chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid positive; Covid positive; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 55-year-old female patient received BNT162b2 (BNT162B2), on 06Jan2021 at 11:00 as dose 1, single (Lot number: ER9231), in left deltoid, on 27Jan2021 at 11:00 as dose 2, single (Lot number: EL9261), in right deltoid and on 26Dec2021 at 10:00 as dose 3 (booster), single (Lot number: 330258D) at the age of 55 years, in left deltoid, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Grief", start date: 2020 (ongoing); "Allergies" (unspecified if ongoing); "Joint health" (unspecified if ongoing); "Bone health" (unspecified if ongoing); "Knee surgery" (ongoing); "Depression", start date: 2020 (ongoing). Concomitant medication(s) included: VENLAFAXINE oral taken for depression, start date: 2020 (ongoing); CETRIZINE oral taken for multiple allergies, start date: 2007 (ongoing); OSTEO BI-FLEX [CHONDROITIN SULFATE;GLUCOSAMINE HYDROCHLORIDE] oral taken for arthropathy, start date: 2015 (ongoing); CALCITRATE oral taken for bone disorder, start date: 2018 (ongoing).  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 17Aug2022, outcome "recovered" (22Aug2022) and all described as "Covid positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Aug2022) Positive; (17Aug2022) Positive.  Clinical course: Complete if a 3rd or Subsequent dose was administered. Check one option: Booster dose due to high risk of frequent institutional or occupational exposure to coronavirus (and at risk of serious COVID-19 complications): Checked, Healthcare. worker. Drug Name: Multivitamin, route: oral. Farmly Covid positive on 14Aug2022. Patient tested positive on 17Aug, only symptoms are sinus drip daily plus low-grade fever 100.5 on day 0. fever free next 5 days. Family Medical History Relevant to Adverse Events (AEs): Her husband contracted COVID early in the pandemic and dead due to the illness in May2020. She had initial exposure, but never had symptoms, therefore never tested but did have a neg antibody test months later. Specific Relevant Test for thromboembolic events with thrombocytopenia was none reported.; Sender's Comments: Based on the information currently available, The casual association between the reported eventS and suspected drug cannot be completely excluded.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Your jabs do not prevent Covid; Your jabs do not prevent Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown).  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 "Your jabs do not prevent Covid".  Clinical course: It was reported that patient had concerns about their new ad with (Name withheld). A sword for unwanted guests. geared toward the unvaccinated. It was insulting, divisive and threatening. They were inciting violence and Patient was reporting them to one of their representatives. Their jabs did not prevent Covid. Stop the (withheld). They had a president placed from his basement who caused enough division. Lay off the unvaccinated.   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: my mom died; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death), outcome "fatal", described as "my mom died". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Clinical course: Reporter was inmate at (institute name withheld). Reporter found out what you put in the vaccines and other pharmecuticals, how you were involved in the Covid 19 scandal and corrupt scientists. Reporter knew all about your nanotechnology trash used to control people. Reporter's mom died because of your secret.  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: my mom died
Sex: F
Vaccine: COVID19
Symptoms: Lymphoma
Clinical narrative: Patients undiagnosed lymphoma was activated/reactivated following Pfizer COVID-19 booster shot.; This is a spontaneous report received from non-contactable reporter(s) (Physician) from a sales representative.  A female patient in her 40's (unknown if pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete, Unknown Manufacturer), for COVID-19 immunization. The following information was reported: LYMPHOMA (medically significant), outcome "unknown", described as "Patients undiagnosed lymphoma was activated/reactivated following Pfizer COVID-19 booster shot.".  Clinical course: Event took place after use of product.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available,The casual association between the reported "LYMPHOMA" and suspected drug cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: stroke; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative. The reporter is the patient.  A 78-year-old male patient received BNT162b2 (COMIRNATY), in 2021 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), administration date: 2021, for COVID-19 IMMUNIZATION. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), 3 months after the suspect product(s) administration, outcome "unknown", described as "stroke". The patient experienced a stroke and otherwise was healthy and active, and still practicing medicine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the temporal relation, the association between the event of cerebrovascular accident and the suspect product cannot be completely ruled out.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 1.33
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: expired acthib administered with no reported adverse event; Initial information received on 07-Feb-2023 regarding an unsolicited valid non-serious case received via health professional and physician. GMI number: 01481511.  This case involves 16 months old male patient to whom expired vaccine HIB (PRP/T) VACCINE [ACT-HIB] administered 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 seven patient cases 2023SA046745, 2023SA045123, 2023SA045388, 2023SA046763, 2023SA046771 and 2023SA046834.  On 31-Jan-2023, the patient received expired fourth dose of suspect HIB (PRP/T) VACCINE at dose 0.5 ml once (lot: UJ594AAA, expiry date: 26-Oct-2022) via intramuscular route in the right deltoid for Immunization with no reported adverse event (expired product administered) at same day latency.  This situation is reported as a medication error due to seven patients being administered expired ACTHIB.  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 expired 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 guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 10.0
Sex: U
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, Medication error, No adverse event
Clinical narrative: patient missed the second dose of IMOVAX RABIES with no reported adverse event; Initial information was received on 08-Feb-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case is linked to case 2023SA047970(CLUSTER).  This case involves a 10 years old and unknown gender patient who missed the second dose of RABIES (HDC) VACCINE [IMOVAX RABIES].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 a  dose of suspect RABIES (HDC) VACCINE (dose, formulation, strength, lot and expiry date: unknown) via unknown route in unknown administration site for dog bite (Immunisation).  On an unknown date the patient developed a non-serious patient missed the second dose of imovax rabies with no reported adverse event (inappropriate schedule of product administration) (unknown latency) following the administration of RABIES (HDC) VACCINE.  It was reported that "Caller states 2 patients received their first dose of IMOVAX 2 weeks ago after being bite by a dog. Their first dose was administered the day of the bite. Caller states they missed their second dose and are coming in today. Caller is asking does he need to restart the series or resume where they left off. This situation is reported to PV due to 2 patients missing their second dose of IMOVAX RABIES in the post exposure series and deviating from the recommended administration schedule".  Action taken with RABIES VACCINE (IMOVAX RABIES) was not applicable.  At time of reporting, the outcome was Unknown for the event patient missed the second dose of imovax rabies with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 11.0
Sex: U
Vaccine: RAB
Symptoms: No adverse event, Product dose omission issue
Clinical narrative: received the first shot of the series of Imovax rabies but did not follow up to get the second shot with no reported adverse event; Initial information received on 08-Feb-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case is linked to case 2023SA047985(CLUSTER).  This case involves a 11 years old and unknown gender patient who had received the first shot of the series of RABIES (HDC) VACCINE [IMOVAX RABIES] but did not follow up to get the second shot with no reported adverse event.  The patient's past medical history, medical treatment(s),concomitant medication, vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect RABIES (HDC) VACCINE (Strength , formulation, lot number and expiry date was unknown) via unknown route in unknown administration site for Immunization.  On an unknown date the patient developed a non-serious event of received the first shot of the series of imovax rabies but did not follow up to get the second shot with no reported adverse event (product dose omission issue) (latency: unknown) following the administration of RABIES (HDC) VACCINE. Patient got bit by a dog 2 weeks ago.  Action taken with RABIES VACCINE (IMOVAX RABIES) was not applicable.  Outcome: Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 2.0
Sex: M
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AEs or PQC reported; PROQUAD was administered after temperature excursion; This spontaneous report as received from a medical assistant refers to a 2 year old male patient with no illness at time of vaccination or pertinent medical history. On 02-JAN-2023, the patient was vaccinated with the first improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) rHA (lot # W029552 exp date dose 14-MAR-2024) (dose not reported) subcutaneously in the right leg at a private hospital. The medical assistant reported that the freezer door was left ajar.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2302USA001034: US-009507513-2302USA001035: US-009507513-2302USA001036: US-009507513-2302USA001038: US-009507513-2302USA001039: US-009507513-2302USA001040: US-009507513-2301USA001095:
Age: 1.42
Sex: M
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AEs or PQC reported; PROQUAD was administered after temperature excursion; This spontaneous report as received from a medical assistant refers to a 17 month old male patient with no illness at time of vaccination or pertinent medical history. The patient had one brother. On 02-JAN-2023, the patient was vaccinated with the first improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) rHA (lot # W029552 exp date 14-MAR-2024) (dose not reported) subcutaneously in the right leg at a private hospital. The medical assistant reported that the freezer door was left ajar.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2302USA001034: US-009507513-2302USA001035: US-009507513-2302USA001036: US-009507513-2302USA001037: US-009507513-2302USA001038: US-009507513-2302USA001039: US-009507513-2301USA001095:
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Lethargy, Lower respiratory tract infection, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: bad chest cold; some pain, at the injection site; lethargy; This spontaneous case was reported by a patient and describes the occurrence of LETHARGY (lethargy), LOWER RESPIRATORY TRACT INFECTION (bad chest cold) and VACCINATION SITE PAIN (some pain, at the injection site) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient had no known allergies. The patient was never been diagnosed with / tested positive for COVID-19. The patient did not have any chronic or long-standing health conditions.  Concomitant products included ASTRAGALUS MONGHOLICUS ROOT (ASTRAGALUS EXTRACT) for Immune enhancement therapy.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced LETHARGY (lethargy) and VACCINATION SITE PAIN (some pain, at the injection site). On 25-Sep-2022, the patient experienced LOWER RESPIRATORY TRACT INFECTION (bad chest cold). On 07-Oct-2022, LOWER RESPIRATORY TRACT INFECTION (bad chest cold) had resolved. At the time of the report, LETHARGY (lethargy) and VACCINATION SITE PAIN (some pain, at the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, SARS-CoV-2 test: (Negative) ran a couple of negative Covid tests.         The patient's weight was reported as 165 (unit not reported).  With the three previous injections, the patient experienced some pain, at the injection site, and lethargy the following day. The patient was not ill but could have felt better having recovered from a bad chest cold a week prior receiving bivalent booster dose. The patient did run a couple of negative Covid tests during the time he had cold.  No treatment details were reported.   This case was linked to (Patient Link).
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: he had been violently throwing up.; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VOMITING (he had been violently throwing up.) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Aneurysm of descending aorta (Aneurysm in the descending aorta of the heart.), Type II diabetes mellitus and Drug allergy (No other allergies aside from Clonidine.).    On 10-Feb-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VOMITING (he had been violently throwing up.). At the time of the report, VOMITING (he had been violently throwing up.) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Reporter's husband got the Moderna Booster shot earlier, February 10, 2022 and he had been violently throwing up. That was the only dose that the husband had a reaction with. Moderna dose was asked but unknown.  Patient did not took any medications to alleviate the symptoms.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Cardiac arrest, Cardiac failure
Clinical narrative: Vx stopped his heart, still in therapies; This case was reported by a consumer via interactive digital media and described the occurrence of cardiac failure in a infant male patient who received DTPa (DTaP vaccine) for prophylaxis.   On an unknown date, the patient received DTaP vaccine. On an unknown date, unknown after receiving DTaP vaccine, the patient experienced cardiac failure (serious criteria GSK medically significant and life threatening). On an unknown date, the outcome of the cardiac failure was unknown.   The reporter considered the cardiac failure to be related to DTaP vaccine.     Additional Information: GSK receipt date: 10-FEB-2023 Reporter's comment: This case was reported by a patient's parent via interactive digital media. The reporter reported that the patient received a dose of DTaP vaccine, and it stopped his heart. The reporter reported that he/she was already in the ambulance on his/her way to the hospital and stated if he/she was not, they would had listed his death as SIDS (sudden infant death syndrome). The patient was 13 (unspecified) now and that vaccine injury still had him in therapies one size did not fit all. Additional Supportive Information: This case was linked with US2023AMR023197 which was reported by same reporter for different patient. Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR023197:Same reporter
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Tested positive for COVID-19; This case was reported by a consumer via call center representative and described the occurrence of covid-19 in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd September 2022, the patient received the 1st dose of Shingrix. In October 2022, less than 2 months after receiving Shingrix, the patient experienced covid-19. On an unknown date, the outcome of the covid-19 was unknown.   It was unknown if the reporter considered the covid-19 to be related to Shingrix.     Additional Information: GSK Receipt date: 07-Feb-2023. Reporter's Comment: Patient is the reporter. Patient stated that tested positive for COVID-19 at the end of October. The reporter consented to follow-up.
Age: 55.0
Sex: M
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Expired Twinrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 55-year-old male patient who received HAB (Twinrix) (batch number 4F3YY, expiry date 1st January 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th February 2023, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 7th February 2023, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 08-Feb-2023. Reporter's Comment: The Vaccine Administration Facility is the same as Primary Reporter. The reporter consented to follow-up. Additional Supportive Information: Patient received an expired Twinrix vaccine, which led to expired vaccine used.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Date the vial was initially stored in the refrigerator was 03-Jan-2023; No adverse event; 2 patients of 6 years old received doses after its BUD of the Monovalent Moderna COVID19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2 patients of 6 years old received doses after its BUD of the Monovalent Moderna COVID19 vaccine), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 03-Jan-2023) and NO ADVERSE EVENT (No adverse event) in a 6-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 018c22a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Feb-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 03-Feb-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (2 patients of 6 years old received doses after its BUD of the Monovalent Moderna COVID19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 03-Jan-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2 patients of 6 years old received doses after its BUD of the Monovalent Moderna COVID19 vaccine), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 03-Jan-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (2 patients of 6 years old received doses after its BUD of the Monovalent Moderna COVID19 vaccine) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 03-Jan-2023).    No concomitant product reported by the reporter. It was reported that the vials were in the carton. Vial size was reported as 2.5ml. It was reported that the vial did not undergo any temperature excursions. No treatment medication reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-709519 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-709519:2nd patient
Age: 64.0
Sex: M
Vaccine: TD
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: patient received tenivac to early with no reported adverse event; Initial information received on 10-Feb-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 64 years old male patient where he received tenivac to early with no reported adverse event while receiving vaccine diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac].  The patient's past medical treatment included Tenivac in 2017.  The patient's concomitant medication(s) and family history were not provided.  On 09-Feb-2023, the patient received 0.5 ml daily (QD) dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult Suspension for injection (batch number- U7189AA and expiration date- 30-Sep-2023) via intramuscular route in the left deltoid (strength: not provided) as Immunization.  On 09-Feb-2023 the patient received tenivac to early with no reported adverse event (inappropriate schedule of product administration) (latency- same day) following the administration of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult.  Action taken- Not applicable.  It was not reported if the patient received a corrective treatment for the event (inappropriate schedule of product administration).  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Tinnitus
Clinical narrative: Upon receiving the second Pfizer Covid-19 shot (second dose), developed worsening tinnitus, which slowly worsened, and became unbearable. This caused the patient to need to reach medical professionals on 20Jan2023 (Dr. 20Jan2023), 31Jan2023 (Au.D.), and PCP on 06Feb2023.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Disability, Hemiplegia, Mobility decreased, Neurological symptom
Clinical narrative: Received J&J CoVid vaccine on September 28, 2021. Ended up in hospital after experience of classic symptoms for stroke. Lost mobility and paralyzed on left side. Regained most functions but still have minor disabilities.
Age: 84.0
Sex: U
Vaccine: UNK
Symptoms: COVID-19
Clinical narrative: Contracted Covid and was fully vaccinated.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Asthenia, Laboratory test normal, Post-traumatic stress disorder
Clinical narrative: Severe anxiety progressing to PTSD. Began within days of vaccine.  Required 2 psych hospitalizations.  Required 4 medications, including round the clock benzodiazepines to function.  Totally debilitated.  Resolved with treatment in Jan/Feb 2022
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Chills, Computerised tomogram abdomen normal, Computerised tomogram head normal, Delusion
Clinical narrative: Fever, chills, nausea, abdominal pain,  BECAME DELUSIONAL, GI bleed, fatigue Came on within hours of vaccine (except GI bleed which occurred in September 2022.  Believes that a group of people tried to murder him and that he got married (neither of which is true)
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Echocardiogram normal, Electroencephalogram normal, Faecal calprotectin, Fatigue, Gastrointestinal haemorrhage
Clinical narrative: Fever, chills, nausea, abdominal pain,  BECAME DELUSIONAL, GI bleed, fatigue Came on within hours of vaccine (except GI bleed which occurred in September 2022.  Believes that a group of people tried to murder him and that he got married (neither of which is true)
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Haemoglobin increased, Nausea, Oesophagogastroduodenoscopy, Pyrexia
Clinical narrative: Fever, chills, nausea, abdominal pain,  BECAME DELUSIONAL, GI bleed, fatigue Came on within hours of vaccine (except GI bleed which occurred in September 2022.  Believes that a group of people tried to murder him and that he got married (neither of which is true)
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: admitted to Medical Center on 2.2.2023 expired 2.14.2023 covid-19 positive 1.20.2023
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac dysfunction, Chills, Pain, SARS-CoV-2 antibody test
Clinical narrative: Irregular cardiac function, body aches chills
Age: 78.0
Sex: M
Vaccine: COVID19, PNC13
Symptoms: Abdominal pain upper, COVID-19, Chest X-ray normal, Cough, Diarrhoea
Clinical narrative: Chief Complaint: fever Additional Medical History:  This is a 79-year-old male with a history of hypertension, high cholesterol and coronary artery disease s/p stents, who presents to the emergency department with a complaint of 24 hours of fever.  Patient denies any history of type 2 diabetes but does say he is borderline diabetic.  Patient has been having symptoms of fever, fatigue, lightheadedness, nonproductive cough and some mild epigastric and right upper quadrant abdominal discomfort.  He thinks he had some loose stools as well.  No reports of any vomiting or sputum production.  He does not have any underlying pulmonary diseases.
Age: 78.0
Sex: M
Vaccine: COVID19, PNC13
Symptoms: Dizziness, Epigastric discomfort, Fatigue, Hypoxia, Pyrexia
Clinical narrative: Chief Complaint: fever Additional Medical History:  This is a 79-year-old male with a history of hypertension, high cholesterol and coronary artery disease s/p stents, who presents to the emergency department with a complaint of 24 hours of fever.  Patient denies any history of type 2 diabetes but does say he is borderline diabetic.  Patient has been having symptoms of fever, fatigue, lightheadedness, nonproductive cough and some mild epigastric and right upper quadrant abdominal discomfort.  He thinks he had some loose stools as well.  No reports of any vomiting or sputum production.  He does not have any underlying pulmonary diseases.
Age: 78.0
Sex: M
Vaccine: COVID19, PNC13
Symptoms: SARS-CoV-2 test positive, White blood cell count decreased
Clinical narrative: Chief Complaint: fever Additional Medical History:  This is a 79-year-old male with a history of hypertension, high cholesterol and coronary artery disease s/p stents, who presents to the emergency department with a complaint of 24 hours of fever.  Patient denies any history of type 2 diabetes but does say he is borderline diabetic.  Patient has been having symptoms of fever, fatigue, lightheadedness, nonproductive cough and some mild epigastric and right upper quadrant abdominal discomfort.  He thinks he had some loose stools as well.  No reports of any vomiting or sputum production.  He does not have any underlying pulmonary diseases.
Age: 0.67
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Bivalent given instead of dose 2 of primary series
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Death, Neoplasm malignant
Clinical narrative: Patient died on 2/7/23 from cancer
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient vaccinated against then tested positive for COVID-19
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient vaccinated against then tested positive for COVID-19
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Agitation, COVID-19, Mental status changes, Productive cough
Clinical narrative: Patient presented to local  ER via ambulance with complaints of altered mental status, agitation and cough with sputum that has been worsening over the last week.  Patient was diagnosed with Covid 2 weeks ago.
Age: 14.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Illness, Skin reaction
Clinical narrative: parents noticed a skin reaction , reported on 2/7/2023,  not sure how long the child had it C19  illness 10/2022, light
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abdominal discomfort, Anal incontinence, Clostridium difficile infection, Clostridium test positive, Frequent bowel movements
Clinical narrative: On 12/06/22 I started having symptoms of excessive bowel movements, no pain just urgency, no control, I went to my doctor and had a stool sample and tested positive for C-diff, I was given medication an antibiotic, vancomycin to help get rid of the bacteria that was causing the C-diff. I took the antibiotic for 10 days, everything cleared within 3 to 4 days after I started taking the medication. My stomach is sensitive even now.
Age: 54.0
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: Patient was not due for a bivalent booster because she already had one on 10/25/22.
Age: 5.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Bivalent dose given in error as primary series dose 1. No known adverse reaction. Patinet tolerated well. Physician notified patient/guardian of administration error. No concerns reported by patient/guardian. Patient is planning to finish series with on dose of monovalent (as dose 2) and then the bivalent following the series timeline requirements.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Anti-cyclic citrullinated peptide antibody, Antibody test, Blood immunoglobulin A, Blood immunoglobulin D, Blood test
Clinical narrative: Sometime in June my back stiffened up and I couldn't move. My legs and feet stiffened up. I went to my doctor and was recommended I visit to a rheumatologist and a hematologist. I saw one in September and was diagnosed with rheumatoid arthritis. The Dr.'s name was reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone, Full blood count, Haemoglobin, Hepatitis B surface antibody, Intrinsic factor antibody
Clinical narrative: Sometime in June my back stiffened up and I couldn't move. My legs and feet stiffened up. I went to my doctor and was recommended I visit to a rheumatologist and a hematologist. I saw one in September and was diagnosed with rheumatoid arthritis. The Dr.'s name was reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Mobility decreased, Musculoskeletal stiffness, Rheumatoid arthritis, Rheumatoid factor quantitative
Clinical narrative: Sometime in June my back stiffened up and I couldn't move. My legs and feet stiffened up. I went to my doctor and was recommended I visit to a rheumatologist and a hematologist. I saw one in September and was diagnosed with rheumatoid arthritis. The Dr.'s name was reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: White blood cell count, X-ray limb
Clinical narrative: Sometime in June my back stiffened up and I couldn't move. My legs and feet stiffened up. I went to my doctor and was recommended I visit to a rheumatologist and a hematologist. I saw one in September and was diagnosed with rheumatoid arthritis. The Dr.'s name was reported.
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Dyspnoea, Fibrin D dimer increased
Clinical narrative: Brief History:  71-year-old male with restrictive lung disease, COPD, AFib, heart failure presenting with known COVID-19 infection in increasing oxygen demand.     Brief Exam:  On initial evaluation he did appear to be quite short of breath and was requiring escalating doses of oxygen from his baseline.  He was treated with nebulizer treatments with improvement.  However, due to his multiple comorbidities, known COVID diagnosis, and oxygen need he will be admitted for further management.  Was given IV dexamethasone here.  Mildly elevated D-dimer likely related to the COVID-19 and within expected range for age adjusted D-dimer.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Patient was to receive Pfizer Bivalent booster for ages 5-11 years (third in this patients series). Instead, patient received a dose of the Pfizer primary series for ages 5-11 years . State and PCP informed. Called and left a VM with the mother.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardioversion, Electrocardiogram abnormal, Heart rate increased, Imaging procedure, Impaired work ability
Clinical narrative: Since the vaccination I have had a series of heart problems that have put me in the emergency room 4 times with heart beats of 200+ per minute. I am now seeing a cardiologist on a regular basis since then. I am also now taking medication daily to help control my heart rate. I have had extensive doctors' appointments since taking the vaccinations. I have had to miss many days of work in order to make these appointments and will have to miss more for upcoming appointments. The cost of these appointments and emergency room visits are staggering to the insurance companies not to mention out of pocket expenses. I have never had any medical conditions at all outside of my arthritis before this vaccination.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Death, Vaccine breakthrough infection
Clinical narrative: COVID-related death/ breakthrough case
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: COVID-related death/ breakthrough case
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Breast pain, Limb discomfort, Pain, Spinal pain
Clinical narrative: On 01/16/2023 I received my Covid-19 vaccine. On 02/05/2023 in the afternoon I noticed an aching discomfort under my left arm which continued to get worse through out the night. the next day the pain continued and started to spread toward my back and the pain continued throughout the day continuing to my spine then to my left breast. The pain was aching as well as burning. I would feel sharp pain shooting out toward my back and front. After reaching out to the doctor I was told to put warm compress and take my VALTREX. Symptoms are ongoing.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Cardiac failure congestive, Chronic obstructive pulmonary disease, Condition aggravated, Dyspnoea
Clinical narrative: Pt with a PMH of COPD, asthma, and heart failure. Pt arrived with increasing shortness of breath, fever, and headache. Pt admitted due to COVID-19 positivity, COPD exacerbation, CHF exacerbation, and dyspnea.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Pt with a PMH of COPD, asthma, and heart failure. Pt arrived with increasing shortness of breath, fever, and headache. Pt admitted due to COVID-19 positivity, COPD exacerbation, CHF exacerbation, and dyspnea.
Age: 68.0
Sex: M
Vaccine: TYP, YF
Symptoms: No adverse event, Product preparation issue
Clinical narrative: No adverse events occurred to client during or after vaccines. Yellow Fever vaccine was accidentally reconstituted with incorrect diulent (sterile water). Sanofi has been contact for further instruction and client has been notified. Client does not report any adverse effects or reactions.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Dizziness
Clinical narrative: lightheaded, dizzy, some negative gastro feelings but no hot water in mouth
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Oropharyngeal pain, Rhinorrhoea, SARS-CoV-2 test positive, Sneezing
Clinical narrative: I was sneezing and had a runny nose. I also had a mild sore throat. I tested for COVID-19 on 08/16/2022 and it was positive. My doctor prescribed Paxlovid which I started taking on August 18, 2022. My symptoms continued for 3 more days. I have since completely recovered from all my symptoms.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Death, Vaccine breakthrough infection
Clinical narrative: COVID-related death/ breakthrough case
Age: 85.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Dose was administered on 13Feb23, the beyond use date of medication (expiration of lot is 05/25/2023) was noted as 11Feb23.  Dose was administered 2 days after the 30 day beyond use date.  Have called Moderna for any additional stability date for this lot, informed it would be 3-5 business days prior to receiving stability data back.  To date no adverse effect has been reported by patient to facility
Age: 1.58
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given vaccine not approved for age
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient vaccinated against then tested positive for COVID-19
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Anger, COVID-19, Dyspnoea, Emotional disorder, Fatigue
Clinical narrative: In the evening it felt like a strep throat infection. Sore, scratchy throat. Went to urgent care, where they ran strep and COVID-19 tests, rapid and PCR. Rapid COVID-19 test was negative, but PCR was positive. Fatigue, malaise, body aches, lasted about a week. Emotional dysregulation lasting about 3 weeks. Very short temper and unable to manage emotions. Things returned to normal except for bouts of breathlessness when speaking.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Oropharyngeal pain, Pain, SARS-CoV-2 test negative, SARS-CoV-2 test positive
Clinical narrative: In the evening it felt like a strep throat infection. Sore, scratchy throat. Went to urgent care, where they ran strep and COVID-19 tests, rapid and PCR. Rapid COVID-19 test was negative, but PCR was positive. Fatigue, malaise, body aches, lasted about a week. Emotional dysregulation lasting about 3 weeks. Very short temper and unable to manage emotions. Things returned to normal except for bouts of breathlessness when speaking.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Streptococcus test negative, Throat irritation
Clinical narrative: In the evening it felt like a strep throat infection. Sore, scratchy throat. Went to urgent care, where they ran strep and COVID-19 tests, rapid and PCR. Rapid COVID-19 test was negative, but PCR was positive. Fatigue, malaise, body aches, lasted about a week. Emotional dysregulation lasting about 3 weeks. Very short temper and unable to manage emotions. Things returned to normal except for bouts of breathlessness when speaking.
Age: 82.0
Sex: M
Vaccine: COVID19-2
Symptoms: Abnormal behaviour, Blood test normal, Culture stool negative, Diarrhoea, Flatulence
Clinical narrative: Gas and diarrhea, continuing with very little change from 12/09/2022 to the present (02/14/2023), being generally active for four hours in the morning, quiet for a couple of hours in late morning, active after lunch, then generally quiet for the afternoon and evening, sometimes acting up on the middle of the night.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered on 1/19/23 was past the Beyond Use Date (1/6/23). Individual was advised that the dose needs to be repeated.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray, Dyspnoea, Echocardiogram, Electrocardiogram, Electrocardiogram ambulatory
Clinical narrative: Noticeable shortness of breath, heart pounding sensation, fatigue, muscle weakness.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Muscular weakness, Palpitations
Clinical narrative: Noticeable shortness of breath, heart pounding sensation, fatigue, muscle weakness.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was administered on 1/19/23, which was after the Beyond Use Date of 1/6/23. Individual was notified that shot will need to be repeated.
Age: 77.0
Sex: M
Vaccine: COVID19-2
Symptoms: Loss of personal independence in daily activities, Malaise, Pain, Tinnitus
Clinical narrative: Following the shot, I had the normal general aches and malaise for a few days,  I am a classical harpsichord player so have always had acute hearing.  About a week after the shot, the Tinnitus began and reached a level that is about the same as a person speaking with a soft voice in a living room setting (i.e. I  must now ask a person to speak up).  The effect on music is significant and has impacted my ability to play the harpsichord as well as enjoy listening to others.
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Fatigue, Feeling abnormal, Headache, Influenza virus test negative
Clinical narrative: I had nasal and sinus congestion and drainage that was clear. I had a mild headache and a low fever around 99 degrees. Later that day in the afternoon, I took a home COVID-19 test and it was negative. Wednesday I was still feeling poorly, so I took another test 24 hours since the first one and it was positive. The symptoms were about the same and a large amount of fatigue. That was the lingering symptom. Once the test was positive, I went to the local clinic and I was prescribed PAXLOVID and I started that on Thursday. I took that whole 5 day course. The doctor recommended I start talking PEPCID instead of TAGAMET. I was also taking ROBITUSSIN DM to help with the drainage. I never had a cough or any chest symptoms. Things resolved within 5 to 7 days. I had the lingering fatigue feeling, but since then that's all cleared up.
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Nasal congestion, Pyrexia, Rhinorrhoea, SARS-CoV-2 test positive, Sinus congestion
Clinical narrative: I had nasal and sinus congestion and drainage that was clear. I had a mild headache and a low fever around 99 degrees. Later that day in the afternoon, I took a home COVID-19 test and it was negative. Wednesday I was still feeling poorly, so I took another test 24 hours since the first one and it was positive. The symptoms were about the same and a large amount of fatigue. That was the lingering symptom. Once the test was positive, I went to the local clinic and I was prescribed PAXLOVID and I started that on Thursday. I took that whole 5 day course. The doctor recommended I start talking PEPCID instead of TAGAMET. I was also taking ROBITUSSIN DM to help with the drainage. I never had a cough or any chest symptoms. Things resolved within 5 to 7 days. I had the lingering fatigue feeling, but since then that's all cleared up.