chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Serum ferritin
Clinical narrative: Incidentally found to have tested positive for COVID-19 despite receiving 2 doses of the Pfizer COVID-19 vaccine; Incidentally found to have tested positive for COVID-19 despite receiving 2 doses of the Pfizer COVID-19 vaccine; This is a literature report for the following literature source(s): "Concomitant mood disorder and stutter in a post-COVID-19 patient A 36-year-old male patient received 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 included: "major depressive disorder" (ongoing); "stutter" (ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant, life threatening), COVID-19 (hospitalization, medically significant, life threatening), outcome "unknown" and all described as "Incidentally found to have tested positive for COVID-19 despite receiving 2 doses of the Pfizer COVID-19 vaccine". The patient underwent the following laboratory tests and procedures: Angiogram: revealed no abnormalities; Computerised tomogram head: revealed no abnormalities; C-reactive protein: normal limits; CSF test: an elevated protein level; Fibrin D dimer: normal limits; within normal limit; Laboratory results: unremarkable; Magnetic resonance imaging head: revealed no abnormalities; Protein total (15-45): 73 mg/dl; SARS-CoV-2 test: Positive; Negative; Serum ferritin (26-388): 530 ng/ml.; Sender's Comments: Based on available information and the temporal association, a possible contributory role of Comirnaty vaccine cannot be excluded for the reported events of "DRUG INEFFECTIVE " and "COVID-19 ".
Sex: F
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: myocarditis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), in 2022 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown". The event "myocarditis" required physician office visit. Therapeutic measures were taken as a result of myocarditis.  Clinical course: Reporter stated that after the second dose of the vaccine last year, as a mandatory requirement to come, his wife developed all the symptoms that were related to myocarditis yet all the doctors that we had been to investigate her situation said that was nothing wrong, but an inflammatory issue and recommended all sort of drugs like steroids and so on trouble was that none of them worked and it feels like there was no real support on how to handle this issue post vaccination.  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: Thrombosis
Clinical narrative: three patients that had clots after the covid vaccine; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "three patients that had clots after the covid vaccine".  Clinical course: Patient Gender: (Male/Female): unknown (3 patients not one- she works in Cardiology -hospital also). Reporter stated "I am vaccinated myself with the bivalent and booster. I believe in the vaccine, however I got recently three patients that had clots after the covid vaccine and they had to be in heparin for 6 months) I would like studies about this problem from the scientific point". The adverse event took place after Pfizer product use. Specify Pfizer Suspect Product(s): Bivalent Pfizer covid 19 vaccine. Date Reported: Sunday, 12Feb2013 at 4:15 pm mst (yes, I confirm the visit actually took place on Sunday at a Urgent care facility)."  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, the causal association between the event thrombosis and the suspect drug 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-202300067081 Different patients, Same reporter, drug, event.;US-PFIZER INC-202300067082 Different patients, Same reporter, drug, event.;
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: Drug ineffective, Myelitis transverse, Suspected COVID-19
Clinical narrative: had Covid 19 and I had all of your vaccines.; had Covid 19 and I had all of your vaccines.; transverse myelitis; 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 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 "had Covid 19 and I had all of your vaccines."; MYELITIS TRANSVERSE (medically significant), outcome "unknown", described as "transverse myelitis". Clinical course: Patient had transverse myelitis. Patient had Covid-19 and stated had all of your vaccines.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: Malaise, Myelitis transverse, Wheelchair user
Clinical narrative: had Covid 19 and I had all of your vaccines.; had Covid 19 and I had all of your vaccines.; transverse myelitis; 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 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 "had Covid 19 and I had all of your vaccines."; MYELITIS TRANSVERSE (medically significant), outcome "unknown", described as "transverse myelitis". Clinical course: Patient had transverse myelitis. Patient had Covid-19 and stated had all of your vaccines.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: Myelitis transverse, Spinal stroke
Clinical narrative: had Covid 19 and I had all of your vaccines.; had Covid 19 and I had all of your vaccines.; transverse myelitis; 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 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 "had Covid 19 and I had all of your vaccines."; MYELITIS TRANSVERSE (medically significant), outcome "unknown", described as "transverse myelitis". Clinical course: Patient had transverse myelitis. Patient had Covid-19 and stated had all of your vaccines.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: Asthenia, Computerised tomogram thorax, Diplegia, Dysstasia, Laboratory test
Clinical narrative: had Covid 19 and I had all of your vaccines.; had Covid 19 and I had all of your vaccines.; transverse myelitis; 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 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 "had Covid 19 and I had all of your vaccines."; MYELITIS TRANSVERSE (medically significant), outcome "unknown", described as "transverse myelitis". Clinical course: Patient had transverse myelitis. Patient had Covid-19 and stated had all of your vaccines.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: Lumbar puncture, Magnetic resonance imaging, Myelitis transverse, Spinal cord infarction, Walking aid user
Clinical narrative: had Covid 19 and I had all of your vaccines.; had Covid 19 and I had all of your vaccines.; transverse myelitis; 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 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 "had Covid 19 and I had all of your vaccines."; MYELITIS TRANSVERSE (medically significant), outcome "unknown", described as "transverse myelitis". Clinical course: Patient had transverse myelitis. Patient had Covid-19 and stated had all of your vaccines.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: Wheelchair user
Clinical narrative: had Covid 19 and I had all of your vaccines.; had Covid 19 and I had all of your vaccines.; transverse myelitis; 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 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 "had Covid 19 and I had all of your vaccines."; MYELITIS TRANSVERSE (medically significant), outcome "unknown", described as "transverse myelitis". Clinical course: Patient had transverse myelitis. Patient had Covid-19 and stated had all of your vaccines.  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: Death
Clinical narrative: Pfizer vaccine has killed; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  An elderly 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: DEATH (death, medically significant), outcome "fatal", described as "Pfizer vaccine has killed". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  Clinical course: Reporter was thinking about all the people that the Pfizer vaccine had killed including his dear wife of 50 years of marriage and he now will probably have to go into an assisted living home as he cannot take care of himself. Their management should be arrested and jailed for life or given the death penalty for all the thousands of others who have died because if their killing vaccine. Reporter considered event was caused by suspect product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Pfizer vaccine has killed
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Gait disturbance, Pain in extremity
Clinical narrative: terrible sometimes unbearable pain in my legs, hips and knees; terrible sometimes unbearable pain in my legs, hips and knees; barely walk at time; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP), 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 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, I took the first 2 Covid shots with no problem), for COVID-19 Immunization, reaction(s): "no problem"; Covid-19 vaccine (Dose 2, I took the first 2 Covid shots with no problem), for COVID-19 Immunization, reaction(s): "no problem". The following information was reported: PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious), outcome "not recovered" and all described as "terrible sometimes unbearable pain in my legs, hips and knees"; GAIT DISTURBANCE (non-serious), outcome "not recovered", described as "barely walk at time".  Additional Information: Patient took the first 2 Covid shots with no problem. Patient took the third one and ever since have terrible sometimes unbearable pain in patient's legs, hips and knees. Patient sometimes wish somebody would amputate them they hurt so badly. Stated this shot has ruined patient's life. Patient can barely walk at times.  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: Cardiac disorder
Clinical narrative: Heart problems; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NUS2023US017600 (Novartis).  A 76-year-old 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: CARDIAC DISORDER (non-serious), outcome "unknown", described as "Heart problems".  Additional information: Product was COVID-19 Vaccine. Reporter stated she got the COVID-19 vaccine, and it caused heart problems.  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: Fatigue, Pain, Pyrexia
Clinical narrative: Fever; Aches; Tiredness; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (ongoing), notes: I am on the lowest dose of an ace inhibitor which has managed my blood pressure for the last 3 years. The patient took concomitant medications. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Fever"; PAIN (non-serious), outcome "unknown", described as "Aches"; FATIGUE (non-serious), outcome "unknown", described as "Tiredness".  Additional Information: Reporter stated, "I am not comfortable using the form you sent to add personally identifiable information under your stated confidentiality policy. However, I will try to provide information about my situation in an effort to help with reporting possible adverse events. I am a female and have not had COVID. I had an original 2 dose regimen of Pfizer vaccine and then 2 Pfizer boosters. Aside from general reactions (fever, aches, tiredness), I had no other symptoms. At the end of Sep, I received the Moderna bivalent booster. Seven days later, my symptoms started. I began having severe visual auras, sight disturbances and dizziness. After consultation with my primary care provider, I had a thorough exam from my ophthalmologist who indicated that there were no changes to my eyes. My doctor then ordered an MRI of my brain. Unfortunately, it was not scheduled until early Dec. I was surprised to learn that I had several subacute ischemic strokes, probably in mid Oct or early Nov. Prior to this, I had no symptoms. I am on the lowest dose of an ace inhibitor which has managed my blood pressure for the last 3 years. My primary care doctor ordered several additional MRI tests, multiple ultrasounds, a heart monitor, EKG, and echocardiogram. All results indicated that I am healthy. At this point, I saw that Pfizer was found to have an increased stroke risk for adults over 65, Since I had kept a diary of my symptoms, I went back and realized that all my symptoms were the most intense in the 3 weeks following my Moderna booster. Since we have ruled out almost everything else, I wanted to report my adverse event in the hope that it will further your research."  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): PFIZER INC-202300067341 same patient/event, different vaccine dose number; PFIZER INC-202300067342 same patient/event, different vaccine dose number; PFIZER INC-202300067343 same patient/event, different vaccine dose number;
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: a large red circle around the injection site,larger than a grapefruit. Itching, redness, swelling,warm to the touch, painful to walk.; a large red circle around the injection site,larger than a grapefruit. Itching, redness, swelling,warm to the touch, painful to walk.; a large red circle around the injection site,larger than a grapefruit. Itching, redness, swelling,warm to the touch, painful to walk.; a large red circle around the injection site,larger than a grapefruit. Itching, redness, swelling,warm to the touch, painful to walk.; a large red circle around the injection site,larger than a grapefruit. Itching, redness, swelling,warm to the touch, painful to walk.; a large red circle around the injection site,larger than a grapefruit. Itching, redness, swelling,warm to the touch, painful to walk.; Initial information received on 10-Feb-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 years old female patient who had a large red circle around the injection site,larger than a grapefruit. itching, redness, swelling,warm to the touch, painful to walk after receiving vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL].  The patient had no past medical history, concomitant medication. The patient medical treatment(s),  vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE Solution for injection in pre-filled syringe (strength was unknown, lot number: U7526AA and expiry date was unknown) via intramuscular route in the right thigh for prophylactic vaccination.  On 10-Feb-2023 the patient developed a non-serious event of a large red circle around the injection site,larger than a grapefruit. itching, redness, swelling,warm to the touch, painful to walk. (pain, vaccination site pruritus, vaccination site erythema, vaccination site swelling, vaccination site warmth and vaccination site pain) (unknown latency) following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE.  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS AND IPV VACCINE (QUADRACEL) was not applicable.  It was not reported if the patient received a corrective treatment for the events.   Outcome: Not Recovered / Not Resolved for all events.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Pain
Clinical narrative: a large red circle around the injection site,larger than a grapefruit. Itching, redness, swelling,warm to the touch, painful to walk.; a large red circle around the injection site,larger than a grapefruit. Itching, redness, swelling,warm to the touch, painful to walk.; a large red circle around the injection site,larger than a grapefruit. Itching, redness, swelling,warm to the touch, painful to walk.; a large red circle around the injection site,larger than a grapefruit. Itching, redness, swelling,warm to the touch, painful to walk.; a large red circle around the injection site,larger than a grapefruit. Itching, redness, swelling,warm to the touch, painful to walk.; a large red circle around the injection site,larger than a grapefruit. Itching, redness, swelling,warm to the touch, painful to walk.; Initial information received on 10-Feb-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 years old female patient who had a large red circle around the injection site,larger than a grapefruit. itching, redness, swelling,warm to the touch, painful to walk after receiving vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL].  The patient had no past medical history, concomitant medication. The patient medical treatment(s),  vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE Solution for injection in pre-filled syringe (strength was unknown, lot number: U7526AA and expiry date was unknown) via intramuscular route in the right thigh for prophylactic vaccination.  On 10-Feb-2023 the patient developed a non-serious event of a large red circle around the injection site,larger than a grapefruit. itching, redness, swelling,warm to the touch, painful to walk. (pain, vaccination site pruritus, vaccination site erythema, vaccination site swelling, vaccination site warmth and vaccination site pain) (unknown latency) following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE.  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS AND IPV VACCINE (QUADRACEL) was not applicable.  It was not reported if the patient received a corrective treatment for the events.   Outcome: Not Recovered / Not Resolved for all events.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Flu; Initial information received on 23-Jan-2023 regarding an unsolicited valid social media serious case received from a consumer/non-health care professional.  This case involves an unknown age and unknown gender patient who experienced flu after 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 produced by unknown manufacturer (with lot number, dose, strength, formulation, expiry date: not reported) via unknown route in unknown administration site for prophylaxis.  On an unknown date the patient developed a serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.   Action taken: Not Applicable.  It was not reported if the patient received a corrective treatment for the event (Flu).  At time of reporting, the outcome was Unknown for the event flu.  Based on information previously received, the case classification has been updated from non valid to social media case and the case has been amended
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Gait disturbance, Limb discomfort, Oedema peripheral
Clinical narrative: could hardly walk/ Cannot walk very good; Legs heavy with fluid/legs filled heavy with fluid; Initial information received on 09-Feb-2023 regarding an unsolicited valid  courtesy non-serious case received via Pfizer from a consumer/non-hcp.  This case involves a 66 years old female patient (90.718 kg) whose legs heavy with fluid/legs filled heavy with fluid and could hardly walk/ cannot walk very good after receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE (MIRAPEX); VITAMINS NOS (MULTIVITAMINS [VITAMINS NOS]); VITAMIN D NOS (VITAMIN D NOS); and COVID-19 VACCINE (COVID-19 VACCINE).  On an unknown date, the patient received an unknown dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (strength, formulation, lot number and expiry date was unknown) via unknown route in unknown administration site for Prophylactic vaccination.  On 06-OCT-2022 the patient developed a non-serious event of  legs heavy with fluid/legs filled heavy with fluid (oedema peripheral) (latency: unknown) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  On an unknown date the patient developed a non-seriousevent of could hardly walk/ cannot walk very good (gait disturbance) (latency: unknown) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT) was not applicable.  It was not reported if the patient received a corrective treatment for the events.   Outcome: Not Recovered / Not Resolved for both events.
Sex: U
Vaccine: MNQ
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Two patients were administered MENQUADFI after not being suitable to use post temperature excursion with no reported adverse event; temperature excursion Negative 5.6 C  for 8 hours was caused by the door to the refrigerator being left open with no reported adverse event; Initial information received on 13-Feb-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves unknown age and unknown gender two patients who were administered meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] after not being suitable to use post temperature excursion with no reported adverse event and temperature excursion negative 5.6 c for 8 hours was caused by the door to the refrigerator being left open 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 an unknown date there was temperature excursion negative 5.6 c for 8 hours was caused by the door to the refrigerator being left open with no reported adverse event (product storage error) for meningococcal A-C-Y-W135 (T CONJ) vaccine.   On an unknown date, the patient received suspect meningococcal A-C-Y-W135 (T CONJ) vaccine at an unknown dose (lot number, expiry date: not reported) at an unknown administration site via unknown route for immunization.  On an unknown date the patient developed a non-serious two patients were administered menquadfi after not being suitable to use post temperature excursion with no reported adverse event (poor quality product administered) (same day latency).  Action taken: Not applicable.  Outcome: Unknown for both the events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: DTAP
Symptoms: Medication error, Poor quality product administered, Product storage error
Clinical narrative: temperature excursion was caused by the door to the refrigerator being left open with no adverse event; Three patients were administered DAPTACEL after not being suitable to use post temperature excursion with no adverse event; Initial information received on 13-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 3 patients of unknown gender who had received Diphtheria-15/Tetanus/5 AC Pertussis vaccine [Daptacel] after not being suitable to use post temperature excursion which was caused by the door to the refrigerator being left open.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patients received an unknown dose of suspect Diphtheria-15/Tetanus/5 AC Pertussis vaccine Suspension for injection (lot: C5893AA, expiry date: 21-JUN-2023) with unknown strength, frequency, route, anatomical location for Immunization and three patients were administered daptacel after not being suitable to use post temperature excursion (poor quality product administered) and temperature excursion was caused by the door to the refrigerator being left open (product storage error)  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: DTAPIPV
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: the temperature excursion was caused by the door to the refrigerator being left open was Negative 5.6 C for 8 HOURS with no reported adverse event; One patient was administered QUADRACEL after not being suitable to use post with no reported adverse event; Initial information received on 13-Feb-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to cases 2023SA051439, 2023SA051499 and 2023SA052444.  This case involves an unknown age/gender patient was administered Diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine [Quadracel] after not being suitable to use post with no reported adverse event and temperature excursion was caused by the door to the refrigerator being left open was negative 5.6 c for 8 hours with no reported adverse event   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect Diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine Suspension for injection (strength and dose were not reported) (lot U7564AA and expiry date- 08-Nov-2024 ) via unknown route in unknown administration site for immnunisation.  On an unknown date one patient was administered quadracel after not being suitable to use post with no reported adverse event (poor quality product administered)   It was reported -The temperature excursion was caused by the door to the refrigerator being left open was negative 5.6 c for 8 hours with no reported adverse event (product storage error) (unknown latency).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for both the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: condition was 48.9F for 7 days due to a refrigerator malfunction on 3-Feb-2023 with no reported adverse event; Adacel was administered post excursion with no reported adverse event; Initial information received from on 13-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 42 years old female patient and it was reported that condition was 48.9f for 7 days due to a refrigerator malfunction on 3-feb-2023 and diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] was administered post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitants and family history were not provided.   It was reported that the condition was 48.9f for 7 days due to a refrigerator malfunction on 3-feb-2023 with no reported adverse event (product storage error) and on 09-Feb-2023, a dose of 0.5 ml (1X) of suspect diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] suspension for injection (batch/lot number: U7648AA and expiry date: 15-feb-2025; strength: unknown) was administered via intramuscular route in the left deltoid for immunization post excursion with no reported adverse event (poor quality product administered) (latency: same day).  Action taken: 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 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:  01489250: 01489329: 01489354:
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Medication error, No adverse event, Poor quality product administered
Clinical narrative: ADACEL being administered post excursion with no reported adverse event; Initial information received on 13-Feb-2023 regarding an unsolicited valid non-serious case received via health professional. Agency number: 01489354  This case involves 49 years old female patient to whom Diphtheria-2/Tetanus/5 AC Pertussis Vaccine [Adacel] being administered post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. This case is linked to cases 2023SA051850, 2023SA051621 and 2023SA052675.  It was reported that "Caller reported a temperature excursion involving unopened Adacel, Tenivac and Menquadfi and was requesting stability information. The condition was 48.9F for 7 days due to a refrigerator malfunction on 3-Feb-2023 (not human error). None of the products were supported by the extended stability data. Caller also reports that 4 Adacel doses were administered after the excursion."    On 06-Feb-2023, the patient received booster dose suspect Adacel vaccine at 0.5ml once (lot: U7648AA, expiration: 15-Feb-2025) via intramuscular route in the left deltoid for Immunization being administered post excursion with no reported adverse event (poor quality product administered) at same day latency.  This situation is reported as a medication error due to ADACEL being administered post excursion.   Action taken with ADACEL vaccine was not applicable.  At time of reporting, the outcome was Unknown for the event poor quality product administered.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Medication error, No adverse event, Single component of a two-component product administered
Clinical narrative: administered the liquid DTAP-IPV without being reconstituted with the ACTHIB component with no adverse event; Initial information was received on 13-Feb-2023 regarding an unsolicited valid non-serious case received from a consumer/non-health-care professional.  This case involves 15 months old female patient who administered the liquid dtap-ipv without being reconstituted with the acthib component with no adverse event while receiving vaccine diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine [Pentacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 09-Feb-2023, the patient received a dose of 0.5 ml suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine (Suspension for injection) (lot UJ682AAA) (strength, expiry date unknown) via intramuscular route in the left vastus lateralis for Immunization.  On 09-Feb-2023 the patient developed a non-serious event of administered the liquid dtap-ipv without being reconstituted with the acthib component with no adverse event (single component of a two-component product administered) (latency: same day) following the administration of diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine.  Action taken : not applicable.  At time of reporting, the outcome was Unknown for the event administered the liquid dtap-ipv without being reconstituted with the acthib component with no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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: 0.58
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: administered an expired ACT-HIB vaccine to a patient, with no reported adverse event; Initial information received on 13-Feb-2023 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves a 7-month-old male patient to whom administered an expired HIB (PRP/T) VACCINE [ACT-HIB] vaccine, 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, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) for Immunisation; PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation; and INFLUENZA VACCINE INACT SPLIT 3V (FLULAVAL) for Immunisation.  On 13-Feb-2023, the patient received dose 3 at 0.5ml total of suspect HIB (PRP/T) VACCINE, Strength: standard (formulation: unknown) (Lot Number: UJ472AC, UJ472ACA; Expiration Date :2022-06-23, 2022-07-08) via intramuscular route in the left thigh for Immunization and on the same day administered an expired act-hib vaccine to a patient, with no reported adverse event (expired product administered).  It was reported that a nurse at the facility misread the expiration date on a vial of ACT-HIB of 23JUN2022 and believed that it didn't expire until 2023 so it was kept in the refrigerator. Caller asked for guidance on how to proceed in this situation. Caller asked if there was a waiting period for re-vaccination or if it could be done right away?   Action taken with HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) was not applicable.  At time of reporting, the outcome was Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: F
Vaccine: UNK
Symptoms: Medication error, No adverse event, Single component of a two-component product administered
Clinical narrative: Patient was administered DTAP-IPV component of PENTACEL without being reconstituted with the lyophilizes ACTHIB component,with no reported adverse event; Initial information was received on 13-Feb-2023 regarding an unsolicited valid non-serious case received from a consumer/non-health-care professional.  This case involves 1 years old female patient who stated patient was administered dtap-ipv component of pentacel without being reconstituted with the lyophilizes acthib component,with no reported adverse event after receiving diphtheria/tetanus/5 hybrid ac pertussis/IPV(vero)/HIB(PRP/T) vaccine [Pentacel (VERO)].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine.  On 10-Feb-2023, the patient received a 0.5ml, total dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/IPV(vero)/HIB(PRP/T) vaccine Suspension for injection (lot: UJ682AAA, expiration date:16-Sep-2023) via intramuscular route in the left vastus lateralis for Immunization.  On 10-Feb-2023 the patient developed a non-serious event patient was administered dtap-ipv component of pentacel without being reconstituted with the lyophilizes acthib component,with no reported adverse event (single component of a two-component product administered) following the administration of diphtheria/tetanus/5 hybrid ac pertussis/IPV(vero)/HIB(PRP/T) vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: patient was given expired menactra this morning with no reported adverse event; Initial information received on 13-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 12 years old male patient who was given expired meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra] this morning 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 HPV vaccine, influenza vaccine (flu [influenza vaccine]) and diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) all for Prophylactic vaccination.  On 13-Feb-2023 at around 10.30, the patient received expired dose of 0.5 ml suspect meningococcal A-C-Y-W135 (D CONJ) vaccine solution for injection (lot: U7208AA, expiry date: 10-Feb-2023) via unknown route in unknown administration site for immunization with no reported adverse event (expired product administered).  Action taken: not applicable.  At time of reporting, the outcome was Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.