chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: hand shaking; low grade temperature; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (hand shaking) and PYREXIA (low grade temperature) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMIN D [VITAMIN D NOS] and VITAMIN B NOS for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TREMOR (hand shaking) and PYREXIA (low grade temperature). At the time of the report, TREMOR (hand shaking) and PYREXIA (low grade temperature) outcome was unknown.            Treatment information was not provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort
Clinical narrative: Joints in his 2 hands that his bothering him; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (Joints in his 2 hands that his bothering him) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis.    In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (Joints in his 2 hands that his bothering him). In 2021, MUSCULOSKELETAL DISCOMFORT (Joints in his 2 hands that his bothering him) had resolved.            Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.  It was reported that 8 joints in his 2 hands that his bothering him. Patient thought it was bizarre that he had arthritis in the same joint. The side effect started after the 2nd dose, it lasted about a week and it all gone.   This case was linked to MOD-2021-270609 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Received a dose of the Moderna vaccine more than 30 days on the fridge.; Expired vaccine used; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Received a dose of the Moderna vaccine more than 30 days on the fridge.) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received a dose of the Moderna vaccine more than 30 days on the fridge.) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, PRODUCT STORAGE ERROR (Received a dose of the Moderna vaccine more than 30 days on the fridge.) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 17-Nov-2021: Follow-up received contains description of the event. Updated the event description in the I-narrative. Deleted previously captured  event Expired vaccine used.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Diplopia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of diplopia (woke up with double vision) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine, batch/lot# 004F21A, 039K202A and 026A21A) for COVID-19 immunization. No medical history reported. Concomitant products included Paracetamol (acetaminophen) for an unknown indication. On Feb 4, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 4, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Oct 26, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Oct 29, 2021, patient experienced diplopia (woke up with double vision). At the time of the report, diplopia (woke up with double vision): not resolved. No treatment medications reported. This case linked to MOD-2021-386478, MOD-2021-386431 (patient link).
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Maternal exposure during pregnancy
Clinical narrative: sore arm; 25 weeks pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (sore arm) and MATERNAL EXPOSURE DURING PREGNANCY (25 weeks pregnant) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (allergic to codeine).    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 21-May-2021 and the estimated date of delivery was 25-Feb-2022. On 05-Nov-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (25 weeks pregnant). On an unknown date, the patient experienced INJECTION SITE PAIN (sore arm). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-fourth week of the pregnancy.  On 05-Nov-2021, MATERNAL EXPOSURE DURING PREGNANCY (25 weeks pregnant) had resolved. At the time of the report, INJECTION SITE PAIN (sore arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication were provided Company Comment : This spontaneous case of maternal exposure during pregnancy concerns a 37-year-old female patient with no relevant medical history who experienced non-serious expected event of injection site pain. The patient did not experience any adverse events associated with maternal exposure during pregnancy. The event injection site pain- occurred unspecified time after the third, booster dose of the Moderna COVID-19 vaccine . The patient was 25 weeks pregnant at the time of vaccination. Rechallenge was not applicable since  the event occurred after the third dose so, no rechallenge was done and recurrence was not applicable.  The benefit-risk relationship of drug is not affected by this report.; Sender's Comments: This spontaneous case of maternal exposure during pregnancy concerns a 37-year-old female patient with no relevant medical history who experienced non-serious expected event of injection site pain. The patient did not experience any adverse events associated with maternal exposure during pregnancy. The event injection site pain- occurred unspecified time after the third, booster dose of the Moderna COVID-19 vaccine . The patient was 25 weeks pregnant at the time of vaccination. Rechallenge was not applicable since  the event occurred after the third dose so, no rechallenge was done and recurrence was not applicable.  The benefit-risk relationship of drug is not affected by this report.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of vaccination site warmth (feels a couple of degrees warmer' than the surrounding skin), vaccination site swelling (raised, firm area where she received the booster) and vaccination site pain (area is tender to the touch) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# unknown) for COVID-19  immunization. No medical history reported. On Nov 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Nov 11, 2021, patient experienced vaccination site warmth (feels a couple of degrees warmer' than the surrounding skin), vaccination site swelling (raised, firm area where she received the booster) and vaccination site pain (area is tender to the touch). At the time of the report, vaccination site warmth (feels a couple of degrees warmer' than the surrounding skin), vaccination site swelling (raised, firm area where she received the booster) and vaccination site pain (area is tender to the touch) outcome: unknown. Reportedly, patient went to bed and waking up the next morning, she observed a raised, firm area where she received the booster. The area was tender to the touch and, from her description, it felt a couple of degrees warmer than the surrounding skin. No concomitant medication or treatment information reported.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Balance disorder, Thirst
Clinical narrative: This spontaneous case reported by an other healthcare professional, describes the occurrence of asthenia (feeling weak), balance disorder (unsteady) and thirst (felt thirsty) in a  patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced asthenia (feeling weak), balance disorder (unsteady) and thirst (felt thirsty). At the time of the report, asthenia (feeling weak), balance disorder (unsteady) and thirst (felt thirsty outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by an other health care professional and describes the occurrence of HEADACHE (Headache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 HEADACHE (Headache). At the time of the report, HEADACHE (Headache) 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. No Treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: This spontaneous case reported by a physician, describes the occurrence of headache in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced headache. At the time of the report, headache outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: This spontaneous case reported by a nurse, describes the occurrence of product temperature excursion issue (excursion from the freezer) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 939901) for COVID-19  immunization. No medical history reported. On Nov 8, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Nov 8, 2021, patient experienced product temperature excursion issue (excursion from the freezer). On Nov 8, 2021, product temperature excursion issue (excursion from the freezer): resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. There was an excursion from their freezer on Oct 1, 2021. They used the excursion tool but there was no option for the excursion they experienced. The tool only gives options for excursions above one hour and not less than, so she does not know how to do the analysis. She stated her team already knew the recommended temperatures and needed to know if the vials were still okay to be used because they were administered to 118 patients.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: There was an excursion from the freezer,vaccine administered to 118 patients; There was an excursion from the freezer,vaccine administered to 118 patients; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer,vaccine administered to 118 patients) and EXPIRED PRODUCT ADMINISTERED (There was an excursion from the freezer,vaccine administered to 118 patients) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (There was an excursion from the freezer,vaccine administered to 118 patients). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer,vaccine administered to 118 patients). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (There was an excursion from the freezer,vaccine administered to 118 patients) had resolved. At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer,vaccine administered to 118 patients) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported.     No treatment medications were reported.  There was an excursion from their freezer on 01-OCT-2021.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: There was an excursion from freezer; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from freezer) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from freezer). On 01-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from freezer) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   There was an excursion from the freezer on 01-Oct-2021 and the nurse used the excursion tool but there was no option for the excursion experienced. The only tool gave the options for excursion above one hour and not less than that so the nurse did not known about the analysis. The nurse stated that the team knew the recommended temperature and wanted to know whether the vials were still in a good condition to be used and were administered to 118 patients. The storage condition at the time of the excursion was frozen, vial size was 7.5 mL and maximum or minimum temperature mentioned as minimum minus 4.2 degree Farhenhit and maximum 5.7 degree Farhenhit. The excursion duration was 6 minutes. On visual inspection, the vials were thawed before administration and there were no color changes or anything abnormal. Total 10 vials or doses were impacted.  No concomitant medications were reported.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Follow up received on 15-Nov-2021 contain updated contact information.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: There was an excrusion from freezer; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excrusion from freezer) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excrusion from freezer). On 25-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excrusion from freezer) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   There was an excursion from the freezer on 01-Oct-2021 and the nurse used the excursion tool but there was no option for the excursion experienced. The only tool gave the options for excursion above one hour and not less than that so the nurse did not known about the analysis. The nurse stated that the team knew the recommended temperature and wanted to know whether the vials were still in a good condition to be used and were administered to 118 patients. The storage condition at the time of the excursion was frozen, vial size was 7.5 mL and maximum or minimum temperature mentioned as minimum minus 4.2 degree Fahrenheit and maximum 5.7 degree Fahrenheit. The excursion duration was 6 minutes. On visual inspection, the vials were thawed before administration and there were no color changes or anything abnormal. Total 10 vials or doses were impacted.  No concomitant medication was provided.            No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Follow up received on 15-Nov-2021 contain updated contact information, patient details and suspect product details
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: There was temperature excursion from their freezer on 01Oct2021; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was temperature excursion from their freezer on 01Oct2021) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was temperature excursion from their freezer on 01Oct2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (There was temperature excursion from their freezer on 01Oct2021) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided No treatment medication were reported  On 01-Oct-2021, There was temperature excursion from  freezer.   It was stated 10 Number of vials/doses were impacted. Storage condition at the time of the excursion was frozen and Minimum temperatures reached 4.2 degrees F and maximum was 5.7 degreed F and Excursion duration was 6 minutes.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: There was an excursion from the freezer; Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 01-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant and treatment medications are provided by the reporter.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case reported by a nurse, describes the occurrence of product temperature excursion issue (there was an excursion from the freezer) and administered expired product (expired vaccine used) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 939901) for COVID-19  immunization. No medical history reported. On Oct 25, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Oct 25, 2021, patient experienced product temperature excursion issue (there was an excursion from the freezer) and administered expired product (expired vaccine used). On Oct 25, 2021, product temperature excursion issue (there was an excursion from the freezer) and administered expired product (expired vaccine used) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: There was an excursion from the freezer; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer). On 25-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication provided No treatment medication provided  There was an excursion from the freezer on 01-Oct-2021 and the nurse used the excursion tool but there was no option for the excursion experienced. The only tool gave the options for excursion above one hour and not less than that so the nurse did not known about the analysis. The nurse stated that the team knew the recommended temperature and wanted to know whether the vials were still in a good condition to be used and were administered to 118 patients. The storage condition at the time of the excursion was frozen, vial size was 7.5 mL and maximum or minimum temperature mentioned as minimum minus 4.2 degree Farhenhit and maximum 5.7 degree Farhenhit. The excursion duration was 6 minutes. On visual inspection, the vials were thawed before administration and there were no color changes or anything abnormal. Total 10 vials or doses were impacted.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Follow up received on 15-Nov-2021 contains Patient demographics, Reporter details updated, Vaccine start date and Dose number of the vaccine.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: Product temperature excursion issue; Expired vaccine used; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Nov-2021 and was forwarded to Moderna on 10-Nov-2021.    This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 25-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.            No treatment information was provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: There was an excursion from the freezer; administered to 118 patients; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) and EXPIRED PRODUCT ADMINISTERED (administered to 118 patients) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) and EXPIRED PRODUCT ADMINISTERED (administered to 118 patients). On 25-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) and EXPIRED PRODUCT ADMINISTERED (administered to 118 patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was stated that, there was excursion from the freezer on 01-Oct-2021 and nurse used the excursion tool but there was no option for the excursion they experienced. The only tool gives the options for excursion above one hour and not less than that so the nurse dose not known about the analysis. The nurse stated that her team know the recommended temperature and wants to know if the vials were still okay to use because they were administered to 118 patients. The storage condition at the time of the excursion was frozen, vial size was 7.5 mL and maximum or minimum temperature reached was as follows; minimum 4.2 degree F and maximum 5.7 degree F. It was also stated that excursion duration was 6 minutes. On visual inspection the vials were thawed before administration and there were no color changes or anything abnormal. Total 10 vials/doses were impacted.  No concomitant medications were reported.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Significant follow-up-Patient demographics, Vaccine start date and Dose number of the vaccine were added
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: Product temperature excursion issue; Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 01-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication provided.  There was an excursion from their freezer on 01-Oct-2021. They used the excursion tool but there is no option for the excursion they experienced. The tool only gives options for excursions above one hour and not less than, so she does not knowhow to do the analysis. She states that her team already knows the recommended temperatures and wants to know if the vials were still okay to be used because they were administered to 118 patients. No treatment medication provided.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: excursion from the freezer/administered to 118 patients(25Oct2021- 49 given ); This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (excursion from the freezer/administered to 118 patients(25Oct2021- 49 given )) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (excursion from the freezer/administered to 118 patients(25Oct2021- 49 given )). On 25-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (excursion from the freezer/administered to 118 patients(25Oct2021- 49 given )) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Additional information contain included patient  and suspect details
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: Excursion from the freezer; Administered to 118 patients (08Nov2021- 14 given); This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion from the freezer) and EXPIRED PRODUCT ADMINISTERED (Administered to 118 patients(08Nov2021- 14 given)) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion from the freezer) and EXPIRED PRODUCT ADMINISTERED (Administered to 118 patients(08Nov2021- 14 given)). On 08-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion from the freezer) and EXPIRED PRODUCT ADMINISTERED (Administered to 118 patients(08Nov2021- 14 given)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was given.  No treatment medication was given. There was an excursion from their freezer on 01-Oct-2021.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Additional information includes patient demographics, Dose details were added
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination. No Medical History information was reported. On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer). On 01-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) had resolved. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   There was excursion from their freezer on 01-Oct-2021. Storage condition at the time of the excursion: Frozen. Vial size: 7.5 mL. Maximum and minimum temperatures reached : Minimum:-4.2 degrees F; Maximum 5.7 degrees F. Excursion duration: 6 minutes.  No concomitant medication was provided.  No treatment medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Additional information contain included patient and suspect details.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: Product temperature excursion issue; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue). On 25-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided by the reporter. Treatment medication was not reported.  Patient reports that maximum or minimum temp reached as applicable(specify temp is in C or F)-minimum:-4.2 degrees F; Maximum : 5.7 degreed F and Excursion duration- 6 minutes. There was another excursion that happened in September. HCP stated it was at 5 point something for a couple of minutes.   This case was linked to MOD-2021-383410 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Added patient details(initials,age,gender) and vaccine information (dose number, date of vaccination)
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: This spontaneous case reported by a nurse, describes the occurrence of product temperature excursion issue (there was an excursion from the freezer) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 939901) for COVID-19 immunization. No medical history reported. On Oct 25, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine, unknown route; 1 dosage form. On Oct 25, 2021, patient experienced product temperature excursion issue (there was an excursion from the freezer). On Oct 25, 2021, product temperature excursion issue (there was an excursion from the freezer) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. Reportedly, there was excursion from the freezer on Oct 1, 2021. Storage condition at the time of the excursion: frozen. Maximum and minimum temperatures reached: Minimum: 4.2 degrees F; maximum 5.7 degrees F. Excursion duration-6 minutes. This case linked to MOD-2021-383410 (patient link). Most recent follow-up information incorporated: On Nov 15, 2021: Significant follow-up: Patient demographics, vaccine start date and dose number of the vaccine added.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: Product temperature excursion issue; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue). On 01-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  It was reported that there was excursion from their freezer on 01-Oct-2021. Storage condition at the time of the excursion was frozen.   Maximum and minimum temperatures reached-Minimum-4.2 degrees F Maximum 5.7 degrees F.  Excursion duration-6 minutes.  Treatment medication was not provided by the reporter.   This case was linked to MOD-2021-383410 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Follow up received contains patient demographics, vaccine start date and dose details.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: This spontaneous case reported by a nurse, describes the occurrence of product temperature excursion issue in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 939901) for COVID-19 immunization. No medical history reported. On Nov 8, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Nov 8, 2021, patient experienced product temperature excursion issue. On Nov 8, 2021, product temperature excursion issue: resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. Reportedly, there was excursion from the freezer on Oct 1, 2021. Storage condition at the time of the excursion was frozen. Maximum and minimum temperatures reached: Minimum: 4.2 degrees F; maximum 5.7 degrees F. Excursion duration: 6 minutes. This case linked to MOD-2021-383410 (patient link). Most recent follow-up information incorporated above included: On Nov 15, 2021: Follow-up received contained patient demographics, vaccine start date and dose details.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: There was an excursion from the freezer; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer). On 25-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) had resolved. 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.   This case was linked to MOD-2021-383410 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Follow-up received contains patient demographics, vaccine start date and dose details
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case reported by a nurse, describes the occurrence of product temperature excursion issue (there was an excursion from the freezer) and administered expired product (there was an excursion from the freezer) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 939901) for COVID-19 immunization. No medical history reported. On Oct 25, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Oct 25, 2021, patient administered expired product (there was an excursion from the freezer). On an unknown date, patient experienced product temperature excursion issue (there was an excursion from the freezer). On Oct 25, 2021, administered expired product (there was an excursion from the freezer) resolved. At the time of the report, product temperature excursion issue (there was an excursion from the freezer) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. There was an excursion from the freezer on Oct 1, 2021. Most recent follow-up information incorporated: On Nov 15, 2021: Patient details received.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: Product temperature excursion issue; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue). On 25-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Non-significant follow up received on 15-Nov-2021, Contact information updated.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: There was temperature excursion from their freezer on 01Oct2021; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was temperature excursion from their freezer on 01Oct2021) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was temperature excursion from their freezer on 01Oct2021). On 25-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was temperature excursion from their freezer on 01Oct2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: There was an excursion from the freezer; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer). On 01-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: There was excursion from the freezer on 01Oct2021; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was excursion from the freezer on 01Oct2021) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was excursion from the freezer on 01Oct2021). On 25-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was excursion from the freezer on 01Oct2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported. There was an excursion from the freezer on 01-Oct-2021 and the vaccine was administered to the patient on 25-10-2021.   This case was linked to MOD-2021-383410 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Follow-up received on 15 Nov 2021 contains patient demographics, vaccine start date and dose details.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: There was temperature excursion from their freezer on 01Oct2021; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was temperature excursion from their freezer on 01Oct2021) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was temperature excursion from their freezer on 01Oct2021). On 01-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was temperature excursion from their freezer on 01Oct2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Medications details were provided. No Treatment Medications details were provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Contact information updated.