chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Limb discomfort, Muscular weakness, Pain in extremity, Tinnitus
Clinical narrative: ringing in both ears; experiencing pain in his injection site shoulder/ get sharp pain when trying to lift my arm/Joint pain; difficult to move arm; arm weak; I would get sharp pain when trying to lift my arm; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (difficult to move arm), MUSCULAR WEAKNESS (arm weak), PAIN IN EXTREMITY (I would get sharp pain when trying to lift my arm), TINNITUS (ringing in both ears) and ARTHRALGIA (experiencing pain in his injection site shoulder/ get sharp pain when trying to lift my arm/Joint pain) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced LIMB DISCOMFORT (difficult to move arm), MUSCULAR WEAKNESS (arm weak), PAIN IN EXTREMITY (I would get sharp pain when trying to lift my arm) and ARTHRALGIA (experiencing pain in his injection site shoulder/ get sharp pain when trying to lift my arm/Joint pain). On 13-Apr-2021, the patient experienced TINNITUS (ringing in both ears). At the time of the report, LIMB DISCOMFORT (difficult to move arm), MUSCULAR WEAKNESS (arm weak) and PAIN IN EXTREMITY (I would get sharp pain when trying to lift my arm) outcome was unknown and TINNITUS (ringing in both ears) and ARTHRALGIA (experiencing pain in his injection site shoulder/ get sharp pain when trying to lift my arm/Joint pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Significant follow-up appended into AER MOD-2021-073879 On 13-May-2021: Non-significant follow up accepted on 14-05-2021 :- Email id updated for the reporter
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Nasal congestion, Product dose omission issue, Pyrexia
Clinical narrative: Stuffy Nose (A Little); Cough; Fever; Missed dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NASAL CONGESTION (Stuffy Nose (A Little)), COUGH (Cough), PYREXIA (Fever) and PRODUCT DOSE OMISSION ISSUE (Missed dose) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included METHOTREXATE for Rheumatoid arthritis, AMLODIPINE and LISINOPRIL for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced NASAL CONGESTION (Stuffy Nose (A Little)), COUGH (Cough), PYREXIA (Fever) and PRODUCT DOSE OMISSION ISSUE (Missed dose). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of UNK, q6h, 2 tablets. On 12-Apr-2021, PRODUCT DOSE OMISSION ISSUE (Missed dose) had resolved. On 21-Apr-2021, COUGH (Cough) and PYREXIA (Fever) had resolved. At the time of the report, NASAL CONGESTION (Stuffy Nose (A Little)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: New events were added. On 27-Apr-2021: Patient demographic detail was updated, concomitant medications were added, treatment medication was added.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong patient received product
Clinical narrative: 16 year old daughter received the 1st dose of Moderna covid-19 vaccin; This spontaneous case was reported by a consumer and describes the occurrence of WRONG PATIENT RECEIVED PRODUCT (16 year old daughter received the 1st dose of Moderna covid-19 vaccin) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced WRONG PATIENT RECEIVED PRODUCT (16 year old daughter received the 1st dose of Moderna covid-19 vaccin). At the time of the report, WRONG PATIENT RECEIVED PRODUCT (16 year old daughter received the 1st dose of Moderna covid-19 vaccin) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications and treatment information were reported.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The patient's past medical history included No adverse event. Concurrent medical conditions included Pregnancy (Planning for pregnancy). Concomitant products included CYANOCOBALAMIN (VIT B 12) for an unknown indication. On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced RASH (rash). On 18-Mar-2021, RASH (rash) had resolved. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications reported. This case was linked to US-MODERNATX, INC.-MOD-2021-073893 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-073893:Crossed linked.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Eye irritation, Taste disorder
Clinical narrative: burning of the eyes; it taste like black pepper; This spontaneous case was reported by a consumer and describes the occurrence of EYE IRRITATION and TASTE DISORDER in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced EYE IRRITATION and TASTE DISORDER. On 02-Apr-2021, EYE IRRITATION had resolved. On 04-Apr-2021, TASTE DISORDER had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC-MOD-2021-073889. Sender's Comments:  US-MODERNATX, INC-MOD-2021-073889: Dose 2.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: low grade "fever 100.5"; "feeling tired"; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (low grade "fever 100.5") and FATIGUE ("feeling tired") in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included AMLODIPINE BESILATE (NORVAS), LEVOTHYROXINE SODIUM (SYNTHROID) and FLUOXETINE HYDROCHLORIDE (PROZAC) for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PYREXIA (low grade "fever 100.5") and FATIGUE ("feeling tired"). On 12-Mar-2021, PYREXIA (low grade "fever 100.5") and FATIGUE ("feeling tired") had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Body temperature;;100.5;The patient had a low-grade fever
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on thigh) and RASH (rash on leg) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 011A21A) for COVID-19 vaccination. No Medical History information was reported. On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced RASH (rash on thigh) and RASH (rash on leg). At the time of the report, RASH (rash on thigh) and RASH (rash on leg) outcome was unknown. Not Provided  No concomitant medication were provided. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Follow up contains no significant information.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness after the 1st dose; Lightheaded after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness after the 1st dose) and DIZZINESS (Lightheaded after the 1st dose) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027821a) for COVID-19 vaccination.     The patient's past medical history included Amputation and Phantom pain. Concomitant products included GABAPENTIN.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced DIZZINESS (Dizziness after the 1st dose) and DIZZINESS (Lightheaded after the 1st dose). At the time of the report, DIZZINESS (Dizziness after the 1st dose) and DIZZINESS (Lightheaded after the 1st dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  Concomitant products included blood thinner and gabapentin.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac discomfort, Dyspnoea, Fall, Hyperhidrosis, Palpitations
Clinical narrative: fell; Breathing issues; Heart palpitations; Pressure in the heart; Vision is blurry; Problems with sweating; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (Breathing issues), PALPITATIONS (Heart palpitations), CARDIAC DISCOMFORT (Pressure in the heart), VISION BLURRED (Vision is blurry) and HYPERHIDROSIS (Problems with sweating) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history.).    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced DYSPNOEA (Breathing issues), PALPITATIONS (Heart palpitations), CARDIAC DISCOMFORT (Pressure in the heart), VISION BLURRED (Vision is blurry) and HYPERHIDROSIS (Problems with sweating). On an unknown date, the patient experienced FALL (fell). At the time of the report, DYSPNOEA (Breathing issues), PALPITATIONS (Heart palpitations), CARDIAC DISCOMFORT (Pressure in the heart), VISION BLURRED (Vision is blurry), HYPERHIDROSIS (Problems with sweating) and FALL (fell) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-073917 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-May-2021: NNI-non significant email response about FU
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: fell; Breathing issues; Heart palpitations; Pressure in the heart; Vision is blurry; Problems with sweating; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (Breathing issues), PALPITATIONS (Heart palpitations), CARDIAC DISCOMFORT (Pressure in the heart), VISION BLURRED (Vision is blurry) and HYPERHIDROSIS (Problems with sweating) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history.).    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced DYSPNOEA (Breathing issues), PALPITATIONS (Heart palpitations), CARDIAC DISCOMFORT (Pressure in the heart), VISION BLURRED (Vision is blurry) and HYPERHIDROSIS (Problems with sweating). On an unknown date, the patient experienced FALL (fell). At the time of the report, DYSPNOEA (Breathing issues), PALPITATIONS (Heart palpitations), CARDIAC DISCOMFORT (Pressure in the heart), VISION BLURRED (Vision is blurry), HYPERHIDROSIS (Problems with sweating) and FALL (fell) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-073917 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-May-2021: NNI-non significant email response about FU
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pain in extremity, Pregnancy test
Clinical narrative: sore arm; pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnant) and PAIN IN EXTREMITY (sore arm) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 027B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 22-Dec-2020 and the estimated date of delivery was 28-Sep-2021. On 15-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnant). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  eleventh week of the pregnancy.  On 15-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (pregnant) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jan-2021, Pregnancy test: positive (Positive) positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Event- Sore arm  added outcome unknown
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: shaking of her legs / And it is very irritating; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TREMOR (shaking of her legs / And it is very irritating) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A or 027620A and 013M20A) for COVID-19 vaccination.     no medical history reported.    On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TREMOR (shaking of her legs / And it is very irritating). At the time of the report, TREMOR (shaking of her legs / And it is very irritating) outcome was unknown.            patient also received her Shingles vaccine on 12Mar2021. She visited her doctor (Neurologist) and was prescribed a Parkinson's medication. She stated, she will not take this Parkinson's' medicine.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Missed second dose within 35 days.; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed second dose within 35 days.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose within 35 days.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed second dose within 35 days.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Photosensitivity reaction
Clinical narrative: hot rash that expanded and now it went away except for the vaccination arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PHOTOSENSITIVITY REACTION (hot rash that expanded and now it went away except for the vaccination arm) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concurrent medical conditions included Pregnancy (The patient planning for pregnancy.). Concomitant products included CYANOCOBALAMIN (VIT B 12) for an unknown indication.    On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced PHOTOSENSITIVITY REACTION (hot rash that expanded and now it went away except for the vaccination arm). At the time of the report, PHOTOSENSITIVITY REACTION (hot rash that expanded and now it went away except for the vaccination arm) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-073882 (E2B Linked Report).; Sender's Comments:  MOD-2021-073882:Crossed linked
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Decreased appetite, Fatigue, Illness, Influenza virus test
Clinical narrative: I was really really ill; "I have no appetite, had no real meal since Thursday"(8Apr2021); Arm is still very sore; Very high fever, 103; "I just feel tired"/just washed out, just laid out"; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (I was really really ill), DECREASED APPETITE ("I have no appetite, had no real meal since Thursday"(8Apr2021)), PAIN IN EXTREMITY (Arm is still very sore), PYREXIA (Very high fever, 103) and FATIGUE ("I just feel tired"/just washed out, just laid out") in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 001B21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included AMLODIPINE BESILATE (NORVAS), LEVOTHYROXINE SODIUM (SYNTHROID) and FLUOXETINE HYDROCHLORIDE (PROZAC) for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced ILLNESS (I was really really ill), DECREASED APPETITE ("I have no appetite, had no real meal since Thursday"(8Apr2021)), PAIN IN EXTREMITY (Arm is still very sore), PYREXIA (Very high fever, 103) and FATIGUE ("I just feel tired"/just washed out, just laid out"). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, ILLNESS (I was really really ill), DECREASED APPETITE ("I have no appetite, had no real meal since Thursday"(8Apr2021)), PAIN IN EXTREMITY (Arm is still very sore), PYREXIA (Very high fever, 103) and FATIGUE ("I just feel tired"/just washed out, just laid out") had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Influenza virus test: negative (Negative) Tested negative for the Flu. On 08-Apr-2021, Body temperature: 103 (High) High Fever of 103.         The patient experienced very high fever, 103 and it knocked her to the knees. She stated that After three days she had only made it from the bed to the couch and the side effects are ongoing.  Action taken with mRNA-1273 in response to the events was not applicable.    This case was linked to MOD-2021-073884 (E2B Linked Report).; Sender's Comments:  MOD-2021-073884:First dose case
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: I was really really ill; "I have no appetite, had no real meal since Thursday"(8Apr2021); Arm is still very sore; Very high fever, 103; "I just feel tired"/just washed out, just laid out"; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (I was really really ill), DECREASED APPETITE ("I have no appetite, had no real meal since Thursday"(8Apr2021)), PAIN IN EXTREMITY (Arm is still very sore), PYREXIA (Very high fever, 103) and FATIGUE ("I just feel tired"/just washed out, just laid out") in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 001B21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included AMLODIPINE BESILATE (NORVAS), LEVOTHYROXINE SODIUM (SYNTHROID) and FLUOXETINE HYDROCHLORIDE (PROZAC) for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced ILLNESS (I was really really ill), DECREASED APPETITE ("I have no appetite, had no real meal since Thursday"(8Apr2021)), PAIN IN EXTREMITY (Arm is still very sore), PYREXIA (Very high fever, 103) and FATIGUE ("I just feel tired"/just washed out, just laid out"). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, ILLNESS (I was really really ill), DECREASED APPETITE ("I have no appetite, had no real meal since Thursday"(8Apr2021)), PAIN IN EXTREMITY (Arm is still very sore), PYREXIA (Very high fever, 103) and FATIGUE ("I just feel tired"/just washed out, just laid out") had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Influenza virus test: negative (Negative) Tested negative for the Flu. On 08-Apr-2021, Body temperature: 103 (High) High Fever of 103.         The patient experienced very high fever, 103 and it knocked her to the knees. She stated that After three days she had only made it from the bed to the couch and the side effects are ongoing.  Action taken with mRNA-1273 in response to the events was not applicable.    This case was linked to MOD-2021-073884 (E2B Linked Report).; Sender's Comments:  MOD-2021-073884:First dose case
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: TCR- Add outcome Recovered
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Fatigue, Hypokinesia, Vaccination site pain, Vaccination site pruritus
Clinical narrative: couldn't lay on her right side; stomach was upset but she didn't have nausea or vomiting; really tired; swelling of the size of a 50-cent piece spread out - injection site; Injection site itches; Pain in the injection site; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE PAIN (Pain in the injection site), VACCINATION SITE SWELLING (swelling of the size of a 50-cent piece spread out - injection site), FATIGUE (really tired), HYPOKINESIA (couldn't lay on her right side) and ABDOMINAL DISCOMFORT (stomach was upset but she didn't have nausea or vomiting) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00638B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Adrenocortical carcinoma. Concomitant products included CORTISONE for an unknown indication.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced VACCINATION SITE PAIN (Pain in the injection site). On 10-Apr-2021, the patient experienced VACCINATION SITE SWELLING (swelling of the size of a 50-cent piece spread out - injection site) and VACCINATION SITE PRURITUS (Injection site itches). On 11-Apr-2021, the patient experienced FATIGUE (really tired), HYPOKINESIA (couldn't lay on her right side) and ABDOMINAL DISCOMFORT (stomach was upset but she didn't have nausea or vomiting). At the time of the report, VACCINATION SITE PAIN (Pain in the injection site), VACCINATION SITE SWELLING (swelling of the size of a 50-cent piece spread out - injection site), FATIGUE (really tired), HYPOKINESIA (couldn't lay on her right side), ABDOMINAL DISCOMFORT (stomach was upset but she didn't have nausea or vomiting) and VACCINATION SITE PRURITUS (Injection site itches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Caller stated that treatment included Tylenol, calamine lotion, and massaging the injection site. Caller states that she is taking chemotherapy drugs for her adrenocortical carcinoma.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: couldn't lay on her right side; stomach was upset but she didn't have nausea or vomiting; really tired; swelling of the size of a 50-cent piece spread out - injection site; Injection site itches; Pain in the injection site; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE PAIN (Pain in the injection site), VACCINATION SITE SWELLING (swelling of the size of a 50-cent piece spread out - injection site), FATIGUE (really tired), HYPOKINESIA (couldn't lay on her right side) and ABDOMINAL DISCOMFORT (stomach was upset but she didn't have nausea or vomiting) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00638B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Adrenocortical carcinoma. Concomitant products included CORTISONE for an unknown indication.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced VACCINATION SITE PAIN (Pain in the injection site). On 10-Apr-2021, the patient experienced VACCINATION SITE SWELLING (swelling of the size of a 50-cent piece spread out - injection site) and VACCINATION SITE PRURITUS (Injection site itches). On 11-Apr-2021, the patient experienced FATIGUE (really tired), HYPOKINESIA (couldn't lay on her right side) and ABDOMINAL DISCOMFORT (stomach was upset but she didn't have nausea or vomiting). At the time of the report, VACCINATION SITE PAIN (Pain in the injection site), VACCINATION SITE SWELLING (swelling of the size of a 50-cent piece spread out - injection site), FATIGUE (really tired), HYPOKINESIA (couldn't lay on her right side), ABDOMINAL DISCOMFORT (stomach was upset but she didn't have nausea or vomiting) and VACCINATION SITE PRURITUS (Injection site itches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Caller stated that treatment included Tylenol, calamine lotion, and massaging the injection site. Caller states that she is taking chemotherapy drugs for her adrenocortical carcinoma.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Neck pain
Clinical narrative: pain in neck, shoulders and back; pain in neck, shoulders and back; pain in neck, shoulders and back; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (pain in neck, shoulders and back), ARTHRALGIA (pain in neck, shoulders and back) and BACK PAIN (pain in neck, shoulders and back) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026G21A and 032M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced NECK PAIN (pain in neck, shoulders and back), ARTHRALGIA (pain in neck, shoulders and back) and BACK PAIN (pain in neck, shoulders and back). At the time of the report, NECK PAIN (pain in neck, shoulders and back), ARTHRALGIA (pain in neck, shoulders and back) and BACK PAIN (pain in neck, shoulders and back) outcome was unknown. Not Provided          Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Non-significant follow up on 13-May-2021
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: back pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included LISINOPRIL, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and rheumatoid arthritis medicine for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2021, the patient experienced BACK PAIN (back pain). At the time of the report, BACK PAIN (back pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-073846 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-073846:Dose 1 of vaccine
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Carpal tunnel syndrome, Fatigue, Hypoaesthesia, Pain
Clinical narrative: Numbness in hand; Throbbing pain; Tingling feet/hands; Carpel Tunnel Syndrome; Pain in arm; Joint pain; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness in hand), PAIN (Throbbing pain), PARAESTHESIA (Tingling feet/hands), CARPAL TUNNEL SYNDROME (Carpel Tunnel Syndrome) and PAIN IN EXTREMITY (Pain in arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product IBUPROFEN (ADVIL 12 HOUR) for Adverse event.    No medical history was reported by the reporter.  Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) and PANTOPRAZOLE for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started IBUPROFEN (ADVIL 12 HOUR) (unknown route) at an unspecified dose. On an unknown date, the patient experienced HYPOAESTHESIA (Numbness in hand), PAIN (Throbbing pain), PARAESTHESIA (Tingling feet/hands), CARPAL TUNNEL SYNDROME (Carpel Tunnel Syndrome), PAIN IN EXTREMITY (Pain in arm), ARTHRALGIA (Joint pain) and FATIGUE (Tiredness). At the time of the report, HYPOAESTHESIA (Numbness in hand) had not resolved and PAIN (Throbbing pain), PARAESTHESIA (Tingling feet/hands), CARPAL TUNNEL SYNDROME (Carpel Tunnel Syndrome), PAIN IN EXTREMITY (Pain in arm), ARTHRALGIA (Joint pain) and FATIGUE (Tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-085423 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Significant follow up: Outcome of the event is ongoing. On 25-Jul-2021: Non-significant follow-up received on 25 Jul 2021.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Numbness in hand; Throbbing pain; Tingling feet/hands; Carpel Tunnel Syndrome; Pain in arm; Joint pain; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness in hand), PAIN (Throbbing pain), PARAESTHESIA (Tingling feet/hands), CARPAL TUNNEL SYNDROME (Carpel Tunnel Syndrome) and PAIN IN EXTREMITY (Pain in arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product IBUPROFEN (ADVIL 12 HOUR) for Adverse event.    No medical history was reported by the reporter.  Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) and PANTOPRAZOLE for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started IBUPROFEN (ADVIL 12 HOUR) (unknown route) at an unspecified dose. On an unknown date, the patient experienced HYPOAESTHESIA (Numbness in hand), PAIN (Throbbing pain), PARAESTHESIA (Tingling feet/hands), CARPAL TUNNEL SYNDROME (Carpel Tunnel Syndrome), PAIN IN EXTREMITY (Pain in arm), ARTHRALGIA (Joint pain) and FATIGUE (Tiredness). At the time of the report, HYPOAESTHESIA (Numbness in hand) had not resolved and PAIN (Throbbing pain), PARAESTHESIA (Tingling feet/hands), CARPAL TUNNEL SYNDROME (Carpel Tunnel Syndrome), PAIN IN EXTREMITY (Pain in arm), ARTHRALGIA (Joint pain) and FATIGUE (Tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-085423 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Significant follow up: Outcome of the event is ongoing. On 25-Jul-2021: Non-significant follow-up received on 25 Jul 2021.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Asthenia, Fatigue, Heart rate, Hyperhidrosis
Clinical narrative: felt beaten up; heart faster than normal; "Like anxiety attack"; sweatings; nausea; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (felt beaten up), PALPITATIONS (heart faster than normal), ANXIETY ("Like anxiety attack"), HYPERHIDROSIS (sweatings) and NAUSEA (nausea) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced ASTHENIA (felt beaten up), PALPITATIONS (heart faster than normal), ANXIETY ("Like anxiety attack"), NAUSEA (nausea) and FATIGUE (tiredness). 09-Apr-2021, the patient experienced HYPERHIDROSIS (sweatings). On 10-Apr-2021, NAUSEA (nausea) had resolved. At the time of the report, ASTHENIA (felt beaten up), PALPITATIONS (heart faster than normal), ANXIETY ("Like anxiety attack"), HYPERHIDROSIS (sweatings) and FATIGUE (tiredness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2021, Heart rate: faster heart beats per minute (High) faster.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications information was reported. No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: NNI FU- No new information
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Palpitations
Clinical narrative: felt beaten up; heart faster than normal; "Like anxiety attack"; sweatings; nausea; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (felt beaten up), PALPITATIONS (heart faster than normal), ANXIETY ("Like anxiety attack"), HYPERHIDROSIS (sweatings) and NAUSEA (nausea) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced ASTHENIA (felt beaten up), PALPITATIONS (heart faster than normal), ANXIETY ("Like anxiety attack"), NAUSEA (nausea) and FATIGUE (tiredness). 09-Apr-2021, the patient experienced HYPERHIDROSIS (sweatings). On 10-Apr-2021, NAUSEA (nausea) had resolved. At the time of the report, ASTHENIA (felt beaten up), PALPITATIONS (heart faster than normal), ANXIETY ("Like anxiety attack"), HYPERHIDROSIS (sweatings) and FATIGUE (tiredness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2021, Heart rate: faster heart beats per minute (High) faster.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications information was reported. No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: NNI FU- No new information
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 12 year old patient received 1st dose of COVID19 vaccine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Apr-2021 and was forwarded to Moderna on 12-Apr-2021.    This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old patient received 1st dose of COVID19 vaccine) in a 12-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Reporter details not available).    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old patient received 1st dose of COVID19 vaccine). On 12-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old patient received 1st dose of COVID19 vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Nurse accidentally administered the Moderna vaccine in a 12 year old patient. Safety can follow up with the nurse. Concomitant medications were not reported. Treatment details not provided   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Added VAER -  Patient demographics was added (race), Product details: Patient route of administration and anatomical location was added
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dizziness, Vomiting
Clinical narrative: coughing up flehm; throwing up; dizziness/light headed when stands; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (coughing up flehm), VOMITING (throwing up) and DIZZINESS (dizziness/light headed when stands) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (coughing up flehm), VOMITING (throwing up) and DIZZINESS (dizziness/light headed when stands). At the time of the report, COUGH (coughing up flehm), VOMITING (throwing up) and DIZZINESS (dizziness/light headed when stands) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were provided. No concomitant medications are listed. The Patient is scheduled to receive her second dose of Moderna Vaccine on 12Apr2021 at 3:00
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 year old received vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old received vaccine) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old received vaccine). On 23-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old received vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous
Clinical narrative: red rash on the bottom of her stomach; red rash has shown up in other parts of her body like her right side of her lower back, right side of her hip, backside, and two spots on her thighs; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red rash on the bottom of her stomach) and RASH (red rash has shown up in other parts of her body like her right side of her lower back, right side of her hip, backside, and two spots on her thighs) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 08-Apr-2021, the patient experienced RASH ERYTHEMATOUS (red rash on the bottom of her stomach) and RASH (red rash has shown up in other parts of her body like her right side of her lower back, right side of her hip, backside, and two spots on her thighs). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form; NAPROXEN SODIUM (ALEVE) at a dose of 1 dosage form and MICONAZOLE NITRATE (NEOSPORIN AF) at a dose of 1 dosage form. At the time of the report, RASH ERYTHEMATOUS (red rash on the bottom of her stomach) and RASH (red rash has shown up in other parts of her body like her right side of her lower back, right side of her hip, backside, and two spots on her thighs) had not resolved.            Action taken with mRNA1273 Moderna vaccine was Not Applicable  No concomitant medication was provided