chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea haemorrhagic
Clinical narrative: bloody diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA HAEMORRHAGIC (bloody diarrhea) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058E21A, 7006320005 and 7006320001) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Sep-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Oct-2020, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Sep-2021, the patient experienced DIARRHOEA HAEMORRHAGIC (bloody diarrhea) (seriousness criterion medically significant). At the time of the report, DIARRHOEA HAEMORRHAGIC (bloody diarrhea) outcome was unknown.            No concomitant medication information was mentioned by reporter  No treatment medication information was mentioned by reporter.  Company comment: This case concerns a 30 year-old female with no medical history provided, who experienced the unexpected event of Diarrhoea Haemorrhagic. This event occurred one day after the third dose of Moderna COVID-19 Vaccine.The benefit-risk relationship of Moderna COVID-19 Vaccine  is not affected by this report.; Sender's Comments: This case concerns a 30 year-old female with no medical history provided, who experienced the unexpected event of Diarrhoea Haemorrhagic. This event occurred one day after the third dose of Moderna COVID-19 Vaccine.The benefit-risk relationship of Moderna COVID-19 Vaccine  is not affected by this report.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vaccines were applied to patients after being refrozen). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant products were reported. No treatment information was reported by the reporter.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: fever/high temperature; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever/high temperature) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, the patient experienced PYREXIA (fever/high temperature). At the time of the report, PYREXIA (fever/high temperature) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: high (High) Body temperature: High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment medications were not provided.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Influenza, Myalgia
Clinical narrative: mini-flu; body aches; headache; chills; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (mini-flu), MYALGIA (body aches), HEADACHE (headache) and CHILLS (chills) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA (mini-flu), MYALGIA (body aches), HEADACHE (headache) and CHILLS (chills). At the time of the report, INFLUENZA (mini-flu), MYALGIA (body aches), HEADACHE (headache) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment reported.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue, Tinnitus
Clinical narrative: His second dose of the vaccine was initially scheduled for yesterday, but he did not go to that appointment; tinnitus increased 10 fold/now it is ringing in my ear 24/7, 365.; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (tinnitus increased 10 fold/now it is ringing in my ear 24/7, 365.) and PRODUCT DOSE OMISSION ISSUE (His second dose of the vaccine was initially scheduled for yesterday, but he did not go to that appointment) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020P21A) for COVID-19 vaccination.     Concurrent medical conditions included Tinnitus.    On 22-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Aug-2021, the patient experienced TINNITUS (tinnitus increased 10 fold/now it is ringing in my ear 24/7, 365.). On 20-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT DOSE OMISSION ISSUE (His second dose of the vaccine was initially scheduled for yesterday, but he did not go to that appointment). The patient was treated with VALACYCLOVIR [VALACICLOVIR] in September 2021 for Tinnitus aggravated, at an unspecified dose and frequency. At the time of the report, TINNITUS (tinnitus increased 10 fold/now it is ringing in my ear 24/7, 365.) had not resolved and PRODUCT DOSE OMISSION ISSUE (His second dose of the vaccine was initially scheduled for yesterday, but he did not go to that appointment) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Myalgia, Nausea, Vaccination complication
Clinical narrative: "bad reaction"; full blown flu-like symptoms; nauseated; feels achy; headaches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION ("bad reaction"), INFLUENZA LIKE ILLNESS (full blown flu-like symptoms), NAUSEA (nauseated), MYALGIA (feels achy) and HEADACHE (headaches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058E21A and 053E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Sep-2021, the patient experienced VACCINATION COMPLICATION ("bad reaction"), INFLUENZA LIKE ILLNESS (full blown flu-like symptoms), NAUSEA (nauseated), MYALGIA (feels achy) and HEADACHE (headaches). At the time of the report, VACCINATION COMPLICATION ("bad reaction"), INFLUENZA LIKE ILLNESS (full blown flu-like symptoms), NAUSEA (nauseated), MYALGIA (feels achy) and HEADACHE (headaches) outcome was unknown.            Concomitant drug was not reported. Treatment medication was not reported.  It was reported that patient was not having sweats.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose was given at 3 weeks; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose was given at 3 weeks) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose was given at 3 weeks). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose was given at 3 weeks) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product reported by reporter. No treatment medication reported by reporter.   This case was linked to MOD-2021-326623 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Myalgia
Clinical narrative: Joint and muscle soreness; muscle soreness; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint and muscle soreness) and MYALGIA (muscle soreness) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Joint and muscle soreness) and MYALGIA (muscle soreness). At the time of the report, ARTHRALGIA (Joint and muscle soreness) and MYALGIA (muscle soreness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, Body temperature: 101.5 (High) temperature of 101.5 degrees..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided by the reporter Treatment information was not provided
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Pain assessment, Vaccination site pain
Clinical narrative: not constant but very consistent pain/area of the shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (not constant but very consistent pain/area of the shot) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049c21a and 041c21a) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes mellitus. Concomitant products included METFORMIN and ATORVASTATIN for an unknown indication.   On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (not constant but very consistent pain/area of the shot). At the time of the report, VACCINATION SITE PAIN (not constant but very consistent pain/area of the shot) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pain assessment (other-Unknown): (abnormal) pain a 9 in a scale of 1 to 10.         Patient used medication for diabetes  Treatment medication was not provided by the reporter  Patient had experienced very consistent pain a 9 in a scale of 1 to 10
Sex: F
Vaccine: COVID19
Symptoms: Hepatitis, Illness, Inappropriate schedule of product administration
Clinical narrative: Hepatitis; sick for a long time; Second dose administered 6 months later; This spontaneous case was reported by a pharmacist and describes the occurrence of HEPATITIS (Hepatitis) and ILLNESS (sick for a long time) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced HEPATITIS (Hepatitis) (seriousness criteria hospitalization and medically significant) and ILLNESS (sick for a long time) (seriousness criterion hospitalization). On 11-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered 6 months later). The patient was hospitalized on sometime in 2021 due to HEPATITIS and ILLNESS. At the time of the report, HEPATITIS (Hepatitis) and ILLNESS (sick for a long time) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered 6 months later) had resolved.        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.   No concomitant medications provided. No treatment medications provided. Could not get the second dose. She received the second dose on11AUG2021 and was told due to the time difference between the first dose and the second dose, it was too long, and she would need to get another dose of the vaccine.  This case concerns a 67-year-old, female patient with no previous relevant medical history, who experienced the unexpected events of hepatitis, and illness. The events occurred on unknown days after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Sender's Comments: This case concerns a 67-year-old, female patient with no previous relevant medical history, who experienced the unexpected events of hepatitis, and illness. The events occurred on unknown days after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Overdose, Product dose omission issue
Clinical narrative: flu-like symptoms; they injected two syringes; missed second dose; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), OVERDOSE (they injected two syringes) and PRODUCT DOSE OMISSION ISSUE (missed second dose) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced OVERDOSE (they injected two syringes). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms) and PRODUCT DOSE OMISSION ISSUE (missed second dose). On 23-Apr-2021, OVERDOSE (they injected two syringes) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms) and PRODUCT DOSE OMISSION ISSUE (missed second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment medications were not provided.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications are provided.  No treatment medications are provided.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications are provided.  No treatment medications are provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case reported by an other healthcare professional, describes the occurrence of administered expired product (expired Moderna vaccine given as a third dose) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 004C21A) for COVID-19 immunization. No medical history reported. On Sep 21, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Sep 21, 2021, patient administered expired product (expired Moderna vaccine given as a third dose). On Sep 21, 2021, administered expired product (expired Moderna vaccine given as a third dose) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. The expired Moderna vaccine administered as a third dose to the patient on Sep 21, 2021, at 2:40 pm. This case linked to MOD-2021-326571 (patient link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications are provided.  No treatment medications are provided.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Some doses that may have been administered past 30 days from being thawed; The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vaccines were applied to patients after being refrozen). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed). On 22-Apr-2021, EXPIRED PRODUCT ADMINISTERED (The vaccines were applied to patients after being refrozen) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant products were reported.  No treatment information was reported by the reporter.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). On 16-Apr-2021, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Medications were provided by the reporter  No Treatment Information were provided by the reporter
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Headache, Product dose omission issue, Rash
Clinical narrative: Allergic reaction 15 minutes after 1st dose; March or April 2021 she received her 1st dose of the Moderna /second dose not yet taken; Headache; Developed rash in front of chest/Developed rash in upper back/Rash in the front and back of her neck reoccurred/Rash in front of chest reoccurred/Rash in upper back reoccurred/Developed a rash in the front and back of her neck; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (Allergic reaction 15 minutes after 1st dose), PRODUCT DOSE OMISSION ISSUE (March or April 2021 she received her 1st dose of the Moderna /second dose not yet taken), HEADACHE (Headache) and RASH (Developed rash in front of chest/Developed rash in upper back/Rash in the front and back of her neck reoccurred/Rash in front of chest reoccurred/Rash in upper back reoccurred/Developed a rash in the front and back of her neck) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ALLERGY TO VACCINE (Allergic reaction 15 minutes after 1st dose), PRODUCT DOSE OMISSION ISSUE (March or April 2021 she received her 1st dose of the Moderna /second dose not yet taken), HEADACHE (Headache) and RASH (Developed rash in front of chest/Developed rash in upper back/Rash in the front and back of her neck reoccurred/Rash in front of chest reoccurred/Rash in upper back reoccurred/Developed a rash in the front and back of her neck). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of UNK dosage form. At the time of the report, ALLERGY TO VACCINE (Allergic reaction 15 minutes after 1st dose), HEADACHE (Headache) and RASH (Developed rash in front of chest/Developed rash in upper back/Rash in the front and back of her neck reoccurred/Rash in front of chest reoccurred/Rash in upper back reoccurred/Developed a rash in the front and back of her neck) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (March or April 2021 she received her 1st dose of the Moderna /second dose not yet taken) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have administered past 30 days from being thawed / The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and POOR QUALITY PRODUCT ADMINISTERED (Some doses that may have administered past 30 days from being thawed / The vaccines were applied to patients after being refrozen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and POOR QUALITY PRODUCT ADMINISTERED (Some doses that may have administered past 30 days from being thawed / The vaccines were applied to patients after being refrozen). At the time of the report, PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and POOR QUALITY PRODUCT ADMINISTERED (Some doses that may have administered past 30 days from being thawed / The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter No treatment information was provided by the reporter
Sex: F
Vaccine: COVID19
Symptoms: Platelet count decreased
Clinical narrative: she got tested and the platelets were low after her first dose of the Moderna Covid19 Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PLATELET COUNT DECREASED (she got tested and the platelets were low after her first dose of the Moderna Covid19 Vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PLATELET COUNT DECREASED (she got tested and the platelets were low after her first dose of the Moderna Covid19 Vaccine). At the time of the report, PLATELET COUNT DECREASED (she got tested and the platelets were low after her first dose of the Moderna Covid19 Vaccine) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       No concomitant medication information was provided. The patient got a waiver pass or whatever from the doctor, that said that she didn't have to get the second one. No treatment medication information was provided. Caller mentioned that she is not the only one who got this, and when clarified if she knew someone who experienced this, she stated that her sister is a nurse, and she got tested and the platelets were low after her first dose of the Moderna Covid19 Vaccine.; Sender's Comments: This case concerns an unknown age, female patient with no relevant medical history, who experienced the unexpected event of platelet count decreased. The event occurred after the first dose of Spikevax (mRNA 1273 vaccine). The rechallenge was not applicable since only information about one dose was disclosed. The causality was not reported by the reporter. The benefit-risk relationship of Spikevax vaccine is not affected by this report.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). On 22-Apr-2021, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous case reported by an other healthcare professional, describes the occurrence of administered expired product (some doses may have been administered past 30 days from being thawed/the vaccine given to patients after being refrozen) and product storage error (some doses may have been administered past 30 days from being thawed/the vaccine given to patients after being refrozen) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 026A21A) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19  vaccine), unknown route; 1 dosage form. On an unknown date, patient administered expired product (some doses may have been administered past 30 days from being thawed/the vaccine given to patients after being refrozen) and product storage error (some doses may have been administered past 30 days from being thawed/the vaccine given to patients after being refrozen). At the time of the report, administered expired product (some doses may have been administered past 30 days from being thawed/the vaccine given to patients after being refrozen) and product storage error (some doses may have been administered past 30 days from being thawed/the vaccine given to patients after being refrozen) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vaccines were applied to patients after being refrozen) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vaccines were applied to patients after being refrozen). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vaccines were applied to patients after being refrozen) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided