chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Illness, Injection site warmth, Rash erythematous, Rash pruritic
Clinical narrative: first dose AE like red rash went away after 10 to 11 days; sickness, tiredness and a rash that she described as itchy, hot and that "doesn't go away"; sickness, tiredness and a rash that she described as itchy, hot and that "doesn't go away"; sickness, tiredness and a rash that she described as itchy, hot and that "doesn't go away"; sickness, tiredness and a rash that she described as itchy, hot and that "doesn't go away"; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sickness, tiredness and a rash that she described as itchy, hot and that "doesn't go away"), RASH PRURITIC (sickness, tiredness and a rash that she described as itchy, hot and that "doesn't go away"), INJECTION SITE WARMTH (sickness, tiredness and a rash that she described as itchy, hot and that "doesn't go away"), RASH ERYTHEMATOUS (first dose AE like red rash went away after 10 to 11 days) and FATIGUE (sickness, tiredness and a rash that she described as itchy, hot and that "doesn't go away") in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031m20a) for COVID-19 vaccination.     No medical history reported.     On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2012, the patient experienced RASH PRURITIC (sickness, tiredness and a rash that she described as itchy, hot and that "doesn't go away"). On 19-Feb-2021, the patient experienced ILLNESS (sickness, tiredness and a rash that she described as itchy, hot and that "doesn't go away"), INJECTION SITE WARMTH (sickness, tiredness and a rash that she described as itchy, hot and that "doesn't go away") and FATIGUE (sickness, tiredness and a rash that she described as itchy, hot and that "doesn't go away"). On an unknown date, the patient experienced RASH ERYTHEMATOUS (first dose AE like red rash went away after 10 to 11 days). The patient was treated with CORTISONE (topical) for Rash pruritic, at an unspecified dose and frequency and ARNICA MONTANA EXTRACT for Rash pruritic, at an unspecified dose and frequency. At the time of the report, ILLNESS (sickness, tiredness and a rash that she described as itchy, hot and that "doesn't go away"), RASH PRURITIC (sickness, tiredness and a rash that she described as itchy, hot and that "doesn't go away"), INJECTION SITE WARMTH (sickness, tiredness and a rash that she described as itchy, hot and that "doesn't go away") and FATIGUE (sickness, tiredness and a rash that she described as itchy, hot and that "doesn't go away") had not resolved and RASH ERYTHEMATOUS (first dose AE like red rash went away after 10 to 11 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications reported were Thyroid pill for drug use for unknown indication.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: TCR received on 14 Jul 2021 which contains patient's name correction and update on AE .
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, Vaccination site rash, Vaccination site urticaria
Clinical narrative: hives on arms; Rash is still ongoing and a bit itchy; Broke out with a rash/hives, on arms, face and chest; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (Broke out with a rash/hives, on arms, face and chest), URTICARIA (hives on arms) and RASH PRURITIC (Rash is still ongoing and a bit itchy) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Fluid retention, Rheumatoid arthritis and Asthma. Concomitant products included METHOTREXATE, APIXABAN (ELIQUIS), BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) and DIURETICS for an unknown indication.    On 09-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 RASH (Broke out with a rash/hives, on arms, face and chest), URTICARIA (hives on arms) and RASH PRURITIC (Rash is still ongoing and a bit itchy). The patient was treated with LORATADINE (BENADRYL 24 FLASH) ongoing since an unknown date at an unspecified dose and frequency and HYDROCORTISONE (HYDROCORTISONE cream) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, RASH (Broke out with a rash/hives, on arms, face and chest) and RASH PRURITIC (Rash is still ongoing and a bit itchy) 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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Rash macular, Vaccination site warmth
Clinical narrative: red blotches around her upper right arm; arm felt warm; more achy; mild right arm ache; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (red blotches around her upper right arm), VACCINATION SITE WARMTH (arm felt warm), PAIN IN EXTREMITY (mild right arm ache) and PAIN (more achy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20a) for COVID-19 vaccination.     No medical history reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced PAIN IN EXTREMITY (mild right arm ache). On 01-Feb-2021, the patient experienced RASH MACULAR (red blotches around her upper right arm), VACCINATION SITE WARMTH (arm felt warm) and PAIN (more achy). The patient was treated with PARACETAMOL (TYLENOL) on 29-Jan-2021 for Blotchy rash, Pain and Vaccination site warmth, at an unspecified dose and frequency. At the time of the report, RASH MACULAR (red blotches around her upper right arm), VACCINATION SITE WARMTH (arm felt warm) and PAIN (more achy) outcome was unknown and PAIN IN EXTREMITY (mild right arm ache) was resolving.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medications were reported.  Additional treatment details included ice, wet cloth.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: Sore arm; Fever of 100.9; Body aches; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever of 100.9), PAIN (Body aches), CHILLS (Chills) and HEADACHE (Headache) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported.   On 23-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 PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever of 100.9), PAIN (Body aches), CHILLS (Chills) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever of 100.9), PAIN (Body aches), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medications were reported.  No treatment information was provided.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Erythema, Joint swelling, Musculoskeletal stiffness, Neck pain
Clinical narrative: pain across the base of the neck; pain migrated from the right arm to the left arm; left elbow swollen; left elobow a little red; left elbow tender; Stiffness in the neck/Stiffness in the left arm/left elbow stiff; left elobow extremally painful; pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of   in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal. Concomitant products included POTASSIUM and SIMVASTATIN (STATIN [SIMVASTATIN]) for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient was treated with OXYCODONE ongoing since an unknown date at an unspecified dose and frequency.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included Blood pressure medications.  Treatment medications included cream that help with pain.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Tenderness, Vaccination site pain
Clinical narrative: pain across the base of the neck; pain migrated from the right arm to the left arm; left elbow swollen; left elobow a little red; left elbow tender; Stiffness in the neck/Stiffness in the left arm/left elbow stiff; left elobow extremally painful; pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of   in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal. Concomitant products included POTASSIUM and SIMVASTATIN (STATIN [SIMVASTATIN]) for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient was treated with OXYCODONE ongoing since an unknown date at an unspecified dose and frequency.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included Blood pressure medications.  Treatment medications included cream that help with pain.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site vasculitis, Vasodilatation, Vein discolouration
Clinical narrative: raised cord going in a vertical direction 6 inches in lengt/ Bulging vein is near lymph node/ raised cord turned out to be a bulging vein; raised cord was observed on the left armpit of the injection site arm; Bulging vein is dark; This spontaneous case was reported by a consumer and describes the occurrence of VASODILATATION (raised cord going in a vertical direction 6 inches in lengt/ Bulging vein is near lymph node/ raised cord turned out to be a bulging vein), INJECTION SITE VASCULITIS (raised cord was observed on the left armpit of the injection site arm) and VEIN DISCOLOURATION (Bulging vein is dark) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced VASODILATATION (raised cord going in a vertical direction 6 inches in lengt/ Bulging vein is near lymph node/ raised cord turned out to be a bulging vein), INJECTION SITE VASCULITIS (raised cord was observed on the left armpit of the injection site arm) and VEIN DISCOLOURATION (Bulging vein is dark). At the time of the report, VASODILATATION (raised cord going in a vertical direction 6 inches in lengt/ Bulging vein is near lymph node/ raised cord turned out to be a bulging vein), INJECTION SITE VASCULITIS (raised cord was observed on the left armpit of the injection site arm) and VEIN DISCOLOURATION (Bulging vein is dark) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications and treatment information were reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Insomnia, Vaccination site erythema, Vaccination site pain, Vaccination site rash
Clinical narrative: developed a rash 3 inches long and 1 inch wide at the injection site; big red circle; couldn't sleep; a little warm; Shoulder very sore; Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (couldn't sleep), VACCINATION SITE WARMTH (a little warm), ARTHRALGIA (Shoulder very sore), VACCINATION SITE PAIN (Pain at the injection site) and VACCINATION SITE RASH (developed a rash 3 inches long and 1 inch wide at the injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced INSOMNIA (couldn't sleep), VACCINATION SITE WARMTH (a little warm), ARTHRALGIA (Shoulder very sore) and VACCINATION SITE PAIN (Pain at the injection site). On 23-Feb-2021, the patient experienced VACCINATION SITE RASH (developed a rash 3 inches long and 1 inch wide at the injection site) and VACCINATION SITE ERYTHEMA (big red circle). At the time of the report, INSOMNIA (couldn't sleep), VACCINATION SITE WARMTH (a little warm), ARTHRALGIA (Shoulder very sore), VACCINATION SITE PAIN (Pain at the injection site), VACCINATION SITE RASH (developed a rash 3 inches long and 1 inch wide at the injection site) and VACCINATION SITE ERYTHEMA (big red circle) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No relevant concomitant medications were reported.  Treatment details included Benadryl (diphenhydramine HCL) and ibuprofen.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: developed a rash 3 inches long and 1 inch wide at the injection site; big red circle; couldn't sleep; a little warm; Shoulder very sore; Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (couldn't sleep), VACCINATION SITE WARMTH (a little warm), ARTHRALGIA (Shoulder very sore), VACCINATION SITE PAIN (Pain at the injection site) and VACCINATION SITE RASH (developed a rash 3 inches long and 1 inch wide at the injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced INSOMNIA (couldn't sleep), VACCINATION SITE WARMTH (a little warm), ARTHRALGIA (Shoulder very sore) and VACCINATION SITE PAIN (Pain at the injection site). On 23-Feb-2021, the patient experienced VACCINATION SITE RASH (developed a rash 3 inches long and 1 inch wide at the injection site) and VACCINATION SITE ERYTHEMA (big red circle). At the time of the report, INSOMNIA (couldn't sleep), VACCINATION SITE WARMTH (a little warm), ARTHRALGIA (Shoulder very sore), VACCINATION SITE PAIN (Pain at the injection site), VACCINATION SITE RASH (developed a rash 3 inches long and 1 inch wide at the injection site) and VACCINATION SITE ERYTHEMA (big red circle) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No relevant concomitant medications were reported.  Treatment details included Benadryl (diphenhydramine HCL) and ibuprofen.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Vaccination site pain
Clinical narrative: Having sore (R arm); R arm started to burning away; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BURNING SENSATION (R arm started to burning away) and VACCINATION SITE PAIN (Having sore (R arm)) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 029H20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Jan-2021, the patient experienced BURNING SENSATION (R arm started to burning away). On an unknown date, the patient experienced VACCINATION SITE PAIN (Having sore (R arm)). The patient was treated with CHLORHEXIDINE GLUCONATE;MICONAZOLE NITRATE for Burning sensation, at an unspecified dose and frequency and IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency. At the time of the report, BURNING SENSATION (R arm started to burning away) and VACCINATION SITE PAIN (Having sore (R arm)) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication use was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Follow-up information received on 19-may-2021 contains non-significant information
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Erythema, Fatigue, Headache, Oropharyngeal pain
Clinical narrative: mild sore throat; cough; red; soreness; headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (mild sore throat), COUGH (cough), ERYTHEMA (red), PAIN (soreness) and HEADACHE (headache) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.  Concomitant products included AMLODIPINE BESILATE, BENAZEPRIL HYDROCHLORIDE (AMLODIPINE BENAZEPRIL), OMEPRAZOLE, DULOXETINE HYDROCHLORIDE (CYMBALTA), PREGABALIN (LYRICA), FAMOTIDINE and VITAMINS NOS for an unknown indication.  On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced OROPHARYNGEAL PAIN (mild sore throat), COUGH (cough), ERYTHEMA (red), PAIN (soreness), HEADACHE (headache) and FATIGUE (fatigue). At the time of the report, OROPHARYNGEAL PAIN (mild sore throat), COUGH (cough), ERYTHEMA (red), PAIN (soreness), HEADACHE (headache) and FATIGUE (fatigue) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Treatment details included Tylenol  (paracetamol) and naproxen.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: mild sore throat; cough; red; soreness; headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (mild sore throat), COUGH (cough), ERYTHEMA (red), PAIN (soreness) and HEADACHE (headache) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.  Concomitant products included AMLODIPINE BESILATE, BENAZEPRIL HYDROCHLORIDE (AMLODIPINE BENAZEPRIL), OMEPRAZOLE, DULOXETINE HYDROCHLORIDE (CYMBALTA), PREGABALIN (LYRICA), FAMOTIDINE and VITAMINS NOS for an unknown indication.  On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced OROPHARYNGEAL PAIN (mild sore throat), COUGH (cough), ERYTHEMA (red), PAIN (soreness), HEADACHE (headache) and FATIGUE (fatigue). At the time of the report, OROPHARYNGEAL PAIN (mild sore throat), COUGH (cough), ERYTHEMA (red), PAIN (soreness), HEADACHE (headache) and FATIGUE (fatigue) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Treatment details included Tylenol  (paracetamol) and naproxen.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Pain in extremity, Palpitations, Peripheral swelling
Clinical narrative: racing heart; Just really tired the next couple of days; Felt a little dizzy; Arm swollen; Arm a little sore; Arm warm; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Felt a little dizzy), PERIPHERAL SWELLING (Arm swollen), PAIN IN EXTREMITY (Arm a little sore), VACCINATION SITE WARMTH (Arm warm) and PALPITATIONS (racing heart) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced PALPITATIONS (racing heart). In February 2021, the patient experienced DIZZINESS (Felt a little dizzy), PERIPHERAL SWELLING (Arm swollen), PAIN IN EXTREMITY (Arm a little sore), VACCINATION SITE WARMTH (Arm warm) and FATIGUE (Just really tired the next couple of days). The patient was treated with PARACETAMOL (TYLENOL) on 10-Feb-2021 for Dizzy, Swelling arm, Pain in arm, Vaccination site warmth and Fatigue, at an unspecified dose and frequency. On 10-Feb-2021, PALPITATIONS (racing heart) had resolved. At the time of the report, DIZZINESS (Felt a little dizzy), PERIPHERAL SWELLING (Arm swollen), PAIN IN EXTREMITY (Arm a little sore), VACCINATION SITE WARMTH (Arm warm) and FATIGUE (Just really tired the next couple of days) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant medications were not specified.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: racing heart; Just really tired the next couple of days; Felt a little dizzy; Arm swollen; Arm a little sore; Arm warm; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Felt a little dizzy), PERIPHERAL SWELLING (Arm swollen), PAIN IN EXTREMITY (Arm a little sore), VACCINATION SITE WARMTH (Arm warm) and PALPITATIONS (racing heart) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced PALPITATIONS (racing heart). In February 2021, the patient experienced DIZZINESS (Felt a little dizzy), PERIPHERAL SWELLING (Arm swollen), PAIN IN EXTREMITY (Arm a little sore), VACCINATION SITE WARMTH (Arm warm) and FATIGUE (Just really tired the next couple of days). The patient was treated with PARACETAMOL (TYLENOL) on 10-Feb-2021 for Dizzy, Swelling arm, Pain in arm, Vaccination site warmth and Fatigue, at an unspecified dose and frequency. On 10-Feb-2021, PALPITATIONS (racing heart) had resolved. At the time of the report, DIZZINESS (Felt a little dizzy), PERIPHERAL SWELLING (Arm swollen), PAIN IN EXTREMITY (Arm a little sore), VACCINATION SITE WARMTH (Arm warm) and FATIGUE (Just really tired the next couple of days) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant medications were not specified.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Diarrhoea, Myalgia
Clinical narrative: Diarrhea; Muscle ache; elevated temperature; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), MYALGIA (Muscle ache) and BODY TEMPERATURE INCREASED (elevated temperature) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical information 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 DIARRHOEA (Diarrhea), MYALGIA (Muscle ache) and BODY TEMPERATURE INCREASED (elevated temperature). At the time of the report, DIARRHOEA (Diarrhea), MYALGIA (Muscle ache) and BODY TEMPERATURE INCREASED (elevated temperature) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No relevant concomitant medications were reported.  No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: bit of a headache; little achy; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (bit of a headache) and PAIN (little achy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported.     On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced HEADACHE (bit of a headache) and PAIN (little achy). In February 2021, HEADACHE (bit of a headache) and PAIN (little achy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: TCR Form appended on 15 JUL 2021: Reporter said that patient is doing fine. And declined for a follow-up.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dyspnoea, Heart rate increased, Nausea
Clinical narrative: Fast heart rate; very congested sinus; can not breath; very weak; sleepy; chills; fever; nausea; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Fast heart rate), SINUS CONGESTION (very congested sinus), DYSPNOEA (can not breath), ASTHENIA (very weak) and SOMNOLENCE (sleepy) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for Immunisation. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (Fast heart rate), SINUS CONGESTION (very congested sinus), DYSPNOEA (can not breath), ASTHENIA (very weak), SOMNOLENCE (sleepy), CHILLS (chills), PYREXIA (fever) and NAUSEA (nausea). At the time of the report, HEART RATE INCREASED (Fast heart rate), SINUS CONGESTION (very congested sinus), DYSPNOEA (can not breath), ASTHENIA (very weak), SOMNOLENCE (sleepy), CHILLS (chills), PYREXIA (fever) and NAUSEA (nausea) outcome was unknown.            No concomitant medication was reported.  No treatment medication was reported.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Sinus congestion, Somnolence
Clinical narrative: Fast heart rate; very congested sinus; can not breath; very weak; sleepy; chills; fever; nausea; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Fast heart rate), SINUS CONGESTION (very congested sinus), DYSPNOEA (can not breath), ASTHENIA (very weak) and SOMNOLENCE (sleepy) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for Immunisation. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (Fast heart rate), SINUS CONGESTION (very congested sinus), DYSPNOEA (can not breath), ASTHENIA (very weak), SOMNOLENCE (sleepy), CHILLS (chills), PYREXIA (fever) and NAUSEA (nausea). At the time of the report, HEART RATE INCREASED (Fast heart rate), SINUS CONGESTION (very congested sinus), DYSPNOEA (can not breath), ASTHENIA (very weak), SOMNOLENCE (sleepy), CHILLS (chills), PYREXIA (fever) and NAUSEA (nausea) outcome was unknown.            No concomitant medication was reported.  No treatment medication was reported.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia, Pain in extremity, Vaccination site pain
Clinical narrative: upper arm pain/lower arm pain; pain in hand; pain in fingers/thumb; numbness in fingers/thumb; numbness in wrist; numbness in hand; injection site soreness; elbow pain; pain in wrist; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (upper arm pain/lower arm pain), PAIN IN EXTREMITY (pain in hand), PAIN IN EXTREMITY (pain in fingers/thumb), HYPOAESTHESIA (numbness in fingers/thumb) and HYPOAESTHESIA (numbness in wrist) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced PAIN IN EXTREMITY (upper arm pain/lower arm pain), PAIN IN EXTREMITY (pain in hand), PAIN IN EXTREMITY (pain in fingers/thumb), HYPOAESTHESIA (numbness in fingers/thumb), HYPOAESTHESIA (numbness in wrist), HYPOAESTHESIA (numbness in hand), VACCINATION SITE PAIN (injection site soreness), ARTHRALGIA (elbow pain) and ARTHRALGIA (pain in wrist). At the time of the report, PAIN IN EXTREMITY (upper arm pain/lower arm pain), PAIN IN EXTREMITY (pain in hand), PAIN IN EXTREMITY (pain in fingers/thumb), HYPOAESTHESIA (numbness in fingers/thumb), HYPOAESTHESIA (numbness in wrist), HYPOAESTHESIA (numbness in hand), VACCINATION SITE PAIN (injection site soreness), ARTHRALGIA (elbow pain) and ARTHRALGIA (pain in wrist) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-143259 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-143259:First dose case
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain, Parosmia, SARS-CoV-2 test positive
Clinical narrative: sense of smell different; Aches all over the body; taste different; vomiting; nausea; Terrible HA; This spontaneous case was reported by a consumer and describes the occurrence of   in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030l20a) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jan-2021, SARS-CoV-2 test positive: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication history not provided by reporter. Treatment information was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: TCR Form received on 28-APR-2021 Contains no new information
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Taste disorder, Vomiting
Clinical narrative: sense of smell different; Aches all over the body; taste different; vomiting; nausea; Terrible HA; This spontaneous case was reported by a consumer and describes the occurrence of   in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030l20a) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jan-2021, SARS-CoV-2 test positive: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication history not provided by reporter. Treatment information was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: TCR Form received on 28-APR-2021 Contains no new information
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Influenza like illness
Clinical narrative: flu like symptoms; lots of coughing; chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), COUGH (lots of coughing) and CHILLS (chills) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No medical history reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), COUGH (lots of coughing) and CHILLS (chills). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), COUGH (lots of coughing) and CHILLS (chills) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No relevant concomitant medications were reported.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Bone pain, Gastrooesophageal reflux disease, Vaccination site erythema, Vaccination site pain
Clinical narrative: bone pain on the back; rare painful rash on injection site; red bump rash around the injection site; Injection site pain; Acid Reflux; back pain; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of GASTROOESOPHAGEAL REFLUX DISEASE (Acid Reflux), BONE PAIN (bone pain on the back), BACK PAIN (back pain), VACCINATION SITE RASH (rare painful rash on injection site) and VOMITING (vomiting) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included GERD. Concurrent medical conditions included Heart disorder.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced GASTROOESOPHAGEAL REFLUX DISEASE (Acid Reflux), BACK PAIN (back pain) and VACCINATION SITE PAIN (Injection site pain). In February 2021, the patient experienced VOMITING (vomiting). On 23-Feb-2021, the patient experienced BONE PAIN (bone pain on the back), VACCINATION SITE RASH (rare painful rash on injection site) and VACCINATION SITE ERYTHEMA (red bump rash around the injection site). The patient was treated with LANSOPRAZOLE for Acid reflux (esophageal), at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Pain, at an unspecified dose and frequency. At the time of the report, GASTROOESOPHAGEAL REFLUX DISEASE (Acid Reflux), BONE PAIN (bone pain on the back), BACK PAIN (back pain), VOMITING (vomiting) and VACCINATION SITE ERYTHEMA (red bump rash around the injection site) outcome was unknown and VACCINATION SITE RASH (rare painful rash on injection site) and VACCINATION SITE PAIN (Injection site pain) had not resolved.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.    No relevant concomitant medications were reported.  Additional treatment includes rubbing hemp oil on skin.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash, Vomiting
Clinical narrative: bone pain on the back; rare painful rash on injection site; red bump rash around the injection site; Injection site pain; Acid Reflux; back pain; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of GASTROOESOPHAGEAL REFLUX DISEASE (Acid Reflux), BONE PAIN (bone pain on the back), BACK PAIN (back pain), VACCINATION SITE RASH (rare painful rash on injection site) and VOMITING (vomiting) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included GERD. Concurrent medical conditions included Heart disorder.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced GASTROOESOPHAGEAL REFLUX DISEASE (Acid Reflux), BACK PAIN (back pain) and VACCINATION SITE PAIN (Injection site pain). In February 2021, the patient experienced VOMITING (vomiting). On 23-Feb-2021, the patient experienced BONE PAIN (bone pain on the back), VACCINATION SITE RASH (rare painful rash on injection site) and VACCINATION SITE ERYTHEMA (red bump rash around the injection site). The patient was treated with LANSOPRAZOLE for Acid reflux (esophageal), at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Pain, at an unspecified dose and frequency. At the time of the report, GASTROOESOPHAGEAL REFLUX DISEASE (Acid Reflux), BONE PAIN (bone pain on the back), BACK PAIN (back pain), VOMITING (vomiting) and VACCINATION SITE ERYTHEMA (red bump rash around the injection site) outcome was unknown and VACCINATION SITE RASH (rare painful rash on injection site) and VACCINATION SITE PAIN (Injection site pain) had not resolved.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.    No relevant concomitant medications were reported.  Additional treatment includes rubbing hemp oil on skin.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Overall numbness of the left cheek from lower jaw and to the eye; This spontaneous case was reported by an other health care professional and describes the occurrence of HYPOAESTHESIA (Overall numbness of the left cheek from lower jaw and to the eye) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No medical history reported.   On 27-Jan-2021 at 5:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021 at 5:30 AM, the patient experienced HYPOAESTHESIA (Overall numbness of the left cheek from lower jaw and to the eye). At the time of the report, HYPOAESTHESIA (Overall numbness of the left cheek from lower jaw and to the eye) had not 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 medications have not been provided.  Treatment information has not been provided.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache
Clinical narrative: Aches in his joints; A headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Aches in his joints), HEADACHE (A headache) and CHILLS (Chills) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.  On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced ARTHRALGIA (Aches in his joints), HEADACHE (A headache) and CHILLS (Chills). At the time of the report, ARTHRALGIA (Aches in his joints), HEADACHE (A headache) and CHILLS (Chills) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   The patient felt like he was experiencing COVID-19 again.  No relevant concomitant medications were reported.  No treatment information was provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness, Insomnia, Pyrexia
Clinical narrative: Couldn't sleep; Was sick all night; headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Couldn't sleep), ILLNESS (Was sick all night), HEADACHE (headache) and PYREXIA (Fever) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No medical history reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced INSOMNIA (Couldn't sleep), ILLNESS (Was sick all night), HEADACHE (headache) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, INSOMNIA (Couldn't sleep), ILLNESS (Was sick all night) and HEADACHE (headache) outcome was unknown and PYREXIA (Fever) had not resolved. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medications were reported.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling cold, Limb discomfort
Clinical narrative: legs feel like lead in the morning; feel cold; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (legs feel like lead in the morning) and FEELING COLD (feel cold) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (legs feel like lead in the morning) and FEELING COLD (feel cold). At the time of the report, LIMB DISCOMFORT (legs feel like lead in the morning) and FEELING COLD (feel cold) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: warm to the touch.; small red mark; tchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm to the touch.), VACCINATION SITE ERYTHEMA (small red mark) and VACCINATION SITE PRURITUS (tchy) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-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 VACCINATION SITE WARMTH (warm to the touch.), VACCINATION SITE ERYTHEMA (small red mark) and VACCINATION SITE PRURITUS (tchy). At the time of the report, VACCINATION SITE WARMTH (warm to the touch.), VACCINATION SITE ERYTHEMA (small red mark) and VACCINATION SITE PRURITUS (tchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications and treatment information were reported.
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Rapid heart beat; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Rapid heart beat) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 05-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced PALPITATIONS (Rapid heart beat). At the time of the report, PALPITATIONS (Rapid heart beat) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Musculoskeletal stiffness, Vaccination site pain
Clinical narrative: Arm I got the injection in is stiff; I felt weak this morning.; Soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Arm I got the injection in is stiff), ASTHENIA (I felt weak this morning.) and VACCINATION SITE PAIN (Soreness at injection site) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included Stent placement since 28-Jan-2021.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Arm I got the injection in is stiff), ASTHENIA (I felt weak this morning.) and VACCINATION SITE PAIN (Soreness at injection site). At the time of the report, MUSCULOSKELETAL STIFFNESS (Arm I got the injection in is stiff), ASTHENIA (I felt weak this morning.) and VACCINATION SITE PAIN (Soreness at injection site) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable Concomitant medications included blood thinner. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-024563 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow up received on 15-JUL-2021 included Mailing address.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: soreness at injection site; Swelling at Injection Site; Red Area; headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), VACCINATION SITE PAIN (soreness at injection site), VACCINATION SITE SWELLING (Swelling at Injection Site) and VACCINATION SITE ERYTHEMA (Red Area) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX), PARACETAMOL (TYLENOL), PRAVASTATIN, CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) and GLUCOSAMINE 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 an unknown date, the patient experienced HEADACHE (headache), VACCINATION SITE PAIN (soreness at injection site), VACCINATION SITE SWELLING (Swelling at Injection Site) and VACCINATION SITE ERYTHEMA (Red Area). At the time of the report, HEADACHE (headache), VACCINATION SITE PAIN (soreness at injection site), VACCINATION SITE SWELLING (Swelling at Injection Site) and VACCINATION SITE ERYTHEMA (Red Area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications include antiprosol, Adroitin, Propetigil and Arthritis Tylenol.