chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vial was in refrigerator all the time prior to administration), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 14-Jul-2022 and was on refrigerator the entire time) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 056A22A) for COVID-19 prophylaxis. No Medical History information was reported. In 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vial was in refrigerator all the time prior to administration). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 14-Jul-2022 and was on refrigerator the entire time) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vial was in refrigerator all the time prior to administration), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 14-Jul-2022 and was on refrigerator the entire time) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Vial was in refrigerator all the time prior to administration) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 14-Jul-2022 and was on refrigerator the entire time). This case contains information for the 5th of 8 adult patients described by the reporter. No concomitant medication was reported by reporter. Patient received booster dose. Total 2 vials and 8 doses were affected. Vial did not undergo any temperature excursion and were in refrigerator the entire time. 4 patients were administered on 22-Jul-2022 and 4 patients on 02-Aug-2022. No treatment medication was reported by reporter.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: No adverse event; Vial was initially stored in refrigerator on 14-Jul-2022 and was in refrigerator the entire time; Vial was initially stored in refrigerator on 14-Jul-2022 and was on refrigerator the entire time; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vial was initially stored in refrigerator on 14-Jul-2022 and was in refrigerator the entire time), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 14-Jul-2022 and was on refrigerator the entire time) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 056A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vial was initially stored in refrigerator on 14-Jul-2022 and was in refrigerator the entire time) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 14-Jul-2022 and was on refrigerator the entire time). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). On 02-Aug-2022, POOR QUALITY PRODUCT ADMINISTERED (Vial was initially stored in refrigerator on 14-Jul-2022 and was in refrigerator the entire time) outcome was unknown. At the time of the report, PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 14-Jul-2022 and was on refrigerator the entire time) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Vial was initially stored in refrigerator on 14-Jul-2022 and was in refrigerator the entire time) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 14-Jul-2022 and was on refrigerator the entire time). Case was created for 6th of 8 adult patient. No concomitant medication was reported by reporter.  Total 2 vials and 8 doses were affected. Vial did not undergo any temperature excursion and were in refrigerator the entire time. 4 patients were administered on 22-Jul-2022 and 4 patients on 2-Aug-2022.  No treatment medication was reported by reporter.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vial was initially stored in refrigerator on 14-Jul-2022 and was in refrigerator the entire time), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 14-Jul-2022 and was in refrigerator the entire time) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 056A22A) for COVID-19 prophylaxis. No Medical History information was reported. In 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vial was initially stored in refrigerator on 14-Jul-2022 and was in refrigerator the entire time). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 14-Jul-2022 and was in refrigerator the entire time) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vial was initially stored in refrigerator on 14-Jul-2022 and was in refrigerator the entire time), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 14-Jul-2022 and was in refrigerator the entire time) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Vial was initially stored in refrigerator on 14-Jul-2022 and was in refrigerator the entire time) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 14-Jul-2022 and was in refrigerator the entire time). No concomitant medications were reported. It was reported that the patient received expired booster dose of vaccine in between 22-Jul-2022 to 02-Aug-2022. Number of doses and vials that were affected were 8 doses from 2 vials. The vial was initially stored in the refrigerator on 14-Jul-2022. The vial did not undergo any temperature excursions. The vial was in refrigerator throughout the entire time and not kept at room temperature. No treatment details was reported.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Vial was initially stored in refrigerator on 14-Jul-2022 and was on refrigerator the entire time; No adverse event; Vial was in refrigerator all the time prior to administration; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vial was in refrigerator all the time prior to administration), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 14-Jul-2022 and was on refrigerator the entire time) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 056A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vial was in refrigerator all the time prior to administration). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 14-Jul-2022 and was on refrigerator the entire time) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vial was in refrigerator all the time prior to administration), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 14-Jul-2022 and was on refrigerator the entire time) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Vial was in refrigerator all the time prior to administration) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 14-Jul-2022 and was on refrigerator the entire time).    This case contained information for the 8th of 8 adult patients described by the reporter.  No concomitant medication was reported by reporter.  Total 2 vials and 8 doses were affected. Vial did not undergo any temperature excursion and were in refrigerator the entire time. 4 patients were administered on 22-Jul-2022 and 4 patients on 02-Aug-2022.  No treatment medication was reported by reporter.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Feeling abnormal, Influenza like illness, Insomnia
Clinical narrative: flu like symptoms; felt like shit; cannot sleep as long through the night; temperature was 100 for 4 days; been more tired; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), FEELING ABNORMAL (felt like shit), INSOMNIA (cannot sleep as long through the night), PYREXIA (temperature was 100 for 4 days) and FATIGUE (been more tired) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045L21A, 058H21A, 007C21A and 038B21A) for COVID-19 prophylaxis.     He had no history of myocarditis or pericarditis.  The patient's past medical history included Cardiac ablation, Pacemaker insertion (cardiac) in 2003 and Cardiac ablation (In the past 2 years). Family history included Hypertrophic cardiomyopathy (with maternal family history (his mother's father)). Concurrent medical conditions included Hypertrophic cardiomyopathy. Concomitant products included AMIODARONE for an unknown indication.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Dec-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. In 2022, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), FEELING ABNORMAL (felt like shit), INSOMNIA (cannot sleep as long through the night), PYREXIA (temperature was 100 for 4 days) and FATIGUE (been more tired). In 2022, INFLUENZA LIKE ILLNESS (flu like symptoms) had resolved. At the time of the report, FEELING ABNORMAL (felt like shit), INSOMNIA (cannot sleep as long through the night), PYREXIA (temperature was 100 for 4 days) and FATIGUE (been more tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.         After receiving the 4th dose of the vaccine experienced flu like symptoms for 4 days with no high fever. Temperature was 100 for 4 days though it normally was 98 and felt like shit. Patient had also been more tired and cannot sleep as long through the night: Would put 8 hours down at night but in the morning at 10:00 tired. The last couple months patient was been going down for 4 to 4.5 hours. Patient wake up, cook something healthy fish and vegetables,  go online. Dead tired at 9:00 PM. Took second batch of cardiac medicine at 10:00 which patient needed to stay up for.  Concomitant medications included stomach medication for colitis and cardiac medicine.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 11-Aug-2022: Follow-up received included no new information. On 11-Aug-2022: Follow-up received included no new information.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: flu like symptoms; felt like shit; cannot sleep as long through the night; temperature was 100 for 4 days; been more tired; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), FEELING ABNORMAL (felt like shit), INSOMNIA (cannot sleep as long through the night), PYREXIA (temperature was 100 for 4 days) and FATIGUE (been more tired) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045L21A, 058H21A, 007C21A and 038B21A) for COVID-19 prophylaxis.     He had no history of myocarditis or pericarditis.  The patient's past medical history included Cardiac ablation, Pacemaker insertion (cardiac) in 2003 and Cardiac ablation (In the past 2 years). Family history included Hypertrophic cardiomyopathy (with maternal family history (his mother's father)). Concurrent medical conditions included Hypertrophic cardiomyopathy. Concomitant products included AMIODARONE for an unknown indication.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Dec-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. In 2022, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), FEELING ABNORMAL (felt like shit), INSOMNIA (cannot sleep as long through the night), PYREXIA (temperature was 100 for 4 days) and FATIGUE (been more tired). In 2022, INFLUENZA LIKE ILLNESS (flu like symptoms) had resolved. At the time of the report, FEELING ABNORMAL (felt like shit), INSOMNIA (cannot sleep as long through the night), PYREXIA (temperature was 100 for 4 days) and FATIGUE (been more tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.         After receiving the 4th dose of the vaccine experienced flu like symptoms for 4 days with no high fever. Temperature was 100 for 4 days though it normally was 98 and felt like shit. Patient had also been more tired and cannot sleep as long through the night: Would put 8 hours down at night but in the morning at 10:00 tired. The last couple months patient was been going down for 4 to 4.5 hours. Patient wake up, cook something healthy fish and vegetables,  go online. Dead tired at 9:00 PM. Took second batch of cardiac medicine at 10:00 which patient needed to stay up for.  Concomitant medications included stomach medication for colitis and cardiac medicine.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 11-Aug-2022: Follow-up received included no new information. On 11-Aug-2022: Follow-up received included no new information.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Heart rate, Hypotension, Oxygen saturation
Clinical narrative: low blood pressure; This spontaneous case was reported by a patient family member or friend and describes the occurrence of HYPOTENSION (low blood pressure) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 078J21A, 011M20A and 078J21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HYPOTENSION (low blood pressure). At the time of the report, HYPOTENSION (low blood pressure) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jan-2022, Blood pressure measurement: low blood pressure. On 03-Jan-2022, Heart rate: rapid heart beat. On 03-Jan-2022, Oxygen saturation: low oxygen saturation.         No concomitant medications were reported.  Patient received her first booster dose.  No treatment medications were reported.   This case was linked to MOD-2021-249289 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; The patient received 1st dose on 25 Jan 2021 and 2nd dose on 09 Feb 2021; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received 1st dose on 25 Jan 2021 and 2nd dose on 09 Feb 2021) and NO ADVERSE EVENT (No adverse event) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015m20a and 012l20a) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received 1st dose on 25 Jan 2021 and 2nd dose on 09 Feb 2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received 1st dose on 25 Jan 2021 and 2nd dose on 09 Feb 2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received 1st dose on 25 Jan 2021 and 2nd dose on 09 Feb 2021).    No concomitant medication information was provided.  Patient was not immunocompromised. The vial did not undergo any temperature excursions.  No treatment information was provided.   This case was linked to MOD-2022-628869 (Patient Link).
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Nausea, Pyrexia
Clinical narrative: low grade fever of 99.3 degrees F; nausea for a couple of hours; daughter has been tired the last two days; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PYREXIA (low grade fever of 99.3 degrees F), FATIGUE (daughter has been tired the last two days) and NAUSEA (nausea for a couple of hours) in a 3-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Patient had no medical history other than allergies. The patient is not tested or diagnosed for COVID.  Concurrent medical conditions included Fruit allergy (pineapples), Allergy to molds and Allergy to animal (dog dandruff).    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2022, the patient experienced FATIGUE (daughter has been tired the last two days). On an unknown date, the patient experienced PYREXIA (low grade fever of 99.3 degrees F) and NAUSEA (nausea for a couple of hours). In August 2022, FATIGUE (daughter has been tired the last two days) had resolved. At the time of the report, PYREXIA (low grade fever of 99.3 degrees F) had not resolved and NAUSEA (nausea for a couple of hours) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.3 99.3 degrees F.         Patient was not receiving concomitant medication. No treatment drug was reported. The patient still had low grade fever of 99.3 degrees F.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for Corona; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (tested positive for Corona) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Immunodeficiency (weak immune system).    In November 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2022, the patient experienced COVID-19 (tested positive for Corona). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 14-Jul-2022 to 19-Jul-2022 at a dose of 100 milligram. At the time of the report, COVID-19 (tested positive for Corona) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2022, SARS-CoV-2 test: (Positive) tested positive for Corona.         No concomitant medications were reported.  The patient confirmed that all of the COVID-19 vaccine shots that he received was with Moderna and was also about to get his second booster dose as Moderna COVID-19 vaccine but he was advised by his doctor to wait 60 days after taking Paxlovid before getting the COVID-19 vaccine. Patient also stated that his immune system was weak and it would be easy for him to get COVID. His last COVID-19 vaccine shot was 8 and a half months ago.  Company comment- This spontaneous case concerns a male patient of unknown age with no reported medical history, who experienced unexpected, non-serious AESI Covid-19 (with positive Sars-CoV test), which occurred at an unknown time with regards to the mRNA-1273 vaccination. The patient was given paxlovid for 5 days. No further information was provided. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a male patient of unknown age with no reported medical history, who experienced unexpected, non-serious AESI Covid-19 (with positive Sars-CoV test), which occurred at an unknown time with regards to the mRNA-1273 vaccination. The patient was given paxlovid for 5 days. No further information was provided. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was initially refrigerated on 13-Jul-2022, its used by day was 11-Aug-2022 but was administered to patient on 12-Aug-2022 before 11 am.; No adverse event; Dose administered after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Vial was initially refrigerated on 13-Jul-2022, its used by day was 11-Aug-2022 but was administered to patient on 12-Aug-2022 before 11 am.) and NO ADVERSE EVENT (No adverse event) in an infant patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9237B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially refrigerated on 13-Jul-2022, its used by day was 11-Aug-2022 but was administered to patient on 12-Aug-2022 before 11 am.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Vial was initially refrigerated on 13-Jul-2022, its used by day was 11-Aug-2022 but was administered to patient on 12-Aug-2022 before 11 am.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vial was initially refrigerated on 13-Jul-2022, its used by day was 11-Aug-2022 but was administered to patient on 12-Aug-2022 before 11 am.).    Concomitant medications were not provided by the reporter. Vial was pulled from the ultra cold on 13-Jul-2022 (no time listed), its used by day was 11-Aug-2022. Based on the count, 13-Jul-2022 was counted as day 1. Vaccine was administered to patient on 12-Aug-2022 before 11 am. Number of doses/vials were 4 infants doses. Vial did not undergo any temperature excursions. The vial was initially stored in the refrigerator on 13-Jul-2022 Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-628905, US-MODERNATX, INC.-MOD-2022-628903, US-MODERNATX, INC.-MOD-2022-628906 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-628905:Infant patient 3 US-MODERNATX, INC.-MOD-2022-628903:Infant patient 2 US-MODERNATX, INC.-MOD-2022-628906:Infant patient 4
Sex: F
Vaccine: COVID19
Symptoms: Periarthritis
Clinical narrative: frozen shoulder; This spontaneous case was reported by a patient and describes the occurrence of PERIARTHRITIS (frozen shoulder) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIARTHRITIS (frozen shoulder). The patient was treated with CORTISONE for Frozen shoulder, at an unspecified dose and frequency. At the time of the report, PERIARTHRITIS (frozen shoulder) had resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant information were reported by the reporter.  It was reported after first dose patient had frozen shoulder and did not go until patient had a cortisone shot.  Company Comment: This is a spontaneous case concerning a female patient of unknown age, with no reported medical history, who experienced the unexpected non-serious AESI Periarthritis (frozen shoulder) which occurred unknown number of days after receiving the 1st dose of mRNA-1273 Vaccine. As reported, a weekend after her first dose, patient had a frozen shoulder that did not go away until she had a cortisone shot. There is no available information regarding diagnostic tests/procedures. The patient's gender remains a predisposition risk factor for the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-628875 (Linked Report).; Sender's Comments: This is a spontaneous case concerning a female patient of unknown age, with no reported medical history, who experienced the unexpected non-serious AESI Periarthritis (frozen shoulder) which occurred unknown number of days after receiving the 1st dose of mRNA-1273 Vaccine. As reported, a weekend after her first dose, patient had a frozen shoulder that did not go away until she had a cortisone shot. There is no available information regarding diagnostic tests/procedures. The patient's gender remains a predisposition risk factor for the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. US-MODERNATX, INC.-MOD-2022-628875:Reporter's case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: vaccine was pulled from the ultra cold on 13-July-2022, its used by day was 11-Aug-2022 and administered on 12-Aug-2022; No adverse event; Dose administered after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (vaccine was pulled from the ultra cold on 13-July-2022, its used by day was 11-Aug-2022 and administered on 12-Aug-2022) and NO ADVERSE EVENT (No adverse event) in an infant patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9237B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine was pulled from the ultra cold on 13-July-2022, its used by day was 11-Aug-2022 and administered on 12-Aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (vaccine was pulled from the ultra cold on 13-July-2022, its used by day was 11-Aug-2022 and administered on 12-Aug-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (vaccine was pulled from the ultra cold on 13-July-2022, its used by day was 11-Aug-2022 and administered on 12-Aug-2022).    No concomitant medication information provided. Number of doses/vials: 4 infants doses. Date the vial was initially stored in the refrigerator was 13-Jul-2022. Used by day was 11-Aug-2022. Based on the count, they counted 13-Jul-2022 as day 1. The vaccine was administered before 11 am. The vial did not undergo any temperature excursions. No treatment information provided. This case belongs to second infant out the 4 infants who received a expired vaccine.   This case was linked to US-MODERNATX, INC.-MOD-2022-628906, US-MODERNATX, INC.-MOD-2022-628905, US-MODERNATX, INC.-MOD-2022-628899 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-628906:Infant patient 4 US-MODERNATX, INC.-MOD-2022-628905:Infant patient 3 US-MODERNATX, INC.-MOD-2022-628899:Infant patient 1
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: pulled from the ultra cold on 13July2022; No adverse event; Dose administered after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (pulled from the ultra cold on 13July2022) and NO ADVERSE EVENT (No adverse event) in an infant patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9237B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (pulled from the ultra cold on 13July2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (pulled from the ultra cold on 13July2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (pulled from the ultra cold on 13July2022).    No concomitant drug was reported. It was reported that the vaccine was pulled from the ultra cold on 13July2022 but there was no time listed. Used by day was 11Aug2022. Based on the count, they counted July13th as day 1. Date of administration of vaccine was reported as 12Aug2022 before 11 AM. No temperature excursion was reported. No Treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-628899, US-MODERNATX, INC.-MOD-2022-628903, US-MODERNATX, INC.-MOD-2022-628906 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-628899:Infant patient 1 US-MODERNATX, INC.-MOD-2022-628903:Infant patient 2 US-MODERNATX, INC.-MOD-2022-628906:Infant patient 4
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was initially stored in the refrigerator on 13-Jul-2022, administered on 12-Aug-2022 and use by date was 11-Aug-2022; No adverse event; Dose administered after 30 day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30 day Use By Date), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 13-Jul-2022, administered on 12-Aug-2022 and use by date was 11-Aug-2022) and NO ADVERSE EVENT (No adverse event) in an infant patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9237B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30 day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 13-Jul-2022, administered on 12-Aug-2022 and use by date was 11-Aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30 day Use By Date), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 13-Jul-2022, administered on 12-Aug-2022 and use by date was 11-Aug-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30 day Use By Date) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 13-Jul-2022, administered on 12-Aug-2022 and use by date was 11-Aug-2022).    Vaccine was administered on 12-Aug-2022 before 11 AM. Concomitant medication list was not provided. It was reported that the vaccine was pulled from the ultra cold on 13J-uly-2022 but there was no time listed. Use by day was 11-Aug-2022. Based on the count, they counted 13-Jul-2022 as day 1. Number of doses per vials were 4 infants doses. The vial was initially stored in the refrigerator on 13-Jul-2022. The vial had not underwent any temperature excursions Treatment information was not provided. This case belongs to the fourth infant out the 4 infants who received a expired vaccine.   This case was linked to US-MODERNATX, INC.-MOD-2022-628905, US-MODERNATX, INC.-MOD-2022-628903, US-MODERNATX, INC.-MOD-2022-628899 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-628905:Infant patient 3 US-MODERNATX, INC.-MOD-2022-628903:Infant patient 2 US-MODERNATX, INC.-MOD-2022-628899:Infant patient 1
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Peripheral swelling, Ultrasound Doppler
Clinical narrative: swelling in her right leg of approximately 1 inch; This spontaneous case was reported by an other health care professional and describes the occurrence of PERIPHERAL SWELLING (swelling in her right leg of approximately 1 inch) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048C21A, 012M20A and 025J20A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy (sulfa allergy) and Fruit allergy (kiwi allergy). Concomitant products included METFORMIN for Diabetes.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced PERIPHERAL SWELLING (swelling in her right leg of approximately 1 inch). The patient was treated with FUROSEMIDE (LASIX [FUROSEMIDE]) at a dose of 3 days and IBUPROFEN at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (swelling in her right leg of approximately 1 inch) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: Everything seemed to be normal.. On an unknown date, Ultrasound Doppler: Everything seemed to be normal..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Two or three weeks after the 1st booster, the patient experienced swelling in right leg of approximately 1 inch, and it was a long term issue that was still ongoing. It did not affected the patient's mobility and there was not pain, it seemed a healthy leg except for swelling. The patient visited an orthopedist and another doctors, and informed had an MRI and a duplex study, and result showed everything to be normal. The physician could not determine a cause for this symptom, but thought it might be due to blood clots, an issue with the patient back or knee. Patient symptoms were ot worse, improve a little but not significantly, but it did not bother.  The patient had treatment with physical therapy and compression sucks for 6 months.  The patient never had tested or diagnosis with COVID. The patient not had medical condition as both acute and chronic illnesses at the time of vaccination. The patient did not had experienced a similar event in the past. The patient had not received other vaccines given within 1 month prior to Moderna COVID-19 vaccine.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Musculoskeletal discomfort, Pain in extremity
Clinical narrative: But now he has a problem with his right shoulder; First dose on 04 Nov 2021, second dose on 04 Mar 2022; Sore right arm; This spontaneous case was reported by a patient and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (But now he has a problem with his right shoulder), PAIN IN EXTREMITY (Sore right arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 04 Nov 2021, second dose on 04 Mar 2022) in a 49-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 030A21A and 048C21A) for COVID-19 vaccination.     No allergies to medications, food and other products was reported.  Patient was not diagnosed or tested positive for COVID-19.  No history relating to mentioned AE and both acute and chronic illnesses at the time of vaccination.  No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine.  Concomitant products included VITAMIN C [ASCORBIC ACID] and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.   On 04-Nov-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 04-Mar-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 04 Nov 2021, second dose on 04 Mar 2022). In 2022, the patient experienced PAIN IN EXTREMITY (Sore right arm). On an unknown date, the patient experienced MUSCULOSKELETAL DISCOMFORT (But now he has a problem with his right shoulder). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL DISCOMFORT (But now he has a problem with his right shoulder) had not resolved, PAIN IN EXTREMITY (Sore right arm) was resolving and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 04 Nov 2021, second dose on 04 Mar 2022) outcome was unknown.            Patient had taken booster dose of Moderna on 03 Feb 2022 (batch no. 007M20A). Booster dose administered before second dose.  Patient took Tylenol for the pain which improved symptoms a little bit.   This case was linked to MOD-2022-629044, MOD-2022-629049 (Patient Link).
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients were administered with Moderna COVID-19 Vaccine after 30-day use by date), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 08-Jul-2022 and administered vaccine on 11-Aug-2022) and NO ADVERSE EVENT (No adverse event) in a 3-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 vaccination. No Medical History information was reported. On 11-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 11-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients were administered with Moderna COVID-19 Vaccine after 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 08-Jul-2022 and administered vaccine on 11-Aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients were administered with Moderna COVID-19 Vaccine after 30-day use by date), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 08-Jul-2022 and administered vaccine on 11-Aug-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patients were administered with Moderna COVID-19 Vaccine after 30-day use by date) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 08-Jul-2022 and administered vaccine on 11-Aug-2022). No concomitant product use was reported. The number of doses/vials around 50 doses from 5 vials. On 08-Jul-2022 the vials were initially stored in the refrigerator. The vaccines were administered from the 07-Aug-2022 until the 11-Aug-2022. Vial did not undergone any temperature excursions. The healthcare professional was not aware of any symptoms for any patient after the vaccine was given. No treatment information was provided.
Age: 1.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was initally stored in refrigrator of 08-jul-2022 and was adminstered on 11-Aug-2022; No adverse event; Patient administered vaccine after 30-day use by date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after 30-day use by date), PRODUCT STORAGE ERROR (Vial was initally stored in refrigrator of 08-jul-2022 and was adminstered on 11-Aug-2022) and NO ADVERSE EVENT (No adverse event) in a 12-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 11-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initally stored in refrigrator of 08-jul-2022 and was adminstered on 11-Aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after 30-day use by date), PRODUCT STORAGE ERROR (Vial was initally stored in refrigrator of 08-jul-2022 and was adminstered on 11-Aug-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after 30-day use by date) and PRODUCT STORAGE ERROR (Vial was initally stored in refrigrator of 08-jul-2022 and was adminstered on 11-Aug-2022).    Concomitant product use was not provided by the reporter. The vial did not undergo temperature excursion. The healthcare professional was not aware of any symptoms for any patient after the vaccine was given. The vial was initially stored in the refrigerator on 08-Jul-2022 and the vaccine was administered from 07-Aug-2022 to 11-Aug-2022. Treatment information was not provided.