chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, UNK
Symptoms: Injection site erythema, Muscular weakness, Pain in jaw
Clinical narrative: jaw pain; facial pain; cough; harder time breathing; out of focus; weekness in leg; fatigue; redness at covid vaccination injections site; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN IN JAW (jaw pain), FACIAL PAIN (facial pain), COUGH (cough), DYSPNOEA (harder time breathing) and DISTURBANCE IN ATTENTION (out of focus) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product MACITENTAN for Pulmonary hypertension.    Concurrent medical conditions included Pulmonary hypertension. Concomitant products included TREPROSTINIL SODIUM (TYVASO) and TADALAFIL for an unknown indication.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and MACITENTAN (Oral) 10 mg. On an unknown date, the patient experienced PAIN IN JAW (jaw pain), FACIAL PAIN (facial pain), COUGH (cough), DYSPNOEA (harder time breathing), DISTURBANCE IN ATTENTION (out of focus), MUSCULAR WEAKNESS (weekness in leg), FATIGUE (fatigue) and INJECTION SITE ERYTHEMA (redness at covid vaccination injections site). At the time of the report, PAIN IN JAW (jaw pain), FACIAL PAIN (facial pain), COUGH (cough), DYSPNOEA (harder time breathing), DISTURBANCE IN ATTENTION (out of focus), MUSCULAR WEAKNESS (weekness in leg), FATIGUE (fatigue) and INJECTION SITE ERYTHEMA (redness at covid vaccination injections site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication was reported.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hypoaesthesia, Myalgia, Paraesthesia
Clinical narrative: fever; headache; muscle/ body ache; chills; legs tingling and numbness; Arm tingling / numbness; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (legs tingling and numbness), PARAESTHESIA (Arm tingling / numbness), PYREXIA (fever), HEADACHE (headache) and MYALGIA (muscle/ body ache) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B221A and 040B221A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history were reported for patient.  Concomitant products included LEVOTHYROXINE from 01-Apr-2021 to an unknown date for Hypothyroidism.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced PARAESTHESIA (Arm tingling / numbness). On 04-Jun-2021, the patient experienced HYPOAESTHESIA (legs tingling and numbness). On an unknown date, the patient experienced PYREXIA (fever), HEADACHE (headache), MYALGIA (muscle/ body ache) and CHILLS (chills). At the time of the report, HYPOAESTHESIA (legs tingling and numbness) and PARAESTHESIA (Arm tingling / numbness) had not resolved and PYREXIA (fever), HEADACHE (headache), MYALGIA (muscle/ body ache) and CHILLS (chills) outcome was unknown.            No treatment medication was reported.   This case was linked to MOD-2021-073036 (Patient Link).
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; headache; muscle/ body ache; chills; legs tingling and numbness; Arm tingling / numbness; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (legs tingling and numbness), PARAESTHESIA (Arm tingling / numbness), PYREXIA (fever), HEADACHE (headache) and MYALGIA (muscle/ body ache) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B221A and 040B221A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history were reported for patient.  Concomitant products included LEVOTHYROXINE from 01-Apr-2021 to an unknown date for Hypothyroidism.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced PARAESTHESIA (Arm tingling / numbness). On 04-Jun-2021, the patient experienced HYPOAESTHESIA (legs tingling and numbness). On an unknown date, the patient experienced PYREXIA (fever), HEADACHE (headache), MYALGIA (muscle/ body ache) and CHILLS (chills). At the time of the report, HYPOAESTHESIA (legs tingling and numbness) and PARAESTHESIA (Arm tingling / numbness) had not resolved and PYREXIA (fever), HEADACHE (headache), MYALGIA (muscle/ body ache) and CHILLS (chills) outcome was unknown.            No treatment medication was reported.   This case was linked to MOD-2021-073036 (Patient Link).
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 20-Jan-2021, PAIN IN EXTREMITY (Sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        Concomitant medication and treatment drug were not reported.   This case was linked to MOD-2021-018165 (Patient Link).
Sex: M
Vaccine: COVID19, UNK
Symptoms: Dyspnoea, Fatigue, Feeling abnormal, SARS-CoV-2 test
Clinical narrative: trouble breathing; Brain Fog; feeling really  tired; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (trouble breathing), FEELING ABNORMAL (Brain Fog) and FATIGUE (feeling really  tired) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product MACITENTAN tablet for Pulmonary hypertension.    The patient's past medical history included COVID-19 in November 2020 and Hospitalization (hospitalized after being diagnosed with COVID.) from 01-Nov-2020 to 05-Nov-2020. Concurrent medical conditions included Primary pulmonary hypertension and Clinical trial participant. Concomitant products included SILDENAFIL CITRATE for an unknown indication.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started MACITENTAN (Oral) 10 mg once a day. On an unknown date, MACITENTAN (Oral) dosage was changed to at an unspecified dose. In April 2021, the patient experienced DYSPNOEA (trouble breathing), FEELING ABNORMAL (Brain Fog) and FATIGUE (feeling really  tired). At the time of the report, DYSPNOEA (trouble breathing), FEELING ABNORMAL (Brain Fog) and FATIGUE (feeling really  tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Nov-2020, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   This case was linked to MOD-2021-162997 (Patient Link).
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (palpitations fast resting heart beat) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Asthma. On 16-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-May-2021, the patient experienced PALPITATIONS (palpitations fast resting heart beat). At the time of the report, PALPITATIONS (palpitations fast resting heart beat) had not resolved. Concomitant product use was not provided by the reporter. Action taken with mRNA-1273 in response to the events was not applicable. Treatment information was not provided.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Wrong product administered
Clinical narrative: patient accidentally received Pfizer vaccine/patient was supposed to get Moderna vaccine second; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient accidentally received Pfizer vaccine/patient was supposed to get Moderna vaccine second) in a 75-year-old female 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.    No medication history was provided.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (patient accidentally received Pfizer vaccine/patient was supposed to get Moderna vaccine second). At the time of the report, WRONG PRODUCT ADMINISTERED (patient accidentally received Pfizer vaccine/patient was supposed to get Moderna vaccine second) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication use was unknown  Treatment information was unknown
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling hot, Limb discomfort, Pain in extremity, Peripheral swelling
Clinical narrative: Sore right arm; Hot to touch; Could not lift up; Swelling; Hives on my abdomen; Temperature of 102; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Sore right arm), FEELING HOT (Hot to touch), LIMB DISCOMFORT (Could not lift up), PERIPHERAL SWELLING (Swelling) and URTICARIA (Hives on my abdomen) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Essential tremor, Eczema, Vitiligo, Undifferentiated connective tissue disease, Rosacea, Allergy to antibiotic (Ciprofloxacin), Lactose intolerance (Lactose), Adhesive tape allergy (Adhesive) and Drug allergy (Hibiclens). Concomitant products included AZELAIC ACID for Rosacea, WOMEN MULTI and KETOCONAZOLE for an unknown indication.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore right arm), FEELING HOT (Hot to touch), LIMB DISCOMFORT (Could not lift up), PERIPHERAL SWELLING (Swelling), URTICARIA (Hives on my abdomen) and PYREXIA (Temperature of 102). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore right arm), FEELING HOT (Hot to touch), LIMB DISCOMFORT (Could not lift up), PERIPHERAL SWELLING (Swelling), URTICARIA (Hives on my abdomen) and PYREXIA (Temperature of 102) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Feb-2021, Body temperature: 102 (High) High.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Urticaria
Clinical narrative: Sore right arm; Hot to touch; Could not lift up; Swelling; Hives on my abdomen; Temperature of 102; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Sore right arm), FEELING HOT (Hot to touch), LIMB DISCOMFORT (Could not lift up), PERIPHERAL SWELLING (Swelling) and URTICARIA (Hives on my abdomen) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Essential tremor, Eczema, Vitiligo, Undifferentiated connective tissue disease, Rosacea, Allergy to antibiotic (Ciprofloxacin), Lactose intolerance (Lactose), Adhesive tape allergy (Adhesive) and Drug allergy (Hibiclens). Concomitant products included AZELAIC ACID for Rosacea, WOMEN MULTI and KETOCONAZOLE for an unknown indication.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore right arm), FEELING HOT (Hot to touch), LIMB DISCOMFORT (Could not lift up), PERIPHERAL SWELLING (Swelling), URTICARIA (Hives on my abdomen) and PYREXIA (Temperature of 102). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore right arm), FEELING HOT (Hot to touch), LIMB DISCOMFORT (Could not lift up), PERIPHERAL SWELLING (Swelling), URTICARIA (Hives on my abdomen) and PYREXIA (Temperature of 102) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Feb-2021, Body temperature: 102 (High) High.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Herpes zoster, Joint swelling
Clinical narrative: swelling in her right wrist; shingles; This spontaneous case was reported by an other health care professional and describes the occurrence of HERPES ZOSTER (shingles) and JOINT SWELLING (swelling in her right wrist) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOFACITINIB CITRATE (XELJANZ XR) for Rheumatoid arthritis.    The patient's past medical history included Unhappiness. Concurrent medical conditions included Rheumatoid arthritis.   On 10-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started TOFACITINIB CITRATE (XELJANZ XR) (Oral) 11 milligram once a day. On 10-Apr-2021, the patient experienced HERPES ZOSTER (shingles). On an unknown date, the patient experienced JOINT SWELLING (swelling in her right wrist). At the time of the report, HERPES ZOSTER (shingles) and JOINT SWELLING (swelling in her right wrist) 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. Treatments were not reported. Patient reports after taking a break for Xelijanz XR, she does not see any changes. The patient also reports that prior to taking Xelianz XR,  she had swelling of the middle finger as reported as a huge mess.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Patient identifier observed and requested for more details. On 26-Jul-2021: Follow-up received contains no new information.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Chills, Myalgia
Clinical narrative: Dull pain and pressure near my heart/pain in my upper right chest area  behind my right breast; chills; Sore painful heart muscle/didn't feel like the actual heart rather a muscle or tendon near or connected to the heart.; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Dull pain and pressure near my heart/pain in my upper right chest area  behind my right breast), CHILLS (chills), MYALGIA (Sore painful heart muscle/didn't feel like the actual heart rather a muscle or tendon near or connected to the heart.) and ARTHRALGIA (joint pain) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (Dull pain and pressure near my heart/pain in my upper right chest area  behind my right breast), CHILLS (chills), MYALGIA (Sore painful heart muscle/didn't feel like the actual heart rather a muscle or tendon near or connected to the heart.) and ARTHRALGIA (joint pain). At the time of the report, CHEST PAIN (Dull pain and pressure near my heart/pain in my upper right chest area  behind my right breast), CHILLS (chills), MYALGIA (Sore painful heart muscle/didn't feel like the actual heart rather a muscle or tendon near or connected to the heart.) and ARTHRALGIA (joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  No treatment information was reported.   This case was linked to MOD-2021-163250 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Non-significant/ outcome unknown On 16-Jul-2021: Non-significant Follow-up
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: tired afterwards; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired afterwards) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (tired afterwards). At the time of the report, FATIGUE (tired afterwards) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant or treatment medications were reported.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Chills
Clinical narrative: dull pain and pressure near my heart/ sore,painful heart muscle; chills; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (dull pain and pressure near my heart/ sore,painful heart muscle), CHILLS (chills) and ARTHRALGIA (Joint pain) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (dull pain and pressure near my heart/ sore,painful heart muscle), CHILLS (chills) and ARTHRALGIA (Joint pain). At the time of the report, CHEST PAIN (dull pain and pressure near my heart/ sore,painful heart muscle) and CHILLS (chills) outcome was unknown and ARTHRALGIA (Joint pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details were provided. No treatment medication details were provided.      Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: significant follow up-Medical History Is updated On 16-Jul-2021: Follow up received contains no new information so consider it as NNI
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products, Product administered to patient of inappropriate age
Clinical narrative: received their 1st dose of Pfizer and came in today and got the Moderna; inappropriate age; This spontaneous case was reported by an other health care professional and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (received their 1st dose of Pfizer and came in today and got the Moderna) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (inappropriate age) in a 16-year-old female 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.    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 and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (received their 1st dose of Pfizer and came in today and got the Moderna) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (inappropriate age). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (received their 1st dose of Pfizer and came in today and got the Moderna) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (inappropriate age) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant and treatment information not provided
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: Vaccination Site Reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Vaccination Site Reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Vaccination Site Reaction). At the time of the report, VACCINATION SITE REACTION (Vaccination Site Reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose decreased
Clinical narrative: blood sugars stayed below 200 for two weeks then went back up; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE DECREASED (blood sugars stayed below 200 for two weeks then went back up) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01IJ20A) for COVID-19 vaccination.     Concomitant products included METFORMIN, ERTUGLIFLOZIN PIDOLATE (STEGLATRO), INSULIN GLARGINE, LIXISENATIDE (SOLIQUA), INSULIN GLARGINE (LANTUS), FENOFIBRATE, LISINOPRIL and ATORVASTATIN for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced BLOOD GLUCOSE DECREASED (blood sugars stayed below 200 for two weeks then went back up). On 20-Jan-2021, BLOOD GLUCOSE DECREASED (blood sugars stayed below 200 for two weeks then went back up) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment drugs are not provided by reporter.   This case was linked to MOD-2021-016534 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy skin) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medication history was provided. 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 PRURITUS (Itchy skin). At the time of the report, PRURITUS (Itchy skin) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. No treatment information was provided. This case was linked to MOD-2021-053404.
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products, Product administered to patient of inappropriate age
Clinical narrative: 16 year old female received their 1st dose of Pfizer and then recieved Moderna vaccine as 2nd dose; Received their 1st dose of Pfizer and came in today and got the Moderna; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old female received their 1st dose of Pfizer and then recieved Moderna vaccine as 2nd dose) and INTERCHANGE OF VACCINE PRODUCTS (Received their 1st dose of Pfizer and came in today and got the Moderna) in a 16-year-old female 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 an unknown indication.    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 and first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old female received their 1st dose of Pfizer and then recieved Moderna vaccine as 2nd dose) and INTERCHANGE OF VACCINE PRODUCTS (Received their 1st dose of Pfizer and came in today and got the Moderna). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old female received their 1st dose of Pfizer and then recieved Moderna vaccine as 2nd dose) and INTERCHANGE OF VACCINE PRODUCTS (Received their 1st dose of Pfizer and came in today and got the Moderna) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment medications were unknown.
Sex: U
Vaccine: COVID19
Symptoms: Eye pain, Eye swelling, Vision blurred
Clinical narrative: pain in my eyes; swelling to eyes; Everytime the sun hot my eyes they blurr up; 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 EYE PAIN (pain in my eyes), EYE SWELLING (swelling to eyes) and VISION BLURRED (Everytime the sun hot my eyes they blurr up) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EYE PAIN (pain in my eyes), EYE SWELLING (swelling to eyes) and VISION BLURRED (Everytime the sun hot my eyes they blurr up). At the time of the report, EYE PAIN (pain in my eyes), EYE SWELLING (swelling to eyes) and VISION BLURRED (Everytime the sun hot my eyes they blurr up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant Medications were provided by the reporter. No Treatment History was provided by the reporter.   Reporter did not allow further contact
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of arthralgia (joint pain from neck to toes still ongoing 2 weeks after the second dose) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 045B21A and 031B21A) for COVID-19 immunization. No medical history reported. On Mar 30, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Apr 27, 2021, received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On May 4, 2021, patient experienced arthralgia (joint pain from neck to toes still ongoing 2 weeks after the second dose). The patient treated with Advil (ibuprofen) for joint pain, at an unspecified dose and frequency. At the time of the report, arthralgia (joint pain from neck to toes still ongoing 2 weeks after the second dose): not resolved. Concomitant medication list not provided. Action taken with mRNA-1273 in response to the event: not applicable. The patient stated the pain in her fingers is constant. When she wakes up, it's the worst with joint pain. Ibuprofen did not help the patient relieve the pain.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Insomnia, Pain in extremity
Clinical narrative: Sore right arm; Couldn't sleep because of the headache/in bed the whole day, mostly trying to sleep; Fatigue/tiredness; Chills; Headache/my headache was terrible; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore right arm), INSOMNIA (Couldn't sleep because of the headache/in bed the whole day, mostly trying to sleep), FATIGUE (Fatigue/tiredness), CHILLS (Chills) and HEADACHE (Headache/my headache was terrible) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024C21A and 031B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LORATADINE and FLUTICASONE for Allergy, VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR [VALACICLOVIR HYDROCHLORIDE]) for an unknown indication.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-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 PAIN IN EXTREMITY (Sore right arm), INSOMNIA (Couldn't sleep because of the headache/in bed the whole day, mostly trying to sleep), FATIGUE (Fatigue/tiredness), CHILLS (Chills) and HEADACHE (Headache/my headache was terrible). The patient was treated with ACETAMINOPHEN at a dose of 500 milligram. At the time of the report, PAIN IN EXTREMITY (Sore right arm), INSOMNIA (Couldn't sleep because of the headache/in bed the whole day, mostly trying to sleep), FATIGUE (Fatigue/tiredness), CHILLS (Chills) and HEADACHE (Headache/my headache was terrible) outcome was unknown.            Concomitant medications includes ocuvite, multivitamin, Fish Oil.   This case was linked to MOD-2021-080294 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow-up received included no new information.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Facial paralysis, Ocular discomfort
Clinical narrative: half of my face paralyzed; My eyes felt like opened more than normal; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of FACIAL PARALYSIS (half of my face paralyzed) and OCULAR DISCOMFORT (My eyes felt like opened more than normal) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. UNK and 037B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 15-May-2021, the patient experienced FACIAL PARALYSIS (half of my face paralyzed) and OCULAR DISCOMFORT (My eyes felt like opened more than normal). At the time of the report, FACIAL PARALYSIS (half of my face paralyzed) and OCULAR DISCOMFORT (My eyes felt like opened more than normal) outcome was unknown.            Concomitant product use was not provided by the reporter. The patient refers to be taking injections [sic] as treatment.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Menstrual disorder
Clinical narrative: I'm getting more and more bloated; I'm missing my period for 12 days now; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISTENSION (I'm getting more and more bloated) and MENSTRUAL DISORDER (I'm missing my period for 12 days now) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISTENSION (I'm getting more and more bloated) and MENSTRUAL DISORDER (I'm missing my period for 12 days now). At the time of the report, ABDOMINAL DISTENSION (I'm getting more and more bloated) and MENSTRUAL DISORDER (I'm missing my period for 12 days now) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported. No Treatment medications ere reported.   This case was linked to MOD-2021-163300 (Patient Link).
Age: 52.0
Sex: U
Vaccine: COVID19
Symptoms: Product administration error, Product storage error
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Second dose was improperly stored and administered) and PRODUCT ADMINISTRATION ERROR (Improperly administered) in a 52-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) 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) (unknown route) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-May-2021, the patient experienced PRODUCT STORAGE ERROR (Second dose was improperly stored and administered) and PRODUCT ADMINISTRATION ERROR (Improperly administered). At the time of the report, PRODUCT STORAGE ERROR (Second dose was improperly stored and administered) and PRODUCT ADMINISTRATION ERROR (Improperly administered) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. No treatment information was provided. This case was linked to US-MODERNATX, INC.-MOD-2021-163779 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-163779:Same reporter
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Influenza like illness, Pyrexia
Clinical narrative: flu-like symptoms with fever; diarrhea; fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms with fever), DIARRHOEA (diarrhea) and PYREXIA (fever) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M201A) for COVID-19 vaccination.     Medical history was not reported.  Concomitant products included SIMVASTATIN for an unknown indication.    On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms with fever), DIARRHOEA (diarrhea) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and BISMUTH SUBSALICYLATE, CALCIUM CARBONATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE;CALCIUM CARBONATE]) at an unspecified dose and frequency. On 06-Mar-2021, INFLUENZA LIKE ILLNESS (flu-like symptoms with fever), DIARRHOEA (diarrhea) and PYREXIA (fever) had resolved.            Concominant medication also include an unknown anti-anxiety medication.  On 24 May 2021, the patient called and reported the first dose of the Moderna Covid-19 vaccine (Lot:031L201A, expiration: unknown) was received on 04 Feb 2021 at pharmacy.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: If it's been six weeks since my first dose; 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (If it's been six weeks since my first dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (If it's been six weeks since my first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (If it's been six weeks since my first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash; 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 RASH (Rash) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Rash). At the time of the report, RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  Treatment medications were unknown.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: severe allergic reaction I had to the first Moderna Vaccine; 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 HYPERSENSITIVITY (severe allergic reaction I had to the first Moderna Vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (severe allergic reaction I had to the first Moderna Vaccine). At the time of the report, HYPERSENSITIVITY (severe allergic reaction I had to the first Moderna Vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue
Clinical narrative: Not much of appetite; Tired; 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 DECREASED APPETITE (Not much of appetite) and FATIGUE (Tired) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DECREASED APPETITE (Not much of appetite) and FATIGUE (Tired). At the time of the report, DECREASED APPETITE (Not much of appetite) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment information was not provided.   Reporter did not allow further contact
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Moderna vaccine given to a 16 year old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna vaccine given to a 16 year old) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna vaccine given to a 16 year old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna vaccine given to a 16 year old) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided by the reporter. Treatment was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Non-significant information provided
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration
Clinical narrative: Violet spots under her armpit; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (Violet spots under her armpit) 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 27-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 SKIN DISCOLOURATION (Violet spots under her armpit). At the time of the report, SKIN DISCOLOURATION (Violet spots under her armpit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications and treatment medications were not provided.  It was reported that the patient received the first dose of Moderna COVID-19 vaccine on 27APR2021 and a week later started having some violet spots under her armpit.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Rash, Rash pruritic
Clinical narrative: pox itch; pox all over her body; fatigue; chills; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (pox itch), RASH (pox all over her body), CHILLS (chills) and FATIGUE (fatigue) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) and ALPRAZOLAM for an unknown indication.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, the patient experienced CHILLS (chills). On 05-May-2021, the patient experienced FATIGUE (fatigue). On 17-May-2021, the patient experienced RASH (pox all over her body). On an unknown date, the patient experienced RASH PRURITIC (pox itch). At the time of the report, RASH PRURITIC (pox itch), RASH (pox all over her body), CHILLS (chills) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment details were provided.