chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Headache, Hypotension, Myalgia, Nasal congestion
Clinical narrative: felt like having COVID again after both doses; blood pressure is low and sometime plummets to about 70/40; nasal congestion; Muscle ache; headache; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (felt like having COVID again after both doses), HYPOTENSION (blood pressure is low and sometime plummets to about 70/40), NASAL CONGESTION (nasal congestion), MYALGIA (Muscle ache) and HEADACHE (headache) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 045B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in October 2020 and Pneumonia in October 2020. Concurrent medical conditions included Hypertension. Concomitant products included LOSARTAN for Blood pressure management, ZOLPIDEM TARTRATE (AMBIEN) for Sleep disorder NOS.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-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 SUSPECTED COVID-19 (felt like having COVID again after both doses), HYPOTENSION (blood pressure is low and sometime plummets to about 70/40), NASAL CONGESTION (nasal congestion), MYALGIA (Muscle ache) and HEADACHE (headache). The patient was treated with CAFFEINE for Hypotension, at an unspecified dose and frequency. At the time of the report, SUSPECTED COVID-19 (felt like having COVID again after both doses), HYPOTENSION (blood pressure is low and sometime plummets to about 70/40) and NASAL CONGESTION (nasal congestion) outcome was unknown and MYALGIA (Muscle ache) and HEADACHE (headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Blood pressure measurement: 68/40 (Low) 68/40. On 26-May-2021, SARS-CoV-2 test: negative (Negative) Nasopharyngeal sample- negative. On 30-May-2021, SARS-CoV-2 test: negative (Negative) Nasopharyngeal sample- negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient also reported taking an unspecified pain medication and a muscle relaxer concomitantly. Patient stated that for SARS-CoV-2 infection got hospitalized on OCT 2.   This case was linked to MOD-2021-220941 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Jul-2021: Follow-up information contains  historical lab test data updated and historical COVID-19  related symptoms updated. On 08-Jul-2021: Follow up received on 08-JUL-2021 and contains No Significant INformation
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: felt like having COVID again after both doses; blood pressure is low and sometime plummets to about 70/40; nasal congestion; Muscle ache; headache; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (felt like having COVID again after both doses), HYPOTENSION (blood pressure is low and sometime plummets to about 70/40), NASAL CONGESTION (nasal congestion), MYALGIA (Muscle ache) and HEADACHE (headache) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 045B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in October 2020 and Pneumonia in October 2020. Concurrent medical conditions included Hypertension. Concomitant products included LOSARTAN for Blood pressure management, ZOLPIDEM TARTRATE (AMBIEN) for Sleep disorder NOS.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-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 SUSPECTED COVID-19 (felt like having COVID again after both doses), HYPOTENSION (blood pressure is low and sometime plummets to about 70/40), NASAL CONGESTION (nasal congestion), MYALGIA (Muscle ache) and HEADACHE (headache). The patient was treated with CAFFEINE for Hypotension, at an unspecified dose and frequency. At the time of the report, SUSPECTED COVID-19 (felt like having COVID again after both doses), HYPOTENSION (blood pressure is low and sometime plummets to about 70/40) and NASAL CONGESTION (nasal congestion) outcome was unknown and MYALGIA (Muscle ache) and HEADACHE (headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Blood pressure measurement: 68/40 (Low) 68/40. On 26-May-2021, SARS-CoV-2 test: negative (Negative) Nasopharyngeal sample- negative. On 30-May-2021, SARS-CoV-2 test: negative (Negative) Nasopharyngeal sample- negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient also reported taking an unspecified pain medication and a muscle relaxer concomitantly. Patient stated that for SARS-CoV-2 infection got hospitalized on OCT 2.   This case was linked to MOD-2021-220941 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Jul-2021: Follow-up information contains  historical lab test data updated and historical COVID-19  related symptoms updated. On 08-Jul-2021: Follow up received on 08-JUL-2021 and contains No Significant INformation
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: report side effects; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Jun-2021 and was forwarded to Moderna on 14-Jun-2021.    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 COMPLICATION (report side effects) 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 VACCINATION COMPLICATION (report side effects). At the time of the report, VACCINATION COMPLICATION (report side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitants were provided. No treatment medications were provided by the Reporter. Med Info Agent: Nensi pandya caller wants to report the side effects.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Cardiac stress test, Cardioversion, Vaccination site erythema, Vaccination site swelling
Clinical narrative: his heart was racing, he was in atrial fibrillation; the injection site was swelled up; injection site was a little red; This spontaneous case was reported by a patient and describes the occurrence of ATRIAL FIBRILLATION (his heart was racing, he was in atrial fibrillation) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 004C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced VACCINATION SITE SWELLING (the injection site was swelled up) and VACCINATION SITE ERYTHEMA (injection site was a little red). On 02-Apr-2021, the patient experienced ATRIAL FIBRILLATION (his heart was racing, he was in atrial fibrillation) (seriousness criterion medically significant). The patient was treated with DILTIAZEM ongoing since an unknown date at a dose of 1 dosage form; FUROSEMIDE ongoing since an unknown date at a dose of 1 dosage form and AMIODARONE HYDROCHLORIDE (PACERONE) ongoing since an unknown date for Heartbeats irregular and Hypertension, at a dose of 200 mg three times a day. On 02-Apr-2021, VACCINATION SITE SWELLING (the injection site was swelled up) and VACCINATION SITE ERYTHEMA (injection site was a little red) had resolved. At the time of the report, ATRIAL FIBRILLATION (his heart was racing, he was in atrial fibrillation) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-May-2021, Cardioversion: normal (normal) heart and vascular system looked fine. On 17-May-2021, Cardiac stress test: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Company comment: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-221013 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jul-2021: Follow up received 0-JUL-2021. No significant information. Contact information updated; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: It has been 57 days since a patient has received 1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (It has been 57 days since a patient has received 1st dose) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (It has been 57 days since a patient has received 1st dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (It has been 57 days since a patient has received 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported by the reporter.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: running a fever; body 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 PYREXIA (running a fever) and MYALGIA (body 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 PYREXIA (running a fever) and MYALGIA (body aches). At the time of the report, PYREXIA (running a fever) and MYALGIA (body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No information regarding corrective treatment was reported by the patient.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effects). At the time of the report, VACCINATION COMPLICATION (Side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Body temperature, Illness, Myalgia
Clinical narrative: been on the couch; pains; Sick at my stomach; Fever running up down; Aches; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (been on the couch), ABDOMINAL PAIN UPPER (pains), ABDOMINAL DISCOMFORT (Sick at my stomach), PYREXIA (Fever running up down) and MYALGIA (Aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient had Covid around March it was not too bad) in March 2021.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jun-2021, the patient experienced ILLNESS (been on the couch), ABDOMINAL PAIN UPPER (pains), ABDOMINAL DISCOMFORT (Sick at my stomach), PYREXIA (Fever running up down) and MYALGIA (Aches). At the time of the report, ILLNESS (been on the couch), ABDOMINAL PAIN UPPER (pains), ABDOMINAL DISCOMFORT (Sick at my stomach), PYREXIA (Fever running up down) and MYALGIA (Aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jun-2021, Body temperature: 101 (High) 101.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no relevant concomitant product was reported.  no treatment product was reported
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: been on the couch; pains; Sick at my stomach; Fever running up down; Aches; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (been on the couch), ABDOMINAL PAIN UPPER (pains), ABDOMINAL DISCOMFORT (Sick at my stomach), PYREXIA (Fever running up down) and MYALGIA (Aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient had Covid around March it was not too bad) in March 2021.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jun-2021, the patient experienced ILLNESS (been on the couch), ABDOMINAL PAIN UPPER (pains), ABDOMINAL DISCOMFORT (Sick at my stomach), PYREXIA (Fever running up down) and MYALGIA (Aches). At the time of the report, ILLNESS (been on the couch), ABDOMINAL PAIN UPPER (pains), ABDOMINAL DISCOMFORT (Sick at my stomach), PYREXIA (Fever running up down) and MYALGIA (Aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jun-2021, Body temperature: 101 (High) 101.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no relevant concomitant product was reported.  no treatment product was reported
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Vaccination site pain
Clinical narrative: Soreness of arm; Light fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness of arm), PYREXIA (Light fever) and CHILLS (Chills) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high since 01-May-2006. Concomitant products included AMLODIPINE for Blood pressure high.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021 at 8:00 AM, the patient experienced VACCINATION SITE PAIN (Soreness of arm), PYREXIA (Light fever) and CHILLS (Chills). On 14-May-2021, VACCINATION SITE PAIN (Soreness of arm), PYREXIA (Light fever) and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information were provided   This case was linked to MOD-2021-220987 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: Follow-up document was received.Secondary Reporter Information was updated. Patient's weight, height, race and ethnic group were added. Event outcome were updated from unknown to recovered, route of administration  added, relevant medical history and causality as reported was updated. Event coding has been changed from Pain in arm to Vaccination site pain. It contains significant information.
Sex: U
Vaccine: COVID19
Symptoms: Underdose, Wrong technique in device usage process
Clinical narrative: Pharmacist states that a needle separated while administering vaccine; Patient was given 0.2 ml of Moderna COVID-19 Vaccine; 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 WRONG TECHNIQUE IN DEVICE USAGE PROCESS (Pharmacist states that a needle separated while administering vaccine) and UNDERDOSE (Patient was given 0.2 ml of Moderna COVID-19 Vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG TECHNIQUE IN DEVICE USAGE PROCESS (Pharmacist states that a needle separated while administering vaccine) and UNDERDOSE (Patient was given 0.2 ml of Moderna COVID-19 Vaccine). At the time of the report, WRONG TECHNIQUE IN DEVICE USAGE PROCESS (Pharmacist states that a needle separated while administering vaccine) and UNDERDOSE (Patient was given 0.2 ml of Moderna COVID-19 Vaccine) 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 medication was not provided.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16 year old was accidentally given the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old was accidentally given the Moderna vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old was accidentally given the Moderna vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old was accidentally given the Moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication not provided. Treatment medication not provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Im still not feeling well/When will I feel better; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Im still not feeling well/When will I feel better) 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) (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 MALAISE (Im still not feeling well/When will I feel better). At the time of the report, MALAISE (Im still not feeling well/When will I feel better) had not resolved.            No treatment information was provided. No concomitant medications were reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache
Clinical narrative: Felt a little weak; Experienced headache; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Felt a little weak) and HEADACHE (Experienced headache) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced ASTHENIA (Felt a little weak) and HEADACHE (Experienced headache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 14-May-2021, ASTHENIA (Felt a little weak) and HEADACHE (Experienced headache) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant products were reported.   This case was linked to MOD-2021-221016 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: magnetic objects sticking at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (magnetic objects sticking at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (magnetic objects sticking at the injection site). At the time of the report, VACCINATION SITE REACTION (magnetic objects sticking at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Treatment information was not provided.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: received the second dose after it underwent a potential temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (received the second dose after it underwent a potential temperature excursion) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (received the second dose after it underwent a potential temperature excursion). On 26-Apr-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (received the second dose after it underwent a potential temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported by the reporter. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Dizziness, Fatigue, Headache
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of DECREASED APPETITE (I couldn't eat anything/appetite is still not what it should be), ASTHENIA (Feeling dizzy and weak), DIZZINESS (Feeling dizzy and weak), HEADACHE (headache) and NAUSEA (Had nausea all day long) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A and 053C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jun-2021, the patient experienced HEADACHE (headache). On 12-Jun-2021, the patient experienced DECREASED APPETITE (I couldn't eat anything/appetite is still not what it should be), ASTHENIA (Feeling dizzy and weak), DIZZINESS (Feeling dizzy and weak) and NAUSEA (Had nausea all day long). On 13-Jun-2021, the patient experienced FATIGUE (Still tired and weak). On 12-Jun-2021, DECREASED APPETITE (I couldn't eat anything/appetite is still not what it should be), ASTHENIA (Feeling dizzy and weak), DIZZINESS (Feeling dizzy and weak), HEADACHE (headache) and NAUSEA (Had nausea all day long) outcome was unknown. On 13-Jun-2021, FATIGUE (Still tired and weak) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. No concomitant medication were reported No treatment medication were reported. The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable. This case was linked to MOD-2021-221009 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of DECREASED APPETITE (I couldn't eat anything/appetite is still not what it should be), ASTHENIA (Feeling dizzy and weak), DIZZINESS (Feeling dizzy and weak), HEADACHE (headache) and NAUSEA (Had nausea all day long) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A and 053C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jun-2021, the patient experienced HEADACHE (headache). On 12-Jun-2021, the patient experienced DECREASED APPETITE (I couldn't eat anything/appetite is still not what it should be), ASTHENIA (Feeling dizzy and weak), DIZZINESS (Feeling dizzy and weak) and NAUSEA (Had nausea all day long). On 13-Jun-2021, the patient experienced FATIGUE (Still tired and weak). On 12-Jun-2021, DECREASED APPETITE (I couldn't eat anything/appetite is still not what it should be), ASTHENIA (Feeling dizzy and weak), DIZZINESS (Feeling dizzy and weak), HEADACHE (headache) and NAUSEA (Had nausea all day long) outcome was unknown. On 13-Jun-2021, FATIGUE (Still tired and weak) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. No concomitant medication were reported No treatment medication were reported. The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable. This case was linked to MOD-2021-221009 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: missed my vaccine scheduled/ it is about 3 months since I took the first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed my vaccine scheduled/ it is about 3 months since I took the 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed my vaccine scheduled/ it is about 3 months since I took the first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed my vaccine scheduled/ it is about 3 months since I took the first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: My husband got a Maderna very bad reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (My husband got a Maderna very bad reaction) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (My husband got a Maderna very bad reaction). At the time of the report, VACCINATION COMPLICATION (My husband got a Maderna very bad reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. Treatment medication was not provided.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: received a single dose of Moderna Covid vaccine in March, but was unable to receive the second; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (received a single dose of Moderna Covid vaccine in March, but was unable to receive the second) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (received a single dose of Moderna Covid vaccine in March, but was unable to receive the second). At the time of the report, PRODUCT DOSE OMISSION ISSUE (received a single dose of Moderna Covid vaccine in March, but was unable to receive the second) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Hepatic enzyme increased
Clinical narrative: increase of a liver enzyme, ALT, from eighteen to sixty-four; This spontaneous case was reported by a pharmacist and describes the occurrence of HEPATIC ENZYME INCREASED (increase of a liver enzyme, ALT, from eighteen to sixty-four) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced HEPATIC ENZYME INCREASED (increase of a liver enzyme, ALT, from eighteen to sixty-four). At the time of the report, HEPATIC ENZYME INCREASED (increase of a liver enzyme, ALT, from eighteen to sixty-four) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Headache, Myalgia, Pain in extremity
Clinical narrative: arm pain after carrying 5-10 pounds items; Joint pain/Left shoulder pain; Muscle pain/whole upper body hurting; Chest pain; Leg pain/arm pain/left arm pain; Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (Chest pain), PAIN IN EXTREMITY (Leg pain/arm pain/left arm pain), PAIN IN EXTREMITY (arm pain after carrying 5-10 pounds items), ARTHRALGIA (Joint pain/Left shoulder pain) and MYALGIA (Muscle pain/whole upper body hurting) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced PAIN IN EXTREMITY (Leg pain/arm pain/left arm pain) and HEADACHE (Headache). On 20-Apr-2021, the patient experienced CHEST PAIN (Chest pain), ARTHRALGIA (Joint pain/Left shoulder pain) and MYALGIA (Muscle pain/whole upper body hurting). On 14-Jun-2021, the patient experienced PAIN IN EXTREMITY (arm pain after carrying 5-10 pounds items). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and METHYLPREDNISOLONE at an unspecified dose and frequency. At the time of the report, CHEST PAIN (Chest pain) and HEADACHE (Headache) outcome was unknown and PAIN IN EXTREMITY (Leg pain/arm pain/left arm pain), PAIN IN EXTREMITY (arm pain after carrying 5-10 pounds items), ARTHRALGIA (Joint pain/Left shoulder pain) and MYALGIA (Muscle pain/whole upper body hurting) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient has had multiple types of testing including blood, autoimmune and neurological testing.  No concomitant medications were reported by the reporter. No treatment medications were reported by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Wrong technique in product usage process
Clinical narrative: utilized multiple vials for one dose; 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 WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (utilized multiple vials for one 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.    In June 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. In June 2021, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (utilized multiple vials for one dose). At the time of the report, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (utilized multiple vials for one dose) 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.   No concomitant medications reported. No treatment information was provided. It was reported that 11 unidentified patients were affected.  These patients received a full 0.5 ml dose.
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: not to be able to smell; not to be able to taste; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (not to be able to smell) and AGEUSIA (not to be able to taste) 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, the patient experienced ANOSMIA (not to be able to smell) and AGEUSIA (not to be able to taste). At the time of the report, ANOSMIA (not to be able to smell) and AGEUSIA (not to be able to taste) outcome was unknown.            No concomitant medication were reported. No treatment medication were given.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Product administered to patient of inappropriate age
Clinical narrative: Pregnant patient; 16 years old patient; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 years old patient) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 26-Nov-2020 and the estimated date of delivery was 06-Sep-2021. On 17-May-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 years old patient). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-fourth week of the pregnancy.  On 17-May-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 years old patient) 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 product use was not provided by the reporter.   ? No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Myalgia
Clinical narrative: Miserable; Hurt all over my body; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Miserable) and MYALGIA (Hurt all over my body) 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, the patient experienced FEELING ABNORMAL (Miserable) and MYALGIA (Hurt all over my body). At the time of the report, FEELING ABNORMAL (Miserable) and MYALGIA (Hurt all over my body) outcome was unknown.            No concomitant medications were reported by the reporter. No treatment medications were reported by the reporter.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Dysgeusia, Injection site reaction, Urticaria
Clinical narrative: Metal in arm, magnetic objects sticking at the injection site and right clavicle; Loss of appetite; Metalic taste in mouth; hives on arm/neck; covid arm; Intense cold chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Metal in arm, magnetic objects sticking at the injection site and right clavicle), DECREASED APPETITE (Loss of appetite), DYSGEUSIA (Metalic taste in mouth), URTICARIA (hives on arm/neck) and INJECTION SITE REACTION (covid arm) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 06A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medication history was reported.  Concomitant products included AMLODIPINE and SIMVASTATIN for an unknown indication.    On 29-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Metal in arm, magnetic objects sticking at the injection site and right clavicle), DECREASED APPETITE (Loss of appetite), DYSGEUSIA (Metalic taste in mouth), URTICARIA (hives on arm/neck), INJECTION SITE REACTION (covid arm) and CHILLS (Intense cold chills). At the time of the report, VACCINATION SITE REACTION (Metal in arm, magnetic objects sticking at the injection site and right clavicle), DECREASED APPETITE (Loss of appetite), DYSGEUSIA (Metalic taste in mouth), URTICARIA (hives on arm/neck), INJECTION SITE REACTION (covid arm) and CHILLS (Intense cold chills) outcome was unknown.            No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: follow-up received on 14-JUN-2021. Contains non significant information On 16-Jun-2021: Added new event loss of appetite. Added start date of loss of appetite On 30-Jun-2021: Email: Video attached with email summarizing that her nail clipper and fork are sticking to her skin.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: Metal in arm, magnetic objects sticking at the injection site and right clavicle; Loss of appetite; Metalic taste in mouth; hives on arm/neck; covid arm; Intense cold chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Metal in arm, magnetic objects sticking at the injection site and right clavicle), DECREASED APPETITE (Loss of appetite), DYSGEUSIA (Metalic taste in mouth), URTICARIA (hives on arm/neck) and INJECTION SITE REACTION (covid arm) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 06A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medication history was reported.  Concomitant products included AMLODIPINE and SIMVASTATIN for an unknown indication.    On 29-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Metal in arm, magnetic objects sticking at the injection site and right clavicle), DECREASED APPETITE (Loss of appetite), DYSGEUSIA (Metalic taste in mouth), URTICARIA (hives on arm/neck), INJECTION SITE REACTION (covid arm) and CHILLS (Intense cold chills). At the time of the report, VACCINATION SITE REACTION (Metal in arm, magnetic objects sticking at the injection site and right clavicle), DECREASED APPETITE (Loss of appetite), DYSGEUSIA (Metalic taste in mouth), URTICARIA (hives on arm/neck), INJECTION SITE REACTION (covid arm) and CHILLS (Intense cold chills) outcome was unknown.            No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: follow-up received on 14-JUN-2021. Contains non significant information On 16-Jun-2021: Added new event loss of appetite. Added start date of loss of appetite On 30-Jun-2021: Email: Video attached with email summarizing that her nail clipper and fork are sticking to her skin.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on eye, mouth, chin and leg; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on eye, mouth, chin and leg) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 17-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (rash on eye, mouth, chin and leg). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency. At the time of the report, RASH (rash on eye, mouth, chin and leg) outcome was unknown.            No concomitant medications were reported by the reporter.  Additional treatment medications included unspecified steroid and itch cream.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Musculoskeletal stiffness
Clinical narrative: My neck feels stiff; I have awaken with a mighty 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 MUSCULOSKELETAL STIFFNESS (My neck feels stiff) and HEADACHE (I have awaken with a mighty 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (My neck feels stiff) and HEADACHE (I have awaken with a mighty headache). At the time of the report, MUSCULOSKELETAL STIFFNESS (My neck feels stiff) and HEADACHE (I have awaken with a mighty headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication were reported. No treatment medication were reported.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Inappropriate schedule of product administration, Insomnia, Malaise, Pyrexia
Clinical narrative: Could not sleep; Does not feel right; Received second dose 8 weeks after the first one; Headache; Slight fever; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Could not sleep), MALAISE (Does not feel right), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose 8 weeks after the first one), HEADACHE (Headache) and PYREXIA (Slight fever) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INSOMNIA (Could not sleep), MALAISE (Does not feel right), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose 8 weeks after the first one), HEADACHE (Headache) and PYREXIA (Slight fever). At the time of the report, INSOMNIA (Could not sleep), MALAISE (Does not feel right), HEADACHE (Headache) and PYREXIA (Slight fever) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose 8 weeks after the first one) had resolved.            No concomitant medications reported. Treatment information not reported.