chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: She stayed positive for COVID for 15 days.; She stayed positive for COVID for 15 days.; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 76-year-old female patient received BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Oct2022 as dose 4 (booster), single (Lot number: CJ6665) at the age of 75 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 18Feb2021 as dose 1, single (Lot number: CN9581), on 11Mar2021 as dose 2, single (Lot number: EN6204) and on 14Dec2021 as dose 3 (booster), single (Lot number: FJ8762) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "She stayed positive for COVID for 15 days.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: She stayed positive for COVID for 15 days. Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient received all of the Pfizer COVID vaccines too, and got COVID. The patient received Paxlovid to treated the Covid-19. Date and Time of Start of Drug: 23Feb2023. Date and Time of Last Administration: 24Feb2023.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 39-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Overweight" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 15Mar2023 to 19Mar2023. 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 available information, a possible contributory role of the subject vaccine cannot be excluded for suspected LOE.   There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Rash macular
Clinical narrative: Headache; Rash is currently like all over my stomach and back; it is not really a rash but like red dots all over my body; 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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Mar2023 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 completed; unknown manufacturer), for Covid-19 Immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown"; RASH MACULAR (non-serious), outcome "not recovered", described as "Rash is currently like all over my stomach and back; it is not really a rash but like red dots all over my body".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 at 15:00 as dose 4 (booster),  single (Lot number: GJ2524) at the age of 60 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure"; "obesity"; "Known allergies: Sulfa". The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 and included treatment with PAXLOVID from 18Mar2023 to 22Mar2023.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 as dose 5 (booster), single (Lot number: 6H9694), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Lot number: EL3246), on 09Feb2021 as dose 2, single (Lot number: EL9262), on 24Sep2021 as dose 3 (booster), single (Lot number: FF3587) and on 22Apr2022 as dose 4 (booster), single (Lot number: FJ4489) for covid-19 immunisation. The patient's relevant medical history included: "Heart disease" (unspecified if ongoing); "Erosive osteoarthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Morphine, reaction(s): "Allergy"; Morphine, reaction(s): "headaches". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Mar2023) negative; (26Mar2023) negative; (29Mar2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 and included Paxlovid from 20Mar2023 to 24Mar2023, lot number 2707493.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID-19; COVID-19; Moderna, Dose: 1-4 / Pfizer, Dose: 5; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 at 17:00 as dose 5 (booster), single (Lot number: GH970205309) at the age of 64 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 06Jan2021 at 12:00 as dose 1, single (Lot number: 037K20a), on 03Feb2021 at 15:00 as dose 2, single (Lot number: 013M20A), on 30Oct2021 at 16:00 as dose 3 (booster), single (Lot number: 039F21A) and on 20May2022 at 17:00 as dose 4 (booster), single (Lot number: 0J8A22A) for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "axial spondyloarthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Hydrochlorothiazide, reaction(s): "known allergies". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 16Sep2022, outcome "unknown", described as "Moderna, Dose: 1-4 / Pfizer, Dose: 5"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, COVID-19: the patient received Paxlovid from 20Mar2023 to 25Mar2023 for treatment of COVID-19.; Sender's Comments: Based on available information, a possible contributory role of the subject vaccine cannot be excluded for suspected LOE.   There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient had not known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. 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.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: bloody nose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient received BNT162b2 (BNT162B2), on 22Jan2022 at 12:00 as dose 4 (booster), single (Lot number: FH8020) at the age of 72 years, in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1st, Time (24hr): 11:15, Anatomical Site of injection: Arm, Route of administration: Intramuscular, Batch/Lot number: EL9261), administration date: 29Jan2021, when the patient was 72-year-old, for Covid-19 immunization, reaction(s): "Nosebleeds"; BNT162b2 (Dose 2nd, Time (24hr): 17:30, Anatomical Site of injection: Arm, Batch/Lot number: WTEM9809), administration date: 18Feb2021, when the patient was 72-year-old, for Covid-19 immunization, reaction(s): "Nosebleeds"; BNT162b2 (Dose 3rd, Time (24hr): 15:00, Anatomical Site of injection: Arm, Batch/Lot number: FC3181), administration date: 16Aug2021, when the patient was 72-year-old, for Covid-19 immunization, reaction(s): "Nosebleeds". The following information was reported: EPISTAXIS (non-serious) with onset 22Jan2022, outcome "recovered", described as "bloody nose". Therapeutic measures were not taken as a result of epistaxis.  Additional information: The adverse event was resulted in less than 24hrs. They tested a short time (20 minutes or less). Blood just flowed out of the patient's nose. It was just annoying and did not seek any medical advice or treatment. Booster dose due to high risk of frequent institutional or occupational exposure to coronavirus (and at risk of serious COVID-19 complications). Booster dose due to a weakened immune system. Use of medications that suppress the immune system (e.g., high dose of corticosteroids, cyclosporine, methotrexate, azathioprine, and biologic therapies like rituximab and etanercept). Vaccine facility Type was Pharmacy Drug or Drug store. Relevant tests was none. Specific relevant test for thromboembolic events with thrombocytopenia was none.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300134163 same reporter/patient/drug, different doses (Dose 5)/AE;US-PFIZER INC-202201337655 same reporter/patient/event, different doses (dose 2);US-PFIZER INC-PV202200098796 same patient, same drug, different dose/events(4th dose);US-PFIZER INC-202201337656 same reporter/patient/event, different doses (dose 3);US-PFIZER INC-PV202200112909 same patient, same drug,event/ different dose (dose 1).;
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site injury
Clinical narrative: shot injured; 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: VACCINATION SITE INJURY (non-serious) with onset Dec2020, outcome "unknown", described as "shot injured".  Additional information: It was reported that the reporter have received two packets requesting information on the passing of mother after her two Pfizer shots. Reporter refused to fill out these pages and it will be futile, in his opinion, to ask the nursing home she was in at the time to do so. The nursing homes, as well as most hospitals and doctors have been ordered, or maybe instructed, to administer treatment as directed by the CDC, the FDA, etc. and will not do anything outside of those boundaries at risk of licensing issues possibly loss of, as has been the case with many doctors that reporter now follow that have stepped outside this box created for them. Reporter wanted to give the name Of the nursing facility, as the reporter believe they will always believe they have done all they  have done in the good name of medical expediency and possibly to this day will never believe that the shots for covid did any harm (name withheld), (Address withheld). If Pfizer were truly interested in reporter's mother's case, Pfizer would start acknowledging all of the known cases of shot injured as with,(Name withheld) injured in trial in Dec2020 and as Of Jan2023, Pfizer has not acknowledged this girl in any way. One organization with just one report (organization Name withheld), press release dated 24Aug2022, in which several injured cases are listed Report Reveals Multiple Covid Shot Injuries. You can look that up if you want to take the initiative. This is just two reports you can research and acknowledge, there are so many many more. Reporter asked that Pfizer do the right thing Stop being part of a mandatory requirement for the shot, acknowledge the risks, acknowledge the injured and help them, stop the push for even further shots down to 6 month old babies stop your greed at the expense Of human lives. Bottom line, stop the deceit.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300057978 same reporter/drug, different patient/AE;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive for COVID; positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 82-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "pain I will injury my shoulder, elbow and hip" (unspecified if ongoing); "pain I will injury my shoulder, elbow and hip" (unspecified if ongoing). Concomitant medication(s) included: SPIRONOLACTONE taken for hypertension; AMLODIPINE taken for blood pressure abnormal (ongoing); PARACETAMOL taken for arthralgia, arthralgia, pain (ongoing). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 02Jan2023, outcome "unknown" and all described as "positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19. Clinical course included: Treatment included Paxlovid from 04Jan2023. The patient did not contact her doctor went to emergency number and was told to test and herself and her husband both were positive for COVID and after that all the shots and booster. Patient was told to take Paxlovid and they would call the prescription to her pharmacy. After COVID which occurred of 02Jan2023. She realized had been getting a horrible UTI (pending clarification). From Nov to End of Feb she was taking several medications not to which was marked-a lot of antibiotics. Methenamine hippurate 1g 2x/day, Cefalexin 250 mg, Cefalexin 500mg 2x/day, which primarily worked, Amoxclav 825-125 mg. "Could these antibiotics have made me more acceptable of getting covid and chill having lasting symptoms".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300135394 same reporter product event, different patient;
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, SARS-CoV-2 test
Clinical narrative: fatigue; headache; body ache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient received BNT162b2 (BNT162B2), on 08Apr2021 at 15:00 as dose 2, single (Lot number: EM8729) at the age of 58 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "high cholesterol" (unspecified if ongoing); "irregular/rapid heartbeat" (unspecified if ongoing). Concomitant medication(s) included: ATENOLOL oral taken for heart rate irregular, start date: 2000 (ongoing); ATORVASTATIN oral taken for blood cholesterol increased, start date: 2000 (ongoing). Vaccination history included: BNT162b2 (Dose: 1st, Date: 18Mar2021, Time: 14:30 PM, Anatomical Site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot number: ER8727), administration date: 18Mar2021, when the patient was 59-year-old, for Covid-19 Immunization. The following information was reported: FATIGUE (non-serious), 1 year 9 months 9 days 9 hrs after the suspect product(s) administration, outcome "recovered"; HEADACHE (non-serious), outcome "recovered"; PAIN (non-serious), outcome "recovered", described as "body ache". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported, the patient had headache, body aches for about 4-6 hours after dose 2 upon waking the next morning. Relevant Tests include Lumira Dx SARS-COV-2 RRA on 19Jan2023, Result: Positive. Specific relevant test for Thromboembolic events with Thrombocytopenia was None. Lack of effect details: No lack of effect - product reduced disease/symptoms to expected level. Adverse event includes headache, body aches, fatigue on 18Jan2023. Seriousness criteria was reported as Not serious. AE outcome was Recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300136129 same reporter/pt, different dose/event;US-PFIZER INC-202300033779 same reporter/pt, different dose/event;
Sex: U
Vaccine: COVID19
Symptoms: White blood cell count, White blood cell count decreased
Clinical narrative: WBC /After the 3rd booster in Oct2022, it was 2.3. It is now 1.7.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), administration date: 2021, for COVID-19 immunization, reaction(s): "WBC was 3.4 and has been dropping since". The following information was reported: WHITE BLOOD CELL COUNT DECREASED (medically significant) with onset Oct2022, outcome "not recovered", described as "WBC /After the 3rd booster in Oct2022, it was 2.3. It is now 1.7.". The patient underwent the following laboratory tests and procedures: White blood cell count: (unspecified date) 7.8, notes: Before vaccination; (2021) 3.4, notes: After second shot; (Oct2022) 2.3; (2023) 1.7. Patient was working with a rheumatologist and hematologist, but they can't figure it out.  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: Linked Report(s) : US-PFIZER INC-PV202300037577 same patient, different vaccine dose, different event;
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: Itchy throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Mar2023 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 but unknown manufacturer), for Covid-19 immunization. The following information was reported: THROAT IRRITATION (non-serious) with onset 28Mar2023, outcome "unknown", described as "Itchy throat". Additional information: Reporter was calling in reference to reporter's daughter. The daughter got a vaccination shot booster shot, and she stayed there for the 15 minutes like they ask she to, but she came home and she was saying she have itchy throat is that a side effect from it. The daughter had a booster and she waited 15 minutes like they are supposed to.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: reports that they believe expired IPOL was administered to a patient with no reported adverse event; Initial information received on 27-Mar-2023 regarding an unsolicited valid  non-serious case received from an other health professional.  This case involves an unknown age and gender patient to whom an expired IPV (VERO) [IPOL] vaccine was administered 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 IPV (VERO), suspension for injection (lot U1A452M , expiry date: 12-Feb-2023) (With unknown strength, route and at unknown administration site) for prophylactic vaccination (immunization).  On an unknown date reporter reported that that an expired ipol was administered to a patient with no reported adverse event(expired product administered) (same day latency).  No lab data were reported.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guideliens. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.33
Sex: F
Vaccine: UNK
Symptoms: No adverse event, Single component of a two-component product administered
Clinical narrative: administered Pentacel without the HIB patient only received the liquid portion with no adverse event; Initial information received on 28-Mar-2023 regarding an unsolicited valid non-serious case received via medical assistant.   This case involves 4 months old female patient to whom Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (VERO)] was administered without the hib patient only received the liquid portion with no adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Pneumococcal Vaccine 13V (PNEUMOCOCCAL 13) for Prophylactic vaccination, and Rotavirus Vaccine for Immunization.  On 27-Mar-2023, the patient was administered suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine at dose 0.5ml once (lot: U7311AA, expiry date: 09-Sep-2023) via intramuscular route in the left thigh for prophylactic vaccination with administered Pentacel without the hib patient only received the liquid portion with no adverse event (single component of a two-component product administered) at same day latency.  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 single component of a two-component 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.
Sex: U
Vaccine: UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired PENTACEL being given to 3 patients with no reported adverse event; Initial information received on 29-Mar-2023 regarding an unsolicited valid non-serious case received via Representative (Employee).  This case involves 3 patients of unspecified demographics who experienced expired Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine [Pentacel] being given to 3 patients 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, 3 patients received expired suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRC5)/HIB(PRP/T) vaccine at dose 0.5 ml once at (unknown: strength, lot number, route in unknown administration site) for prophylactic vaccination with no reported adverse event (expired product administered) at same day latency.  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.
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired engerix B was administered; This non-serious case was reported by a nurse via sales rep and described the occurrence of expired vaccine used in a male patient who received HBV (Engerix B) (expiry date JAN-2023) for prophylaxis.   On 16-MAR-2023, the patient received Engerix B. On 16-MAR-2023, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Expired engerix B was administered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 14-MAR-2023 The reporter did not consent to follow up. The patient received a Engerix B vaccine which was already expired, which led to expired vaccine used.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis reactive, Gait disturbance, Joint swelling
Clinical narrative: Reactive arthritis; Swollen ankles & knees; Patient can limp/cant walk; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ARTHRITIS REACTIVE (Reactive arthritis) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. ASKU and ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced ARTHRITIS REACTIVE (Reactive arthritis) (seriousness criterion medically significant), JOINT SWELLING (Swollen ankles & knees) and GAIT DISTURBANCE (Patient can limp/cant walk). At the time of the report, ARTHRITIS REACTIVE (Reactive arthritis) and JOINT SWELLING (Swollen ankles & knees) had not resolved and GAIT DISTURBANCE (Patient can limp/cant walk) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Patient was totally healthy prior to vaccination.  No treatment information was provided.  Company Comment This spontaneous case concerns a 34-years-old-female patient, with no medical history reported who experienced the unexpected seriousness criterion medically significant event of Arthritis reactive (AESI); the unexpected events of gait disturbance and joint swellling unknown days after 3rd.  dose of  mRNA- 1273 vaccine. The primary schedule was with moderna vaccine in 2021 without exact dates information. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events seriousness was assessed based on medical judgement.
Age: 89.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Patient's issues are resolved. I told her I would document the reddness she had on most of her right arm. Patient did take antibotics to treat it.
Age: 32.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dysphonia, Dyspnoea, Fatigue, Lethargy
Clinical narrative: Systemic: Exhaustion / Lethargy-Medium, Systemic: Pt states that her voice became raspy, she's fatigued, shortness of breath, when laying on her back at night it's hard to breath-Medium, Additional Details: Patient is currently 18 weeks pregnant. She was told that some of these symptoms could be caused from the pregnancy. She said she was not pregnant at the time that symptoms arose. She currently does not have regular insurance, only the RX for pregnancy.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: red, circumscribed rash at the site of injection, treated with zyrtec 10mg BID x 7 days
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Extra dose administered, No adverse event
Clinical narrative: No Adverse effects, Issue was too many doses given due to incorrect documentation within immunization tabs. Resident is stable with no complications at this time.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: hospitalized with covid; fully vaccinated with booster
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cardiac stress test, Cough, Dyspnoea exertional, Echocardiogram, Exercise tolerance decreased
Clinical narrative: I got my vaccination in September and I developed influenza B in November.  I coughed non stop for about two weeks and sort of lingered for quite a while. Since then, I've had more problems with coughing. The biggest thing that I have noticed is that I get really short of breath when I'm walking. When I climb stairs it feels like I'm dragging my behind behind me and it takes me a while to catch my breath. I also have been experiencing a lot of fatigue. I do take a lot of medicine so I don't know if the fatigue is from the medicine or related to this but it has definitely become more prevalent in the last few month. I'm not accomplishing much, I can't exercise like I used to. I've gained a lot of weight and used to be a smoker, as well. I've had an echocardiogram and I have an order for a chest XRay probably next week. In June I have a breathing test scheduled and after all the results are in I will see a pulmonologist. When at the pulmonologist for the Echo, they had me do a 6 min walking test to look at my breathing. My oxygen levels were fine but I was clearly out of breath. I did have a lung screening before I had influenza because I was a previous smoker, and that was clear.
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Fatigue, Influenza B virus test positive, Loss of personal independence in daily activities, Weight increased
Clinical narrative: I got my vaccination in September and I developed influenza B in November.  I coughed non stop for about two weeks and sort of lingered for quite a while. Since then, I've had more problems with coughing. The biggest thing that I have noticed is that I get really short of breath when I'm walking. When I climb stairs it feels like I'm dragging my behind behind me and it takes me a while to catch my breath. I also have been experiencing a lot of fatigue. I do take a lot of medicine so I don't know if the fatigue is from the medicine or related to this but it has definitely become more prevalent in the last few month. I'm not accomplishing much, I can't exercise like I used to. I've gained a lot of weight and used to be a smoker, as well. I've had an echocardiogram and I have an order for a chest XRay probably next week. In June I have a breathing test scheduled and after all the results are in I will see a pulmonologist. When at the pulmonologist for the Echo, they had me do a 6 min walking test to look at my breathing. My oxygen levels were fine but I was clearly out of breath. I did have a lung screening before I had influenza because I was a previous smoker, and that was clear.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Moderna given to employee expired 8 days ago
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Echocardiogram normal, Electrocardiogram abnormal, Electrocardiogram ambulatory abnormal, Heart rate irregular
Clinical narrative: The first thing I notices was my heart wasn't beating regularly. I then stopped every time I noticed I would give myself a moment and go lay. After about 15minutes of rest I was able to return to my activity. I would get very dizzy, and it wasn't brought on by exercise. I would be doing normal things...I reported to the doctor and didn't get much feedback. I went and got a smart watch to help me track this issue. I took an EKG on my smart watch, and the numbers were 30 PVC per minute and then I took my report to my doctor. They told me to come in and I was referred to a cariologist. I was on Holter Monitor to confirm the runs of the PVC, i was  also given a ECHO test that showed no additional damage. and an injection refraction of 45that was unchanged. I was then put on a beta-blocker, and I set to take 5 milligrams 2x a day. The side effects were intolerable to me. I had tingling in my hands and feet, and they would turn colors and they would Vaso constrict and turn blue and I had zero feeling. I stopped taking the full dose .25 to 5 milligrams at night only and this did help the PVC. This process took some time to master but it did work.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Ventricular extrasystoles
Clinical narrative: The first thing I notices was my heart wasn't beating regularly. I then stopped every time I noticed I would give myself a moment and go lay. After about 15minutes of rest I was able to return to my activity. I would get very dizzy, and it wasn't brought on by exercise. I would be doing normal things...I reported to the doctor and didn't get much feedback. I went and got a smart watch to help me track this issue. I took an EKG on my smart watch, and the numbers were 30 PVC per minute and then I took my report to my doctor. They told me to come in and I was referred to a cariologist. I was on Holter Monitor to confirm the runs of the PVC, i was  also given a ECHO test that showed no additional damage. and an injection refraction of 45that was unchanged. I was then put on a beta-blocker, and I set to take 5 milligrams 2x a day. The side effects were intolerable to me. I had tingling in my hands and feet, and they would turn colors and they would Vaso constrict and turn blue and I had zero feeling. I stopped taking the full dose .25 to 5 milligrams at night only and this did help the PVC. This process took some time to master but it did work.
Age: 53.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pruritus
Clinical narrative: Vaccinator taking care of the patient. During initial screening she reported that she had an allergic reaction 16 hours after getting her Pfizer Monovalent COVID-19 booster shot in August of 2022, so her doctor recoment to switch for Moderna bivaleon. We let patient to wait for 30 minutes rather than 15 minutes. Vaccinator was check on pt. after 10 min, she was fine. Approximately 20 minutes she walked back to my table saying that she felt itchy on the side of her neck but denied any other complaints at the time. We get epi pen kit in case and we contacted 911. We checking her VS:HR 90, BP140/70, RR20,she did not have swelling in her face/tongue, uticaria, a hoarse voice, stridor, respiratory reaction.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, COVID-19, Cough, Infection, Pyrexia
Clinical narrative: I experienced a breakthrough case of COVID-19 with extremely runny nose, I have never had such a runny nose in my life. I had a cough, aches and pains in my joints and a fever of 103 degrees.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: I experienced a breakthrough case of COVID-19 with extremely runny nose, I have never had such a runny nose in my life. I had a cough, aches and pains in my joints and a fever of 103 degrees.
Age: 0.83
Sex: F
Vaccine: PNC13
Symptoms: Circumstance or information capable of leading to medication error, Wrong product administered
Clinical narrative: Patient was due for Polio but physician wrote order or PCV13. Grandmother, whom has legal custody of patient was made aware. Patient will receive polio at next visit.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain in extremity
Clinical narrative: terrible headache, chills, significant left arm pain 12+ hours
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood test, Pain in extremity, Thrombosis, Ultrasound scan
Clinical narrative: I had pain in my leg that turned out to be a blood clot.
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthropathy, Blood test normal, Bone pain, Condition aggravated, Hip arthroplasty
Clinical narrative: 10/4/2022  My bones ached several days after my vaccination which aggravated my hip , which was already bad, but this exacerbated my hip.  On 3/15/23 I had a hip replacement.
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: Magnetic resonance imaging joint
Clinical narrative: 10/4/2022  My bones ached several days after my vaccination which aggravated my hip , which was already bad, but this exacerbated my hip.  On 3/15/23 I had a hip replacement.
Age: 52.0
Sex: F
Vaccine: COVID19-2
Symptoms: Magnetic resonance imaging abnormal, Rotator cuff syndrome
Clinical narrative: Left rotator cuff tear.
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Malaise, Nasopharyngitis, SARS-CoV-2 test positive
Clinical narrative: I felt like I had a head cold I tested on 28MAR2023 and I was positive, I m still positive and I still feel worst. I contacted my doctor and prescribed me Paxlovid, I have not felt so much better after but just a little but.
Age: 12.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Erythema, Skin warm
Clinical narrative: redness, warmth
Age: 75.0
Sex: M
Vaccine: COVID19-2, FLUA4
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Positive test on 3/9/23. Treatment includes admission with symptom management.
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Sinusitis
Clinical narrative: I experienced a continuous chronic sinus infection, I have to flush my sinuses everyday and take a nasal spray. I can't seem to get rid of this sinus infection, I've been experiencing this since vaccination.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Underdose
Clinical narrative: Pt was put on schedule for COVID #3, not double checking age pt was given a 6m-4y dose as #3 before booster was even do, they received lower dose vaccine before booster was even need.  Spoke to CDC- recommendations: do not repeat dose. However, providers may administer 1 bivalent booster dose as a repeat dose based on clinical judgement and patient preference. In this case, space the repeat dose after the dose given in error by at least 2 months.
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Headache, Nasal congestion, Nasopharyngitis
Clinical narrative: I woke up feeling like I had a cold. I was starting to cough a little bit and had nasal congestion. The symptoms got worse. I was coughing a little more and had a little bit of a headache. The next day, I tested for COVID-19 at home. The result was negative. I thought I just had a bad cold. I was coughing and my nose was running a lot more. On day four, I tested for COVID-19 again. The result was positive. I called my doctor. He prescribed PAXLOVID. I started it the same day. I was told to take it for five days. The medicine seemed to calm my cough, but it didn't go away completely. The nasal congestion just stopped. The medicine tasted metallic. I took another COVID-19 test at the end of the fifth day of taking the medication. The result was still positive. I took another COVID-19 test on March 18, 2023. The result was negative. I still have a lingering cough. I took another COVID-19 test on March 22, 2023. The result was still negative. I have a cough in the morning and when my throat is dry.
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: I woke up feeling like I had a cold. I was starting to cough a little bit and had nasal congestion. The symptoms got worse. I was coughing a little more and had a little bit of a headache. The next day, I tested for COVID-19 at home. The result was negative. I thought I just had a bad cold. I was coughing and my nose was running a lot more. On day four, I tested for COVID-19 again. The result was positive. I called my doctor. He prescribed PAXLOVID. I started it the same day. I was told to take it for five days. The medicine seemed to calm my cough, but it didn't go away completely. The nasal congestion just stopped. The medicine tasted metallic. I took another COVID-19 test at the end of the fifth day of taking the medication. The result was still positive. I took another COVID-19 test on March 18, 2023. The result was negative. I still have a lingering cough. I took another COVID-19 test on March 22, 2023. The result was still negative. I have a cough in the morning and when my throat is dry.
Age: 77.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Pain, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: On 02/16/2023, midday, I had congestion, lots of aches and pains, I felt lousy. I had no fever and a little cough.  That evening, I tested positive for COVID-19. I called my doctor for a telehealth visit. He prescribed Paxlovid. I start Paxlovid on 02/17/2023. I took it for 5 days. Symptoms went away rapidly. Five days later, on 02/22/2023, I tested negative. Symptoms came back and I was testing positive again with mild symptoms.
Age: 57.0
Sex: M
Vaccine: COVID19-2
Symptoms: Computerised tomogram normal, Dizziness, Feeling abnormal, Paraesthesia, Tinnitus
Clinical narrative: I experienced some lightheadedness and some tingling in my brain. I went to the emergency room in January of this year because I thought I had a stroke and I heard this popping noise in my head. The doctor found nothing in the CAT scan. I feel better now for the most part, but I have a follow-up with my doctor in April 2023.
Age: 4.0
Sex: F
Vaccine: COVID19-2
Symptoms: Influenza virus test negative, Lethargy, Malaise, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: She was lethargic at daycare and kept saying she was sick. She spiked a fever that night. We gave her MOTRIN and took her to the doctor the next day. They tested her for COVID-19, Flu, and Strep and she tested negative. We continued to give MOTRIN and she was better in a couple days.
Age: 4.0
Sex: F
Vaccine: COVID19-2
Symptoms: Streptococcus test negative
Clinical narrative: She was lethargic at daycare and kept saying she was sick. She spiked a fever that night. We gave her MOTRIN and took her to the doctor the next day. They tested her for COVID-19, Flu, and Strep and she tested negative. We continued to give MOTRIN and she was better in a couple days.
Age: 37.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Incorrect product formulation administered
Clinical narrative: Wrong vaccine administered. Pt was due for a bivalent formulation and received a monovalent.  Pt counselled by clinician.
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood test, Computerised tomogram abnormal, Dizziness, Electrocardiogram abnormal, Muscular weakness
Clinical narrative: I became dizzy, my legs were weak I called the ambulance, they checked vital signs and felt that I needed to the emergency room for further testing. Upon arriving at the emergency room, they EKG, CAT, scan, bloodwork, they felt I needed to stay overnight, for observation. It was determined I have benign paroxysmal positional vertigo; I was prescribed ANTIVERT to held with being dizzy that I took for ten days. I now have it to take as needed.
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Vertigo positional
Clinical narrative: I became dizzy, my legs were weak I called the ambulance, they checked vital signs and felt that I needed to the emergency room for further testing. Upon arriving at the emergency room, they EKG, CAT, scan, bloodwork, they felt I needed to stay overnight, for observation. It was determined I have benign paroxysmal positional vertigo; I was prescribed ANTIVERT to held with being dizzy that I took for ten days. I now have it to take as needed.
Age: 13.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Dizziness, Nausea, Pallor, Tinnitus
Clinical narrative: Pt felt dizzy and lightheaded, nauseas. ringing in ears, and pt's complexion was pale. Called a triage for pt and was brought back to a room. Pt was instructed to lay down, with feet elevated. She was given an ice pack. Took vital signs until they were at base line/ normal.  Note: pt was at check out when this reaction happened
Age: 13.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Bradycardia, Dizziness, Flushing, Nausea, Pallor
Clinical narrative: Pt felt dizzy and lightheaded, nauseas. ringing in ears, and pt's complexion was pale. Called a triage for pt and was brought back to a room. Pt was instructed to lay down, with feet elevated. She was given an ice pack. Took vital signs until they were at base line/ normal.  Note: pt was at check out when this reaction happened