chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: M
Vaccine: FLUC4
Symptoms: Pain in extremity
Clinical narrative: This is non-serious spontaneous case, initially received on 08-Feb-2018, from other non-health professional, concerning an 11-year-old, male child patient. On 06-Feb-2018, the patient was administered with FLUCELVAX QIV (dose, route of administration, anatomical location, batch number and expiry date: not reported). On 07-Feb-2018, after one day of vaccination, the patient had soreness in arm. At the time of this report, the outcome of the event not reported. This case was considered as lost to follow-up since, the patient's mother requested not to be contacted for follow up.
Age: 57.0
Sex: M
Vaccine: FLUC4
Symptoms: Infection, Pain, Swelling
Clinical narrative: This is spontaneous case, initially received from a Pharmacist on 13-Feb-2018, concerning a 57-year-old adult male patient. The patient's current condition included acid reflux (esophageal) (reflux as reported). The patient's concomitant medication included omeprazole for an unknown indication. On 29-Jan-2018, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left Deltoid, number: 196498, expiry date: 30-Jun-2018). It was stated that, the vaccine was done with no issues (as reported). On 07-Feb-2018, after 10 days of vaccination, the patient experienced swelling at under clavicle not near injection site. It was reported that, the patient's family physician suggested (ordered as reported) an MRI (magnetic resonance imaging) and antibiotic for infection. The patient did not specify whether the pain was in muscle or in bone. At the time of report the outcome of the event was not recovered. The reporter assessed the event swelling at under clavicle not near injection site as non-serious. Follow-up report received from the pharmacist o 28-Feb-2018: It was reported that, the patient's family physician suggested (ordered as reported) an MRI and antibiotic for infection. The patient did no specify whether the pain was in muscle or in bone. It was stated that, the vaccine was done with no issues (as reported). Amended narrative accordingly. Significant case correction received on 13-Mar-2018: The 'as determined' causality of the event bone swelling was changed from unassessable to not related in the event assessment tab. Case comment was updated accordingly.
Age: 47.0
Sex: F
Vaccine: FLUC4
Symptoms: Neuropathy peripheral, Paraesthesia, Tremor
Clinical narrative: This non-serious spontaneous case, initially received on 09-Feb-2018, was reported by a pharmacist and concerns a 47-year-old female adult patient. The patient had no diabetes, heart disease or asthma before getting the injection. Concomitant medications were not reported. On 21-Jan-2018, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 195241, expiry date: 30-Jun-2018). On the same day, after vaccination, the patient developed tingling in feet and tremors (patient stated that event started at the night, hence unsure of the onset date). Subsequently, the patient was diagnosed with neuropathy and was under prescriber's care, but she has no idea of what treatment she was given. At the time of this report, the patient had not recovered from the events. Follow-up received from the pharmacist on 09-Mar-2018: It was reported that, the patient had no diabetes, heart disease or asthma before getting the injection. The patient was under a provider's care, but she has no idea of what treatment she was given. Upon internal review, it was realized that the onset date of the event neuropathy was not captured. Hence, onset date of the event was added in the event tab. The narrative was amended accordingly. Follow-up received from the pharmacist on 02-Apr-2018: The reporter confirmed that, the start date of diagnosis (neuropathy) was 21-Jan-2018. The narrative was amended accordingly.
Age: 64.0
Sex: F
Vaccine: FLUC4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This is a spontaneous case, initially received from pharmacist on 21-Feb-2018, concerns a 64-year-old adult female patient. The patient had no medical history. The patient's concomitant medication included LIBRAX. On 04-Jan-2018, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 195124 and expiry date: 30-Apr-2018). On 21-Feb-2018, patient was again administered with second dose of FLUCELVAX QIV (in a same season). It was reported that, no adverse effects were noted after the vaccination. The reporter assessed the events as non-serious. Non-significant follow up received on 09-Apr-2018: As there is no new information in the source document, hence no changes were made in narrative.
Sex: F
Vaccine: FLUC4
Symptoms: Exposure via skin contact, Syringe issue, Underdose
Clinical narrative: This spontaneous case, initially received from the other health care professional on 09-Feb-2018, concerns 36-year-old adult, female patient. The patient's medical history and concomitant medications not reported. On 08-Feb-2018, the patient was administered with partial dose of FLUCELVAX QIV (dose: less than 0.5ml as reported, intramuscular, anatomical location: arm, route of administration, batch number and expiry date: not reported), as the needle was not placed on syringe correctly. While administration half of vaccine leaked onto patient's arm. The reporter assessed this as non-serious. Follow-up received from the reporter on 26-Mar-2018: Follow-up for this case was not being sought as response was not available. Non-significant case correction received with IRD 26-Mar-2018: Typo error (follow was changed to follow-up). Case comment was changed. Non-significant case correction received with IRD 09-Feb-2018: Dose: less than 0.5ml as reported, so deleted from dose field and mentioned in the narrative.
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This is a non-serious spontaneous case, initially received from other health professional on 12-Feb-2018, concerning a patient of an unspecified age and gender. On an unknown date, FLUCELVAX vaccine was kept in the refrigerator where temperature reached a max temperature of 53.2 F and was out of range for 5 hours and 57 minutes. It was reported that excursion occurred on 15-Jan-2018. On 20-Jan-2018, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 195250, expiry date: 30-Jun-2018) which underwent temperature excursion. It was reported that, the patient had no adverse events after the vaccination. Follow up received on 28-Feb-2018: The vaccine details (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid and indication: influenza prophylaxis) were updated. It was confirmed that, vaccine was administered on 20-Jan-2018. The narrative was amended accordingly.
Age: 57.0
Sex: F
Vaccine: FLUC4
Symptoms: Product storage error
Clinical narrative: This is a spontaneous case, initially received from other health professional on 30-Jan-2018, concerning a 57-year-old, adult, female patient. The patient's medical history and concomitant medications were not reported. On an unspecified date, it was reported that FLUCELVAX QUADRIVALENT vaccine which undergone temperature excursion for about 45 minutes and reported lowest as temperature 0.18 degrees C. It was reported that there are four different excursions which are all exceeding 30 minutes range (explicitly coded as incorrect product storage). On 30-Jan-2018, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch  number: 195215 and expiry date: 30-Apr-2018) (explicitly coded as drug administration error). The reporter assessed this case as non-serious.
Age: 47.0
Sex: F
Vaccine: FLUC4
Symptoms: Feeling abnormal, Product preparation issue
Clinical narrative: This is non-serious spontaneous case, initially received from a consumer on 13-Feb-2018, concerning 47-year-old female patient. The patient did not have any medical  history and was not taking any medication. On 13-Feb-2018, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number and expiry date: not reported). It was reported that the vaccine was not shaken before administration (considered as drug administration error). On the same day, after vaccine administration, the patient felt like water when needle went in. The patient did not feel like there was water fluid in the injection. The patient did not have pain at the injection site and no other symptoms. The patient's feeling of water immediately went away. The patient had query regarding shaking of the vaccine before administration. The outcome of the event was reported as recovered.
Age: 1.17
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 a consumer on 14-Feb-2018, concerning a 01-year-old male infant patient. The patient did not have any medical history and was not taking any concomitant medication. On 13-Feb-2018, the 01-year-old (under 4 years of age) patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: anterolateral thigh, batch number and expiry date: not reported) (explicitly coded as inappropriate age at vaccine administration). The patient did not experienced any adverse event after the vaccination. the reporter assessed the event as non-serious. Non-significant follow up received on 28-Feb-2018: As per the reporter, batch number and expiry date of the suspect vaccine were not available. Non-significant case correction received with IRD 14-Feb-2018: The narrative was corrected.
Age: 30.0
Sex: M
Vaccine: FLUC4
Symptoms: Exposure via skin contact, Injection site extravasation
Clinical narrative: This spontaneous case, initially received from a pharmacist on 31-Jan-2018, concerns a 30-year-old, adult, male patient. The patient had no health conditions and concomitant medications. On 31-Jan-2018, the patient administered with FLUCELVAX QIV (dose: (less than the full dose as reported), route of administration: intramuscular, anatomical location: right deltoid, batch number: 195235 and expiry date: 31-May-2018). It was reported that, after the injection, once the syringe pulled out, the vaccine dripped out from the injection site and pharmacist assumed that the patient received less than the full dose. Patient cleaned up the injection site and applied the BAND AID. The reporter assessed the events as non-serious.
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 01-Feb-2018, concerning a 03-year-old (child) male patient. The patient's medical history and concomitant medications were not reported. On 27-Jan-2018, 03-year-old child (under age of 4) was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 196498 and expiry date: 30-Jun-2018). It was stated that, no adverse event was reported after the vaccination. The reporter assessed the event as non-serious. Significant follow-up received on 13-Mar-2018: It was reported that, while attempted to contact the reporter, no response have been received. Case was closed as lost to follow-up. Non-significant case correction received with IRD 01-Feb-2018: The case comment was corrected from 'the causality of the event is assessed as not related by considering the incidental nature of the event' to 'the causality of the event is assessed as not related by considering the accidental nature of the event'.
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product complaint, Syringe issue, Underdose
Clinical narrative: This is a spontaneous case, initially received from a pharmacist on 30-Jan-2018, concerning a 21-year-old adult female patient. On 01-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: less than 0.5 ml, batch number: 195221, route of administration, anatomical location and expiry date: not reported). It was reported that, vaccine leaked between syringe and needle while administering to the patient (explicitly coded as syringe leak). It was stated that, there was no signs of damage on the syringe and needle used was easy point/retractable technologies. The needle was not attached tightly. As a result, partial dose was administered to the patient (less than 0.5 ml) (explicitly coded as incomplete dose administered). The defective units were reported as one and discovered during use. This report was associated with PTC (product technical complaint) with PTC reference number: 1027499. Based on the investigation performed, it was stated that, after completing the fill finish  investigation of the batch production records and manufacturing systems involved in Batch 195221, investigation determined that it was unlikely the defect identified in the complaint was the result of the manufacturing process. However, it could not be confirmed whether a defect existed in the needle or whether the user inadvertently applied pressure to the retractable needle color-coded tab during administration. As per the PTC report, it was stated that, the vaccine was leaked at Luer lock of the syringe. There were no signs of damage on the syringe, needle and packaging or no signs of leakage on the packaging. Syringe was stored in the original packaging before use and needle was tightly attached. It was reported that, no adverse effects were noted after the vaccination. The reporter assessed the events as non-serious. Non-significant case correction received 30-Jan-2018: The report was changed from 20-Jan-2018 to 30-Jan-2018 in narrative. Narrative was changed accordingly. Follow-up received from the quality assurance department on 28-Jun-2018: It was stated that, there was no signs of damage on the syringe and needle used was easy point/retractable technologies. The needle was attached tightly. After completing the fill finish investigation of the batch production records and manufacturing systems involved in Batch 195221, investigation determined that it was unlikely the defect identified in the complaint was the result of the manufacturing process. However, it could not be confirmed whether a defect existed in the needle or whether the user inadvertently applied pressure to the retractable needle color-coded tab during administration. The narrative was amended accordingly.
Sex: F
Vaccine: FLUC4
Symptoms: Pruritus, Swelling face
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional (consumer) on 19-Feb-2018, concerning a female patient of unspecified age. The patient's medical history and concomitant medication was not reported. On an unspecified date, the patient was administered FLUCELVAX QIV (dose, route of administration, anatomical location, batch number and expiry date: not reported). On an unspecified date, the patient experienced itching and swelling on the left side of the face after administration of the vaccine. At the time of this report, the outcome of the events (itching and swelling on the left side of the face) was not reported. This case was considered as lost to follow-up.
Age: 10.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-serious spontaneous case, initially received on 19-Mar-2018, was reported by other health professional and concerns a 10-year-old, child of unspecified gender. It was reported that, on an unspecified date, the temperature of the refrigerator in which vaccine was stored dropped to 32 F and was out of range for a total of 1 hour off and on for 2 weeks. On 31-Jan-2018, the patient was administered with FLUCELVAX QIV (dose, route of administration: intramuscular, anatomical location: right deltoid, batch number: 195236, expiry date: 31-May-2018). No adverse event was reported. Follow-up report received from other health professional on 19-Mar-2018: The report type was changed from invalid to spontaneous report. The age of the patient, start date of the event (31-Jan-2018), route of administration (intramuscular) and anatomical location (right deltoid) were added. Narrative amended accordingly. Non-significant follow-up received from the reporter on 07-May-2018: No adverse event was reported upon administration of vaccine stored out of temperature. Narrative was amended accordingly.
Age: 67.0
Sex: F
Vaccine: FLUC4
Symptoms: Abdominal pain, Abdominal pain lower, Body temperature increased, Dizziness, Nausea
Clinical narrative: This non-serious spontaneous case, initially received on 21-Feb-2018, from other non-health professional, concerning a 66-year-old, elderly, female patient. The patient's history included urinary tract infection (unspecified date). The patient's current condition included: hypothyroidism. The patient's concomitant medication included SYNTHROID for an unknown indication. On 08-Jan-2018, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular anatomical location: deltoid, batch number and expiry date: not reported). On the same day (08-Jan-2018), within a couple of hours of vaccination, the patient had hives, severe rash on lower legs and itch all over, these symptoms lasted for 3 weeks. The patient's body temperature (100.0 F) was increased. It was reported that, the patient also experienced dizziness and nausea along with severe abdominal pain, no vomiting was reported. On 09-Jan-2018, the patient consulted a general physician. The patient received treatment medications BACTRIM and TYLENOL for possible urinary tract infection (UTI) and left lower abdominal pain. Urine specimen analysis was not performed and no blood was found in urine. On an unspecified date, the patient had recovered from all the events (dizziness, abdominal pain, nausea, itching, hives, rash and fever). Follow-up received from other non-health professional on 19-Mar-2018: Added current condition as hypothyroidism in the patient tab. It was confirmed that the, patient received treatment medications BACTRIM and TYLENOL. The outcome of the event rash was changed from not recovered to recovered (in the event tab). The narrative amended accordingly. Follow-up received from the reporter on 09-Apr-2018: Added UTI in the history and indication for the treatment drugs TYLENOL and BACTRIM (UTI and left lower abdominal pain). Urine specimen analysis was not done and blood was not found in urine. Narrative was amended accordingly. Non-significant case-correction received with IRD 09-Apr-2018: The event term was updated from UTI to possible UTI in narrative and the case comment was amended. Narrative was amended accordingly.
Age: 67.0
Sex: F
Vaccine: FLUC4
Symptoms: Pruritus generalised, Rash, Urticaria
Clinical narrative: This non-serious spontaneous case, initially received on 21-Feb-2018, from other non-health professional, concerning a 66-year-old, elderly, female patient. The patient's history included urinary tract infection (unspecified date). The patient's current condition included: hypothyroidism. The patient's concomitant medication included SYNTHROID for an unknown indication. On 08-Jan-2018, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular anatomical location: deltoid, batch number and expiry date: not reported). On the same day (08-Jan-2018), within a couple of hours of vaccination, the patient had hives, severe rash on lower legs and itch all over, these symptoms lasted for 3 weeks. The patient's body temperature (100.0 F) was increased. It was reported that, the patient also experienced dizziness and nausea along with severe abdominal pain, no vomiting was reported. On 09-Jan-2018, the patient consulted a general physician. The patient received treatment medications BACTRIM and TYLENOL for possible urinary tract infection (UTI) and left lower abdominal pain. Urine specimen analysis was not performed and no blood was found in urine. On an unspecified date, the patient had recovered from all the events (dizziness, abdominal pain, nausea, itching, hives, rash and fever). Follow-up received from other non-health professional on 19-Mar-2018: Added current condition as hypothyroidism in the patient tab. It was confirmed that the, patient received treatment medications BACTRIM and TYLENOL. The outcome of the event rash was changed from not recovered to recovered (in the event tab). The narrative amended accordingly. Follow-up received from the reporter on 09-Apr-2018: Added UTI in the history and indication for the treatment drugs TYLENOL and BACTRIM (UTI and left lower abdominal pain). Urine specimen analysis was not done and blood was not found in urine. Narrative was amended accordingly. Non-significant case-correction received with IRD 09-Apr-2018: The event term was updated from UTI to possible UTI in narrative and the case comment was amended. Narrative was amended accordingly.
Age: 3.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This is a spontaneous case, initially received from pharmacist on 22-Jan-2018, concerns a 03-year-old (child) patient of an unspecified gender. The patient's medical history and concomitant medications were not reported. On an unspecified, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number and expiry date: not reported) (explicitly coded as inappropriate age at vaccine administration). It was reported that, no adverse event had occurred after the vaccination. The reporter assessed the event as non-serious. Significant follow up received on 01-Mar-2018: There had been no response from the reporter, hence this report was considered as lost to follow up. No changes were made in the narrative.
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 on 30-Jan-2018, was reported by other non-health professional and concerns a 03-year-old female child. The patient had no medical history or concomitant medications. On 30-Jan-2018, the patient was administered FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid batch number: 195240A, expiry date: 30-Jun-2018). It was reported that, the patient had no adverse event following the vaccination. The reporter assessed the case as non-serious.
Age: 3.0
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This is a non-serious spontaneous case, initially received from other health professional (nurse) on 18-Jan-2018, concerning a 39-month, female child. The patient's medical history and concomitant medications were not reported. On 12-Jan-2018, the patient (less than 4 years of age) was given FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left thigh, batch number: 195129, expiry date: 31-May-2018). It was reported that the patient did not experience any adverse event. The reporter assessed the event inappropriate age at vaccination as non-serious.
Age: 0.5
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 22-Jan-2018, concerns a 06-month-old infant male patient. The patient had no medical history. The patient did not receive any concomitant medications. On 22-Jan-2018, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: anterolateral thigh, batch number: 195235, expiry date: 31-May-2018) under age of 04-year-old. It was reported that, no adverse event was noted after the vaccination. The reporter assessed the event as non-serious.
Age: 12.0
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This is a spontaneous case, initially received on 24-Jan-2018 from other health professional concerning a 12-year-old, adolescent, female patient. On an unspecified date in Dec-2017, the vaccine underwent first temperature excursion. It was reported that, FLUCELVAX Quadrivalent PFS had been out of range for 80 hours, reaching the highest temperature of 9.1 C (explicitly coded as incorrect product storage). On 21-Dec-2017, the patient was administered with FLUCELVAX QIV after the first temperature excursion (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid (reported as right or left deltoid), batch number: 195228, expiry date: 31-May-2018) (explicitly coded as drug administration error). It was reported that, the patient did not experience any adverse event following vaccination. The reporter assessed the events (incorrect product storage and drug administration error) as non-serious. Significant case correction received 24-Jan-2018: Added start date of the event (incorrect product storage) as Dec-2017 in the product tab.
Age: 4.0
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This is a spontaneous case, initially received on 24-Jan-2018, was reported by a nurse and concerns a 04-year-old female child. The patient's medical history and concomitant medications were not reported. On an unspecified date in Dec-2017, the vaccine underwent first temperature excursion. It was reported that, FLUCELVAX QUADRIVALENT PFS had been out of range for 80 hours, and reached at the highest temperature of 9.1 Celsius (explicitly considered as incorrect product storage). On 04-Dec-2017, the patient was administered with FLUCELVAX QIV (dose 0.5 ml, route of administration: intramuscular, anatomical location: left/right deltoid, batch number: 195228, expiry date: 31-May-2018) (explicitly considered as drug administration error). The patient had no adverse event following the vaccination. The reporter assessed the events as non-serious.
Age: 54.0
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This is a spontaneous case, initially received from other health professional on 30-Jan-2018, concerning a 54-year-old, adult, female patient. The patient's medical history and concomitant medications were not reported. It was reported that, on an unspecified date, storage temperature FLUCELVAX vaccine reached 0.18 degrees C, for about 45 minutes and there were four different excursions which are all exceeding 30 minutes range. On 30-Jan-2018, the patient was administered with FLUCELVAX QIV which undergone temperature excursion (route of administration: intramuscular, anatomical location: deltoid, batch number: 195215 and expiry date: 30-Apr-2018, dose: not reported). It was reported that, the patient had not experienced any adverse event after the vaccination and patient was not revaccinated. The reporter assessed this case as non-serious. Follow up received on 19-Feb-2018: The reporter confirmed that, the patient had not experienced any adverse event after the vaccination and patient was not revaccinated. The narrative was amended accordingly.
Age: 74.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain in extremity
Clinical narrative: The spontaneous case, initially received from other non-health professional (consumer) on 16-Jan-2018, concerning 74-year-old, elderly, female patient. The patient's current conditions included Hashimoto's, migraines and depression. The patient was allergic to egg. It was reported that, exposure to egg caused pain in the calf of the patient. The patient's concomitant medications included ARMOUR thyroid, SYNTHROID, progesterone capsule, estrogen patch for an unknown indication. On 11-Jan-2018, the patient was administered with FLUCELVAX QIV (dose: 0.5ml, route of administration: intramuscular, anatomical location: left deltoid (left arm), batch number: 195241 and expiry date: 30-Jun-2018). On the same day of vaccination in the evening, the patient had deep pain in right calf muscle about the size of a nickel. No treatment medications were given to the patient. The patient went for physical therapy on 23-Jan-2018, which helped a little from pain. The patient recovered from the event (deep pain in right calf muscle). The reporter assessed the case as non-serious. Follow up report received on 27-Feb-2018: The patient's current conditions (Hashimoto's, migraines and depression). Batch number (195241) and expiry date (30-Jun-2018) was added. The outcome of the event was changed from not recovered to recovered. The narrative was amended accordingly.
Age: 63.0
Sex: M
Vaccine: FLUC4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This is a non-serious spontaneous case, initially received from other non-health professional on 30-Jan-2018, concerning a 63-year-old, adult, male patient. The patient's current conditions included diabetes, hypercholesterolemia and hypertension (from an unspecified date). The patient's concomitant medication included: ASA, metformin, TOPROL, REVATIO, ZOCOR and benazepril for an unknown indication. On 30-Jan-2018, the patient was administered with expired FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 185887 and expiry date: 30-Apr-2017). It was reported that, the patient did not experience any adverse event after the administration of vaccine.
Age: 30.0
Sex: F
Vaccine: FLUC4
Symptoms: Exposure during pregnancy, Syringe issue
Clinical narrative: This is a non-serious spontaneous case, initially received from pharmacist on 12-Jan-2018, concerning a 30-year-old, adult, female pregnant patient. The patient previous pregnancies were unknown. The patient's last menstrual period (LMP) was unknown. On an unspecified date, it was reported that syringe completely fell apart while trying to vaccinate. since the adapter piece (where syringe was screwed to needle) fell off from the syringe and the same thing happened with the second syringe. This case was associated with product technical complaint (PTC) and the corresponding reference number was 1027149. Based on the investigation performed, it was concluded that FLUCELVAX Batch 195243 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified in the manufacturing process, or relating to the syringes or stopper components, and no trends were identified for the batch for syringes for Luer Lock separation during administration due to using of the Easy Point retractable needles. The most likely root cause was attributed to improper handling by the user. On 12-Jan-2018, the patient was administered with FLUCELVAX QIV pre-filled syringe (PFS) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 195243 and expiry date: 30-Jun-2018) on an unspecified week of pregnancy. It was reported that, the patient had not experienced any adverse event. The estimated date of delivery (EDD) was on unspecified date in May-2018. Non-significant follow up received on 30-Mar-2018: The reporter had no information on patient's last menstrual period (LMP) and exact estimated date of delivery (EDD). No changes were made in the narrative. Follow-up report received from QA (quality assurance) department on 28-Jun-2018: Based on the investigation performed, no internal root cause was identified in the manufacturing process, or relating to the syringes or stopper components, and no trends were identified for the batch for syringes for Luer Loc separation during administration due to use of the Easy Point retractable needles. The most likely root cause was attributed to improper handling by the user. The narrative was amended accordingly.
Sex: F
Vaccine: FLUC4
Symptoms: Blister
Clinical narrative: This non-serious spontaneous case, initially received on 03-Jan-2018, reported by a pharmacist, concerns a female patient of an unspecified age. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was administered with FLUCELVAX QIV (dose, route of administration, anatomical location, batch number and expiry date: not reported). On an unspecified date, after the vaccination (duration unspecified), the patient developed a little yellow blister. The pharmacist inquired, if the FLUCELVAX vaccine contains any egg products and reported that, she did not know whether the patient was allergic to egg. At the time of this report the pharmacist stated that, the patient was fine (recovered). Non-significant follow-up received from the pharmacist on 08-Feb-2018: No additional information was available; hence no changes were made in the narrative.
Age: 71.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site haemorrhage, Injection site mass
Clinical narrative: This is a spontaneous case, initially received from a pharmacist on 26-Jan-2018, concerning a 71-year-old, elderly, female patient. The patient's medical history and concomitant medications were not reported. On 26-Jan-2018, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 196498, expiry date: 30-Jun-2018). On the same day (26-Jan-2018), after vaccination, the patient had bleeding at the injection site, so she applied pressure on it. However, lump was developed on the arm of the patient which was neither red nor warm but just a quarter size of knot. At the time of this report, the patient had not yet recovered from the events (injection site bleeding and vaccination site lump). The reporter assessed the events (injection site bleeding and injection site lump) as non-serious.
Age: 32.0
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This is a spontaneous case, initially received on 02-Jan-2018, reported by other health professional (nurse), concerning a 32-year-old adult female patient. This report was linked to case 201800029. The patient's medical history and concomitant medications were not reported. It was reported that, FLUCELVAX QIV vaccine reached 58-degree F and was out of range for about 5 hours (explicitly coded as incorrect product storage). On 02-Jan-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 195236 and expiry date: 30 -May-2018) which underwent temperature excursion (58-degree F and was out of range for about 5 hours) (explicitly coded as drug administration error). The reporter stated that, the patient did not experience any adverse effect after the vaccination. The reporter assessed this case as non-serious. Follow up received on 07-Feb-2018: The patient's date of birth and age (32-year-old) were updated. The narrative was amended accordingly.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Employee Health Nurse gave varicella to above as per protocol direction, patient reported the next day reaction to vaccine. RN instructed her per clinic. The area was 3 inches x 10 inches redness with 2 inches in diameter induration of area where vaccine was given. Warm to touch. No loss of muscle tone per her statement "If area doesn't improve or resolve I will see someone." Doing homecare right now.
Age: 4.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received on 24-Jan-2018, was reported by a nurse and concerns a 04-year-old male child. The patient's medical history and concomitant medications were not reported. On an unspecified date in Dec-2017, the vaccine underwent first temperature excursion. It was reported that, FLUCELVAX QUADRIVALENT PFS had been out of range for 80 hours, and reached at the highest temperature of 9.1 Celsius. On 04-Dec-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left/right deltoid, batch number: 195228, expiry date: 31-May-2018). The patient had no adverse event following the vaccination. The reporter assessed the events as non-serious.
Age: 16.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This is a spontaneous case, initially received on 24-Jan-2018 from other health professional, concerning a 16-year-old, adolescent, male patient. On an unspecified date in Dec-2017, the vaccine underwent first temperature excursion. It was reported that, FLUCELVAX QUADRIVALENT PFS had been out of range for 80 hours, reaching the highest temperature of 9.1 C (explicitly coded as incorrect product storage). On 21-Dec-2017, the patient was administered with FLUCELVAX QIV after the first temperature excursion (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid (reported as right or left deltoid), batch number: 195228, expiry date: 31-May-2018) (explicitly coded as drug administration error). It was reported that, the patient did not developed any adverse event following vaccination. The reporter assessed the events (incorrect product storage and drug administration error) as non-serious. Significant case correction received with IRD 24-Jan-2018: Added start date of the event incorrect product storage as (unspecified date in Dec-2017) in the product tab.
Age: 55.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received on 02-Jan-2018 from other health professional (nurse), concerning a 55-year-old adult male patient. This report linked to case 201800029. It was reported that, vaccine reached temperature of 58-degree F for 5 hours (explicitly coded as incorrect product storage). On 02-Jan-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, anatomical location: deltoid, route of administration: intramuscular, batch number: 195236 and expiry date: 30-May-2018), which underwent temperature excursion of 58-degree F for 5 hours (explicitly coded drug administration error). It was stated that, no adverse event effects were noted after the vaccination. The reporter assessed the case as non-serious.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Cough, Rash pruritic, Sleep disorder, Urticaria
Clinical narrative: Developing itchy rash as small hives in the posterior neck and (L) antecubitous area, improved with BENADRYL 1 dose - monitor 20-30 minutes, rash resolved, VS stable. Cough with running, when season changes, wake up at night time for cough. School before running VENTOLIN, at home running or before bed.
Age: 12.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Tremor
Clinical narrative: Patient presented a few minutes after Tdap in RT deltoid and flu vaccine in LT deltoid. C/O RT arm shaking. I had her lay on her LT side. Shaking stopped. I brought her a cup of water. She was able to drink it. RT arm began shaking again. I had her lay down and advised Dr.
Age: 21.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain in extremity
Clinical narrative: This initial spontaneous case, was received from nurse on 16-Nov-2017, concerning a 21-year-old adult female patient. The patient's medical history included high functioning autism. The patient's concomitant medication included unspecified psychotropics for an unknown indication. On 10-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 195211, and expiry date: Mar-2018). On the same day, after receiving the vaccine, patient experienced soreness in arm. No treatment was taken for the event. The same day (10-Oct-2017), the patient was recovered from the event after one hour. The reporter assessed the event as non-serious.
Age: 61.0
Sex: M
Vaccine: FLUC4, PPV
Symptoms: Chills, Injected limb mobility decreased, Injection site pain
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 19-May-2018 by Seqirus from VAERS (VAERS ID: 710502) concerns a 61-year-old, adult male patient. The patient's concomitant medications included atorvastatin, PERCOCET, lisinopril, prednisone, folic acid, clopidogrel for unknown indications. On 26-Aug-2018, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml (reported as unknown), route of administration: intramuscular, anatomical location: right arm, batch number: 195213, expiry date: not reported). On the same day, the patient was administered with PNEUMOVAX (dose: 2 DF, route of administration: intramuscular, anatomical location: right arm, batch number: N005096, expiry date: not reported). On 26-Aug-2018, the patient experienced chills which lasted for several hours during sleep. The patient also experienced soreness at the site of injection and difficulty in moving arm. On an unspecified date, the patient reported that pain had reduced (recovering). The patient had recovered from the event chills. The reporter assessed this case as non-serious.
Age: 60.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Headache, Malaise
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 16-Aug-2018 by Seqirus from VAERS (VAERS ID: 722697), concerns a 60-year-old, adult, female patient. The patient had no historical conditions, current conditions and allergies. On 25-Oct-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: injection (SYR as reported), anatomical location left arm, batch number: 195220 and expiry date: not reported]. On the same day (25-Oct-2017), about 25 minutes after vaccination, the patient felt fainted. The patient continued to feel unwell for about 2 hours after vaccination. The patient left the facility with mild headache, but the patient had otherwise recovered [as reported]. At the time of this report, the outcome of the events (dizziness and malaise) was recovered and the event (headache) was not recovered. The reporter assessed the case as non-serious.
Age: 32.0
Sex: M
Vaccine: FLUC4, HEPA, TYP, YF
Symptoms: Dermatitis contact, Injection site erythema, Injection site reaction, Injection site vesicles
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 724278), concerns a 32-year-old, adult, male patient. The patient's current condition included scalp psoriasis (reported as historical condition). The patient was allergic to penicillin. The concomitant medication included ketoconazole topical for an unknown. On 30-Oct-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, frequency reported as unknown, route of administration: intramuscular, anatomical location: right arm, batch number: 195124 and expiry date: not reported). On the same day, the patient was also administered non-company suspect vaccines HAVRIX (dose: reported as 1, route of administration: intramuscular, anatomical location: right arm, batch number 39Y4G and expiry date: not reported), TYPHIM VI (route of administration: intramuscular, anatomical location: right arm, batch number: N2H34, dose: unknown and expiry date: not reported) and STAMARIL (route of administration: subcutaneous, anatomical location: left arm, batch number: M51762V, dose: unknown and expiry date: not reported). It was reported that, the patients received three vaccines in the same right arm. On 31-Oct-2017, one day after vaccination, the patient developed an erythematous blister in an area of 0.25 x 1 cm on his right deltoid which was non-tender and non-pruritic. It appeared to be contact dermatitis from the removal of BAND AID 24 hours later. The patient made an office visit. At the time of this report, the patient had not recovered from the events. The reporter assessed the case as non-serious. Update received on 27-Sep-2018: Non-significant case correction (IRD: 26-Aug-2018): In the case comment, co-suspect vaccine, STAMARIL was removed and "into the same arm (considered as drug administration error)" was added after TYPHIM VI.
Age: 46.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Hypoaesthesia oral, Injection site pain, Injection site pruritus
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 724339), concerns a 46-year-old, adult female patient. The patient had no current illnesses. The patient was not taking any concomitant medications. On 20-Oct-2017, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, frequency reported as unknown, anatomical location: right arm, batch number: 195243, route of administration: unknown and expiry date: not reported). On the same day (20-Oct-2017) approximately 10 minutes after vaccination, the patient presented with itching and soreness at the site. The patient's cheeks were reddened with a peri-oral numbing sensation. The patient took BENADRYL 25 mg orally as a treatment. At the time of the report, the patient had recovered from the events. The reporter assessed the case as non-serious.
Age: 51.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous case, reported by other health professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 724349), concerns a 51-year-old, adult, female patient. The patient did not have any current conditions. On 15-Oct-2017, the patient was administered the suspect vaccine FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical site: left arm, batch number: 195238 and expiry date: not reported) and co-suspect vaccine ZOSTAVAX (dose, route of administration: subcutaneous, batch number: N014942, anatomical site: unknown and expiry date: not reported). On 16-Oct-2017, 1 day after vaccination, the patient experienced redness, swelling and warmth at the site of ZOSTAVAX injection. On 17-Oct-2017, the patient made an emergency room visit (urgent care)/office visit and was prescribed with BACTRIM DS. On an unspecified date, the patient had recovered from the events. The reporter assessed the case as non-serious. Update received on 20-Sep-2018: Non-significant case correction (IRD: 26-Aug-2018): The sentence in the case comment was changed from 'the causality is assessed as unassessable as the both vaccines given via different routes and site of ZOSTAVAX was not reported to 'the causality is assessed as unassessable due to unknown site of co-suspect ZOSTAVAX administration and reaction occurring at ZOSTAVAX injection site'.
Age: 21.0
Sex: F
Vaccine: FLUC4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 26-Aug-2018 by Seqirus from VAERS (VAERS ID: 724389), concerns a 21-year-old, adult, female patient. The patient's current conditions included acne, allergic rhinitis (also reported as historical condition). Patient was allergic to cats and dust mites. At the time of vaccination, the patient was taking MIRENA, XYZAL and spironolactone for unknown indications. On 01-Oct-2017, the patient was administered FLUCELVAX QIVc [route of administration: intramuscular, anatomical location: left arm, dose: 0.5 ml, batch number: not reported and expiry date: not reported]. On the same day after vaccination, the patient had pain in left shoulder/upper arm which was persisting 3 weeks after injection with limited shoulder range of motion. On an unknown date, the patient made an office visit. At the time of this report, the patient had not recovered from the events. The reporter assessed the case as non-serious.