chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: 2 second doses administered after exposure to room temperature greater than 24 hours; 2 second doses administered after exposure to room temperature greater than 24 hours; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2 second doses administered after exposure to room temperature greater than 24 hours) and PRODUCT TEMPERATURE EXCURSION ISSUE (2 second doses administered after exposure to room temperature greater than 24 hours) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (2 second doses administered after exposure to room temperature greater than 24 hours) and PRODUCT TEMPERATURE EXCURSION ISSUE (2 second doses administered after exposure to room temperature greater than 24 hours). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (2 second doses administered after exposure to room temperature greater than 24 hours) and PRODUCT TEMPERATURE EXCURSION ISSUE (2 second doses administered after exposure to room temperature greater than 24 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. No treatment details were reported.  Storage condition at the time of the excursion: refrigerated storage. Maximum temperature reached: 10 degrees Celsius. Excursion duration: 1 hour 20 minutes. Date vial(s) moved from freezer to refrigerator: 01-Oct-2021.   This case was linked to MOD-2021-374033, MOD-2021-373996, MOD-2021-374534, MOD-2021-373961, MOD-2021-374033 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm is still sore; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm is still sore) 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 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 PAIN IN EXTREMITY (arm is still sore). At the time of the report, PAIN IN EXTREMITY (arm is still sore) had not resolved.            No concomitant medications were reported. No treatment details were reported.   Reporter did not allow further contact
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vaccination complication
Clinical narrative: I had an average reaction to first shot; Had medium sized fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (I had an average reaction to first shot), FATIGUE (Had medium sized fatigue) and HEADACHE (Headache) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (I had an average reaction to first shot), FATIGUE (Had medium sized fatigue) and HEADACHE (Headache). At the time of the report, VACCINATION COMPLICATION (I had an average reaction to first shot), FATIGUE (Had medium sized fatigue) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product information was provided. No treatment information was provided.   This case was linked to MOD-2021-374716 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Nov-2021: Follow up received contains Patient details and event .
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Chromaturia, Lymphadenopathy, Nausea
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of CHROMATURIA (orange urine "like orange Gatorade"), ASTHENIA (weakness), ABDOMINAL DISCOMFORT (stomach complaints), PAIN (Achiness) and LYMPHADENOPATHY (visible swollen lymph nodes of left side of neck) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A, 025B21A and 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Lymphoma.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-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 an unknown date, the patient experienced CHROMATURIA (orange urine "like orange Gatorade"), ASTHENIA (weakness), ABDOMINAL DISCOMFORT (stomach complaints), PAIN (Achiness), LYMPHADENOPATHY (visible swollen lymph nodes of left side of neck), NAUSEA (nausea) and VOMITING (vomiting). At the time of the report, CHROMATURIA (orange urine "like orange Gatorade"), ASTHENIA (weakness), ABDOMINAL DISCOMFORT (stomach complaints), PAIN (Achiness), LYMPHADENOPATHY (visible swollen lymph nodes of left side of neck), NAUSEA (nausea) and VOMITING (vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: elevated liver function (High) elevated liver function. On an unknown date, X-ray: negative (Negative) negative.         Ultrasound was done and the patient was waiting for further results. The patient had no symptoms until 1 week after the booster dose.  No concomitant medication reported. No treatment information was provided.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Vomiting
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of CHROMATURIA (orange urine "like orange Gatorade"), ASTHENIA (weakness), ABDOMINAL DISCOMFORT (stomach complaints), PAIN (Achiness) and LYMPHADENOPATHY (visible swollen lymph nodes of left side of neck) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A, 025B21A and 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Lymphoma.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-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 an unknown date, the patient experienced CHROMATURIA (orange urine "like orange Gatorade"), ASTHENIA (weakness), ABDOMINAL DISCOMFORT (stomach complaints), PAIN (Achiness), LYMPHADENOPATHY (visible swollen lymph nodes of left side of neck), NAUSEA (nausea) and VOMITING (vomiting). At the time of the report, CHROMATURIA (orange urine "like orange Gatorade"), ASTHENIA (weakness), ABDOMINAL DISCOMFORT (stomach complaints), PAIN (Achiness), LYMPHADENOPATHY (visible swollen lymph nodes of left side of neck), NAUSEA (nausea) and VOMITING (vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: elevated liver function (High) elevated liver function. On an unknown date, X-ray: negative (Negative) negative.         Ultrasound was done and the patient was waiting for further results. The patient had no symptoms until 1 week after the booster dose.  No concomitant medication reported. No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Chondrocalcinosis pyrophosphate
Clinical narrative: Developed pseudogout in his elbow; This spontaneous case was reported by a consumer and describes the occurrence of CHONDROCALCINOSIS PYROPHOSPHATE (Developed pseudogout in his elbow) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHONDROCALCINOSIS PYROPHOSPHATE (Developed pseudogout in his elbow). At the time of the report, CHONDROCALCINOSIS PYROPHOSPHATE (Developed pseudogout in his elbow) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.   This case was linked to -MODERNATX, INC.-MOD-2021-160528 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  -MODERNATX, INC.-MOD-2021-160528:MOD21-160528 - Same reporter
Sex: U
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: 6 people have had vision issues; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (6 people have had vision issues) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VISUAL IMPAIRMENT (6 people have had vision issues). At the time of the report, VISUAL IMPAIRMENT (6 people have had vision issues) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment medications provided.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: gave 11 patients Moderna Covid-19 Vaccine doses  on 6Oct2021 from a vial that had been moved from frozen to refrigerated storage when they received them on 30Aug2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (gave 11 patients Moderna Covid-19 Vaccine doses  on 6Oct2021 from a vial that had been moved from frozen to refrigerated storage when they received them on 30Aug2021) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (gave 11 patients Moderna Covid-19 Vaccine doses  on 6Oct2021 from a vial that had been moved from frozen to refrigerated storage when they received them on 30Aug2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (gave 11 patients Moderna Covid-19 Vaccine doses  on 6Oct2021 from a vial that had been moved from frozen to refrigerated storage when they received them on 30Aug2021) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Feeling abnormal, Headache
Clinical narrative: Not feeling 100%; Diarrhea; Fatigue; Mild headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Not feeling 100%), DIARRHOEA (Diarrhea), FATIGUE (Fatigue) and HEADACHE (Mild headache) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Urinary tract infection.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Not feeling 100%), DIARRHOEA (Diarrhea), FATIGUE (Fatigue) and HEADACHE (Mild headache). At the time of the report, FEELING ABNORMAL (Not feeling 100%), DIARRHOEA (Diarrhea), FATIGUE (Fatigue) and HEADACHE (Mild headache) outcome was unknown.            Before receiving the booster dose patient was taking antibiotics as she was experiencing an urinary tract infection 1 day before No concomitant medications were provided.  No treatment medications were provided.   This case was linked to MOD-2021-374165 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm) and FATIGUE (little tiredness) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore arm) and FATIGUE (little tiredness). At the time of the report, VACCINATION SITE PAIN (sore arm) and FATIGUE (little tiredness) outcome was unknown.            No concomitant medication was provided.  Treatment medication was not provided by the reporter.   This case was linked to MOD-2021-374119, MOD-2021-374179 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: sore arm; little tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and FATIGUE (little tiredness) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first 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 FATIGUE (little tiredness). At the time of the report, PAIN IN EXTREMITY (sore arm) and FATIGUE (little tiredness) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant products were reported.  No treatment information was reported by the reporter.   This case was linked to MOD-2021-374119, MOD-2021-374165 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Received Sputnik vaccine on 27-May-2021 and Moderna vaccine on 26-Aug-2021; 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 INTERCHANGE OF VACCINE PRODUCTS (Received Sputnik vaccine on 27-May-2021 and Moderna vaccine on 26-Aug-2021) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for an unreported indication: SPUTNIK V (At Argentina) on 27-May-2021.    On 26-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Received Sputnik vaccine on 27-May-2021 and Moderna vaccine on 26-Aug-2021). On 26-Aug-2021, INTERCHANGE OF VACCINE PRODUCTS (Received Sputnik vaccine on 27-May-2021 and Moderna vaccine on 26-Aug-2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided.   It was reported that the patient came in to receive Moderna Booster after receiving second dose of Moderna vaccine on 26-Aug-2021  Treatment information was not provided.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Vaccination site erythema, Vaccination site infection, Vaccination site pain, Vaccination site warmth
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm), PERIPHERAL SWELLING (Swollen, about 4 inches on the left and right arm), VACCINATION SITE INFECTION (Looks infected), VACCINATION SITE PAIN (Hurts) and VACCINATION SITE ERYTHEMA (Red arm) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Warm), PERIPHERAL SWELLING (Swollen, about 4 inches on the left and right arm), VACCINATION SITE INFECTION (Looks infected), VACCINATION SITE PAIN (Hurts) and VACCINATION SITE ERYTHEMA (Red arm). At the time of the report, VACCINATION SITE WARMTH (Warm), PERIPHERAL SWELLING (Swollen, about 4 inches on the left and right arm), VACCINATION SITE INFECTION (Looks infected), VACCINATION SITE PAIN (Hurts) and VACCINATION SITE ERYTHEMA (Red arm) outcome was unknown.       No relevant concomitant medications was reported. Treatment information was not provided.    This case was linked to MOD-2021-374319 (Patient Link).
Age: 69.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: We have some Moderna COVID-19 vaccine that was given after the expiration date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have some Moderna COVID-19 vaccine that was given after the expiration date.) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (We have some Moderna COVID-19 vaccine that was given after the expiration date.). In October 2021, EXPIRED PRODUCT ADMINISTERED (We have some Moderna COVID-19 vaccine that was given after the expiration date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided.  It was reported that the vial was initially stored in refrigerator on 24 -Sep-2021.And the date of administration of vaccine was from 24-Oct-2021 to 27-Oct-2021..The vial didn't undergone any temperature excursions.  Treatment information was not provided.
Age: 30.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: We have some Moderna Covid-019 vaccine that was given after the expiration date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) in a 30-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    In October 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.). In October 2021, EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.  The vial was initially stored in the refrigerator on 24 Sep 2021 . The vial did not undergo any temperature excursion.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included UBIDECARENONE (COQ-10) and COLECALCIFEROL (VITAMIN D3) for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore arm). At the time of the report, VACCINATION SITE PAIN (sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications was reported. No treatment drug details was reported.   This case was linked to MOD-2021-374377, MOD-2021-374385 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Mother is extremely fatigued after her booster dose; Mother has a headache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Mother is extremely fatigued after her booster dose) and HEADACHE (Mother has a headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Mother is extremely fatigued after her booster dose) and HEADACHE (Mother has a headache). At the time of the report, FATIGUE (Mother is extremely fatigued after her booster dose) and HEADACHE (Mother has a headache) outcome was unknown.            No concomitant medications were reported  No treatment information was provided. patient received her first Moderna Medical  in March 2021.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dysphagia, Dyspnoea, Peripheral swelling, Pyrexia
Clinical narrative: swelling in her legs bilaterally; difficulty swallowing; shortness of breath; rash in legs bilaterally; chills; fever; This spontaneous case was reported by a physician and describes the occurrence of PERIPHERAL SWELLING (swelling in her legs bilaterally), DYSPHAGIA (difficulty swallowing), DYSPNOEA (shortness of breath), RASH (rash in legs bilaterally) and CHILLS (chills) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Medical history was not provided by the reporter.  Concomitant products included ALBUTEROL [SALBUTAMOL] for Asthma, LOSARTAN, VITAMIN D NOS and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, the patient experienced PERIPHERAL SWELLING (swelling in her legs bilaterally), DYSPHAGIA (difficulty swallowing), DYSPNOEA (shortness of breath), RASH (rash in legs bilaterally), CHILLS (chills) and PYREXIA (fever). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (swelling in her legs bilaterally), DYSPHAGIA (difficulty swallowing), DYSPNOEA (shortness of breath), RASH (rash in legs bilaterally), CHILLS (chills) and PYREXIA (fever) 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.   Patient mentioned that she went for urgent care and she was given some medications.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: swelling in her legs bilaterally; difficulty swallowing; shortness of breath; rash in legs bilaterally; chills; fever; This spontaneous case was reported by a physician and describes the occurrence of PERIPHERAL SWELLING (swelling in her legs bilaterally), DYSPHAGIA (difficulty swallowing), DYSPNOEA (shortness of breath), RASH (rash in legs bilaterally) and CHILLS (chills) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Medical history was not provided by the reporter.  Concomitant products included ALBUTEROL [SALBUTAMOL] for Asthma, LOSARTAN, VITAMIN D NOS and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, the patient experienced PERIPHERAL SWELLING (swelling in her legs bilaterally), DYSPHAGIA (difficulty swallowing), DYSPNOEA (shortness of breath), RASH (rash in legs bilaterally), CHILLS (chills) and PYREXIA (fever). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (swelling in her legs bilaterally), DYSPHAGIA (difficulty swallowing), DYSPNOEA (shortness of breath), RASH (rash in legs bilaterally), CHILLS (chills) and PYREXIA (fever) 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.   Patient mentioned that she went for urgent care and she was given some medications.
Age: 81.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: We have some Moderna COVID-19 vaccine that was given after the expiration date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have some Moderna COVID-19 vaccine that was given after the expiration date.) in an 81-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (We have some Moderna COVID-19 vaccine that was given after the expiration date.). In October 2021, EXPIRED PRODUCT ADMINISTERED (We have some Moderna COVID-19 vaccine that was given after the expiration date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided. Treatment information was not provided. Date the vial was initially stored in the refrigerator: 24-Sept-2021. Date(s) of administration of vaccine: 24Oct2021 - 27Oct2021.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccine administered past published expiry date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine administered past published expiry date) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine administered past published expiry date). On 03-Nov-2021, EXPIRED PRODUCT ADMINISTERED (vaccine administered past published expiry date) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product was provided by the reporter. No treatment medication was provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 2nd Dose administered beyond 30-day use; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2nd Dose administered beyond 30-day use) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (2nd Dose administered beyond 30-day use). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (2nd Dose administered beyond 30-day use) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. No treatment information was reported. Reporter stated that the date taken out of freezer: 08-SEP-2021
Age: 81.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: We have some Moderna Covid-19 vaccine that was given after the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-19 vaccine that was given after the expiration date) in an 81-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.   In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient 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. In October 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-19 vaccine that was given after the expiration date). In October 2021, EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-19 vaccine that was given after the expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   4 vials were stored in refrigerator 24-Sep-2021 with no temperature excursions. Dose was given on between 24-Oct-2021 to 27-Oct-2021.  No concomitant medication was reported by reporter. No treatment medication was reported by reporter.
Age: 72.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Moderna Covid-019 vaccine that was given after the expiration date; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid-019 vaccine that was given after the expiration date) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-019 vaccine that was given after the expiration date). On 27-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-019 vaccine that was given after the expiration date) had resolved.            No concomitant medications were provided. No treatment medications were reported.  Date of administration of vaccine: 24Oct2021 - 27Oct2021.
Sex: M
Vaccine: COVID19
Symptoms: Product dosage form confusion
Clinical narrative: I received my booster shot today but I was previously told that the shot should be 50mcg and she gave 25mcg; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSAGE FORM CONFUSION (I received my booster shot today but I was previously told that the shot should be 50mcg and she gave 25mcg) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 25 mcg. On 03-Nov-2021, the patient experienced PRODUCT DOSAGE FORM CONFUSION (I received my booster shot today but I was previously told that the shot should be 50mcg and she gave 25mcg). On 03-Nov-2021, PRODUCT DOSAGE FORM CONFUSION (I received my booster shot today but I was previously told that the shot should be 50mcg and she gave 25mcg) had resolved.            Concomitant medication use was unknown Treatment information was unknown
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 2nd Dose administered beyond 30-day use; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2nd Dose administered beyond 30-day use) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (2nd Dose administered beyond 30-day use). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (2nd Dose administered beyond 30-day use) 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: 32.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: We have some Moderna Covid-019 vaccine that was given after the expiration date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) in a 32-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.). In October 2021, EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided.  No treatment medication was provided.  Date the vial was initially stored in the refrigerator was 24-Sep-2021. Date of administration of vaccine was 24-Oct-2021 - 27-Oct-2021.
Age: 80.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: We have some Moderna Covid-019 vaccine that was given after the expiration date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) in an 80-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.). On 03-Nov-2021, EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment information was unknown.  On 24-Sep-2021, the vial was initially stored in the refrigerator. 4 vials (15 dose). 44 doses were used.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: We have some Moderna Covid-019 vaccine that was given after the expiration date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.). On 03-Nov-2021, EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitants drugs were reported. No treatment drug was reported The vial was initially stored in the refrigerator on 24Sept2021 No temperature excursions.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received a dose more than 30 days in the fridge; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a dose more than 30 days in the fridge) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003F21A) 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) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a dose more than 30 days in the fridge). In 2021, EXPIRED PRODUCT ADMINISTERED (received a dose more than 30 days in the fridge) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter. Treatment information was not provided.
Age: 69.0
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose, Interchange of vaccine products
Clinical narrative: 3 patients who received Johnson and Johnson for their first dose came in to receive the Moderna booster and were given a full dose of 0.5mL; INTERCHANGE OF VACCINE; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (3 patients who received Johnson and Johnson for their first dose came in to receive the Moderna booster and were given a full dose of 0.5mL) and INTERCHANGE OF VACCINE PRODUCTS (INTERCHANGE OF VACCINE) in a 69-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 an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (3 patients who received Johnson and Johnson for their first dose came in to receive the Moderna booster and were given a full dose of 0.5mL) and INTERCHANGE OF VACCINE PRODUCTS (INTERCHANGE OF VACCINE). At the time of the report, ACCIDENTAL OVERDOSE (3 patients who received Johnson and Johnson for their first dose came in to receive the Moderna booster and were given a full dose of 0.5mL) and INTERCHANGE OF VACCINE PRODUCTS (INTERCHANGE OF VACCINE) 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
Sex: U
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (receiving 2 doses of the Moderna COVID19 vaccine and 2 doses of the Pfizer COVID19 vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. aehp235 and jpxcb76) 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, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (receiving 2 doses of the Moderna COVID19 vaccine and 2 doses of the Pfizer COVID19 vaccine). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (receiving 2 doses of the Moderna COVID19 vaccine and 2 doses of the Pfizer COVID19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication information was provided.  It was reported that patient received 2 doses of the Moderna COVID-19 vaccine and 2 doses of the Pfizer COVID-19 vaccine.
Age: 27.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: We have some Moderna Covid-019 vaccine that was given after the expiration date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) in a 27-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.). In October 2021, EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided. Date the vial was initially stored in the refrigerator: 24-Sept-2021. Date(s) of administration of vaccine: 24-Oct-2021-27-Oct-2021.
Age: 78.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: We have some Moderna Covid-019 vaccine that was given after the expiration date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) in a 78-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.). On 03-Nov-2021, EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial was initially stored in refrigerator on 24-Sep-2021.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 2nd Dose administered beyond 30-day use; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2nd Dose administered beyond 30-day use) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (2nd Dose administered beyond 30-day use). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (2nd Dose administered beyond 30-day use) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment information were reported by the reporter