chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site cellulitis
Clinical narrative: Initial information received on 08-Oct-2018 regarding an unsolicited valid serious case received from a other health professional. This case is linked to case 2018SA280096 (same reporter). This case involves Elderly female patient (age not reported), who experienced developed band like around lateral side of her arm 1-2 inches below the injection site/cellulitis, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. On 03-Oct-2018, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot: UJ004AB and expiry date: 30-Mar-2019) via intramuscular route in the left deltoid. On an unknown date, the patient developed a serious developed band like around lateral side of her arm 1-2 inches below the injection site/cellulitis (cellulitis) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. This event was assessed as medically significant. No lab data was reported. Final diagnosis was developed band like around lateral side of her arm 1-2 inches below the injection site/ cellulitis. No corrective treatment was received. The patient outcome is reported as Unknown for developed band like around lateral side of her arm 1-2 inches below the injection site/ cellulitis. Documents held by the sender: none. Sender's Comments: This case involves an elderly patient who presented with cellulitis near vaccination site. Time to onset is not known. There is, moreover, no information regarding patient's medical condition at time of vaccination, identification of the causative organism, safety of the vaccination procedure and lab tests ruling out alternate etiologies. There is a possibility that the cellulitis is due to a pre-existing nidus of infection or introduction of skin commensals during inoculation. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Croup infectious, Pertussis
Clinical narrative: Initial information received on 08-Oct-2018 regarding an unsolicited valid serious case received from a non-healthcare professional (office staff). This case involves a 24 months old female patient who experienced croupy cough, while she received vaccine FLUZONE QUADRIVALENT. The patient's past vaccination(s) included two doses of INFLUENZA VACCINE on an unspecified date of 2017. The patient's medical treatment(s) and family history were not provided. No concomitant vaccines were given. On 05-Oct-2018, the patient received a 0.25 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number: U26259A and expiry date: 30-Jun-2019) in the left thigh. On an unknown date, the patient developed a serious croupy cough, 12 hours following the administration of INFLUENZA QUADRIVAL A-B VACCINE. The event was assessed as medically significant. Patient was taken to emergency urgent care around 11:30 PM on 05-Oct-2018. No Lab data was reported. Final diagnosis was croupy cough. The patient was treated with EPINEPHRINE injection, IBUPROFEN and 0.25 ml DEXAMETHASONE on an unknown date. The outcome of the event was not reported. Documents held by the sender: none. Sender's Comments: Patient presented with croupy cough 12 hours after vaccination. Further information including patient's medical history, concomitant medications, previous vaccination and tolerance, laboratory investigations excluding other etiology would be needed to fully assess this case. Based on available information, the role of vaccine cannot be assessed.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: Initial information received on 08-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 37 years old female patient who received vaccine FLUZONE QUADRIVALENT. The patients past medical history, concomitant medication and family history were not provided. On 08-Oct-2018, the patient received a 0.5ml dose of suspect FLUZONE QUADRIVALENT lot UT5934LA, expiry date 30-Jun-2018 via intramuscular route in unknown administration site. It was an actual medication error due to expired vaccine used. It was reported that patient given FLUZONE on 08-Oct-2018 from last year that expired on 30-Jun-2018. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Sex: U
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Initial information received on 08-Oct-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown demographic patient who administered third dose IMOVAX RABIES (batch umber not reported via unknown route in unknown administration site) on a unspecified date of July. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error case due to Inappropriate schedule of vaccine administered (inappropriate schedule). It was reported that the patient was given 3rd dose on Day 14 instead of on Day 21. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RVX
Symptoms: Incorrect product formulation administered, No adverse event, Product preparation issue
Clinical narrative: Initial information received on 08-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non HCP (office staff). This case involves a six-months old male patient who received only DTaP portion without ActHib portion of PENTACEL. The patient's past medical history, medical treatment(s), was not reported. Concomitant medications included ROTAVIRUS VACCINE and PREVNAR 13. It was case of actual medication error as inappropriate reconstitution technique. It was reported that the reporter did not mix the ActHib portion with the DTaP portion but gave the DTaP 0.5ml IM left thigh. No reported side effects at this time. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Syringe issue, Underdose
Clinical narrative: Initial information received on 08-Oct-2018 regarding an unsolicited valid non-serious case received from other health care professional (Medical Assistant). This case involves a 4 years, 10 months old male patient who received vaccine FLUZONE QUADRIVALENT. The patients past medical history and family history were not provided. It was an actual medication error due to vaccine under dose and syringe leak. On 28-Sep-2018, the patient received a 0.5ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT6261LA, expiry date 30-Jun-2019 via unknown route in unknown administration site. This was not his 1st flu immunization. He did not receive any other vaccines on 09-Sep-2018. It was reported by Medical assistant with product technical complaint that during vaccine administration, pre-filled FLUZONE syringe leaked a lot between needle and hub/ table paper was wet and uncertain how much vaccine the child received. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Sex: U
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 08-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to case 2018SA280692 same reporter for 10 years old. This case involves a 14 years old patient (gender unknown) (weight 63.5 kg) received vaccine FLUBLOK QIV. The patients past medical history, concomitant medication and family history were not provided. On 23-Sep-1018, the patient received injection of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number, expiry date and dose not reported via unknown route in unknown administration site. It was an actual medication error due to inappropriate age at vaccine administration. It was reported that Intern gave a 14-year-old FLUBLOK QIV/no bad reactions reported. The patient did not experience any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender - none.
Sex: U
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 08-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to case 2018SA280687 same reporter for 14 years old. This case involves a 10 years old patient (gender unknown) (weight 56.6 kg) received vaccine FLUBLOK QIV. The patients past medical history, concomitant medication and family history were not provided.  On 23-Sep-1018, the patient received injection of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number, expiry date and dose not reported via unknown route in unknown administration site. It was an actual medication error due to inappropriate age at vaccine administration. It was reported that Intern gave a 10-year-old FLUBLOCK QIV. The patient did not experience any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Age: 47.0
Sex: F
Vaccine: FLUR4
Symptoms: Erythema, Mycobacterium tuberculosis complex test negative, Pruritus, Rash
Clinical narrative: Initial information received on 08-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case involves a 47 years old female patient who experienced rash is raised, slightly elevated, itches, and red when she scratched it and red when she scratched, while she received vaccine FLUBLOK QIV. The patient's past medical history and concomitant medications were not provided. On 06-Sep-2018, the patient received a single dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported in the left arm. On an unknown date, the patient developed a non-serious rash a week after vaccination, rash was raised, slightly elevated following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. On an unknown date, the patient developed a non-serious itches, and red when she scratched it following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. On an unknown date, the patient developed a non-serious red when she scratched following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. Patient was given a steroid injection to help with the inflammation, name not known and they took blood work. Patient was given another shot, put on a Prednisone taper and an H blocker (name not known). Patient underwent patch testing. (Other relevant tests included Patient receive a Tuberculosis test, name not known, the same day it came back negative). Final diagnosis was red when she scratched, itches, and red when she scratched it and rash is raised, slightly elevated. As lab test, patient did receive a TB test, name not known, the same day that came back negative. The patient outcome is reported as Unknown for rash is raised, slightly elevated, as Unknown for itches, and red when she scratched it and as Unknown for red when she scratched.
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Initial information received on 08-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves female patient of an unknown age who experienced pain at the injection site, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 05-Oct-2018, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported (dose, expiry date, route and site of administration were unknown). On an unknown date, patient developed a non-serious pain at the injection site, following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Relevant tests were not reported. Final diagnosis was pain at the injection site. It was not reported if the patient received a corrective treatment. The outcome of the event was not reported. Documents held by the sender: none.
Age: 6.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 08-Oct-2018 regarding an unsolicited valid non-serious case received from non healthcare professional (office manager). This case is linked with 2018SA280895 (same reporter). This case involves a six-years old female patient who was vaccinated with a 0.5 ml dose of FLUBLOK QIV via intramuscular route in the right thigh on 05-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccines were given on the day of the visit. At the time of the event, the patient had ongoing egg allergy (allergic to eggs). It was a case of actual medication error due to inappropriate age at vaccine administration. No adverse events have been reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 1.17
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 08-Oct-2018 regarding an unsolicited valid non-serious case received from a non-healthcare professional (office manager). This case is linked with 2018SA280875 (same reporter). This case involves a 14 months old male patient who was vaccinated with a 0.5 ml dose of FLUBLOK QIV via intramuscular route in the right thigh on 05-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccines were given on the day of the visit. At the time of the event, the patient had ongoing egg allergy. It was a case of actual medication error due to inappropriate age at vaccine administration. No adverse events have been reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 08-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 61 years old male patient who was vaccinated with a 0.5 ml dose of FLUZONE HIGH DOSE lot UJ004AB; expiry date; 30-Mar-2019 via intramuscular route in the left deltoid on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to inappropriate age at vaccine administration and overdose, since FLUZONE HD is only approved for use in patients 65 years of age or older. No adverse events/symptoms have been reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: M
Vaccine: FLU3
Symptoms: Lymphadenopathy
Clinical narrative: Initial information received on 08-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional. This case involves an elderly male patient (age was not reported) who experienced the medial aspect of his left elbow had swollen lymph nodes and they are still swollen, while he received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 05-Oct-2018 at 01:30 PM, the patient received a dose of suspect Influenza USP Trival A-B High Dose Subvirion Vaccine (lot number not reported) in the left upper arm. On 05-Oct-2018 at 10:30 PM, the patient developed a non-serious the medial aspect of his left elbow had swollen lymph nodes and they are still swollen (lymphadenopathy), 9 hours following the administration of Influenza USP Trival A-B High Dose Subvirion Vaccine. No lab data reported. Final diagnosis was the medial aspect of his left elbow had swollen lymph nodes and they are still swollen. It was not reported if the patient received a corrective treatment. The caller repeatedly asked for medical advice, guidance on what this might be and how to treat it, what to be concerned about. He was referred to HCP. The patient outcome is reported as Not Recovered / Not Resolved on an unknown date for the event. List of documents held by sender: none.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information received on 05-Oct-2018 regarding an unsolicited valid non-serious case received from a non-healthcare professional. This case is linked to 2018SA279965, 2018SA279966, 2018SA279967, 2018SA279973, 2018SA281633, 2018SA281635, 2018SA281636, 2018SA281637, 2018SA281634, 2018SA281632, 2018SA279979, 2018SA281687 and 2018SA281692 (same reporter). This case involves a four months-old (also reported as five months-old) female patient who was vaccinated with PENTACEL (batch number: C5507AA, expiration date: 05-Sep-2019, dose, left thigh was the site of administration the route was not reported for both vaccines) on 12-Sep-2018 which was stored at 30 F temperature for four hours. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage. It was reported that no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: F
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Initial information received on 08-Oct-2018 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a 25-years-old female patient who received third dose of vaccine IMOVAX RABIES on day 14 instead of day 21. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. On 24 July 2018, the patient received a third once 0.5 ml intramuscular dose of suspect IMOVAX VACCINE in left deltoid lot number NIG401M exp date, 23 July 2019, strength was standard for immunization, pre-exposure. The patient received first and second once 0.5 ml intramuscular dose of suspect IMOVAX VACCINE in left deltoid lot number NIG401M exp date, 23 July 2019 respectively on 10 July 2018 and 17 July 2018, strength was standard for immunization, pre-exposure. It was a case of actual medication error due to inappropriate schedule of vaccine administered. It was not reported that if any adverse event occurred or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none Follow up information received on 10 October 2018. Patient demographic and age was updated. Vaccination details was updated.
Sex: U
Vaccine: FLU4
Symptoms: Syringe issue, Underdose
Clinical narrative: Initial information received on 09-Oct-2018 regarding an unsolicited valid non-serious case received from medical assistant (non health care professional). Global number: CO2018-00328. This case involves a patient (age and gender not reported) who was vaccinated with an incomplete dose of vaccine FLUZONE QUADRIVALENT (batch number: UT6261LA, expiration date: 30-Jun-2019, dose, route and site of administration was not reported) on 28 Sep 2018. The patient's medical history and concomitant medications were not reported. It was also a case of syringe issue as it was reported that vaccine leaked a lot between the needle and the hub. It was an actual medication error due to vaccine underdose which occurred as it was uncertain how much vaccine the child received. It was not known whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: F
Vaccine: FLUR4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Initial information regarding an unsolicited valid non-serious case received on 08-Oct-2018 from a consumer. This case involves an unknown age female patient who experienced upper arm redness and swelling hand size, while she received vaccine FLUBLOK QIV. The patients past medical history included Food allergy. The patients past medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA1807 via unknown route in unknown administration site. The patient developed a non-serious upper arm redness and swelling hand size (vaccination site inflammation) (Unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. Other relevant tests included no lab data. Final diagnosis was upper arm redness and swelling hand size. It was not reported if the patient received a corrective treatment. The patient outcome was unknown for the event. List of documents held by sender: none.
Age: 16.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial information received on 09-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves 16 years old male patient who was vaccinated with two doses of FLUZONE QUADRIVALENT UT6258KA via intramuscular route in the right deltoid and left deltoid on 27-Sep-2018 and 09-Oct-2018 respectively. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. This was an actual medication error due to extra dose administered. It was reported that the patient had 2 doses of the FLUZONE QIV. It was reported that the patient did not experience any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Syringe issue, Underdose
Clinical narrative: Initial information received on 09-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 66 years old male patient was vaccinated with a dose (less than 0.5 ml) of FLUZONE HIGH DOSE (lot: UJ023A; expiry date: 25-Apr-2019) in the left deltoid on 09-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case actual medication error due to vaccine under dose. It was also a case of syringe issue as there was leakage from the needle hub. It was not reported whether the patient experienced any adverse events after vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Underdose
Clinical narrative: Initial information regarding an unsolicited valid non-serious case received on 09-Oct-2018 from a nurse. This case involves an unknown age 45 months old patient who received 0.25mL FLUZONE QUADRIVALENT instead of the 0.5ml from the vaccine FLUZONE QUADRIVALENT (Batch number, expiration date, dose, route and site of administration was not reported) on 08-Oct-2018. The patients medical history and concomitant medications were not reported. It was an actual medication error due to vaccine underdose (received 0.25 ml FLUZONE QUADRIVALENT instead of the 0.5 ml) It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Circumstance or information capable of leading to medication error, Underdose
Clinical narrative: Initial information received on 09-Oct-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves 27 month old patient who received FLUZONE QUADRIVALENT (batch number UJ025AC, expiry date, 30 June 2018) left deltoid on 30 june2019. It was a case of actual medication error due Extra dose administered Aand Drug administration error as 27 month-old child, received FLUZONE QUADRIVALENT (0.5ml) in her left deltoid. The child pulled away during injection. The MA continued injecting and states that all but a few drops went in, but child's mother is MD and states that only about 0.25ml. It was unknown if any adverse event occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial information regarding an unsolicited valid non-serious case received on 09-Oct-2018 from a Pharmacy student (consumer). This case involves a 13 months old patient who accidentally injected with 0.5 ml of FLUZONE QUADRIVALENT instead of 0.25 ml from the vaccine FLUZONE QUADRIVALENT (Batch number: UT6331LA, route: intramuscular and site of administration was thigh nos, expiration date and was unknown) on 09-Oct-2018. The patients medical history and concomitant medications were not reported. It was an actual medication error due to Accidental overdose (accidentally injected with 0.5ml of FLUZONE QUADRIVALENT instead of 0.25mL/No AE). No adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 0.25
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Initial information received on 09-Oct-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a three-months old (also reported as four-months old) female patient who received only HIB portion of vaccine PENTACEL without mixing DTap-IPV. The patient's past medical history was not provided. Concomitant medications included ROTATEQ for Immunisation; and PREVNAR for Immunisation on an unknown date. On 09-Oct-2018, the patient received a 0.5 ml second single dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot C5575AA (expiry date: 13-Oct-2019) via unknown route. It was a case of actual medication error due to Inappropriate reconstitution technique. The HIB was mixed with only sterile water diluent. No adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 0.33
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 09-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a four months old female patient who received second dose of vaccine ACTHIB lot UI803AA, expiry date: 21-SEP-2018 via intramuscular route in the right thigh on an unspecified date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ROTAVIRUS VACCINE for Immunisation; and KINRIX for Immunisation. It was an actual medication error due to expired vaccine used. It was reported that no reported issue or complaints by the mother. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, HIBV, PNC13, RV5
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial information received on 09-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 4 months old male patient who received 0.5 mL dose of vaccines PENTACEL lot C5517AA in the left thigh (Lot Lyophilized powder vial lot C5517AA expiry date: 9/15/2019, Liquid vial Lot C5422AA NDC expiry date 9/15/2019) (route not reported) on 08-Oct-2018. Patient also received vaccines ACTHIB lot UI907AA in the left thigh (Lot for ACTHIB: Liquid U6047AA expiry date: 10/24/2019, Powder UI907AA, expiry date: 10/26/2019) (route and dose not reported) on 08-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR for Immunisation; and ROTATEQ for Immunisation. It was an actual medication error due to extra dose administered. It was reported that gave a complete PENTACEL vaccine, both liquid and lyophilized powder vials reconstituted properly, and she also gave him a second dose of ACTHIB for a total or 2 HIB vaccines. No reaction reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Initial information received on 09-Oct-2018 regarding an unsolicited valid non-serious case received from a health care professional. This case involves two-year old male patient who received a 0.5 mL dose of FLUZONE QUADRIVALENT (batch number UT6301JA, expiry date 30 June 2018) intramuscular  in right thigh on 04 Oct 2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to overdose as patient under 3 years of age, reports he was "just three days shy of his 3rd birthday" and was administered FLUZONE QUADRIVALENT 0.5mL. It was unknown if any adverse event occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Initial information received on 09-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves two-year old female patient who received 0.5 mL dose of FLUZONE QUADRIVALENT (batch number UI996AB, expiry date 30 June 2019) in right thigh on 09 Oct 2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to overdose. It was unknown if any adverse event occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 1.67
Sex: F
Vaccine: FLU4, MMR
Symptoms: Incorrect dose administered
Clinical narrative: Initial information received on 09-Oct-2018 regarding an unsolicited valid non-serious case received from office staff. This case involves 20 month old female patient who received FLUZONE QUADRIVALENT (batch number UI982AC, expiry date, not reported) intramuscularly in right deltoid on 08 Oct 2018. Concomitant vaccine included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE. It was a case of actual medication error due to vaccine overdose as 1 year 8 month old female child was given a FLUZONE QUADRIVALENT 0.5ml injection on 08Oct2018. It was unknown if any adverse event occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 8.0
Sex: M
Vaccine: FLUR4
Symptoms: Expired product administered, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 09-Oct-2018 regarding an unsolicited valid non-serious case received from an nurse. This case involves an eight year old male patient who received 0.5 ml expired dose of FLUBLOK QIV (batch number QFAA1813, expiry date, 30 June 2018) right deltoid on 08 Oct 2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to inappropriate age at vaccine administration as 8 year old boy received FLUBLOK QUADRIVALENT and expired vaccine used. It was unknown if any adverse event occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 09-Oct-2018 regarding an unsolicited valid non-serious case received from an nurse. This case involves 13 year old female patient who received FLUBLOK QIV (batch number QFAA1805, expiry date, 02 June 2019) intramuscularly in left deltoid on an unspecified date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to Inappropriate age at vaccine administration as inadvertently gave FLUBLOCK 0.5 ml IM left Deltoid today to a 13 year old patient. It was reported that the patient did not experienced any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Sex: F
Vaccine: FLUR4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial information received on 09-Oct-2018 regarding an unsolicited valid non-serious case received from an office staff on behalf of physician. This case involves 20 year old female patient who received FLUBLOK QIV (batch number, expiry date, route and site of administration were not reported) on 12 Sep 2018 and again on 08 Oct 2018. It was a case of actual medication error due to extra dose administered as 20 yo female got the FLUBLOK twice. Caller said a patient got it once on September 12 and again yesterday, October 8th. The patient has not reported having any adverse reactions to this. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered
Clinical narrative: Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from other healthcare professional. This case involves 80 years old male patient who received 0.5 mL dose of vaccine FLUZONE HIGH DOSE lot UI885AB, expiry date: 29-MAY-2018 via intramuscular route in the right arm on 10-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to expired vaccine used. It was unknown whether patient experienced any adverse reaction after vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.