chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: a lot of itching in my feet, a lot of itching in my hands, a lot of itching in other parts, it has not stopped, it is kind of a problem.; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (a lot of itching in my feet, a lot of itching in my hands, a lot of itching in other parts, it has not stopped, it is kind of a problem.) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A, 043L20A and 017E21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Hyperthyroidism, LIOTHYRONINE SODIUM (CYTOMEL) for Hypothyroidism, HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]) for Lupus-like syndrome.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 26-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 3 dosage form. On an unknown date, the patient experienced PRURITUS (a lot of itching in my feet, a lot of itching in my hands, a lot of itching in other parts, it has not stopped, it is kind of a problem.). At the time of the report, PRURITUS (a lot of itching in my feet, a lot of itching in my hands, a lot of itching in other parts, it has not stopped, it is kind of a problem.) outcome was unknown.            No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of epistaxis (bloody noses) 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 a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced epistaxis (bloody noses). At the time of the report, epistaxis (bloody noses) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information reported.
Sex: U
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Palpitations
Clinical narrative: Chest pressure; Trouble breathing; Palpitations; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Chest pressure), DYSPNOEA (Trouble breathing) and PALPITATIONS (Palpitations) 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 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, the patient experienced CHEST DISCOMFORT (Chest pressure) and DYSPNOEA (Trouble breathing). In 2021, the patient experienced PALPITATIONS (Palpitations). At the time of the report, CHEST DISCOMFORT (Chest pressure) had not resolved and DYSPNOEA (Trouble breathing) and PALPITATIONS (Palpitations) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drug details were reported. No treatment details were reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: side effect; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (side effect) 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 ADVERSE REACTION (side effect). At the time of the report, ADVERSE REACTION (side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment medications were provided.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Nasopharyngitis
Clinical narrative: Cold like symptoms; Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold like symptoms) and INFLUENZA LIKE ILLNESS (Flu like symptoms) in a 56-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 30-Aug-2021, the patient experienced NASOPHARYNGITIS (Cold like symptoms) and INFLUENZA LIKE ILLNESS (Flu like symptoms). At the time of the report, NASOPHARYNGITIS (Cold like symptoms) and INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and medication information provided.  No treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding
Clinical narrative: Spotting, menstrual spotting; This spontaneous case was reported by a consumer and describes the occurrence of INTERMENSTRUAL BLEEDING (Spotting, menstrual spotting) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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 INTERMENSTRUAL BLEEDING (Spotting, menstrual spotting). At the time of the report, INTERMENSTRUAL BLEEDING (Spotting, menstrual spotting) outcome was unknown.            No Concomitant medications were reported. No Treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Caller reports that the person that drove with her also received 3rd dose and she was also very sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Caller reports that the person that drove with her also received 3rd dose and she was also very sick) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Caller reports that the person that drove with her also received 3rd dose and she was also very sick). At the time of the report, ILLNESS (Caller reports that the person that drove with her also received 3rd dose and she was also very sick) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 12-Sep-2021: Follow up document received contains no new information
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: My son missed second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (My son missed second dose) 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 15-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 PRODUCT DOSE OMISSION ISSUE (My son missed second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (My son missed second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant informations were reported.  No Treatment informations were reported
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: This spontaneous case reported by a pharmacist, describes the occurrence of product administered to patient of inappropriate age (15-year-old received first dose) in a 15-year-old female patient 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 administered to patient of inappropriate age (15-year-old received first dose). At the time of the report, administered to patient of inappropriate age (15-year-old received first dose): resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: Sore Arm; Feeling tired; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore Arm), FATIGUE (Feeling tired) and HEADACHE (Headache) 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 29-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Aug-2021, the patient experienced MYALGIA (Sore Arm), FATIGUE (Feeling tired) and HEADACHE (Headache). At the time of the report, MYALGIA (Sore Arm), FATIGUE (Feeling tired) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment informations were reported. No Concomitant informations were reported.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Did not get the 2nd dose of Moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Did not get the 2nd dose of Moderna COVID-19 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.    In July 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Did not get the 2nd dose of Moderna COVID-19 vaccine). In 2021, PRODUCT DOSE OMISSION ISSUE (Did not get the 2nd dose of Moderna COVID-19 vaccine) had resolved.            No relevant concomitant medications were reported. Patient moved and didn't get the second Treatment information was unknown.   Reporter did not allow further contact
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; This spontaneous case was reported by a physician and describes the occurrence of PYREXIA (fever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-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 PYREXIA (fever). At the time of the report, PYREXIA (fever) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment drug details was reported.   This case was linked to MOD-2021-304502 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, SARS-CoV-2 test, Somnolence
Clinical narrative: loss of taste; loss of smell; Still COVID-19 positive after first vaccine; sleep a lot; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Still COVID-19 positive after first vaccine), AGEUSIA (loss of taste), ANOSMIA (loss of smell) and SOMNOLENCE (sleep a lot) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     The patient's past medical history included Flu like symptoms (had flu-like symptoms). Concurrent medical conditions included COVID-19 (Patient stated that she tested positive for COVID-19 four weeks prior to vaccination) since July 2021 and Diabetes.    On 08-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Aug-2021, the patient experienced COVID-19 (Still COVID-19 positive after first vaccine). On an unknown date, the patient experienced AGEUSIA (loss of taste), ANOSMIA (loss of smell) and SOMNOLENCE (sleep a lot). At the time of the report, COVID-19 (Still COVID-19 positive after first vaccine), AGEUSIA (loss of taste) and ANOSMIA (loss of smell) had not resolved and SOMNOLENCE (sleep a lot) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2021, SARS-CoV-2 test: positive (Positive) Tested positive four weeks prior to vaccination. On 29-Aug-2021, SARS-CoV-2 test: positive (Positive) Patient is still positive after vaccination. On 04-Sep-2021, SARS-CoV-2 test: negative (Negative) Negative - not detected.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Sep-2021: Follow up document received on 06-SEP-2021 information included -relevant medically history were added. new lab result were added. additional events were  added.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Has a lot of pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Has a lot of pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Has a lot of pain). At the time of the report, PAIN (Has a lot of pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were mentioned. No treatment details were reported.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication was reported.  No treatment medication use was reported.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort
Clinical narrative: pressure in her head that comes and goes away; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (pressure in her head that comes and goes away) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Sep-2021, the patient experienced HEAD DISCOMFORT (pressure in her head that comes and goes away). At the time of the report, HEAD DISCOMFORT (pressure in her head that comes and goes away) 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.   No treatment information was provided.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness
Clinical narrative: sicker than a dog; really bad headache; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ILLNESS (sicker than a dog) and HEADACHE (really bad headache) in a 43-year-old female patient 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) (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 ILLNESS (sicker than a dog) and HEADACHE (really bad headache). At the time of the report, ILLNESS (sicker than a dog) and HEADACHE (really bad headache) outcome was unknown.            No concomitant medication and treatment medication information provided.The afternoon after receiving the second dose the patient experienced a really bad headache and  felt "sicker than a dog." The reporter did not know when or if these symptoms have resolved.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Influenza like illness, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: like the flu; body aches; ran a temperature 5 hours later/ next morning she had 101 temperature; She had a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (like the flu), PAIN IN EXTREMITY (She had a sore arm), MYALGIA (body aches) and PYREXIA (ran a temperature 5 hours later/ next morning she had 101 temperature) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L21A and 011J00A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal, Skin disorder NOS and Hair disorder NOS. Concomitant products included DOXYCYCLINE and ALBUTEROL [SALBUTAMOL] for an unknown indication.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (She had a sore arm). 10-Feb-2021, the patient experienced PYREXIA (ran a temperature 5 hours later/ next morning she had 101 temperature). On 11-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (like the flu) and MYALGIA (body aches). On 13-Feb-2021, INFLUENZA LIKE ILLNESS (like the flu), PAIN IN EXTREMITY (She had a sore arm), MYALGIA (body aches) and PYREXIA (ran a temperature 5 hours later/ next morning she had 101 temperature) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Feb-2021, Body temperature: high (High) She ran a temperature 5 hours later. On 11-Feb-2021, Body temperature: 101 (High) She had 101 temperature.         Other concomitant medications included patient taking medications for blood pressure, skin and hair condition medications. No treatment details were provided.   This case was linked to MOD-2021-304944, MOD-2021-301915 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of tinnitus in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced tinnitus. At the time of the report, tinnitus outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information reported. Upon follow-up regarding the event experienced, some other people had tinnitus, but not as bad. Most recent follow-up information incorporated: On Sep 7, 2021: Follow-up document contained no new information.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Influenza like illness
Clinical narrative: Diarrhea; Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms) and DIARRHOEA (diarrhea) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History Information was reported.  Concomitant products included PRIMIDONE, MELATONIN, DIPHENHYDRAMINE HCL, COLECALCIFEROL (VITAMIN D3), ACETYLSALICYLIC ACID (BABY ASPIRIN), DICLOFENAC SODIUM, LEVOTHYROXINE, ROSUVASTATIN CALCIUM (CRESTOR), SERTRALINE and QUETIAPINE FUMARATE (SEROQUEL) for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms). On 08-Feb-2021, the patient experienced DIARRHOEA (diarrhea). On 05-Feb-2021, INFLUENZA LIKE ILLNESS (flu like symptoms) had resolved. At the time of the report, DIARRHOEA (diarrhea) 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.   Other Concomitant medication included CoQ10 No Treatment information was provided   This case was linked to MOD-2021-305232 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Sep-2021: Non-significant follow-up
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Peripheral swelling, Vaccination site erythema, Vaccination site pain
Clinical narrative: Arm is swollen; Arm is red; Injection site arm began to hurt and it became progressively more painful/ Arm is very painful; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm is swollen), VACCINATION SITE ERYTHEMA (Arm is red), VACCINATION SITE PAIN (Injection site arm began to hurt and it became progressively more painful/ Arm is very painful) and HEADACHE (Headache) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-2021, the patient experienced VACCINATION SITE PAIN (Injection site arm began to hurt and it became progressively more painful/ Arm is very painful) and HEADACHE (Headache). On 02-Sep-2021, the patient experienced PERIPHERAL SWELLING (Arm is swollen) and VACCINATION SITE ERYTHEMA (Arm is red). At the time of the report, PERIPHERAL SWELLING (Arm is swollen), VACCINATION SITE ERYTHEMA (Arm is red), VACCINATION SITE PAIN (Injection site arm began to hurt and it became progressively more painful/ Arm is very painful) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not  provided.  On 02-Sep-2021, the patient's arm was very painful. The patient was unable to take pain medications.
Age: 90.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Interchange of vaccine products
Clinical narrative: third shot of Moderna, 2 Pfizer shots previously; third shot of Moderna, 2 Pfizer shots previously; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (third shot of Moderna, 2 Pfizer shots previously) and INTERCHANGE OF VACCINE PRODUCTS (third shot of Moderna, 2 Pfizer shots previously) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    Concurrent medical conditions included Immunocompromised.   On 25-Aug-2021, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) at an unspecified dose. On 30-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (third shot of Moderna, 2 Pfizer shots previously). 30-Aug-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (third shot of Moderna, 2 Pfizer shots previously). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (third shot of Moderna, 2 Pfizer shots previously) had resolved and INTERCHANGE OF VACCINE PRODUCTS (third shot of Moderna, 2 Pfizer shots previously) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not reported  Treatment information was not reported
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: This spontaneous case was reported by an other healthcare professional, describes the occurrence of pyrexia (after taking the shot I have a fever) 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 a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced pyrexia (after taking the shot I have a fever). At the time of the report, pyrexia (after taking the shot I have a fever) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine):  unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Lymphadenopathy, Magnetic resonance imaging, Musculoskeletal chest pain
Clinical narrative: pain right sided under breast and rib cage; lymph nodes still swollen; feels hot like fever; achy; sore deltoid; vomited; chills; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore deltoid), LYMPHADENOPATHY (lymph nodes still swollen), CHILLS (chills), VOMITING (vomited) and MUSCULOSKELETAL CHEST PAIN (pain right sided under breast and rib cage) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 97621A and 011D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, the patient experienced CHILLS (chills). On 01-Sep-2021, the patient experienced VOMITING (vomited). On an unknown date, the patient experienced MYALGIA (sore deltoid), LYMPHADENOPATHY (lymph nodes still swollen), MUSCULOSKELETAL CHEST PAIN (pain right sided under breast and rib cage), FEELING HOT (feels hot like fever) and PAIN (achy). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MYALGIA (sore deltoid), LYMPHADENOPATHY (lymph nodes still swollen), CHILLS (chills), VOMITING (vomited), MUSCULOSKELETAL CHEST PAIN (pain right sided under breast and rib cage), FEELING HOT (feels hot like fever) and PAIN (achy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: Lymph nodes were swollen.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant informations were reported.   This case was linked to MOD-2021-306265 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Vomiting
Clinical narrative: pain right sided under breast and rib cage; lymph nodes still swollen; feels hot like fever; achy; sore deltoid; vomited; chills; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore deltoid), LYMPHADENOPATHY (lymph nodes still swollen), CHILLS (chills), VOMITING (vomited) and MUSCULOSKELETAL CHEST PAIN (pain right sided under breast and rib cage) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 97621A and 011D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, the patient experienced CHILLS (chills). On 01-Sep-2021, the patient experienced VOMITING (vomited). On an unknown date, the patient experienced MYALGIA (sore deltoid), LYMPHADENOPATHY (lymph nodes still swollen), MUSCULOSKELETAL CHEST PAIN (pain right sided under breast and rib cage), FEELING HOT (feels hot like fever) and PAIN (achy). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MYALGIA (sore deltoid), LYMPHADENOPATHY (lymph nodes still swollen), CHILLS (chills), VOMITING (vomited), MUSCULOSKELETAL CHEST PAIN (pain right sided under breast and rib cage), FEELING HOT (feels hot like fever) and PAIN (achy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: Lymph nodes were swollen.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant informations were reported.   This case was linked to MOD-2021-306265 (Patient Link).
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Inappropriate schedule of product administration
Clinical narrative: waited 90 days to get his 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (waited 90 days to get his 2nd dose) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047C21A and 010A21A) for COVID-19 vaccination.     The patient's past medical history included Heart disease gonococcal NOS and Stent insertion NOS. Concurrent medical conditions included Injury NOS. Concomitant products included PRASUGREL HYDROCHLORIDE (EFFIENT), LISINOPRIL, METOPROLOL TARTRATE (METOPROLOL XL), PANTOPRAZOLE, ASPIRIN [ACETYLSALICYLIC ACID] and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (waited 90 days to get his 2nd dose). On 18-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (waited 90 days to get his 2nd dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Aug-2021, Electrocardiogram: negative (Negative) Negative..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient reported that he does not smoke, is under weight, had no blood pressure or cholesterol problem.  No treatment information was provided.  Patient had 5 stents put in every 3 months periodically. During his 5th procedure on 22-Feb-2021, he had last stent put in and he felt fine after the surgery.   This case was linked to MOD-2021-306596 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: had more trouble with the second shot; This case was received via an unknown source (no reference has been entered for a health authority or partner) on 02-Sep-2021 and was forwarded to Moderna on 02-Sep-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (had more trouble with the 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) (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 more trouble with the second shot). At the time of the report, VACCINATION COMPLICATION (had more trouble with the second shot) outcome was unknown.            No Concomitant drugs were reported.  No Treatment information  were reported.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: many pains; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN (many pains) 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 PAIN (many pains). At the time of the report, PAIN (many pains) outcome was unknown. Not Provided      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.  It was reported that, patient was false positives for cancer with the vaccine.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Balance disorder, Chills, Dyspnoea, Eye pain
Clinical narrative: eyes ached; she had no stamina; could not put one foot in front of the other; palpitations/heart was racing; couldn't breathe/did not have the  breathing capacity/ thought she was having a heart attack; chemo fog/brain fog; Blurred vision; felt nauseous; Terrible chills; Severe Headache/terrible headaches; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (chemo fog/brain fog), VISION BLURRED (Blurred vision), PALPITATIONS (palpitations/heart was racing), DYSPNOEA (couldn't breathe/did not have the  breathing capacity/ thought she was having a heart attack) and EYE PAIN (eyes ached) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Degenerative disc disease, Headache and Chemotherapy. Concurrent medical conditions included Breast cancer.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced FEELING ABNORMAL (chemo fog/brain fog), VISION BLURRED (Blurred vision), NAUSEA (felt nauseous), CHILLS (Terrible chills) and HEADACHE (Severe Headache/terrible headaches). In April 2021, the patient experienced PALPITATIONS (palpitations/heart was racing) and DYSPNOEA (couldn't breathe/did not have the  breathing capacity/ thought she was having a heart attack). On an unknown date, the patient experienced EYE PAIN (eyes ached), ASTHENIA (she had no stamina) and BALANCE DISORDER (could not put one foot in front of the other). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Headache, at an unspecified dose and frequency. On 30-Mar-2021, NAUSEA (felt nauseous) and CHILLS (Terrible chills) had resolved. In April 2021, PALPITATIONS (palpitations/heart was racing) had resolved. At the time of the report, FEELING ABNORMAL (chemo fog/brain fog), VISION BLURRED (Blurred vision), EYE PAIN (eyes ached), ASTHENIA (she had no stamina), BALANCE DISORDER (could not put one foot in front of the other) and HEADACHE (Severe Headache/terrible headaches) outcome was unknown and DYSPNOEA (couldn't breathe/did not have the  breathing capacity/ thought she was having a heart attack) had resolved.            She had breast cancer and chemotherapy 6 years ago and was in remission. She was not taking any medications. She had a degenerative disc disorder and had no history of headaches except during chemotherapy. She was a runner. She drank lots of water.   No relevant concomitant medications were reported   This case was linked to MOD-2021-296038 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Nausea, Palpitations, Vision blurred
Clinical narrative: eyes ached; she had no stamina; could not put one foot in front of the other; palpitations/heart was racing; couldn't breathe/did not have the  breathing capacity/ thought she was having a heart attack; chemo fog/brain fog; Blurred vision; felt nauseous; Terrible chills; Severe Headache/terrible headaches; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (chemo fog/brain fog), VISION BLURRED (Blurred vision), PALPITATIONS (palpitations/heart was racing), DYSPNOEA (couldn't breathe/did not have the  breathing capacity/ thought she was having a heart attack) and EYE PAIN (eyes ached) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Degenerative disc disease, Headache and Chemotherapy. Concurrent medical conditions included Breast cancer.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced FEELING ABNORMAL (chemo fog/brain fog), VISION BLURRED (Blurred vision), NAUSEA (felt nauseous), CHILLS (Terrible chills) and HEADACHE (Severe Headache/terrible headaches). In April 2021, the patient experienced PALPITATIONS (palpitations/heart was racing) and DYSPNOEA (couldn't breathe/did not have the  breathing capacity/ thought she was having a heart attack). On an unknown date, the patient experienced EYE PAIN (eyes ached), ASTHENIA (she had no stamina) and BALANCE DISORDER (could not put one foot in front of the other). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Headache, at an unspecified dose and frequency. On 30-Mar-2021, NAUSEA (felt nauseous) and CHILLS (Terrible chills) had resolved. In April 2021, PALPITATIONS (palpitations/heart was racing) had resolved. At the time of the report, FEELING ABNORMAL (chemo fog/brain fog), VISION BLURRED (Blurred vision), EYE PAIN (eyes ached), ASTHENIA (she had no stamina), BALANCE DISORDER (could not put one foot in front of the other) and HEADACHE (Severe Headache/terrible headaches) outcome was unknown and DYSPNOEA (couldn't breathe/did not have the  breathing capacity/ thought she was having a heart attack) had resolved.            She had breast cancer and chemotherapy 6 years ago and was in remission. She was not taking any medications. She had a degenerative disc disorder and had no history of headaches except during chemotherapy. She was a runner. She drank lots of water.   No relevant concomitant medications were reported   This case was linked to MOD-2021-296038 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of hypoesthesia (just received the second shot and arm is a little numb) 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 second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced hypoesthesia (just received the second shot and arm is a little numb). At the time of the report, hypoesthesia (just received the second shot and arm is a little numb) outcome: unknown. No concomitant medication or treatment information reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patient received a dose  that was stored at room temperature for more than 12 hours; the syringe was kept at room temperature but the vial was returned to fridge.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a dose  that was stored at room temperature for more than 12 hours) and PRODUCT STORAGE ERROR (the syringe was kept at room temperature but the vial was returned to fridge.) 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 03-Sep-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 EXPIRED PRODUCT ADMINISTERED (Patient received a dose  that was stored at room temperature for more than 12 hours) and PRODUCT STORAGE ERROR (the syringe was kept at room temperature but the vial was returned to fridge.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a dose  that was stored at room temperature for more than 12 hours) and PRODUCT STORAGE ERROR (the syringe was kept at room temperature but the vial was returned to fridge.) 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 medications were not reported. treatment drugs were not reported.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Hyperhidrosis, Illness, Musculoskeletal stiffness, Myalgia
Clinical narrative: Got really sick; Had a reaction after the 2nd dose; It was rough; High fever; Body aches; Sweating; Bottom of feet hurt; Was real weak; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got really sick), VACCINATION COMPLICATION (Had a reaction after the 2nd dose), MUSCULOSKELETAL STIFFNESS (It was rough), PYREXIA (High fever) and MYALGIA (Body aches) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 02B21A, 013AZ(2)1A and 035C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart valve operation NOS (Patient had open heart surgery last year prior to moderna vaccine,) since an unknown date. Concurrent medical conditions included Diabetes mellitus insulin-dependent, Thyroid disorder and Hypertension. Concomitant products included INSULIN LISPRO (HUMALOG) for Diabetes mellitus insulin-dependent, ACETYLSALICYLIC ACID (BABY ASPIRIN) for Heart valve operation NOS, BENAZEPRIL for Hypertension, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder, BRINZOLAMIDE (AZOPT) and DULOXETINE for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (Got really sick), VACCINATION COMPLICATION (Had a reaction after the 2nd dose), MUSCULOSKELETAL STIFFNESS (It was rough), PYREXIA (High fever), MYALGIA (Body aches), HYPERHIDROSIS (Sweating), PAIN IN EXTREMITY (Bottom of feet hurt) and ASTHENIA (Was real weak). At the time of the report, ILLNESS (Got really sick), VACCINATION COMPLICATION (Had a reaction after the 2nd dose), MUSCULOSKELETAL STIFFNESS (It was rough), PYREXIA (High fever), MYALGIA (Body aches), HYPERHIDROSIS (Sweating), PAIN IN EXTREMITY (Bottom of feet hurt) and ASTHENIA (Was real weak) outcome was unknown.            No treatment information was provided.   This case was linked to MOD-2021-307315 (Patient Link).