chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Knee pain/Joint aches in the spine area around the shoulder blade/reappearing side effect; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Knee pain/Joint aches in the spine area around the shoulder blade/reappearing side effect) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 044A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ARTHRALGIA (Knee pain/Joint aches in the spine area around the shoulder blade/reappearing side effect). At the time of the report, ARTHRALGIA (Knee pain/Joint aches in the spine area around the shoulder blade/reappearing side effect) had not resolved.            No treatment medications were reported.  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 02-Aug-2021: Updated vaccine route and location and updated event coding; 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.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: my first does was 4/2/21 can I get the seco; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (my first does was 4/2/21 can I get the seco) 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 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (my first does was 4/2/21 can I get the seco). At the time of the report, PRODUCT DOSE OMISSION ISSUE (my first does was 4/2/21 can I get the seco) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Feeling abnormal, Hypoaesthesia
Clinical narrative: He started feeling dizziness 4 days after receiving 1st dose/He felt light headed in his head.; He felt like everything was moving; He felt numbness in his head; He was loosing his balance; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (He started feeling dizziness 4 days after receiving 1st dose/He felt light headed in his head.), FEELING ABNORMAL (He felt like everything was moving), HYPOAESTHESIA (He felt numbness in his head) and BALANCE DISORDER (He was loosing his balance) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jun-2021, the patient experienced DIZZINESS (He started feeling dizziness 4 days after receiving 1st dose/He felt light headed in his head.), FEELING ABNORMAL (He felt like everything was moving), HYPOAESTHESIA (He felt numbness in his head) and BALANCE DISORDER (He was loosing his balance). On 28-Jun-2021, DIZZINESS (He started feeling dizziness 4 days after receiving 1st dose/He felt light headed in his head.), FEELING ABNORMAL (He felt like everything was moving), HYPOAESTHESIA (He felt numbness in his head) and BALANCE DISORDER (He was loosing his balance) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication use was unknown Treatment information was unknown
Sex: U
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: severe chest pains/last about 20 minutes and then go away; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (severe chest pains/last about 20 minutes and then go away) 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 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (severe chest pains/last about 20 minutes and then go away). At the time of the report, CHEST PAIN (severe chest pains/last about 20 minutes and then go away) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: swollen feet; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen feet) 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 29-Jun-2021, the patient experienced PERIPHERAL SWELLING (swollen feet). At the time of the report, PERIPHERAL SWELLING (swollen feet) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was provided by the reporter. No treatment medications was  provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: feel feverish; headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (feel feverish) and HEADACHE (headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced PYREXIA (feel feverish) and HEADACHE (headache). At the time of the report, PYREXIA (feel feverish) and HEADACHE (headache) outcome was unknown.            No concomitant medication was reported. No treatment medication was reported.
Age: 24.0
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient is past the 35 day mark from the first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient is past the 35 day mark from the first dose) in a 24-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient is past the 35 day mark from the first dose). On 09-Mar-2021, PRODUCT DOSE OMISSION ISSUE (Patient is past the 35 day mark from the first dose) had resolved.        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.   No Concomitant medications were provided No Treatment information provided
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Blister
Clinical narrative: had small blistery patch on her arm on the right wrist almost like poison ivy; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (had small blistery patch on her arm on the right wrist almost like poison ivy) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 023C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced BLISTER (had small blistery patch on her arm on the right wrist almost like poison ivy). At the time of the report, BLISTER (had small blistery patch on her arm on the right wrist almost like poison ivy) had resolved.            No Concomitant medications were provided  No Treatment medications were provided   This case was linked to MOD-2021-240459 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: No new information was received.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: very itchy; Rash reappeared; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (very itchy) and RASH (Rash reappeared) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A and 001C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jun-2021, the patient experienced RASH PRURITIC (very itchy) and RASH (Rash reappeared). At the time of the report, RASH PRURITIC (very itchy) and RASH (Rash reappeared) had not resolved.            No relevant concomitant medications were reported.  No treatment information was provided.  No relevant Lab Data was provided.  No relevant medical history was provided.   This case was linked to MOD-2021-240450 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Additional information received contain no significant information.
Sex: U
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: This spontaneous case reported by a patient, describes the occurrence of nausea in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced nausea. At the time of the report, nausea outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information provided.
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: experiencing tinnitus since receiving my vaccine in Dec/Jan; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (experiencing tinnitus since receiving my vaccine in Dec/Jan) 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 TINNITUS (experiencing tinnitus since receiving my vaccine in Dec/Jan). At the time of the report, TINNITUS (experiencing tinnitus since receiving my vaccine in Dec/Jan) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: I received my 1st dose on 12FEB2021 & decided not to receive second dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I received my 1st dose on 12FEB2021 & decided not to receive second dose) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     The patient's past medical history included Rheumatoid arthritis. Concomitant products included LISINOPRIL for Blood pressure, ETANERCEPT (ENBREL) for Rheumatoid arthritis, METOPROLOL, SIMVASTATIN and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I received my 1st dose on 12FEB2021 & decided not to receive second dose). On 12-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I received my 1st dose on 12FEB2021 & decided not to receive second dose) had resolved.        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.   No Treatment information provided
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea
Clinical narrative: Strong Diarrhea after Second Shot; Stomach Pain after Second Shot; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Strong Diarrhea after Second Shot) and ABDOMINAL PAIN UPPER (Stomach Pain after Second Shot) 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) (Intramuscular) 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 28-Jun-2021, the patient experienced DIARRHOEA (Strong Diarrhea after Second Shot) and ABDOMINAL PAIN UPPER (Stomach Pain after Second Shot). At the time of the report, DIARRHOEA (Strong Diarrhea after Second Shot) and ABDOMINAL PAIN UPPER (Stomach Pain after Second Shot) outcome was unknown.            Concomitant product use was not provided.   Treatment information was not provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Fatigue, Feeling abnormal, Headache
Clinical narrative: diarrhea; felt all over crappy; weakness; fatigue; headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), FEELING ABNORMAL (felt all over crappy), ASTHENIA (weakness), FATIGUE (fatigue) and HEADACHE (headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C(2/Z)1A -cllr unsure of letters) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history were reported by the reporter.  Concomitant products included LOSARTAN, SPIRONOLACTONE, ATENOLOL and ROSUVASTATIN for an unknown indication.    On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (diarrhea), FEELING ABNORMAL (felt all over crappy), ASTHENIA (weakness), FATIGUE (fatigue), HEADACHE (headache) and NAUSEA (nausea). At the time of the report, DIARRHOEA (diarrhea), FEELING ABNORMAL (felt all over crappy), ASTHENIA (weakness), FATIGUE (fatigue), HEADACHE (headache) and NAUSEA (nausea) 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.   No treatment information were provided.   This case was linked to MOD-2021-240538 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Fallow up received and contains no new information.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: diarrhea; felt all over crappy; weakness; fatigue; headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), FEELING ABNORMAL (felt all over crappy), ASTHENIA (weakness), FATIGUE (fatigue) and HEADACHE (headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C(2/Z)1A -cllr unsure of letters) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history were reported by the reporter.  Concomitant products included LOSARTAN, SPIRONOLACTONE, ATENOLOL and ROSUVASTATIN for an unknown indication.    On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (diarrhea), FEELING ABNORMAL (felt all over crappy), ASTHENIA (weakness), FATIGUE (fatigue), HEADACHE (headache) and NAUSEA (nausea). At the time of the report, DIARRHOEA (diarrhea), FEELING ABNORMAL (felt all over crappy), ASTHENIA (weakness), FATIGUE (fatigue), HEADACHE (headache) and NAUSEA (nausea) 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.   No treatment information were provided.   This case was linked to MOD-2021-240538 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Fallow up received and contains no new information.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: missed second dose of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed second dose of vaccine) 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, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed second dose of vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed second dose of vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported by the reporter. No treatment medications were provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: small red area on my arm that I had my shot on, not at the same spot as shot, small red rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (small red area on my arm that I had my shot on, not at the same spot as shot, small red rash) 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 RASH ERYTHEMATOUS (small red area on my arm that I had my shot on, not at the same spot as shot, small red rash). At the time of the report, RASH ERYTHEMATOUS (small red area on my arm that I had my shot on, not at the same spot as shot, small red rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were not reported. No treatment medications were not provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: itchy rash on both arms; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (itchy rash on both arms) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009D21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Blood pressure high, High cholesterol and Asthma.    On 25-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jun-2021, the patient experienced RASH PRURITIC (itchy rash on both arms). At the time of the report, RASH PRURITIC (itchy rash on both arms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The concomitants include medications for diabetes, high blood pressure, high cholesterol and asthma. No treatment was reported.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pruritus, Pyrexia, Rash
Clinical narrative: It has spread become very itchy; had a rash start up 7 days after my 2nd shotshot; Fever; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (It has spread become very itchy), RASH (had a rash start up 7 days after my 2nd shotshot), PYREXIA (Fever) and FATIGUE (fatigue) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 PRURITUS (It has spread become very itchy), RASH (had a rash start up 7 days after my 2nd shotshot), PYREXIA (Fever) and FATIGUE (fatigue). At the time of the report, PRURITUS (It has spread become very itchy), RASH (had a rash start up 7 days after my 2nd shotshot), PYREXIA (Fever) and FATIGUE (fatigue) outcome was unknown.            No concomitant medication was reported.  No treatment medication was reported.  For mRNA-1273 (COVID 19 Vaccine Moderna), the reporter did not provide any causality assessments.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: Sore arm at injection site; Sore arm/He is still experiencing soreness of the arm of the injection; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm/He is still experiencing soreness of the arm of the injection) and VACCINATION SITE PAIN (Sore arm at injection site) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026a21a and 030m20a) 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) (Intramuscular) 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 09-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Sore arm/He is still experiencing soreness of the arm of the injection). On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm at injection site). At the time of the report, PAIN IN EXTREMITY (Sore arm/He is still experiencing soreness of the arm of the injection) and VACCINATION SITE PAIN (Sore arm at injection site) had not resolved.            No Concomitant medications were provided  No Treatment information provided   This case was linked to MOD21-116785, MOD-2021-014458, MOD-2021-266235 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow up information contains no new information On 26-Jul-2021: Follow-up received: does not contain any new information. On 27-Jul-2021: Follow up received and does not contain new confirmation. On 28-Jul-2021: Significant Follow-up received and event added
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Rash, Rash erythematous
Clinical narrative: weakness; rash on neck/skin on neck got red; rash on one side (right side of rib/ trunk)/rash on neck/calf - right leg (rash); tiredness; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), RASH ERYTHEMATOUS (rash on neck/skin on neck got red), RASH (rash on one side (right side of rib/ trunk)/rash on neck/calf - right leg (rash)) and FATIGUE (tiredness) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011D21A and 041C(2/Z)1A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LOSARTAN POTASSIUM (LOSARTAN [LOSARTAN POTASSIUM]), SPIRONOLACTONE, ATENOLOL and ROSUVASTATIN for an unknown indication.   On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-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 ASTHENIA (weakness), RASH ERYTHEMATOUS (rash on neck/skin on neck got red), RASH (rash on one side (right side of rib/ trunk)/rash on neck/calf - right leg (rash)) and FATIGUE (tiredness). The patient was treated with HYDROCORTISONE for Rash, at a dose of 1 dosage form. At the time of the report, ASTHENIA (weakness), RASH ERYTHEMATOUS (rash on neck/skin on neck got red), RASH (rash on one side (right side of rib/ trunk)/rash on neck/calf - right leg (rash)) and FATIGUE (tiredness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information included tea tree body wash.   This case was linked to MOD-2021-240508 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Follow-up received: contains no new information
Sex: U
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: cough; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough) 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 COUGH (cough). At the time of the report, COUGH (cough) 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.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Feeling tired between Moderna Covid-19 vaccinations; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FATIGUE (Feeling tired between Moderna Covid-19 vaccinations) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Feeling tired between Moderna Covid-19 vaccinations). At the time of the report, FATIGUE (Feeling tired between Moderna Covid-19 vaccinations) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported. The patient takes Methotrexate for a medical condition that requires an immune suppressant. The patients Doctor asked him to stop taking the methotrexate 1 week before the first vaccination and 2 weeks after the second vaccination with no doses in between vaccinations No treatment medications reported.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen underarm lymph node; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen underarm lymph node) 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, the patient experienced LYMPHADENOPATHY (Swollen underarm lymph node). At the time of the report, LYMPHADENOPATHY (Swollen underarm lymph node) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No information regarding corrective treatment was reported by the patient.     Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Non -significant follow-up received she just wanted to know the deadline to send the AE form to safety
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: How long are the Moderna side effects likely to last for; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (How long are the Moderna side effects likely to last for) 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 (How long are the Moderna side effects likely to last for). At the time of the report, VACCINATION COMPLICATION (How long are the Moderna side effects likely to last for) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       for mRNA-1273 (Moderna COVID-19 Vaccine) (intramuscular), the reporter did not provide any causality assessment.  Concomitant drug was not reported. Treatment medication was not reported.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Limb mass, Myalgia
Clinical narrative: arms was very sore; lump in my arm started getting bigger and turning red; turning red; This spontaneous case was reported by a consumer and describes the occurrence of LIMB MASS (lump in my arm started getting bigger and turning red), ERYTHEMA (turning red) and MYALGIA (arms was very sore) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jun-2021, the patient experienced LIMB MASS (lump in my arm started getting bigger and turning red) and ERYTHEMA (turning red). On an unknown date, the patient experienced MYALGIA (arms was very sore). At the time of the report, LIMB MASS (lump in my arm started getting bigger and turning red), ERYTHEMA (turning red) and MYALGIA (arms was very sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: GS CHILLS; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (GS CHILLS) 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 CHILLS (GS CHILLS). At the time of the report, CHILLS (GS CHILLS) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications were reported. Treatment information was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Got first dose of vaccine on 12feb21 and still did not get second dose on 29jun21; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a non-health professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Got first dose of vaccine on 12feb21 and still did not get second dose on 29jun21) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder.    On 12-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 PRODUCT DOSE OMISSION ISSUE (Got first dose of vaccine on 12feb21 and still did not get second dose on 29jun21). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Got first dose of vaccine on 12feb21 and still did not get second dose on 29jun21) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided. no concomitant medications are provided. Reporter stated that the patient was suffers from an autoimmune disease and she had concern on 2nd dose.
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomiting off and on; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomiting off and on ) 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 VOMITING (Vomiting off and on ). At the time of the report, VOMITING (Vomiting off and on ) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment medications were unknown.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 2 patients received a vaccine that were first punctured yesterday; 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 (2 patients received a vaccine that were first punctured yesterday) 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 29-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (2 patients received a vaccine that were first punctured yesterday). On 29-Jun-2021, EXPIRED PRODUCT ADMINISTERED (2 patients received a vaccine that were first punctured yesterday) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information not provided. List of concomitant medication were not given.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Infection
Clinical narrative: My pcr test today was positive; infected; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (My pcr test today was positive) and INFECTION (infected) 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.   In February 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 COVID-19 (My pcr test today was positive) and INFECTION (infected). At the time of the report, COVID-19 (My pcr test today was positive) and INFECTION (infected) outcome was unknown.            No relevant Concomitant Medications were reported. No Treatment Information Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Rash, Skin disorder
Clinical narrative: Developed a rash that was very very bad; Skin disease; patient has not received the second dose of the vaccine and it is more than 36 days from the first dise; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Developed a rash that was very very bad), SKIN DISORDER (Skin disease) and PRODUCT DOSE OMISSION ISSUE (patient has not received the second dose of the vaccine and it is more than 36 days from the first dise) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Herpes eyelid (Had a history of herpes in her eyes.) and Anxiety attack. Concomitant products included VALACYCLOVIR [VALACICLOVIR] for Herpes eyelid, MULTIVITAMIN [VITAMINS NOS] and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 04-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 RASH (Developed a rash that was very very bad), SKIN DISORDER (Skin disease) and PRODUCT DOSE OMISSION ISSUE (patient has not received the second dose of the vaccine and it is more than 36 days from the first dise). The patient was treated with CORTISONE at an unspecified dose and frequency. At the time of the report, RASH (Developed a rash that was very very bad), SKIN DISORDER (Skin disease) and PRODUCT DOSE OMISSION ISSUE (patient has not received the second dose of the vaccine and it is more than 36 days from the first dise) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products used included  pressure Vision.  Treatment medication included she took pills and applied topical cortisone.  She had reached out to her health care provider and dermatologist and they cannot seem to help her.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of upper abdominal pain (my stomach hurts) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced upper abdominal pain (my stomach hurts). At the time of the report, upper abdominal pain (my stomach hurts) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information reported.
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Muscular weakness, Paraesthesia
Clinical narrative: Numbness in hands; tingling in hands; brother-in-law has the same thigh muscle weakness; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness in hands), PARAESTHESIA (tingling in hands) and MUSCULAR WEAKNESS (brother-in-law has the same thigh muscle weakness) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (Numbness in hands), PARAESTHESIA (tingling in hands) and MUSCULAR WEAKNESS (brother-in-law has the same thigh muscle weakness). At the time of the report, HYPOAESTHESIA (Numbness in hands), PARAESTHESIA (tingling in hands) and MUSCULAR WEAKNESS (brother-in-law has the same thigh muscle weakness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment details were reported.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Erythema, Peripheral swelling, Vaccination site warmth
Clinical narrative: Her arm is swollen; Her arm is swollen and red; hot to touch; It hurts from her shoulder to her elbow.; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Her arm is swollen), ERYTHEMA (Her arm is swollen and red), VACCINATION SITE WARMTH (hot to touch) and ARTHRALGIA (It hurts from her shoulder to her elbow.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Medical history was not provided.     On 21-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jun-2021, the patient experienced PERIPHERAL SWELLING (Her arm is swollen), ERYTHEMA (Her arm is swollen and red), VACCINATION SITE WARMTH (hot to touch) and ARTHRALGIA (It hurts from her shoulder to her elbow.). At the time of the report, PERIPHERAL SWELLING (Her arm is swollen), ERYTHEMA (Her arm is swollen and red), VACCINATION SITE WARMTH (hot to touch) and ARTHRALGIA (It hurts from her shoulder to her elbow.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication information was not provided. Concomitant medication information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow Up information was received on 26-Jul-2021 and  Events Outcome updated.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Missed the 2nd dose of Moderna COVID-19 Vaccine; 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 PRODUCT DOSE OMISSION ISSUE (Missed the 2nd dose of Moderna COVID-19 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed the 2nd dose of Moderna COVID-19 Vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed the 2nd dose of Moderna COVID-19 Vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: feel sick; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Jun-2021 and was forwarded to Moderna on 29-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feel sick) 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 28-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 29-Jun-2021, the patient experienced MALAISE (feel sick). At the time of the report, MALAISE (feel sick) outcome was unknown.            No concomitant medications or treatment details were provided by the reporter.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 13 year old vaccinated; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 year old vaccinated) in a 13-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jun-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 year old vaccinated). On 25-Jun-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 year old vaccinated) had resolved.        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.   No concomitant medication was reported. No treatment medication was reported.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Date of 1st dose 2May2021 patient has not received 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Date of 1st dose 2May2021 patient has not received 2nd dose) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Date of 1st dose 2May2021 patient has not received 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Date of 1st dose 2May2021 patient has not received 2nd dose) 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.   Concomitant product : Herbs