chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Body temperature increased, Insomnia, Nausea, Retching
Clinical narrative: dry heaves; up all night; sever nausea; This spontaneous case was reported by a consumer and describes the occurrence of RETCHING (dry heaves), INSOMNIA (up all night) and NAUSEA (sever nausea) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced RETCHING (dry heaves), INSOMNIA (up all night) and NAUSEA (sever nausea). At the time of the report, RETCHING (dry heaves), INSOMNIA (up all night) and NAUSEA (sever nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature increased: 98.8 (Inconclusive) 98.8 F (normal is 97 F).         No concomitant medication was reported.  It was reported the patient was up all night due to severe nausea and dry heaves.  No treatment medication was reported. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: covid vaccine make it hard to breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (covid vaccine make it hard to breath) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (covid vaccine make it hard to breath). At the time of the report, DYSPNOEA (covid vaccine make it hard to breath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.   Reporter did not allow further contact
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discharge
Clinical narrative: Band-aid fell off and they felt that it was wet; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE DISCHARGE (Band-aid fell off and they felt that it was wet) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jun-2021, the patient experienced VACCINATION SITE DISCHARGE (Band-aid fell off and they felt that it was wet). At the time of the report, VACCINATION SITE DISCHARGE (Band-aid fell off and they felt that it was wet) 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: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: severe swelling of my feet and legs; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (severe swelling of my feet and legs) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (severe swelling of my feet and legs). At the time of the report, PERIPHERAL SWELLING (severe swelling of my feet and legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by reporter. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Axillary mass, Peripheral swelling
Clinical narrative: Lump under arm; Swelling under arm; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY MASS (Lump under arm) and PERIPHERAL SWELLING (Swelling under arm) 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 AXILLARY MASS (Lump under arm) and PERIPHERAL SWELLING (Swelling under arm). At the time of the report, AXILLARY MASS (Lump under arm) and PERIPHERAL SWELLING (Swelling under arm) outcome was unknown.        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
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Body aches 2 weeks after 2nd shot; 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 MYALGIA (Body aches 2 weeks after 2nd shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYALGIA (Body aches 2 weeks after 2nd shot). At the time of the report, MYALGIA (Body aches 2 weeks after 2nd shot) outcome was unknown.            No concomitant medication were reported. No treatment information was reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Inappropriate schedule of product administration, Rash pruritic, Vaccination site rash
Clinical narrative: dizziness; experiencing the rash and it's still itchy; took the first dose on 26Feb2021 and took her second dose  on19March2021; fatigue; rash in left arm  at the injection site that spread to right arm and leg; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), RASH PRURITIC (experiencing the rash and it's still itchy), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (took the first dose on 26Feb2021 and took her second dose  on19March2021), FATIGUE (fatigue) and VACCINATION SITE RASH (rash in left arm  at the injection site that spread to right arm and leg) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. EN6204 and EL9265) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure. Concomitant products included SIMVASTATIN for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced DIZZINESS (dizziness), RASH PRURITIC (experiencing the rash and it's still itchy), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (took the first dose on 26Feb2021 and took her second dose  on19March2021), FATIGUE (fatigue) and VACCINATION SITE RASH (rash in left arm  at the injection site that spread to right arm and leg). The patient was treated with TRIAMCINOLONE for Vaccination site rash and Itchy rash, at a dose of 1 dosage form. On 19-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (took the first dose on 26Feb2021 and took her second dose  on19March2021) had resolved. At the time of the report, DIZZINESS (dizziness) and FATIGUE (fatigue) outcome was unknown and RASH PRURITIC (experiencing the rash and it's still itchy) and VACCINATION SITE RASH (rash in left arm  at the injection site that spread to right arm and leg) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that the patient also took unspecified blood pressure medications and antidepressants.
Sex: U
Vaccine: COVID19
Symptoms: Influenza
Clinical narrative: Flu symptoms after the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Flu symptoms after the 2nd dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jun-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 INFLUENZA (Flu symptoms after the 2nd dose). At the time of the report, INFLUENZA (Flu symptoms after the 2nd dose) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Influenza
Clinical narrative: Flu with no fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Flu with no fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA (Flu with no fever). At the time of the report, INFLUENZA (Flu with no fever) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were mentioned.  The patient was concerned if she should get the second dose if she still has the flu.  No treatment details were reported.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: Patient was given dose from cracked vial; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Patient was given dose from cracked vial) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jun-2021 at 10:30 AM, 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 13-Jun-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Patient was given dose from cracked vial). On 13-Jun-2021, PRODUCT ADMINISTRATION ERROR (Patient was given dose from cracked vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Relevant concomitant product usage were not reported by the reporter.  No treatment details were added.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Fatigue, Pain in extremity, Tenderness
Clinical narrative: Extreme hair loss; arm was tender for the next 4 to 5 days; Arm was a little sore, little achy; Tired; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Extreme hair loss), TENDERNESS (arm was tender for the next 4 to 5 days), PAIN IN EXTREMITY (Arm was a little sore, little achy) and FATIGUE (Tired) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050C21A and 016C21A) for COVID-19 vaccination.     Concomitant products included ESTRADIOL (ESTROGEN) and PROGESTERONE for an unknown indication.   On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ALOPECIA (Extreme hair loss), TENDERNESS (arm was tender for the next 4 to 5 days), PAIN IN EXTREMITY (Arm was a little sore, little achy) and FATIGUE (Tired). At the time of the report, ALOPECIA (Extreme hair loss) outcome was unknown and TENDERNESS (arm was tender for the next 4 to 5 days), PAIN IN EXTREMITY (Arm was a little sore, little achy) and FATIGUE (Tired) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications also included hormone replacement therapy.  The patient began experiencing extreme hair loss after the second dose which became extensive a week later after vaccination. She reported losing a handful of hair.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Malaise, Myalgia, Vaccination site erythema, Vaccination site pain
Clinical narrative: felt bad; shot site hah a rash and warmth.; shot site hah a rash; vaccination site erythema; Muscle pain; Chills; vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (felt bad), VACCINATION SITE WARMTH (shot site hah a rash and warmth.), VACCINATION SITE RASH (shot site hah a rash), VACCINATION SITE ERYTHEMA (vaccination site erythema) and MYALGIA (Muscle pain) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (felt bad), VACCINATION SITE WARMTH (shot site hah a rash and warmth.), VACCINATION SITE RASH (shot site hah a rash), VACCINATION SITE ERYTHEMA (vaccination site erythema), MYALGIA (Muscle pain), CHILLS (Chills) and VACCINATION SITE PAIN (vaccination site pain). At the time of the report, MALAISE (felt bad), VACCINATION SITE WARMTH (shot site hah a rash and warmth.), VACCINATION SITE RASH (shot site hah a rash), VACCINATION SITE ERYTHEMA (vaccination site erythema), MYALGIA (Muscle pain), CHILLS (Chills) and VACCINATION SITE PAIN (vaccination site pain) outcome was unknown.            No concomitant medications was included. No treatment drug details was provided.   I had an adverse reaction after my second dose and a week later had a relapse with a reaction at the injection site and I had pain at the injection site and chills and redness at the injection site. I felt as bad a week after as I did the 2nd day after my 2nd injection. This is information that should be shared with patients. I had to call my doctor.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow up information received, event vaccination site erythema added.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site warmth
Clinical narrative: felt bad; shot site hah a rash and warmth.; shot site hah a rash; vaccination site erythema; Muscle pain; Chills; vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (felt bad), VACCINATION SITE WARMTH (shot site hah a rash and warmth.), VACCINATION SITE RASH (shot site hah a rash), VACCINATION SITE ERYTHEMA (vaccination site erythema) and MYALGIA (Muscle pain) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (felt bad), VACCINATION SITE WARMTH (shot site hah a rash and warmth.), VACCINATION SITE RASH (shot site hah a rash), VACCINATION SITE ERYTHEMA (vaccination site erythema), MYALGIA (Muscle pain), CHILLS (Chills) and VACCINATION SITE PAIN (vaccination site pain). At the time of the report, MALAISE (felt bad), VACCINATION SITE WARMTH (shot site hah a rash and warmth.), VACCINATION SITE RASH (shot site hah a rash), VACCINATION SITE ERYTHEMA (vaccination site erythema), MYALGIA (Muscle pain), CHILLS (Chills) and VACCINATION SITE PAIN (vaccination site pain) outcome was unknown.            No concomitant medications was included. No treatment drug details was provided.   I had an adverse reaction after my second dose and a week later had a relapse with a reaction at the injection site and I had pain at the injection site and chills and redness at the injection site. I felt as bad a week after as I did the 2nd day after my 2nd injection. This is information that should be shared with patients. I had to call my doctor.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow up information received, event vaccination site erythema added.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Limb discomfort
Clinical narrative: not able to move legs for 6 hours after couple of hours of receiving the vaccine/ legs were not working 100 percent; felt sick; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (not able to move legs for 6 hours after couple of hours of receiving the vaccine/ legs were not working 100 percent) and ILLNESS (felt sick) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-May-2021, the patient experienced LIMB DISCOMFORT (not able to move legs for 6 hours after couple of hours of receiving the vaccine/ legs were not working 100 percent) and ILLNESS (felt sick). At the time of the report, LIMB DISCOMFORT (not able to move legs for 6 hours after couple of hours of receiving the vaccine/ legs were not working 100 percent) had not resolved and ILLNESS (felt sick) outcome was unknown.            No concomitant medications were reported by the reporter.  The patient reported that her legs were working, but not well and still had issues at the time of this report.  Treatment medication was not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Feeling of body temperature change, Headache
Clinical narrative: fatigue,tired; headaches; feverish; chills; flu like symptoms; hot cold; dizziness; sick; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), FEELING OF BODY TEMPERATURE CHANGE (hot cold), DIZZINESS (dizziness), ILLNESS (sick) and FATIGUE (fatigue,tired) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Jun-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), FEELING OF BODY TEMPERATURE CHANGE (hot cold), DIZZINESS (dizziness), ILLNESS (sick), HEADACHE (headaches), PYREXIA (feverish) and CHILLS (chills). On an unknown date, the patient experienced FATIGUE (fatigue,tired). On 09-Jun-2021, FATIGUE (fatigue,tired) outcome was unknown. At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), FEELING OF BODY TEMPERATURE CHANGE (hot cold), DIZZINESS (dizziness), ILLNESS (sick), HEADACHE (headaches), PYREXIA (feverish) and CHILLS (chills) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Illness, Influenza like illness, Pyrexia
Clinical narrative: fatigue,tired; headaches; feverish; chills; flu like symptoms; hot cold; dizziness; sick; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), FEELING OF BODY TEMPERATURE CHANGE (hot cold), DIZZINESS (dizziness), ILLNESS (sick) and FATIGUE (fatigue,tired) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Jun-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), FEELING OF BODY TEMPERATURE CHANGE (hot cold), DIZZINESS (dizziness), ILLNESS (sick), HEADACHE (headaches), PYREXIA (feverish) and CHILLS (chills). On an unknown date, the patient experienced FATIGUE (fatigue,tired). On 09-Jun-2021, FATIGUE (fatigue,tired) outcome was unknown. At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), FEELING OF BODY TEMPERATURE CHANGE (hot cold), DIZZINESS (dizziness), ILLNESS (sick), HEADACHE (headaches), PYREXIA (feverish) and CHILLS (chills) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: got really sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got really sick) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (got really sick). At the time of the report, ILLNESS (got really sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Chills after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills after the 1st dose) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     The medical history was not provided by the reported.  Concomitant products included ATENOLOL and LISINOPRIL for Blood pressure, SIMVASTATIN for Cholesterol, ACETYLSALICYLIC ACID (ASPIRIN), LEVOTHYROXINE SODIUM (SYNTHROID), OMEPRAZOLE and VITAMIN D NOS for an unknown indication.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, the patient experienced CHILLS (Chills after the 1st dose). On 27-Apr-2021, CHILLS (Chills after the 1st dose) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.        No information regarding treatment was provided.
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) (unknown route) 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) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of vaccination site warmth (the injection spot is warm), vaccination site swelling (the injection spot is swollen), vaccination site erythema (the injection spot is red) and vaccination site pain (the injection spot is very sore) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced vaccination site warmth (the injection spot is warm), vaccination site swelling (the injection spot is swollen), vaccination site erythema (the injection spot is red) and vaccination site pain (the injection spot is very sore). At the time of the report, vaccination site warmth (the injection spot is warm), vaccination site swelling (the injection spot is swollen), vaccination site erythema (the injection spot is red) and vaccination site pain (the injection spot is very sore) outcome: unknown. No concomitant medication or treatment information reported. Reporter did not allow further contact.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chills, Feeling abnormal, Flushing, Limb discomfort
Clinical narrative: Pins and needles /Tingling sensation in her left arm after the 2nd dose; Lips were really bright red after the 2nd dose; Cheeks got flushed and pink after the 2nd dose; Burning and discomfort in her left arm after her 2nd dose; Burning and discomfort in her left arm after her 2nd dose; Not feeling good after the 2nd dose; Feeling nauseous after the 2nd dose; Chills after the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning and discomfort in her left arm after her 2nd dose), FEELING ABNORMAL (Not feeling good after the 2nd dose), PARAESTHESIA (Pins and needles /Tingling sensation in her left arm after the 2nd dose), LIP ERYTHEMA (Lips were really bright red after the 2nd dose) and FLUSHING (Cheeks got flushed and pink after the 2nd dose) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A and 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ATENOLOL, LISINOPRIL, ACETYLSALICYLIC ACID (BABY ASPIRIN), LEVOTHYROXINE SODIUM (SYNTHROID), OMEPRAZOLE, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and SIMVASTATIN for an unknown indication.   On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-May-2021, the patient experienced FEELING ABNORMAL (Not feeling good after the 2nd dose), NAUSEA (Feeling nauseous after the 2nd dose) and CHILLS (Chills after the 2nd dose). On 27-May-2021, the patient experienced BURNING SENSATION (Burning and discomfort in her left arm after her 2nd dose), PARAESTHESIA (Pins and needles /Tingling sensation in her left arm after the 2nd dose), LIP ERYTHEMA (Lips were really bright red after the 2nd dose), FLUSHING (Cheeks got flushed and pink after the 2nd dose) and LIMB DISCOMFORT (Burning and discomfort in her left arm after her 2nd dose). On 26-May-2021, FEELING ABNORMAL (Not feeling good after the 2nd dose), NAUSEA (Feeling nauseous after the 2nd dose) and CHILLS (Chills after the 2nd dose) had resolved. At the time of the report, BURNING SENSATION (Burning and discomfort in her left arm after her 2nd dose), PARAESTHESIA (Pins and needles /Tingling sensation in her left arm after the 2nd dose), LIP ERYTHEMA (Lips were really bright red after the 2nd dose), FLUSHING (Cheeks got flushed and pink after the 2nd dose) and LIMB DISCOMFORT (Burning and discomfort in her left arm after her 2nd dose) outcome was unknown.            No treatment information provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Lip erythema, Nausea, Paraesthesia
Clinical narrative: Pins and needles /Tingling sensation in her left arm after the 2nd dose; Lips were really bright red after the 2nd dose; Cheeks got flushed and pink after the 2nd dose; Burning and discomfort in her left arm after her 2nd dose; Burning and discomfort in her left arm after her 2nd dose; Not feeling good after the 2nd dose; Feeling nauseous after the 2nd dose; Chills after the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning and discomfort in her left arm after her 2nd dose), FEELING ABNORMAL (Not feeling good after the 2nd dose), PARAESTHESIA (Pins and needles /Tingling sensation in her left arm after the 2nd dose), LIP ERYTHEMA (Lips were really bright red after the 2nd dose) and FLUSHING (Cheeks got flushed and pink after the 2nd dose) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A and 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ATENOLOL, LISINOPRIL, ACETYLSALICYLIC ACID (BABY ASPIRIN), LEVOTHYROXINE SODIUM (SYNTHROID), OMEPRAZOLE, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and SIMVASTATIN for an unknown indication.   On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-May-2021, the patient experienced FEELING ABNORMAL (Not feeling good after the 2nd dose), NAUSEA (Feeling nauseous after the 2nd dose) and CHILLS (Chills after the 2nd dose). On 27-May-2021, the patient experienced BURNING SENSATION (Burning and discomfort in her left arm after her 2nd dose), PARAESTHESIA (Pins and needles /Tingling sensation in her left arm after the 2nd dose), LIP ERYTHEMA (Lips were really bright red after the 2nd dose), FLUSHING (Cheeks got flushed and pink after the 2nd dose) and LIMB DISCOMFORT (Burning and discomfort in her left arm after her 2nd dose). On 26-May-2021, FEELING ABNORMAL (Not feeling good after the 2nd dose), NAUSEA (Feeling nauseous after the 2nd dose) and CHILLS (Chills after the 2nd dose) had resolved. At the time of the report, BURNING SENSATION (Burning and discomfort in her left arm after her 2nd dose), PARAESTHESIA (Pins and needles /Tingling sensation in her left arm after the 2nd dose), LIP ERYTHEMA (Lips were really bright red after the 2nd dose), FLUSHING (Cheeks got flushed and pink after the 2nd dose) and LIMB DISCOMFORT (Burning and discomfort in her left arm after her 2nd dose) outcome was unknown.            No treatment information provided.
Sex: U
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: heart rate increased; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (heart rate increased) 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, the patient experienced HEART RATE INCREASED (heart rate increased). At the time of the report, HEART RATE INCREASED (heart rate increased) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Heart rate: 105 (High) 105 heart rate to 136 for two days since getting 2nd shot..         No treatment information was provided.  No relevant concomitant medications were reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Rash, Vaccination site warmth
Clinical narrative: my arm is still sore; arm is still sore and its hot; now have a rash; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (my arm is still sore), VACCINATION SITE WARMTH (arm is still sore and its hot) and RASH (now have a rash) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jun-2021, the patient experienced PAIN IN EXTREMITY (my arm is still sore), VACCINATION SITE WARMTH (arm is still sore and its hot) and RASH (now have a rash). At the time of the report, PAIN IN EXTREMITY (my arm is still sore), VACCINATION SITE WARMTH (arm is still sore and its hot) and RASH (now have a rash) had resolved.            No concomitant medication was reported by the reporter. No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: follow up received: event outcome updated
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pyrexia (fever) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced pyrexia (fever). At the time of the report, pyrexia (fever) outcome: unknown. No concomitant medication or treatment information reported. Reporter did not allow further contact.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: my vaccination site is warm; vaccination site is red; vaccination site is kind of swollen; 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 SITE WARMTH (my vaccination site is warm), VACCINATION SITE ERYTHEMA (vaccination site is red) and VACCINATION SITE SWELLING (vaccination site is kind of swollen) 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 SITE WARMTH (my vaccination site is warm), VACCINATION SITE ERYTHEMA (vaccination site is red) and VACCINATION SITE SWELLING (vaccination site is kind of swollen). At the time of the report, VACCINATION SITE WARMTH (my vaccination site is warm), VACCINATION SITE ERYTHEMA (vaccination site is red) and VACCINATION SITE SWELLING (vaccination site is kind of swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Relevant concomitant medications was reported. Treatment information was not provided.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Lip blister, Pain in extremity, Pyrexia
Clinical narrative: "blisters on lips"; arm pain; joint pain; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of LIP BLISTER ("blisters on lips"), PAIN IN EXTREMITY (arm pain), ARTHRALGIA (joint pain), PYREXIA (fever) and CHILLS (chills) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 042B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-May-2021, the patient experienced PAIN IN EXTREMITY (arm pain), ARTHRALGIA (joint pain), PYREXIA (fever) and CHILLS (chills). On 19-May-2021, the patient experienced LIP BLISTER ("blisters on lips"). The patient was treated with ACYCLOVIR [ACICLOVIR] ongoing since an unknown date for Lip blister, at an unspecified dose and frequency. On 17-May-2021, PAIN IN EXTREMITY (arm pain), ARTHRALGIA (joint pain), PYREXIA (fever) and CHILLS (chills) had resolved. At the time of the report, LIP BLISTER ("blisters on lips") outcome was unknown.            No concomitant medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever). At the time of the report, PYREXIA (fever) outcome was unknown.            Concomitant product use was not reported.  Treatment Information was not reported.   Reporter did not allow further contact
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was 16 yo at first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient was 16 yo at first dose) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient was 16 yo at first dose). On 16-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient was 16 yo at first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not reported.   No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow-up received and contains non-significant information
Sex: U
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: can't sleep; 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 INSOMNIA (can't sleep) 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 INSOMNIA (can't sleep). At the time of the report, INSOMNIA (can't sleep) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information was not reported.   Treatment information was not reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Chromaturia
Clinical narrative: morning urine is dark like blood/ morning urine is being dark red/peeing out blood; This spontaneous case was reported by a consumer and describes the occurrence of CHROMATURIA (morning urine is dark like blood/ morning urine is being dark red/peeing out blood) 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 CHROMATURIA (morning urine is dark like blood/ morning urine is being dark red/peeing out blood). At the time of the report, CHROMATURIA (morning urine is dark like blood/ morning urine is being dark red/peeing out blood) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  The patient reported having no fever or pain.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: very sick; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (very sick) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION COMPLICATION (very sick). At the time of the report, VACCINATION COMPLICATION (very sick) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: developed a cough; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (developed a cough) 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-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jun-2021, the patient experienced COUGH (developed a cough). At the time of the report, COUGH (developed a cough) outcome was unknown.            Concomitant medications were not provided by reporter. Treatment information was not provided by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Renal pain
Clinical narrative: got my 2nd shot and noticing my kidney is really hurting on one side/kidney s are hurting after second shot; This spontaneous case was reported by a consumer and describes the occurrence of RENAL PAIN (got my 2nd shot and noticing my kidney is really hurting on one side/kidney s are hurting after second shot) 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) 2 dosage form. On an unknown date, the patient experienced RENAL PAIN (got my 2nd shot and noticing my kidney is really hurting on one side/kidney s are hurting after second shot). At the time of the report, RENAL PAIN (got my 2nd shot and noticing my kidney is really hurting on one side/kidney s are hurting after second shot) outcome was unknown.            Concomitant product use was not provided. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Lip swelling, Vaccination complication
Clinical narrative: severe lip swelling; breakout; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (severe lip swelling) and VACCINATION COMPLICATION (breakout) 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 LIP SWELLING (severe lip swelling) and VACCINATION COMPLICATION (breakout). At the time of the report, LIP SWELLING (severe lip swelling) and VACCINATION COMPLICATION (breakout) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported by the reporter.  Treatment medication was not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Received the Moderna COVID-19 Vaccine and have experienced a side effect; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Received the Moderna COVID-19 Vaccine and have experienced a side effect) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Received the Moderna COVID-19 Vaccine and have experienced a side effect). At the time of the report, VACCINATION COMPLICATION (Received the Moderna COVID-19 Vaccine and have experienced a side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.   No treatment medication was reported.