chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer). The reporter is the patient. A 21-year-old female patient (not pregnant) received BNT162b2, BNT162b2 OMI BA.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for COVID-19 immunization; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for COVID-19 immunization. The patient's relevant medical history included: "Lupus" (unspecified if ongoing); "Ulcerative Colitis" (unspecified if ongoing). Concomitant medication(s) included: PLAQUENIL [HYDROXYCHLOROQUINE PHOSPHATE], start date: 15Oct2015; PROZAC; WELLBUTRIN; SPIRONOLACTONE. Past drug history included: Nsaids, reaction(s): "known allergies: NSAIDs". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective and COVID-19 as the patient received PAXLOVID since 26Oct2022 until 31Oct2022. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative, notes: testing negative after finishing PAXLOVID.   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: Gait disturbance, Joint range of motion decreased, Muscle injury, Myalgia
Clinical narrative: medial calf muscle injury; muscle pain upon walking; decreased range of motion; decreased range of motion like cannot push off on left foot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Mar2021 as dose 2, single (Lot number: EP6955) intramuscular for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EL3247, Route of Administration: Intramuscular), administration date: 04Mar2021, for Covid-19 immunization. The following information was reported: JOINT RANGE OF MOTION DECREASED (disability) with onset 04Nov2022, outcome "not recovered", described as "decreased range of motion"; GAIT DISTURBANCE (disability) with onset 04Nov2022, outcome "not recovered", described as "decreased range of motion like cannot push off on left foot"; MUSCLE INJURY (disability) with onset 04Nov2022, outcome "not recovered", described as "medial calf muscle injury "; MYALGIA (disability) with onset 04Nov2022, outcome "not recovered", described as "muscle pain upon walking ". Patient was playing pickle ball when she felt and heard a pop in her left calf. Injury is to the medial calf muscles resulting in muscle pain upon walking and decreased range of motion like cannot push off on left foot. The patient place ice to the area for 20 minutes 3 times a day.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Patient received Moderna as dose number 3 and Pfizer bivalent booster as dose number 4; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 56-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Oct2022 as DOSE 4 (BOOSTER), SINGLE (batch/lot number: unknown) at the age of 56 years, administered in the left arm for COVID-19 immunization; elasomeran (MODERNA COVID-19 VACCINE), on 03Dec2021 as DOSE 3 (BOOSTER), SINGLE (batch/lot number: unknown), administered in the left arm for COVID-19 immunization; covid-19 vaccine (COVID-19 VACCINE), as DOSE 1, SINGLE (batch/lot number: unknown) and as DOSE 2, SINGLE (batch/lot number: unknown) for COVID-19 immunization. The patient had no relevant medical history: no other medical history and no known allergies. There were no concomitant medications; no other medications in two weeks. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 09Oct2022, outcome "unknown" described as "Patient received Moderna as dose number 3 and Pfizer bivalent booster as dose number 4"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "not recovered" and all described as "Treatment of COVID-19." The patient underwent the following laboratory tests and procedures: COVID-19 test (SARS-CoV-2 test): (Oct2022) Positive, notes: Treatment of COVID-19 (Paxlovid treatment start date: 22Oct2022). Therapeutic measures were taken as a result of Drug ineffective, Covid-19.  Additional information: Vaccine lot numbers unknown, reason: unable to locate or read the details.  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: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A 48-year-old male patient received BNT162b2 (BNT162B2), on 21Dec2020 as dose 3 (booster), single (Lot number: Ej1685) at the age of 46 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Known allergies: Lentils" (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 Oct2022, outcome "recovered" (2022) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Nov2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect products to the reported event Drug ineffective and Covid-19 cannot be completely excluded.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID-19; 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.  An 85-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), 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: COVID-19 (medically significant) with onset Jun2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset Jun2022, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19, the patient received Bebtelovimab. Clinical course: the patient wants to get a Covid #5 shot and wants to make sure that the Bebtelovimab dose doesn't affect it in anyway.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: recovering from COVID; recovering from COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 70-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), 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 "recovering" and all described as "recovering from COVID". Patient was at home and had sniffles, a bit of a cough, and get to take extra naps.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201274674 Same reporter/event, different patient;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Had the COVID during the trial; Had the COVID during the trial; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A 78-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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 "Had the COVID during the trial". Clinical courses is as follows: I had the COVID during the trial. we have already reported this information while we were a part of the COVID trials. Wife reports, My husband he needs the omicron/flu shot or he will die if he catches the flu.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Generalised tonic-clonic seizure
Clinical narrative: Grand mal seizure; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), in Dec2021 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: Bnt162b2 (Dose 1), administration date: Dec2021, for COVID-19 immunization. The following information was reported: GENERALISED TONIC-CLONIC SEIZURE (medically significant), 20 days after the suspect product(s) administration, outcome "unknown", described as "Grand mal seizure". Clinical course: It was reported that 20 days after 2nd shot, she suffered a grand mal seizure. Later, she also received the booster and 19-20 days after receiving the booster she suffered another grand mal seizure.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information in the case, an association between the reported events and The suspected drug cannot be ruled out.  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. ,Linked Report(s) : US-PFIZER INC-202201277773 same reporter/patient/event, different dose.;
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: experienced COVID-19; experienced COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent. Other Case identifier(s): 2022NVX-US-000003914 (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 INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "experienced COVID-19".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Ankylosing spondylitis
Clinical narrative: Ankylosing spondylitis flares up after Covid vaccines; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-ABBVIE-4148818.  A 49-year-old female patient received BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Batch/Lot number: unknown), on 08Apr2021 as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (ongoing) as unk (40mg/0.4ml) subcutaneous for ankylosing spondylitis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANKYLOSING SPONDYLITIS (medically significant), outcome "not recovered", described as "Ankylosing spondylitis flares up after Covid vaccines". The action taken for adalimumab was dosage not changed. Therapeutic measures were taken as a result of ankylosing spondylitis.  The reporter considered "ankylosing spondylitis flares up after covid vaccines" related to BNT162b2.  Causalities: The reporter's causality for the event(s) of Ankylosing spondylitis flares up after Covid vaccines with Adalimumab Solution for Injection was Reasonable Possibility The reporter's causality for the event(s) of Ankylosing spondylitis flares up after Covid vaccines with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Reasonable Possibility Company's opinion was that the causality for the event(s) of Ankylosing spondylitis flares up after Covid vaccines with Adalimumab Solution for Injection was Not Provided Company opinion was that the causality for the event(s) of Ankylosing spondylitis flares up after Covid vaccines with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Not Provided.  Assessment Results: Humira 40mg/0.4ml:  Spondylitis ankylosing aggravated, Non-Health Care Professional, Global Introspection, Probable. Humira 40mg/0.4ml: Spondylitis ankylosing aggravated, Market Authorization Holder (MAH) Pfizer BioNTech COVID-19 vaccine: Spondylitis ankylosing aggravated, Market Authorization Holder (MAH) Pfizer BioNTech COVID-19 vaccine: Spondylitis ankylosing aggravated, Non-Health Care Professional, Global Introspection, Possible Clinical Course: It was unknown if patient was enrolled in COVID-19-Vaccine Trial. Treatment Drugs: The patient was treated with Cymbalta  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information, there is reasonable possibility of causal association between the events  and the suspect drug  BNT162b2  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: U
Vaccine: COVID19
Symptoms: Arthritis
Clinical narrative: inflammatory arthritis caused by the BNT162b2 COVID vaccination; This is a literature report for the following literature source(s):  A patient (no qualifiers provided) 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: ARTHRITIS (medically significant), outcome "unknown", described as "inflammatory arthritis caused by the BNT162b2 COVID vaccination".; Sender's Comments: As there is limited information in the case provided, the causal association between the event 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. ,Linked Report(s) : US-PFIZER INC-202201280037 Same article/drug/event and different patients.;US-PFIZER INC-202201280036 Same article/drug/event and different patients.;
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Not breath well; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): LRN4765087.  A 76-year-old male patient received BNT162b2 (BNT162B2), in May2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 75 years for covid-19 immunisation. The patient's relevant medical history included: "Left Shoulder Pain" (unspecified if ongoing), notes: Left Shoulder Pain; "Interstitial pulmonary disease, unspecified" (ongoing), notes: Interstitial pulmonary disease, unspecified; "Hypothyroidism" (ongoing); "High Cholesterol" (ongoing); "Gastroesophageal Reflux" (ongoing); "Anxiety" (ongoing); "Fluid in lungs" (ongoing), notes: Fluid in lungs; "Enlarged prostate" (ongoing); "Low Potassium levels with Lasix use" (ongoing), notes: Patient's concurrent condition included: Low Potassium levels with Lasix Use. Concomitant medication(s) included: SYNTHROID; SIMVASTATIN; SYMBICORT; LASIX [FUROSEMIDE]; POTASSIUM CHLORIDE; PREDNISONE; LEXAPRO; TRAMADOL; PROAIR [SALBUTAMOL SULFATE]; TAMSULOSIN; ALBUTEROL [SALBUTAMOL]; OMEPRAZOLE. Past drug history included: Lasix, reaction(s): "Low Potassium levels with Lasix Use", notes: Patient's concurrent condition included: Low Potassium levels with Lasix Use. The following information was reported: DYSPNOEA (non-serious), outcome "unknown", described as "Not breath well".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain, Vaccination site pain
Clinical narrative: some fatigue; Injection site pain; Minor body aches; 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), on 03Nov2022 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: VACCINATION SITE PAIN (non-serious) with onset Nov2022, outcome "unknown", described as "Injection site pain"; PAIN (non-serious) with onset Nov2022, outcome "unknown", described as "Minor body aches"; FATIGUE (non-serious) with onset Nov2022, outcome "unknown", described as "some fatigue". Additional information: Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Swelling of eyelid
Clinical narrative: unusual swelling of my upper lid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. 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; unknown manufacturer), for COVID-19 immunization. The following information was reported: SWELLING OF EYELID (non-serious), 48 hrs after the suspect product(s) administration, outcome "not recovered", described as "unusual swelling of my upper lid". Additional information: patient stated "approximately 48 hours after my last booster shot I had an unusual swelling of my upper lid this this has remained present now for approximately 2 weeks I was curious to learn if others have reported this and what your theory might be why it happened".  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: Atrial fibrillation, Disease recurrence
Clinical narrative: She had atrial fibrillation return and it was after she received the Covid-19 booster.; She had atrial fibrillation return and it was after she received the Covid-19 booster.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NUS2022US212084.  A 75-year-old 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) for covid-19 immunisation. The patient's relevant medical history included: "atrial fibrillation" (unspecified if ongoing), notes: atrial fibrillation return. The patient's 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: ATRIAL FIBRILLATION (medically significant), DISEASE RECURRENCE (medically significant), outcome "unknown" and all described as "She had atrial fibrillation return and it was after she received the Covid-19 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: F
Vaccine: COVID19
Symptoms: Hemiplegic migraine
Clinical narrative: She saw there was another girl who got the same thing and they said this was hemiplegic migraines and the shot caused it; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  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: HEMIPLEGIC MIGRAINE (non-serious), outcome "unknown", described as "She saw there was another girl who got the same thing and they said this was hemiplegic migraines and the shot caused it". Additional information: The reporter wanted to know what the treatment was for the girl (patient) to help her daughter.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: being sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) The reporter is the patient.  A 55-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: ILLNESS (non-serious), outcome "unknown", described as "being sick".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Muscle pain; This is a spontaneous report received from contactable reporter(s) (Physician). Other Case identifier(s): 2022NVX-US-000003929 (Novavax).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), 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, Unknown manufacturer), for COVID-19 immunization. The following information was reported: MYALGIA (non-serious), outcome "recovered", described as "Muscle pain".  Additional information:  It was reported the patient experienced 3 months of significant muscle pain.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: blood clot; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP), Program ID: (Unknown). The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (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: Bnt162b2 (Dose 1), for COVID-19 Immunization; Bnt162b2 (Dose 2), for COVID-19 Immunization; Bnt162b2 (Dose 3), for COVID-19 Immunization. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "blood clot". Patient already took Pfizer Covid-19 Vaccine and 2 doses of Booster shot and then he's having health problems and he wanted to know why the shot gave him blood clot.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 7.0
Sex: M
Vaccine: TDAP
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 7 year old male that received a dose of Adacel with no adverse event; Initial information received on 31-Oct-2022 regarding an unsolicited valid non-serious case from other health professional.  This case involves a 7 year old male that received a dose of diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 30-Oct-2022, the patient received suspect diphtheria-2/tetanus/5 AC pertussis vaccine Suspension for injection at an unknown dose (lot U6984AA, strength, expiry date: not reported) via intramuscular route in unknown administration site for prophylactic vaccination(immunisation).  On 30-Oct-2022, 7 year old male that received a dose of adacel with no 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 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: FLU3
Symptoms: Medication error, No adverse event, Wrong product administered
Clinical narrative: received Fluzone SD instead of Fluzone HD with no reported adverse event; Initial information received on 31-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves Elderly male patient who received INFLUENZA QUADRIVAL A-B INTRADERMAL VACCINE (FLUZONE SD) instead of Fluzone HD with no reported adverse event while receiving 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 QUADRIVAL A-B INTRADERMAL VACCINE, Solution for injection in pre-filled syringe, ( lot number and expiry date: not reported)  via intramuscular route in unknown administration site for immunization.  On an unknown date the patient received Fluzone SD instead of fluzone HD with no reported adverse event (wrong product administered) (latency: same day).  Action taken : not applicable.  Outcome: unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 12.0
Sex: M
Vaccine: FLUR4
Symptoms: Incorrect route of product administration, Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Flublok QIV given to patient 12 years old with no reported adverse event; Flublok QIV given by cutaneous route with no reported adverse event; Initial information received on 31-Oct-2022 regarding an unsolicited valid non-serious case received via health professional.  This case involves a 12-year-old male patient who had INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] given by cutaneous route with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On unknown date in October 2022, the 12 years old patient received suspect FLUBLOK QIV VACCINE at (unknown: formulation, strength, dose) (lot: 4928107288) via cutaneous route in unknown administration site for annual flu vaccination (product administered to patient of inappropriate age and incorrect route of product administration) at same day latency. It was unknown if the company suspect product inappropriately used as per local Marketing authorization.  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for both 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 15.0
Sex: M
Vaccine: FLUR4
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Flublok QIV given to a 15 year old male with no reported adverse event; Initial information received on 31-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 15 years old male patient who reported INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV]given to a 15 year old male with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 27-Oct-2022 or 28-oct-2022, the patient received a  dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE pre-filled syringe (strength, dose,lot number not reported) via cutaneous route in unknown administration site for flu immunization.  On 27-Oct-2022 or 28-oct-2022,  the patient reported a non-serious event  INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. (flublok qiv) given to a 15 year old male with no reported adverse event (product administered to patient of inappropriate age).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event product administered to patient of inappropriate age.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLU4
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age, Product storage error
Clinical narrative: pharmacist says that fluzone hd qiv may have been given to a 45 year old with no reported ae; a fluzone high-dose vaccine for her, but then she said she thought she might have already gotten it, so they did not administer. prepared syringe was placed back in the refrigerator with no reported ae; Initial information received on 01-Nov-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case is linked to cases 2022SA454572(CLUSTER), 2022SA455035(CLUSTER) and 2022SA455035(CLUSTER).  This case involves a 45 years old female patient and pharmacist says that INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] may have been given with no reported ae(adverse event) and a fluzone high-dose vaccine for her, but then she said she thought she might have already gotten it, so they did not administer. prepared syringe was placed back in the refrigerator with no reported ae.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (strength, formulation was unknown, lot UJ93788 and expiry date was unknown) via unknown route in unknown administration site for immunization.  On an unknown date the patient developed a non-serious event of pharmacist says that fluzone hd qiv may have been given to a 45 year old with no reported ae (product administered to patient of inappropriate age) (latency: same day) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. On an unknown date the patient developed a non-serious event of a fluzone high-dose vaccine for her, but then she said she thought she might have already gotten it, so they did not administer. prepared syringe was placed back in the refrigerator with no reported ae (product storage error) (latency: unknown) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV 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.; Sender's Comments:  SanofiPVPortal20221103000136:
Sex: F
Vaccine: FLUX
Symptoms: Eczema
Clinical narrative: got a flu shot recently and ended up with full blown eczema on her forearms after this.; Initial information received on 25-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp via specialty pharmacy case.   This case involves Adult female patient (129.27 kg) who got a flu shot (Influenza Vaccine) recently and ended up with full blown eczema on her forearms after this.  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 Drug allergy with DOXYCYCLINE HYCLATE, DEMEROL, PENICILLIN VK, BENADRYL, ZYRTEC, SULFAMETHOXAZOLE, CEFUROXIME and Latex allergy.   On an unknown date, the patient received a dose of suspect Influenza Vaccine by unknown manufacturer (strength, formulation, dose, route, batch number and expiry date: unknown) in unknown administration site for prophylactic vaccination.  On an unknown date the patient got a flu shot recently and ended up with full blown eczema on her forearms after this. (eczema) (unknown latency).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (got a flu shot recently and ended up with full blown eczema on her forearms after this.).  At time of reporting, the outcome was Unknown for the event got a flu shot recently and ended up with full blown eczema on her forearms after this..
Sex: F
Vaccine: FLUX
Symptoms: Exposure via breast milk, Medication error, No adverse event, Poor quality product administered
Clinical narrative: was given vaccine warm temperature excursion and she needed to get re vaccinated with no reported adverse event; she is breastfeeding with no adverse event; Initial information received from on 27-Oct-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 41 years old female patient who was given vaccine warm temperature excursion and she needed to get re vaccinated and she is breastfeeding with no adverse event while receiving vaccine 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 by unknown manufacturer (strength, formulation, dose, route, batch number and expiry date: unknown) in unknown administration site for prophylactic vaccination.  On an unknown date the patient was given vaccine warm temperature excursion and she needed to get re vaccinated with no reported adverse event (poor quality product administered) (unknown latency). On an unknown date the patient is breastfeeding with no adverse event (exposure via breast milk) (unknown latency). It was reported that her family member got a flu vaccine and got a call that the product that she was given had a warm temperature excursion and she needed to get revaccinated but she is worried since she is breastfeeding.  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: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: under the age of 65 receive fluzone high dose in error, with no reported adverse event; Initial information received on 27-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2022SA448810(CLUSTER).  This case involves Adult and unknown gender patient who is under the age of 65 received influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent] in error 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 under the age of 65 received a  dose of suspect influenza quadrival A-B high dose HV vaccine (lot UT7729BA; Expiration Date: 30-Jun-2023) via unknown route in unknown administration site for immunization in error with no reported 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.
Age: 59.0
Sex: F
Vaccine: TD
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: was given an expired tenivac with no reported adverse event; Initial information was received on 28-Oct-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves 59 years old female patient who was given an expired diphtheria-2/tetanus-5 adsorbed toxoids NO PRESERVATIVE ADULT [Tenivac] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 19-Sep-2022, the patient received standard diphtheria-2/tetanus-5 adsorbed toxoids NO PRESERVATIVE ADULT suspension for injection at a dose of 0.5 ml once (lot U6831AA, expiry date - 10-Aug-2022) via unknown route in unknown administration site for Immunization and was given an expired diphtheria-2/tetanus-5 adsorbed toxoids NO PRESERVATIVE ADULT with no reported adverse event (expired product administered) (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 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: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Contraindication to vaccination, Urticaria
Clinical narrative: hives; has a mild allergy to egg; Initial information received on 28-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 36 years old female patient who experienced hives and has a mild allergy to egg (contraindication for the vaccine administered) while receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  The patient's past vaccination(s) included FLUBLOK. The patient's past medical history, medical treatment(s) and family history were not provided. At the time of the event, the patient had ongoing Food allergy.   On 26-Oct-2022, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (formulation, strength, dose and lot number not reported) via unknown route in unknown administration site for prophylactic vaccination, but since, the patient had mild allergy to egg, she was administered contraindicated vaccine (contraindicated product administered) (latency: same day).  On an unknown date, the patient developed a non-serious event of hives (urticaria) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It was reported, she received the Fluzone QIV vaccine on 26Oct2022 and usually gets the Flublok because she has a mild allergy to egg. She states she developed hives and treated it with Benadryl and the hives went away.   Action taken was not applicable.  The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Urticaria.  At time of reporting, the outcome was Recovered / Resolved on an unknown date for the event hives and was Unknown for the event has a mild allergy to egg.  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: 2.0
Sex: M
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: an expired ipol was given to a patient with no reported adverse event; Initial information was received on 28-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 2 years old male patient who was administered an expired 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 28-Oct-2022, the patient received ipv (VERO) standard suspension for injection at a dose of 0.25 ml once (lot TIE872M, expiry date - 10-Oct-2022) via intramuscular route in the right thigh for Immunization and patient was administered an expired ipv (VERO) with no reported adverse event (expired product administered) (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.