chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient receiving ADACEL instead of DAPTACEL with no reported adverse event; Initial information received on 23-May-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 3 years old male patient who had received diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel]  instead of daptacel with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 23-May-2022, the patient received a  0.5 ml dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine (strength, formulation: unknown) (lot U6984AA and expiry date: 18-Mar-2023) (Drug Interval Dosage : Once Drug Treatment Duration) via intramuscular route in unknown administration site for prophylactic vaccination.  On 23-May-2022 (latency: same day) the patient receiving adacel instead of daptacel with no reported adverse event (wrong product administered) following the administration of diphtheria-2/tetanus/5 AC pertussis vaccine.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event patient receiving adacel instead of daptacel with no reported 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 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: 1.25
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received an expired dose of ACT-HIB with no reported adverse event; Initial information was received on 23-May-2022 regarding an unsolicited valid non-serious case from a pharmacist via call center.  This case involves a 15 months old male patient who received an expired dose of act-hib with no reported adverse event while receiving vaccine HIB (PRP/T) Vaccine [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular 3-Component, Tetanus Vaccine Toxoid (Infanrix) and Pneumococcal Vaccine CONJ 13V (CRM197) (Prevnar 13) for Prophylactic vaccination.  On 23-May-2022, the patient received 0.5 ml dose of suspect HIB (PRP/T) Vaccine once (batch/lot number: UJ661AAA, expiration date: 06-May-2022, strength: standard) via intramuscular route in the thigh nos for immunization (formulation: unknown).  On 23-May-2022, it was reported that the patient received an expired dose of act-hib with no reported adverse event (expired product administered) (latency: same day) following the administration of HIB (PRP/T) Vaccine.  Action taken: not applicable  At time of reporting, the outcome was Unknown for the event (expired product administered).   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.
Sex: F
Vaccine: UNK
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: expired PENTACEL vaccine that was given to the patient, with no reported adverse event; Initial information received on 23-May-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 1 years old female patient and it was reported that expired Pentacel vaccine that was given to the patient, with no reported adverse event while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 20-May-2022, the patient received 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE, once,  (lot: UJ435AAA ; expiry date: 20-May-2022) in the left thigh for immunization.  it was reported that there was expired pentacel vaccine that was given to the patient, with no reported adverse event (expired product administered) (onset: 20-May-2022) (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 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: 0.58
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: 7 month old child was given a dose of QUADRACEL/was to be given VAXELIS and PREVNAR 13 instead with no adverse event; Initial information was received on 23-May-2022 regarding an unsolicited valid non-serious case received from a patient via call center.   This case involves a 7 months old male patient who experienced 7 month old child was given a dose of quadracel/was to be given vaxelis and prevnar 13 instead with no adverse event while receiving vaccine diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [QUADRACEL].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 23-May-2022, the patient received a dose of suspect diphtheria-15/tetanus/5 hybrid ACpertussis/IPV (MRC5) vaccine (lot C5970AA) (dose, formulation, strength, and expiry date: unknown) via intramuscular route in the left thigh for prophylactic vaccination.  On 23-MAY-2022 the patient developed a non-serious 7 month old child was given a dose of quadracel/was to be given vaxelis and prevnar 13 instead with no adverse event (wrong product administered) (latency same day) following the administration ofdiphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event 7 month old child was given a dose of quadracel/was to be given vaxelis and prevnar 13 instead with 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 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: 10.0
Sex: M
Vaccine: DTAPIPVHIB, IPV, TD
Symptoms: No adverse event, Product storage error
Clinical narrative: 1.7C for 30 minutes due to the thermometer being set too cold with no reported adverse event; Initial information received on 23-May-2022 regarding an unsolicited valid non-serious case received from health professional.  This case is linked to case 2022SA192000(CLUSTER).  This case involves a 10 years old male patient who experienced 1.7c for 30 minutes due to the thermometer being set too cold with no reported adverse event while receiving vaccines diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac], diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine [Pentacel](Vero) and ipv (vero) [Ipol].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis b vaccine (Hepatitis B Vaccine) for Prophylactic vaccination.  On 02-May-2022, the patient received a dose of 0.5 ml of suspect IPV (VERO) with lot number T1E871M, expiration date- 10-Oct-2022 via intramuscular route in the left deltoid with unknown strength for immunization.  On an unknown date, the patient received a dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine and diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult lot number, expiration date, dose, strength not reported via unknown route in unknown administration site for Prophylactic vaccination.  On 02-MAY-2022 the patient developed a non-serious event "1.7c for 30 minutes due to the thermometer being set too cold with no reported adverse event (product storage error) " (same day latency).  It was reported " Caller reported a temperature excursion involving punctured, and administered to 3 patients after the excursion, IPOL, and unopened PENTACEL and TENIVAC and is requesting stability information. The condition was 1.7C for 30 minutes due to the thermometer being set too cold (not human error). The IPOL was not supported by the extended stability data, however the unopened PENTACEL and TENIVAC were supported by the extended stability data. "   Action taken 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 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.; Sender's Comments:  01115339: 01115364: 01115305:
Age: 7.0
Sex: F
Vaccine: IPV
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: temperature excursion for 1.7C for 30 minutes of Ipol and administered to 3 patients after the excursion; Initial information received on 23-May-2022 regarding an unsolicited valid non-serious case received from a other health professional via call center  This case is linked to case 2022SA192719 and 2022SA192724.   This case involves a 7 years old female patient who experienced temperature excursion for 1.7c for 30 minutes of ipol and administered to 3 patients after the excursion while receiving vaccine IPV (VERO) [IPOL].   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), hepatitis b vaccine (HEPATITIS B [HEPATITIS B VACCINE]) and diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (BOOSTRIX) for Immunisation.  On 09-May-2022, the patient received 0.5 ml of suspect ipv (vero) lot T1E871M via intramuscular route in the left deltoid (formulation unknown, strength: standard and expiry date: 10-Oct-2022) for immunization.  On 09-May-2022 the patient experienced non-serious event temperature excursion for 1.7c for 30 minutes of ipol and administered to 3 patients after the excursion (poor quality product administered) (latency same day) following the administration of ipv (vero).  Action taken:was not applicable.  At time of reporting, the outcome was Unknown for the event temperature excursion for 1.7c for 30 minutes of ipol and administered to 3 patients after the excursion.  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: 7.0
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: inadvertently administered which was deemed unsuitable for use after a temperature excursion, with no adverse event; Initial information received on 24-May-2022 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 7 years old female patient who inadvertently administered which was deemed unsuitable for use after a temperature excursion, with no adverse event while receiving vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 16-Feb-2022, the patient received a dose of suspect IPV (VERO) Suspension for injection (lot T1D482M, expiry date : 25-Jul-2022; strength,: not reported) via intramuscular route in unknown administration site as prophylactic vaccination.  It was reported that, on 16-FEB-2022 a dose of IPOL was inadvertently administered which was deemed unsuitable for use after a temperature excursion on 02-FEB-2022, with no adverse event (poor quality product administered) (latency: same day) following the administration of IPV (VERO).  Caller reporting the dose was administered on 16-FEB-2022, but only brought to her attention yesterday when the office experienced a second excursion, will call back if additional products were affected. Caller reporting a temperature excursion was reported to them in Feb-2022 and the multi dose vial of IPOL that was unsuitable was not discarded. Caller reporting to her knowledge only one patient was affected but will contact us if she finds additional patients who were administered the product. Caller with question on whether patient needs to be revaccinated.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event inadvertently administered which was deemed unsuitable for use after a temperature excursion, with 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 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: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: received an extra dose of MENACTRA with no reported adverse event; Initial information received on 24-May-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 16 years old female patient who received an extra dose of menactra with no reported adverse event while receiving vaccine meningococcal a-c-y-w135 (d conj) [Menactra].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 22-Jun-2021, the patient received a  dose of suspect Menactra vaccine Solution for injection dose: 0.5 ml frequency: once lot U6920AA and expiry date: 15-Apr-2022 (strength: unknown) via intramuscular route in the left arm for immunisation. On 23-Jul-2021 she also received a dose of the same vaccine 0.5 ml once.  On 23-Jul-2021 the patient developed a non-serious event "received an extra dose of menactra with no reported adverse event" (extra dose administered) (latency: 1 month 1 day).  It was reported that when the patient returned for a wellness check this year, it was discovered that they had received the extra dose of Menactra.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment 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 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.; Sender's Comments:  01116793:
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient received the extra dose of menactra with no adverse event; Initial information received on 24-May-2022 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 16 years old male patient who received the extra dose of menactra with no adverse event while receiving vaccine meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 23-Jul-2021, the patient received suspect at a dose of 0.5 ml total meningococcal A-C-Y-W135 (D CONJ) vaccine (lot U6920AA, expiry date: 15-Apr-2022, form, strength: not reported) via intramuscular route in the left arm for immunisation.  On 23-Jul-2021 the patient received the extra dose of menactra with no adverse event (extra dose administered, latency: same day) following the administration of meningococcal A-C-Y-W135 (D CONJ) vaccine.   It was reported that when the patient returned for a wellness check this year, it was discovered that they had received the extra dose of menactra.  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 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.; Sender's Comments:  01116730:
Age: 16.0
Sex: M
Vaccine: IPV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Medical assistant reports that she gave 10 doses (the whole vial) of IPOL to a patient with no reported adverse event; Initial information received on 24-May-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 16 years old male patient who experienced medical assistant reports that she gave 10 doses (the whole vial) of ipol to a patient with no reported adverse event while receiving vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP).  On 24-May-2022, the patient received a dose of suspect Ipol suspension for injection dose: 10 DF frequency: once lot T1E872M and expiry date 10-Oct-2022 via subcutaneous route in the left arm (strength: unknown) for immunisation.  On 24-May-2022 the patient developed a non-serious event "medical assistant reports that she gave 10 doses (the whole vial) of ipol to a patient with no reported adverse event" (vaccine overdose) (latency: same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.
Age: 0.83
Sex: M
Vaccine: FLU4
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: administered FLUZONE QUADRIVALENT MDV post excursion.; Initial information received on 24-May-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 10 months old male patient who was administered fluzone quadrivalent mdv post excursion. while receiving vaccine influenza quadrival a-b vaccine [Fluzone Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 14-Apr-2022, the patient received a  dose of suspect influenza quadrival a-b vaccine lot UJ705AB via intramuscular route in the left thigh. (formulation: unknown, strength: standard,  and expiry date: 30-June-2022)   the patient was administered fluzone quadrivalent mdv post excursion. (poor quality product administered) following the administration of influenza quadrival a-b vaccine.  Action taken with quadrivalent influenza vaccine was not applicable.  At time of reporting, the outcome was Unknown for the event administered fluzone quadrivalent mdv post excursion.   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: 26.0
Sex: F
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: an expired dose of TENIVAC was inadvertently administered to a patient with no reported adverse event; Initial information received on 24-May-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 26 years old female patient whom an expired dose of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] was inadvertently administered to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 24-May-2022, the patient received an expired dose 0.5 ml of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult (lot U6669AA; Expiry date: 15-May-2022) via intramuscular route in unknown administration site for Immunization inadvertently with no reported adverse event (expired product administered).  Action taken : not applicable.  At time of reporting, the outcome was Unknown for the event an expired dose of tenivac was inadvertently administered to a patient with no reported 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 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: 4.0
Sex: M
Vaccine: UNK
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: expired dose of PENTACEL was administered with no reported adverse event; Initial information received on 24-May-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 years old male patient who was administered expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE INACT (HEP A IN VAC) for Immunisation; and MEASLES VACCINE LIVE, MUMPS VACCINE LIVE, RUBELLA VACCINE LIVE (MEASLES, MUMPS AND RUBELLA) for Immunisation.  On 24-May-2022, the patient received a dose of 0.5 ml of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE  (formulation, strength: unknown) lot UJ424AA, expiration date: 21-May-2022, via intramuscular route in unknown administration site as prophylactic vaccination.  On 24-MAY-2022 the patient was administered expired dose of pentacel with no reported adverse event (expired product administered) same day following the administration of suspect vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (expired dose of PENTACEL was administered with no reported adverse 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 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: 1.92
Sex: F
Vaccine: TD
Symptoms: Expired product administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: almost 2 year-old girl has presented for a TD immunization with no adverse event; patient was given expired TD Adsorbed vaccination with no adverse event reported; Initial information received on 25-May-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 23 months old female patient , almost 2 year-old girl has presented for a TD immunization with no adverse event and patient was given expired td adsorbed vaccination with no adverse event reported while receiving vaccine diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac].  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 diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult Suspension for injection (expiry date: 22-May-2022; dose, lot number , strength: not reported) via unknown route in unknown administration site as prophylactic vaccination. Information on batch number requested.  On an unknown date, an almost 2 year-old girl has presented for a TD immunization with no adverse event (Product administered to patient of inappropriate age) and the patient was given expired td adsorbed vaccination with no adverse event reported (expired product administered) (unknown latency) following the administration of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult.  Action taken : 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 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.
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Menactra administered to a patient today was expired/expiration 22apr2022 ,with no reported adverse event; Initial information received on 25-May-2022 regarding an unsolicited valid non-serious case received from a physician via call center (web/email communication).  This case involves an patient of unknown gender and age who reported  menactra administered to a patient today was expired/expiration 22apr2022 ,with no reported adverse event while receiving vaccine Meningococcal A-C-Y-W135 (D Conj) Vaccine [Menactra].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 25-May-2022, the patient received a 0.5 ml total dose of suspect meningococcal a-c-y-w135 (d conj) vaccine, frequency: once, lot UA6920AA, expiry date: 22-Apr-2022 (unknown: strength and formulation) via unknown route in unknown administration site as Immunization.  On 25-MAY-2022 the patient developed a non-serious event menactra administered to a patient today was expired/expiration 22apr2022, with no reported adverse event (expired product administered) (latency: same day) following the administration of meningococcal a-c-y-w135 (d conj) vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (expired product administered).  At time of reporting, the outcome was Unknown for the event expired product administered.    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.
Sex: U
Vaccine: YF
Symptoms: No adverse event, Product preparation error
Clinical narrative: sterile water was used to reconstitute the vaccine, with no reported adverse event; Initial information received on 26-May-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who experienced sterile water was used to reconstitute the vaccine, with no reported adverse event while receiving vaccine YELLOW FEVER VACCINE - US [YF-VAX].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included WATER FOR INJECTION (STERILE WATER) for Vehicle solution use.  On 26-May-2022, the patient received a  dose of suspect YELLOW FEVER VACCINE - US lot number not reported via unknown route in unknown administration site for Immunisation.  On 26-MAY-2022 (latency: Same day) the patient developed a non-serious sterile water was used to reconstitute the vaccine, with no reported adverse event (product preparation error) following the administration of YELLOW FEVER VACCINE - US.  Action taken with YELLOW FEVER VACCINE (YF-VAX) was not applicable.  It was not reported if the patient received a corrective treatment for the event (sterile water was used to reconstitute the vaccine, with no reported adverse event).  At time of reporting, the outcome was Unknown for the event sterile water was used to reconstitute the vaccine, with no reported 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 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: M
Vaccine: YF
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: administered the YF-VAX intramuscularly instead of subcutaneously with no reported adverse event; Initial information received on 26-May-2022 regarding an unsolicited valid non-serious case received from a other health professional via call center.  This case involves a 42 years old male patient who  reported administered the yf-vax intramuscularly instead of subcutaneously with no reported adverse event while receiving vaccine yellow fever vaccine [YF-VAX].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Typhoid Vaccine (Typhoid) for Immunisation.  On 26-May-2022, the patient received a 0.5 ml dose of suspect yellow fever vaccine - US lot uj563aa, expiry date: 23-May-2023, unknown strength and formulation, frequency: once, via intramuscular route in the left deltoid for prophylactic vaccination.  On 26-MAY-2022 the patient developed a non-serious event administered the yf-vax intramuscularly instead of subcutaneously with no reported adverse event (incorrect route of product administration) (latency: same day) following the administration of yellow fever vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (incorrect route of product administration).  At time of reporting, the outcome was Unknown for the event incorrect route of product administration.      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 regulatory agency. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: RAB
Symptoms: No adverse event, Off label use
Clinical narrative: take the 2nd IMOVAX vaccine 2 weeks after the scheduled dose with no reported adverse event; Initial information received on 27-May-2022 regarding an unsolicited valid non-serious case received via other health professional.  This case involves an unknown age male patient who experienced take the 2nd imovax vaccine 2 weeks after the scheduled dose with no reported adverse event while receiving vaccine rabies (hdc) vaccine (Imovax Rabies).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 19-May-2022, the patient received a dose of suspect rabies (hdc) vaccine lot U1D221M (dose, route and administration site: unknown) for Immunization.  It was stated that patient had the 1st rabies (hdc) vaccine on 19-May-2022. The patient was due for the 2nd dose of rabies (hdc) vaccine today, 27-May-2022, however the pharmacist stated that the rabies (hdc) vaccine will not be available until approximately 2 weeks from now. She asks it acceptable to take the 2nd rabies (hdc) vaccine 2 weeks after the scheduled dose (off label use) (unknown latency).  Action taken: not applicable.  Outcome was Unknown
Sex: M
Vaccine: DTAP
Symptoms: Hypersensitivity
Clinical narrative: got an allergic reaction; Initial information received on 27-May-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves an unknown age male patient who experienced got an allergic reaction while receiving vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  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 Daptacel (formulation, strength, dose, lot number, expiration date, route of administration and administration site: unknown) as prophylactic vaccination (immunization). Information regarding the batch number for this case was requested.   On an unknown onset and latency, the patient developed a non-serious got an allergic reaction (allergic reaction to excipient) following the administration of Daptacel.  It was reported that "Caller stated that her son got an allergic reaction, and she is trying to narrow down which ingredient of Dtap that might have caused it. She did not clarify if it was DAPTACEL and the call got disconnected due to bad reception before any contact information is collected. This is reported as a possible adverse event due to allergic reaction experienced by the patient."  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 Unknown for the event.
Age: 19.0
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient came in to receive TUBERSOL and accidentally received IPOL intradermally instead with no adverse event; patient came in to receive TUBERSOL and accidentally received IPOL intradermally instead with no adverse event; Initial information received on 31-May-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 19 years old female patient who came in to receive tubersol and accidentally received ipol intradermally instead with no adverse event while receiving vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 31-May-2022, the patient received a dose of suspect IPV (VERO) at a dose of 0.1 ml (lot T1D482M and expiry date: 25-Jul-2022; strength: unknown) via intradermal route in unknown administration site as prophylactic vaccination.  On 31-May-2022, the patient came in to receive tubersol and accidentally received ipol intradermally instead with no adverse event (wrong product administered) and incorrect route of product administration) (latency: same day) following the administration of IPV (VERO).  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 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: 70.0
Sex: F
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: reported that a patient received 2 doses of MENACTRA at 4 weeks apart, instead of the recommended 8 weeks apart with no reported adverse event; Initial information received on 31-May-2022 regarding an unsolicited valid non-serious case received from a other health professional via call center.  This case involves a 70 years old female patient who experienced reported that a patient received 2 doses of menactra at 4 weeks apart, instead of the recommended 8 weeks apart with no reported adverse event while receiving vaccine Meningococcal A-C-Y-W135 (D Conj) Vaccine [Menactra].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Eculizumab (Soliris).  On 18-Jan-2022, the patient received 0.5 ml dose of suspect meningococcal a-c-y-w135 (d conj) vaccine lot U6952AA Expiration date: 09-Jun-2022, frequency: once, unknown strength and formulation via intramuscular route in the left deltoid as immunization and received same vaccine at the interval of 4 weeks with unknown batch lot, route, administration site, frequency, formulation and expiry date.  On 18-JAN-2022 the patient developed a non-serious event reported that a patient received 2 doses of menactra at 4 weeks apart, instead of the recommended 8 weeks apart with no reported adverse event (inappropriate schedule of product administration) latency: unknown following the administration of meningococcal a-c-y-w135 (d conj) vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (inappropriate schedule of product administration).  At time of reporting, the outcome was Unknown for the event inappropriate schedule of product administration.   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: 1.25
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired vaccine was administered to a patient with no adverse event; Initial information received on 31-May-2022 regarding an unsolicited valid non-serious case received via other health professional.  This case involves a 15 months old male patient who experienced expired vaccine was administered to a patient with no adverse event while receiving vaccine hib (prp/t) vaccine (Act-Hib).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine conj 13v (crm197) (Prevnar 13).  On 31-May-2022, the patient received a dose of suspect hib (prp/t) vaccine at a dose of 0.5 ml with lot UJ513AB and expiry date: 29-May-2022 (expired product administered) via intramuscular route in left thigh for Immunization.  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: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: consumer only receiving the dtap-ipv portion and not the hib portion due to the staff member not knowing to mix the two parts with no reported adverse event; Initial information received on 31-May-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 3 years old female patient, consumer only receiving the dtap-ipv portion and not the hib portion due to the staff member not knowing to mix the two parts with no reported adverse event while receiving vaccine diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis b vaccine (hepatitis b vaccine) for prophylactic vaccination; and measles vaccine live (enders-edmonston), mumps vaccine live (jeryl lynn), rubella vaccine live (wistar ra 27/3), varicella zoster vaccine live (oka/merck) (proquad) for prophylactic vaccination.  On 19-May-2022, the patient received a dose of suspect vaccine diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine suspension for injection (lot U6990AA, expiry date: 07-Au-2022; strength: unknown) total one day at a dose of 0.5 ml via intramuscular route in the left deltoid as prophylactic vaccination.  On 19-MAY-2022, the consumer only receiving the dtap-ipv portion and not the hib portion due to the staff member not knowing to mix the two parts with no reported adverse event (product preparation error) following the administration of diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) 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 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.
Sex: U
Vaccine: TD
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: given an expired vaccine TENIVAC to a patient 2 weeks ago, with no reported adverse event; Initial information received on 01-Jun-2022 regarding an unsolicited valid non-serious case received from a other health professional via call center.  This case involves a patient of unknown gender and age who was given an expired vaccine tenivac to a patient 2 weeks ago, with no reported adverse event while receiving vaccine Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac].  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 diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult (dose, route, strength, formulation, frequency, batch lot number: unknown), expiry date: 15-May-2022 in unknown administration site as immunization.  On an unknown date the patient developed a non-serious event given an expired vaccine tenivac to a patient 2 weeks ago, with no reported adverse event (expired product administered) (unknown latency) following the administration of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (expired product administered).  At time of reporting, the outcome was Unknown for the event expired product administered.     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: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Nausea, vomiting, fever of 102°f