chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Feeling of body temperature change, Headache, Hyperhidrosis, Malaise
Clinical narrative: This initial spontaneous case, received on 19-Sep-2017, reported by a pharmacist and concerns a 52-year-old, adult, female patient. Patient's medical history was not reported. The pharmacist reported that, AFLURIA QUADRIVALENT about 100 doses were received, 20 doses were administered and three patients experienced the events. On 08-Sep-2017, the patient (1 of 3 patients) received AFLURIA QUADRIVALENT (dose: 0.5ml, batch number: XF30506 (as reported), expiry date: 29-Jun-2018, route of administration, anatomical location was not reported). On 15-Sep-2017, after administration of AFLURIA QUADRIVALENT, the patient was extremely sick with the symptoms such as chills, headache, hot and cold flashed, night sweats. The patient also had nausea, fever and sweating (reported as sweats). It was reported that the patient could not get out of bed for five days. At the time of the report, the events chills, headache, nausea, fever and sweating were recovered, while hot and cold flashed, night sweats were not recovered. The reporter assessed the report as non-serious. Follow-up received on 27-Sep-2017: The date of vaccination (08-Sep-2017) and event onset date (15-Sep-2017) was updated. New events nausea, fever and sweats were added. The outcome of the events (chills, headache, nausea, fever and sweating) was updated. Narrative amended accordingly. Significant case correction was received on 11-Oct-2017: The patient's age in the narrative and case comment were added. Narrative amended accordingly.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Night sweats, Pyrexia
Clinical narrative: This initial spontaneous case, received on 19-Sep-2017, reported by a pharmacist and concerns a 52-year-old, adult, female patient. Patient's medical history was not reported. The pharmacist reported that, AFLURIA QUADRIVALENT about 100 doses were received, 20 doses were administered and three patients experienced the events. On 08-Sep-2017, the patient (1 of 3 patients) received AFLURIA QUADRIVALENT (dose: 0.5ml, batch number: XF30506 (as reported), expiry date: 29-Jun-2018, route of administration, anatomical location was not reported). On 15-Sep-2017, after administration of AFLURIA QUADRIVALENT, the patient was extremely sick with the symptoms such as chills, headache, hot and cold flashed, night sweats. The patient also had nausea, fever and sweating (reported as sweats). It was reported that the patient could not get out of bed for five days. At the time of the report, the events chills, headache, nausea, fever and sweating were recovered, while hot and cold flashed, night sweats were not recovered. The reporter assessed the report as non-serious. Follow-up received on 27-Sep-2017: The date of vaccination (08-Sep-2017) and event onset date (15-Sep-2017) was updated. New events nausea, fever and sweats were added. The outcome of the events (chills, headache, nausea, fever and sweating) was updated. Narrative amended accordingly. Significant case correction was received on 11-Oct-2017: The patient's age in the narrative and case comment were added. Narrative amended accordingly.
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Feeling of body temperature change, Headache, Hyperhidrosis, Malaise
Clinical narrative: This initial non-serious spontaneous case, received on 19-Sep-2017, reported by a pharmacist and concerns a male patient of unknown age. Patient's medical history was not reported. The pharmacist reported that, AFLURIA QUADRIVALENT about 100 doses were received, 20 doses were administered and three patients experienced the events. On 12-Sep-2017, the patient received AFLURIA QUADRIVALENT (dose: 0.5ml, batch number: XF30506 (as reported), expiry date: 29-Jun-2018, route of administration, anatomical location was not reported). On 20-Sep-2017, after administration, the patient was extremely sick with symptoms hot and cold flashed, malaise. The patient had headache, nausea, fever, sweats, chills. It was reported that, the patient went to emergency room. The outcome of the events were recovered. Follow-up report received on 27-Sep-2017: Start date of the product administered (12-Sep-2017) and start date of the event (20-Sep-2017) was updated. The events nausea and fever were added. Amended narrative accordingly. Case correction received on 11-Oct-2017: Event sweats was added with start date.
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Nausea, Pyrexia
Clinical narrative: This initial non-serious spontaneous case, received on 19-Sep-2017, reported by a pharmacist and concerns a male patient of unknown age. Patient's medical history was not reported. The pharmacist reported that, AFLURIA QUADRIVALENT about 100 doses were received, 20 doses were administered and three patients experienced the events. On 12-Sep-2017, the patient received AFLURIA QUADRIVALENT (dose: 0.5ml, batch number: XF30506 (as reported), expiry date: 29-Jun-2018, route of administration, anatomical location was not reported). On 20-Sep-2017, after administration, the patient was extremely sick with symptoms hot and cold flashed, malaise. The patient had headache, nausea, fever, sweats, chills. It was reported that, the patient went to emergency room. The outcome of the events were recovered. Follow-up report received on 27-Sep-2017: Start date of the product administered (12-Sep-2017) and start date of the event (20-Sep-2017) was updated. The events nausea and fever were added. Amended narrative accordingly. Case correction received on 11-Oct-2017: Event sweats was added with start date.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This is a spontaneous case, initially received from other health professional (nurse) on 07-Feb-2018, concerning a 57-months-old, child male patient. On 06-Feb-2018, the patient (under 5 years of age) was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left vastus lateralis, batch number: XF35009, expiry date: 30-Jun-2018). The reporter assessed the event as non-serious. Significant follow up received on 26-Mar-2018: This case was considered as lost to follow up. Hence, no amendment was done in the narrative.
Sex: U
Vaccine: FLU4
Symptoms: Incorrect route of drug administration
Clinical narrative: This initial spontaneous case, was received on 21-Sep-2017 from a pharmacist, concerning a patient of an unspecified age and gender. The patient's medical history and concomitant medications were not reported. On 21-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intravenous push, batch number, expiry date, anatomical location: not reported). It was reported that, AFLURIA QUADRIVALENT was given to a patient via IV (intravenous) push instead of IM route (explicitly coded as incorrect route of drug administration). The reporter assessed the events as non-serious.
Age: 65.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Underdose
Clinical narrative: This non-serious initial spontaneous case, was received on 22-Sep-2017, from other health professional concerning a 65-year-old elderly male patient. The patient's medical history and concomitant medications were not reported. On 21-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: less than 0.5 ml (as reported), route of administration: intramuscular, batch number: 00144621A, expiry date: 31-May-2018, anatomical location: not reported). It was reported that the patient was administered the vaccine with a 0.5 inches needle, hence possibly received only a partial dose, less than 0.5 ml. The patient did not experience any adverse event. The reporter assessed the report as non-serious. Follow up received from health care professional on 25-Oct-2017: Added event no adverse event. Amended narrative accordingly.
Age: 49.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: This initial spontaneous case, was received from a nurse on 09-Nov-2017, concerning a 49-year-old, adult male patient. The patient's current conditions included high blood pressure, high cholesterol, diabetes and historical conditions were low thyroid, heart murmur. The concomitant medications included insulin, BYETTA, glimepiride, hydrochlorothiazide, metformin, losartan, pioglitazone, and VYTORIN. On 02-Nov-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch no: XF31407 and expiry date: 30-Jun-2018). It was reported that the vaccine reached 35.82F and 35.96F degrees but went back into range within 10-15 minutes. It was reported that the vaccine did not freeze. The patient was administered with that vaccine and had no event after administration. The reporter assessed this case as non-serious.
Age: 51.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Underdose, Wrong technique in product usage process
Clinical narrative: This initial spontaneous case, was received on 22-Sep-2017, from other health professional (nurse), concerning a 51-year-old, adult, male patient. The patient's medical history and concomitant medications were not reported. On 21-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: less than 0.5 ml (as reported), route of administration: intramuscular, batch number: 00144621A, expiry date:31-May-2018, anatomical location: not reported). It was reported that, the patient was administered the vaccine with a 0.5 inches needle (explicitly considered as wrong injection technique), hence possible received only a partial dose (explicitly considered as incomplete dose administered). It was reported that, the patient had not experienced any adverse event. At the time of this report, the outcome was not reported for the events. The reporter considered the events as non-serious. Follow-up received on 25-Oct-2017: The additional event (no adverse event) was added. It was reported that, the patient had not experienced any adverse event. The narrative was amended accordingly.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Underdose, Wrong technique in product usage process
Clinical narrative: This initial spontaneous case, was received on 22-Sep-2017, from other health professional (nurse), concerning a 21-year-old, adult, female patient. The patient's medical history and concomitant medications were not reported. On 21-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: less than 0.5 ml (as reported), route of administration: intramuscular, batch number: 00144621A, expiry date:31-May-2018, anatomical location: not reported). It was reported that, the patient was administered the vaccine with a 0.5 inches needle, hence possibly received only a partial dose. It was reported that, the patient had not experienced any adverse event. At the time of this report, the outcome was not reported for the events. The reporter considered the events as non-serious. Follow-up received on 25-Oct-2017: The additional event (no adverse event) was added. It was reported that, the patient had not experienced any adverse event. The narrative was amended accordingly.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Underdose, Wrong technique in product usage process
Clinical narrative: This initial spontaneous case, was received on 22-Sep-2017, from other health professional (nurse), concerning a 31-year-old, adult, female patient. The patient's medical history and concomitant medications were not reported. On 21-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: less than 0.5 ml (as reported), route of administration: intramuscular, batch number: 00144621A, expiry date: 31-May-2018, anatomical location: not reported). It was reported that the patient was administered the vaccine with a 0.5 inches needle (explicitly considered as wrong injection technique), hence possibly received only a partial dose (explicitly considered as incomplete dose administered). It was reported that, the patient had not experienced any adverse event. At the time of this report, the outcome was not reported for the events. The reporter considered the events as non-serious. Follow-up received on 25-Oct-2017: The additional event (no adverse event) was added. It was reported that, the patient had not experienced any adverse event. The narrative was amended accordingly.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Underdose, Wrong technique in product usage process
Clinical narrative: This initial spontaneous case, was received on 22-Sep-2017, from other health professional (nurse), concerning a 24-year-old, adult, female patient. The patient's medical history and concomitant medications were not reported. On 21-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: less than 0.5 ml (as reported), route of administration: intramuscular, batch number: 00144621A, expiry date:31-May-2018, anatomical location: not reported). It was reported that, the patient was administered the vaccine with a 0.5 inches needle (explicitly considered as wrong injection technique), hence possibly received only a partial dose (explicitly considered as incomplete dose administered). It was reported that, the patient had not experienced any adverse event. At the time of this report, the outcome was not reported for the events. The reporter considered the events as non-serious. Follow-up received on 25-Oct-2017: The additional event (no adverse event) was added. It was reported that, the patient had not experienced any adverse event. The narrative was amended accordingly.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from other health professional on 18-Oct-2017, concerning a female patient of unspecified age. The patient's current condition included breast feeding. On 06-Oct-2017, the patient received AFLURIA QUADRIVALENT (dose: 0.5 ml, anatomical location: left arm, batch number, expiry date, route of administration: not reported). It was reported that, the vaccine has been stored under temperature up to 53 F for an undetermined amount of time. Reporter stated that, the vaccine had been stored outside of the recommended temperature range. It was reported that, over 1500 patients and staff also received AFLURIA QUAD that was stored outside of the recommended temperatures. No adverse reactions have been reported. The outcome of the events was not reported. The reporter assessed the event as non-serious. Significant case correction received with IRD 18-Oct-2017: Added new event as 'drug administration error'. The event no adverse event was removed from the event tab. Narrative amended accordingly.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Underdose, Wrong technique in product usage process
Clinical narrative: This spontaneous case, was initially received on 22-Sep-2017, from other health professional (nurse), concerning a 60-year-old, adult, male patient. The patient's medical history and concomitant medications were not reported. On 21-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: less than 0.5 ml (as reported), route of administration: intramuscular, batch number: 00144621A, expiry date:31-May-2018, anatomical location: not reported). It was reported that the patient was administered the vaccine with a 0.5 inches needle, hence possibly received only a partial dose. It was reported that, the patient had not experienced any adverse event. At the time of this report, the outcome was not reported for the events. The reporter considered the events as non-serious. Significant case correction received with IRD 26-Sep-2017: The event "no adverse event" was removed from the event section and a new classification "special case with no AE" was added. Follow-up received on 25-Oct-2017: The additional event (no adverse event) was added. It was reported that, the patient had not experienced any adverse event. The narrative was amended accordingly. Significant case correction received with IRD 25-Oct-2017: The event "no adverse event" was removed from the event section and a new classification "special case with no AE" was added in general tab.
Age: 25.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Underdose, Wrong technique in product usage process
Clinical narrative: This initial spontaneous case, was received on 22-Sep-2017, from other health professional, concerning a 25-year-old, adult, male patient. The patient's medical history and concomitant medications were not reported. On 21-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: less than 0.5 ml (as reported), route of administration: intramuscular, batch number: 00144621A, expiry date:31-May-2018, anatomical location: not reported). It was reported that the patient was administered the vaccine with a 0.5 inches needle (explicitly considered as wrong injection technique), hence possible received only a partial dose (explicitly considered as incomplete dose administered). It was reported that, the patient had not experienced any adverse event. The reporter considered the events as non-serious. Follow-up received on 25-Oct-2017: The additional event (no adverse event) was added. It was reported that, the patient had not experienced any adverse event. The narrative was amended accordingly.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Underdose, Wrong technique in product usage process
Clinical narrative: This initial spontaneous case, was received on 22-Sep-2017, from other health professional (nurse), concerning a 45-year-old, adult, female patient. The patient's medical history and concomitant medications were not reported. On 21-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: less than 0.5 ml (as reported), route of administration: intramuscular, batch number: 00144621A, expiry date:31-May-2018, anatomical location: not reported). It was reported that, the patient was administered the vaccine with a 0.5 inches needle, hence possibly received only a partial dose. It was reported that the patient, had not experienced any adverse event. At the time of the report, the outcome of the events was not reported. The reporter considered the events as non-serious. Follow-up received on 25-Oct-2017: The additional event (no adverse event) was added. It was reported that the patient had not experienced any adverse event. The narrative was amended accordingly.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: This initial spontaneous case, was received on 28-Nov-2017, from other health professional, concerning a 60-year-old adult male patient. On 24-Nov-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: XF34409, expiry date: Jun-2018), which was stored at a maximum temperature of 57.6 degrees F, about 5 hours (explicitly considered as incorrect product storage and drug administration error). The reporter assessed the event as non-serious.
Sex: F
Vaccine: FLU4
Symptoms: Amniocentesis normal, Anaemia, Exposure during pregnancy, Prenatal screening test, Thyroxine free decreased
Clinical narrative: This is a non-serious spontaneous case, initially received from other health professional on 20-Dec-2017 and concerns a 44-year-old, adult female pregnant patient of body weight 143 kg and height 60.7 cm. The patient had no family history of major congenital malformations. The patient had no history of tobacco, alcohol or illicit drug use. The patient had 3 previous pregnancies from which 2 pregnancies had full term live births and 1 pregnancy had spontaneous abortion. The patient's current condition included UTI (urinary tract infection) (since an unspecified date). The patient's concomitant medications included VITAFOL and MACROBID for UTI (urinary tract infection). The patient's LMP (last menstrual phase) date was 05-Apr-2017. The patient had a singleton pregnancy. On 22-Aug-2017, amniocentesis was done which found to be normal and cystic fibrosis mutation analysis was performed and found to be normal (no major congenital malformations noted). On 17-Oct-2017, at gestation age of 28 weeks, the patient was administered with AFLURIA QUADRIVALENT (batch number: 00644623A, route of administration, dose, anatomical location and expiry date: not reported) (explicitly coded as vaccine exposure during pregnancy). On an unspecified date, the patient had UTI, anemia and low free thyroxine. The patient started the treatment with MACROBID capsule (2nd course, 100 mg, bid [two times a day]) (from 24-Oct-2017 to 31-Oct-2017) for UTI,  Ferrosol tablet (325 mg, qd [every day), and SYNTHROID tablet (50 mcg, qd) (from 24-Oct-2017 to continued). At the time of this report, the outcome of the events was not reported. The EDD (estimated date of delivery) was reported as 10-Jan-2018. Non-significant case correction received 20-Dec-2017 on 06-Feb-2018: The case comment was corrected.
Sex: F
Vaccine: FLU4
Symptoms: Urinary tract infection
Clinical narrative: This is a non-serious spontaneous case, initially received from other health professional on 20-Dec-2017 and concerns a 44-year-old, adult female pregnant patient of body weight 143 kg and height 60.7 cm. The patient had no family history of major congenital malformations. The patient had no history of tobacco, alcohol or illicit drug use. The patient had 3 previous pregnancies from which 2 pregnancies had full term live births and 1 pregnancy had spontaneous abortion. The patient's current condition included UTI (urinary tract infection) (since an unspecified date). The patient's concomitant medications included VITAFOL and MACROBID for UTI (urinary tract infection). The patient's LMP (last menstrual phase) date was 05-Apr-2017. The patient had a singleton pregnancy. On 22-Aug-2017, amniocentesis was done which found to be normal and cystic fibrosis mutation analysis was performed and found to be normal (no major congenital malformations noted). On 17-Oct-2017, at gestation age of 28 weeks, the patient was administered with AFLURIA QUADRIVALENT (batch number: 00644623A, route of administration, dose, anatomical location and expiry date: not reported) (explicitly coded as vaccine exposure during pregnancy). On an unspecified date, the patient had UTI, anemia and low free thyroxine. The patient started the treatment with MACROBID capsule (2nd course, 100 mg, bid [two times a day]) (from 24-Oct-2017 to 31-Oct-2017) for UTI,  Ferrosol tablet (325 mg, qd [every day), and SYNTHROID tablet (50 mcg, qd) (from 24-Oct-2017 to continued). At the time of this report, the outcome of the events was not reported. The EDD (estimated date of delivery) was reported as 10-Jan-2018. Non-significant case correction received 20-Dec-2017 on 06-Feb-2018: The case comment was corrected.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Discomfort, Joint swelling, Pruritus generalised, Tenderness
Clinical narrative: This is a spontaneous case, initially received on 10-Jan-2018 from other health professional (nurse), concerning 35-year-old, adult, female patient. The patient's medical history and concomitant medications were not reported. On 08-Jan-2018, the patient was administered with AFLURIA QUARDIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: XF33208, expiry date: 30-Jun-2018). On 09-Jan-2018, after 1 day of vaccination, the patient experienced general itchiness but more specific to the ankle. In addition, she complained of painful and swollen ankle. It was reported that, 6 hours later, both the ankles of the patient were still swollen, and it was tender which made her uncomfortable. The patient took BENADRYL to ease the symptoms and to sleep. The patient had not yet recovered from the events swollen ankles, pain in ankle, tenderness, generalized itching and discomfort (reported as still experiencing the symptoms). The reporter considered the events as non-serious. Follow up received on 06-Mar-2018: The AE follow up information had not received in 30 days, hence this report was considered the events as non-serious. Follow up received on 06-Mar-2018: The AE follow up information had not retrieved in 30 days, hence this report was considered as lost to follow up. No amendment was done in the narrative.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure via skin contact, No adverse event, Underdose
Clinical narrative: This is spontaneous case, initially received on 24-Jan-2018, was reported by a other health professional and concerns a 30-year-old, adult female patient. The patient's medical history and concomitant medications were not reported. On 24-Jan-2018, the patient was administered with half dose of AFLURIA QUADRIVALENT (dose: 0.25 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: XF35109, expiry date: 30-Jun-2018) (explicitly considered as incomplete dose administered), as rest of the vaccine leaked down her arm (explicitly considered as exposure via skin contact). It was reported that, no adverse events were noted. The reporter assessed the case as non-serious.
Age: 32.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from a pharmacist on 29-Jan-2018, concerning a 32-year-old adult male patient. The patient's medical history and concomitant medications were not reported. It was reported that, AFLURIA QUADRIVALENT (single opened MDV (multi-dose vial)) underwent temperature excursion (first excursion) at room temperature of 76-degree F for 30-40 minutes (not more than an hour). On 25-Jan-2018, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: 00944611A and expiry date: 30-Jun-2018) which underwent temperature excursion. It was stated that, the patient did not experience any adverse events after the vaccination. The reporter assessed the events as non-serious. Non-significant follow up received on 06-Feb-2018: The reporter confirmed that, the patient did not experience any adverse events after the vaccination. The narrative was amended accordingly.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from a pharmacist on 29-Jan-2018, concerning a 41-year-old adult female patient. This report was linked to case 201800198. The patient's medical history and concomitant medications were not reported. It was reported that, AFLURIA QUADRIVALENT vaccine (single, opened MDV (multi dose vial)) underwent temperature excursion (first excursion) at room temperature of 76-degree F for 30-40 minutes (not more than an hour). On 25-Jan-2018, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number; 00944611A and expiry date: 30-Jun-2018) which underwent temperature excursion. It was stated that, the patient did not experience any adverse events after the vaccination. The reporter assessed the events as non-serious. Non-significant follow up received on 06-Feb-2018: The reporter confirmed that, the patient did not experience any adverse events after the vaccination. The narrative was amended accordingly.
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult male patient of unspecified age. This refers 37 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (TIV) (batch number 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice parks for 6 days and had reached unknown temperature during transport instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient. The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reported of adverse effect after vaccination (no adverse effect). The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse event) and reporter's comment. Amended narrative accordingly.
Sex: U
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This non-serious spontaneous case, was initially received from other health professional, concerning a patient of an unspecified age and gender. On an unspecified date in Sep-2017, the patient received AFLURIA QUADRIVALENT (batch number: 00644623A (reported as 644623A), expiry date: Jun-2018, dose, route of administration, anatomical location: not reported). On an unspecified date, the patient experienced mild reactions at the injection site including redness, warmth and slight swelling. The outcome was not reported. The reporter did not provide the seriousness assessment. Non-significant case correction received with IRD 22-Sep-2017: Batch no. (00644623A) was captured in the case form and narrative was amended accordingly.
Sex: M
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous case, initially received from other non-health professional on 07-Feb-2018 and concerns a 4-year-old, child of unspecified gender. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was administered with AFLURIA QUADRIVALENT (dose, route of administration, anatomical location, batch number and expiry date: not reported). The reporter assessed the event as non-serious.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Fear, Gait disturbance, Headache, Nausea, Pain in extremity
Clinical narrative: This spontaneous case, initially received from the other non-health care professional (patient) on 30-Jan-2018, concerns 62-year-old, adult, female patient. The patient's current condition included hypertension (since an unspecified date). The patient's concomitant medications included losartan, Propranolol for hypertension and Multivitamins for unknown indications. On 24-Jan-2018, the patient was administered with AFLURIA QUADRIVALENT (dose:0.5ml, route of administration: intramuscular, anatomical location: left deltoid, batch number; XF32808 and expiry date: 30-Jun-2018). On 26-Jan-2018, after 2 days of vaccination, the patient developed pain in the upper thighs and lower quads of both legs, headache and vomiting. It was reported that, the patient's walk was slow and could not walk and she was unable to walk on the stairs. The patient was scared and applied ice on her legs and done salt baths. The patient stated that, the pain lasted for 4 days. On an unspecified date, the patient had recovered from the events difficulty in walking, headache, nausea, scary and pain in legs. The reporter assessed this case as non-serious. Follow-up received from the other non-health care professional (patient) on 01-Mar-2018: The patient confirmed that, she had no other medical history except hypertension (current condition). It was reported that the patient had recovered from the event pain in legs and was able to walk again. Narrative was amended accordingly. Significant case correction received with IRD 30-Jan-2018: Verbatim for the event 'gait disturbance' was changed from couldn't walk my stairs to could not walk my stairs. LLT was changed for the event pain in extremity from pain in legs to pain in extremity, as pain occurred in both thighs and legs. Amended narrative accordingly. Non-significant case correction received with IRD 30-Jan-2018: The verbatim for the event, nausea was corrected from 'She developed [headache and nausea] after receiving the vaccine' to 'She developed [headache and] and nausea after receiving the vaccine'. No changes were made in narrative.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: This spontaneous case, initially received from the other non-health care professional (patient) on 30-Jan-2018, concerns 62-year-old, adult, female patient. The patient's current condition included hypertension (since an unspecified date). The patient's concomitant medications included losartan, Propranolol for hypertension and Multivitamins for unknown indications. On 24-Jan-2018, the patient was administered with AFLURIA QUADRIVALENT (dose:0.5ml, route of administration: intramuscular, anatomical location: left deltoid, batch number; XF32808 and expiry date: 30-Jun-2018). On 26-Jan-2018, after 2 days of vaccination, the patient developed pain in the upper thighs and lower quads of both legs, headache and vomiting. It was reported that, the patient's walk was slow and could not walk and she was unable to walk on the stairs. The patient was scared and applied ice on her legs and done salt baths. The patient stated that, the pain lasted for 4 days. On an unspecified date, the patient had recovered from the events difficulty in walking, headache, nausea, scary and pain in legs. The reporter assessed this case as non-serious. Follow-up received from the other non-health care professional (patient) on 01-Mar-2018: The patient confirmed that, she had no other medical history except hypertension (current condition). It was reported that the patient had recovered from the event pain in legs and was able to walk again. Narrative was amended accordingly. Significant case correction received with IRD 30-Jan-2018: Verbatim for the event 'gait disturbance' was changed from couldn't walk my stairs to could not walk my stairs. LLT was changed for the event pain in extremity from pain in legs to pain in extremity, as pain occurred in both thighs and legs. Amended narrative accordingly. Non-significant case correction received with IRD 30-Jan-2018: The verbatim for the event, nausea was corrected from 'She developed [headache and nausea] after receiving the vaccine' to 'She developed [headache and] and nausea after receiving the vaccine'. No changes were made in narrative.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous case, initially received from the other health care professional on 07-Feb-2018, concerns a 04-year-7-months-old child, male patient. On 07-Feb-2018, the patient (below 5 years of age) was administered with AFLURIA QUADRIVALENT (dose: 0.5ml, route of administration: intramuscular, anatomical location: left vastus lateralis (thigh), batch number: XF35009 and expiry date: 30-Jun-2018). The reporter assessed this case as non-serious. Follow-up received on 26-Mar-2018: This case was considered as lost to follow-up since no response was received in 30 days.
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from other health professional on 08-Feb-2018 and concerns a patient of unspecified age and gender. The patient's medical history and concomitant medications were not reported. On 12-Dec-2017, a bottle of AFLURIA was opened and stored for more than 28 days. On 08-Feb-2018, the patient was administered with AFLURIA QUADRIVALENT (batch number: 00644611A, expiry date: 30-Jun-2018, dose, route of administration and anatomical location: not reported). It was reported that patient didn't experience any adverse events. The reporter assessed the events as non-serious. Follow-up received on 21-Mar-2018: Follow-up for this case is not being sought as response was not received from the reporter.
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: This non-serious spontaneous case, initially received on 22-Feb-2018, was reported by a pharmacist and concerns a patient of unspecified age and gender. On an unspecified date, the patient was administered with AFLURIA QUADRIVALENT (dose, route of administration, anatomical location, batch number, expiry date: not reported) that had possibly passed the 28-day expiration. Non-significant case correction received with IRD 22-Feb-2018: The seriousness criteria (non-serious) was added in the lead sentence.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous case, initially received from pharmacist on 01-Mar-2018, concerning a 3-year-old, male child. The patient had no medical history and concomitant medications. On 01-Mar-2018, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: XF35309 and expiry date: 30-Jun-2018) (explicitly coded as inappropriate age at vaccine administration). It was reported that, the patient did not experience any adverse reactions after the vaccination. The reporter assessed this case as non-serious. Non-significant case correction received 01-Mar-2018: Grammatical mistake in case comment was corrected. Non-significant follow up received on 10-Apr-2018: The reporter confirmed that, the patient did not experience any adverse reactions.
Age: 77.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Injection site pain, Injection site reaction, Pain in extremity, Rash macular
Clinical narrative: This is a non-serious spontaneous case, initially received from pharmacist on 02-Mar-2018, concerning a 77-year-old, elderly, male patient. The patient's medical history and concomitant medications were not reported. On 07-Feb-2018, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number and expiry date: not reported). On 01-Mar-2018, after 23 days of vaccination, the patient developed blotchy skin in upper arm, where injection was given (skin blotches) which looked like as liver spots. On an unspecified date, the patient had joint pain and pain from left armpit to his wrist (pain in arm). At the time of this report, the patient had recovered from the events. Follow-up report received from pharmacist on 28-Mar-2018: The date of birth and the age of the patient was updated. The outcome (recovered) for all the events was updated. Narrative amended accordingly.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure via skin contact, Needle issue, No adverse event
Clinical narrative: This non-serious initial spontaneous case, was received from other health professional (nurse) on 30-Oct-2017, concerning a 63-year-old female patient. The patient had no medical history and she did not receive any concomitant vaccine. On 30-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (batch number; XF35109, expiry date: 30-Jun-2018, dose, route of administration: topical to skin, anatomical location: not reported). The nurse went to administer the vaccine to the patient and did not have needle on syringe and the entire dose went down the patient's arm and no adverse reactions had occurred. The arm was immediately washed off with soap and water and she had not any problems. The nurse also stated that the patient did not actually receive the vaccine, the contact of the syringe when plunger pushed went all over the top of skin but did not penetrate skin. Follow up received from nurse on 22-Nov-2017: added reporter's comment.
Sex: F
Vaccine: FLU4
Symptoms: Exposure via eye contact, Eye irrigation, No adverse event
Clinical narrative: This initial spontaneous case, received on 27-Oct-2017, reported by other-health professional and concerns a female patient of unspecified age. On 27-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose, route of administration, anatomical location, batch number, expiry date: not reported). On 27-Oct-2017, while injecting the vaccine, the nurse splashed the vaccine in her eye. The patient washed her eye and she did not experienced any side effects. At the time of this report, the outcome of the events was not reported.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Bursitis, Pain in extremity
Clinical narrative: This non-serious initial spontaneous case, was received from a pharmacist on 25-Oct-2017, concerning a 25-year-old adult female patient. On 02-Oct-2017, the patient administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: XF30607, expiry date: 30-Jun-2018). Around 04-Oct-2017, 2 days after receiving the shot, the patient complained of sore arm. On an unspecified date, the patient also developed bursitis. It was reported that the arm in which she took the shot get better but it went to the other arm. At the time of this report, the patient had not yet recovered from the event bursitis and outcome of the event pain in arm was not reported. The reporter assessed the events as non-serious.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Injection site pain, Insomnia, Pain
Clinical narrative: This initial spontaneous case, was received from other non-health professional (consumer) on 19-Oct-2017, concerning a 52-year-old, adult, female patient. The patient's historical condition included injection site soreness (every year after vaccination). The patient's current condition included hypothyroidism (since an unspecified date). The patient's concomitant medication included levothyroxine for an unknown indication. On 17-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, batch number; 00844611A, expiry date: 29-Jun-2017, anatomical location: left deltoid, route of administration: intramuscular). On 18-Oct-2017, 13 hrs 25 min after vaccination, the patient's arm was sore, which was almost immobile and pain was so bad. The injection site was little sore and she could not use her arm. It was reported that, if she held her arm against her chest, then she did not feel the pain and could raise her arm above her head without pain but as soon as she started to lower her arm, the patient was severe. She felt like her bone was bruised (a deep pain) and she could hardly sleep last night (as reported). Anytime she moved her arm, the pain was severe. On 19-Oct-2017, this morning (as reported), pain was worse and pain was also in her hand. She felt numbness in hand and feet. She used ICY HOT patches (one time) and massage for the treatment of the events. The reporter stated that, her condition would get better. It was reported that, the pain was recovered after 5 days and other events were ongoing (not recovered). The reporter assessed the events as non-serious. Follow up received on 08-Nov-2017: The route of administration (intramuscular), anatomical location (left deltoid) and outcome of the event pain from not recovered to recovered after 5 days were updated. The narrative was amended accordingly.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: This initial spontaneous case, was received from other non-health professional (consumer) on 19-Oct-2017, concerning a 52-year-old, adult, female patient. The patient's historical condition included injection site soreness (every year after vaccination). The patient's current condition included hypothyroidism (since an unspecified date). The patient's concomitant medication included levothyroxine for an unknown indication. On 17-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, batch number; 00844611A, expiry date: 29-Jun-2017, anatomical location: left deltoid, route of administration: intramuscular). On 18-Oct-2017, 13 hrs 25 min after vaccination, the patient's arm was sore, which was almost immobile and pain was so bad. The injection site was little sore and she could not use her arm. It was reported that, if she held her arm against her chest, then she did not feel the pain and could raise her arm above her head without pain but as soon as she started to lower her arm, the patient was severe. She felt like her bone was bruised (a deep pain) and she could hardly sleep last night (as reported). Anytime she moved her arm, the pain was severe. On 19-Oct-2017, this morning (as reported), pain was worse and pain was also in her hand. She felt numbness in hand and feet. She used ICY HOT patches (one time) and massage for the treatment of the events. The reporter stated that, her condition would get better. It was reported that, the pain was recovered after 5 days and other events were ongoing (not recovered). The reporter assessed the events as non-serious. Follow up received on 08-Nov-2017: The route of administration (intramuscular), anatomical location (left deltoid) and outcome of the event pain from not recovered to recovered after 5 days were updated. The narrative was amended accordingly.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This initial spontaneous case, was received from other non-health professional, concerns a 58-year-old, adult female patient. On 17-Oct-2017, the patient was administered with AFLURIA QUAD (dose: 0.5 ml, route of administration: subcutaneous, anatomical location: right deltoid, batch no: XT59906, and expiry date: not reported). On 17-Oct-2017, the patient was administered with flu vaccine through subcutaneous route of administration which was explicitly coded as inappropriate route of vaccination. The patient did not experience any symptoms afterwards. The reporter considered this case as non-serious.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site abscess, No adverse event, Underdose, Wrong technique in product usage process
Clinical narrative: This initial spontaneous case, received on 19-Oct-2017, reported by other health professional concerning a 29-year-old adult female patient. The patient's current condition was immunocompromised. On 18-Oct-2017, the patient received AFLURIA QUADRIVALENT (route of administration: intramuscular/subcutaneous (IM and maybe SC: as reported), batch number: 01444621A (as reported), expiry date: 30-Jun-2018, dose and anatomical location was not reported). At the time of administration, the patient's skin was pulled to the side, kind of little on her skin to the left and not sure of the quantity of vaccine received through intramuscular and through subcutaneous. The patient did not received full dose (explicitly coded as under dose), because the pharma jet injector slipped during the administration (explicitly coded as drug administration error). No adverse events were reported after vaccination. As stated, the patient was immunocompromised, however the reporter doesn't know whether the events were due to a particular disease as it was not provided by the patient. At the time of this report, the outcome of the event (injection site abrasion) was recovered and other events were not reported. The reporter assessed this case as non-serious. Significant case correction was received with IRD 19-Oct-2017: The event 'drug administration error' was deleted.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy
Clinical narrative: This non-serious spontaneous case, was initially received on 25-Sep-2017, concerning a 42-year-old adult pregnant female patient. On 25-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5ml, route of administration: intramuscular, batch number: 00544611A, expiry date: 16-Jun-2018, anatomical location: not reported). It was reported that, vaccine was administered to a pregnant woman (explicitly coded as vaccine exposure during pregnancy). The patient said everything was fine and that she was healthy enough. The estimated date of delivery was reported as 11-Apr-2018. The outcome of the event was not reported. The reporter assessed the event as non-serious. Non-significant case correction received with IRD 22-Sep-2017: Batch number was updated on the screen. Narrative was amended accordingly.