chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm was sore) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Medical history information was not reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE PAIN (arm was sore). At the time of the report, VACCINATION SITE PAIN (arm was sore) outcome was unknown. Not Provided          Concomitant product use was not provided.  No treatment details were reported.    This case was linked to MOD-2021-016954 (Patient Link). This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Feb-2021 and was forwarded to Moderna on 19-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm was sore) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Medical history information was not reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE PAIN (arm was sore). At the time of the report, VACCINATION SITE PAIN (arm was sore) outcome was unknown. Not Provided          Concomitant product use was not provided.  No treatment details were reported.    This case was linked to MOD-2021-016954 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Head Ache; Chills; Fever of 101 Degrees Farenheight; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 101 Degrees Farenheight), MYALGIA (Body ache), HEADACHE (Head Ache) and CHILLS (Chills) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-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 PYREXIA (Fever of 101 Degrees Farenheight), MYALGIA (Body ache), HEADACHE (Head Ache) and CHILLS (Chills). At the time of the report, PYREXIA (Fever of 101 Degrees Farenheight), MYALGIA (Body ache), HEADACHE (Head Ache) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medications were not provided by reporter.   Reporter did not allow further contact
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeding disorder, Nausea, Pyrexia, Vomiting
Clinical narrative: dizzy; can't eat; temperature of 102.5; nauseous; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), FEEDING DISORDER (can't eat), PYREXIA (temperature of 102.5), NAUSEA (nauseous) and VOMITING (vomiting) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced DIZZINESS (dizzy), FEEDING DISORDER (can't eat), PYREXIA (temperature of 102.5), NAUSEA (nauseous) and VOMITING (vomiting). At the time of the report, DIZZINESS (dizzy), FEEDING DISORDER (can't eat), PYREXIA (temperature of 102.5), NAUSEA (nauseous) and VOMITING (vomiting) outcome was unknown.            Treatment and concomitant medications were not provided by reporter.   This case was linked to MOD-2021-016945 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chromaturia
Clinical narrative: very dark urine; This spontaneous case was reported by a consumer and describes the occurrence of CHROMATURIA (very dark urine) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 immunisation.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced CHROMATURIA (very dark urine). On 18-Feb-2021, CHROMATURIA (very dark urine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medications were not provided by reporter.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pruritus, Vaccination site rash
Clinical narrative: little bit tired; the site of injection is a little bit itchy; the site of injection has a tiny bit of rash; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (little bit tired), INJECTION SITE PRURITUS (the site of injection is a little bit itchy) and VACCINATION SITE RASH (the site of injection has a tiny bit of rash) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030120A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (little bit tired), INJECTION SITE PRURITUS (the site of injection is a little bit itchy) and VACCINATION SITE RASH (the site of injection has a tiny bit of rash). At the time of the report, FATIGUE (little bit tired), INJECTION SITE PRURITUS (the site of injection is a little bit itchy) and VACCINATION SITE RASH (the site of injection has a tiny bit of rash) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and concomitant medications were not provided by reporter.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Influenza like illness, Insomnia, Myalgia, Pyrexia
Clinical narrative: achy; body hurting all over; flushed face; fever; pain at the injection site; trouble sleeping; feels like she has the flu; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (achy; body hurting all over), FLUSHING (flushed face), PYREXIA (fever), VACCINATION SITE PAIN (pain at the injection site) and INSOMNIA (trouble sleeping) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced MYALGIA (achy; body hurting all over), FLUSHING (flushed face), PYREXIA (fever), VACCINATION SITE PAIN (pain at the injection site), INSOMNIA (trouble sleeping) and INFLUENZA LIKE ILLNESS (feels like she has the flu). At the time of the report, MYALGIA (achy; body hurting all over), FLUSHING (flushed face), PYREXIA (fever), VACCINATION SITE PAIN (pain at the injection site), INSOMNIA (trouble sleeping) and INFLUENZA LIKE ILLNESS (feels like she has the flu) 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.   Treatment medications included Sleeping pills. No concomitant medications were provided by reporter.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: achy; body hurting all over; flushed face; fever; pain at the injection site; trouble sleeping; feels like she has the flu; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (achy; body hurting all over), FLUSHING (flushed face), PYREXIA (fever), VACCINATION SITE PAIN (pain at the injection site) and INSOMNIA (trouble sleeping) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced MYALGIA (achy; body hurting all over), FLUSHING (flushed face), PYREXIA (fever), VACCINATION SITE PAIN (pain at the injection site), INSOMNIA (trouble sleeping) and INFLUENZA LIKE ILLNESS (feels like she has the flu). At the time of the report, MYALGIA (achy; body hurting all over), FLUSHING (flushed face), PYREXIA (fever), VACCINATION SITE PAIN (pain at the injection site), INSOMNIA (trouble sleeping) and INFLUENZA LIKE ILLNESS (feels like she has the flu) 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.   Treatment medications included Sleeping pills. No concomitant medications were provided by reporter.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Rash, Vaccination site erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Itching at the injection site; Redness at injection site; Rashy at injection site; Rash all over the body; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching at the injection site), VACCINATION SITE ERYTHEMA (Redness at injection site), VACCINATION SITE RASH (Rashy at injection site), RASH (Rash all over the body) and HEADACHE (headache) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included Heart disorder and Allergy.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itching at the injection site), VACCINATION SITE ERYTHEMA (Redness at injection site), VACCINATION SITE RASH (Rashy at injection site), RASH (Rash all over the body) and HEADACHE (headache). On 20-Feb-2021, HEADACHE (headache) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Itching at the injection site), VACCINATION SITE ERYTHEMA (Redness at injection site), VACCINATION SITE RASH (Rashy at injection site) and RASH (Rash all over the body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and concomitant medications were not provided by reporter.   Reporter did not allow further contact
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Myalgia, Nervousness
Clinical narrative: fatigue; felt shakey/ felt like my sugar had dropped; feel nervous/buzzy feeling/nervousness; dizziness; Chills; muscle aches/body aches; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), MYALGIA (muscle aches/body aches), TREMOR (felt shakey/ felt like my sugar had dropped), NERVOUSNESS (feel nervous/buzzy feeling/nervousness) and DIZZINESS (dizziness) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cirrhosis liver (Medical history reported as cirrhosis of the liver.). Concurrent medical conditions included Diabetes (Medical history reported as diabetes.).    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced CHILLS (Chills) and MYALGIA (muscle aches/body aches). On 24-Jan-2021, the patient experienced TREMOR (felt shakey/ felt like my sugar had dropped), NERVOUSNESS (feel nervous/buzzy feeling/nervousness) and DIZZINESS (dizziness). On 27-Jan-2021, the patient experienced FATIGUE (fatigue). At the time of the report, CHILLS (Chills), MYALGIA (muscle aches/body aches), TREMOR (felt shakey/ felt like my sugar had dropped), NERVOUSNESS (feel nervous/buzzy feeling/nervousness), DIZZINESS (dizziness) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and concomitant medications were not provided by reporter.   Reporter did not allow further contact
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: fatigue; felt shakey/ felt like my sugar had dropped; feel nervous/buzzy feeling/nervousness; dizziness; Chills; muscle aches/body aches; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), MYALGIA (muscle aches/body aches), TREMOR (felt shakey/ felt like my sugar had dropped), NERVOUSNESS (feel nervous/buzzy feeling/nervousness) and DIZZINESS (dizziness) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cirrhosis liver (Medical history reported as cirrhosis of the liver.). Concurrent medical conditions included Diabetes (Medical history reported as diabetes.).    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced CHILLS (Chills) and MYALGIA (muscle aches/body aches). On 24-Jan-2021, the patient experienced TREMOR (felt shakey/ felt like my sugar had dropped), NERVOUSNESS (feel nervous/buzzy feeling/nervousness) and DIZZINESS (dizziness). On 27-Jan-2021, the patient experienced FATIGUE (fatigue). At the time of the report, CHILLS (Chills), MYALGIA (muscle aches/body aches), TREMOR (felt shakey/ felt like my sugar had dropped), NERVOUSNESS (feel nervous/buzzy feeling/nervousness), DIZZINESS (dizziness) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and concomitant medications were not provided by reporter.   Reporter did not allow further contact
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination complication
Clinical narrative: Symptoms were mild; Tested positive for COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID) and VACCINATION COMPLICATION (Symptoms were mild) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced COVID-19 (Tested positive for COVID). On 10-Feb-2021, the patient experienced VACCINATION COMPLICATION (Symptoms were mild). At the time of the report, COVID-19 (Tested positive for COVID) and VACCINATION COMPLICATION (Symptoms were mild) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Feb-2021, SARS-CoV-2 test: positive Positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were provided.  Treatment medications included BAM Infusion used on 10 Feb 2021.   This case was linked to MOD-2021-256806 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow up received and event outcome was updated.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Fatigue, Pyrexia
Clinical narrative: Diagnosed with COVID; fever; fatigue; a little cough; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (a little cough), COVID-19 (Diagnosed with COVID), PYREXIA (fever) and FATIGUE (fatigue) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), TAMSULOSIN HYDROCHLORIDE (FLOMAX RELIEF), LOSARTAN and RANITIDINE for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced COUGH (a little cough), PYREXIA (fever) and FATIGUE (fatigue). On 16-Jan-2021, the patient experienced COVID-19 (Diagnosed with COVID). At the time of the report, COUGH (a little cough), COVID-19 (Diagnosed with COVID), PYREXIA (fever) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included Tylenol    Reporter did not allow further contact
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Site of the injection warm; Site of the injection red; Site of the injection swollen; Site of the injection sore; Aching joints; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Site of the injection warm), INJECTION SITE ERYTHEMA (Site of the injection red), INJECTION SITE SWELLING (Site of the injection swollen), INJECTION SITE PAIN (Site of the injection sore) and ARTHRALGIA (Aching joints) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included Fusion of vertebra and Laminectomy spinal. Concurrent medical conditions included Spinal stenosis. Concomitant products included IBUPROFEN, VITAMIN D NOS, HYDROCHLOROTHIAZIDE (DIURETIC [HYDROCHLOROTHIAZIDE]) and OMEPRAZOLE for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced INJECTION SITE WARMTH (Site of the injection warm), INJECTION SITE ERYTHEMA (Site of the injection red), INJECTION SITE SWELLING (Site of the injection swollen), INJECTION SITE PAIN (Site of the injection sore) and ARTHRALGIA (Aching joints). At the time of the report, INJECTION SITE WARMTH (Site of the injection warm), INJECTION SITE ERYTHEMA (Site of the injection red), INJECTION SITE SWELLING (Site of the injection swollen), INJECTION SITE PAIN (Site of the injection sore) and ARTHRALGIA (Aching joints) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not provided by reporter.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Nausea
Clinical narrative: Weak; Nausea; Headache; This spontaneous case was reported by an other health professional (subsequently medically confirmed) and describes the occurrence of ASTHENIA (Weak), NAUSEA (Nausea) and HEADACHE (Headache) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 542L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021 at 6:00 AM, the patient experienced ASTHENIA (Weak), NAUSEA (Nausea) and HEADACHE (Headache). At the time of the report, ASTHENIA (Weak), NAUSEA (Nausea) and HEADACHE (Headache) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. Treatment medications were not provided by reporter.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Gait disturbance
Clinical narrative: Very Dizzy; Unsteady; A spontaneous report was received from a Consumer concerning a 88-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events very dizzy, unsteady.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 17 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: 013L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 18 Feb 2021, the patient experienced the events very dizzy. unsteady.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events include, very dizzy, unsteady was not reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: Lips are swollen; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Lips are swollen) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013m20a) for COVID-19 vaccination.     The patient's past medical history included Adverse event.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced LIP SWELLING (Lips are swollen). At the time of the report, LIP SWELLING (Lips are swollen) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment details were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Headache
Clinical narrative: itchy injection site; redness; inflammed, like little balls around it; dizzy; weakness; headache; chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), ASTHENIA (weakness), VACCINATION SITE PRURITUS (itchy injection site), HEADACHE (headache) and CHILLS (chills) in a female patient of an unknown age 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 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced DIZZINESS (dizzy), ASTHENIA (weakness), HEADACHE (headache), CHILLS (chills) and FATIGUE (fatigue). On 18-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itchy injection site), VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE RASH (inflammed, like little balls around it). At the time of the report, DIZZINESS (dizzy), ASTHENIA (weakness), VACCINATION SITE PRURITUS (itchy injection site), HEADACHE (headache), CHILLS (chills), FATIGUE (fatigue), VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE RASH (inflammed, like little balls around it) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  No treatment details were provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: itchy injection site; redness; inflammed, like little balls around it; dizzy; weakness; headache; chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), ASTHENIA (weakness), VACCINATION SITE PRURITUS (itchy injection site), HEADACHE (headache) and CHILLS (chills) in a female patient of an unknown age 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 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced DIZZINESS (dizzy), ASTHENIA (weakness), HEADACHE (headache), CHILLS (chills) and FATIGUE (fatigue). On 18-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itchy injection site), VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE RASH (inflammed, like little balls around it). At the time of the report, DIZZINESS (dizzy), ASTHENIA (weakness), VACCINATION SITE PRURITUS (itchy injection site), HEADACHE (headache), CHILLS (chills), FATIGUE (fatigue), VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE RASH (inflammed, like little balls around it) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  No treatment details were provided.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Large, oval shape area around the injection site that is swollen; large, oval shape area around the injection site that is red; itching at the injection site; A spontaneous report was received from a health care professional concerning, an 72-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced itchiness /  vaccination site pruritis, swollen in oval shape/vaccination site swelling and redness/vaccination site erythema.   The patient's medical history included blood pressure and cholesterol . There was no concomitant medication provided.  On 16 Jan 2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number:  28L20A)via unknown route of administration in left arm for prophylaxis of COVID-19 infection.   On 24 Jan 2021, the patient noticed that large area around the injection site is swollen and red  in oval shape and also experienced itchiness. The patient put hydrocortisone on it .  Action taken with mRNA-1273 in response to the events was considered to be unknown.  The outcome of the events swollen and red and also itchiness is considered to be recovered / resolved.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema
Clinical narrative: 3 diameter inch red spot; A spontaneous report was received from a consumer concerning a 72 years old, male patient who experienced 3 diameter inch red spot (Injection site erythema).   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.     The patient received their first of two planned doses of mRNA-1273 (Batch number: 032L20A) on 23-Jan-2021 in the left arm for prophylaxis of COVID-19 infection.   On 2-Feb-2021 the patients experienced 3 diameter inch red spot in the same arm of the injection 10 days later. Treatment information was not provided.    Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event 3 diameter inch red spot was not reported.
Sex: U
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: rash; hives; A spontaneous report was received from a (Other HCP) concerning an unknown age and gender of patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Rash and hives.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced rash and hives. Laboratory details not provided. Treatment details included as Steroid.  Action taken with mRNA-1273 in response to the events was not reported.  At the time of this report, the outcome of the event were unknown
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Headache, Malaise
Clinical narrative: dizziness; weakness; feeling unwell; headache; nausea; tired; pain at the injection; A spontaneous report was received from a consumer concerning a female patient of 89 year old, who was received Moderna's COVID-19 vaccine(Mrna-1273) and experienced headache, pain at the injection site, nausea,tiredness,weakness,dizziness and felt unwell. The patients medical history,as provided by the reporter,included blood pressure,heart disease,blood clotting.No relevant Concomitant medications were reported. On 20 feb 2021,prior to the onset of events, the Patient received their second of two planned dose of Mrna-1273(Lot number: unknown ) vaccine intramuscularly for prophylaxis of COVID-19 infection. On 20 feb 2021,couple of hours later patient experienced headache, pain at the injection site, nausea,tiredness,weakness,dizziness and felt unwell.  No Treatment information for the event was provided. The outcome for the event headache, pain at the injection site, nausea,tiredness,weakness,felt unwell and dizziness was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vaccination site pain
Clinical narrative: dizziness; weakness; feeling unwell; headache; nausea; tired; pain at the injection; A spontaneous report was received from a consumer concerning a female patient of 89 year old, who was received Moderna's COVID-19 vaccine(Mrna-1273) and experienced headache, pain at the injection site, nausea,tiredness,weakness,dizziness and felt unwell. The patients medical history,as provided by the reporter,included blood pressure,heart disease,blood clotting.No relevant Concomitant medications were reported. On 20 feb 2021,prior to the onset of events, the Patient received their second of two planned dose of Mrna-1273(Lot number: unknown ) vaccine intramuscularly for prophylaxis of COVID-19 infection. On 20 feb 2021,couple of hours later patient experienced headache, pain at the injection site, nausea,tiredness,weakness,dizziness and felt unwell.  No Treatment information for the event was provided. The outcome for the event headache, pain at the injection site, nausea,tiredness,weakness,felt unwell and dizziness was not reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 69-year-old female elderly exposed to mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) , while the parent received the product for COVID-19 vaccination.    MEDICAL HISTORY (Parent): Unknown.     No Medical History information was reported.    On 26-Jan-2021, the parent received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 27-Jan-2021, the elderly was diagnosed with PAIN IN EXTREMITY (Sore arm). The Elderly was exposed to mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  At the time of the report, PAIN IN EXTREMITY (Sore arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment information was reported by reporter.    Reporter did not allow further contact
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Feeling abnormal
Clinical narrative: feels like I was hit with somethinng; chest pain in the middle of her chest; A spontaneous report was received from a consumer concerning a 56 year old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced felt like hit with something/ feeling abnormal and chest pain in the middle of her chest.  The patient's medical history was not included. Concomitant products were not included.  On 02 Feb 2021, prior to the onset of events the patient received first dose of their two planned doses of mRNA-1273 (Batch N0:007M20A) for prophylaxis of covid 19 infection.  On 02 Feb 2021, the patient experienced chest pain in the middle of her chest felt like she got hit in the chest with something.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events, felt like hit with something/ feeling abnormal and chest pain in the middle of her chest were unknown.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Depressed mood, Headache, Pyrexia, Swelling
Clinical narrative: chills; depressed mood; pyrexia; headache; swelling; A spontaneous report was received from a healthcare professional concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events down for the count, fever, chills, headache, swelling.  The patient's medical history was  provided that included long standing high blood pressure,heart attack,  No relevant concomitant medications were reported.  On 12-FEB-2021, pior to the onset of the events the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 12 Feb 2021, the patient experienced the events down for the count. fever, chills, headache and swelling.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, down for the count, fever, chills, headache and swelling was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Fatigue, Heart rate, Heart rate abnormal, Heart rate increased
Clinical narrative: Doesn't feel well; Fatigued; Elevated Heart Rate; High blood pressure; Heart rate fluctuating; A spontaneous report was received from a consumer concerning her husband, a 77- year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events, high blood pressure(hypertension), elevated heart rate(heart rate increased), fluctuating heart rate(heart rate abnormal), fatigued(fatigue) and doesn't feel well(malaise).   The patient's medical history, as provided by the reporter included, prostate cancer/bone cancer. Concomitant medications were not provided by the reporter.  On 20 JAN 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 030L20A) intramuscularly for prophylaxis of COVID-19 infection. On 17 FEB 2021 at 09:00 AM, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 030M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 20 JAN 2021, it was reported that the patient experienced elevated heart rate after first dose. On 17 FEB 2021 at 06:00 PM, the patients' blood pressure got elevated and heart rate got elevated and then, was fluctuating. On 18 FEB 2021, the patient experienced the event fatigue and wasn't sure if it was part of vaccine or heart medication and also, he was not feeling well. On 17 FEB 2021, the lab tests performed included blood pressure 150/91mmHg at 06:00 PM, 192/101mmHg at 07:00 PM and heart rate 97 sec. Treatment for the events included two Clonidine 0.2ml.  Consent to safety was obtained.  Action taken with mRNA-1273 in response to the event(s) was not applicable.  The event high blood pressure was considered to be recovered on 18 FEB 2021. The outcome of the events, elevated heart rate, fluctuating heart rate, fatigued and doesn't feel well were unknown.
Sex: M
Vaccine: COVID19
Symptoms: Hypertension, Malaise
Clinical narrative: Doesn't feel well; Fatigued; Elevated Heart Rate; High blood pressure; Heart rate fluctuating; A spontaneous report was received from a consumer concerning her husband, a 77- year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events, high blood pressure(hypertension), elevated heart rate(heart rate increased), fluctuating heart rate(heart rate abnormal), fatigued(fatigue) and doesn't feel well(malaise).   The patient's medical history, as provided by the reporter included, prostate cancer/bone cancer. Concomitant medications were not provided by the reporter.  On 20 JAN 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 030L20A) intramuscularly for prophylaxis of COVID-19 infection. On 17 FEB 2021 at 09:00 AM, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 030M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 20 JAN 2021, it was reported that the patient experienced elevated heart rate after first dose. On 17 FEB 2021 at 06:00 PM, the patients' blood pressure got elevated and heart rate got elevated and then, was fluctuating. On 18 FEB 2021, the patient experienced the event fatigue and wasn't sure if it was part of vaccine or heart medication and also, he was not feeling well. On 17 FEB 2021, the lab tests performed included blood pressure 150/91mmHg at 06:00 PM, 192/101mmHg at 07:00 PM and heart rate 97 sec. Treatment for the events included two Clonidine 0.2ml.  Consent to safety was obtained.  Action taken with mRNA-1273 in response to the event(s) was not applicable.  The event high blood pressure was considered to be recovered on 18 FEB 2021. The outcome of the events, elevated heart rate, fluctuating heart rate, fatigued and doesn't feel well were unknown.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: had two severe rashes on their arm; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed a rash.   The patient's medical history was not provided.  No relevant concomitant medications were reported.   On 16 Jan 2021, approximately nine days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.   The patient experienced two rashes on her arm on 25 Jan 2021.   No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the event rash was not reported.  Reporter causality for the events was not provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Headache, Injection site swelling, Pyrexia
Clinical narrative: redness in my arm; Swelling around the shot; headache; a low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness in my arm), INJECTION SITE SWELLING (Swelling around the shot), HEADACHE (headache) and PYREXIA (a low grade fever) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced ERYTHEMA (redness in my arm), INJECTION SITE SWELLING (Swelling around the shot), HEADACHE (headache) and PYREXIA (a low grade fever). On 06-Feb-2021, HEADACHE (headache) and PYREXIA (a low grade fever) had resolved. On 08-Feb-2021, INJECTION SITE SWELLING (Swelling around the shot) had resolved. At the time of the report, ERYTHEMA (redness in my arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications were provided.  No treatment details were provided.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous
Clinical narrative: Red dots on both hands; rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red dots on both hands) and RASH (rash) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.  On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 11-Feb-2021, the patient experienced RASH ERYTHEMATOUS (Red dots on both hands) and RASH (rash). At the time of the report, RASH ERYTHEMATOUS (Red dots on both hands) and RASH (rash) outcome was unknown. Unknown    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site pruritus, Injection site swelling, Injection site vesicles, Injection site warmth
Clinical narrative: Injection site warmth; Injection site induration; Injection site blisters; Injection Site swelling; Injection site pruritus; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Injection site warmth), INJECTION SITE INDURATION (Injection site induration), INJECTION SITE VESICLES (Injection site blisters), INJECTION SITE SWELLING (Injection Site swelling) and INJECTION SITE PRURITUS (Injection site pruritus) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced INJECTION SITE WARMTH (Injection site warmth), INJECTION SITE INDURATION (Injection site induration), INJECTION SITE VESICLES (Injection site blisters), INJECTION SITE SWELLING (Injection Site swelling) and INJECTION SITE PRURITUS (Injection site pruritus). On 02-Feb-2021, INJECTION SITE WARMTH (Injection site warmth), INJECTION SITE INDURATION (Injection site induration), INJECTION SITE VESICLES (Injection site blisters), INJECTION SITE SWELLING (Injection Site swelling) and INJECTION SITE PRURITUS (Injection site pruritus) 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 medications were provided.  No treatment details were provided.
Sex: U
Vaccine: COVID19
Symptoms: Nightmare, Sleep disorder
Clinical narrative: complications sleeping; nightmares; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of SLEEP DISORDER (complications sleeping) and NIGHTMARE (nightmares) 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 SLEEP DISORDER (complications sleeping) and NIGHTMARE (nightmares). At the time of the report, SLEEP DISORDER (complications sleeping) and NIGHTMARE (nightmares) 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.   The patient's medical history and relevant concomitant medications weren't reported. Treatment information was not provided.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: Tenderness below and on the side of the injection site; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Tenderness below and on the side of the injection site) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included INSULIN, AMLODIPINE, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), ROSUVASTATIN, HYDRALAZINE and VITAMIN D NOS for an unknown indication.    On 22-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TENDERNESS (Tenderness below and on the side of the injection site). At the time of the report, TENDERNESS (Tenderness below and on the side of the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site nodule, Vaccination site pain, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Hot to the touch; Knot; itchiness at the injection site; Hard; Rash; Soreness day of injection; Swollen (area around injection); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot to the touch), VACCINATION SITE NODULE (Knot), VACCINATION SITE PRURITUS (itchiness at the injection site), VACCINATION SITE INDURATION (Hard) and VACCINATION SITE RASH (Rash) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Hot to the touch), VACCINATION SITE NODULE (Knot), VACCINATION SITE PRURITUS (itchiness at the injection site), VACCINATION SITE INDURATION (Hard), VACCINATION SITE RASH (Rash), VACCINATION SITE PAIN (Soreness day of injection) and VACCINATION SITE SWELLING (Swollen (area around injection)). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Hot to the touch), VACCINATION SITE NODULE (Knot), VACCINATION SITE PRURITUS (itchiness at the injection site), VACCINATION SITE INDURATION (Hard), VACCINATION SITE RASH (Rash), VACCINATION SITE PAIN (Soreness day of injection) and VACCINATION SITE SWELLING (Swollen (area around injection)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant Medication was provided.