chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 82.0
Sex: F
Vaccine: FLUX
Symptoms: Clumsiness, Decreased appetite, Immunisation reaction
Clinical narrative: had a flu shot reaction Friday afternoon, Saturday and Sunday and felt like she gonna die; was cold and constantly under blanket; no appetite but liquid only; bumping into things; Initial information received on 10-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case is linked to case 2022SA417185 (CLUSTER).  This case involves a 82 years old female patient who experienced had a flu shot reaction friday afternoon, saturday and sunday and felt like she gonna die, was cold and constantly under blanket, no appetite but liquid only and bumping into things after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (dose, formulation, strength lot and expiry date: unknown) via unknown route in an unknown administration site for prophylaxis vaccination.  On an unknown date the patient developed a non-serious had a flu shot reaction friday afternoon, saturday and sunday and felt like she gonna die (immunisation reaction), cold and constantly under blanket (feeling cold), no appetite but liquid only (decreased appetite) and bumping into things  (clumsiness) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the events (had a flu shot reaction Friday afternoon, Saturday and Sunday and felt like she gonna die, was cold and constantly under blanket, no appetite but liquid only, bumping into things ).  At time of reporting, the outcome was Recovered / Resolved for all events
Sex: U
Vaccine: FLUX
Symptoms: Expired product administered, No adverse event
Clinical narrative: user received their flu shot, they noticed the stock expired 30JUN21 with no adverse event; Initial information received on 17-Oct-2022 regarding an unsolicited valid non-serious case received via health professional.  This case involves patient of unspecified demographics who received their Influenza Vaccine (Flu Vaccine), they noticed the stock expired 30jun21 with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received expired suspect Flu Vaccine produced by unknown manufacturer expiry date 30-Jun-2021 at (unknown: formulation, strength, dose, lot number, route in unknown administration site) for prophylactic vaccination, they noticed the stock expired 30jun21 with no adverse event (expired product administered) at same day latency.  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the 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 the 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: 70.0
Sex: U
Vaccine: TD
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: medication error due to temperature excursion that exceeded the stability data and Tenivac was administered to patient, with no reported adverse event; medication error due to temperature excursion that exceeded the stability data and Tenivac was administered to patient, with no reported adverse event; Initial information received on 12-Oct-2022 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional (hcp).  This case involves a 70-year-old (unknown gender) patient, reported a medication error due to temperature excursion that exceeded the stability data and DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [Tenivac] was administered to patient, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 10-Aug-2022, the patient received suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT strength: standard (formulation, dose , route: unknown) (lot number: U7092AA and expiry date: 24-Jun-2023) in unknown administration site for Immunization and on the same day tenivac was administered to patient, with no reported adverse event (poor quality product administered) and medication error due to temperature excursion that exceeded the stability data, with no reported adverse event (product storage error) (unknown latency).  Action taken with DIPHTHERIA AND TETANUS TOXOIDS (TENIVAC) was not applicable for both events.  At time of reporting, the outcome was Unknown for both events.  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 the guidelines. 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: U
Vaccine: FLU3
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: medication error due to temperature excursion product administered to patient with no reported AE; medication error due to temperature excursion product administered to patient with no reported AE; Initial information received  on 12-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-health care professional.  This case involves a 59 years old of an unknown gender patient who was administered vaccines post medication error due to temperature excursion with no reporter adverse event , after receiving vaccine INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 26-Sep-2022, the patient received a  dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED( lot UJ899AA and expiration date:30-Jun-2023) at an unknown dose via unknown route in unknown administration site as prophylactic vaccination.  On 26-Sep-2022 ,the patient developed a non-serious  event of medication error due to temperature excursion product administered to patient with no reported ae (poor quality product administered) (latency: same day)(Product storage error )(Latency: Unknown).   Action taken :not applicable  It was not reported if the patient received a corrective treatment for the events.   Outcome: Unknown for both events   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 the 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. and unknown gender patient who experienced medication error due to temperature excursion product administered to patient with no reported ae and medication error due to temperature excursion product administered to patient with no reported ae while receiving vaccine
Age: 24.0
Sex: U
Vaccine: FLU4
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: temperature excursion that exceeded the stability data with no reported adverse event; administered to patient after excursion with no adverse event; Initial information received on 12-Oct-2022 regarding an unsolicited valid non-serious case from a consumer/non-hcp.  This case involves a 24 years old and unknown gender patient to whom administered influenza quadrival A-B multidose vaccine preserved [Fluzone Quadrivalent Multidose] after excursion with no adverse event and temperature excursion that exceeded the stability data with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 22-Sep-2022, the patient received suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED at an unknown dose (lot UJ899AA, expiry date: 30-Jun-2023) via unknown route in unknown administration site for prophylactic vaccination (immunisation).  On 22-Sep-2022 there was temperature excursion that exceeded the stability data with no reported adverse event (product storage error) and administered to patient after excursion with no adverse event (poor quality product administered) same day following the administration of influenza quadrival A-B multidose vaccine preserved.  Action taken: Not applicable.  Outcome: Unknown for both the events.   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 the 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: 43.0
Sex: U
Vaccine: FLU4
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: product administration post temperature excursion that exceeded the stability data documented in the local labelling with no reported  adverse event; product administration post temperature excursion that exceeded the stability data documented in the local labelling with no reported  adverse event; Initial information received on 12-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-healthcare professional (hcp).   This case involves a 43 years old and unknown gender patient to whom INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE QUADRIVALENT MULTIDOSE] administration post temperature excursion that exceeded the stability data documented in the local labelling with no reported  adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 22-Sep-2022, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (dose, formulation, strength: unknown) (lot UJ899AA, 23-Jun-2023) via unknown route in unknown administration site for immunization post temperature excursion that exceeded the stability data documented in the local labelling with no reported  adverse event (product storage error)(poor quality product administered)  following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the events.   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 the 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: 11.0
Sex: U
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration, Medication error, No adverse event
Clinical narrative: patient that was given MENACTRA, 1st dose at age 11 and 2nd dose at age 12. He is also asking if a booster dose should be given at 16 with no reported adverse event; Initial information received on 12-Oct-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 12 years old and unknown gender patient who experienced patient that was given MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA], 1st dose at age 11 and 2nd dose at age 12. he is also asking if a booster dose should be given at 16 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date, the patient received a 1 dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE at an unknown dose (lot number, expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination. On an unknown fate, the patient received 2nd of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  On an unknown date the patient given menactra, 1st dose at age 11 and 2nd dose at age 12. he is also asking if a booster dose should be given at 16 with no reported adverse event (inappropriate schedule of product administration) (same day latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  Action taken: Not applicable.  Outcome: Unknown.   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 the 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: 71.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered, Medication error, No adverse event
Clinical narrative: sheet of paper it stated received 0.5 mL but should be 0.7 mL with no reported adverse event; Initial information received on 13-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 71-year-old male patient who reported sheet of paper stated received 0.5 ml but should be 0.7 ml of vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [Fluzone High-Dose Quadrivalent] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. This case is linked to cases 2022SA425178, 2022SA424555.   On 11-Oct-2022, the patient received a dose of suspect Fluzone High-Dose Quadrivalent vaccine received dose 0.5 ml instead should be 0.7ml (lot: UJ900AA, expiry date: 30-Jun-2023) via intramuscular route in unknown administration site for immunization with no reported adverse event (incorrect dose administered) same day latency.   Patient stated that the prefilled syringes appeared orange, when the consumer asked about the color, the pharmacist stated that it was just the needle cover on the syringes. Consumer asked if they should receive another influenza vaccine this year. The consumer states that he would like to be contacted regarding this event. When the consumer asked the pharmacist about the volume being incorrect the pharmacist replied, I made an error.   Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the 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 the 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
Symptoms: Extra dose administered
Clinical narrative: staff administered 2 doses with no reported adverse event; Initial information received on 13-Oct-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age and gender patient who experienced staff administered 2 doses with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a  dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE twice(strength, dose, formulation, route, lot number not reported) in unknown administration site for immunization.  On an unknown date the patient reported a non-serious staff administered 2 doses with no reported adverse event (extra dose administered) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Action taken: not applicable.   At time of reporting, the outcome was Unknown for the 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 the 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: 60.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: Tenivac that was administered had expired, with no adverse event; Initial information received on 13-Oct-2022 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves a 60-year-old male patient to whom DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [Tenivac] that was administered had expired, with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Influenza Vaccine for Prophylactic vaccination.  On 13-Oct-2022, the patient received 0.5ml dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (Drug Treatment Duration: once) (strength, formulation: unknown) (lot number: U6831AA and expiry date: 08-Oct-2022) via intramuscular route in the left deltoid for Immunization and that was administered had expired, with no adverse event (expired product administered; latency: same day).  Vaccine was administered by a medical assistant.   Action taken was Not applicable.  At time of reporting, the outcome was Unknown.  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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: patient was administered expired DAPTACEL with no reported adverse event; Initial information received on 14-Oct-2022 regarding an unsolicited valid  non-serious case from other health professional.  This case is linked to case 2022SA426580.  This case involves an unknown age and unknown gender patient who was administered expired diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.    On 13-Oct-2022, the patient received suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE at a dose of 0.5 ml total (lot C5774CA, expiry date: 18-Sep-2022) via unknown route in unknown administration site for prophylactic vaccination(immunisation) (expired product administered, latency: same day).   Action taken: Not applicable.  Outcome: Unknown.    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 the 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: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: she gave ADACEL instead of DTaP to a 3 year old with no reported adverse event; she gave ADACEL instead of DTaP to a 3 year old with no reported adverse event; Initial information received on 14-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 3 years old female patient and it was reported that she was given adacel instead of dtap to a 3 year old with no reported adverse event while receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A) for Immunisation.  On 13-Oct-2022, the patient received a dose of 0.5 ml of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (formulation, strength: unknown) lot U7276AA, expiration date: 21-Jan-2024 via intramuscular route in the right thigh as immunization .  On 13-OCT-2022 the patient was given adacel instead of dtap to a 3 year old with no reported adverse event (wrong product administered) (product administered to patient of inappropriate age) same day following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for all.    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 the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 2.0
Sex: U
Vaccine: FLUR3
Symptoms: No adverse event, Off label use, Product administered to patient of inappropriate age
Clinical narrative: administration of FLUBLOK to a patient younger than indicated with no reported adverse event; Initial information was receivedon 14-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 2 years old and unknown gender patient who stated administration of influenza quadrivalent recombinant vaccine [Flublok] to a patient younger than indicated with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received suspect influenza quadrivalent recombinant vaccine lot number not reported via unknown route in unknown administration site (formulation, dose, frequency, expiry date and strength: unknown) for Immunization and stated administration of influenza quadrivalent recombinant vaccine to a patient younger than indicated with no reported adverse event (off label use) (unknown latency).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Wrong product administered
Clinical narrative: over 65 and had gotten the FLUZONE QUAD and not the FLUZONE HD QUAD with no reported adverse event; Initial information received on 17-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves Elderly female patient who was over 65 and had gotten the INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] and not the INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] with no reported adverse event.  The patient's past medical history, medical treatment(s), Concomitant medication, vaccination(s) and family history were not provided.  On an unknown date the patient developed a non-serious event of over 65 and had gotten the fluzone quad (dose, strength, formulation, route, administration site, batch and expiry date was unknown for prophylactic vaccination) and not the fluzone hd quad with no reported adverse event (wrong product administered) (latency: Sam day) following the administration of INFLUENZA QUADRIVAL A-B VACCINE and INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.. She wants to know what she should do at this time..  Action taken : not applicable.  Outcome: Unknown  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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of adacel was administered with no reported adverse event; Initial information received on 17-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 12 years old female patient who had expired dose of adacel was administered with no reported adverse event while receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included INFLUENZA VACCINE INACT SPLIT 4V (FLUZONE QUADRIVALENT); HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL); and MENINGOCOCCAL VACCINE A/C/Y/W CONJ (TET TOX) (MENQUADFI).  On 17-Oct-2022, the patient received 0.5 mL total dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE once (formulation and strength not reported; lot C5788CA and expiry date: 14-Oct-2022) via intramuscular route in the left arm for prophylactic vaccination.  On 17-Oct-2022, (latency: same day) the patient had expired dose of adacel was administered with no reported adverse event (expired product administered) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (ADACEL) was not applicable.  At time of reporting, the outcome was Unknown for the 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 the guidelines. 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: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Poor quality product administered
Clinical narrative: patient was administered FLUZONE QIV NP post excursion with no reported adverse event; Initial information regarding an unsolicited valid non-serious case received via health professional on 17-Oct-2022. RA number: 01324986.  This case involves a 62-year-old male patient who experienced patient was administered Influenza Quadrival A-B Vaccine [Fluzone QIV] np post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 17-Oct-2022, the patient received suspect Fluzone QIV np vaccine at dose 0.5 ml once via intramuscular route in the left deltoid (lot: UT7701AA, expiry date: 30-Jun-2023) for Immunization post excursion with no reported adverse event (poor quality product administered) at same day latency.  It was reported that "Caller previously reported a temperature excursion See cases: 01324650 and 01324926 for details. Caller stated that she needs to report that 1 patient was administered FLUZONE QIV NP post excursion. This situation is reported as a medication error due to temperature excursion that exceeded the stability data and FLUZONE QIV NP was administered to 1 patient post excursion."  Action taken: Not applicable.  No corrective treatment was received for the event.  At time of reporting, the outcome was Unknown for the 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 the 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: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A fluzone high-dose quadrivalent was inadvertently given to patient under the age of 65 years with no reported adverse event; Initial information received on 17-Oct-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 51 years old female patient to whom fluzone high-dose quadrivalent was inadvertently given to patient under the age of 65 years with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 17-Oct-2022, the patient received 0.7 ml of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ919AD, expiry-30-06-23) (strength: unknown) via intramuscular route in the left deltoid for immunization.   On 17-OCT-2022 the patient developed a non-serious a fluzone high-dose quadrivalent was inadvertently given to patient under the age of 65 years with no reported adverse event (product administered to patient of inappropriate age) (latency same day)  Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT) was not applicable.  Outcome unknown    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 the 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: 76.0
Sex: M
Vaccine: FLU4
Symptoms: Fatigue, Feeling abnormal, Lethargy
Clinical narrative: experienced fogginess; fatigue; experienced lethargy; Initial information received on 17-Oct-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 76 years old male patient who experienced fogginess, fatigue and experienced lethargy while receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past vaccination(s) included COVID-19 VACCINE. The patient's past medical history, medical treatment(s) and family history were not provided.   On 11-Oct-2022, the patient received 0.7 mL total dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE once (formulation, strength and lot number not reported) via unknown route in the right arm for prophylactic vaccination.  On 12-Oct-2022, the patient developed non-serious events of experienced fogginess (feeling abnormal), fatigue and experienced lethargy (lethargy) (latency: 1 day) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT) was not applicable.  It was not reported if the patient received a corrective treatment for the events (experienced fogginess, fatigue, experienced lethargy).  At time of reporting, the outcome was Recovered / Resolved on an unknown date for all the events.
Sex: F
Vaccine: FLUX
Symptoms: Vaccination site pain
Clinical narrative: always being tender at the injection site with getting her vaccinations; Initial information received on 17-Oct-2022 regarding an unsolicited valid non-serious case received via consumer/non-hcp.  This case involves an unknown age female patient who experienced always being tender at the injection site with getting her vaccinations while receiving vaccine Influenza Vaccine (Flu vaccine).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. This case is linked to case 2022SA433828(FLUZONE HD QUAD vaccine).   On an unknown date, the patient received suspect INFLUENZA VACCINE produced by unknown manufacturer at (unknown: formulation, dose, lot number, route in unknown administration site) for prophylactic vaccination. Information regarding batch and expiry date requested.  On an unknown onset and latency, the patient developed a non-serious always being tender at the injection site with getting her vaccinations (vaccination site pain).  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Recovered on an unknown date for the event.
Age: 10.0
Sex: F
Vaccine: FLUC4
Symptoms: Extra dose administered
Clinical narrative: In error, the patient received 2 flu vaccine doses this season.
Age: 57.0
Sex: M
Vaccine: COVID19-2, FLUA4
Symptoms: Arthralgia, Asthenia, Body temperature increased, Bone pain, Fatigue
Clinical narrative: Serious fatigue, muscle ache, bone pain all over body. Random 'arthritis pain,' toes, fingers, arms, legs, everywhere. One area would hurt for a minute, then something else would hurt. No one place lasted more than a few seconds. But it just kept coming.    Over heated core temperature with cold hands and feet, woke me up from a deep sleep, but I was too weak and miserable to do anything about it, like peel the covers back to cool off. Miserable  Very similar reaction to each of the other vaccine doses in the series. But this was the worst.   Seems a very 'flu like,' response, only lasting about twelve hours. The worst of it was only three or four hours.   Once I was strong enough to get out of bed for more than a couple minutes, about six hours later, some Aleve really helped with the symptoms. Much better the evening following the injection. Still a little foggy and taking it slow, four days later.   Again, very similar reaction to the first three doses. I just did not report the symptoms then.
Age: 57.0
Sex: M
Vaccine: COVID19-2, FLUA4
Symptoms: Feeling abnormal, Influenza like illness, Myalgia, Peripheral coldness, Sleep disorder
Clinical narrative: Serious fatigue, muscle ache, bone pain all over body. Random 'arthritis pain,' toes, fingers, arms, legs, everywhere. One area would hurt for a minute, then something else would hurt. No one place lasted more than a few seconds. But it just kept coming.    Over heated core temperature with cold hands and feet, woke me up from a deep sleep, but I was too weak and miserable to do anything about it, like peel the covers back to cool off. Miserable  Very similar reaction to each of the other vaccine doses in the series. But this was the worst.   Seems a very 'flu like,' response, only lasting about twelve hours. The worst of it was only three or four hours.   Once I was strong enough to get out of bed for more than a couple minutes, about six hours later, some Aleve really helped with the symptoms. Much better the evening following the injection. Still a little foggy and taking it slow, four days later.   Again, very similar reaction to the first three doses. I just did not report the symptoms then.
Age: 6.0
Sex: F
Vaccine: FLUC4
Symptoms: Extra dose administered
Clinical narrative: In error, the patient received 2 flu vaccines this flu season.
Age: 10.0
Sex: F
Vaccine: FLUC4
Symptoms: Extra dose administered
Clinical narrative: In error, the patient received 2 flu vaccines this flu season
Age: 29.0
Sex: F
Vaccine: COVID19-2
Symptoms: Fall, Head injury, Syncope
Clinical narrative: PT FAINTED AND FELL OFF CHAIR AFTER GETTING THE VACCINE. SHE HIT HER HEAD, SHE WENT TO THE ER. SHE WAS DISCHARGED ON THE SAME DAY. MD DIDN'T NEED TO DO A CT SCAN ON HER
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Possibly given monovalent instead of bivalent
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Possibly given monovalent instead of bivalent
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Possibly given monovalent instead of bivalent
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Possibly given monovalent instead of bivalent
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Possibly given monovalent instead of bivalent
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Possibly given monovalent instead of bivalent
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Possibly given monovalent instead of bivalent
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Chills, Erythema, Injection site pain
Clinical narrative: Soreness at injection site. Redness/localized reaction ~2.5 inches in diameter. Severe muscle pain in neck and shoulders. Debilitating migraine headache. Nausea (possibly related to headache rather than vaccine). Subclinical fever. Mild chills.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Local reaction, Migraine, Myalgia, Nausea, Neck pain
Clinical narrative: Soreness at injection site. Redness/localized reaction ~2.5 inches in diameter. Severe muscle pain in neck and shoulders. Debilitating migraine headache. Nausea (possibly related to headache rather than vaccine). Subclinical fever. Mild chills.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Soreness at injection site. Redness/localized reaction ~2.5 inches in diameter. Severe muscle pain in neck and shoulders. Debilitating migraine headache. Nausea (possibly related to headache rather than vaccine). Subclinical fever. Mild chills.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Possibly given monovalent instead of bivalent
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Possibly given monovalent instead of bivalent
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: possibly given monovalent instead of bivalent
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Possibly received monovalent instead of bivalent
Age: 33.0
Sex: F
Vaccine: FLUC4
Symptoms: Nausea
Clinical narrative: Nausea?ongoing
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Death, Intensive care, Respiratory failure
Clinical narrative: Stable after vaccine administration. 10 days later, presented in extremis to the Emergency Department - sepsis / respiratory failure. Transferred to higher level of care (PICU), where the patient died 4 days later of COVID pneumonia.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Sepsis
Clinical narrative: Stable after vaccine administration. 10 days later, presented in extremis to the Emergency Department - sepsis / respiratory failure. Transferred to higher level of care (PICU), where the patient died 4 days later of COVID pneumonia.
Age: 38.0
Sex: M
Vaccine: FLUC4
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Coordination abnormal, Dizziness, Dysarthria, Eye movement disorder
Clinical narrative: I am biting tongue. Eye coordination, blurry, foggy feeling. Tunnel vision . Always in a fog. Balance issues/Coordination issues when walking, Slurred Speech. complete sex drive disfunction. Dizzy spells. Enlarged Prostate. Lose train of thoughts more often. Insomnia, having difficulty sleeping. Unexplained Pressure in the head/brain.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Gait disturbance, Head discomfort, Insomnia, Laboratory test
Clinical narrative: I am biting tongue. Eye coordination, blurry, foggy feeling. Tunnel vision . Always in a fog. Balance issues/Coordination issues when walking, Slurred Speech. complete sex drive disfunction. Dizzy spells. Enlarged Prostate. Lose train of thoughts more often. Insomnia, having difficulty sleeping. Unexplained Pressure in the head/brain.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Prostatomegaly, Sexual dysfunction, Thinking abnormal, Tongue biting, Tunnel vision
Clinical narrative: I am biting tongue. Eye coordination, blurry, foggy feeling. Tunnel vision . Always in a fog. Balance issues/Coordination issues when walking, Slurred Speech. complete sex drive disfunction. Dizzy spells. Enlarged Prostate. Lose train of thoughts more often. Insomnia, having difficulty sleeping. Unexplained Pressure in the head/brain.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: I am biting tongue. Eye coordination, blurry, foggy feeling. Tunnel vision . Always in a fog. Balance issues/Coordination issues when walking, Slurred Speech. complete sex drive disfunction. Dizzy spells. Enlarged Prostate. Lose train of thoughts more often. Insomnia, having difficulty sleeping. Unexplained Pressure in the head/brain.
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pruritus
Clinical narrative: Three hours after injection, developed itching all over body.  This is despite the fact I had taken 50 mg of Benadryl and a 24 hour Allegra and Pepcid prior to the appointment per family doctor's instruction.  Took additional 50mg of Benadryl six hours after the first dose.  This stopped the itching for several hours, but about 1:00 a.m. itching returned.
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Aphonia, Chills, Fatigue, Insomnia, Rhinorrhoea
Clinical narrative: over 7 days:  chills, teeth chattering, constantly clear running nose, exhaustion, lost voice, difficulty sleeping
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site bruising, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Swelling at Injection Site-Mild
Age: 81.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium
Age: 64.0
Sex: M
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Dose in Series Given Too Early-
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain, Rash erythematous
Clinical narrative: Large red rash and pain
Age: 12.0
Sex: M
Vaccine: FLUC4
Symptoms: Chills, Dizziness, Flushing, Haemorrhage, Hyperhidrosis
Clinical narrative: Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Visual Changes/Disturbances-Medium, Additional Details: Patient was given the vaccination into L deltoid. Started to bleed after the needle was withdrawn, and a bandaid was applied. The patient witnessed the bleeding. Patient was stable as pharmacist returned to the pharmacy. Moments later the patients father said the son was not okay. He was experiencing cold sweats, blurred vision, and lightheadedness. The pharmacist attended the patient right away. There were no sign or symptoms of anaphylaxis. EMS was called. There were no further issues.
Age: 12.0
Sex: M
Vaccine: FLUC4
Symptoms: Visual impairment
Clinical narrative: Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Visual Changes/Disturbances-Medium, Additional Details: Patient was given the vaccination into L deltoid. Started to bleed after the needle was withdrawn, and a bandaid was applied. The patient witnessed the bleeding. Patient was stable as pharmacist returned to the pharmacy. Moments later the patients father said the son was not okay. He was experiencing cold sweats, blurred vision, and lightheadedness. The pharmacist attended the patient right away. There were no sign or symptoms of anaphylaxis. EMS was called. There were no further issues.
Age: 44.0
Sex: F
Vaccine: FLUC4
Symptoms: Injected limb mobility decreased, Injection site bruising, Injection site erythema, Injection site pain
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Additional Details: Patient has pain redness and tenderness around site of injection can not lift arm above her head
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Syringe issue
Clinical narrative: Error: Leaking from Syringe-
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Mild, Additional Details: localized pain
Age: 21.0
Sex: M
Vaccine: COVID19-2
Symptoms: Wrong product administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 10.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High-
Age: 43.0
Sex: F
Vaccine: COVID19-2
Symptoms: Feeling hot, Flushing, Hyperhidrosis, Immediate post-injection reaction, Presyncope
Clinical narrative: Systemic: Flushed / Sweating-Severe, Additional Details: sweating, felt so hot immediately after the vaccine, and almost faint
Age: 53.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Age: 33.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: PT GIVEN 0.25ML. NO ADVERSE EVENTS NOTED