chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gingivitis, Pain, Pain in jaw
Clinical narrative: jaw pain; gum infection; pain; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN JAW (jaw pain), GINGIVITIS (gum infection), PAIN (pain) and FATIGUE (tiredness) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-May-2021, the patient experienced PAIN IN JAW (jaw pain), GINGIVITIS (gum infection), PAIN (pain) and FATIGUE (tiredness). At the time of the report, PAIN IN JAW (jaw pain), GINGIVITIS (gum infection), PAIN (pain) and FATIGUE (tiredness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment reported: Advil   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non significant Follow up appended
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: He felt really tired for couple of days; This spontaneous case was reported by an other caregiver and describes the occurrence of FATIGUE (He felt really tired for couple of days) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025j20a) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced FATIGUE (He felt really tired for couple of days). At the time of the report, FATIGUE (He felt really tired for couple of days) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided. No lab Data  This all for 1st Dose   This case was linked to MOD-2021-168108 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Details aboutv2nd dose adverse events On 14-Jun-2021: Non significant follow up
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Fatigue, Feeling abnormal, Headache
Clinical narrative: fatigue; headaches; nauseous; joints were hurting; bones were hurting; severe flu symptoms; so feverish; still having migraines; feel drugged; I went in severe shake mode; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (fatigue), HEADACHE (headaches), NAUSEA (nauseous), ARTHRALGIA (joints were hurting) and BONE PAIN (bones were hurting) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (fatigue), HEADACHE (headaches), NAUSEA (nauseous), ARTHRALGIA (joints were hurting), BONE PAIN (bones were hurting), INFLUENZA (severe flu symptoms), PYREXIA (so feverish), MIGRAINE (still having migraines), FEELING ABNORMAL (feel drugged) and TREMOR (I went in severe shake mode). At the time of the report, FATIGUE (fatigue), HEADACHE (headaches), NAUSEA (nauseous), ARTHRALGIA (joints were hurting), BONE PAIN (bones were hurting), INFLUENZA (severe flu symptoms), PYREXIA (so feverish), MIGRAINE (still having migraines), FEELING ABNORMAL (feel drugged) and TREMOR (I went in severe shake mode) outcome was unknown. Not Provided      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.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: non significant followup
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza, Migraine, Nausea, Pyrexia, Tremor
Clinical narrative: fatigue; headaches; nauseous; joints were hurting; bones were hurting; severe flu symptoms; so feverish; still having migraines; feel drugged; I went in severe shake mode; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (fatigue), HEADACHE (headaches), NAUSEA (nauseous), ARTHRALGIA (joints were hurting) and BONE PAIN (bones were hurting) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (fatigue), HEADACHE (headaches), NAUSEA (nauseous), ARTHRALGIA (joints were hurting), BONE PAIN (bones were hurting), INFLUENZA (severe flu symptoms), PYREXIA (so feverish), MIGRAINE (still having migraines), FEELING ABNORMAL (feel drugged) and TREMOR (I went in severe shake mode). At the time of the report, FATIGUE (fatigue), HEADACHE (headaches), NAUSEA (nauseous), ARTHRALGIA (joints were hurting), BONE PAIN (bones were hurting), INFLUENZA (severe flu symptoms), PYREXIA (so feverish), MIGRAINE (still having migraines), FEELING ABNORMAL (feel drugged) and TREMOR (I went in severe shake mode) outcome was unknown. Not Provided      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.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: non significant followup
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: headache; fever / experiences episodes of fever here and there; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and PYREXIA (fever / experiences episodes of fever here and there) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METFORMIN and albuterol spray for an unknown indication.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache) and PYREXIA (fever / experiences episodes of fever here and there). At the time of the report, HEADACHE (headache) and PYREXIA (fever / experiences episodes of fever here and there) outcome was unknown. Not Provided          The concomitant medication was high blood pressure medicine. The treatment information was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: follow-up Added and contains Non Significant Information
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site swelling
Clinical narrative: vaccination site swelling; feverish; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE SWELLING (vaccination site swelling) and PYREXIA (feverish) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 17-May-2021, the patient experienced VACCINATION SITE SWELLING (vaccination site swelling) and PYREXIA (feverish). At the time of the report, VACCINATION SITE SWELLING (vaccination site swelling) and PYREXIA (feverish) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non-Significant follow up appended to AER
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pruritus
Clinical narrative: Vaccination site induration; itchy arm/ developed an itchy arm around the injection site; a large red induration around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Vaccination site induration), VACCINATION SITE PRURITUS (itchy arm/ developed an itchy arm around the injection site) and VACCINATION SITE ERYTHEMA (a large red induration around the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Heart attack in January 2021.    On 19-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, the patient experienced VACCINATION SITE INDURATION (Vaccination site induration). 24-May-2021, the patient experienced VACCINATION SITE PRURITUS (itchy arm/ developed an itchy arm around the injection site) and VACCINATION SITE ERYTHEMA (a large red induration around the injection site). At the time of the report, VACCINATION SITE INDURATION (Vaccination site induration), VACCINATION SITE PRURITUS (itchy arm/ developed an itchy arm around the injection site) and VACCINATION SITE ERYTHEMA (a large red induration around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported No treatment medications were reported   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow-up information received contains no new information. On 23-Jul-2021: Follow-up information received contains no new information.
Sex: U
Vaccine: COVID19
Symptoms: Ocular hyperaemia
Clinical narrative: Very, very red eyes; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of OCULAR HYPERAEMIA (Very, very red eyes) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OCULAR HYPERAEMIA (Very, very red eyes). At the time of the report, OCULAR HYPERAEMIA (Very, very red eyes) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment medication use was not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Intentional product use issue
Clinical narrative: first dose received on 29th March, still has not taken second dose (36 days passed since first dose); This spontaneous case was reported by a patient and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (first dose received on 29th March, still has not taken second dose (36 days passed since first dose)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-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 INTENTIONAL PRODUCT USE ISSUE (first dose received on 29th March, still has not taken second dose (36 days passed since first dose)). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (first dose received on 29th March, still has not taken second dose (36 days passed since first dose)) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: NNI
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Colitis, Fall, Feeling cold, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Colitis; vomiting; terrible reaction in the left and right leg (pain); fall; muscle stiffness; feel cold; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (feel cold), PAIN IN EXTREMITY (terrible reaction in the left and right leg (pain)), FALL (fall), MUSCULOSKELETAL STIFFNESS (muscle stiffness) and COLITIS (Colitis) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Psoriasis and Thyroid disorder NOS. Concomitant products included VITAMINS NOS for an unknown indication.   On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FEELING COLD (feel cold). On 22-May-2021, the patient experienced PAIN IN EXTREMITY (terrible reaction in the left and right leg (pain)), FALL (fall), MUSCULOSKELETAL STIFFNESS (muscle stiffness) and VOMITING (vomiting). On an unknown date, the patient experienced COLITIS (Colitis). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 22-May-2021, FEELING COLD (feel cold) had resolved. At the time of the report, PAIN IN EXTREMITY (terrible reaction in the left and right leg (pain)), FALL (fall), MUSCULOSKELETAL STIFFNESS (muscle stiffness), COLITIS (Colitis) and VOMITING (vomiting) outcome was unknown. Not Provided          The concomitant medication include Thyroid medication. Prior vaccine Psoriasis vaccine  and experienced a big lump around ribs (a year before her COVID vaccine).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up received on 26-may-2021 contains no new information.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Colitis; vomiting; terrible reaction in the left and right leg (pain); fall; muscle stiffness; feel cold; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (feel cold), PAIN IN EXTREMITY (terrible reaction in the left and right leg (pain)), FALL (fall), MUSCULOSKELETAL STIFFNESS (muscle stiffness) and COLITIS (Colitis) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Psoriasis and Thyroid disorder NOS. Concomitant products included VITAMINS NOS for an unknown indication.   On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FEELING COLD (feel cold). On 22-May-2021, the patient experienced PAIN IN EXTREMITY (terrible reaction in the left and right leg (pain)), FALL (fall), MUSCULOSKELETAL STIFFNESS (muscle stiffness) and VOMITING (vomiting). On an unknown date, the patient experienced COLITIS (Colitis). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 22-May-2021, FEELING COLD (feel cold) had resolved. At the time of the report, PAIN IN EXTREMITY (terrible reaction in the left and right leg (pain)), FALL (fall), MUSCULOSKELETAL STIFFNESS (muscle stiffness), COLITIS (Colitis) and VOMITING (vomiting) outcome was unknown. Not Provided          The concomitant medication include Thyroid medication. Prior vaccine Psoriasis vaccine  and experienced a big lump around ribs (a year before her COVID vaccine).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up received on 26-may-2021 contains no new information.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Myalgia, Pyrexia
Clinical narrative: fever (103.7 degrees Fahrenheit); body aches; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (fever (103.7 degrees Fahrenheit)) and MYALGIA (body aches) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 032M20A) for COVID-19 vaccination.     no medical history was reported.  Concomitant products included LEVOTHYROXINE SODIUM (LEVOXYL), HYDROCHLOROTHIAZIDE and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced PYREXIA (fever (103.7 degrees Fahrenheit)) and MYALGIA (body aches). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PYREXIA (fever (103.7 degrees Fahrenheit)) and MYALGIA (body aches) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: (High) 103.7 degrees Fahrenheit.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non Significant Follow-up; Reporter's Comments: NA; Sender's Comments: NA
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non-significant follow-up added.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Dyspnoea, Nausea, Palpitations, Vaccination site pain
Clinical narrative: palpitations; nausea; pain in the injection arm; lack of air; colics; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (lack of air), ABDOMINAL PAIN (colics), PALPITATIONS (palpitations), NAUSEA (nausea) and VACCINATION SITE PAIN (pain in the injection arm) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Asthma, Menopause and Diabetic. Concurrent medical conditions included Blood pressure management. Concomitant products included METFORMIN and ALBUTEROL [SALBUTAMOL] for an unknown indication.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-May-2021, the patient experienced DYSPNOEA (lack of air), ABDOMINAL PAIN (colics), NAUSEA (nausea) and VACCINATION SITE PAIN (pain in the injection arm). On an unknown date, the patient experienced PALPITATIONS (palpitations). At the time of the report, DYSPNOEA (lack of air), ABDOMINAL PAIN (colics), PALPITATIONS (palpitations), NAUSEA (nausea) and VACCINATION SITE PAIN (pain in the injection arm) outcome was unknown.            No treatment medications were reported.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue
Clinical narrative: didnt received second dose for 3 months; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and PRODUCT DOSE OMISSION ISSUE (didnt received second dose for 3 months) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (didnt received second dose for 3 months). At the time of the report, COVID-19 (COVID-19) and PRODUCT DOSE OMISSION ISSUE (didnt received second dose for 3 months) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       patient was treated with monoclonal antibodies on 24-02-2021.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Nonsignificant Follow up appended
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Feeling sick; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling sick) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Feeling sick). At the time of the report, MALAISE (Feeling sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant Medication was provided. No treatment  was provided.     Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: No new information was reported.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased, Chills, Glycosylated haemoglobin increased, Headache, Inflammation
Clinical narrative: she does not feel well; blood sugar started getting high; her vitamin D level is also low; A1C is high now again/; the glands on her neck is swollen; till have an inflammation in her body,; fever; Chills; headache; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (she does not feel well), BLOOD GLUCOSE INCREASED (blood sugar started getting high), VITAMIN D DECREASED (her vitamin D level is also low), GLYCOSYLATED HAEMOGLOBIN INCREASED (A1C is high now again/) and LYMPHADENOPATHY (the glands on her neck is swollen) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A and 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (she does not feel well), BLOOD GLUCOSE INCREASED (blood sugar started getting high), VITAMIN D DECREASED (her vitamin D level is also low), GLYCOSYLATED HAEMOGLOBIN INCREASED (A1C is high now again/), LYMPHADENOPATHY (the glands on her neck is swollen), INFLAMMATION (till have an inflammation in her body,), PYREXIA (fever), CHILLS (Chills) and HEADACHE (headache). At the time of the report, MALAISE (she does not feel well), BLOOD GLUCOSE INCREASED (blood sugar started getting high), VITAMIN D DECREASED (her vitamin D level is also low), GLYCOSYLATED HAEMOGLOBIN INCREASED (A1C is high now again/), LYMPHADENOPATHY (the glands on her neck is swollen), INFLAMMATION (till have an inflammation in her body,), PYREXIA (fever), CHILLS (Chills) and HEADACHE (headache) outcome was unknown.                Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non significant Follow up appended
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Malaise, Pyrexia, Vitamin D decreased
Clinical narrative: she does not feel well; blood sugar started getting high; her vitamin D level is also low; A1C is high now again/; the glands on her neck is swollen; till have an inflammation in her body,; fever; Chills; headache; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (she does not feel well), BLOOD GLUCOSE INCREASED (blood sugar started getting high), VITAMIN D DECREASED (her vitamin D level is also low), GLYCOSYLATED HAEMOGLOBIN INCREASED (A1C is high now again/) and LYMPHADENOPATHY (the glands on her neck is swollen) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A and 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (she does not feel well), BLOOD GLUCOSE INCREASED (blood sugar started getting high), VITAMIN D DECREASED (her vitamin D level is also low), GLYCOSYLATED HAEMOGLOBIN INCREASED (A1C is high now again/), LYMPHADENOPATHY (the glands on her neck is swollen), INFLAMMATION (till have an inflammation in her body,), PYREXIA (fever), CHILLS (Chills) and HEADACHE (headache). At the time of the report, MALAISE (she does not feel well), BLOOD GLUCOSE INCREASED (blood sugar started getting high), VITAMIN D DECREASED (her vitamin D level is also low), GLYCOSYLATED HAEMOGLOBIN INCREASED (A1C is high now again/), LYMPHADENOPATHY (the glands on her neck is swollen), INFLAMMATION (till have an inflammation in her body,), PYREXIA (fever), CHILLS (Chills) and HEADACHE (headache) outcome was unknown.                Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non significant Follow up appended
Sex: U
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: still feeling side effects after second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (still feeling side effects after second dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (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 an unknown date, the patient experienced ADVERSE REACTION (still feeling side effects after second dose). At the time of the report, ADVERSE REACTION (still feeling side effects after second dose) outcome was unknown. Not Provided          Concomitant medications were not provided.  Treatment information was not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow-up information received on 26-MAY-2021 contains non-significant information.
Sex: U
Vaccine: COVID19
Symptoms: Feeling hot
Clinical narrative: right foot has been hot since I got my vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (right foot has been hot since I got my vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING HOT (right foot has been hot since I got my vaccine). At the time of the report, FEELING HOT (right foot has been hot since I got my vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was unknown by the reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: NNI
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Diarrhoea, Vomiting
Clinical narrative: Tested positive for COVID-19 after receiving the 2 doses of the Moderna CoviD-19 Vaccine; Diarrhea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19 after receiving the 2 doses of the Moderna CoviD-19 Vaccine), DIARRHOEA (Diarrhea) and VOMITING (Vomiting) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Cardiovascular disease, unspecified and Diabetes.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-May-2021, the patient experienced DIARRHOEA (Diarrhea) and VOMITING (Vomiting). On 24-May-2021, the patient experienced COVID-19 (Tested positive for COVID-19 after receiving the 2 doses of the Moderna CoviD-19 Vaccine). On 23-May-2021, DIARRHOEA (Diarrhea) and VOMITING (Vomiting) had resolved. At the time of the report, COVID-19 (Tested positive for COVID-19 after receiving the 2 doses of the Moderna CoviD-19 Vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-May-2021, SARS-CoV-2 test: negative (Negative) Negative. On 24-May-2021, SARS-CoV-2 test: positive (Positive) Positive.         Concomitant medication included diabetes medications and Heart stent medications.  Treatment medication use information was not provided by reporter   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Followed up Received on 25-MAY-2021 That contains Email Id updated and dosage regimen updated and concomitants were updated and event updated On 25-May-2021: Non-Significant follow up appended to AER On 25-May-2021: Follow-up received does not contain any significant information. On 29-Jun-2021: Follow-up received updated medical history, lab data and outcome of the events.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, Peripheral swelling, Product dose omission issue
Clinical narrative: pain between his thumb and pointer finger; pain in elbow/pain in shoulders; left hand is swollen; missed his second dose of vaccine; pain in left hand; This spontaneous case was reported by an other caregiver and describes the occurrence of PAIN IN EXTREMITY (pain in left hand), PAIN IN EXTREMITY (pain between his thumb and pointer finger), ARTHRALGIA (pain in elbow/pain in shoulders), PERIPHERAL SWELLING (left hand is swollen) and PRODUCT DOSE OMISSION ISSUE (missed his second dose of vaccine) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced PAIN IN EXTREMITY (pain in left hand). On an unknown date, the patient experienced PAIN IN EXTREMITY (pain between his thumb and pointer finger), ARTHRALGIA (pain in elbow/pain in shoulders), PERIPHERAL SWELLING (left hand is swollen) and PRODUCT DOSE OMISSION ISSUE (missed his second dose of vaccine). At the time of the report, PAIN IN EXTREMITY (pain in left hand), PAIN IN EXTREMITY (pain between his thumb and pointer finger), ARTHRALGIA (pain in elbow/pain in shoulders), PERIPHERAL SWELLING (left hand is swollen) and PRODUCT DOSE OMISSION ISSUE (missed his second dose of vaccine) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: non significant follow up case has no new information
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Hyperhidrosis, Hypokinesia
Clinical narrative: literally can't do any movement; Unable to sleep; Muscle spasm shoulder and left region of his back; sweating; bad neck stiffness; joint pain(left wrist, left elbow, sleft houlders,left  rotated cuff); Throbbing pain on his left arm; chills; very fatigue, when he stand to do something for 5-8 minutes, it's like he ran a marathon; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (literally can't do any movement), INSOMNIA (Unable to sleep), MUSCLE SPASMS (Muscle spasm shoulder and left region of his back), HYPERHIDROSIS (sweating) and MUSCULOSKELETAL STIFFNESS (bad neck stiffness) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced HYPOKINESIA (literally can't do any movement), INSOMNIA (Unable to sleep), MUSCLE SPASMS (Muscle spasm shoulder and left region of his back), HYPERHIDROSIS (sweating), MUSCULOSKELETAL STIFFNESS (bad neck stiffness), ARTHRALGIA (joint pain(left wrist, left elbow, sleft houlders,left  rotated cuff)), MYALGIA (Throbbing pain on his left arm), CHILLS (chills) and FATIGUE (very fatigue, when he stand to do something for 5-8 minutes, it's like he ran a marathon). The patient was treated with METAXALONE (FLEXURA) ongoing since an unknown date at an unspecified dose and frequency; NAPROXEN ongoing since an unknown date at an unspecified dose and frequency; KETOROLAC TROMETHAMINE (TORADOL) ongoing since an unknown date at an unspecified dose and frequency and METHYLPREDNISOLONE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, HYPOKINESIA (literally can't do any movement), INSOMNIA (Unable to sleep), MUSCLE SPASMS (Muscle spasm shoulder and left region of his back), HYPERHIDROSIS (sweating), MUSCULOSKELETAL STIFFNESS (bad neck stiffness), ARTHRALGIA (joint pain(left wrist, left elbow, sleft houlders,left  rotated cuff)), MYALGIA (Throbbing pain on his left arm), CHILLS (chills) and FATIGUE (very fatigue, when he stand to do something for 5-8 minutes, it's like he ran a marathon) outcome was unknown.            Company Comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non-significant Follow up; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Muscle spasms, Musculoskeletal stiffness, Myalgia
Clinical narrative: literally can't do any movement; Unable to sleep; Muscle spasm shoulder and left region of his back; sweating; bad neck stiffness; joint pain(left wrist, left elbow, sleft houlders,left  rotated cuff); Throbbing pain on his left arm; chills; very fatigue, when he stand to do something for 5-8 minutes, it's like he ran a marathon; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (literally can't do any movement), INSOMNIA (Unable to sleep), MUSCLE SPASMS (Muscle spasm shoulder and left region of his back), HYPERHIDROSIS (sweating) and MUSCULOSKELETAL STIFFNESS (bad neck stiffness) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced HYPOKINESIA (literally can't do any movement), INSOMNIA (Unable to sleep), MUSCLE SPASMS (Muscle spasm shoulder and left region of his back), HYPERHIDROSIS (sweating), MUSCULOSKELETAL STIFFNESS (bad neck stiffness), ARTHRALGIA (joint pain(left wrist, left elbow, sleft houlders,left  rotated cuff)), MYALGIA (Throbbing pain on his left arm), CHILLS (chills) and FATIGUE (very fatigue, when he stand to do something for 5-8 minutes, it's like he ran a marathon). The patient was treated with METAXALONE (FLEXURA) ongoing since an unknown date at an unspecified dose and frequency; NAPROXEN ongoing since an unknown date at an unspecified dose and frequency; KETOROLAC TROMETHAMINE (TORADOL) ongoing since an unknown date at an unspecified dose and frequency and METHYLPREDNISOLONE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, HYPOKINESIA (literally can't do any movement), INSOMNIA (Unable to sleep), MUSCLE SPASMS (Muscle spasm shoulder and left region of his back), HYPERHIDROSIS (sweating), MUSCULOSKELETAL STIFFNESS (bad neck stiffness), ARTHRALGIA (joint pain(left wrist, left elbow, sleft houlders,left  rotated cuff)), MYALGIA (Throbbing pain on his left arm), CHILLS (chills) and FATIGUE (very fatigue, when he stand to do something for 5-8 minutes, it's like he ran a marathon) outcome was unknown.            Company Comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non-significant Follow up; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Peripheral swelling, Pyrexia, Swelling face
Clinical narrative: injection arm "blew up" down to her hand; face swollen; almost fell in the middle of the night because of balance; vertigo; uncontrollable diarrhea; fever of 102.5; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (injection arm "blew up" down to her hand), SWELLING FACE (face swollen), VERTIGO (almost fell in the middle of the night because of balance; vertigo), DIARRHOEA (uncontrollable diarrhea) and PYREXIA (fever of 102.5) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 016M20A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: STEROIDS (2012 patient was given too much steroid, an amount that should have been taken once a month was taken everyday for three years and and it affected her immune system. Nowthe patient has a compromised immune system.) from 2012 to 2015. Concurrent medical conditions included AFib. Concomitant products included DIMENHYDRINATE (DRAMAMINE) for Vertigo.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (injection arm "blew up" down to her hand), SWELLING FACE (face swollen), VERTIGO (almost fell in the middle of the night because of balance; vertigo), DIARRHOEA (uncontrollable diarrhea) and PYREXIA (fever of 102.5). At the time of the report, PERIPHERAL SWELLING (injection arm "blew up" down to her hand), SWELLING FACE (face swollen), VERTIGO (almost fell in the middle of the night because of balance; vertigo), DIARRHOEA (uncontrollable diarrhea) and PYREXIA (fever of 102.5) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102.5 (High) high fever of 102.5.           Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up was received on 25 May 2021 included no newinformation.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: injection arm "blew up" down to her hand; face swollen; almost fell in the middle of the night because of balance; vertigo; uncontrollable diarrhea; fever of 102.5; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (injection arm "blew up" down to her hand), SWELLING FACE (face swollen), VERTIGO (almost fell in the middle of the night because of balance; vertigo), DIARRHOEA (uncontrollable diarrhea) and PYREXIA (fever of 102.5) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 016M20A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: STEROIDS (2012 patient was given too much steroid, an amount that should have been taken once a month was taken everyday for three years and and it affected her immune system. Nowthe patient has a compromised immune system.) from 2012 to 2015. Concurrent medical conditions included AFib. Concomitant products included DIMENHYDRINATE (DRAMAMINE) for Vertigo.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (injection arm "blew up" down to her hand), SWELLING FACE (face swollen), VERTIGO (almost fell in the middle of the night because of balance; vertigo), DIARRHOEA (uncontrollable diarrhea) and PYREXIA (fever of 102.5). At the time of the report, PERIPHERAL SWELLING (injection arm "blew up" down to her hand), SWELLING FACE (face swollen), VERTIGO (almost fell in the middle of the night because of balance; vertigo), DIARRHOEA (uncontrollable diarrhea) and PYREXIA (fever of 102.5) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102.5 (High) high fever of 102.5.           Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up was received on 25 May 2021 included no newinformation.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Tiredness; Headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness) and HEADACHE (Headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     no medial history reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and (unknown route) at an unspecified dose. On an unknown date, the patient experienced FATIGUE (Tiredness) and HEADACHE (Headache). At the time of the report, FATIGUE (Tiredness) and HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided by the reporter no treatment information reported by the reporter   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up received  on 25-May-2021,contain non significant information
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Feeling abnormal, Gait disturbance, Pain in extremity
Clinical narrative: felt like someone was crushing her hand,; could not walk; feet were burning; legs give out every now; tremors are worse; It is terrible/It is awful/Felt everything was accelerated; bad shoulder which felt like was on fire; 103 degrees fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (felt like someone was crushing her hand,), GAIT DISTURBANCE (could not walk), BURNING SENSATION (feet were burning), PAIN IN EXTREMITY (legs give out every now) and TREMOR (tremors are worse) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19, Tremor and Peripheral neuropathy. Concomitant products included PREGABALIN (LYRICA), DULOXETINE HYDROCHLORIDE (CYMBALTA), OXCARBAZEPINE and VALPROATE SEMISODIUM (DIVALPROEX) for an unknown indication.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (felt like someone was crushing her hand,), GAIT DISTURBANCE (could not walk), BURNING SENSATION (feet were burning), PAIN IN EXTREMITY (legs give out every now), TREMOR (tremors are worse), FEELING ABNORMAL (It is terrible/It is awful/Felt everything was accelerated), ARTHRALGIA (bad shoulder which felt like was on fire) and PYREXIA (103 degrees fever). At the time of the report, PAIN IN EXTREMITY (felt like someone was crushing her hand,), GAIT DISTURBANCE (could not walk), BURNING SENSATION (feet were burning), PAIN IN EXTREMITY (legs give out every now), TREMOR (tremors are worse), FEELING ABNORMAL (It is terrible/It is awful/Felt everything was accelerated), ARTHRALGIA (bad shoulder which felt like was on fire) and PYREXIA (103 degrees fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment listed.