chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: YF
Symptoms: Biopsy brain abnormal, CSF test abnormal, Flavivirus test positive, Neurological symptom
Clinical narrative: mild neuro symptoms; Initial information received on 11-May-2022 regarding an unsolicited valid  serious case received from a other health professional.  This case involves a patient of unknown age and gender who experienced mild neuro symptoms,  after receiving vaccine YELLOW FEVER VACCINE -  [YF-VAX].  The patient's past medical history included received an organ ( Organ transplant.)  The patient's past medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an organ from the vaccinated individual who received an unknown dose of suspect yellow fever vaccine, unknown formulation and strength, ( lot number and expiry date:  not reported)  via unknown route in unknown administration site for prophylactic vaccination. The organs of the vaccinated individual were donated. Some of these organ recipients developed neurologic symptoms and YF virus was found in cerebrospinal  fluid (CSF) or brain tissue.  On an unknown date the patient experienced mild neuro symptoms (neurological symptom) (unknown latency) . This event was assessed as medically significant.  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the event (mild neuro symptoms).  At time of reporting, the outcome was Unknown for the event mild neuro symptoms.; Sender's Comments: Sanofi company comment dated 17-May-2022: This case involves patient of an unknown age and gender who experienced mild neuro symptoms after receiving organ from vaccinated person with YELLOW FEVER VACCINE - [YF-VAX] . Case will be reevaluated post further update on concomitant medications, concurrent condition during vaccination, underlying disease, laboratory investigations excluding alternative etiologies for the reported event which will preclude a comprehensive assessment of this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Doctor gave 1/2 Pentacel only the liquid portion with no reported adverse event; Initial information received on 13-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 states doctor gave 1/2 pentacel only the liquid portion 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.   On an unknown date, the patient received a  dose of suspect Suspension for injection DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious doctor gave 1/2 pentacel only the liquid portion with no reported adverse event (incorrect dose administered) (unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL) was not applicable.  It was not reported if the patient received a corrective treatment for the event (Doctor gave 1/2 Pentacel only the liquid portion with no reported adverse event).  At time of reporting, the outcome was Unknown for the event doctor gave 1/2 pentacel only the liquid portion 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: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Incorrect route of product administration, Injection site bruising, Product administration error, Product storage error, Skin haemorrhage
Clinical narrative: bleeding under the skin; reported bruising at the injection site; administration may have been too high in the deltoid, closer to the joint/temperature excursion at 76 F to 78 fahrenheit as left out of refrigerator for 12 hours; Initial information received on 21-Jan-2022 regarding an unsolicited valid non-serious case received from healthcare professional.  This case involves a 24 years old female patient who had bleeding under the skin, reported bruising at the injection site and administration may have been too high in the deltoid, closer to the joint while receiving 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.  On 13-May-2022, the patient received a dose 0.5 ml total once of suspect diphtheria-2/tetanus/5 ac pertussis vaccine Strength: standard form: injection lot C5923AA, expiry date: 14-Oct-2022 via intramuscular route in the right deltoid but might have been a little high for Immunisation.  On 13-May-2022 (Latency: same day) the patient developed a non-serious bleeding under the skin (skin haemorrhage), bruising at the injection site (vaccination site bruising) and administration may have been too high in the deltoid, closer to the joint and temperature excursion at 76 F to 78 Fahrenheit as left out of refrigerator for 12 hours (product administration error).   The caller stated that the administration may have been too high in the deltoid, closer to the joint. The caller noted that there may be bleeding under the skin. The patient was worried that it wasn't administered properly since it was little high and caused bruising. The patient denies any pain, redness, swelling, or drainage.   Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (bleeding under the skin, reported bruising at the injection site).  At time of reporting, the outcome was Unknown for all the events (bleeding under the skin, was Unknown for the event reported bruising at the injection site and was Unknown for the event administration may have been too high in the deltoid, closer to the joint.)    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.   Additional information was received on 16-May-2022: case was updated from non-case to valid case. Patient details, Therapy details, event details and medically confirmed was updated.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient receiving an expired dose of menactra, with no AE (adverse event); Initial information received on 05-May-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 11 years old male patient who received an expired dose of menactra, with no ae (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 HPV vaccine.  On 03-May-2022, the patient received a 0.5ml dose of suspect meningococcal a-c-y-w135 (d conj) vaccine unknown formulation and strength lot U6919AB via intramuscular route in the left deltoid for prophylactic vaccination.  Same day, the patient received an expired dose of menactra, with no ae (expired product administered).  Action taken: Not applicable   Corrective treatment: Not reported   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: 1.92
Sex: F
Vaccine: DTAP
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: vaccines given post excursion with no reported adverse event.; vaccines being given post temperature excursion with no reported adverse event.; Initial information received on 06-May-2022 regarding an unsolicited valid  non-serious case received from a other health professional.   This case involves a 23 months old female patient who was being given vaccines post excursion with no reported adverse event with  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 03-May-2022, the patient received a 0.5ml dose of suspect diphtheria-15/tetanus/5 ac pertussis vaccine lot C5829BA expiration date 01-Mar-2023 via intramuscular route in the left thigh for immunization.  Patient vaccines being given post temperature excursion with no reported adverse event. (poor quality product administered and Product storage error)  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: 2.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccines given post excursion with no reported adverse event; Initial information received on 06-May-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2 years old male patient who experienced vaccines given post excursion 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),  and family history were not provided.  Concomitant medications included hepatitis a vaccine (Hepatitis A); measles vaccine, mumps vaccine, rubella vaccine (MMR) and varicella zoster vaccine (Varicella vaccine) for Immunisation.  On 04-May-2022, the patient received a dose 0.5 ml once of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine suspension for injection Strength: standard lot UJ613AAA via intramuscular route in the right thigh for Immunisation.  On 04-MAY-2022 the patient was given vaccines post excursion with no reported adverse event (product storage error) Latency: same day.   Action taken was not applicable.  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.
Age: 4.0
Sex: M
Vaccine: IPV
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: the excursion was a temporary thing and there had not been another since with no ae; IPOL was administered after the excursion with no ae; Initial information received on 06-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 experienced the excursion was a temporary thing and there had not been another since with no ae while receiving vaccine IPV (VERO) [IPOL] post excursion.  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 5-component, tetanus vaccine toxoid (Adacel); measles vaccine, mumps vaccine, rubella vaccine (MMR)and varicella zoster vaccine (Varicella Vaccine).  On 22-FEB-2022, vaccines were exposed to highest temperature of 48 degrees F for 30 minutes at most. Caller stated that the excursion was a temporary thing and there had not been another since (Product temperature excursion issue). IPOL was used post excursion but upon further probing, the caller stated she is not sure if the IPOL was opened at the time of excursion.   On 28-Feb-2022, 6 days after excursion, the patient received a dose of suspect IPV (VERO) unknown formulation and strength/lot T1D481M via intramuscular route in unknown administration site for immunization post excursion (poor quality vaccine administered).   Action taken: Not applicable for both  Corrective treatment: Not applicable  Outcome: Unknown for both; Sender's Comments:  case 01092927:
Age: 27.0
Sex: M
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, Intentional product misuse, No adverse event
Clinical narrative: patient receiving his IMOVAX day 7 dose on day 8 with no adverse event; Initial information received on 11-May-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 27 years old male patient who experienced patient receiving his imovax day 7 dose on day 8 with no 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 03-May-2022, the patient received a  dose of suspect RABIES (HDC) VACCINE lot T1E321M (expiry date: unknown)  via intramuscular route in unknown administration site for Immunisation.  On 11-MAY-2022 the patient developed a non-serious patient receiving his imovax day 7 dose on day 8 with no adverse event (intentional product misuse) 8 days following the administration of RABIES (HDC) VACCINE.  Action taken with RABIES VACCINE (IMOVAX RABIES) was not applicable.  It was not reported if the patient received a corrective treatment for the event (patient receiving his IMOVAX day 7 dose on day 8 with no adverse event).  At time of reporting, the outcome was Unknown for the event patient receiving his imovax day 7 dose on day 8 with no adverse event.
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: ACTHIB expired and administered to a patient; Initial information received on 11-May-2022 regarding an unsolicited valid non-serious case received from a other health professional.   This case involves a 1 years old female patient who was  administered expired vaccine with no AE with 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 measles vaccine, mumps vaccine, rubella vaccine (MMR) for Prophylactic vaccination; varicella zoster vaccine (Varicella Vaccine) for Prophylactic vaccination; pneumococcal vaccine conj (Pneumococcal Conjugate Vaccine) for Prophylactic vaccination; hepatitis a vaccine for Prophylactic vaccination; and diphtheria vaccine toxoid, hib vaccine conj (TET TOX), pertussis vaccine acellular 5-component, polio vaccine inact 3v (MRC 5), tetanus vaccine toxoid (Pentacel) for Prophylactic vaccination.  On 11-May-2022, the patient received a 0.5ml dose of suspect HIB (PRP/T) VACCINE unknown formulation and strength lot UJ661AAA expiry date 06-May-2022 via intramuscular route in the right thigh for prophylactic vaccination.  ACTHIB was expired and administered to a patient  (expired product administered). Medical assistant wants to know how soon the dose should be repeated.  Action taken: Not applicable.  Corrective treatment: Not reported  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: 4.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 4 year old patient receiving ADACEL instead of DAPTACEL with no reported adverse event; Initial information received on 12-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 experienced 4 year old patient receiving adacel instead of daptacel 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.  On 21-Sep-2018, the patient received a 5th dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine once Suspension for injection (dose, lot number, strength, expiry date not reported) via unknown route in unknown administration site as prophylactic vaccination.  On 21-Sep-2018, the 4 year old patient receiving diphtheria-2/tetanus/5 AC pertussis vaccine instead of daptacel with no reported adverse event (product use issue) (latency: same day).The HCP asks how they should proceed with the immunizations and if the ADACEL dose was valid.  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.
Age: 2.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Single component of a two-component product administered
Clinical narrative: administration of PENTACEL without the Hib component, got the liquid component of PENTACEL without the lyophilized component with no reported adverse event; Initial information received on 12-May-2022 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 2 years old female patient who experienced administration of diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel] without the hib component, got the liquid component of pentacel without the lyophilized component 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 pneumococcal vaccine conj 7v (crm197) (Prevnar) for prophylactic vaccination; influenza vaccine (influenza) for prophylactic vaccination; and hepatitis a vaccine (hepatitis a) for Prophylactic vaccination.  On 06-Dec-2021, the patient received a 4 dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/IPV(MRC5)/HIB(PRP/T) vaccine Suspension for injection at a dose of 0.5 ml total (lot UJ464AB; expiry date: 21-May-2022;, strength unknown) via intramuscular route in the right thigh as Immunization.  On 06-DEC-2021, the diphtheria/tetanus/5 hybrid ac pertussis/IPV(MRC5)/HIB(PRP/T) vaccine without the hib component, got the liquid component of diphtheria/tetanus/5 hybrid ac pertussis/IPV(MRC5)/HIB(PRP/T) without the lyophilized component with no reported adverse event (single component of a two-component product administered) (latency: same day).  It was reported that she would like to know if she should start over the whole dose or if she could reconstitute the powder with something else and administer it.  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.
Age: 22.0
Sex: F
Vaccine: IPV
Symptoms: Incorrect route of product administration, No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: IPOL instead of TUBERSOL 0.1 ml intradermally with no adverse event; Initial information received on 13-May-2022 regarding an unsolicited valid non-serious case received via other health professional.  This case involves a 22 years old female patient who had ipol instead of tubersol 0.1 ml intradermally 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.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (Boostrix).  On an unknown date, the patient received a dose of suspect ipv (vero) with at a dose of 0.1 ml with lot V1A121M via intradermal route in right arm for prophylactic vaccination.  On an unknown date the patient had ipol instead of tubersol 0.1 ml intradermally with no adverse event (Wrong product administered) (unknown latency) following the administration of ipv (vero).  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: 0.5
Sex: M
Vaccine: DTAPIPVHIB, IPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Medical Assistant mistakenly gave a patient an IPOL vaccination in addition to their PENTACEL vaccination on 12MAY2022, causing the patient to receive an extra dose of IPV with no other reported adverse event; Initial information received on 13-May-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 6 months old male patient to whom it was reported that medical assistant mistakenly gave a patient an IPV (VERO) [IPOL] vaccination in addition to their diphtheria/tetanus/5 HYBRID AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel] vaccination on 12may2022, causing the patient to receive an extra dose of ipv with no other reported adverse event.  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 12-May-2022, the patient received 0.5 ml dose of suspect IPV (VERO) (lot U1C571M; expiry date 17-Jun-2023) along with  0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ542AAA, expiry date; 10-Jul-2022) via intramuscular route in unknown administration site for Prophylactic vaccination it was reported medical assistant mistakenly gave a patient an ipol vaccination in addition to their pentacel vaccination on 12may2022, causing the patient to receive an extra dose of ipv with no other reported adverse event (extra dose administered) (latency same day)  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.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Single component of a two-component product administered
Clinical narrative: only the DTAP-IPV portion was given and not the Hib portion with no adverse event; Initial information received on 13-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 experienced only the dtap-ipv portion was given and not the hib portion with no adverse event while receiving 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 measles vaccine, mumps vaccine, rubella vaccine (MMR vaccine) for Immunization.  On 13-May-2022, the patient received Dose: 4, 0.5 ml once of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine Suspension for injection strength: standard, lot U7197BA, expiry date: 18-Jan-2023 via unknown route and administration site for immunization.   On 13-May-2022 the patient developed a non-serious event as only the dtap-ipv portion was given and not the hib portion with no adverse event (single component of a two-component product administered). Caller mentioned that they discarded the Hib portion already to refrain from confusion.   Action taken was not applicable.  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: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered ACTHIB to a patient after it was expired for a week with no reported adverse event; Initial information received on 13-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 administered acthib to a patient after it was expired for a week 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.  On an unknown date, the patient received a  dose of suspect HIB (PRP/T) VACCINE (lot number and expiry date was unknown) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious administered acthib to a patient after it was expired for a week with no reported adverse event (expired product administered) (unknown latency) following the administration of HIB (PRP/T) VACCINE.  Action taken with HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) was not applicable.  It was not reported if the patient received a corrective treatment for the event (administered ACTHIB to a patient after it was expired for a week with no reported adverse event).  At time of reporting, the outcome was Unknown for the event administered acthib to a patient after it was expired for a week 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: 10.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: gave a 10 year old a Menquadfi booster dose with no reported adverse event; Initial information received on 16-May-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 10 years old male patient gave a  menquadfi booster dose with no reported adverse event while receiving vaccine MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI].   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 (BOOSTRIX) for Prophylactic vaccination; and HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) for Prophylactic vaccination.  On 15-Apr-2022, the patient received a  dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE lot U7249AA (expiry date: 11-Mar-2024) via intramuscular route in unknown administration site for Immunization.  On 15-APR-2022 (Latency: Same day) the patient developed a non-serious gave a 10 year old a menquadfi booster dose with no reported adverse event (product administered to patient of inappropriate age) following the administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE.  Action taken with MENINGOCOCCAL VACCINE (MENQUADFI) was not applicable.  It was not reported if the patient received a corrective treatment for the event (gave a 10 year old a Menquadfi booster dose with no reported adverse event).  At time of reporting, the outcome was Unknown for the event gave a 10 year old a menquadfi booster dose 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: 1.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Extra dose administered, No adverse event
Clinical narrative: 16 month old was given 2 doses of Hib. He was given ACTHIB when he already got a dose of PENTACEL (with no reported adverse event); Initial information received on 16-May-2022 regarding an unsolicited valid non-serious case received from healthcare professional.  This case involves a 16 months old male patient who was given 2 doses of hib he was given acthib when he already got a dose of pentacel (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 pneumococcal vaccine conj 7v (crm197) (Prevnar) and hib vaccine conj (tet tox) (Acthib) for prophylactic vaccination.  On 16-May-2022, the patient received 0.5 ml dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine [Pentacel] (lot UJ641AA and expiry date 28-Feb-2023 via intramuscular route in the right thigh) (strength, formulation: unknown) for immunization.  On 16-May-2022 the patient developed a non-serious event "16-month-old was given 2 doses of hib. he was given acthib when he already got a dose of pentacel (with no reported adverse event) (extra dose administered) same day following the administration of diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine [Pentacel]."  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: 31.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of menactra with no adverse event; Initial information received on 17-May-2022 regarding an unsolicited valid non-serious case received via consumer/non-hcp.  This case involves a 31 years old female patient who experienced expired 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.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (Tdap) for Prophylactic vaccination.  On 16-May-2022, the patient received a dose of suspect meningococcal a-c-y-w135 (d conj) vaccine lot U6691AA via intramuscular route in arm for immunization.  Reportedly an expired dose of meningococcal a-c-y-w135 (d conj) vaccine was given to a patient yesterday (expired product administered), 16-May-2022, manger did not know which arm the dose was administered, she did not provide the NDC number as she was at a different medical office.   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.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: an expired dose of ACTHIB was administered to a patient. The ACTHIB expired on 06MAY2022. with no adverse event.; Initial information was received on 17-May-2022 regarding an unsolicited valid non-serious case received from a health care professional via call center.   This case involves an unknown age and unknown gender patient who experienced an expired dose of acthib was administered to a patient. the acthib expired on 06-may-2022. 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.   On 16-MAY-2022 , the patient received a  dose of suspect HIB (PRP/T) VACCINE (dose, formulation, strength, lot and expiry date: unknown) via unknown route in unknown administration site for prophylactic vaccination.   On 16-MAY-2022 the patient developed a non-serious an expired dose of acthib was administered to a patient. the acthib expired on 06may2022. with no 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 an expired dose of acthib was administered to a patient. the acthib expired on 06may2022. 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 65.0
Sex: F
Vaccine: TD
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: states that they had a dose of tenivac which expired 15may2022/states they administered the tenivac to a patient today,with no reported adverse event; Initial information received on 17-May-2022 regarding an unsolicited valid non-serious case received from a healthcare professional via Physician.  This case involves a 65 years old female elderly patient who states that they had a dose of tenivac which expired 15may2022 states they administered the tenivac to a patient today,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) and family history were not provided. No patient history and risk factors provided. The patient's past vaccination(s) included TDaP in 2007 for Prophylactic vaccination.  Concomitant medications included Pneumococcal Vaccine CONJ 20V (CRM197) (Prevnar 20) for Prophylactic vaccination.  On 17-May-2022, the patient received 0.5 ml (TOTAL) dose of suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult (lot U6669AA; expiry date: 15-May-2022) (strength, formulation: unknown) via intramuscular route (administration site: Left upper extremity) for Immunization.  On 17-MAY-2022 the patient states that they had a dose of tenivac which expired 15may2022 states they administered the tenivac to a patient today,with no reported adverse event (expired product administered) following the administration of Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult.  No lab data was reported.   Action taken with Diphtheria and Tetanus Toxoids (Tenivac) was 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: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: give a TENIVAC dose today after it expired, with no reported adverse event; Initial information received on 18-May-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 60 years old female patient who was given a tenivac dose today after it expired, 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.  Concomitant medications included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).  On 18-May-2022, the patient received dose of  0.5 ml of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT, ( lot:  U6603AA ; expiry date: 05-Mar-2022)  via intramuscular route in the left deltoid for immunization.  It was reported that the patient was given a tenivac dose that day after it expired, with no reported adverse event (expired product administered)  (onset date: 18-May-2022; latency: same day) 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 for the event give a tenivac dose today after it expired, 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 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: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Urticaria
Clinical narrative: broke out into full body hives after receiving quadracel; Initial information received on 18-May-2022 regarding an unsolicited valid non-serious case received from a physician via call center.  This case involves a 5-year-old female patient who broke out into full body hives after receiving vaccine Diphtheria-15/Tetanus/5 Hybrid Ac Pertussis/Ipv (Mrc5) Vaccine [Quadracel].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine (dose, route, strength, formulation, frequency, batch lot number and expiry date: unknown) in unknown administration site for immunization. Information on batch lot number is requested.  On an unknown date the patient developed a non-serious event broke out into full body hives after receiving quadracel (urticaria) (unknown latency) following the administration of diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine.  it was reported that the HCP (health care professional) said this has been reported previously and they had received form to complete. Unable to locate previous report.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (urticaria).  At time of reporting, the outcome was Unknown for the event urticaria.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: covid-19; covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from Regulatory Authority. The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Apr2022 at 11:00 as dose 4 (booster), single (Lot number: KK9895) at the age of 75 years, in left arm for covid-19 immunisation; moderna coviD-19 vaccine (MODERNA COVID-19 VACCINE), on 26Jan2021 as dose 1, single (Lot number: 042L20A), in left arm, on 25Feb2021 as dose 2, single (Lot number: 010A21A), in left arm and on 21Oct2021 as dose 3 (booster), single (Lot number: 076C21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN taken for hypertension. The following information was reported: DRUG INEFFECTIVE (medically significant), 18 days 13 hrs after the suspect product(s) administration, outcome "unknown", COVID-19 (medically significant), 18 days 13 hrs after the suspect product(s) administration, outcome "not recovered" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (15May2022) positive with milder symptoms, notes: positive with milder symptoms. Therapeutic measures were taken as a result of covid-19.  Clinical course- The patient receive any other vaccines within 4 weeks prior to the COVID vaccine. and also received other medication in 2weeks.  No follow-up attempts are needed. No further information is expected.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes, under left arm
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Flushing, Hyperhidrosis, Lethargy
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Contusion, Erythema, Joint swelling, Lymphadenopathy
Clinical narrative: Systemic: Lymph Node Swelling-Mild, Additional Details: Patient experienced swelling on back of arm, not injection site. Also it was itchy and appeared reddish. It was more swollen around the elbow. Bruise present at back of arm. Sharp pain below left armpit area, maybe lymph nodes. Some night sweats, no fever, no bodyaches.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Night sweats, Peripheral swelling, Pruritus
Clinical narrative: Systemic: Lymph Node Swelling-Mild, Additional Details: Patient experienced swelling on back of arm, not injection site. Also it was itchy and appeared reddish. It was more swollen around the elbow. Bruise present at back of arm. Sharp pain below left armpit area, maybe lymph nodes. Some night sweats, no fever, no bodyaches.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Amnesia, Asthenia, Fatigue, Headache, Hypertension
Clinical narrative: Long lasting fatigue and urge to sleep during the day, long lasting pain at injection site (left shoulder), loss of overall body strength and muscle tone, sporadic borderline high/high blood pressure readings with no prior history of BP problems, headaches (worsening over time) memory loss (worsening over time)