There was no evidence of defect or adverse finding from a prenatal test and no birth defect or congenital anomalies were noted. The patient's estimated delivery date (EDD) was reported as 06-Feb-2019. The reporter assessed this case as non-serious. Update received on 02-Nov-2018: Non-significant case correction (IRD: 27-Sep-2018): The sentence in the narrative was changed from 'the patient had no birth defects and congenital anomalies were occurred in previous pregnancies" to "the patient had no history of birth defects and congenital anomalies in the previous pregnancies".
Age: 34.0
Sex: F
Vaccine: FLUC4
Symptoms: Exposure during pregnancy, No adverse event, Prenatal screening test
Clinical narrative: This is a spontaneous case (prospective) pregnancy case, initially received from other non-health professional (consumer) on 01-Nov-2018 and follow-up received on 08-Nov-2018 combinedly processed), concerning a 34-year-old, adult, female pregnant patient. The patient had 1 previous pregnancy. The patient had no history of still birth, miscarriage, birth defect and congenital anomaly in previous pregnancy. The patient had no paternal medical history (hereditary disease). The father did no take any medication prior to conception. The patient did not take any contraceptives. The patient's current condition included gestational diabetes. The patient's concomitant medication included pre-natal vitamins for an unknown indication. The patient's last menstrual period (LMP) date was 25-Mar-2018. It was reported that, it was patient's second pregnancy. There was no evidence of defect or adverse finding from prenatal test. On 30-Oct-2018, at 31 weeks gestational, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252672, expiry date: 30-Jun-2019) (explicitly coded as vaccine exposure during pregnancy). At the time of the report, the patient and foetus had not experienced any adverse events. The patient's estimated deliver date (EDD) was reported as 31-Dec-2018. The reporter assessed this case as non-serious.
Age: 42.0
Sex: F
Vaccine: FLUC4
Symptoms: Exposure during pregnancy, No adverse event, Prenatal screening test
Clinical narrative: This spontaneous case, initially received (combinedly processed with follow-up received on 03-Oct-2018) on 01-Oct-2018 from other non-health professional (consumer), concerns a 42-year-old, adult, female pregnant patient. The patient had 3 previous pregnancies in which first pregnancy was miscarriage, second pregnancy was ectopic, and third pregnancy was stillbirth at 40 weeks. The patient had no relevant maternal and paternal medical history. The patient did not use any contraceptive method. The patient had no birth defects and congenital anomalies were occurred in previous pregnancies. The patient did not use any medications prior to pregnancy. It was reported that patient's husband took unspecified medications prior to conception. The patient's concomitant medications included prenatal vitamin and folic acid for unknown indications. The patient's last menstrual period date (LMP) was 05-May-2018. On 01-Oct-2018, at gestational age of 21-weeks (second trimester of pregnancy) the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252380 and expiry date: 31-May-2019]. No treatment measures were taken. It was reported that, after vaccination administration, the patient did not experience any adverse event. There was no evidence of defect or adverse finding from a prenatal test and no birth defect or congenital anomalies were noted. The patient's estimated delivery date (EDD) was reported as 04-Feb-2019. The reporter assessed this case as non-serious.
Age: 54.0
Sex: F
Vaccine: FLUC4
Symptoms: Hypersensitivity, Injection site pruritus, Pruritus
Clinical narrative: This is a non-serious spontaneous case, initially received from pharmacist on 29-Oct-2018, concerning a 54-year-old, adult, female patient. The patient's current condition included rheumatoid arthritis. The concomitant medications included PLAQUENIL and CELEBREX. On 25-Oct-2018, the patient was administered FLUCELVAX QIVc [route of administration: intramuscular, anatomical location: left arm, dose: 0.5 ml, batch number: 252659 and expiry date: 31-May-2019]. On the same day, in the evening after vaccination, the patient had an allergy (Thursday as reported). The patient's injection site was very itchy, and it became very itchy along with her wrist. The outcome was not reported.
Age: 74.0
Sex: F
Vaccine: FLUC4
Symptoms: Joint range of motion decreased, Laboratory test, Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous case, initially received from other non-health professional on 24-Oct-2018, concerns a 74-year-old, elderly female patient. The patient's current conditions included hypothyroidism, hypertension and hyperlipidemia (reported as medical history) (since an unspecified date). The concomitant medications included Calcium, Vit D3, Vit B12, Levothyroxine, simvastatin and amlodipine for unknown indications. On 01-Oct-2018, the patient was administered FLUCELVAX QIVc [dose: 5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252227 and expiry date: 31-May-2019]. On an unspecified date in Oct-2018, 1 to 2 days after vaccination, the patient experienced pain, swelling and decreased range of motion in the arm. On an unspecified date, the patient underwent lab tests, diagnostic tests and the results were not reported. At the time of this report, the patient had not recovered from the events. The reporter assessed the case as non-serious.
Sex: F
Vaccine: FLUC4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This non-serious spontaneous (prospective) pregnancy case, initially received from other non-health professional on 26-Oct-2018, concerning a female patient of unspecified age. On an unspecified date, at 16 weeks gestation, the patient was administered FLUCELVAX QIVc [dose, route of administration, anatomical location, batch number, expiry date: not reported]. The patient reported that the vaccine was administered without prior consultation. At this time of this report, no adverse event was reported.
Age: 31.0
Sex: F
Vaccine: FLUC4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This is a non-serious spontaneous case, initially received from other non-health professional on 03-Oct-2018, concerns a 31-year-old, adult pregnant female patient. The patient's concomitant medication included prenatal vitamins during pregnancy for an unknown indication. The patient's last menstrual period (LMP) date was 11-May-2018. On 03-Oct-2018, the pregnant patient (gestation period: 20 weeks) was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number; 252656 and expiry date: 31-May-2019). No adverse reactions were reported after administration of the vaccine. The estimated date of delivery was reported as 15-Feb-2019. Follow-up received from other non-health professional on 21-Nov-2018: Added patient's last menstrual period (LMP) date (11-May-2018) in the patient tab and updated reference number (Med info number: SEQ18-06031) in the additional information tab. Narrative was amended accordingly.
Age: 33.0
Sex: F
Vaccine: FLUC4
Symptoms: Exposure during pregnancy, No adverse event, Prenatal screening test
Clinical narrative: This spontaneous case, initially received on 18-Oct-2018 from other non-health professional (consumer), concerns a 33-year-old, adult, female pregnant patient. The patient had 4 previous pregnancies in which the patient had 2 miscarriages. The patient had no relevant maternal and paternal medical history. The patient did not use any contraceptive method. The patient had no birth defects and congenital anomalies were occurred in previous pregnancies. The patient's current condition included hypothyroidism (since an unspecified date). It was reported that patient's husband did not used any medications prior to conception and the patient took levothyroxine for an unknown indication prior to pregnancy and during the pregnancy. The patient's last menstrual period date (LMP) was 16-May-2018. On 17-Oct-2018, at gestational age of 22-weeks (second trimester of pregnancy) the patient was administered FLUCELVAX QIVC [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number and expiry date: not reported] (explicitly coded as vaccine exposure during pregnancy). No treatment measures were taken. It was reported that, after vaccine administration, the patient did not experience any adverse event. There was no evidence of defect or adverse finding from a prenatal test and no birth defect or congenital anomalies were noted. The patient's estimated delivery date (EDD) was reported as 20-Feb-2019. The reporter assessed this case as non-serious.
Sex: F
Vaccine: FLUC4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous case, initially received from pharmacist on 17-Oct-2018, concerns a pregnant patient of an unspecified age. The patient had no medical history. The patient's concomitant medications included Prenatal vitamins and levothyroxine. On 17-Oct-2018, at a gestational age of 9 weeks and 3 days (first trimester of pregnancy), the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number and expiry date not reported). The patient had not experienced any adverse event after vaccination. The reporter assessed the case as non-serious.
Age: 68.0
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 68-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 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 201805482 was crossed linked to original case 201804863 due to same reporter.
Age: 43.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This is a spontaneous case, initially received on 07-Nov-2018 from other health professional (nurse), concerning a 43-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. At the time of this report, no adverse events were reported. This case is linked to case 201805327 owing 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 and the case comment were amended accordingly.
Sex: F
Vaccine: FLUC4
Symptoms: Fatigue, Injection site pain, Tenderness
Clinical narrative: This is a spontaneous case, reported by other non-health professional (consumer) on 05-Nov-2018, concerning a female patient of unspecified age. On an unspecified date in 2017, the patient experienced little bit tired with body aches due to the FLUCELVAX vaccine. The patient's current condition included egg allergy. On an unspecified date in Oct-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number and expiry date: not reported]. On an unspecified date in Oct-2018, the patient had recovered from the events (reported as lasted only for 1 day). The reporter assessed this case as non-serious. Non-significant follow-up from the reporter on 27-Nov-2018: No additional information was available in the source document, hence no changes were made in narrative.
Age: 79.0
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 79-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 19-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 201805442 was crossed linked to original case 201804863 due to same reporter.
Age: 64.0
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 64-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: 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 201805426 was crossed linked to original case 201804863 due to same reporter.
Sex: F
Vaccine: FLUX
Symptoms: Pain, Rhinorrhoea
Clinical narrative: This is a non-serious spontaneous case, initially received from other healthcare professional on 29-Jun-2018 and concerns an adult, female patient of unspecified age. On an unspecified date in 2009, the patient was administered INN Flu Vaccine Seasonal (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On an unspecified date in 2009, following vaccination, the patient experienced pain, aches and sniffles. The outcome of the event was not reported. This case 201802743 was cross-linked to case 201800197 due to same patient/reporter. Update 31-Jul-2018: Significant case correction was performed with IRD 29-Jun-2018: The 'as determined causality' of the events (Sniffles and Pain/aches) was changed from unassessable to related. The narrative statement was corrected, and case comment was correct accordingly.
Age: 50.0
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This is a spontaneous case, initially received from other health professional (nurse) on 07-Nov-2018, concerns a 50-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: 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 (201805236) 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 (50-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: 3.0
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 the physician on 07-Nov-2018, concerning a 03-year-old female child. The patient had no concomitant medications at the time of vaccination. On 06-Nov-2018, the patient (under age of 4 years) was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252682 and expiry date: 30-Jun-2019) (explicitly coded as inappropriate age at vaccine administration). At the time of this report, no adverse event was reported. The reporter assessed this case as non-serious.
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This 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 Tmax 8.2 degree centigrade for 4 minutes. On 22-Oct-2018, vaccine underwent second temperature excursion with Tmax 9.8 degree centigrade for 23 minutes. On an unspecified date, two temperature excursions were identified after an audit. On 22-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 events after administration.
Age: 2.0
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 on 08-Nov-2018, concerning a 02-year-old male child patient. The patient had no medical history and concomitant medications. On 08-Nov-2018, the patient (under 4 years) was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: vastus lateralis (thigh) (as reported), batch number: 252661 and expiry date: 31-May-2019], in vastus lateralis of thigh region. The patient did not experience any adverse event after vaccination. The reporter assessed the case as non-serious. Non-significant follow-up received from other health professional on 28-Nov-2018: The reporter confirmed that, the patient did not experience any adverse events.
Age: 49.0
Sex: F
Vaccine: FLUC4
Symptoms: Fatigue, Lymphadenopathy, Pain, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: This non-serious spontaneous case initially received from other non-health professional on 07-Nov-2018, concerning a 49-year-old, adult, female patient. On 02-Nov-2018, the patient was administered FLUCELVAX QIV (dose, route of administration, anatomical location, batch number, expiry date: not reported). On an unknown date, after vaccination, the patient felt she felt achy, tired, and have been congested with a runny nose. The patient stated her glands in neck starting swelling and small lumps forming on lymph nodes in her neck. The outcome of the events was not reported.
Age: 12.0
Sex: M
Vaccine: FLUC4
Symptoms: Exposure via skin contact, Injection site extravasation, Syringe issue, Underdose
Clinical narrative: This is a spontaneous case, initially received from a pharmacist on 07-Nov-2018, concerning a 12-year-old, adolescent, male patient. The patient had no medical history and did not receive any concomitant medications. On 07-Nov-2018, the patient was administered partial dose of FLUCELVAX QIVc [dose: less than 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252667 and expiry date: 30-Jun-2019]. It was reported that during vaccination, he tried to push down the plunger, it didn't go forward. So, he pulled out and then pulled a bit more. When he finished administering all the liquid, he removed the needle from the patient's arm then the liquid came out and ran down the patient's arm. A bubble of clear liquid came out which went 2/3 inches down and then cleaned with cotton swab. It was hard to determine the volume of the liquid that came out which was more than a couple of drops. The pharmacist stated that, the patient had only a partial administration but not the full dose and he was not looking at the patient's arm but when he looked the liquid was coming out at the place where it was injected. The outcome of the event (injection site leaking) was not reported. The reporter assessed the case as non-serious.
Age: 64.0
Sex: M
Vaccine: FLUC4
Symptoms: Lymphadenopathy
Clinical narrative: This is a spontaneous case initially received from other health professional (pharmacist) on 05-Nov-2018, concerning a 64-year-old, adult, male patient. The patient's medical history and concomitant medications were not reported. On 08-Oct-2018, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252673, expiry date: 30-Jun-2019). On an unspecified date (reported as two or three days) after vaccination, the patient developed swollen lymph node on left side of his neck. The patient had been treated with antibiotics and anti-inflammatory agent. Even after the treatment, the swelling was still present. At the time of this report, the patient had not recovered from the event. The reporter assessed this case as non-serious. This case was considered as lost to follow up as the reporter did not provide consent for follow up.
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This 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 Tmax 8.2 degree centigrade for 4 minutes. On 22-Oct-2018, vaccine underwent second temperature excursion with Tmax 9.8 degree centigrade for 23 minutes. On an unspecified date, two temperature excursions were identified after an audit. On 25-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 events after administration. This case is linked to (201805262) 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: 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: 81.0
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 an 81-year-old, elderly patient of an unspecified gender. It was reported that, FLUCELVAX QIVc underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius (explicitly coded as incorrect product storage). On 12-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 (explicitly coded as drug administration error). At the time of this report, no adverse event was reported. This case 201805486 was crossed linked to original case 201804863 due to same reporter.
Age: 59.0
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 59-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 15-Oct-2018, the patient was administered FLUCELVAX QIVc [route of administration: intramuscular, anatomical location: left deltoid, batch number: 250230 (as reported), expiry date: 31-May-2019 and dose: not reported] which underwent temperature excursion. The reported batch number (250230), does not match Seqirus batch numbers, however, because the reporter named Seqirus product 'FLUCELVAX QIVc' as the suspect vaccine, this report has been conservatively entered as a Seqirus case. At the time of this report, no adverse event was reported. This case 201805476 was crossed linked to original cases 201804863 due to same reporter.
Age: 48.0
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 48-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 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 201805475 was crossed linked to original cases 201804863 due to same reporter.
Age: 67.0
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 67-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 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 201805472 was crossed linked to original cases 201804863 due to same reporter.
Age: 26.0
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received on 07-Nov-2018 from the other health professional (nurse), concerns a 26-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 (explicitly coded incorrect product storage). 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 (explicitly coded as drug administration error). The patient experienced no adverse event after the vaccination. This case (201805340) 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.
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 25-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: 52.0
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 52-year-old adult female. 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 (explicitly coded as incorrect product storage). 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, expiry date: 31-May-2019) which underwent temperature excursion (explicitly coded as drug administration error). At the time of this report, no adverse events were reported. The reporter assessed this case as non-serious. This case (201805349) 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 (52-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: 0.83
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 10-month-old, infant, female patient. 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 4 years) was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, 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. The reporter assessed the case as non-serious. This case is linked to case: 201805298 (same reporter).