chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2 NOS), on 25Nov2022 at 12:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which includes Paxlovid treatment from 23Apr2023 to 28Apr2023. Clinical course: Patient was not taking any other medications in 2 weeks. Patient had no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300181341 Same patient, different product, different event;
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 41 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "PCOS" (unspecified if ongoing); "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing). The patient's concomitant medications were not reported. The patient had no known allergies.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: COVID 19 Treatment; Negative, notes: testing negative for multiple days. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid Tablets from 21Oct2022 to 26Oct2022. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Nov2022 at 13:00 as dose 4 (booster), single (Lot number: G51514) at the age of 45 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 10Mar2021 at 13:00 as dose 1, single (Lot number: EN6Z08), in left arm, on 31Mar2021 at 18:00 as dose 2, single (Lot number: ER8734), in left arm and on 03Dec2021 at 14:00 as dose 3 (booster), single (Lot number: FE3594), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 26Apr2023 to 30Apr2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300182689 Same patient, Same reporter, Different product, Different events;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 5 (booster), single (Lot number: GH9694), in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 15Apr2022 as dose 4 (booster), single (Lot number: FK9894), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "laryngopharyngeal reflux" (unspecified if ongoing); "mixed hyperlipidemia" (unspecified if ongoing); "GAD" (unspecified if ongoing); "Iodine contrast allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovering" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 48-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Oct2022 as dose 4 (booster), single (Lot number: Gh9697) at the age of 47 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 14Apr2021 as dose 1, single (Lot number: Er8731), in left arm, on 05May2021 as dose 2, single (Lot number: Ew0171), in left arm and on 14Jan2022 as dose 3 (booster), single (Lot number: 33130ba), in right arm for covid-19 immunisation. The patient's relevant medical history included: "DM" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "Morbid obesity" (unspecified if ongoing); "Known allergies: Yes" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 including Paxlovid from 25Apr2023 to 30Apr2023.; Sender's Comments: Based on the given information , the possible contributory role of the suspect for the event vaccination failure and covid-19 cannot be excluded.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 at 12:00 as dose 5 (booster), single (Lot number: GJ2524), in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 08Apr2022 at 14:00 as dose 4 (booster), single (Lot number: FK9893), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "in remission from MG (diagnosed 2010), not on any immunosupressive drugs", start date: 2010 (unspecified if ongoing), notes: in remission from MG (diagnosed 2010), not on any immunosuppressive drugs. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04May2023) Negative, notes: paxlovid rebound tested negative 1 day; (06May2023) Positive, notes: after finished paxlovid tested positive 3 days after finished paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid).
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 51-year-old male patient received BNT162b2 (BNT162B2), on 14Jul2022 as dose number unknown, single (Lot number: Fj4991) at the age of 50 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing). The patient had no known allergy. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from Apr2023 to 03May2023. .
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Oct2022 as dose number unknown, single (Lot number: GJ3277) at the age of 39 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient had no known allergy. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19 including Paxlovid from 27Apr2023 to 02May2023.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; Interchange of vaccine products; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 27-year-old male patient received BNT162b2 (BNT162B2), on 07Jan2022 as dose 3 (booster), single (Lot number: 33025BD) at the age of 26 years, in left arm for COVID-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 06Apr2021 as dose 1, single (Lot number: 027B21A), in left arm and on 04May2021 as dose 2, single (Lot number: 017C21A), in left arm for COVID-19 immunisation. The patient's relevant medical history included: "ADHD" (unspecified if ongoing). Concomitant medication(s) included: DEXTROAMPHETAMINE [DEXAMFETAMINE], start date: Sep2022, stop date: May2023; TRAZODONE, start date: Sep2022, stop date: May2023. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 07Jan2022, outcome "recovered with sequelae"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovered with sequelae" (May2023) and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2023) Negative. Therapeutic measures were taken as a result of drug ineffective, COVID-19 which included nirmatrelvir/ ritonavir (PAXLOVID) from 28Apr2023 to 02May2023.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I tested positive for Covid on 17Mar; I tested positive for Covid on 17Mar; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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) all with onset 17Mar2023, outcome "unknown" and all described as "I tested positive for Covid on 17Mar". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Mar2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient stated, "I had all my boosters including the bivalent one in Sep2022. I begged and pleaded to get another the beginning of Mar2023 because I was going. I was denied. I tested positive for Covid on 17Mar, got Paxlovid on 19Mar".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Atrial fibrillation, Bundle branch block left, Cardiac disorder, Cardiac failure congestive, Cardiomyopathy
Clinical narrative: cardiomyopathy; LBBB; sleep apnea; CHF; Afib; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), on 25Sep2020 at 14:45 as dose number unknown, single (Batch/Lot number: unknown) at the age of 66 years, in left deltoid for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BUNDLE BRANCH BLOCK LEFT (hospitalization) with onset Sep2020, outcome "unknown", described as "LBBB"; CARDIOMYOPATHY (hospitalization, medically significant) with onset Sep2020, outcome "unknown"; ATRIAL FIBRILLATION (medically significant) with onset Oct2020, outcome "unknown", described as "Afib"; CARDIAC FAILURE CONGESTIVE (medically significant) with onset Oct2020, outcome "unknown", described as "CHF"; SLEEP APNOEA SYNDROME (non-serious) with onset Jan2023, outcome "unknown", described as "sleep apnea". The patient was hospitalized for cardiomyopathy, bundle branch block left (start date: 30Sep2020). The patient underwent the following laboratory tests and procedures: Ejection fraction: (2020) 10. Therapeutic measures were taken as a result of cardiomyopathy, bundle branch block left, cardiac failure congestive, atrial fibrillation.  Additional information: The patient reported, "I have CHF and Afib, use pacemaker/defibrillator for left branch bundle block. Recent diagnosis of severe sleep apnea. Heart issues diagnosed in Oct2020, after I had a dose of Prevnar 13 along with COVID, flu, and shingles shots, 25Sep2020. I was admitted to hospital on 30Sep2020 with chest pain and diagnosed with LBBB and cardiomyopathy- at that time my ejection fraction was 10. Pacemaker/defibrillator was implanted 12Nov2020. Wanted to let you know as I had neglected to mention the events that were subsequent to the Prevnar 13 dose."  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Chest pain, Ejection fraction decreased, Implantable defibrillator insertion, Sleep apnoea syndrome
Clinical narrative: cardiomyopathy; LBBB; sleep apnea; CHF; Afib; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), on 25Sep2020 at 14:45 as dose number unknown, single (Batch/Lot number: unknown) at the age of 66 years, in left deltoid for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BUNDLE BRANCH BLOCK LEFT (hospitalization) with onset Sep2020, outcome "unknown", described as "LBBB"; CARDIOMYOPATHY (hospitalization, medically significant) with onset Sep2020, outcome "unknown"; ATRIAL FIBRILLATION (medically significant) with onset Oct2020, outcome "unknown", described as "Afib"; CARDIAC FAILURE CONGESTIVE (medically significant) with onset Oct2020, outcome "unknown", described as "CHF"; SLEEP APNOEA SYNDROME (non-serious) with onset Jan2023, outcome "unknown", described as "sleep apnea". The patient was hospitalized for cardiomyopathy, bundle branch block left (start date: 30Sep2020). The patient underwent the following laboratory tests and procedures: Ejection fraction: (2020) 10. Therapeutic measures were taken as a result of cardiomyopathy, bundle branch block left, cardiac failure congestive, atrial fibrillation.  Additional information: The patient reported, "I have CHF and Afib, use pacemaker/defibrillator for left branch bundle block. Recent diagnosis of severe sleep apnea. Heart issues diagnosed in Oct2020, after I had a dose of Prevnar 13 along with COVID, flu, and shingles shots, 25Sep2020. I was admitted to hospital on 30Sep2020 with chest pain and diagnosed with LBBB and cardiomyopathy- at that time my ejection fraction was 10. Pacemaker/defibrillator was implanted 12Nov2020. Wanted to let you know as I had neglected to mention the events that were subsequent to the Prevnar 13 dose."  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Incorrect route of product administration, Suspected COVID-19
Clinical narrative: contracted COVID-19; contracted COVID-19; Inappropriate route of vaccination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) subcutaneous for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "contracted COVID-19"; INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "Inappropriate route of vaccination". Clinical course: Patient contracted covid-19 about two weeks after their Pfizer covid-19 booster shots.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300180836 Same reporter/patient, different drug/AE;US-PFIZER INC-202300180963 Same reporter, different patient, different drug/AE;US-PFIZER INC-202300180835 Same reporter/ drug/ event for different patients;US-PFIZER INC-202300180962 Same reporter/patient, drug/AE;
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: saddle pulmonary embolism; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, unknown manufacturer), for COVID-19 immunization. The following information was reported: PULMONARY EMBOLISM (medically significant), outcome "unknown", described as "saddle pulmonary embolism". Clinical Course: Reporter's father had saddle pulmonary embolism that occurred within days of receiving his "safe and effective" COVID booster.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Diagnosed with Bell's palsy; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), 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: BELL'S PALSY (medically significant), outcome "unknown", described as "Diagnosed with Bell's palsy". Clinical course: Event took place after use of product.  No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Disturbance in attention, Impaired quality of life, Tinnitus
Clinical narrative: After second shot, my ears started running. I have been to three doctors because I'm suffering from Tinnitus. There is no help for Tinnitus; There has been many days where I don't even get in the car because I can't concentrate; I am very angry. Your covid vaccine has ruined my quality of life; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP), Program ID:The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Sep2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: TINNITUS (non-serious) with onset Sep2021, outcome "unknown", described as "After second shot, my ears started ringing. I have been to three doctors because I'm suffering from Tinnitus. There is no help for Tinnitus"; IMPAIRED QUALITY OF LIFE (non-serious) with onset Sep2021, outcome "unknown", described as "I am very angry. Your covid vaccine has ruined my quality of life"; DISTURBANCE IN ATTENTION (non-serious) with onset Sep2021, outcome "unknown", described as "There has been many days where I don't even get in the car because I can't concentrate". The events "after second shot, my ears started running. i have been to three doctors because i'm suffering from tinnitus. there is no help for tinnitus", "there has been many days where i don't even get in the car because i can't concentrate" and "i am very angry. your covid vaccine has ruined my quality of life" required physician office visit.  Additional information: It was reported that the patient was very angry as the Pfizer's covid vaccine had ruined the patient's quality of life. After second shot in Sep2021, the patient's ears started running and have been suffering since then. Patient should be compensated for the misery and not only the one that is suffering from this and also reported as Pfizer make billions from just the Covid vaccine. Patient went to three doctors because of the suffering from tinnitus and there is no help for it. There had been many days where patient don't even get in the car because the patient can't concentrate.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 1.0
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Medication error, No adverse event, Product storage error
Clinical narrative: temperature excursion as temperature reached: negative -40f degrees for 8 hours and 25 minutes with no reported adverse event; received both Daptacel and Acthib post-temperature excursion where the vaccines were not suitable for use with no reported adverse event; Initial information received on 01-May-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves 1 years old female patient and reporter reported temperature excursion as temperature reached: negative -40f degrees for 8 hours and 25 minutes with no reported adverse event and received both haemophilus type B (HIB) (PRP/T) vaccine [ACT-HIB] and diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] post-temperature excursion where the vaccines were not suitable for use with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 18-Apr-2023, the patient received a  dose of suspect haemophilus type B (HIB) (PRP/T) vaccine Powder and solvent for solution for injection at a dose of 0.5 ml total (lot U026802, expiry date- 03-NOV-2023) via intramuscular route in the left arm for Immunization and also received a dose of suspect diphtheria-15/tetanus/5 AC pertussis vaccine Suspension for injection at a dose of 0.5 ml total (lot C5969AD, expiry date- 17-FEB-2024) via intramuscular route in the left arm for Immunization.  Caller reported that temperature excursion for haemophilus type B (HIB) (PRP/T) vaccine and diphtheria-15/tetanus/5 AC pertussis vaccine as temperature reached: negative -40f degrees for 8 hours and 25 minutes with no reported adverse event (product storage error) (unknown latency) and received both daptacel and acthib post-temperature excursion where the vaccines were not suitable for use with no reported adverse event (poor quality product administered) (latency- same day).  Action taken 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.; Sender's Comments:  US-SA-2023SA137908:01597142 US-SA-2023SA138048:01597145 US-SA-2023SA137832:01597167 US-SA-2023SA136956:01597157
Age: 7.0
Sex: F
Vaccine: DT
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: daughter was not able to finish the immunization series by her 7th birthday due to illness with no adverse event; Initial information received on 02-May-2023 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 7 years old female patient was not able to finish the immunization series by her 7th birthday due to illness with no adverse event while receiving vaccine diphtheria and tetanus toxoids.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient was not able to finish the immunization series of suspect diphtheria and tetanus toxoids produced by unknown manufacturer (dose, form, strength, batch number and expiry date unknown) via unknown route in unknown administration site for immunization by her 7th birthday due to illness with no adverse event (routine immunisation schedule incomplete) (same day latency). Information on the batch number was requested.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event daughter was not able to finish the immunization series by her 7th birthday due to illness with no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Medication error, No adverse event, Wrong product administered
Clinical narrative: 20 month old patient received a quadracel vaccine on his 12th month instead of pentacel, this is supposedly his 4th dose on his pentacel series with no reported adverse event; Initial information received on 02-May-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 12 months old male patient and is reported 20 month old patient received a diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] on his 12th month instead of pentacel, this is supposedly his 4th dose on his pentacel series with no reported adverse.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 22-Aug-2022, the patient received a dose 0.5 ml TOTAL of suspect Diphtheria-15/Tetanus/5 Hybrid AC Pertussis/IPV (MRC5) Vaccine Suspension for injection strength, expiry date: not reported lot C6002BA via unknown route in left leg for Immunization.  On 22-AUG-2022 the patient developed a non-serious 20 month old patient received a quadracel vaccine on his 12th month instead of pentacel, this is supposedly his 4th dose on his pentacel series with no reported adverse event (wrong product administered) on the same day.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event 20 month old patient received a quadracel vaccine on his 12th month instead of pentacel, this is supposedly his 4th dose on his pentacel series 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: 5.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 5 year old patient was given pentacel in error (with no reported adverse event); pentacel vaccine code 242 with batch number UJ806AA was administered (with no reported adverse event); Initial information received on 02-May-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 5 years old female patient who was given diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel] of code 242 with batch number UJ806AA in error (with no reported adverse event).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.  Concomitant medications included Pneumococcal Vaccine CONJ 7V (CRM197) (Prevnar) and Measles Vaccine, Mumps Vaccine, Rubella Vaccine (MMR), both for Prophylactic vaccination.  On 02-May-2023, The Physician misread the birthdate and thought that the patient was 4 and the patient of age 5 received a dose of suspect Diphtheria/Tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine of standard strength at 0.5 ml dose, suspension for injection of code 242 with lot: UJ806AA via intramuscular route in the right deltoid for prophylactic vaccination (Immunization) with no reported adverse event (product administered to patient of inappropriate age) and (expired product administered) (latency: same day).  Action taken: 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: RAB
Symptoms: Off label use
Clinical narrative: off-label use as per local labelling due to four doses given instead of five with no reported adverse event; Initial information received on 03-May-2023 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (patient).  This case involves an unknown age male patient for whom four doses given instead of five with no reported adverse event while receiving vaccine Rabies (HDC) vaccine [Imovax Rabies].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received four doses instead of five doses of suspect Rabies (HDC) vaccine Powder and solvent for suspension for injection with unknown strength, batch number & expiry date via unknown route in unknown administration site for post exposure immunization (Immunisation) (off label use) (unknown latency). Information on the batch number was requested.  This situation is reported as an off-label use as per local labelling due to four doses given instead of five.  Action taken: not applicable.  At time of reporting, the outcome was Unknown.
Sex: U
Vaccine: DTAPIPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered expired QUADRACEL with no reported adverse event; Initial information received on 03-May-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender 3 patients who had been administered expired diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 27-Mar-2023, the patients received a dose of suspect diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine Suspension for injection (lot number- C5251AA, expiry date- 22-MAR-2023) via unknown route in unknown administration site for prophylactic vaccination.  On 27-Mar-2023, (latency- same day), the patients developed a non-serious event of administered expired diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine with no reported adverse event (expired product administered).  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 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: IPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: received an extra dose of Ipol with no reported adverse event; Initial information received on 03-May-2023 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (non-healthcare professional).  This case involves an unknown age and unknown gender patient who had received an extra dose of poliomyelitis vaccine (inactivated) IPV (VERO) [IPOL] 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 dose of suspect poliomyelitis vaccine (inactivated) IPV (VERO) Suspension for injection (with an unknown dosage, strength, lot number, expiry date) via unknown route in unknown administration site for Prophylactic vaccination.  Information on the batch number was requested  On an unknown date, the patient received an extra dose of poliomyelitis vaccine (inactivated) IPV (VERO) with no reported adverse event (extra dose administered) (latency- same day). Caller wanted to what the next steps they should take.  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 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, Medication error, No adverse event
Clinical narrative: they administered the expired diluent to a patient, with no reported adverse event; Initial information received on 03-May-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who had administered the expired diluent to a patient, with no reported adverse event after 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 0.5 ml once of suspect HIB (PRP/T) vaccine strength, formulation, expiration date and lot number not reported via unknown route in unknown administration site for immunisation.  On an unknown date the patient developed a non-serious event they administered the expired diluent to a patient, with no reported adverse event (product preparation error) (unknown latency).  Action taken was not applicable.  corrective treatment: not reported for the event (they administered the expired diluent to a patient, with no reported adverse event).  Outcome: Unknown for the event they administered the expired diluent to a patient, with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: RAB
Symptoms: Illness, Medication error, No adverse event, Product dose omission issue
Clinical narrative: Patient is out sick today and missed the second dose with no reported adverse event; Initial information received on 05-May-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age female patient who was out sick today and missed the second dose with no reported adverse event for rabies (HDC) vaccine [Imovax Rabies].  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 Illness.  On an unknown date, the patient received a dose of suspect rabies (HDC) vaccine Powder and solvent for suspension for injection (with an unknown dosage, lot number, strength, expiry date) via unknown route in unknown administration site for Immunization.  On 05-May-2023 the patient developed a non-serious event of patient is out sick today and missed the second dose with no reported adverse event (product dose omission issue) (unknown latency) for rabies (HDC) vaccine  Reportedly, Caller stated that she has patient that was due for second dose of IMOVAX. She thinks this would be booster doses for patient but is unsure. Patient is out sick today and missed the second dose. Caller stated the patient can come in next week to get dose, but caller wanted to know will they need an additional dose due to them missing second dose in the 7-day window period.   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: 18.0
Sex: M
Vaccine: YF
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: patient was accidentally administered YF-VAX as a IM injection instead of a Sub-Q injection with no reported adverse event; Initial information was received on 05-May-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves 18 years old male patient who was accidentally administered yellow fever vaccine - [Yf-Vax] as a im injection instead of a sub-q injection with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 01-May-2023, the patient received a dose of 0.5 ml of suspect yellow fever vaccine - (Solution for injection) (Frequency : Once) (lot UJ818AA, Expiry date: 31-Jan-2024) (strength unknown) via intramuscular route in the left upper arm for Immunization.  On 01-May-2023 the patient developed a non-serious event of patient was accidentally administered yf-vax as a im injection instead of a sub-q injection with no reported adverse event (incorrect route of product administration) (latency: same day) following the administration of yellow fever vaccine - .  Action taken with yellow fever vaccine (Yf-Vax) was not applicable.  At time of reporting, the outcome was Unknown for the event patient was accidentally administered yf-vax as a im injection instead of a sub-q injection with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: receiving an expired adacel with no reported adverse event; Initial information was received on 05-May-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves 42 years old female patient who receiving an expired diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis b vaccine RHBSAG (YEAST) (Recombivax) for Prophylactic vaccination.  On 04-May-2023, the patient received a dose 1 of 0.5 ml of suspect diphtheria-2/tetanus/5 ac pertussis vaccine (Suspension for injection) (lot U7004AA, Expiry date :27-Apr-2023) (strength : unknown) via intramuscular route in the left deltoid for immunization.  On 04-May-2023 the patient developed a non-serious event of receiving an expired adacel with no reported adverse event (expired product administered) (latency: same day) following the administration of diphtheria-2/tetanus/5 ac pertussis vaccine.  Action taken with DIPHTHERIA, TETANUS and acellular pertussis vaccine (Adacel) was not applicable.  At time of reporting, the outcome was Unknown for the event receiving an expired adacel 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: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: Fever; Chills; Headache; Body aches; Arm pain; This non-serious case was reported by a consumer and described the occurrence of fever in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included fluticasone propionate + salmeterol xinafoate (Advair) and salbutamol (Ventolin).   On 03-MAY-2023, the patient received Shingrix (left deltoid). On 04-MAY-2023, 1 days after receiving Shingrix, the patient experienced fever (Verbatim: Fever), chills (Verbatim: Chills), headache (Verbatim: Headache), general body pain (Verbatim: Body aches) and pain in arm (Verbatim: Arm pain). The outcome of the fever, chills, headache, general body pain and pain in arm were not resolved.   The reporter considered the fever, chills, headache, general body pain and pain in arm to be related to Shingrix.     The company considered the fever, chills, headache, general body pain and pain in arm to be related to Shingrix.   Additional Information: GSK receipt date: 04-May-2023 This report was submitted in english submitted by GSK employee reporting ref. This report was submitted via the online direct entry reporting system. Please process using the related SOP. Initially the patient was not pregnant. The patient was on unknown other products Advair and Ventolin in January 2012 and was ongoing. This was subsequent dose (Fever, chills, headache, body aches, arm pain). The patient received the Shingrix vaccine on 03 May 2023. The Shingrix manufacturer unspecified expiry date of Shingrix. The patient experienced Fever, chills, headache, body aches, arm pain that was on-going. The consumer reported seriousness as non-serious for Fever, chills, headache, body aches, arm pain. The consumer asked is there any additional information about the adverse event. The patient's age and Date of Birth was not related to an existing case. The reporter consent to follow up.