chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: FLUC4
Symptoms: Product storage error
Clinical narrative: This spontaneous case, initially received from a nurse on 07-Dec-2017, concerning a 58-year-old adult female patient. The patient's medical history and concomitant medications were not reported. It was reported that, the vaccine underwent temperature excursion for about 30 minutes at the lowest temperature of 34.7-degrees F on 12-November and reoccurred on 27-November through first December (unspecified year) with the lowest 27.5 degrees F. On 01-Dec-2017, the patient was administered with FLUCELVAX QIV (batch number: 195250, expiry date: 30-Jun-2018, dose route of administration and anatomical location: not reported). The reporter assessed the events as non-serious. Follow up report received on 05-Jan-2018: This case was considered as lost to follow up, as nurse does not want to provide any further information.
Age: 69.0
Sex: F
Vaccine: FLUC4
Symptoms: Product storage error
Clinical narrative: This is spontaneous case, initially received from other-health professional (nurse) on 07-Dec-2017, concerning a 69-year-old elderly female patient. The patient's medical history and concomitant medications were not reported. It was reported that FLUCELVAX was out of recommended range for few days which occurred on 12-Nov-2017 for about 30 minutes lowest temperature 34.7 degrees F and reoccurred on 27-Nov-2017 through 01-Dec-2017 with the lowest 27.5 degrees F. On 01-Dec-2017, the patient was administered with FLUCELVAX QUADRIVALENT (batch no: 195250 and expiry date: 30-Jun-2018, dose, route of administration and anatomical location: not reported). The reporter assessed this case as non-serious. Follow up report received on 29-Jan-2018: It was reported that, the nurse did not want to provide any further information, hence the case was lost to follow up. Non-significant case correction received with IRD 07-Dec-2017: The case comment was corrected. No changes were made in the narrative.
Age: 47.0
Sex: M
Vaccine: FLUC4
Symptoms: Product storage error
Clinical narrative: This spontaneous case, initially received from other health professional (nurse) on 07-Dec-2017, concerning a 47-year-old adult male patient. The patient's medical history and concomitant medications were not reported. It was reported that FLUCELVAX was out of recommended range for a few days which occurred on 12-Nov-2017 for about 30 minutes lowest temperature 34.7 degrees F and re-occurred on 27-Nov-2017 through 01-Dec-2017 with the lowest 27.5 degrees F. On 01-Dec-2017, the patient was administered with FLUCELVAX QUADRIVALENT (batch number: 195250 and expiry date: 30-Jun-2018, dose, route of administration and anatomical location: not reported). The reporter assessed this case as non-serious. Follow up report received on 29-Jan-2018: It was reported that, the nurse does not want to provide any further information, hence the case is lost to follow up. Non-significant case correction received with the IRD 07-Dec-2017: The case comment was corrected.
Sex: M
Vaccine: FLUC4
Symptoms: Extra dose administered
Clinical narrative: This initial spontaneous case, was received from a pharmacist on 21-Nov-2017, concerns a male patient of unspecified age. On an unknown date, the patient was administered with FLUCELVAX QIV (dose, route of administration, anatomical location, batch no. and expiry date: not reported). It was reported that the patient received the flu vaccine twice: one at the hospital and other at the office which was explicitly coded as inappropriate schedule of vaccine administered and at the time of this report the reporter did not have further information. The reporter wanted to know if there was anything the patient should watch for. The reporter assessed the report as non-serious.
Age: 60.0
Sex: M
Vaccine: FLUC4
Symptoms: Product storage error
Clinical narrative: This spontaneous case, initially received from other health professional (nurse) on 07-Dec-2017, concerning a 60-year-old adult male patient. The patient's medical history and concomitant medications were not reported. It was reported that, FLUCELVAX was out of recommended range for a few days which occurred on 12-Nov-2017 for about 30 minutes lowest temperature 34.7 degrees F and re-occurred on 27-Nov-2017 through 01-Dec-2017 with the lowest 27.5 degrees F. On 01-Dec-2017, the patient was administered with FLUCELVAX QUADRIVALENT (batch number: 195250 and expiry date: 30-Jun-2018, dose, route of administration and anatomical location: not reported) which was out of recommended range. The reporter assessed this case as non-serious. Non-significant follow up received on 29-Jan-2018: No new information received.
Age: 50.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from nurse on 07-Dec-2017, concerning a 50-year-old, adult male patient. The patient's medical history and concomitant medications were not reported. The suspect vaccine FLUCELVAX QIV underwent temperature excursion for about 30 minutes and lowest temperature was 34.7-degree F (out of the recommended range). On 01-Dec-2017, the patient was administered with FLUCELVAX QIV which underwent temperature excursion (batch number: 195250, expiry date: 30-Jun-2018, dose, route of administration and anatomical location: not reported). The reporter assessed the events as non-serious. Case correction received with IRD 07-Dec-2017: Added classification as "special case with no AE" in the general tab. Updated expiry date of suspect vaccine as 30-Jun-2018 (in the product tab). The narrative was amended accordingly.
Age: 62.0
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from nurse on 07-Dec-2017, concerning a 62-year-old, adult female patient. The patient's medical history and concomitant medications were not reported. The suspect vaccine FLUCELVAX QIV underwent temperature excursion for about 30 minutes and lowest temperature was 34.7-degrees F (out of recommended range). On 29-Nov-2017, the patient was administered with FLUCELVAX QIV which underwent temperature excursion (batch number: 195250, expiry date: 30-Jun-2018, dose, route of administration and anatomical location: not reported). The reporter assessed the events (incorrect product storage and drug administration error) as non-serious. Case correction received with IRD 07-Dec-2017: Added classification as "special case with no AE" in the general tab. Updated expiry date of suspect vaccine as 30-Jun-2018 (in the product tab). The narrative was amended accordingly.
Age: 50.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, initially received from nurse on 07-Dec-2017, concerning a 50-year-old, adult male patient. The patient's medical history and concomitant medications were not reported. It was reported that FLUCELVAX QIV underwent temperature excursion for about 30 minutes and lowest temperature was 34.7-degrees F (out of the recommended range) (explicitly coded as incorrect product storage). On 29-Nov-2017, the patient was administered with FLUCELVAX QIV which underwent temperature excursion (batch number: 195226, expiry date: 30-Apr-2018, dose, route of administration and anatomical location: not reported) (explicitly coded as drug administration error). The reporter assessed the events as non-serious. Case correction received 07-Dec-2017: Added classification as "special case with no AE" in the general tab. Updated expiry date of suspect vaccine as 30-Apr-2018 (in the product tab). The narrative was amended accordingly.
Age: 27.0
Sex: F
Vaccine: FLUC4
Symptoms: Product storage error
Clinical narrative: This spontaneous case, initially received from nurse on 07-Dec-2017, concerning a 27-year-old adult female patient. The patient's medical history and concomitant medications were not reported. It was reported that, the vaccine underwent temperature excursion for about 30 minutes at the lowest temperature of 34.7-degree F on 12-November and reoccurred on 27-November with the lowest 27.5 degrees F. On 29-Nov-2017, the patient was administered with FLUCELVAX QIV (batch number: 195250, expiry date: 30-Jun-2018, dose, route of administration and anatomical location: not reported). The reporter assessed the events as non-serious. Follow up report received on 05-Jan-2018: This case was considered as lost to follow up, as nurse does not want to provide any further information.
Age: 62.0
Sex: F
Vaccine: FLUC4
Symptoms: Product storage error
Clinical narrative: This spontaneous case, initially received from nurse on 07-Dec-2017, concerning a 62-year-old adult female patient. The patient's medical history and concomitant medications were not reported. It was reported that, the vaccine underwent temperature excursion for about 30 minutes at the lowest temperature of 34.7-degrees F on 12-November and reoccurred on 27-November with the lowest 27.5 degrees F. On 29-Nov-2017, the patient was administered with FLUCELVAX QIV (batch number: 195250, expiry date: 30-Jun-2018, dose, route of administration and anatomical location: not reported). The reporter assessed the events as non-serious. Follow up report received on 05-Jan-2018: This case was considered as lost to follow up, as nurse does not want to provide any further information.
Age: 24.0
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This is a non-serious spontaneous case, initially received from other health care professional on 15-Nov-2017, concerning a 24-year-old, adult, female patient. It was reported that, the vaccine was not refrigerated in consumer care. Hence, the vaccine was exposed to temperature above 46F for greater than 64 hours likely to be affected. On 15-Nov-2017, the patient was administered with FLUCELVAX QIV that underwent temperature excursion (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number and expiry date: not reported). It was reported that, the patient did not experience any adverse event and there was no information on readministration of vaccine. The reporter assessed the events as non-serious. Follow-up received from other health professional on 11-Jan-2018: The reporter stated that, the vaccine was not refrigerated in consumer care. The patient was administered with vaccine and no adverse effects were reported. There was no information on readministration of vaccine. The narrative was amended accordingly.
Age: 43.0
Sex: F
Vaccine: FLUC4
Symptoms: Product storage error
Clinical narrative: This spontaneous case, initially received from nurse on 07-Dec-2017, concerning a 43-year-old adult female patient. The patient's medical history and concomitant medications were not reported. It was reported that, the vaccine underwent temperature excursion (out of the recommended range) for about 30 minutes at the lowest temperature of 34.7-degrees F on 12-November and reoccurred on 27-November with the lowest 27.5 degrees F (explicitly coded as incorrect product storage). On 29-Nov-2017, the patient was administered with FLUCELVAX QIV (batch number: 195250, expiry date: 30-Jun-2018, dose, route of administration and anatomical location: not reported) (explicitly coded as drug administration error). The reporter assessed the events as non-serious. Follow up report received on 05-Jan-2018: This case was considered as lost to follow up, as nurse does not want to provide any further information.
Sex: F
Vaccine: FLUC4
Symptoms: Exposure via breast milk
Clinical narrative: This initial spontaneous case, was received on 07-Dec-2017 from a pharmacist, concerns a female patient of unspecified age. On unspecified date, the patient administered with FLUCELVAX QIV (dose, anatomical location, route of administration, batch number, expiry date: not reported). On unspecified date, the breast-feeding patient might have received a flu vaccine. At the time of this report, the outcome of the event was not reported. The reporter assessed the event as non-serious.
Sex: F
Vaccine: FLUC4
Symptoms: Pain in extremity
Clinical narrative: This initial spontaneous case received, was received from nurse on 16-Nov-2017, concerning a 68-year-old, adult, female patient. The patient surgical history included cancer surgery and the patient was a smoker. The concomitant medications were not reported. On 17-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 195211, and expiry date: Mar-2018). On the same day of vaccination, patient experienced soreness in arm after receiving the vaccine, symptom resolved within one hour. At the time of this report, the patient was completely recovered from the event. The reporter assessed the case as non-serious.
Age: 55.0
Sex: M
Vaccine: FLUC4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This non-serious initial spontaneous case, was received from pharmacist on 22-Nov-2017, concerning a 55-year-old adult male patient. The patient's medical history and concomitant medications were not reported. On 22-Nov-2017, the patient was administered FLUCELVAX QIV (dose: 0.5 ml, route of administration; intramuscular, anatomical location: deltoid, batch number: 195229, expiry date: May-2018). It was reported that, the patient received 2 doses in the same season (explicitly coded as inappropriate schedule of vaccine administered) and no adverse effects were noted. The reporter assessed the event as non-serious.
Age: 27.0
Sex: F
Vaccine: FLUC4
Symptoms: Exposure via skin contact, Syringe issue
Clinical narrative: This spontaneous case, initially received from other health professional (Pharmacist) on 13-Dec-2017, concerning a 27-year-old, adult female patient. The patient's medical history and concomitant medication was not reported. This case was associated with the product technical complaint (PTC) and the corresponding reference number was 1026624. On 13-Dec-2017, the patient was administered with FLUCELVAX Quadrivalent (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch no: 195222 and expiry date: 30-Apr-2018). On the same day, while administering the vaccine by the pharmacist, it looked like the needle was coming off the syringe and syringe leaked between the hub and syringe during administration (explicitly coded as needle issue). It was reported that the syringe leaked onto patient's arm (explicitly coded as exposure via skin contact and syringe leak). Another dose of vaccine was administered with another PFS. It was reported that patient received total dose (0.5ml) after readministration and no adverse events were occurred after vaccine readministration. Based on the product technical complaint (PTC) report it was concluded that the defect identified in the complaint was either the result of the manufacturing process or was present in the syringes or stoppers provided by an approved outside vendor. This investigation determined that it was unlikely that the defect identified in the complaint was the result of the manufacturing process. However, it cannot 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. Therefore, the most likely root cause found that no internal root cause was confirmed, and no external/user root cause was determined. Narrative amended accordingly. The reporter assessed the events as non-serious. Follow-up from pharmacist received (follow-up 2 received on 26-Jan-2018 and combinedly processed) on 12-Jan-2018: The pharmacist confirmed that patient received a total dose (0.5ml) after readministration and no adverse events were occurred after vaccine readministration. From the PTC report it was concluded that the defect identified in the complaint was either the result of the manufacturing process or was present in the syringes or stoppers provided by an approved outside vendor. This investigation determined that it was unlikely that the defect identified in the complaint was the result of the manufacturing process. However, it cannot 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. Therefore, the most likely root cause found that no internal root cause was confirmed, and no external/user root cause was determined. Narrative amended accordingly.
Age: 50.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous case, was initially on 13-Dec-2017, from the other health professional, concerning a 50-year-old adult male patient. On 13-Dec-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5ml, route of administration: intramuscular, anatomical location: batch number: 195233 and expiry date: 31-May-2018). It was reported that, vaccine has been exposed to this temperature excursion above 46 F. It was reported that, the patient did not experience any adverse event. The reporter considered this case as non-serious.
Age: 36.0
Sex: F
Vaccine: FLUC4
Symptoms: Pruritus, Rash, Rash generalised, Rash vesicular
Clinical narrative: This spontaneous case, initially received on 23-Nov-2017 from a pharmacist, concerning a 36-year-old, adult female patient. Concomitant medication included SYNTHROID and XANAX. On 09-Nov-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 195227, expiry date: 31-May-2018). On the same day (09-Nov-2017), the patient experienced blistering rash all over body after receiving flu vaccine. It was reported that the patient also had itching now and then (comes and go as reported) and rash remains on left arm and left leg. No lab tests were performed. At the time of this report, the patient had not yet recovered from the event. The reporter considered the case as non-serious. Follow up received from the reporter on 10-Jan-2018: The patient had no relevant medical history. The suspect product (INN Flu Vaccine Seasonal) to FLUCELVAX QIV according to the batch number: 195227. It was reported that the patient had itching now and then (comes and goes as reported) and rash was remained in left arm and left leg and no lab test was performed. Narrative was amended accordingly.
Age: 26.0
Sex: F
Vaccine: FLUC4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This initial spontaneous case, was received from other health professional on 12-Dec-2017, concerns a 26-year-old adult female pregnant patient. The patient's medical included spontaneous abortion in 2015. Her family history includes Huntington's disease. Her concomitant medications included prenatal vitamins. On 10-Nov-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5ml, batch no: 195229, expiry date: 31-May-2018, route of administration and anatomical location: not reported). On 06-Dec-2017, the patient was administered with second dose of FLUCELVAX Quadrivalent. The reporter states that pregnant patient might have received 2 doses of FLUCELVAX (explicitly coded as drug overdose) and the reporter is not sure whether the patient was given an actual second dose. It was given that the patient did not experience any event following vaccination. The estimated date of delivery reported as 29-Jan-2018. The reporter assessed this case as non-serious. Follow received from report 15-Jan-2018: It was reported that the reporter not confirmed about the second dose of FLUCELVAX and there was no further information available. It was stated that FLUCELVAX administered in error or Tdap (reason unknown). No adverse events reported.
Age: 27.0
Sex: F
Vaccine: FLUC4
Symptoms: Mobility decreased, Pain, Pain in extremity
Clinical narrative: This is a spontaneous case, initially received on 12-Dec-2017, from other health professional (pharmacist), concerning a 27-year-old, adult female patient. The patient did not have medical history. The patient's concomitant medications were not reported. On 30-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch no: 195246 and expiry date: 30-Jun-2018). After administration of FLUCELVAX (reported as a few months ago), the patient had limited mobility ever since the shot. It was reported that, her arm was hurting and she had trouble in lifting anything. Patient suspected that it might be a nerve or tendon reaction and complained of pain (like a shooting pain) and limited mobility when she moved her arm up and down. On 31-Oct-2017, the patient started feeling pain and later it got worse. The reporter stated that, the patient did not receive any medication to treat the events. The outcome of the events was not recovered (reported as ongoing). The reporter assessed the events as non-serious. Follow-up received on 08-Feb-2018: This case was considered lost to follow-up since the reporter could not be contacted for further information after the attempt made in 30 days.
Age: 1.5
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This initial spontaneous case, was received on 11-Dec-2017, from other health professional, concerning 18-months-old male infant. On 11-Dec-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left thigh, batch number: 195230, expiry date: 31-May-2018). (explicitly coded as inappropriate age at vaccination). It was reported that, the patient did not experience any adverse event. The reporter considered this case as non-serious.
Age: 25.0
Sex: F
Vaccine: FLUC4
Symptoms: Condition aggravated, Depression
Clinical narrative: This spontaneous case, initially received on 28-Nov-2017 from other health professional (nurse), concerning a 25-year-old, adult female patient. The patient current condition included: depression, migraine and hypertension. The patient concomitant medications were Nortriptyline, Melatonin, ZOFRAN, labetalol and naproxen for migraine. On 08-Dec-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 195249, expiry date: Jun-2018). On 09-Dec-2017 (not sure), the patient was feeling more depressive after receiving the flu vaccine. At the time of the report, the patient had not recovered from the events. The reporter assessed the events as non-serious. Follow up report received on 09-Feb-2018: Follow-up for this case is not being sought as reporter information is not available". Hence this case is considered as lost to follow up.
Age: 14.0
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Product complaint, Underdose
Clinical narrative: This is a spontaneous case, initially received on 11-Dec-2017 (combinedly processed with follow-up received on 15-Jan-2018), from a pharmacist and concerns a 14-year-old adolescent female patient. The patient had no medical and medication history were not reported (reported as clean health history). On 08-Dec-2017, during the preparation of the syringe for vaccination, air bubble was noticed which popped out (lost some amount of vaccine). Subsequently, the patient was administered with FLUCELVAX QIV (route of administration: intramuscular, anatomical location: right deltoid, batch no: 195232, expiry date: 31-May-2018, dose: not sure if the patient received the full dose [as reported]) (explicitly considered as incomplete dose administered). This case was associated with product technical complaint (PTC) and the corresponding reference number was 1027286. The patient did not experience any adverse events, and everything was normal. It was reported that, the patient had decided not to take second dose of flu vaccine. The reporter assessed this case as non-serious.
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Crying, Haematoma, Vaccination site pain
Clinical narrative: This is a spontaneous case, initially received from pharmacist on 26-Dec-2017, concerning a 59-year-old adult female patient. The patient had no relevant medical history and she did not receive any concomitant medications. On 29-Nov-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, 25-gauge 1 inch needle, batch number: 195245, expiry date: 30-Jun-2018). On the same day, 2 to 3 hrs after vaccination, the patient experienced pain in the arm at the vaccination site. It was reported that the pain was horrible. The patient consulted her physician, who said she had a hematoma". The physician advised the patient to take TYLENOL, ibuprofen, meloxicam (for pain) and apply heat to the area (warm compresses 4 times a day). The patient also reported that it hurt every day to the point and she cried from the pain. At the time of this report, the patient had not yet recovered from the events. The reporter assessed this case as non-serious. Non-significant follow up received on 07-Feb-2018: The reporter confirmed that, the patient had no relevant medical history. Non-significant case correction received 26-Dec-2017: Narrative was reframed "The patient consulted her physician, who said she had a hematoma'.
Age: 35.0
Sex: F
Vaccine: FLUC4
Symptoms: No adverse event, Syringe issue
Clinical narrative: This non-serious spontaneous case, initially received on 22-Dec-2017, from a pharmacist and concerns a 35-year-old adult female patient. On an unspecified date, the patient was administered with FLUCELVAX (dose: 0.25 as reported (units: not reported), route of administration: intramuscular, batch number: 195242, anatomical location: right arm and expiry date: 30-Jun-2018) (explicitly coded as incomplete dose administered). During administration, the vaccine dripped from the needle where it was attached the syringe (explicitly coded as product leakage). The PTC number was reported as 1026861). The health care professional was not exposed to the vaccine. It was reported that, the patient did not experience any adverse event after vaccination.
Age: 48.0
Sex: M
Vaccine: FLUC4
Symptoms: Incorrect route of product administration, Injection site induration, Product administered at inappropriate site, Wrong product administered
Clinical narrative: This is a spontaneous case, initially received from other health professional (nurse) on 20-Dec-2017, concerning a 48-year-old, adult, male patient. The patient's concomitant medication included: Diltiazem. On 13-Dec-2017, the patient was inadvertently administered with FLUCELVAX QIV (dose: 0.1 ml, route of administration: intradermal, batch no: 195125, expiry date: 30-Apr-2018 and anatomical location: left forearm). It was reported that, the nurse meant to administer PPD (purified protein derivative) instead of FLUCELVAX (explicitly coded as wrong vaccine administered, inappropriate route of vaccination and incomplete dose administered). On an unspecified date, after vaccination, the patient developed a large (25 mm) induration. The patient did not receive any treatment medication. At the time of this report, the patient was still recovering from the event injection site induration. The reporter assessed this case as non-serious.
Age: 40.0
Sex: F
Vaccine: FLUC4
Symptoms: Exposure via skin contact, No adverse event, Product complaint, Syringe issue
Clinical narrative: This spontaneous case, initially received from Pharmacist on 11-Dec-2017, concerning a 40-year-old adult female patient. The patient had no medical history and he had not received any concomitant medications. On 11-Dec-2017, the patient was administered with FLUCELVAX QIV (trade name, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 195225A and expiry date: 30-Apr-2018). It was reported that, patient received the partial dose as some of vaccine leaked onto arm from the plunger area (explicitly coded as incomplete dose administered and product leakage). There were no any signs of damage on the syringe and needle and they were tightly attached. The PTC number (product technical complaint) was reported as 1026564. It was reported that, the patient did not experience any adverse event. The reporter assessed the event as non-serious. Follow-up received from on 13-Dec-2017: Added PTC number (product technical complaint: 1026564). Follow up report received on 09-Jan-2018: It was reported that, the patient did not experience any adverse event. The narrative was amended accordingly.
Sex: U
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This initial spontaneous case, was received from other health professional (pharmacist) on 22-Nov-2017, concerns a patient of unspecified age and gender. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was administered with FLUCELVAX QUADRIVALENT (batch number: 195211, expiry date: Mar-2018, dose, route of administration and anatomical location: not reported). It was reported that, the refrigerator reached a temperature of 47F-56F for 456 hours in which the flu vaccine was stored. The reporter stated that the patient received flu vaccine which was stored outside the recommended range. The reporter stated that it was the first-time excursion and there was no adverse event (reported as no AE) to report. The reporter assessed the case as non-serious.
Age: 38.0
Sex: M
Vaccine: FLUC4
Symptoms: Lethargy, Paraesthesia, Vomiting projectile
Clinical narrative: This is a spontaneous case, initially received from other non-health professional (consumer) on 21-Dec-2017, concerning a 38-year-old, adult, male patient. The patient's current condition included: egg allergy and hypertension (since an unspecified dates). The patient's concomitant medication included: unspecified medication which was used to control hypertension (reported as hypertension was well controlled with medication). On 19-Dec-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch no: 195129, expiry date: 30-Apr-2018). On an unspecified date in Dec-2017, after 12 hours of vaccination, the patient experienced projectile vomiting, tingling in hands and feet. In addition, he was very lethargic. However, the patient did not receive any treatment for the events. The patient had recovered from the events projectile vomiting, tingling feet/hands and not yet recovered from the event lethargic. The reporter assessed all 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 initial spontaneous case was received on 24-Nov-2017, from other-health professional, concerning a 3-year-old male patient. On 24-Nov-2017, the patient was administered with FLUCELVAX QIV (dose 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch no: 195243 and expiry date: Jun-2018). It was reported that no adverse events were noted after vaccination. The reporter considered this case as non-serious.
Sex: F
Vaccine: FLUC4
Symptoms: Exposure during pregnancy, No adverse event, Underdose
Clinical narrative: This spontaneous case, initially received on 27-Nov-2017, from a consumer, concerns a female pregnant patient of an unspecified age. The patient's medical history and concomitant medications were not reported. On 26-Nov-2017, the pregnant patient was administered with FLUCELVAX QIV (dose: less than 0.5 ml (as reported), route of administration, anatomical location, batch number, expiry date: not reported), at 34 weeks of pregnancy and the vaccine was expelled twice from the pre-filled syringe before administration. The reporter considered the events as non-serious. Significant case correction received with IRD 27-Nov-2017: Added classification "Special Case with No AE" in relevant field.
Age: 3.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 19-Jan-2018, concerns a 39 and half month old (child) patient of an unspecified gender. On an unspecified age, the patient was administered with FLUCELVAX QIV (dose, route of administration, anatomical location, batch number, and expiry date: not reported). It was stated that, no adverse event was reported after the vaccination.
Age: 2.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This is a spontaneous case, initially received on 29-Nov-2017, from other health professional (nurse), concerning a 02-year-old male child. The patient's medical history included GERD (Gastroesophageal reflux disease). On 02-Oct-2017, the patient was administered with FLUCELVAX QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left thigh, batch number: 195218, expiry date: 30-Apr-2018). It was reported that the patient had no adverse event. The reporter assessed the case as non-serious. Non-significant follow-up received from other health professional (nurse) received on 02-Jan-2018: The other health professional (nurse) confirmed that patient did not have any adverse event.
Age: 24.0
Sex: F
Vaccine: FLUC4, FLUX
Symptoms: Extra dose administered, Maternal exposure before pregnancy, No adverse event
Clinical narrative: This initial non-serious spontaneous case, was received on 28-Nov-2017, from other health professional, concerning a 24-year-old adult female pregnant patient. The patient's concomitant medication included prenatal vitamins for an unknown indication. The patient's LMP (last menstrual period) was reported as 07-Mar-2017. On 16-Oct-2017, the pregnant patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 195218, expiry date: 30-Apr-2018), and a second dose of flu vaccine was given to the patient within one season on 27-Oct-2017. It was reported that no adverse event has occurred. The patient's EDD (estimated date of delivery) was reported as 12-Dec-2017.
Age: 61.0
Sex: F
Vaccine: FLUC4
Symptoms: Cough, Fatigue, Influenza, Upper respiratory tract infection
Clinical narrative: This spontaneous case, initially received on 08-Mar-2018 was reported by other non-health professional (consumer) and concerns a 61-year-old adult female patient. The patient's current condition included diabetes and concomitant medications included unspecified diabetes medications. On 29-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number, expiry date: not reported). On 30-Sep-2017, the next day of vaccination, the patient developed flu symptoms. On an unspecified date, the patient consulted physician, who diagnosed upper respiratory infection (URI), fatigue and cough. The patient was prescribed with ROBITUSSIN for cough. At the time of this report the patient had not recovered from the events. The reporter assessed the case as non-serious.
Age: 1.5
Sex: M
Vaccine: FLUC4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: This spontaneous case, initially received from other health professional on 27-Feb-2018, concerning an 18-months infant male patient. The patient's historical condition included: cold. Historical drug included: flu vaccine for an unknown indication. Current condition included: plagiocephaly and gross motor developmental delay. Concomitant medications included: CLARITIN, Albuterol, Saline and unspecified nasal spray. On 26-Feb-2018, the patient (under 5 years of age) was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left thigh, batch number: 195235, expiry date: 31-May-2018 (explicitly coded as inappropriate age at vaccine administration). The reporter assessed the event as non-serious.
Age: 64.0
Sex: F
Vaccine: FLUC4
Symptoms: Device leakage, Exposure via skin contact
Clinical narrative: This is a spontaneous case, initially received from other health professional on 28-Feb-2018, concerning a 64-year-old adult female patient. The patient's medical history and concomitant medications were not reported. On 27-Feb-2018, while drawing the FLUCELVAX QIV (batch number: 195125 and expiry date: 30-Apr-2018), the vaccine leaked from MDV (multi dose vial) stopper's puncture hole on the patient's (administrator's) hands and patient washed her hands. The defect was discovered during use of product. The packaging was not damaged and packaging (carton, leaflet) were not appeared wet or water damaged. The 23-gauge needle and syringe size of 3 ml were used. No air was added to the vial from the syringe but when needle was extracted, vaccine sprayed out of the punctured hole. Leak was observed at the point of needle exit and no leak was observed around the edges of the stopper. This report was associated with PTC (product technical complaint) with PTC reference number: 1028299. The investigation performed, concluded that FLUCELVAX Batch 195125 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 vial or stopper components. The most likely root cause will be attributed to improper handling by the user. It was reported that, no adverse effects were noted. The reporter assessed the events as non-serious. Follow-up received quality assurance department on 12-Apr-2018: The investigation performed, concluded that FLUCELVAX Batch 195125 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 vial or stopper components. The most likely root cause will be attributed to improper handling by the user. Narrative was amended accordingly.
Age: 43.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: This spontaneous case, initially received from a consumer on 06-Feb-2018, concerning a 43-year-old adult female patient. Patient had no medical history and was not taking any concomitant medication. On 30-Jan-2018, the patient was administered with FLUCELVAX QIV (dosage: 0.5ml, batch number: 195126, route of administration: intramuscular). On 31-Jan-2018, 1 days after administration of vaccine, the patient experienced severe pain in the same shoulder and arm where she got the shot. The patient reported that the events became more severe on 01-Feb-2018. The patient had treatment of ibuprofen (800 mg, route unknown), but did not get better. She went to the doctor where she had prescription for tramadol (50mg, route: not reported, 1 every 6 hours). The patient recovered from the events (reported as 6 weeks later, no exact date). The reporter considered the case non-serious. Significant follow-up report received on 30-Mar-2018: Outcome was changed from recovering to recovered (reported as 6 weeks later, no exact date). Amended narrative accordingly.
Age: 37.0
Sex: F
Vaccine: FLUC4
Symptoms: Incorrect route of product administration, Injection site erythema, Wrong product administered
Clinical narrative: This spontaneous case, initially received from other health professional (Nurse) on 18-Dec-2017, concerning a 37-year-old, adult female patient. The patient's medical and medication history was not reported. On 18-Dec-2017, the patient was inadvertently administered with FLUCELVAX QIV (dose: 0.1 ml, route of administration: intradermal, batch no: 195128, expiry date: 30-Apr-2018 and anatomical location: not reported). It was reported that the nurse meant to administer PPD (purified protein derivative) instead of FLUCELVAX. On the same day, the patient developed mild redness at the site of injection. The patient recovered from the event mild redness at the sire of injection on 18-Dec-2017. The reporter assessed the events as non-serious. Non-significant case correction was received on 18-Dec-2017: Narrative was corrected.
Age: 54.0
Sex: M
Vaccine: FLUC4
Symptoms: Product storage error
Clinical narrative: This is a spontaneous case, initially received on 05-Feb-2018 from other health professional, concerning a 54-year-old, adult male patient. It was reported that, the FLUCELVAX was exposed to temps above 8C. Later, the temperature of the refrigerator was dropped to 0.01C and was out of range for about 8.5 hours which was the second excursion (explicitly coded as incorrect product storage). On 22-Jan-2018, the patient was administered with FLUCELVAX QIV that was outside the recommended range (batch number: 195125, expiry date: 30-Apr-2018, dose, route of administration, anatomical location: not reported) (explicitly coded as drug administration error). The reporter assessed the events as non-serious.
Age: 50.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This is a spontaneous case, initially received from other health professional (nurse) on 16-Jan-2018, concerning a 50-year-old, adult male patient. This report was linked to the case (201800102). The patient's medical history and concomitant medication was not reported. It was reported that, the FLUCELVAX QUADRIVALENT vaccine was exposed to 2 temperature excursions, above 46 F (48 F) and below 36 F (33F). On 03-Jan-2018, the patient was administered with FLUCELVAX QIV after second excursion (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: 195219 and expiry date: 30-Apr-2018). It was reported that, no adverse event was reported post vaccination. The reporter assessed this case as non-serious.
Age: 43.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This is a spontaneous case, initially received from other health professional (nurse) on 16-Jan-2018, concerning a 43-year-old, adult, male patient. This report was linked to 201800103. It was reported that, the patient was allergic to ciprofloxacin ear drops when he was young. It was reported that the FLUCELVAX QUADRIVALENT vaccines were exposed to 2 temperature excursions, above 46 F (48 F) and below 36 F (33 F). On 03-Jan-2018, the patient was administered with FLUCELVAX QIV after second excursion (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: 195219 and expiry date: 30-Apr-2018). It was reported that, no adverse event was reported post vaccination. The reporter assessed this case as non-serious. Follow-up report received on 23-Mar-2018: It was reported that, the patient was allergic to ciprofloxacin ear drops when he was young and no further information was provided. Amended narrative accordingly.
Age: 35.0
Sex: M
Vaccine: FLUC4
Symptoms: Product storage error
Clinical narrative: This non-serious spontaneous case, initially received on 05-Feb-2018 from other health professional, concerning a 35-year-old, adult male patient. It was reported that, the FLUCELVAX was exposed to temps above 8C (reported as first excursion). Later the temperature of the refrigerator was dropped to -0.01C and was out of range for about 8.5 hours which was the second excursion. On 22-Jan-2018, the patient was administered with FLUCELVAX QIV (batch number: 195125, expiry date: 30-Apr-2018, dose, route of administration, anatomical location: not reported) (stored out of recommended conditions). The reporter assessed the events as non-serious.
Age: 59.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Arthralgia, Fatigue, Laboratory test, Paraesthesia
Clinical narrative: Multiple arthralgias, fatigue, paresthesias. Has had many tests and consultations with specialists as well as an acute hospital stay. Continues to have ongoing symptoms requiring medical management.
Age: 59.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Alanine aminotransferase increased, Arthralgia, Aspartate aminotransferase increased, Asthenia, Autoimmune disorder
Clinical narrative: Multiple arthralgias, fatigue, paresthesias. Has had many tests and consultations with specialists as well as an acute hospital stay. Continues to have ongoing symptoms requiring medical management.
Age: 59.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Back pain, Blood count normal, Blood creatine phosphokinase abnormal, Blood urea nitrogen/creatinine ratio, C-reactive protein increased
Clinical narrative: Multiple arthralgias, fatigue, paresthesias. Has had many tests and consultations with specialists as well as an acute hospital stay. Continues to have ongoing symptoms requiring medical management.
Age: 59.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Carpal tunnel decompression, Chiropractic, Computerised tomogram abdomen, Computerised tomogram pelvis, Computerised tomogram thorax
Clinical narrative: Multiple arthralgias, fatigue, paresthesias. Has had many tests and consultations with specialists as well as an acute hospital stay. Continues to have ongoing symptoms requiring medical management.
Age: 59.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Depressed mood, Discomfort, Dyskinesia, Dysstasia, Electrocardiogram ambulatory
Clinical narrative: Multiple arthralgias, fatigue, paresthesias. Has had many tests and consultations with specialists as well as an acute hospital stay. Continues to have ongoing symptoms requiring medical management.
Age: 59.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Fatigue, Gait disturbance, Heart rate irregular, Hypoaesthesia, Immobile
Clinical narrative: Multiple arthralgias, fatigue, paresthesias. Has had many tests and consultations with specialists as well as an acute hospital stay. Continues to have ongoing symptoms requiring medical management.
Age: 59.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Inflammation, Loss of personal independence in daily activities, Mastication disorder, Muscle atrophy, Muscle twitching
Clinical narrative: Multiple arthralgias, fatigue, paresthesias. Has had many tests and consultations with specialists as well as an acute hospital stay. Continues to have ongoing symptoms requiring medical management.
Age: 59.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Musculoskeletal pain, Musculoskeletal stiffness, Pain, Pain in extremity, Pain in jaw
Clinical narrative: Multiple arthralgias, fatigue, paresthesias. Has had many tests and consultations with specialists as well as an acute hospital stay. Continues to have ongoing symptoms requiring medical management.
Age: 59.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Palpitations, Physical deconditioning, Red blood cell sedimentation rate increased, Ultrasound scan, Urinary tract disorder
Clinical narrative: Multiple arthralgias, fatigue, paresthesias. Has had many tests and consultations with specialists as well as an acute hospital stay. Continues to have ongoing symptoms requiring medical management.
Age: 59.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Vaccination site pain, Weight decreased, Wheelchair user
Clinical narrative: Multiple arthralgias, fatigue, paresthesias. Has had many tests and consultations with specialists as well as an acute hospital stay. Continues to have ongoing symptoms requiring medical management.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Decreased appetite, Lethargy, Peripheral swelling, Pyrexia
Clinical narrative: Right arm swollen/fever/lethargic/decrease in appetite.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: (L) arm - red - warm to touch -swollen at site. (R) arm - same as above.
Sex: M
Vaccine: FLUC4
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous case, initially received from other non-health professional on 08-Feb-2018, concerning a 09-year-old, child, male patient. On 06-Feb-2018, the patient was administered with FLUCELVAX QIV (dose, route of administration, anatomical location, batch number, expiry date: not reported). On 07-Feb-2018, after 1 day vaccination, the patient had soreness of arm and leg (pain in extremities). The outcome of the event was not reported. The reporter assessed the event as non-serious. The case was considered as lost to follow-up since, the patient's mother requested not to be contacted for follow up.