chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Interchange of vaccine products; Tested positive again/Has the patient received a COVID-19 vaccination? Yes, 25Feb2021 Moderna/25Mar2021 Moderna/08Nov2021 Moderna/13Mar2022 Pfizer; Tested positive again/Has the patient received a COVID-19 vaccination? Yes, 25Feb2021 Moderna/25Mar2021 Moderna/08Nov2021 Moderna/13Mar2022 Pfizer; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 56-year-old female patient received BNT162b2 (BNT162B2), on 13Mar2022 as dose 4 (booster) single (Batch/Lot number: unknown) at the age of 55 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 25Feb2021 as dose 1, single (Batch/Lot number: unknown), on 25Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 08Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Is the patient a smoker/Formed smoker: No" (unspecified if ongoing), notes: Is the patient a smoker/Formed smoker: No. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 13Mar2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Tested positive again/Has the patient received a COVID-19 vaccination? Yes, 25Feb2021 Moderna/25Mar2021 Moderna/08Nov2021 Moderna/13Mar2022 Pfizer". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Apr2022) Positive, notes: positive test at home; (2022) Negative, notes: tested negative for several days; (2022) Positive, notes: symptoms returned and test positive for another week. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The reported COVID-19 positive after BNT162B2 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.The causal association between the at-risk event interchange of vaccine products and the use of suspect product BNT162B2 cannot be fully excluded.
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, COVID-19, Drug ineffective, Investigation, Polymerase chain reaction
Clinical narrative: he tested positive for SARS-CoV-2; he tested positive for SARS-CoV-2; This is a literature report for the following literature source(s):  A 64-year-old male patient received BNT162b2 (BNT162B2), on 23Dec2020 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "mantle cell lymphoma", start date: 2017 (ongoing); "autologous hematopoietic stem cell transplantation", start date: Aug2020 (unspecified if ongoing); "chemotherapy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Rituximab, start date: Dec2020, for mantle cell lymphoma. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant, life threatening), COVID-19 (hospitalization, medically significant, life threatening) all with onset 05Jan2021, outcome "unknown" and all described as "he tested positive for SARS-CoV-2". The patient underwent the following laboratory tests and procedures: Antibody test: (unspecified date) 24.60 ug/ml, notes: detectable levels; Viral whole genome sequences: (unspecified date) five of the nine positive; Polymerase chain reaction: (05Jan2021) Positive, notes: for SARS-CoV-2. Therapeutic measures were taken as a result of drug ineffective, covid-19. The following death information was reported, despite no fatal outcome. The patient date of death was 2021. Reported cause of death: "multiple healthcare-associated pneumonias", "pneumothoracies", "bleeding from the ECMOsite". It was not reported if an autopsy was performed.; Sender's Comments: Based on the available information, the reported serious events Drug Ineffective and COVID-19 cannot be excluded for the suspect drug.; Reported Cause(s) of Death: multiple healthcare-associated pneumonias; pneumothoracies; bleeding from the ECMOsite
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I had covid in Jul2022/Aug2022 - 1 tested positive for 2 wks; I had covid in Jul2022/Aug2022 - 1 tested positive for 2 wks; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 19Apr2021 at 10:00 as dose 1, single (Lot number: EW0162), in left arm, on 10May2021 at 10:00 as dose 2, single (Lot number: EW0173), in left arm, on 01Oct2021 at 16:00 as dose 3 (booster), single (Lot number: FE3590), in left arm and on 30Mar2022 at 16:00 as dose 4 (booster), single (Lot number: FK9895), in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Booster dose due to a weakened immune system" (unspecified if ongoing), notes: Booster dose due to a weakened immune system; "Current or recent cancer" (unspecified if ongoing), notes: Current or recent cancer: Checked; "No/non-functioning, spleen" (unspecified if ongoing), notes: No/non-functioning, spleen or kidney failure: Checked; "kidney failure" (unspecified if ongoing), notes: No/non-functioning, spleen or kidney failure: Checked. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "I had covid in Jul2022/Aug2022 - 1 tested positive for 2 wks". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: I Had several covid-19 test before hospital procedures- don't know dates- all Negative; (2022) Positive.  Clinical course: booster dose (other): 30Nov2022, bivalent lot# GT6742. prior vaccinations (within 4 weeks), vaccine name: flu, anatomical site of infection: left arm. test: patient had several covid-19 test before hospital procedures- don't know dates- all negative. patient had Covid in Jul2022/Aug2022 - 1 tested positive for 2 wks. specific relevant test for thromboembolic events with thrombocytopenia: none
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: My mom died from the vaccine;   This is a solicited report received from a non-contactable reporter(s) (Consumer or other non HCP). The patient is the reporter's mother.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death), outcome "fatal", described as "My mom died from the vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As per the limited available information the event death is possibly related to the suspect. it will be reassessed once more information available. 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.; Reported Cause(s) of Death: My mom died from the vaccine
Sex: U
Vaccine: FLUX
Symptoms: Bronchitis, Influenza
Clinical narrative: bronchitis; Flu; Initial information received on 08-Jan-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp(health care professional).  This case involves an unknown age and unknown gender patient who experienced bronchitis and flu while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for Immunization.  On an unknown date the patient developed a non-serious bronchitis and  flu (influenza)  (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "I got the flu shot this year and got the flu which turned to bronchitis so I've been down 2 weeks !!!! Will not get it again".  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (bronchitis, Flu).  At time of reporting, the outcome was Unknown for the event bronchitis and was Unknown for the event flu.
Sex: U
Vaccine: FLUX
Symptoms: No adverse event, Vaccination failure
Clinical narrative: it did not work with no reported adverse event; Initial information received on 06-Jan-2023 regarding an unsolicited valid Social Media serious case received via consumer/non-healthcare professional.  This case involves an unknown age and unknown gender patient who stated that it did not work with no reported adverse event while receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (form, strength, batch lot number, expiry date: unknown) not reported via unknown route in unknown administration site for Prophylactic vaccination.  On an unknown date the patient had an event of it did not work with no reported adverse event (vaccination failure) (unknown latency) following the administration of influenza vaccine.   Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event.  Outcome: Unknown.  Seriousness Criteria: This event was assessed as medically significant.; Sender's Comments: Sanofi company comment dated 11-Jan-2022: This case involves an unknown age and unknown gender patient who stated that it did not work with no reported adverse event while receiving influenza vaccine. The time to onset was compatible with the role of vaccine. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, concomitants, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Post-acute COVID-19 syndrome
Clinical narrative: took flu shot in September, got flu on Friday; Initial information was received on 08-Jan-2023 regarding an unsolicited valid non-serious case received from a consumer/non-health-care professional via Social Media.  This case involves an unknown age and unknown gender patient who took flu shot in september, got flu on friday after receiving  influenza vaccine.  The patient's past medical history included COVID-19 in Jan-2022. The patient's past vaccination(s) included COVID-19 VACCINE with COVID shots and boosters. The patient's past medical treatment(s) and family history were not provided. At the time of the event, the patient had ongoing long COVID.  In September 2022, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (strength, dose, formulation, frequency, lot number and expiry date: not reported) via unknown route in unknown administration site for Flu (Influenza).  On 06-Jan-2023, (latency 3 months approximately) the patient took flu shot in september, got flu on friday (influenza) (unknown latency) following the administration of influenza vaccine.  It is unknown if there were lab data/results available.   Action taken was 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.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Did and still got the flu and still not over it 1 month now; Initial information received on 09-Jan-2023 regarding an unsolicited valid social media non-serious case received via consumer/non-hcp.  This case involves adult and unknown gender patient who experienced did and still got the flu and still not over it 1 month now while receiving vaccine Influenza Vaccine (flu shot).  It was unknown if the patient had any medical history, concomitant disease, or risk factor.   On an unknown date, the patient received suspect Influenza Vaccine produced by unknown manufacturer at (unknown: formulation, strength, dose, lot number, route in unknown administration site) for prophylactic vaccination. Information regarding batch number requested.  On an unknown date, the patient reported still got the flu and still not over it 1 month now (influenza) at unknown latency following the administration of Influenza Vaccine.  Action taken: Not applicable. It was unknown if there were lab data/results available.   It was unknown that if the company suspect product inappropriately used as per local Marketing authorization.  Corrective treatment: not reported.  At time of reporting, the outcome was not recovered for the event Influenza.
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: pregnant patient took fluzone, with no reported adverse event; Initial information received on 07-Jan-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 22 years old female patient who is pregnant and took Influenza Quadrival A-B Vaccine [Fluzone QIV], with no reported adverse event.   Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported pregnant patient took fluzone, with no reported adverse event at 17 weeks of pregnancy and the patient was exposed to Influenza Quadrival A-B Vaccine at 17 weeks of pregnancy, during second pregnancy trimester for Influenza Quadrival A-B Vaccine.  The date of last menstrual period was reported as 14-Sep-2022. The estimated due date is 17-Jun-2023.  It is unknown if the patient had any medical history, concomitant disease or risk factor.   The patient's past medical treatment(s), vaccination(s) and family history were not provided.  The patient had unknown previous pregnancy/ies.   On 06-Jan-2023, the patient received dose 1 of suspect Influenza Quadrival A-B Vaccine Suspension for injection (with an unknown strength, lot number and expiry date) via intramuscular route in unknown administration site for prophylactic vaccination.  On 06-Jan-2023, the pregnant patient took Influenza Quadrival A-B Vaccine, with no reported adverse event (exposure during pregnancy) (Latency: same day).  It is unknown if the patient experienced any additional symptoms/events.  It is unknown if there were lab data/results available.  It was reported Did the mother experience any adverse events: NO. Was the company suspect product inappropriately used as per local Marketing authorization: Unknown  Action taken: not applicable.  Outcome: Unknown   Additionally, at time of reporting, the pregnancy is still ongoing.
Sex: U
Vaccine: FLUX
Symptoms: COVID-19, Influenza
Clinical narrative: covid; Flu; Initial information received on 09-Jan-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional.  This case involves an unknown age and gender patient who experienced covid and flu while receiving vaccine Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect Influenza vaccine produced by unknown manufacturer (lot number, expiry date: not reported) via unknown route in unknown administration site (form, strength: unknown) for flu.  On an unknown date the patient developed non-serious events of covid (covid-19) and flu (influenza) (unknown latency) following the administration of Influenza vaccine.  Action taken- Not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for both the events.
Age: 16.0
Sex: F
Vaccine: FLUX
Symptoms: Inappropriate schedule of product administration, Medication error, No adverse event
Clinical narrative: mistakenly received second FLUZONE QIV NP injection of the season on 09JAN2023 one month after receiving their first FLUZONE QIV NP vaccination. (with no reported adverse event); Initial information received on 10-Jan-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 16 year old female patient who had mistakenly received second fluzone qiv np injection of the season on 09jan2023 one month after receiving their first fluzone qiv np vaccination. (with no reported adverse event) after receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 09-Jan-2023, the patient received a dose 2 of 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE for suspension for injection (lot: UT7731MA, expiry date: 30-Jun-2023, strength not reported) via intramuscular route in the left deltoid for Influenza immunization.  On 09-JAN-2023, the patient developed a non-serious event mistakenly received second fluzone qiv np injection of the season on 09-jan-2023 one month after receiving their first fluzone qiv np vaccination. (with no reported adverse event) (inappropriate schedule of product administration) same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  No lab data was available.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Extra dose administered, Inappropriate schedule of product administration, Medication error, No adverse event
Clinical narrative: patient is administered an extra dose of Adacel after receiving it one year prior with no reported adverse event; inadvertently administering an extra dose of Adacel vaccine with no reported adverse event; Initial information  received on 10-Jan-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 65 years old female patient and it was reported that patient administered an extra dose of adacel after receiving it one year prior and inadvertently administering an extra dose of adacel vaccine with no reported adverse event after receiving Diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 09-Jan-2023, the patient received a booster dose, 0.5 ml (milliliter) (1x) (once) of suspect Diphtheria-2/tetanus/5 AC pertussis vaccine, Suspension for injection (lot number: U7549AA, expiry date: 04-Nov-2024) (with unknown strength) via intramuscular route in the left deltoid for immunization.  On 09-Jan-2023, Nurse reported that patient inadvertently administered an extra dose of adacel vaccine with no reported adverse event (extra dose administered) and patient administered an extra dose of Adacel after receiving it one year prior with no reported adverse event (inappropriate schedule of product administration) (latency: same day) following the administration of Diphtheria-2/tetanus/5 AC pertussis vaccine.  It was also reported that "Caller is requesting information on the possible side effects that can occur due to receiving the vaccine too soon".  No lab data were reported.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for both events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.33
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: was administered ACTHIB that was reconstituted with expired diluent, with no reported adverse event; Initial information received on 10-Jan-2023 regarding an unsolicited valid non-serious case received via physician.  This case involves a 16-month-old and unknown gender patient who was administered HIB (PRP/T) vaccine [ACT-HIB] that was reconstituted with expired diluent, with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection (batch lot: UJ604AA) (expiry date: 31-Mar-2023) (strength: unknown) via unknown route in unknown administration site for Immunization.  On an unknown date the patient had a non-serious event of was administered ACT-HIB that was reconstituted with expired diluent, with no reported adverse event (expired product administered) (latency: same day) following the administration of HIB (PRP/T) vaccine.  Action taken with haemophilus type B (HIB) vaccine (ACT-HIB) 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 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: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Blood test, Cardiomegaly, Chest pain, Computerised tomogram
Clinical narrative: Bp 210 over 110 enlarged heart shortness of breath and back and chest pain
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, X-ray
Clinical narrative: Bp 210 over 110 enlarged heart shortness of breath and back and chest pain
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Tinnitus
Clinical narrative: Ringing in ears
Age: 93.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Death, Respiratory disorder, Respiratory symptom, SARS-CoV-2 test positive
Clinical narrative: She tested positive  COVID on 12/08/2022 with progressive respiratory symptoms.  She over the course of the next ten days declined from a respiratory standpoint with progressive COVID respiratory symptoms, became unresponsive and expired on 12/18/2022.
Age: 93.0
Sex: F
Vaccine: COVID19-2
Symptoms: Unresponsive to stimuli
Clinical narrative: She tested positive  COVID on 12/08/2022 with progressive respiratory symptoms.  She over the course of the next ten days declined from a respiratory standpoint with progressive COVID respiratory symptoms, became unresponsive and expired on 12/18/2022.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in refrigerator on 05-Dec-2022 and was administred on 09-Jan-2023; No Adverse Event; Patient received dose after the 30-day use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received dose after the 30-day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 05-Dec-2022 and was administred on 09-Jan-2023) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 013H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 09-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received dose after the 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 05-Dec-2022 and was administred on 09-Jan-2023) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received dose after the 30-day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 05-Dec-2022 and was administred on 09-Jan-2023) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received dose after the 30-day use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 05-Dec-2022 and was administred on 09-Jan-2023).    No concomitant medications were reported.   The vial size was 2.5 milliliter. The vial was initially stored in refrigerator on 05-Dec-2022. The vial did not undergo any temperature excursion.  No treatment details were reported.   This case was linked to MODERNATX, INC.-MOD-2023-696087 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2023-696087:Patient 7 out of 8 Patients
Age: 41.0
Sex: F
Vaccine: COVID19-2
Symptoms: Fatigue, Mobility decreased, Myalgia, Pyrexia
Clinical narrative: Fever ranging from 99,4 to 101.0 lasting for 12 hours starting at 8AM on 01/12/2023, extreme fatigue and muscle aches to the point of not being able to get out of bed. All symptoms resolved around 8 PM on 01/12/2023.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired Engerix administered; This case was reported by a nurse via sales rep and described the occurrence of expired vaccine used in a neonate patient who received HBV (Engerix B) (batch number LH3RJ, expiry date unknown) for prophylaxis.   On 2nd November 2018, the patient received Engerix B. On 2nd November 2018, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 06-JAN-2023 Reporter's Comments: A patient received a birth dose of a GlaxoSmithKline (GSK) Hepatitis B vaccine and was documented as expired.  No outcomes information available as this information was provided by a school to the reporter. The reporter consented to follow up. Additional Supportive Information: The patient received expired dose of Engerix-B, which led to expired vaccine used. In order to reflect age group as vaccination and event onset date was same.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: Fever; Body aches; Headache; Arm soreness; This case was reported by a consumer and described the occurrence of fever in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had experienced shingles 3 times, beginning when was 11).   On 4th January 2023, the patient received Shingrix. On 4th January 2023, less than a day after receiving Shingrix, the patient experienced fever, general body pain, headache and pain in arm. On an unknown date, the outcome of the fever, general body pain, headache and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the fever, general body pain, headache and pain in arm to be related to Shingrix.     Additional Information: GSK Receipt date: 05-Jan-2023. Reporter's Comment: This report was submitted via the online direct entry reporting system. The symptoms were treated. The reporter consented to follow up.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: After receiving my 4th Covid shot, my resting hear rate increased to 80 beats per minute. My normal resting rate is between 70 ? 70 beats per minute. The shot was the Moderna 042H22A. It took approximately 3 days for my heart rate to return to normal. I use the digital app monitor my activities and heart rate. I can provide data screen shots as needed.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain lower, Acute kidney injury, Bladder catheterisation, Blood creatinine increased, Chromaturia
Clinical narrative: Patient recently consented to participate in the Johnson & Johnson study on 12/22/2022 and has yet to meet the eligibility criteria presented to the emergency department on 12/28/2022 with complaints of left facial pain and pressure intensity for the past 6 weeks and increased urinary frequency and urgency with white mucus and clots in her urine requiring more frequent self-caths. Patient stated they had been seen by their primary prior and completed 3 rounds of antibiotics with ciprofloxacin, then doxycycline, then Bactrim most recently. Patient also reports that for the past 4 days prior to emergency department visit they were having urgency with urination and noticed a dark, cloudy urine. Patient denies any associated dysuria, fever, nausea, or vomiting. Patient stated initially self-medicated for their symptoms with 1 week of ciprofloxacin, followed by 2 weeks of doxycycline as per ENT, and finally an additional 2 weeks of Bactrim after culture and sensitivity was obtained 12/28/2022. Last dose of Bactrim was 12/28/2022 for a total of 6 weeks. Patient also reported sharp stabbing LLQ pain at the site of her kidney transplant on 12/28/2022. Pain comes and goes last a few seconds for about 5/10 intensity. Patient seen and evaluated in examination room in ER. Patient without any focal neurologic deficits. Patient with immunosuppression and has persistent sinus infection. Urinalysis also positive with leukocyte esterase and white blood cells acute kidney injury with a creatinine of 1.53 and a GFR of 39. CT SINUS unremarkable and Ultrasound of left kidney transplant on 12/28/2022 ultrasound was normal. FINAL DIAGNOSIS: Klebsiella pneumoniae UTI chronic sinusitis With history of Neurogenic bladder w/ recurrent UTI Patient given Tylenol 650mg, PO every 4 hrs as needed, Zyloprim 200mg, PO BID, famotidine 10mg, PO, once a day PRN, Morphine 1mg injection, IV once on 12/29/22. Patient Discharged on 12/30/2022, discharged with oral antibiotics: ciprofloxacin 500 mg twice a day for 3 days and one time dose 150mg fluconazole in case you get a yeast infection. And instructed to follow up with your primary care physician in clinic. Principal investigator assessment is not related to study.
Sex: U
Vaccine: COVID19
Symptoms: Chronic sinusitis, Computerised tomogram head normal, Condition aggravated, Culture urine, Discomfort
Clinical narrative: Patient recently consented to participate in the Johnson & Johnson study on 12/22/2022 and has yet to meet the eligibility criteria presented to the emergency department on 12/28/2022 with complaints of left facial pain and pressure intensity for the past 6 weeks and increased urinary frequency and urgency with white mucus and clots in her urine requiring more frequent self-caths. Patient stated they had been seen by their primary prior and completed 3 rounds of antibiotics with ciprofloxacin, then doxycycline, then Bactrim most recently. Patient also reports that for the past 4 days prior to emergency department visit they were having urgency with urination and noticed a dark, cloudy urine. Patient denies any associated dysuria, fever, nausea, or vomiting. Patient stated initially self-medicated for their symptoms with 1 week of ciprofloxacin, followed by 2 weeks of doxycycline as per ENT, and finally an additional 2 weeks of Bactrim after culture and sensitivity was obtained 12/28/2022. Last dose of Bactrim was 12/28/2022 for a total of 6 weeks. Patient also reported sharp stabbing LLQ pain at the site of her kidney transplant on 12/28/2022. Pain comes and goes last a few seconds for about 5/10 intensity. Patient seen and evaluated in examination room in ER. Patient without any focal neurologic deficits. Patient with immunosuppression and has persistent sinus infection. Urinalysis also positive with leukocyte esterase and white blood cells acute kidney injury with a creatinine of 1.53 and a GFR of 39. CT SINUS unremarkable and Ultrasound of left kidney transplant on 12/28/2022 ultrasound was normal. FINAL DIAGNOSIS: Klebsiella pneumoniae UTI chronic sinusitis With history of Neurogenic bladder w/ recurrent UTI Patient given Tylenol 650mg, PO every 4 hrs as needed, Zyloprim 200mg, PO BID, famotidine 10mg, PO, once a day PRN, Morphine 1mg injection, IV once on 12/29/22. Patient Discharged on 12/30/2022, discharged with oral antibiotics: ciprofloxacin 500 mg twice a day for 3 days and one time dose 150mg fluconazole in case you get a yeast infection. And instructed to follow up with your primary care physician in clinic. Principal investigator assessment is not related to study.
Sex: U
Vaccine: COVID19
Symptoms: Facial pain, Glomerular filtration rate decreased, Haemorrhage urinary tract, Immunosuppression, Klebsiella infection
Clinical narrative: Patient recently consented to participate in the Johnson & Johnson study on 12/22/2022 and has yet to meet the eligibility criteria presented to the emergency department on 12/28/2022 with complaints of left facial pain and pressure intensity for the past 6 weeks and increased urinary frequency and urgency with white mucus and clots in her urine requiring more frequent self-caths. Patient stated they had been seen by their primary prior and completed 3 rounds of antibiotics with ciprofloxacin, then doxycycline, then Bactrim most recently. Patient also reports that for the past 4 days prior to emergency department visit they were having urgency with urination and noticed a dark, cloudy urine. Patient denies any associated dysuria, fever, nausea, or vomiting. Patient stated initially self-medicated for their symptoms with 1 week of ciprofloxacin, followed by 2 weeks of doxycycline as per ENT, and finally an additional 2 weeks of Bactrim after culture and sensitivity was obtained 12/28/2022. Last dose of Bactrim was 12/28/2022 for a total of 6 weeks. Patient also reported sharp stabbing LLQ pain at the site of her kidney transplant on 12/28/2022. Pain comes and goes last a few seconds for about 5/10 intensity. Patient seen and evaluated in examination room in ER. Patient without any focal neurologic deficits. Patient with immunosuppression and has persistent sinus infection. Urinalysis also positive with leukocyte esterase and white blood cells acute kidney injury with a creatinine of 1.53 and a GFR of 39. CT SINUS unremarkable and Ultrasound of left kidney transplant on 12/28/2022 ultrasound was normal. FINAL DIAGNOSIS: Klebsiella pneumoniae UTI chronic sinusitis With history of Neurogenic bladder w/ recurrent UTI Patient given Tylenol 650mg, PO every 4 hrs as needed, Zyloprim 200mg, PO BID, famotidine 10mg, PO, once a day PRN, Morphine 1mg injection, IV once on 12/29/22. Patient Discharged on 12/30/2022, discharged with oral antibiotics: ciprofloxacin 500 mg twice a day for 3 days and one time dose 150mg fluconazole in case you get a yeast infection. And instructed to follow up with your primary care physician in clinic. Principal investigator assessment is not related to study.
Sex: U
Vaccine: COVID19
Symptoms: Laboratory test, Micturition urgency, Pollakiuria, Procedural pain, Sinusitis
Clinical narrative: Patient recently consented to participate in the Johnson & Johnson study on 12/22/2022 and has yet to meet the eligibility criteria presented to the emergency department on 12/28/2022 with complaints of left facial pain and pressure intensity for the past 6 weeks and increased urinary frequency and urgency with white mucus and clots in her urine requiring more frequent self-caths. Patient stated they had been seen by their primary prior and completed 3 rounds of antibiotics with ciprofloxacin, then doxycycline, then Bactrim most recently. Patient also reports that for the past 4 days prior to emergency department visit they were having urgency with urination and noticed a dark, cloudy urine. Patient denies any associated dysuria, fever, nausea, or vomiting. Patient stated initially self-medicated for their symptoms with 1 week of ciprofloxacin, followed by 2 weeks of doxycycline as per ENT, and finally an additional 2 weeks of Bactrim after culture and sensitivity was obtained 12/28/2022. Last dose of Bactrim was 12/28/2022 for a total of 6 weeks. Patient also reported sharp stabbing LLQ pain at the site of her kidney transplant on 12/28/2022. Pain comes and goes last a few seconds for about 5/10 intensity. Patient seen and evaluated in examination room in ER. Patient without any focal neurologic deficits. Patient with immunosuppression and has persistent sinus infection. Urinalysis also positive with leukocyte esterase and white blood cells acute kidney injury with a creatinine of 1.53 and a GFR of 39. CT SINUS unremarkable and Ultrasound of left kidney transplant on 12/28/2022 ultrasound was normal. FINAL DIAGNOSIS: Klebsiella pneumoniae UTI chronic sinusitis With history of Neurogenic bladder w/ recurrent UTI Patient given Tylenol 650mg, PO every 4 hrs as needed, Zyloprim 200mg, PO BID, famotidine 10mg, PO, once a day PRN, Morphine 1mg injection, IV once on 12/29/22. Patient Discharged on 12/30/2022, discharged with oral antibiotics: ciprofloxacin 500 mg twice a day for 3 days and one time dose 150mg fluconazole in case you get a yeast infection. And instructed to follow up with your primary care physician in clinic. Principal investigator assessment is not related to study.
Sex: U
Vaccine: COVID19
Symptoms: Ultrasound kidney normal, Urinary tract infection, Urine abnormality, Urine analysis abnormal, Urine leukocyte esterase positive
Clinical narrative: Patient recently consented to participate in the Johnson & Johnson study on 12/22/2022 and has yet to meet the eligibility criteria presented to the emergency department on 12/28/2022 with complaints of left facial pain and pressure intensity for the past 6 weeks and increased urinary frequency and urgency with white mucus and clots in her urine requiring more frequent self-caths. Patient stated they had been seen by their primary prior and completed 3 rounds of antibiotics with ciprofloxacin, then doxycycline, then Bactrim most recently. Patient also reports that for the past 4 days prior to emergency department visit they were having urgency with urination and noticed a dark, cloudy urine. Patient denies any associated dysuria, fever, nausea, or vomiting. Patient stated initially self-medicated for their symptoms with 1 week of ciprofloxacin, followed by 2 weeks of doxycycline as per ENT, and finally an additional 2 weeks of Bactrim after culture and sensitivity was obtained 12/28/2022. Last dose of Bactrim was 12/28/2022 for a total of 6 weeks. Patient also reported sharp stabbing LLQ pain at the site of her kidney transplant on 12/28/2022. Pain comes and goes last a few seconds for about 5/10 intensity. Patient seen and evaluated in examination room in ER. Patient without any focal neurologic deficits. Patient with immunosuppression and has persistent sinus infection. Urinalysis also positive with leukocyte esterase and white blood cells acute kidney injury with a creatinine of 1.53 and a GFR of 39. CT SINUS unremarkable and Ultrasound of left kidney transplant on 12/28/2022 ultrasound was normal. FINAL DIAGNOSIS: Klebsiella pneumoniae UTI chronic sinusitis With history of Neurogenic bladder w/ recurrent UTI Patient given Tylenol 650mg, PO every 4 hrs as needed, Zyloprim 200mg, PO BID, famotidine 10mg, PO, once a day PRN, Morphine 1mg injection, IV once on 12/29/22. Patient Discharged on 12/30/2022, discharged with oral antibiotics: ciprofloxacin 500 mg twice a day for 3 days and one time dose 150mg fluconazole in case you get a yeast infection. And instructed to follow up with your primary care physician in clinic. Principal investigator assessment is not related to study.
Sex: U
Vaccine: COVID19
Symptoms: White blood cells urine positive
Clinical narrative: Patient recently consented to participate in the Johnson & Johnson study on 12/22/2022 and has yet to meet the eligibility criteria presented to the emergency department on 12/28/2022 with complaints of left facial pain and pressure intensity for the past 6 weeks and increased urinary frequency and urgency with white mucus and clots in her urine requiring more frequent self-caths. Patient stated they had been seen by their primary prior and completed 3 rounds of antibiotics with ciprofloxacin, then doxycycline, then Bactrim most recently. Patient also reports that for the past 4 days prior to emergency department visit they were having urgency with urination and noticed a dark, cloudy urine. Patient denies any associated dysuria, fever, nausea, or vomiting. Patient stated initially self-medicated for their symptoms with 1 week of ciprofloxacin, followed by 2 weeks of doxycycline as per ENT, and finally an additional 2 weeks of Bactrim after culture and sensitivity was obtained 12/28/2022. Last dose of Bactrim was 12/28/2022 for a total of 6 weeks. Patient also reported sharp stabbing LLQ pain at the site of her kidney transplant on 12/28/2022. Pain comes and goes last a few seconds for about 5/10 intensity. Patient seen and evaluated in examination room in ER. Patient without any focal neurologic deficits. Patient with immunosuppression and has persistent sinus infection. Urinalysis also positive with leukocyte esterase and white blood cells acute kidney injury with a creatinine of 1.53 and a GFR of 39. CT SINUS unremarkable and Ultrasound of left kidney transplant on 12/28/2022 ultrasound was normal. FINAL DIAGNOSIS: Klebsiella pneumoniae UTI chronic sinusitis With history of Neurogenic bladder w/ recurrent UTI Patient given Tylenol 650mg, PO every 4 hrs as needed, Zyloprim 200mg, PO BID, famotidine 10mg, PO, once a day PRN, Morphine 1mg injection, IV once on 12/29/22. Patient Discharged on 12/30/2022, discharged with oral antibiotics: ciprofloxacin 500 mg twice a day for 3 days and one time dose 150mg fluconazole in case you get a yeast infection. And instructed to follow up with your primary care physician in clinic. Principal investigator assessment is not related to study.
Sex: F
Vaccine: COVID19
Symptoms: Blood lactic acid increased, Diagnostic procedure, Electrocardiogram ambulatory normal, Electroencephalogram normal, Epilepsy
Clinical narrative: On 12/14/21 I had a galactic or focal seizure (my own diagnosis). This was three weeks after I had received the COVID-19 Booster (Pfizer). When I received the booster, I believe I was given a full dose of the vaccine and not a half dose. I was rushed to the hospital by ambulance on that day and admitted for 3 days because I was having symptoms of a stoke or TIA. In the ER and all throughout my hospital stay, all lab work and diagnostics were clear/normal and so my discharge diagnosis was Syncope. I was not put on any medication after this incident, but was to follow up with neurologist; that follow-up lead to a 24-hr EEG, a Holter monitor for 72hrs, and an overnight sleep study being completed. All of those studies showed nothing. 5 months later, on 5/6/22 I had a full blown epileptic seizure and was once again rushed to the ER. This time my lactic acid levels were extremely elevated and the doctors confirmed that this was definitely a seizure. I was not admitted to the hospital, but was started on Keppra 500mg PO BID and reported to the DMV; my driving privileges were suspended for 6 months. I have now been on Keppra for 8 months and have been seizure free. I believe that this new onset of seizures was brought on by the COVID-19 booster, however, the doctors will not admit to that. I put it in all of my records now. Inpatient 12/14 to 12/17, and then ER 5/6/22
Sex: F
Vaccine: COVID19
Symptoms: Impaired driving ability, Laboratory test normal, Neurological symptom, Partial seizures, Sleep study normal
Clinical narrative: On 12/14/21 I had a galactic or focal seizure (my own diagnosis). This was three weeks after I had received the COVID-19 Booster (Pfizer). When I received the booster, I believe I was given a full dose of the vaccine and not a half dose. I was rushed to the hospital by ambulance on that day and admitted for 3 days because I was having symptoms of a stoke or TIA. In the ER and all throughout my hospital stay, all lab work and diagnostics were clear/normal and so my discharge diagnosis was Syncope. I was not put on any medication after this incident, but was to follow up with neurologist; that follow-up lead to a 24-hr EEG, a Holter monitor for 72hrs, and an overnight sleep study being completed. All of those studies showed nothing. 5 months later, on 5/6/22 I had a full blown epileptic seizure and was once again rushed to the ER. This time my lactic acid levels were extremely elevated and the doctors confirmed that this was definitely a seizure. I was not admitted to the hospital, but was started on Keppra 500mg PO BID and reported to the DMV; my driving privileges were suspended for 6 months. I have now been on Keppra for 8 months and have been seizure free. I believe that this new onset of seizures was brought on by the COVID-19 booster, however, the doctors will not admit to that. I put it in all of my records now. Inpatient 12/14 to 12/17, and then ER 5/6/22