chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: DTAP, HIBV
Symptoms: Expired product administered
Clinical narrative: Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a patient of an unknown demographics who was vaccinated with an expired dose of ACT-HIB lot number not reported via unknown route on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DAPTACEL for Immunisation. It was a case of actual medication error due to expired vaccine used. 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: U
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a patient (unknown demographics) who received an expired dose of vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapies received. On 10-Oct-2018, the patient received a 0.5 ml single dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot PNCU1852AD (expiry date: 30-Jun-2018). It was a case of actual medication error due to expired vaccine used. No AE symptoms noted. 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.
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from an other Health Care Professional (medical assistant) in the United States. This case involves 54 patients of an  unknown demographics who received an expired dose of vaccine FLUZONE HIGH DOSE which was passed the two day shipment time frame. The patient's past medical history and concomitant medications were not provided. On an unknown date (Date range would have been from August when shipment received to 10-Oct-2018), the patient received a 0.5 ml single dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE, lot UJ0048AB via unknown route. It was a case of actual medication error due to incorrect product storage and expired vaccine used. It was reported that there had been approximately 54 people that have received the vaccine. According to the MA they received their vaccines back in August and they were unaware that they were not received within the two-day shipping limit. MA stated that the vaccines were shipped on a Thursday and they did not receive the vaccines until a Monday. MA stated that they have not gone through the records to which patients received the invalid dose at that time. No adverse event was experienced. 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: No adverse event, Product storage error
Clinical narrative: Initial information regarding an unsolicited valid non-serious case received on 10-Oct-2018 from a nurse.  This case is linked to cases 2018SA284746, 2018SA284747, 2018SA284748, 2018SA284749, 2018SA284750, 2018SA284751, 2018SA284752, 2018SA284753, 2018SA284754 and 2018SA284755. This case involves a patient (age and gender not reported) who was vaccinated with a dose of FLUZONE QUADRIVALENT (lot number and Expiry date not reported) via intramuscular route in the left deltoid on an unknown date which was outside of the recommended temp range. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage (patient's were given vaccines that were outside of the recommended temp range). No information about any 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: 7.0
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information regarding an unsolicited valid non-serious case received on 10-Oct-2018 from a nurse. This case is linked to cases 2018SA284725, 2018SA284730, 2018SA284726, 2018SA284727, 2018SA284723, 2018SA284724, 2018SA284728, 2018SA284729, 2018SA284731, 2018SA284732, 2018SA284733, 2018SA284734, 2018SA284735, 2018SA284736 and 2018SA277767. This case involves an unknown gender seven year old patient who was vaccinated with a dose of FLUZONE QUADRIVALENT (Batch number: U1997AA, expiration date: 30-Jun-2019, route: intramuscular and site of administration: left deltoid) on 02-Oct-2018. The patients medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage (patients were given vaccines that were outside of the recommended temp range). No information about any 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 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: Product storage error
Clinical narrative: Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA284709, 2018SA284710, 2018SA284711, 2018SA284707, 2018SA284722, 2018SA284723, 2018SA284724, 2018SA284726, 2018SA284727, 2018SA284728, 2018SA284729, 2018SA284730, 2018SA284731, 2018SA284732, 2018SA284733, 2018SA284734, 2018SA284735 and 2018SA284736 from same reporter. This case involves Adult patient (gender unknown) who received vaccine FLUZONE QUADRIVALENT. The patients past medical history, concomitant medication and family history were not provided. On an unknown date, the patient received a 0.5ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot U1997AA, expiry date 30-Jun-2019 via intramuscular route in the left deltoid. It was an actual medication error due to incorrect product storage. It was reported that patients were given vaccines that were outside of the recommended temp range (below 32F). 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: FLU4
Symptoms: Product storage error
Clinical narrative: Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA284710, 2018SA284709, 2018SA284711, 2018SA284707, 2018SA284722, 2018SA284723, 2018SA284724, 2018SA284725, 2018SA284727, 2018SA284728, 2018SA284729, 2018SA284730, 2018SA284731, 2018SA284732, 2018SA284734, 2018SA284735, 2018SA284736 and 2018SA284733, from same reporter. This case involves Adolescent patient (gender unknown) who received vaccine FLUZONE QUADRIVALENT. The patients past medical history, concomitant medication and family history were not provided. On an unknown date, the patient received a 0.5ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE, lot U1997AA, expiry date 30-Jun-2019 via intramuscular route in the left deltoid. It was an actual medication error due to incorrect product storage. It was reported that patients were given vaccines that were outside of the recommended temp range (below 32F). 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: FLU4
Symptoms: Product storage error
Clinical narrative: Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA284725, 2018SA284730, 2018SA284709, 2018SA284710, 2018SA284711, 2018SA284707, 2018SA284722, 2018SA284723, 2018SA284724, 2018SA284726, 2018SA284728, 2018SA284729, 2018SA284731, 2018SA284732, 2018SA284733, 2018SA284734, 2018SA284735 and 2018SA284736, from same reporter. This case involves child patient (gender unknown) who received vaccine FLUZONE QUADRIVALENT. The patients past medical history, concomitant medication and family history were not provided. On an unknown date, the patient received a 0.5ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot U1997AA, expiry date 30-Jun-2019 via intramuscular route in the left deltoid. It was an actual medication error due to incorrect product storage. It was reported that patient was given vaccines that were outside of the recommended temp range (below 32F). 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 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: 10.0
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to 2018SA284709, 2018SA284710, 2018SA284711, 2018SA284707, 2018SA284722, 2018SA284723, 2018SA284724, 2018SA284725, 2018SA284726, 2018SA284727, 2018SA284729, 2018SA284730, 2018SA284731, 2018SA284732, 2018SA284733, 2018SA284734, 2018SA284735, 2018SA284736 and 2018SA277767 (same reporter). This case involves a 11 years old patient (gender not reported) who was vaccinated with FLUZONE QUADRIVALENT (Batch number: UI997AA, expiration date: 30-JUN-2019) via intramuscular in the left deltoid on 02-OCT-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to incorrect product storage. It was reported that vaccines that were outside of the recommended temp range (below 32 F). It was not reported that 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.
Age: 13.0
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to 2018SA284709, 2018SA284710, 2018SA284711, 2018SA284707, 2018SA284722, 2018SA284723, 2018SA284724, 2018SA284725, 2018SA284726, 2018SA284727, 2018SA284728, 2018SA284730,  2018SA284731, 2018SA284732, 2018SA284733, 2018SA284734, 2018SA284735, and 2018SA284736 (same reporter). This case involves a 13 years old patient (gender not reported) who was vaccinated with FLUZONE QUADRIVALENT (Batch number: UI997AA, expiration date: 30-JUN-2019) via intramuscular in the left deltoid on 02-OCT-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to incorrect product storage. It was reported that vaccines that were outside of the recommended temp range (below 32 F). It was not reported that 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.
Age: 5.0
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to 2018SA284709, 2018SA284710, 2018SA284711, 2018SA284707, 2018SA284722, 2018SA284723, 2018SA284724, 2018SA284725, 2018SA284726, 2018SA284727, 2018SA284728, 2018SA284729, 2018SA284731, 2018SA284732, 2018SA284733, 2018SA284734, 2018SA284735, and 2018SA284736 (same reporter). This case involves a 5 years old patient (gender not reported) who was vaccinated with FLUZONE QUADRIVALENT (Batch number: UI997AA, expiration date: 30-JUN-2019) via intramuscular in the left deltoid on 02-OCT-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to incorrect product storage. It was reported that vaccines that were outside of the recommended temp range (below 32 F). It was not reported that 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.
Age: 15.0
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to 2018SA284709, 2018SA284710, 2018SA284711, 2018SA284707, 2018SA284722, 2018SA284723, 2018SA284724, 2018SA284725, 2018SA284726, 2018SA284727, 2018SA284728, 2018SA284729, 2018SA284730, 2018SA284732, 2018SA284733, 2018SA284734, 2018SA284735, and 2018SA284736 (same reporter). This case involves a 15 years old patient who was vaccinated with FLUZONE QUADRIVALENT (Batch number: UI997AA, expiration date: 30-JUN-2019) via intramuscular in the left deltoid on 02-OCT-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to incorrect product storage. It was reported that vaccines that were outside of the recommended temp range (below 32 F). It was not reported that 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.
Age: 17.0
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to 2018SA284709, 2018SA284710, 2018SA284711, 2018SA284707, 2018SA284722, 2018SA284723, 2018SA284724, 2018SA284725, 2018SA284726, 2018SA284727, 2018SA284728, 2018SA284729, 2018SA284730, 2018SA284731, 2018SA284733, 2018SA284734, 2018SA284735, 2018SA284736 and 2018SA277767 (same reporter). This case involves a 17 years old patient (gender not reported) who was vaccinated with FLUZONE QUADRIVALENT (Batch number: UI997AA, expiration date: 30-JUN-2019) via intramuscular in the right deltoid on 02-OCT-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to incorrect product storage. It was reported that vaccines that were outside of the recommended temp range (below 32 F). It was not reported that 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.
Age: 6.0
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to 2018SA284709, 2018SA284710, 2018SA284711, 2018SA284707, 2018SA284722, 2018SA284723, 2018SA284724, 2018SA284725, 2018SA284726, 2018SA284727, 2018SA284728, 2018SA284729, 2018SA284730,  2018SA284731 , 2018SA284732, 2018SA284734, 2018SA284735, 2018SA284736 and 2018SA277767 (same reporter). This case involves a six-years old patient (gender not reported) who was vaccinated with FLUZONE QUADRIVALENT (Batch number: UI997AA, expiration date: 30-JUN-2019) via intramuscular in the left deltoid on 02-OCT-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to incorrect product storage. It was reported that vaccines that were outside of the recommended temp range (below 32 F). It was not reported that 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 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: 3.0
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Initial information regarding an unsolicited valid non-serious case received on 10-Oct-2018 from a nurse. This case is linked to cases 2018SA284746, 2018SA284747, 2018SA284721, 2018SA284749, 2018SA284750, 2018SA284751, 2018SA284752, 2018SA284753, 2018SA284754 and 2018SA284755. This case involves an unknown gender 37 months old who was vaccinated with a dose of FLUZONE QUADRIVALENT (Batch number: U1997AA, route: intramuscular, site of administration: left vastus lateralis, expiration date and dose was not reported) on 03-Oct-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage. No information about any 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: 10.0
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Initial information regarding an unsolicited valid non-serious case received on 10-Oct-2018 from a nurse. This case is linked to cases 2018SA284746, 2018SA284747, 2018SA284721, 2018SA284748, 2018SA284750, 2018SA284751, 2018SA284752, 2018SA284753, 2018SA284754 and 2018SA284755. This case involves an unknown gender 10 years old who was vaccinated with a dose of FLUZONE QUADRIVALENT (Batch number: U1997AA, route: intramuscular, site of administration: left deltoid, expiration date and dose was not reported) on 03-Oct-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage (patients were given vaccines that were outside of the recommended temperature range). No information about any 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.
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 a nurse. This case involves a 68 years old male patient and reported that patient received expired dose of FLUZONE HIGH-DOSE vaccine and suspect vaccine was FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 09-Oct-2018, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number: UI842AB) (expiry date:04-Apr-2018 and dose in series was not reported) via intramuscular route in the right deltoid. It was a case of actual medication error due to expired product administered. It was unknown if 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.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Incorrect product formulation administered, Product preparation issue, Wrong technique in product usage process
Clinical narrative: Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a two months old male patient who received components of PENTACEL (first dose, batch number: C5463AA, expiration date: 26-Jul-2019, dose: 0.5 ml, via intramuscular route in the right thigh) separately on 10-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR 13 for Immunisation; and ROTATEQ for Immunisation. It was an actual medication error due to inappropriate reconstitution technique and wrong technique in product usage process. It was reported that PENTACEL components were administered separately, reported DTaP+IPV liquid portion was administered and then the ACTHIB portion was administered separately and was reconstituted with sterile diluent but not 0.4% NaCl solution. Components of PENTACEL 0.5mL IM in two injections to his right thigh were administered. Patient was administered the liquid component of PENTACEL in one injection and then received the ACTHIB powder component in one injection, and the ACTHIB component was reconstituted with a sterile diluent made by Merck. It was unknown 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.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Underdose
Clinical narrative: Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves four-years old female patient who received a dose of FLUZONE QUADRIVALENT (batch number, expiration date, dose, route of administration were not reported) (site of administration: Left Deltoid) on 06-Oct-2018. The patient's medical history and concomitant medications were not reported. The child has received FLUZONE every year (1st year: 0.25ml x 2) It was an actual medication error due to vaccine underdose. It was reported that child did not receive the entire 0.5 ml. It was unknown 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 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: FLUX, HEPA
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a six-year-old female patient for whom medication error was reported, while she received 0.5 ml of vaccine FLUZONE (0.5 ml) (batch number: UI998AE, expiration date: 30-Jun-2019, via unknown route in right deltoid) on 27-Sep-2018. On an unknown date, the patient was again vaccinated with the FLUZONE (Batch number, expiry date, dose, route and site of administration was not reported). Then the patient was given a second Flu Vaccine at school (vaccine name unknown) in the last week (on 8-Oct-2018 to 10-Oct-2018) and the child never received the Flu vaccine prior to 2018. The patient's medical history were not reported. The patient received concomitant vaccination with Hepatitis A vaccine in left arm. It was an actual medication error due to extra dose administration of vaccine. No reported reactions. 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. Additional information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. The dosage regimen was updated. Narrative updated accordingly. List of documents held by sender: none.
Sex: M
Vaccine: FLU3
Symptoms: Exposure via skin contact, Underdose
Clinical narrative: Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a male patient of an unknown demographics who was vaccinated with a dose of FLUZONE HIGH DOSE (batch number, expiration date, dose, and route of administration was not reported for both vaccines) in arm NOS. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to underdose. It was reported that remnants of product dripped down to patient's arm so it might not have entered his system so the actual amount was unknown. It was also reported that there was a poor documentation in the medical records of the vaccination so the reporter did not know whether there was an actual issue with the FLUZONE HIGH-DOSE product and/or with the needle used. It is also a case of exposure via skin contact. It was unknown 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: FLU4, MNQ
Symptoms: Extra dose administered
Clinical narrative: Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 11 years old female patient who received vaccine MENACTRA. The patient's past medical history and family history were not provided. Concomitant medications included FLUARIX QUADRIVALENT 0.5ml in left deltoid on 09-Oct-2018. On 09-Oct-2018, the patient received a second dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U6015AA, expiry date 06-Oct-2019 via intramuscular route in unknown administration site. The patient also first dose on unknown date two and half weeks ago for same suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. It was an actual medication error due to extra dose administered. It was reported that MA gave MENACTRA on 10/9/2018 to an 11 yr old had the first dose in the series of MENACTRA 2 1/2 weeks previously and the MA read the record incorrectly and gave it again. 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.
Age: 0.5
Sex: F
Vaccine: HIBV, PPV
Symptoms: Expired product administered
Clinical narrative: Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case involves a six months old female patient who administered with an expired dose of 0.5 mL ACTHIB (Batch number: UI807AAA, expiration date: 01-OCT-2018) via unknown route in the left thigh on 02-OCT-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Pneumococcal Vaccine. It was actual medication error due to expired vaccine used. It was not reported that 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 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: 63.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 11-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves 63 year old male patient who received 0.5 ml dose of FLUZONE HIGH DOSE (batch number, expiry date, site of administration were not reported) in left arm on 03 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 Pharmacist reported a dose of FLUZONE HIGH DOSE given to a patient under 65 years of age. No known reported side effects 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 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: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Arthritis, Chills, Feeling cold, Influenza like illness
Clinical narrative: Initial information regarding an unsolicited valid non-serious case received on 11-Oct-2018 from a consumer. This case involves a 71 years old female patient who experienced could not sleep, flu like symptoms, arthritis like inflammation pain, total body joint aches, painful underarm down to elbow, possible fever and cold chills, while she received vaccine FLUZONE HIGH DOSE. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 10-Oct-2018, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via intramuscular route in the left arm. On an unknown date, the patient developed a non-serious could not sleep (sleep disorder), flu like symptoms (influenza like illness), arthritis like inflammation pain (inflammatory pain), total body joint aches (arthralgia), painful underarm down to elbow (arthralgia), fever (pyrexia) and cold chills (chills) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Other relevant tests included no lab data. Final diagnosis was cold chills, possible fever, painful underarm down to elbow, total body joint aches, arthritis like inflammation pain, flu like symptoms and could not sleep. The patient was treated with OXYCODONE for Product used for unknown indication. The patient outcome was not reported. List of documents held by sender: none.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Insomnia, Pain in extremity, Pyrexia
Clinical narrative: Initial information regarding an unsolicited valid non-serious case received on 11-Oct-2018 from a consumer. This case involves a 71 years old female patient who experienced could not sleep, flu like symptoms, arthritis like inflammation pain, total body joint aches, painful underarm down to elbow, possible fever and cold chills, while she received vaccine FLUZONE HIGH DOSE. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 10-Oct-2018, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via intramuscular route in the left arm. On an unknown date, the patient developed a non-serious could not sleep (sleep disorder), flu like symptoms (influenza like illness), arthritis like inflammation pain (inflammatory pain), total body joint aches (arthralgia), painful underarm down to elbow (arthralgia), fever (pyrexia) and cold chills (chills) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Other relevant tests included no lab data. Final diagnosis was cold chills, possible fever, painful underarm down to elbow, total body joint aches, arthritis like inflammation pain, flu like symptoms and could not sleep. The patient was treated with OXYCODONE for Product used for unknown indication. The patient outcome was not reported. List of documents held by sender: none.
Age: 0.92
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13
Symptoms: Expired product administered
Clinical narrative: Initial information received on 11-Oct-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 1 years old female patient for whom received a PENTACEL vaccine that was expired was reported, while she received vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Hepatitis B Vaccine for Immunisation; PREVNAR 13 for Immunisation; and FLUZONE QUADRIVALENT 0.5 ml for Immunisation. On 10-Oct-2018, the patient received a 0.5 ml standard dose of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine, lot C5230AA expiry date 02-Sep-2018 via unknown route in the right thigh. The patient developed a non-serious received a PENTACEL vaccine that was expired (expired product administered) unknown latency following the administration of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine. Lab data not reported. The case is actual medication error due to expired vaccine used. Final diagnosis was received a PENTACEL vaccine that was expired. It was unknown whether patient experienced any adverse reaction after vaccination. Outcome of the event was not applicable. 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: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 11-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 34 years old female patient for whom FLUZONE HIGH DOSE was administered to someone under 65 was reported, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in unknown administration site. The patient developed a non-serious FLUZONE HIGH DOSE was administered to someone under 65 (drug administered to patient of inappropriate age) Unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Reporter stated that they were unsure it was administered yet because the paperwork was done incorrectly. Lab data not reported. Final diagnosis was FLUZONE HIGH DOSE was administered to someone under 65. This case is actual medication error case due to inappropriate age at vaccine administration. The outcome of event of FLUZONE HIGH DOSE was administered to someone under 65 was not applicable. 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: 3.0
Sex: U
Vaccine: FLU4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial information received on 11-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 3 years old patient (also reported as 3 year 8 month old) who received a does of 0.25ml instead of the correct dose of 0.5ml, no adverse event, while he/she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 10-Oct-2018, the patient received a 0.25 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT6259NA, expiry date- 30-Jun-2019 via intramuscular route in the right arm. It was also a case of actual medication error due to vaccine underdose. The patient had not experienced any 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 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.
Sex: U
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial information received on 11-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 08 months old patient for whom received the second dose of FLUZONE QUADRIVALENT at 2 weeks and 2 days from the first dose was reported, while he/she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccines were given. On 10-Oct-2018, the patient received a dose 2 of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT6259LA expiry date 30-Jun-2019 via intramuscular route in the left thigh. On 24-Sep-2018 he/she also received a dose 1 of the same vaccine lot UT6259LA expiry date 30-Jun-2019 via intramuscular route in the left thigh. The patient developed a non-serious received the second dose of FLUZONE QUADRIVALENT at 2 weeks and 2 days from the first dose. Unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Lab data not reported. The case is actual medication error due to inappropriate schedule of vaccine administered. Final diagnosis was received the second dose of FLUZONE QUADRIVALENT at 2 weeks and 2 days from the first dose. No AE symptoms have been reported. Outcome of the event was not applicable. 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: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Mobility decreased, Muscular weakness, Neuralgia, Rotator cuff syndrome
Clinical narrative: Shoulder impingement syndrome related to in proper administration of vaccine into shoulder resulted in nerve pain, low of motion, weakness and numbness extended to fingers and across the shoulder blade.