chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: headache; Tiredness; some muscle aches; 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 HEADACHE (headache), FATIGUE (Tiredness) and MYALGIA (some muscle aches) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache), FATIGUE (Tiredness) and MYALGIA (some muscle aches). At the time of the report, HEADACHE (headache), FATIGUE (Tiredness) and MYALGIA (some muscle aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported by the reporter. No treatment was reported by the reporter.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Myalgia, Pain of skin, Pyrexia, Vaccination site pain
Clinical narrative: Dizzy; Tender scalp; Achy; Fever; Slightly sore at injection site; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), PAIN OF SKIN (Tender scalp), MYALGIA (Achy), PYREXIA (Fever) and VACCINATION SITE PAIN (Slightly sore at injection site) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A and 004C21A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included ATORVASTATIN and AMLODIPINE for an unknown indication.   On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-May-2021, the patient experienced DIZZINESS (Dizzy), PAIN OF SKIN (Tender scalp), MYALGIA (Achy), PYREXIA (Fever) and VACCINATION SITE PAIN (Slightly sore at injection site). At the time of the report, DIZZINESS (Dizzy), PAIN OF SKIN (Tender scalp), MYALGIA (Achy), PYREXIA (Fever) and VACCINATION SITE PAIN (Slightly sore at injection site) outcome was unknown.            Treatment details was not reported by the reporter.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Broke out in hives after 2 weeks after 1st dose; This spontaneous case was reported by a physician and describes the occurrence of URTICARIA (Broke out in hives after 2 weeks after 1st dose) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017c21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, the patient experienced URTICARIA (Broke out in hives after 2 weeks after 1st dose). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL TOTAL) for Hives, at a dose of 1 dosage form. At the time of the report, URTICARIA (Broke out in hives after 2 weeks after 1st dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 11-Aug-2021: Follow up information included no new information.
Sex: U
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Chills for 23 days; 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 CHILLS (Chills for 23 days) 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 07-May-2021, the patient experienced CHILLS (Chills for 23 days). At the time of the report, CHILLS (Chills for 23 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   Reporter did not allow further contact
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Both arms hurt for a couple days after the shots; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 28-May-2021. The most recent information was received on 23-Jul-2021 and was forwarded to Moderna on 24-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Both arms hurt for a couple days after the shots) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003b21a and 041b21a) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Both arms hurt for a couple days after the shots). The patient was treated with IBUPROFEN for Pain, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Both arms hurt for a couple days after the shots) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) dosing remained unchanged.       The concomitant medications were not provided.   This case was linked to MOD-2021-090542 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Added patient information which includes height, weight, race and ethnicity. Added Treatment information which includes Ibuprofen. Updated outcome of the event.
Sex: U
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: dry cough / coughing; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of COUGH (dry cough / coughing) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (dry cough / coughing). At the time of the report, COUGH (dry cough / coughing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper
Clinical narrative: stomach ache; 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 ABDOMINAL PAIN UPPER (stomach ache) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (stomach ache). At the time of the report, ABDOMINAL PAIN UPPER (stomach ache) outcome was unknown.            The action taken with mRNA-1273(Moderna COVID-19 Vaccine ) was not applicable No concomitant medications were reported by the reporter. No treatment drugs were reported by the reporter.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: itching around injection site; redness around injection site; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching around injection site) and VACCINATION SITE ERYTHEMA (redness around injection site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (itching around injection site) and VACCINATION SITE ERYTHEMA (redness around injection site). At the time of the report, VACCINATION SITE PRURITUS (itching around injection site) and VACCINATION SITE ERYTHEMA (redness around injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided by the reporter. Treatment medications were not provided by the reporter.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: side effects after second dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects after second dose) in an adult male patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects after second dose). At the time of the report, VACCINATION COMPLICATION (side effects after second dose) outcome was unknown.            Concomitant medications were not provided. Treatment information was not provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Headache, Musculoskeletal stiffness
Clinical narrative: Stiff neck; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiff neck) and HEADACHE (Headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-May-2021, the patient experienced HEADACHE (Headache). On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiff neck). At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiff neck) and HEADACHE (Headache) outcome was unknown.            Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   Reporter did not allow further contact
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (Headache) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-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) (Intramuscular) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received first vaccine on April 10, more than 28 days ago; 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received first vaccine on April 10, more than 28 days ago) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 10-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received first vaccine on April 10, more than 28 days ago). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received first vaccine on April 10, more than 28 days ago) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications details was not reported by the reporter. Treatment details was not reported by the reporter.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: 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 HEADACHE (headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Unknown and Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown.            Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   Reporter did not allow further contact
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Incorrect route of product administration, Underdose
Clinical narrative: Inappropriate route of vaccination; some of the dose ran out down the patient's arm; some of the dose ran out down the patient's arm; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination), DEVICE CONNECTION ISSUE (some of the dose ran out down the patient's arm) and UNDERDOSE (some of the dose ran out down the patient's arm) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     Medical history not provided by the reporter.  Concomitant products included ORAL CONTRACEPTIVE NOS for an unknown indication.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-May-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination), DEVICE CONNECTION ISSUE (some of the dose ran out down the patient's arm) and UNDERDOSE (some of the dose ran out down the patient's arm). At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination), DEVICE CONNECTION ISSUE (some of the dose ran out down the patient's arm) and UNDERDOSE (some of the dose ran out down the patient's arm) outcome was unknown.            This case was linked to MOD-2021-187207 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: follow up information received on 28may2021 contains non significant follow up
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Cold sweat, Decreased appetite, Eye pain
Clinical narrative: my arm was swollen and tender; cold sweat; crust in both eyes; painful eye / sting in my eyes; loss of appetite; has not received the second dose >42 days; rash on my left arm; headache; pain in her joints; arm tender / pain in my calf; chills; fatigue; terribly ill for 2 weeks; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (terribly ill for 2 weeks), PERIPHERAL SWELLING (my arm was swollen and tender), COLD SWEAT (cold sweat), EYELID MARGIN CRUSTING (crust in both eyes) and EYE PAIN (painful eye / sting in my eyes) in an 85-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.     No Medical History information was reported.    On 04-Feb-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 ILLNESS (terribly ill for 2 weeks), PERIPHERAL SWELLING (my arm was swollen and tender), COLD SWEAT (cold sweat), EYELID MARGIN CRUSTING (crust in both eyes), EYE PAIN (painful eye / sting in my eyes), DECREASED APPETITE (loss of appetite), PRODUCT DOSE OMISSION ISSUE (has not received the second dose >42 days), RASH (rash on my left arm), HEADACHE (headache), ARTHRALGIA (pain in her joints), MYALGIA (arm tender / pain in my calf), CHILLS (chills) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ILLNESS (terribly ill for 2 weeks) and PRODUCT DOSE OMISSION ISSUE (has not received the second dose >42 days) had resolved and PERIPHERAL SWELLING (my arm was swollen and tender), COLD SWEAT (cold sweat), EYELID MARGIN CRUSTING (crust in both eyes), EYE PAIN (painful eye / sting in my eyes), DECREASED APPETITE (loss of appetite), RASH (rash on my left arm), HEADACHE (headache), ARTHRALGIA (pain in her joints), MYALGIA (arm tender / pain in my calf), CHILLS (chills) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported by the reporter.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Eyelid margin crusting, Fatigue, Headache, Illness, Myalgia
Clinical narrative: my arm was swollen and tender; cold sweat; crust in both eyes; painful eye / sting in my eyes; loss of appetite; has not received the second dose >42 days; rash on my left arm; headache; pain in her joints; arm tender / pain in my calf; chills; fatigue; terribly ill for 2 weeks; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (terribly ill for 2 weeks), PERIPHERAL SWELLING (my arm was swollen and tender), COLD SWEAT (cold sweat), EYELID MARGIN CRUSTING (crust in both eyes) and EYE PAIN (painful eye / sting in my eyes) in an 85-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.     No Medical History information was reported.    On 04-Feb-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 ILLNESS (terribly ill for 2 weeks), PERIPHERAL SWELLING (my arm was swollen and tender), COLD SWEAT (cold sweat), EYELID MARGIN CRUSTING (crust in both eyes), EYE PAIN (painful eye / sting in my eyes), DECREASED APPETITE (loss of appetite), PRODUCT DOSE OMISSION ISSUE (has not received the second dose >42 days), RASH (rash on my left arm), HEADACHE (headache), ARTHRALGIA (pain in her joints), MYALGIA (arm tender / pain in my calf), CHILLS (chills) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ILLNESS (terribly ill for 2 weeks) and PRODUCT DOSE OMISSION ISSUE (has not received the second dose >42 days) had resolved and PERIPHERAL SWELLING (my arm was swollen and tender), COLD SWEAT (cold sweat), EYELID MARGIN CRUSTING (crust in both eyes), EYE PAIN (painful eye / sting in my eyes), DECREASED APPETITE (loss of appetite), RASH (rash on my left arm), HEADACHE (headache), ARTHRALGIA (pain in her joints), MYALGIA (arm tender / pain in my calf), CHILLS (chills) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported by the reporter.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Product dose omission issue, Rash
Clinical narrative: my arm was swollen and tender; cold sweat; crust in both eyes; painful eye / sting in my eyes; loss of appetite; has not received the second dose >42 days; rash on my left arm; headache; pain in her joints; arm tender / pain in my calf; chills; fatigue; terribly ill for 2 weeks; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (terribly ill for 2 weeks), PERIPHERAL SWELLING (my arm was swollen and tender), COLD SWEAT (cold sweat), EYELID MARGIN CRUSTING (crust in both eyes) and EYE PAIN (painful eye / sting in my eyes) in an 85-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.     No Medical History information was reported.    On 04-Feb-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 ILLNESS (terribly ill for 2 weeks), PERIPHERAL SWELLING (my arm was swollen and tender), COLD SWEAT (cold sweat), EYELID MARGIN CRUSTING (crust in both eyes), EYE PAIN (painful eye / sting in my eyes), DECREASED APPETITE (loss of appetite), PRODUCT DOSE OMISSION ISSUE (has not received the second dose >42 days), RASH (rash on my left arm), HEADACHE (headache), ARTHRALGIA (pain in her joints), MYALGIA (arm tender / pain in my calf), CHILLS (chills) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ILLNESS (terribly ill for 2 weeks) and PRODUCT DOSE OMISSION ISSUE (has not received the second dose >42 days) had resolved and PERIPHERAL SWELLING (my arm was swollen and tender), COLD SWEAT (cold sweat), EYELID MARGIN CRUSTING (crust in both eyes), EYE PAIN (painful eye / sting in my eyes), DECREASED APPETITE (loss of appetite), RASH (rash on my left arm), HEADACHE (headache), ARTHRALGIA (pain in her joints), MYALGIA (arm tender / pain in my calf), CHILLS (chills) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: Experience side effects 6 days after first dose; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Experience side effects 6 days after first 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,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ADVERSE EVENT (Experience side effects 6 days after first dose). At the time of the report, ADVERSE EVENT (Experience side effects 6 days after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Headache, Myalgia, Vaccination site pain
Clinical narrative: Stomach ache; Soreness at injection site; Head ache; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach ache), VACCINATION SITE PAIN (Soreness at injection site), HEADACHE (Head ache) and MYALGIA (Body ache) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-May-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach ache), VACCINATION SITE PAIN (Soreness at injection site), HEADACHE (Head ache) and MYALGIA (Body ache). At the time of the report, ABDOMINAL PAIN UPPER (Stomach ache), VACCINATION SITE PAIN (Soreness at injection site), HEADACHE (Head ache) and MYALGIA (Body ache) outcome was unknown.            Concomitant product use was not provided. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was  not applicable.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: I didn't get the second Moderna vaccine for 5 weeks; 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I didn't get the second Moderna vaccine for 5 weeks) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I didn't get the second Moderna vaccine for 5 weeks). On 28-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I didn't get the second Moderna vaccine for 5 weeks) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Side effect; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effect) 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,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION COMPLICATION (Side effect). At the time of the report, VACCINATION COMPLICATION (Side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Paraesthesia
Clinical narrative: Feeling a little bit of tingling in my hand; Felt tired; A lot of pain on my arm; 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 PARAESTHESIA (Feeling a little bit of tingling in my hand), FATIGUE (Felt tired) and MYALGIA (A lot of pain on my arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient medical history was not provided by the reporter.     On 27-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (Feeling a little bit of tingling in my hand), FATIGUE (Felt tired) and MYALGIA (A lot of pain on my arm). At the time of the report, PARAESTHESIA (Feeling a little bit of tingling in my hand), FATIGUE (Felt tired) and MYALGIA (A lot of pain on my arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    Reporter did not allow further contact
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 of 102.3 after 2nd 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 28-May-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever of 102.3 after 2nd dose). At the time of the report, PYREXIA (fever of 102.3 after 2nd dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 102.3 (High) 102.3.
Sex: M
Vaccine: COVID19
Symptoms: Infectious mononucleosis
Clinical narrative: Mononucleosis; This spontaneous case was reported by a consumer and describes the occurrence of INFECTIOUS MONONUCLEOSIS (Mononucleosis) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     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 INFECTIOUS MONONUCLEOSIS (Mononucleosis). At the time of the report, INFECTIOUS MONONUCLEOSIS (Mononucleosis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that patient received Moderna COVID-19  vaccine 3 weeks ago and after that he had mononucleosis.  Concomitant product use was not provided. Treatment information was not provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm hursts really bad; 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 PAIN IN EXTREMITY (Arm hursts really bad) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm hursts really bad). At the time of the report, PAIN IN EXTREMITY (Arm hursts really bad) outcome was unknown.            Concomitant medication were not reported Treatment medication information were not reported  Action taken with mRNA-1273 in response to the event was not applicable.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Administered 1 mL instead of a 0.5 mL; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (Administered 1 mL instead of a 0.5 mL) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (Administered 1 mL instead of a 0.5 mL). At the time of the report, ACCIDENTAL OVERDOSE (Administered 1 mL instead of a 0.5 mL) had 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.   Concomitant product use was not provided. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Arm hurt) 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 30-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 MYALGIA (Arm hurt). At the time of the report, MYALGIA (Arm hurt) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Follow up received on 09-Jun-2021 contain significant information: Outcome of the event changed from unknown to recovered,
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Bone pain, Pyrexia
Clinical narrative: Pain in all my bones; I feel weak; I feel feverish; 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 BONE PAIN (Pain in all my bones), ASTHENIA (I feel weak) and PYREXIA (I feel feverish) 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 27-May-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, the patient experienced BONE PAIN (Pain in all my bones), ASTHENIA (I feel weak) and PYREXIA (I feel feverish). At the time of the report, BONE PAIN (Pain in all my bones), ASTHENIA (I feel weak) and PYREXIA (I feel feverish) outcome was unknown.            Concomitant product use was not provided. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was  not applicable.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Nausea, Somnolence
Clinical narrative: Slept alot; Dizzy; Sweating; Nausea; 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 SOMNOLENCE (Slept alot), DIZZINESS (Dizzy), HYPERHIDROSIS (Sweating) and NAUSEA (Nausea) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (Slept alot), DIZZINESS (Dizzy), HYPERHIDROSIS (Sweating) and NAUSEA (Nausea). At the time of the report, SOMNOLENCE (Slept alot), DIZZINESS (Dizzy), HYPERHIDROSIS (Sweating) and NAUSEA (Nausea) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not Applicable.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: Had a fever all night; Aches all over; Head hurts; 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 (Had a fever all night), MYALGIA (Aches all over) and HEADACHE (Head hurts) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (Had a fever all night), MYALGIA (Aches all over) and HEADACHE (Head hurts). At the time of the report, PYREXIA (Had a fever all night), MYALGIA (Aches all over) and HEADACHE (Head hurts) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: under 18 years old, received the vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under 18 years old, received the vaccine) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C21A and 014C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under 18 years old, received the vaccine). On 18-May-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under 18 years old, received the vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported.  No treatment information was provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Age: 66.0
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Illness, Malaise, Myalgia, Nausea
Clinical narrative: Terrible chest conges; No energy; Hurt everywhere; Nauseous; Feeling ill; Sick; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY TRACT CONGESTION (Terrible chest conges), ILLNESS (Sick), ASTHENIA (No energy), MALAISE (Feeling ill) and MYALGIA (Hurt everywhere) in a 66-year-old patient of an unknown gender 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.    In January 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RESPIRATORY TRACT CONGESTION (Terrible chest conges), ILLNESS (Sick), ASTHENIA (No energy), MALAISE (Feeling ill), MYALGIA (Hurt everywhere) and NAUSEA (Nauseous). At the time of the report, RESPIRATORY TRACT CONGESTION (Terrible chest conges), ILLNESS (Sick), ASTHENIA (No energy), MALAISE (Feeling ill), MYALGIA (Hurt everywhere) and NAUSEA (Nauseous) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient received their Moderna vaccines in January and three months later the patient began to feel ill. The patient also reported that it was now 5 weeks into this feeling and the patient can't take it anymore.  Reportedly, the patient hurt everywhere and felt nauseous, having no energy and had a Terrible chest conge.  No Concomitant product use was reported. No treatment information was provided.
Age: 66.0
Sex: U
Vaccine: COVID19
Symptoms: Respiratory tract congestion
Clinical narrative: Terrible chest conges; No energy; Hurt everywhere; Nauseous; Feeling ill; Sick; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY TRACT CONGESTION (Terrible chest conges), ILLNESS (Sick), ASTHENIA (No energy), MALAISE (Feeling ill) and MYALGIA (Hurt everywhere) in a 66-year-old patient of an unknown gender 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.    In January 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RESPIRATORY TRACT CONGESTION (Terrible chest conges), ILLNESS (Sick), ASTHENIA (No energy), MALAISE (Feeling ill), MYALGIA (Hurt everywhere) and NAUSEA (Nauseous). At the time of the report, RESPIRATORY TRACT CONGESTION (Terrible chest conges), ILLNESS (Sick), ASTHENIA (No energy), MALAISE (Feeling ill), MYALGIA (Hurt everywhere) and NAUSEA (Nauseous) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient received their Moderna vaccines in January and three months later the patient began to feel ill. The patient also reported that it was now 5 weeks into this feeling and the patient can't take it anymore.  Reportedly, the patient hurt everywhere and felt nauseous, having no energy and had a Terrible chest conge.  No Concomitant product use was reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Vertigo, Vomiting
Clinical narrative: Felt like the room was spinning; Very nauseous; Throwing up; Headache; Chills; 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 VERTIGO (Felt like the room was spinning), NAUSEA (Very nauseous), VOMITING (Throwing up), HEADACHE (Headache) and CHILLS (Chills) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VERTIGO (Felt like the room was spinning), NAUSEA (Very nauseous), VOMITING (Throwing up), HEADACHE (Headache) and CHILLS (Chills). At the time of the report, VERTIGO (Felt like the room was spinning), NAUSEA (Very nauseous), VOMITING (Throwing up), HEADACHE (Headache) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient post receiving their first dose of vaccine experienced very nauseous, headache, throwing up and chills. Reportedly, the patient felt like the room was spinning for about 2 days   No Concomitant product use was reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Anxiety
Clinical narrative: Anxiety; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of ANXIETY (Anxiety) 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 ANXIETY (Anxiety). At the time of the report, ANXIETY (Anxiety) 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.   The reporter was a pharmacist who was reporting on behalf of their patient who received their vaccine dose and had anxiety for at least a month. Reportedly, the anxiety been ongoing.   No Concomitant product use was reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: I have 101,7 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 (I have 101,7 fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (I have 101,7 fever). At the time of the report, PYREXIA (I have 101,7 fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.7 (High) fever-101.7.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitants were reported. No treatment was reported.