chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Body temperature, Feeling abnormal, Myalgia, Productive cough
Clinical narrative: Sound on her right ear has become unbearable and it never goes away; Productive cough (dark yellow sputum); Making her crazy; Little fever (99 something - her normal temperature is 97); Body aches; This spontaneous case was reported by an other health care professional and describes the occurrence of TINNITUS (Sound on her right ear has become unbearable and it never goes away), PRODUCTIVE COUGH (Productive cough (dark yellow sputum)), FEELING ABNORMAL (Making her crazy), PYREXIA (Little fever (99 something - her normal temperature is 97)) and MYALGIA (Body aches) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 020B21A) for COVID-19 vaccination.     The patient's past medical history included Hay fever, Fibromyalgia, Biliary colic (Gallbladder attack) in 2009 and Pancreatitis (For which she was admitted in the ICU). Concurrent medical conditions included Type 1 diabetes mellitus (at 65 years old) since 2019 and Osteoarthritis. 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. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced TINNITUS (Sound on her right ear has become unbearable and it never goes away), PRODUCTIVE COUGH (Productive cough (dark yellow sputum)), FEELING ABNORMAL (Making her crazy), PYREXIA (Little fever (99 something - her normal temperature is 97)) and MYALGIA (Body aches). At the time of the report, TINNITUS (Sound on her right ear has become unbearable and it never goes away), PRODUCTIVE COUGH (Productive cough (dark yellow sputum)), FEELING ABNORMAL (Making her crazy), PYREXIA (Little fever (99 something - her normal temperature is 97)) and MYALGIA (Body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 99 something (High) Her normal temperature is 97. On an unknown date, Blood test: abnormal (abnormal) Pancreas  not producing insulin.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.   This case was linked to MOD-2021-295816 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tinnitus
Clinical narrative: Sound on her right ear has become unbearable and it never goes away; Productive cough (dark yellow sputum); Making her crazy; Little fever (99 something - her normal temperature is 97); Body aches; This spontaneous case was reported by an other health care professional and describes the occurrence of TINNITUS (Sound on her right ear has become unbearable and it never goes away), PRODUCTIVE COUGH (Productive cough (dark yellow sputum)), FEELING ABNORMAL (Making her crazy), PYREXIA (Little fever (99 something - her normal temperature is 97)) and MYALGIA (Body aches) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 020B21A) for COVID-19 vaccination.     The patient's past medical history included Hay fever, Fibromyalgia, Biliary colic (Gallbladder attack) in 2009 and Pancreatitis (For which she was admitted in the ICU). Concurrent medical conditions included Type 1 diabetes mellitus (at 65 years old) since 2019 and Osteoarthritis. 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. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced TINNITUS (Sound on her right ear has become unbearable and it never goes away), PRODUCTIVE COUGH (Productive cough (dark yellow sputum)), FEELING ABNORMAL (Making her crazy), PYREXIA (Little fever (99 something - her normal temperature is 97)) and MYALGIA (Body aches). At the time of the report, TINNITUS (Sound on her right ear has become unbearable and it never goes away), PRODUCTIVE COUGH (Productive cough (dark yellow sputum)), FEELING ABNORMAL (Making her crazy), PYREXIA (Little fever (99 something - her normal temperature is 97)) and MYALGIA (Body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 99 something (High) Her normal temperature is 97. On an unknown date, Blood test: abnormal (abnormal) Pancreas  not producing insulin.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.   This case was linked to MOD-2021-295816 (Patient Link).
Age: 40.0
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Urine abnormality
Clinical narrative: back hurts; pee with foam; chest hurts; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back hurts), URINE ABNORMALITY (pee with foam) and CHEST PAIN (chest hurts) in a 40-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.    On 05-Aug-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 BACK PAIN (back hurts), URINE ABNORMALITY (pee with foam) and CHEST PAIN (chest hurts). At the time of the report, BACK PAIN (back hurts), URINE ABNORMALITY (pee with foam) and CHEST PAIN (chest hurts) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drugs provided. Treatment medications was not reported. Requested for follow-up due to incomplete details of the patient.
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: 7 case pairs (more than one person in household) of tinnitus; 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 TINNITUS (7 case pairs (more than one person in household) of tinnitus) 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 TINNITUS (7 case pairs (more than one person in household) of tinnitus). At the time of the report, TINNITUS (7 case pairs (more than one person in household) of tinnitus) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 31-Aug-2021: ADR form received- No new information
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Exercise tolerance decreased, Mobility decreased
Clinical narrative: The day after receiving 1st dose, he noticed that his back started hurting.; He hasn't been doing any physical exercise which he had been doing in past because of back pain that started after receiving 1st dose; He feels very limited doing physical activity because of back pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (The day after receiving 1st dose, he noticed that his back started hurting.), EXERCISE TOLERANCE DECREASED (He hasn't been doing any physical exercise which he had been doing in past because of back pain that started after receiving 1st dose) and MOBILITY DECREASED (He feels very limited doing physical activity because of back pain) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In July 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced BACK PAIN (The day after receiving 1st dose, he noticed that his back started hurting.), EXERCISE TOLERANCE DECREASED (He hasn't been doing any physical exercise which he had been doing in past because of back pain that started after receiving 1st dose) and MOBILITY DECREASED (He feels very limited doing physical activity because of back pain). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, BACK PAIN (The day after receiving 1st dose, he noticed that his back started hurting.), EXERCISE TOLERANCE DECREASED (He hasn't been doing any physical exercise which he had been doing in past because of back pain that started after receiving 1st dose) and MOBILITY DECREASED (He feels very limited doing physical activity because of back pain) outcome was unknown.            No concomitant medication provided. The day after receiving 1st dose, patient started to  hurt his back. Patient took 2nd dose on 10Aug2021 on his right arm.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Missed second dose, 6 months after first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed second dose, 6 months after first dose) in a male 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.    In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose, 6 months after first dose). On 25-Aug-2021, PRODUCT DOSE OMISSION ISSUE (Missed second dose, 6 months after first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient received the first dose of Moderna COVID-19 vaccine 6 months ago. Relevant concomitant medications were not provided by the reporter. Treatment medication was not reported.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: dose administered from a vial at room temperature for greater then 24 hours; dose administered from a vial at room temperature for greater then 24 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (dose administered from a vial at room temperature for greater then 24 hours) and EXPIRED PRODUCT ADMINISTERED (dose administered from a vial at room temperature for greater then 24 hours) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (dose administered from a vial at room temperature for greater then 24 hours) and EXPIRED PRODUCT ADMINISTERED (dose administered from a vial at room temperature for greater then 24 hours). At the time of the report, PRODUCT STORAGE ERROR (dose administered from a vial at room temperature for greater then 24 hours) outcome was unknown and EXPIRED PRODUCT ADMINISTERED (dose administered from a vial at room temperature for greater then 24 hours) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication was reported.  2 doses administered. # of doses and vials: 2 doses given from 1 vial  Total amount of time vial exposed to room temperature range (8-25 C or 46-77 F): Room temperature for greater then 24 hours. Approximately 24Aug2021 10:30AM to 25Aug2021 12:45pm date and time of dose administration.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Gait disturbance, Headache, Mobility decreased
Clinical narrative: painful breathing; fatigue / tired; whole body hurts; can't lift anything; can hardly walk; right arm hurts at injection site; feeling sluggish; light headaches; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (painful breathing), FATIGUE (fatigue / tired), PAIN (whole body hurts), MOBILITY DECREASED (can't lift anything) and GAIT DISTURBANCE (can hardly walk) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033C21A and 022C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure and Thyroid disorder.   On 25-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Aug-2021, the patient experienced DYSPNOEA (painful breathing), FATIGUE (fatigue / tired), PAIN (whole body hurts), MOBILITY DECREASED (can't lift anything), GAIT DISTURBANCE (can hardly walk), VACCINATION SITE PAIN (right arm hurts at injection site), SLUGGISHNESS (feeling sluggish) and HEADACHE (light headaches). At the time of the report, DYSPNOEA (painful breathing), FATIGUE (fatigue / tired), PAIN (whole body hurts), MOBILITY DECREASED (can't lift anything), GAIT DISTURBANCE (can hardly walk), VACCINATION SITE PAIN (right arm hurts at injection site), SLUGGISHNESS (feeling sluggish) and HEADACHE (light headaches) outcome was unknown.            No concomitant medication was mentioned. No treatment medication was mentioned.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Sluggishness, Vaccination site pain
Clinical narrative: painful breathing; fatigue / tired; whole body hurts; can't lift anything; can hardly walk; right arm hurts at injection site; feeling sluggish; light headaches; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (painful breathing), FATIGUE (fatigue / tired), PAIN (whole body hurts), MOBILITY DECREASED (can't lift anything) and GAIT DISTURBANCE (can hardly walk) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033C21A and 022C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure and Thyroid disorder.   On 25-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Aug-2021, the patient experienced DYSPNOEA (painful breathing), FATIGUE (fatigue / tired), PAIN (whole body hurts), MOBILITY DECREASED (can't lift anything), GAIT DISTURBANCE (can hardly walk), VACCINATION SITE PAIN (right arm hurts at injection site), SLUGGISHNESS (feeling sluggish) and HEADACHE (light headaches). At the time of the report, DYSPNOEA (painful breathing), FATIGUE (fatigue / tired), PAIN (whole body hurts), MOBILITY DECREASED (can't lift anything), GAIT DISTURBANCE (can hardly walk), VACCINATION SITE PAIN (right arm hurts at injection site), SLUGGISHNESS (feeling sluggish) and HEADACHE (light headaches) outcome was unknown.            No concomitant medication was mentioned. No treatment medication was mentioned.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Nausea, Vomiting
Clinical narrative: nausea; vomiting; severely tired; achy joints; This spontaneous case was reported by a pharmacist and describes the occurrence of NAUSEA (nausea), VOMITING (vomiting), FATIGUE (severely tired) and ARTHRALGIA (achy joints) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NAUSEA (nausea), VOMITING (vomiting), FATIGUE (severely tired) and ARTHRALGIA (achy joints). At the time of the report, NAUSEA (nausea), VOMITING (vomiting), FATIGUE (severely tired) and ARTHRALGIA (achy joints) 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 was not provided.  Treatment information was not provided.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Pyrexia
Clinical narrative: Sweats; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweats), CHILLS (Chills) and PYREXIA (Fever) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Relapsing multiple sclerosis. Concomitant products included OCRELIZUMAB (OCREVUS) for an unknown indication.    On 15-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Aug-2021, the patient experienced HYPERHIDROSIS (Sweats), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, HYPERHIDROSIS (Sweats), CHILLS (Chills) and PYREXIA (Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications were not reported.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Illness, Pyrexia
Clinical narrative: Got sick for a day; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got sick for a day), PYREXIA (Fever) and CHILLS (Chills) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21A and 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced ILLNESS (Got sick for a day), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, ILLNESS (Got sick for a day), PYREXIA (Fever) and CHILLS (Chills) had resolved.            No relevant concomitant medications were reported. The patient took lot of fluids as treatment.   This case was linked to US-MODERNATX, INC.-MOD-2021-296473 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-296473:Cross linked case
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: It's been 5 months since my first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (It's been 5 months since my first vaccine) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (It's been 5 months since my first vaccine). On 25-Mar-2021, PRODUCT DOSE OMISSION ISSUE (It's been 5 months since my first vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Aug-2021: Significant follow up appended. Which includes First dose start date added and new event is updated i.e.,  It's been 5 months since my first vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: slight rash where I got my vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (slight rash where I got my vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (slight rash where I got my vaccine). At the time of the report, VACCINATION SITE RASH (slight rash where I got my vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided by the reporter  No treatment medication were provided by the reporter   Reporter did not allow further contact
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site pruritus
Clinical narrative: has diffuse pruritus on both arms and one leg; local itching pruritus at the injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Aug-2021 and was forwarded to Moderna on 26-Aug-2021.    This spontaneous case was reported by a physician and describes the occurrence of PRURITUS (has diffuse pruritus on both arms and one leg) and VACCINATION SITE PRURITUS (local itching pruritus at the injection site) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Hypercholesteraemia.   On 13-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced VACCINATION SITE PRURITUS (local itching pruritus at the injection site). On 26-Aug-2021, the patient experienced PRURITUS (has diffuse pruritus on both arms and one leg). At the time of the report, PRURITUS (has diffuse pruritus on both arms and one leg) and VACCINATION SITE PRURITUS (local itching pruritus at the injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient reported anti-hypertensive medications as concomitant medication.  other treatment medication Claritin 10 mg orally for unknown indication.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Eye disorder, Eye swelling, Lip disorder, Lip swelling, Pharyngeal swelling
Clinical narrative: knots in my bottom lip and top lip; Eyes swelled up; Eyes popped out; Lips swelled up; Throat swelled out; This spontaneous case was reported by a consumer and describes the occurrence of LIP DISORDER (knots in my bottom lip and top lip), EYE SWELLING (Eyes swelled up), EYE DISORDER (Eyes popped out), LIP SWELLING (Lips swelled up) and PHARYNGEAL SWELLING (Throat swelled out) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043D21A and 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced LIP DISORDER (knots in my bottom lip and top lip), EYE SWELLING (Eyes swelled up), EYE DISORDER (Eyes popped out), LIP SWELLING (Lips swelled up) and PHARYNGEAL SWELLING (Throat swelled out). The patient was treated with EPINEPHRINE (intravenous) for Adverse event, at an unspecified dose and frequency. At the time of the report, LIP DISORDER (knots in my bottom lip and top lip), EYE SWELLING (Eyes swelled up), EYE DISORDER (Eyes popped out), LIP SWELLING (Lips swelled up) and PHARYNGEAL SWELLING (Throat swelled out) outcome was unknown.            Concomitant product was not provided by the reporter.   This case was linked to MOD-2021-297314 (Patient Link).
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore injection site arm) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Sore injection site arm). At the time of the report, VACCINATION SITE PAIN (Sore injection site arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The treatment history was not reported. The concomitant medication was not reported.   This case was linked to MOD-2021-297493, MOD-2021-297494 (Patient Link).
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose was given at 13 hours post puncture expiration (vial had been punctured at 10:30 AM on 25/Aug/2021); This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose was given at 13 hours post puncture expiration (vial had been punctured at 10:30 AM on 25/Aug/2021)) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A, 031B21A and 003F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Aug-2021 at 11:30 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose was given at 13 hours post puncture expiration (vial had been punctured at 10:30 AM on 25/Aug/2021)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose was given at 13 hours post puncture expiration (vial had been punctured at 10:30 AM on 25/Aug/2021)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were provided by the reporter. No treatment medication were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 26-Aug-2021: Follow-up received and included suspect dose details updated and updated narrative.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccinated with the expired vaccine for their 2nd doses; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccinated with the expired vaccine for their 2nd doses) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Aug-2021 at 10:16 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccinated with the expired vaccine for their 2nd doses). On 26-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Vaccinated with the expired vaccine for their 2nd doses) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided. No treatment medications were provided.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; This spontaneous case was reported by a nurse and describes the occurrence of FATIGUE (Fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In February 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 FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) for Fatigue, at an unspecified dose and frequency. At the time of the report, FATIGUE (Fatigue) 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 provided by the reporter.   This case was linked to MOD-2021-297796 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness in the injection site; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness in the injection site) 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 VACCINATION SITE PAIN (soreness in the injection site). At the time of the report, VACCINATION SITE PAIN (soreness in the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reported that Adverse Event is getting worse  Concomitant product was not provided by the reporter  Treatment information was not provided   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: Sore throat common; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat common) 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 OROPHARYNGEAL PAIN (Sore throat common). At the time of the report, OROPHARYNGEAL PAIN (Sore throat common) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported No Treatment information was reported   Reporter did not allow further contact
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Extreme Hair loss/bad hair loss; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Extreme Hair loss/bad hair loss) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) 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) (Intramuscular) .5 milliliter. On 25-Jan-2021, the patient experienced ALOPECIA (Extreme Hair loss/bad hair loss) (seriousness criterion hospitalization). At the time of the report, ALOPECIA (Extreme Hair loss/bad hair loss) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant product use was not provided by the reporter.   A week after receiving first dose, patient began to fall out in big clumps. Patient once had long thick hair, 8 months later her hair was so bald. Patient had to wear a wig. It came out in clumps of hair which had never happened in her life. On 16-Feb-2021, received second dose.  No treatment information was provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Significant follow up - verbatam added; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Ill-defined disorder, Product administered to patient of inappropriate age
Clinical narrative: medical condition; 17 year old given vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of ILL-DEFINED DISORDER (medical condition) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009A21A and 038C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jun-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old given vaccine.). On an unknown date, the patient experienced ILL-DEFINED DISORDER (medical condition) (seriousness criterion hospitalization). On 05-Jul-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old given vaccine.) had resolved. At the time of the report, ILL-DEFINED DISORDER (medical condition) outcome was unknown.            Concomitant product use was not provided by the reporter. No treatment information was provided.  This report refers to a case of product administered to patient of inappropriate age for mRNA-1273 (lot 009A21A and 038C21A) with associated unspecified adverse event.  Very limited information regarding this event has been provided at this time. Further information regarding temporal association and indication for Hospitalization is necessary to assess causality.; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273 (lot 009A21A and 038C21A) with associated unspecified adverse event.  Very limited information regarding this event has been provided at this time. Further information regarding temporal association and indication for Hospitalization is necessary to assess causality.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Fluid retention, Heart valve incompetence, Pneumonia, Product dose omission issue
Clinical narrative: liquid retention on the right leg; aortic valvle replacement. 2nd process, because of a "leaking valvle; difficult breathing. He was admited in ER.; pneumonia; He never get the 2nd dose of Moderna.; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (pneumonia), DYSPNOEA (difficult breathing. He was admited in ER.), HEART VALVE INCOMPETENCE (aortic valvle replacement. 2nd process, because of a "leaking valvle) and FLUID RETENTION (liquid retention on the right leg) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pneumonia, Thoracic cavity drainage on 04-Mar-2021 and Aortic valve replacement (Replacement 2nd process, because of leaking valve) on 29-Mar-2021.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced DYSPNOEA (difficult breathing. He was admited in ER.) (seriousness criterion hospitalization). On 29-Mar-2021, the patient experienced HEART VALVE INCOMPETENCE (aortic valvle replacement. 2nd process, because of a "leaking valvle) (seriousness criterion hospitalization). In 2021, the patient experienced PNEUMONIA (pneumonia) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced FLUID RETENTION (liquid retention on the right leg) (seriousness criterion hospitalization) and PRODUCT DOSE OMISSION ISSUE (He never get the 2nd dose of Moderna.). At the time of the report, PNEUMONIA (pneumonia), DYSPNOEA (difficult breathing. He was admited in ER.), HEART VALVE INCOMPETENCE (aortic valvle replacement. 2nd process, because of a "leaking valvle) and FLUID RETENTION (liquid retention on the right leg) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (He never get the 2nd dose of Moderna.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment medications were not reported.  On 4 March2021 Doctor performed a thoracic drainage,On 29 march patient went to the hospital for aortic valve replacement 2nd process, because of leaking valve and patient suffered with liquid retention on the right leg.  Company Comment  This is a case of Product dose omission of a 75 year old male patient. Very limited information regarding the events have been provided at this time. Patient's history of Pneumonia may be a confounding factor. Further information has been requested.; Sender's Comments: This is a case of Product dose omission of a 75 year old male patient. Very limited information regarding the events have been provided at this time. Patient's history of Pneumonia may be a confounding factor. Further information has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome, Spinal X-ray
Clinical narrative: Guillain-Barre syndrome/spinal test that was positive for Guillan-Barre syndrome; This spontaneous case was reported by a consumer and describes the occurrence of GUILLAIN-BARRE SYNDROME (Guillain-Barre syndrome/spinal test that was positive for Guillan-Barre syndrome) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 046A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-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 GUILLAIN-BARRE SYNDROME (Guillain-Barre syndrome/spinal test that was positive for Guillan-Barre syndrome) (seriousness criterion medically significant). At the time of the report, GUILLAIN-BARRE SYNDROME (Guillain-Barre syndrome/spinal test that was positive for Guillan-Barre syndrome) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Spinal X-ray: positive (Positive) positive for Guillain-Barre syndrome.         No concomitant medications information was reported. No treatment medications were provided.  Company Comment: This report refers to a case of  Guillan-Barre syndrome in a 60-year old female which developed after vaccinating with second dose of mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This report refers to a case of  Guillan-Barre syndrome in a 60-year old female which developed after vaccinating with second dose of mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Muscle spasms, Myalgia, Pain in extremity, Peripheral swelling
Clinical narrative: Confirmed a blood clot in the left leg; Like a "Charlie Horse"; left leg started to feel pain; Left leg swelled; Left leg got hot; Soreness on the left calf muscle/like a sore muscle; This spontaneous case was reported by a nurse and describes the occurrence of THROMBOSIS (Confirmed a blood clot in the left leg) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Aug-2021, the patient experienced MUSCLE SPASMS (Like a "Charlie Horse"), PAIN IN EXTREMITY (left leg started to feel pain), PERIPHERAL SWELLING (Left leg swelled), FEELING HOT (Left leg got hot) and MYALGIA (Soreness on the left calf muscle/like a sore muscle). On 28-Aug-2021, the patient experienced THROMBOSIS (Confirmed a blood clot in the left leg) (seriousness criterion medically significant). The patient was treated with RIVAROXABAN (XARELTO) for Clot blood, at an unspecified dose and frequency. At the time of the report, THROMBOSIS (Confirmed a blood clot in the left leg), MUSCLE SPASMS (Like a "Charlie Horse"), PAIN IN EXTREMITY (left leg started to feel pain), PERIPHERAL SWELLING (Left leg swelled), FEELING HOT (Left leg got hot) and MYALGIA (Soreness on the left calf muscle/like a sore muscle) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Aug-2021, Ultrasound Doppler: abnormal (abnormal) Confirmed a blood clot in the left leg.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Relevant concomitant medication was reported as birth control pills. She went to see her physician on 28-Aug-2021, and her doctor performed a Doppler test and test confirmed a blood clot in the left leg. She was prescribed Xarelto and will need to take the medication for three months. Company comment: 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. However, 7 months since the second dose and birth control pills as concomitant medication could be confounders for the events. Further information has been requested.   This case was linked to MOD-2021-003812 (Patient Link).; 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. However, 7 months since the second dose and birth control pills as concomitant medication could be confounders for the events. Further information has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis, Ultrasound Doppler
Clinical narrative: Confirmed a blood clot in the left leg; Like a "Charlie Horse"; left leg started to feel pain; Left leg swelled; Left leg got hot; Soreness on the left calf muscle/like a sore muscle; This spontaneous case was reported by a nurse and describes the occurrence of THROMBOSIS (Confirmed a blood clot in the left leg) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Aug-2021, the patient experienced MUSCLE SPASMS (Like a "Charlie Horse"), PAIN IN EXTREMITY (left leg started to feel pain), PERIPHERAL SWELLING (Left leg swelled), FEELING HOT (Left leg got hot) and MYALGIA (Soreness on the left calf muscle/like a sore muscle). On 28-Aug-2021, the patient experienced THROMBOSIS (Confirmed a blood clot in the left leg) (seriousness criterion medically significant). The patient was treated with RIVAROXABAN (XARELTO) for Clot blood, at an unspecified dose and frequency. At the time of the report, THROMBOSIS (Confirmed a blood clot in the left leg), MUSCLE SPASMS (Like a "Charlie Horse"), PAIN IN EXTREMITY (left leg started to feel pain), PERIPHERAL SWELLING (Left leg swelled), FEELING HOT (Left leg got hot) and MYALGIA (Soreness on the left calf muscle/like a sore muscle) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Aug-2021, Ultrasound Doppler: abnormal (abnormal) Confirmed a blood clot in the left leg.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Relevant concomitant medication was reported as birth control pills. She went to see her physician on 28-Aug-2021, and her doctor performed a Doppler test and test confirmed a blood clot in the left leg. She was prescribed Xarelto and will need to take the medication for three months. Company comment: 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. However, 7 months since the second dose and birth control pills as concomitant medication could be confounders for the events. Further information has been requested.   This case was linked to MOD-2021-003812 (Patient Link).; 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. However, 7 months since the second dose and birth control pills as concomitant medication could be confounders for the events. Further information has been requested.