chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose administered more than 35 days; This spontaneous case was reported by a physician and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose administered more than 35 days) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013m20a and 042l20a) for COVID-19 vaccination.     Concurrent medical conditions included Low back pain (No change in current condition) since 1992, Hypercholesterolemia (No change in current condition) since 2010, Prostatic hypertrophy (No change in current condition) since 2018, Reflux esophagitis (No change in current condition) since 2015, Asthma (mild asthma since childhood, untreated) and Drug allergy (The patient had allergy to unknown past drug). Concomitant products included SIMVASTATIN from January 2010 to an unknown date for Hypercholesterolaemia, CELECOXIB (CELEBREX) from January 2012 to an unknown date for Low back pain, MORNIFLUMATE (FLOMAX [MORNIFLUMATE]) from January 2018 to an unknown date for Prostatic hypertrophy, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) from January 2015 to an unknown date for Reflux esophagitis.   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose administered more than 35 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose administered more than 35 days) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment details were provided   This case was linked to MOD-2022-570652 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2022: Follow-up recieved contains significant information, Concomitant drug information (start date and dosage text) updated.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Rebound COVID symptoms; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Rebound COVID symptoms) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    The patient's past medical history included GERD and Anxiety. Concurrent medical conditions included Soy allergy (Soy), Penicillin allergy (Penicillin) and Drug allergy. Concomitant products included GUAIFENESIN from 12-May-2022 to 15-May-2022 for an unknown indication.   On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 23-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Rebound COVID symptoms). At the time of the report, COVID-19 (Rebound COVID symptoms) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was taking other medication within 2 weeks of starting COVID-19 treatment. Patient reported that she had rebound of COVID-19 symptoms.  No treatment information was provided.  Device date was 24-May-2022.  Company comment: This spontaneous case concerns a 27-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19,which occurred  168 after receiving third dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid from 13-may-2022 to 17-may-2022. She was tested positive 6 days after the treatment with Paxlovid, The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: Company comment: This spontaneous case concerns a 27-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19,which occurred  168 after receiving third dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid from 13-may-2022 to 17-may-2022. She was tested positive 6 days after the treatment with Paxlovid, The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID 19; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (COVID 19) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy, Penicillin allergy, Asthma (borderline asthma) and GERD. Concomitant products included OMEPRAZOLE, FEXOFENADINE and COLECALCIFEROL (VITAMIN D3 1000) for an unknown indication.    On 02-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID 19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 11-May-2022 to 16-May-2022 for COVID-19 vaccination, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID 19) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: positive (Positive) Relapse of Covid at 14 days after original symptoms and 12 days after original positive test..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the  Device Date is 24May2022  Relapse of COVID-19 at 14 days after original symptoms and 12 days after original positive test and starting Paxlovid. Tested positive after having had 4 negative tests over 6 days. Developed severe URI signs, malaise, exhaustion, etc. tested positive that evening. Still sick now at 2-3 days after relapse.  OTC medications to treat clinical symptoms  Company comment: This spontaneous case concerns a 37-year-old female patient with no relevant medical history who experienced the unexpected non serious AESI of COVID 19 which occurred unknown days after the administration of third dose of mRNA-1273 vaccine in COVID 19 vaccination series. Patient received NIRMATRELVIR, RITONAVIR (Paxlovid) as treatment for COVID 19 from 11-May to 16-May. Patient tested positive again after having 4 negative tests over 6 days. She developed severe upper respiratory infection signs, malaise, and exhaustion. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 37-year-old female patient with no relevant medical history who experienced the unexpected non serious AESI of COVID 19 which occurred unknown days after the administration of third dose of mRNA-1273 vaccine in COVID 19 vaccination series. Patient received NIRMATRELVIR, RITONAVIR (Paxlovid) as treatment for COVID 19 from 11-May to 16-May. Patient tested positive again after having 4 negative tests over 6 days. She developed severe upper respiratory infection signs, malaise, and exhaustion. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Eye pain, Fatigue, Headache, Inappropriate schedule of product administration
Clinical narrative: sore throat; eye aches; difficulty sleeping; Extreme fatigue; body aches; chills; headaches; Patient took Pfizer dose 3 on 19-Mar-2022 and Moderna dose 4 on 30-Mar-2022; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took Pfizer dose 3 on 19-Mar-2022 and Moderna dose 4 on 30-Mar-2022), OROPHARYNGEAL PAIN (sore throat), EYE PAIN (eye aches), INSOMNIA (difficulty sleeping) and FATIGUE (Extreme fatigue) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016J21-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Drug use for unknown indication: Pfizer/BioNTech (Dose Number: 1  Batch/Lot No: EN6201  Location of injection: Arm Right  Vaccine Administration Time: 11:15 AM) on 26-Feb-2021, Pfizer/BioNTech (Dose number: 2 Batch/Lot No: EW0187 Location of injection: Arm Right  Vaccine Administration Time: 02:30 PM) on 27-Aug-2021 and Pfizer/BioNTech (Dose number: 3 Batch/Lot No: EN6208 Location of injection: Arm Right  Vaccine Administration Time: 11:45 AM) on 19-Mar-2022. Past adverse reactions to the above products included No adverse event with Pfizer/BioNTech, Pfizer/BioNTech and Pfizer/BioNTech. Concurrent medical conditions included Drug allergy (Unknown drug).    On 30-Mar-2022 at 2:45 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took Pfizer dose 3 on 19-Mar-2022 and Moderna dose 4 on 30-Mar-2022). On 18-May-2022 at 11:00 AM, the patient experienced OROPHARYNGEAL PAIN (sore throat), EYE PAIN (eye aches), INSOMNIA (difficulty sleeping), FATIGUE (Extreme fatigue), MYALGIA (body aches), CHILLS (chills) and HEADACHE (headaches). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took Pfizer dose 3 on 19-Mar-2022 and Moderna dose 4 on 30-Mar-2022), OROPHARYNGEAL PAIN (sore throat), EYE PAIN (eye aches), INSOMNIA (difficulty sleeping), FATIGUE (Extreme fatigue), MYALGIA (body aches), CHILLS (chills) and HEADACHE (headaches) outcome was unknown.            No concomitant medications were reported. The patient previously received a COVID-19 Vaccine. It was unknown that the patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment.  The patient had treatment for COVID-19 (unspecified). Device Date: 21-May-2022
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Myalgia, Oropharyngeal pain
Clinical narrative: sore throat; eye aches; difficulty sleeping; Extreme fatigue; body aches; chills; headaches; Patient took Pfizer dose 3 on 19-Mar-2022 and Moderna dose 4 on 30-Mar-2022; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took Pfizer dose 3 on 19-Mar-2022 and Moderna dose 4 on 30-Mar-2022), OROPHARYNGEAL PAIN (sore throat), EYE PAIN (eye aches), INSOMNIA (difficulty sleeping) and FATIGUE (Extreme fatigue) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016J21-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Drug use for unknown indication: Pfizer/BioNTech (Dose Number: 1  Batch/Lot No: EN6201  Location of injection: Arm Right  Vaccine Administration Time: 11:15 AM) on 26-Feb-2021, Pfizer/BioNTech (Dose number: 2 Batch/Lot No: EW0187 Location of injection: Arm Right  Vaccine Administration Time: 02:30 PM) on 27-Aug-2021 and Pfizer/BioNTech (Dose number: 3 Batch/Lot No: EN6208 Location of injection: Arm Right  Vaccine Administration Time: 11:45 AM) on 19-Mar-2022. Past adverse reactions to the above products included No adverse event with Pfizer/BioNTech, Pfizer/BioNTech and Pfizer/BioNTech. Concurrent medical conditions included Drug allergy (Unknown drug).    On 30-Mar-2022 at 2:45 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took Pfizer dose 3 on 19-Mar-2022 and Moderna dose 4 on 30-Mar-2022). On 18-May-2022 at 11:00 AM, the patient experienced OROPHARYNGEAL PAIN (sore throat), EYE PAIN (eye aches), INSOMNIA (difficulty sleeping), FATIGUE (Extreme fatigue), MYALGIA (body aches), CHILLS (chills) and HEADACHE (headaches). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took Pfizer dose 3 on 19-Mar-2022 and Moderna dose 4 on 30-Mar-2022), OROPHARYNGEAL PAIN (sore throat), EYE PAIN (eye aches), INSOMNIA (difficulty sleeping), FATIGUE (Extreme fatigue), MYALGIA (body aches), CHILLS (chills) and HEADACHE (headaches) outcome was unknown.            No concomitant medications were reported. The patient previously received a COVID-19 Vaccine. It was unknown that the patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment.  The patient had treatment for COVID-19 (unspecified). Device Date: 21-May-2022
Age: 78.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 79-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 Crohn's disease.    Concurrent medical conditions included Crohn's disease (MODERATE TO SEVERE ADULT).   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Apr-2022, received fourth 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) 40 milligram every two weeks. In May 2022, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: positive (Positive) Positive.         The patient was not enrolled in COVID-19 vaccine trial.  No treatment information was reported.  Company comment- This spontaneous case concerns a 79-year-old female patient with relevant medical condition of Chron´s disease treated with Adalimumab (reported as co-suspect), who experienced the unexpected non-serious  COVID-19, after receiving a fourth dose of mRNA-1273 vaccine. Patient received as first, second and booster dose (in an appropriate interval) mRNA-1273 vaccine. Details of symptoms, clinical course, investigation reports and treatment were not provided. The current pandemic situation of COVID-19 could be a confounder. Elderly age of the patient and treatment with Adalimumab remains as possible risk factors. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This spontaneous case concerns a 79-year-old female patient with relevant medical condition of Chron´s disease treated with Adalimumab (reported as co-suspect), who experienced the unexpected non-serious  COVID-19, after receiving a fourth dose of mRNA-1273 vaccine. Patient received as first, second and booster dose (in an appropriate interval) mRNA-1273 vaccine. Details of symptoms, clinical course, investigation reports and treatment were not provided. The current pandemic situation of COVID-19 could be a confounder. Elderly age of the patient and treatment with Adalimumab remains as possible risk factors. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Spironolactone).    On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 13-May-2022 to 17-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) was resolving.            No concomitant medications were reported  On 22-MAY-2022 patient experienced rebound of symptoms.  Company comment-This spontaneous case concerns a patient of unknown age and gender, with no relevant medical history reported, who experienced the non-serious unexpected AESI of COVID-19 on an unknown date after third dose of mRNA-1273 vaccine. Patient was being treated with Paxlovid (NIRMATRELVIR, RITONAVIR) for Covid from 13th to 17th May2022, patient also had rebound of symptoms after completion of treatment with Paxlovid .Outcome of the event was resolving at the time of report. The current pandemic situation of COVID 19 may remain as confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.  Patient was not taking any other medications or products within 2 weeks of starting COVID-19 treatment. Device Date was reported as 23-May-2022.; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender, with no relevant medical history reported, who experienced the non-serious unexpected AESI of COVID-19 on an unknown date after third dose of mRNA-1273 vaccine. Patient was being treated with Paxlovid (NIRMATRELVIR, RITONAVIR) for Covid from 13th to 17th May2022, patient also had rebound of symptoms after completion of treatment with Paxlovid .Outcome of the event was resolving at the time of report. The current pandemic situation of COVID 19 may remain as confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Some booster vaccines that were past 30 days in fridge; Expired vaccine administered/Booster vaccine that was past 30 days in fridge given after 45 days in refrigerator; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered/Booster vaccine that was past 30 days in fridge given after 45 days in refrigerator) and PRODUCT STORAGE ERROR (Some booster vaccines that were past 30 days in fridge) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 vaccination.     No Medical History information was reported.    In May 2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In May 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered/Booster vaccine that was past 30 days in fridge given after 45 days in refrigerator). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Some booster vaccines that were past 30 days in fridge). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered/Booster vaccine that was past 30 days in fridge given after 45 days in refrigerator) and PRODUCT STORAGE ERROR (Some booster vaccines that were past 30 days in fridge) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter.  Patient took 2nd booster.  No treatment medication was reported by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2022: patient demographics added, dose details added
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: after their first booster they had minor side effect minor soreness, where got the vaccine; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (after their first booster they had minor side effect minor soreness, where got the vaccine) and FATIGUE (Tiredness) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 71f21a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Previously administered products included for Product used for unknown indication: Pfizer (Dose 2) and Pfizer (Dose 1). Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer. Concurrent medical conditions included Allergic reaction to bee sting.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (after their first booster they had minor side effect minor soreness, where got the vaccine) and FATIGUE (Tiredness). At the time of the report, VACCINATION SITE PAIN (after their first booster they had minor side effect minor soreness, where got the vaccine) and FATIGUE (Tiredness) outcome was unknown.            No concomitant medication was reported.  After the first booster the patient had minor side effect minor soreness and tiredness. By the third day the patient had soreness on the left side, where got the vaccine.  No treatment medication was reported.   This case was linked to MOD-2022-576257 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Invalid dose administration/ patient administered a dose of the Moderna COVID-19 vaccine after the 30 day beyond use date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Invalid dose administration/ patient administered a dose of the Moderna COVID-19 vaccine after the 30 day beyond use date) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 vaccination.     No Medical History information was reported.    In May 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In May 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Invalid dose administration/ patient administered a dose of the Moderna COVID-19 vaccine after the 30 day beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Invalid dose administration/ patient administered a dose of the Moderna COVID-19 vaccine after the 30 day beyond use date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product reported by reporter. The patient had received 2nd booster. The dates of administration were 03-May-2022, 04-May-2022, 09-May-2022, 11-May-2022, 17-May-2022, and 20-May-2022. No treatment medication reported by reporter.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Oct-2021 at 3:51 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On 27-Oct-2021 at 3:51 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 52.61 for dose administered on 27-OCT -2021. No concomitant medications were reported. Batch number 035C21A underwent temperature excursion on 27-OCT-2021 with temperature 29 and 32 Fahrenheit from 09:00 AM to 10:00 AM. This vial was moved to fridge on 05-OCT-2021 and beyond use date for the vial was reported as 04-NOV-2021. Product moved to clinic on 27-OCT-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a brand traceable temperature monitor at every hour. No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: doses administered past 30 day beyond use date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past 30 day beyond use date) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past 30 day beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses administered past 30 day beyond use date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  The patient had received 2nd booster.  The dates of administration were 03-May-2022, 04-May-2022, 09-May-2022, 11-May-2022, 17-May-2022, and 20-May-2022.  Treatment information was not reported.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered a dose of the Moderna COVID-19 vaccine after the 30 day beyond use date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered a dose of the Moderna COVID-19 vaccine after the 30 day beyond use date) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 vaccination.     No Medical History information was reported.    In May 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In May 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered a dose of the Moderna COVID-19 vaccine after the 30 day beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered a dose of the Moderna COVID-19 vaccine after the 30 day beyond use date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter.  Patient took 2nd booster.  No treatment medication was reported by reporter.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Doses administered past 30 day beyond use date; doses administered past 30 day beyond use date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past 30 day beyond use date) and PRODUCT STORAGE ERROR (Doses administered past 30 day beyond use date) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 vaccination.     No Medical History information was reported.    In May 2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In May 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past 30 day beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Doses administered past 30 day beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses administered past 30 day beyond use date) and PRODUCT STORAGE ERROR (Doses administered past 30 day beyond use date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. 16 patients were administered a dose of the Moderna COVID-19 vaccine after the 30 day beyond use date period. Dates of administration were 3-MAY-2022, 4-MAY-2022, 9-MAY-2022, 11-MAY-2022, 17-MAY-2022, and 20-MAY-2022. Treatment medication was not reported.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Abdominal pain upper, Headache
Clinical narrative: Stomach ache; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach ache) and HEADACHE (Headache) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No relevant medical history. No Known drug allergy.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-May-2022, received fourth 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 an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Stomach ache) and HEADACHE (Headache). At the time of the report, ABDOMINAL PAIN UPPER (Stomach ache) and HEADACHE (Headache) outcome was unknown.            No Concomitant medication were reported. It was reported that the drug HUMIRA was ineffective with outcome unknown. It was unknown whether the patient was enrolled in COVID-19 vaccine clinical trial. No treatment drug were reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Pyrexia
Clinical narrative: Shingles; COVID VACCINE ISSUE/FEVER; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles) and PYREXIA (COVID VACCINE ISSUE/FEVER) in a 66-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 Rheumatoid arthritis.    No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Aug-2021, 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. In 2021, the patient experienced PYREXIA (COVID VACCINE ISSUE/FEVER). In April 2022, the patient experienced HERPES ZOSTER (Shingles). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALTREX) at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (Shingles) and PYREXIA (COVID VACCINE ISSUE/FEVER) outcome was unknown.            No concomitant medication were provided It was reported that with respect to  HUMIRA Product for shingles Action taken was given as unknown, causality will be not reported and de challenge  Is not applicable  and for fever action taken unknown causality not reported  and de challenge is Not applicable.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 4:20 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 52.98 on 03-Apr-2021. Concomitant products were not provided.  On 03-Apr-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 210, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 03-Apr-2021. 20 vials were sent to clinic. Vaccine BUD date was 29-Apr-2021 (Batch number: 030B21A).   The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a  traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The  explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 12:03 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 12:03 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 34.02 on 15-Apr-2021.  Concomitant products were not provided.  On 15-Apr-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 188, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 06-Apr-2021, vial was moved to clinic on 15-Apr-2021. 18 vials were sent to clinic. Vaccine BUD date was 09-May-2021 (Batch number: 044B21A ).  On 15-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 AM: 39, 1PM: 43, 2 PM: 44, 3 PM: 44, 4 PM: 42 and 5 PM: 42.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021 at 1:20 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 1:20 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 42.83 on 31-Mar-2021.  Concomitant products were not provided.  On 31-Mar-2021, Excursion time was 09 AM, temperature was 32, total doses given for the day was 199, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 31-Mar-2021. 14 vials were sent to clinic. Vaccine BUD date was 29-Apr-2021.  On 31-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 32, 9 AM: 32, 10 AM: 40, 11 AM: 42, 12 AM: 43, 1PM: 44, 2 PM: 46, 3 PM: 46, 4 PM: 44 and 5 PM: 44.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021 at 11:26 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Apr-2021 at 11:26 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 34.02.  No concomitant medications were reported.  Batch number 007C21A administered on 27-Apr-2021 had  temperature of 35 at 09:00 AM, 34 at 10.00AM and 35 at 01.00 PM. This vial was moved to fridge on 19-Apr-2021 and beyond use date for the vial was reported as 19-May-2021. Product moved to clinic on 27-Apr-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 10:45 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 10:45 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Age of patient was reported as 29.99  On 15-Apr-2021 at 09:00 A.M., the temperature recorded was 34 degree Fahrenheit and vial was initially moved to the fridge on 06-Apr-2021 and beyond use date was 05-May-2021. Product moved to clinic on 15-Apr-2021.  Vial was stored on cooler 1, on 15-Apr-2021, Excursion duration At 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 AM: 39, 1PM: 43, 2 PM : 44, 3 PM: 44, 4 PM: 42 and 5 PM : 42.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour. No treatment medications were reported.