chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: FLU4
Symptoms: Needle issue, Underdose
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 10 years old male patient for whom the needle must not have been attached securely and needle must not have been on appropriately as part of the vaccine came out of the side was reported, while he received vaccine FLUZONE QUADRIVALENT. The patient's past vaccination(s) included FLUZONE. The patient's past medical history, medical treatment(s) and family history were not provided. No other vaccines were given concomitantly. On 11-Oct-2018, the patient received a 0.5ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UJ035AA expiry date 30-Jun-2019 via unknown route in the right deltoid. The patient developed a non-serious the needle must not have been attached securely unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE. The patient developed a non-serious needle must not have been on appropriately as part of the vaccine came out of the side. Unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Lab data not reported. Final diagnosis was needle must not have been on appropriately as part of the vaccine came out of the side and the needle must not have been attached securely. It was not reported if the patient received a corrective treatment. The outcome of event of needle must not have been on appropriately as part of the vaccine came out of the side. and the needle must not have been attached securely were 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: 0.33
Sex: M
Vaccine: DTAPIPV, HIBV, PNC13, RVX
Symptoms: Wrong product administered
Clinical narrative: Initial information received on 24-Oct-2018 regarding an unsolicited valid non-serious case received from Office Staff. This case involves a four months old male patient who received third dose of 0.5 mL vaccine QUADRACEL lot C5497AA, expiry date: 17-Jul-2020 via intramuscular route in the left thigh on 24-Oct-2018 instead of PENTACEL (batch number and expiry date not reported). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation; HIB VACCINE (HIB) for Immunisation; and PREVNAR 13 for Immunisation. It was actual medication error due to wrong vaccine administered. 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.
Age: 16.0
Sex: U
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 24-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 16 years old patient (gender not reported) who received a dose of vaccine FLUBLOK QIV (lot number not reported) via unknown route in unknown administration site 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. It was not reported if patients 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: 0.17
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 24-Oct-2018 regarding an unsolicited valid non-serious case received from a other health care professional. This case involves a two months old male patient who was vaccinated with a 0.25 ml dose of FLUZONE QUADRIVALENT (Batch number: UT6262NA, expiration date: 30-Jun-2019, route: intramuscular and site of administration: left thigh) on 24-Oct-2018. The patients medical history were not reported. No concomitant vaccinations given. It was an actual medication error due to inappropriate age at vaccine administration (FLUZONE QUADRIVALENT was administered to a 2 month old baby/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: 76.0
Sex: U
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: Initial information received on 24-Oct-2018 regarding an unsolicited valid non-serious case received from other health professional. This case is linked to case 2018SA298495, 2018SA298512, 2018SA298536, 2018SA298512, 2018SA298593, 2018SA298603, 2018SA298611, 2018SA298622, 2018SA298631, 2018SA298644, 2018SA298649, 2018SA298573, 2018SA298692, 2018SA298695, 2018SA298701 (same reporter). This case involves a 76-year-old patient (gender not reported) who was vaccinated with a dose of FLUZONE HIGH DOSE lot U1995AB, expiry date: 20-Jun-2019 via intramuscular route in unknown site on an unknown date (reported as during the period 01Oct2018 to 08Oct2018). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccines were administered with the FLUZONE HIGH DOSE. It is an actual medication error case due to incorrect product storage. It was reported that temperature report of the refrigerator showed that the FLUZONE HD was frozen at some time and were injected to 15 patients. It was unknown whether the 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.
Sex: U
Vaccine: FLU4
Symptoms: Rubber sensitivity
Clinical narrative: Initial information received on 24-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves patient of an unknown demographics who experienced severe latex allergy last year to a flu product, 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 an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported (dose, expiry date, route and site of administration were unknown). On an unknown date, the patient developed a non-serious severe latex allergy last year to a flu product following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Other relevant tests included no lab data. Final diagnosis was having a severe latex allergy last year to a flu product. It was not reported if the patient received a corrective treatment. The outcome of the event was not reported. List of documents held by sender- none.
Sex: F
Vaccine: FLU4
Symptoms: Skin burning sensation
Clinical narrative: Initial information received on 24-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves an unknown age female patient who felt burning or warmth in her skin at the chest or upper torso area around the shoulder and neck, while she received vaccine FLUZONE QUADRIVALENT. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. On unknown date, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UJ025AC via unknown route in the arm NOS. The patient was treated with BENADRYL ITCH. The patient experienced a non-serious felt burning or warmth in her skin at the chest or upper torso area around the shoulder and neck (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Other relevant tests included no lab data. Final diagnosis was felt burning or warmth in her skin at the chest or upper torso area around the shoulder and neck. The patient outcome was not reported. List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered, Incorrect dose administered
Clinical narrative: Initial information received on 24-Oct-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a 28 months old patient (also reported as 6 month old) who received 0.5 ml inadvertently instead of 0.25 ml of FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant medication received. On 24-Oct-2018, the patient received a single 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot U6263CA via intramuscular route in the right thigh. It was a case of actual medication error due to accidental overdose and expired vaccine used. It was unknown whether 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 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.
Age: 1.25
Sex: F
Vaccine: DTAP, HEP, PNC13
Symptoms: Expired product administered
Clinical narrative: Initial information received on 24-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 15 months old female patient who had inadvertently received an expired dose of DAPTACEL lot C5065AA, expiry date- 08-Oct-2018 via intramuscular route in the left thigh on 23-Oct-2018. 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; and PREVENAR 13 for Immunisation. It was a case of actual medication error due to expired vaccine used. It was not reported if the patient experienced any adverse event 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.
Sex: F
Vaccine: FLU4
Symptoms: Erythema multiforme, Injection site rash, Rash generalised
Clinical narrative: Initial information received on 24-Oct-2018 regarding an unsolicited valid non-serious case received from other health care professional. This case involves a 47 years old female patient who experienced developed a rash to the injection all over her hands, legs and face/rash looks like little dots multiform, while she received vaccine FLUZONE QUADRIVALENT. The patients past medical history, concomitant medication and family history were not provided. The patient did not receive any other vaccine other than suspect. On 27-Sep-2018, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT6261KA, expiry date 30-Jun-2019 via intramuscular route in the right deltoid. On 28-Sep-2018, the patient developed a non-serious rash to the injection all over her hands, legs and face/rash looks like little dots multiform 1 day following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Lab data was not provided. Final diagnosis was developed a rash to the injection all over her hands, legs and face/rash looks like little dots multiform. As a corrective treatment, the patient was given DIPROLENE cream and will be starting MEDROL dose pack on 24-Oct-2018. The patient outcome is reported as Unknown for developed a rash to the injection all over her hands, legs and face/rash looks like little dots multiform. List of documents held by sender- none.
Age: 71.0
Sex: F
Vaccine: FLU3, FLUA3, PPV
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: Initial information received on 24-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 71 years old female patient who was vaccinated with a dose of FLUZONE HIGH DOSE instead of PNEUMOVAX 23 on an unspecified date. Patient was also vaccinated with FLUAD vaccine on an unspecified date. 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 extra dose administered and wrong vaccine administered (patient intended to receive PNEUMOVAX 23, but administered FLUZONE HD). It was reported that, the patient had no reactions. 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: 5.0
Sex: U
Vaccine: DTAPIPV, IPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial information received on 24-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 5 years old unknown gender patient who was vaccinated with a 0.5 ml dose of IPOL (Batch number: N1K93IM, expiration date: 18-Nov-2019, route: subcutaneous and site of administration: right arm) on 23-Oct-2018. The patient also received dose of KINRIX (route: intramuscular and site of administration: right deltoid) on 23-Oct-2018. The patient's medical history medications were not reported. It was an actual medication error due to inappropriate age at vaccine administration (IPOL was administered to 5 year old patient/No AE), Extra dose administered (administered KINRIX that contains 0.5mL of polio vaccine, as well as IPOL/No AE) and inappropriate route of vaccination (IPOL was administered subcutaneously/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: 80.0
Sex: U
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Initial information received on 24-Oct-2018 regarding an unsolicited valid non-serious case received from a Pharmacist. This case involves an 80 years old patient (gender not reported) who received a dose of 0.5 ml dose of vaccine FLUZONE HIGH DOSE (lot number not reported) via unknown route in unknown administration site on 24-Oct-2018 and another dose one month apart. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccine were given. It was a case of actual medication error due to extra dose administered. It was reported that the patient had no significant reaction with the first dose. It was not reported if patient had any adverse event following extra dose. 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: DTAPIPVHIB, HEP, PNC13
Symptoms: Product preparation issue
Clinical narrative: Initial information received on 24-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 6 months old female patient who received 0.5 ML of vaccine PENTACEL that was mixed with PROQUAD and not the HIB portion of the vaccine, (lot C5572AA and expiration date 31-Oct-2019) via intramuscular route in the right thigh on 17-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVENAR for Immunisation; and HEPATITIS B VACCINE for Immunisation. It was a case of actual medication error due to inappropriate reconstitution technique. It was not reported 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 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: FLU4
Symptoms: Product storage error
Clinical narrative: Initial information received on 25-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a patient who was administered the unstable vaccine FLUZONE QUADRIVALENT (Batch number, expiration date, dose, route and site of administration was not reported) on an unknown date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage (patient had been administered the unstable vaccine). 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 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: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 25-Oct-2018 regarding an unsolicited valid non-serious case received from a other healthcare professional. This case is linked to cases 2018SA297838 and 2018SA297839 (same reporter). This case involves a four-years old female patient who was inadvertently administered 0.5 ml once dose of FLUZONE HIGH DOSE (Batch number: UJ030AB and expiration date: 05-May-2019) via intramuscularly in the right thigh on 22-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccines given at the time. It was a case of actual medication error due to inappropriate age at vaccine administration and overdose because the vaccine was inadvertently given to a 4 year old patient. It was unknown if any adverse event occurred or not following the administration of the 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: FLU3
Symptoms: Product storage error
Clinical narrative: Initial information received on 24-Oct-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a patient of an unknown demographics who received 0.5 mL dose of vaccine FLUZONE HIGH DOSE lot U1995AB (expiry date, route and site of administration were not reported) on an unknown date. 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 patients were injected with previously frozen 0.5 mL FLUZONE HD. The caller stated that the staff were unaware that temperature reading from the refrigerator showed that the FLUZONE HD vaccines were frozen at some point in time. 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.
Sex: U
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: Initial information received on 24-Oct-2018 regarding an unsolicited valid non-serious case received from other health professional. This case is linked to case 2018SA298495, 2018SA298512, 2018SA298536, 2018SA298573, 2018SA298593, 2018SA298603, 2018SA298611, 2018SA298622, 2018SA298631, 2018SA298644, 2018SA298649, 2018SA297575, 2018SA298692, 2018SA298695, 2018SA298701 (same reporter). This case involves a patient of an unknown demographics who received 5 mL dose of vaccine FLUZONE HIGH DOSE lot U1995AB, expiry date: 20-Jun-2019 via intramuscular route (site of administration not reported) on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to overdose and incorrect product storage. It was reported that patients were injected with previously frozen 5 mL FLUZONE HD. The caller stated that the staff were unaware that temperature reading from the refrigerator showed that the FLUZONE HD vaccines were frozen at some point in time. 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.
Sex: U
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: Initial information received on 24-Oct-2018 regarding an unsolicited valid non-serious case received from other health professional. This case is linked to cases 2018SA298495, 2018SA298512, 2018SA297575, 2018SA298701, 2018SA298573, 2018SA298593, 2018SA298603, 2018SA298611, 2018SA298622, 2018SA298631, 2018SA298644, 2018SA298649, 2018SA298692 and 2018SA298695 (same reporter). This case involves a patient of an unknown demographics who received 5 ml dose of vaccine FLUZONE HIGH DOSE lot U1995AB, expiry date:20-Jun-2019 via intramuscular route (site of administration not reported) on an unknown date (between 01Oct2018 to 08Oct2018). The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccine was administered. It was actual medication error due to incorrect product storage and overdose (patients were injected with this previously frozen FLUZONE HD). It was reported that patients were injected with previously frozen FLUZONE HD. The caller stated that the staff were unaware that temperature reading from the refrigerator showed that the FLUZONE HD vaccines were frozen at some point in time. 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.
Sex: U
Vaccine: FLU3
Symptoms: Overdose, Product storage error
Clinical narrative: Initial information received on 24-Oct-2018 regarding an unsolicited valid non-serious case received from an other health professional. This case was linked to cases 2018SA298495, 2018SA298512, 2018SA298536, 2018SA298536, 2018SA298573, 2018SA298603, 2018SA298611, 2018SA298622, 2018SA298631, 2018SA298644, 2018SA298649, 2018SA297575, 2018SA298692, 2018SA298695, 2018SA298701 and 2018SA298573 (same reporter). This case involves a 70-year-old age patient (gender unspecified) who received previously frozen vaccine, FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccines were administered with the FLUZONE HIGH DOSE. On an unknown date (in between 01-Oct-2018 to 08-Oct-2018), the patient received a single 5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot U1995AB (20-Jun-2019) via intramuscular route in unknown administration site (either the left arm or right arm). It was a case of actual medication error due to incorrect product storage and overdose. It was reported that there was a possible temperature excursion of vaccine when it was known that the temperature report from the refrigerator showed that the FLUZONE HD was already frozen previously. The reporter also stated the patient was called and scheduled to be re-injected. It was unknown if the patient 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.
Sex: U
Vaccine: FLU3
Symptoms: Overdose, Product storage error
Clinical narrative: Initial information received on 24-Oct-2018 regarding an unsolicited valid non-serious case received from other health care professional. This case is linked to cases 2018SA298495, 2018SA298512, 2018SA298536, 2018SA298593, 2018SA298573, 2018SA297575, 2018SA298622, 2018SA298644, 2018SA298649, 2018SA298611, 2018SA298692, 2018SA298695 and 2018SA298701 (same reporter). This case involves a patient (age and gender not reported) who was vaccinated with a 5 ml dose of FLUZONE HIGH DOSE which was previously frozen, (lot U1995AB and Exp. Date 20 Jun 2018) via intramuscular route in the arm (either right or left) during the period lasting 01Oct2018 to 08Oct2018. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to incorrect product storage and overdose. It was not reported if the patient experienced any adverse event or not. 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: FLU3
Symptoms: Overdose, Product storage error
Clinical narrative: Initial information received on 24-Oct-2018 regarding an unsolicited valid non-serious case received from a other health care professional. This case is linked to cases 2018SA298495, 2018SA298512, 2018SA298536, 2018SA298593, 2018SA298573, 2018SA298622, 2018SA298603, 2018SA298631, 2018SA298644, 2018SA298649, 2018SA297575, 2018SA298692, 2018SA298695 and 2018SA298701 (same reporter). This case involves a patient of an unknown demographics who received 5 ml dose of vaccine FLUZONE HIGH DOSE lot U1995AB, expiry date: 20-Jun-2019 via intramuscular route and site of administration arm NOS on an unknown date which was stored incorrectly. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to overdose (patients was injected 5 ml with this previously frozen FLUZONE HD) and incorrect product storage (temperature reading from the refrigerator showed that the FLUZONE HD vaccines were frozen at some point in time). 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.
Sex: U
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: Initial information received on 24-Oct-2018 regarding an unsolicited valid non-serious case received from an other health care professional. This case is linked to cases 2018SA298495, 2018SA298512, 2018SA298536, 2018SA298593, 2018SA298573, 2018SA297575, 2018SA298603, 2018SA298611, 2018SA298631, 2018SA298644, 2018SA298649, 2018SA298692, 2018SA298695, 2018SA298701 and 2018SA298649. This case involves a patient (age and gender not reported) who was vaccinated with dose of FLUZONE HIGH DOSE which was previously frozen, (lot U1995AB and Exp. Date 20 Jun 2018) via intramuscular route in the arm (either right or left) during the period 01 Oct 2018 to 08 Oct 2018. The patients medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage. No any information about 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: U
Vaccine: FLU3
Symptoms: Overdose, Product storage error
Clinical narrative: Initial information received on 24-Oct-2018 regarding an unsolicited valid non-serious case received from an other health professional. This case was linked to cases 2018SA298495, 2018SA298512, 2018SA298536, 2018SA298536, 2018SA298573, 2018SA298603, 2018SA298611, 2018SA298622, 2018SA298593, 2018SA298644, 2018SA298649, 2018SA297575, 2018SA298692, 2018SA298695, 2018SA298701 and 2018SA298573 (same reporter). This case involves a patient (age and gender unspecified) who received previously frozen vaccine, FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccines were administered with the FLUZONE HD. On an unknown date (in between 01-Oct-2018 to 08-Oct-2018), the patient received a once dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot U1995AB (expiry date- 20-Jun-2019) via intramuscular route in unknown administration site (either the left arm or right arm). It was a case of actual medication error due to incorrect product storage and overdose. It was reported that there was a possible temperature excursion of vaccine when it was known that the temperature report from the refrigerator showed that the FLUZONE HD was already frozen previously. The reporter also stated the patient was called and scheduled to be re-injected. It was unknown if the patient 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.
Sex: U
Vaccine: FLU3
Symptoms: Overdose, Product storage error
Clinical narrative: Initial information received on 24-Oct-2018 regarding an unsolicited valid non-serious case received from an other health professional. This case was linked to cases 2018SA298695, 2018SA298512, 2018SA298536, 2018SA298593, 2018SA298573, 2018SA298495, 2018SA298603, 2018SA298611, 2018SA298622, 2018SA298631, 2018SA298649, 2018SA297575, 2018SA298692, 2018SA298701 and 2018SA298649 (same reporter). This case involves a patient (age and gender unspecified) who received previously frozen vaccine, FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccines were administered with the FLUZONE HIGH DOSE. On an unknown date (in between 01-Oct-2018 to 08-Oct-2018), the patient received a single dose (also reported as 5 mls) of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot U1995AB (20-Jun-2019) via intramuscular route in unknown administration site (either the left arm or right arm). It was a case of actual medication error due to incorrect product storage and overdose. It was reported that there was a possible temperature excursion of vaccine when it was known that the temperature report from the refrigerator showed that the FLUZONE HD was already frozen previously. The reporter also stated the patient was called and scheduled to be re-injected. It was unknown if the patient 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.
Sex: U
Vaccine: FLU3
Symptoms: Overdose, Product storage error
Clinical narrative: Initial information received on 24-Oct-2018 regarding an unsolicited valid non-serious case received from other health professional. This case is linked to case 2018SA298495, 2018SA298512, 2018SA298536, 2018SA298573, 2018SA298593, 2018SA298603, 2018SA298611, 2018SA298622, 2018SA298631, 2018SA298644, 2018SA298512, 2018SA297575, 2018SA298692, 2018SA298695, 2018SA298701 (same reporter). This case involves a patient of an unknown demographics who received 5 mL dose of vaccine FLUZONE HIGH DOSE lot U1995AB, expiry date: 20-Jun-2019 via intramuscular route in arm NOS on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccines were administered with the FLUZONE HD. It was actual medication error due to Overdose and incorrect product storage. It was reported that patients were injected with previously frozen 5 mL FLUZONE HD. The caller stated that the staff were unaware that temperature reading from the refrigerator showed that the FLUZONE HD vaccines were frozen at some point in time. 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.
Age: 72.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Chills, Cough, Deafness bilateral, Influenza, Pyrexia
Clinical narrative: Initial information received on 25-Oct-2018 regarding an unsolicited valid serious case received from a consumer. This case involves a 72 years old female patient who experienced lost hearing in both ears and flu, 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 11-Sep-2018, the patient received a dose of suspect 0.5 mL INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via intramuscular route in right arm. On 17-Oct-2018, the, the patient developed a serious event lost hearing in both ears (deafness bilateral), one month six days following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. This event was assessed as medically significant. On 15-Oct-2018, the patient developed a non-serious flu (influenza like illness) with symptoms cough, temperature was 102 degrees (pyrexia) and chills, one month four days following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. It was reported that the patient had a cough up until yesterday (recovered), fever and chills, 2 days after she had gotten the flu she noticed she lost her hearing. She lost hearing in both ears but the left ear was starting to get better. She still could not hear out of her right ear and described that the sound she hears in her right ear a silent sound. Relevant test included body temperature 102 degree Celsius. Final diagnosis was flu and lost hearing in both ears. It was not reported if the patient received a corrective treatment. On an unknown date, the patient was recovered from cough. The outcome of the other events was not reported. List of documents held by sender: none.; Sender's Comments: This case involves a 72 years old patient who presented with lost hearing in both ears and flu with fever, chills, cough post vaccination with FLUZONE HIGH DOSE. Time to onset is unknown. Additional information regarding patient's medical history, condition at the time of vaccination, etiological workup and investigation reports to identify alternative etiology are needed for complete assessment of the case. Based upon the reported information, the role of the vaccines cannot be assessed.
Age: 72.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Unevaluable event
Clinical narrative: Initial information received on 25-Oct-2018 regarding an unsolicited valid serious case received from a consumer. This case involves a 72 years old female patient who experienced lost hearing in both ears and flu, 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 11-Sep-2018, the patient received a dose of suspect 0.5 mL INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via intramuscular route in right arm. On 17-Oct-2018, the, the patient developed a serious event lost hearing in both ears (deafness bilateral), one month six days following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. This event was assessed as medically significant. On 15-Oct-2018, the patient developed a non-serious flu (influenza like illness) with symptoms cough, temperature was 102 degrees (pyrexia) and chills, one month four days following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. It was reported that the patient had a cough up until yesterday (recovered), fever and chills, 2 days after she had gotten the flu she noticed she lost her hearing. She lost hearing in both ears but the left ear was starting to get better. She still could not hear out of her right ear and described that the sound she hears in her right ear a silent sound. Relevant test included body temperature 102 degree Celsius. Final diagnosis was flu and lost hearing in both ears. It was not reported if the patient received a corrective treatment. On an unknown date, the patient was recovered from cough. The outcome of the other events was not reported. List of documents held by sender: none.; Sender's Comments: This case involves a 72 years old patient who presented with lost hearing in both ears and flu with fever, chills, cough post vaccination with FLUZONE HIGH DOSE. Time to onset is unknown. Additional information regarding patient's medical history, condition at the time of vaccination, etiological workup and investigation reports to identify alternative etiology are needed for complete assessment of the case. Based upon the reported information, the role of the vaccines cannot be assessed.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 25-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA298672, 2018SA298673, 2018SA298674, 2018SA298675, 2018SA298676, 2018SA298677, 2018SA298678, and 2018SA298679 (same reporter). This case involves a 49-Years old female patient who was inadvertently administered with a dose of 0.5 mL FLUZONE HIGH DOSE (frequency once) lot UJ039AA, expiry date 15-May-2019 via unknown route in unknown site on 25-Oct-2018. The patient's medical history and concomitant medications were not reported. It is an actual medication error case due to inappropriate age at vaccine administration and overdose. It was reported that employees were inadvertently administered FLUZONE HIGH DOSE to the employees aged 32-62 years old. At the time of report, none of the patients report any reaction. 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.