chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Fluzone HD was accidently given to 4 year old, with no ae; Fluzone HD was accidently given to 4 year old, with no ae; Initial information received on 01-Nov-2019 regarding an unsolicited valid non-serious case received from a health-care professional (nurse) via phone.  This case is linked with 2019SA307286.   This case involves a 4-years male patient, who was vaccinated with a dose of INFLUENZA VACCINE TRIVALENT [FLUZONE HIGH DOSE), (Batch number: UJ287AA and expiration date: 28-MAY-2020 at a dose of 0.5 ml via Intramuscular in Left Vastus Lateralis on 01-Nov-2019.  The patient medical history and concomitant medications were not reported.  It was the case of inappropriate age at vaccine administration and overdose.  At the time of reporting, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: FLU3
Symptoms: Exposure via skin contact, No adverse event, Syringe issue
Clinical narrative: while removing the needle from patient's arm, some of the medication ran down his arm, no AE; while removing the needle from patient's arm, some of the medication ran down his arm, no AE; Syringe leaked when administered, no AE; Initial information received on 14-Oct-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a male patient of an unknown age who received a dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UJ251AD, expiry date: 01-May-2020) via unknown route in the arm NOS.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to vaccine underdose.  It was also a case of Exposure via skin contact and syringe issue.   Reporter stated that when she was removing the needle from his arm, some of the medication ran down his arm.  Syringe leaked when administered.  At the time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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.
Sex: U
Vaccine: FLU3
Symptoms: Needle issue, No adverse event, Underdose
Clinical narrative: the needle was not on secure enough and the fluid from the vaccine leaked everywhere/ no AE; the needle was not on secure enough and the fluid from the vaccine leaked everywhere/ no AE; Initial information received on 30-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.   This case involves (unknown age and gender) patient who received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot number: UJ288AB, Expiry date: 30-Jun-2020) via unknown route and site of administration on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to needle issue and vaccine underdose.   It was reported that she administered a Fluzone High-Dose to patient however the needle was not on secure enough and the fluid from the vaccine leaked everywhere.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Dysphagia, Headache, Injection site pain, Nausea
Clinical narrative: pain in their arms at injection site,; nausea; vomiting; diarrhea; headaches; Initial information received on 30-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case is linked to case 2019SA304088   This case involves a 66 years old male patient who experienced Nausea (Nausea), vomiting (vomiting), diarrhea (diarrhoea), headaches (headache), pain in their arms at injection site (vaccination site pain) while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 28-Oct-2019, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number and Expiry date unknown) via unknown route in unknown administration site.  On 28-Oct-2019 , the patient developed a non-serious Nausea (Nausea), vomiting (vomiting), diarrhea (diarrhoea), headaches (headache), in same evening following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  On an unknown date, the patient experienced non-serious pain in their arms at injection site (vaccination site pain) (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 Swallowing difficult, pain in their arms at injection site, headaches, diarrhea, vomiting, nausea and Severe sore throat.  It was not reported if the patient received a corrective treatment.  On an unknown date, the event outcome is reported as Recovered for nausea, vomiting, diarrhea, headaches after 24 hours and not recovered for pain in their arms at injection site.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Vomiting
Clinical narrative: pain in their arms at injection site,; nausea; vomiting; diarrhea; headaches; Initial information received on 30-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case is linked to case 2019SA304088   This case involves a 66 years old male patient who experienced Nausea (Nausea), vomiting (vomiting), diarrhea (diarrhoea), headaches (headache), pain in their arms at injection site (vaccination site pain) while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 28-Oct-2019, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number and Expiry date unknown) via unknown route in unknown administration site.  On 28-Oct-2019 , the patient developed a non-serious Nausea (Nausea), vomiting (vomiting), diarrhea (diarrhoea), headaches (headache), in same evening following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  On an unknown date, the patient experienced non-serious pain in their arms at injection site (vaccination site pain) (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 Swallowing difficult, pain in their arms at injection site, headaches, diarrhea, vomiting, nausea and Severe sore throat.  It was not reported if the patient received a corrective treatment.  On an unknown date, the event outcome is reported as Recovered for nausea, vomiting, diarrhea, headaches after 24 hours and not recovered for pain in their arms at injection site.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Cold sweat, Dizziness, Headache, Heart rate increased, Nausea
Clinical narrative: blurred vision; bodyache; increased heart rate; nausea; clamminess; dizziness/ lightheadedness; headache; Initial information regarding this unsolicited valid non-serious case received from a pharmacist and transmitted to Sanofi on 04-Nov-2019.  This case involves a 27 years old female patient who experienced blurred vision (PT: vision blurred), bodyache (PT: pain), increased heartrate (PT: heart rate increased), nausea (PT: Nausea), clamminess (PT: cold sweat), dizziness (PT: dizziness), headache (PT: headache) and lightheadedness (PT: Dizziness), while she received vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE].  Relevant medical history and concomitant medication were unknown.  No other vaccine was given.  On 02-Oct-2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (0.5 ml Vial) (lot: UJ223AB expiry date: 30-Jun-2020) via intramuscular route in the right arm.  On 02-Oct-2019, the patient developed a non-serious blurred vision (PT: vision blurred), bodyache (PT: pain), increased heartrate (PT: heart rate increased), nausea (PT: Nausea), clamminess (PT: cold sweat), dizziness (PT: dizziness), headache (PT: headache) and lightheadedness (PT: Dizziness), 30 minutes following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.  Action taken was not applicable.  Corrective treatment was unknown for all events.  At the time of reporting, outcome was unknown for all events.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Vision blurred
Clinical narrative: blurred vision; bodyache; increased heart rate; nausea; clamminess; dizziness/ lightheadedness; headache; Initial information regarding this unsolicited valid non-serious case received from a pharmacist and transmitted to Sanofi on 04-Nov-2019.  This case involves a 27 years old female patient who experienced blurred vision (PT: vision blurred), bodyache (PT: pain), increased heartrate (PT: heart rate increased), nausea (PT: Nausea), clamminess (PT: cold sweat), dizziness (PT: dizziness), headache (PT: headache) and lightheadedness (PT: Dizziness), while she received vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE].  Relevant medical history and concomitant medication were unknown.  No other vaccine was given.  On 02-Oct-2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (0.5 ml Vial) (lot: UJ223AB expiry date: 30-Jun-2020) via intramuscular route in the right arm.  On 02-Oct-2019, the patient developed a non-serious blurred vision (PT: vision blurred), bodyache (PT: pain), increased heartrate (PT: heart rate increased), nausea (PT: Nausea), clamminess (PT: cold sweat), dizziness (PT: dizziness), headache (PT: headache) and lightheadedness (PT: Dizziness), 30 minutes following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.  Action taken was not applicable.  Corrective treatment was unknown for all events.  At the time of reporting, outcome was unknown for all events.
Sex: U
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: HCP stated the Flublok was given to 3 kids who are under the age of 3 with no adverse event; Initial information received on 05-Nov-2019 and follow-up information received on 06-Nov-2019 regarding an unsolicited valid non-serious case from a physician.  This case involves a 22 month old (gender not reported) patients who received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT 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, vaccination and family history were not provided.  It was a case of actual medication error due to inappropriate age at vaccine administration.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information of the batch number was requested.
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product distribution issue, Product storage error
Clinical narrative: received a Fluzone Quadrivalent after 2 days of shipping and vaccine was not viable, no adverse event; received a Fluzone Quadrivalent after 2 days of shipping and vaccine was not viable, no adverse event; Initial information regarding this unsolicited valid non-serious case received from a pharmacist on 05-Nov-2019.  This case is linked to 2019SA310491 and 2019SA310490.  This case involves a 56 year old female patient who received a dose of 0.5 ml of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UJ270AA, Expiration date 30-JUN-2020) via intramuscular route in the left deltoid in Nov-2019 after 2 days of shipping, vaccines were nonviable.  The patient's past medical history, medical treatment(s), vaccination(s), and family history were not provided.  No other vaccine was given.   It was a case of actual medication error due to product storage error and product distribution issue.  it was reported that patient received a Fluzone Quadrivalent after 2 days of shipping which were not viable.  At the time of report no adverse events were observed.  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 Disclaimer: 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: FLU3
Symptoms: No adverse event, Product distribution issue, Product storage error
Clinical narrative: received a Fluzone Quadrivalent after 2 days of shipping, vaccines were nonviable, no adverse event; received a Fluzone Quadrivalent after 2 days of shipping, vaccines were nonviable, no adverse event; Initial information regarding this unsolicited valid non-serious case received from a pharmacist on 05-Nov-2019.  This case is linked to 2019SA310489 and 2019SA310490.  This case involves a 40 year old female patient who received a dose of 0.5 ml of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UJ270AA, Expiration date 30-JUN-2020) via unknown route in the left deltoid in Nov-2019 after 2 days of shipping, vaccines were nonviable.  The patient's past medical history, medical treatment(s), vaccination(s), and family history were not provided.  No other vaccine was given.   It was a case of actual medication error due to product storage error and product distribution issue.  it was reported that patient received a Fluzone Quadrivalent after 2 days of shipping which were not viable.  At the time of report no adverse events were observed.  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 Disclaimer: 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: FLU3
Symptoms: No adverse event, Overdose, Product administered to patient of inappropriate age
Clinical narrative: 6 yo patient received a Fluzone HD, no ad verse event; 6 yo patient received a Fluzone HD, no ad verse event; Initial information received on 06-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff).  This case involves a 6 years old female patient who received 0.5 ml dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (Lot no: lot UJ274AB  and Expiry date: 26-May-2020) via unknown route on 31-Oct-2019.  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 inappropriate age at vaccine administration and Overdose. It was reported that INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE]. It was reported that flozaone high dose administered to child patient of 6year old with no ae.   At the time of reporting, the patient had no 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: Injection site erythema, Injection site inflammation, Injection site swelling
Clinical narrative: Redness and Swelling at the injection site; redness and swelling at the injection site; Redness and Swelling at the injection site; Initial information received on 07-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves 4 patients (unknown age and gender) who experienced redness and swelling at the injection site and redness (vaccination site inflammation) while they received vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, 4 patients received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] lot number UJ237AB and exp date 30Jun20 via unknown route in unknown administration site.  On an unknown date, (unknown latency) 4 patients developed a non-serious redness and swelling at the injection site (vaccination site inflammation with symptoms vaccination site swelling and vaccination site erythema) following the administration of ENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED vaccine.  (Other relevant lab test was not reported).  Final diagnosis was redness and swelling at the injection site and redness and swelling at the injection site.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as unknown for redness and swelling at the injection site and as unknown for redness and swelling at the injection site.
Sex: M
Vaccine: FLU4
Symptoms: Hypersomnia
Clinical narrative: The patient did not wake up on 31-Oct-2019; Initial information received on 07-Nov-2019 regarding an unsolicited valid non-serious case received from a physician..  This case involves a 19 month old male patient who did not wake up on 31-Oct-2019 (Hypersomnia), while he received vaccine influenza quadrival A-B vaccine [Fluzone Quadrivalent].  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 UT6647JA, pre-filled syringe) via unknown route in unknown administration site.  On 31-Oct-2019, the patient did not wake up (hypersomnia), unknown latency following the administration of influenza quadrival A-B vaccine.  Other lab tests were not reported.  Final diagnosis was hypersomnia.   It was not reported if the patient received a corrective treatment.  The outcome of the event was not reported.
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Erythema, Injury, Nodule, Swelling
Clinical narrative: knot on arm; bruises; swelling; redness; Initial information received on 12-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  Medical history, concurrent condition and concomitant medication was unknown.  This case involves a 71 years old female patient who experienced knot on arm (PT: Large arm swelling), swelling (PT: Swelling), bruises (PT: bruise) and redness (PT: erythema), INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UJ285AA Expiration date: 02-Jun-2020) on 01-Nov-2019.  on an unknown date, (latency unknown) patient had a severe reaction with Fluzone HD and also experienced a knot on arm (PT: Large arm swelling), swelling (PT: Swelling), bruises (PT: bruise) and redness (PT: erythema).Her physician described it as a trauma.  corrective treatment was Cortisone and event outcome was Unknown at the time of reporting.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Mobility decreased, Pain in extremity
Clinical narrative: arm pain/ sore arm; Their arm is sore and hard to lift up; patients states that they felt the injection burning; Initial information regarding this unsolicited valid non-serious case received from an physician assistant and transmitted to Sanofi on 14-Nov-2019.  This case involves a 67 years old female patient who experienced arm pain [Pain in extremity], their arm is sore and hard to lift up [Injected limb mobility decreased] and patients states that they felt the injection burning [vaccination site pain], while she received vaccine Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 22-Oct-2019, the patient received a dose of suspect Influenza 0.5 ml Usp Trival A-B High Dose Subvirion Vaccine (lot UJ285AB and Exp. Date 02-Jun-2020) via unknown route in arm NOS.  On an unknown date, the patient developed a non-serious arm pain [Pain in extremity], their arm is sore and hard to lift up [Injected limb mobility decreased] and patients states that the felt the injection burning [Injection site pain], (a month) following the administration of Usp Trival A-B High Dose Subvirion Vaccine.  Corrective treatment was unknown for all events.  At the time of reporting, outcome was Not Recovered / Not Resolved for all events.
Age: 15.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product distribution issue, Product storage error
Clinical narrative: Fluzone Quad had given to a patient yesterday that was invalid, due to delay in shipping time, no AE; Fluzone Quad had given to a patient yesterday that was invalid, due to delay in shipping time, no AE; Initial information received on 12-Nov-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to cases 2019SA317566, 2019SA320727, 2019SA320730, 2019SA320731 and 2019SA320729 (same reporter).  This case involved a 15 year old male patient who received a dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot number-UJ3058A, Expiry date- 20-Jun-2020) via an unknown route in an unknown administration site on 11-Nov-2019, which was delay in shipping time.  Medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant drug were not reported.   It was a case of actual medication error due to incorrect product storage and product shipment delay. Vaccine was invalid due to prolonged shipping time.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 12.0
Sex: M
Vaccine: DTAP, TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 12 year old patient inadvertently received Daptacel instead of Adacel, No AE; 12 year old patient inadvertently received Daptacel instead of Adacel, No AE; Initial information received on 18-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 12 years old male patient who was inadvertently vaccinated with 0.5 ml dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot C5366AA, expiry date: 07-Feb-2020, via intramuscular route in the left deltoid) instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] on 18-Nov-2019.   The patient's past vaccination(s) included Daptacel with all doses in Daptacel series. The patient's past medical history, medical treatment(s) and family history were not provided. Concomitant medications included INFLUENZA VACCINE (FLU).  It was a case of actual medication error due to wrong vaccine administered and Inappropriate age at vaccine administration.  At the time of the report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: RAB, UNK
Symptoms: No adverse event, Product administered at inappropriate site
Clinical narrative: Imogam and Imovax both administered in the buttocks, no AE; Initial information received on 19-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 28 years old male patient who received RABIES (HDC) VACCINE [IMOVAX RABIES] and while treated with HUMAN RABIES IMMUNOGLOBULIN [IMOGAM RABIES-HT](lot number and expiry date not reported) via unknown route in the buttock nos on 30 Aug 2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Patient had potential exposure to rabies on 27 Aug 2019 due to possible bat bite on left hand.  It was a case of actual medication error due to Product administered at inappropriate site.  It was reported that the possible bat bite on left hand. Imogam and Imovax both administered in the buttocks but Imovax 3 days late. Patient received 6 doses Imovax were recommended.Imovax series received in the deltoid, 5th dose administered since initial dose given in the buttocks.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event, Syringe issue
Clinical narrative: medication leaking out of the syringe barrel, no AE; medication leaking out of the syringe barrel due to crack is in it, no AE; Initial information received on 20-Nov-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 78 years old female patient who received a 0.5 mL INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot UJ290AB, expiry date: 09-Jun-2020, via intramuscular route in unknown administration site on 20-Nov-2019.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to Inappropriate dose of vaccine administered.  It was also a case of syringe leak.  It was reported that pharmacist was attempting to inject Fluzone High-Dose vaccine to a 78 year-old female. When he pressed down on the plunger, he noted the medication leaking out of the syringe barrel. The caller stated the needle had already pierced the patient's skin when this issue was discovered. He stopped and re-vaccinated with a different Fluzone HD pre-filled syringe  No adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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.
Sex: M
Vaccine: FLU3
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: 61-year-old patient received Fluzone High-Dose, no AE; 61-year-old patient received Fluzone High-Dose, no AE; Initial information received on 20-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 61 years old male patient received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UJ252AA expiry date: 01-May-2020) via intramuscular route in the left deltoid from a month ago.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No other vaccines given that day.  It was an actual medication error case due to inappropriate age at vaccine administration and overdose.   The patient did not report side effects.  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.
Age: 2.0
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: patient received vaccine that was compromised due to the temperature excursion, No AE; Initial information received on 20-Nov-2019 regarding an unsolicited valid non-serious case received from other health care professional.  This case is linked with case 2019SA291040 (same reporter).  This case involves a 26 months old female patient who received a dose of vaccine IPV (VERO) [IPOL] (lot P1E701M and expiry date 09-Nov-2020) via unknown route in the left thigh on 13-Sep-2019, which was compromised in the temperature excursion, vial was opened at the time of the temperature excursion.  Medical history and concomitant medication were not provided.  It was a case of actual medication error due to incorrect product storage.   At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: patient was given Pentacel but just the liquid, without the powder, no AE; Initial information received on 20-Nov-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves patient (unknown demographic) who received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number and expiry date not reporterd) 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 also a case of actual medication error due to product preparation issue.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 17.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Overdose, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient accidentally received the Fluzone HD instead of the Fluzone Quad. vaccine; Patient accidentally received the Fluzone HD instead of the Fluzone Quad. vaccine; Patient accidentally received the Fluzone HD instead of the Fluzone Quad. vaccine; Headache; Initial information received on 20-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 17 years old male patient who experienced headache (headache), while he received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, medical treatments, vaccinations and family history were not provided.   On 18-Nov-2019, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [lot number: UJ281AA, Expiry date: 16-MAY-2020] via unknown route in the left deltoid.  On 19-Nov-2019, the patient developed a non-serious headache, one-day following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  It was also a case of actual medication error due to wrong product administered, product administered to patient of inappropriate age and overdose.  Other relevant tests included No lab data.  Final diagnosis was headache.  It was not reported if the patient received a corrective treatment.  On 20-Nov-2019, the patient recovered from Headache (reported as he was feeling fine today).   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: FLUR4
Symptoms: Expired product administered, No adverse event
Clinical narrative: After administration, the nurse noticed that the vaccine was from 2018-2019/no AE; Initial information received on 21-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.   This case involves a patient of unknown demographics for whom it was reported that after administration, the nurse noticed that the vaccine was from 2018-2019 (PT: Expired product administered) for vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Lot QFAA1820, expiry date 30-Jun-2019).  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 expired product administered.  At the time of this report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired Fluzone Quad was given to a 4 year old child in error with no adverse event; Initial information received on 21-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer (office staff).    This case involves an expired Fluzone Quad was given to a 4 year old child in error with no adverse event (PT: Expired product administered) for vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (Lot UJ009AA, expiry date 30-Jun-2019) via intramuscular route in the right arm on 21-Nov-2019.   Medical history and concomitant medication was not reported.  It was a case of actual medication error due to expired vaccine used.  It was unknown if any adverse event occurred.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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.
Sex: U
Vaccine: DTAP
Symptoms: Product prescribing error
Clinical narrative: doctor had placed an order for a Daptacel, Daptacel was drawn up for a patient, according to the patient record the Daptacel was not needed, no AE.; Initial information received on 20-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a child patient (age and gender not reported) for whom a doctor placed an order for a DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot C5366AA, expiry 07-Feb-2020) 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 potential medication error due to product prescribing error. Caller stated that a doctor had placed an order for a Daptacel. Once the staff drew up the Daptacel, the mom showed the doctor the vaccine record for her child and the child wasn't due for a Daptacel.  It was unknown whether the vaccine was administered 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 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.
Age: 1.0
Sex: U
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: a HCP administered an Ipol vaccine to the patient that hadexpired, No AE; Initial information received on 20-Nov-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 12 month old patient of unknown gender who received an expired dose of IPV (VERO) [IPOL] VACCINE (lot N1K931M, Exp. Date 18-NOV-2019) via unknown route in Right Vastus Lateralis on 20-Nov-2019.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); HIB VACCINE CONJ (TET TOX) (ACTHIB) and PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE).  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 expired vaccine used.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.25
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: sterile water was used to reconstitute the ActHIB instead of the 0.4% Sodium Chloride, no AE; Initial information received on 21-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 15 months old male patient who received vaccine HIB (PRP/T) VACCINE [ACT-HIB] lot UJ177AAB, Exp. Date 08-Feb-2021 via intramuscular route in the left thigh on 21-Nov-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (VARIVAX) and INFLUENZA VACCINE INACT SPLIT VIRION 4V (FLUZONE QUADRIVALENT) for Immunisation.  It was an actual medication error case due to wrong solution used in drug reconstitution.  It was reported that sterile water was used to reconstitute the Act-HIB instead of the 0.4 percent Sodium Chloride.  The patient had no side effects.  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: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: large quarter sized rash on his arm; Initial information received on 21-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves a 4 years old male patient who experienced large quarter sized rash on his arm (rash), while he received vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP).  On 21-Nov-2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot UJ244AA via unknown route in the left arm.  On an unknown date , the patient developed a non-serious large quarter sized rash on his arm (rash) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.  Other relevant test was not reported.  Final diagnosis was Localised rash.   It was not reported if the patient received a corrective treatment.  The event outcome is reported as Unknown for large quarter sized rash on his arm.
Sex: F
Vaccine: FLUX
Symptoms: Discomfort, Lethargy
Clinical narrative: lethargic; uncomfortable; Initial information received on 18-Nov-2019 regarding an unsolicited valid non-serious case from a consumer/non-hcp.  This case is linked to case 2019SA322188 (same reporter).  This case involves a female patient who experienced being uncomfortable (discomfort) and being lethargic (lethargy), while she received vaccine INFLUENZA VACCINE.  The patient's past medical history, concomitant treatment(s), vaccination(s) and family history were not provided.   On 06-Dec-2018, the patient received a dose  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot 3B9Y2 via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious being lethargic (lethargy) and being uncomfortable (discomfort) Unknown latency following the administration of INFLUENZA VACCINE.  No lab test reported.  Final diagnosis was lethargy and discomfort.   It was not reported if the patient received any corrective treatment.  The events being uncomfortable and being lethargic were resolved on an unknown date (the symptoms lasted the weekend).
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient was given an expired Daptacel, no AE; Initial information received on 22-Nov-2019 regarding an unsolicited valid non-serious case received from consumer or non-healthcare professional.  This case is linked to case 2019SA327223 (same reporter).  This case involves 4 year old female patient who received a dose (fourth in series) of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL]  lot C5307AA expiry date: 23-Oct-2019 via unknown route in unknown administration site on 15-Nov-2019.  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.  It was of actual medication error case due to expired vaccine used.  At the time of reporting the patient had no 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.