chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Vaccination site erythema, Vaccination site pain
Clinical narrative: Redness, pain and warm to the touch around the IS; Redness, pain and warm to the touch around the IS; Redness, pain and warm to the touch around the IS; Tiredness; lLttle nausea feeling; Headache; A spontaneous report was received from a consumer concerning a 66-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced redness, pain and warm to the touch around is/ vaccination site erythema, redness, pain and warm to the touch around the is/ vaccination site pain, vaccination site warmth,headache, nausea, tiredness/fatigue.   The patient's medical history was not provided. No relevant concomitant medications were reported.  On 22Feb2021, approximately two days prior to the onset of  events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 043L20A) via intramuscular route  for prophylaxis of COVID-19 infection.  On 22Feb2021, the patient experienced the event(s) redness, pain and warm to the touch around the is/ vaccination site erythema, redness, pain and warm to the touch around the is/ vaccination site pain, vaccination site warmth, headache, nausea, tiredness/fatigue.  No treatment information was provided. The patient did not receive any treatment. Lab details were not provided.   Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of event(s), redness, pain and warm to the touch around  is/ vaccination site erythema, redness, pain and warm to the touch around the is/ vaccination site pain, vaccination site warmth, headache, nausea, tiredness/fatigue was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Redness, pain and warm to the touch around the IS; Redness, pain and warm to the touch around the IS; Redness, pain and warm to the touch around the IS; Tiredness; lLttle nausea feeling; Headache; A spontaneous report was received from a consumer concerning a 66-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced redness, pain and warm to the touch around is/ vaccination site erythema, redness, pain and warm to the touch around the is/ vaccination site pain, vaccination site warmth,headache, nausea, tiredness/fatigue.   The patient's medical history was not provided. No relevant concomitant medications were reported.  On 22Feb2021, approximately two days prior to the onset of  events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 043L20A) via intramuscular route  for prophylaxis of COVID-19 infection.  On 22Feb2021, the patient experienced the event(s) redness, pain and warm to the touch around the is/ vaccination site erythema, redness, pain and warm to the touch around the is/ vaccination site pain, vaccination site warmth, headache, nausea, tiredness/fatigue.  No treatment information was provided. The patient did not receive any treatment. Lab details were not provided.   Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of event(s), redness, pain and warm to the touch around  is/ vaccination site erythema, redness, pain and warm to the touch around the is/ vaccination site pain, vaccination site warmth, headache, nausea, tiredness/fatigue was unknown.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Diagnosed with positive COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Diagnosed with positive COVID-19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) 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 05-Feb-2021, the patient experienced COVID-19 (Diagnosed with positive COVID-19). At the time of the report, COVID-19 (Diagnosed with positive COVID-19) outcome was unknown.   DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) a few days after receiving the first dose of Moderna COVID-19 vaccine.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  No concomitant medications and treatment details were provided.   This case was linked to MOD-2021-023205, MOD-2021-022629, MOD-2021-022705, MOD-2021-022973 (E2B Linked Report).; Sender's Comments:  MOD-2021-023205:same reporter MOD-2021-022629:same reporter MOD-2021-022705:same reporter MOD-2021-022973:same reporter US-MODERNATX, INC.-MOD-2021-023205:
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm is sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm is sore) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm is sore). At the time of the report, PAIN IN EXTREMITY (arm is sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment medication included Motrin.
Sex: M
Vaccine: COVID19
Symptoms: Muscle strain, Myalgia
Clinical narrative: Pulled a muscle when out in the yard doing work; Hurts when he walks; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE STRAIN (Pulled a muscle when out in the yard doing work) and MYALGIA (Hurts when he walks) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Feb-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 24-Feb-2021, the patient experienced MUSCLE STRAIN (Pulled a muscle when out in the yard doing work) and MYALGIA (Hurts when he walks). At the time of the report, MUSCLE STRAIN (Pulled a muscle when out in the yard doing work) and MYALGIA (Hurts when he walks) outcome was unknown.            No concomitant product use was reported  No treatment information was provided   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: TCR received on 28-APR-2021 and does not any new information
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: redness at the injection site (size of a cookie)/Pancake-size less red are; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (redness at the injection site (size of a cookie)/Pancake-size less red are) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Cipro). Concomitant products included APIXABAN (ELIQUIS), DILTIAZEM HCL and FUROSEMIDE for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE ERYTHEMA (redness at the injection site (size of a cookie)/Pancake-size less red are). At the time of the report, VACCINATION SITE ERYTHEMA (redness at the injection site (size of a cookie)/Pancake-size less red are) had resolved.            Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Added patient demographics, concomitant drugs, updated the outcome of the event redness at the injection site from unknown to recovered
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hypertension, Peripheral swelling, Pyrexia
Clinical narrative: chills; pretty bad headache; elevated blood pressure; I had obviously the swollen arm, feverish arm; 101.7 fever for most of the day; A spontaneous report was received from a consumer concerning a 72-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hypertension (elevated blood pressure), peripheral swelling (swollen arm), pyrexia (101.7 fever), chills and headache.  The patient's medical history was not provided. Concomitant medications reported were diltiazem ER 180 mg for drug use for unknown indication.  On 19 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 025L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. On 19 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 010M20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 19 Feb 2021, the patient experienced swollen arm and feverish arm and also stated that she had elevated blood pressure and 101.7 fever. On 20 Feb 2021, the patient experienced pretty bad headache and chills.  Treatment details included Patient reports taking Tylenol for headache.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Illness, Oropharyngeal pain, Pain in extremity, Pyrexia
Clinical narrative: soreness at arm; woke up with fever 100.1 F.; scratchy throat; Sick; Sore throat, scratchy throat; cough; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick), OROPHARYNGEAL PAIN (Sore throat, scratchy throat), COUGH (cough), PAIN IN EXTREMITY (soreness at arm) and THROAT IRRITATION (scratchy throat) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced ILLNESS (Sick), OROPHARYNGEAL PAIN (Sore throat, scratchy throat), COUGH (cough) and THROAT IRRITATION (scratchy throat). On 23-Feb-2021, the patient experienced PAIN IN EXTREMITY (soreness at arm) and PYREXIA (woke up with fever 100.1 F.). At the time of the report, ILLNESS (Sick), OROPHARYNGEAL PAIN (Sore throat, scratchy throat), COUGH (cough), PAIN IN EXTREMITY (soreness at arm), THROAT IRRITATION (scratchy throat) and PYREXIA (woke up with fever 100.1 F.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information not provided.  Treatment information not provided.  Action taken with mRNA-1273 in response to the event/s was not applicable
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: soreness at arm; woke up with fever 100.1 F.; scratchy throat; Sick; Sore throat, scratchy throat; cough; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick), OROPHARYNGEAL PAIN (Sore throat, scratchy throat), COUGH (cough), PAIN IN EXTREMITY (soreness at arm) and THROAT IRRITATION (scratchy throat) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced ILLNESS (Sick), OROPHARYNGEAL PAIN (Sore throat, scratchy throat), COUGH (cough) and THROAT IRRITATION (scratchy throat). On 23-Feb-2021, the patient experienced PAIN IN EXTREMITY (soreness at arm) and PYREXIA (woke up with fever 100.1 F.). At the time of the report, ILLNESS (Sick), OROPHARYNGEAL PAIN (Sore throat, scratchy throat), COUGH (cough), PAIN IN EXTREMITY (soreness at arm), THROAT IRRITATION (scratchy throat) and PYREXIA (woke up with fever 100.1 F.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information not provided.  Treatment information not provided.  Action taken with mRNA-1273 in response to the event/s was not applicable
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Myalgia, Pain in extremity, Poor quality sleep
Clinical narrative: I was having migraines all nightmigraine; body ache; arm hurts a little bit; couldnt sleep well last night; A spontaneous report was received from a healthcare professional concerning a 70-years-old  female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Migraine (having migraines all night), Myalgia ( body ache), Pain in extremities (arm hurts a little bit) and Poor quality sleep (couldn't sleep well last night).  The patient's medical history was not provided. Concomitant medications reported were Amitriptyline, Sumatriptan for unknown indication.  On 22 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 031L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 22 Feb 2021, the patient stated experiencing that her arm hurts a little bit and was having migraines all night, had body aches and she couldn't sleep well last night.  Treatment details included None.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events was reported to be unknown.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pain
Clinical narrative: really tired; my muscles are sore; they kind of ache; A spontaneous report was received from a consumer concerning a 80-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fatigue (tired), myalgia (muscles are sore) and pain (kind of ache).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 25 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 012L20A) intramuscularly for prophylaxis of COVID-19 infection. On 22 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 028L20A) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient stated she was really tired, her  muscles was sore and had a kind of ache.  Treatment details included Not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events was unknown.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 31-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 7006320006 and 7006320002) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (Live, full- term birth.) on Feb-2012. Concurrent medical conditions included Drug allergy (Aspirin).   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-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 14-Jan-2021 and the estimated date of delivery was 21-Oct-2021. On 12-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fourth week of the pregnancy.  On 12-Feb-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Feb-2021, Pregnancy test positive: positive (Positive) Positive.         Patient had a history of pregnancy with end date FEB-2012 resulted in Live full term birth . The date of positive pregnancy test was 18-Feb-2021. Concomitant medications was not reported . No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-Feb-2021: Internal review on 26-Jul-2021 resulted in update of pregnancy information, lab data and narrative regenerated .
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEADACHE (headache) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0385K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Red (spot is about the size of a silver dollar) area below the injection site; Tender area below the injection site; Swollen area below injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE ERYTHEMA (Red (spot is about the size of a silver dollar) area below the injection site), VACCINATION SITE PAIN (Tender area below the injection site) and VACCINATION SITE SWELLING (Swollen area below injection site) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red (spot is about the size of a silver dollar) area below the injection site), VACCINATION SITE PAIN (Tender area below the injection site) and VACCINATION SITE SWELLING (Swollen area below injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Red (spot is about the size of a silver dollar) area below the injection site), VACCINATION SITE PAIN (Tender area below the injection site) and VACCINATION SITE SWELLING (Swollen area below injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pyrexia
Clinical narrative: Chills; Bad headache; Nausea; High Fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHILLS (Chills), HEADACHE (Bad headache), NAUSEA (Nausea) and PYREXIA (High Fever) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-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 CHILLS (Chills), HEADACHE (Bad headache), NAUSEA (Nausea) and PYREXIA (High Fever). At the time of the report, CHILLS (Chills), HEADACHE (Bad headache), NAUSEA (Nausea) and PYREXIA (High Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: Extremely itchy wetly rash; Rash on chest; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Extremely itchy wetly rash) and RASH (Rash on chest) in a 94-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) 1 dosage form. On 20-Jan-2021, the patient experienced RASH PRURITIC (Extremely itchy wetly rash) and RASH (Rash on chest). At the time of the report, RASH PRURITIC (Extremely itchy wetly rash) and RASH (Rash on chest) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   Treatment information was not provided.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose abnormal, Dizziness, Presyncope, Somnolence, Vaccination site pain
Clinical narrative: Felt like he was going to pass out; Lightheaded; Blood glucose abnormal; Sleep all day; Soreness in arm; A spontaneous report (), was received from a consumer (patient), concerning himself, 73 years-old male patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced felt like he was going to pass out (loss of consciousness), lightheaded (dizziness), soreness in arm (pain in extremity), and sleep all day (somnolence).  The patient's current conditions included hypertension and diabetes. Concomitant medications included unspecified blood pressure medication and insulin.  On 18 Feb 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (lot/batch: 006MZ0A), intramuscularly in arm for prophylaxis of COVID-19 infection.  On 18 Feb 2021, on the same day, the patient had soreness in his arm. On 19 Feb 2021, next day on Friday, the patient was sleepy all day. On 22 Feb 2021, the patient felt like he was going to pass out and was lightheaded. The patient's blood sugar was 160 (unknown units). No treatment information was reported.  Action taken with second dose of mRNA-1273 in response to the events was unknown.  The outcome of events felt like he was going to pass out, lightheaded, soreness in arm, and sleep all day were unknown.; Reporter'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.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: itchy rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (itchy rash) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (itchy rash). At the time of the report, RASH PRURITIC (itchy rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: head ache/ got a head ache that lasted 2 days and has gone down the neck; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (head ache/ got a head ache that lasted 2 days and has gone down the neck) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced HEADACHE (head ache/ got a head ache that lasted 2 days and has gone down the neck). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. At the time of the report, HEADACHE (head ache/ got a head ache that lasted 2 days and has gone down the neck) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash erythematous, Rash macular
Clinical narrative: lighter pink blotches on chest going down to the waist; a little up on the upper right thigh; Now it has gotten darker and is reaching up her neck; arm hurt the next day; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (lighter pink blotches on chest going down to the waist; a little up on the upper right thigh) and RASH ERYTHEMATOUS (Now it has gotten darker and is reaching up her neck) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced RASH MACULAR (lighter pink blotches on chest going down to the waist; a little up on the upper right thigh) and RASH ERYTHEMATOUS (Now it has gotten darker and is reaching up her neck). At the time of the report, RASH MACULAR (lighter pink blotches on chest going down to the waist; a little up on the upper right thigh) and RASH ERYTHEMATOUS (Now it has gotten darker and is reaching up her neck) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Infection, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: redness; pain; itching; swollen; looked infected, was pretty severe; This spontaneous case was reported by a health care professional and describes the occurrence of INFECTION (looked infected, was pretty severe), VACCINATION SITE ERYTHEMA (redness), VACCINATION SITE PAIN (pain), VACCINATION SITE PRURITUS (itching) and VACCINATION SITE SWELLING (swollen) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness), VACCINATION SITE PAIN (pain), VACCINATION SITE PRURITUS (itching) and VACCINATION SITE SWELLING (swollen). In February 2021, the patient experienced INFECTION (looked infected, was pretty severe). At the time of the report, INFECTION (looked infected, was pretty severe), VACCINATION SITE PAIN (pain), VACCINATION SITE PRURITUS (itching) and VACCINATION SITE SWELLING (swollen) had not resolved and VACCINATION SITE ERYTHEMA (redness) 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.   Patent take lot of medications. Patent take Antibiotic as a Treatment medication
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Feeling abnormal, Headache, Illness, Myalgia
Clinical narrative: "Massively Sick"; "Crummy"; Body Pain; Headaches; Nauseas; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS ("Massively Sick"), FEELING ABNORMAL ("Crummy"), MYALGIA (Body Pain), HEADACHE (Headaches) and NAUSEA (Nauseas) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced ILLNESS ("Massively Sick"), FEELING ABNORMAL ("Crummy"), MYALGIA (Body Pain), HEADACHE (Headaches) and NAUSEA (Nauseas). At the time of the report, ILLNESS ("Massively Sick"), FEELING ABNORMAL ("Crummy"), MYALGIA (Body Pain), HEADACHE (Headaches) and NAUSEA (Nauseas) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Oct-2020, COVID-19: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant Medications were  provided by Reporter. No  Treatment Medications were  provided by Reporter.   This case was linked to MOD21-036591 (E2B Linked Report).; Sender's Comments:  MOD21-036591:Cross Linked Doc
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: "Massively Sick"; "Crummy"; Body Pain; Headaches; Nauseas; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS ("Massively Sick"), FEELING ABNORMAL ("Crummy"), MYALGIA (Body Pain), HEADACHE (Headaches) and NAUSEA (Nauseas) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced ILLNESS ("Massively Sick"), FEELING ABNORMAL ("Crummy"), MYALGIA (Body Pain), HEADACHE (Headaches) and NAUSEA (Nauseas). At the time of the report, ILLNESS ("Massively Sick"), FEELING ABNORMAL ("Crummy"), MYALGIA (Body Pain), HEADACHE (Headaches) and NAUSEA (Nauseas) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Oct-2020, COVID-19: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant Medications were  provided by Reporter. No  Treatment Medications were  provided by Reporter.   This case was linked to MOD21-036591 (E2B Linked Report).; Sender's Comments:  MOD21-036591:Cross Linked Doc
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: reaction to the first dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (reaction to the first dose) 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced VACCINATION COMPLICATION (reaction to the first dose). At the time of the report, VACCINATION COMPLICATION (reaction to the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Action taken with mRNA-1273 in response to the events was not Applicable.  No concomitant medications were provided.  No treatment medications were provided.   This case was linked to MOD21-036558, MOD21-036629 (Patient Link).   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: red sport about 2 inches around; swelling in the same area as the redness; my arm felt a little bit achy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (my arm felt a little bit achy), VACCINATION SITE ERYTHEMA (red sport about 2 inches around) and VACCINATION SITE SWELLING (swelling in the same area as the redness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced VACCINATION SITE PAIN (my arm felt a little bit achy). On 22-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (red sport about 2 inches around) and VACCINATION SITE SWELLING (swelling in the same area as the redness). At the time of the report, VACCINATION SITE PAIN (my arm felt a little bit achy), VACCINATION SITE ERYTHEMA (red sport about 2 inches around) and VACCINATION SITE SWELLING (swelling in the same area as the redness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Upon in internal review on 21 May 2021, the age was corrected to unknown age.  No concomitant medications reported by investigator No treatment medications provided by the reporter.  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   Most recent FOLLOW-UP information incorporated above includes: On 23-Feb-2021: Upon internal review on 07 Jun 2021, it was discovered that the patient age was incorrectly captured , which was a MI error. The patient age and narrative has been updated to unknown age with reports re-submission and significant amendment is performed for the correction.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Cough, Headache, Pain
Clinical narrative: Cough; Body ache; Chills; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), PAIN (Body ache), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache) 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 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 04-Feb-2021, the patient experienced COUGH (Cough), PAIN (Body ache), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, COUGH (Cough), PAIN (Body ache), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Body temperature: 101.7 (High) 101.7 and 102.7 (High) 102.7 by midnight.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Cough; Body ache; Chills; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), PAIN (Body ache), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache) 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 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 04-Feb-2021, the patient experienced COUGH (Cough), PAIN (Body ache), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, COUGH (Cough), PAIN (Body ache), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Body temperature: 101.7 (High) 101.7 and 102.7 (High) 102.7 by midnight.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pustule, Rash, Rash erythematous, Rash pruritic, Rash pustular
Clinical narrative: Rash on arms, hands, chest and upper back; Rash was red, itchy; Rash was red, itchy; pustules and painful; pustules on arms, hands and chest; Pustules on chest; This spontaneous case was reported by a consumer and describes the occurrence of RASH PUSTULAR (pustules on arms, hands and chest), PUSTULE (Pustules on chest), RASH (Rash on arms, hands, chest and upper back), RASH PRURITIC (Rash was red, itchy) and RASH ERYTHEMATOUS (Rash was red, itchy) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History was provided by the reporter.  The patient's past medical history included Crohn's disease since 04-Mar-2014.   On 29-Jan-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On 03-Mar-2021 at 2:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.   On 30-Jan-2021, the patient experienced RASH PUSTULAR (pustules on arms, hands and chest) and PUSTULE (Pustules on chest). On 03-Feb-2021, the patient experienced RASH (Rash on arms, hands, chest and upper back). 03-Feb-2021, the patient experienced RASH PRURITIC (Rash was red, itchy), RASH ERYTHEMATOUS (Rash was red, itchy) and PUSTULE (pustules and painful).   The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for Adverse event, at an unspecified dose and frequency; PREDNISOLONE for Adverse event, at an unspecified dose and frequency and ADALIMUMAB (HUMIRA) (subcutaneous) ongoing from 06-Jun-2014 for Crohn's disease, at a dose of 40 milligram per week.   At the time of the report, RASH PUSTULAR (pustules on arms, hands and chest), PUSTULE (Pustules on chest), RASH (Rash on arms, hands, chest and upper back), RASH PRURITIC (Rash was red, itchy), RASH ERYTHEMATOUS (Rash was red, itchy) and PUSTULE (pustules and painful) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: New events added. Concomitant drug information updated. Dose #2 information updated.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Erythema, Headache, Injection site inflammation, Muscle spasms
Clinical narrative: Redness; cramps; bowel issues, feel sick to her stomach; inflammation which is spread around the injection site; headaches; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness), MUSCLE SPASMS (cramps), ABDOMINAL DISCOMFORT (bowel issues, feel sick to her stomach), INJECTION SITE INFLAMMATION (inflammation which is spread around the injection site) and HEADACHE (headaches) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0530M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included HYDROCHLOROTHIAZIDE and SIMVASTATIN for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced ERYTHEMA (Redness), MUSCLE SPASMS (cramps), ABDOMINAL DISCOMFORT (bowel issues, feel sick to her stomach), INJECTION SITE INFLAMMATION (inflammation which is spread around the injection site) and HEADACHE (headaches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ERYTHEMA (Redness), MUSCLE SPASMS (cramps), ABDOMINAL DISCOMFORT (bowel issues, feel sick to her stomach), INJECTION SITE INFLAMMATION (inflammation which is spread around the injection site) and HEADACHE (headaches) had not resolved.        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.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Cough, Discomfort, Headache
Clinical narrative: very uncomfortable; little cough; head cold; little achiness and headache; chills; bad muscle aches; joint aches; ankles aches; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (little cough), NASOPHARYNGITIS (head cold), DISCOMFORT (very uncomfortable), MYALGIA (bad muscle aches) and ARTHRALGIA (joint aches) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included VALSARTAN, OMEPRAZOLE, SERTRALINE, ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) and FEXOFENADINE HYDROCHLORIDE (ALLEGRA ALLERGY) for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced MYALGIA (bad muscle aches) and ARTHRALGIA (joint aches). 20-Feb-2021, the patient experienced ARTHRALGIA (ankles aches). On 21-Feb-2021, the patient experienced CHILLS (chills). On 22-Feb-2021, the patient experienced COUGH (little cough), NASOPHARYNGITIS (head cold) and HEADACHE (little achiness and headache). On 23-Feb-2021, the patient experienced DISCOMFORT (very uncomfortable). At the time of the report, COUGH (little cough), NASOPHARYNGITIS (head cold), DISCOMFORT (very uncomfortable), MYALGIA (bad muscle aches), ARTHRALGIA (joint aches), ARTHRALGIA (ankles aches), HEADACHE (little achiness and headache) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nasopharyngitis
Clinical narrative: very uncomfortable; little cough; head cold; little achiness and headache; chills; bad muscle aches; joint aches; ankles aches; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (little cough), NASOPHARYNGITIS (head cold), DISCOMFORT (very uncomfortable), MYALGIA (bad muscle aches) and ARTHRALGIA (joint aches) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included VALSARTAN, OMEPRAZOLE, SERTRALINE, ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) and FEXOFENADINE HYDROCHLORIDE (ALLEGRA ALLERGY) for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced MYALGIA (bad muscle aches) and ARTHRALGIA (joint aches). 20-Feb-2021, the patient experienced ARTHRALGIA (ankles aches). On 21-Feb-2021, the patient experienced CHILLS (chills). On 22-Feb-2021, the patient experienced COUGH (little cough), NASOPHARYNGITIS (head cold) and HEADACHE (little achiness and headache). On 23-Feb-2021, the patient experienced DISCOMFORT (very uncomfortable). At the time of the report, COUGH (little cough), NASOPHARYNGITIS (head cold), DISCOMFORT (very uncomfortable), MYALGIA (bad muscle aches), ARTHRALGIA (joint aches), ARTHRALGIA (ankles aches), HEADACHE (little achiness and headache) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: shortness of breath when up and down stairs; light headedness; low grade temperature; more fatigue; rash at injection site; tenderness at injection site; itching at injection site; soreness in her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in her arm), DYSPNOEA (shortness of breath when up and down stairs), DIZZINESS (light headedness), PYREXIA (low grade temperature) and FATIGUE (more fatigue) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D), LOVASTATIN and ATORVASTATIN CALCIUM (AVASTATIN) for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced PAIN IN EXTREMITY (soreness in her arm). On 18-Feb-2021, the patient experienced DYSPNOEA (shortness of breath when up and down stairs), DIZZINESS (light headedness), PYREXIA (low grade temperature), FATIGUE (more fatigue), VACCINATION SITE RASH (rash at injection site), VACCINATION SITE PAIN (tenderness at injection site) and VACCINATION SITE PRURITUS (itching at injection site). At the time of the report, PAIN IN EXTREMITY (soreness in her arm), DYSPNOEA (shortness of breath when up and down stairs), DIZZINESS (light headedness), PYREXIA (low grade temperature), FATIGUE (more fatigue), VACCINATION SITE RASH (rash at injection site), VACCINATION SITE PAIN (tenderness at injection site) and VACCINATION SITE PRURITUS (itching at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.