chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Tension, Vomiting
Clinical narrative: Cough; Throat dry; Migraine; Nausea; Nervous tension; Unable to walk; Vomitng;  This spontaneous case was reported by a patient and describes the occurrence of DRY THROAT (2 minutes later her throat went completely dry she did not feel that she could not breathe, she was able to drink water), GAIT INABILITY (she started to walk, and even though she did not feel dizzy, she could not walk straight or "elegantly"), TENSION (the next day she was completely wired for a 24-36hr period), MIGRAINE (She took a nap and woke up with a migrane) and COUGH (cough) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.  No medical history was reported. Concomitant products included LANSOPRAZOLE and LEVOTHYROXINE for an unknown indication.  On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced DRY THROAT (2 minutes later her throat went completely dry she did not feel that she could not breathe, she was able to drink water), GAIT INABILITY (she started to walk, and even though she did not feel dizzy, she could not walk straight or "elegantly") and NAUSEA (The first 10 minutes felt mild nauseosness). On 16-Jan-2021, the patient experienced TENSION (the next day she was completely wired for a 24-36hr period). On 17-Jan-2021, the patient experienced MIGRAINE (She took a nap and woke up with a migrane) and VOMITING (Ended up vomiting). On an unknown date, the patient experienced COUGH (cough). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Sleep problem, at an unspecified dose and frequency. On 15-Jan-2021, NAUSEA (The first 10 minutes felt mild nauseosness) had resolved. On 17-Jan-2021, TENSION (the next day she was completely wired for a 24-36hr period), MIGRAINE (She took a nap and woke up with a migrane) and VOMITING (Ended up vomiting) had resolved. At the time of the report, DRY THROAT (2 minutes later her throat went completely dry she did not feel that she could not breathe, she was able to drink water) and GAIT INABILITY (she started to walk, and even though she did not feel dizzy, she could not walk straight or "elegantly") was resolving and COUGH (cough) had resolved.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99 (High) 99 degree Fahrenheit.     Action taken with mRNA-1273 in response to the event was not applicable.  This case was linked to MOD-2021-219219, MOD-2021-219219 (Patient Link).  Most recent FOLLOW-UP information incorporated above includes: On 12-Jun-2021: Added event, lab data and dosage information.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Gait disturbance, Headache
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), GAIT DISTURBANCE (Could barely walk into her house), MALAISE (Not feeling well), ASTHENIA (Felt weak) and HEADACHE (Headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 in December 2020. On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 02-Feb-2021, the patient experienced GAIT DISTURBANCE (Could barely walk into her house), MALAISE (Not feeling well), ASTHENIA (Felt weak), HEADACHE (Headache), PYREXIA (Body temperature at 102.5), MYALGIA (Muscle ache) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm), GAIT DISTURBANCE (Could barely walk into her house), MALAISE (Not feeling well), ASTHENIA (Felt weak), HEADACHE (Headache), PYREXIA (Body temperature at 102.5), MYALGIA (Muscle ache) and CHILLS (Chills) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Feb-2021, Body temperature: 102.5 (High) High. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), GAIT DISTURBANCE (Could barely walk into her house), MALAISE (Not feeling well), ASTHENIA (Felt weak) and HEADACHE (Headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 in December 2020. On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 02-Feb-2021, the patient experienced GAIT DISTURBANCE (Could barely walk into her house), MALAISE (Not feeling well), ASTHENIA (Felt weak), HEADACHE (Headache), PYREXIA (Body temperature at 102.5), MYALGIA (Muscle ache) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm), GAIT DISTURBANCE (Could barely walk into her house), MALAISE (Not feeling well), ASTHENIA (Felt weak), HEADACHE (Headache), PYREXIA (Body temperature at 102.5), MYALGIA (Muscle ache) and CHILLS (Chills) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Feb-2021, Body temperature: 102.5 (High) High. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Arthralgia, Body temperature, Fatigue, Feeling abnormal
Clinical narrative: Strong stomach pain; Brain fog; Shoulder pain; slight fever that rose to 102.5 F; nausea; extreme fatigue; Pain in injection spot; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of ABDOMINAL PAIN (Strong stomach pain), FEELING ABNORMAL (Brain fog), ARTHRALGIA (Shoulder pain), PYREXIA (slight fever that rose to 102.5 F) and NAUSEA (nausea) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 30-Mar-2020. Previously administered products included for an unreported indication: SHINGRIX (Slight fever and flu-like symptoms after the second shringrix 50 mcg vaccination.) in January 2020. Concurrent medical conditions included Thyroid disorder NOS since 2002, heart palpitation since 2016, Blood pressure high since 2017 and High cholesterol since 2012. Concomitant products included LOSARTAN and ACETYLSALICYLIC ACID (ASPIRIN 81) for Blood pressure increased, SIMVASTATIN for High cholesterol, LEVOTHYROXINE for Hypothyroidism, ATENOLOL for Palpitations.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced ABDOMINAL PAIN (Strong stomach pain), FEELING ABNORMAL (Brain fog), ARTHRALGIA (Shoulder pain), PYREXIA (slight fever that rose to 102.5 F), NAUSEA (nausea), FATIGUE (extreme fatigue) and INJECTION SITE PAIN (Pain in injection spot). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 29-Jan-2021, ABDOMINAL PAIN (Strong stomach pain), FEELING ABNORMAL (Brain fog), ARTHRALGIA (Shoulder pain), PYREXIA (slight fever that rose to 102.5 F), NAUSEA (nausea), FATIGUE (extreme fatigue) and INJECTION SITE PAIN (Pain in injection spot) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jan-2021, Body temperature: 102.5 f (High) 102.5 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-158001 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Vaccine adverse event reporting form was received. Updated medical history, concomitant medications, treatment and events.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Nausea, Pyrexia
Clinical narrative: Strong stomach pain; Brain fog; Shoulder pain; slight fever that rose to 102.5 F; nausea; extreme fatigue; Pain in injection spot; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of ABDOMINAL PAIN (Strong stomach pain), FEELING ABNORMAL (Brain fog), ARTHRALGIA (Shoulder pain), PYREXIA (slight fever that rose to 102.5 F) and NAUSEA (nausea) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 30-Mar-2020. Previously administered products included for an unreported indication: SHINGRIX (Slight fever and flu-like symptoms after the second shringrix 50 mcg vaccination.) in January 2020. Concurrent medical conditions included Thyroid disorder NOS since 2002, heart palpitation since 2016, Blood pressure high since 2017 and High cholesterol since 2012. Concomitant products included LOSARTAN and ACETYLSALICYLIC ACID (ASPIRIN 81) for Blood pressure increased, SIMVASTATIN for High cholesterol, LEVOTHYROXINE for Hypothyroidism, ATENOLOL for Palpitations.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced ABDOMINAL PAIN (Strong stomach pain), FEELING ABNORMAL (Brain fog), ARTHRALGIA (Shoulder pain), PYREXIA (slight fever that rose to 102.5 F), NAUSEA (nausea), FATIGUE (extreme fatigue) and INJECTION SITE PAIN (Pain in injection spot). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 29-Jan-2021, ABDOMINAL PAIN (Strong stomach pain), FEELING ABNORMAL (Brain fog), ARTHRALGIA (Shoulder pain), PYREXIA (slight fever that rose to 102.5 F), NAUSEA (nausea), FATIGUE (extreme fatigue) and INJECTION SITE PAIN (Pain in injection spot) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jan-2021, Body temperature: 102.5 f (High) 102.5 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-158001 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Vaccine adverse event reporting form was received. Updated medical history, concomitant medications, treatment and events.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness
Clinical narrative: Stiff neck on the same side of the injection; A spontaneous report was received from a Healthcare Professional concerning a 49-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event of stiff neck on the same side of the injection.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 14 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 029L20A) intramuscularly in right arm for prophylaxis of COVID-19 infection.   On unspecified date, the patient experienced stiff neck on the same side of the injection.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On 03 Feb 2021 the outcome of events stiff neck on the same side of the injection was reported not resolved.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: swelling went down to elbow; very hard and very itchy with 2 inch diameter; Redness/very red; swelling/kinda puffy; This spontaneous case was reported by a health care professional and describes the occurrence of JOINT SWELLING (swelling went down to elbow), VACCINATION SITE PRURITUS (very hard and very itchy with 2 inch diameter), VACCINATION SITE ERYTHEMA (Redness/very red) and VACCINATION SITE SWELLING (swelling/kinda puffy) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure. Concomitant products included AMLODIPINE for Blood pressure.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (very hard and very itchy with 2 inch diameter), VACCINATION SITE ERYTHEMA (Redness/very red) and VACCINATION SITE SWELLING (swelling/kinda puffy). On 30-Jan-2021, the patient experienced JOINT SWELLING (swelling went down to elbow). The patient was treated with IBUPROFEN on 29-Jan-2021 at an unspecified dose and frequency. At the time of the report, JOINT SWELLING (swelling went down to elbow) had resolved and VACCINATION SITE PRURITUS (very hard and very itchy with 2 inch diameter), VACCINATION SITE ERYTHEMA (Redness/very red) and VACCINATION SITE SWELLING (swelling/kinda puffy) 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.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Diarrhoea, Dyspnoea, Nausea, Pyrexia
Clinical narrative: cough; shortness breath; high temperature; diarrhea; nausea; vomiting; This spontaneous case was reported by a patient and describes the occurrence of COUGH (cough), DYSPNOEA (shortness breath), PYREXIA (high temperature), DIARRHOEA (diarrhea) and NAUSEA (nausea) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-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 COUGH (cough), DYSPNOEA (shortness breath), PYREXIA (high temperature), DIARRHOEA (diarrhea), NAUSEA (nausea) and VOMITING (vomiting). At the time of the report, COUGH (cough), DYSPNOEA (shortness breath), PYREXIA (high temperature), DIARRHOEA (diarrhea), NAUSEA (nausea) and VOMITING (vomiting) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported were blood pressure, anti-depressive, cholesterol and allergies pills.  No treatment medications were provided by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: cough; shortness breath; high temperature; diarrhea; nausea; vomiting; This spontaneous case was reported by a patient and describes the occurrence of COUGH (cough), DYSPNOEA (shortness breath), PYREXIA (high temperature), DIARRHOEA (diarrhea) and NAUSEA (nausea) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-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 COUGH (cough), DYSPNOEA (shortness breath), PYREXIA (high temperature), DIARRHOEA (diarrhea), NAUSEA (nausea) and VOMITING (vomiting). At the time of the report, COUGH (cough), DYSPNOEA (shortness breath), PYREXIA (high temperature), DIARRHOEA (diarrhea), NAUSEA (nausea) and VOMITING (vomiting) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported were blood pressure, anti-depressive, cholesterol and allergies pills.  No treatment medications were provided by the reporter.; 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: Pruritus, Swelling, Vaccination site pain
Clinical narrative: itchy; big lump; her arm was very sore; This spontaneous case was reported by a consumer and describes the occurrence of   in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included MESALAMINE for an unknown indication.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: redness (Started at the spot of injection and then started to go down. It has her hand size this redness); had pain Started at the spot of injection; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE ERYTHEMA (redness (Started at the spot of injection and then started to go down. It has her hand size this redness)) and VACCINATION SITE PAIN (had pain Started at the spot of injection) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE PAIN (had pain Started at the spot of injection). On 08-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness (Started at the spot of injection and then started to go down. It has her hand size this redness)). At the time of the report, VACCINATION SITE ERYTHEMA (redness (Started at the spot of injection and then started to go down. It has her hand size this redness)) and VACCINATION SITE PAIN (had pain Started at the spot of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were provided by the reporter.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Red upper arm that is itchy and swollen and blotchy; Red upper arm that is itchy and swollen and blotchy; Red upper arm that is itchy and swollen and blotchy; Red upper arm that is itchy and swollen and blotchy; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Red upper arm that is itchy and swollen and blotchy), VACCINATION SITE PRURITUS (Red upper arm that is itchy and swollen and blotchy), VACCINATION SITE ERYTHEMA (Red upper arm that is itchy and swollen and blotchy) and VACCINATION SITE SWELLING (Red upper arm that is itchy and swollen and blotchy) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jan-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 RASH MACULAR (Red upper arm that is itchy and swollen and blotchy), VACCINATION SITE PRURITUS (Red upper arm that is itchy and swollen and blotchy), VACCINATION SITE ERYTHEMA (Red upper arm that is itchy and swollen and blotchy) and VACCINATION SITE SWELLING (Red upper arm that is itchy and swollen and blotchy). At the time of the report, RASH MACULAR (Red upper arm that is itchy and swollen and blotchy), VACCINATION SITE PRURITUS (Red upper arm that is itchy and swollen and blotchy), VACCINATION SITE ERYTHEMA (Red upper arm that is itchy and swollen and blotchy) and VACCINATION SITE SWELLING (Red upper arm that is itchy and swollen and blotchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided. Concomitant product use was unknown by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Dyskinesia, Peripheral swelling
Clinical narrative: arm was swollen, very red and very hard, hot to the touch, the size of their hand and; hey have limited range movement with their arm, and when they try to move it is painful; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm was swollen, very red and very hard, hot to the touch, the size of their hand and) and DYSKINESIA (hey have limited range movement with their arm, and when they try to move it is painful) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Jan-2021, the patient experienced PERIPHERAL SWELLING (arm was swollen, very red and very hard, hot to the touch, the size of their hand and) and DYSKINESIA (hey have limited range movement with their arm, and when they try to move it is painful). At the time of the report, PERIPHERAL SWELLING (arm was swollen, very red and very hard, hot to the touch, the size of their hand and) and DYSKINESIA (hey have limited range movement with their arm, and when they try to move it is painful) outcome was unknown. Not Provided          No relevant concomitant medications were reported. Treatment details included none
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Limb injury
Clinical narrative: (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LIMB INJURY (Got a cut on their hand). At the time of the report, LIMB INJURY (Got a cut on their hand) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Just a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Just a sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Just a sore arm). At the time of the report, PAIN IN EXTREMITY (Just a sore arm) outcome was unknown. Not Provided
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Injection site pain, Myalgia
Clinical narrative: Has a 100.0 fever, chills, headache, body ache, and soreness at injection site.; Has a 100.0 fever, chills, headache, body ache, and soreness at injection site; Has a 100.0 fever, chills, headache, body ache, and soreness at injection site; Has a 100.0 fever, chills, headache, body ache, and soreness at injection site; Has a 100.0 fever, chills, headache, body ache, and soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Has a 100.0 fever, chills, headache, body ache, and soreness at injection site.), CHILLS (Has a 100.0 fever, chills, headache, body ache, and soreness at injection site), HEADACHE (Has a 100.0 fever, chills, headache, body ache, and soreness at injection site), MYALGIA (Has a 100.0 fever, chills, headache, body ache, and soreness at injection site) and INJECTION SITE PAIN (Has a 100.0 fever, chills, headache, body ache, and soreness at injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced PYREXIA (Has a 100.0 fever, chills, headache, body ache, and soreness at injection site.), CHILLS (Has a 100.0 fever, chills, headache, body ache, and soreness at injection site), HEADACHE (Has a 100.0 fever, chills, headache, body ache, and soreness at injection site), MYALGIA (Has a 100.0 fever, chills, headache, body ache, and soreness at injection site) and INJECTION SITE PAIN (Has a 100.0 fever, chills, headache, body ache, and soreness at injection site). At the time of the report, PYREXIA (Has a 100.0 fever, chills, headache, body ache, and soreness at injection site.), CHILLS (Has a 100.0 fever, chills, headache, body ache, and soreness at injection site), HEADACHE (Has a 100.0 fever, chills, headache, body ache, and soreness at injection site), MYALGIA (Has a 100.0 fever, chills, headache, body ache, and soreness at injection site) and INJECTION SITE PAIN (Has a 100.0 fever, chills, headache, body ache, and soreness at injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Feb-2021, Body temperature: 100 (Inconclusive) 100.0.         Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Follow up received on 19APR2021, No new information and patient stated that she was feeling fine.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Has a 100.0 fever, chills, headache, body ache, and soreness at injection site.; Has a 100.0 fever, chills, headache, body ache, and soreness at injection site; Has a 100.0 fever, chills, headache, body ache, and soreness at injection site; Has a 100.0 fever, chills, headache, body ache, and soreness at injection site; Has a 100.0 fever, chills, headache, body ache, and soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Has a 100.0 fever, chills, headache, body ache, and soreness at injection site.), CHILLS (Has a 100.0 fever, chills, headache, body ache, and soreness at injection site), HEADACHE (Has a 100.0 fever, chills, headache, body ache, and soreness at injection site), MYALGIA (Has a 100.0 fever, chills, headache, body ache, and soreness at injection site) and INJECTION SITE PAIN (Has a 100.0 fever, chills, headache, body ache, and soreness at injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced PYREXIA (Has a 100.0 fever, chills, headache, body ache, and soreness at injection site.), CHILLS (Has a 100.0 fever, chills, headache, body ache, and soreness at injection site), HEADACHE (Has a 100.0 fever, chills, headache, body ache, and soreness at injection site), MYALGIA (Has a 100.0 fever, chills, headache, body ache, and soreness at injection site) and INJECTION SITE PAIN (Has a 100.0 fever, chills, headache, body ache, and soreness at injection site). At the time of the report, PYREXIA (Has a 100.0 fever, chills, headache, body ache, and soreness at injection site.), CHILLS (Has a 100.0 fever, chills, headache, body ache, and soreness at injection site), HEADACHE (Has a 100.0 fever, chills, headache, body ache, and soreness at injection site), MYALGIA (Has a 100.0 fever, chills, headache, body ache, and soreness at injection site) and INJECTION SITE PAIN (Has a 100.0 fever, chills, headache, body ache, and soreness at injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Feb-2021, Body temperature: 100 (Inconclusive) 100.0.         Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Follow up received on 19APR2021, No new information and patient stated that she was feeling fine.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Heart rate increased, Hypersensitivity
Clinical narrative: Weakness; Fast Heartbeat; Dizziness; believes she is experiencing a severe allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), HEART RATE INCREASED (Fast Heartbeat), DIZZINESS (Dizziness) and HYPERSENSITIVITY (believes she is experiencing a severe allergic reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced ASTHENIA (Weakness), HEART RATE INCREASED (Fast Heartbeat), DIZZINESS (Dizziness) and HYPERSENSITIVITY (believes she is experiencing a severe allergic reaction). At the time of the report, ASTHENIA (Weakness), HEART RATE INCREASED (Fast Heartbeat), DIZZINESS (Dizziness) and HYPERSENSITIVITY (believes she is experiencing a severe allergic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia
Clinical narrative: Had lack of taste; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Had lack of taste) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AGEUSIA (Had lack of taste). At the time of the report, AGEUSIA (Had lack of taste) 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.   Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash macular, Vaccination site erythema, Vaccination site warmth
Clinical narrative: Red blotch reaction; Itching; Injection site is warmer that the rest of her arm; Arm is red for about 4 inches by 2 inches at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Red blotch reaction), PRURITUS (Itching), VACCINATION SITE WARMTH (Injection site is warmer that the rest of her arm) and VACCINATION SITE ERYTHEMA (Arm is red for about 4 inches by 2 inches at the injection site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ATENOLOL and CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM WITH VITAMIN D 3) for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced RASH MACULAR (Red blotch reaction), PRURITUS (Itching), VACCINATION SITE WARMTH (Injection site is warmer that the rest of her arm) and VACCINATION SITE ERYTHEMA (Arm is red for about 4 inches by 2 inches at the injection site). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at a dose of 1 dosage form and IBUPROFEN at a dose of 1 dosage form. At the time of the report, RASH MACULAR (Red blotch reaction), PRURITUS (Itching), VACCINATION SITE WARMTH (Injection site is warmer that the rest of her arm) and VACCINATION SITE ERYTHEMA (Arm is red for about 4 inches by 2 inches at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Itching/ Round circle at injection site; Redness at injection site; Pain at injection site (R); Hot to touch at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot to touch at injection site), VACCINATION SITE PRURITUS (Itching/ Round circle at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (Pain at injection site (R)) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Shellfish allergy.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Hot to touch at injection site) and VACCINATION SITE PAIN (Pain at injection site (R)). On 29-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itching/ Round circle at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site). On 02-Feb-2021, VACCINATION SITE PRURITUS (Itching/ Round circle at injection site) had resolved. At the time of the report, VACCINATION SITE WARMTH (Hot to touch at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (Pain at injection site (R)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Patient was feeling okay at the time of this report.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate increased, Nausea
Clinical narrative: Difficulty breathing; Fast heartbeat; Little bit of nausea; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty breathing), HEART RATE INCREASED (Fast heartbeat) and NAUSEA (Little bit of nausea) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-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 DYSPNOEA (Difficulty breathing), HEART RATE INCREASED (Fast heartbeat) and NAUSEA (Little bit of nausea). At the time of the report, DYSPNOEA (Difficulty breathing), HEART RATE INCREASED (Fast heartbeat) and NAUSEA (Little bit of nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was reported. No treatment details was reported.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pain, Pyrexia
Clinical narrative: Body aches; Temperature of 101.3; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), PYREXIA (Temperature of 101.3) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 09L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced PAIN (Body aches), PYREXIA (Temperature of 101.3) and HEADACHE (Headache). At the time of the report, PAIN (Body aches), PYREXIA (Temperature of 101.3) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.3 (Inconclusive) temperature of 101.3.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   concomitant medications were not provided. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-022474, US-MODERNATX, INC.-MOD-2021-047944 (E2B Linked Report).; 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. Further information has been requested US-MODERNATX, INC.-MOD-2021-047944:Crosslinked (MOD21-018102) US-MODERNATX, INC.-MOD-2021-022474:Crosslinked (MOD21-018102)
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Tension
Clinical narrative: Tension; Back pain; This spontaneous case was reported by a consumer and describes the occurrence of TENSION (Tension) and BACK PAIN (Back pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-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 TENSION (Tension) and BACK PAIN (Back pain). At the time of the report, TENSION (Tension) and BACK PAIN (Back pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details was not reported. No concomitant medication was reported.
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Swelling of the face; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Swelling of the face) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING FACE (Swelling of the face). At the time of the report, SWELLING FACE (Swelling of the face) outcome was unknown. Not Provided          concomitant medications were not reported. Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset of the event, a causal relationship cannot be excluded.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Injection site urticaria, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: injection site reaction; Arm started to feel warm; Itchy arm; reaction grew 6 inches in diameter and looked like hives; A spontaneous report was received from a 38-year-old female patient concerning herself who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a delayed skin reaction, injection site warmth, pruritus and urticaria.  The patient's medical history included allergies and she had an epinephrine pen in case of any severe allergic reaction.  On 15 Jan 2021, approximately seven days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number:026L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 22 Jan 2021, the patient experienced what she described as "Covid arm".  The patient's arm felt warm and itchy and the reaction grew 6 inches in diameter and looked like hives.  Treatment for the events included diphenhydramine, acetaminophen, and a warm compress.  Action taken with mRNA-1273 in response to the events resolved.   The outcome of the events injection site reaction, arm started to feel warm, itchy, reaction grew 6 inches in diameter, looked like hives were considered resolved on 24 Jan 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: very faint pink rash shaped as a band that was 2 inches wide and about 1 inch below the injection site; just a little itchy; This spontaneous case was reported by a consumer and describes the occurrence of RASH (very faint pink rash shaped as a band that was 2 inches wide and about 1 inch below the injection site) and PRURITUS (just a little itchy) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure, Cholesterol, Hypothyroidism, GERD, Anxiety and Sleep disorder NOS. Concomitant products included ALPRAZOLAM for Anxiety, QUETIAPINE FUMARATE (SEROQUEL) for Sleep disorder NOS.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Dec-2020, the patient experienced RASH (very faint pink rash shaped as a band that was 2 inches wide and about 1 inch below the injection site) and PRURITUS (just a little itchy). At the time of the report, RASH (very faint pink rash shaped as a band that was 2 inches wide and about 1 inch below the injection site) and PRURITUS (just a little itchy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Current condition includes blood pressure, cholesterol, hypothyroidism and Gastroesophageal reflux disease, anxiety, sleep. Concomitant medications were medicine for her blood pressure, cholesterol, hypothyroidism and Gastroesophageal reflux disease,  Alprazolam for her anxiety and Seroquel for sleep. Treatment details included For the symptoms: Kenalog cream.,
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pain, Tenderness
Clinical narrative: Pretty red and concerning on Sunday morning/ It has not spread and it has dimmed in redness; Her arm was warm on Saturday; Her arm was tender; Sore to the touch after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Sore to the touch after vaccination), FEELING HOT (Her arm was warm on Saturday), TENDERNESS (Her arm was tender) and ERYTHEMA (Pretty red and concerning on Sunday morning/ It has not spread and it has dimmed in redness) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     The patient's past medical history included Mastectomy (Patient previously had a double mastectomy and does not have lymph nodes in her left arm.).    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced PAIN (Sore to the touch after vaccination) and TENDERNESS (Her arm was tender). On 30-Jan-2021, the patient experienced FEELING HOT (Her arm was warm on Saturday). On 31-Jan-2021, the patient experienced ERYTHEMA (Pretty red and concerning on Sunday morning/ It has not spread and it has dimmed in redness). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 1 dosage form and BISABOLOL, CERESIN, PARAFFIN SOFT, PARAFFIN, LIQUID, WOOL ALCOHOLS (AQUAPHOR HEALING) (topical) for Adverse event, at a dose of 1 dosage form. At the time of the report, PAIN (Sore to the touch after vaccination), FEELING HOT (Her arm was warm on Saturday), TENDERNESS (Her arm was tender) and ERYTHEMA (Pretty red and concerning on Sunday morning/ It has not spread and it has dimmed in redness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient does not have lymph nodes in her left arm.  No Concomitant medication was received by the patient.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Follow up received on 21-APR-2021: contains Non-Significant information.Added reporter contact detail Fax number. On 12-Jul-2021: Follow up received and outcome updated to be Recovered/Resolved