chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: RSV, RSV
Symptoms: Exposure during pregnancy, Product use issue, Wrong product administered
Clinical narrative: I was wrongly administered Arexvy at 9 months pregnant; This non-serious prospective pregnancy case was reported by a consumer via sales rep and described the occurrence of drug exposure during pregnancy in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 20-OCT-2023, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced drug exposure during pregnancy (Verbatim: I was wrongly administered Arexvy at 9 months pregnant). The outcome of the drug exposure during pregnancy was unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 23-OCT-2023 The patient reported that was wrongly administered with Arexvy at 9 months pregnant.  The patient was concern because it was contraindicated for pregnant women.  The reporter asked the risks to the fetus. The reporter consented to follow up.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myocardial infarction
Clinical narrative: died at home within a few days of feeling ill; ill/feel ill; The initial case was missing the following minimum criteria: [Unspecified number of patients]. Upon receipt of follow-up information on [30Oct2023], 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.  A 72-year-old female patient received bnt162b2 (BNT162B2), on 19Nov2021 as dose 2, single (Batch/Lot number: unknown) at the age of 72 years for covid-19 immunisation. The patient's relevant medical history included: "Thyroid" (ongoing); "High Cholesterol" (ongoing). The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: MALAISE (medically significant) with onset Nov2021, 5 hrs after the suspect product(s) administration, outcome "unknown", described as "ill/feel ill"; DEATH (death), outcome "fatal", described as "died at home within a few days of feeling ill". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Clinical course: It was unknown if other vaccinations were received within four weeks prior to the first administration date of the suspect vaccine, unknown if relevant diagnostic and confirmatory test results for event(s),COVID-19 testing was conducted, unknown if specific relevant test for thromboembolic events with thrombocytopenia was conducted. It was reported by the reporter that they had history of heart attacks however her mom was healthy she felt ill as soon as she was given the injection 5 hrs into receiving the vaccine.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.  Follow up (30Oct2023): This is a spontaneous follow up report received from same contactable consumer. Updated information included: Case updated to Valid, patient details, relevant medical history, historical vaccine, suspect dose details, vaccine facility address and new events added.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: died at home within a few days of feeling ill
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death, Malaise
Clinical narrative: died at home within a few days of feeling ill; ill/feel ill; The initial case was missing the following minimum criteria: [Unspecified number of patients]. Upon receipt of follow-up information on [30Oct2023], 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.  A 72-year-old female patient received bnt162b2 (BNT162B2), on 19Nov2021 as dose 2, single (Batch/Lot number: unknown) at the age of 72 years for covid-19 immunisation. The patient's relevant medical history included: "Thyroid" (ongoing); "High Cholesterol" (ongoing). The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: MALAISE (medically significant) with onset Nov2021, 5 hrs after the suspect product(s) administration, outcome "unknown", described as "ill/feel ill"; DEATH (death), outcome "fatal", described as "died at home within a few days of feeling ill". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Clinical course: It was unknown if other vaccinations were received within four weeks prior to the first administration date of the suspect vaccine, unknown if relevant diagnostic and confirmatory test results for event(s),COVID-19 testing was conducted, unknown if specific relevant test for thromboembolic events with thrombocytopenia was conducted. It was reported by the reporter that they had history of heart attacks however her mom was healthy she felt ill as soon as she was given the injection 5 hrs into receiving the vaccine.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.  Follow up (30Oct2023): This is a spontaneous follow up report received from same contactable consumer. Updated information included: Case updated to Valid, patient details, relevant medical history, historical vaccine, suspect dose details, vaccine facility address and new events added.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: died at home within a few days of feeling ill
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Atrial fibrillation, Dyspnoea, Electrocardiogram, Fatigue, Malaise
Clinical narrative: I am short of breath, high heart rate, showing afib; I am short of breath, high heart rate, showing afib; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (I am short of breath, high heart rate, showing afib) in a 70-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Heart failure (The patient was 70 years old with some heart failure issues but have never had afib).    On 17-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In October 2023, the patient experienced ATRIAL FIBRILLATION (I am short of breath, high heart rate, showing afib) (seriousness criterion medically significant) and DYSPNOEA (I am short of breath, high heart rate, showing afib). At the time of the report, ATRIAL FIBRILLATION (I am short of breath, high heart rate, showing afib) and DYSPNOEA (I am short of breath, high heart rate, showing afib) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2023, Heart rate: High heart rate.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  The patient received the Moderna covid vaccine. Between then and now at the time of report the patient had short of breath, high heart rate and showing afib. It came about right after the vaccine.  He had a cardioversion scheduled for later in November.  Treatment information was not provided.   Company Comment: This is a spontaneous case concerning a 70-year-old, male with relevant current condition of Heart failure, who experienced the serious (due to medically significant) unexpected AESI of Atrial fibrillation, and the non-serious unexpected event of Dyspnoea. The event Atrial fibrillation occurred on an unknown date in October, after a dose of SPIKEVAX 2023-2024. Clinical course and supportive diagnostic procedures were not reported. The patient had a cardioversion scheduled for later in November. The outcome of the event was reported as not recovered. The mentioned medical history remains as a confounder. The benefit-risk relationship of SPIKEVAX 2023-2024 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 01-Nov-2023: Live follow-up information received included updated Reporter and Reference Id updated.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Palpitations
Clinical narrative: I am short of breath, high heart rate, showing afib; I am short of breath, high heart rate, showing afib; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (I am short of breath, high heart rate, showing afib) in a 70-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Heart failure (The patient was 70 years old with some heart failure issues but have never had afib).    On 17-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In October 2023, the patient experienced ATRIAL FIBRILLATION (I am short of breath, high heart rate, showing afib) (seriousness criterion medically significant) and DYSPNOEA (I am short of breath, high heart rate, showing afib). At the time of the report, ATRIAL FIBRILLATION (I am short of breath, high heart rate, showing afib) and DYSPNOEA (I am short of breath, high heart rate, showing afib) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2023, Heart rate: High heart rate.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  The patient received the Moderna covid vaccine. Between then and now at the time of report the patient had short of breath, high heart rate and showing afib. It came about right after the vaccine.  He had a cardioversion scheduled for later in November.  Treatment information was not provided.   Company Comment: This is a spontaneous case concerning a 70-year-old, male with relevant current condition of Heart failure, who experienced the serious (due to medically significant) unexpected AESI of Atrial fibrillation, and the non-serious unexpected event of Dyspnoea. The event Atrial fibrillation occurred on an unknown date in October, after a dose of SPIKEVAX 2023-2024. Clinical course and supportive diagnostic procedures were not reported. The patient had a cardioversion scheduled for later in November. The outcome of the event was reported as not recovered. The mentioned medical history remains as a confounder. The benefit-risk relationship of SPIKEVAX 2023-2024 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 01-Nov-2023: Live follow-up information received included updated Reporter and Reference Id updated.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Atrial fibrillation, Dyspnoea, Electrocardiogram, Heart rate increased
Clinical narrative: I am short of breath, high heart rate, showing afib; I am short of breath, high heart rate, showing afib; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (I am short of breath, high heart rate, showing afib) in a 70-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Heart failure (The patient was 70 years old with some heart failure issues but have never had afib).    On 17-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In October 2023, the patient experienced ATRIAL FIBRILLATION (I am short of breath, high heart rate, showing afib) (seriousness criterion medically significant) and DYSPNOEA (I am short of breath, high heart rate, showing afib). At the time of the report, ATRIAL FIBRILLATION (I am short of breath, high heart rate, showing afib) and DYSPNOEA (I am short of breath, high heart rate, showing afib) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2023, Heart rate: High heart rate.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  The patient received the Moderna covid vaccine. Between then and now at the time of report the patient had short of breath, high heart rate and showing afib. It came about right after the vaccine.  He had a cardioversion scheduled for later in November.  Treatment information was not provided.   Company Comment: This is a spontaneous case concerning a 70-year-old, male with relevant current condition of Heart failure, who experienced the serious (due to medically significant) unexpected AESI of Atrial fibrillation, and the non-serious unexpected event of Dyspnoea. The event Atrial fibrillation occurred on an unknown date in October, after a dose of SPIKEVAX 2023-2024. Clinical course and supportive diagnostic procedures were not reported. The patient had a cardioversion scheduled for later in November. The outcome of the event was reported as not recovered. The mentioned medical history remains as a confounder. The benefit-risk relationship of SPIKEVAX 2023-2024 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 01-Nov-2023: Live follow-up information received included updated Reporter and Reference Id updated.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Atrial fibrillation, Dyspnoea, Heart rate increased
Clinical narrative: I am short of breath, high heart rate, showing afib; I am short of breath, high heart rate, showing afib; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (I am short of breath, high heart rate, showing afib) in a 70-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Heart failure (The patient was 70 years old with some heart failure issues but have never had afib).    On 17-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In October 2023, the patient experienced ATRIAL FIBRILLATION (I am short of breath, high heart rate, showing afib) (seriousness criterion medically significant) and DYSPNOEA (I am short of breath, high heart rate, showing afib). At the time of the report, ATRIAL FIBRILLATION (I am short of breath, high heart rate, showing afib) and DYSPNOEA (I am short of breath, high heart rate, showing afib) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2023, Heart rate: High heart rate.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  The patient received the Moderna covid vaccine. Between then and now at the time of report the patient had short of breath, high heart rate and showing afib. It came about right after the vaccine.  He had a cardioversion scheduled for later in November.  Treatment information was not provided.   Company Comment: This is a spontaneous case concerning a 70-year-old, male with relevant current condition of Heart failure, who experienced the serious (due to medically significant) unexpected AESI of Atrial fibrillation, and the non-serious unexpected event of Dyspnoea. The event Atrial fibrillation occurred on an unknown date in October, after a dose of SPIKEVAX 2023-2024. Clinical course and supportive diagnostic procedures were not reported. The patient had a cardioversion scheduled for later in November. The outcome of the event was reported as not recovered. The mentioned medical history remains as a confounder. The benefit-risk relationship of SPIKEVAX 2023-2024 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 01-Nov-2023: Live follow-up information received included updated Reporter and Reference Id updated.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cognitive disorder, Dizziness, Fatigue, Headache, Hyperaesthesia
Clinical narrative: PCR Nasal swab Positive; PCR Nasal swab Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 17-year-old male patient received bnt162b2 (BNT162B2), on 02Apr2021 at 12:00 as dose 1, single (Lot number: ER8737), in left arm and on 29Apr2021 at 12:00 as dose 2, single (Lot number: EW0171) at the age of 17 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "ADHD" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2021, outcome "unknown" and all described as "PCR Nasal swab Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2021) Positive, notes: Nasal Swab/PCR. Clinical course: Patient also received  bnt162b2 (BNT162B2), on 13Dec2021 at 12:00 as dose 3 (booster), single (Lot number: FJ8757), in left arm for covid-19 immunisation. Patient had no known allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300350549 Same patient/same product, different event;
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Musculoskeletal pain, Nausea, Pruritus, Temperature regulation disorder
Clinical narrative: PCR Nasal swab Positive; PCR Nasal swab Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 17-year-old male patient received bnt162b2 (BNT162B2), on 02Apr2021 at 12:00 as dose 1, single (Lot number: ER8737), in left arm and on 29Apr2021 at 12:00 as dose 2, single (Lot number: EW0171) at the age of 17 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "ADHD" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2021, outcome "unknown" and all described as "PCR Nasal swab Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2021) Positive, notes: Nasal Swab/PCR. Clinical course: Patient also received  bnt162b2 (BNT162B2), on 13Dec2021 at 12:00 as dose 3 (booster), single (Lot number: FJ8757), in left arm for covid-19 immunisation. Patient had no known allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300350549 Same patient/same product, different event;
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: PCR Nasal swab Positive; PCR Nasal swab Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 17-year-old male patient received bnt162b2 (BNT162B2), on 02Apr2021 at 12:00 as dose 1, single (Lot number: ER8737), in left arm and on 29Apr2021 at 12:00 as dose 2, single (Lot number: EW0171) at the age of 17 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "ADHD" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2021, outcome "unknown" and all described as "PCR Nasal swab Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2021) Positive, notes: Nasal Swab/PCR. Clinical course: Patient also received  bnt162b2 (BNT162B2), on 13Dec2021 at 12:00 as dose 3 (booster), single (Lot number: FJ8757), in left arm for covid-19 immunisation. Patient had no known allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300350549 Same patient/same product, different event;
Sex: F
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product preparation error
Clinical narrative: Caller states the patient is fine and nothing happened; A patient received the varicella vaccine and instead of it being reconstituted with diluent it was reconstituted with RETACRIT on accident.; This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. Her concurrent coditions included hypothyroidism and seasonal allergy. The patient's medical history included delivery, she was a postpartum patient, right after had baby. Concomitant therapies included levothyroxine.  On 22-SEP-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 milliliter, subcutaneously, lot #X010531, expiration date 11-APR-2025 (injection site was not reported) for prophylaxis.  A nurse who was giving the patient a varicella virus vaccine live (oka/merck)(VARIVAX), instead of mixing it with sterile diluent, mixed it with epoetin zeta (RETACRIT) and administered intramuscularly, later clarified subcutaneously. The reporter asked if there was any stability data or any information on what would happen. The patient was fine and nothing happened after it was administered. She was not typically on epoetin zeta (RETACRIT).
Age: 47.0
Sex: U
Vaccine: VARCEL
Symptoms: Contraindicated product administered
Clinical narrative: No symptoms reported; Administering VARIVAX to a patient that is immunocompromised. No symptoms reported; This spontaneous report was received from a Pharmacist and refers to a 47-year-old immunocompromised patient of unspecified gender. The patient's medical history was not reported. Concomitant therapies were not reported.  On 05-OCT-2023 the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) injection, lot #W031812, expiration date: 05-OCT-2024, administered for prophylaxis (strength, and route of administration were not provided).  The patient was also receiving adalimumab (HUMIRA) (contraindicated product administered).  No symptoms or further details reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: HCP was transferred from specialist to evaluate expired PNEUMOVAX 23(PFS) inadvertently given to a patient. HCP stated no side effects have been reported. HCP confirmed there was no T/E. HCP stated it was an MA who administered the vaccine. HCP was s; HCP was transferred from specialist to evaluate expired PNEUMOVAX 23(PFS) inadvertently given to a patient. HCP stated no side effects have been reported. HCP confirmed there was no T/E. HCP stated it was an MA who administered the vaccine. HCP was s; Information has been received from an specialist via a health care professional, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 25-SEP-2023, the patient was inadvertently vaccinated by a medical assistant (MA) with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, 1 dose, lot #U032086, expiration date: 29-AUG-2023, administered for prophylaxis (strength, and route of administration were not provided). No adverse effects were reported.   The reporting health care professional confirmed there was no temperature excursions.
Sex: F
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE/PQC; HCP called to report that a dose of MMR II was inadvertently administered after undergoing a TE.; This spontaneous report was received from a nurse referring to an 8-years-old female patient. The patient's pertinent medical history, concomitant therapies, and drug reactions or allergies were not reported.  On 12-OCT-2023, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live recombinant human albumin (rHa) (M-M-R II) injection 0.5 mL, lot number: U038863 was verified to be a valid lot number for Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live rHa (M-M-R II), expiration date was provided and upon internal validation was confirmed to be: 20-JUN-2024 as prophylaxis (route of administration, frequency, anatomical location, lot number, and expiration date were not reported), was inadvertently administered after undergoing a temperature excursion (Product storage error) with a temperature of 53.9 F for 1 hour (no previous excursions). No additional adverse event (AE).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No AE/PQC reported; product was administered after experiencing temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant therapies were not reported.  On 10-OCT-2023, the patient was vaccinated with improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) for prophylaxis (lot # X010531, expiration date: 11-APR-2025; strength, dose and route of administration were not reported). The vaccine had been stored under -1.8 degrees Celsius for 1 hour and 6 minutes (product storage error). There was no previous temperature excursion. No adverse event (AE) or product quality complaint (PQC) was reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no AE; expired vaccine and expired diluent administered; This spontaneous report was received from a medical assistant and refers to a patient of unknow age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 18-OCT-2023, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, 0.5 milliliter, lot #U025200, expiration date: 13-AUG-2023, administered for prophylaxis (strength, and route of administration were not provided); and  sterile diluent (STERILE DILUENT) solution for injection/infusion, unknown, lot #T029530, expiration date: 10-MAR-2023 (strength, route of administration, and indication were not provided) (Expired product administered). Products had not experienced temperature excursion through date of administration. No additional adverse event was reported.
Age: 34.0
Sex: F
Vaccine: MMR
Symptoms: Pain in extremity, Product administered by wrong person
Clinical narrative: MMR II was administered intradermally rather than sub-cutaneous or intramuscular / process medication error ocurred at: administration; Was the operator trained? No MD administered due to no RN available; Sore arm; This spontaneous report was received from a physician and refers to an unspecified patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 18-OCT-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, administered intradermally rather than sub-cutaneous or intramuscular (Incorrect route of product administration) (strength, lot #, expiry date, dose, and indication were not provided). It was confirmed with HCP that no signs/symptoms of adverse reactions had been reported.   This case was considered as non-valid due to lack of patient identifiers.  Follow-up information has been received from the physician on 26-OCT-2023.  The patient was a 34-year-old female.  On 18-OCT-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection (Lot number 3P993 is an invalid lot number for M-M-R II, expiration date reported as 30-JUN-2024) at a dose of 5 ml, administered intradermally instead of sub-cutaneous or intramuscular (Incorrect route of product administration) at her left arm (reported as L triceps). The vaccine was administered by a medical doctor (MD) as no registered nurse (RN) was available at private doctor's office/hospital, however, it was reported that the operator of vaccine (MD) was not trained (Product administered by wrong person). It was mentioned that the patient had no illness at time of vaccination.  On an unspecified date in October 2023, the patient experienced sore arm (Pain in extremity) (also reported that the patient had no adverse reaction [conflicting information]). It was not required a prescription drug treatment for the experience.  The outcome of the event of sore arm and its causal relationship with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), were not provided.
Sex: F
Vaccine: MMR
Symptoms: Occupational exposure to product
Clinical narrative: No additional symptoms were reported/No additional AE/PQC; inadvertent exposure to MMR-II during vaccine preparation for a patient; Nurse stated that during preparation of the vaccine, she accidently splashed a small amount of MMR-II into her own eye.; This spontaneous report has been received from a 33-year-old female nurse, referring to herself. Information regarding current conditions, pertinent medical history, previous drug reactions or allergies and concomitant medications were not provided.  On 19-OCT-2023, the nurse experienced an inadvertent exposure to measles, mumps, and rubella recombinant Human albumin (rHA) (Wistar RA 27-3) virus vaccine, live (M-M-R II) subcutaneous injection (dose, route of administration and anatomical location of vaccination were not provided; lot number W035197 has been verified to be valid, expiration date 24-MAY-2024) during vaccine preparation for a patient as prophylaxis (accidental exposure to product); she accidently splashed a small amount of the vaccine into her own eye (occupational exposure to product). No additional symptoms or events were reported. The patient that was scheduled for the measles, mumps, and rubella recombinant Human albumin (rHA) (Wistar RA 27-3) virus vaccine, live (M-M-R II) administration was still able to receive a full dose.
Age: 14.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No other AE and no PQC; Administration to a 14 Year Old Patient; This spontaneous report was received from a pharmacist and referred to a 14-year-old patient of unknown gender. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On 17-OCT-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant Human albumin (rHA) (PROQUAD) injection, lot #X012610, expiration date: 29-OCT-2024, administered for prophylaxis (strength, anatomical site of administration and route of administration were not provided) administered by a Health Professional (product administered to patient of inappropriate age). No other adverse event (AE).
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Adverse event, Alopecia, Anaemia, Arthralgia, Autoimmune disorder
Clinical narrative: Systemic Lupus Erythematosus, joint pain, extreme fatigue, thinning hair,malar rash, anemia; deep vein thrombosis; pulmonary embolism; costochondritis; neurological; constellation of adverse symptoms, complications, injuries, and other adverse events; complications and other adverse events; This spontaneous report was received from a lawyer regarding a case in litigation and referred to a currently adult female patient. No information was provided regarding concomitant medications, concurrent conditions or medical history. The patient was a healthy prior to receiving quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). On unknown dates (at age of 16 of the patient), the patient vaccined with first, second and third dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection (strength, dose, lot #, expiry date and route of administration were not provided) for prophylaxis. Following her vaccinations, the patient began to have joint pain, extreme fatigue, thinning hair, and malar rash. As the months progressed, so did the patient's symptoms. She was seen by multiple physicians and specialists for her complaints. Based upon her chronic and severe post-vaccination symptoms. The patient had been diagnosed with various medical conditions with autoimmune and neurological (neurological disorder), injuries, including but not limited to: lupus, systemic lupus erythematosus, anemia, deep vein thrombosis, pulmonary embolism, costochondritis as well as a constellation of adverse symptoms, complications, injuries, and other adverse events (Ill-defined disorder, adverse event). The patient had been unable to engage in activities a young person would normally enjoy and had been unable to maintain a full-time job due to her symptoms. The outcome of all events was considered as not recovered. The lawyer considered quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) caused all events. Upon internal review, the events systemic lupus erythematosus, deep vein thrombosis and pulmonary embolism were determined to be medically significant. All events were considered as disability.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Butterfly rash, Costochondritis, Deep vein thrombosis, Disability, Fatigue
Clinical narrative: Systemic Lupus Erythematosus, joint pain, extreme fatigue, thinning hair,malar rash, anemia; deep vein thrombosis; pulmonary embolism; costochondritis; neurological; constellation of adverse symptoms, complications, injuries, and other adverse events; complications and other adverse events; This spontaneous report was received from a lawyer regarding a case in litigation and referred to a currently adult female patient. No information was provided regarding concomitant medications, concurrent conditions or medical history. The patient was a healthy prior to receiving quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). On unknown dates (at age of 16 of the patient), the patient vaccined with first, second and third dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection (strength, dose, lot #, expiry date and route of administration were not provided) for prophylaxis. Following her vaccinations, the patient began to have joint pain, extreme fatigue, thinning hair, and malar rash. As the months progressed, so did the patient's symptoms. She was seen by multiple physicians and specialists for her complaints. Based upon her chronic and severe post-vaccination symptoms. The patient had been diagnosed with various medical conditions with autoimmune and neurological (neurological disorder), injuries, including but not limited to: lupus, systemic lupus erythematosus, anemia, deep vein thrombosis, pulmonary embolism, costochondritis as well as a constellation of adverse symptoms, complications, injuries, and other adverse events (Ill-defined disorder, adverse event). The patient had been unable to engage in activities a young person would normally enjoy and had been unable to maintain a full-time job due to her symptoms. The outcome of all events was considered as not recovered. The lawyer considered quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) caused all events. Upon internal review, the events systemic lupus erythematosus, deep vein thrombosis and pulmonary embolism were determined to be medically significant. All events were considered as disability.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Ill-defined disorder, Impaired work ability, Loss of personal independence in daily activities, Nervous system disorder, Pulmonary embolism
Clinical narrative: Systemic Lupus Erythematosus, joint pain, extreme fatigue, thinning hair,malar rash, anemia; deep vein thrombosis; pulmonary embolism; costochondritis; neurological; constellation of adverse symptoms, complications, injuries, and other adverse events; complications and other adverse events; This spontaneous report was received from a lawyer regarding a case in litigation and referred to a currently adult female patient. No information was provided regarding concomitant medications, concurrent conditions or medical history. The patient was a healthy prior to receiving quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). On unknown dates (at age of 16 of the patient), the patient vaccined with first, second and third dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection (strength, dose, lot #, expiry date and route of administration were not provided) for prophylaxis. Following her vaccinations, the patient began to have joint pain, extreme fatigue, thinning hair, and malar rash. As the months progressed, so did the patient's symptoms. She was seen by multiple physicians and specialists for her complaints. Based upon her chronic and severe post-vaccination symptoms. The patient had been diagnosed with various medical conditions with autoimmune and neurological (neurological disorder), injuries, including but not limited to: lupus, systemic lupus erythematosus, anemia, deep vein thrombosis, pulmonary embolism, costochondritis as well as a constellation of adverse symptoms, complications, injuries, and other adverse events (Ill-defined disorder, adverse event). The patient had been unable to engage in activities a young person would normally enjoy and had been unable to maintain a full-time job due to her symptoms. The outcome of all events was considered as not recovered. The lawyer considered quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) caused all events. Upon internal review, the events systemic lupus erythematosus, deep vein thrombosis and pulmonary embolism were determined to be medically significant. All events were considered as disability.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Systemic lupus erythematosus
Clinical narrative: Systemic Lupus Erythematosus, joint pain, extreme fatigue, thinning hair,malar rash, anemia; deep vein thrombosis; pulmonary embolism; costochondritis; neurological; constellation of adverse symptoms, complications, injuries, and other adverse events; complications and other adverse events; This spontaneous report was received from a lawyer regarding a case in litigation and referred to a currently adult female patient. No information was provided regarding concomitant medications, concurrent conditions or medical history. The patient was a healthy prior to receiving quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). On unknown dates (at age of 16 of the patient), the patient vaccined with first, second and third dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection (strength, dose, lot #, expiry date and route of administration were not provided) for prophylaxis. Following her vaccinations, the patient began to have joint pain, extreme fatigue, thinning hair, and malar rash. As the months progressed, so did the patient's symptoms. She was seen by multiple physicians and specialists for her complaints. Based upon her chronic and severe post-vaccination symptoms. The patient had been diagnosed with various medical conditions with autoimmune and neurological (neurological disorder), injuries, including but not limited to: lupus, systemic lupus erythematosus, anemia, deep vein thrombosis, pulmonary embolism, costochondritis as well as a constellation of adverse symptoms, complications, injuries, and other adverse events (Ill-defined disorder, adverse event). The patient had been unable to engage in activities a young person would normally enjoy and had been unable to maintain a full-time job due to her symptoms. The outcome of all events was considered as not recovered. The lawyer considered quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) caused all events. Upon internal review, the events systemic lupus erythematosus, deep vein thrombosis and pulmonary embolism were determined to be medically significant. All events were considered as disability.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Adnexa uteri pain, Bradykinesia, Complication of pregnancy, Dysmenorrhoea
Clinical narrative: miscarriage; ovarian cysts/ovarian pain/dysmenorrhea; chronic migraines/headaches; chronic pelvic congestion syndrome; decreased or slow movements; The patient has been unable to engage in activities that a young person her age would normally enjoy; Her educational performance suffered; GERD; The patient endured difficult pregnancies thereafter; rash on her arm; chronic fatigue; This initial spontaneous report was received from a lawyer regarding a case in litigation concerning to a 14-year-old female patient. Information regarding medical history, concurrent conditions and concomitant medications was not provided.  On unknown dates, the patient was inoculated with the first, second and third doses of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (dose, strength, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis. On an unknown date, subsequently after receiving Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL), the patient experienced a rash on her arm, decreased or slow movements, headaches, ovarian pain, dysmenorrhea, gastrointestinal problems such as gastrooesophageal reflux disease (GERD), chronic migraines, chronic fatigue, pelvic congestion, and she developed cysts on her ovaries. She was seen by multiple physicians and frequently visited the Emergency Room for these complaints. She suffered a miscarriage and endured difficult pregnancies (pregnancy disorder) thereafter. The first-time patient discovered that her injuries could have been caused by Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) was in February 2021. Furthermore, the patient had been unable to engage in activities that a young person her age would normally enjoy. She had suffered chronic fatigue and pain which made it difficult to function. Her educational performance suffered because of her symptoms and daily tasks became burdensome. Moreover, the patient suffered and continued to suffer severe and permanent physical injuries, and associated symptomology and had suffered severe and permanent emotional injuries, including pain and suffering. The outcome of the event of the events was unknown. The reporter considered the events to be related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL).  Upon internal review, the events of abortion spontaneous, ovarian cysts, GERD, migraine, pelvic congestion, hypokinesia, pregnancy disorder, loss of personal independence in daily activities, educational problem, rash and fatigue were considered to be disabling events. The event of abortion spontaneous was determined to be medically significant event.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Educational problem, Fatigue, Gastrointestinal disorder, Gastrooesophageal reflux disease, Headache
Clinical narrative: miscarriage; ovarian cysts/ovarian pain/dysmenorrhea; chronic migraines/headaches; chronic pelvic congestion syndrome; decreased or slow movements; The patient has been unable to engage in activities that a young person her age would normally enjoy; Her educational performance suffered; GERD; The patient endured difficult pregnancies thereafter; rash on her arm; chronic fatigue; This initial spontaneous report was received from a lawyer regarding a case in litigation concerning to a 14-year-old female patient. Information regarding medical history, concurrent conditions and concomitant medications was not provided.  On unknown dates, the patient was inoculated with the first, second and third doses of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (dose, strength, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis. On an unknown date, subsequently after receiving Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL), the patient experienced a rash on her arm, decreased or slow movements, headaches, ovarian pain, dysmenorrhea, gastrointestinal problems such as gastrooesophageal reflux disease (GERD), chronic migraines, chronic fatigue, pelvic congestion, and she developed cysts on her ovaries. She was seen by multiple physicians and frequently visited the Emergency Room for these complaints. She suffered a miscarriage and endured difficult pregnancies (pregnancy disorder) thereafter. The first-time patient discovered that her injuries could have been caused by Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) was in February 2021. Furthermore, the patient had been unable to engage in activities that a young person her age would normally enjoy. She had suffered chronic fatigue and pain which made it difficult to function. Her educational performance suffered because of her symptoms and daily tasks became burdensome. Moreover, the patient suffered and continued to suffer severe and permanent physical injuries, and associated symptomology and had suffered severe and permanent emotional injuries, including pain and suffering. The outcome of the event of the events was unknown. The reporter considered the events to be related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL).  Upon internal review, the events of abortion spontaneous, ovarian cysts, GERD, migraine, pelvic congestion, hypokinesia, pregnancy disorder, loss of personal independence in daily activities, educational problem, rash and fatigue were considered to be disabling events. The event of abortion spontaneous was determined to be medically significant event.