chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous case, initially received from other health professional (nurse) on 29-Oct-2018, concerns a 3-year-old (reported as 3.5), child male patient. The patient had no relevant medical history and no concomitant medications. On 29-Oct-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: 252664 and expiry date: 30-Jun-2019). No adverse reactions reported after administration of the vaccine. The reporter assessed this case as non-serious.
Age: 86.0
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from other non-health professional (consumer) on 26-Oct-2018, concerns an 86-year-old, elderly female patient. On 16-Oct-2018, the vaccine underwent temperature excursion. On an unspecified date in Oct-2018, the patient was inadvertently administered FLUCELVAX QIVc that underwent temperature excursion [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252664 and expiry date: 30-Jun-2019]. The patient did not experience any adverse events after vaccination. The reporter assessed this case as non-serious. This case (201805005) was cross-linked to the case: 201805002 reported by the same reporter. Follow-up report received from the reporter on 13-Nov-2018: The onset date of the event incorrect product storage was updated as 16-Oct-2018 and expiry date of the suspect vaccine was updated as 30-Jun-2019. The reporter confirmed that, the patient did not experience any adverse events after vaccination. The reporter refused to provide the patient's initials and date of vaccine administration. The narrative and case comment were amended accordingly.
Age: 74.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from other non-health professional on 26-Oct-2018, concerns a 74-year-old, elderly male patient. On 16-Oct-2018, the vaccine underwent temperature excursion. On an unspecified date in Oct-2018, the patient was inadvertently administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252664 and expiry date: 30-Jun-2019). The patient did not experience any adverse events after vaccination. The reporter assessed this case as non-serious. This case (201805004) was cross-linked to the case: 201805002 reported by the same reporter. Follow-up received from other non-health professional on 13-Nov-2018: The onset date of the event incorrect product storage was updated as 16-Oct-2018 and expiry date of the suspect vaccine was updated as 30-Jun-2019. The reporter confirmed that, the patient did not experience any adverse events after vaccination. The reporter refused to provide the patient's initials and date of vaccine administration. The narrative and case comment were amended accordingly.
Age: 60.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from other non-health professional (consumer) on 26-Oct-2018, concerns a 60-year-old, adult, male patient. On 16-Oct-2018, temperature excursion of the vaccine occurred. On an unspecified date in Oct-2018, the patient was inadvertently administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252664 and expiry date: 30-Jun-2019) which underwent temperature excursion. The patient did not experience any adverse events after vaccination. The reporter assessed this case as non-serious. This case (201805010) was cross-linked to the case: 201805002 reported by the same reporter. Follow-up report received on 13-Nov-2018: The reporter refused to provide the patient's initials. The onset date of the event incorrect product storage was updated as 16-Oct-2018 and expiry date of the suspect vaccine was updated as 30-Jun-2019. The reporter confirmed that, the patient did not experience any adverse events after vaccination. The narrative and case comment were amended accordingly.
Age: 78.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from other non-health professional (consumer) on 26-Oct-2018, concerns a 78-year-old, elderly male patient. On 16-Oct-2018, the vaccine underwent temperature excursion. On an unspecified date in Oct-2018, the patient was inadvertently administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252664 and expiry date: 30-Jun-2018) which underwent temperature excursion. The patient had not experienced any adverse event after the vaccine administration. The reporter assessed this case as non-serious. This case 201805012 was cross-linked to the case: 201805002 reported by the same reporter. Follow-up report received on 13-Nov-2018: The reporter refused to provide the patient's initials. The onset date of the event incorrect product storage was updated as 16-Oct-2018 and expiry date of the suspect vaccine was updated as 30-Jun-2019. The reporter confirmed that, the patient did not experience any adverse events after vaccination. The narrative and case comment were amended accordingly.
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from other non-health professional (consumer) on 26-Oct-2018, concerns a 56-year-old adult female patient. On 16-Oct-2018, the vaccine underwent temperature excursion. On an unspecified date in Oct-2018, the patient was inadvertently administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252664 and expiry date: 30-Jun-2019). The patient did not experience any adverse events after vaccination. The reporter assessed this case as non-serious. This case (201805016) was cross-linked to the case: 201805002 reported by the same reporter. Follow-up report received on 13-Nov-2018: The reporter refused to provide the patient's initials. The onset date of the event incorrect product storage was updated as 16-Oct-2018 and expiry date of the suspect vaccine was updated as 30-Jun-2019. The reporter confirmed that, the patient did not experience any adverse events after vaccination. The narrative and case comment were amended accordingly.
Age: 41.0
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from other non-health professional (consumer) on 26-Oct-2018, concerns a 41-year-old, adult, female patient. On 16-Oct-2018, the vaccine underwent temperature excursion. On an unspecified date in Oct-2018, the patient was inadvertently administered FLUCELVAX QIVc that underwent temperature excursion [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252664 and expiry date: 30-Jun-2019]. The patient did not experience any adverse events after vaccination. The reporter assessed this case as non-serious. This case (201805017) was cross-linked to the case: 201805002 reported by the same reporter. Follow-up report received from the reporter on 13-Nov-2018: The onset date of the event incorrect product storage was updated as 16-Oct-2018 and expiry date of the suspect vaccine was updated as 30-Jun-2019. The reporter confirmed that, the patient did not experience any adverse events after vaccination. The reporter refused to provide the patient's initials and date of vaccine administration. The narrative and case comment were amended accordingly.
Age: 57.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from other non-health professional on 26-Oct-2018, concerns a 57-year-old, adult, male patient. On 16-Oct-2018, temperature excursion of the vaccine occurred. On an unspecified date in Oct-2018, the patient was inadvertently administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252664 and expiry date: 30-Jun-2019) which underwent temperature excursion. The patient did not experience any adverse events after vaccination. The reporter assessed this case as non-serious. This case (201805018) was cross-linked to the case: 201805002 reported by the same reporter. Follow-up report received on 13-Nov-2018: The reporter refused to provide the patient's initials. The onset date of the event incorrect product storage was updated as 16-Oct-2018 and expiry date of the suspect vaccine was updated as 30-Jun-2019. The reporter confirmed that, the patient did not experience any adverse events after vaccination. The narrative and case comment were amended accordingly.
Age: 74.0
Sex: F
Vaccine: FLUC4
Symptoms: Expired product administered, Hypoaesthesia, Paraesthesia
Clinical narrative: This is a spontaneous case, initially received from a pharmacist on 29-Oct-2018, concerning a 74-year-old elderly female patient. The patient's concomitant medications were unknown. On an unspecified date in Oct-2018 (3 weeks ago as reported), the patient was administered expired FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252668 and expiry date: 29-Jun-2018]. On an unspecified date in Oct-2018 (within couple of days as reported), after vaccination, the patient experienced tingling and numbness in the left arm. It was reported that the patient could see the stars when touching the shoulder blade. The treatment measures were unknown. At the time of this report, the outcome of the events was not reported. The reporter assessed the case as non-serious.
Age: 62.0
Sex: F
Vaccine: FLUC4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous case, initially received from non-health professional on 31-Oct-2018, concerns a 62-year-old, elderly female patient. The patient's current condition included diabetes, hypercholesterolemia, hypothyroidism and anxiety (reported as medical history). The patient was allergic to pickles. The patient's concomitant medications included insulin, VICTOZA, metformin, TOUJEO, WELCHOL, JARDIANCE, LIPITOR, levothyroxine, EFFEXOR and aspirin for unknown indications. On 30-Oct-2018, the patient was administered an expired vaccine FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 195246 and expiry date: 30-Jun-2018]. No adverse event was reported after administration of the vaccine. The reporter assessed this case as non-serious.
Sex: F
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 female patient of an unspecified age. On an unspecified date, the vaccine underwent temperature excursion for 2 hours, reaching a minimum temperature of 34-degree Fahrenheit. It was the first-time excursion. 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 administration. This case is linked to 201805100 (same reporter).
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 other health professional (nurse) on 29-Oct-2018, concerning a 3-year-old, female child patient. On 26-Oct-2018, the patient (underage of 4 years) was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252228 and expiry date: 31-May-2019]. No adverse events were reported after administration of the vaccine. The reporter assessed the case as non-serious. Non-significant follow up received from the reporter on 27-Nov-2018: Reporter stated that, the patient had no medical history and ICD I73 was provided in error. Narrative was amended accordingly.
Age: 63.0
Sex: F
Vaccine: FLUC4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous case, initially received from other health professional (nurse) on 06-Nov-2018, concerns a 63-year-old, adult female patient. On 01-Nov-2018, the patient was administered expired FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 195216, and expiry date: 30-Apr-2018]. The patient did not experience any adverse events after vaccine administration. The reporter assessed the case as non-serious. This case was linked to 201805215 due to same reporter. Non-significant follow-up received from other health professional (nurse) on 21-Nov-2018: The reporter confirmed that, the patient didn't experience any adverse reactions after administration of the expired dose vaccine.
Age: 45.0
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This is a spontaneous case, initially received from other non-health professional on 01-Nov-2018, concerning a 45-year-old, adult female patient. The patient's current condition included hyperthyroidism and concomitant medication included LEVOTHROID for an unknown indication. On an unspecified date, following the power outage the temperature at which the vaccine stored reached a maximum temperature of 10.1 C for 90 minutes. This was first time excursion. On 01-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. At the time of this report, no adverse event was reported. The reporter assessed this case as non-serious.
Age: 28.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia
Clinical narrative: This is a spontaneous case, initially received from pharmacist on 05-Nov-2018, concerning a 28-year-old, adult, female patient. The patient's medical history and concomitant medications were unknown. On 23-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252230 and expiry date: 31-May-2019). On an unspecified date in 2018, after vaccination, the patient experienced soreness in the shoulder joint lasting more than few days. At the time of this report, the outcome of the event was unknown. 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 spontaneous case, initially received on 16-OCT-2018 from other non-health professional (consumer), concerns a 34-year-old, adult, female pregnant patient. The patient had 1 previous pregnancy. 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 pregnancy. The patient had no medical history. It was reported that patient's husband did not use any medications prior to conception and the patient did not use any medications prior to the pregnancy and took prenatal vitamins. The patient's last menstrual period date (LMP) was 09-Sep-2018. On 16-Oct-2018, at gestational age of 05-weeks (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]. 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 16-Jun-2019. The reporter assessed this case as non-serious.
Age: 21.0
Sex: F
Vaccine: FLUC4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous case, initially received from other health professional (nurse) on 13-Feb-2018, concerning a 21-year-old, adult female pregnant patient. On 13-Feb-2018, the pregnant patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 195235, expiry date: 31-May-2018). It was reported that, the patient did not experience any adverse effects. The reporter considered the event, vaccine exposure during pregnancy as non-serious. Significant follow up received on 27-Mar-2018: This case was considered as lost to follow up. Hence, no amendment was done in the narrative.
Age: 54.0
Sex: F
Vaccine: FLUC4
Symptoms: Pruritus generalised, Urticaria
Clinical narrative: This is spontaneous case, initially received from other health professional on 16-Oct-2018, concerning a 54-year-old, adult, female patient. The patient reported that she was allergic to sulfa drugs which caused hives with nausea and vomiting. The patient's concomitant medication included zolpidem, Sertraline and omeprazole for unknown indications. On 09-Oct-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: 252672, expiry date: 30-Jun-2019]. On the same day of vaccination (in the afternoon, approximately 7 hours, as reported), the patient experienced hives with itching all over. The patient took BENADRYL but was not effective in controlling the itch. On 10-Oct-2018, in the morning, the patient was treated with 8 mg DECADRON. At 5 PM, an additional 8 mg of DECADRON was given along with 6 mg CELESTONE in evening and oral ATARAX to control itch. No edema and anaphylactic symptoms were noted. The post vaccination symptoms lasted for 2-3 days (as reported). On an unspecified date, the patient had intermittent times when she seemed to itch all over just momentarily but subsided without medication. It was reported that, the patient did not have any symptoms in the past 2-3 weeks (as reported). On an unspecified date in Oct-2018, the patient had recovered from the events. The reporter assessed the events as non-serious. Follow-up report received from other health professional on 27-Nov-2018: The patient initials were updated and date of birth was updated in the patient tab. Route of administration, anatomical location, batch number and expiry date were updated in the product tab. The outcome of the events was updated from 'not reported' to 'resolved' with stop date as Oct-2018 in the event tab. The narrative was amended accordingly.
Age: 37.0
Sex: F
Vaccine: FLUC4
Symptoms: Exposure during pregnancy, Prenatal screening test
Clinical narrative: This is a spontaneous case, initially received on 03-Jan-2018, was reported by other health professional (consumer) and concerns a 37-year-old adult female pregnant patient. The patient had no medical history. The patient had no previous pregnancy. The patient had no relevant maternal or paternal medical history pertinent to pregnancy. The patient did not receive any contraceptive methods or concomitant medications. The fetus's father received an unspecified medication prior to conception. The patient's LMP (last menstrual period) was reported as an unspecified date in Jun-2017. The patient did not receive any medications prior or during the pregnancy. It was reported that, there was no evidence of defect or adverse finding from a prenatal test. On 11-Nov-2017 (during second trimester), the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number and expiry date: not reported). It was reported that, the fetus had no adverse event. The EDD (estimated date of delivery) was reported as 27-Mar-2018. The reporter assessed the 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 16-Nov-2018, concerning a 02-year-old, child, female patient. The patient neither had any medical history nor concomitant medications. On 16-Nov-2018, the patient (age less than 4 years) was administered FLUCELVAX QIVc [route of administration: intramuscular, anatomical location: left anterolateral aspect of thigh, dose: 0.5 ml, batch number: 252232 and expiry date: 31-May-2019]. At the time of report, no adverse event was reported. The reporter assessed this case as non-serious.
Age: 42.0
Sex: M
Vaccine: FLUC4
Symptoms: Pain in extremity
Clinical narrative: This is a non-serious spontaneous case, initially received from a pharmacist on 29-Oct-2018, concerning a 42-year-old, adult male patient. On an unspecified date in Oct-2018, the patient was administered FLUCELVAX QIVc [dose, route of administration, anatomical location, batch number and expiry date: not reported]. On an unspecified date in Oct-2018, after vaccination, the patient experienced pain in arm. The outcome of the event was not reported at the time of this report.
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 29-Oct-2018, concerning a 03-year-old, male child patient. The patient did not have any medical history. The patient did not receive any concomitant medications. On 29-Oct-2018, the patient (under age of 4 years) was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular and anatomical location: deltoid, batch number: 252679 and expiry date: 30-Jun-2019). The patient's mother and the pediatrician were notified. At the time of this report, no adverse event was reported. The reporter assessed the case as non-serious.
Age: 6.0
Sex: M
Vaccine: FLUC4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous case, initially received from other health professional (nurse) on 06-Nov-2018, concerns a 6-year-old, male child patient. On 30-Oct-2018, the patient was administered expired FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 195216, and expiry date: 30-Apr-2018]. The patient didn't experience any adverse reactions after administration of the expired dose. The reporter assessed the case as non-serious. Non-significant follow-up received from the nurse on 21-Nov-2018: The nurse confirmed that, the patient didn't experience any adverse reactions after administration of the expired dose.
Age: 64.0
Sex: M
Vaccine: FLUC4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous case, initially received from other health professional (nurse) on 06-Nov-2018, concerns a 64-year-old, adult male patient. On 31-Oct-2018, the patient was administered expired FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 195216, and expiry date: 30-Apr-2018]. The patient did not experience any adverse events after vaccine administration. The reporter assessed the case as non-serious. This case was linked to 201805215 due to same reporter. Non-significant follow-up received from the nurse on 21-Nov-2018: The reporter confirmed that, the patient did not experience any adverse reactions after administration of the expired vaccine. The narrative was amended accordingly.
Age: 57.0
Sex: M
Vaccine: FLUC4
Symptoms: Hypersensitivity, Lip swelling, Pruritus
Clinical narrative: This is a spontaneous case, initially received from other health professional (nurse) on 25-Oct-2018, concerning a 57-year-old, adult male patient. The patient was allergic to peanuts which upsets his stomach. The patient did not receive any other vaccines or concomitant medications. On 24-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252667 and expiry date: 30-Jun-2019). On the same day, 2 hours after vaccination, the patient experienced allergic reaction on face, rash on right cheek, itchiness and swollen lips. The patient had no difficulty in breathing. The patient was treated with BENADRYL after which the events got improved but still ongoing. The outcome was recovering on an unspecified date. The reporter assessed the case as non-serious and related to the suspect vaccine (believed it was due to vaccine).
Age: 32.0
Sex: F
Vaccine: FLUC4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous case, initially received from other non-health professional (consumer) on 22-Oct-2018, concerns a 32-year-old adult female pregnant patient. The patient's historical condition included infertility which was resolved. The patient's historical drugs (taken prior to pregnancy) included fertility medication, ZYRTEC(dose: 10 mg, oral ) and vitamin D (dose: 2000 IU, oral) for unknown indications. The patient had used birth control pills (contraceptive) for unknown indication. The patient's concomitant medication included Calcium (dose: 500 mg), Prenatal vitamins , DHA (dose: 300 mg), Probiotics and Cromolyn nasal spray for unknown indications. The patient's last menstrual period (LMP) date was 31-Mar-2018. On 04-Oct-2018, the pregnant patient at gestation age of 28 weeks (third trimester) was administered with 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). The patient did not experience any adverse effect after the vaccination. The patient's estimated date of delivery (EDD) was 26-Dec-2018. The reporter assessed the case as non-serious.
Age: 32.0
Sex: F
Vaccine: FLUC4
Symptoms: Exposure during pregnancy, Prenatal screening test, Ultrasound antenatal screen normal
Clinical narrative: This non-serious spontaneous case, initially received from other health professional on 09-Oct-2018, concerning a 32-year-old, adult, female patient. The patient had no family history of major congenital malformations. The patient historical condition included four previous full-term live births, four previous spontaneous abortions and one previous ectopic pregnancy and the patients current condition included anaemia, constipation, gestational diabetes, nausea, chlamydia/yeast, urinary tract infection (UTI) and candidiasis. The patient's concomitant medications included Prenatal vitamins for pregnancy, Promethazine for nausea, COLACE for constipation, Ferrous sulphate for anaemia, MACROBID for urinary tract infections, terconazole for candidiasis and amoxicillin for chlamydia. The patient's last menstrual period date (LMP) was 15-Jan-2018. On an unspecified date, the pregnant patient received FLUCELVAX QIVc [dose, route of administration, anatomical location, batch number, expiry date: not reported). On 07-May-2018, the patient's first trimester screening was done and it was normal and no major congenital malformations noted. On 08-Aug-2018, 29-Aug-2018 and 01-Oct-2018, the patient underwent ultrasound and results were normal and no major congenital malformations noted. The patient's estimated date of delivery (EDD) was 22-Oct-2018.
Age: 52.0
Sex: F
Vaccine: FLUC4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous case, initially received from other health professional (nurse) on 06-Nov-2018, concerns a 52-year-old, adult female patient. On 31-Oct-2018, the patient was administered expired FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 195216, and expiry date: 30-Apr-2018]. The patient did not experience any adverse events after vaccine administration. The reporter assessed the case as non-serious. This case was linked to 201805215 due to same reporter. Non-significant follow-up received from nurse on 21-Nov-2018: The nurse confirmed that, the patient did not experience any adverse event after administration of the expired dose.
Age: 34.0
Sex: F
Vaccine: FLUC4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This non-serious spontaneous case, initially received on 24-Sep-2018 and follow up on 02-Oct-2018 (combinedly processed), from other non-health professional (consumer), concerns a female pregnant patient of unspecified age. The patient had 2 previous pregnancies. On 09-Dec-2017, at approximately 10 weeks, the patient had a miscarriage or still birth due to blighted ovum, the embryo or fetus stopped growing at very early stage. The patient's current condition included mild polycystic ovarian syndrome (PCOS) (since an unspecified date). The last menstrual period (LMP) was 18-Apr-2018. The estimated delivery date (EDD) was 23-Jan-2019. The patient did not use birth control pills but had natural family planning method. On 21-Sep-2018, at approximately 22 weeks gestation (second trimester), the pregnant patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252661, expiry date: 31-May-2019]. The patient did not experience unspecified adverse events after vaccination. Update received on 24-Sep-2018: Significant case correction (IRD: 24-Sep-2018): The classification 'special case with no AE' was removed from the general tab. The event 'adverse event NOS' was added in the event tab. No changes were made in the narrative. Follow-up reported received from reporter on 20-Nov-2018: The patient's previous pregnancy history, historical condition (miscarriage or stillbirth), current condition (polycystic ovarian syndrome), estimated delivery date (23-Jan-2019) and last menstrual period (18-Apr-2018) were added. The reporter confirmed that the patient had a natural family planning method and no use of birth control pill and no unspecified adverse reactions were experienced after vaccination. The event (adverse event NOS) was deleted and the classification 'special case with no AE' was added in the general tab. The narrative was amended accordingly. Non-significant case amendment (20-Nov-2018): The sentences 'the company assessed the causality of the event: adverse event NOS an unassessable due lack of information regarding onset latency and the kind of reaction occurred' and 'experienced unspecified adverse event' were removed from the case comment.
Age: 26.0
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 on 18-Nov-2018 and follow-up received on 19-Oct-2018 (combinedly processed), concerning a 26-year-old, adult, female pregnant patient. The patient had 1 previous pregnancy. The patient had no history of still birth, miscarriage, congenital anomaly and birth defect in previous pregnancy. The patient had no maternal medical history relevant to pregnancy and had no paternal medical history (hereditary disease). The patient did not take any contraceptives. The patient's current condition included asthma. The patient's concomitant medication included BREO ELLIPTA inhaler (reported as BREO inhaler). The patient's last menstrual period (LMP) date was 06-May-2018. It was reported that, it was patient's second pregnancy. There was no evidence of a defect or adverse finding from a prenatal test. On 13-Oct-2018, at 23 weeks gestational, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 252664, expiry date: 30-Jun-2019). 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 08-Feb-2019. 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 case, initially received on 01-Oct-2018, combinedly processed with the follow-up IRD 03-Oct-2018, from other non-health professional (consumer), concerns a female pregnant patient of 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 this report, the patient did not experience any adverse event.
Age: 36.0
Sex: F
Vaccine: FLUC4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This is a spontaneous case (prospective) pregnancy case, initial and follow-up received from other non-health professional (consumer) on 05-Nov-2018 (combinedly processed), concerning a 36-year-old, adult, female pregnant patient. The patient had no previous pregnancy. The patient did not have any relevant medical history. The patient had no relevant maternal and paternal medical history. The patient did not use any contraceptive method. The patient's concomitant medications included Prenatal vitamins, Vitamin D supplement and Omega 3 supplement for unknown indications. The patient's husband had not received any medications prior to conception. The patient's last menstrual period date (LMP) was 11-Aug-2018. On 05-Nov-2018, at 12 weeks gestation, 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 and foetus did not experience any adverse event after the vaccination. The patient's estimated delivery date (EDD) was reported as 17-May-2019. The reporter assessed this case as non-serious.
Age: 58.0
Sex: F
Vaccine: FLUC4
Symptoms: Pruritus
Clinical narrative: This spontaneous case, initially received from other health professional (nurse) on 15-Oct-2018, concerns a 58-year-old, adult female patient. The patient's current condition included seasonal allergies. The patient did not administered any concomitant medications. On 09-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252664 and expiry date: 30-Jun-2019). On the same day (reported as same evening), after the vaccination, the patient experienced systemic itching which lasted for 24 hours. The patient took over-the-counter (OTC) allergy medicines (drugs unspecified) as a treatment measure for the event. On 10-Oct-2018, in the evening, the patient had recovered from the event. The reporter assessed the case as non-serious. Follow up received from the reporter on 12-Nov-2018: New event 'rash' was added in the event tab. It was reported that the reporter was not aware of any skin diseases that the patient might have. The only medications that the patient took were the over the counter allergy medicines. Follow-up received from other health professional on 21-Nov-2018: The reporter confirmed that the patient experienced systemic itching and took OTC medicines. Hence, the event- rash was deleted from the event tab. The narrative was amended accordingly.
Age: 35.0
Sex: F
Vaccine: FLUC4
Symptoms: Maternal exposure before pregnancy, No adverse event
Clinical narrative: This spontaneous case, initially received from other non-health professional on 24-Sep-2018, concerning a 35-year-old, adult pregnant female patient. There was no maternal and paternal medical history (relevant to pregnancy). The patient did not take any medications prior to and during pregnancy. The patient's husband did not take any medications prior to conception. The patient did not use any contraceptive methods. On 24-Sep-2018, the pregnant patient (reported as first pregnancy) was administered FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252230 (as reported 252130) and expiry date: not reported). It was reported that, the patient's foetus did not experience any adverse event after the vaccination. The patient's estimated delivery date was 31-Oct-2018. The reporter assessed this case as non-serious.
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This is a spontaneous case, initially received from other non-health professional on 14-Nov-2018, concerning a female patient of an unspecified age. On an unspecified date, the FLUCELVAX QIVc vaccine underwent first temperature excursion with maximum temperature (Tmax) 8.2 degree centigrade for 4 minutes. On 22-Oct-2018, vaccine underwent second temperature excursion with Tmax 9.8 degree centigrade for 4 minutes. On 22-Oct-2018, vaccine underwent second temperature excursion with Tmax 9.8 centigrade for 23 minutes. On an unspecified date, two temperature excursions were identified after an audit. On 31-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 events after administered. This case is linked to 201805262 (same reporter).
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This is a 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 under first temperature excursion with maximum temperature (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 06-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. The patient did not experience any adverse events after vaccination. This case is linked to 201805262 (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 an 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 29-Oct-2018, the patient was inadvertently administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration, 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).
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 degrees 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 29-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).
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 (explicitly coded as incorrect product storage). On an unspecified date, two temperature excursions were identified after an audit. On 31-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 (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.
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 degrees 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 05-Nov-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).
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This is a spontaneous case, initially received from other non-health professional on 14-Nov-2018, concerning a female patient of unspecified age. On an unspecified date, the FLUCELVAX QIVc underwent first temperature excursion with maximum temperature (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 (explicitly coded as incorrect product storage). On an unspecified date, two temperature excursions were identified after and audit. On 01-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 and adverse events after administration. This case is linked to 201805262 (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 degrees 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 06-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. The patient did not experience any adverse effect after the vaccination.
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 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 (explicitly coded as incorrect product storage). On an unspecified date, two temperature excursions were identified after an audit. On 06-Nov-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 (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.
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 06-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. The patient did not experience any adverse effect after the vaccination. This case is linked to 201805262 (same reporter).
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This is a 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 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 06-Nov-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 vaccination. This case is linked to 201805262 (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 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 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. The patient did not experience any adverse events after the vaccination. This case is linked to 201805262 (same reporter).