chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody, Bronchoalveolar lavage, Bronchoscopy, Computerised tomogram thorax, Culture
Clinical narrative: Covid-19 vaccine related pneumonitis; This is a literature report.  A 72-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster); single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "ED" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: PNEUMONITIS (hospitalization, medically significant, life threatening), 2 days after the suspect product(s) administration, outcome "recovered", described as "Covid-19 vaccine related pneumonitis". The patient was hospitalized for pneumonitis (hospitalization duration: 5 day(s)). The event "covid-19 vaccine related pneumonitis" required emergency room visit. The patient underwent the following laboratory tests and procedures: Antinuclear antibody: positive; Bronchoalveolar lavage: WBC 204 /cumm with lymphocytic predominance; Bronchoscopy: revealed diffuse erythematous with copious, thick, whitish mucus plugging airways; Computerised tomogram thorax: revealed bil ground-glass opacities; Culture: positive, notes: for candida albicans in 1/2 pooled sample; Silver stain: negative, notes: for P. jirovecii; Microbiology test: negative; Serology test: negative; White blood cell count: 204 /mm3. Therapeutic measures were taken as a result of pneumonitis.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported event "PNEUMONITIS" and the suspect drug cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug 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: Investigation, Microbiology test, Pneumonitis, Serology test, White blood cell count
Clinical narrative: Covid-19 vaccine related pneumonitis; This is a literature report.  A 72-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster); single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "ED" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: PNEUMONITIS (hospitalization, medically significant, life threatening), 2 days after the suspect product(s) administration, outcome "recovered", described as "Covid-19 vaccine related pneumonitis". The patient was hospitalized for pneumonitis (hospitalization duration: 5 day(s)). The event "covid-19 vaccine related pneumonitis" required emergency room visit. The patient underwent the following laboratory tests and procedures: Antinuclear antibody: positive; Bronchoalveolar lavage: WBC 204 /cumm with lymphocytic predominance; Bronchoscopy: revealed diffuse erythematous with copious, thick, whitish mucus plugging airways; Computerised tomogram thorax: revealed bil ground-glass opacities; Culture: positive, notes: for candida albicans in 1/2 pooled sample; Silver stain: negative, notes: for P. jirovecii; Microbiology test: negative; Serology test: negative; White blood cell count: 204 /mm3. Therapeutic measures were taken as a result of pneumonitis.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported event "PNEUMONITIS" and the suspect drug cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug 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: Psoriasis
Clinical narrative: She woke up when had some rash on her legs and the doctor told her it's psoriasis; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), in Apr2021 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: PSORIASIS (non-serious) with onset 2021, outcome "unknown", described as "She woke up when had some rash on her legs and the doctor told her it's psoriasis".  Additional information: it was reported that the caller mentioned she had a booster shot last April of the Pfizer Covid-19 vaccine. She woke up when had some rash on her legs and the doctor told her it was psoriasis.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201210271 same reporter/patient/AE; different dose number;
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test, Physical examination, Pulmonary embolism, Pulmonary infarction
Clinical narrative: left-sided pulmonary emboli involving the left lower lobe with pulmonary infarction; left-sided pulmonary emboli involving the left lower lobe with pulmonary infarction; This is a literature report for the following literature source(s).  A 24-year-old 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: PULMONARY INFARCTION (hospitalization, medically significant, life threatening), PULMONARY EMBOLISM (hospitalization, medically significant, life threatening), outcome "unknown" and all described as "left-sided pulmonary emboli involving the left lower lobe with pulmonary infarction". The patient underwent the following laboratory tests and procedures: Blood fibrinogen: elevated; Coagulation test: Negative; Computerised tomogram thorax: left-sided pulmonary emboli, notes: pulmonary infarction; Haemodynamic test: stable; Haemoglobin: was stable, notes: throughout the hospital course; Labs: were stable; Physical examination: reduced breath sounds, notes: n the left lower lobe. Therapeutic measures were taken as a result of pulmonary infarction, pulmonary embolism: apixaban (ELIQUIS)  Course of the event. A 24 year old male with no significant past medical history presented to the emergency department due to shortness of breath, hemoptysis and chest pain. He denied any family history or personal history of clotting disorders. He received the mRNA COVID-19 Pfizer vaccine 5 days prior to symptom onset. He describes it as constant sharp pain with varying intensity that he rates a 6/10 and can reach a 10/10 pain exacerbated with lying flat and deep breathing. He also states he has been coughing up a teaspoon amount of blood with this chest pain. Physical examination revealed reduced breath sounds in the left lower lobe. Patient was hemodynamically stable. Lab were stable and hemoglobin was stable throughout the hospital course. Fibrinogen was elevated and hypercoagulable work-up was negative. CTA of chest was performed and revealed left-sided pulmonary emboli involving the left lower lobe with pulmonary infarction. Therefore, he was managed by Eliquis. According to the Authors this case is a demonstration of a rare occurrence of isolated PE with no evidence of DVT in such close proximity to receiving the mRNA COVID-19 Pfizer vaccination; Sender's Comments: Based on available information, the causal association between the event Pulmonary infarction, Pulmonary embolism and suspect drug BNT162b2 cannot be completely 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 87.0
Sex: M
Vaccine: COVID19-2
Symptoms: Body temperature, Death, Oxygen saturation, Unresponsive to stimuli
Clinical narrative: no vital signs of life; unresponsive to stimuli; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  An 87-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 4 (booster), single (Lot number: GJ5342) at the age of 87 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "oxygen dependent" (unspecified if ongoing); "hospice" (unspecified if ongoing); "emphysema" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "chronic kidney disease" (unspecified if ongoing); "heart failure" (unspecified if ongoing). Concomitant medication(s) included: DIGOXIN; ELIQUIS, start date: 21Sep2022, stop date: 21Sep2022; ALBUTEROL [SALBUTAMOL]; DUONEB; LORAZEPAM; MORPHINE. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN; Lot number: unknown), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN; Lot number: unknown), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3; MANUFACTUERER UNKNOWN; Lot number: unknown), for COVID-19 Immunization. The following information was reported: DEATH (death, medically significant) with onset 21Sep2022, outcome "fatal", described as "no vital signs of life"; UNRESPONSIVE TO STIMULI (medically significant) with onset 21Sep2022, outcome "unknown". The patient underwent the following laboratory tests and procedures: Body temperature: (21Sep2022) 97.8 Fahrenheit, notes: at 9:47am; Oxygen saturation: (21Sep2022) 98 %, notes: on 2L oxygen at 9:47am. The patient date of death was 21Sep2022. The reported cause of death was unknown. It was not reported if an autopsy was performed.  Clinical course: Patient showed no signs and symptoms of adverse event after vaccination, but patient was found around 9:00 pm unresponsive, no vital signs of life.; Sender's Comments: Based on the available reported information, the causal association between the events and the suspect drug BNT162B2 cannot be 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.; Reported Cause(s) of Death: no vital signs of life
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness at the injection site after the Pfizer bivalent vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 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 completed; unknown manufacturer), for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2022, outcome "unknown", described as "Soreness at the injection site after the Pfizer bivalent vaccine".  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: Vaccination site pain
Clinical narrative: Soreness at the injection site after the Pfizer bivalent vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) 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 completed, Manufacturer: Unknown), for COVID-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Soreness at the injection site after the Pfizer bivalent vaccine".  Additional information: Event took place after use of product.  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: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Pain; Fever; This is a spontaneous report received from contactable reporter(s) (Other HCP). Other Case identifier(s): 2022NVX-US-000003594.  A female patient received BNT162b2 (BNT162B2), on 02Oct2021 as dose 3 (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: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Pain"; PYREXIA (non-serious), outcome "unknown", described as "Fever".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug intolerance
Clinical narrative: Patient experienced significant reaction and did not tolerate it well; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000003588 (on behalf of Novavax).  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 INTOLERANCE (non-serious), outcome "unknown", described as "Patient experienced significant reaction and did not tolerate it well". Additional information: On 21Sep2022, it was reported that a patient started treatment on an unspecified date with Pfizer BioNTech COVID-19 Vaccine at an unspecified dose for COVID-19 immunization. The patient experienced significant reaction and did not tolerate it well.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive; tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient received BNT162b2 (COMIRNATY), 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 had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive". It was reported that patient had she had fever of 101, headache, sore throat, and fatigue. The patient underwent the following laboratory tests and procedures: Body temperature: 101, notes: had fever of 101; SARS-CoV-2 test: Positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Pain in extremity
Clinical narrative: had Pfizer covid-19 vaccine and flu shot to left arm and complained of left arm pain; Initial information received on 01-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 65 years old male patient (101.587 kg) who had pfizer covid-19 vaccine and flu shot (INFLUENZA VACCINE ) to left arm and complained of left arm pain while also being treated with 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.  On 13-Jul-2022, the patient started taking TREPROSTINIL SODIUM (formulation: unknown, strength: 0.6 mg/ml) 54 ug QID inhalational (lot - 2102217, expiration date:31-Dec-2024) for Secondary pulmonary arterial hypertension.  On 28-Sep-2022, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer, and PFIZER BIONTECH COVID-19 VACCINE not produced by Sanofi Pasteur (formulation, strength: unknown) lot number not reported via intramuscular route in the left arm.  On 28-SEP-2022 the patient had pfizer covid-19 vaccine and flu shot to left arm and complained of left arm pain (pain in extremity) 2 months 15 days following the first dose intake of TREPROSTINIL SODIUM and same day latency following the other suspect vaccines.  It was unknown if there were lab data/results available. It was unknown if the company suspect product inappropriately used as per local Marketing authorization.  Action taken with TREPROSTINIL SODIUM was unknown. Action taken was not applicable for other vaccines.  Corrective treatment: PARACETAMOL (TYLENOL) for Pain.  At time of reporting, the outcome was Unknown for the event
Sex: U
Vaccine: FLU4
Symptoms: Accidental exposure to product, Device connection issue, Incorrect dose administered
Clinical narrative: needle was not attached tightly enough and patient received about half the dose and the other half went down her arm with no reported adverse event; needle was not attached tightly enough and patient received about half the dose and the other half went down her arm 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 involves an unknown age and unknown gender patient and reporter stated that needle was not attached tightly enough and patient received about half the dose and the other half went down her arm with no reported adverse event after receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT]. 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 INFLUENZA QUADRIVAL A-B VACCINE Suspension for injection (strength, lot number and expiry date was unknown) via unknown route in unknown administration site for Prophylactic vaccination.  On an unknown date the patient developed a non-serious event of needle was not attached tightly enough and patient received about half the dose and the other half went down her arm with no reported adverse event (accidental exposure to product, incorrect dose administered) (latency: same day) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.. It was unknown if suspect product inappropriately used as per local Marketing authorization.  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: 82.0
Sex: F
Vaccine: FLUX
Symptoms: COVID-19, Illness, Urticaria
Clinical narrative: broke out in hives; Initial information received on 27-Sep-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-health care professional.  This case is linked to case 2022SA410416(CLUSTER).  This case involves a 82 years old female patient who broke out in hives , after receiving vaccine INFLUENZA VACCINE.  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 allergy to 15 drugs and is severely allergic to sulfa drugs.   On an unknown date of 2012 followed by unknown date of 2013,( in later years received a 1/2 dose) the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for immunization.  On an unknown date, the patient broke out in hives (urticaria) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported " she received the Pfizer Covid vaccine. She had platelets. She got sick with Covid from 15Dec2021 to 09Jan2022. She had one Covid booster and then was sick for 7 days from it. The sickness from the booster was just like having Covid."  Action taken :not applicable.  It was not reported if the patient received a corrective treatment for the event (broke out in hives).  At time of reporting, the outcome was Unknown for the event broke out in hives.; Reporter's Comments: 1/2 dose
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: under age 65 years old received a Fluzone HD vaccine with no 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 62 years old female patient who is under age 65 years old received a influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent] vaccine with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 05-Oct-2022, the patient received a  dose of suspect influenza quadrival A-B high dose HV vaccine (lot UT7743A; formulation, dose, strength and expiry date not reported) via intramuscular route in unknown administration site for (flu vaccine) prophylactic vaccination  On 05-OCT-2022 the patient  under age 65 years old received a fluzone hd vaccine with no adverse event (product administered to patient of inappropriate age).  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: FLU4
Symptoms: Accidental exposure to product
Clinical narrative: inadvertently administered FLUZONE QIV NP from last season to a patient with no reported adverse event; Initial information received on 03-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health care professional.  This case involves an unknown age and unknown gender patient who was inadvertently administered fluzone QIV NP from last season to a patient with no reported adverse event after receiving vaccine influenza quadrival A-B vaccine [Fluzone QIV].  The patient's past medical history, medical treatment(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect influenza quadrival A-B vaccine at an unknown dose (lot number: not reported; strength, formulation and expiry date unknown) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient was inadvertently administered fluzone QIV NP from last season to a patient with no reported adverse event (Accidental exposure to product) (latency same day) following the administration of influenza quadrival A-B 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: 87.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Wrong product administered
Clinical narrative: patient received fluzone quadrivalent (np) instead of the fluzone high-dose quadrivalent, with no reported adverse event; Initial information was received on 03-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 87 years old male patient who experienced patient received fluzone quadrivalent (np) instead of the fluzone high-dose quadrivalent, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 29-SEP-2022, the patient received 0.5 ml of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot- UT7701KA) instead of the fluzone high-dose quadrivalent (lot- Unknown) (wrong vaccine administered) (latency same day) (dose, formulation, strength, and expiry date: unknown) via unknown route in an unknown administration site for prophylaxis vaccination.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event patient received fluzone quadrivalent (np) instead of the fluzone high-dose quadrivalent, with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: the next day he got sick; Initial information received on 03-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-HCP.  This case involves an unknown age male patient who stated that the next day he got sick after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a  dose of suspect influenza vaccine (with an unknown strength, formulation, dose, frequency, route, lot number, expiry date) for Immunization.  On an unknown date the patient stated the next day he got sick (illness) (unknown latency) following the administration of vaccine.  No lab data was reported  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.
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: vaccine administered of which diluent and powder had expired 20-Sep2022 with no reported adverse event; Initial information was received on 03-Oct-2022 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves a 1 year old male patient who was administered vaccine of which diluent and powder had expired 20-Sep-2022 with no reported adverse event while receiving vaccine HIB (PRP/T) Vaccine [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant included: Diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP) for immunization.  On 29-Sep-2022, the patient received 0.5 ml (dose 4) of suspect HIB (PRP/T) Vaccine powder and solvent for solution for injection (unknown strength) (batch number: UJ574AAA, expiration date: 20-Sep-2022) via intramuscular route in the left leg (left thigh) for Immunization of which diluent and powder had expired 20-Sep-2022 with no reported adverse event (Expired product administered ) (latency: same day).  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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: 32.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: patient under the recommended age range was given FLUZONE HD 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 involves a 32 years old female patient who was represented with patient under the recommended age range was given influenza quadrival A-B high dose hv vaccine [Fluzone high-dose quadrivalent] with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 22-Sep-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 UJ901AA, expiry date - 30-Jun-2023) (formulation and strength: unknown) via intramuscular route in the left deltoid for Immunization.  On 22-Sep-2022 the patient under the recommended age range was given fluzone hd with no reported adverse event (product use issue) (latency: same day) following the administration of vaccine.  No lab data was reported  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: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: FLUZONE HD was administered to a patient less than 65 years old with no reported adverse event; Initial information received on 03-Oct-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 59 years old female patient who was administered Influenza Quadrival A-B High Dose HV Vaccine [Fluzone High-Dose Quadrivalent] who was less than 65 years old with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 03-Oct-2022, the patient received suspect Influenza Quadrival A-B High Dose HV Vaccine at dose of 0.7 ml, once (Suspension for injection in pre-filled syringe) (strength: unknown) (lot UT7718AA, exp date: 30-Jun-2023) via intramuscular route to left deltoid to patient who was less than 65 years old with no reported adverse event (Product administered to patient of inappropriate age) for influenza(Latency: same day).  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: 37.0
Sex: F
Vaccine: TD
Symptoms: Expired product administered
Clinical narrative: expired TENIVAC was accidently given to a patient 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 involves a 37 years old female patient and expired tenivac was accidently given to a patient with no reported adverse event while receiving vaccine diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac].  The patient's past medical history, medical treatment(s), concomitant(s) and family history were not provided.   On 03-Oct-2022, the reporter stated patient received a dose of expired tenivac with standard strength at a dose of 0.5 mL total (Dose = 0.25 mL to 2 mL for vaccines or 0.1 mL for TB skin test )(lot number: C5779AA; expiry date : 02-Oct-2022) via intramuscular route in the left deltoid for Immunization) was accidently given to a patient with no reported adverse event (expired product administered) (latency :same day).  It was reported reporting an expired TENIVAC was accidently given to a patient. She states that the expiration was on 02Oct2022 and wondered if it was still valid only being given hours after expiring.   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: U
Vaccine: FLU4
Symptoms: Medication error, No adverse event, Wrong product administered
Clinical narrative: FLUZONE QUADRIVALENT was administered instead of the FLUZONE HIGH-DOSE QUADRIVALENT with no reported adverse event; Initial information received on 04-Oct-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient who administered fluzone quadrivalent instead of the fluzone high dose quadrivalent with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medication and family history were not provided.   On an unknown date, the patient was administered fluzone quadrivalent (Influenza Quadrival A-B Vaccine) at dose of 0.5 ml instead of the fluzone high-dose quadrivalent with no reported adverse event (wrong product administered) lot number not reported via unknown route in unknown administration site for Immunization.  Caller states if it is acceptable to give the additional influenza vaccine or if they can administer more of Fluzone to equal to the dose of the High-Dose. This situation is reported as a medication error due to administering the wrong vaccine.  Action taken: not applicable.  Outcome: Unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Medication error, Wrong product administered
Clinical narrative: given Fluzone Quadrivalent standard dose in error as the patient qualifies for FLUZONE HD 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 an unknown age female patient who was given INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] standard dose in error as the patient qualifies for INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD] 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 0.5 mL total dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (formulation, strength, route, administration site and lot number not reported) instead of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  On an unknown date, the patient was given fluzone quadrivalent standard dose in error as the patient qualifies for fluzone hd with no reported adverse event (wrong product administered) (unknown latency).  Action taken was not applicable with both the suspects.  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: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea
Clinical narrative: difficulty breathing; trouble breathing; Initial information received on 04-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-HCP.  This case involves a 73 years old female patient who was reported with difficulty breathing; trouble breathing while receiving influenza quadrival A-B high dose hv vaccine [Fluzone high-dose quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Allergic asthma.  Concomitant medications included salbutamol (albuterol [Salbutamol]) for Immunisation.  On an unknown date, the patient received a  dose of suspect influenza quadrival A-B high dose hv vaccine lot number not reported via unknown route in unknown administration site (with an unknown strength, formulation, expiry date, dose, frequency) for immunization.  On an unknown date the patient developed a difficulty breathing; trouble breathing (dyspnoea) (unknown latency) following the administration of vaccine.  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 Recovered / Resolved on an unknown date for the event.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: FLUZONE QIV HIGH DOSE was administered to a 20 year old patient today 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 20 years old female patient to whom INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] was administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 05-Oct-2022, the patient received 0.7 ml dose, once (1x) of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE ( lot UJ917AD, exp date: 30-Jun-2023) via intramuscular route in the left deltoid for immunization with no reported adverse event (product administered to patient of inappropriate age) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 41.0
Sex: M
Vaccine: DTAP
Symptoms: Wrong product administered
Clinical narrative: doctors administered DAPTACEL instead of ADACEL with no reported AE; Initial information received on 05-Oct-2022 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 41 years old male patient who was administered DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead of Adacel with no reported AE (adverse event)  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 05-Oct-2022, the patient received 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE with standard strength (formulation: unknown) ( lot C5828AA, exp date: 30-Mar-2023) via intramuscular route in the right deltoid for immunization instead of Adacel with no reported AE (wrong product administered) (latency: sme day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Accidental exposure to product, Exposure via skin contact
Clinical narrative: it dripped down patient's arm, not sure how much came out with no reported adverse event; Initial information received on 06-Oct-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 67 years old male patient who while receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] and the vaccine dripped down patient's arm, not sure how much came out 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 a  dose of 0.7 ml of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (formulation, strength: unknown) lot number UJ928AA and expiration date: 30-Jun-2023 via intramuscular route in the left deltoid as Immunization  On an unknown date in 2022 the vaccine dripped down patient's arm, not sure how much came out with no reported adverse event (accidental exposure to product). (latency: unknown). Would like to know if they need to revaccinate or what they should do. This situation was reported as an accidental exposure.  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: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient under 65 was accidentally administered the Fluzone HD Quadrivalent with no reported adverse event; Initial information received on 06-Oct-2022 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 61 years old female patient who was under 65 and accidentally administered the influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included elasomeran (Moderna COVID-19 vaccine) for COVID-19 immunisation.  On 05-Oct-2022, the patient received suspect influenza quadrival A-B high dose HV vaccine at a dose of 0.7 ml total (lot UJ926AA, expiry date: 30-Jun-2023) via intramuscular route in the left deltoid for immunisation.  On 05-Oct-2022 the patient under 65 was accidentally administered the fluzone hd quadrivalent with no reported adverse event (product administered to patient of inappropriate age, 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.