chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), FATIGUE (Tiredness), HEADACHE (Headache), NAUSEA (Nausea) and PYREXIA (Fever) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced PYREXIA (Fever). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), FATIGUE (Tiredness), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, PAIN IN EXTREMITY (Sore arm), FATIGUE (Tiredness), HEADACHE (Headache), NAUSEA (Nausea) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Apr-2021, Body temperature: 100.4 (High) Unknown.         Concomitant product use was not provided. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was  not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-081834 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Follow up received on 20 May 2021 contains non-significant information included update on reporter information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-081834:For First dose
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: only first dose received; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (only first dose received) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2020, 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 (only first dose received). At the time of the report, PRODUCT DOSE OMISSION ISSUE (only first dose received) had resolved. Not Provided      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 reported. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Non-Significant information.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: itching with welts on her arms, legs, and chest; itching with welts on her arms, legs, and chest; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (itching with welts on her arms, legs, and chest) and PRURITUS (itching with welts on her arms, legs, and chest) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced URTICARIA (itching with welts on her arms, legs, and chest) and PRURITUS (itching with welts on her arms, legs, and chest). At the time of the report, URTICARIA (itching with welts on her arms, legs, and chest) and PRURITUS (itching with welts on her arms, legs, and chest) had resolved.            No concomitant medications were reported.  No treatment was provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Follow up received on 20-MAY-2021 included AE information.
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain
Clinical narrative: axillary pain; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Tenderness left underarm) 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 15-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 TENDERNESS (Tenderness left underarm). At the time of the report, TENDERNESS (Tenderness left underarm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Relevant concomitant medications was reported.  Treatment information was not provided.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: vague headache; little chills; This spontaneous case was reported by a nurse and describes the occurrence of HEADACHE (vague headache) and CHILLS (little chills) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 072A21A and 007B21A) for COVID-19 vaccination.     Concomitant products included LOSARTAN, AMLODIPINE and LEVOTHYROXINE for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (vague headache) and CHILLS (little chills). At the time of the report, HEADACHE (vague headache) and CHILLS (little chills) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information were reported.  Action taken with the drug in response to events was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-081929 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-081929:2nd dose case
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Tenderness
Clinical narrative: tenderness; covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid-19) and TENDERNESS (tenderness) 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 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 15-Apr-2021, the patient experienced COVID-19 (covid-19). On an unknown date, the patient experienced TENDERNESS (tenderness). At the time of the report, COVID-19 (covid-19) outcome was unknown and TENDERNESS (tenderness) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Products known to have been used by the patient, within two weeks prior to the event were not provided.  The Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: follow-up received on 20 may 2021.second dose details was updated.event outcome was updated.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort
Clinical narrative: Upset stomach; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Upset stomach) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced ABDOMINAL DISCOMFORT (Upset stomach). At the time of the report, ABDOMINAL DISCOMFORT (Upset stomach) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No corrective treatment was reported.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Computerised tomogram, Dizziness, Fatigue, Headache
Clinical narrative: Eyes have been bothering me like I want to keep closing them; Strained; Lightheadedness; Dull headache; Fatigue; Chills; Slight headache over my eyes; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR DISCOMFORT (Eyes have been bothering me like I want to keep closing them), MUSCLE STRAIN (Strained), DIZZINESS (Lightheadedness), HEADACHE (Dull headache) and FATIGUE (Fatigue) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 072A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LOSARTAN, AMLODIPINE and LEVOTHYROXINE for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced FATIGUE (Fatigue), CHILLS (Chills) and HEADACHE (Slight headache over my eyes). On an unknown date, the patient experienced OCULAR DISCOMFORT (Eyes have been bothering me like I want to keep closing them), MUSCLE STRAIN (Strained), DIZZINESS (Lightheadedness) and HEADACHE (Dull headache). At the time of the report, OCULAR DISCOMFORT (Eyes have been bothering me like I want to keep closing them), MUSCLE STRAIN (Strained), DIZZINESS (Lightheadedness), HEADACHE (Dull headache), FATIGUE (Fatigue), CHILLS (Chills) and HEADACHE (Slight headache over my eyes) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: normal (normal) normal. On an unknown date, Ophthalmological examination: normal (normal) normal.         No treatment medications were reported.  Action taken with the drug in response to events was not applicable.      Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: On 26-May-2021, follow up document was attached which states the event have resolved.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle strain, Ocular discomfort, Ophthalmological examination
Clinical narrative: Eyes have been bothering me like I want to keep closing them; Strained; Lightheadedness; Dull headache; Fatigue; Chills; Slight headache over my eyes; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR DISCOMFORT (Eyes have been bothering me like I want to keep closing them), MUSCLE STRAIN (Strained), DIZZINESS (Lightheadedness), HEADACHE (Dull headache) and FATIGUE (Fatigue) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 072A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LOSARTAN, AMLODIPINE and LEVOTHYROXINE for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced FATIGUE (Fatigue), CHILLS (Chills) and HEADACHE (Slight headache over my eyes). On an unknown date, the patient experienced OCULAR DISCOMFORT (Eyes have been bothering me like I want to keep closing them), MUSCLE STRAIN (Strained), DIZZINESS (Lightheadedness) and HEADACHE (Dull headache). At the time of the report, OCULAR DISCOMFORT (Eyes have been bothering me like I want to keep closing them), MUSCLE STRAIN (Strained), DIZZINESS (Lightheadedness), HEADACHE (Dull headache), FATIGUE (Fatigue), CHILLS (Chills) and HEADACHE (Slight headache over my eyes) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: normal (normal) normal. On an unknown date, Ophthalmological examination: normal (normal) normal.         No treatment medications were reported.  Action taken with the drug in response to events was not applicable.      Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: On 26-May-2021, follow up document was attached which states the event have resolved.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Heart rate, Heart rate increased, Palpitations, Product dose omission issue
Clinical narrative: Palpitations; Felt overwhelmed, had to lay down; Racing heart rate; 88 days since first dose was administered on 22Jan2021 patient never went for 2nd dose.; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpitations), FEELING ABNORMAL (Felt overwhelmed, had to lay down), HEART RATE INCREASED (Racing heart rate) and PRODUCT DOSE OMISSION ISSUE (88 days since first dose was administered on 22Jan2021 patient never went for 2nd dose.) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. C42L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced PALPITATIONS (Palpitations), FEELING ABNORMAL (Felt overwhelmed, had to lay down), HEART RATE INCREASED (Racing heart rate) and PRODUCT DOSE OMISSION ISSUE (88 days since first dose was administered on 22Jan2021 patient never went for 2nd dose.). At the time of the report, PALPITATIONS (Palpitations) and HEART RATE INCREASED (Racing heart rate) had resolved and FEELING ABNORMAL (Felt overwhelmed, had to lay down) and PRODUCT DOSE OMISSION ISSUE (88 days since first dose was administered on 22Jan2021 patient never went for 2nd dose.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jan-2021, Heart rate: racing (High) Heart rate increased..     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       No concomitant medicines were reported. No treatment information were reported.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 1st dose of Moderna vaccine was administered to a 16yr old patient; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1st dose of Moderna vaccine was administered to a 16yr old patient) in a 15-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (NO RELEVANT HISTORY PROVIDED.).    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1st dose of Moderna vaccine was administered to a 16yr old patient). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1st dose of Moderna vaccine was administered to a 16yr old patient) had resolved. Not Provided      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 medicines were reported. No treatment information were reported.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Inappropriate schedule of product administration, Pyrexia
Clinical narrative: Late schedule of vaccine; Headache; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Late schedule of vaccine), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 026L20A) for COVID-19 vaccination.     The patient's past medical history included Shingles (at the age of 17, 55 yrs ago).   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever). On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Late schedule of vaccine). On 05-Apr-2021, HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Late schedule of vaccine) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment medication information was not provided by the reporter.  Action taken with the drug in response to events was not applicable.   This case was linked to MOD-2021-036376 (Patient Link).
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Soreness in injection arm), VACCINATION SITE SWELLING (swelling at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PRURITUS (Itchiness at injection site) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. Concomitant products included PANTOPRAZOLE for an unknown indication. On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced VACCINATION SITE PAIN (Soreness in injection arm). On 17-Apr-2021, the patient experienced VACCINATION SITE SWELLING (swelling at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PRURITUS (Itchiness at injection site). On 11-Apr-2021, VACCINATION SITE PAIN (Soreness in injection arm) had resolved. At the time of the report, VACCINATION SITE SWELLING (swelling at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PRURITUS (Itchiness at injection site) had not resolved. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication not provided.  Treatment medication not provided.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: fatigue; This spontaneous case was reported by a physician and describes the occurrence of FATIGUE (fatigue) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.). Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (ANTIHISTAMINE) and VITAMINS NOS for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced FATIGUE (fatigue). At the time of the report, FATIGUE (fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication includes annihilator.   This case was linked to MOD-2021-016404, MOD-2021-016404 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Myalgia, Pain, Pyrexia
Clinical narrative: About 12 hours later after 1st dose, she started with really bad ringing in her ears; She felt like she was confused; Light headed; Pain; Aches; She had fever; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (About 12 hours later after 1st dose, she started with really bad ringing in her ears), CONFUSIONAL STATE (She felt like she was confused), DIZZINESS (Light headed), PAIN (Pain) and MYALGIA (Aches) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 03A21A and 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced TINNITUS (About 12 hours later after 1st dose, she started with really bad ringing in her ears), CONFUSIONAL STATE (She felt like she was confused), DIZZINESS (Light headed), PAIN (Pain), MYALGIA (Aches) and PYREXIA (She had fever). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, TINNITUS (About 12 hours later after 1st dose, she started with really bad ringing in her ears), CONFUSIONAL STATE (She felt like she was confused), DIZZINESS (Light headed), PAIN (Pain), MYALGIA (Aches) and PYREXIA (She had fever) outcome was unknown.            No concomitant medicines were reported. Treatment medication included acetaminophen.   This case was linked to MOD-2021-082890 (E2B Linked Report).; Sender's Comments:  MOD-2021-082890:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: About 12 hours later after 1st dose, she started with really bad ringing in her ears; She felt like she was confused; Light headed; Pain; Aches; She had fever; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (About 12 hours later after 1st dose, she started with really bad ringing in her ears), CONFUSIONAL STATE (She felt like she was confused), DIZZINESS (Light headed), PAIN (Pain) and MYALGIA (Aches) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 03A21A and 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced TINNITUS (About 12 hours later after 1st dose, she started with really bad ringing in her ears), CONFUSIONAL STATE (She felt like she was confused), DIZZINESS (Light headed), PAIN (Pain), MYALGIA (Aches) and PYREXIA (She had fever). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, TINNITUS (About 12 hours later after 1st dose, she started with really bad ringing in her ears), CONFUSIONAL STATE (She felt like she was confused), DIZZINESS (Light headed), PAIN (Pain), MYALGIA (Aches) and PYREXIA (She had fever) outcome was unknown.            No concomitant medicines were reported. Treatment medication included acetaminophen.   This case was linked to MOD-2021-082890 (E2B Linked Report).; Sender's Comments:  MOD-2021-082890:
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: 0.1 mL administered in 3 patients each; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of INCORRECT DOSE ADMINISTERED (0.1 mL administered in 3 patients each) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .1 ml. On 18-Mar-2021, the patient experienced INCORRECT DOSE ADMINISTERED (0.1 mL administered in 3 patients each). At the time of the report, INCORRECT DOSE ADMINISTERED (0.1 mL administered in 3 patients each) outcome was unknown. Details not Provided.      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 medicines were reported. No treatment information were reported.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness, Headache, Hypoaesthesia
Clinical narrative: neck and shoulder are tight; neck and shoulder are swollen; headache; Shoulder is painful; face, shouilder and leg were numb really bad; numbness in both arms; dizziness; body aches; shot needles pain; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (face, shouilder and leg were numb really bad), HYPOAESTHESIA (numbness in both arms), DIZZINESS (dizziness), JOINT STIFFNESS (neck and shoulder are tight) and JOINT SWELLING (neck and shoulder are swollen) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure (Taking blood pressure medications), Cholesterol (taking cholesterol medications) and Arthritis. Concomitant products included VITAMINS NOS for an unknown indication.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced VACCINATION SITE PAIN (shot needles pain), PYREXIA (fever), MYALGIA (body aches) and CHILLS (chills). On 15-Apr-2021, the patient experienced HYPOAESTHESIA (numbness in both arms) and DIZZINESS (dizziness). On 16-Apr-2021, the patient experienced HYPOAESTHESIA (face, shouilder and leg were numb really bad). On 20-Apr-2021, the patient experienced JOINT STIFFNESS (neck and shoulder are tight), JOINT SWELLING (neck and shoulder are swollen), HEADACHE (headache) and ARTHRALGIA (Shoulder is painful). On 15-Apr-2021, VACCINATION SITE PAIN (shot needles pain), PYREXIA (fever) and CHILLS (chills) had resolved. At the time of the report, HYPOAESTHESIA (face, shouilder and leg were numb really bad), DIZZINESS (dizziness), JOINT STIFFNESS (neck and shoulder are tight), JOINT SWELLING (neck and shoulder are swollen), HEADACHE (headache), MYALGIA (body aches) and ARTHRALGIA (Shoulder is painful) outcome was unknown and HYPOAESTHESIA (numbness in both arms) had not resolved.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    Treatment of the events were not reported.
Sex: F
Vaccine: COVID19
Symptoms: Joint stiffness, Joint swelling, Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: neck and shoulder are tight; neck and shoulder are swollen; headache; Shoulder is painful; face, shouilder and leg were numb really bad; numbness in both arms; dizziness; body aches; shot needles pain; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (face, shouilder and leg were numb really bad), HYPOAESTHESIA (numbness in both arms), DIZZINESS (dizziness), JOINT STIFFNESS (neck and shoulder are tight) and JOINT SWELLING (neck and shoulder are swollen) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure (Taking blood pressure medications), Cholesterol (taking cholesterol medications) and Arthritis. Concomitant products included VITAMINS NOS for an unknown indication.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced VACCINATION SITE PAIN (shot needles pain), PYREXIA (fever), MYALGIA (body aches) and CHILLS (chills). On 15-Apr-2021, the patient experienced HYPOAESTHESIA (numbness in both arms) and DIZZINESS (dizziness). On 16-Apr-2021, the patient experienced HYPOAESTHESIA (face, shouilder and leg were numb really bad). On 20-Apr-2021, the patient experienced JOINT STIFFNESS (neck and shoulder are tight), JOINT SWELLING (neck and shoulder are swollen), HEADACHE (headache) and ARTHRALGIA (Shoulder is painful). On 15-Apr-2021, VACCINATION SITE PAIN (shot needles pain), PYREXIA (fever) and CHILLS (chills) had resolved. At the time of the report, HYPOAESTHESIA (face, shouilder and leg were numb really bad), DIZZINESS (dizziness), JOINT STIFFNESS (neck and shoulder are tight), JOINT SWELLING (neck and shoulder are swollen), HEADACHE (headache), MYALGIA (body aches) and ARTHRALGIA (Shoulder is painful) outcome was unknown and HYPOAESTHESIA (numbness in both arms) had not resolved.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    Treatment of the events were not reported.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Dry mouth, Myalgia, Paraesthesia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DRY MOUTH (Dryness in mouth and tongue), ABDOMINAL PAIN UPPER (Very slight stomach ache), PARAESTHESIA (One of the reactions tiny pins and needles in lower legs or top of feet), MYALGIA (Muscle soreness from left shoulder to left wrist) and CHILLS (I had some chills that lasted for only an hour or two each day) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No medical history reported. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced DRY MOUTH (Dryness in mouth and tongue), MYALGIA (Muscle soreness from left shoulder to left wrist) and CHILLS (I had some chills that lasted for only an hour or two each day). On 19-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (Very slight stomach ache) and PYREXIA (I had a slight fever). On 14-Apr-2021, the patient experienced PARAESTHESIA (One of the reactions tiny pins and needles in lower legs or top of feet). On 19-Mar-2021, DRY MOUTH (Dryness in mouth and tongue), ABDOMINAL PAIN UPPER (Very slight stomach ache), CHILLS (I had some chills that lasted for only an hour or two each day) and PYREXIA (I had a slight fever) had resolved. On 21-Mar-2021, MYALGIA (Muscle soreness from left shoulder to left wrist) had resolved. At the time of the report, PARAESTHESIA (One of the reactions tiny pins and needles in lower legs or top of feet) outcome was unknown. No concomitant medicines were reported. No treatment information were reported. Action taken with the drug in response to events was not applicable. This case was linked to US-MODERNATX, INC.-MOD-2021-082342 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-082342:2nd dose of vaccine.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DRY MOUTH (Dryness in mouth and tongue), ABDOMINAL PAIN UPPER (Very slight stomach ache), PARAESTHESIA (One of the reactions tiny pins and needles in lower legs or top of feet), MYALGIA (Muscle soreness from left shoulder to left wrist) and CHILLS (I had some chills that lasted for only an hour or two each day) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No medical history reported. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced DRY MOUTH (Dryness in mouth and tongue), MYALGIA (Muscle soreness from left shoulder to left wrist) and CHILLS (I had some chills that lasted for only an hour or two each day). On 19-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (Very slight stomach ache) and PYREXIA (I had a slight fever). On 14-Apr-2021, the patient experienced PARAESTHESIA (One of the reactions tiny pins and needles in lower legs or top of feet). On 19-Mar-2021, DRY MOUTH (Dryness in mouth and tongue), ABDOMINAL PAIN UPPER (Very slight stomach ache), CHILLS (I had some chills that lasted for only an hour or two each day) and PYREXIA (I had a slight fever) had resolved. On 21-Mar-2021, MYALGIA (Muscle soreness from left shoulder to left wrist) had resolved. At the time of the report, PARAESTHESIA (One of the reactions tiny pins and needles in lower legs or top of feet) outcome was unknown. No concomitant medicines were reported. No treatment information were reported. Action taken with the drug in response to events was not applicable. This case was linked to US-MODERNATX, INC.-MOD-2021-082342 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-082342:2nd dose of vaccine.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: tested positive for covid 19, three days after receiving first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (tested positive for covid 19, three days after receiving first dose) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (tested positive for covid 19, three days after receiving first dose). At the time of the report, COVID-19 (tested positive for covid 19, three days after receiving first 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.   A pharmacist reported on a patient that had received his first dose of the vaccine on either 22-Mar-2021 or 23-Mar-2021. Three days after receiving the first dose, the patient contracted COVID-19.   Concomitant product use and treatment information was not provided.  The reporter consented to Safety followup.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: joint pain, mainly on the left side of their body; This spontaneous case was reported by a pharmacist and describes the occurrence of ARTHRALGIA (joint pain, mainly on the left side of their body) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included COLECALCIFEROL (VIT D [COLECALCIFEROL]) for an unknown indication.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (joint pain, mainly on the left side of their body). At the time of the report, ARTHRALGIA (joint pain, mainly on the left side of their body) outcome was unknown. Not Provided      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.   Treatment medication was not provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: injection site was a little sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (injection site was a little sore) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Heart failure (NOS).    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced VACCINATION SITE PAIN (injection site was a little sore). At the time of the report, VACCINATION SITE PAIN (injection site was a little sore) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment medication details was reported.   This case was linked to MOD-2021-082160 (Patient Link).
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Blood count, Injection site pain
Clinical narrative: pain at injection site left arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (pain at injection site left arm) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     The patient's past medical history included Shingles. Previously administered products included for Shingles: VARICELLA ZOSTER VACCINE LIVE (Patient had first marketed Shingle vaccine years ago with LOT #044A21A).    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced INJECTION SITE PAIN (pain at injection site left arm). The patient was treated with VALACICLOVIR at a dose of UNK,twice daily. On 13-Feb-2021, INJECTION SITE PAIN (pain at injection site left arm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood count: unknown (Inconclusive) Blood work performed and diagnosis was "shingles".     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 reported   This case was linked to MOD-2021-068478 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: adverse reaction; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of ADVERSE REACTION (adverse reaction) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (adverse reaction). At the time of the report, ADVERSE REACTION (adverse reaction) 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 medications reported by investigator. No treatment medications provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: follow up received on 19/05/21 with No new information
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Pharyngeal swelling, Rash, Swelling face
Clinical narrative: swelling of her throat; swelling of her face; swelling of her lips; a rash; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (swelling of her throat), SWELLING FACE (swelling of her face), LIP SWELLING (swelling of her lips) and RASH (a rash) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PHARYNGEAL SWELLING (swelling of her throat), SWELLING FACE (swelling of her face), LIP SWELLING (swelling of her lips) and RASH (a rash). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, PHARYNGEAL SWELLING (swelling of her throat), SWELLING FACE (swelling of her face), LIP SWELLING (swelling of her lips) and RASH (a rash) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; 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 COVID-19 (COVID-19) 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 19-Mar-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 COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) COVID-19 positive test.     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
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Attention deficit hyperactivity disorder, Back pain, Chills, Discomfort, Feeling abnormal
Clinical narrative: Sinus infection; Attention deficit hyperactivity disorder; Problems in walking; Felt like garbage; Problems in washing or dressin/Some problems with performing usual activities; Pain/Aches; Discomfort; Back pain; Chills; Fever; This spontaneous case was reported by a physician and describes the occurrence of SINUSITIS (Sinus infection), ATTENTION DEFICIT HYPERACTIVITY DISORDER (Attention deficit hyperactivity disorder), GAIT DISTURBANCE (Problems in walking), FEELING ABNORMAL (Felt like garbage) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Problems in washing or dressin/Some problems with performing usual activities) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Vitamin D deficiency in August 2020, Ankylosing spondylitis and Shortness of breath. Concurrent medical conditions included Depression, Anxiety, Anemia, Asthma, Cough and Rheumatoid arthritis. Concomitant products included ADALIMUMAB (HUMIRA) from 12-Jan-2021 to 26-Jan-2021 for Ankylosing spondylitis, ESCITALOPRAM OXALATE (LEXAPRO) for Depression, VITAMIN D3 for Vitamin D deficiency, VORTIOXETINE HYDROBROMIDE (TRINTELLIX).   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SINUSITIS (Sinus infection), ATTENTION DEFICIT HYPERACTIVITY DISORDER (Attention deficit hyperactivity disorder), GAIT DISTURBANCE (Problems in walking), FEELING ABNORMAL (Felt like garbage), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Problems in washing or dressin/Some problems with performing usual activities), PAIN (Pain/Aches), DISCOMFORT (Discomfort), BACK PAIN (Back pain), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, SINUSITIS (Sinus infection) had resolved, ATTENTION DEFICIT HYPERACTIVITY DISORDER (Attention deficit hyperactivity disorder), FEELING ABNORMAL (Felt like garbage), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown, GAIT DISTURBANCE (Problems in walking), PAIN (Pain/Aches), DISCOMFORT (Discomfort) and BACK PAIN (Back pain) was resolving and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Problems in washing or dressin/Some problems with performing usual activities) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided. the lab data reported was tuberculosis on unknown date and results. concomitant medication includes Antibitics.  Action taken with mRNA-1273 in response to the events was not Applicable.