chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was initially stored in refrigerator on 22Aug2022 and administered on 26Sep2022; No Adverse event; Received expired Monovalent vaccine after 30 day beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired Monovalent vaccine after 30 day beyond use date), PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 22Aug2022 and administered on 26Sep2022) and NO ADVERSE EVENT (No Adverse event) in a 3-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AR9236B and AR9237B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 22-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 26-Sep-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 26-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired Monovalent vaccine after 30 day beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 22Aug2022 and administered on 26Sep2022) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired Monovalent vaccine after 30 day beyond use date), PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 22Aug2022 and administered on 26Sep2022) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Received expired Monovalent vaccine after 30 day beyond use date) and PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 22Aug2022 and administered on 26Sep2022).    Concomitant Medication use information was not provided by reporter.  It was reported that vaccine coordinator was calling to report that some patients (Adults and Pediatrics) received expired Moderna COVID-19 vaccine after 30 days beyond use date 22-Sep-2022.  There were unbroken cartons. Vial size for 6 months to 5 years was 2.5 ml. The vial was initially stored in the refrigerator on 22-Aug-2022. The patient was given vaccine after BUD date. The vial did not undergo any temperature excursions.  Treatment Medication use information was not provided by reporter.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was initially stored in refrigerator on 22Aug2022 and administered on 23Sep2022; No Adverse event; vaccine was administered to patient past it's Beyond use date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine was administered to patient past it's Beyond use date), PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 22Aug2022 and administered on 23Sep2022) and NO ADVERSE EVENT (No Adverse event) in a 5-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9237B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Sep-2022 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 23-Sep-2022 at 4:00 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine was administered to patient past it's Beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 22Aug2022 and administered on 23Sep2022) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine was administered to patient past it's Beyond use date), PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 22Aug2022 and administered on 23Sep2022) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (vaccine was administered to patient past it's Beyond use date) and PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 22Aug2022 and administered on 23Sep2022).    PNo concomitant information was reported. Product: Monovalent  Vail size: 2.5ml Date the vial was initially stored in the refrigerator: 22AUG2022. The vial did not undergo any temperature excursions. No treatment information was reported.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Illness, Immunisation reaction, Pain
Clinical narrative: the patient became very ill; Symptoms of COVID-19; She described that the mRNA vaccine elevated her body reaction and it went into overdrive; Felt achy; Chills; extreme fatigue/Tired and flat on her back; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (She described that the mRNA vaccine elevated her body reaction and it went into overdrive), PAIN (Felt achy), ILLNESS (the patient became very ill), SUSPECTED COVID-19 (Symptoms of COVID-19) and CHILLS (Chills) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced PAIN (Felt achy), CHILLS (Chills) and FATIGUE (extreme fatigue/Tired and flat on her back). On an unknown date, the patient experienced IMMUNISATION REACTION (She described that the mRNA vaccine elevated her body reaction and it went into overdrive), ILLNESS (the patient became very ill) and SUSPECTED COVID-19 (Symptoms of COVID-19). In January 2022, FATIGUE (extreme fatigue/Tired and flat on her back) had resolved. At the time of the report, IMMUNISATION REACTION (She described that the mRNA vaccine elevated her body reaction and it went into overdrive), PAIN (Felt achy), ILLNESS (the patient became very ill), SUSPECTED COVID-19 (Symptoms of COVID-19) and CHILLS (Chills) outcome was unknown.            No concomitant product reported by reporter.  Patient had no reaction to first and second dose of the vaccine. Within 2 days of vaccination patient experienced extreme fatigue.  No treatment medication reported by reporter.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: the patient became very ill; Symptoms of COVID-19; She described that the mRNA vaccine elevated her body reaction and it went into overdrive; Felt achy; Chills; extreme fatigue/Tired and flat on her back; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (She described that the mRNA vaccine elevated her body reaction and it went into overdrive), PAIN (Felt achy), ILLNESS (the patient became very ill), SUSPECTED COVID-19 (Symptoms of COVID-19) and CHILLS (Chills) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced PAIN (Felt achy), CHILLS (Chills) and FATIGUE (extreme fatigue/Tired and flat on her back). On an unknown date, the patient experienced IMMUNISATION REACTION (She described that the mRNA vaccine elevated her body reaction and it went into overdrive), ILLNESS (the patient became very ill) and SUSPECTED COVID-19 (Symptoms of COVID-19). In January 2022, FATIGUE (extreme fatigue/Tired and flat on her back) had resolved. At the time of the report, IMMUNISATION REACTION (She described that the mRNA vaccine elevated her body reaction and it went into overdrive), PAIN (Felt achy), ILLNESS (the patient became very ill), SUSPECTED COVID-19 (Symptoms of COVID-19) and CHILLS (Chills) outcome was unknown.            No concomitant product reported by reporter.  Patient had no reaction to first and second dose of the vaccine. Within 2 days of vaccination patient experienced extreme fatigue.  No treatment medication reported by reporter.
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was stored in refrigerator on 22-Aug-2022 and vaccine was administered on 26-Sep-2022; No Adverse event; Dose administered after 30 days use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30 days use by date), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 22-Aug-2022 and vaccine was administered on 26-Sep-2022) and NO ADVERSE EVENT (No Adverse event) in a 3-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AR9236B and AR9237B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 29-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 26-Sep-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 26-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30 days use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 22-Aug-2022 and vaccine was administered on 26-Sep-2022) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30 days use by date), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 22-Aug-2022 and vaccine was administered on 26-Sep-2022) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30 days use by date) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 22-Aug-2022 and vaccine was administered on 26-Sep-2022).    No concomitant medication was reported. It was reported that vaccine coordinator was calling to report that some patients (Adults and Pediatrics) received expired Moderna COVID-19 vaccine after 30 day beyond use date (22-Sep-2022). There were unbroken cartons. Vial size for 6 months to 5 year. The vial was initially stored in the refrigerator on 22-Aug-2022. The patient was given vaccine after BUD date. The vial did not undergo any temperature excursions. No treatment medication was reported.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 22-Aug-2022 and was administered on 26-Sep-2022; No Adverse event; Dose administered after 30 days use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30 days use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 22-Aug-2022 and was administered on 26-Sep-2022) and NO ADVERSE EVENT (No Adverse event) in a 2-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Sep-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 26-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30 days use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 22-Aug-2022 and was administered on 26-Sep-2022) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30 days use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 22-Aug-2022 and was administered on 26-Sep-2022) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30 days use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 22-Aug-2022 and was administered on 26-Sep-2022).    No concomitant medication was reported. It was reported that vaccine coordinator was calling to report that some patients (Adults and Pediatrics) received expired Moderna COVID-19 vaccine after 30 day beyond use date (22-Sep-2022). There were unbroken cartons. Vial size for 6 months to 5 year. The vial was initially stored in the refrigerator on 22-Aug-2022. The patient was given vaccine after BUD date. The vial did not undergo any temperature excursions. No treatment medication was reported.
Age: 0.92
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vials were initially stored in refrigerator on 22-Aug-2022 and adminsitered on 23-Sep-2022; No adverse event; Received expired  Monovalent vaccine after 30 day beyond use date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired  Monovalent vaccine after 30 day beyond use date), PRODUCT STORAGE ERROR (Vials were initially stored in refrigerator on 22-Aug-2022 and adminsitered on 23-Sep-2022) and NO ADVERSE EVENT (No adverse event) in an 11-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9237B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Sep-2022 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 23-Sep-2022 at 4:00 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired  Monovalent vaccine after 30 day beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vials were initially stored in refrigerator on 22-Aug-2022 and adminsitered on 23-Sep-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired  Monovalent vaccine after 30 day beyond use date), PRODUCT STORAGE ERROR (Vials were initially stored in refrigerator on 22-Aug-2022 and adminsitered on 23-Sep-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Received expired  Monovalent vaccine after 30 day beyond use date) and PRODUCT STORAGE ERROR (Vials were initially stored in refrigerator on 22-Aug-2022 and adminsitered on 23-Sep-2022).    No concomitant medication was reported.  It was reported that vaccine coordinator was calling to report that some patients (Adults and Pediatrics) received expired Moderna COVID-19 vaccine after 30 day beyond use date (22-Sep-2022).  There were unbroken cartons. Vial size for 6 months to 5 year patient was 2.5 milliliter and for adults 5.5 milliliter. The vial was initially stored in the refrigerator on 22-Aug-2022. The patient given vaccine after BUD date. Vials were initially stored in refrigerator on 22-Aug-2022.  The vial did not undergo any temperature excursions.  No treatment medication was reported.
Age: 27.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19, Inappropriate schedule of product administration, Injection site pruritus
Clinical narrative: Itchy after injection around the abdomen; Contracted Covid-19; First dose was taken 01-Dec-2021 and Second dose was taken  20-Dec-2021; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Itchy after injection around the abdomen), COVID-19 (Contracted Covid-19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was taken 01-Dec-2021 and Second dose was taken  20-Dec-2021) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ulcerative colitis.    Concurrent medical conditions included Ulcerative colitis.   On 01-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Dec-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Single Dose Pen,40MG/0.4ML. On 20-Dec-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was taken 01-Dec-2021 and Second dose was taken  20-Dec-2021). On an unknown date, the patient experienced INJECTION SITE PRURITUS (Itchy after injection around the abdomen) and COVID-19 (Contracted Covid-19). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, INJECTION SITE PRURITUS (Itchy after injection around the abdomen), COVID-19 (Contracted Covid-19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was taken 01-Dec-2021 and Second dose was taken  20-Dec-2021) outcome was unknown.            Concomitant product use was not provided by the reporter. The reporter's causality for the event(s) of Contracted Covid-19 and Itchy after injection around the abdomen with Adalimumab Solution for Injection was Not Provided. It was unknown if patient was enrolled in COVID-19-Vaccine Trial.
Age: 1.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error, SARS-CoV-2 test
Clinical narrative: Vials were initially stored in refrigerator on 22-Aug-2022 and administered on 23-Sep-2022; No Adverse event; patient given vaccine after BUD date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient given vaccine after BUD date), PRODUCT STORAGE ERROR (Vials were initially stored in refrigerator on 22-Aug-2022 and administered on 23-Sep-2022) and NO ADVERSE EVENT (No Adverse event) in a 1-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9237B) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 on 01-Jul-2022. Previously administered products included for Product used for unknown indication: Flu quadrivalent injectable pfree (Lot: UT7682MA, intramuscular, Left thigh and dose 3.) on 30-Aug-2022. Past adverse reactions to the above products included No adverse event with Flu quadrivalent injectable pfree.    On 23-Sep-2022 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 23-Sep-2022 at 4:00 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (patient given vaccine after BUD date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vials were initially stored in refrigerator on 22-Aug-2022 and administered on 23-Sep-2022) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient given vaccine after BUD date), PRODUCT STORAGE ERROR (Vials were initially stored in refrigerator on 22-Aug-2022 and administered on 23-Sep-2022) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jul-2022, SARS-CoV-2 test: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (patient given vaccine after BUD date) and PRODUCT STORAGE ERROR (Vials were initially stored in refrigerator on 22-Aug-2022 and administered on 23-Sep-2022).    No concomitant medication was reported.  Vaccine coordinator was calling to report that some patients (Adults and Pediatrics) received expired Moderna COVID-19 vaccine after 30 days beyond use date (22-Sep-2022). Date the vial was initially stored in the refrigerator was 22 AUG 2022.  There were unbroken cartons. Vial size for 6 months to 5 years.  The vial did not undergo any temperature excursions.  No treatment information was provided.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Pericarditis
Clinical narrative: This literature-non-study case was reported in a literature article and describes the occurrence of PERICARDITIS (acute pericarditis) in a 28-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.   LITERATURE REFERENCE:  No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERICARDITIS (acute pericarditis) (seriousness criterion medically significant). At the time of the report, PERICARDITIS (acute pericarditis) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered PERICARDITIS (acute pericarditis) to be related.    No concomitant and treatment medications were provided.  Patient had acute pericarditis, induced by second dose of the Moderna COVID-19 vaccine. The authors stated that although there are other potential etiologies that could explain myocarditis and pericarditis in this cases, it was important to consider the COVID-19 vaccine as a plausible cause.  Company comment: This literature-non-study case report concerns a 28-year-old male patient with no medical history available, who experienced serious (medically significant) expected event of Pericarditis which occurred after the second dose of the mRNA-1273-1273 vaccine. At the time of this report, very limited information is provided and the outcome and clinical course of the event remained unknown. Temporal relationship between vaccination and occurrence of the event remained also unknown since dates were not available. Further information is expected. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this.; Sender's Comments: This literature-non-study case report concerns a 28-year-old male patient with no medical history available, who experienced serious (medically significant) expected event of Pericarditis which occurred after the second dose of the mRNA-1273-1273 vaccine. At the time of this report, very limited information is provided and the outcome and clinical course of the event remained unknown. Temporal relationship between vaccination and occurrence of the event remained also unknown since dates were not available. Further information is expected. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this.
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was stored on refrigerator on 22-Aug-2022 and vaccine was administered on 23-Sep-2022; No adverse event; Patient given vaccine after BUD date, expire beyond date 22-Sep-2022, vaccine administered 23-Sep-2022; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient given vaccine after BUD date, expire beyond date 22-Sep-2022, vaccine administered 23-Sep-2022), PRODUCT STORAGE ERROR (Vaccine was stored on refrigerator on 22-Aug-2022 and vaccine was administered on 23-Sep-2022) and NO ADVERSE EVENT (No adverse event) in a 2-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AR9237B and AR9237B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 12-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 23-Sep-2022 at 4:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 23-Sep-2022 at 4:00 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient given vaccine after BUD date, expire beyond date 22-Sep-2022, vaccine administered 23-Sep-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored on refrigerator on 22-Aug-2022 and vaccine was administered on 23-Sep-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient given vaccine after BUD date, expire beyond date 22-Sep-2022, vaccine administered 23-Sep-2022), PRODUCT STORAGE ERROR (Vaccine was stored on refrigerator on 22-Aug-2022 and vaccine was administered on 23-Sep-2022) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient given vaccine after BUD date, expire beyond date 22-Sep-2022, vaccine administered 23-Sep-2022) and PRODUCT STORAGE ERROR (Vaccine was stored on refrigerator on 22-Aug-2022 and vaccine was administered on 23-Sep-2022).    No concomitant medication was reported.  Vaccine coordinator was calling to report that some patients received expired Moderna COVID-19 vaccine after 30 days beyond use date (22-Sep-2022).  There were unbroken cartons. Vial size for 6 months to 5 years.  The vial did not undergo any temperature excursions.  No treatment information was provided.
Age: 1.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was stored on refrigerator on 22-Aug-2022 and vaccine was administered on 23-Sep-2022; No Adverse event; patient given vaccine after BUD date, expire beyond date 22-Sep-2022, vaccine administered 23-Sep-2022; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient given vaccine after BUD date, expire beyond date 22-Sep-2022, vaccine administered 23-Sep-2022), PRODUCT STORAGE ERROR (Vaccine was stored on refrigerator on 22-Aug-2022 and vaccine was administered on 23-Sep-2022) and NO ADVERSE EVENT (No Adverse event) in a 1-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9237B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Sep-2022 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 23-Sep-2022 at 4:00 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient given vaccine after BUD date, expire beyond date 22-Sep-2022, vaccine administered 23-Sep-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored on refrigerator on 22-Aug-2022 and vaccine was administered on 23-Sep-2022) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient given vaccine after BUD date, expire beyond date 22-Sep-2022, vaccine administered 23-Sep-2022), PRODUCT STORAGE ERROR (Vaccine was stored on refrigerator on 22-Aug-2022 and vaccine was administered on 23-Sep-2022) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (patient given vaccine after BUD date, expire beyond date 22-Sep-2022, vaccine administered 23-Sep-2022) and PRODUCT STORAGE ERROR (Vaccine was stored on refrigerator on 22-Aug-2022 and vaccine was administered on 23-Sep-2022).    Concomitant product use was not provided by the reporter.  It was reported vaccine was not gone under any temperature excursion.  Treatment information was not provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Psoriasis
Clinical narrative: Sick; Plaque psoriasis flare-up; This spontaneous case was reported by a patient and describes the occurrence of PSORIASIS (Plaque psoriasis flare-up) and ILLNESS (Sick) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis. On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In January 2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 01-May-2022, the patient experienced PSORIASIS (Plaque psoriasis flare-up). On an unknown date, the patient experienced ILLNESS (Sick). At the time of the report, PSORIASIS (Plaque psoriasis flare-up) outcome was unknown and ILLNESS (Sick) had resolved.      Concomitant products were not reported.  Moderna was reported 4782589. It was unknown if patient was enrolled in COVID-19-Vaccine Trial. Assessment results for Humira was provided Sickness, Non-Health Care Professional, Global Introspection, Possible and for Psoriasis aggravated, Non-Health Care Professional, Global Introspection, Not Related.  Treatment medications were not reported.
Age: 67.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Psoriasis
Clinical narrative: Breakout of plaque psoriasis on chin; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Breakout of plaque psoriasis on chin) in an elderly female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On 17-Oct-2022, 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 started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PSORIASIS (Breakout of plaque psoriasis on chin). At the time of the report, PSORIASIS (Breakout of plaque psoriasis on chin) was resolving. Not Provided   Concomitant product use was not provided by the reporter.  The patient experienced breakout of plaque psoriasis on chin usually appeared right before next dose with Risankizumab Solution for Injection, Single-Dose Prefilled Syringe with Needle Guard.   On unknown date, the patient experienced breakout of plaque psoriasis on chin usually appeared right before next dose.  It was unknown if patient was enrolled in COVID-19-Vaccine Trial.  The reporter's causality for the event of Breakout of plaque psoriasis on chin usually appear right before next dose unknown onset with Moderna COVID-19 vaccine (Elasomeran) was Not Provided.  Treatment information was not provided.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: expiration date 27Nov2022, Date that the vial was initially stored in the fridge 30Nov2022; No adverse event; Patient received an expired monovalent vaccine lot #082b22a expiration date 27Nov2022 as a second dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired monovalent vaccine lot #082b22a expiration date 27Nov2022 as a second dose), PRODUCT STORAGE ERROR (expiration date 27Nov2022, Date that the vial was initially stored in the fridge 30Nov2022) and NO ADVERSE EVENT (No adverse event) in a 28-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 082b22a) for COVID-19 prophylaxis.     No Medical History information was reported.   On 30-Nov-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 30-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired monovalent vaccine lot #082b22a expiration date 27Nov2022 as a second dose). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (expiration date 27Nov2022, Date that the vial was initially stored in the fridge 30Nov2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received an expired monovalent vaccine lot #082b22a expiration date 27Nov2022 as a second dose), PRODUCT STORAGE ERROR (expiration date 27Nov2022, Date that the vial was initially stored in the fridge 30Nov2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received an expired monovalent vaccine lot #082b22a expiration date 27Nov2022 as a second dose) and PRODUCT STORAGE ERROR (expiration date 27Nov2022, Date that the vial was initially stored in the fridge 30Nov2022).    No relevant concomitant medications were reported. Date that the vial was initially stored in the fridge was 30 Nov 2022. The vial didn't undergo any temperature excursions. No treatment medication reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccine was accidentally given one day after its expiration date; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine was accidentally given one day after its expiration date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine was accidentally given one day after its expiration date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine was accidentally given one day after its expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (vaccine was accidentally given one day after its expiration date).    Concomitant medication was not reported. Treatment drug was not reported.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient received a monovalent dose - lot 044c22a 0.5ml - instead of a bivalent dose as a 4th dose; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received a monovalent dose - lot 044c22a 0.5ml - instead of a bivalent dose as a 4th dose) and NO ADVERSE EVENT (No adverse event) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044c22a) 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) .5 milliliter. 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 WRONG PRODUCT ADMINISTERED (Patient received a monovalent dose - lot 044c22a 0.5ml - instead of a bivalent dose as a 4th dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received a monovalent dose - lot 044c22a 0.5ml - instead of a bivalent dose as a 4th 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 a monovalent dose - lot 044c22a 0.5ml - instead of a bivalent dose as a 4th dose).    No concomitant medications were reported. No treatment information was provided.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: diagnosed with covid in June 2022 and had worse symptom; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (diagnosed with covid in June 2022 and had worse symptom) in a 51-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. In June 2022, the patient experienced COVID-19 (diagnosed with covid in June 2022 and had worse symptom). At the time of the report, COVID-19 (diagnosed with covid in June 2022 and had worse symptom) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. No concomitant products reported. It was reported that patient had worse symptom than her husband. Patient was not hospitalized.  No treatment products reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-680917 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-680917:Husbend case (Reporter case)
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 11-Oct-2022 but vaccines were admistered on 16-Nov-2022 and 30-Nov-2022; No adverse event; Patient received bivalent doses after its beyond use date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received bivalent doses after its beyond use date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Oct-2022 but vaccines were admistered on 16-Nov-2022 and 30-Nov-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. 061f22a) for COVID-19 prophylaxis.     No Medical History information was reported.    In November 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. In November 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received bivalent doses after its beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Oct-2022 but vaccines were admistered on 16-Nov-2022 and 30-Nov-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received bivalent doses after its beyond use date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Oct-2022 but vaccines were admistered on 16-Nov-2022 and 30-Nov-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 (Patient received bivalent doses after its beyond use date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Oct-2022 but vaccines were admistered on 16-Nov-2022 and 30-Nov-2022).    No concomitant medication information was provided.  Dose administered after 30-day Use By Date or after manufacturer date of expiry   Vial size was reported as 2.5ml  The vial was initially stored in the refrigerator on 11-Oct-2022  Date(s) of administration of vaccine on 16-Nov-2022 for 5 patients and on 30-Nov-2022 for 3 patients in two different vials.  The vial did not undergo any temperature excursions.  No treatment medication were provided.  This case contains information for the 4th out of 8 patients.   This case was linked to US-MODERNATX, INC.-MOD-2022-680810, US-MODERNATX, INC.-MOD-2022-680811, US-MODERNATX, INC.-MOD-2022-680808 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-680810:Samer Reporter US-MODERNATX, INC.-MOD-2022-680811:Samer Reporter US-MODERNATX, INC.-MOD-2022-680808:Samer Reporter
Sex: F
Vaccine: COVID19
Symptoms: Cardiac failure, Drug ineffective, Suspected COVID-19
Clinical narrative: heart failure; very mild case of covid; very mild case of covid; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient. A female patient received BNT162b2 (COMIRNATY), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "very mild case of covid"; CARDIAC FAILURE (medically significant), outcome "unknown", described as "heart failure". Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: She explained that she has the first shot of the covid vaccine, but she had some health problems, particularly, heart failure and did not feel to get another one as she prioritized getting medication for this. The patient inquired about bivalent formulation if she needs to complete the first 2 dose before she could get the bivalent formulation. It was further reported that during the summer of 2021, she contracted a "very mild case" of covid, and her primary care provider recommended that she get the monoclonal antibodies which helped her greatly. She also mentioned that her PCP told her she can get the bivalent vaccine.  The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.
Age: 74.0
Sex: M
Vaccine: COVID19, 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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 15Jun2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 74 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "SLL/CLL - never treated, no symptoms" (unspecified if ongoing), notes: SLL/CLL - never treated, no symptoms; "SLL/CLL - never treated, no symptoms" (unspecified if ongoing), notes: SLL/CLL - never treated, no symptoms. There were no concomitant medications. 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, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient has no known allergies.  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-202201337240 same patient, different vaccine dose number, different event;
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: pain I had been experiencing in my left knee and ankle suddenly disappeared.  I reported the same thing when I received the first two doses of Cominarty; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received BNT162b2 (COMIRNATY), on 19Feb2021 as dose 1, single (Lot number: EL3247) at the age of 45 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "pain I had been experiencing in my left knee and ankle suddenly disappeared.  I reported the same thing when I received the first two doses of Cominarty".  Additional Information: The patient did not receive other vaccines within four weeks prior to COVID vaccine. It was reported that pain had been experiencing in my left knee and ankle suddenly disappeared. Reported the same thing when patient  received the first two doses of Cominarty. Prior to vaccination, the patient was not diagnosed with COVID-19.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201337257 same patient/drug, different dose/event;US-PFIZER INC-202201337388 Same patient/drug; different dose/event;