chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: Vaccine exposure via breast milk; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (Vaccine exposure via breast milk) in a patient of an unknown age and gender exposed to mRNA-1273 (Moderna COVID-19 Vaccine) , while the mother received the product for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jul-2021, the mother received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient was diagnosed with EXPOSURE VIA BREAST MILK (Vaccine exposure via breast milk). At the time of the report, EXPOSURE VIA BREAST MILK (Vaccine exposure via breast milk) outcome was unknown.            Concomitant product use was not provided by the reporter.   Treatment information was not provided.   Patient mother received the COVID-19 moderna vaccine on July 15th and august 12th, currently breast feeding was wondering if there was a clinical trial she could volunteer for.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (low grinding headache right across forehead) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047C21A and 043B21A) for COVID-19 vaccination. No Medical History information was reported. On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-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 HEADACHE (low grinding headache right across forehead). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) ongoing since an unknown date at an unspecified dose and frequency and IBUPROFEN ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, HEADACHE (low grinding headache right across forehead) outcome was unknown.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Same problem with the rash after several weeks; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Same problem with the rash after several weeks) 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 RASH (Same problem with the rash after several weeks). At the time of the report, RASH (Same problem with the rash after several weeks) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided. No treatment medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Inhibitory drug interaction
Clinical narrative: Her medicine she had been taking since 1984 was no longer functioning since she received the vaccine; Felt tired ever so often since she got the shot; This spontaneous case was reported by a consumer and describes the occurrence of INHIBITORY DRUG INTERACTION (Her medicine she had been taking since 1984 was no longer functioning since she received the vaccine) and FATIGUE (Felt tired ever so often since she got the shot) 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 INHIBITORY DRUG INTERACTION (Her medicine she had been taking since 1984 was no longer functioning since she received the vaccine) and FATIGUE (Felt tired ever so often since she got the shot). At the time of the report, INHIBITORY DRUG INTERACTION (Her medicine she had been taking since 1984 was no longer functioning since she received the vaccine) and FATIGUE (Felt tired ever so often since she got the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided by reporter. Treatment information was not provided.   This case was linked to MOD-2021-293598 (Patient Link).
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram, Chest discomfort, Fatigue
Clinical narrative: feeling heaviness in his chest; vaccine made him feel tired all the time.; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (feeling heaviness in his chest) and FATIGUE (vaccine made him feel tired all the time.) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No medical information provided.  Concomitant products included CLOPIDOGREL, PANTOPRAZOLE and VITAMIN D3 for an unknown indication.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced CHEST DISCOMFORT (feeling heaviness in his chest) and FATIGUE (vaccine made him feel tired all the time.). At the time of the report, CHEST DISCOMFORT (feeling heaviness in his chest) and FATIGUE (vaccine made him feel tired all the time.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Angiogram: normal (normal) NORMAL.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       breathing test was done on 14-APR-2021 and the results were normal.  No treatment medication provided.  Patient had received second dose on 28Feb2021 and batch no. was 011A21A. Second shot was in left non dominant deltoid.   This case was linked to MOD-2021-293596 (Patient Link).
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: She got a little tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (She got a little tired) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030120A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced FATIGUE (She got a little tired). At the time of the report, FATIGUE (She got a little tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications was provided.  No treatment medications was provided.   This case was linked to MOD-2021-293565 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Swelling
Clinical narrative: body is swelling up; Arm is still sore; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (body is swelling up) and PAIN IN EXTREMITY (Arm is still sore) 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 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 SWELLING (body is swelling up) and PAIN IN EXTREMITY (Arm is still sore). At the time of the report, SWELLING (body is swelling up) and PAIN IN EXTREMITY (Arm is still sore) outcome was unknown.            No concomitant medications were provided by reporter.  No treatment details were provided by reporter.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Experienced mild effects from the virus/got COVID after the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Experienced mild effects from the virus/got COVID after the vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Experienced mild effects from the virus/got COVID after the vaccine). At the time of the report, COVID-19 (Experienced mild effects from the virus/got COVID after the vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment information was not provided.  Patient experienced mild effects from the virus. How long would it take to pass and when would patient test negative so patient can travel Getting COVID After the Vaccine.   Reporter did not allow further contact
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Off label use
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Received a 3rd dose / Caller is not immunocompromised and has not received an organ transplant) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 3 doses of the moderna covid-19 vaccine by injection on 17FEB2021 (023M20A), 19MAR2021 (046A21A), and 18AUG2021 (052E21A).) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052E21A, 046A21A and 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, the patient experienced OFF LABEL USE (Received a 3rd dose / Caller is not immunocompromised and has not received an organ transplant) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 3 doses of the moderna covid-19 vaccine by injection on 17FEB2021 (023M20A), 19MAR2021 (046A21A), and 18AUG2021 (052E21A).). At the time of the report, OFF LABEL USE (Received a 3rd dose / Caller is not immunocompromised and has not received an organ transplant) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 3 doses of the moderna covid-19 vaccine by injection on 17FEB2021 (023M20A), 19MAR2021 (046A21A), and 18AUG2021 (052E21A).) had resolved.            concomitant and treatment drugs were not provided
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (adverse reaction) 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, the patient experienced ADVERSE EVENT (adverse reaction). At the time of the report, ADVERSE EVENT (adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drugs were reported. No Treatment information  were reported.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: soreness in the arm; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in the arm) and FATIGUE (fatigue) in a 64-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 PAIN IN EXTREMITY (soreness in the arm) and FATIGUE (fatigue). At the time of the report, PAIN IN EXTREMITY (soreness in the arm) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.                   No treatment medication was reported.   This case was linked to MOD-2021-293377, MOD-2021-293637.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vial might been used after 12hs of being punctured; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vial might been used after 12hs of being punctured) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vial might been used after 12hs of being punctured). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vial might been used after 12hs of being punctured) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Caller had a question regarding the application of the moderna covid-19 vaccine after the vial was punctured for 12hs. Treatment medication was  not reported. Relevant concomitant medications were not provided by the reporter.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: fatigue; soreness in the arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), MYALGIA (soreness in the arm) and HEADACHE (headache) in a 64-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (fatigue), MYALGIA (soreness in the arm) and HEADACHE (headache). At the time of the report, FATIGUE (fatigue) and MYALGIA (soreness in the arm) outcome was unknown and HEADACHE (headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information were not provided by the reporter. Concomitant medications were not reported by reporter.   This case was linked to MOD-2021-293377, MOD-2021-293631 (Patient Link).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Insomnia, Pain, Pain in extremity, Product dose omission issue
Clinical narrative: I haven't gotten the second dose yet; I was waking up in the middle of the night, having that pinching; sharp pains, like somebody was actually pinching me; It was only in my right leg from ankle area to calf/I would be walking and then I would feel like somebody was stabbing; It was almost like a stab around my ankle area, I would be walking and then I would feel like somebody was stabbing; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (I was waking up in the middle of the night, having that pinching), PAIN (sharp pains, like somebody was actually pinching me), PAIN IN EXTREMITY (It was only in my right leg from ankle area to calf/I would be walking and then I would feel like somebody was stabbing), ARTHRALGIA (It was almost like a stab around my ankle area, I would be walking and then I would feel like somebody was stabbing) and PRODUCT DOSE OMISSION ISSUE (I haven't gotten the second dose yet) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No Medical History information was provided by the reporter.  Concomitant products included GABAPENTIN for an unknown indication.    On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In June 2021, the patient experienced INSOMNIA (I was waking up in the middle of the night, having that pinching), PAIN (sharp pains, like somebody was actually pinching me), PAIN IN EXTREMITY (It was only in my right leg from ankle area to calf/I would be walking and then I would feel like somebody was stabbing) and ARTHRALGIA (It was almost like a stab around my ankle area, I would be walking and then I would feel like somebody was stabbing). On 20-Aug-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (I haven't gotten the second dose yet). On 20-Aug-2021, PRODUCT DOSE OMISSION ISSUE (I haven't gotten the second dose yet) had resolved. At the time of the report, INSOMNIA (I was waking up in the middle of the night, having that pinching), PAIN (sharp pains, like somebody was actually pinching me), PAIN IN EXTREMITY (It was only in my right leg from ankle area to calf/I would be walking and then I would feel like somebody was stabbing) and ARTHRALGIA (It was almost like a stab around my ankle area, I would be walking and then I would feel like somebody was stabbing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cough, Mobility decreased, Muscular weakness
Clinical narrative: she can not stand; Weakness in the body; Weakness in legs; Dry cough; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Dry cough), MUSCULAR WEAKNESS (Weakness in legs), ASTHENIA (Weakness in the body) and MOBILITY DECREASED (she can not stand) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 026A21A) for COVID-19 vaccination.     Concurrent medical conditions included COPD. Concomitant products included TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA) and FORMOTEROL FUMARATE, GLYCOPYRRONIUM BROMIDE (BEVESPI AEROSPHERE) for COPD.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced COUGH (Dry cough). In July 2021, the patient experienced MUSCULAR WEAKNESS (Weakness in legs). On 20-Aug-2021, the patient experienced ASTHENIA (Weakness in the body). On an unknown date, the patient experienced MOBILITY DECREASED (she can not stand). At the time of the report, COUGH (Dry cough), MUSCULAR WEAKNESS (Weakness in legs), ASTHENIA (Weakness in the body) and MOBILITY DECREASED (she can not stand) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The treatment information was  not provided.
Age: 74.0
Sex: U
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Myalgia
Clinical narrative: Loss of appetite; Various muscle pain; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Loss of appetite), MYALGIA (Various muscle pain) and FATIGUE (Fatigue) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DECREASED APPETITE (Loss of appetite), MYALGIA (Various muscle pain) and FATIGUE (Fatigue). At the time of the report, DECREASED APPETITE (Loss of appetite), MYALGIA (Various muscle pain) and FATIGUE (Fatigue) had not resolved. Not Provided          No concurrent and treatment medication was reported by patient.  Patient wanted to know that vaccination ID and need to know that those were correct and valid or not.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: nasty cold; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (nasty cold) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (nasty cold). At the time of the report, NASOPHARYNGITIS (nasty cold) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment information were provided by the reporter. No Concomitant medications were reported by reporter. Additional event: mild symptoms   This case was linked to MOD-2021-133296, MOD-2021-133355.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Pain in extremity
Clinical narrative: Sore arm; Muscle aches; Fatigue; Headache; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (Sore arm), MYALGIA (Muscle aches), FATIGUE (Fatigue) and HEADACHE (Headache) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Aug-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 21-Aug-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), MYALGIA (Muscle aches), FATIGUE (Fatigue) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Sore arm), MYALGIA (Muscle aches), FATIGUE (Fatigue) and HEADACHE (Headache) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided Treatment information was not reported
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: Itching at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching at the injection site) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Aug-2021, the patient experienced VACCINATION SITE PRURITUS (Itching at the injection site). At the time of the report, VACCINATION SITE PRURITUS (Itching at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant medications were not provided. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort
Clinical narrative: Felt diffuse chest pressure throughout the chest; This spontaneous case was reported by an other health care professional and describes the occurrence of CHEST DISCOMFORT (Felt diffuse chest pressure throughout the chest) 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 12-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Aug-2021, the patient experienced CHEST DISCOMFORT (Felt diffuse chest pressure throughout the chest). On 14-Aug-2021, CHEST DISCOMFORT (Felt diffuse chest pressure throughout the chest) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment information was not provided.   This case was linked to MOD-2021-293700 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: gave 3rd vaccine dose from the expired vial; Patient took the third dose outside the window period; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (gave 3rd vaccine dose from the expired vial) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took the third dose outside the window period) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052E211A, 037K20A and 010M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included APIXABAN (ELIQUIS), METOPROLOL, SIMVASTATIN and ANASTROZOLE for an unknown indication.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-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. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (gave 3rd vaccine dose from the expired vial) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took the third dose outside the window period). At the time of the report, EXPIRED PRODUCT ADMINISTERED (gave 3rd vaccine dose from the expired vial) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took the third dose outside the window period) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient was immunocompromised.  The treatment information was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (vaccination adverse reaction) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (vaccination adverse reaction). At the time of the report, VACCINATION COMPLICATION (vaccination adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details were provided. No treatment information was mentioned.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate irregular, Maternal exposure during pregnancy
Clinical narrative: Irregular heartbeat; Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of HEART RATE IRREGULAR (Irregular heartbeat) and MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) 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. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced HEART RATE IRREGULAR (Irregular heartbeat) and MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). At the time of the report, HEART RATE IRREGULAR (Irregular heartbeat) outcome was unknown and MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product information was provided.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Chest discomfort
Clinical narrative: Light chest tightness; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Light chest tightness) 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, the patient experienced CHEST DISCOMFORT (Light chest tightness). At the time of the report, CHEST DISCOMFORT (Light chest tightness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Influenza like illness, Nausea, Pyrexia
Clinical narrative: Flu like symptoms; weak/tired Covid-19 feeling; weak/tired Covid-19 feeling; very nauseated; Fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), ASTHENIA (weak/tired Covid-19 feeling), FATIGUE (weak/tired COVID-19 feeling), NAUSEA (very nauseated) and PYREXIA (Fever) 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 INFLUENZA LIKE ILLNESS (Flu like symptoms), ASTHENIA (weak/tired COVID-19 feeling), FATIGUE (weak/tired Covid-19 feeling), NAUSEA (very nauseated) and PYREXIA (Fever). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), ASTHENIA (weak/tired Covid-19 feeling), FATIGUE (weak/tired Covid-19 feeling), NAUSEA (very nauseated) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment information was not provided.   Reporter did not allow further contact
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: arm pain; muscle/body aches; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (arm pain) and MYALGIA (muscle/body aches) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hypertension (Constant for a while) in 2007 and Chest pain. Concurrent medical conditions included Drug allergy, Tension headache (Once a week usually, not recall last HA) since 28-Feb-2021, SLE nephritis (Knee pain, low energy (continued after vaccination and ondoing)) since 24-Jun-2021 and Depression. Concomitant products included FLUOXETINE for Depression, TRAZODONE for Tension headache, HYDROXYCHLOROQUINE, MYCOPHENOLATE MOFETIL (MYCOPHENOLATE), PREDNISONE, SPIRONOLACTONE, ARIPIPRAZOLE (ABILIFY), VITAMIN D NOS and FOLIC ACID for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm pain) and MYALGIA (muscle/body aches). At the time of the report, PAIN IN EXTREMITY (arm pain) and MYALGIA (muscle/body aches) 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.   Treatment information was not provided.   This case was linked to MOD-2021-293783, MOD-2021-291097, MOD-2021-291097 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Sharp pain in chest; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Sharp pain in chest) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021 at 11:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (Sharp pain in chest). At the time of the report, CHEST PAIN (Sharp pain in chest) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product was not provided by the reporter. Treatment information was not provided. Laboratory details: EKG, chest X ray diagnosis were unclear CT scan, respiratory testing ,echocardiogram, blood work and CT angiogram with and without contrast results were not provided   This case was linked to MOD-2021-114557 (Patient Link).
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Sore arm; muscle soreness; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and MYALGIA (muscle soreness) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Chest pain. Concurrent medical conditions included Drug allergy (prevacid), SLE nephritis (glomerular disease in SLE) since 25-Jun-2021, Tension headache (tension type headache) since 28-Feb-2021, Hypertension (constant for a while) since 2007, SLE syndrome aggravated (possible SLE flare up at time, no blood work taken.) and Depression. Concomitant products included FLUOXETINE for Depression, TRAZODONE for Tension headache, HYDROXYCHLOROQUINE, MYCOPHENOLATE MOFETIL (MYCOPHENOLATE), PREDNISONE, SPIRONOLACTONE, ARIPIPRAZOLE (ABILIFY), VITAMIN D NOS and FOLIC ACID for an unknown indication.    On 23-Mar-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 PAIN IN EXTREMITY (Sore arm) and MYALGIA (muscle soreness). At the time of the report, PAIN IN EXTREMITY (Sore arm) and MYALGIA (muscle soreness) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The Treatment history was not reported. Patient had not taken any OTC medicines to try to alleviate symptoms since receiving moderna dose.      This case was linked to MOD-2021-291097, MOD-2021-293779 (Patient Link).
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Pain
Clinical narrative: pain in the heel; received a third dose of the Moderna COVID-19 vaccine and was not immunocompromised; This spontaneous case was reported by a nurse and describes the occurrence of PAIN (pain in the heel) and EXTRA DOSE ADMINISTERED (received a third dose of the Moderna COVID-19 vaccine and was not immunocompromised) in a 70-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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (pain in the heel) and EXTRA DOSE ADMINISTERED (received a third dose of the Moderna COVID-19 vaccine and was not immunocompromised). The patient was treated with DEXAMETHASONE for Pain, at a dose of 1 dosage form. At the time of the report, PAIN (pain in the heel) outcome was unknown and EXTRA DOSE ADMINISTERED (received a third dose of the Moderna COVID-19 vaccine and was not immunocompromised) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered PAIN (pain in the heel) to be not related. No further causality assessment was provided for EXTRA DOSE ADMINISTERED (received a third dose of the Moderna COVID-19 vaccine and was not immunocompromised).    He had pain in the heel, for a reason unrelated to the vaccine according to the Nurse. No concomitant medications provided.
Sex: U
Vaccine: COVID19
Symptoms: Injection site swelling
Clinical narrative: Swelling at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (Swelling at injection site) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE SWELLING (Swelling at injection site). At the time of the report, INJECTION SITE SWELLING (Swelling at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: After 3rd dose - rash on the the left arm below where I received the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (After 3rd dose - rash on the the left arm below where I received the injection) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (After 3rd dose - rash on the the left arm below where I received the injection). At the time of the report, VACCINATION SITE RASH (After 3rd dose - rash on the the left arm below where I received the injection) outcome was unknown.            No historical medications were reported.   Reporter did not allow further contact
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, Illness, Product dose omission issue
Clinical narrative: Bronchitis; felt very very sick; She had the 1st shot on  april. She didn´t get the 2nd dose yet; This spontaneous case was reported by a consumer and describes the occurrence of BRONCHITIS (Bronchitis), PRODUCT DOSE OMISSION ISSUE (She had the 1st shot on  april. She didn´t get the 2nd dose yet) and ILLNESS (felt very very sick) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (She had the 1st shot on  april. She didn´t get the 2nd dose yet). On an unknown date, the patient experienced BRONCHITIS (Bronchitis) and ILLNESS (felt very very sick). At the time of the report, BRONCHITIS (Bronchitis) and ILLNESS (felt very very sick) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (She had the 1st shot on  april. She didn´t get the 2nd dose yet) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided Treatment information was not reported  Doctor had diagnosed Bronchitis may/may not be related to the vaccine. (both believes was not).
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site hypoaesthesia
Clinical narrative: Whole arm where the patient got the injection went numb, from the shoulder to the fingertips; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HYPOAESTHESIA (Whole arm where the patient got the injection went numb, from the shoulder to the fingertips) 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 VACCINATION SITE HYPOAESTHESIA (Whole arm where the patient got the injection went numb, from the shoulder to the fingertips). At the time of the report, VACCINATION SITE HYPOAESTHESIA (Whole arm where the patient got the injection went numb, from the shoulder to the fingertips) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products were reported.  No treatment information provided.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Pyrexia
Clinical narrative: flu-like symptoms; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), CHILLS (chills) and PYREXIA (fever) in a 58-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), CHILLS (chills) and PYREXIA (fever). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Chills and Fever, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), CHILLS (chills) and PYREXIA (fever) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       The patient had no throwing up after the first dose. Relevant concomitant medications were not provided by the reporter.   This case was linked to MOD-2021-293913 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site bruising
Clinical narrative: Random bruising outside of injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Random bruising outside of injection site) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE BRUISING (Random bruising outside of injection site). At the time of the report, VACCINATION SITE BRUISING (Random bruising outside of injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment medications provided.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Vaccination site erythema, Vaccination site rash, Vaccination site swelling
Clinical narrative: the arm is very swollen; About the area on arm where the vaccine was injected has swollen up; there is a little dot there; there is a little red rash; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (the arm is very swollen), VACCINATION SITE SWELLING (About the area on arm where the vaccine was injected has swollen up), VACCINATION SITE ERYTHEMA (there is a little dot there) and VACCINATION SITE RASH (there is a little red rash) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049E21A and 040C21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.   On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2021, the patient experienced PERIPHERAL SWELLING (the arm is very swollen), VACCINATION SITE SWELLING (About the area on arm where the vaccine was injected has swollen up), VACCINATION SITE ERYTHEMA (there is a little dot there) and VACCINATION SITE RASH (there is a little red rash). At the time of the report, PERIPHERAL SWELLING (the arm is very swollen), VACCINATION SITE SWELLING (About the area on arm where the vaccine was injected has swollen up), VACCINATION SITE ERYTHEMA (there is a little dot there) and VACCINATION SITE RASH (there is a little red rash) outcome was unknown.            Concomitant medication includes Blood thinners and Blood pressure Medication.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: had reactions to second dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (had reactions to second dose) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (had reactions to second dose). At the time of the report, VACCINATION COMPLICATION (had reactions to second dose) outcome was unknown.            No concomitant medications were reported. No treatment details was reported.