chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Breast mass, Chills, Hyperhidrosis, Insomnia, Lymphadenopathy
Clinical narrative: sweats; arm hurt; lump in the front part of my breast left side; swollen arm; crease; cant sleep at night; i cant move it; arm is still killing me (injection site); chills; fever; bodyache; enlarged lymph node; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweats), VACCINATION SITE PAIN (arm hurt), BREAST MASS (lump in the front part of my breast left side), PERIPHERAL SWELLING (swollen arm) and SKIN WRINKLING (crease) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B(8)2 (Z)1A and 030A2(Z)1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No specified medical history has been reported.  Concomitant products included VITAMIN D NOS, LEVOTHYROXINE and LISINOPRIL for an unknown indication.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-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 HYPERHIDROSIS (sweats), VACCINATION SITE PAIN (arm hurt), BREAST MASS (lump in the front part of my breast left side), PERIPHERAL SWELLING (swollen arm), SKIN WRINKLING (crease), INSOMNIA (cant sleep at night), MOBILITY DECREASED (i cant move it), VACCINATION SITE PAIN (arm is still killing me (injection site)), CHILLS (chills), PYREXIA (fever), MYALGIA (bodyache) and LYMPHADENOPATHY (enlarged lymph node). At the time of the report, HYPERHIDROSIS (sweats), VACCINATION SITE PAIN (arm hurt), BREAST MASS (lump in the front part of my breast left side), PERIPHERAL SWELLING (swollen arm), SKIN WRINKLING (crease), INSOMNIA (cant sleep at night), MOBILITY DECREASED (i cant move it), VACCINATION SITE PAIN (arm is still killing me (injection site)), CHILLS (chills), PYREXIA (fever), MYALGIA (bodyache) and LYMPHADENOPATHY (enlarged lymph node) 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.   This case was linked to MOD-2021-264071 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: follow up received contain reporter details, patient demographics, event details
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Myalgia, Peripheral swelling, Pyrexia, Skin wrinkling
Clinical narrative: sweats; arm hurt; lump in the front part of my breast left side; swollen arm; crease; cant sleep at night; i cant move it; arm is still killing me (injection site); chills; fever; bodyache; enlarged lymph node; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweats), VACCINATION SITE PAIN (arm hurt), BREAST MASS (lump in the front part of my breast left side), PERIPHERAL SWELLING (swollen arm) and SKIN WRINKLING (crease) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B(8)2 (Z)1A and 030A2(Z)1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No specified medical history has been reported.  Concomitant products included VITAMIN D NOS, LEVOTHYROXINE and LISINOPRIL for an unknown indication.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-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 HYPERHIDROSIS (sweats), VACCINATION SITE PAIN (arm hurt), BREAST MASS (lump in the front part of my breast left side), PERIPHERAL SWELLING (swollen arm), SKIN WRINKLING (crease), INSOMNIA (cant sleep at night), MOBILITY DECREASED (i cant move it), VACCINATION SITE PAIN (arm is still killing me (injection site)), CHILLS (chills), PYREXIA (fever), MYALGIA (bodyache) and LYMPHADENOPATHY (enlarged lymph node). At the time of the report, HYPERHIDROSIS (sweats), VACCINATION SITE PAIN (arm hurt), BREAST MASS (lump in the front part of my breast left side), PERIPHERAL SWELLING (swollen arm), SKIN WRINKLING (crease), INSOMNIA (cant sleep at night), MOBILITY DECREASED (i cant move it), VACCINATION SITE PAIN (arm is still killing me (injection site)), CHILLS (chills), PYREXIA (fever), MYALGIA (bodyache) and LYMPHADENOPATHY (enlarged lymph node) 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.   This case was linked to MOD-2021-264071 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: follow up received contain reporter details, patient demographics, event details
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sweats; arm hurt; lump in the front part of my breast left side; swollen arm; crease; cant sleep at night; i cant move it; arm is still killing me (injection site); chills; fever; bodyache; enlarged lymph node; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweats), VACCINATION SITE PAIN (arm hurt), BREAST MASS (lump in the front part of my breast left side), PERIPHERAL SWELLING (swollen arm) and SKIN WRINKLING (crease) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B(8)2 (Z)1A and 030A2(Z)1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No specified medical history has been reported.  Concomitant products included VITAMIN D NOS, LEVOTHYROXINE and LISINOPRIL for an unknown indication.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-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 HYPERHIDROSIS (sweats), VACCINATION SITE PAIN (arm hurt), BREAST MASS (lump in the front part of my breast left side), PERIPHERAL SWELLING (swollen arm), SKIN WRINKLING (crease), INSOMNIA (cant sleep at night), MOBILITY DECREASED (i cant move it), VACCINATION SITE PAIN (arm is still killing me (injection site)), CHILLS (chills), PYREXIA (fever), MYALGIA (bodyache) and LYMPHADENOPATHY (enlarged lymph node). At the time of the report, HYPERHIDROSIS (sweats), VACCINATION SITE PAIN (arm hurt), BREAST MASS (lump in the front part of my breast left side), PERIPHERAL SWELLING (swollen arm), SKIN WRINKLING (crease), INSOMNIA (cant sleep at night), MOBILITY DECREASED (i cant move it), VACCINATION SITE PAIN (arm is still killing me (injection site)), CHILLS (chills), PYREXIA (fever), MYALGIA (bodyache) and LYMPHADENOPATHY (enlarged lymph node) 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.   This case was linked to MOD-2021-264071 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: follow up received contain reporter details, patient demographics, event details
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Can I give a patient the second dose if it has been more than 6 weeks in between; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Can I give a patient the second dose if it has been more than 6 weeks in between) 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 (Can I give a patient the second dose if it has been more than 6 weeks in between). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Can I give a patient the second dose if it has been more than 6 weeks in between) 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 were mentioned. No treatment details were reported.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate
Clinical narrative: slight shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (slight shortness of breath) 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 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jul-2021, the patient experienced DYSPNOEA (slight shortness of breath). At the time of the report, DYSPNOEA (slight shortness of breath) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jul-2021, Heart rate: increased (High) faster than usual.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was reported. No treatment drug details was reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 2 patients (2 doses) given that could have been doses greater then 30 days in refrigeration; 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 EXPIRED PRODUCT ADMINISTERED (2 patients (2 doses) given that could have been doses greater then 30 days in refrigeration) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (2 patients (2 doses) given that could have been doses greater then 30 days in refrigeration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2 patients (2 doses) given that could have been doses greater then 30 days in refrigeration) 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.
Sex: U
Vaccine: COVID19
Symptoms: Axillary pain, Pain in extremity, Paraesthesia
Clinical narrative: Fingers tingling; Arm hurting on the sa; Arm pit hurting; This spontaneous case was reported by a patient and describes the occurrence of PARAESTHESIA (Fingers tingling), PAIN IN EXTREMITY (Arm hurting on the sa) and AXILLARY PAIN (Arm pit hurting) 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 PARAESTHESIA (Fingers tingling), PAIN IN EXTREMITY (Arm hurting on the sa) and AXILLARY PAIN (Arm pit hurting). At the time of the report, PARAESTHESIA (Fingers tingling), PAIN IN EXTREMITY (Arm hurting on the sa) and AXILLARY PAIN (Arm pit hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported by the reporter. No treatment medications were reported by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Greater than 35 days after  the first dose of the Moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Greater than 35 days after  the first dose of the Moderna Covid-19 vaccine) 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 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Greater than 35 days after  the first dose of the Moderna Covid-19 vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Greater than 35 days after  the first dose of the Moderna Covid-19 vaccine) 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.   No concomitant product use was provided by the reporter. Treatment information was not provided.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Inflammation, Pyrexia, Weight decreased
Clinical narrative: short of breath; coughing up foam that is up in her chest and lungs; inflammation that are all ongoing; lost 68 pounds; fever to 102; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (short of breath), COUGH (coughing up foam that is up in her chest and lungs), INFLAMMATION (inflammation that are all ongoing), WEIGHT DECREASED (lost 68 pounds) and PYREXIA (fever to 102) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (short of breath), COUGH (coughing up foam that is up in her chest and lungs), INFLAMMATION (inflammation that are all ongoing), WEIGHT DECREASED (lost 68 pounds) and PYREXIA (fever to 102). At the time of the report, DYSPNOEA (short of breath), COUGH (coughing up foam that is up in her chest and lungs), INFLAMMATION (inflammation that are all ongoing), WEIGHT DECREASED (lost 68 pounds) and PYREXIA (fever to 102) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported. No Treatment information was reported.   This case was linked to MOD-2021-263909 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Follow-up information received on 22-JUL-2021 and contains General tab - Phone number, address Events tab - Newevents added.Consent to follow up-Yes
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Nausea
Clinical narrative: Bloating; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISTENSION (Bloating) and NAUSEA (Nausea) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISTENSION (Bloating) and NAUSEA (Nausea). At the time of the report, ABDOMINAL DISTENSION (Bloating) and NAUSEA (Nausea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment information was reported.   Reporter did not allow further contact
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: "lumps" in her lymph nodes on the right side of her upper chest; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY ("lumps" in her lymph nodes on the right side of her upper chest) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Breast cancer (Patients Past medical history includes a breast cancer diagnoses (under arm; left side) in 2015 (age 62).).    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY ("lumps" in her lymph nodes on the right side of her upper chest). At the time of the report, LYMPHADENOPATHY ("lumps" in her lymph nodes on the right side of her upper chest) 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.   relevant concomitant medications were reported i.e., chemotherapy treatments for breast cancer. No treatment information was provided.   This case was linked to MOD-2021-264169 (Patient Link).
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Myalgia, Respiratory disorder, Vaccination site erythema, Vaccination site pain
Clinical narrative: warm at injection site; flu-like symptoms; respiratory issues; sore arm; red at injection site; tender  at injection site.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm at injection site), INFLUENZA LIKE ILLNESS (flu-like symptoms), RESPIRATORY DISORDER (respiratory issues), MYALGIA (sore arm) and VACCINATION SITE ERYTHEMA (red at injection site) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (warm at injection site), INFLUENZA LIKE ILLNESS (flu-like symptoms), RESPIRATORY DISORDER (respiratory issues), MYALGIA (sore arm), VACCINATION SITE ERYTHEMA (red at injection site) and VACCINATION SITE PAIN (tender  at injection site.). At the time of the report, VACCINATION SITE WARMTH (warm at injection site), INFLUENZA LIKE ILLNESS (flu-like symptoms), RESPIRATORY DISORDER (respiratory issues), MYALGIA (sore arm), VACCINATION SITE ERYTHEMA (red at injection site) and VACCINATION SITE PAIN (tender  at injection site.) 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.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow up received contains no new information.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: warm at injection site; flu-like symptoms; respiratory issues; sore arm; red at injection site; tender  at injection site.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm at injection site), INFLUENZA LIKE ILLNESS (flu-like symptoms), RESPIRATORY DISORDER (respiratory issues), MYALGIA (sore arm) and VACCINATION SITE ERYTHEMA (red at injection site) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (warm at injection site), INFLUENZA LIKE ILLNESS (flu-like symptoms), RESPIRATORY DISORDER (respiratory issues), MYALGIA (sore arm), VACCINATION SITE ERYTHEMA (red at injection site) and VACCINATION SITE PAIN (tender  at injection site.). At the time of the report, VACCINATION SITE WARMTH (warm at injection site), INFLUENZA LIKE ILLNESS (flu-like symptoms), RESPIRATORY DISORDER (respiratory issues), MYALGIA (sore arm), VACCINATION SITE ERYTHEMA (red at injection site) and VACCINATION SITE PAIN (tender  at injection site.) 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.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow up received contains no new information.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: have diarrhea not as bad from my second shot of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (have diarrhea not as bad from my second shot of the 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (have diarrhea not as bad from my second shot of the vaccine). At the time of the report, DIARRHOEA (have diarrhea not as bad from my second shot of the vaccine) outcome was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Woke up with shot site hot; Woke up with shot site red; Woke up with shot site puffy; Woke up with shot site sore to touch; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (Woke up with shot site hot), VACCINATION SITE ERYTHEMA (Woke up with shot site red), VACCINATION SITE SWELLING (Woke up with shot site puffy) and VACCINATION SITE PAIN (Woke up with shot site sore to touch) 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 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jul-2021, the patient experienced VACCINATION SITE WARMTH (Woke up with shot site hot), VACCINATION SITE ERYTHEMA (Woke up with shot site red), VACCINATION SITE SWELLING (Woke up with shot site puffy) and VACCINATION SITE PAIN (Woke up with shot site sore to touch). At the time of the report, VACCINATION SITE WARMTH (Woke up with shot site hot), VACCINATION SITE ERYTHEMA (Woke up with shot site red), VACCINATION SITE SWELLING (Woke up with shot site puffy) and VACCINATION SITE PAIN (Woke up with shot site sore to touch) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided.  Treatment information was not provided.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: breathing had gotten more difficult; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (breathing had gotten more difficult) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Pulmonary arterial hypertension. Concomitant products included TREPROSTINIL from August 2021 to an unknown date for Pulmonary arterial hypertension.    In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (breathing had gotten more difficult). At the time of the report, DYSPNOEA (breathing had gotten more difficult) had not resolved. Not Provided          On an unknown date in 2021, 3 weeks ago patient took Moderna vaccine and his breathing had since gotten more difficult. The patient had reached out to physician.  No treatment medication was reported by reporter.   Reporter did not allow further contact
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Dyspnoea, Pyrexia, SARS-CoV-2 antibody test
Clinical narrative: diagnosed with new variant of COVID-19; Low grade fever; Can't breath/Can't always clear my airway; Cough that is different than it normally is; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Can't breath/Can't always clear my airway), COUGH (Cough that is different than it normally is), COVID-19 (diagnosed with new variant of COVID-19) and PYREXIA (Low grade fever) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to animal (Allergy to horses) and COPD. Concomitant products included VALSARTAN (DIOVAN), OXYCODONE HYDROCHLORIDE (OXYCONTIN), OXYCODONE, METHOCARBAMOL (ROBAXIN), TIZANIDINE HYDROCHLORIDE (ZANAFLEX) and GABAPENTIN for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jul-2021, the patient experienced DYSPNOEA (Can't breath/Can't always clear my airway), COUGH (Cough that is different than it normally is) and PYREXIA (Low grade fever). On an unknown date, the patient experienced COVID-19 (diagnosed with new variant of COVID-19). At the time of the report, DYSPNOEA (Can't breath/Can't always clear my airway), COUGH (Cough that is different than it normally is), COVID-19 (diagnosed with new variant of COVID-19) and PYREXIA (Low grade fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jul-2021, SARS-CoV-2 antibody test: positive (Positive) Patient was diagnosed with new variant of COVID-19.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No treatment information was reported
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Vaccination site pain; 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) 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 SITE PAIN (Vaccination site pain). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Intentional product use issue
Clinical narrative: Greater than 35 days since the first dose of the Moderna Covid-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (Greater than 35 days since the first dose of the Moderna Covid-19 vaccine) in a 92-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Greater than 35 days since the first dose of the Moderna Covid-19 vaccine). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (Greater than 35 days since the first dose of the Moderna Covid-19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was unknown.   For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.    Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Follow-up information received  contains Reporter information  updated address, city, postal code, phone number and fax number. Patient information updated DOB, age at time of reaction. Vaccine information updated batch number, route of administration.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: extended time period between 1st and 2nd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (extended time period between 1st and 2nd dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (extended time period between 1st and 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (extended time period between 1st and 2nd 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.   Concomitant medication was not provided.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Really sick for 3-4 days; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Really sick for 3-4 days) 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 ILLNESS (Really sick for 3-4 days). At the time of the report, ILLNESS (Really sick for 3-4 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Additional information included outcome of the event
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injected limb mobility decreased, Vaccination site pain
Clinical narrative: Headache time to time; Arm keeps hurting after the injection/ Unable to use arm daily/ Site of injection still sore/ Arm sore, can not raise or sleep on arm; Site of injection still sore/ Arm sore, can not raise or sleep on arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm keeps hurting after the injection/ Unable to use arm daily/ Site of injection still sore/ Arm sore, can not raise or sleep on arm), VACCINATION SITE PAIN (Site of injection still sore/ Arm sore, can not raise or sleep on arm) and HEADACHE (Headache time to time) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm keeps hurting after the injection/ Unable to use arm daily/ Site of injection still sore/ Arm sore, can not raise or sleep on arm) and VACCINATION SITE PAIN (Site of injection still sore/ Arm sore, can not raise or sleep on arm). On an unknown date, the patient experienced HEADACHE (Headache time to time). At the time of the report, PAIN IN EXTREMITY (Arm keeps hurting after the injection/ Unable to use arm daily/ Site of injection still sore/ Arm sore, can not raise or sleep on arm), VACCINATION SITE PAIN (Site of injection still sore/ Arm sore, can not raise or sleep on arm) and HEADACHE (Headache time to time) had not resolved.            No concomitant medications was provided. No treatment medications was provided.  The patient's ethnicity was reported as EXACT .  Patient was prescribed with steroid injection, but refused to take it. The patient was unable to use arm daily, had to sleep in certain position with arm, site at injection site was still sore and was unable to hold arm any longer.  On 29-Jun-2021, the patient visited the physician's office for arm sore, can not raise or sleep on arm.   This case was linked to MOD-2021-263574 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Race information were updated, product dose information was added, adverse events verbatim, start date and events outcome was 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.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: My arm was sore at the injection site; I was tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (My arm was sore at the injection site) and FATIGUE (I was tired) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A and 016C21A) 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 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced VACCINATION SITE PAIN (My arm was sore at the injection site) and FATIGUE (I was tired). At the time of the report, VACCINATION SITE PAIN (My arm was sore at the injection site) and FATIGUE (I was tired) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-264191 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypersomnia, Lymphadenopathy
Clinical narrative: sleeping 11-12 hours at night; feeling more tired than usual; glands are swollen; ihaving more fatigue like a short term disability; increased lymph nodes; feeling more exhausted than usual; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (sleeping 11-12 hours at night), FATIGUE (feeling more tired than usual), LYMPHADENOPATHY (glands are swollen), FATIGUE (ihaving more fatigue like a short term disability) and LYMPHADENOPATHY (increased lymph nodes) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  The patient's past medical history included Constipation. Concurrent medical conditions included Chronic fatigue syndrome, Hypothyroidism and Irritable bowel syndrome. Concomitant products included LEVOTHYROXINE, DULOXETINE HYDROCHLORIDE (CYMBALTA), TRAZODONE, LINACLOTIDE (LINZESS) and VITAMINS NOS for an unknown indication.   On 15-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 an unknown date, the patient experienced HYPERSOMNIA (sleeping 11-12 hours at night), FATIGUE (feeling more tired than usual), LYMPHADENOPATHY (glands are swollen), FATIGUE (ihaving more fatigue like a short term disability), LYMPHADENOPATHY (increased lymph nodes) and FATIGUE (feeling more exhausted than usual). At the time of the report, HYPERSOMNIA (sleeping 11-12 hours at night), FATIGUE (feeling more tired than usual), LYMPHADENOPATHY (glands are swollen), FATIGUE (ihaving more fatigue like a short term disability), LYMPHADENOPATHY (increased lymph nodes) and FATIGUE (feeling more exhausted than usual) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication reported such as cocktail for IV therapy to boost the immune system.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Bedridden, Vaccination complication
Clinical narrative: A bad reaction that lasted for about a week; Bed ridden; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (A bad reaction that lasted for about a week) and BEDRIDDEN (Bed ridden) 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 COMPLICATION (A bad reaction that lasted for about a week) and BEDRIDDEN (Bed ridden). At the time of the report, VACCINATION COMPLICATION (A bad reaction that lasted for about a week) and BEDRIDDEN (Bed ridden) 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 reported. Treatment information not reported.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: developed hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (developed hives) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Jul-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. In July 2021, the patient experienced URTICARIA (developed hives). At the time of the report, URTICARIA (developed hives) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow-up information received contains non-significant information.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered a punctured vial that was left in the fridge for 24 hours to at least 3 patients.; 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 EXPIRED PRODUCT ADMINISTERED (Administered a punctured vial that was left in the fridge for 24 hours to at least 3 patients.) 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 EXPIRED PRODUCT ADMINISTERED (Administered a punctured vial that was left in the fridge for 24 hours to at least 3 patients.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered a punctured vial that was left in the fridge for 24 hours to at least 3 patients.) 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 were provided by reporter. Treatment medications were not provided by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, Influenza, Myalgia
Clinical narrative: Stomach problems; Felt like they had the flu; Sore Arms; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach problems), INFLUENZA (Felt like they had the flu) and MYALGIA (Sore Arms) 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 ABDOMINAL DISCOMFORT (Stomach problems), INFLUENZA (Felt like they had the flu) and MYALGIA (Sore Arms). At the time of the report, ABDOMINAL DISCOMFORT (Stomach problems), INFLUENZA (Felt like they had the flu) and MYALGIA (Sore Arms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drug was not reported. Treatment medication was not reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: arm was sore at the vaccination site; I was tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm was sore at the vaccination site) and FATIGUE (I was tired) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021, the patient experienced VACCINATION SITE PAIN (arm was sore at the vaccination site) and FATIGUE (I was tired). At the time of the report, VACCINATION SITE PAIN (arm was sore at the vaccination site) and FATIGUE (I was tired) outcome was unknown.            No Concomitant medications were provided  No treatment medications were provided   This case was linked to MOD-2021-264170 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Fatigue, Hot flush
Clinical narrative: Felt hot chills; Dizzy; Hard time exhaling; Ttired; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (Felt hot chills), DIZZINESS (Dizzy), DYSPNOEA (Hard time exhaling) and FATIGUE (Ttired) 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 HOT FLUSH (Felt hot chills), DIZZINESS (Dizzy), DYSPNOEA (Hard time exhaling) and FATIGUE (Ttired). At the time of the report, HOT FLUSH (Felt hot chills), DIZZINESS (Dizzy), DYSPNOEA (Hard time exhaling) and FATIGUE (Ttired) had resolved.            No Medical History information was reported. No concomitant medication was reported.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Gastrooesophageal reflux disease, Myalgia
Clinical narrative: acid reflux; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux) and MYALGIA (sore arm) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001c21a and 016C21a) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jul-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 GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux) and MYALGIA (sore arm). At the time of the report, GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux) and MYALGIA (sore arm) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: It's past 42 days since she received her 1st dose/patient received her 1st dose on May 31st; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (It's past 42 days since she received her 1st dose/patient received her 1st dose on May 31st   ) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036C21A and 051C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (It's past 42 days since she received her 1st dose/patient received her 1st dose on May 31st   ). On 31-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (It's past 42 days since she received her 1st dose/patient received her 1st dose on May 31st   ) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   Patient reported that she did not see any severe adverse effect. She also stated that she did not come to work because she was very busy so she delayed second dose.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow up information contains significant info added Second Dose information provided and event coding updated.