chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 83-year-old female patient received BNT162b2 (BNT162B2), on 29Sep2021 as dose 3 (booster), single (Lot number: FF2587) at the age of 83 years for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 immunization; Bnt162b2 (Dose 2, single), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "recovering".  Additional Information: The patient believes that fatigue was after the third vaccination but it wasn't constant, one day this week, one day next month. End Date: Might happen this month then not happen again until next month. However, it was clarified it is ongoing but has improved as it used to be every other day, then every other week, and now by month.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, Fatigue, Taste disorder
Clinical narrative: Can only taste sweet and salty; Can't smell; fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 84-year-old female patient received BNT162b2 (BNT162B2), on 13Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 84 years for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Batch/lot number: FF25872), administration date: 29Sep2021, when the patient was 83-year-old, for COVID-19 immunization, reaction(s): "Fatigue"; Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization. The following information was reported: TASTE DISORDER (non-serious) with onset 2022, outcome "not recovered", described as "Can only taste sweet and salty"; ANOSMIA (non-serious) with onset 2022, outcome "not recovered", described as "Can't smell"; FATIGUE (non-serious) with onset 2022, outcome "recovering". Additional information: Can only taste sweet and salty: Start Date: Didn't pay any attention to it. Clarified that food isn't her favorite thing, eats for nourishment, then realized she could only taste sweet. Can't taste chocolate and that is serious. Started sometime after the last booster, the fourth shot in the series.  Recognized she wasn't tasting but ignored it because she thought it was something else. Then a month later realized she couldn't smell anything while going to the bathroom. Outcome: Ongoing and has gotten worse, can't taste chocolate.  Can't smell: Start Date: About the same time as she noticed she was not able to taste anything. Can't smell when she is in the bathroom and doesn't have to open windows. Read some material when she got her vaccinations and realized it was dangerous because she can't smell smoke or gas which is dangerous. Testing: Hasn't mentioned her side effects to her HCP because she was dealing with other things. Has an appointment next month. She is an old lady and doesn't have energy to deal with a bunch of things at once. Doesn't have energy: Thinks at 85 she doesn't have the energy like when she was younger. Clarified she doesn't have as much energy due to her age which started before receiving the Pfizer COVID-19 vaccines and the fatigue was different and the fatigue started after receiving the Pfizer COVID-19 vaccine.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300070379 Same patient/product; different dose/events;
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Suicidal ideation
Clinical narrative: since you poisoned me and I wanna kill myself! Well, you gave it to me and I'm going to kill myself; peg allergy after getting the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (Unknown). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SUICIDAL IDEATION (medically significant, life threatening), outcome "unknown", described as "since you poisoned me and I wanna kill myself! Well, you gave it to me and I'm going to kill myself"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "PEG (Polyethylene Glycol) allergy after getting the vaccine". The events "since you poisoned me and i wanna kill myself!  Well, you gave it to me and I'm going to kill myself" and "peg allergy after getting the vaccine" required physician office visit. Course of events: A patient was asking for information on an antidote or medication for PEG allergy after getting the vaccine. She has consulted her healthcare provider a hundred times, they don't have any treatment. She wanted to know if there is a treatment (for peg allergy), "since you poisoned me and I wanna kill myself! Well, you gave it to me and I'm going to kill myself and hold you responsible".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: blotchy red rash; The initial case was missing the following minimum criteria: Unspecified product. Upon receipt of follow-up information on 14Feb2023, this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  An 83-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Dec2022 as dose 4 (booster), single (Lot number: EL06742) at the age of 83 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Single, EP6955), administration date: 23Mar2021, when the patient was 82-year-old, for COVID-19 Immunization; BNT162b2 (Dose 2, Single, ER8735), administration date: 14Apr2021, when the patient was 82-year-old, for COVID-19 Immunization; BNT162b2 (Dose 3, Single, FE3590), administration date: 25Oct2021, when the patient was 82-year-old, for COVID-19 Immunization. The following information was reported: RASH ERYTHEMATOUS (non-serious) with onset 08Dec2022, outcome "not recovered", described as "blotchy red rash". Therapeutic measures were taken as a result of rash erythematous. Additional information: For Only: Vaccination Facility Type: Pharmacy/Drug Store, Patient was not admitted to hospital due to adverse event. Treatment received: Prednisone 2 weeks later Triamcinolone.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: long term covin, includes: short of breath, cough, very tired and catch breath; long term covin, includes: short of breath, cough, very tired and catch breath; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). 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 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 "long term covin, includes: short of breath, cough, very tired and catch breath".  Clinical course: I took you Covid vaccine x3 I now have long term covin. These are just some of my problems.  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: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cough, Dyspnoea, Fatigue, Gait disturbance, Pulmonary thrombosis
Clinical narrative: long term covin, includes: short of breath, cough, very tired and catch breath; long term covin, includes: short of breath, cough, very tired and catch breath; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). 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 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 "long term covin, includes: short of breath, cough, very tired and catch breath".  Clinical course: I took you Covid vaccine x3 I now have long term covin. These are just some of my problems.  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.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Ischaemic stroke, Laboratory test, Magnetic resonance imaging, Urine analysis
Clinical narrative: Ischemic stroke; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 24Feb2021 as dose 2, single (Lot number: EN6203) at the age of 67 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure", start date: 2020 (unspecified if ongoing), notes: Losartan keeps in check since stroke Baby; "High Cholesterol", start date: 2020 (unspecified if ongoing), notes: Atorvastatin, then Profluent after stroke. The patient's family history included: "Stroke" (unspecified if ongoing), notes: Mother had stroke after taking celebrex years ago. The patient's concomitant medications were not reported. Vaccination history included: pfizer/biontech coviD-19 vaccine (DOSE 1, SINGLE, Time: AM, Site and route of injection: Left arm, Route of administration: Intramuscular, Batch/Lot number: EL9264), administration date: 03Feb2021, when the patient was 67-year-old, for COVID-19 immunization, reaction(s): "COVID-19". The following information was reported: ISCHAEMIC STROKE (hospitalization, life threatening) with onset 11Mar2021 at 12:00, outcome "recovered" (12Mar2021 at 12:00), described as "Ischemic stroke". The patient was hospitalized for ischaemic stroke (start date: 11Mar2021, discharge date: 12Mar2021, hospitalization duration: 1 day(s)). The event "ischemic stroke" required emergency room visit. The patient underwent the following laboratory tests and procedures: Battery of tests: (11Mar2021) Ischemic Stroke; Magnetic resonance imaging: (unspecified date) Unknown result; Urine analysis: (unspecified date) Unknown result. Therapeutic measures were taken as a result of ischaemic stroke (Lisinopril, Losartan, Atorvastatin). The clinical course was reported as follows:  had ischemic stroke 16 days after second COVID vaccination. At the time I asked view of Withheld doctors if they were reporting to you. They said no, since it wasn't a known side effect.
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: runny nose off/on; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Feb2023 as dose number unknown (booster), single (Lot number: GJ3277) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE , MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: RHINORRHOEA (non-serious) with onset 14Feb2023, outcome "unknown", described as "runny nose off/on".; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021351166 Same patient, different vaccine dose number and different event.;
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Suddenly I  appear to be cured from a disease which there is no cure for; This is a spontaneous report received from a contactable reporter(s) (Nurse), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hereditary hemochromatosis" (not ongoing); "COVID" (unspecified if ongoing), notes: The only thing they have come up with is either your COVID vaccine or getting COVID. The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "Suddenly I  appear to be cured from a disease which there is no cure for". Additional information: Reporter is a RN (Registered Nurse) who has Hereditary Hemochromatosis. Stated "Suddenly I appear to be cured from a disease which there is no cure for. No doctor can make sense of it. The only thing they have come up with is either your COVID vaccine or getting COVID."   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  An adult female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Chronic lung disease" (unspecified if ongoing), notes: Chronic lung disease (such as chronic obstructive pulmonary disease [COPD] and cystic fibrosis); "chronic obstructive pulmonary disease" (unspecified if ongoing), notes: Chronic lung disease (such as chronic obstructive pulmonary disease [COPD] and cystic fibrosis); "cystic fibrosis" (unspecified if ongoing), notes: Chronic lung disease (such as chronic obstructive pulmonary disease [COPD] and cystic fibrosis); "congenital heart disease" (unspecified if ongoing), notes: Heart disease (such as congenital heart disease, congestive heart failure and coronary artery disease); "congestive heart failure" (unspecified if ongoing), notes: Heart disease (such as congenital heart disease, congestive heart failure and coronary artery disease); "coronary artery disease" (unspecified if ongoing), notes: Heart disease (such as congenital heart disease, congestive heart failure and coronary artery disease); "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick". Additional information: Patient was asked why would she chose current high-dose flu vaccine and to describe her reasons as fully as she can: This is the kind she has been getting over the years with no side effects; she got sick after every covid shot she got, so she is staying away from the mRNA kind  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: Myocarditis
Clinical narrative: Acute myocarditis; This is a literature report for the following literature source(s):   A patient (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, 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 - manufacturer unknown (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown", described as "Acute myocarditis".; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the event and 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.,Linked Report(s) : US-PFIZER INC-202300069723 Same article/ drug/event and different patient;
Sex: U
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: Myocarditis Following mRNA COVID-19 Vaccine; This is a literature report for the following literature source(s):  A patient (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, 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: MYOCARDITIS (medically significant), outcome "unknown", described as "Myocarditis Following mRNA COVID-19 Vaccine". Sender's Comments: As there is limited information in the case provided, the causal association between the reported event: "Myocarditis" and the suspect drug BNT162B2 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, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Approximately one month after receiving the bivalent booster, the patient got COVID; Approximately one month after receiving the bivalent booster, the patient got COVID; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the parent.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Approximately one month after receiving the bivalent booster, the patient got COVID".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a vaccine varies individually and can be affected by different factors including product potency; however, a contributory role of BNT162b2, BNT162b2 omi ba.4-5 to the events COVID-19 and drug ineffective cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202300069827 same patient/drug, different event.;
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Vaccines don't work; Vaccines don't work; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (RA).  An adult male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Vaccines don't work". 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-202300072190 same reporter/vaccine/event, different patient;
Sex: M
Vaccine: COVID19
Symptoms: Echocardiogram, Electrocardiogram, Magnetic resonance imaging heart, Myopericarditis, Troponin
Clinical narrative: Myopericarditis; This is a literature report for the following literature source(s):  A male patient in his 20's received BNT162b2 (BNT162B2), 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 (DOSE 1, MANUFACTURER UNKNOWN), for Covid-19 immunisation; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for Covid-19 immunisation. The following information was reported: MYOPERICARDITIS (medically significant), 3 days after the suspect product(s) administration, outcome "recovered". The patient underwent the following laboratory tests and procedures: Echocardiogram: depressed EF; Electrocardiogram: PR tract sloping and ST elevation in V1-V3; Magnetic resonance imaging heart: unknown results; Troponin: Increased.; Sender's Comments: Based on the information available, the causal relationship between the reported event and 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.
Sex: U
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered an expired Adacel vaccine this morning with no reported AE; Initial information received on 09-Feb-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves patient of unknown demographics who received expired diphtheria-2 /tetanus/5 AC pertussis vaccine [Adacel] this morning 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, patient received an unknown dose of suspect diphtheria-2 /tetanus/5 AC pertussis vaccine, suspension for injection (lot number, expiry date not reported) via unknown route in unknown administration site for Prophylactic vaccination.  Caller stated that she administered an expired Adacel vaccine this morning (expired product administered) (latency same day).and is calling for the next steps." The caller stated that the patient would be coming in for a well child appointment. The caller was asked for additional AE information, but she declined and stated that she had to get back to her patient.   Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event administered an expired adacel vaccine this morning with no reported ae.  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.  Based on information previously received, case validity has been amended from non valid to valid with no AE. Text updated accordingly.
Age: 1.25
Sex: F
Vaccine: FLU4
Symptoms: Guillain-Barre syndrome
Clinical narrative: was hospitalized and diagnosed with Guillain Barre Syndrome; Initial information received on 13-Feb-2023 regarding an unsolicited valid serious case received from a nurse.  This case is linked to case 2023SA053830(CLUSTER).  This case involves a 15-month-old female patient who was hospitalized and diagnosed with guillain barre syndrome after receiving vaccine influenza quadrival A-B vaccine [Fluzone QIV].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.    On 20-Jan-2023, the patient received suspect influenza quadrival A-B vaccine at an unknown dose (lot number, expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination (immunisation).  On an unknown date in 2023, the patient was hospitalized and diagnosed with guillain barre syndrome (guillain-barre syndrome) (unknown latency) following the administration of influenza quadrival A-B vaccine.   Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown.  Seriousness criteria: Medically significant and the patient was hospitalized for this event; Sender's Comments: Sanofi company comment dated 16-Feb-2023: This case involves a 15-month-old female patient who was hospitalized and diagnosed with guillain barre syndrome after receiving vaccine influenza quadrival A-B vaccine [Fluzone QIV]. Additional information regarding condition at the time of vaccination, concomitant disease, concomitant medication would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.
Age: 68.0
Sex: M
Vaccine: YF
Symptoms: No adverse event, Poor quality product administered, Product preparation error
Clinical narrative: YF-VAX was administered after it was mixed with sterile water instead of the diluent provided with no reported adverse event; YF-VAX was administered after it was mixed with sterile water instead of the diluent provided with no reported adverse event; Initial information received on 14-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 68 years old male patient was administered Yellow fever vaccine (yf-vax) after it was mixed with sterile water instead of the diluent provided 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 Typhoid vaccine live oral (ty21a) (VIVOTIF) for Prophylactic vaccination.  On 10-Feb-2023, the patient received suspect Yellow fever vaccine - Solution for injection at dose of 0.5 ml (strength were not provided) (lot UJ782AA and expiry date-17-Feb-2024) via intramuscular route in the left deltoid for immunization after it was mixed with sterile water instead of the diluent provided with no reported adverse event (latency-same day) (Vaccine preparation error) (Poor quality vaccine administered).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error
Age: 11.0
Sex: F
Vaccine: MEN, MNQ
Symptoms: Inappropriate schedule of product administration, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: patient received a MENACTRA vaccine at age 11 (08-Aug-2016), age 16 (24-Sep-2021) and MENQUADFI at age 18 (13Feb2023) with no reported adverse event; patient received a MENACTRA vaccine at age 11 (08-Aug-2016), age 16 (24-Sep-2021) and MENQUADFI at age 18 (13Feb2023) with no reported adverse event; Initial information received on 14-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 11 years old female patient and it was reported patient received a meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra] at age 11 (08-aug-2016), age 16 (24-sep-2021) and Menquadfi at age 18 (13-feb-2023) with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 08-Aug-2016, the patient received an unknown dose of suspect meningococcal A-C-Y-W135 (D CONJ) vaccine solution for injection (batch/lot number, expiry date, strength and route: not reported) in unknown administration site at age 11, on 24-Sep-2021 she received another dose of the same vaccine at age 16 both for immunization and Menquadfi at age 18 (13-feb-2023) with no reported adverse event (inappropriate schedule of product administration) (product administered to patient of inappropriate age) (unknown latency).  It was reported that MA states that they have a patient who was accidentally injected with MENQUADFI instead of a Meningococcal B vaccine. The MA asks if there is an issue with taking MENQUADFI so close together, what to expect, and how long they should wait until they give the Meningococcal B vaccine.  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.; Sender's Comments:  01491174:
Age: 0.5
Sex: M
Vaccine: FLU4
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: received 2 FLUZONE QIV np injections 8 days apart, with no reported adverse event; Initial information received  on 15-Feb-2023 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 6-month-old male patient who received 2 INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] injections 8 days apart, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.    On 01-Nov-2022, the patient received a 1st dose of suspect INFLUENZA QUADRIVAL A-B VACCINE at an unknown dose (lot number, expiry date: not reported) via unknown route in unknown administration site for immunization. On 09-Nov-2022 he also received a Second dose of the same vaccine at a dose of 0.5 ml once (lot UT7723LA, expiry date: 30-Jun-2023) via intramuscular route in unknown administration site for immunisation.  On 09-Nov-2022 the patient received 2 fluzone qiv np injections 8 days apart, with no reported adverse event (inappropriate schedule of product administration) 8 days following the administration of INFLUENZA QUADRIVAL A-B VACCINE first dose and same day latency following the second dose.  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: 17.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: an expired tenivac was given with no reported adverse event; Initial information received on 15-Feb-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 17-year-old male patient to whom an expired diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] was given with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Hepatitis B Vaccine; HPV VACCINE VLP RL1 4V (YEAST) (Gardasil); measles vaccine, mumps vaccine, rubella vaccine (MMR) and polio vaccine (Polio) all for Prophylactic vaccination.  On 10-Feb-2023, the patient received suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult at a dose of 0.5 ml once (lot U6922AA, expiry date: 22-Jan-2023) via intramuscular route in the left deltoid for immunization.  On 10-Feb-2023, an expired tenivac was given with no reported adverse event (expired 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: 13.0
Sex: F
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration, No adverse event, Wrong product administered
Clinical narrative: accidentally given an ADACEL vaccination instead of the intended varicella vaccination with no reported adverse event; patient receiving 2 Tdap vaccinations within 2 days with no reported adverse event; Initial information received on 15-Feb-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 13 years old female patient who had accidentally given an diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] vaccination instead of the intended varicella vaccination and patient receiving 2 tdap vaccinations within 2 days with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (Boostrix) for Prophylactic vaccination.  On 14-Feb-2023, the patient received 0.5 ml (milligram) (once) (standard: strength) of suspect diphtheria-2/tetanus/5 AC pertussis vaccine, suspension for injection (With unknown lot number and expiration) via intramuscular route in the deltoid NOS for immunization.  On 14-Feb-2023, caller reported that patient had accidentally given an adacel vaccination instead of the intended varicella vaccination with no reported adverse event (wrong product administered) and patient receiving 2 tdap vaccinations within 2 days with no reported adverse event (inappropriate schedule of product administration) (latency: same day) following the administration of diphtheria-2/tetanus/5 AC pertussis vaccine.  It was also reported that Pharmacist asked if there was anything to look out for such as seizures so that he could inform the patient's parents?.  No lab data were reported.  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: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Chest discomfort, Pain, Pain in extremity
Clinical narrative: Soreness in arm that calmed down and radiated to heart and chest area causing tightness. No pain and so not seeking medical attention but wanted to report the chest tightness, especially on the left side near the injection site, to share symptoms from the vaccine. The tightness in the chest doesn't bother me except for the fact its on the left side (near the injection site) around my heart. It's been constant for 10 hours now but I think it will go away in a couple days with the soreness in arm.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, X-ray
Clinical narrative: Excruciating pain in the knee joints down to feet.  Took about 10 days to function somewhat.  Still have constant pain.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anxiety, Cardiac monitoring, Computerised tomogram, Condition aggravated, Dizziness
Clinical narrative: Fatigue, anxiety,dizziness,lightheaded,brain fog.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Echocardiogram, Electrocardiogram, Fatigue, Feeling abnormal, Magnetic resonance imaging
Clinical narrative: Fatigue, anxiety,dizziness,lightheaded,brain fog.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ultrasound abdomen
Clinical narrative: Fatigue, anxiety,dizziness,lightheaded,brain fog.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Autoimmune disorder, Chest X-ray, Chest discomfort
Clinical narrative: Muscle pain, weakness, tinnitus, headache, BP 200 range hypertension crisis, difficulty breathing, chest tightness, couldn?t walk, loss of bladder control, GI and upper right side pain, autoimmune phenomenon, vasculitis, chest wall muscle pain, neuropathy hands and feet, snow vision, brain fog, lost consciousness 1x and woke to husband clearing vomit from my mouth to start CPR, bruising of unknown origin.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Contusion, Dyspnoea, Feeling abnormal, Gait disturbance
Clinical narrative: Muscle pain, weakness, tinnitus, headache, BP 200 range hypertension crisis, difficulty breathing, chest tightness, couldn?t walk, loss of bladder control, GI and upper right side pain, autoimmune phenomenon, vasculitis, chest wall muscle pain, neuropathy hands and feet, snow vision, brain fog, lost consciousness 1x and woke to husband clearing vomit from my mouth to start CPR, bruising of unknown origin.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Gastrointestinal pain, Headache, Hypertensive crisis, Laboratory test, Loss of consciousness
Clinical narrative: Muscle pain, weakness, tinnitus, headache, BP 200 range hypertension crisis, difficulty breathing, chest tightness, couldn?t walk, loss of bladder control, GI and upper right side pain, autoimmune phenomenon, vasculitis, chest wall muscle pain, neuropathy hands and feet, snow vision, brain fog, lost consciousness 1x and woke to husband clearing vomit from my mouth to start CPR, bruising of unknown origin.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Musculoskeletal chest pain, Myalgia, Neuropathy peripheral, Tinnitus
Clinical narrative: Muscle pain, weakness, tinnitus, headache, BP 200 range hypertension crisis, difficulty breathing, chest tightness, couldn?t walk, loss of bladder control, GI and upper right side pain, autoimmune phenomenon, vasculitis, chest wall muscle pain, neuropathy hands and feet, snow vision, brain fog, lost consciousness 1x and woke to husband clearing vomit from my mouth to start CPR, bruising of unknown origin.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary incontinence, Vasculitis, Visual snow syndrome, Vomiting
Clinical narrative: Muscle pain, weakness, tinnitus, headache, BP 200 range hypertension crisis, difficulty breathing, chest tightness, couldn?t walk, loss of bladder control, GI and upper right side pain, autoimmune phenomenon, vasculitis, chest wall muscle pain, neuropathy hands and feet, snow vision, brain fog, lost consciousness 1x and woke to husband clearing vomit from my mouth to start CPR, bruising of unknown origin.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness bilateral, Tinnitus
Clinical narrative: Extreme tinnitus in both ears. Hearing loss in both ears.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Computerised tomogram thorax abnormal, Deep vein thrombosis, Dyspnoea, Fibrin D dimer
Clinical narrative: Months after the vaccine i developed chest tightness, shortness of breath without exertion. High heart rates at rest. By august I was diagnosed with DVT and multiple bilateral PE?s
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Ultrasound Doppler abnormal
Clinical narrative: Months after the vaccine i developed chest tightness, shortness of breath without exertion. High heart rates at rest. By august I was diagnosed with DVT and multiple bilateral PE?s
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: High pitched ringing in right ear (like a dog whistle), left ear ringing to a lesser extent
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysarthria, Electromyogram, Fall, Gait disturbance, Hemiparesis
Clinical narrative: Started approximately First of November with right upper extremity weakness, then falling frequently, then right leg weakness, then difficulty walking, then slurred speech. Seen by various Doctors, Neurologists local and also seen at local Clinics. Multiple tests ran. They advised no cure, I have had PT & OT, Staring Speech Therapy in March. Now diagnosed with Primary lateral Sclerosis  , Hemiparesis of dominant side  & Dysarthria
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Lumbar puncture, Magnetic resonance imaging, Nerve conduction studies, Upper motor neurone lesion
Clinical narrative: Started approximately First of November with right upper extremity weakness, then falling frequently, then right leg weakness, then difficulty walking, then slurred speech. Seen by various Doctors, Neurologists local and also seen at local Clinics. Multiple tests ran. They advised no cure, I have had PT & OT, Staring Speech Therapy in March. Now diagnosed with Primary lateral Sclerosis  , Hemiparesis of dominant side  & Dysarthria
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: X-ray
Clinical narrative: Started approximately First of November with right upper extremity weakness, then falling frequently, then right leg weakness, then difficulty walking, then slurred speech. Seen by various Doctors, Neurologists local and also seen at local Clinics. Multiple tests ran. They advised no cure, I have had PT & OT, Staring Speech Therapy in March. Now diagnosed with Primary lateral Sclerosis  , Hemiparesis of dominant side  & Dysarthria
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Chronic obstructive pulmonary disease, Condition aggravated, Loss of personal independence in daily activities
Clinical narrative: About a week and a half after receiving the Moderna booster, my COPD went into hyperdrive.  normal activities that did not limit me were all of a sudden a struggle.  The only thing that changes was the receipt of the Moderna Booster.  I suffer the impact described above to this day which motivates me to file this report
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Dysmenorrhoea, Intermenstrual bleeding, Premature menopause
Clinical narrative: Dysmenorrhea/Amenorrhea   Dysmenorrhea starting June 13 lasting for a period of 14 days, followed by amenorrhea  starting June 27-September 19th. This ended with a brief period of spotting from the 19th through the 24th. Early menopause was given as a differential diagnosis from OB/GYN.
Age: 7.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Syncope
Clinical narrative: Syncope episode lasting  several seconds
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine administered had beyond use date of 2/11/23 but administered on 2/17/23. No adverse event reported
Age: 78.0
Sex: F
Vaccine: DTAP, VARZOS
Symptoms: Abdominal discomfort, Abdominal pain, Asthenia, Chills, Decreased appetite
Clinical narrative: Headache, Overall Body Aches, Upper abdominal discomfort, Lower abdominal cramping,. Nausea, Chills Overall body weakness, loss of appetite
Age: 78.0
Sex: F
Vaccine: DTAP, VARZOS
Symptoms: Headache, Nausea, Pain
Clinical narrative: Headache, Overall Body Aches, Upper abdominal discomfort, Lower abdominal cramping,. Nausea, Chills Overall body weakness, loss of appetite
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cough, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Main events include fever (temporary) and a cough that has persisted from the day after the vaccine until now.  She says that she has been to the ER because of her cough multiple times.  Tested negative for COVID on all occations since.
Age: 27.0
Sex: F
Vaccine: COVID19-2
Symptoms: Erythema, Eyelid irritation, Hypersensitivity, Pruritus, Skin swelling
Clinical narrative: 14 days after the vaccination, I woke up and felt itching all over my body. The itching continued throughout the day. In the afternoon I felt discomfort in the lower eyelid of my left eye similar to the discomfort you feel when you are about to get a cold sore. In the evening and after continuing with the itching I noticed that after scratching the area where I scratched it swells. The skin is marked and turns red. I am currently taking an antihistamine for the allergy. The areas that itch the most are the back of my neck. My legs, head, arms, hands, face, armpits and soles of my feet are also itchy. The antihistamine calms the itching but does not take it away completely.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test normal, Burning sensation, Temperature intolerance, X-ray normal
Clinical narrative: Burning sensation in lower, front left leg. More sensitive to hot and cold. Will sometimes travel to different parts of the lower leg. Blood test and x-ray were done. Nothing showed on the x-ray or blood test. Nothing has been done further. I still experience the burning sensation.
Age: 83.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site pain
Clinical narrative: patient came in on 02/17/23  and reported a side effect of pain on the injection site *(Right Arm)that has been ongoing since 10/4/2022. According to patient she has tried ibuprofen, tylenol and lidocaine patch but the pain did not subside.