chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: FLU3
Symptoms: Influenza like illness, Pain, Pyrexia
Clinical narrative: flu like symptoms; fever that left them in bed for 1-2 days; aches/pain; Initial information received on 17-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case was linked to 2019SA290955 (same reporter).  This case involves a 75 years old male patient who experienced flu like symptoms, while he 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.  Patient was not on concomitant therapy.   On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ238AA via intramuscular route in the arm upper.  On an unknown date, The patient developed a non-serious flu like symptoms(influenza like illness), fever that left them in bed for 1-2 days (pyrexia) and aches/pain (pain) Unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  No lab test reported.  Final diagnosis was flu like symptoms, fever and pain.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Recovered / Resolved on an unknown date for the events.
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: patient received, in his left arm, a dose of Menactra which was beyond its expiration date/no AE; Initial information received on 17-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves male patient who received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] in his left arm after its expiration date.  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 MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U5835AB, Feb-2019.  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 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: 0.17
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: they gave a patient expired Pentacel, no AE; Initial information received on 17-Oct-2019 regarding an unsolicited valid non-serious case received from other healthcare professional.  This case involves a two months old male patient who received first 0.5 ml dose of expired vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot C5573AA, other lot C5427BA, Exp. Date 13-Oct-2019) via unknown route in the right deltoid on 15-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE, PNEUMOCOCCAL VACCINE and HEPATITIS B VACCINE for Immunisation.  It was a case of actual medication error due to expired vaccine used.  At the time of reporting, no adverse reactions were reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Overdose, Product administered to patient of inappropriate age
Clinical narrative: Patient, 60 yrs old, was given Fluzone High Dose, NO AE; Patient, 60 yrs old, was given Fluzone High Dose, NO AE; Initial information received on 17-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 60 years old male patient who received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] 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 and overdose.  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 on the batch number was requested.
Age: 90.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: Fluzone HD was inadvertently administered to a patient from the delayed shipment, no AE; Fluzone HD was inadvertently administered to a patient from the delayed shipment, no AE; Initial information received on 18-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 90 years old female patient who received 0.5 ml dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UJ274AA, Exp. Date 26-May-2020) via intramuscular route in the left deltoid on 18-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 case due to incorrect product storage. It was also a case of product shipment delay.  It was reported that shipment of Fluzone HD was delivered on 16-Oct-2019, however was not received until 18-Oct-2019. Caller reports one dose of Fluzone HD was inadvertently administered to a 90 yo patient from the delayed shipment.  No adverse reaction reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: HEP, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: newborn received Adacel instead of Hep B, no AE; newborn received Adacel, no AE; Initial information received on 18-Oct-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a newborn patient (age and gender not reported) who received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number not reported via unknown route in unknown administration site) instead of HEPATITIS B VACCINE 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 wrong vaccine administered and inappropriate age at vaccine administration.  At the time of reporting, no adverse reactions were 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 on the batch number was requested.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered at inappropriate site
Clinical narrative: a 5 years old female received a 0.5 ml dose of Fluzone Quadrivalent vaccine in her inner thigh instead of the deltoid muscle/No AE; Initial information received on 18-Oct-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a five years old female patient who received a 0.5 ml dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] in her inner thigh instead of the deltoid muscle lot number and expiry date not reported via unknown route on 16-Oct-2019.  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 VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) on 16-Oct-2019.  It was an actual medication error due to vaccine administered at inappropriate site.  There were no side effects 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.  Information on the batch number was requested.
Sex: U
Vaccine: HEPA, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: infant was given an Adacel vaccine instead of a Hepatitis vaccine in error / no AE; 3 hours old patient administered Adacel vaccine / no AE; Initial information received on 18-Oct-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 3 hours old patient who received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] instead of HEPATITIS VACCINES  (lot number and Expiry date unknown) via unknown route in unknown administration site, on 18-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 case due to wrong vaccine administered and Inappropriate age at vaccine administration.  It was reported that The patient will be in the hospital for 48 hours per standard protocol and will be monitored. lot/exp: UTR The physician is not linked to the same system as the hospital where the patient was born. 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 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.  Information on the batch number was requested.
Age: 11.0
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Overdose, Product administered to patient of inappropriate age
Clinical narrative: the 11 year old received the Fluzone HD with no side effects; the 11 year old received the Fluzone HD with no side effects; Initial information received on 18-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 11 years old patient who received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot number not reported via unknown route in unknown administration site On 18-Oct-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 inappropriate age at vaccine administration and overdose.  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 on the batch number was requested.
Age: 11.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Overdose, Product administered to patient of inappropriate age
Clinical narrative: a 11 yr old child was by mistake given Fluzone HD/No AE; a 11 year old child was by mistake given Fluzone HD/No AE; Initial information received on 18-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 11 years old male patient who received by mistake 0.5 mL dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot UJ287AA, expiry date-28-05-2020 via unknown route in unknown administration site on 18-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Asthma without complications. No other vaccines received.  It was a case of actual medication error due to inappropriate age at vaccine administration and overdose.  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.
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Overdose, Product administered to patient of inappropriate age
Clinical narrative: a patient under 65 year of age received Fluzone High-Dose/No AE; a patient under 65 year of age received Fluzone High-Dose/No AE; Initial information received on 18-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a female patient of an unknown age (under 65 years) who received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] 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.  At the time of the event, the patient had ongoing Lung disorder and Autoimmune disorder.   It was a case of actual medication error due to inappropriate age at vaccine administration and overdose.  It was reported that patient under 65 year of age stated that she has been given the Fluzone HD previously due to her lung disease and autoimmune disease. Patient was wanting to have Fluzone HD administered again, Pharmacist stated that the patient called her HCP while standing in line and was told to get Fluzone Quadrivalent. Pharmacist stated that she was unsure if the patient really received Fluzone High-Dose in the past but she received Quadrivalent from her.  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 on the batch number was requested.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise
Clinical narrative: patient got sick for the night; Initial information received on 18-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 65 years old female patient who got sick for the night, 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. Patient's sister is 95, has cancer, low in weight and fragile.  On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious got sick for the night (malaise) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Patient described it as having a bad night.  (Other relevant tests included no lab data.)  Final diagnosis was patient got sick for the night.  It was not reported if the patient received a corrective treatment.  The patient was Recovering from sickness.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: a consumer received 2 Fluzone High Dose vaccines in one day/No AE; Initial information received on 18-Oct-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves patient of an unknown demographics who received two doses of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] 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 extra dose administered.  It was given in a nursing home. Pharmacist do have a note saying that some guy was given two doses of Fluzone High-Dose vaccine in the same day.  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 on the batch number was requested.
Sex: F
Vaccine: FLU3, PNC13, VARZOS
Symptoms: Arthritis, Fatigue, Feeling abnormal, Influenza, Myalgia
Clinical narrative: feel bad; flare up about a week after receiving the injection and weeks have gone by and its getting worse; feels tired; muscle aches; had a temperature, low grade fever; has a mild case of the flu; Initial information received on 18-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 72 years old female patient who was feel bad, flare up about a week after receiving the injection and weeks have gone by and its getting worse, feels tired, muscle aches, had a temperature, low grade fever and has a mild case of the flu, while she received vaccines PREVNAR 13, SHINGRIX and 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 24-Sep-2019, the patient received a dose of suspect SHINGRIX not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site.  On 24-Sep-2019, the patient received a dose of suspect PREVNAR 13 not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site.  On 24-Sep-2019, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in unknown administration site.  In the first week or so there no pain at the injection site or any other problems.  On an unknown date, the patient developed a non-serious feel bad (feeling abnormal), flare up about a week after receiving the injection and weeks have gone by and its getting worse (arthritis), feels tired (fatigue), muscle aches (myalgia), had a temperature, low grade fever (pyrexia) and has a mild case of the flu (influenza like illness) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE, SHINGRIX and PREVNAR 13.  (Other relevant tests included no lab data.)  Final diagnosis was Mild has a mild case of the flu, had a temperature, low grade fever, muscle aches, feels tired, flare up about a week after receiving the injection and weeks have gone by and its getting worse and feel bad.   It was not reported if the patient received a corrective treatment.  The outcome of the event was reported as Unknown for all the events.  Information on the batch number was requested.
Sex: F
Vaccine: FLU3, PNC13, VARZOS
Symptoms: Pyrexia
Clinical narrative: feel bad; flare up about a week after receiving the injection and weeks have gone by and its getting worse; feels tired; muscle aches; had a temperature, low grade fever; has a mild case of the flu; Initial information received on 18-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 72 years old female patient who was feel bad, flare up about a week after receiving the injection and weeks have gone by and its getting worse, feels tired, muscle aches, had a temperature, low grade fever and has a mild case of the flu, while she received vaccines PREVNAR 13, SHINGRIX and 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 24-Sep-2019, the patient received a dose of suspect SHINGRIX not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site.  On 24-Sep-2019, the patient received a dose of suspect PREVNAR 13 not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site.  On 24-Sep-2019, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in unknown administration site.  In the first week or so there no pain at the injection site or any other problems.  On an unknown date, the patient developed a non-serious feel bad (feeling abnormal), flare up about a week after receiving the injection and weeks have gone by and its getting worse (arthritis), feels tired (fatigue), muscle aches (myalgia), had a temperature, low grade fever (pyrexia) and has a mild case of the flu (influenza like illness) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE, SHINGRIX and PREVNAR 13.  (Other relevant tests included no lab data.)  Final diagnosis was Mild has a mild case of the flu, had a temperature, low grade fever, muscle aches, feels tired, flare up about a week after receiving the injection and weeks have gone by and its getting worse and feel bad.   It was not reported if the patient received a corrective treatment.  The outcome of the event was reported as Unknown for all the events.  Information on the batch number was requested.
Age: 13.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Overdose, Product administered to patient of inappropriate age
Clinical narrative: a 13-year-old female received Fluzone HD inadvertently/No AE; a 13-year-old female received Fluzone HD inadvertently/No AE; Initial information received on 18-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 13 years old female patient who received 0.5 mL vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot UJ268AA, expiry date- 10-May-2020 (Frequency = once) via intramuscular route in the left deltoid on 17-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccines received.  It was a case of actual medication error due to inappropriate age at vaccine administration and overdose.  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.
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used/no AE; Initial information received on 18-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 16 years old male patient who received expired dose of vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant therapy was received.  On an unknown date, the patient received a 0.5 ml single booster dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot C6016AA (exp: 09-Oct-2019) via intramuscular route in the right arm.  It was of actual medication error due to expired vaccine used.  It was unknown whether adverse event was experienced 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: 1.33
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: a 16 month old was administered an expired dose of Daptacel, no AE; Initial information received on 18-Oct-2019 regarding an unsolicited valid non-serious case received from an other health care professional.  This case involves a 16 months old female patient who received a 0.5 ml dose of expired vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number: C5254AA and expiry date: 18-Sep-2019) via intramuscular route in the left thigh.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACTHIB) and PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE).  It was an actual medication error due to expired vaccine used.  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: 33.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: a 33 years male patient was accidentally vaccinated with Fluzone Quadrivalent vaccine that was expired, no AE; Initial information received on 18-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA292827 (same reporter).  This case involves a 33 years old male patient who received an 0.5 ml dose expired vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] Prefilled Syringe lot UJ049AB, expiry date: 30-Jun-2019 via Intramuscular route in the left arm on 18-Oct-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 vaccine used.  The patient experienced no 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.
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired Menactra was administered to a patient on today, No AE; Initial information received on 18-Oct-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves unknown demographic patient who received a dose of expired vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (Lot No: U6016AA, Expiration date: 09-Oct-2019) via unknown route in unknown administration site on 18-Oct-2019.   The patients 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 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: F
Vaccine: FLU3
Symptoms: Expired product administered
Clinical narrative: administered a dose of Fluzone High-Dose that was expired; Initial information received on 18-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 69 years old female patient who received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] and reported that administered a dose of Fluzone High-dose that was expired (expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 18-Oct-2019, the patient received a dose of suspect 0.5 ml INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ044AA and expiry date 04-Jun-2019 via intramuscular route in the left arm.  It was a case of actual medication error due to expired vaccine used.  It was unknown if the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Accidental exposure to product, Exposure via skin contact, No adverse event
Clinical narrative: some of the medication squirted out of the site into mouth and on lip with no adverse event; Initial information received on 17-Oct-2019 regarding an unsolicited valid non-serious case received from a health professional.  This case is linked with case ID 2019SA290921 (Same reporter).   This case involves a 35-years-old female patient (staff member) who was exposed to  vaccine and reported some of the medication squirted out of the site into mouth and on lip (accidental exposure to product), while administering INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE QUADRIVALENT] (lot number UJ255AA) to a patient. Staff member was sent for a bloodborne pathogen work-up per facility protocol.  The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was as actual medication error due to accidental occupational exposure to product.  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 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: 17.0
Sex: U
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Flublok Quadrivalent was accidentally administered to 17 year old with no adverse event; Initial information received on 17-Oct-2019 regarding an unsolicited valid non-serious case received from a health professional.  This case is linked with case ID 2019SA291192 (Same reporter).   This case involves a 17-year-old patient of unknown gender who was accidentally administered with dose of QUADRIVALENT RECOMBINANT INFLUENZA VACCINE [FLUBLOK QIV] (lot number not reported via unknown route in unknown administration site).  The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was as actual medication error due to inappropriate age at vaccine administration.  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 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.  Information on the batch number was requested.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Pyrexia, Skin warm
Clinical narrative: On the evening of the shot developed pain in my arm, fever and redness. This continue for 2 days, then developed a fever. The fever was on and off for 1 week. The arm became warm and then hot and painful during this first. Took advil and used ice, but barely helped.  Week 2 the pain continue, arm was not warm and very painful.  Week 3 the pain continue, arm was warm and occasionally painful  Week 4 the symptoms began to reduce and by the end of the week 4 was beginning to feel better
Age: 84.0
Sex: F
Vaccine: FLUA3
Symptoms: Back pain, Diarrhoea, Dry mouth, Injection site pain, Malaise
Clinical narrative: Severe vomiting, Diarrhea, nausea, injection site pain, lower back pain, dry mouth  Vomiting stopped after 24 hours. Nausea continued for 4 days. General malaise for a week.
Age: 84.0
Sex: F
Vaccine: FLUA3
Symptoms: Nausea, Vomiting
Clinical narrative: Severe vomiting, Diarrhea, nausea, injection site pain, lower back pain, dry mouth  Vomiting stopped after 24 hours. Nausea continued for 4 days. General malaise for a week.
Age: 9.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Headache, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Elevated fever of 102.9 with max doses of tylenol and ibuprofen.  Headache, nausea vomiting, stuffy nose. Intense site pain. Presented like cellulitis. Red, Hot and Indurated.  Site grew to 12cm x 14cm
Age: 9.0
Sex: M
Vaccine: PPV
Symptoms: Injection site warmth, Nasal congestion, Nausea, Pyrexia, Vomiting
Clinical narrative: Elevated fever of 102.9 with max doses of tylenol and ibuprofen.  Headache, nausea vomiting, stuffy nose. Intense site pain. Presented like cellulitis. Red, Hot and Indurated.  Site grew to 12cm x 14cm
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Feeling cold, Hyperhidrosis, Injection site erythema
Clinical narrative: Patient experienced dizziness, sweating, cold chills, achy muscles, nausea, hives on face and neck, swollen red arm at injections site
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Myalgia, Nausea, Urticaria
Clinical narrative: Patient experienced dizziness, sweating, cold chills, achy muscles, nausea, hives on face and neck, swollen red arm at injections site
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Left thigh patient developed 10 x 11 cm erythematous swelling to left thigh, mildly tender,noted 15 minutes after injection. pt monitored for another 20 minutes and released home. no sob or cough noted. family advised Benadryl at home
Age: 46.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Headache, Nausea, Pain, Vomiting
Clinical narrative: Pt received vaccine on saturday morning. On saturday afternoon pt got Headaches. Sunday pt still had Headaches, chills, aches and vomiting but NO FEVER. Monday headaches cleared and pt went to the doctor. Received Motrin for headaches, and zofran for n/v. Pt feels fine now.
Age: 69.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: None; however, the vaccine was pre-drawn the night before, which is not recommended.
Age: 68.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: None; however, the vaccine was pre-drawn the night before, which is not recommended.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: None; however, the vaccine was pre-drawn the night before, which is not recommended.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: None; however, the vaccine was pre-drawn the night before, which is not recommended.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Dysphagia, Full blood count, Haematology test, Laboratory test, Muscular weakness
Clinical narrative: difficulty swallowing , upper extremity weakness, difficulty with speech
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Speech disorder
Clinical narrative: difficulty swallowing , upper extremity weakness, difficulty with speech
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: None; however, the vaccine was pre-drawn the night before, which is not recommended.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: None; however, the vaccine was pre-drawn the night before, which is not recommended.
Age: 72.0
Sex: F
Vaccine: HEP
Symptoms: Allergy to vaccine, Angioedema, Hypersensitivity, Mechanical ventilation, Swollen tongue
Clinical narrative: RN Verified patient order to receive Engerix IM 40mcg, patient had no known drug allergies or allergies to ingredients. Engerix IM 40mcg administered in left upper deltoid. Patient alert, responding to verbal commands, and oriented x4. At 1330 patient reported to clinic that her tongue was swollen. 1332 RN at chairside to assess patient. Patient was in no apparent respiratory distress, respirations unlabored. 1335 Benadryl 50 mg IVP given. Symptoms improved. Patient denied SOB upon discharge. Engerix IM added to allergy list.  After discharge, pt was transported to hospital via EMS to hospital for allergic reaction.  She experienced angioedema and was placed on ventilator until symptoms resolved.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: None; however, the vaccine was pre-drawn the night before, which is not recommended.
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: None; however, the vaccine was pre-drawn the night before, which is not recommended.
Age: 38.0
Sex: M
Vaccine: FLU4
Symptoms: Anxiety, Dizziness, Nausea, Panic attack
Clinical narrative: APPROXIMATELY 1 HOUR AFTER RECEIVING VACCINE PATIENT REPORTED FEELING LIGHTHEADED, DIZZY AND NAUSEATED
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Headache, Syncope
Clinical narrative: Patient started to have a headache and feel dizzy after injections, patient wanted to try to make it to the car, but fainted outside the building.  Mom was able to catch her, no s/s of harm.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: None; however, the vaccine was pre-drawn the night before, which is not recommended.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: None; however, the vaccine was pre-drawn the night before, which is not recommended.
Age: 12.0
Sex: F
Vaccine: FLU4, HEPA, HPV9
Symptoms: Muscle rigidity, Seizure like phenomena, Tremor
Clinical narrative: Patient obtained 3 immunizations. She was in mid-conversation, when suddenly, she fell back onto the exam table and displayed seizure-like symptoms for 30-45 seconds. She was rigid and shaking during the episode. She was not incontinent of stool or urine. When symptoms subsided, she was alert and oriented x4. She was provided water and crackers, as patient reported only having a Go-gurt for breakfast. PA was contacted and advised to have patient be evaluated by PCP or in the ER. Mother was contacted and notified of event. Mother then reported patient had a similar episode about 1 year ago, although she had not reported this when contacted for the contraindication questions. Mother was able to contact patient's PCP and they advised to follow-up in their office at a later date. Mother reported that PCP can order further workup, if indicated. Mother did come and pickup patient from school to be monitored for the rest of the day. Mother was provided letter with description of episode.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: None; however, the vaccine was pre-drawn the night before, which is not recommended.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: None; however, the vaccine was pre-drawn the night before, which is not recommended.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Rash, Swelling
Clinical narrative: Patient states rash and redness at swell leading towards chest
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: None; however, the vaccine was pre-drawn the night before, which is not recommended.
Age: 50.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: None; however, the vaccine was pre-drawn the night before, which is not recommended.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Back pain, Influenza like illness, Injection site erythema, Injection site pain
Clinical narrative: Pain, redness, and swelling at the injection site Flu like symptoms, arthralgias (specifically back pain) and myalgias, night sweats about 12 hours after vaccination. Treated with conservative care (ice pack, Celebrex, rest)
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Myalgia, Night sweats
Clinical narrative: Pain, redness, and swelling at the injection site Flu like symptoms, arthralgias (specifically back pain) and myalgias, night sweats about 12 hours after vaccination. Treated with conservative care (ice pack, Celebrex, rest)
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Wrong technique in product usage process
Clinical narrative: None; however, the vaccine was pre-drawn the night before, which is not recommended.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Malaise, Pyrexia
Clinical narrative: Extreme swelling,  soreness, pain and heat at injection site. Low grade fever general malaise.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling, Injection site warmth
Clinical narrative: The patient returned to the pharmacy on Monday morning, two days after the injection.  She stated that Saturday evening (the night of the injection), her arm developed a large knot where the vaccination had been injected.  She rubbed the area to try and rub the knot out.  The next morning she woke up to her entire left bicep area red, swollen, and feverish.  She went to the doctor two days later (on Monday) and received a steroid dose pack and an antibiotic in case an infection had set up in the area.  Her arm was not swollen when she picked up her medications, but it was still red in a certain area.
Age: 49.0
Sex: M
Vaccine: FLU4
Symptoms: Wrong technique in product usage process
Clinical narrative: None; however, the vaccine was pre-drawn the night before, which is not recommended.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Wrong technique in product usage process
Clinical narrative: None; however, the vaccine was pre-drawn the night before, which is not recommended.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Rash pruritic
Clinical narrative: Patient said arm had a rash about 3 to 4 inches around and that it did itch .  Today October 28th no itching but rash is still present
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Wrong technique in product usage process
Clinical narrative: None; however, the vaccine was pre-drawn the night before, which is not recommended.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Diarrhoea, Feeling abnormal, Headache
Clinical narrative: Could not lift my arm up severe pain   Fever/ chills Severe body aches Headache Diarrhea  No energy / Feel horrible
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain, Pyrexia
Clinical narrative: Could not lift my arm up severe pain   Fever/ chills Severe body aches Headache Diarrhea  No energy / Feel horrible