chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Extra dose administered, Off label use
Clinical narrative: Received third dose even though it is not 8 months yet; Extra dose administered; 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 OFF LABEL USE (Received third dose even though it is not 8 months yet) and EXTRA DOSE ADMINISTERED (Extra dose administered) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and 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 OFF LABEL USE (Received third dose even though it is not 8 months yet) and EXTRA DOSE ADMINISTERED (Extra dose administered). At the time of the report, OFF LABEL USE (Received third dose even though it is not 8 months yet) and EXTRA DOSE ADMINISTERED (Extra dose administered) had resolved.            No relevant concomitant medications were reported.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Headache the same day as getting your first shot; Tired; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache the same day as getting your first shot) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache the same day as getting your first shot) and FATIGUE (Tired). At the time of the report, HEADACHE (Headache the same day as getting your first shot) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information was provided.   Reporter did not allow further contact
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Vaccination site reaction
Clinical narrative: broke out in hives that evening; magnetic at the injection site/stuck at the injection site, not the whole arm; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (broke out in hives that evening) and VACCINATION SITE REACTION (magnetic at the injection site/stuck at the injection site, not the whole arm) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced URTICARIA (broke out in hives that evening) and VACCINATION SITE REACTION (magnetic at the injection site/stuck at the injection site, not the whole arm). At the time of the report, URTICARIA (broke out in hives that evening) and VACCINATION SITE REACTION (magnetic at the injection site/stuck at the injection site, not the whole arm) 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.  Patient was advised not to get the second dose  The patient stated that she and her coworker are magnetic at the injection site. Three of them received the Pfizer COVID19 Vaccine , two coworkers also received the Moderna COVID19 Vaccine , and two coworkers received the Johnson & Johnson COVID19 Vaccine.   They messed around with their name badges.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested porsitive for COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested porsitive for COVID) 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 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Jul-2021, the patient experienced COVID-19 (tested porsitive for COVID). At the time of the report, COVID-19 (tested porsitive for COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jul-2021, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medications were reported.  On 29-Jul-2021, patient received a Regeneron treatment (monoclonal antibodies for COVID).  Patient was not aware that he had to wait 90 days to get another dose.  Patient consider that probably got COVID before getting the vaccine.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 24-Aug-2021: Follow-up received and contains no new information.
Sex: U
Vaccine: COVID19
Symptoms: Breast mass, Breast pain
Clinical narrative: I have pain in my; a lump in my breast; This spontaneous case was reported by a consumer and describes the occurrence of BREAST PAIN (I have pain in my) and BREAST MASS (a lump in my breast) 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 BREAST PAIN (I have pain in my) and BREAST MASS (a lump in my breast). At the time of the report, BREAST PAIN (I have pain in my) and BREAST MASS (a lump in my breast) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided by the reporter. Treatment information was not provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot, Injection site induration, Malaise, Mobility decreased
Clinical narrative: was not feeling well; She stayed in bed for the next day and that was it; She didn't run a high temperature then. Her arm had a rectangle 4" by 6", it was swollen and hard.; This time, her arm didn't get hard but got very swollen and hot; Her arm had a rectangle 4" by 6", it was swollen and hard. The hard area was 3/4 inch thick.; very tired; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (was not feeling well), MOBILITY DECREASED (She stayed in bed for the next day and that was it), PERIPHERAL SWELLING (She didn't run a high temperature then. Her arm had a rectangle 4" by 6", it was swollen and hard.), FEELING HOT (This time, her arm didn't get hard but got very swollen and hot) and INJECTION SITE INDURATION (Her arm had a rectangle 4" by 6", it was swollen and hard. The hard area was 3/4 inch thick.) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A, 025120-2A and 088D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Immunocompromised and Drug allergy. Concomitant products included INSULIN, CLOPIDOGREL BISULFATE (PLAVIX), EZETIMIBE (ZETIA) and ATORVASTATIN for an unknown indication.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (was not feeling well), MOBILITY DECREASED (She stayed in bed for the next day and that was it), PERIPHERAL SWELLING (She didn't run a high temperature then. Her arm had a rectangle 4" by 6", it was swollen and hard.), FEELING HOT (This time, her arm didn't get hard but got very swollen and hot), INJECTION SITE INDURATION (Her arm had a rectangle 4" by 6", it was swollen and hard. The hard area was 3/4 inch thick.) and FATIGUE (very tired). At the time of the report, MALAISE (was not feeling well), MOBILITY DECREASED (She stayed in bed for the next day and that was it), PERIPHERAL SWELLING (She didn't run a high temperature then. Her arm had a rectangle 4" by 6", it was swollen and hard.), FEELING HOT (This time, her arm didn't get hard but got very swollen and hot), INJECTION SITE INDURATION (Her arm had a rectangle 4" by 6", it was swollen and hard. The hard area was 3/4 inch thick.) and FATIGUE (very tired) outcome was unknown.            No treatment medication was reported.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: was not feeling well; She stayed in bed for the next day and that was it; She didn't run a high temperature then. Her arm had a rectangle 4" by 6", it was swollen and hard.; This time, her arm didn't get hard but got very swollen and hot; Her arm had a rectangle 4" by 6", it was swollen and hard. The hard area was 3/4 inch thick.; very tired; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (was not feeling well), MOBILITY DECREASED (She stayed in bed for the next day and that was it), PERIPHERAL SWELLING (She didn't run a high temperature then. Her arm had a rectangle 4" by 6", it was swollen and hard.), FEELING HOT (This time, her arm didn't get hard but got very swollen and hot) and INJECTION SITE INDURATION (Her arm had a rectangle 4" by 6", it was swollen and hard. The hard area was 3/4 inch thick.) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A, 025120-2A and 088D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Immunocompromised and Drug allergy. Concomitant products included INSULIN, CLOPIDOGREL BISULFATE (PLAVIX), EZETIMIBE (ZETIA) and ATORVASTATIN for an unknown indication.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (was not feeling well), MOBILITY DECREASED (She stayed in bed for the next day and that was it), PERIPHERAL SWELLING (She didn't run a high temperature then. Her arm had a rectangle 4" by 6", it was swollen and hard.), FEELING HOT (This time, her arm didn't get hard but got very swollen and hot), INJECTION SITE INDURATION (Her arm had a rectangle 4" by 6", it was swollen and hard. The hard area was 3/4 inch thick.) and FATIGUE (very tired). At the time of the report, MALAISE (was not feeling well), MOBILITY DECREASED (She stayed in bed for the next day and that was it), PERIPHERAL SWELLING (She didn't run a high temperature then. Her arm had a rectangle 4" by 6", it was swollen and hard.), FEELING HOT (This time, her arm didn't get hard but got very swollen and hot), INJECTION SITE INDURATION (Her arm had a rectangle 4" by 6", it was swollen and hard. The hard area was 3/4 inch thick.) and FATIGUE (very tired) outcome was unknown.            No treatment medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of hypoesthesia (I have numbness in my arm & leg on left-side) in a  patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced hypoesthesia (I have numbness in my arm & leg on left-side). At the time of the report, hypoesthesia (I have numbness in my arm & leg on left-side): unresolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. Concomitant medications and treatment information not provided.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088O21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIARRHOEA (Diarrhea). At the time of the report, DIARRHOEA (Diarrhea) had not resolved.            No concomitant medication was reported by the reporter. No treatment was reported by the reporter.  About 4-5 hours after getting vaccinated, the patient developed diarrhea with no gas pain/stomach pain. He mentioned that it just flowed. It was still on going at the time report.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Dyspnoea, Musculoskeletal discomfort, X-ray
Clinical narrative: pain, She has been in constant constant pain; can't use my shoulder; they found it was arthritis; trouble breathing, affected her breathing; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain, She has been in constant constant pain), MUSCULOSKELETAL DISCOMFORT (can't use my shoulder), ARTHRITIS (they found it was arthritis) and DYSPNOEA (trouble breathing, affected her breathing) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0U7B21A and 007321A) for COVID-19 vaccination.     The patient's past medical history included Polio. Concurrent medical conditions included COPD, Emphysema and Heart failure.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-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 (pain, She has been in constant constant pain), MUSCULOSKELETAL DISCOMFORT (can't use my shoulder), ARTHRITIS (they found it was arthritis) and DYSPNOEA (trouble breathing, affected her breathing). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 500 mg twice a day; OXYCODONE for Pain, at an unspecified dose and frequency and EUPATORIUM CANNABINUM ESSENTIAL OIL (HEMP SEED OIL) for Pain, at an unspecified dose and frequency. At the time of the report, PAIN (pain, She has been in constant constant pain), MUSCULOSKELETAL DISCOMFORT (can't use my shoulder), ARTHRITIS (they found it was arthritis) and DYSPNOEA (trouble breathing, affected her breathing) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray: arthritis (abnormal) Arthritis.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Musculoskeletal stiffness, Myalgia, Pyrexia
Clinical narrative: arm were she got the injection was stiff which goes up to the neck; arm were she got the injection was more painful; joint soreness; fever; chills; muscle soreness; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (arm were she got the injection was stiff which goes up to the neck), ARTHRALGIA (joint soreness), PYREXIA (fever), CHILLS (chills) and MYALGIA (muscle soreness) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020.    On 21-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, the patient experienced ARTHRALGIA (joint soreness), PYREXIA (fever), CHILLS (chills) and MYALGIA (muscle soreness). On 24-Aug-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (arm were she got the injection was stiff which goes up to the neck) and VACCINATION SITE PAIN (arm were she got the injection was more painful). At the time of the report, MUSCULOSKELETAL STIFFNESS (arm were she got the injection was stiff which goes up to the neck), ARTHRALGIA (joint soreness), PYREXIA (fever), CHILLS (chills), MYALGIA (muscle soreness) and VACCINATION SITE PAIN (arm were she got the injection was more painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided by the reporter.   No treatment information was provided by the reporter.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: arm were she got the injection was stiff which goes up to the neck; arm were she got the injection was more painful; joint soreness; fever; chills; muscle soreness; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (arm were she got the injection was stiff which goes up to the neck), ARTHRALGIA (joint soreness), PYREXIA (fever), CHILLS (chills) and MYALGIA (muscle soreness) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020.    On 21-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, the patient experienced ARTHRALGIA (joint soreness), PYREXIA (fever), CHILLS (chills) and MYALGIA (muscle soreness). On 24-Aug-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (arm were she got the injection was stiff which goes up to the neck) and VACCINATION SITE PAIN (arm were she got the injection was more painful). At the time of the report, MUSCULOSKELETAL STIFFNESS (arm were she got the injection was stiff which goes up to the neck), ARTHRALGIA (joint soreness), PYREXIA (fever), CHILLS (chills), MYALGIA (muscle soreness) and VACCINATION SITE PAIN (arm were she got the injection was more painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided by the reporter.   No treatment information was provided by the reporter.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Muscle swelling, Nausea
Clinical narrative: Arm being a different size since receiving the vaccine, has no idea if it is associated with the inoculation, it is very odd; It looks like her muscle is bigger, from the elbow to shoulder, her arm is like an inch bigger on the left side than the right side, it does not hurt or anything, it has not changed; It looks weird; Swelling at the injection site; Headache; Tired for the day; A little nausea; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm being a different size since receiving the vaccine, has no idea if it is associated with the inoculation, it is very odd), MUSCLE SWELLING (It looks like her muscle is bigger, from the elbow to shoulder, her arm is like an inch bigger on the left side than the right side, it does not hurt or anything, it has not changed), FEELING ABNORMAL (It looks weird), VACCINATION SITE SWELLING (Swelling at the injection site) and HEADACHE (Headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension and Depression. Concomitant products included BUPROPION for Antidepressant therapy, AMLODIPINE and VALSARTAN for Hypertension, VITAMIN D NOS and VITAMINS NOS for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-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 PERIPHERAL SWELLING (Arm being a different size since receiving the vaccine, has no idea if it is associated with the inoculation, it is very odd), MUSCLE SWELLING (It looks like her muscle is bigger, from the elbow to shoulder, her arm is like an inch bigger on the left side than the right side, it does not hurt or anything, it has not changed), FEELING ABNORMAL (It looks weird), VACCINATION SITE SWELLING (Swelling at the injection site), HEADACHE (Headache), FATIGUE (Tired for the day) and NAUSEA (A little nausea). At the time of the report, PERIPHERAL SWELLING (Arm being a different size since receiving the vaccine, has no idea if it is associated with the inoculation, it is very odd), MUSCLE SWELLING (It looks like her muscle is bigger, from the elbow to shoulder, her arm is like an inch bigger on the left side than the right side, it does not hurt or anything, it has not changed), FEELING ABNORMAL (It looks weird), VACCINATION SITE SWELLING (Swelling at the injection site), HEADACHE (Headache), FATIGUE (Tired for the day) and NAUSEA (A little nausea) outcome was unknown.            She stated her muscle is different size from the site of vaccination elbow to shoulder and her left side inch bigger than right. Patient stated she didn't took any medications. Patient stated she just had a pneumonia shot about 2 weeks ago,
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Vaccination site swelling
Clinical narrative: Arm being a different size since receiving the vaccine, has no idea if it is associated with the inoculation, it is very odd; It looks like her muscle is bigger, from the elbow to shoulder, her arm is like an inch bigger on the left side than the right side, it does not hurt or anything, it has not changed; It looks weird; Swelling at the injection site; Headache; Tired for the day; A little nausea; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm being a different size since receiving the vaccine, has no idea if it is associated with the inoculation, it is very odd), MUSCLE SWELLING (It looks like her muscle is bigger, from the elbow to shoulder, her arm is like an inch bigger on the left side than the right side, it does not hurt or anything, it has not changed), FEELING ABNORMAL (It looks weird), VACCINATION SITE SWELLING (Swelling at the injection site) and HEADACHE (Headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension and Depression. Concomitant products included BUPROPION for Antidepressant therapy, AMLODIPINE and VALSARTAN for Hypertension, VITAMIN D NOS and VITAMINS NOS for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-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 PERIPHERAL SWELLING (Arm being a different size since receiving the vaccine, has no idea if it is associated with the inoculation, it is very odd), MUSCLE SWELLING (It looks like her muscle is bigger, from the elbow to shoulder, her arm is like an inch bigger on the left side than the right side, it does not hurt or anything, it has not changed), FEELING ABNORMAL (It looks weird), VACCINATION SITE SWELLING (Swelling at the injection site), HEADACHE (Headache), FATIGUE (Tired for the day) and NAUSEA (A little nausea). At the time of the report, PERIPHERAL SWELLING (Arm being a different size since receiving the vaccine, has no idea if it is associated with the inoculation, it is very odd), MUSCLE SWELLING (It looks like her muscle is bigger, from the elbow to shoulder, her arm is like an inch bigger on the left side than the right side, it does not hurt or anything, it has not changed), FEELING ABNORMAL (It looks weird), VACCINATION SITE SWELLING (Swelling at the injection site), HEADACHE (Headache), FATIGUE (Tired for the day) and NAUSEA (A little nausea) outcome was unknown.            She stated her muscle is different size from the site of vaccination elbow to shoulder and her left side inch bigger than right. Patient stated she didn't took any medications. Patient stated she just had a pneumonia shot about 2 weeks ago,
Sex: F
Vaccine: COVID19
Symptoms: Rash vesicular
Clinical narrative: Blistering rash (Second Dose); This spontaneous case was reported by a consumer and describes the occurrence of RASH VESICULAR (Blistering rash (Second Dose)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (hospitalized due to Covid19 in December for a week). Concurrent medical conditions included Fibromyalgia, Blood pressure high and Sleep loss.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH VESICULAR (Blistering rash (Second Dose)). At the time of the report, RASH VESICULAR (Blistering rash (Second Dose)) outcome was unknown.            Concomitant medication was not provided. Treatment information was not provided.   This case was linked to MOD-2021-295024, MOD-2021-295772 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Rash vesicular
Clinical narrative: Blistering rash experienced whit the first shoot of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of RASH VESICULAR (Blistering rash experienced whit the first shoot of the vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Was hospitalized due to Covid19 in December for a week before receiving the first shoot of the Moderna vaccine in march) in December 2020. Concurrent medical conditions included Blood pressure high, Fibromyalgia and Sleep loss.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH VESICULAR (Blistering rash experienced whit the first shoot of the vaccine). At the time of the report, RASH VESICULAR (Blistering rash experienced whit the first shoot of the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medication were not reported. No treatment information was provided by the reporter.   This case was linked to MOD-2021-295770, MOD-2021-295024 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Pain in extremity, Tinnitus
Clinical narrative: Strange swishing sound on her right ear; Arm got a little sore; This spontaneous case was reported by an other health care professional and describes the occurrence of TINNITUS (Strange swishing sound on her right ear) and PAIN IN EXTREMITY (Arm got a little sore) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     The patient's past medical history included Gallbladder disorder NOS (admitted in the ICU) in 2009 and Pancreatitis (admitted in the ICU) in 2009. Concurrent medical conditions included Type 1 diabetes mellitus (at 65 years old), Osteoarthritis, Hay fever and Fibromyalgia. Concomitant products included INSULIN for Type 1 diabetes mellitus.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced TINNITUS (Strange swishing sound on her right ear) and PAIN IN EXTREMITY (Arm got a little sore). At the time of the report, TINNITUS (Strange swishing sound on her right ear) and PAIN IN EXTREMITY (Arm got a little sore) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2009, Blood test: abnormal (abnormal) Pancreas is not producing insulin.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.  The 2nd dose was given on 04 May 2021 with lot number 008C21A.   This case was linked to MOD-2021-295852 (Patient Link).
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Probably 39 days since first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Probably 39 days since first dose) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) 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 17-Jul-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Probably 39 days since first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Probably 39 days since first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided. Treatment information was not provided.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Rash, Skin discolouration
Clinical narrative: Fingers being swollen his pinky thumb and his ring finger; Pink spots down his legs, arms and back.; Itchy; Rash now for two and a half months; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Fingers being swollen his pinky thumb and his ring finger), SKIN DISCOLOURATION (Pink spots down his legs, arms and back.), PRURITUS (Itchy) and RASH (Rash now for two and a half months) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus and Psoriasis.   In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced PERIPHERAL SWELLING (Fingers being swollen his pinky thumb and his ring finger), SKIN DISCOLOURATION (Pink spots down his legs, arms and back.), PRURITUS (Itchy) and RASH (Rash now for two and a half months). At the time of the report, PERIPHERAL SWELLING (Fingers being swollen his pinky thumb and his ring finger), SKIN DISCOLOURATION (Pink spots down his legs, arms and back.), PRURITUS (Itchy) and RASH (Rash now for two and a half months) had not resolved.            Additional concurrent medical condition included Sparkling Disposition. Concomitant medications was not provided by the reporter. Treatment information was not provided. First vaccine was given around the 05-MAY-2021 or 06-MAY-2021, patient was unsure of the exact date.Second vaccine was given around the 05-JUN-2021 or 06-JUN-2021, patient was unsure of the exact date. The patient had a rash now for two and a half months.  It started with his fingers being swollen his pinky thumb and his ring finger. He had pink spots down his legs, arms and back. It was worse, down his arms and hands. Itchy.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness
Clinical narrative: She started feeling little light headed some time after receiving 2nd dose; Once in a while she loses her balance, She still has that issue; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (She started feeling little light headed some time after receiving 2nd dose) and BALANCE DISORDER (Once in a while she loses her balance, She still has that issue) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 007M20A) for COVID-19 vaccination.     No medical history reported.  Concomitant products included LISINOPRIL for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced BALANCE DISORDER (Once in a while she loses her balance, She still has that issue). On 23-Feb-2021, the patient experienced DIZZINESS (She started feeling little light headed some time after receiving 2nd dose). At the time of the report, DIZZINESS (She started feeling little light headed some time after receiving 2nd dose) and BALANCE DISORDER (Once in a while she loses her balance, She still has that issue) had not resolved.            Treatment medication was not provided.  Patient started feeling little lightheaded sometime after receiving 2nd dose and it was not constant however every once in a while, patient loses balance and still has that issue.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Migraine, Pain, Pain in extremity, Polymenorrhoea
Clinical narrative: tachycardia increased; Period got weird spotting in middle of month and cycle shorter with spotting before and after; Sever leg pain; migraine; Period got weird spotting in middle of month and cycle shorter with spotting before and after; chronic pain getting worse; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (tachycardia increased), VAGINAL HAEMORRHAGE (Period got weird spotting in middle of month and cycle shorter with spotting before and after), PAIN IN EXTREMITY (Sever leg pain), MIGRAINE (migraine) and POLYMENORRHOEA (Period got weird spotting in middle of month and cycle shorter with spotting before and after) in a 39-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.     Concomitant products included LORATADINE for an unknown indication.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TACHYCARDIA (tachycardia increased), VAGINAL HAEMORRHAGE (Period got weird spotting in middle of month and cycle shorter with spotting before and after), PAIN IN EXTREMITY (Sever leg pain), MIGRAINE (migraine), POLYMENORRHOEA (Period got weird spotting in middle of month and cycle shorter with spotting before and after), PAIN (chronic pain getting worse) and FATIGUE (fatigue). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, TACHYCARDIA (tachycardia increased), VAGINAL HAEMORRHAGE (Period got weird spotting in middle of month and cycle shorter with spotting before and after), PAIN IN EXTREMITY (Sever leg pain), MIGRAINE (migraine), POLYMENORRHOEA (Period got weird spotting in middle of month and cycle shorter with spotting before and after), PAIN (chronic pain getting worse) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound scan: normal (normal) No blood clots were found..         Patient reported that she is on IUD.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia, Ultrasound scan, Vaginal haemorrhage
Clinical narrative: tachycardia increased; Period got weird spotting in middle of month and cycle shorter with spotting before and after; Sever leg pain; migraine; Period got weird spotting in middle of month and cycle shorter with spotting before and after; chronic pain getting worse; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (tachycardia increased), VAGINAL HAEMORRHAGE (Period got weird spotting in middle of month and cycle shorter with spotting before and after), PAIN IN EXTREMITY (Sever leg pain), MIGRAINE (migraine) and POLYMENORRHOEA (Period got weird spotting in middle of month and cycle shorter with spotting before and after) in a 39-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.     Concomitant products included LORATADINE for an unknown indication.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TACHYCARDIA (tachycardia increased), VAGINAL HAEMORRHAGE (Period got weird spotting in middle of month and cycle shorter with spotting before and after), PAIN IN EXTREMITY (Sever leg pain), MIGRAINE (migraine), POLYMENORRHOEA (Period got weird spotting in middle of month and cycle shorter with spotting before and after), PAIN (chronic pain getting worse) and FATIGUE (fatigue). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, TACHYCARDIA (tachycardia increased), VAGINAL HAEMORRHAGE (Period got weird spotting in middle of month and cycle shorter with spotting before and after), PAIN IN EXTREMITY (Sever leg pain), MIGRAINE (migraine), POLYMENORRHOEA (Period got weird spotting in middle of month and cycle shorter with spotting before and after), PAIN (chronic pain getting worse) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound scan: normal (normal) No blood clots were found..         Patient reported that she is on IUD.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Received the vaccine and has an active Covid-19 infection; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Received the vaccine and has an active Covid-19 infection) 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 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-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 COVID-19 (Received the vaccine and has an active Covid-19 infection). At the time of the report, COVID-19 (Received the vaccine and has an active Covid-19 infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drug details were reported. No treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: No second dose after 6 weeks; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (No second dose after 6 weeks) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (No second dose after 6 weeks). At the time of the report, PRODUCT DOSE OMISSION ISSUE (No second dose after 6 weeks) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing was delayed on an unknown date.       No concomitant product was provided by the reporter.  No treatment medication was provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache
Clinical narrative: Chemo fog (brain fog) months later; Headache; 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 FEELING ABNORMAL (Chemo fog (brain fog) months later) and HEADACHE (Headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Chemo fog (brain fog) months later) and HEADACHE (Headache). At the time of the report, FEELING ABNORMAL (Chemo fog (brain fog) months later) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were not reported. The treatment information was not provided.    This case was linked to MOD-2021-295786 (Patient Link).
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: wife had tinnitus 1 month after had Moderna Covid-19 Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (wife had tinnitus 1 month after had Moderna Covid-19 Vaccine) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced TINNITUS (wife had tinnitus 1 month after had Moderna Covid-19 Vaccine). At the time of the report, TINNITUS (wife had tinnitus 1 month after had Moderna Covid-19 Vaccine) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported.  On 10-Mar-2021 patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) in unknown route with batch no. 031M20A.  Patient reported that she developed tinnitus 1 month and a half after getting the vaccine and that she's still having it. she first noticed it between 18 Mar 2021 - 21 Mar 2021.   Most recent FOLLOW-UP information incorporated above includes: On 27-Aug-2021: Follow up received contains Vaccine information.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Body temperature, Induration, Peripheral swelling, Pruritus
Clinical narrative: Fever; arm was swollen/ the  swelling is spreading around the arm; arm was hard underneath; Below injection site above elbow she developed a blister that itches; blister that itches; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm was swollen/ the  swelling is spreading around the arm), INDURATION (arm was hard underneath), BLISTER (Below injection site above elbow she developed a blister that itches), PRURITUS (blister that itches) and PYREXIA (Fever) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Aug-2021, the patient experienced PERIPHERAL SWELLING (arm was swollen/ the  swelling is spreading around the arm), INDURATION (arm was hard underneath), BLISTER (Below injection site above elbow she developed a blister that itches) and PRURITUS (blister that itches). On 22-Aug-2021, the patient experienced PYREXIA (Fever). On 23-Aug-2021, PYREXIA (Fever) had resolved. At the time of the report, PERIPHERAL SWELLING (arm was swollen/ the  swelling is spreading around the arm), INDURATION (arm was hard underneath), BLISTER (Below injection site above elbow she developed a blister that itches) and PRURITUS (blister that itches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Aug-2021, Body temperature: 100.4 (High) Fever-100.4F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment was not provided.  Pharmacist suggested patient a cold pack and Benadryl.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; arm was swollen/ the  swelling is spreading around the arm; arm was hard underneath; Below injection site above elbow she developed a blister that itches; blister that itches; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm was swollen/ the  swelling is spreading around the arm), INDURATION (arm was hard underneath), BLISTER (Below injection site above elbow she developed a blister that itches), PRURITUS (blister that itches) and PYREXIA (Fever) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Aug-2021, the patient experienced PERIPHERAL SWELLING (arm was swollen/ the  swelling is spreading around the arm), INDURATION (arm was hard underneath), BLISTER (Below injection site above elbow she developed a blister that itches) and PRURITUS (blister that itches). On 22-Aug-2021, the patient experienced PYREXIA (Fever). On 23-Aug-2021, PYREXIA (Fever) had resolved. At the time of the report, PERIPHERAL SWELLING (arm was swollen/ the  swelling is spreading around the arm), INDURATION (arm was hard underneath), BLISTER (Below injection site above elbow she developed a blister that itches) and PRURITUS (blister that itches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Aug-2021, Body temperature: 100.4 (High) Fever-100.4F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment was not provided.  Pharmacist suggested patient a cold pack and Benadryl.