chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site warmth
Clinical narrative: developed a red patch on injection site; patch is hard in the middle; patch is warm like feverish; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (developed a red patch on injection site), VACCINATION SITE INDURATION (patch is hard in the middle) and VACCINATION SITE WARMTH (patch is warm like feverish) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Cholesterol and Anxiety. Concomitant products included VITAMIN D [VITAMIN D NOS] 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 01-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (developed a red patch on injection site), VACCINATION SITE INDURATION (patch is hard in the middle) and VACCINATION SITE WARMTH (patch is warm like feverish). At the time of the report, VACCINATION SITE ERYTHEMA (developed a red patch on injection site), VACCINATION SITE INDURATION (patch is hard in the middle) and VACCINATION SITE WARMTH (patch is warm like feverish) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for covid) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included METFORMIN for an unknown indication.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced COVID-19 (tested positive for covid). At the time of the report, COVID-19 (tested positive for covid) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, SARS-CoV-2 test: positive (Positive) POSITIVE.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Mar-2021: Therapy details and outcome of the event updated.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite
Clinical narrative: Loss of appetite; Weakness; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Loss of appetite) and ASTHENIA (Weakness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DECREASED APPETITE (Loss of appetite) and ASTHENIA (Weakness). At the time of the report, DECREASED APPETITE (Loss of appetite) and ASTHENIA (Weakness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information not provided. Treatment information not provided
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Burning sensation, Chills, Dizziness, Fatigue
Clinical narrative: Hungrier; Thirsty; Headache; Nausea; Chills; Dizziness; Legs felt like fire; Did not taste; Extremely tired; She couldn´t sleep; A spontaneous report, was received from a consumer (patient), a 58 years-old female patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced dizziness, chills, legs felt like fire (burning sensation), headache, nausea, did not taste (ageusia), extremely tired (fatigue), hungrier (hunger), thirsty (thirst), and she couldn't sleep (insomnia).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 23 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 039K20A), intramuscularly for the prophylaxis of COVID-19 infection.  On 20 Jan 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch: 028L20A, expiry date: 09 Jul 2021), intramuscularly for the prophylaxis of COVID-19 infection.  On 20 Jan 2021, after the second shot, the patient stated that the vaccine hit her worse than the first shot to the point that she was out from work. She was dizzy, experienced chills, her legs were like fire, headache, nausea, did not taste, extremely tired. The following day on 21 Jan 2021, the patient woke up hungry and thirsty. The patient does not have a primary care physician. On an unknown date in Jan 2021, after the shot, the patient could not sleep and received treatment medication with migrotin. No further information was available.  Action taken with second dose of mRNA-1273 in response to the events was not applicable.   The outcome of events, dizziness, chills, legs felt like fire, headache, nausea, did not taste, extremely tired, hungrier, thirsty, and she couldn't sleep were not reported.; Reporter's Comments: This case concerns a 58 Y/O F with PMH headache, fatigue, dizziness, injection site pain after first dose mRNA-1273, who had NS unexpected dizziness, thirst, hunger, insomnia, burning sensation, ageusia and NS expected fatigue, headache, chills, nausea. Event onset the same day as second dose mRNA-1273. Event outcomes unknown. Based on 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.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hunger, Insomnia, Nausea, Thirst
Clinical narrative: Hungrier; Thirsty; Headache; Nausea; Chills; Dizziness; Legs felt like fire; Did not taste; Extremely tired; She couldn´t sleep; A spontaneous report, was received from a consumer (patient), a 58 years-old female patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced dizziness, chills, legs felt like fire (burning sensation), headache, nausea, did not taste (ageusia), extremely tired (fatigue), hungrier (hunger), thirsty (thirst), and she couldn't sleep (insomnia).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 23 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 039K20A), intramuscularly for the prophylaxis of COVID-19 infection.  On 20 Jan 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch: 028L20A, expiry date: 09 Jul 2021), intramuscularly for the prophylaxis of COVID-19 infection.  On 20 Jan 2021, after the second shot, the patient stated that the vaccine hit her worse than the first shot to the point that she was out from work. She was dizzy, experienced chills, her legs were like fire, headache, nausea, did not taste, extremely tired. The following day on 21 Jan 2021, the patient woke up hungry and thirsty. The patient does not have a primary care physician. On an unknown date in Jan 2021, after the shot, the patient could not sleep and received treatment medication with migrotin. No further information was available.  Action taken with second dose of mRNA-1273 in response to the events was not applicable.   The outcome of events, dizziness, chills, legs felt like fire, headache, nausea, did not taste, extremely tired, hungrier, thirsty, and she couldn't sleep were not reported.; Reporter's Comments: This case concerns a 58 Y/O F with PMH headache, fatigue, dizziness, injection site pain after first dose mRNA-1273, who had NS unexpected dizziness, thirst, hunger, insomnia, burning sensation, ageusia and NS expected fatigue, headache, chills, nausea. Event onset the same day as second dose mRNA-1273. Event outcomes unknown. Based on 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.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: Sore Arm Injected Arm; Pain on the Injection Site; Bad Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore Arm Injected Arm), VACCINATION SITE PAIN (Pain on the Injection Site) and HEADACHE (Bad Headache) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included SALBUTAMOL SULFATE (PROAIR HFA) for Asthma.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE PAIN (Sore Arm Injected Arm), VACCINATION SITE PAIN (Pain on the Injection Site) and HEADACHE (Bad Headache). At the time of the report, VACCINATION SITE PAIN (Sore Arm Injected Arm), VACCINATION SITE PAIN (Pain on the Injection Site) and HEADACHE (Bad Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not reported.   This case was linked to MOD-2021-264431 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Follow-up received included outcome of all events updated to recovered.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pruritus, Vaccination site rash
Clinical narrative: big lump that was hard, round the size of orange; Redness; Red and rash around it; Painful itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (big lump that was hard, round the size of orange), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE RASH (Red and rash around it) and VACCINATION SITE PRURITUS (Painful itching) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J2OA) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ENALAPRIL, METOPROLOL, DILTIAZEM HYDROCHLORIDE (CARTIA XT) and HYDROCHLOROTHIAZIDE for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE MASS (big lump that was hard, round the size of orange), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE RASH (Red and rash around it) and VACCINATION SITE PRURITUS (Painful itching). On 18-Jan-2021, VACCINATION SITE MASS (big lump that was hard, round the size of orange), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE RASH (Red and rash around it) and VACCINATION SITE PRURITUS (Painful itching) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Benadryl and Tylenol
Sex: U
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: received the vaccine and is breastfeeding; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (received the vaccine and is breastfeeding) in a patient of an unknown age and gender exposed to mRNA-1273 (Moderna COVID-19 Vaccine) , while the mother received the product for COVID-19 vaccination.    MEDICAL HISTORY (Parent): Concurrent medical conditions included Maternal exposure during breast feeding.    No Medical History information was reported.    On an unknown date, the mother received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient was diagnosed with EXPOSURE VIA BREAST MILK (received the vaccine and is breastfeeding). At the time of the report, EXPOSURE VIA BREAST MILK (received the vaccine and is breastfeeding) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 23-Mar-2021: TCR form is received on 23-MAR-2021 and does not contain any new information; Sender's Comments: This is a case of product exposure during breastfeeding with no associated adverse events. Patient will continue to be contacted for further monitoring of adverse events.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Red at injection site 3x2 inches; Swollen at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red at injection site 3x2 inches) and VACCINATION SITE SWELLING (Swollen at injection site) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 07K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-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 VACCINATION SITE ERYTHEMA (Red at injection site 3x2 inches) and VACCINATION SITE SWELLING (Swollen at injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Red at injection site 3x2 inches) and VACCINATION SITE SWELLING (Swollen at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment medications was not provided by reporter.   This case was linked to MOD-2021-254082 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Follow up received on 16-APR-2021 and patient's address details were updated. On 12-Jul-2021: Follow up received on 12 Jul 2021 included updated event outcome.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm was a little sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was a little sore) in a 75-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 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm was a little sore). At the time of the report, PAIN IN EXTREMITY (Arm was a little sore) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information  was not provided  by the reporter.  Treatment medication information  was not provided  by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: The follow up document received on 12-JUL-2021 contains NO NEW information.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: soreness; fatigue; muscle pain; joint pain; chills; fever; the worst and horrible headache; injection site pain; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (injection site pain), the first episode of FATIGUE (fatigue), INJECTION SITE PAIN (soreness), the second episode of FATIGUE (fatigue) and MYALGIA (muscle pain) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Jan-2021, the patient experienced INJECTION SITE PAIN (injection site pain) and the first episode of FATIGUE (fatigue). On 02-Feb-2021, the patient experienced INJECTION SITE PAIN (soreness), the second episode of FATIGUE (fatigue), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills), PYREXIA (fever) and HEADACHE (the worst and horrible headache). At the time of the report, INJECTION SITE PAIN (injection site pain), INJECTION SITE PAIN (soreness), the last episode of FATIGUE (fatigue), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills), PYREXIA (fever) and HEADACHE (the worst and horrible headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD21-021865 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Non significant follow up received on 21-APR-2021, reporter email updated.; Sender's Comments:  MOD21-021865:cross link
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: soreness; fatigue; muscle pain; joint pain; chills; fever; the worst and horrible headache; injection site pain; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (injection site pain), the first episode of FATIGUE (fatigue), INJECTION SITE PAIN (soreness), the second episode of FATIGUE (fatigue) and MYALGIA (muscle pain) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Jan-2021, the patient experienced INJECTION SITE PAIN (injection site pain) and the first episode of FATIGUE (fatigue). On 02-Feb-2021, the patient experienced INJECTION SITE PAIN (soreness), the second episode of FATIGUE (fatigue), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills), PYREXIA (fever) and HEADACHE (the worst and horrible headache). At the time of the report, INJECTION SITE PAIN (injection site pain), INJECTION SITE PAIN (soreness), the last episode of FATIGUE (fatigue), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills), PYREXIA (fever) and HEADACHE (the worst and horrible headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD21-021865 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Non significant follow up received on 21-APR-2021, reporter email updated.; Sender's Comments:  MOD21-021865:cross link
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Diarrhoea, Fatigue, Headache, Hypoaesthesia oral
Clinical narrative: diarrhea; flu-like symptoms; no appetite; numbness tongue; body ache; fatigue; headache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), INFLUENZA LIKE ILLNESS (flu-like symptoms), DECREASED APPETITE (no appetite), HYPOAESTHESIA ORAL (numbness tongue) and PAIN (body ache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (Pat medical history not provided) since an unknown date. Concomitant products included PANTOPRAZOLE and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced DIARRHOEA (diarrhea), INFLUENZA LIKE ILLNESS (flu-like symptoms), DECREASED APPETITE (no appetite), HYPOAESTHESIA ORAL (numbness tongue), PAIN (body ache), FATIGUE (fatigue) and HEADACHE (headache). At the time of the report, DIARRHOEA (diarrhea) and HYPOAESTHESIA ORAL (numbness tongue) had not resolved and INFLUENZA LIKE ILLNESS (flu-like symptoms), DECREASED APPETITE (no appetite), PAIN (body ache), FATIGUE (fatigue) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment activities for event included taking Advil :2 on Wednesday when symptoms started, 2 on the next day. concomitant medication included blood pressure medicine
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pain
Clinical narrative: diarrhea; flu-like symptoms; no appetite; numbness tongue; body ache; fatigue; headache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), INFLUENZA LIKE ILLNESS (flu-like symptoms), DECREASED APPETITE (no appetite), HYPOAESTHESIA ORAL (numbness tongue) and PAIN (body ache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (Pat medical history not provided) since an unknown date. Concomitant products included PANTOPRAZOLE and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced DIARRHOEA (diarrhea), INFLUENZA LIKE ILLNESS (flu-like symptoms), DECREASED APPETITE (no appetite), HYPOAESTHESIA ORAL (numbness tongue), PAIN (body ache), FATIGUE (fatigue) and HEADACHE (headache). At the time of the report, DIARRHOEA (diarrhea) and HYPOAESTHESIA ORAL (numbness tongue) had not resolved and INFLUENZA LIKE ILLNESS (flu-like symptoms), DECREASED APPETITE (no appetite), PAIN (body ache), FATIGUE (fatigue) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment activities for event included taking Advil :2 on Wednesday when symptoms started, 2 on the next day. concomitant medication included blood pressure medicine
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash, Swelling
Clinical narrative: swelling bumps; rash; redness; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness), SWELLING (swelling bumps) and RASH (rash) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L00A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced ERYTHEMA (redness). On 24-Jan-2021, the patient experienced SWELLING (swelling bumps) and RASH (rash). On 26-Jan-2021, SWELLING (swelling bumps) and RASH (rash) had resolved. At the time of the report, ERYTHEMA (redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Itching; Redness; Swelling; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Itching), INJECTION SITE ERYTHEMA (Redness) and INJECTION SITE SWELLING (Swelling) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.  Concomitant products included FISH OIL for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced INJECTION SITE PRURITUS (Itching), INJECTION SITE ERYTHEMA (Redness) and INJECTION SITE SWELLING (Swelling). At the time of the report, INJECTION SITE PRURITUS (Itching), INJECTION SITE ERYTHEMA (Redness) and INJECTION SITE SWELLING (Swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment Ice Pack, Ibuprofen
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Erythema, Illness, Injection site warmth
Clinical narrative: Stomach sickness; red rash on the back of her left arm; red rash on the back of her left arm; a bit swollen, a bit red, and very hot that she could feel it through her shirt.; left arm was very swollen and red; sick all that night; vomiting and diarrhea; vomiting and diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick all that night), DIARRHOEA (vomiting and diarrhea), INJECTION SITE WARMTH (a bit swollen, a bit red, and very hot that she could feel it through her shirt.), PERIPHERAL SWELLING (left arm was very swollen and red) and VOMITING (vomiting and diarrhea) in a 63-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.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced ILLNESS (sick all that night), DIARRHOEA (vomiting and diarrhea), PERIPHERAL SWELLING (left arm was very swollen and red) and VOMITING (vomiting and diarrhea). On 03-Feb-2021, the patient experienced INJECTION SITE WARMTH (a bit swollen, a bit red, and very hot that she could feel it through her shirt.), RASH (red rash on the back of her left arm) and ERYTHEMA (red rash on the back of her left arm). On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Stomach sickness). The patient was treated with PROMETHAZINE HYDROCHLORIDE (PHENERGAN [PROMETHAZINE HYDROCHLORIDE]) for Stomach sickness, at an unspecified dose and frequency. On 03-Feb-2021, DIARRHOEA (vomiting and diarrhea) had resolved. At the time of the report, ILLNESS (sick all that night), INJECTION SITE WARMTH (a bit swollen, a bit red, and very hot that she could feel it through her shirt.), PERIPHERAL SWELLING (left arm was very swollen and red), VOMITING (vomiting and diarrhea), RASH (red rash on the back of her left arm), ERYTHEMA (red rash on the back of her left arm) and ABDOMINAL DISCOMFORT (Stomach sickness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment details included Phenergan for stomach sickness.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Rash, Vomiting
Clinical narrative: Stomach sickness; red rash on the back of her left arm; red rash on the back of her left arm; a bit swollen, a bit red, and very hot that she could feel it through her shirt.; left arm was very swollen and red; sick all that night; vomiting and diarrhea; vomiting and diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick all that night), DIARRHOEA (vomiting and diarrhea), INJECTION SITE WARMTH (a bit swollen, a bit red, and very hot that she could feel it through her shirt.), PERIPHERAL SWELLING (left arm was very swollen and red) and VOMITING (vomiting and diarrhea) in a 63-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.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced ILLNESS (sick all that night), DIARRHOEA (vomiting and diarrhea), PERIPHERAL SWELLING (left arm was very swollen and red) and VOMITING (vomiting and diarrhea). On 03-Feb-2021, the patient experienced INJECTION SITE WARMTH (a bit swollen, a bit red, and very hot that she could feel it through her shirt.), RASH (red rash on the back of her left arm) and ERYTHEMA (red rash on the back of her left arm). On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Stomach sickness). The patient was treated with PROMETHAZINE HYDROCHLORIDE (PHENERGAN [PROMETHAZINE HYDROCHLORIDE]) for Stomach sickness, at an unspecified dose and frequency. On 03-Feb-2021, DIARRHOEA (vomiting and diarrhea) had resolved. At the time of the report, ILLNESS (sick all that night), INJECTION SITE WARMTH (a bit swollen, a bit red, and very hot that she could feel it through her shirt.), PERIPHERAL SWELLING (left arm was very swollen and red), VOMITING (vomiting and diarrhea), RASH (red rash on the back of her left arm), ERYTHEMA (red rash on the back of her left arm) and ABDOMINAL DISCOMFORT (Stomach sickness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment details included Phenergan for stomach sickness.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site rash
Clinical narrative: Right arm got red, like a rash; Rash on right arm expanding and the center is lighter and the borders are reddish; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Right arm got red, like a rash) and VACCINATION SITE ERYTHEMA (Rash on right arm expanding and the center is lighter and the borders are reddish) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20F) for COVID-19 vaccination.     Concurrent medical conditions included Neuropathy. Concomitant products included ATORVASTATIN for Cholesterol, GABAPENTIN for Neuropathy.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced VACCINATION SITE RASH (Right arm got red, like a rash) and VACCINATION SITE ERYTHEMA (Rash on right arm expanding and the center is lighter and the borders are reddish). At the time of the report, VACCINATION SITE RASH (Right arm got red, like a rash) and VACCINATION SITE ERYTHEMA (Rash on right arm expanding and the center is lighter and the borders are reddish) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site rash
Clinical narrative: injections site arm itchy; arm was kind of red; arm was kind of sore; Pink rash at the site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (injections site arm itchy), VACCINATION SITE RASH (Pink rash at the site), VACCINATION SITE ERYTHEMA (arm was kind of red) and VACCINATION SITE PAIN (arm was kind of sore) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) 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 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE RASH (Pink rash at the site) and VACCINATION SITE PAIN (arm was kind of sore). On 03-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (injections site arm itchy) and VACCINATION SITE ERYTHEMA (arm was kind of red). At the time of the report, VACCINATION SITE PRURITUS (injections site arm itchy), VACCINATION SITE RASH (Pink rash at the site), VACCINATION SITE ERYTHEMA (arm was kind of red) and VACCINATION SITE PAIN (arm was kind of sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment information was not provided.   This case was linked to MOD-2021-084241 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Therapy details, event onset date and event term updated. On 24-May-2021: Initial Additional-1: Outcome of AE
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Pyrexia, Rash
Clinical narrative: chills; fever; rash all over body; fatigue; loss of appetite; A spontaneous report was received from a 52-years-old  female patient concerning herself who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events chills, fatigue, loss of appetite, fever, rash full body.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 3 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 012L20A) intramuscularly  at an unknown anatomical location for prophylaxis of COVID-19 infection.  On 3 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 012M20A) intramuscularly at an unknown anatomical location for prophylaxis of COVID-19 infection.  On 3 Feb 2021, the patient experienced the events fatigue, loss of appetite, fever and rash full body.  On 4 Feb 2021, the patient experienced the event chills .   Treatment details included Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events chills, fatigue,loss of appetite, fever and rash full body was unknown.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia, Vomiting
Clinical narrative: Body Aches; Vomits; Fever; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body Aches), VOMITING (Vomits), PYREXIA (Fever) and HEADACHE (Headaches) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039H20A) 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) 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 05-Feb-2021, the patient experienced PAIN (Body Aches), VOMITING (Vomits), PYREXIA (Fever) and HEADACHE (Headaches). At the time of the report, PAIN (Body Aches), VOMITING (Vomits), PYREXIA (Fever) and HEADACHE (Headaches) had resolved.            No concomitant medications were provided No treatment information provided   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Followup received and updated event outcome and action taken.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: threw up, and was concerned if the vaccine leaked out; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (threw up, and was concerned if the vaccine leaked out) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided). Concomitant products included Acid Suppressants and PANCRELIPASE (PANCREATIC ENZYMES) for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced VOMITING (threw up, and was concerned if the vaccine leaked out). At the time of the report, VOMITING (threw up, and was concerned if the vaccine leaked out) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information 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: Anxiety, Arthralgia, Blood pressure increased, Heart rate increased, Pain
Clinical narrative: rapid heart beat; elevated blood pressure; heart palpitations; anxiety; body aches; joint aches; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (rapid heart beat), BLOOD PRESSURE INCREASED (elevated blood pressure), PALPITATIONS (heart palpitations), ANXIETY (anxiety) and PAIN (body aches) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event .     On 30-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 HEART RATE INCREASED (rapid heart beat), BLOOD PRESSURE INCREASED (elevated blood pressure), PALPITATIONS (heart palpitations), ANXIETY (anxiety), PAIN (body aches) and ARTHRALGIA (joint aches). On 30-Jan-2021, HEART RATE INCREASED (rapid heart beat), BLOOD PRESSURE INCREASED (elevated blood pressure), PALPITATIONS (heart palpitations), ANXIETY (anxiety), PAIN (body aches) and ARTHRALGIA (joint aches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: rapid heart beat; elevated blood pressure; heart palpitations; anxiety; body aches; joint aches; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (rapid heart beat), BLOOD PRESSURE INCREASED (elevated blood pressure), PALPITATIONS (heart palpitations), ANXIETY (anxiety) and PAIN (body aches) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event .     On 30-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 HEART RATE INCREASED (rapid heart beat), BLOOD PRESSURE INCREASED (elevated blood pressure), PALPITATIONS (heart palpitations), ANXIETY (anxiety), PAIN (body aches) and ARTHRALGIA (joint aches). On 30-Jan-2021, HEART RATE INCREASED (rapid heart beat), BLOOD PRESSURE INCREASED (elevated blood pressure), PALPITATIONS (heart palpitations), ANXIETY (anxiety), PAIN (body aches) and ARTHRALGIA (joint aches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: had a reaction to it; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (had a reaction to it) 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 No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced ADVERSE REACTION (had a reaction to it). At the time of the report, ADVERSE REACTION (had a reaction to it) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications were reported.  No treatment medications were reported.    Reporter did not allow further contact
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Feeling abnormal, Myalgia, Paraesthesia
Clinical narrative: tingling in my arms and hands; light headed and dizzy; heart was beating fast; didn't feel right; Aches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling in my arms and hands), DIZZINESS (light headed and dizzy), TACHYCARDIA (heart was beating fast), FEELING ABNORMAL (didn't feel right) and MYALGIA (Aches) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 24-Jan-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced MYALGIA (Aches) and CHILLS (Chills). On 24-Jan-2021 at 1:07 PM, the patient experienced PARAESTHESIA (tingling in my arms and hands), DIZZINESS (light headed and dizzy), TACHYCARDIA (heart was beating fast) and FEELING ABNORMAL (didn't feel right). On 25-Jan-2021, MYALGIA (Aches) and CHILLS (Chills) had resolved. At the time of the report, PARAESTHESIA (tingling in my arms and hands), DIZZINESS (light headed and dizzy), TACHYCARDIA (heart was beating fast) and FEELING ABNORMAL (didn't feel right) had resolved.            No Concomitant information  provided. No Treatment information  provided   This case was linked to MOD-2021-021375, MOD-2021-102438 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Completed ADR form includes additional patient details, vaccine details, and event details
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: tingling in my arms and hands; light headed and dizzy; heart was beating fast; didn't feel right; Aches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling in my arms and hands), DIZZINESS (light headed and dizzy), TACHYCARDIA (heart was beating fast), FEELING ABNORMAL (didn't feel right) and MYALGIA (Aches) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 24-Jan-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced MYALGIA (Aches) and CHILLS (Chills). On 24-Jan-2021 at 1:07 PM, the patient experienced PARAESTHESIA (tingling in my arms and hands), DIZZINESS (light headed and dizzy), TACHYCARDIA (heart was beating fast) and FEELING ABNORMAL (didn't feel right). On 25-Jan-2021, MYALGIA (Aches) and CHILLS (Chills) had resolved. At the time of the report, PARAESTHESIA (tingling in my arms and hands), DIZZINESS (light headed and dizzy), TACHYCARDIA (heart was beating fast) and FEELING ABNORMAL (didn't feel right) had resolved.            No Concomitant information  provided. No Treatment information  provided   This case was linked to MOD-2021-021375, MOD-2021-102438 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Completed ADR form includes additional patient details, vaccine details, and event details
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Dizziness, Myalgia, Vaccination site pain
Clinical narrative: back started killing him; soreness at injection site; muscle ache; Felt woozy; A spontaneous report was received from a Consumer concerning a 72-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced woozy, soreness at injection site, muscle ache, and back started killing him.  The patient's medical history include psoriasis, high blood pressure, gout, shattered collar bone, multiple degenerative disks, bad back and AMD. Concomitant medications reported were lisinopril, Lipitor and alopurinol were reported.  On 8 Jan 2021, prior to the onset of the events the patient received his first of two planned doses of mRNA-1273 (lot/batch: 011J20A) for prophylaxis of COVID-19 infection.  On 8 Jan 2021, the patient experienced the events felt woozy. soreness at injection site, muscle ache and  On 22 Jan 2021, the patient experienced the events back started killing him.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, felt woozy, soreness at injection site, muscle ache, and back started killing him was unknown.; 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.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in 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 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm). At the time of the report, PAIN IN EXTREMITY (Pain in arm) outcome was unknown.            No concomitant medications reported.  Treatment medications was not provided by the reporter   Reporter did not allow further contact