chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: drove 12 hours which led her not able to stand up; sweating; she had sever reaction after receiving 2nd dose; could not lift her head up off the pillow for 24 hours; had temperature; chills; This spontaneous case was reported by a consumer and describes the occurrence of DYSSTASIA (drove 12 hours which led her not able to stand up), HYPERHIDROSIS (sweating), VACCINATION COMPLICATION (she had sever reaction after receiving 2nd dose), HEAD DISCOMFORT (could not lift her head up off the pillow for 24 hours) and PYREXIA (had temperature) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concurrent medical conditions included Non-smoker. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and VITAMINS NOS for an unknown indication.    On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSSTASIA (drove 12 hours which led her not able to stand up), HYPERHIDROSIS (sweating), VACCINATION COMPLICATION (she had sever reaction after receiving 2nd dose), HEAD DISCOMFORT (could not lift her head up off the pillow for 24 hours), PYREXIA (had temperature) and CHILLS (chills). At the time of the report, DYSSTASIA (drove 12 hours which led her not able to stand up), HYPERHIDROSIS (sweating), VACCINATION COMPLICATION (she had sever reaction after receiving 2nd dose), HEAD DISCOMFORT (could not lift her head up off the pillow for 24 hours), PYREXIA (had temperature) and CHILLS (chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.   This case was linked to MOD-2021-334391, MOD-2021-335707 (Patient Link).
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: This spontaneous case reported by an other healthcare professional, describes the occurrence of administered product to patient of inappropriate age (a patient under the age of 18 received the first dose of the Moderna vaccine) in a 13-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 005C21A) for COVID-19 immunization. No medical history reported. On Sep 29, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Sep 29, 2021, administered product to patient of inappropriate age (a patient under the age of 18 received the first dose of the Moderna vaccine). On Sep 29, 2021, administered product to patient of inappropriate age (a patient under the age of 18 received the first dose of the Moderna vaccine) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine):  unknown. The reporter did not provide any causality assessments, concomitant medications or treatment information.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: Pfizer COVID-19 3rd dose administered to Moderna patient, The doctor intentionally gave a 3rd dose of Pfizer COVID-19 vaccine and told him that it was approved to be used; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Pfizer COVID-19 3rd dose administered to Moderna patient, The doctor intentionally gave a 3rd dose of Pfizer COVID-19 vaccine and told him that it was approved to be used) in a 71-year-old male patient 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 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 September 2021, the patient experienced OFF LABEL USE (Pfizer COVID-19 3rd dose administered to Moderna patient, The doctor intentionally gave a 3rd dose of Pfizer COVID-19 vaccine and told him that it was approved to be used). At the time of the report, OFF LABEL USE (Pfizer COVID-19 3rd dose administered to Moderna patient, The doctor intentionally gave a 3rd dose of Pfizer COVID-19 vaccine and told him that it was approved to be used) had resolved.            No relevant concomitant medications were reported.  No treatment information was provided.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: With the first shot he was down for a week; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (With the first shot he was down for a week) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Apr-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 (With the first shot he was down for a week). At the time of the report, VACCINATION COMPLICATION (With the first shot he was down for a week) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products were reported. No treatment drugs were reported   This case was linked to MOD-2021-336266 (Patient Link).
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Mobility decreased, Pain, Pain in extremity
Clinical narrative: hands that are hurting like it triggered an arthritic condition; in the fingers, particularly the left hand; painful to move/painful to touch; cannot make a fist; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (hands that are hurting like it triggered an arthritic condition), PAIN IN EXTREMITY (in the fingers, particularly the left hand), PAIN (painful to move/painful to touch) and MOBILITY DECREASED (cannot make a fist) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 062E21A, 003B21A and 031M20A) for COVID-19 vaccination.     No Medical History information was provided.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced PAIN IN EXTREMITY (in the fingers, particularly the left hand), PAIN (painful to move/painful to touch) and MOBILITY DECREASED (cannot make a fist). On an unknown date, the patient experienced ARTHRALGIA (hands that are hurting like it triggered an arthritic condition). The patient was treated with IBUPROFEN for Adverse event, at a dose of once in a while and DICLOFENAC SODIUM (VOLTAREN ARTHRITIS PAIN) for Adverse event, at an unspecified dose and frequency. At the time of the report, ARTHRALGIA (hands that are hurting like it triggered an arthritic condition) had not resolved and PAIN IN EXTREMITY (in the fingers, particularly the left hand), PAIN (painful to move/painful to touch) and MOBILITY DECREASED (cannot make a fist) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported; Sender's Comments: This case concerns a 67-year-old, male patient with no reported relevant medical history, who experienced the unexpected events of Arthralgia, pain, pain in extremity, and mobility decreased. The events started  approximately three weeks after the third dose of Spikevax. The rechallenge was not applicable as no additional dose is expected to be given. The benefit-risk relationship of Spikevax is not affected by this report.
Age: 68.0
Sex: U
Vaccine: COVID19
Symptoms: Headache, Illness, Myalgia, Pyrexia
Clinical narrative: Sick for a few days; headache; Fever; Sore arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Sep-2021 and was forwarded to Moderna on 29-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick for a few days), HEADACHE (headache), PYREXIA (Fever) and MYALGIA (Sore arm) in a 68-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 05-Feb-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 an unknown date, the patient experienced ILLNESS (Sick for a few days), HEADACHE (headache), PYREXIA (Fever) and MYALGIA (Sore arm). At the time of the report, ILLNESS (Sick for a few days), HEADACHE (headache), PYREXIA (Fever) and MYALGIA (Sore arm) outcome was unknown.            Patient never had COVID-19.  No concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain
Clinical narrative: minor achiness; stiff; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (minor achiness) and MUSCULOSKELETAL STIFFNESS (stiff) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis.    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 PAIN (minor achiness) and MUSCULOSKELETAL STIFFNESS (stiff). At the time of the report, PAIN (minor achiness) and MUSCULOSKELETAL STIFFNESS (stiff) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was reported.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Fatigue, Pneumonia, Product dose omission issue
Clinical narrative: second shot was scheduled for 11 Sep 2021 and he did not receive it because he had COVID-19 (Missed the second shot (46 days post first vaccine); Tired; Bilateral Pneumonia; COVID-19 disease; Cough; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Bilateral Pneumonia) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, the patient experienced PNEUMONIA (Bilateral Pneumonia) (seriousness criterion medically significant), COVID-19 (COVID-19 disease), COUGH (Cough) and FATIGUE (Tired). On 11-Sep-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (second shot was scheduled for 11 Sep 2021 and he did not receive it because he had COVID-19 (Missed the second shot (46 days post first vaccine)). On 11-Sep-2021, PRODUCT DOSE OMISSION ISSUE (second shot was scheduled for 11 Sep 2021 and he did not receive it because he had COVID-19 (Missed the second shot (46 days post first vaccine)) had resolved. On 24-Sep-2021, PNEUMONIA (Bilateral Pneumonia) and COVID-19 (COVID-19 disease) had resolved. At the time of the report, COUGH (Cough) and FATIGUE (Tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Sep-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   No treatment information was provided.  Company comment This is a  case of Product Dose Omission Issue in a 59-year-old male patient no relevant medical history, who experienced the serious unexpected event of Pneumonia and COVID 19. The event occurred 28 days after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Sender's Comments: This is a  case of Product Dose Omission Issue in a 59-year-old male patient no relevant medical history, who experienced the serious unexpected event of Pneumonia and COVID 19. The event occurred 28 days after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: second shot was scheduled for 11 Sep 2021 and he did not receive it because he had COVID-19 (Missed the second shot (46 days post first vaccine); Tired; Bilateral Pneumonia; COVID-19 disease; Cough; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Bilateral Pneumonia) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, the patient experienced PNEUMONIA (Bilateral Pneumonia) (seriousness criterion medically significant), COVID-19 (COVID-19 disease), COUGH (Cough) and FATIGUE (Tired). On 11-Sep-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (second shot was scheduled for 11 Sep 2021 and he did not receive it because he had COVID-19 (Missed the second shot (46 days post first vaccine)). On 11-Sep-2021, PRODUCT DOSE OMISSION ISSUE (second shot was scheduled for 11 Sep 2021 and he did not receive it because he had COVID-19 (Missed the second shot (46 days post first vaccine)) had resolved. On 24-Sep-2021, PNEUMONIA (Bilateral Pneumonia) and COVID-19 (COVID-19 disease) had resolved. At the time of the report, COUGH (Cough) and FATIGUE (Tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Sep-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   No treatment information was provided.  Company comment This is a  case of Product Dose Omission Issue in a 59-year-old male patient no relevant medical history, who experienced the serious unexpected event of Pneumonia and COVID 19. The event occurred 28 days after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Sender's Comments: This is a  case of Product Dose Omission Issue in a 59-year-old male patient no relevant medical history, who experienced the serious unexpected event of Pneumonia and COVID 19. The event occurred 28 days after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Moderna vaccine vial which was thawed on 10JUL2021 and would expire on 11AUG2021 after thawing. However, a dose was administered from this vial to a patient on 13SEP2021; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine vial which was thawed on 10JUL2021 and would expire on 11AUG2021 after thawing. However, a dose was administered from this vial to a patient on 13SEP2021) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine vial which was thawed on 10JUL2021 and would expire on 11AUG2021 after thawing. However, a dose was administered from this vial to a patient on 13SEP2021). On 13-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine vial which was thawed on 10JUL2021 and would expire on 11AUG2021 after thawing. However, a dose was administered from this vial to a patient on 13SEP2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient has not reported any adverse reactions to this dose yet  No  concomitant and  treatment informations were reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-Oct-2021: Follow-up include no new information.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 8 patients got expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (8 patients got expired vaccine) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (8 patients got expired vaccine). On 28-Sep-2021, EXPIRED PRODUCT ADMINISTERED (8 patients got expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case reported by a physician, describes the occurrence of administered expired product (administration of vaccine past 30 days in the fridge) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 035C21A) for COVID-19 immunization. No medical history reported. On Sep 24, 2021, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Sep 24, 2021, patient administered expired product (administration of vaccine past 30 days in the fridge). At the time of the report, administered expired product (administration of vaccine past 30 days in the fridge) resolved. The reporter did not provide any causality assessments, concomitant medications or treatment information. Most recent follow-up information incorporated: On Oct 1, 2021: Corrected/updated date of birth.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient upset because they had given them an expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient upset because they had given them an expired vaccine) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient upset because they had given them an expired vaccine). On 29-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Patient upset because they had given them an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication was reported.  No treatment medications were reported
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Malaise, Myalgia
Clinical narrative: Not normal; leg pain; swelling in the arm; feeling unwell; headaches everyday; soreness in the arm and body aches; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Not normal), PAIN IN EXTREMITY (leg pain), PERIPHERAL SWELLING (swelling in the arm), MALAISE (feeling unwell) and HEADACHE (headaches everyday) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Sep-2021, the patient experienced FEELING ABNORMAL (Not normal), PAIN IN EXTREMITY (leg pain), PERIPHERAL SWELLING (swelling in the arm), MALAISE (feeling unwell), HEADACHE (headaches everyday), MYALGIA (soreness in the arm and body aches) and FATIGUE (fatigue). At the time of the report, FEELING ABNORMAL (Not normal), PAIN IN EXTREMITY (leg pain), PERIPHERAL SWELLING (swelling in the arm), MALAISE (feeling unwell), HEADACHE (headaches everyday), MYALGIA (soreness in the arm and body aches) and FATIGUE (fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product included vitamins.  No treatment medication reported by reporter.  Patient stated she never had headaches before.   Most recent FOLLOW-UP information incorporated above includes: On 29-Sep-2021: Translation Document received on 03-oct-2021. Added vitamins as concomitant product. Event outcome captured. Event onset date captured.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Not normal; leg pain; swelling in the arm; feeling unwell; headaches everyday; soreness in the arm and body aches; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Not normal), PAIN IN EXTREMITY (leg pain), PERIPHERAL SWELLING (swelling in the arm), MALAISE (feeling unwell) and HEADACHE (headaches everyday) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Sep-2021, the patient experienced FEELING ABNORMAL (Not normal), PAIN IN EXTREMITY (leg pain), PERIPHERAL SWELLING (swelling in the arm), MALAISE (feeling unwell), HEADACHE (headaches everyday), MYALGIA (soreness in the arm and body aches) and FATIGUE (fatigue). At the time of the report, FEELING ABNORMAL (Not normal), PAIN IN EXTREMITY (leg pain), PERIPHERAL SWELLING (swelling in the arm), MALAISE (feeling unwell), HEADACHE (headaches everyday), MYALGIA (soreness in the arm and body aches) and FATIGUE (fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product included vitamins.  No treatment medication reported by reporter.  Patient stated she never had headaches before.   Most recent FOLLOW-UP information incorporated above includes: On 29-Sep-2021: Translation Document received on 03-oct-2021. Added vitamins as concomitant product. Event outcome captured. Event onset date captured.
Sex: U
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: Vaccine gave him Myocarditis; 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 MYOCARDITIS (Vaccine gave him Myocarditis) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.   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 MYOCARDITIS (Vaccine gave him Myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (Vaccine gave him Myocarditis) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Concomitant medications was not provided by the reporter Treatment information was not provided.  Company Comment: This case concerns a patient of unknown age and gender with no relevant medical history  reportedwho experienced serious expected event of myocarditis. The event occurred after an unknown dose. Rechallenge was unknown due to lack of information regarding number of doses administered and reoccurrence of the event. The benefit-risk relationship of drug is not affected by this report; Sender's Comments: This case concerns a patient of unknown age and gender with no relevant medical history  reportedwho experienced serious expected event of myocarditis. The event occurred after an unknown dose. Rechallenge was unknown due to lack of information regarding number of doses administered and reoccurrence of the event. The benefit-risk relationship of drug is not affected by this report
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms for 12 hours after first vaccination; This spontaneous case was reported by a patient family member or friend and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms for 12 hours after first vaccination) in a 76-year-old male patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms for 12 hours after first vaccination). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms for 12 hours after first vaccination) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patients symptoms lasted for 12 hours. No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-336858 (Patient Link).
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Neoplasm malignant, Renal cancer
Clinical narrative: cromophobe renal carcinoma; cancerous tumor; This spontaneous case was reported by a consumer and describes the occurrence of RENAL CANCER (cromophobe renal carcinoma) and NEOPLASM MALIGNANT (cancerous tumor) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 010M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced RENAL CANCER (cromophobe renal carcinoma) (seriousness criterion medically significant) and NEOPLASM MALIGNANT (cancerous tumor) (seriousness criterion medically significant). The patient was treated with Surgery for Renal cancer and Surgery for Neoplasm malignant. At the time of the report, RENAL CANCER (cromophobe renal carcinoma) and NEOPLASM MALIGNANT (cancerous tumor) outcome was unknown.            No concomitant medication was mentioned.  On May2021 patient was diagnosed with a cancerous tumor, cromophobe renal carcinoma, and had a surgical removal of it as treatment.  Company comment -This case concerns a 69-year-old, male patient with no relevant medical history, who experienced the unexpected event of Renal cancer and Neoplasm malignant. The events occurred on an unknown day in May, 2021 after the second dose of Moderna Covid-19 vaccine. The rechallenge was not applicable, as the event happened only after the second dose. The events were considered related to the product per the reporter's assessment. The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report.; Sender's Comments: This case concerns a 69-year-old, male patient with no relevant medical history, who experienced the unexpected event of Renal cancer and Neoplasm malignant. The events occurred on an unknown day in May, 2021 after the second dose of Moderna Covid-19 vaccine. The rechallenge was not applicable, as the event happened only after the second dose. The events were considered related to the product per the reporter's assessment. The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: mix Moderna series and Pfizer booster; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (mix Moderna series and Pfizer booster) 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 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 and 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (mix Moderna series and Pfizer booster). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (mix Moderna series and Pfizer booster) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Vaccination complication
Clinical narrative: severe allergic reaction; problem in her ears; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (severe allergic reaction) and EAR DISCOMFORT (problem in her ears) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (severe allergic reaction) and EAR DISCOMFORT (problem in her ears). At the time of the report, VACCINATION COMPLICATION (severe allergic reaction) and EAR DISCOMFORT (problem in her ears) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: pain in the arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain in the arm) and HEADACHE (headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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. On an unknown date, the patient experienced VACCINATION SITE PAIN (pain in the arm) and HEADACHE (headache). At the time of the report, VACCINATION SITE PAIN (pain in the arm) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment medications were not reported.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Influenza
Clinical narrative: Sick; Got the flu; This spontaneous case was reported by a physician and describes the occurrence of ILLNESS (Sick) and INFLUENZA (Got the flu) in a 27-year-old female patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Sick) and INFLUENZA (Got the flu). At the time of the report, ILLNESS (Sick) had resolved and INFLUENZA (Got the flu) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  The patient took a couple of weeks to recover from  sickness.  No treatment information was provided.     This case was linked to MOD-2021-337080 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: arm hurt; chills; fever of 99.9 degrees F; body aches; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (arm hurt), CHILLS (chills), PYREXIA (fever of 99.9 degrees F) and MYALGIA (body aches) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included HIV infection (which she contracted from her husband), Chronic fatigue, Chronic bronchitis, Chronic pneumonia, Degenerative joint disease, Seasonal allergy and Penicillin allergy. Concomitant products included FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for Allergy, HYDROCODONE BITARTRATE, PARACETAMOL (VICODIN) for Degenerative joint disease, BICTEGRAVIR SODIUM, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (BIKTARVY) for HIV disease, EPINEPHRINE (EPIPEN) for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced VACCINATION SITE PAIN (arm hurt), CHILLS (chills), PYREXIA (fever of 99.9 degrees F) and MYALGIA (body aches). On 28-Feb-2021, VACCINATION SITE PAIN (arm hurt), CHILLS (chills), PYREXIA (fever of 99.9 degrees F) and MYALGIA (body aches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Feb-2021, Body temperature: 99.9 (High) 99.9 degree F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.   This case was linked to MOD-2021-337239 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: receiving a Moderna COVID19 vaccine dose after 2 doses of Pfizer's COVID19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (receiving a Moderna COVID19 vaccine dose after 2 doses of Pfizer's COVID19 vaccine) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for an unreported indication: PFIZER BIONTECH COVID-19 VACCINE (patient had received 2 doses of the Pfizer's COVID19 vaccine).    On 26-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (receiving a Moderna COVID19 vaccine dose after 2 doses of Pfizer's COVID19 vaccine). On 26-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (receiving a Moderna COVID19 vaccine dose after 2 doses of Pfizer's COVID19 vaccine) 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.   Treatment information was not provided.
Age: 54.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 54-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment  medications were provided. Time from first puncture was 3.5 hours.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of vaccine past 30 days in the fridge; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past 30 days in the fridge) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past 30 days in the fridge). On 27-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past 30 days in the fridge) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that the vials were stored in the refrigerator on 03-May-2021 and administered on 27-Aug-2021.  Concomitant medications were not reported.  Treatment medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 01-Oct-2021: Follow up received and added first dose date.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore left injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore left injection site arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050C21A, 031A21A and 016B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-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 received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore left injection site arm). At the time of the report, VACCINATION SITE PAIN (Sore left injection site arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications provided. No treatment medications provided.   This case was linked to MOD-2021-337382, MOD-2021-336875.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Parosmia, Vaccination site pain
Clinical narrative: Metallic taste the mouth and smell; Her hair are falling off; Can feel the pain on bony area, ribs, joints; Metallic taste the mouth and smell; Pain that is radiating to back down to their finger/can feel the pain on bony area; Have arm pain at the injection site; Can feel the pain on bony area, ribs, joints; 6 weeks after the 1st dose to get the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PAROSMIA (Metallic taste the mouth and smell), ALOPECIA (Her hair are falling off), MUSCULOSKELETAL CHEST PAIN (Can feel the pain on bony area, ribs, joints), DYSGEUSIA (Metallic taste the mouth and smell) and PAIN (Pain that is radiating to back down to their finger/can feel the pain on bony area) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  The patient's past medical history included Suspected COVID-19 (Patient had a past medical history of quarantine with COVID-19 symptoms since her boyfriend who was full diagnosed with COVID-19. They both were on quarantine prior to getting the vaccine. All the symptoms related to COVID-19 was cleared up before starting the new job.). Concomitant products included BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE (BUPRENORPHINE/NALOXONE) for an unknown indication.   On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Sep-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 PAROSMIA (Metallic taste the mouth and smell), ALOPECIA (Her hair are falling off), MUSCULOSKELETAL CHEST PAIN (Can feel the pain on bony area, ribs, joints), DYSGEUSIA (Metallic taste the mouth and smell), PAIN (Pain that is radiating to back down to their finger/can feel the pain on bony area), VACCINATION SITE PAIN (Have arm pain at the injection site), ARTHRALGIA (Can feel the pain on bony area, ribs, joints) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (6 weeks after the 1st dose to get the 2nd dose). At the time of the report, PAROSMIA (Metallic taste the mouth and smell), ALOPECIA (Her hair are falling off), MUSCULOSKELETAL CHEST PAIN (Can feel the pain on bony area, ribs, joints), DYSGEUSIA (Metallic taste the mouth and smell), PAIN (Pain that is radiating to back down to their finger/can feel the pain on bony area), VACCINATION SITE PAIN (Have arm pain at the injection site), ARTHRALGIA (Can feel the pain on bony area, ribs, joints) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (6 weeks after the 1st dose to get the 2nd dose) outcome was unknown.            No treatment information provided.  Patient was taking buprenorphine/naloxone 8mg/2mg and believed that her metallic taste could be correlated to this medicine. But other symptoms were from the vaccine.   This case was linked to MOD-2021-336567 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in the arm) 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 PAIN IN EXTREMITY (pain in the arm). At the time of the report, PAIN IN EXTREMITY (pain in the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided. Treatment information was not provided.
Age: 92.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after 3 days after the time from first puncture the vial; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after 3 days after the time from first puncture the vial) in a 92-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006c21a) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after 3 days after the time from first puncture the vial). On 05-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after 3 days after the time from first puncture the vial) had resolved. Not Provided    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 were reported. No treatment were reported.   This case was linked to MOD-2021-333546 (Patient Link).
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired vaccine) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired vaccine). On 08-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Received expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment medication were reported.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient hasn't received 2nd dose yet because of health issues; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose yet because of health issues) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-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 PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose yet because of health issues). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose yet because of health issues) had resolved.            Concomitant medication was not provided.  Treatment information was not provided.   Reporter did not allow further contact