chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Nasal congestion, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: SORE THROAT; CONGESTION; RUNNY NOSE; MUSCLE ACHES; FATIGUE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced sore throat, congestion, runny nose, muscle aches, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sore throat, congestion, runny nose, muscle aches, and fatigue. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pain, Pain in extremity, Pyrexia
Clinical narrative: IT HURT / BODY ACHES / PAIN; CHILLS; SORE ARM; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced it hurt / body aches / pain, chills, sore arm, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from it hurt / body aches / pain, chills, sore arm, and fever. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Somnolence
Clinical narrative: DIZZINESS; SLEEPY ALL DAY; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 19-JUN-2021 18:50 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 20-JUN-2021, the subject experienced dizziness. On 20-JUN-2021, the subject experienced sleepy all day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sleepy all day on 20-JUN-2021, and had not recovered from dizziness. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: DIZZY; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 18-JUN-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 18-JUN-2021, the subject experienced dizzy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of dizzy was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 18-JUN-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 19-JUN-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Feeling hot, Pruritus, Swelling face
Clinical narrative: SWOLLEN FACE; LEFT EYE WAS VERY SWOLLEN SO IT WAS DIFFICULT TO SEE OUT OF IT; ITCHY FACE; HOT FACE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 17-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On JUN-2021, the subject experienced swollen face. On JUN-2021, the subject experienced left eye was very swollen so it was difficult to see out of it. On JUN-2021, the subject experienced itchy face. On JUN-2021, the subject experienced hot face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the swollen face, hot face, left eye was very swollen so it was difficult to see out of it and itchy face was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Vertigo
Clinical narrative: VERTIGO; FOGGY FEELING; CONSTANT HEADACHES; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced vertigo, foggy feeling, and constant headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from constant headaches, and the outcome of vertigo and foggy feeling was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Flushing, Headache, Hyperhidrosis, Injection site pruritus, Nausea
Clinical narrative: INJECTION SITE FELT ITCHY; ENTIRE BODY FLUSH; BODY SWEATY; FELT ROUGH; NAUSEATED; HEADACHE; HIGH FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced injection site felt itchy, entire body flush, body sweaty, felt rough, nauseated, headache, and high fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, and high fever, and the outcome of injection site felt itchy, entire body flush, nauseated, felt rough and body sweaty was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Sensory disturbance
Clinical narrative: INJECTION SITE FELT ITCHY; ENTIRE BODY FLUSH; BODY SWEATY; FELT ROUGH; NAUSEATED; HEADACHE; HIGH FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced injection site felt itchy, entire body flush, body sweaty, felt rough, nauseated, headache, and high fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, and high fever, and the outcome of injection site felt itchy, entire body flush, nauseated, felt rough and body sweaty was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Headache, Nausea, Vomiting
Clinical narrative: VOMITING; BAD CHEST PAIN; NAUSEA; BAD HEADACHES; This spontaneous report received from a patient concerned a 37 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A,  expiry: 07-AUG-2021) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-MAY-2021, the subject experienced vomiting. On 25-MAY-2021, the subject experienced bad chest pain. On 25-MAY-2021, the subject experienced nausea. On 25-MAY-2021, the subject experienced bad headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, vomiting, bad headaches, and bad chest pain. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Neoplasm
Clinical narrative: TUMOR; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced tumor. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tumor was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VIAL WAS KEPT AT ROOM TEMPERATURE FOR 3 HOURS; POOR QUALITY VACCINE ADMINISTERED; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy to sulfa. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: 07-AUG-2021) dose was not reported, administered on 21-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-JUN-2021, the subject experienced vial was kept at room temperature for 3 hours. On 21-JUN-2021, the subject experienced poor quality vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vial was kept at room temperature for 3 hours and poor quality vaccine administered was not reported. This report was non-serious.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Ataxia, Balance disorder, Cerebrovascular accident, Headache, Hypoaesthesia
Clinical narrative: Stroke; numbness in left hand; Headache; Ataxia left arm,; Motor skill issues/steadiness, unbalance; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042C20A and 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroid disorder. Concomitant products included LEVOTHYROXINE for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jan-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization and medically significant), ATAXIA (Ataxia left arm,), BALANCE DISORDER (Motor skill issues/steadiness, unbalance) and HEADACHE (Headache). On an unknown date, the patient experienced HYPOAESTHESIA (numbness in left hand). The patient was hospitalized from 25-Jan-2021 to 26-Jan-2021 due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) had resolved, ATAXIA (Ataxia left arm,) and HYPOAESTHESIA (numbness in left hand) had not resolved and BALANCE DISORDER (Motor skill issues/steadiness, unbalance) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that on an unspecified start date the patient is currently in OT.  Treatment information not reported.  Company Comment: 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.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Follow up received by safety 10-Jun-2021 included  an ADR added. Reporter address is updated. Patient height, weight, race and ethnicity is captured. Information of first and second vaccination updated. Event information was updated. new events, stroke and ataxia in left arm added and the events led the patient to visit ER.; 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: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chest pain, Dyspnoea, Fatigue, Myalgia
Clinical narrative: Has not received 2nd dose; Arm pain; Shoulder blade catch sore muscle\ arm pain; Fatigue; Pain at injection site; Myocarditis; Shortness of breath; weakness; Chest pain; Neck pain; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (Myocarditis) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included DULOXETINE, GLIMEPIRIDE, LISINOPRIL and METFORMIN for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criterion medically significant), DYSPNOEA (Shortness of breath), ASTHENIA (weakness), CHEST PAIN (Chest pain), NECK PAIN (Neck pain), PAIN (Arm pain), MYALGIA (Shoulder blade catch sore muscle\ arm pain), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Pain at injection site). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Has not received 2nd dose). On 02-Apr-2021, VACCINATION SITE PAIN (Pain at injection site) had resolved. At the time of the report, MYOCARDITIS (Myocarditis), ASTHENIA (weakness), PRODUCT DOSE OMISSION ISSUE (Has not received 2nd dose), MYALGIA (Shoulder blade catch sore muscle\ arm pain) and FATIGUE (Fatigue) outcome was unknown and DYSPNOEA (Shortness of breath), CHEST PAIN (Chest pain), NECK PAIN (Neck pain) and PAIN (Arm pain) was resolving.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No treatment information was provided. Patient stated that he thinks he may have had COVID in Dec2019 or Jan2020.  This case concerns a 55-year-old male patient did not receive the second dose 4-6 weeks post first dose of mRNA-1273  product dose omission, .The remaining events are temporarily associated with the product use and hence, a causal relationship cannot be excluded. Myalgia and pain are consistent with the product known safety profile.  Product dose omission is not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Added new event and updated vaccine dose information.; Sender's Comments: This case concerns a 55-year-old male patient did not receive the second dose 4-6 weeks post first dose of mRNA-1273  product dose omission, .The remaining events are temporarily associated with the product use and hence, a causal relationship cannot be excluded. Myalgia and pain are consistent with the product known safety profile.  Product dose omission is not applicable.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis, Neck pain, Pain, Product dose omission issue, Vaccination site pain
Clinical narrative: Has not received 2nd dose; Arm pain; Shoulder blade catch sore muscle\ arm pain; Fatigue; Pain at injection site; Myocarditis; Shortness of breath; weakness; Chest pain; Neck pain; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (Myocarditis) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included DULOXETINE, GLIMEPIRIDE, LISINOPRIL and METFORMIN for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criterion medically significant), DYSPNOEA (Shortness of breath), ASTHENIA (weakness), CHEST PAIN (Chest pain), NECK PAIN (Neck pain), PAIN (Arm pain), MYALGIA (Shoulder blade catch sore muscle\ arm pain), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Pain at injection site). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Has not received 2nd dose). On 02-Apr-2021, VACCINATION SITE PAIN (Pain at injection site) had resolved. At the time of the report, MYOCARDITIS (Myocarditis), ASTHENIA (weakness), PRODUCT DOSE OMISSION ISSUE (Has not received 2nd dose), MYALGIA (Shoulder blade catch sore muscle\ arm pain) and FATIGUE (Fatigue) outcome was unknown and DYSPNOEA (Shortness of breath), CHEST PAIN (Chest pain), NECK PAIN (Neck pain) and PAIN (Arm pain) was resolving.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No treatment information was provided. Patient stated that he thinks he may have had COVID in Dec2019 or Jan2020.  This case concerns a 55-year-old male patient did not receive the second dose 4-6 weeks post first dose of mRNA-1273  product dose omission, .The remaining events are temporarily associated with the product use and hence, a causal relationship cannot be excluded. Myalgia and pain are consistent with the product known safety profile.  Product dose omission is not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Added new event and updated vaccine dose information.; Sender's Comments: This case concerns a 55-year-old male patient did not receive the second dose 4-6 weeks post first dose of mRNA-1273  product dose omission, .The remaining events are temporarily associated with the product use and hence, a causal relationship cannot be excluded. Myalgia and pain are consistent with the product known safety profile.  Product dose omission is not applicable.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Product administered to patient of inappropriate age, Syncope
Clinical narrative: Fainting episode; Dehydration; Received 1st Moderna dose at age 14; This spontaneous case was reported by a pharmacist and describes the occurrence of SYNCOPE (Fainting episode) in a 14-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received 1st Moderna dose at age 14). On an unknown date, the patient experienced SYNCOPE (Fainting episode) (seriousness criterion medically significant) and DEHYDRATION (Dehydration). On 25-May-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received 1st Moderna dose at age 14) had resolved. At the time of the report, SYNCOPE (Fainting episode) and DEHYDRATION (Dehydration) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered SYNCOPE (Fainting episode) to be not related. No further causality assessments were provided for PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received 1st Moderna dose at age 14) and DEHYDRATION (Dehydration).    No concomitant medications were provided. No treatment medications were provided.  Company Comment: This report refers to a case of product administered to patient of inappropriate age (14- year old) for mRNA-1273 (lot number 016C21A) with associated AEs reported as syncope and dehydration.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Follow-up received on 10 June 2021.Follow-up letter uploaded. New information included added events, including serious event of fainting. On 11-Jun-2021: Follow-up received on 11 June 2021.General tab information was updated (like information regarding the person completing form). In patient tab patient's height and weight was added.In product tab anatomical location was added.Events like syncope and dehydration were added in events tab.; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age (14- year old) for mRNA-1273 (lot number 016C21A) with associated AEs reported as syncope and dehydration.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Meningitis, Pneumonia, Sepsis, Systemic lupus erythematosus
Clinical narrative: Pneumonia; Meningitis; Sepsis; Probable lupus; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia), MENINGITIS (Meningitis), SEPSIS (Sepsis) and SYSTEMIC LUPUS ERYTHEMATOSUS (Probable lupus) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-May-2021, the patient experienced PNEUMONIA (Pneumonia) (seriousness criteria hospitalization prolonged and medically significant), MENINGITIS (Meningitis) (seriousness criteria hospitalization prolonged and medically significant), SEPSIS (Sepsis) (seriousness criteria hospitalization prolonged and medically significant) and SYSTEMIC LUPUS ERYTHEMATOSUS (Probable lupus) (seriousness criteria hospitalization prolonged and medically significant). The patient was hospitalized on 24-May-2021 due to MENINGITIS, PNEUMONIA, SEPSIS and SYSTEMIC LUPUS ERYTHEMATOSUS. At the time of the report, PNEUMONIA (Pneumonia), MENINGITIS (Meningitis), SEPSIS (Sepsis) and SYSTEMIC LUPUS ERYTHEMATOSUS (Probable lupus) had not resolved.            Concomitant medication were not reported. No known allergies for the patient. No treatment information was provided. The reporter stated that the patient is currently admitted in a hospital on a critical condition. The patient was first hospitalized last month on 14 May 2021, and was discharged on 18 May 2021. The patient was re-admitted on 24 May 2021 under critical condition. The patient doesn't have the vaccination card and was unable to provide some important details.  Very limited information regarding these events have been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events have been provided at this time. Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: Afib came roaring back; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (Afib came roaring back) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included Cardiac ablation in June 2020. Concurrent medical conditions included Atrial fibrillation.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced ATRIAL FIBRILLATION (Afib came roaring back) (seriousness criterion medically significant). The patient was treated with Surgery (Cardiac ablation) for Atrial fibrillation. At the time of the report, ATRIAL FIBRILLATION (Afib came roaring back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  Concomitant product use was not provided. Patient had to unfergo cardiac ablation again 3 Jun 2021.  Company comment 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. Patient's history of atrial fibrillation may be a confounding factor. No further information is expected.   Reporter did not allow further contact; 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. Patient's history of atrial fibrillation may be a confounding factor. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Fall, Loss of consciousness
Clinical narrative: Passed out; She dropped; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant) and FALL (She dropped). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out) and FALL (She dropped) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Apr-2021, Blood pressure measurement: low (Low) very low.         Concomitant medication swere not reported.  No treatment information was reported. The patient reported that the ambulance came and went to emergency room, a nd was admitted in the hospital for 3 hours. The patient had no other diseases, and was crying and asking for help about her bills, because she had no insurance and needed help.; 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: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Ankle fracture, Product dose omission issue
Clinical narrative: Son fractured ankle on 5May2021 a day before he was supposed to get 2nd dose; 62 days since date of first dose 8Apr2021.; This spontaneous case was reported by a consumer and describes the occurrence of ANKLE FRACTURE (Son fractured ankle on 5May2021 a day before he was supposed to get 2nd dose) in a 21-year-old male 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 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 05-May-2021, the patient experienced ANKLE FRACTURE (Son fractured ankle on 5May2021 a day before he was supposed to get 2nd dose) (seriousness criterion hospitalization). On 06-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (62 days since date of first dose 8Apr2021.). The patient was treated with Surgery for Ankle fracture. On 06-May-2021, PRODUCT DOSE OMISSION ISSUE (62 days since date of first dose 8Apr2021.) had resolved. At the time of the report, ANKLE FRACTURE (Son fractured ankle on 5May2021 a day before he was supposed to get 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided. Due to fractured ankle, the patient never received the second dose which was scheduled for 6May2021. The patient could not get the vaccine due to surgery for fractured ankle.  This case concerns a 21-year-old male patient  who did not to receive the second dose (product dose omission) due to fractured ankle. .  The event of fracturesd ankle is assessed as not related to mRNA-1273 use based on biological implausibility.  Product dose omission is assessed as not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Patient age was updated.; Sender's Comments: This case concerns a 21-year-old male patient  who did not to receive the second dose (product dose omission) due to fractured ankle. .  The event of fracturesd ankle is assessed as not related to mRNA-1273 use based on biological implausibility.  Product dose omission is assessed as not applicable.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Bloody nose that would not stop/ her bloody nose episodes have been occurring on and off; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EPISTAXIS (Bloody nose that would not stop/ her bloody nose episodes have been occurring on and off) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028921A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced EPISTAXIS (Bloody nose that would not stop/ her bloody nose episodes have been occurring on and off) (seriousness criterion hospitalization). The patient was hospitalized on 03-Apr-2021 due to EPISTAXIS. At the time of the report, EPISTAXIS (Bloody nose that would not stop/ her bloody nose episodes have been occurring on and off) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  Treatment included saline, humidifier and other treatments, not specified. Very limited information regarding the event has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding the event has been provided at this time. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Seizure
Clinical narrative: Seizure; Patient passed out; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Seizure) and LOSS OF CONSCIOUSNESS (Patient passed out) in an 18-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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SEIZURE (Seizure) (seriousness criterion medically significant) and LOSS OF CONSCIOUSNESS (Patient passed out) (seriousness criterion medically significant). At the time of the report, SEIZURE (Seizure) and LOSS OF CONSCIOUSNESS (Patient passed out) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Age at vaccination not reported.  Concomitant medications not reported.  Treatment information was not provided.  Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Had seizure immediately after getting the shot; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Had seizure immediately after getting the shot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SEIZURE (Had seizure immediately after getting the shot) (seriousness criterion medically significant). At the time of the report, SEIZURE (Had seizure immediately after getting the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. No treatment information was reported. Very limited information regarding the event has been provided at this time. No further information is expected.; Sender's Comments: Very limited information regarding the event has been provided at this time. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Cough, Fatigue, Feeling abnormal
Clinical narrative: Sore arm; Dry cough; Mind fog; Feeling weak; Tired; Low grade fever; Headache; Lung infection; Covid-19 positive; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Lung infection) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Smoker.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2021, the patient experienced PNEUMONIA (Lung infection) (seriousness criterion medically significant) and COVID-19 (Covid-19 positive). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), COUGH (Dry cough), FEELING ABNORMAL (Mind fog), ASTHENIA (Feeling weak), FATIGUE (Tired), PYREXIA (Low grade fever) and HEADACHE (Headache). On 01-Jun-2021, COVID-19 (Covid-19 positive) had resolved. At the time of the report, PNEUMONIA (Lung infection), PAIN IN EXTREMITY (Sore arm), COUGH (Dry cough), FEELING ABNORMAL (Mind fog), ASTHENIA (Feeling weak), FATIGUE (Tired), PYREXIA (Low grade fever) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, SARS-CoV-2 test: positive (Positive) positive. On 01-Jun-2021, SARS-CoV-2 test: negative (Negative) negative.         No concomitant medication reported. The patient experienced a sore arm and feeling weak and tired. The patient experienced low grade fever, dry cough, mind fog, and headaches for 2-3 days. The patient developed a lung infection and had to be placed on antibiotics.  Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the reported events, a causal relationship cannot be excluded. Headache fatigue and pyrexia are consistent with the product known safety profile.  Based on biological implausibility, Covid-19 and pneumonia are assessed as not related to product use; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the reported events, a causal relationship cannot be excluded. Headache fatigue and pyrexia are consistent with the product known safety profile.  Based on biological implausibility, Covid-19 and pneumonia are assessed as not related to product use
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Pneumonia, Pyrexia, SARS-CoV-2 test
Clinical narrative: Sore arm; Dry cough; Mind fog; Feeling weak; Tired; Low grade fever; Headache; Lung infection; Covid-19 positive; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Lung infection) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Smoker.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2021, the patient experienced PNEUMONIA (Lung infection) (seriousness criterion medically significant) and COVID-19 (Covid-19 positive). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), COUGH (Dry cough), FEELING ABNORMAL (Mind fog), ASTHENIA (Feeling weak), FATIGUE (Tired), PYREXIA (Low grade fever) and HEADACHE (Headache). On 01-Jun-2021, COVID-19 (Covid-19 positive) had resolved. At the time of the report, PNEUMONIA (Lung infection), PAIN IN EXTREMITY (Sore arm), COUGH (Dry cough), FEELING ABNORMAL (Mind fog), ASTHENIA (Feeling weak), FATIGUE (Tired), PYREXIA (Low grade fever) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, SARS-CoV-2 test: positive (Positive) positive. On 01-Jun-2021, SARS-CoV-2 test: negative (Negative) negative.         No concomitant medication reported. The patient experienced a sore arm and feeling weak and tired. The patient experienced low grade fever, dry cough, mind fog, and headaches for 2-3 days. The patient developed a lung infection and had to be placed on antibiotics.  Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the reported events, a causal relationship cannot be excluded. Headache fatigue and pyrexia are consistent with the product known safety profile.  Based on biological implausibility, Covid-19 and pneumonia are assessed as not related to product use; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the reported events, a causal relationship cannot be excluded. Headache fatigue and pyrexia are consistent with the product known safety profile.  Based on biological implausibility, Covid-19 and pneumonia are assessed as not related to product use
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Haematemesis
Clinical narrative: vomiting blood; severe pain in left hip area; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATEMESIS (vomiting blood) in a patient of an unknown age and gender 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 30-May-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 HAEMATEMESIS (vomiting blood) (seriousness criterion medically significant) and ARTHRALGIA (severe pain in left hip area). At the time of the report, HAEMATEMESIS (vomiting blood) and ARTHRALGIA (severe pain in left hip area) outcome was unknown.            No concomitant medication were provided by the reporter. The lot/batch number for mRNA-1273 was not provided. Treatment information was not provided.  Very limited information regarding these events has been provided at this time. No further information is expected as the reporter did not allow further contact.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding these events has been provided at this time. No further information is expected as the reporter did not allow further contact.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Inappropriate schedule of product administration
Clinical narrative: COVID pneumonia; Will receive the second dose of the vaccine more than 36 days after the first one; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 PNEUMONIA (COVID pneumonia) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided.  Concomitant products included ALBUTEROL [SALBUTAMOL], CITALOPRAM, DESVENLAFAXINE, FLUTICASONE, LORAZEPAM and COLECALCIFEROL (VITAMIN D3) for an unknown indication.    On 16-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 COVID-19 PNEUMONIA (COVID pneumonia) (seriousness criteria hospitalization and medically significant) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Will receive the second dose of the vaccine more than 36 days after the first one). The patient was hospitalized on 01-Apr-2021 due to COVID-19 PNEUMONIA. At the time of the report, COVID-19 PNEUMONIA (COVID pneumonia) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Will receive the second dose of the vaccine more than 36 days after the first one) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was not able to received the second dose due to hospitalization. No treatment information was provided.  Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Follow-up information will be processed at the same time as the initial report. Patient demographics were updated.; Sender's Comments: Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Choking, Cough, Epistaxis
Clinical narrative: Started choking on spit; Everytime i cough my nose bleeds now; Everytime i cough my nose bleeds now; This spontaneous case was reported by a consumer and describes the occurrence of CHOKING (Started choking on spit) in a patient of an unknown age and gender 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHOKING (Started choking on spit) (seriousness criterion medically significant), COUGH (Everytime i cough my nose bleeds now) and EPISTAXIS (Everytime i cough my nose bleeds now). At the time of the report, CHOKING (Started choking on spit), COUGH (Everytime i cough my nose bleeds now) and EPISTAXIS (Everytime i cough my nose bleeds now) outcome was unknown.            No concomitant product use was reported. No treatment information was provided  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; 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.