chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: expired vial was moved from the freezer to the fridge on 29-Apr-2022; Vaccine was expired on 05-May-2022 and administered on 06-May-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 05-May-2022 and administered on 06-May-2022) and PRODUCT STORAGE ERROR (expired vial was moved from the freezer to the fridge on 29-Apr-2022) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 084J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 05-May-2022 and administered on 06-May-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (expired vial was moved from the freezer to the fridge on 29-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 05-May-2022 and administered on 06-May-2022) and PRODUCT STORAGE ERROR (expired vial was moved from the freezer to the fridge on 29-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial did not undergo any temperature excursions.  No concomitant medications were provided by the reporter.  It was reported that they have vaccinated only nine people with Moderna on 06-May-2022. They originally thought it was 10. Of those, all were boosters except one who had their second dose.  No treatment medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2022: Follow-up contains non significant information. Narrative updated. On 11-May-2022: Significant Live follow-up appended-  verbatim of product storage error was updated. Date on which vial was removed from refrigeration updated
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Rheumatological examination, Therapeutic response unexpected
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Huge improvements from Rheumatory Arthritis after 2nd dose//Huge improvements in RA lab numbers after 2nd dose) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 030L20A) for COVID-19 vaccination.     Previously administered products included for RA: Methotrexate (Patient stopped Methotrexate in 2018 because she had cancer) in 2018, Leflunomide (Prior to vaccination. she stopped Leflunomide and in AUG2020) until August 2020. Past adverse reactions to the above products included No adverse event with Leflunomide and Methotrexate. Concurrent medical conditions included Rheumatoid arthritis (Patient  was diagnosed with RA in 2014) since 2014 and Cancer.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Huge improvements from Rheumatory Arthritis after 2nd dose//Huge improvements in RA lab numbers after 2nd dose). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Huge improvements from Rheumatory Arthritis after 2nd dose//Huge improvements in RA lab numbers after 2nd dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Rheumatological examination: normal (normal) zero positive RA.         No concomitant medication were reported. Patient stated that after vaccination all positive RA numbers went down. All RA manifestations went away. Lab test Predictors of RA were completely gone. The patient had minimal arthritis symptoms from time to time and it goes away without using any medications. No treatment information were provided..   This case was linked to MOD-2022-564583, MOD-2022-564650, MOD-2022-564658 (Patient Link).
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was initially stored in the refrigerator less than a month ago, and vaccine was expired on 05-May-2022; Nine people vaccinated with the expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Nine people vaccinated with the expired vaccine) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator less than a month ago, and vaccine was expired on 05-May-2022) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 084J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Nine people vaccinated with the expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator less than a month ago, and vaccine was expired on 05-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Nine people vaccinated with the expired vaccine) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator less than a month ago, and vaccine was expired on 05-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  The vial did not undergo any temperature excursions.  Less than a month ago vial was initially stored in the refrigerator (HCP believed it was last Friday).  No treatment medication were provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Rheumatological examination, Therapeutic response unexpected
Clinical narrative: Maintained all improvements with RA after 3rd full dose/Improvements in IL6 driven autoimmune disease after vaccination/Rheumatory Arthritis (RA)  has gone away after 4 Moderna vaccination; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Maintained all improvements with RA after 3rd full dose/Improvements in IL6 driven autoimmune disease after vaccination/Rheumatory Arthritis (RA)  has gone away after 4 Moderna vaccination) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     Previously administered products included for RA: Methotrexate in 2018 and Leflunomide until August 2020. Past adverse reactions to the above products included No adverse event with Leflunomide and Methotrexate. Concurrent medical conditions included RA since 2014 and Cancer.    On 02-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Maintained all improvements with RA after 3rd full dose/Improvements in IL6 driven autoimmune disease after vaccination/Rheumatory Arthritis (RA)  has gone away after 4 Moderna vaccination). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Maintained all improvements with RA after 3rd full dose/Improvements in IL6 driven autoimmune disease after vaccination/Rheumatory Arthritis (RA)  has gone away after 4 Moderna vaccination) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Rheumatological examination: zero positive ra Zero positive RA.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. It was reported that patient was diagnosed with Rheumatoid arthritis in 2014. After each shot of Moderna COVID-19 vaccine patient noticed huge improvements from Rheumatoid arthritis and the lab numbers showed it too, all positive Rheumatoid arthritis numbers went down. The patient had minimal arthritis symptoms from time to time and it goes away without using any medications. Patient also stated that COVID-19 vaccine causes a Leukotriene storm. The IL6 driven autoimmune disease improved after Moderna COVID-19 vaccine. No treatment details were reported.   This case was linked to MOD-2022-564648, MOD-2022-564658 (Patient Link).
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Blood cholesterol, Hypocholesterolaemia, Therapeutic response unexpected
Clinical narrative: cholesterol levels have decreased significantly after each dose of the Moderna COVID-19 vaccine / Dropping of the cholesterol level; Bad Cholesterol went down / Good Cholesterol went up; This spontaneous case was reported by an other health care professional and describes the occurrence of HYPOCHOLESTEROLAEMIA (cholesterol levels have decreased significantly after each dose of the Moderna COVID-19 vaccine / Dropping of the cholesterol level) and THERAPEUTIC RESPONSE UNEXPECTED (Bad Cholesterol went down / Good Cholesterol went up) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in 2020. Concurrent medical conditions included Drug allergy (Allergy to statins) and Hypercholesterolemia.    On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOCHOLESTEROLAEMIA (cholesterol levels have decreased significantly after each dose of the Moderna COVID-19 vaccine / Dropping of the cholesterol level) and THERAPEUTIC RESPONSE UNEXPECTED (Bad Cholesterol went down / Good Cholesterol went up). At the time of the report, HYPOCHOLESTEROLAEMIA (cholesterol levels have decreased significantly after each dose of the Moderna COVID-19 vaccine / Dropping of the cholesterol level) and THERAPEUTIC RESPONSE UNEXPECTED (Bad Cholesterol went down / Good Cholesterol went up) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood cholesterol: decreased Patient had blood test to prove the correlation to decreased cholesterol level.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had COVID in 2020 the first initial drop was noticed. Concomitant product information was not provided. Treatment information was not provided.   This case was linked to MOD-2022-564744, MOD-2022-564749, MOD-2022-564750 (Patient Link).
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Low density lipoprotein, Low density lipoprotein decreased, Pain in extremity, SARS-CoV-2 test false negative, Somnolence
Clinical narrative: cholesterol levels have decreased significantly after each dose of the Moderna COVID-19 vaccine / Dropping of the cholesterol level; Bad Cholesterol went down / Good Cholesterol went up; This spontaneous case was reported by an other health care professional and describes the occurrence of HYPOCHOLESTEROLAEMIA (cholesterol levels have decreased significantly after each dose of the Moderna COVID-19 vaccine / Dropping of the cholesterol level) and THERAPEUTIC RESPONSE UNEXPECTED (Bad Cholesterol went down / Good Cholesterol went up) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in 2020. Concurrent medical conditions included Drug allergy (Allergy to statins) and Hypercholesterolemia.    On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOCHOLESTEROLAEMIA (cholesterol levels have decreased significantly after each dose of the Moderna COVID-19 vaccine / Dropping of the cholesterol level) and THERAPEUTIC RESPONSE UNEXPECTED (Bad Cholesterol went down / Good Cholesterol went up). At the time of the report, HYPOCHOLESTEROLAEMIA (cholesterol levels have decreased significantly after each dose of the Moderna COVID-19 vaccine / Dropping of the cholesterol level) and THERAPEUTIC RESPONSE UNEXPECTED (Bad Cholesterol went down / Good Cholesterol went up) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood cholesterol: decreased Patient had blood test to prove the correlation to decreased cholesterol level.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had COVID in 2020 the first initial drop was noticed. Concomitant product information was not provided. Treatment information was not provided.   This case was linked to MOD-2022-564744, MOD-2022-564749, MOD-2022-564750 (Patient Link).
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: cholesterol levels have decreased significantly after each dose of the Moderna COVID-19 vaccine / Dropping of the cholesterol level; Bad Cholesterol went down / Good Cholesterol went up; This spontaneous case was reported by an other health care professional and describes the occurrence of HYPOCHOLESTEROLAEMIA (cholesterol levels have decreased significantly after each dose of the Moderna COVID-19 vaccine / Dropping of the cholesterol level) and THERAPEUTIC RESPONSE UNEXPECTED (Bad Cholesterol went down / Good Cholesterol went up) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in 2020. Concurrent medical conditions included Drug allergy (Allergy to statins) and Hypercholesterolemia.    On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOCHOLESTEROLAEMIA (cholesterol levels have decreased significantly after each dose of the Moderna COVID-19 vaccine / Dropping of the cholesterol level) and THERAPEUTIC RESPONSE UNEXPECTED (Bad Cholesterol went down / Good Cholesterol went up). At the time of the report, HYPOCHOLESTEROLAEMIA (cholesterol levels have decreased significantly after each dose of the Moderna COVID-19 vaccine / Dropping of the cholesterol level) and THERAPEUTIC RESPONSE UNEXPECTED (Bad Cholesterol went down / Good Cholesterol went up) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood cholesterol: decreased Patient had blood test to prove the correlation to decreased cholesterol level.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had COVID in 2020 the first initial drop was noticed. Concomitant product information was not provided. Treatment information was not provided.   This case was linked to MOD-2022-564744, MOD-2022-564749, MOD-2022-564750 (Patient Link).
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Blood cholesterol decreased, Low density lipoprotein, Pain in extremity, Somnolence, Therapeutic response unexpected
Clinical narrative: cholesterol levels have decreased significantly after each dose of the Moderna COVID-19 vaccine / Dropping of the cholesterol level; Bad Cholesterol went down / Good Cholesterol went up; This spontaneous case was reported by an other health care professional and describes the occurrence of HYPOCHOLESTEROLAEMIA (cholesterol levels have decreased significantly after each dose of the Moderna COVID-19 vaccine / Dropping of the cholesterol level) and THERAPEUTIC RESPONSE UNEXPECTED (Bad Cholesterol went down / Good Cholesterol went up) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in 2020. Concurrent medical conditions included Drug allergy (Allergy to statins) and Hypercholesterolemia.    On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOCHOLESTEROLAEMIA (cholesterol levels have decreased significantly after each dose of the Moderna COVID-19 vaccine / Dropping of the cholesterol level) and THERAPEUTIC RESPONSE UNEXPECTED (Bad Cholesterol went down / Good Cholesterol went up). At the time of the report, HYPOCHOLESTEROLAEMIA (cholesterol levels have decreased significantly after each dose of the Moderna COVID-19 vaccine / Dropping of the cholesterol level) and THERAPEUTIC RESPONSE UNEXPECTED (Bad Cholesterol went down / Good Cholesterol went up) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood cholesterol: decreased Patient had blood test to prove the correlation to decreased cholesterol level.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had COVID in 2020 the first initial drop was noticed. Concomitant product information was not provided. Treatment information was not provided.   This case was linked to MOD-2022-564744, MOD-2022-564749, MOD-2022-564750 (Patient Link).
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Low density lipoprotein, Pain in extremity, Somnolence, Therapeutic response unexpected
Clinical narrative: cholesterol levels have decreased significantly after each dose of the Moderna COVID-19 vaccine / Dropping of the cholesterol level; Bad Cholesterol went down / Good Cholesterol went up; This spontaneous case was reported by an other health care professional and describes the occurrence of HYPOCHOLESTEROLAEMIA (cholesterol levels have decreased significantly after each dose of the Moderna COVID-19 vaccine / Dropping of the cholesterol level) and THERAPEUTIC RESPONSE UNEXPECTED (Bad Cholesterol went down / Good Cholesterol went up) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in 2020. Concurrent medical conditions included Drug allergy (Allergy to statins) and Hypercholesterolemia.    On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOCHOLESTEROLAEMIA (cholesterol levels have decreased significantly after each dose of the Moderna COVID-19 vaccine / Dropping of the cholesterol level) and THERAPEUTIC RESPONSE UNEXPECTED (Bad Cholesterol went down / Good Cholesterol went up). At the time of the report, HYPOCHOLESTEROLAEMIA (cholesterol levels have decreased significantly after each dose of the Moderna COVID-19 vaccine / Dropping of the cholesterol level) and THERAPEUTIC RESPONSE UNEXPECTED (Bad Cholesterol went down / Good Cholesterol went up) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood cholesterol: decreased Patient had blood test to prove the correlation to decreased cholesterol level.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had COVID in 2020 the first initial drop was noticed. Concomitant product information was not provided. Treatment information was not provided.   This case was linked to MOD-2022-564744, MOD-2022-564749, MOD-2022-564750 (Patient Link).
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Blood cholesterol, Hypocholesterolaemia, Therapeutic response unexpected
Clinical narrative: Cholesterol level decreased significantly after each dose of the Moderna  vaccine / Dropping of the cholesterol level / LDL Cholesterol was at 176 and 10 days after the 2nd booster it dropped to 144; Drowsiness; Cholesterol went down from 176 to 144; Sore arm; This spontaneous case was reported by an other health care professional and describes the occurrence of BLOOD CHOLESTEROL DECREASED (Cholesterol level decreased significantly after each dose of the Moderna  vaccine / Dropping of the cholesterol level / LDL Cholesterol was at 176 and 10 days after the 2nd booster it dropped to 144), SOMNOLENCE (Drowsiness), THERAPEUTIC RESPONSE UNEXPECTED (Cholesterol went down from 176 to 144) and PAIN IN EXTREMITY (Sore arm) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005M21A, 065F21A, 029L20A and 039K20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in 2020. Concurrent medical conditions included Drug allergy (Allergy to statins) and Hypercholesterolemia.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BLOOD CHOLESTEROL DECREASED (Cholesterol level decreased significantly after each dose of the Moderna  vaccine / Dropping of the cholesterol level / LDL Cholesterol was at 176 and 10 days after the 2nd booster it dropped to 144), SOMNOLENCE (Drowsiness), THERAPEUTIC RESPONSE UNEXPECTED (Cholesterol went down from 176 to 144) and PAIN IN EXTREMITY (Sore arm). At the time of the report, BLOOD CHOLESTEROL DECREASED (Cholesterol level decreased significantly after each dose of the Moderna  vaccine / Dropping of the cholesterol level / LDL Cholesterol was at 176 and 10 days after the 2nd booster it dropped to 144), SOMNOLENCE (Drowsiness), THERAPEUTIC RESPONSE UNEXPECTED (Cholesterol went down from 176 to 144) and PAIN IN EXTREMITY (Sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Apr-2022, Low density lipoprotein: 144 Dropped to 144. Patient had blood test to prove the correlation to decreased cholesterol level.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug reported. No treatment information was provided by the reporter. Patient also mentioned that he had blood tests and medical records to prove the correlation.   This case was linked to MOD-2022-564739, MOD-2022-564744, MOD-2022-564749 (Patient Link).
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Low density lipoprotein, Low density lipoprotein decreased, Pain in extremity, SARS-CoV-2 test false negative, Somnolence
Clinical narrative: Cholesterol level decreased significantly after each dose of the Moderna  vaccine / Dropping of the cholesterol level / LDL Cholesterol was at 176 and 10 days after the 2nd booster it dropped to 144; Drowsiness; Cholesterol went down from 176 to 144; Sore arm; This spontaneous case was reported by an other health care professional and describes the occurrence of BLOOD CHOLESTEROL DECREASED (Cholesterol level decreased significantly after each dose of the Moderna  vaccine / Dropping of the cholesterol level / LDL Cholesterol was at 176 and 10 days after the 2nd booster it dropped to 144), SOMNOLENCE (Drowsiness), THERAPEUTIC RESPONSE UNEXPECTED (Cholesterol went down from 176 to 144) and PAIN IN EXTREMITY (Sore arm) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005M21A, 065F21A, 029L20A and 039K20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in 2020. Concurrent medical conditions included Drug allergy (Allergy to statins) and Hypercholesterolemia.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BLOOD CHOLESTEROL DECREASED (Cholesterol level decreased significantly after each dose of the Moderna  vaccine / Dropping of the cholesterol level / LDL Cholesterol was at 176 and 10 days after the 2nd booster it dropped to 144), SOMNOLENCE (Drowsiness), THERAPEUTIC RESPONSE UNEXPECTED (Cholesterol went down from 176 to 144) and PAIN IN EXTREMITY (Sore arm). At the time of the report, BLOOD CHOLESTEROL DECREASED (Cholesterol level decreased significantly after each dose of the Moderna  vaccine / Dropping of the cholesterol level / LDL Cholesterol was at 176 and 10 days after the 2nd booster it dropped to 144), SOMNOLENCE (Drowsiness), THERAPEUTIC RESPONSE UNEXPECTED (Cholesterol went down from 176 to 144) and PAIN IN EXTREMITY (Sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Apr-2022, Low density lipoprotein: 144 Dropped to 144. Patient had blood test to prove the correlation to decreased cholesterol level.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug reported. No treatment information was provided by the reporter. Patient also mentioned that he had blood tests and medical records to prove the correlation.   This case was linked to MOD-2022-564739, MOD-2022-564744, MOD-2022-564749 (Patient Link).
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Cholesterol level decreased significantly after each dose of the Moderna  vaccine / Dropping of the cholesterol level / LDL Cholesterol was at 176 and 10 days after the 2nd booster it dropped to 144; Drowsiness; Cholesterol went down from 176 to 144; Sore arm; This spontaneous case was reported by an other health care professional and describes the occurrence of BLOOD CHOLESTEROL DECREASED (Cholesterol level decreased significantly after each dose of the Moderna  vaccine / Dropping of the cholesterol level / LDL Cholesterol was at 176 and 10 days after the 2nd booster it dropped to 144), SOMNOLENCE (Drowsiness), THERAPEUTIC RESPONSE UNEXPECTED (Cholesterol went down from 176 to 144) and PAIN IN EXTREMITY (Sore arm) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005M21A, 065F21A, 029L20A and 039K20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in 2020. Concurrent medical conditions included Drug allergy (Allergy to statins) and Hypercholesterolemia.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BLOOD CHOLESTEROL DECREASED (Cholesterol level decreased significantly after each dose of the Moderna  vaccine / Dropping of the cholesterol level / LDL Cholesterol was at 176 and 10 days after the 2nd booster it dropped to 144), SOMNOLENCE (Drowsiness), THERAPEUTIC RESPONSE UNEXPECTED (Cholesterol went down from 176 to 144) and PAIN IN EXTREMITY (Sore arm). At the time of the report, BLOOD CHOLESTEROL DECREASED (Cholesterol level decreased significantly after each dose of the Moderna  vaccine / Dropping of the cholesterol level / LDL Cholesterol was at 176 and 10 days after the 2nd booster it dropped to 144), SOMNOLENCE (Drowsiness), THERAPEUTIC RESPONSE UNEXPECTED (Cholesterol went down from 176 to 144) and PAIN IN EXTREMITY (Sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Apr-2022, Low density lipoprotein: 144 Dropped to 144. Patient had blood test to prove the correlation to decreased cholesterol level.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug reported. No treatment information was provided by the reporter. Patient also mentioned that he had blood tests and medical records to prove the correlation.   This case was linked to MOD-2022-564739, MOD-2022-564744, MOD-2022-564749 (Patient Link).
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Blood cholesterol decreased, Low density lipoprotein, Pain in extremity, Somnolence, Therapeutic response unexpected
Clinical narrative: Cholesterol level decreased significantly after each dose of the Moderna  vaccine / Dropping of the cholesterol level / LDL Cholesterol was at 176 and 10 days after the 2nd booster it dropped to 144; Drowsiness; Cholesterol went down from 176 to 144; Sore arm; This spontaneous case was reported by an other health care professional and describes the occurrence of BLOOD CHOLESTEROL DECREASED (Cholesterol level decreased significantly after each dose of the Moderna  vaccine / Dropping of the cholesterol level / LDL Cholesterol was at 176 and 10 days after the 2nd booster it dropped to 144), SOMNOLENCE (Drowsiness), THERAPEUTIC RESPONSE UNEXPECTED (Cholesterol went down from 176 to 144) and PAIN IN EXTREMITY (Sore arm) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005M21A, 065F21A, 029L20A and 039K20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in 2020. Concurrent medical conditions included Drug allergy (Allergy to statins) and Hypercholesterolemia.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BLOOD CHOLESTEROL DECREASED (Cholesterol level decreased significantly after each dose of the Moderna  vaccine / Dropping of the cholesterol level / LDL Cholesterol was at 176 and 10 days after the 2nd booster it dropped to 144), SOMNOLENCE (Drowsiness), THERAPEUTIC RESPONSE UNEXPECTED (Cholesterol went down from 176 to 144) and PAIN IN EXTREMITY (Sore arm). At the time of the report, BLOOD CHOLESTEROL DECREASED (Cholesterol level decreased significantly after each dose of the Moderna  vaccine / Dropping of the cholesterol level / LDL Cholesterol was at 176 and 10 days after the 2nd booster it dropped to 144), SOMNOLENCE (Drowsiness), THERAPEUTIC RESPONSE UNEXPECTED (Cholesterol went down from 176 to 144) and PAIN IN EXTREMITY (Sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Apr-2022, Low density lipoprotein: 144 Dropped to 144. Patient had blood test to prove the correlation to decreased cholesterol level.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug reported. No treatment information was provided by the reporter. Patient also mentioned that he had blood tests and medical records to prove the correlation.   This case was linked to MOD-2022-564739, MOD-2022-564744, MOD-2022-564749 (Patient Link).
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Low density lipoprotein, Pain in extremity, Somnolence, Therapeutic response unexpected
Clinical narrative: Cholesterol level decreased significantly after each dose of the Moderna  vaccine / Dropping of the cholesterol level / LDL Cholesterol was at 176 and 10 days after the 2nd booster it dropped to 144; Drowsiness; Cholesterol went down from 176 to 144; Sore arm; This spontaneous case was reported by an other health care professional and describes the occurrence of BLOOD CHOLESTEROL DECREASED (Cholesterol level decreased significantly after each dose of the Moderna  vaccine / Dropping of the cholesterol level / LDL Cholesterol was at 176 and 10 days after the 2nd booster it dropped to 144), SOMNOLENCE (Drowsiness), THERAPEUTIC RESPONSE UNEXPECTED (Cholesterol went down from 176 to 144) and PAIN IN EXTREMITY (Sore arm) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005M21A, 065F21A, 029L20A and 039K20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in 2020. Concurrent medical conditions included Drug allergy (Allergy to statins) and Hypercholesterolemia.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BLOOD CHOLESTEROL DECREASED (Cholesterol level decreased significantly after each dose of the Moderna  vaccine / Dropping of the cholesterol level / LDL Cholesterol was at 176 and 10 days after the 2nd booster it dropped to 144), SOMNOLENCE (Drowsiness), THERAPEUTIC RESPONSE UNEXPECTED (Cholesterol went down from 176 to 144) and PAIN IN EXTREMITY (Sore arm). At the time of the report, BLOOD CHOLESTEROL DECREASED (Cholesterol level decreased significantly after each dose of the Moderna  vaccine / Dropping of the cholesterol level / LDL Cholesterol was at 176 and 10 days after the 2nd booster it dropped to 144), SOMNOLENCE (Drowsiness), THERAPEUTIC RESPONSE UNEXPECTED (Cholesterol went down from 176 to 144) and PAIN IN EXTREMITY (Sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Apr-2022, Low density lipoprotein: 144 Dropped to 144. Patient had blood test to prove the correlation to decreased cholesterol level.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug reported. No treatment information was provided by the reporter. Patient also mentioned that he had blood tests and medical records to prove the correlation.   This case was linked to MOD-2022-564739, MOD-2022-564744, MOD-2022-564749 (Patient Link).
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Myelitis transverse
Clinical narrative: transverse myelitis; This literature-non-study case was reported in a literature article and describes the occurrence of MYELITIS TRANSVERSE (transverse myelitis) in a 64-year-old male patient 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYELITIS TRANSVERSE (transverse myelitis) (seriousness criterion medically significant). At the time of the report, MYELITIS TRANSVERSE (transverse myelitis) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered MYELITIS TRANSVERSE (transverse myelitis) to be related.    No Concomitant Medications were reported. No Treatment information was reported. Patient experienced transverse myelitis 11 months previouslyas a result of receiving the Moderna mRNA vaccine.  Company comment.  This is a literature non-study case concerning a 64  year old male patient with no medical history reported, who experienced the unexpected, serious medically significant AESI myelitis transverse, one day after the administration a dose of mRNA-1273 vaccine, considered as second dose of his COVID  19 vaccination schedule; no information about previous dose was provided. No further details were provided for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a literature non-study case concerning a 64  year old male patient with no medical history reported, who experienced the unexpected, serious medically significant AESI myelitis transverse, one day after the administration a dose of mRNA-1273 vaccine, considered as second dose of his COVID  19 vaccination schedule; no information about previous dose was provided. No further details were provided for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: pfizer first dose and moderna second dose; This spontaneous case was reported by a medical assistant and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (pfizer first dose and moderna second dose) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: Pfizer (Dose 1) on 05-May-2021. Past adverse reactions to the above products included No adverse event with Pfizer. Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 26-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (pfizer first dose and moderna second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (pfizer first dose and moderna second dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were provided.   This case was linked to MOD-2022-560565 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: got  two vaccinations and 3 boosters for Moderna and not immunocompromised; This spontaneous case was reported by a patient and describes the occurrence of EXTRA DOSE ADMINISTERED (got  two vaccinations and 3 boosters for Moderna and not immunocompromised) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Heart disorder.   On an unknown date, the patient received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, 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 EXTRA DOSE ADMINISTERED (got  two vaccinations and 3 boosters for Moderna and not immunocompromised). At the time of the report, EXTRA DOSE ADMINISTERED (got  two vaccinations and 3 boosters for Moderna and not immunocompromised) outcome was unknown.    Concomitant medication information was not provided by the reporter. The patient was not immunocompromised. Treatment information was not provided by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 11-May-2022: Non Significant Follow-up appended
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain at the site of injection\received the Moderna vaccine on his left arm, which is where he was experiencing the pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at the site of injection\received the Moderna vaccine on his left arm, which is where he was experiencing the pain) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046L21A) for COVID-19 vaccination.     No allergies (medications, food and other products) reported.  Patient did not test COVID positive or diagnosed with it. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Previously administered products included for Product used for unknown indication: Pfizer (Dose 1), Pfizer (1st booster) and Pfizer (Dose 2). Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer and Pfizer. Concomitant products included PANTOPRAZOLE for GERD, APIXABAN (ELIQUIS), LOSARTAN, FINASTERIDE and FUROSEMIDE (LASIX [FUROSEMIDE]) for an unknown indication.    On 04-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2022, the patient experienced VACCINATION SITE PAIN (pain at the site of injection\received the Moderna vaccine on his left arm, which is where he was experiencing the pain). At the time of the report, VACCINATION SITE PAIN (pain at the site of injection\received the Moderna vaccine on his left arm, which is where he was experiencing the pain) was resolving.            On the morning of 05-MAY-2022, He received the Moderna vaccine on his left arm, which was where he was experiencing the pain. He said that the pain was still somewhat there, but it never inhibited him from doing any activities. He said that the pain was improving since it first started. Outcome was very slight residual effects. Adverse event did not cause patient to seek medical care.  No treatment drug was reported.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: patient received a dose from a vial that had been punctured for more than 12 hours and left at room temperature for more than 24 hours; patient received a dose from a vial that had been punctured for more than 12 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received a dose from a vial that had been punctured for more than 12 hours) and PRODUCT STORAGE ERROR (patient received a dose from a vial that had been punctured for more than 12 hours and left at room temperature for more than 24 hours) in a male patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 04L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-May-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 10-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received a dose from a vial that had been punctured for more than 12 hours). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (patient received a dose from a vial that had been punctured for more than 12 hours and left at room temperature for more than 24 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received a dose from a vial that had been punctured for more than 12 hours) and PRODUCT STORAGE ERROR (patient received a dose from a vial that had been punctured for more than 12 hours and left at room temperature for more than 24 hours) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  The reporter reported that, from the vial a shot was given on 09-May-2022 and then the vial did not get thrown away. But on 10-May-2022, from that vial a pharmacist gave the dose. Vial sat out between the time, for 29 hours.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-565190 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2022: Follow-up information included no new information.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: two patients received  a dose from a vial that had been punctured for more than 12 hours and left at room temperature for more than 24 hours.; two patients received  a dose from a vial that had been punctured for more than 12 hours and left at room temperature for more than 24 hours.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (two patients received  a dose from a vial that had been punctured for more than 12 hours and left at room temperature for more than 24 hours.) and PRODUCT STORAGE ERROR (two patients received  a dose from a vial that had been punctured for more than 12 hours and left at room temperature for more than 24 hours.) in a female patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 04L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-May-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 10-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (two patients received  a dose from a vial that had been punctured for more than 12 hours and left at room temperature for more than 24 hours.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (two patients received  a dose from a vial that had been punctured for more than 12 hours and left at room temperature for more than 24 hours.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (two patients received  a dose from a vial that had been punctured for more than 12 hours and left at room temperature for more than 24 hours.) and PRODUCT STORAGE ERROR (two patients received  a dose from a vial that had been punctured for more than 12 hours and left at room temperature for more than 24 hours.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medication was not reported.   This case was linked to MOD-2022-565188 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2022: No new information.