chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Impaired work ability
Clinical narrative: Heart Problems; Cannot work; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (Heart Problems) and IMPAIRED WORK ABILITY (Cannot work) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 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 CARDIAC DISORDER (Heart Problems) and IMPAIRED WORK ABILITY (Cannot work). At the time of the report, CARDIAC DISORDER (Heart Problems) and IMPAIRED WORK ABILITY (Cannot work) outcome was unknown.            No Concomitant medication was reported.    No treatment medications were reported.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
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; 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) and PRODUCT STORAGE ERROR (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 26-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 06-Oct-2021, 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) and PRODUCT STORAGE ERROR (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). On 06-Oct-2021, 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) and PRODUCT STORAGE ERROR (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.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment medications were not provided.
Age: 90.0
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 90-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.   Concomitant medication was not provided.  Treatment information was not provided.  The patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) on 24Oct2021 - 27Oct2021. Date the vial was initially stored in the refrigerator is24-Sept-2021.
Age: 87.0
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 87-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 information was reported. No treatment information was reported. Reporter has stated that the vaccine was administered between 24Oct2021 - 27Oct2021.
Age: 59.0
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 59-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 information was provided  No treatment medication information was provided
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Lymphadenopathy, Pain in extremity, Pruritus
Clinical narrative: Expected her arm to hurt/Underarm started to hurt/Underarm started to hurt; Arm was really itchy/Had to scratch her arm; It was bizarre; Gland under her armpit into are breast tissue was swollen/Gland under her armpit into are breast tissue still tender; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Expected her arm to hurt/Underarm started to hurt/Underarm started to hurt), PRURITUS (Arm was really itchy/Had to scratch her arm), FEELING ABNORMAL (It was bizarre) and LYMPHADENOPATHY (Gland under her armpit into are breast tissue was swollen/Gland under her armpit into are breast tissue still tender) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A, 010M20A and 002A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Nov-2021, the patient experienced PAIN IN EXTREMITY (Expected her arm to hurt/Underarm started to hurt/Underarm started to hurt), PRURITUS (Arm was really itchy/Had to scratch her arm), FEELING ABNORMAL (It was bizarre) and LYMPHADENOPATHY (Gland under her armpit into are breast tissue was swollen/Gland under her armpit into are breast tissue still tender). At the time of the report, PAIN IN EXTREMITY (Expected her arm to hurt/Underarm started to hurt/Underarm started to hurt), PRURITUS (Arm was really itchy/Had to scratch her arm), FEELING ABNORMAL (It was bizarre) and LYMPHADENOPATHY (Gland under her armpit into are breast tissue was swollen/Gland under her armpit into are breast tissue still tender) was resolving.            No concomitant medications were reported. No treatment information were reported. She stated he had clarified the information about the arm pain under the arm. Caller verified it was the left arm.   Most recent FOLLOW-UP information incorporated above includes: On 03-Nov-2021: Non-significant Follow Up Appended on 03 -Nov-21, included anatomical location and narrative updated.
Age: 28.0
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 28-year-old patient of an unknown gender who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    In October 2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (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 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.  Date of administration of vaccine: 24-OCT-2021 -  27-OCT-2021.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Lymph node pain
Clinical narrative: Redness; Pain/ tenderness and swelling of the lymph nodes in the same arm of the injection; Swelling/ tenderness and swelling of the lymph nodes in the same arm of the injection; tenderness and swelling of the lymph nodes in the same arm of the injection; fatigue; headache; muscle pain; joint pain; chills; nausea and vomiting; nausea and vomiting; Fever; This spontaneous case was reported by a consumer and describes the occurrence of LYMPH NODE PAIN (tenderness and swelling of the lymph nodes in the same arm of the injection), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle pain) and ARTHRALGIA (joint pain) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033F21A, 031C20A and 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced LYMPH NODE PAIN (tenderness and swelling of the lymph nodes in the same arm of the injection), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills), NAUSEA (nausea and vomiting), VOMITING (nausea and vomiting) and PYREXIA (Fever). On 01-Nov-2021, the patient experienced VACCINATION SITE SWELLING (Swelling/ tenderness and swelling of the lymph nodes in the same arm of the injection). On 03-Nov-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE PAIN (Pain/ tenderness and swelling of the lymph nodes in the same arm of the injection). At the time of the report, LYMPH NODE PAIN (tenderness and swelling of the lymph nodes in the same arm of the injection), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills), NAUSEA (nausea and vomiting), VOMITING (nausea and vomiting), PYREXIA (Fever), VACCINATION SITE SWELLING (Swelling/ tenderness and swelling of the lymph nodes in the same arm of the injection), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE PAIN (Pain/ tenderness and swelling of the lymph nodes in the same arm of the injection) outcome was unknown.     Concomitant product use was not provided by the reporter. Treatment medication use was not provided by the reporter.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, Vaccination site erythema, Vaccination site pain
Clinical narrative: Redness; Pain/ tenderness and swelling of the lymph nodes in the same arm of the injection; Swelling/ tenderness and swelling of the lymph nodes in the same arm of the injection; tenderness and swelling of the lymph nodes in the same arm of the injection; fatigue; headache; muscle pain; joint pain; chills; nausea and vomiting; nausea and vomiting; Fever; This spontaneous case was reported by a consumer and describes the occurrence of LYMPH NODE PAIN (tenderness and swelling of the lymph nodes in the same arm of the injection), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle pain) and ARTHRALGIA (joint pain) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033F21A, 031C20A and 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced LYMPH NODE PAIN (tenderness and swelling of the lymph nodes in the same arm of the injection), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills), NAUSEA (nausea and vomiting), VOMITING (nausea and vomiting) and PYREXIA (Fever). On 01-Nov-2021, the patient experienced VACCINATION SITE SWELLING (Swelling/ tenderness and swelling of the lymph nodes in the same arm of the injection). On 03-Nov-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE PAIN (Pain/ tenderness and swelling of the lymph nodes in the same arm of the injection). At the time of the report, LYMPH NODE PAIN (tenderness and swelling of the lymph nodes in the same arm of the injection), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills), NAUSEA (nausea and vomiting), VOMITING (nausea and vomiting), PYREXIA (Fever), VACCINATION SITE SWELLING (Swelling/ tenderness and swelling of the lymph nodes in the same arm of the injection), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE PAIN (Pain/ tenderness and swelling of the lymph nodes in the same arm of the injection) outcome was unknown.     Concomitant product use was not provided by the reporter. Treatment medication use was not provided by the reporter.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vomiting
Clinical narrative: Redness; Pain/ tenderness and swelling of the lymph nodes in the same arm of the injection; Swelling/ tenderness and swelling of the lymph nodes in the same arm of the injection; tenderness and swelling of the lymph nodes in the same arm of the injection; fatigue; headache; muscle pain; joint pain; chills; nausea and vomiting; nausea and vomiting; Fever; This spontaneous case was reported by a consumer and describes the occurrence of LYMPH NODE PAIN (tenderness and swelling of the lymph nodes in the same arm of the injection), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle pain) and ARTHRALGIA (joint pain) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033F21A, 031C20A and 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced LYMPH NODE PAIN (tenderness and swelling of the lymph nodes in the same arm of the injection), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills), NAUSEA (nausea and vomiting), VOMITING (nausea and vomiting) and PYREXIA (Fever). On 01-Nov-2021, the patient experienced VACCINATION SITE SWELLING (Swelling/ tenderness and swelling of the lymph nodes in the same arm of the injection). On 03-Nov-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE PAIN (Pain/ tenderness and swelling of the lymph nodes in the same arm of the injection). At the time of the report, LYMPH NODE PAIN (tenderness and swelling of the lymph nodes in the same arm of the injection), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills), NAUSEA (nausea and vomiting), VOMITING (nausea and vomiting), PYREXIA (Fever), VACCINATION SITE SWELLING (Swelling/ tenderness and swelling of the lymph nodes in the same arm of the injection), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE PAIN (Pain/ tenderness and swelling of the lymph nodes in the same arm of the injection) outcome was unknown.     Concomitant product use was not provided by the reporter. Treatment medication use was not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Chromaturia
Clinical narrative: orange urine; 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 CHROMATURIA (orange urine) 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 CHROMATURIA (orange urine). At the time of the report, CHROMATURIA (orange urine) outcome was unknown.            Concomitant medications was not provided by the reporter. Treatment information was not provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Headache, Mass, Paraesthesia, Pruritus
Clinical narrative: feeling needles sticking inside her body sticking her arms; itchiness; bumps; red area like an infection all over her arms and legs and left side of her face; little low grade fever; awful headaches like being kick by a horse, not regular headache; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (feeling needles sticking inside her body sticking her arms), PRURITUS (itchiness), MASS (bumps), ERYTHEMA (red area like an infection all over her arms and legs and left side of her face) and PYREXIA (little low grade fever) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. #010a21a and #039k20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included BENAZEPRIL and AMLODIPINE for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-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 PARAESTHESIA (feeling needles sticking inside her body sticking her arms), PRURITUS (itchiness), MASS (bumps), ERYTHEMA (red area like an infection all over her arms and legs and left side of her face), PYREXIA (little low grade fever) and HEADACHE (awful headaches like being kick by a horse, not regular headache). At the time of the report, PARAESTHESIA (feeling needles sticking inside her body sticking her arms), PRURITUS (itchiness), MASS (bumps), ERYTHEMA (red area like an infection all over her arms and legs and left side of her face), PYREXIA (little low grade fever) and HEADACHE (awful headaches like being kick by a horse, not regular headache) outcome was unknown.            Patient reported that she was taking High blood pressure medications.  The treatment information was not provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: feeling needles sticking inside her body sticking her arms; itchiness; bumps; red area like an infection all over her arms and legs and left side of her face; little low grade fever; awful headaches like being kick by a horse, not regular headache; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (feeling needles sticking inside her body sticking her arms), PRURITUS (itchiness), MASS (bumps), ERYTHEMA (red area like an infection all over her arms and legs and left side of her face) and PYREXIA (little low grade fever) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. #010a21a and #039k20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included BENAZEPRIL and AMLODIPINE for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-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 PARAESTHESIA (feeling needles sticking inside her body sticking her arms), PRURITUS (itchiness), MASS (bumps), ERYTHEMA (red area like an infection all over her arms and legs and left side of her face), PYREXIA (little low grade fever) and HEADACHE (awful headaches like being kick by a horse, not regular headache). At the time of the report, PARAESTHESIA (feeling needles sticking inside her body sticking her arms), PRURITUS (itchiness), MASS (bumps), ERYTHEMA (red area like an infection all over her arms and legs and left side of her face), PYREXIA (little low grade fever) and HEADACHE (awful headaches like being kick by a horse, not regular headache) outcome was unknown.            Patient reported that she was taking High blood pressure medications.  The treatment information was not provided.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Patient had a sore left arm; injection site swollen; injection site itchy; injection site hot to the touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Patient had a sore left arm), VACCINATION SITE SWELLING (injection site swollen), VACCINATION SITE PRURITUS (injection site itchy) and VACCINATION SITE WARMTH (injection site hot to the touch) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE PAIN (Patient had a sore left arm), VACCINATION SITE SWELLING (injection site swollen), VACCINATION SITE PRURITUS (injection site itchy) and VACCINATION SITE WARMTH (injection site hot to the touch). At the time of the report, VACCINATION SITE PAIN (Patient had a sore left arm), VACCINATION SITE SWELLING (injection site swollen), VACCINATION SITE PRURITUS (injection site itchy) and VACCINATION SITE WARMTH (injection site hot to the touch) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.   This case was linked to MOD-2021-375119 (Patient Link).
Age: 65.0
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 65-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-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 reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-Nov-2021: Patient details and suspect drug details updated.
Age: 70.0
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 70-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 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 EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.). At the time of the report, 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 by reporter. No treatment medications were reported.
Age: 74.0
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 74-year-old patient of an unknown gender who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    In October 2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (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 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.   Date of administration of vaccine was between 24Oct2021 - 27Oct2021.  No concomitant information was reported.  No treatment information was reported.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Had soreness in my left injection site arm.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Had soreness in my left injection site arm.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-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 (Had soreness in my left injection site arm.). At the time of the report, VACCINATION SITE PAIN (Had soreness in my left injection site arm.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided by the reporter. No Treatment information was reported.   This case was linked to MOD-2021-375113 (Patient Link).
Age: 82.0
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 82-year-old patient of an unknown gender who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (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 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment medication reported. Date of the vials was initially stored in the refrigerator: 24Sept2021
Age: 62.0
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 another 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 62-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) .25 ml. 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.   Concomitant medications were not provided Treatment medications were not provided It was reported that 4 vials (15 dose). 44 doses. vials were stored in the refrigerator on 24-sep-2021. Vaccine was administration between 24Oct2021 - 27Oct2021. vials did not undergo any temperature excursions.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, COVID-19, Hypersensitivity, Nasopharyngitis, SARS-CoV-2 antibody test
Clinical narrative: Minor head cold; Lost her sense of smell; Allergy-like symptoms; Contracted COVID; Contracted COVID; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS, ANOSMIA (Lost her sense of smell, VACCINATION FAILURE, COVID-19, and HYPERSENSITIVITY in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2021, the patient experienced VACCINATION FAILURE and COVID-19. On an unknown date, the patient experienced NASOPHARYNGITIS, ANOSMIA, and HYPERSENSITIVITY. At the time of the report, NASOPHARYNGITIS, ANOSMIA, VACCINATION FAILURE, COVID-19, and HYPERSENSITIVITY outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available) On an unknown date, SARS-CoV-2 antibody test positive, Patient still has antibodies.         No concomitant medications were provided. No treatment medications were reported.  This case concerns a 49 year old female with no reported medical history, who experienced Non-serious unexpected events, AESI, Covid 19, and Anosmia and other unexpected events of vaccination failure, nasopharyngitis, expected event of hypersensitivity reaction. These events occurred approximately 5 months after vaccination with the 2nd dose of mRNA-1273 vaccine (Moderna Covid 19 Vaccine). The re-challenge for this case is not applicable. The  benefit-risk relationship of mRNA-1273 vaccine (Moderna Covid 19 vaccine) is not affected by this report. This case concerns a 49 year old female with no reported medical history, who experienced Non-serious unexpected events, AESI, Covid 19, and Anosmia and other unexpected events of vaccination failure, nasopharyngitis, expected event of hypersensitivity reaction. These events occurred approximately 5 months after vaccination with the 2nd dose of mRNA-1273 vaccine (Moderna Covid 19 Vaccine). The re-challenge for this case is not applicable. The benefit-risk relationship of mRNA-1273 vaccine (Moderna Covid 19 vaccine ) is not affected by this report.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: Minor head cold; Lost her sense of smell; Allergy-like symptoms; Contracted COVID; Contracted COVID; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS, ANOSMIA (Lost her sense of smell, VACCINATION FAILURE, COVID-19, and HYPERSENSITIVITY in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2021, the patient experienced VACCINATION FAILURE and COVID-19. On an unknown date, the patient experienced NASOPHARYNGITIS, ANOSMIA, and HYPERSENSITIVITY. At the time of the report, NASOPHARYNGITIS, ANOSMIA, VACCINATION FAILURE, COVID-19, and HYPERSENSITIVITY outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available) On an unknown date, SARS-CoV-2 antibody test positive, Patient still has antibodies.         No concomitant medications were provided. No treatment medications were reported.  This case concerns a 49 year old female with no reported medical history, who experienced Non-serious unexpected events, AESI, Covid 19, and Anosmia and other unexpected events of vaccination failure, nasopharyngitis, expected event of hypersensitivity reaction. These events occurred approximately 5 months after vaccination with the 2nd dose of mRNA-1273 vaccine (Moderna Covid 19 Vaccine). The re-challenge for this case is not applicable. The  benefit-risk relationship of mRNA-1273 vaccine (Moderna Covid 19 vaccine) is not affected by this report. This case concerns a 49 year old female with no reported medical history, who experienced Non-serious unexpected events, AESI, Covid 19, and Anosmia and other unexpected events of vaccination failure, nasopharyngitis, expected event of hypersensitivity reaction. These events occurred approximately 5 months after vaccination with the 2nd dose of mRNA-1273 vaccine (Moderna Covid 19 Vaccine). The re-challenge for this case is not applicable. The benefit-risk relationship of mRNA-1273 vaccine (Moderna Covid 19 vaccine ) is not affected by this report.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 022M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (loss of smell and taste, had a fever, and aches and pains.) in March 2020.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced FATIGUE (tired). At the time of the report, FATIGUE (tired) outcome was unknown.            Concomitant medications reported included Flu Shot. Treatment information was not provided by the reporter. Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-376660, MOD-2021-375104 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Dose administered beyond 30-day use; Dose administered beyond 30-day use; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Dose administered beyond 30-day use) and EXPIRED PRODUCT ADMINISTERED (Dose administered beyond 30-day use) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 22-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced PRODUCT STORAGE ERROR (Dose administered beyond 30-day use) and EXPIRED PRODUCT ADMINISTERED (Dose administered beyond 30-day use). On 22-Oct-2021, PRODUCT STORAGE ERROR (Dose administered beyond 30-day use) and EXPIRED PRODUCT ADMINISTERED (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 provided by the reporter  No Treatment Information were provided by the reporter It was reported that date taken out of freezer was 9/8/2021.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: gave 1 full dose & 11 booster doses of the Moderna Covid-19 Vaccine on 2Nov2021 from a vial (lot # 011F21A) that had been refrigerated for more than 30 days (since 1Oct2021); gave 1 full dose & 11 booster doses of the Moderna Covid-19 Vaccine on 2Nov2021 from a vial; 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 EXPIRED PRODUCT ADMINISTERED (gave 1 full dose & 11 booster doses of the Moderna Covid-19 Vaccine on 2Nov2021 from a vial (lot # 011F21A) that had been refrigerated for more than 30 days (since 1Oct2021)) and PRODUCT STORAGE ERROR (gave 1 full dose & 11 booster doses of the Moderna Covid-19 Vaccine on 2Nov2021 from a vial) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (gave 1 full dose & 11 booster doses of the Moderna Covid-19 Vaccine on 2Nov2021 from a vial (lot # 011F21A) that had been refrigerated for more than 30 days (since 1Oct2021)) and PRODUCT STORAGE ERROR (gave 1 full dose & 11 booster doses of the Moderna Covid-19 Vaccine on 2Nov2021 from a vial). On 02-Nov-2021, EXPIRED PRODUCT ADMINISTERED (gave 1 full dose & 11 booster doses of the Moderna Covid-19 Vaccine on 2Nov2021 from a vial (lot # 011F21A) that had been refrigerated for more than 30 days (since 1Oct2021)) and PRODUCT STORAGE ERROR (gave 1 full dose & 11 booster doses of the Moderna Covid-19 Vaccine on 2Nov2021 from a vial) 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.   This case was linked to MOD-2021-375089 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Nov-2021: Follow-up information received on 05-NOV-2021 contains no new information.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: m gave 1 full dose & 11 booster doses of the Moderna Covid-19 Vaccine on 2Nov2021 from a vial that had been refrigerated for more than 30 days; gave 1 full dose & 11 booster doses of the Moderna Covid-19 Vaccine on 2Nov2021 from a vial (lot # 011F21A) that had been refrigerated for more than 30 days (since 1Oct2021); 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 EXPIRED PRODUCT ADMINISTERED (gave 1 full dose & 11 booster doses of the Moderna Covid-19 Vaccine on 2Nov2021 from a vial (lot # 011F21A) that had been refrigerated for more than 30 days (since 1Oct2021)) and PRODUCT STORAGE ERROR (m gave 1 full dose & 11 booster doses of the Moderna Covid-19 Vaccine on 2Nov2021 from a vial that had been refrigerated for more than 30 days) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-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 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 02-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (gave 1 full dose & 11 booster doses of the Moderna Covid-19 Vaccine on 2Nov2021 from a vial (lot # 011F21A) that had been refrigerated for more than 30 days (since 1Oct2021)). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (m gave 1 full dose & 11 booster doses of the Moderna Covid-19 Vaccine on 2Nov2021 from a vial that had been refrigerated for more than 30 days). On 02-Nov-2021, EXPIRED PRODUCT ADMINISTERED (gave 1 full dose & 11 booster doses of the Moderna Covid-19 Vaccine on 2Nov2021 from a vial (lot # 011F21A) that had been refrigerated for more than 30 days (since 1Oct2021)) had resolved. At the time of the report, PRODUCT STORAGE ERROR (m gave 1 full dose & 11 booster doses of the Moderna Covid-19 Vaccine on 2Nov2021 from a vial that had been refrigerated for more than 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided  Treatment medication was not provided by the reporter   It was reported that the vials had been refrigerated for more than 30 days (since 1Oct2021).   This case was linked to MOD-2021-375085 (Patient Link).
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle tightness
Clinical narrative: back muscles felt really tight; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TIGHTNESS in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F21D, 031M20A and 004M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Oct-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MUSCLE TIGHTNESS. The patient was treated with TYLENOL for Adverse event, at a dose of 1 dosage form. At the time of the report, MUSCLE TIGHTNESS had not resolved.            Concomitant medications were not provided.  The muscle tightness had not bothered the patient.