chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error, Product temperature excursion issue
Clinical narrative: They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; Frozen vials, removed and transported at refrigerated temp, re-frozen at time of arrival; They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at time of arrival) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939906) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at time of arrival). At the time of the report, PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at time of arrival) outcome was unknown. Not Provided      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 medication were provided.  No treatment medication were provided.
Sex: F
Vaccine: COVID19
Symptoms: Leukaemia
Clinical narrative: recently diagnosed Leukemia; This spontaneous case was reported by a consumer and describes the occurrence of LEUKAEMIA (recently diagnosed Leukemia) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced LEUKAEMIA (recently diagnosed Leukemia) (seriousness criterion medically significant). At the time of the report, LEUKAEMIA (recently diagnosed Leukemia) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant medication and treatment details were not provided.  Company comment: This case concerns a female patient (age not provided) with no relevant medical history, who experienced the unexpected serious event of Leukemia. The event occurred at an unspecified interval after an unknown dose of mRNA-1273 (Moderna covid-19). Limited information provided preludes a complete medical and causal assessment of this case. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.; Sender's Comments: This case concerns a female patient (age not provided) with no relevant medical history, who experienced the unexpected serious event of Leukemia. The event occurred at an unspecified interval after an unknown dose of mRNA-1273 (Moderna covid-19). Limited information provided preludes a complete medical and causal assessment of this case. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: The immunocompromised patient received the booster dose which was half dose; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (The immunocompromised patient received the booster dose which was half dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised (Patient had since started long term steroid use.).   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. On an unknown date, the patient experienced UNDERDOSE (The immunocompromised patient received the booster dose which was half dose). At the time of the report, UNDERDOSE (The immunocompromised patient received the booster dose which was half dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The patient mentioned to pharmacist that since started long term steroid use, patient became  immunocompromised. Few months since the booster dose, but pharmacist wondered if the patient qualified for any additional doses and whether it would be a half or full dose. No treatment information was provided.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information were provided. Date the vial was initially stored in the refrigerator was 04Nov2021. Dates of administration of vaccine was 05Nov2021 and 12Nov2021. The vial didn't undergo any temperature excursions.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient was administered from an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient was administered from an expired vaccine) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.   In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient was administered from an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient was administered from an expired vaccine) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient administered expired vaccine which was initially stored on 04-Nov-2021 patients were administered with dose in which some vaccinated on 05-Nov-2021 and 12-Nov-2021. The vial did not undergo any temperature excursions.HCP stated, no adverse event occurred as result of this misadministration, patients were monitored.  No Treatment medications were reported.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 34 patients were administered from an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (34 patients were administered from an expired vaccine) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (34 patients were administered from an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (34 patients were administered from an expired vaccine) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information were provided. Date the vial was initially stored in the refrigerator was 4Nov2021. Dates of administration of vaccine was 05Nov2021 and 12Nov2021. The vial didn't undergo any temperature excursions.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient was administered from an expired vaccine /misadministration; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient was administered from an expired vaccine /misadministration) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.   In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient was administered from an expired vaccine /misadministration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient was administered from an expired vaccine /misadministration) outcome was unknown. Not Provided    For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details were reported. The vial was initially stored in the refrigerator on 04-Nov-2021.Dates of administration of vaccine Some were on 05-Nov-2021 and the other doses on 12-Nov-2021.The vial did not undergo any temperature excursions. HCP stated, no adverse event occurred as result of this misadministration, patients were monitored. No treatment information details were reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information were provided. Date the vial was initially stored in the refrigerator was 04Nov2021. Dates of administration of vaccine were 05Nov2021 and 12Nov2021. The vial didn't undergo any temperature excursions.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient was administered from an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient was administered from an expired vaccine) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient was administered from an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient was administered from an expired vaccine) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details were reported. The vial was initially stored in the refrigerator on 04-Nov-2021.Dates of administration of vaccine Some were on 05-Nov-2021 and the other doses on 12-Nov-2021.The vial did not undergo any temperature excursions. HCP stated, no adverse event occurred as result of this misadministration, patients were monitored. No treatment information details were reported..
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: They administered patients and staff from an expired vaccine/Dose administered after 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They administered patients and staff from an expired vaccine/Dose administered after 30-day Use By Date or after manufacturer date of expiry) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (They administered patients and staff from an expired vaccine/Dose administered after 30-day Use By Date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They administered patients and staff from an expired vaccine/Dose administered after 30-day Use By Date or after manufacturer date of expiry) outcome was unknown. 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 details were reported.  The vial was initially stored in the refrigerator on 04-Nov-2021 and the booster dose of the vaccine was administered to the patient on either 05-Nov-2021 or on 12-Nov-2021. The vial had not undergone any temperature excursions.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered after 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Patient received the booster dose. It was reported that two vials were administered from same lot number. 1st vial was administered on 05-Nov-2021 and 2nd vial was administered on 12-Nov-2021. On 04-Nov-2021, the vials was initially stored in the refrigerator. The vial did not undergo any temperature excursions. There was no adverse event as a result of this misadministration, patients were monitored.  No treatment information was provided.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: patient received dose of Moderna vaccine beyond 30-day use by date; Vaccine placed in refrigerator on 05-Jan-2022 and administered more than 30 days after moving to refrigerator; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received dose of Moderna vaccine beyond 30-day use by date) and PRODUCT STORAGE ERROR (Vaccine placed in refrigerator on 05-Jan-2022 and administered more than 30 days after moving to refrigerator) in an 88-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 003J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received dose of Moderna vaccine beyond 30-day use by date). In February 2022, the patient experienced PRODUCT STORAGE ERROR (Vaccine placed in refrigerator on 05-Jan-2022 and administered more than 30 days after moving to refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received dose of Moderna vaccine beyond 30-day use by date) and PRODUCT STORAGE ERROR (Vaccine placed in refrigerator on 05-Jan-2022 and administered more than 30 days after moving to refrigerator) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-Mar-2022: Follow up contains no new information.
Age: 32.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: patient received expired Moderna Covid-19 vaccine; The vial had been left out at room air from the day before.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received expired Moderna Covid-19 vaccine) and PRODUCT STORAGE ERROR (The vial had been left out at room air from the day before.) in a 32-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2022 at 10:50 AM, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 03-Mar-2022, the patient experienced PRODUCT STORAGE ERROR (The vial had been left out at room air from the day before.). On 04-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received expired Moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received expired Moderna Covid-19 vaccine) and PRODUCT STORAGE ERROR (The vial had been left out at room air from the day before.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  It was reported as following, Date the vial was initially stored in the refrigerator was 01-Mar-2022.  Date(s) and time(S) vial was first punctured was at 6pm on 03-Mar-2022. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F):16 hrs 35 min.   This case was linked to MOD-2022-503171 (Patient Link).
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Allergy test, Eczema, Rash
Clinical narrative: Patient has never had eczema in his life before; Patient developed a general rash complete body rash after the vaccine/He had a complete body rash all over except for his face/He was breaking out in patches; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Patient developed a general rash complete body rash after the vaccine/He had a complete body rash all over except for his face/He was breaking out in patches) and ECZEMA (Patient has never had eczema in his life before) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 011LZ014) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergic to Levaquin).   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2021, the patient experienced RASH (Patient developed a general rash complete body rash after the vaccine/He had a complete body rash all over except for his face/He was breaking out in patches). On an unknown date, the patient experienced ECZEMA (Patient has never had eczema in his life before). The patient was treated with PREDNISONE in August 2021 at an unspecified dose and frequency. At the time of the report, RASH (Patient developed a general rash complete body rash after the vaccine/He had a complete body rash all over except for his face/He was breaking out in patches) and ECZEMA (Patient has never had eczema in his life before) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Allergy test: nothing showed up (normal) nothing showed up.         No concomitant medications reported.  It mentioned that the patient took medical care PCP, visited 3 dermatologists and allergist.  On an unknown date in Jul-2021, the patient was breaking out in patches and by the end of Aug the patient had a complete body rash all over expect for face. Patient visited the doctor in late august got prescribed with prednisone and unspecified antibiotics and the rash was completely gone, but when stopped the treatment the rash came back worse than before so again prescribed with prednisone and same thing happened when treatment stopped the rash came back, patient had an allergy test and nothing showed up, patient was prescribed a sera topical for 2 weeks on back and looks great.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Electrocardiogram, Mobility decreased, Palpitations, Tendonitis
Clinical narrative: couldn't lift up her hand; Tendonitis; palpitations; shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of TENDONITIS (Tendonitis), PALPITATIONS (palpitations), DYSPNOEA (shortness of breath) and MOBILITY DECREASED (couldn't lift up her hand) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 011LZ014) for COVID-19 vaccination.     The patient's past medical history included Viral cardiomyopathy (Started year before the COVID pandemic and with exercise had palpitations when she is tired). Concurrent medical conditions included Drug allergy, Shellfish allergy and Iodine allergy.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced MOBILITY DECREASED (couldn't lift up her hand). In 2021, the patient experienced TENDONITIS (Tendonitis), PALPITATIONS (palpitations) and DYSPNOEA (shortness of breath). At the time of the report, TENDONITIS (Tendonitis), PALPITATIONS (palpitations), DYSPNOEA (shortness of breath) and MOBILITY DECREASED (couldn't lift up her hand) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: multiple contractions (normal) Normal sinus with multiple contractions..         Concomitant medication was not reported.  1st dose: 15Jan2021, Lot number; 011LZ014 (unsure if its an H or an A). About 3 weeks after the 2nd shot patient couldn't lift up the hand. Treatment medication was not reported.   This case was linked to MOD-2022-503135, MOD-2022-502854 (Patient Link).
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Date the vial was initially stored in the refrigerator on25 Jan 2022/ Date of administration of vaccine 03 Mar 2022; Four patients received an expired 30-day use by date booster dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Four patients received an expired 30-day use by date booster dose) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on25 Jan 2022/ Date of administration of vaccine 03 Mar 2022) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022J21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Four patients received an expired 30-day use by date booster dose). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on25 Jan 2022/ Date of administration of vaccine 03 Mar 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Four patients received an expired 30-day use by date booster dose) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on25 Jan 2022/ Date of administration of vaccine 03 Mar 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were provided.  The vial was initially stored in the refrigerator on  25 Jan 2022. The vial did not undergo any temperature excursion. It was reported that the patients were not experiencing any symptoms after receiving the vaccine.   No treatment information was provided.   This case was linked to MOD-2022-503153, MOD-2022-503157, MOD-2022-503162 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Dyspnoea, Electrocardiogram, Palpitations
Clinical narrative: After each shot she started having palpitations; shortness of breath; she had an EKG but it showed normal sinus with multiple contractions.; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (After each shot she started having palpitations), DYSPNOEA (shortness of breath) and CARDIAC DISORDER (she had an EKG but it showed normal sinus with multiple contractions.) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 079F21A, 004M20A and 011LZ014) for COVID-19 vaccination.     The patient's past medical history included Cardiomyopathy (Year before the COVID pandemic, with exercise she had palpitations when she was tired.). Concurrent medical conditions included Drug allergy, Allergy to animal and Allergy to chemicals.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced PALPITATIONS (After each shot she started having palpitations), DYSPNOEA (shortness of breath) and CARDIAC DISORDER (she had an EKG but it showed normal sinus with multiple contractions.). At the time of the report, PALPITATIONS (After each shot she started having palpitations), DYSPNOEA (shortness of breath) and CARDIAC DISORDER (she had an EKG but it showed normal sinus with multiple contractions.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: showed multiple contractions It showed normal sinus with multiple contractions..         No Concomitant medication reported   Patient was unsure if First dose was an H or an A Patient was asking if her husband should receive the booster shot. Patient mentioned that she was not sure if she and her husband experienced side effects from the vaccine. Patient was calling to know if there were any reports about developing a body rash kind of systemic autoimmune rash that doesn't go away.  No Treatment medication reported   This case was linked to MOD-2022-503124 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives; This spontaneous case was reported by a physician and describes the occurrence of URTICARIA (hives) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced URTICARIA (hives). At the time of the report, URTICARIA (hives) had not resolved.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  Concomitant medication of the patient was not reported.  The event was ongoing since November for 4 months.  No treatment information was provided by the reporter.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Four patients received an expired 30-day use by date booster dose) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022J21A, 009C21A and 009C21A) for COVID-19 vaccination. No Medical History information was reported. On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2022, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Four patients received an expired 30-day use by date booster dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Four patients received an expired 30-day use by date booster dose) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was reported by the reporter. No treatment medication was reported by the reporter. This case was linked to MOD-2022-503162, MOD-2022-503133, MOD-2022-503157 (Patient Link).
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Four patients received an expired 30-day use by date booster dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Four patients received an expired 30-day use by date booster dose) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022J21A, 009C21A and 009C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Four patients received an expired 30-day use by date booster dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Four patients received an expired 30-day use by date booster dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication reported. Patients were not experiencing any symptoms after receiving the vaccine. HCP wanted data on efficacy of vaccines administered after 30-day use by date. It had been reported that no allergies. No Treatment medication reported.   This case was linked to MOD-2022-503162 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Four patients received an expired 30-day use by date booster dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Four patients received an expired 30-day use by date booster dose) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022J21A, 036B21A and 027A21A) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81), METFORMIN and LOSARTAN for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Four patients received an expired 30-day use by date booster dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Four patients received an expired 30-day use by date booster dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment were reported.   This case was linked to MOD-2022-503133, MOD-2022-503153, MOD-2022-503157 (Patient Link).
Age: 35.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial had been left out at room air from the day before; We gave 2 doses of expired Moderna Covid-19 vaccine.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We gave 2 doses of expired Moderna Covid-19 vaccine.) and PRODUCT STORAGE ERROR (Vial had been left out at room air from the day before) in a 35-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2022 at 10:35 AM, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 04-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (We gave 2 doses of expired Moderna Covid-19 vaccine.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial had been left out at room air from the day before). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We gave 2 doses of expired Moderna Covid-19 vaccine.) and PRODUCT STORAGE ERROR (Vial had been left out at room air from the day before) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information was not provided Treatment information was not provided  It was reported as following, Date the vial was initially stored in the refrigerator was 01-Mar-2022.  Date(s) and time(S) vial was first punctured was at 6pm on 03-Mar-2022. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F):16 hrs 35 min.   This case was linked to MOD-2022-502865 (Patient Link).
Age: 35.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Chills, Feeling abnormal, Headache, Nasopharyngitis, Product storage error
Clinical narrative: Vial had been left out at room air from the day before; We gave 2 doses of expired Moderna Covid-19 vaccine.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We gave 2 doses of expired Moderna Covid-19 vaccine.) and PRODUCT STORAGE ERROR (Vial had been left out at room air from the day before) in a 35-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2022 at 10:35 AM, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 04-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (We gave 2 doses of expired Moderna Covid-19 vaccine.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial had been left out at room air from the day before). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We gave 2 doses of expired Moderna Covid-19 vaccine.) and PRODUCT STORAGE ERROR (Vial had been left out at room air from the day before) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information was not provided Treatment information was not provided  It was reported as following, Date the vial was initially stored in the refrigerator was 01-Mar-2022.  Date(s) and time(S) vial was first punctured was at 6pm on 03-Mar-2022. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F):16 hrs 35 min.   This case was linked to MOD-2022-502865 (Patient Link).
Age: 35.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Vial had been left out at room air from the day before; We gave 2 doses of expired Moderna Covid-19 vaccine.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We gave 2 doses of expired Moderna Covid-19 vaccine.) and PRODUCT STORAGE ERROR (Vial had been left out at room air from the day before) in a 35-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2022 at 10:35 AM, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 04-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (We gave 2 doses of expired Moderna Covid-19 vaccine.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial had been left out at room air from the day before). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We gave 2 doses of expired Moderna Covid-19 vaccine.) and PRODUCT STORAGE ERROR (Vial had been left out at room air from the day before) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information was not provided Treatment information was not provided  It was reported as following, Date the vial was initially stored in the refrigerator was 01-Mar-2022.  Date(s) and time(S) vial was first punctured was at 6pm on 03-Mar-2022. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F):16 hrs 35 min.   This case was linked to MOD-2022-502865 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered the Moderna COVID 19 vaccine 25.5 hours after the vial was punctured) in a 68-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 026L21B) for COVID-19 vaccination. No Medical History information was reported. On 04-Mar-2022 at 1:00 PM, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 04-Mar-2022 at 1:00 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered the Moderna COVID 19 vaccine 25.5 hours after the vial was punctured). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered the Moderna COVID 19 vaccine 25.5 hours after the vial was punctured) outcome was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. The vial was initially stored in the refrigerator on 21-Feb-2022. The vial was first punctured on 03-Mar-2022 at 9:30 AM. Post puncture, the vial was stored in room temperature. The vial did not underwent any temperature excursions. Total amount of time the vial was exposed to room temperature was 25.4 hours. No treatment medications were reported.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: patients administered Moderna vaccine while temperature excursion assessment was ongoing; patients administered Moderna vaccine while temperature excursion assessment was ongoing; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered Moderna vaccine while temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing) in a 26-year-old female patient 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) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered Moderna vaccine while temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered Moderna vaccine while temperature excursion assessment was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The treatment information was unknown.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Erythema, Hypertension, Illness, Ocular hyperaemia
Clinical narrative: Became very sick; Blood pressure went up; Eyes were blood shot; Face was beet red; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Became very sick), HYPERTENSION (Blood pressure went up), OCULAR HYPERAEMIA (Eyes were blood shot) and ERYTHEMA (Face was beet red) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy, Contrast media allergy (contrast dye) and Drug allergy (Allergic to Advair).    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 ILLNESS (Became very sick) (seriousness criterion medically significant), HYPERTENSION (Blood pressure went up) (seriousness criterion medically significant), OCULAR HYPERAEMIA (Eyes were blood shot) (seriousness criterion medically significant) and ERYTHEMA (Face was beet red) (seriousness criterion medically significant). At the time of the report, ILLNESS (Became very sick), HYPERTENSION (Blood pressure went up), OCULAR HYPERAEMIA (Eyes were blood shot) and ERYTHEMA (Face was beet red) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Nov-2021, Blood pressure measurement: high (High) Blood pressure went up.         Reported that Patient not had both Acute and Chronic illnesses at the time of vaccination. Patient had not tested Covid positive. Also reported that Other vaccines given within 1 month prior to Moderna COVID-19 vaccine. Concomitant product use was not provided by the reporter.  Treatment information was not provided. Patient had not experienced similar event in the past.Outcome of events was reported as gotten better. Symptoms and status was improved. Patient went to Emergency and said it was a reaction from the vaccine.  Company comment: This case concerns a 73-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of Illness, Hypertension, Occular  Peraema, and Erythema. The events occurred approximately 1 day after the third dose of mRNA-1273 (Moderna covid-19 vaccine). The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.     Most recent FOLLOW-UP information incorporated above includes: On 04-Mar-2022: Follow up includes no new information.; Sender's Comments: This case concerns a 73-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of Illness, Hypertension, Occular  Peraema, and Erythema. The events occurred approximately 1 day after the third dose of mRNA-1273 (Moderna covid-19 vaccine). The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.