chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
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 no. Unknown) 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 HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided. Concomitant product use was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: welts look like bug bites; how do i treat my rash; 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 URTICARIA (welts look like bug bites) and RASH (how do i treat my rash) 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 URTICARIA (welts look like bug bites) and RASH (how do i treat my rash). At the time of the report, URTICARIA (welts look like bug bites) and RASH (how do i treat my rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medications are provided. treatment to the events not reported.
Sex: U
Vaccine: COVID19
Symptoms: Illness, Inappropriate schedule of product administration
Clinical narrative: It has been 8 weeks since the first shot; illness; 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 (It has been 8 weeks since the first shot) and ILLNESS (illness) 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (It has been 8 weeks since the first shot) and ILLNESS (illness). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (It has been 8 weeks since the first shot) had resolved and ILLNESS (illness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitants were reported. No treatment was reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Tenderness on the injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Tenderness on the injection Site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced VACCINATION SITE PAIN (Tenderness on the injection Site). On 29-Apr-2021, VACCINATION SITE PAIN (Tenderness on the injection Site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was given. No laboratory details was given. No treatment information was given. The Second dose is scheduled for 27MAY2021 at 2:40PM.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen glands in the neck and under the ear; 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 LYMPHADENOPATHY (Swollen glands in the neck and under the ear) 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 LYMPHADENOPATHY (Swollen glands in the neck and under the ear). At the time of the report, LYMPHADENOPATHY (Swollen glands in the neck and under the ear) outcome was unknown.            no concomitant drugs and treatment medications were provided.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Eyelid skin dryness, Rash
Clinical narrative: eyelids were flaky; severe rash on body; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EYELID SKIN DRYNESS (eyelids were flaky) and RASH (severe rash on body) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 016M20A) for COVID-19 vaccination.     No medical history provided.  Concomitant products included LOSARTAN and ATORVASTATIN 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 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced EYELID SKIN DRYNESS (eyelids were flaky) and RASH (severe rash on body). At the time of the report, EYELID SKIN DRYNESS (eyelids were flaky) and RASH (severe rash on body) was resolving.            Treatment medication given for patient include steroids and topical steroid cream.  Action taken with mRNA-1273 in response to the event was not applicable.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Diarrhoea, Fatigue
Clinical narrative: muscle and joint pain, described as being sore; fever; diarrhea; fatigue and being tired; headache; muscle and joint pain, described as being sore; chills started a couple of days ago; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), FATIGUE (fatigue and being tired), HEADACHE (headache), ARTHRALGIA (muscle and joint pain, described as being sore) and CHILLS (chills started a couple of days ago) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METFORMIN, PARACETAMOL (ACETAMINOPHEN EXTRA STRENGTH), LISINOPRIL, PIROXICAM (PAXIL [PIROXICAM]), ARIPIPRAZOLE (ABILIFY), COLECALCIFEROL (VITAMIN D3) and VITAMIN B COMPLEX for an unknown indication.    On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, the patient experienced CHILLS (chills started a couple of days ago). On 19-May-2021, the patient experienced DIARRHOEA (diarrhea), FATIGUE (fatigue and being tired), HEADACHE (headache), ARTHRALGIA (muscle and joint pain, described as being sore) and PYREXIA (fever). On an unknown date, the patient experienced MYALGIA (muscle and joint pain, described as being sore). At the time of the report, DIARRHOEA (diarrhea), FATIGUE (fatigue and being tired), HEADACHE (headache), ARTHRALGIA (muscle and joint pain, described as being sore), CHILLS (chills started a couple of days ago), PYREXIA (fever) and MYALGIA (muscle and joint pain, described as being sore) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.7 (High) 101.7 degrees.. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications are reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Followup document contains about the lab test.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia, SARS-CoV-2 test
Clinical narrative: muscle and joint pain, described as being sore; fever; diarrhea; fatigue and being tired; headache; muscle and joint pain, described as being sore; chills started a couple of days ago; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), FATIGUE (fatigue and being tired), HEADACHE (headache), ARTHRALGIA (muscle and joint pain, described as being sore) and CHILLS (chills started a couple of days ago) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METFORMIN, PARACETAMOL (ACETAMINOPHEN EXTRA STRENGTH), LISINOPRIL, PIROXICAM (PAXIL [PIROXICAM]), ARIPIPRAZOLE (ABILIFY), COLECALCIFEROL (VITAMIN D3) and VITAMIN B COMPLEX for an unknown indication.    On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, the patient experienced CHILLS (chills started a couple of days ago). On 19-May-2021, the patient experienced DIARRHOEA (diarrhea), FATIGUE (fatigue and being tired), HEADACHE (headache), ARTHRALGIA (muscle and joint pain, described as being sore) and PYREXIA (fever). On an unknown date, the patient experienced MYALGIA (muscle and joint pain, described as being sore). At the time of the report, DIARRHOEA (diarrhea), FATIGUE (fatigue and being tired), HEADACHE (headache), ARTHRALGIA (muscle and joint pain, described as being sore), CHILLS (chills started a couple of days ago), PYREXIA (fever) and MYALGIA (muscle and joint pain, described as being sore) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.7 (High) 101.7 degrees.. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications are reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Followup document contains about the lab test.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema
Clinical narrative: Redness at the injection site, it had increased in size, and little less lighter / red spot at injection spot; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Redness at the injection site, it had increased in size, and little less lighter / red spot at injection spot) in a 121-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No medical history were reported.     On 17-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, the patient experienced INJECTION SITE ERYTHEMA (Redness at the injection site, it had increased in size, and little less lighter / red spot at injection spot). At the time of the report, INJECTION SITE ERYTHEMA (Redness at the injection site, it had increased in size, and little less lighter / red spot at injection spot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitants and treatment medicines were reported.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow-up information was received on 26-MAY-2021 and it contains No New information
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Vaccination site pruritus, Vomiting
Clinical narrative: itching at the injection site; vomiting; fatigue; Soreness; Slight 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 VACCINATION SITE PRURITUS (itching at the injection site), VOMITING (vomiting), FATIGUE (fatigue), MYALGIA (Soreness) and HEADACHE (Slight 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (itching at the injection site), VOMITING (vomiting), FATIGUE (fatigue), MYALGIA (Soreness) and HEADACHE (Slight headache). At the time of the report, VACCINATION SITE PRURITUS (itching at the injection site), VOMITING (vomiting), FATIGUE (fatigue), MYALGIA (Soreness) and HEADACHE (Slight headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Vaccination site pain; super tired; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) and FATIGUE (super tired) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Vaccination site pain) and FATIGUE (super tired). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) and FATIGUE (super tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication was not reported
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Pt received 2nd dose 7days after receiving initial dose; 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Pt received 2nd dose 7days after receiving initial 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 22-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 29-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Pt received 2nd dose 7days after receiving initial dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Pt received 2nd dose 7days after receiving initial dose) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Diarrhoea
Clinical narrative: modest diarrhea; Lumbar back pain problem; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 26-May-2021. The most recent information was received on 26-Jul-2021 and was forwarded to Moderna on 26-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (modest diarrhea) and BACK PAIN (Lumbar back pain problem) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A20A and 010M204) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-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 DIARRHOEA (modest diarrhea) and BACK PAIN (Lumbar back pain problem). The patient was treated with Physical therapy for Back pain. At the time of the report, DIARRHOEA (modest diarrhea) had resolved and BACK PAIN (Lumbar back pain problem) was resolving.            No treatment and concomitant medications were reported. Patient reports that the diarrhea may or may not be associated with the two dosses of moderna. Patient is currently taking physical therapy which is helping.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow-Up received on 26 Jul 2021, contains updated patient initials, event reported by primary source for the event  lower back ache changed to lumbar back pain problem, outcome of the event diarrhea updated from unknown to recovered, outcome of the event lumbar back pain updated from unknown to recovering and non-drug treatment for back pain.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Gait disturbance, Myalgia, Pain in extremity
Clinical narrative: Pain in my joints, pain in hands; A little fatigue; Muscle pain; Pain in upper part of the hands; Walking like a really old man; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Pain in my joints, pain in hands), FATIGUE (A little fatigue), MYALGIA (Muscle pain), PAIN IN EXTREMITY (Pain in upper part of the hands) and GAIT DISTURBANCE (Walking like a really old man) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical history was provided by the reporter.  Concurrent medical conditions included Blood pressure. Concomitant products included NIFEDIPINE (NIFEDIPINE L) for Hypertension.    On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Pain in my joints, pain in hands), FATIGUE (A little fatigue), MYALGIA (Muscle pain), PAIN IN EXTREMITY (Pain in upper part of the hands) and GAIT DISTURBANCE (Walking like a really old man). At the time of the report, ARTHRALGIA (Pain in my joints, pain in hands), FATIGUE (A little fatigue), MYALGIA (Muscle pain), PAIN IN EXTREMITY (Pain in upper part of the hands) and GAIT DISTURBANCE (Walking like a really old man) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Insomnia, Oropharyngeal pain
Clinical narrative: Dry cough; severe pain in throat/like a tickle; Cant sleep because of cough; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Dry cough), OROPHARYNGEAL PAIN (severe pain in throat/like a tickle) and INSOMNIA (Cant sleep because of cough) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Mar-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 26-Mar-2021, the patient experienced COUGH (Dry cough), OROPHARYNGEAL PAIN (severe pain in throat/like a tickle) and INSOMNIA (Cant sleep because of cough). At the time of the report, COUGH (Dry cough), OROPHARYNGEAL PAIN (severe pain in throat/like a tickle) and INSOMNIA (Cant sleep because of cough) outcome was unknown.            Treatment information was not provided. Concomitant product use was not provided. Lab data was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Experiencing high temperature since 12 hours; 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 (Experiencing high temperature since 12 hours) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Experiencing high temperature since 12 hours). At the time of the report, PYREXIA (Experiencing high temperature since 12 hours) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.         Experiencing high temperature since 12 hours
Sex: U
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: coughing; 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 COUGH (coughing) 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 COUGH (coughing). At the time of the report, COUGH (coughing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizziness; 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 DIZZINESS (dizziness) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced DIZZINESS (dizziness). At the time of the report, DIZZINESS (dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        AE submitted   Reporter did not allow further contact
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea, Vaccination site pain, Vomiting
Clinical narrative: dizziness, felt very dizzy; vaccination site pain; threw up; severe headache; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness, felt very dizzy), VACCINATION SITE PAIN (vaccination site pain), VOMITING (threw up), HEADACHE (severe headache) and NAUSEA (nauseous) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, the patient experienced DIZZINESS (dizziness, felt very dizzy), VACCINATION SITE PAIN (vaccination site pain), VOMITING (threw up), HEADACHE (severe headache) and NAUSEA (nauseous). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIZZINESS (dizziness, felt very dizzy), VACCINATION SITE PAIN (vaccination site pain), VOMITING (threw up), HEADACHE (severe headache) and NAUSEA (nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: migraine; 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 MIGRAINE (migraine) 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 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 MIGRAINE (migraine). At the time of the report, MIGRAINE (migraine) outcome was unknown.            Action taken with mRNA-1273 in response to the event were not applicable. Treatment medication were not reported. Concomitant medication were not reported
Sex: M
Vaccine: COVID19
Symptoms: Product storage error, Wrong technique in product usage process
Clinical narrative: Dropped a vial out of refrigerator 3 to 4 feet.; It may have shaken when it hit the ground; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Dropped a vial out of refrigerator 3 to 4 feet.) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (It may have shaken when it hit the ground) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034c21a) 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 PRODUCT STORAGE ERROR (Dropped a vial out of refrigerator 3 to 4 feet.) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (It may have shaken when it hit the ground). At the time of the report, PRODUCT STORAGE ERROR (Dropped a vial out of refrigerator 3 to 4 feet.) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (It may have shaken when it hit the ground) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Cough, Pyrexia
Clinical narrative: Stayed in bed all day; Fever and stayed in bad all day; Cough; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), BEDRIDDEN (Stayed in bed all day) and PYREXIA (Fever and stayed in bad all day) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in February 2021 and Pacemaker insertion (cardiac) since an unknown date. Concurrent medical conditions included Stroke. Concomitant products included METOPROLOL and CLOPIDOGREL BISULFATE (PLAVIX) for an unknown indication.    On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-May-2021, the patient experienced COUGH (Cough) and PYREXIA (Fever and stayed in bad all day). On an unknown date, the patient experienced BEDRIDDEN (Stayed in bed all day). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, COUGH (Cough), BEDRIDDEN (Stayed in bed all day) and PYREXIA (Fever and stayed in bad all day) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Influenza like illness, Poor quality sleep, Restless legs syndrome, Vaccination site pain
Clinical narrative: he was miserable; flu like symptoms; his legs were restless; he did not sleep well; He had achy arm, really sore arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (he was miserable), INFLUENZA LIKE ILLNESS (flu like symptoms), RESTLESS LEGS SYNDROME (his legs were restless), POOR QUALITY SLEEP (he did not sleep well) and VACCINATION SITE PAIN (He had achy arm, really sore arm) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A. and 040A21A) for COVID-19 vaccination.     The patient's past medical history included Renal transplant (36 years ago) since an unknown date.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-May-2021, the patient experienced FEELING ABNORMAL (he was miserable), INFLUENZA LIKE ILLNESS (flu like symptoms), RESTLESS LEGS SYNDROME (his legs were restless), POOR QUALITY SLEEP (he did not sleep well) and VACCINATION SITE PAIN (He had achy arm, really sore arm). At the time of the report, FEELING ABNORMAL (he was miserable), INFLUENZA LIKE ILLNESS (flu like symptoms), RESTLESS LEGS SYNDROME (his legs were restless), POOR QUALITY SLEEP (he did not sleep well) and VACCINATION SITE PAIN (He had achy arm, really sore arm) outcome was unknown.            No concomitant medications were provided. No treatment information was provided.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Lymph node pain, Pyrexia, Vaccination site pain
Clinical narrative: Pain in left arm, Vaccination site pain; Fever; Pain in lymph node; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain in left arm, Vaccination site pain), PYREXIA (Fever), LYMPH NODE PAIN (Pain in lymph node) and HEADACHE (Headache) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043L20A and 002C21A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], PARACETAMOL (TYLENOL) and CAFFEINE for Migraine.   On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-May-2021, the patient experienced VACCINATION SITE PAIN (Pain in left arm, Vaccination site pain), PYREXIA (Fever), LYMPH NODE PAIN (Pain in lymph node) and HEADACHE (Headache). At the time of the report, VACCINATION SITE PAIN (Pain in left arm, Vaccination site pain), PYREXIA (Fever), LYMPH NODE PAIN (Pain in lymph node) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-May-2021, Body temperature: 100.7 (High) body temperature: 100.7 F.         Action taken with mRNA-1273 in response to the event was not applicable. Patient mentioned that doctor prescribed Maxalt but that doesn't work properly so patient does not administer it.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Received 1st dose then tested positive for COVID 19; 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 SARS-COV-2 TEST POSITIVE (Received 1st dose then tested positive for COVID 19) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     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 SARS-COV-2 TEST POSITIVE (Received 1st dose then tested positive for COVID 19). At the time of the report, SARS-COV-2 TEST POSITIVE (Received 1st dose then tested positive for COVID 19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment information was not provided.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site reaction, Vaccination site urticaria
Clinical narrative: "COVID arm"; hard welts about 4 by 3 inches; itchiness; large red welts; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION ("COVID arm"), VACCINATION SITE URTICARIA (hard welts about 4 by 3 inches), VACCINATION SITE PRURITUS (itchiness) and VACCINATION SITE ERYTHEMA (large red welts) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     Medical history was not provided by the reporter.  Concomitant products included LORATADINE for an unknown indication.    On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, the patient experienced VACCINATION SITE REACTION ("COVID arm"), VACCINATION SITE URTICARIA (hard welts about 4 by 3 inches), VACCINATION SITE PRURITUS (itchiness) and VACCINATION SITE ERYTHEMA (large red welts). At the time of the report, VACCINATION SITE REACTION ("COVID arm"), VACCINATION SITE URTICARIA (hard welts about 4 by 3 inches), VACCINATION SITE PRURITUS (itchiness) and VACCINATION SITE ERYTHEMA (large red welts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       After 3 days itchiness stopped. Patient still has hard welts  about 4 by 3 inches. No laboratory details was given. No treatment information was given.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: second dose greater than 34 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 PRODUCT DOSE OMISSION ISSUE (second dose greater than 34 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 an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (second dose greater than 34 days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (second dose greater than 34 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication provided. No concomitant medication provided. Patient received first dose of Covid vaccine in December and was concerned if patient could get 2nd dose or does it need repeated .
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Received vaccine on 31 day of refrigerator storage; 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 PRODUCT STORAGE ERROR (Received vaccine on 31 day of refrigerator storage) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A.) 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 PRODUCT STORAGE ERROR (Received vaccine on 31 day of refrigerator storage). At the time of the report, PRODUCT STORAGE ERROR (Received vaccine on 31 day of refrigerator storage) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The reporter stated that seventeen patients were administered with vaccine on 31 day of being stored in the refrigerator. It was mentioned that there was no temperature excursion and the temperature was strictly maintained. The expiration date was till October 2021. No further information was provided.  Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Vaccination site erythema, Vaccination site warmth
Clinical narrative: redness is spreading slowly; area is mildly warm to the touch; redness at vax site a week after receiving the vax; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness is spreading slowly), VACCINATION SITE WARMTH (area is mildly warm to the touch) and VACCINATION SITE ERYTHEMA (redness at vax site a week after receiving the vax) 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) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (redness is spreading slowly), VACCINATION SITE WARMTH (area is mildly warm to the touch) and VACCINATION SITE ERYTHEMA (redness at vax site a week after receiving the vax). At the time of the report, ERYTHEMA (redness is spreading slowly), VACCINATION SITE WARMTH (area is mildly warm to the touch) and VACCINATION SITE ERYTHEMA (redness at vax site a week after receiving the vax) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product was not provided by the reporter.  Treatment information was not provided.  Additional information reported include that the patient had no change in skin texture.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse drug reaction, Feeling abnormal, Headache, Pain in extremity, Paraesthesia
Clinical narrative: had a lot of reactions; had brain fog; bad headaches; covid arm; tingling in hands and feet that lasted for weeks; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (had a lot of reactions), FEELING ABNORMAL (had brain fog), HEADACHE (bad headaches), PAIN IN EXTREMITY (covid arm) and PARAESTHESIA (tingling in hands and feet that lasted for weeks) in a 26-year-old male patient 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 ADVERSE DRUG REACTION (had a lot of reactions), FEELING ABNORMAL (had brain fog), HEADACHE (bad headaches), PAIN IN EXTREMITY (covid arm) and PARAESTHESIA (tingling in hands and feet that lasted for weeks). At the time of the report, ADVERSE DRUG REACTION (had a lot of reactions), FEELING ABNORMAL (had brain fog), HEADACHE (bad headaches), PAIN IN EXTREMITY (covid arm) and PARAESTHESIA (tingling in hands and feet that lasted for weeks) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Heart rate irregular
Clinical narrative: Irregular heartbeats for 8 hours after vaccine administration; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEART RATE IRREGULAR (Irregular heartbeats for 8 hours after vaccine administration) 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 HEART RATE IRREGULAR (Irregular heartbeats for 8 hours after vaccine administration). At the time of the report, HEART RATE IRREGULAR (Irregular heartbeats for 8 hours after vaccine administration) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: Fever; Felt bad all day yesterday/still feeling bad/Does not feel good; Sore arm; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt bad all day yesterday/still feeling bad/Does not feel good), VACCINATION SITE PAIN (Sore arm), PYREXIA (Fever) and MYALGIA (Body aches) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 039A21A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic back pain. Concomitant products included HYDROCODONE for Chronic back pain.   On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-May-2021, the patient experienced VACCINATION SITE PAIN (Sore arm) and MYALGIA (Body aches). On 25-May-2021, the patient experienced FEELING ABNORMAL (Felt bad all day yesterday/still feeling bad/Does not feel good). On 26-May-2021, the patient experienced PYREXIA (Fever). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Fever, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (Felt bad all day yesterday/still feeling bad/Does not feel good), VACCINATION SITE PAIN (Sore arm), PYREXIA (Fever) and MYALGIA (Body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-May-2021, Body temperature: 99.7 (Inconclusive) Fever- 99.7degrees.         Patient reported that he takes monthly injections in the back for the chronic back pain. Action taken with mRNA is not applicable.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rush all over their body that has increasingly gotten worse through out the days; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rush all over their body that has increasingly gotten worse through out the days) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009c21a) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 01-Oct-2020. Concurrent medical conditions included Hypertension and Bipolar disorder. Concomitant products included VENLAFAXINE, TRAZODONE and LAMOTRIGINE for an unknown indication.    On 16-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, the patient experienced RASH (rush all over their body that has increasingly gotten worse through out the days). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, RASH (rush all over their body that has increasingly gotten worse through out the days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treatment medication include topical creams.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: arm where i got the shot is itchy; arm where i got the shot is raised; arm where i got the shot is red; 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 (arm where i got the shot is itchy), VACCINATION SITE SWELLING (arm where i got the shot is raised) and VACCINATION SITE ERYTHEMA (arm where i got the shot is red) 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.    In 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 VACCINATION SITE PRURITUS (arm where i got the shot is itchy), VACCINATION SITE SWELLING (arm where i got the shot is raised) and VACCINATION SITE ERYTHEMA (arm where i got the shot is red). At the time of the report, VACCINATION SITE PRURITUS (arm where i got the shot is itchy), VACCINATION SITE SWELLING (arm where i got the shot is raised) and VACCINATION SITE ERYTHEMA (arm where i got the shot is red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided No treatment medications provided
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: administered the second dose to a patient 14 days after the first dose; 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (administered the second dose to a patient 14 days after the first dose) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (administered the second dose to a patient 14 days after the first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (administered the second dose to a patient 14 days after the first dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided.