chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: expired dose given; Vial punctured at 10:39 on 12-APR-2022, Dose given 16:00 on 13-APR-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose given) and PRODUCT STORAGE ERROR (Vial punctured at 10:39 on 12-APR-2022, Dose given 16:00 on 13-APR-2022) in a 63-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose given). In April 2022, the patient experienced PRODUCT STORAGE ERROR (Vial punctured at 10:39 on 12-APR-2022, Dose given 16:00 on 13-APR-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired dose given) and PRODUCT STORAGE ERROR (Vial punctured at 10:39 on 12-APR-2022, Dose given 16:00 on 13-APR-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. It was reported that vial was punctured at 10:39 on 12-APR-2022 and stored at room temperature. Dose given at 16:00 on 13-APR-2022. Vial was moved from freezer to fridge on 11-Apr-2022. No treatment medication were provided.
Age: 64.0
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: 40 patients administered with vaccines that have undergone temperature excursion; 40 patients administered with vaccines that have undergone temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (40 patients administered with vaccines that have undergone temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (40 patients administered with vaccines that have undergone temperature excursion) in a 64-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (40 patients administered with vaccines that have undergone temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (40 patients administered with vaccines that have undergone temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (40 patients administered with vaccines that have undergone temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (40 patients administered with vaccines that have undergone temperature excursion) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications was reported It was reported that only lot number: 059H21A was affected and it was first thawed on 28-Jan-2022 It was reported maximum or minimum  temperatures reached as applicable (specify temp is in C or F) on 28-Jan-2022 temp range positive 34.7F to positive 41.2F, on 30-Jan-2022 temp range positive 34.7F to positive 41.2F which occurred for 48 hours; on 31-Jan-2022 temp range positive 34.7F to positive 41.2F for 12 hours and on 04-Feb-2022 temp range positive 35.2F to positive 41.7F for 12 hours. No treatment information was reported.
Age: 32.0
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered with vaccines that have undergone temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (patients administered with vaccines that have undergone temperature excursion) in a 32-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination. Previously administered products included for Product used for unknown indication: JANSSEN COVID-19 VACCINE (1st dose) on 10-Apr-2021. Past adverse reactions to the above products included No adverse event with JANSSEN COVID-19 VACCINE. On 30-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patients administered with vaccines that have undergone temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered with vaccines that have undergone temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered with vaccines that have undergone temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (patients administered with vaccines that have undergone temperature excursion) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not reported. Vaccines were thawed on 28-Jan-2022. It was reported Maximum or minimum temperatures reached as applicable (specify temp is in C or F) on 28-Jan-2022 temp range positive 34.7F to positive 41.2F, on 30-Jan-2022 temp range positive 34.7F to positive 41.2F which occurred for 48 hours; on 31-Jan-2022 temp range positive 34.7F to positive 41.2F for 12 hours and on 04-Feb-2022 temp range positive 35.2F to positive 41.7F for 12 hours. It was reported that the patient did not experience any adverse event. Treatment information was not reported.
Age: 64.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: expired dose given; Vial punctured at 10:39 on 12apr2022, Dose given 17:48 on 13apr2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose given) and PRODUCT STORAGE ERROR (Vial punctured at 10:39 on 12apr2022, Dose given 17:48 on 13apr2022) in a 64-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2022 at 5:48 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2022 at 5:48 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose given). In April 2022, the patient experienced PRODUCT STORAGE ERROR (Vial punctured at 10:39 on 12apr2022, Dose given 17:48 on 13apr2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired dose given) and PRODUCT STORAGE ERROR (Vial punctured at 10:39 on 12apr2022, Dose given 17:48 on 13apr2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product was reported.   Date the vial was moved from freezer to fridge is11apr2022. Vial punctured at 10:39 on 12apr2022 and stored at room temperature. Dose was given at 17:48 on 13apr2022. This was the patient's second booster dose.   No treatment information was reported.
Age: 56.0
Sex: U
Vaccine: COVID19
Symptoms: Cardiac failure
Clinical narrative: Seeing heart failure specialist soon to see if cause of heart failure was covid vaccine or chemo.; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FAILURE (Seeing heart failure specialist soon to see if cause of heart failure was covid vaccine or chemo.) in a 56-year-old patient of an unknown gender 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 CARDIAC FAILURE (Seeing heart failure specialist soon to see if cause of heart failure was covid vaccine or chemo.) (seriousness criterion medically significant). At the time of the report, CARDIAC FAILURE (Seeing heart failure specialist soon to see if cause of heart failure was covid vaccine or chemo.) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Medication Information was provided.  No Treatment Drug was provided by reporter. Company comment This spontaneous case concerns 56-year-old patient of an unknown gender with no medical history reported, who experienced the unexpected, serious (due to medically significant) AESI of s Cardiac failure, which occurred on an unknown date. The patient received a dose of the mRNA-1273 vaccine on an unknown date. It was reported: "Seeing heart failure specialist soon to see if cause of heart failure was covid vaccine or chemo". The course of the event and treatment information was not provided. If "chemo" suggests medical history of cancer with chemotherapy, this could be a confounder for the event cardiac failure. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns 56-year-old patient of an unknown gender with no medical history reported, who experienced the unexpected, serious (due to medically significant) AESI of s Cardiac failure, which occurred on an unknown date. The patient received a dose of the mRNA-1273 vaccine on an unknown date. It was reported: "Seeing heart failure specialist soon to see if cause of heart failure was covid vaccine or chemo". The course of the event and treatment information was not provided. If "chemo" suggests medical history of cancer with chemotherapy, this could be a confounder for the event cardiac failure. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: 102 Degrees Farenheit fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (102 Degrees Farenheit fever) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013120A and 013C20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (Patient had allergies to almost Everything), Peanut allergy, Shellfish allergy and Asthma. Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA ALLERGY), PREGABALIN (LYRICA), MONTELUKAST SODIUM (SINGULAIR) and XYLOMETAZOLINE HYDROCHLORIDE (NASAL SPRAY II) for Allergy, METOPROLOL and AMLODIPINE from February 2022 to an unknown date for Blood pressure, IBUPROFEN (ADVIL ARTHRITIS PAIN) for Pain, HCTZ for Swelling.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 an unknown date, the patient experienced PYREXIA (102 Degrees Farenheit fever). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) ongoing since an unknown date for Pain, at a dose of 500 milligram once a day. At the time of the report, PYREXIA (102 Degrees Farenheit fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 degrees fahrenheit (High) 102 Degrees Fahrenheit.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2022-540261 (Patient Link).
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: administered booster doses from a vial that had been open for 24h, the vial was kept in the refrigerator at normal room temperature; 7 patients were administered booster doses from a vial that had been open for 24 h; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (7 patients were administered booster doses from a vial that had been open for 24 h) and PRODUCT STORAGE ERROR (administered booster doses from a vial that had been open for 24h, the vial was kept in the refrigerator at normal room temperature) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2022 at 8:02 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 14-Apr-2022 at 8:02 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (7 patients were administered booster doses from a vial that had been open for 24 h). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (administered booster doses from a vial that had been open for 24h, the vial was kept in the refrigerator at normal room temperature). At the time of the report, EXPIRED PRODUCT ADMINISTERED (7 patients were administered booster doses from a vial that had been open for 24 h) and PRODUCT STORAGE ERROR (administered booster doses from a vial that had been open for 24h, the vial was kept in the refrigerator at normal room temperature) 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 vial was kept in the refrigerator at normal room temperature. The vial was initially stored in the refrigerator on 12 Apr 2022. The vial was first punctured on 13 Apr 2022 at 8:00 am. Post puncture the vials were refrigerated at 4-5 degree Celsius. The vials did not undergo any temperature excursion.  Total amount of time the vial was exposed to room temperature range  was 30 min or less. The patient did not have any symptoms.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2022: Follow up was received and contains no new information
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired vaccine administered past 12 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine administered past 12 hours) in a  patient of an unknown age and gender 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 EXPIRED PRODUCT ADMINISTERED (expired vaccine administered past 12 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired vaccine administered past 12 hours) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided. No treatment medication were provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 2 doses administered more than 12 hours post puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2 doses administered more than 12 hours post puncture) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 001M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (2 doses administered more than 12 hours post puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2 doses administered more than 12 hours post puncture) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment medication reported.   Additional information reported regarding date when vial was initially stored in the refrigerator was 11 Apr 2022. 2 doses from 1 vial was administered past 12 hours post puncture. On 12 Apr 2022 at 10:40 AM the vial was first punctured. From first puncture on 12 Apr 2022 at 10:40 AM till the last dose was administered on 13Apr2022 5:45 PM the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F):
Age: 24.0
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patients administered with vaccines that have undergone temperature excursion; Patients administered with vaccines that have undergone temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patients administered with vaccines that have undergone temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered with vaccines that have undergone temperature excursion) in a 24-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients administered with vaccines that have undergone temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered with vaccines that have undergone temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patients administered with vaccines that have undergone temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered with vaccines that have undergone temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  Reporter stated that the vial was stored in refrigerator at the time of excursion. Vial was thawed on 28-Jan-2022. It was patient's booster dose.  On 28-Jan-2022 Maximum or minimum temperatures reached range was positive 34.7 degree Fahrenheit to positive 41.2 degree Fahrenheit, on 30-Jan-2022 temperature range was positive 34.7 degree Fahrenheit to positive 41.2 degree Fahrenheit which occurred approximately for 48 hours, on 31-Jan-2022 temperature range was positive 34.7 degree Fahrenheit to positive 41.2 degree Fahrenheit for 12 hours and on 04-Feb-2022 temperature range was positive 35.2 degree Fahrenheit to positive 41.7 degree Fahrenheit for 12 hours.  Reporter also stated that no patient had reported any adverse events.  No treatment drug information was provided.
Age: 20.0
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patient was administered with vaccines that had undergone temperature excursion; Patient was administered with vaccines that had undergone temperature excursion; This spontaneous case was reported by a medical assistant and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that had undergone temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccines that had undergone temperature excursion) in a 20-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     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 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that had undergone temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccines that had undergone temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that had undergone temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccines that had undergone temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 30-Jan-2022, the patient received the booster dose of Moderna COVID-19 Vaccine. No concomitant medications were reported.   Vaccines were thawed on 28-Jan-2022.  It was reported Maximum or minimum temperatures reached as on 28-Jan-2022 temperature range positive 34.7 F to positive 41.2 F, on 30-Jan-2022 temperature range positive 34.7 F to positive 41.2 F which occurred for 48 hours. On 31-Jan-2022 temperature range positive 34.7 F to positive 41.2 F for 12 hours and on 04-Feb-2022 temperature range positive 35.2 F to positive 41.7 F for 12 hours.  It was reported that the patient did not experience any adverse event.  No treatment medications were provided.   This case was linked to MOD-2022-539812 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: 40 patients administered with vaccines that have undergone temperature excursion; on 31Jan2022 temp range: positive 34.7F to positive 41.2F for 12 hours; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (40 patients administered with vaccines that have undergone temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (on 31Jan2022 temp range: positive 34.7F to positive 41.2F for 12 hours) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 31-Jan-2022, 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 PRODUCT TEMPERATURE EXCURSION ISSUE (40 patients administered with vaccines that have undergone temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (on 31Jan2022 temp range: positive 34.7F to positive 41.2F for 12 hours). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (40 patients administered with vaccines that have undergone temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (on 31Jan2022 temp range: positive 34.7F to positive 41.2F for 12 hours) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment drug details was reported.  The vials had Maximum or minimum temperatures reached, as applicable (specify temp is in C or F). On 28Jan2022 temp range: positive 34.7F to positive 41.2F; on 30Jan2022 temp range: positive 34.7F to positive 41.2F which occurred approximately for 48 hours; on 31Jan2022 temp range: positive 34.7F to positive 41.2F for 12 hours and on 04Feb2022 temp range: positive 35.2F to positive 41.7F for 12 hours.  The vial was thawed on 28-Jan-2022.
Age: 75.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial expired on 29-Jan-2022 and was stored in the refrigerator; A nurse administered 4 doses of expired Moderna Covid-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A nurse administered 4 doses of expired Moderna Covid-19 vaccine) and PRODUCT STORAGE ERROR (The vial expired on 29-Jan-2022 and was stored in the refrigerator) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 032F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 04-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A nurse administered 4 doses of expired Moderna Covid-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial expired on 29-Jan-2022 and was stored in the refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A nurse administered 4 doses of expired Moderna Covid-19 vaccine) and PRODUCT STORAGE ERROR (The vial expired on 29-Jan-2022 and was stored in the refrigerator) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. The vial was initially stored in the refrigerator on 04-Feb-2022. The vial did not undergo any temperature excursions. Also reported dose administered after 30-day use by date or after manufacturer date of expiry. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2022: Follow up received contains no new information.
Age: 39.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Extra dose administered
Clinical narrative: 1 of the recipients was redosed at another one of our clinics.; A nurse administered 4 doses of expired Moderna Covid-19 vaccine.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A nurse administered 4 doses of expired Moderna Covid-19 vaccine.) and EXTRA DOSE ADMINISTERED (1 of the recipients was redosed at another one of our clinics.) in a 39-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 032F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 18-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A nurse administered 4 doses of expired Moderna Covid-19 vaccine.). On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (1 of the recipients was redosed at another one of our clinics.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A nurse administered 4 doses of expired Moderna Covid-19 vaccine.) and EXTRA DOSE ADMINISTERED (1 of the recipients was redosed at another one of our clinics.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  On 18-Feb-2022, the vial was initially stored In refrigerator: . The vial did not undergo any temperature excursions.  No treatment medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2022: Non-significant follow up recieved
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Received full dose for 1st booster dose in error; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Received full dose for 1st booster dose in error) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Chronic kidney disease.   On 10-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 10-Sep-2021, the patient experienced ACCIDENTAL OVERDOSE (Received full dose for 1st booster dose in error). At the time of the report, ACCIDENTAL OVERDOSE (Received full dose for 1st booster dose in error) outcome was unknown.      No concomitant medications were reported. It was reported that patient was health freak. It was reported that, when she went to receive her first Moderna booster dose she was given a full dose instead of a half dose. It was stated that, patient was not considered immunocompromised. Patient did not experience a similar event in the past and AE did not cause patient to seek medical care. No treatment medications were reported.   Reporter did not allow further contact
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Influenza like illness, Pain
Clinical narrative: little soreness; flu like symptoms; This spontaneous case was reported by a physician and describes the occurrence of PAIN (little soreness) and INFLUENZA LIKE ILLNESS (flu like symptoms) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient had never been diagnosed with/ tested positive for COVID-19.  Concurrent medical conditions included Environmental allergy (Environmental allergies) and Blood pressure abnormal.  On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PAIN (little soreness) and INFLUENZA LIKE ILLNESS (flu like symptoms). At the time of the report, PAIN (little soreness) and INFLUENZA LIKE ILLNESS (flu like symptoms) outcome was unknown.      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication included medication for blood pressure. Treatment medication was not reported.   This case was linked to MOD-2022-540074, MOD-2022-540077, MOD-2022-540079 (Patient Link).   Reporter did not allow further contact
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Influenza like illness, Myalgia
Clinical narrative: little soreness; flu like symptoms; This spontaneous case was reported by a physician and describes the occurrence of PAIN (little soreness) and INFLUENZA LIKE ILLNESS (flu like symptoms) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient had never been diagnosed with/ tested positive for COVID-19.  Concurrent medical conditions included Environmental allergy (Environmental allergies) and Blood pressure abnormal.  On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PAIN (little soreness) and INFLUENZA LIKE ILLNESS (flu like symptoms). At the time of the report, PAIN (little soreness) and INFLUENZA LIKE ILLNESS (flu like symptoms) outcome was unknown.      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication included medication for blood pressure. Treatment medication was not reported.   This case was linked to MOD-2022-540074, MOD-2022-540077, MOD-2022-540079 (Patient Link).   Reporter did not allow further contact
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Influenza like illness, Pain
Clinical narrative: Flu like symptoms; Little soreness; This spontaneous case was reported by a physician and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) and MYALGIA (Little soreness) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient never had COVID-19 test or diagnosis. The patient's concurrent medical condition includes Blood pressure since an unknown date.  Concurrent medical conditions included Environmental allergy.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) and MYALGIA (Little soreness). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) and MYALGIA (Little soreness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications includes blood pressure medications (Unknown). Treatment information was not provided.   This case was linked to MOD-2022-540072, MOD-2022-540077, MOD-2022-540079 (Patient Link).   Reporter did not allow further contact
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Influenza like illness, Myalgia
Clinical narrative: Flu like symptoms; Little soreness; This spontaneous case was reported by a physician and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) and MYALGIA (Little soreness) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient never had COVID-19 test or diagnosis. The patient's concurrent medical condition includes Blood pressure since an unknown date.  Concurrent medical conditions included Environmental allergy.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) and MYALGIA (Little soreness). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) and MYALGIA (Little soreness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications includes blood pressure medications (Unknown). Treatment information was not provided.   This case was linked to MOD-2022-540072, MOD-2022-540077, MOD-2022-540079 (Patient Link).   Reporter did not allow further contact
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: administered the full dose of the Moderna vaccine as her second booster; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (administered the full dose of the Moderna vaccine as her second booster) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    In April 2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. In April 2022, the patient experienced ACCIDENTAL OVERDOSE (administered the full dose of the Moderna vaccine as her second booster). At the time of the report, ACCIDENTAL OVERDOSE (administered the full dose of the Moderna vaccine as her second booster) outcome was unknown.            Patient was over 50 years old and had their 4th Moderna this morning. It was reported that patient was administered the full dose of the Moderna vaccine as her second booster. No concomitant medication information provided. No treatment medication information provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2022: Follow-up received contained no new information.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pain
Clinical narrative: little soreness; flu like symptoms; This spontaneous case was reported by a physician and describes the occurrence of PAIN (little soreness) and INFLUENZA LIKE ILLNESS (flu like symptoms) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048C21A and 023M20A) for COVID-19 vaccination.     Concurrent medical conditions included Environmental allergy.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, 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 PAIN (little soreness) and INFLUENZA LIKE ILLNESS (flu like symptoms). At the time of the report, PAIN (little soreness) and INFLUENZA LIKE ILLNESS (flu like symptoms) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication reported included unknown drug for blood pressure.  It was reported that patient has never been diagnosed/tested positive for COVID-19.  No treatment information was provided.   This case was linked to MOD-2022-540074, MOD-2022-540079, MOD-2022-540072 (Patient Link).   Reporter did not allow further contact
Age: 40.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration, Product temperature excursion issue
Clinical narrative: Patient administered with vaccine that have undergone temperature excursion; First dose on 30-Nov-2021 and second dose on 04-Feb-2022; Patient administered with vaccine that have undergone temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered with vaccine that have undergone temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered with vaccine that have undergone temperature excursion) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 30-Nov-2021 and second dose on 04-Feb-2022) in a 40-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Nov-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 04-Feb-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered with vaccine that have undergone temperature excursion) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 30-Nov-2021 and second dose on 04-Feb-2022). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered with vaccine that have undergone temperature excursion). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered with vaccine that have undergone temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered with vaccine that have undergone temperature excursion) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 30-Nov-2021 and second dose on 04-Feb-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment medications were not provided.  The expiry date of vial was reported as 27-Mar-2022 and also reported that the vial was thawed on 28-Jan-2022. It was reported that vial were stored in refrigerator at the time of the excursion and maximum or minimum temperature reached as on 28-Jan-2022 temp range: positive 34.7 F to positive 41.2 F; on 30-Jan-2022 temp range: positive 34.7 F to positive 41.2 F which occurred approximately for 48 hours; on 31-Jan-2022 temp range: positive 34.7 F to positive 41.2 F for 12 hours and on 04-Feb-2022 temp range: positive 35.2 F to positive 41.7 F for 12 hours. It was also reported that all vials were administered and patient reported no other adverse events.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, Viral rash
Clinical narrative: mildly diffused viral exanthem; mildly itchy rash from neck to thighs; This spontaneous case was reported by a physician and describes the occurrence of VIRAL RASH (mildly diffused viral exanthem) and RASH PRURITIC (mildly itchy rash from neck to thighs) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065K21A, 048C21A and 023M20A) for COVID-19 vaccination.     The patient had never been diagnosed with/ tested positive for COVID-19.  Concurrent medical conditions included Blood pressure abnormal and Environmental allergy.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2022, the patient experienced VIRAL RASH (mildly diffused viral exanthem) and RASH PRURITIC (mildly itchy rash from neck to thighs). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) for Rash, at an unspecified dose and frequency. At the time of the report, VIRAL RASH (mildly diffused viral exanthem) and RASH PRURITIC (mildly itchy rash from neck to thighs) was resolving.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication included unspecified drug for blood pressure. It was reported that, 48 hours after the 2nd booster dose she experienced mildly diffused viral exanthem which she depicted as mildly itchy rash from neck to thighs. She still had it, but it was resolving.   This case was linked to MOD-2022-540077, MOD-2022-540074 (Patient Link).   Reporter did not allow further contact
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Headache
Clinical narrative: Dizziness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and HEADACHE (Headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient never had COVID-19 test or diagnosis and did not took other vaccines within 1 month prior to Moderna COVID-19 vaccine. The patient's concurrent medical condition includes Blood pressure.  The patient's past medical history included Mitral valve replacement (15 years ago). Concurrent medical conditions included Drug allergy (Beta blockers (some)), Diabetes, Cholesterosis, Heart disorder and Glaucoma. Concomitant products included WARFARIN SODIUM (JANTOVEN) for Anticoagulant therapy, HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN HCTZ) for Blood pressure management, METOPROLOL SUCCINATE for Cardiac disorder, SIMVASTATIN for Cholesterosis, GLIMEPIRIDE for Diabetes, LATANOPROST and BRIMONIDINE for Glaucoma.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 23-Jan-2021, the patient experienced DIZZINESS (Dizziness) and HEADACHE (Headache). On 27-Jan-2021, DIZZINESS (Dizziness) and HEADACHE (Headache) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient stated that AE did not cause patient to seek medical care and patient did not experienced similar events in the past. Patient also stated that due to a mitral valve issue that was diagnosed about 15 years ago she was put on blood thinners once she had the surgery for the mechanical heart valve. Recent status was reported as Stable. Due to this issue, her doctors have categorized her as a high risk patient. She had an increased chance of getting serious infections for even smaller infections like sinus.  No treatment medication information was provided.   This case was linked to MOD-2022-540353, MOD-2022-540288 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Delirium, Headache, Nausea, Pain
Clinical narrative: Dizziness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and HEADACHE (Headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient never had COVID-19 test or diagnosis and did not took other vaccines within 1 month prior to Moderna COVID-19 vaccine. The patient's concurrent medical condition includes Blood pressure.  The patient's past medical history included Mitral valve replacement (15 years ago). Concurrent medical conditions included Drug allergy (Beta blockers (some)), Diabetes, Cholesterosis, Heart disorder and Glaucoma. Concomitant products included WARFARIN SODIUM (JANTOVEN) for Anticoagulant therapy, HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN HCTZ) for Blood pressure management, METOPROLOL SUCCINATE for Cardiac disorder, SIMVASTATIN for Cholesterosis, GLIMEPIRIDE for Diabetes, LATANOPROST and BRIMONIDINE for Glaucoma.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 23-Jan-2021, the patient experienced DIZZINESS (Dizziness) and HEADACHE (Headache). On 27-Jan-2021, DIZZINESS (Dizziness) and HEADACHE (Headache) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient stated that AE did not cause patient to seek medical care and patient did not experienced similar events in the past. Patient also stated that due to a mitral valve issue that was diagnosed about 15 years ago she was put on blood thinners once she had the surgery for the mechanical heart valve. Recent status was reported as Stable. Due to this issue, her doctors have categorized her as a high risk patient. She had an increased chance of getting serious infections for even smaller infections like sinus.  No treatment medication information was provided.   This case was linked to MOD-2022-540353, MOD-2022-540288 (Patient Link).