chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Product storage error; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Product storage error) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Product storage error) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter  It was mentioned that the vial was initially refrigerated on 26-Oct-2021, the vial did not undergo any temperature excursion and patient did not experienced any adverse events.  No treatment medication was provided by the reporter.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine expired on 13-Oct-2021 and then stored in refrigerator on 26-Oct-2021; dose was given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose was given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13-Oct-2021 and then stored in refrigerator on 26-Oct-2021) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose was given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 13-Oct-2021 and then stored in refrigerator on 26-Oct-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose was given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13-Oct-2021 and then stored in refrigerator on 26-Oct-2021) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication of the patient was not reported. There was no temperature excursion. The reporter reported that that there was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned. The patient did not experience any adverse event.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-491837 (Patient Link).
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine expired on 13-Oct-2021 and then stored in refrigerator on 18-Oct-2021; dose was given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose was given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13-Oct-2021 and then stored in refrigerator on 18-Oct-2021) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose was given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 13-Oct-2021 and then stored in refrigerator on 18-Oct-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose was given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13-Oct-2021 and then stored in refrigerator on 18-Oct-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter was infection control manager.  Concomitant medication of the patient was not reported.  There was no temperature excursion. The reporter reported that that there was a confusion between the expiration date printed in the carton and the expiration date when the code was scanned.  The patient did not experience any adverse event.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-491837 (Patient Link).
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: 606 doses were given after expiration date; Vaccine was stored after expiration date in the refrigerator; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine was stored after expiration date in the refrigerator) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored after expiration date in the refrigerator). On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine was stored after expiration date in the refrigerator) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications and treatment were reported.  No adverse events reported.   No temperature excursion of the product was reported.  There was no product complaint associated. Vaccine was refrigerated on 18-Oct-2021.   This case was linked to MOD-2022-491837 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine stored in refrigerator on 18-Oct-2021, expired product 13-Oct-2021, administered date on 26-Oct-2022; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 18-Oct-2021, expired product 13-Oct-2021, administered date on 26-Oct-2022) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 18-Oct-2021, expired product 13-Oct-2021, administered date on 26-Oct-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 18-Oct-2021, expired product 13-Oct-2021, administered date on 26-Oct-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.   On 18-Oct-2021, the vial was initially stored in the refrigerator. The Vial did not go undergo any temperature excursion. The patient received the booster dose. The patient had no any adverse event post administration of expired vaccine.  Treatment information was not provided.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Dose was given after expiration date; expired vaccine is stored and then administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date) and PRODUCT STORAGE ERROR (expired vaccine is stored and then administered) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced PRODUCT STORAGE ERROR (expired vaccine is stored and then administered). On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date) and PRODUCT STORAGE ERROR (expired vaccine is stored and then administered) 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 patient had not experienced any adverse event and No Temp excursion was happened to the suspect vaccine.  The product was placed in refrigerator on 18-Oct-2021.   This case was linked to MOD-2022-491837 (Patient Link).
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine expired on 13-Oct-2021 and placed in refrigerator on 18-Oct-2021; Doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13-Oct-2021 and placed in refrigerator on 18-Oct-2021) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 13-Oct-2021 and placed in refrigerator on 18-Oct-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13-Oct-2021 and placed in refrigerator on 18-Oct-2021) 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 there was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned. No adverse events were reported. Vial did not undergo any temperature excursion. Vial was placed in refrigerator on 18-Oct-2021.  No treatment medications were reported.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: 606 doses were given after expiration date; Vaccine kept in refrigerator on 10/04/2021, expiration date is 10/13/2021, administered on 10/15/2021; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine kept in refrigerator on 10/04/2021, expiration date is 10/13/2021, administered on 10/15/2021) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Oct-2021, the patient experienced PRODUCT STORAGE ERROR (Vaccine kept in refrigerator on 10/04/2021, expiration date is 10/13/2021, administered on 10/15/2021). On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine kept in refrigerator on 10/04/2021, expiration date is 10/13/2021, administered on 10/15/2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  Date the vial was placed in the refrigerator was 04-Oct-2021. There was no temperature excursion. The reporter reported that that there was a confusion between the expiration date printed in the carton and the expiration date when the code was scanned.  The patient did not experience any adverse event.  No treatment information was provided by the reporter.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous case reported by a nurse, describes the occurrence of administered expired product (606 doses given after expiration date/received expired dose beyond expiry date: Oct 3, 2021) and product storage error in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 043B21A) for COVID-19 immunization. No medical history reported. On Dec 3, 2021, patient received the 3rd dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Dec 3, 2021, patient administered expired product (606 doses given after expiration date/received expired dose beyond expiry date: Oct 3, 2021). On an unknown date, patient experienced product storage error. At the time of the report, administered expired product (606 doses given after expiration date/received expired dose beyond expiry date: Oct 3, 2021) and product storage error outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. The vial placed in the refrigerator on Dec 28, 2021, did not undergo any temperature excursion. The patient did not experience any adverse event.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired vaccine greater than 12 hours post puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired vaccine greater than 12 hours post puncture) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired vaccine greater than 12 hours post puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired vaccine greater than 12 hours post puncture) 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 treatment medications were reported.  Patient in their 30's received vaccine which is initially stored in refrigerator on 03-Mar-2022, on 07-Mar-2022 at 05:00 PM vial was initially punctured and stored in room temperature range (8 degree to 25 degree C, 46 degree to 77 degree F) for about 20 hours, on 08-Mar-2022 two patients got vaccinated at 12:45PM and 01:17PM. It mentioned that the vial did not undergo any temperature excursions.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F); Dose administered greater than 12 hours post puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours post puncture) and PRODUCT STORAGE ERROR (Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F)) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2022 at 1:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2022 at 1:00 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours post puncture) and PRODUCT STORAGE ERROR (Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°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. On 07-Mar-2021 at 09:18 AM vial was initially punctured and kept at room temperature range (8 degree to 25 degree C, 46 degree  to 77 degree F) for about 28 hours. It mentioned that the vial did not undergo any temperature excursions.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Mar-2022: Significant information: Suspect drug details updated.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Patient received a COVID-19 vaccine and still got COVID-19 after that; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Patient received a COVID-19 vaccine and still got COVID-19 after that) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Patient received a COVID-19 vaccine and still got COVID-19 after that). At the time of the report, COVID-19 (Patient received a COVID-19 vaccine and still got COVID-19 after that) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.  Company comment: This spontaneous case concerns a female patient of unknown age with no medical history reported, who experienced nonserious unexpected AESI event of COVID 19, unspecified days after receiving a dose of mRNA-1273. It is reported that patient received a COVID-19 vaccine and still got COVID-19 after that, and the patient did not know if she received Moderna COVID-19 Vaccine. At the time of reporting, outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient of unknown age with no medical history reported, who experienced nonserious unexpected AESI event of COVID 19, unspecified days after receiving a dose of mRNA-1273. It is reported that patient received a COVID-19 vaccine and still got COVID-19 after that, and the patient did not know if she received Moderna COVID-19 Vaccine. At the time of reporting, outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired vaccine 12 hours post puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired vaccine 12 hours post puncture) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired vaccine 12 hours post puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired vaccine 12 hours post puncture) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The pharmacist was calling to report that two patients in their 30's received expired booster of Moderna. The dose was administered >12 post puncture. The date the vial was initially stored in the refrigerator was 03-Mar-2022. The date and time the vial first punctured was 07-Mar-2022 at 5PM. The date and time of administration of vaccine was on 08-Mar-2022 at 12:45PM and 1:17PM. The vial was stored in room temperature post puncture.   Reportedly, the vial didn't undergo any temperature excursions. The total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) was about 20 hours.  It was also reported that the vial was not exposed to room temperature for more than 24 hours.  No treatment information was provided.   This case was linked to MOD-2022-505347 (Patient Link).
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Myalgia, Pain in extremity
Clinical narrative: both of his lower extremities (below knee) has muscle aches and pain; both of his lower extremities (below knee) has muscle aches and pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (both of his lower extremities (below knee) has muscle aches and pain) and MYALGIA (both of his lower extremities (below knee) has muscle aches and pain) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Cholesterol total abnormal NOS.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (both of his lower extremities (below knee) has muscle aches and pain) and MYALGIA (both of his lower extremities (below knee) has muscle aches and pain). At the time of the report, PAIN IN EXTREMITY (both of his lower extremities (below knee) has muscle aches and pain) and MYALGIA (both of his lower extremities (below knee) has muscle aches and pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: normal (normal) Normal.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications included high blood pressure medication and cholesterol medications.  Patient weight reported as 185. Patient had been to many specialists and  ruled out all other conditions. Patient visited neurologist, RA doctor, cardiologist, orthopedist.  They recommended patient to get physical therapy.   This case was linked to MOD-2022-505549, MOD-2022-505568 (Patient Link).
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Myalgia, Pain
Clinical narrative: it got worse; pain was from hamstrings to down below ankles; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (it got worse) and MYALGIA (pain was from hamstrings to down below ankles) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 027A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced PAIN (it got worse) and MYALGIA (pain was from hamstrings to down below ankles). In October 2021, PAIN (it got worse) and MYALGIA (pain was from hamstrings to down below ankles) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2021, Magnetic resonance imaging: normal normal.         Concomitant medications included high blood pressure medication and cholesterol medications.  The patient had been to many specialists and they ruled out all other conditions.  He saw neurologist, RA doctor, cardiologist, orthopedist.  The patient was recommended to get physical therapy.   This case was linked to MOD-2022-505486, MOD-2022-505568 (Patient Link).
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Joint stiffness, Myalgia, Pain in extremity
Clinical narrative: Gait is crippled, crippled until he takes a few steps to warm up; stiffness of the knee,he cannot bend his knee well to take a step; both of his lower extremities (below knee) has muscle pain and pain; both of his lower extremities (below knee) has muscle aches/Pain was from hamstrings to down below ankles; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Gait is crippled, crippled until he takes a few steps to warm up), JOINT STIFFNESS (stiffness of the knee,he cannot bend his knee well to take a step), PAIN IN EXTREMITY (both of his lower extremities (below knee) has muscle pain and pain) and MYALGIA (both of his lower extremities (below knee) has muscle aches/Pain was from hamstrings to down below ankles) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (on high blood pressure medication) and Blood cholesterol abnormal (on Cholesterol Medications.).    On 09-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Dec-2021, the patient experienced GAIT DISTURBANCE (Gait is crippled, crippled until he takes a few steps to warm up), JOINT STIFFNESS (stiffness of the knee,he cannot bend his knee well to take a step), PAIN IN EXTREMITY (both of his lower extremities (below knee) has muscle pain and pain) and MYALGIA (both of his lower extremities (below knee) has muscle aches/Pain was from hamstrings to down below ankles). At the time of the report, GAIT DISTURBANCE (Gait is crippled, crippled until he takes a few steps to warm up), JOINT STIFFNESS (stiffness of the knee,he cannot bend his knee well to take a step), PAIN IN EXTREMITY (both of his lower extremities (below knee) has muscle pain and pain) and MYALGIA (both of his lower extremities (below knee) has muscle aches/Pain was from hamstrings to down below ankles) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The concomitant medications included unspecified medications for High blood pressure and Cholesterol.  No Treatment medications reported   This case was linked to MOD-2022-505486, MOD-2022-505549 (Patient Link).
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired dose administered (booster); This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered (booster)) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048L21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: J&J (First dose) on 12-Mar-2021. Past adverse reactions to the above products included No adverse event with J&J.    On 08-Mar-2022 at 9:45 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 08-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered (booster)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered (booster)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter.  No treatment details were provided.  Patient height  was reported as 5'6". It was reported that the dose was administered more than 12(US) hours post puncture. The vial was initially stored in the refrigerator on 07-Mar-2022 and vial was first punctured 07-Mar-2022 at 2:30 PM. Vaccine did not undergo any temperature excursions the vial was exposed to room temperature range (8 degree Celsius to 25 degree Celsius equal to 46 degree to 77 degree Fahrenheit) under 5 minutes per HCP.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: Rash that never go away; Dermatologist diagnosed Dermatographism itchy rash; This spontaneous case was reported by a physician and describes the occurrence of RASH (Rash that never go away) and RASH PRURITIC (Dermatologist diagnosed Dermatographism itchy rash) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 060H21A, 010M20A and 10323711) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu vaccine in 2020. Past adverse reactions to the above products included No adverse event with Flu vaccine. Concurrent medical conditions included Drug allergy (Zyban), Pernicious anemia and Fibroids.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Dec-2021, the patient experienced RASH (Rash that never go away) and RASH PRURITIC (Dermatologist diagnosed Dermatographism itchy rash). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA 24 HOUR) on 06-Jan-2022 for Rash and Itchy rash, at a dose of 180 milligram, once a day and HYDROXYZINE on 06-Jan-2022 for Rash and Itchy rash, at a dose of 10 milligram twice a day. At the time of the report, RASH (Rash that never go away) and RASH PRURITIC (Dermatologist diagnosed Dermatographism itchy rash) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient reported that she never tested positive for Covid-19. No concomitant medications were reported.
Age: 66.0
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain in extremity
Clinical narrative: sore arm; feeling like eh after the booster dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and FEELING ABNORMAL (feeling like eh after the booster dose) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and FEELING ABNORMAL (feeling like eh after the booster dose). At the time of the report, PAIN IN EXTREMITY (sore arm) and FEELING ABNORMAL (feeling like eh after the booster dose) outcome was unknown.            No concomitant medication information was provided. No treatment medication information was provided.   This case was linked to MOD-2022-505839 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 08-Mar-2022: Follow-up received Email doc attached to the initial version.
Age: 66.0
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: felt like death on a cracker; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt like death on a cracker) in a 66-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 second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (felt like death on a cracker). At the time of the report, FEELING ABNORMAL (felt like death on a cracker) outcome was unknown.      No Concomitant information was reported.  No Treatment information was reported.   This case was linked to MOD-2022-505816 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 08-Mar-2022: Non-significant follow up appended due to email doc attached to the initial version.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Inadvertently administered booster dose of vaccine from a punctured vial that was left out overnight for 26 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Inadvertently administered booster dose of vaccine from a punctured vial that was left out overnight for 26 hours) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: J and J vaccine (First dose) on 21-Apr-2021. Past adverse reactions to the above products included No adverse event with J and J vaccine.    On 08-Mar-2022 at 2:20 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Inadvertently administered booster dose of vaccine from a punctured vial that was left out overnight for 26 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Inadvertently administered booster dose of vaccine from a punctured vial that was left out overnight for 26 hours) 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 Treatment medications were reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: immunocompromise patient received a booster instead of a Third dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (immunocompromise patient received a booster instead of a Third dose) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 27-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Aug-2021, the patient experienced ACCIDENTAL UNDERDOSE (immunocompromise patient received a booster instead of a Third dose). At the time of the report, ACCIDENTAL UNDERDOSE (immunocompromise patient received a booster instead of a Third dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was mentioned that patient had no Allergies to medications, food and other products. Patient had not experienced similar events in past.  Concomitant medications details were not reported by the reporter.  Patient did not seek any medical care (office visit, Urgent care, ER and hospitalized) for the adverse event.  Reportedly, Bone marrow specialist recommend the patient to get the booster.  Treatment details was not reported by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Immunocompromised patient received Moderna booster dose as third dose in series; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Immunocompromised patient received Moderna booster dose as third dose in series) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    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 ACCIDENTAL UNDERDOSE (Immunocompromised patient received Moderna booster dose as third dose in series). At the time of the report, ACCIDENTAL UNDERDOSE (Immunocompromised patient received Moderna booster dose as third dose in series) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  It was reported that the patient got her first two doses of Moderna booster. Instead of signing-up for immunocompromise, instead of getting the full dose the patient got the half dose. Reporter stated that they are the pharmacy that gave patient's first, second and booster dose.  No treatment information was provided by the reporter.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 08-Mar-2022: Follow-up received and included no new information.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: immunocompromised patient received booster dose, instead of third dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (immunocompromised patient received booster dose, instead of third dose) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006d21a, 038a21a and 006m20a) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: Flu shot (Sanofi Pasteur high dose Flu shot was given intramuscularly (Lot: UJ74AA)) on 05-Oct-2021. Past adverse reactions to the above products included No adverse event with Flu shot. Concurrent medical conditions included Rheumatoid arthritis.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL UNDERDOSE (immunocompromised patient received booster dose, instead of third dose). At the time of the report, ACCIDENTAL UNDERDOSE (immunocompromised patient received booster dose, instead of third dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had no known allergies.  The patient took unknown medication for rheumatoid arthritis.  No treatment information was provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Patient is immunocompromised, given 0.25 ml instead of 0.5 ml for 3rd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient is immunocompromised, given 0.25 ml instead of 0.5 ml for 3rd dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient is immunocompromised, given 0.25 ml instead of 0.5 ml for 3rd dose). At the time of the report, ACCIDENTAL UNDERDOSE (Patient is immunocompromised, given 0.25 ml instead of 0.5 ml for 3rd dose) outcome was unknown.  or mRNFA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Treatment medication was not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Electrolyte imbalance, Muscle spasms, Pyrexia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of muscle spasms (cramping), electrolyte imbalances and pyrexia (she experienced fever) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced muscle spasms (cramping), electrolyte imbalances and pyrexia (she experienced fever). At the time of the report, muscle spasms (cramping), electrolyte imbalances and pyrexia (she experienced fever) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information provided.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: 2nd dose administered to a pregnant patient; This spontaneous prospective pregnancy case was reported by a pharmacist and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (2nd dose administered to a pregnant patient) in a 27-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 042J21A and 066H21A) for COVID-19 vaccination.     Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 08-Feb-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 08-Mar-2022, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 08-Mar-2022, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (2nd dose administered to a pregnant patient). On 08-Mar-2022, MATERNAL EXPOSURE DURING PREGNANCY (2nd dose administered to a pregnant patient) had resolved.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication was reported. No medical history was provided.  It was reported that it was unknown whether patient had any allergies, whether patient had any COVID positive diagnosis. Also It was unknown if patient had any Acute and Chronic illnesses at the time of vaccination. I t was unknown if patient was administered with any other vaccines within 1 month prior to Moderna COVID-19 vaccine. 2nd dose of vaccine was administrated after 28days since the storage. Last menstrual period or due date of the patient was unknown.
Age: 54.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Inappropriate schedule of product administration
Clinical narrative: First dose on 16-Mar-21 and second dose on 21-Apr-21; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 16-Mar-21 and second dose on 21-Apr-21) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product INFLUENZA VACCINE INACT SPLIT 4V (FLUARIX QUADRIVALENT) for an unknown indication.    Concurrent medical conditions included Immunocompromised, Psoriatic arthritis, Kidney atrophic, Hepatitis C, Premature ovarian failure, Elevated liver enzymes, Osteoporosis, Insomnia, Depression and Psoriasis. Concomitant products included SERTRALINE for Depression, MIRTAZAPINE for Insomnia, ALENDRONATE SODIUM (ALENDRONATE) for Osteoporosis, DUPILUMAB for Psoriasis, CELECOXIB (CELEBREX) for Psoriatic arthritis.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient received first dose of INFLUENZA VACCINE INACT SPLIT 4V (FLUARIX QUADRIVALENT) (Intramuscular) 1 dosage form. On 21-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 16-Mar-21 and second dose on 21-Apr-21). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 16-Mar-21 and second dose on 21-Apr-21) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient weight was reported as 13 pounds.  Patient had no allergies to medications, food and other products. Patient had no acute illnesses at the time of vaccination and up to one month before.  No treatment medication was provided.   This case was linked to MOD-2022-496302 (Patient Link).
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: after getting the 1st dose, he was diagnosed to have Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (after getting the 1st dose, he was diagnosed to have Covid-19) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (after getting the 1st dose, he was diagnosed to have Covid-19). At the time of the report, COVID-19 (after getting the 1st dose, he was diagnosed to have Covid-19) 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.   Concomitant medication list was not provided. Treatment information was not provided. The patient received his 1st dose of moderna covid-19 vaccine sometime late dec-2020 or early jan-2021.   Company comment: This is a spontaneous case concerning a 83-year-old, male patient with no relevant medical condition, who experienced the unexpected non-serious AESI event of Covid-19. The event Covid-19 exact occurrence was unknown but stated that the event occurred after the first dose of mRNA-1273 vaccine administration. No reported treatment information. The outcome of the event was unknown. The patient's age, incomplete primary dose of mRNA-1273 vaccine and current Covid-19 pandemic remains confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-506968 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 83-year-old, male patient with no relevant medical condition, who experienced the unexpected non-serious AESI event of Covid-19. The event Covid-19 exact occurrence was unknown but stated that the event occurred after the first dose of mRNA-1273 vaccine administration. No reported treatment information. The outcome of the event was unknown. The patient's age, incomplete primary dose of mRNA-1273 vaccine and current Covid-19 pandemic remains confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.