chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, Pain in extremity
Clinical narrative: Cramping has moved to his lower leg; Leg pain moved to lower leg; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Cramping has moved to his lower leg) and PAIN IN EXTREMITY (Leg pain moved to lower leg) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (Cramping has moved to his lower leg) and PAIN IN EXTREMITY (Leg pain moved to lower leg). At the time of the report, MUSCLE SPASMS (Cramping has moved to his lower leg) and PAIN IN EXTREMITY (Leg pain moved to lower leg) outcome was unknown.            Concomitant information was not provided.   The reporter did not know when patient received his first shots. She thought it he received both in February.  Treatment information was not provided.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Blood immunoglobulin G, COVID-19, SARS-CoV-2 antibody test positive
Clinical narrative: breakthrough COVID-19; This literature-study case was reported in a literature article and describes the occurrence of COVID-19 (breakthrough COVID-19) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE: (PRIVACY)    The patient's past medical history included Stem cell transplant (Auto HSCT (allogeneic hematopoietic stem cell transplant recipient) was treatment given.). Concurrent medical conditions included Multiple myeloma.    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 COVID-19 (breakthrough COVID-19) (seriousness criterion hospitalization). At the time of the report, COVID-19 (breakthrough COVID-19) outcome was unknown. Possible    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood immunoglobulin G: 0.075 0.075 Post-vaccination and 3096.9 3096.9 Post-vaccination. On an unknown date, SARS-CoV-2 antibody test positive: positive (Positive) SARS CoV 2 RNA, RT PCR.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered COVID-19 (breakthrough COVID-19) to have an unknown relationship.    Concomitant product and treatment medication use was not provided by the reporter.  This literature report case concerns a 75 year-old male with a history of multiple myeloma and  Auto HSCT (allogeneic hematopoietic stem cell transplant); who experienced the  unexpected serious (as per hospitalization) AESI event of COVID-19.  The event started 194 days after the second dose of an unknown product administration schedule of mRNA-1273 vaccine. The outcome of the event is unknown. The rechallenge is not applicable. The medical history of Multiple myeloma and transplantation are relevant predisposing factors for the event COVID-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report; Sender's Comments: This literature report case concerns a 75 year-old male with a history of multiple myeloma and  Auto HSCT (allogeneic hematopoietic stem cell transplant); who experienced the  unexpected serious (as per hospitalization) AESI event of COVID-19.  The event started 194 days after the second dose of an unknown product administration schedule of mRNA-1273 vaccine. The outcome of the event is unknown. The rechallenge is not applicable. The medical history of Multiple myeloma and transplantation are relevant predisposing factors for the event COVID-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Little bit more of pain than what I had for the other two; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Little bit more of pain than what I had for the other two) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 029L20A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included VITAMIN D NOS and LORATADINE (CLARITINE) for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-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 PAIN (Little bit more of pain than what I had for the other two). The patient was treated with ETHANOL, THYMOL (LISTERINE ANTISEPTIC MOUTHWASH) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, PAIN (Little bit more of pain than what I had for the other two) outcome was unknown.            Reporter stated that the patient taken blood pressure medicine.   This case was linked to MOD-2021-387300, MOD-2021-387845 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Non-Significant Follow up, Reporter contact information updated
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and EXPIRED PRODUCT ADMINISTERED (Expired product administered) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired product administered). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue). On 08-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired product administered) had resolved. At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) had resolved. Not Provided      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.  There was an excursion from their freezer on 01 Oct 2021.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: follow-up received on 15-NOV-2021 includes  patient details was updated
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: There was an excursion from the freezer; administered to 118 patients; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) and EXPIRED PRODUCT ADMINISTERED (administered to 118 patients) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) and EXPIRED PRODUCT ADMINISTERED (administered to 118 patients). On 01-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) and EXPIRED PRODUCT ADMINISTERED (administered to 118 patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   No treatment information was provided.   This case was linked to MOD-2021-383410 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Added patient information (patient initials, age, gender), vaccine information (dose number, date of vaccination)
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: Product temperature excursion issue; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue). On 01-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   This case was linked to MOD-2021-387782 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Added patient details(initials,age,gender) and vaccine information (dose number, date of vaccination)
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Booster dose administered to child; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Booster dose administered to child) in a 5-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 15-Nov-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Booster dose administered to child). On 15-Nov-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Booster dose administered to child) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication taken. No treatment medication received.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue). On 01-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) 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.   Most recent FOLLOW-UP information incorporated above includes: On 15-Oct-2021: Follow-up received on 15 Oct 2021 contain patient identifier details.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: Expired vaccine used; Product temperature excursion issue; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue). On 01-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 01-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) had resolved. On 01-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) 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.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Follow-up received which included patient details (initials, age, gender) and vaccine information ( date of vaccination, dose number).
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: there was an excursion from their freezer on 01 oct 2021; expired product administered; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (there was an excursion from their freezer on 01 oct 2021) and EXPIRED PRODUCT ADMINISTERED (expired product administered) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (there was an excursion from their freezer on 01 oct 2021) and EXPIRED PRODUCT ADMINISTERED (expired product administered). On 12-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (there was an excursion from their freezer on 01 oct 2021) and EXPIRED PRODUCT ADMINISTERED (expired product administered) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not reported. Treatment medications was not reported.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: Product temperature excursion issue; expired product administered; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and EXPIRED PRODUCT ADMINISTERED (expired product administered) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and EXPIRED PRODUCT ADMINISTERED (expired product administered). On 12-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and EXPIRED PRODUCT ADMINISTERED (expired product administered) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not reported. Treatment medications was not reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case reported by a nurse, describes the occurrence of product temperature excursion issue (there was an excursion from the freezer) and administered expired product (administered to 118 patients) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 939901) for COVID-19  immunization. No medical history reported. On Nov 1, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Nov 1, 2021, patient experienced product temperature excursion issue (there was an excursion from the freezer) and administered expired product (administered to 118 patients). At the time of the report, product temperature excursion issue (there was an excursion from the freezer) and administered expired product (administered to 118 patients) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: Administerd to 118 patients; There was an excursion from the freezer; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administerd to 118 patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administerd to 118 patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administerd to 118 patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) 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.   This case was linked to MOD-2021-383410 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: patient demographics were updated.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: There was excursion from the freezer; administered to 118 patients; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (There was excursion from the freezer ) and EXPIRED PRODUCT ADMINISTERED (administered to 118 patients) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced PRODUCT STORAGE ERROR (There was excursion from the freezer ) and EXPIRED PRODUCT ADMINISTERED (administered to 118 patients). On 01-Nov-2021, PRODUCT STORAGE ERROR (There was excursion from the freezer ) and EXPIRED PRODUCT ADMINISTERED (administered to 118 patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   No treatment information provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) and EXPIRED PRODUCT ADMINISTERED (There was an excursion from their freezer/they were administered to 118 patients.) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer). On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (There was an excursion from their freezer/they were administered to 118 patients.). On 01-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) had resolved. On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (There was an excursion from their freezer/they were administered to 118 patients.) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided  On 01-Oct-2021, There was temperature excursion from  freezer.   It was stated 10 Number of vials/doses were impacted. Storage condition at the time of the excursion was frozen and Minimum temperatures reached 4.2 degrees F and maximum was 5.7 degreed F and Excursion duration was 6 minutes.  No treatment medications were provided.    Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Follow-up received which included  patient details (initials, age, gender) and vaccine information ( date of vaccination, dose number).
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: There was an excursion from the freezer; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer). On 08-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment medications were not provided.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: feeling tired for a day after her first dose; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (feeling tired for a day after her first dose) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma (had lung issues). Concomitant products included GUAIFENESIN for an unknown indication.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced FATIGUE (feeling tired for a day after her first dose). On 20-Jan-2021, FATIGUE (feeling tired for a day after her first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications also included Asthma medications for lungs. Treatment information was not provided.   This case was linked to MOD-2021-387215 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Off label use
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (Received 3rd dose instead of booster) and OFF LABEL USE (received a 3rd dose of 0.5 mL, and the patient is not immunocompromised) in a female patient of an unknown age 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (Received 3rd dose instead of booster) and OFF LABEL USE (received a 3rd dose of 0.5 mL, and the patient is not immunocompromised). At the time of the report, ACCIDENTAL OVERDOSE (Received 3rd dose instead of booster) and OFF LABEL USE (received a 3rd dose of 0.5 mL, and the patient is not immunocompromised) 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: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: The following day I had a low grade fever including chills; I had a low grade fever; Fatigue; 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 CHILLS (The following day I had a low grade fever including chills), PYREXIA (I had a low grade fever) and FATIGUE (Fatigue) 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 30-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Oct-2021, the patient experienced CHILLS (The following day I had a low grade fever including chills), PYREXIA (I had a low grade fever) and FATIGUE (Fatigue). On 01-Nov-2021, CHILLS (The following day I had a low grade fever including chills), PYREXIA (I had a low grade fever) and FATIGUE (Fatigue) had resolved.            No concomitant medications reported by reporter No treatment medications provided by the reporter.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: there was an excrusion from freezer; Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (there was an excrusion from freezer) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (there was an excrusion from freezer) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 01-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (there was an excrusion from freezer) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      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 was reported. There was an excursion from their freezer on 01-Oct-2021. They used the excursion tool but there is no option for the excursion they experienced. The tool only gives options for excursions above one hour and not less than, so she does not knowhow to do the analysis. She states that her team already knows the recommended temperatures and wants to know if the vials were still okay to be used because they were administered to 118 patients.   This case was linked to MOD-2021-383410 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Added patient details(initials,age,gender) and vaccine information (dose number, date of vaccination)
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: There was an excrusion from freezer on 1 Oct 2021; Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excrusion from freezer on 1 Oct 2021) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excrusion from freezer on 1 Oct 2021) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 25-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excrusion from freezer on 1 Oct 2021) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment medication was provided.   This case was linked to MOD-2021-387514 (Patient Link).
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Terribly tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Terribly tired) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 03M20A and 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Drug allergy (tetracycline), Drug allergy (sulfa), Thyroiditis and Hashimoto's thyroiditis (Thyroid-hashmitos). Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), METOPROLOL, LEVOTHYROXINE SODIUM (LEVOTHYROXIN), VITAMIN D NOS, ASCORBIC ACID (VITAMIN C ASC ACID), CALCIUM and MAGNESIUM for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced FATIGUE (Terribly tired). At the time of the report, FATIGUE (Terribly tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not reported.  Treatment medications was not reported.   This case was linked to MOD-2021-358968 (Patient Link).
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration
Clinical narrative: Positive coronavirus test; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive coronavirus test) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced COVID-19 (Positive coronavirus test). On 13-Jan-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, COVID-19 (Positive coronavirus test) outcome was unknown.            No concomitant medication was reported by reporter. No treatment medication was reported by reporter.; Sender's Comments: This is a case of Inappropriate schedule of product administration for this 33-year-old male patient with no relevant medical history reported, who experienced non serious, unexpected, AESI event of COVID-19. The event occurred on an unknown date after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Headache, Influenza like illness, Malaise, Rhinorrhoea, Vaccination complication
Clinical narrative: Reaction/catch something; Feeling like the flu; Feeling lousy; runny nose; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Reaction/catch something), INFLUENZA LIKE ILLNESS (Feeling like the flu), MALAISE (Feeling lousy), RHINORRHOEA (runny nose) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. and INFLUENZA VACCINE (FLU) (unknown route) at an unspecified dose. On an unknown date, the patient experienced VACCINATION COMPLICATION (Reaction/catch something), INFLUENZA LIKE ILLNESS (Feeling like the flu), MALAISE (Feeling lousy), RHINORRHOEA (runny nose) and HEADACHE (Headache). At the time of the report, VACCINATION COMPLICATION (Reaction/catch something), INFLUENZA LIKE ILLNESS (Feeling like the flu), MALAISE (Feeling lousy), RHINORRHOEA (runny nose) and HEADACHE (Headache) outcome was unknown.            Patient received 2 doses of the vaccine and the booster dose, patient had a reaction when she received the flu shot at the same time.  Patient had an emergency and she was taken by an ambulance.  No Treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-Nov-2021: follow up received has no new information(NNI).; Sender's Comments: This is a case of a female patient with unknown age , who experienced Non-serious , unexpected events of Vaccination complication , Inlfuenza like illness , malaise, rhinorrhea and expected event of headache after vaccination with unknown dose number  of mRNA-1273 vaccine ( Moderna Covid 19 vaccine ) . It was reported that these events occurred after vaccination together with vaccination with  Influenza vaccine ( C0-suspect ) .  The patient was taken to the hospital via ambulance because  of the said events however outcome was not reported. The dates of the vaccination were not reported and based on the report it is not clear on what particular dose number  of the mRNA -1273 vaccine  ( Moderna Covid 19 Vaccine ) the patient developed the said events.   It was only reported that the patient had 3 doses of the mRNA -1273 vaccine . The re-challenge for this case is not applicable since the outcome of the events is unknown and no additional doses will be administered. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine is not affected by this report.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: There was an excursion from their freezer; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from their freezer) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from their freezer). On 01-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from their freezer) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was provided. No treatment medication details was provided. There was excursion from freezer on 01 oct 2021 , gave Excursion above 1 hour.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, SARS-CoV-2 test
Clinical narrative: flu like symtoms after booster shot, although it lasted for about 18 fours; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symtoms after booster shot, although it lasted for about 18 fours) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included TRIAMTERENE and ESTRADIOL for an unknown indication.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symtoms after booster shot, although it lasted for about 18 fours). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symtoms after booster shot, although it lasted for about 18 fours) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Dec-2020, SARS-CoV-2 test: positive (Positive) Positive.         No treatment medication reported.   This case was linked to MOD-2021-336321 (Patient Link).
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vial had been punctured for greater than 12 hours when the doses were administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vial had been punctured for greater than 12 hours when the doses were administered) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 077C21B) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vial had been punctured for greater than 12 hours when the doses were administered). On 04-Nov-2021, EXPIRED PRODUCT ADMINISTERED (vial had been punctured for greater than 12 hours when the doses were administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2021-385958, MOD-2021-388696 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Nov-2021: Follow-up received contains updated Reporter information, Patient details, Dose details and Event information.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects) in a male patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effects). At the time of the report, VACCINATION COMPLICATION (Side effects) outcome was unknown.            No concomitant medications were provided.  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Nov-2021: Follow up received contains no new information.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered post the expiration date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered post the expiration date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) 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 (administered post the expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered post the expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided.  It was reported that some patient received Moderna vaccine on 10-NOV-2021, 11-NOV-2021 and 12-NOV-2021.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Follow up received vaccine expiry date was added.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Patient wanted to report his reaction after Moderna vaccine/reaction following vaccination; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Patient wanted to report his reaction after Moderna vaccine/reaction following vaccination) in a male patient of an unknown age 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 VACCINATION COMPLICATION (Patient wanted to report his reaction after Moderna vaccine/reaction following vaccination). At the time of the report, VACCINATION COMPLICATION (Patient wanted to report his reaction after Moderna vaccine/reaction following vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment details were reported.  Company Comment: This case concerns a male subject of unknown age, with unknown medical history, who experienced the non-serious  unexpected event of Vaccination complication. The event occurred unknown number of days after a dose of mRNA 1273 VACCINE, dose number unknown. At the time of the report, outcome of the event was Unknown. Rechallenge is not applicable as no information regarding the dose number was given. The benefit-risk relationship of mRNA 1273 VACCINE is not affected by this report.; Sender's Comments: This case concerns a male subject of unknown age, with unknown medical history, who experienced the non-serious  unexpected event of Vaccination complication. The event occurred unknown number of days after a dose of mRNA 1273 VACCINE, dose number unknown. At the time of the report, outcome of the event was Unknown. Rechallenge is not applicable as no information regarding the dose number was given. The benefit-risk relationship of mRNA 1273 VACCINE is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Product colour issue, Product physical issue, Product storage error
Clinical narrative: Broken/Cracked Vials; Slushy/Delayed Thawing Product; discoloration; unusual appearance i.e. cloudy/Shattered vial that wouldn't thaw and cloudy vials.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT PHYSICAL ISSUE (Broken/Cracked Vials), PRODUCT STORAGE ERROR (Slushy/Delayed Thawing Product) and PRODUCT COLOUR ISSUE (discoloration; unusual appearance i.e. cloudy/Shattered vial that wouldn't thaw and cloudy vials.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) 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 11-Nov-2021, the patient experienced PRODUCT PHYSICAL ISSUE (Broken/Cracked Vials), PRODUCT STORAGE ERROR (Slushy/Delayed Thawing Product) and PRODUCT COLOUR ISSUE (discoloration; unusual appearance i.e. cloudy/Shattered vial that wouldn't thaw and cloudy vials.). On 11-Nov-2021, PRODUCT PHYSICAL ISSUE (Broken/Cracked Vials), PRODUCT STORAGE ERROR (Slushy/Delayed Thawing Product) and PRODUCT COLOUR ISSUE (discoloration; unusual appearance i.e. cloudy/Shattered vial that wouldn't thaw and cloudy vials.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication was reported.  The package was received on 08Nov2021, approximately.  After 5 hours in the fridge, the contents of the vial were rock solid. Also, the rest of the vials looked extremely cloudy.  No vaccines were administered from these vials.  This case concerns a Product quality issue, Product storage error, and Product color issue in mRNA-1273  vaccine with batch/lot no. 067F21A, administered to a patient of an unknown age and gender with no relevant medical history, who had no reported adverse event. The incident  occurred on the day the patient received the dose of mRNA-1273 Vaccine. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This case concerns a Product quality issue, Product storage error, and Product color issue in mRNA-1273  vaccine with batch/lot no. 067F21A, administered to a patient of an unknown age and gender with no relevant medical history, who had no reported adverse event. The incident  occurred on the day the patient received the dose of mRNA-1273 Vaccine. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired vials were used (Second Dose); Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vials were used (Second Dose)) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vials were used (Second Dose)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired vials were used (Second Dose)) 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.