chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial initially stored in refrigerator on 18 oct 2022; No adverse event; bivalent Moderna COVID19 vaccine were given after the beyond use date BUD 17Nov2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (bivalent Moderna COVID19 vaccine were given after the beyond use date BUD 17Nov2022), PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 18 oct 2022) 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. 051d22a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 18-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (bivalent Moderna COVID19 vaccine were given after the beyond use date BUD 17Nov2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 18 oct 2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (bivalent Moderna COVID19 vaccine were given after the beyond use date BUD 17Nov2022), PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 18 oct 2022) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (bivalent Moderna COVID19 vaccine were given after the beyond use date BUD 17Nov2022) and PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 18 oct 2022).    14 doses of the bivalent Moderna COVID19 vaccine were given after the beyond use date BUD 17Nov2022 No concomitant medications were reported. Vial size was reported as 2.5ml On  18Oct2022, the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions. No treatment medications were reported. This case contains information for the 14th of 14 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-675260, US-MODERNATX, INC.-MOD-2022-675264, US-MODERNATX, INC.-MOD-2022-675268, US-MODERNATX, INC.-MOD-2022-675259, US-MODERNATX, INC.-MOD-2022-675269, US-MODERNATX, INC.-MOD-2022-675270 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-675260:Patient 14 US-MODERNATX, INC.-MOD-2022-675264:same reporter US-MODERNATX, INC.-MOD-2022-675268:Patient 14 US-MODERNATX, INC.-MOD-2022-675269: US-MODERNATX, INC.-MOD-2022-675259:Patient 14 US-MODERNATX, INC.-MOD-2022-675270:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive also; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (tested positive also) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, 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 an unknown date, the patient experienced COVID-19 (tested positive also) (seriousness criterion hospitalization). At the time of the report, COVID-19 (tested positive also) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.         No concomitant medications were reported. Patient had received previous Moderna vaccinations. No treatment medications were reported.  Company Comment: This is a spontaneous case concerning a female patient of an unknown age with no reported medical history, who experienced the unexpected, serious, event of COVID-19 which led to the hospitalization of the patient and occurred on an unknown date after receiving a dose of mRNA-1273.222 (BA.4/BA.5) Original/Omicron Bivalent Vaccine. No further information on risk factors, co morbidities, clinical course and management of the event was available in the report. The reported outcome of the event was unknown. The ongoing COVID-19 pandemic remains a confounder. The benefit-risk relationship of mRNA-1273.214 (BA.1) Original/Omicron Bivalent Vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This is a spontaneous case concerning a female patient of an unknown age with no reported medical history, who experienced the unexpected, serious, event of COVID-19 which led to the hospitalization of the patient and occurred on an unknown date after receiving a dose of mRNA-1273.222 (BA.4/BA.5) Original/Omicron Bivalent Vaccine. No further information on risk factors, co morbidities, clinical course and management of the event was available in the report. The reported outcome of the event was unknown. The ongoing COVID-19 pandemic remains a confounder. The benefit-risk relationship of mRNA-1273.214 (BA.1) Original/Omicron Bivalent Vaccine is not affected by this report.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: fly like symptoms; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (fly like symptoms) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (fly like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (fly like symptoms) outcome was unknown.            No concomitant medication was reported. Patient had no fever or life threatening issues. Patient was in relatively good health and patient had O neg blood. No concomitant medication were reported. Patient took the offered four doses Covid Moderna vaccine, at the appropriate times. The vaccine gave fly like symptoms but no fever or life threatening issues. No treatment information was provided by the reporter.   This case was linked to MOD-2022-675330 (Patient Link).
Age: 82.0
Sex: M
Vaccine: COVID19-2
Symptoms: Body temperature, Fatigue, Immunisation reaction, Nasopharyngitis, Pyrexia
Clinical narrative: slept 12 hours; tired; Temperature has been bouncing around/not gone higher than 106; really bad cold; reaction; This spontaneous case was reported by a patient and describes the occurrence of NASOPHARYNGITIS (really bad cold), IMMUNISATION REACTION (reaction), SOMNOLENCE (slept 12 hours), FATIGUE (tired) and PYREXIA (Temperature has been bouncing around/not gone higher than 106) in an 82-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Nov-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In November 2022, the patient experienced NASOPHARYNGITIS (really bad cold), IMMUNISATION REACTION (reaction) and PYREXIA (Temperature has been bouncing around/not gone higher than 106). On 20-Nov-2022, the patient experienced SOMNOLENCE (slept 12 hours) and FATIGUE (tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, NASOPHARYNGITIS (really bad cold) had not resolved and IMMUNISATION REACTION (reaction), SOMNOLENCE (slept 12 hours), FATIGUE (tired) and PYREXIA (Temperature has been bouncing around/not gone higher than 106) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2022, Body temperature: the value had not gone higher than 106.         No concomitant medication was reported. The patient had no problem with any of the shots so far-the first two doses and two boosters.  The temperature had been bouncing around and had not gone higher than 106.
Age: 82.0
Sex: M
Vaccine: COVID19-2
Symptoms: Somnolence
Clinical narrative: slept 12 hours; tired; Temperature has been bouncing around/not gone higher than 106; really bad cold; reaction; This spontaneous case was reported by a patient and describes the occurrence of NASOPHARYNGITIS (really bad cold), IMMUNISATION REACTION (reaction), SOMNOLENCE (slept 12 hours), FATIGUE (tired) and PYREXIA (Temperature has been bouncing around/not gone higher than 106) in an 82-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Nov-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In November 2022, the patient experienced NASOPHARYNGITIS (really bad cold), IMMUNISATION REACTION (reaction) and PYREXIA (Temperature has been bouncing around/not gone higher than 106). On 20-Nov-2022, the patient experienced SOMNOLENCE (slept 12 hours) and FATIGUE (tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, NASOPHARYNGITIS (really bad cold) had not resolved and IMMUNISATION REACTION (reaction), SOMNOLENCE (slept 12 hours), FATIGUE (tired) and PYREXIA (Temperature has been bouncing around/not gone higher than 106) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2022, Body temperature: the value had not gone higher than 106.         No concomitant medication was reported. The patient had no problem with any of the shots so far-the first two doses and two boosters.  The temperature had been bouncing around and had not gone higher than 106.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Immunisation reaction, Underdose
Clinical narrative: For 18, I've months shortness of breath, extreme shortness of breath; symptoms started after 2nd shot; Patient received 0.25 ml of second dose of Morderna vaccine; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (For 18, I've months shortness of breath, extreme shortness of breath), IMMUNISATION REACTION (symptoms started after 2nd shot) and UNDERDOSE (Patient received 0.25 ml of second dose of Morderna vaccine) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood cholesterol abnormal. Concomitant products included ATORVASTATIN for Blood cholesterol abnormal.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 10-Feb-2021, the patient experienced UNDERDOSE (Patient received 0.25 ml of second dose of Morderna vaccine). On an unknown date, the patient experienced DYSPNOEA (For 18, I've months shortness of breath, extreme shortness of breath) and IMMUNISATION REACTION (symptoms started after 2nd shot). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, DYSPNOEA (For 18, I've months shortness of breath, extreme shortness of breath) had not resolved and IMMUNISATION REACTION (symptoms started after 2nd shot) and UNDERDOSE (Patient received 0.25 ml of second dose of Morderna vaccine) outcome was unknown.            It was reported that patient had months shortness of breath, extreme shortness of breath, slowly got worsen symptoms started after 2nd shot.   This case was linked to MOD-2022-675668 (Patient Link).
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Dyspnoea, Hypertrophic cardiomyopathy, Left ventricular hypertrophy, Magnetic resonance imaging
Clinical narrative: For 18, I've months shortness of breath, extreme shortness of breath; symptoms started after 2nd shot; Patient received 0.25 ml of second dose of Morderna vaccine; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (For 18, I've months shortness of breath, extreme shortness of breath), IMMUNISATION REACTION (symptoms started after 2nd shot) and UNDERDOSE (Patient received 0.25 ml of second dose of Morderna vaccine) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood cholesterol abnormal. Concomitant products included ATORVASTATIN for Blood cholesterol abnormal.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 10-Feb-2021, the patient experienced UNDERDOSE (Patient received 0.25 ml of second dose of Morderna vaccine). On an unknown date, the patient experienced DYSPNOEA (For 18, I've months shortness of breath, extreme shortness of breath) and IMMUNISATION REACTION (symptoms started after 2nd shot). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, DYSPNOEA (For 18, I've months shortness of breath, extreme shortness of breath) had not resolved and IMMUNISATION REACTION (symptoms started after 2nd shot) and UNDERDOSE (Patient received 0.25 ml of second dose of Morderna vaccine) outcome was unknown.            It was reported that patient had months shortness of breath, extreme shortness of breath, slowly got worsen symptoms started after 2nd shot.   This case was linked to MOD-2022-675668 (Patient Link).
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging heart
Clinical narrative: For 18, I've months shortness of breath, extreme shortness of breath; symptoms started after 2nd shot; Patient received 0.25 ml of second dose of Morderna vaccine; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (For 18, I've months shortness of breath, extreme shortness of breath), IMMUNISATION REACTION (symptoms started after 2nd shot) and UNDERDOSE (Patient received 0.25 ml of second dose of Morderna vaccine) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood cholesterol abnormal. Concomitant products included ATORVASTATIN for Blood cholesterol abnormal.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 10-Feb-2021, the patient experienced UNDERDOSE (Patient received 0.25 ml of second dose of Morderna vaccine). On an unknown date, the patient experienced DYSPNOEA (For 18, I've months shortness of breath, extreme shortness of breath) and IMMUNISATION REACTION (symptoms started after 2nd shot). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, DYSPNOEA (For 18, I've months shortness of breath, extreme shortness of breath) had not resolved and IMMUNISATION REACTION (symptoms started after 2nd shot) and UNDERDOSE (Patient received 0.25 ml of second dose of Morderna vaccine) outcome was unknown.            It was reported that patient had months shortness of breath, extreme shortness of breath, slowly got worsen symptoms started after 2nd shot.   This case was linked to MOD-2022-675668 (Patient Link).
Sex: F
Vaccine: COVID19-2
Symptoms: Accidental underdose, Circumstance or information capable of leading to medication error, No adverse event
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25 ml of bivalent booster), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Thinks that the pharmacist only gave her 0.25 ml) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25 ml of bivalent booster), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Thinks that the pharmacist only gave her 0.25 ml) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25 ml of bivalent booster), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Thinks that the pharmacist only gave her 0.25 ml) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for ACCIDENTAL UNDERDOSE (Received 0.25 ml of bivalent booster) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Thinks that the pharmacist only gave her 0.25 ml).    No concomitant medication were reported.  Patient asked if dosage of the Moderna booster with the bivalent vaccine is half an ml. She thinks that the pharmacist only gave her 0.25 ml. She stated that she spoke with an infectious disease physician, who told to get the other 0.25 ml right away.  No treatment information was provided by the reporter.   Reporter did not allow further contact
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient received the Moderna monovalent instead of bivalent as his 1st booster dose; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received the Moderna monovalent instead of bivalent as his 1st booster dose) and NO ADVERSE EVENT (No adverse event) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 074B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Nov-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Nov-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received the Moderna monovalent instead of bivalent as his 1st booster dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received the Moderna monovalent instead of bivalent as his 1st booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received the Moderna monovalent instead of bivalent as his 1st booster dose).    No concomitant medications were reported. No treatment details were reported.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Incorrect dose administered
Clinical narrative: mild discomfort; had received a dose of the pediatric presentation of the vaccine as a booster/ mild dose/younger dose; This spontaneous case was reported by a pharmacist and describes the occurrence of DISCOMFORT (mild discomfort) and INCORRECT DOSE ADMINISTERED (had received a dose of the pediatric presentation of the vaccine as a booster/ mild dose/younger dose) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Sep-2022, received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Sep-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INCORRECT DOSE ADMINISTERED (had received a dose of the pediatric presentation of the vaccine as a booster/ mild dose/younger dose). On an unknown date, the patient experienced DISCOMFORT (mild discomfort). At the time of the report, DISCOMFORT (mild discomfort) and INCORRECT DOSE ADMINISTERED (had received a dose of the pediatric presentation of the vaccine as a booster/ mild dose/younger dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient was told to wait 60 days before receiving an  dose of the Bivalent vaccine.  No treatment was given to the patient.
Age: 72.0
Sex: F
Vaccine: FLUX
Symptoms: Malaise, Off label use
Clinical narrative: feeling sick; current dose reported as 108µg (18 breaths), four times a day (QID) via inhalation(IH) route; Initial information received on 11-Nov-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 72 years old female patient (81.6 kg) who experienced feeling sick and current dose reported as 108µg (18 breaths), four times a day (qid) via inhalation(ih) route while receiving vaccine INFLUENZA VACCINE and while treated with TREPROSTINIL SODIUM.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Pulmonary arterial hypertension.  Concomitant medications included TADALAFIL (TADALAFIL); AMBRISENTAN (AMBRISENTAN); APIXABAN (ELIQUIS); and NIFEDIPINE (NIFEDIPINE).  On an unknown date, the patient started taking TREPROSTINIL SODIUM Unknown 108 ug QID (with an unknown batch number) for Pulmonary arterial hypertension. 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 Influenza immunization.  On 08-NOV-2022 the patient developed a non-serious feeling sick (malaise) (unknown latency) following the first dose intake and (unknown latency) following the last dose intake of TREPROSTINIL SODIUM. On 08-NOV-2022 the patient developed a non-serious current dose reported as 108µg (18 breaths), four times a day (qid) via inhalation(ih) route (off label use) (unknown latency) following the first dose intake and (unknown latency) following the last dose intake of TREPROSTINIL SODIUM.On 08-NOV-2022 the patient developed a non-serious feeling sick (malaise) (unknown latency) following the administration of INFLUENZA VACCINE. On 08-NOV-2022 the patient developed a non-serious current dose reported as 108µg (18 breaths), four times a day (qid) via inhalation(ih) route (off label use) (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 (feeling sick, current dose reported as 108µg (18 breaths), four times a day (QID) via inhalation(IH) route).  At time of reporting, the outcome was Unknown for the event feeling sick and was Unknown for the event current dose reported as 108µg (18 breaths), four times a day (qid) via inhalation(ih) route.
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: office administered an expired highdose flu vaccine from 2021-2022 season (with no reported adverse event); Initial information received on 15-Nov-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves Adult and unknown gender patient who reported office administered an expired INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] from 2021-2022 season (with no reported adverse event).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a  dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE Suspension for injection in pre-filled syringe (lot UJ690AB) via intramuscular route in unknown administration site for Prophylactic vaccination .  On an unknown date the patient reported  a non-serious event office administered an expired INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] from 2021-2022 season (with no reported adverse event) (expired product administered) (unknown latency).  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 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: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: staff member administered FLUZONE HIGH-DOSE QIV to a patient that is 60 years of age with no reported adverse event.; Initial information was received on 17-Nov-2022 regarding an unsolicited valid non-serious case from an other health professional.  This case involves a staff member administered influenza quadrival A-B high dose HV vaccine [Fluzone high-dose quadrivalent] to a 60 years old female patient with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 17-Nov-2022, staff member administered dose of 0.7 ml once suspect influenza quadrival A-B high dose HV vaccine (lot number: UT7733BA, expiry date, formulation: Unknown) via intramuscular route in the left deltoid for Immunisation to a patient that is 60 years of age with no reported adverse event (product administered to patient of inappropriate age) (latency: same day).  No lab data reported.  Action taken: not applicable.  Outcome: Unknown for the event staff member administered fluzone high-dose qiv to a patient that is 60 years of age with no reported adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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: 0.17
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 2-month-old patient that was given FLUZONE QUADRIVALENT NP, with no reported adverse event; Initial information received on 17-Nov-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2 months old female patient who was given influenza quadrival a-b vaccine [Fluzone Quadrivalent], with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis b vaccine; diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (Pentacel); pneumococcal vaccine conj 13v (crm197) (Prevenar 13); and rotavirus vaccine for immunization.  On 17-Nov-2022, the patient received a dose of 0.5 ml once of suspect influenza quadrival a-b vaccine Suspension for injection standard (lot UT7759KA, expiry date- 30-JUN-2023) via intramuscular route in the left vastus lateralis for Immunization, with no reported adverse event (product administered to patient of inappropriate age) (latency same day).  Action taken was 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 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: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Dizziness, Fatigue, Heart rate increased, SARS-CoV-2 test negative
Clinical narrative: Fatigue, coughing, sneezing, rapid heart rate, dizzy spells
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Sneezing
Clinical narrative: Fatigue, coughing, sneezing, rapid heart rate, dizzy spells
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Fatigue, Headache, Respiratory tract congestion
Clinical narrative: Positive COVID home test. Runny Nose, Cough, Fatigue, Congestion, Headache
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: Positive COVID home test. Runny Nose, Cough, Fatigue, Congestion, Headache
Age: 18.0
Sex: M
Vaccine: COVID19-2
Symptoms: Asthenia, Blood pressure systolic decreased, Confusional state, Dizziness, Fatigue
Clinical narrative: Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Hypotension-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Weakness-Mild, Additional Details: patient was seated, fainted/passed out, regained conciousness, systolic bp low, HR normal. monitored it and it came back up, he stated vision changes and nausea, notified parent we were going to call the ambulance due to low bp and as precaution, parent did not want that, told parent take him to ER to be monitored. patient did recover after seating and gained normal function and was able to walk out with parent (Dad)
Age: 18.0
Sex: M
Vaccine: COVID19-2
Symptoms: Hypotension, Lethargy, Loss of consciousness, Nausea, Syncope
Clinical narrative: Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Hypotension-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Weakness-Mild, Additional Details: patient was seated, fainted/passed out, regained conciousness, systolic bp low, HR normal. monitored it and it came back up, he stated vision changes and nausea, notified parent we were going to call the ambulance due to low bp and as precaution, parent did not want that, told parent take him to ER to be monitored. patient did recover after seating and gained normal function and was able to walk out with parent (Dad)
Age: 18.0
Sex: M
Vaccine: COVID19-2
Symptoms: Unresponsive to stimuli, Visual impairment
Clinical narrative: Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Hypotension-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Weakness-Mild, Additional Details: patient was seated, fainted/passed out, regained conciousness, systolic bp low, HR normal. monitored it and it came back up, he stated vision changes and nausea, notified parent we were going to call the ambulance due to low bp and as precaution, parent did not want that, told parent take him to ER to be monitored. patient did recover after seating and gained normal function and was able to walk out with parent (Dad)
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Eye swelling, Fatigue, Injection site erythema, Injection site pain
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Joint Pain-Medium, Additional Details: Long streaking rash from injection site several inches above and below. Baseball sized swekking that occurred 2 days post vaccination.
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site pruritus, Injection site rash, Injection site streaking, Injection site swelling, Lethargy
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Joint Pain-Medium, Additional Details: Long streaking rash from injection site several inches above and below. Baseball sized swekking that occurred 2 days post vaccination.
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Mouth swelling, Pain, Swelling face, Swollen tongue
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Joint Pain-Medium, Additional Details: Long streaking rash from injection site several inches above and below. Baseball sized swekking that occurred 2 days post vaccination.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: arm warn red and swollen. Recommended to see primary dr and ask if any care is needed , antibiotics or other.
Age: 46.0
Sex: F
Vaccine: COVID19-2
Symptoms: Needle issue
Clinical narrative: Error: Wrong Needle Length-
Age: 14.0
Sex: M
Vaccine: FLU4
Symptoms: Presyncope, Seizure
Clinical narrative: Systemic: vasovagal episode-Mild, Systemic: Seizure-Mild, Additional Details: Mother called stating after vaccine was given, pt experienced a seizure. Contacted Hospital, the ER department stated it was worked up as a vasovagal episode after a vaccine. After vaccination, I did not notice any injection site reactions.
Age: 19.0
Sex: M
Vaccine: HPV9
Symptoms: Chest discomfort, Chest pain, Dizziness, Nausea, Pallor
Clinical narrative: Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Mild, Additional Details: pt fainted for a few second then he regain his consciousness and response to his family questions. pt look a little pale.
Age: 19.0
Sex: M
Vaccine: HPV9
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Mild, Additional Details: pt fainted for a few second then he regain his consciousness and response to his family questions. pt look a little pale.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Ear infection, Gastroenteritis viral, Illness, Malaise, Pain
Clinical narrative: At 3 am after receiving second dose of Moderna vaccine I woke with my whole body aching. No pain medicine would help ease the pain/ache and it lasted until 3 pm. I thought it was just a reaction to the vaccine and it would be over. Now the handful of times I?ve gotten sick since the vaccine if I have even the mildest of fever, I will get those body aches all over. I got an ear infection (outer and middle of same ear) in 7/22 and I had full body aches for 3 days before the antibiotics finally helped beat the ear infection. If I get a seasonal bug, full body aches. I had stomach bug 11/22 and I got full body aches. It doesn?t matter what illness I have, if I get a slight fever I will have full body aches.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Sleep disorder
Clinical narrative: At 3 am after receiving second dose of Moderna vaccine I woke with my whole body aching. No pain medicine would help ease the pain/ache and it lasted until 3 pm. I thought it was just a reaction to the vaccine and it would be over. Now the handful of times I?ve gotten sick since the vaccine if I have even the mildest of fever, I will get those body aches all over. I got an ear infection (outer and middle of same ear) in 7/22 and I had full body aches for 3 days before the antibiotics finally helped beat the ear infection. If I get a seasonal bug, full body aches. I had stomach bug 11/22 and I got full body aches. It doesn?t matter what illness I have, if I get a slight fever I will have full body aches.
Age: 52.0
Sex: M
Vaccine: COVID19-2
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Severe
Age: 28.0
Sex: M
Vaccine: COVID19-2
Symptoms: Dizziness, Nausea, Syncope, Tremor, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Nausea-Mild, Systemic: Shakiness-Medium, Additional Details: Patient fainted ~5 - 10 minutes after Moderna Bivalent booster and Flucelvax shots were administered - patient recovered within 1 minute; Benadryl 50mg oral solution was given along with water - patient was able to sit up and use the bathroom until mother came to drive him home.
Age: 33.0
Sex: F
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: pediatric dose given instead of adult dose
Age: 1.0
Sex: M
Vaccine: COVID19
Symptoms: Rash erythematous, Rash papular
Clinical narrative: Small circular rash that is raised and red
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Feeling abnormal, Herpes zoster, Rash, Rash pruritic
Clinical narrative: Developed a rash on abdomen. Very itchy and causing discomfort. Was  on a cruise so didn't attend to it. Took Prednisone orally to abate the symptoms. Still miserable after returning  home after the cruise and went to an Urgent Care on 10/11/2021 and was diagnosed with Shingles. I asked the doctor if this could be related to the vaccine and was told yes.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis reactive, Blood creatinine normal, Blood glucose normal, Blood magnesium normal, Blood potassium normal
Clinical narrative: Patient was exceptionally tired 10/24/2022 to 10/27/2022. The evening of 10/27/2022 she had diarrhea and emesis. She had nausea but not dysuria. Patient was brought to the ER at 5 AM on 10/28/2022. Patient was presented to the ER 10/28/2022 with fever, chills, myalgias. In the ER, she was documented pyuria. Patient was diagnosed with Sepsis secondary to UTI. UTI was confirmed with urine cultures. Workup revealed UTI with positive LE and nitrite and 25 WBCs. This event is not a continuation of a previous episode of Sepsis on 8/22/2022. Patient was treated with ceftriaxone and cipro. During this stay, patient developed polyarthritis, suspected reactive arthritis, on 11/1/2022. This caused pain in right hand and foot pain, swelling, and left neck pain. Patient had no fever at this point. A steroid burst with complete resolution in pain for the reactive arthritis. Prednisone taper was started for reactive arthritis: 20 mg daily x 5 days, followed by 15 mg daily x 5 days, followed by 10 mg daily x 5 days, then resume home dose of prednisone 5 mg daily. Evaluation of hand: severe osteoarthrosis of the STT joint. Moderate osteoarthrosis at the first CMC joint. Mild to moderate osteoarthrosis of the MCP joints. Mild osteoarthrosis of the interphalangeal joints. Small ossicle distal to the pisiform and triquetrum, well marginated and likely from old trauma. Otherwise negative. No acute or subacute fracture. No chondrocalcinosis. Subject was administered the Janssen Ad26.CoV2.S vaccine on 10/17/2022. This adverse event is unrelated to the Janssen Ad26.CoV2.S vaccine that was administered on 10/17/2022. Patient was discharged from the hospital on 11/4/2022 in stable condition. Sepsis resolving/resolved with follow-up requested. Swelling resolving. Follow-up appointments were scheduled.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Blood sodium normal, Chills, Culture urine positive, Diarrhoea, Fatigue
Clinical narrative: Patient was exceptionally tired 10/24/2022 to 10/27/2022. The evening of 10/27/2022 she had diarrhea and emesis. She had nausea but not dysuria. Patient was brought to the ER at 5 AM on 10/28/2022. Patient was presented to the ER 10/28/2022 with fever, chills, myalgias. In the ER, she was documented pyuria. Patient was diagnosed with Sepsis secondary to UTI. UTI was confirmed with urine cultures. Workup revealed UTI with positive LE and nitrite and 25 WBCs. This event is not a continuation of a previous episode of Sepsis on 8/22/2022. Patient was treated with ceftriaxone and cipro. During this stay, patient developed polyarthritis, suspected reactive arthritis, on 11/1/2022. This caused pain in right hand and foot pain, swelling, and left neck pain. Patient had no fever at this point. A steroid burst with complete resolution in pain for the reactive arthritis. Prednisone taper was started for reactive arthritis: 20 mg daily x 5 days, followed by 15 mg daily x 5 days, followed by 10 mg daily x 5 days, then resume home dose of prednisone 5 mg daily. Evaluation of hand: severe osteoarthrosis of the STT joint. Moderate osteoarthrosis at the first CMC joint. Mild to moderate osteoarthrosis of the MCP joints. Mild osteoarthrosis of the interphalangeal joints. Small ossicle distal to the pisiform and triquetrum, well marginated and likely from old trauma. Otherwise negative. No acute or subacute fracture. No chondrocalcinosis. Subject was administered the Janssen Ad26.CoV2.S vaccine on 10/17/2022. This adverse event is unrelated to the Janssen Ad26.CoV2.S vaccine that was administered on 10/17/2022. Patient was discharged from the hospital on 11/4/2022 in stable condition. Sepsis resolving/resolved with follow-up requested. Swelling resolving. Follow-up appointments were scheduled.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Haematocrit decreased, Haemoglobin decreased, Myalgia, Nausea, Neck pain
Clinical narrative: Patient was exceptionally tired 10/24/2022 to 10/27/2022. The evening of 10/27/2022 she had diarrhea and emesis. She had nausea but not dysuria. Patient was brought to the ER at 5 AM on 10/28/2022. Patient was presented to the ER 10/28/2022 with fever, chills, myalgias. In the ER, she was documented pyuria. Patient was diagnosed with Sepsis secondary to UTI. UTI was confirmed with urine cultures. Workup revealed UTI with positive LE and nitrite and 25 WBCs. This event is not a continuation of a previous episode of Sepsis on 8/22/2022. Patient was treated with ceftriaxone and cipro. During this stay, patient developed polyarthritis, suspected reactive arthritis, on 11/1/2022. This caused pain in right hand and foot pain, swelling, and left neck pain. Patient had no fever at this point. A steroid burst with complete resolution in pain for the reactive arthritis. Prednisone taper was started for reactive arthritis: 20 mg daily x 5 days, followed by 15 mg daily x 5 days, followed by 10 mg daily x 5 days, then resume home dose of prednisone 5 mg daily. Evaluation of hand: severe osteoarthrosis of the STT joint. Moderate osteoarthrosis at the first CMC joint. Mild to moderate osteoarthrosis of the MCP joints. Mild osteoarthrosis of the interphalangeal joints. Small ossicle distal to the pisiform and triquetrum, well marginated and likely from old trauma. Otherwise negative. No acute or subacute fracture. No chondrocalcinosis. Subject was administered the Janssen Ad26.CoV2.S vaccine on 10/17/2022. This adverse event is unrelated to the Janssen Ad26.CoV2.S vaccine that was administered on 10/17/2022. Patient was discharged from the hospital on 11/4/2022 in stable condition. Sepsis resolving/resolved with follow-up requested. Swelling resolving. Follow-up appointments were scheduled.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Nitrite urine present, Osteoarthritis, Pain in extremity, Peripheral swelling, Polyarthritis
Clinical narrative: Patient was exceptionally tired 10/24/2022 to 10/27/2022. The evening of 10/27/2022 she had diarrhea and emesis. She had nausea but not dysuria. Patient was brought to the ER at 5 AM on 10/28/2022. Patient was presented to the ER 10/28/2022 with fever, chills, myalgias. In the ER, she was documented pyuria. Patient was diagnosed with Sepsis secondary to UTI. UTI was confirmed with urine cultures. Workup revealed UTI with positive LE and nitrite and 25 WBCs. This event is not a continuation of a previous episode of Sepsis on 8/22/2022. Patient was treated with ceftriaxone and cipro. During this stay, patient developed polyarthritis, suspected reactive arthritis, on 11/1/2022. This caused pain in right hand and foot pain, swelling, and left neck pain. Patient had no fever at this point. A steroid burst with complete resolution in pain for the reactive arthritis. Prednisone taper was started for reactive arthritis: 20 mg daily x 5 days, followed by 15 mg daily x 5 days, followed by 10 mg daily x 5 days, then resume home dose of prednisone 5 mg daily. Evaluation of hand: severe osteoarthrosis of the STT joint. Moderate osteoarthrosis at the first CMC joint. Mild to moderate osteoarthrosis of the MCP joints. Mild osteoarthrosis of the interphalangeal joints. Small ossicle distal to the pisiform and triquetrum, well marginated and likely from old trauma. Otherwise negative. No acute or subacute fracture. No chondrocalcinosis. Subject was administered the Janssen Ad26.CoV2.S vaccine on 10/17/2022. This adverse event is unrelated to the Janssen Ad26.CoV2.S vaccine that was administered on 10/17/2022. Patient was discharged from the hospital on 11/4/2022 in stable condition. Sepsis resolving/resolved with follow-up requested. Swelling resolving. Follow-up appointments were scheduled.