chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 0.25 ml dose  for a booster dose, to two patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (0.25 ml dose  for a booster dose, to two patients) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007C21A, 021C21A, 066H21A and 064A22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 09-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (0.25 ml dose  for a booster dose, to two patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (0.25 ml dose  for a booster dose, to two patients) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No Allergies with medications, food and other products.   patient ever had COVID positive test or diagnosis was reported as unknown.  No medical history was reported with AE and both Acute and Chronic illnesses at the time of vaccination.  The patient did not experience a similar event in the past.  No treatment medications were reported.   This case was linked to MOD-2022-607752, MOD-2022-607755 (Patient Link).
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: First booster dose given after expiration date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (First booster dose given after expiration date) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 064A22A, 0471321A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Jul-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 09-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (First booster dose given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (First booster dose given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported. No treatment medications were provided.   This case was linked to MOD-2022-607744 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Immunocompromised patient received booster dose of the Moderna Covid 19 vaccine instead of third primary dose.; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Immunocompromised patient received booster dose of the Moderna Covid 19 vaccine instead of third primary 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 Asthma, Heart disease, unspecified and Immunocompromised.    In February 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In February 2022, the patient experienced ACCIDENTAL UNDERDOSE (Immunocompromised patient received booster dose of the Moderna Covid 19 vaccine instead of third primary dose.). At the time of the report, ACCIDENTAL UNDERDOSE (Immunocompromised patient received booster dose of the Moderna Covid 19 vaccine instead of third primary dose.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that the patient had received first 2 doses in Aug-2021 and Sep-2021, came for booster. The patient was immunocompromised and should have had a full dose in Feb-2022, but was given half (booster) dose of 0.25 milliliter. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: received half dose of Moderna; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (received half dose of Moderna) 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-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced UNDERDOSE (received half dose of Moderna). At the time of the report, UNDERDOSE (received half dose of Moderna) outcome was unknown.        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 information were reported by the reporter. It was reported as on 30-DEC-2021 patient received half dose of Moderna.   This case was linked to MOD-2022-608716 (Patient Link).
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: kept in refrigerator for that entire month at 41.3 f.; Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (kept in refrigerator for that entire month at 41.3 f.) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049L21A, 012H21B, 022C21A and 047A21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 15-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 11-Jul-2022 at 10:30 AM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 11-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (kept in refrigerator for that entire month at 41.3 f.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (kept in refrigerator for that entire month at 41.3 f.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Drug thawed on 19-May-22 with a use by date of 18-Jun-22. Vial was kept in refrigerator for that entire month at 41.3 f.    The vial did not underwent any temperature excursion.   No adverse events was reported.  No treatment medications were reported.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was stored in refrigerator on 02-Jun-2022 and administered on 06-Jul-2022; Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 02-Jun-2022 and administered on 06-Jul-2022) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059M21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Coronary artery disease since 27-Aug-2015, Hypertension since 02-Mar-2016, Hyperlipidemia since 04-Oct-2018, Allergic rhinitis since 07-Oct-2021 and BPH since 07-Oct-2021. Concomitant products included CETIRIZINE from 07-Oct-2021 to an unknown date for Allergic rhinitis, FINASTERIDE from 07-Oct-2021 to an unknown date for BPH, ACETYLSALICYLIC ACID (ASPIRIN 81) from 27-Aug-2013 to an unknown date for Coronary artery disease, PRAVASTATIN from 27-Aug-2015 to an unknown date for Hyperlipidemia and Coronary artery disease, METOPROLOL TARTRATE from 15-Mar-2018 to an unknown date for Hypertension and Coronary artery disease.    On 06-Jul-2022 at 8:57 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 02-Jun-2022 and administered on 06-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 02-Jun-2022 and administered on 06-Jul-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Vial was initially stored on refrigerator on 02-Jun-2022. The vial did not undergo any temperature excursion.  No adverse events were reported. Treatment medication was not provided by the reporter.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine initially stored in refrigerator on 02-Jun-2022 and administered on 07-Jul-2022; Patient received a booster dose of Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a booster dose of Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration) and PRODUCT STORAGE ERROR (Vaccine initially stored in refrigerator on 02-Jun-2022 and administered on 07-Jul-2022) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059M21A, 009C21A and 009C21A) for COVID-19 prophylaxis.     The patient's past medical history included Carpal tunnel syndrome on 13-Nov-2015. Concurrent medical conditions included Hyperlipidemia since 21-Jan-2022, Hypertension since 21-Jan-2022, Impaired fasting glucose since 03-Jan-2022 and Impotence since 07-Nov-2013. Concomitant products included AMLODIPINE from 21-Jan-2022 to an unknown date for Hypertension.   On 27-Jul-2021 at 10:02 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 24-Aug-2021 at 9:44 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 07-Jul-2022 at 8:26 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 07-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a booster dose of Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine initially stored in refrigerator on 02-Jun-2022 and administered on 07-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a booster dose of Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration) and PRODUCT STORAGE ERROR (Vaccine initially stored in refrigerator on 02-Jun-2022 and administered on 07-Jul-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial did not undergo temperature excursions. The patient did not report any adverse events. 6 patients on 05-Jul-2022, 6 patients on 06-Jul-2022, and 3 patients on 07-Jul-022. No treatment medication were reported.   This case was linked to MOD-2022-607866 (Patient Link).
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was initially stored in refrigerator on 02 Jun 2022 and administered on 06 Jul 2022.; Patient was administered with expired booster vaccine beyound 30 days use by date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered with expired booster vaccine beyound 30 days use by date.) and PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 02 Jun 2022 and administered on 06 Jul 2022.) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059M21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Hypertension since 09-Nov-2017, Type 2 diabetes mellitus since 09-Nov-2017, Hyperlipidemia since 14-Nov-2018, Neuropathy since 04-Feb-2019 and Heart disease, unspecified since 17-Jun-2022. Concomitant products included SEMAGLUTIDE from 27-Jun-2022 to an unknown date for Diabetes, CLOPIDOGREL from 13-Apr-2022 to an unknown date for Heart disease, unspecified, ATORVASTATIN from 30-Sep-2021 to an unknown date for Hyperlipidemia, LOSARTAN from 09-Mar-2022 to an unknown date for Hypertension, PREGABALIN from 08-Dec-2021 to an unknown date for Neuropathy.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 21-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Jul-2022 at 8:24 AM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 06-Jul-2022 at 8:24 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered with expired booster vaccine beyound 30 days use by date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 02 Jun 2022 and administered on 06 Jul 2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered with expired booster vaccine beyound 30 days use by date.) and PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 02 Jun 2022 and administered on 06 Jul 2022.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was unknown whether patient had ever diagnosed with nor tested positive for COVID-19.  No adverse events noted at this time.   It was reported that the vials had not undergone any temperature excursions.  No treatment medications were reported.   This case was linked to MOD-2022-607864 (Patient Link).
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine stored in refrigerator on 02Jun2022 and administered on 05Jul2022; Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration.) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 02Jun2022 and administered on 05Jul2022) in a 92-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 059M21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Hypertension since 12-Jan-2016, Coronary artery disease since 19-Aug-2016, Prostate cancer since 19-Aug-2016, GERD since 12-Jan-2016 and Hyperlipidemia since 12-Jan-2016. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN EC) from 21-Dec-2011 to an unknown date for Coronary artery disease, SIMVASTATIN from 08-Oct-2019 to an unknown date for Hyperlipidemia and Coronary artery disease, METOPROLOL TARTRATE from 18-Oct-2019 to an unknown date for Hypertension and Coronary artery disease, MULTIVITAMIN [VITAMINS NOS] from 29-Dec-2008 to an unknown date for Supplementation therapy.    On 05-Jul-2022 at 10:10 AM, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 05-Jul-2022 at 10:10 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 02Jun2022 and administered on 05Jul2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration.) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 02Jun2022 and administered on 05Jul2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Patient did not have any known allergies to medications, food and other products. It was unknown if patient had ever been diagnosed with/ tested positive for COVID-19. Patient did not have acute illnesses at the time of vaccination and up to one month before.  No adverse events noted at the reporting time. Patient received a dose of Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration.  Number of doses/vials were 15 doses / 3 red cap vials.  On 02-Jun-2022, the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursion.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-604302 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-604302:Master case
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was initially stored in refrigerator on 02-Jun-2022 and was administered on 05-Jul-2022.; Patient received a booster dose of Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a booster dose of Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration.) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 02-Jun-2022 and was administered on 05-Jul-2022.) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059M21A and 032F21A) for COVID-19 prophylaxis.     Concurrent medical conditions included GERD since 20-Aug-2020, Hyperlipidemia since 15-Jul-2020, Migraine since 08-Dec-2018, Hypertension since 08-Dec-2018 and Vitamin D deficiency since 15-Jul-2020. Concomitant products included FAMOTIDINE from 22-Jul-2020 to an unknown date for GERD, PRAVASTATIN from 06-Jul-2022 to an unknown date for Hyperlipidemia, HYDROCHLOROTHIAZIDE from 21-Mar-2019 to an unknown date for Hypertension, PROPRANOLOL HYDROCHLORIDE (PROPRANOLOL [PROPRANOLOL HYDROCHLORIDE]) from 08-Nov-2019 to an unknown date for Migraine and Hypertension, CHOLECALCIFEROL from 15-Jul-2020 to an unknown date for Vitamin D deficiency.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 20-Nov-2021 at 9:19 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 05-Jul-2022 at 1:56 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 05-Jul-2022 at 1:56 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a booster dose of Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 02-Jun-2022 and was administered on 05-Jul-2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a booster dose of Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration.) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 02-Jun-2022 and was administered on 05-Jul-2022.) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial was initially stored in the refrigerator on 02-JUN-2022 The vial did not undergo any temperature excursions. No adverse events had occurred. Treatment information was not provided.   This case was linked to MOD-2022-607867 (Patient Link).
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was initially stored in refrigerator on 02-Jun-2022 and was administered on 05-Jul-2022; Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 02-Jun-2022 and was administered on 05-Jul-2022) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059M21A) for COVID-19 prophylaxis.     Acute illnesses at the time of vaccination and up to one month before were given as none.  Previously administered products included for Product used for unknown indication: Janssen (Fully vaccinated with 1 dose) in June 2021. Past adverse reactions to the above products included No adverse event with Janssen. Concurrent medical conditions included Drug allergy (haloperidol allergy), Drug allergy (divalproex allergy), Hypertension, Type 2 diabetes mellitus, Bipolar I disorder, Anxiety disorder and Substance abuse. Concomitant products included LITHIUM CARBONATE from 28-Dec-2020 to an unknown date for Bipolar I disorder, METFORMIN from 17-Jun-2021 to an unknown date, SEMAGLUTIDE from 21-Sep-2021 to an unknown date and INSULIN GLARGINE from 17-Jun-2021 to an unknown date for Diabetes, LOSARTAN from 02-Feb-2022 to an unknown date for Hypertension, PNEUMOCOCCAL VACCINE CONJ 20V (CRM197) (PREVNAR 20) for an unknown indication.    On 05-Jul-2022 at 2:06 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 05-Jul-2022 at 2:06 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 02-Jun-2022 and was administered on 05-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 02-Jun-2022 and was administered on 05-Jul-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received a booster dose of vaccine from a vial that had exceeded its 30 day working expiration. No adverse events noted at the time of reporting. Number of doses and vials were reported as 15 doses and 3 red cap vials.  Vial was initially stored in the refrigerator on 02-JUN-2022  The vial did not undergo any temperature excursions.  No treatment medication was reported.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine initially stored in refrigerator on 02-Jun-2022 and adminsitered on 07-Jul-2022; Patient received a booster dose of Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a booster dose of Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration) and PRODUCT STORAGE ERROR (Vaccine initially stored in refrigerator on 02-Jun-2022 and adminsitered on 07-Jul-2022) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059M21A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Influenza (Afluria) (Dose no: 1, route: Intramuscular) on 09-Nov-2021, Zoster (Shingrix) (Dose no: 2, body site: left deltoid, route: Intramuscular and lot no:D4CZ3) on 21-Dec-2021. Past adverse reactions to the above products included No adverse reaction with Influenza (Afluria) and Zoster (Shingrix). Concurrent medical conditions included Allergy to metals (Allergy to Iron), Pulmonary hypertension since 20-Nov-2018, Heart failure since 26-Jun-2019, Atrial fibrillation since 08-Nov-2018, Vitamin D deficiency since 09-Nov-2018 and Hypokalemia since 27-Aug-2020.   On 03-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 06-Jul-2022 at 1:33 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 06-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a booster dose of Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine initially stored in refrigerator on 02-Jun-2022 and adminsitered on 07-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a booster dose of Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration) and PRODUCT STORAGE ERROR (Vaccine initially stored in refrigerator on 02-Jun-2022 and adminsitered on 07-Jul-2022) 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. The vial did not undergo temperature excursions. The patient did not report any adverse events. 6 patients on 05-Jul-2022, 6 patients on 06-Jul-2022, and 3 patients on 07-Jul-022. No treatment medication were reported.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: Heart disease; This spontaneous case was reported by a pharmacist and describes the occurrence of CARDIAC DISORDER (Heart disease) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Known allergy was reported.  Concurrent medical conditions included Hypertension since 09-Nov-2017, Type 2 diabetes mellitus since 09-Nov-2017, Hyperlipidemia since 14-Nov-2018, Neuropathy since 04-Feb-2019 and Heart disease, unspecified since 17-Jun-2022. Concomitant products included SEMAGLUTIDE from 27-Jun-2022 to an unknown date for Diabetes, ATORVASTATIN from 30-Sep-2021 to an unknown date for Hyperlipidemia, LOSARTAN from 09-Mar-2022 to an unknown date for Hypertension, PREGABALIN from 08-Dec-2021 to an unknown date for Neuropathy.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 21-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Jun-2022, the patient experienced CARDIAC DISORDER (Heart disease). The patient was treated with CLOPIDOGREL (oral) ongoing from 13-Apr-2022 for Heart disease, unspecified, at a dose of daily. At the time of the report, CARDIAC DISORDER (Heart disease) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Pharmacist was called to report that about 15 adult patients received expired booster Moderna COVID-19 vaccine on 05-Jul-2022 through 07-Jul-2022. The Lot number reported as 059M21A and manufacturing expiry date 15-OCT-2022. The Number of doses were 15 and Vials were 3 Red Cap. On 02JUN2022, the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions.   This case was linked to MOD-2022-607837 (Patient Link).
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperlipidaemia, Hypertension, Impaired fasting glucose
Clinical narrative: Hyperlipidemia; Hypertension; Impaired fasting glucose; This spontaneous case was reported by a pharmacist and describes the occurrence of HYPERLIPIDAEMIA (Hyperlipidemia), IMPAIRED FASTING GLUCOSE (Impaired fasting glucose) and HYPERTENSION (Hypertension) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 009C21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Impotence since 07-Nov-2013 and Carpal tunnel syndrome since 13-Nov-2015.   On 27-Jul-2021 at 10:02 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 24-Aug-2021 at 9:44 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 03-Jan-2022, the patient experienced IMPAIRED FASTING GLUCOSE (Impaired fasting glucose). On 21-Jan-2022, the patient experienced HYPERLIPIDAEMIA (Hyperlipidemia) and HYPERTENSION (Hypertension). The patient was treated with AMLODIPINE (oral) ongoing from 21-Jan-2022 for Hypertension, at a dose of 5 milligram once a day. At the time of the report, HYPERLIPIDAEMIA (Hyperlipidemia) and IMPAIRED FASTING GLUCOSE (Impaired fasting glucose) outcome was unknown and HYPERTENSION (Hypertension) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. It was reported that it is unknown that the patient has ever been diagnosed with or tested positive for COVID-19.   This case was linked to MOD-2022-607808 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Dose 1 was administered on 08-Mar-2021 and Dose 2 was adminsitered on  20-Nov-2021; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 was administered on 08-Mar-2021 and Dose 2 was adminsitered on  20-Nov-2021) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 prophylaxis.     No known allergies were reported.  Concurrent medical conditions included GERD since 20-Aug-2020, Hyperlipidemia since 15-Jul-2020, Migraine since 08-Dec-2018, Hypertension since 08-Dec-2018 and Vitamin D deficiency since 15-Jul-2020. Concomitant products included FAMOTIDINE from 22-Jul-2020 to an unknown date for GERD, PRAVASTATIN from 06-Jul-2022 to an unknown date for Hyperlipidemia, HYDROCHLOROTHIAZIDE from 21-Mar-2019 to an unknown date for Hypertension, PROPRANOLOL HYDROCHLORIDE (PROPRANOLOL SANDOZ) from 08-Nov-2019 to an unknown date for Migraine and Hypertension, CHOLECALCIFEROL from 15-Jul-2020 to an unknown date for Vitamin D deficiency.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 20-Nov-2021 at 9:19 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 20-Nov-2021 at 9:19 AM, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 was administered on 08-Mar-2021 and Dose 2 was adminsitered on  20-Nov-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 was administered on 08-Mar-2021 and Dose 2 was adminsitered on  20-Nov-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was provided.   This case was linked to MOD-2022-607851 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Product administration interrupted, Product dose omission issue
Clinical narrative: received 1st primary series dose 8 months ago, never received 2nd primary series dose; she didn't receive the second primary series dose because she "didn't want it"; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (received 1st primary series dose 8 months ago, never received 2nd primary series dose) and PRODUCT DOSE OMISSION ISSUE (she didn't receive the second primary series dose because she "didn't want it") in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (received 1st primary series dose 8 months ago, never received 2nd primary series dose) and PRODUCT DOSE OMISSION ISSUE (she didn't receive the second primary series dose because she "didn't want it"). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (received 1st primary series dose 8 months ago, never received 2nd primary series dose) and PRODUCT DOSE OMISSION ISSUE (she didn't receive the second primary series dose because she "didn't want it") outcome was unknown.            No concomitant drug information was provided.  The reporter wants to know if it was okay to receive the second dose now.  No treatment drug information was provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: got Covid after getting the first booster and the primary series of the Moderna covid19 vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (got Covid after getting the first booster and the primary series of the Moderna covid19 vaccine.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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. On an unknown date, the patient experienced COVID-19 (got Covid after getting the first booster and the primary series of the Moderna covid19 vaccine.). At the time of the report, COVID-19 (got Covid after getting the first booster and the primary series of the Moderna covid19 vaccine.) outcome was unknown.            It was reported as the age was over 50 years.  No concomitant information was reported. No treatment information was provided.  Company comment: This spontaneous case concerns a patient of over 50-years-old with no medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 which occurred in context to the third dose of mRNA-1273 vaccine in covid-19 vaccination series. Latency cannot be assessed since vaccination date was not disclosed. It was reported as got Covid after getting the first booster and the primary series of the Moderna covid19 vaccine with outcome was unknown. The Clinical course, Concomitant medication, treatment details were not provided, and the events outcome was unknown.  Ongoing COVID-19 Pandemia remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a patient of over 50-years-old with no medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 which occurred in context to the third dose of mRNA-1273 vaccine in covid-19 vaccination series. Latency cannot be assessed since vaccination date was not disclosed. It was reported as got Covid after getting the first booster and the primary series of the Moderna covid19 vaccine with outcome was unknown. The Clinical course, Concomitant medication, treatment details were not provided, and the events outcome was unknown.  Ongoing COVID-19 Pandemia remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: I got really sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (I got really sick) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     It was unknown if the patient had allergies to medications, food and other products. It was unknown if the patient ever had COVID positive test or diagnosis. It was unknown if the patient was given any other vaccines within 1 month prior to Moderna COVID-19 vaccine.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 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 received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (I got really sick). At the time of the report, ILLNESS (I got really sick) had resolved.            No concomitant medications were reported.  The patient received the second full dose a month later after the 1st dose. After the second dose the patient got really sick. The patient said the adverse event got recovered and the symptoms improved.  It was unknown if the adverse event did cause the patient to seek medical care. It was unknown if the patient had experienced a similar event in the past.  The patient also received the first booster dose and reported that they didn't get that sick, though and it got recovered and the symptoms improved.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-608471 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-608471:Husband's case (Same reporter)
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration
Clinical narrative: Two weeks after receiving this dose, she saw a small patch of discoloration under her left chin; This spontaneous case was reported by a patient and describes the occurrence of SKIN DISCOLOURATION (Two weeks after receiving this dose, she saw a small patch of discoloration under her left chin) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     The patient never had a COVID positive test or diagnosis. It was reported that no other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. The patient had not experienced a similar event in the past.  Concurrent medical conditions included Lichen planopilaris (pre-existing autoimmune condition, which was a form of alopecia In remission stage,recent status : stable) since 2019 and Allergy (Betadine (cleaning substance used for surgeries)).    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 13-Mar-2021, the patient experienced SKIN DISCOLOURATION (Two weeks after receiving this dose, she saw a small patch of discoloration under her left chin). At the time of the report, SKIN DISCOLOURATION (Two weeks after receiving this dose, she saw a small patch of discoloration under her left chin) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant drug was reported. After experiencing skin discoloration, patient did not think much of that and proceeded to receive her second dose of the Moderna vaccine. No treatment was received at the time of dose 1.   This case was linked to MOD-2022-608592 (Patient Link).
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperphagia, Vomiting
Clinical narrative: eat an abnormally large dinner; single episode of vomiting; This spontaneous case was reported by a patient family member or friend and describes the occurrence of HYPERPHAGIA (eat an abnormally large dinner) and VOMITING (single episode of vomiting) in a 2-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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 HYPERPHAGIA (eat an abnormally large dinner) and VOMITING (single episode of vomiting). At the time of the report, HYPERPHAGIA (eat an abnormally large dinner) and VOMITING (single episode of vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered VOMITING (single episode of vomiting) to be not related. No further causality assessment was provided for HYPERPHAGIA (eat an abnormally large dinner).    No concomitant medications were reported.   It was reported that in the evening after vaccination, the patient had a single episode of vomiting. He had no other symptoms after that, and he was not fussy and he was afebrile. The patient did eat an abnormally large dinner and the vomiting occurred immediately aft receiving warm milk prior to bedtime. The patient's pediatrician was informed, who felt that the vomiting was unlikely related to vaccine.  No treatment details were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-608437 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-608437:(Same reporter)
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: unauthorized full dose received, not immunocompromised but received a third full dose; This spontaneous case was reported by a patient and describes the occurrence of INCORRECT DOSE ADMINISTERED (unauthorized full dose received, not immunocompromised but received a third full dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (unauthorized full dose received, not immunocompromised but received a third full dose). At the time of the report, INCORRECT DOSE ADMINISTERED (unauthorized full dose received, not immunocompromised but received a third full dose) outcome was unknown.            Patient was not immunocompromised.  No concomitant medications were reported.  Patient received 2 doses of the primary series initially. Patient then got a booster dose however patient  wanted a full dose hence received a third full dose.           No treatment information was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: vomited; This spontaneous case was reported by an other health care professional and describes the occurrence of VOMITING (vomited) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jul-2022, the patient experienced VOMITING (vomited). At the time of the report, VOMITING (vomited) 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 drug reported. Patient received Moderna pediatric (6 month to 5-year-old) dose of Covid-19 vaccine on the morning of 12-JUL-2022  and vomited around 7:30 or 8pm on 12 JUL 2022. No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-608406 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-608406:(Same reporter)
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: got really sick; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ILLNESS (got really sick) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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, 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 experienced ILLNESS (got really sick). At the time of the report, ILLNESS (got really sick) had resolved.            No concomitant medications were reported. The patient got really sick after the second dose. After the first booster, he did not get that sick, though. It was unknown if the patient experienced a similar event in the past. No treatment medications were reported.   This case was linked to MOD-2022-608110 (Patient Link).