chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Gait inability, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: Unable to walk/couldn't move legs; had to contrite hard just to walk, then I just got worse.; Harder to keep my balance; Weaker; Feeling extremely tired all the time; Kept falling; Hands would ache; I started to drop things and it was difficult; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP), Program ID: The reporter is the patient. A 30-year-old patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GAIT INABILITY (non-serious), outcome "not recovered", described as "Unable to walk/couldn't move legs"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "had to contrite hard just to walk, then I just got worse."; BALANCE DISORDER (non-serious), outcome "unknown", described as "Harder to keep my balance"; ASTHENIA (non-serious), outcome "unknown", described as "Weaker"; FATIGUE (non-serious), outcome "unknown", described as "Feeling extremely tired all the time"; FALL (non-serious), outcome "unknown", described as "Kept falling"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Hands would ache"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "I started to drop things and it was difficult".  Additional information Description of Event Outcome: It was started after getting your vaccine. Reporter is 30-year-old. Who has been unable to walk since Mar. Reporter started walking funny start in Nov last year. Reporter started walking width and it was starting for the reporter to be harder to keep the balance. Reporter started getting weaker and feeling extremely tired all the time. Reporter had to contrite hard just to walk, then reporter just got worse. Reporter kept falling and eventually reporter stop walking. Reporter could not move legs and my hands would ache. Reporter started to drop things and it was difficult.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Skin disorder
Clinical narrative: I just realized that my skin condition started days after receiving my 1st Covid vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP), Program ID:  The reporter is the patient.  A 75-year-old patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "diabetic" (unspecified if ongoing); "Primary Billiary cirrhosis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: SKIN DISORDER (non-serious), outcome "unknown", described as "I just realized that my skin condition started days after receiving my 1st Covid vaccine".  Additional information: Description of Event Outcome: I am a 75-year-old diabetic who also has Primary Billiary cirrhosis and I just realized that my skin condition started days after receiving my 1st Covid vaccine. I just received my 4th shot and my eczema condition continues on getting worse. As I researched chat rooms looking for some knowledge I found a trend of others who also suffered the same fate.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: low grade temperature; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: . The reporter is the parent.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation.  The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "low grade temperature". Additional information: My son had a low grade temperature just for a day.  The information on the batch/lot number for BNT162B2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: testing positive for COVID-19; testing positive for COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "testing positive for COVID-19". It was reported that, the patient was scheduled to get a booster tomorrow. It was further stated that, however, someone advised her that she needs to wait three months to get it after testing positive for COVID-19 and she is asking for additional information if she needs to wait for 90 days. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Immune thrombocytopenia, Platelet count
Clinical narrative: Immune thrombocytopenic purpura following Pfizer-BioNTech COVID-19 Vaccine with presenting features of petechiae, gum bleeding, epistaxis, and subconjunctival hemorrhage; This is a literature report for the following literature source(s).  A 67-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "DM" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Depression" (unspecified if ongoing); "B12 deficiency" (unspecified if ongoing); "Headaches" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1; symptoms 14 days after the first dose), for COVID-19 immunization, reaction(s): "Symptoms". The following information was reported: IMMUNE THROMBOCYTOPENIA (hospitalization, medically significant), 2 days after the suspect product(s) administration, outcome "unknown", described as "Immune thrombocytopenic purpura following Pfizer-BioNTech COVID-19 Vaccine with presenting features of petechiae, gum bleeding, epistaxis, and subconjunctival hemorrhage". The patient was hospitalized for immune thrombocytopenia (hospitalization duration: 14 day(s)). The patient underwent the following laboratory tests and procedures: Platelet count: 3 x10 3/mm3. Therapeutic measures were taken as a result of immune thrombocytopenia including prednisone, IVIG, platelet, ACA, rituximab, and TPO-RA. Per clinical course, the patient was discharged on day 14 (received rituximab and TPO-RA outpatient).; Sender's Comments: Based on the close temporal relationship, the association between the event immune thrombocytopenia with BNT162b2 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Aspartate aminotransferase, Blood lactate dehydrogenase, Immune thrombocytopenia, Neutrophil count, Platelet count
Clinical narrative: Immune Thrombocytopenic Purpura; Iatrogenic thrombocytosis; This is a literature report for the following literature source:  A 69-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "Cataract" (unspecified if ongoing); "squamous cell carcinoma" (unspecified if ongoing); "basal cell carcinoma" (unspecified if ongoing); "Bruising" (unspecified if ongoing); "gum bleeding" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: IMMUNE THROMBOCYTOPENIA (hospitalization, medically significant), 14 days after the suspect product administration, outcome "unknown", described as "Immune Thrombocytopenic Purpura"; THROMBOCYTOSIS (non-serious), outcome "unknown", described as "Iatrogenic thrombocytosis". The event "iatrogenic thrombocytosis" required emergency room visit. The patient underwent the following laboratory tests and procedures: Aspartate aminotransferase: High; Blood lactate dehydrogenase: High; Neutrophil count: 5 x 10^3/uL; Platelet count: 5 x 10^3/uL. Therapeutic measures were taken as a result of immune thrombocytopenia with platelet, IVIG, dexamethasone, TPO-RA, vincristine, and prednisone. Additional information: The patient was discharged for the event Immune Thrombocytopenic Purpura with return to ER for iatrogenic thrombocytosis. No comment if the second dose was given.; Sender's Comments: Based on the temporal relationship, the association between the events immune thrombocytopenia and thrombocytosis with BNT162b2 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Thrombocytosis
Clinical narrative: Immune Thrombocytopenic Purpura; Iatrogenic thrombocytosis; This is a literature report for the following literature source:  A 69-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "Cataract" (unspecified if ongoing); "squamous cell carcinoma" (unspecified if ongoing); "basal cell carcinoma" (unspecified if ongoing); "Bruising" (unspecified if ongoing); "gum bleeding" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: IMMUNE THROMBOCYTOPENIA (hospitalization, medically significant), 14 days after the suspect product administration, outcome "unknown", described as "Immune Thrombocytopenic Purpura"; THROMBOCYTOSIS (non-serious), outcome "unknown", described as "Iatrogenic thrombocytosis". The event "iatrogenic thrombocytosis" required emergency room visit. The patient underwent the following laboratory tests and procedures: Aspartate aminotransferase: High; Blood lactate dehydrogenase: High; Neutrophil count: 5 x 10^3/uL; Platelet count: 5 x 10^3/uL. Therapeutic measures were taken as a result of immune thrombocytopenia with platelet, IVIG, dexamethasone, TPO-RA, vincristine, and prednisone. Additional information: The patient was discharged for the event Immune Thrombocytopenic Purpura with return to ER for iatrogenic thrombocytosis. No comment if the second dose was given.; Sender's Comments: Based on the temporal relationship, the association between the events immune thrombocytopenia and thrombocytosis with BNT162b2 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: spiked a fever between 99-100 degrees; Initial information received on 04-Oct-2022 regarding an unsolicited valid non-serious case from other health professional.  This case involves an unknown age and unknown gender patient who had spiked a fever between 99-100 degrees after receiving vaccine influenza vaccine.  The patient's past medical treatment(s), vaccination(s), concomitant medication and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date in Sep-2022, the patient received suspect influenza vaccine produced by unknown manufacturer at an unknown dose (lot number, expiry date: not reported) via unknown route in unknown administration site as flu shot(Influenza immunization).  On an unknown date in Sep-2022 the patient had spiked a fever between 99-100 degrees (pyrexia) (same day latency) following the administration of influenza vaccine.  Relevant laboratory test results included: Body temperature - On an unknown date in Sep-2022: [between 99-100 degrees]  Action taken: Not applicable.  The patient was treated with paracetamol (Tylenol) for Fever.  Outcome: Recovered / Resolved in September 2022 for the event spiked a fever between 99-100 degrees.
Age: 58.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: This case involves a 60 years old female patient (66 kg) who was tested positive for covid while receiving vaccines COVID-19 VACCINE and INFLUENZA VACCINE and while treated with TREPROSTINIL SODIUM [TYVASO].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Pulmonary arterial hypertension.  Concomitant medications included SILDENAFIL CITRATE (REVATIO); and MACITENTAN (OPSUMIT).  On 04-Nov-2020, the patient started taking TYVASO (TREPROSTINIL SODIUM, concentration of 0.6 mg/ml) delivered by Tyvaso Inhalation Device (TD-300/A) at a dosage of 54 ug QID (four times a day) via inhalational route (with an unknown formulation and batch number) for Pulmonary arterial hypertension.  On 13-Sep-2022, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (formulation, strength, dose, route and lot number not reported) and a Booster dose of suspect COVID-19 VACCINE not produced by Sanofi Pasteur (formulation, strength, dose, route and lot number not reported), both for prophylactic immunization.  On an unknown date in Sep-2022, the patient developed a non-serious event of tested positive for covid (covid-19) (unknown latency) following the first dose intake of TREPROSTINIL SODIUM, and following the administration of INFLUENZA VACCINE and COVID-19 VACCINE.  On 13 Sep 2022, the patient got both a Covid third booster and a flu vaccine and ended up catching Covid (COVID-19) (coronavirus disease) and had to go to urgent care and placed on molnupiravir and medication for Covid. She was using more oxygen than normal while having Covid.  Relevant laboratory test results included: SARS-CoV-2 test - In September 2022: Positive UNK  Action taken with TREPROSTINIL SODIUM (TYVASO) was unknown. Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) and COVID-19 VACCINE (COVID-19 VACCINE) was not applicable.  The patient was treated with MOLNUPIRAVIR and medication for Covid for COVID-19.  At time of reporting, the outcome was Unknown for the event tested positive for covid.
Age: 22.0
Sex: F
Vaccine: IPV
Symptoms: Poor quality product administered, Tuberculin test
Clinical narrative: Max/Low Temperature reached: 54.3 degrees Fahrenheit Duration out of recommended range: 2 hours and 45 minutes/ received a dose since the excursion occurred with no reported adverse event; Initial information received on 03-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to cases 2022SA409280(CLUSTER) and 2022SA410650(CLUSTER).  This case involves a 22 years old female patient and reporter states that max/low temperature reached: 54.3 degrees fahrenheit duration out of recommended range: 2 hours and 45 minutes/ received a dose since the excursion occurred with no reported adverse event involving vaccine IPV (VERO) [IPOL] and while treated with TUBERCULIN TEST [TUBERSOL].  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.    On 30-Sep-2022, the patient started taking TUBERSOL (TUBERCULIN TEST) Solution for injection at a dose of 0.1 mL in Left lower forearm intradermal (strength, formulation was unknown, lot - C5928A, 01-Mar-2024) for Skin test. On an unknown date, the patient received an unknown dose of suspect IPV (VERO)(strength, formulation, frequency, lot number and expiry date was unknown) via unknown route in unknown administration site for prophylactic vaccination.  On 30-Sep-2022 the patient developed a non-serious event of max/low temperature reached: 54.3 degrees fahrenheit duration out of recommended range: 2 hours and 45 minutes/ received a dose since the excursion occurred with no reported adverse event (poor quality product administered) (Latency: same day) following the first dose intake of TUBERCULIN TEST and (Latency: unknown) following the administration of IPV (VERO). Extended stability data cover the excursion. This situation was reported as a medication error due to administration post temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.  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.
Sex: F
Vaccine: FLUR3
Symptoms: Chills, Feeling cold
Clinical narrative: feeling generally cold; chills running up and down her legs; Initial information received on 04-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves an unknown age female patient (50.34 kg) who was feeling generally cold and chills running up and down her legs while receiving vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE, with an unknown formulation and strength, ( lot number and expiry date: not reported) via unknown route in unknown administration site for immunization. Information regarding batch number has been requested  On an unknown date the patient developed a non-serious event of " feeling generally cold" with chills running up and down her legs" (feeling cold)  (chills) (latency: unknown) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the events (feeling generally cold, chills running up and down her legs).  Outcome: unknown
Age: 7.0
Sex: F
Vaccine: DTAP, DTAPIPV, TDAP
Symptoms: Inappropriate schedule of product administration, Medication error, No adverse event
Clinical narrative: patient was on a delayed immunization schedule with no reported adverse event; Initial information received on 04-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 7 years old female patient was on a delayed immunization schedule with no reported adverse event involving vaccines DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL], DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] and DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (strength, formulation, lot number and expiry date were unknown) via unknown route in unknown administration site for Immunization. In August 2021, the patient received a 1st unknown dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (strength, formulation, lot number and expiry date were unknown) via unknown route in unknown administration site for Immunization. In October 2021 she also received a second dose of the same vaccine (strength, formulation, lot number and expiry date were unknown) via unknown route in unknown administration site for Immunization. In March 2022  she also received a 3rd dose  (strength, formulation, lot number and expiry date were unknown) via unknown route in unknown administration site for Immunization. On an unknown date, the patient received an unknown dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (strength, formulation, lot number and expiry date were unknown) via unknown route in unknown administration site for Immunization.  On an unknown date the patient developed a non-serious patient was on a delayed immunization schedule with no reported adverse event (inappropriate schedule of product administration, Latency: unknown). Patient was in the office for a fourth dose today on 04-Oct-2022, but wasn't sure what to give between QUADRACEL, DAPTACEL and ADACEL due to the patient's age not being indicated for either of those vaccines.  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: 14.0
Sex: F
Vaccine: IPV
Symptoms: Poor quality product administered
Clinical narrative: IPOL being administered post excursion with no reported adverse event; Initial information regarding an unsolicited valid non-serious case received  via Nurse on 04-Oct-2022. Agency number: 01306722  This case involves a 14-year-old female patient to whom IPV (VERO) [IPOL] being administered post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. This case is linked to cases 2022SA412359 and 2022SA412040.  Concomitant medications included Hepatitis B Vaccine for Immunization.  On 23-Sep-2022, the patient received 2nd dose of suspect IPOL vaccine being administered post excursion at dose 0.5ml once (lot: U1C571M, expiry date: 17-Jun-2023) via intramuscular route in the left deltoid for immunization with no reported adverse event (poor quality product administered) at same day latency.  Action taken: Not applicable.  At time of reporting, the outcome was not recovered.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 12.0
Sex: M
Vaccine: IPV
Symptoms: Poor quality product administered
Clinical narrative: vaccines have been more than likely used since the excursion with no reported adverse event; Initial information received on 04-Oct-2022 regarding an unsolicited valid non-serious case from a nurse.  This case is linked to cases 2022SA411401, 2022SA412043 and 2022SA412359.  This case involves a 12 years old male patient for whom IPV (VERO) [IMOVAX POLIO] vaccines have been more than likely used since the excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication 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) all for Immunisation.  On 21-Sep-2022, the patient received suspect IPV (VERO) at a dose of 0.5 ml total (lot U1C571M, expiry date: 17-Jun-2023) via intramuscular route in the left deltoid for prophylactic vaccination(immunisation).  On 21-Sep-2022 IPV (VERO) vaccines have been more than likely used since the excursion with no reported adverse event (poor quality product administered, latency: same day) .  Action taken: Not applicable.  Outcome: Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Wrong product administered
Clinical narrative: fluzone high dose qiv was administered to at 15 year old patient instead of the prescribed fluzone qiv on 04oct2022 with no reported adverse event; Initial information received on 05-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 15 years old female patient who stated that influenza quadrival A-B high dose hv vaccine [Fluzone high-dose quadrivalent] was administered instead of the prescribed fluzone qiv on 04oct2022 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 04-Oct-2022, the patient received a dose of suspect influenza quadrival A-B high dose hv vaccine at a dose of 0.7 ml once (lot UJ918AA, expiry date - 30-Jun-2023) (with an unknown strength, form) via intramuscular route in the right arm for Immunization.  On 04-Oct-2022 the 15 years old female patient who was administered influenza quadrival A-B high dose hv vaccine instead of the prescribed fluzone qiv with no reported adverse event (wrong product administered) (latency: same day) following the administration of vaccine.  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.
Age: 1.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: patient received an expired dose of daptacel with no reported adverse event; Initial information received on 06-Oct-2022 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves a 1-year-old male patient to who received an expired dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [Daptacel] 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 13v (pneumococcal vaccine 13v) and measles vaccine;mumps vaccine;rubella vaccine;varicella zoster vaccine) (MMRV) for Immunisation.  On 04-Oct-2022, the patient received an expired dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE Strength: standard (formulation, dose, frequency: unknown) (lot number: C5774AA and expiry date: 18-Sep-2022) via intramuscular route in the right thigh with no reported adverse event (expired product administered; latency same day) for Immunization.  It was reported, Caller would like to know what they should do. This situation is reported as a medication error due to an expired dose being administered to a patient. An expired dose of DAPTACEL was inadvertently administered to a patient  Action taken with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DAPTACEL) was not applicable.  At time of reporting, the outcome was Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Blood chloride increased, Chest X-ray normal, Cold sweat, Electrocardiogram normal, Nervousness
Clinical narrative: episode of supraventricular tachycardia (SVT) with heartbeat in the 290s range.; pale; clammy; scared; Initial information was received on 06-Oct-2022 regarding an unsolicited valid  non-serious case received from a nurse.  This case is linked to case 2022SA414365.  This case involves a 16 years old female patient who experienced episode of supraventricular tachycardia (svt) with heartbeat in the 290s range. while receiving vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical treatment included MENINGOCOCCAL VACCINE A/C and TDAP on 11-JUL-2018. The patient's past medical history, vaccination(s) and family history were not provided.  On 26-Jul-2022, the patient received 0.5 ml of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U7268AA) (strength and expiry: unknown) via intramuscular route in the left deltoid prophylactic vaccination.   On 24-AUG-2022 the patient developed a non-serious episode of supraventricular tachycardia (svt) with heartbeat in the 290s range. (supraventricular tachycardia) with symptoms pale (pallor) clammy (cold sweat) and scared (nervousness) (latency 29 days) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  It was reported that "The ER doctor advised her to follow-up with her primary care physician. Two days later, on 26-Aug-2022, they saw a new pediatrician, who advised follow-up with a pediatric cardiologist. She saw the pediatric cardiologist on 27-Sep-2022".   Relevant laboratory test results included: Blood chloride - On an unknown date:  [slightly elevated levels] Chest X-ray - On an unknown date:  [normal] Electrocardiogram - On an unknown date:  [normal] Heart rate - On 24-Aug-2022: 270 beats/min then 298 beats/min [via pulse oximeter] then 204 beats/min then 88 beats/min  Action taken with MENINGOCOCCAL VACCINE (MENACTRA) was not applicable.  Corrective treatment-intravenous fluids and follow-up care  At time of reporting, the outcome was Recovering / Resolving for the event episode of supraventricular tachycardia (svt) with heartbeat in the 290s range
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Pallor, Supraventricular tachycardia
Clinical narrative: episode of supraventricular tachycardia (SVT) with heartbeat in the 290s range.; pale; clammy; scared; Initial information was received on 06-Oct-2022 regarding an unsolicited valid  non-serious case received from a nurse.  This case is linked to case 2022SA414365.  This case involves a 16 years old female patient who experienced episode of supraventricular tachycardia (svt) with heartbeat in the 290s range. while receiving vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical treatment included MENINGOCOCCAL VACCINE A/C and TDAP on 11-JUL-2018. The patient's past medical history, vaccination(s) and family history were not provided.  On 26-Jul-2022, the patient received 0.5 ml of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U7268AA) (strength and expiry: unknown) via intramuscular route in the left deltoid prophylactic vaccination.   On 24-AUG-2022 the patient developed a non-serious episode of supraventricular tachycardia (svt) with heartbeat in the 290s range. (supraventricular tachycardia) with symptoms pale (pallor) clammy (cold sweat) and scared (nervousness) (latency 29 days) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  It was reported that "The ER doctor advised her to follow-up with her primary care physician. Two days later, on 26-Aug-2022, they saw a new pediatrician, who advised follow-up with a pediatric cardiologist. She saw the pediatric cardiologist on 27-Sep-2022".   Relevant laboratory test results included: Blood chloride - On an unknown date:  [slightly elevated levels] Chest X-ray - On an unknown date:  [normal] Electrocardiogram - On an unknown date:  [normal] Heart rate - On 24-Aug-2022: 270 beats/min then 298 beats/min [via pulse oximeter] then 204 beats/min then 88 beats/min  Action taken with MENINGOCOCCAL VACCINE (MENACTRA) was not applicable.  Corrective treatment-intravenous fluids and follow-up care  At time of reporting, the outcome was Recovering / Resolving for the event episode of supraventricular tachycardia (svt) with heartbeat in the 290s range
Age: 31.0
Sex: M
Vaccine: FLUR3
Symptoms: No adverse event, Wrong product administered
Clinical narrative: FLUBLOK was given instead of FLULAVAL, with no reported adverse event; Initial information received on 06-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 31 years old male patient to whom influenza quadrivalent recombinant vaccine [Flublok] was given instead of flulaval, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 06-Oct-2022, the patient received suspect influenza quadrivalent recombinant vaccine at dose of 0.5mL once (strength unknown) (lot QSAA2222, expiry date: 30- Jun-2023) via intramuscular route to left deltoid instead of flulaval, with no reported adverse event (wrong product administered) for immunization (latency: same day).  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 15.0
Sex: F
Vaccine: IPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: one of their staff administer IPOL to a patient with 3 weeks interval with no reported AE; Initial information received on 06-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 15 years old female patient who reported one of their staff administer IPV (VERO) [IPOL] to a patient with 3 weeks interval 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 DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Immunisation; and HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation.  On 02-Mar-2022, the patient received a 0.5 ml dose of suspect IPV (VERO) ( lot number not reported) via intramuscular route in the right arm. On 25-Mar-2022 the patient  also received a  dose of the same vaccine  with an unknown batch number via intramuscular route in the right arm for immunization.  On 25-Mar-2022 the patient reported a non-serious event one of their staff administer IPV (VERO)to a patient with 3 weeks interval with no reported adverse event (inappropriate schedule of product administration).  Action taken: not applicable.  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.
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: They have administered an expired DAPTACEL to a 1 year and 6 months old patient with no reported adverse event.; Initial information received on 06-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 18 months old female patient who was administered an expired diphtheria-15/tetanus/5 ac pertussis vaccine [daptacel] with no reported adverse event.  Concomitant medications included HIB VACCINE CONJ (TET TOX) (HIBERIX) for Prophylactic vaccination.  On 30-Sep-2022, a 1 year and 6 months old patient received an expired 0.5 ml, (once) dose of suspect diphtheria-15/tetanus/5 ac pertussis vaccine (lot C5774CA, expiry date 18-Sep-2022, strength: standard) via intramuscular route in the left thigh for immunization with no reported adverse event. (expired product administered).  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.
Sex: U
Vaccine: YF
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: receiving the Yf-Vax via intramuscular and not the subcutaneous as the label instructs,with no reported adverse event; Initial information was received on 07-Oct-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 received the yellow fever vaccine [Yf-Vax] via intramuscular and not the subcutaneous as the label instructs,with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a suspect yellow fever vaccine solution for injection at a dose of 0.5 ml once lot number not reported via intramuscular route in unknown administration site (expiry date and strength: unknown) for immunization.  On an unknown date the patient received the yellow fever vaccine via intramuscular and not the subcutaneous as the label instructs,with no reported adverse event (incorrect route of product administration) (unknown latency) following the administration of vaccine.  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.
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Upon verification the nurse confirmed that the patient was informed by the employer that the flu vaccine administered to her was already expired and that is the reason why the patient consulted their facility with no reported adverse event; Initial information received on 07-Oct-2022 regarding an unsolicited valid  non-serious case received from a non-healthcare professional.  This case involves an unknown age female patient who was informed by the employer upon nurse confirmation, that Influenza Quadrival A-B Vaccine [Fluzone Quadrivalent] administered to her was already expired and that is the reason why the patient consulted their facility with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient was administered the expired Influenza Quadrival A-B Vaccine informed by the employer upon nurse confirmation and that is the reason why the patient consulted their facility with no reported adverse event (expired product administered) (route, form, strength, dose, expiry date and lot batch no) in an unknown administration site for immunization.  It was reported that 'Clinic manager called inquiring when they can give a patient her dose of FLUZONE QUADRIVALENT as the patient was given an expired FLUZONE QUADRIVALENT just a week ago from a different facility which is facilitated by the patient's employer'.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: MNQ
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Menquadfi in the refrigerator and unmonitored for 1 week due to a provider removing the data logger and not putting it back in the refrigerator with no reported adverse event; Menquadfi was administered to 1 patient during the time the product was unmonitored in the refrigerator with no reported adverse event; Initial information received on 07-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case US-SA-2022SA417024.  This case involves an unknown age and unknown gender patient who was administered meningococcal a-c-y-w135 (t conj) vaccine [menquadfi] which was kept in the refrigerator and unmonitored for 1 week due to a provider removing the data logger and not putting it back in the refrigerator with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect meningococcal a-c-y-w135 (t conj) vaccine (Solution for injection) (lot U7299AA; expiry date: 04-Aug-2024) (strength, route unknown) via intramuscular route in unknown administration site for Prophylactic vaccination (Immunisation).  On an unknown date the patient was administered menquadfi which was kept in the refrigerator and unmonitored for 1 week due to a provider removing the data logger and not putting it back in the refrigerator with no reported adverse event (product storage error) (poor quality product administered).  Action taken with meningococcal vaccine was not applicable.  At time of reporting, the outcome was Unknown for both the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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: M
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: 3-days after getting the FLUZONE HIGH_DOSE Quadrivalent the arms began to hurt,; Initial information was received on 07-Oct-2022 regarding an unsolicited valid non-serious case received from a consumer/non healthcare professional.  This case is linked to case 2022SA417472(CLUSTER).  This case involves a male patient with unknown age and reporter reported 3-days after getting the Influenza quadrival A-B high dose HV vaccine [Fluzone high-dose quadrivalent] the arms began to hurt.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 28-Sep-2022, the patient received a dose of suspect Influenza quadrival A-B high dose HV vaccine (with unknown strength, dose, route, administration site, form, lot number, expiration date) for Immunization. Information on the batch number was requested.  On 01-Oct-2022, 3 days after getting the fluzone high_dose quadrivalent the arms began to hurt, (pain in extremity) (latency: 3 days).  It was reported: A Consumer reporting that 3-days after getting the FLUZONE HIGH_DOSE Quadrivalent the arms began to hurt. The Caller reported that her arm hurts worse than her husbands and that the provider told them to use ice. Caller is reporting that she received a FLUZONE QIV HD dose on 9/28/2022, and the day after her arm started to hurt, and has continued to hurt since then. She is asking if this is normal or what she can expect.   Action taken: Not applicable.  Corrective treatment: Not reported.   Outcome: Not Recovered / Not Resolved.