chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Drooling, Oral discomfort, Respiratory tract congestion
Clinical narrative: Drooling; That night patient hadn't eaten and became acutely congested; felt like there were marbles in his mouth; This case was reported by a other health professional via call center representative and described the occurrence of drooling in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number YZ97N, expiry date 26th August 2022) for prophylaxis.   Co-suspect products included PROQUAD for prophylaxis.   On 10th September 2020 16:30, the patient received the 1st dose of Kinrix .5 ml and PROQUAD. On 10th September 2020 18:00, 1 hr 30 min after receiving Kinrix, the patient experienced drooling, respiratory tract congestion and oral discomfort. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the drooling, respiratory tract congestion and oral discomfort were recovered/resolved.   It was unknown if the reporter considered the drooling, respiratory tract congestion and oral discomfort to be related to Kinrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received a dose of Kinrix and ProQuad in right thigh.  At 6pm that night patient hadn't eaten and became acutely congested, was drooling and felt like there were marbles in his mouth.  The patient's mom gave him Bendaryl and he seemed spaced out.  The symptoms subsided immediately after receiving Benadryl.  He had no issues in the past.  Consented to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Rash at the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number NP33H, expiry date 8th April 2022) for prophylaxis.   On 28th August 2020, the patient received the 1st dose of Shingrix. On 28th August 2020, immediately after receiving Shingrix, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was recovered/resolved.   It was unknown if the reporter considered the injection site rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Pharmacist stated that a patient received the first dose of Shingrix and developed a rash at the injection site soon after.  The patient did not report it right away, and the rash was now resolved.  She was inquiring should she receive the 2nd dose. The reporter consented to follow up. The case had been linked with US2020191564 same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020191564:same reporter
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Nausea, Pyrexia, Vertigo
Clinical narrative: Fever; Nausea; Vertigo; The initial case was missing the following minimum criteria: Unidentifiable Patient. Upon receipt of follow-up information on (28Sep2020), this case now contains all required information to be considered valid. This is a spontaneous report from a contactable physician via Pfizer sales representative. This physician reported similar events for 5 patients. This is the 1st of 5 patients.  A 17-year-old male patient received meningococcal group b rlp2086 (TRUMENBA, lot number: CN8296), intramuscular on 26Aug2020 14:04 at a single dose (also reported as 1-1-1/2) for Men B/ immunisation, and 2nd dose of meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA, lot number: U6596AA), intramuscular on right arm on 26Aug2020 14:04 at unknown dose for immunisation. The patient previously took 1st dose of meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA) on unspecified date. The patient's concomitant medications were not reported. The patient experienced fever 27Aug2020, nausea and vertigo on 27Aug2020. The events did not cause hospitalization. The patient took Benadryl and Advil on 27Aug2020 as treatment for the events. The outcome of the event fever was recovered on 30Aug2020 while unknown for other events. The physician reported that the suspect product had a causal effect to the adverse events.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020375958 Same reporter, similar drugs and events, different patient; -PFIZER INC-2020375956 Same reporter, similar drugs and events, different patient;US-PFIZER INC-2020375957 Same reporter, similar drugs and events, different patient; -PFIZER INC-2020375959 Same reporter, similar drugs and events, different patient
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: a patient received a 1 mL dose of Fluzone Quadrivalent instead of a 0.5 mL dose, no AE.; Initial information was received on 23-Sep-2020 regarding an unsolicited valid non-serious case from a Nurse.  This case is linked to cases 2020SA263271, 2020SA263260 and 2020SA263223 (same reporter).  This case involves a 64 years old male patient who received a 1 mL dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE QUAD T] instead of 0.5 ml (overdose).  Medical history, medical treatment, vaccination, and family history were not provided.  The patient did not receive any other vaccine concomitantly.  On 22-Sep-2020, the patient received 1 mL dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [lot UJ475AA, expiry date: 30-Jun-2021] instead of 0.5 mL via an intramuscular route at the right deltoid for prophylactic vaccination (overdose).  It was a case of overdose (actual medication error case, latency 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.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: patient received 1 mL of FLUZONE QIV instead of 0.5 mL/No AE; Initial information was received on 23-Sep-2020 regarding an unsolicited valid non-serious case from a Nurse.  This case is linked to cases 2020SA263223, 2020SA263253 and 2020SA263260. (same reporter)  This case involves a 58-year-old female patient who received a 1 mL dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE QUAD T] instead of 0.5 ml (overdose).  Medical history, medical treatment, vaccination, and family history were not provided.  The patient did not receive any other vaccine concomitantly.  On 22-Sep-2020, the patient received 1 mL dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [lot UJ475AA, expiry date: 30-Jun-2021] instead of 0.5 mL via an intramuscular route at the right deltoid for prophylactic vaccination (overdose).  It was a case of overdose (actual medication error case, latency 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.
Age: 1.92
Sex: M
Vaccine: DTAP, HIBV
Symptoms: No adverse event
Clinical narrative: Caller stated that a male 23 month old patient was supposed to receive ACTHIB but only received the diluent with no adverse event; Initial information received on 17-Sep-2020 regarding an unsolicited valid non-serious case from Nurse.  This case involves a 23 months old male patient who received 0.5 ml once dose of vaccine HIB (PRP/T) VACCINE [ACT-HIB] (batch number: U6849AA, expiry date: 22-JAN-2022) via an intramuscular route in right thigh (product preparation error) on 11-Sep-2020 for prophylactic vaccination.  The patient's medical history, past medical treatment and family history were not provided.  Concomitant medication included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP VACCINE) for Immunization.  Caller stated that the 23 months old male was supposed to receive ACTHIB but only received the diluent with no adverse event.  It was an actual medication error case due to product preparation error (latency : same day).  No laboratory test was reported.  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.
Sex: U
Vaccine: FLUR4
Symptoms: No adverse event, Product distribution issue, Product storage error
Clinical narrative: Pharmacist reported receiving a shipment of Flublok Quadrivalent that was deemed unsuitable due to a delay in the shipment. However, by the time he was informed by the company, he had already administered a dose to a patient/no adverse event; Pharmacist reported receiving a shipment of Flublok Quadrivalent that was deemed unsuitable due to a delay in the shipment. However, by the time he was informed by the company, he had already administered a dose to a patient/no adverse event; Initial information received on 17-Sep-2020 regarding an unsolicited valid non-serious case from a pharmacist via call.  This case involved a patient with unknown demographic who received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (batch number and expiry date unknown) via unknown route in unknown administration site (Product storage error and Product distribution issue) on an unknown date for prophylactic vaccination.  The patient's medical history, past medical treatment, past vaccination(s),concomitant medication(s) and family history were not provided.  It was an actual medication error case due to Improper storage of product in use and Product shipment delay (latency: unknown).  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.  There will be no information available on the batch number for this case.
Age: 15.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: administered Flublok to a 15 year old, no AE; Initial information received on 18-Sep-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 15 years old male patient who was administered a 0.5 mL once dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot: QFAA2014 expiry date: 30-Jun-2021) via an intramuscular route in the right arm as prophylactic vaccination on 17-Sep-2020.  The patient's medical history, past medical treatment, past vaccination and family history were not provided. Concomitant medication were not reported.  It was an actual medication error due to inappropriate age at vaccine administration on same day.  It was not reported if the patient received any corrective treatment.  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: 14.0
Sex: F
Vaccine: FLU4, FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 14 year old patient received a dose of Flublok instead of Fluzone QD/no AE; 14 year old patient received a dose of Flublok/no AE; Initial information was received on 18-Sep-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case is linked to cases 2020SA257773 and 2020SA258275. (Same reporter)  This case involves a 14 year old female patient who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] [lot number: UJ455AAA, expiry date: 17-May-2021] instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] once via unknown route at the left deltoid for prophylactic vaccination (wrong product administered and product administered to patient of inappropriate age).   Medical history, past medical treatment, vaccination and family history were not provided.  No other vaccine was administered concomitantly.  It was a case of actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered. (Latency: same time as of vaccination)  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: 48.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 48 year old received Fluzone Quadrivalent High Dose in error/No AE; 48 year old received Fluzone Quadrivalent High Dose in error/No AE; Initial information was received on 18-Sep-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 48 year old male patient who received a 0.7 ml once dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] [lot number: UJ484AB and expiry date: 30-Jun-2021] via an intramuscular route in the left arm, on 14-Sep-2020 in error, for prophylactic vaccination (product administered to patient of inappropriate age and overdose).   Medical history, medical treatment, concomitant drugs and family history were not provided. No other vaccines were used.  It was a case of overdose and actual medication error due to inappropriate age at vaccine administration. (Latency: on the same day of vaccination)  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: 0.17
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: gave the DTaP-IPV portion and HiB portion of Pentacel separately to patient and diluted HIB in sterile water, no AE; Based on information received on 21-Sep-2020, the report previously considered as non-valid became valid as patient identifier reported.  Initial information was received on 20-Sep-2020 regarding an unsolicited non-valid non-serious case received from the pharmacist.  This case involves 2 months old male patient who was vaccinated with first dose of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (batch number and expiry date not reported) via an unknown route at an unknown administration site on 19-Sep-2020 (also reported as 19-Jul-2020) for prophylactic vaccination however the DTaP-IPV and HIB portions of Pentacel vaccine were given separately and Hib portion was diluted with sterile water instead of 0.4 % saline solution (product preparation issue).  The patient's medical history, past medical treatment, vaccination, family history and concomitant medication were not provided.  It was an actual medication error case due to inappropriate reconstitution technique (latency was same day).  The reporter imagine DTaP-IPV component will count as valid dose of DTaP and IPV vaccines, but had questions on the validity of the Hib component with sterile water and asked if the Hib will need to be redone with the 0.4% saline.  No adverse event reported at the time of reporting.  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.  Follow-up information was received on 21-Sep-2020 regarding an unsolicited valid non-serious case received from the pharmacist.  The case validity, event coding updated, patient demographics added.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLU4, UNK
Symptoms: No adverse event, Wrong product administered
Clinical narrative: FLUZONE QUADRIVALENT was inadvertently administered to a patient over the age of 65 when the patient requested to receive FLUZONE HD QUADRIVALENT/no AE; Initial information received on 21-Sep-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a female patient (over of 65 years age) who inadvertently received a 0.5 mL dose of  INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] [lot number and expiry date not reported] via an intramuscular route at the left arm, on 14-Sep-2020 for prophylactic vaccination, when she had requested to receive INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (wrong vaccine administered).   Medical history, medical treatment, vaccination and family history were not provided.  Patient did not receive any other vaccines as concomitant medication.   It was a case of actual medication error due to wrong vaccine administered. [latency: at the same time of vaccination]   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: U
Vaccine: FLU4, FLUR4, UNK
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: About 16 patients were vaccinated with flu vaccines subcutaneously instead of intramuscularly using 5/8 inches needle, no AE; About 16 patients were vaccinated with flu vaccines subcutaneously instead of intramuscularly using 5/8 inches needle, no AE; Initial information received on 21-Sep-2020 regarding this unsolicited valid non-serious case from a pharmacist was received from a pharmacist.  This case involved about 16 patients (unknown demographics) who were vaccinated subcutaneously instead of intramuscularly using 5/8 inches needle with flu vaccines, INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV], INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] and INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] on an unknown date (lot number and expiry date not reported for all) in unknown administration site for prophylactic vaccination. (incorrect route of product administration)(wrong device used).  Relevant medical history, medical treatment, vaccination, concomitant medications and family history were not provided.  It was a case of actual medication error due to inappropriate route of vaccination and wrong device used.  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: 59.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: while administering the vaccine to the patient, the vaccine started "dripping from the bottom where the plunger is", no AE; Vaccine was leaking upon administering to a patient and patient received a partial dose of the vaccine, no AE; Initial information received on 21-Sep-2020 regarding an unsolicited valid non-serious case received from a pharmacist in the United States.  This case involves a 59-year-old female patient who received a partial dose of the vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (underdose) as the vaccine started dripping from the bottom where the plunger was (Syringe issue).  Medical history, medical treatment, vaccination and family history were not provided.  The patient did not receive any concomitant vaccination.  On 21-Sep-2020, the patient received a partial dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT7000CA and expiry date: 30-Jun-2021) via an intramuscular route in the left arm for prophylactic vaccination. The patient was supposed to receive 0.5 ml.  It was a case of actual medication error due to Vaccine underdose (underdose) (same day latency). It was also the case of Syringe issue.   There was no sign of damage with the vial, plunger intact upon opening the carton, no difficulty pushing the plunger during administration. There was leaking around the plunger. PTC (product technical complaint) assessment was physical.  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: U
Vaccine: FLU3, UNK
Symptoms: No adverse event, Wrong product administered
Clinical narrative: A patient over 65 years of age received Fluzone Quadrivalent instead of Fluzone Quadrivalent High-dose, no AE; Initial information was received on 21-Sep-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a patient over 65 years of age (exact age and gender unspecified) who received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination on an unknown date instead of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (Wrong product administered).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  It was a case of an actual medication error due to wrong vaccine administered (latency same day).  The reporter did not have any more information on the vaccines given or the patient due to working remotely and not having all the information. There was no more information for this report.  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.  There will be no information available on lot number.
Age: 14.0
Sex: U
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 14 year old patient received Flublok by mistake/ NO AE; Initial information received on 21-Sep-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 14-years-old patient (gender not reported) who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number: QFAA2014 and expiry date: 30-Jun-2021) by mistake (product administered to patient of inappropriate age) on an unknown date via unknown route in unknown administration site for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  It was an actual medication error case due to inappropriate age at vaccine administration (latency: same day)  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: 15.0
Sex: M
Vaccine: FLU3, FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: A 15 year old caucasian male patient was mistakenly administered Flublok instead of Fluzone, no AE; A 15 year old male patient was mistakenly administered Flublok instead of Fluzone, no AE; Initial information received on 21-Sep-2020 regarding an unsolicited valid non-serious case from other health professional.  This case involves a 15 years old male patient who was mistakenly vaccinated with INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] instead of FLUZONE [INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE (Suspension for injection,  , ] (lot numbers, expiration date for both the vaccines were not reported) via unknown route in unknown administration site for prophylactic vaccination on unspecified date (PT: wrong product administered; product administered to patient of inappropriate age).  The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to inappropriate age at vaccine administration (same day latency) and wrong vaccine administered (same day latency).  No adverse event reported at the time of reporting.  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.  There will be no information on the batch number for this case.
Age: 84.0
Sex: M
Vaccine: FLU4
Symptoms: Discomfort, Dizziness
Clinical narrative: dizziness; Initial information was received on 22-Sep-2020 regarding an unsolicited valid non-serious case from the pharmacist via phone.  This case involves an 84 year old male patient who experienced dizziness, while he received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  The patient had not received other vaccine concomitantly.  The patient had no adverse event or symptom at the time of injection.  On 21-Sep-2020, the patient received a 0.7 ml once dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (injection, lot UJ480AA and expiration date 30-Jun-2021) via an intramuscular route in the left deltoid for prophylactic vaccination.  On 22-Sep-2020, the patient developed non-serious dizziness, 1 day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. The patient was not feeling comfortable while driving or walking around the house.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome was unknown.
Sex: U
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: IPOL exposed to temperature of 39.2 degrees F to 0.5 degrees F and back to 39.4 degrees F within 6 minutes, no AE; Initial information was received on 22-Sep-2020 regarding an unsolicited valid non-serious case received from other health care professional.  This case involves a patient (with an unknown demographics) who received POLIOMYELITIS VACCINE (INACTIVATED) (IPV) (VERO) [IPOL] (lot R1B251M, Expiry date 13-Mar-2021) via an unknown route in an unknown administration site for prophylactic vaccination on an unknown date, that had a cold chain deviation and temperature went to 39.2 degrees Fahrenheit to 0.5 degrees Fahrenheit and back to 39.4 degrees Fahrenheit within 6 minutes, cause of the excursion was unknown (product storage error).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  This was an actual medication error case due to product storage error temperature too low.  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: 3.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 3 year old female patient received a dose of Flublok, no AE; Initial information received on 22-Sep-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 3 year old female patient who received FLUBLOK QIV (product administered to patient of inappropriate age).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On 18-Sep-2020, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QFAA2029 and expiry date: not reported) via an intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of actual medication error due to inappropriate age at vaccine administration (same day latency).  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: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: a 79 years old female patient received 1 ml dose of Fluzone Quadrivalent instead a 0.5 mL dose, No AE; Initial information received on 23-Sep-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2020SA263271, 2020SA263260 and 2020SA263253 (same reporter).  This case involves a 79 years old female patient who received a 1 mL dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] Injection [lot UJ475AA, expiry date: 30-Jun-2021] instead of 0.5 mL via an intramuscular route at right deltoid, on 22-Sep-2020 for prophylactic vaccination.  Medical history, medical treatment, vaccination and family history were not provided.  No other vaccines given to the patient.  It was a case of overdose (latency same day).   No adverse event symptoms experienced by the patient.  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: 3.0
Sex: F
Vaccine: FLU3, FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: A 3-years-old female patient inadvertently received a dose of Flublok vaccine rather than Fluzone/no AE; A 3-years-old female patient inadvertently received a dose of Flublok vaccine rather than Fluzone/no AE; Initial information was received on 23-Sep-2020 regarding an unsolicited valid non-serious case from the other health care professional.  This case is linked to case 2020SA262410 (same reporter).  This case involves a 3-years-old female patient who inadvertently received a 0.5 mL dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] [prefilled syringe, lot number: QFA2029 and expiry date was reported as 30-Jun-2021, but reporter was not sure about the expiration date] rather than INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] via an intramuscular route at the deltoid, on 18-Sep-2020 (Friday) for prophylactic vaccination (wrong product administered and product administered to patient of inappropriate age).  Medical history, medical treatment, vaccination and family history were not provided.  It was reported that patient received no other concomitant medication.   It was a case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration (latency: at the time of vaccination).  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: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: a patient that was given an expired dose of last year's formula of FLUZONE HIGH-DOSE with no adverse event; Initial information received on 23-Sep-2020 regarding an unsolicited valid non-serious case received from an other health care professional.  This case involves a 65 years old female patient who received a 0.5 ml once dose of an expired vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] Single-dose, prefilled syringe (lot: UJ311AB, expiry date: 30-Jun-2020), via unknown route and site, on 23-Sep-2020. (Expired product administered)  The patient's medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications were not reported.  It was an actual medication error due to expired vaccine used. It was reported that a patient was given an expired dose of Fluzone High-Dose. It was last year's formula of Fluzone High-Dose. (latency: on the same day)  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: M
Vaccine: FLUX
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: in error patient received a flu vaccine which was not made especially for people over 65 years of age/no AE; Initial information was received on 23-Sep-2020 regarding an unsolicited valid non-serious case from a consumer or non-health care professional (patient).  This case involves male patient (age unspecified) who received an INFLUENZA VACCINE [FLU VACCINE] [lot number and expiry date not reported] in error which was not made especially for people over 65 years of age via an unknown route at an unknown administration site, on an unknown date for prophylactic vaccination (product administered to patient of inappropriate age).  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  It was a case of actual mediation error due to inappropriate age at vaccine administration.  It was reported that, patient did not known name of flu vaccine.   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.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLUR4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: injection site red, swollen and hot to touch; injection site red; injection site swollen; injection site hot to touch; Initial information was received on 24-Sep-2020 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional.  This case involves a 36 year old female patient whose injection site was red, swollen and hot to touch (injection site inflammation), while she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 17-Sep-2020, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported via unknown route on the underside of her upper left arm for prophylactic vaccination  On an unknown date, the patient injection site was red, swollen and hot to touch (injection site inflammation) with symptoms: injection site erythema, injection site swelling and injection site warmth (unknown latency, non-serious event) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  No laboratory data was provided  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on lot number.
Age: 12.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a 12 years old patient was accidently administered a dose of Flublok vaccine/No AE; Initial information received on 25-Sep-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 12 years old female patient who received a 0.5 mL dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot: QFAA2011, expiry date: 30-Jun-2021), via intramuscular route in the left arm accidentally on 24-Sep-2020 for prophylactic vaccination (Product administered to patient of inappropriate age).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  The patient had no concomitant medications.  It was an actual medication error due to the inappropriate age at vaccine administration (latency: 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.
Sex: F
Vaccine: FLU4, UNK
Symptoms: No adverse event, Wrong product administered
Clinical narrative: A Patient who was over 65 years of age inadvertently received Fluzone Quadrivalent rather than Fluzone High-Dose Quadrivalent /No AE; Initial information received on 25-Sep-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a over 65 years of age female patient who received a 0.5 mL dose of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (batch number and expiry date not reported) via un unknown route and administration site on an unknown date for prophylactic vaccination, inadvertently rather than  INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (Wrong product administered).  The patient's medical history, medical treatments, concomitant therapy, vaccinations and family history were not provided.  It was an actual medication error due to the wrong vaccine administered (latency: at the time of vaccination).  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.  There will be no information available on the batch number for this case.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: A patient received an expired dose of Fluzone vaccine/No AE; Initial information received on 25-Sep-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 50 years old female patient who received an expired of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] (lot number: UJ223AA, expiry date: 22-Sep-2020) via un unknown route and site on an unknown date for prophylactic vaccination (expired product administered).  The patient's medical history, medical treatments, concomitant therapy, vaccinations and family history were not provided.  It was an actual medication error due to the 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.