chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Lymphadenitis, Pain, Pruritus, Tenderness
Clinical narrative: Injection site reaction; Swelling of the lymph nodes; Tenderness; Pain; Pinkness/redness; Hardness; itching; A spontaneous report was received from a Consumer concerning a female patient of unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events injection site reaction, swelling of the lymph nodes, tenderness, pain, pinkness redness, hardness and itching.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 21-Jan-2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  Patient had an injection site reaction, swelling of the lymph nodes, tenderness, pain, and some pinkness/redness. She would like to know how long these effects last. She no longer has pain or tenderness, but still swelling, hardness, pinkness/redness, and itching.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of events, injection site reaction was unknown,. The outcome of events, swelling of the lymph nodes, pinkness redness, hardness, itching was not recovered. The outcome of events, tenderness and pain was recovered.; 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: Vaccination site induration, Vaccination site reaction
Clinical narrative: Injection site reaction; Swelling of the lymph nodes; Tenderness; Pain; Pinkness/redness; Hardness; itching; A spontaneous report was received from a Consumer concerning a female patient of unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events injection site reaction, swelling of the lymph nodes, tenderness, pain, pinkness redness, hardness and itching.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 21-Jan-2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  Patient had an injection site reaction, swelling of the lymph nodes, tenderness, pain, and some pinkness/redness. She would like to know how long these effects last. She no longer has pain or tenderness, but still swelling, hardness, pinkness/redness, and itching.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of events, injection site reaction was unknown,. The outcome of events, swelling of the lymph nodes, pinkness redness, hardness, itching was not recovered. The outcome of events, tenderness and pain was recovered.; 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: Injection site induration, Pain in extremity, Pruritus, Vaccination site erythema
Clinical narrative: Arm was real sore; Experienced a 4 inch red area around the injection site; Hard lump around the injection site; Arm was itchy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was real sore), VACCINATION SITE ERYTHEMA (Experienced a 4 inch red area around the injection site), INJECTION SITE INDURATION (Hard lump around the injection site) and PRURITUS (Arm was itchy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm was real sore), VACCINATION SITE ERYTHEMA (Experienced a 4 inch red area around the injection site), INJECTION SITE INDURATION (Hard lump around the injection site) and PRURITUS (Arm was itchy). The patient was treated with Ibuprofen at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm was real sore), VACCINATION SITE ERYTHEMA (Experienced a 4 inch red area around the injection site), INJECTION SITE INDURATION (Hard lump around the injection site) and PRURITUS (Arm was itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO-BISMOL) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Patient reports that she took some Pepto-Bismol, but it's not helping.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: I just want to report a minor side effect for 2 weeks now; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (I just want to report a minor side effect for 2 weeks now) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (I just want to report a minor side effect for 2 weeks now). At the time of the report, VACCINATION COMPLICATION (I just want to report a minor side effect for 2 weeks now) 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.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Feeling abnormal, Influenza like illness, Injection site discolouration, Injection site mass
Clinical narrative: pink spot on arm - right arm; kind of lump - right arm; mild flu symptoms; nausea; no appetite; generally sick all over; Just don't feel great; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INJECTION SITE DISCOLOURATION (pink spot on arm - right arm), INJECTION SITE MASS (kind of lump - right arm), INFLUENZA LIKE ILLNESS (mild flu symptoms), NAUSEA (nausea) and DECREASED APPETITE (no appetite) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) 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 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced INJECTION SITE DISCOLOURATION (pink spot on arm - right arm), INJECTION SITE MASS (kind of lump - right arm), INFLUENZA LIKE ILLNESS (mild flu symptoms), NAUSEA (nausea), DECREASED APPETITE (no appetite), MALAISE (generally sick all over) and FEELING ABNORMAL (Just don't feel great). At the time of the report, INJECTION SITE DISCOLOURATION (pink spot on arm - right arm), INJECTION SITE MASS (kind of lump - right arm), INFLUENZA LIKE ILLNESS (mild flu symptoms), NAUSEA (nausea), DECREASED APPETITE (no appetite), MALAISE (generally sick all over) and FEELING ABNORMAL (Just don't feel great) 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.  Treatment medication included one acetaminophen.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea
Clinical narrative: pink spot on arm - right arm; kind of lump - right arm; mild flu symptoms; nausea; no appetite; generally sick all over; Just don't feel great; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INJECTION SITE DISCOLOURATION (pink spot on arm - right arm), INJECTION SITE MASS (kind of lump - right arm), INFLUENZA LIKE ILLNESS (mild flu symptoms), NAUSEA (nausea) and DECREASED APPETITE (no appetite) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) 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 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced INJECTION SITE DISCOLOURATION (pink spot on arm - right arm), INJECTION SITE MASS (kind of lump - right arm), INFLUENZA LIKE ILLNESS (mild flu symptoms), NAUSEA (nausea), DECREASED APPETITE (no appetite), MALAISE (generally sick all over) and FEELING ABNORMAL (Just don't feel great). At the time of the report, INJECTION SITE DISCOLOURATION (pink spot on arm - right arm), INJECTION SITE MASS (kind of lump - right arm), INFLUENZA LIKE ILLNESS (mild flu symptoms), NAUSEA (nausea), DECREASED APPETITE (no appetite), MALAISE (generally sick all over) and FEELING ABNORMAL (Just don't feel great) 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.  Treatment medication included one acetaminophen.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: Diarrhea; Fever; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and PYREXIA (Fever) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced DIARRHOEA (Diarrhea) and PYREXIA (Fever). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency; BISMUTH SUBSALICYLATE (KAOPECTATE [BISMUTH SUBSALICYLATE]) at an unspecified dose and frequency and BISMUTH SUBSALICYLATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE]) at an unspecified dose and frequency. On 25-Jan-2021, DIARRHOEA (Diarrhea) and PYREXIA (Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment medicines include Motrin, kaopectate and pepto bismol.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 30-Mar-2021: TCR attached; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Paraesthesia, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Tingling on my face and jaw; 10th day post vaccine the redness came back.; Fatigue; Red circle on injection site arm; Arm got sore; Swelling at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling on my face and jaw), MYALGIA (Arm got sore), VACCINATION SITE SWELLING (Swelling at injection site), VACCINATION SITE ERYTHEMA (Red circle on injection site arm) and VACCINATION SITE ERYTHEMA (10th day post vaccine the redness came back.) in a 44-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.     The patient's past medical history included No adverse event (No medical history reported.).   On 08-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 08-Jan-2021, the patient experienced MYALGIA (Arm got sore) and VACCINATION SITE SWELLING (Swelling at injection site). On 09-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red circle on injection site arm) and FATIGUE (Fatigue). On 17-Jan-2021, the patient experienced PARAESTHESIA (Tingling on my face and jaw) and VACCINATION SITE ERYTHEMA (10th day post vaccine the redness came back.). At the time of the report, PARAESTHESIA (Tingling on my face and jaw) had not resolved, MYALGIA (Arm got sore), VACCINATION SITE SWELLING (Swelling at injection site), VACCINATION SITE ERYTHEMA (10th day post vaccine the redness came back.) and FATIGUE (Fatigue) outcome was unknown and VACCINATION SITE ERYTHEMA (Red circle on injection site arm) had resolved.            This case was linked to MOD-2021-017852, MOD-2021-079605 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Apr-2021: The patient took the second dose therefore action taken is changed to not applicable. The outcome of the event tingling on my face and jaw was changed from unknown to not recovered/resolved .
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: flu-like symptoms which went away and recurred a few days later; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms which went away and recurred a few days later) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms which went away and recurred a few days later). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms which went away and recurred a few days later) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Patient experienced flu-like symptoms which went away and recurred a fewdays later.   Most recent FOLLOW-UP information incorporated above includes: On 18-Apr-2021: Follow up received on 18APR2021, 2nd dose details updated.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dry mouth, Headache, Rash, Tonsillar inflammation
Clinical narrative: tonsil irritation; stomach ache; Tonsil dryness; Rash; headache; I had a lot of itching at the injection site; Injection site redness; injection site swelling; This spontaneous case was reported by a consumer and describes the occurrence of TONSILLAR INFLAMMATION (tonsil irritation), ABDOMINAL PAIN UPPER (stomach ache), DRY MOUTH (Tonsil dryness), RASH (Rash) and VACCINATION SITE PRURITUS (I had a lot of itching at the injection site) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE SWELLING (injection site swelling). On 30-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (I had a lot of itching at the injection site). On 01-Feb-2021, the patient experienced TONSILLAR INFLAMMATION (tonsil irritation), ABDOMINAL PAIN UPPER (stomach ache), DRY MOUTH (Tonsil dryness), RASH (Rash) and HEADACHE (headache). On 28-Jan-2021, VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE SWELLING (injection site swelling) had resolved. At the time of the report, TONSILLAR INFLAMMATION (tonsil irritation), ABDOMINAL PAIN UPPER (stomach ache), DRY MOUTH (Tonsil dryness), RASH (Rash), VACCINATION SITE PRURITUS (I had a lot of itching at the injection site) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication not reported. Treatment medication not reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: contact info updated
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: tonsil irritation; stomach ache; Tonsil dryness; Rash; headache; I had a lot of itching at the injection site; Injection site redness; injection site swelling; This spontaneous case was reported by a consumer and describes the occurrence of TONSILLAR INFLAMMATION (tonsil irritation), ABDOMINAL PAIN UPPER (stomach ache), DRY MOUTH (Tonsil dryness), RASH (Rash) and VACCINATION SITE PRURITUS (I had a lot of itching at the injection site) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE SWELLING (injection site swelling). On 30-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (I had a lot of itching at the injection site). On 01-Feb-2021, the patient experienced TONSILLAR INFLAMMATION (tonsil irritation), ABDOMINAL PAIN UPPER (stomach ache), DRY MOUTH (Tonsil dryness), RASH (Rash) and HEADACHE (headache). On 28-Jan-2021, VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE SWELLING (injection site swelling) had resolved. At the time of the report, TONSILLAR INFLAMMATION (tonsil irritation), ABDOMINAL PAIN UPPER (stomach ache), DRY MOUTH (Tonsil dryness), RASH (Rash), VACCINATION SITE PRURITUS (I had a lot of itching at the injection site) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication not reported. Treatment medication not reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: contact info updated
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Cough, Fatigue, Nasal congestion, SARS-CoV-2 test
Clinical narrative: slight cough; congestion; scratching in my throat; sore shoulder; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (scratching in my throat), COUGH (slight cough), NASAL CONGESTION (congestion), ARTHRALGIA (sore shoulder) and FATIGUE (fatigue) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and PANTOPRAZOL [PANTOPRAZOLE] for an unknown indication.    On 23-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 ARTHRALGIA (sore shoulder) and FATIGUE (fatigue). On 26-Jan-2021, the patient experienced THROAT IRRITATION (scratching in my throat). On 01-Feb-2021, the patient experienced COUGH (slight cough) and NASAL CONGESTION (congestion). On 25-Jan-2021, ARTHRALGIA (sore shoulder) had resolved. At the time of the report, THROAT IRRITATION (scratching in my throat), COUGH (slight cough), NASAL CONGESTION (congestion) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jan-2021, SARS-CoV-2 test: negative (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treatment information not provided.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: slight cough; congestion; scratching in my throat; sore shoulder; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (scratching in my throat), COUGH (slight cough), NASAL CONGESTION (congestion), ARTHRALGIA (sore shoulder) and FATIGUE (fatigue) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and PANTOPRAZOL [PANTOPRAZOLE] for an unknown indication.    On 23-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 ARTHRALGIA (sore shoulder) and FATIGUE (fatigue). On 26-Jan-2021, the patient experienced THROAT IRRITATION (scratching in my throat). On 01-Feb-2021, the patient experienced COUGH (slight cough) and NASAL CONGESTION (congestion). On 25-Jan-2021, ARTHRALGIA (sore shoulder) had resolved. At the time of the report, THROAT IRRITATION (scratching in my throat), COUGH (slight cough), NASAL CONGESTION (congestion) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jan-2021, SARS-CoV-2 test: negative (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treatment information not provided.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Rash
Clinical narrative: 2 days later, developed rash on the abdomen, both arms; redness at the injection site.; This spontaneous case was reported by a health care professional and describes the occurrence of RASH (2 days later, developed rash on the abdomen, both arms) and INJECTION SITE ERYTHEMA (redness at the injection site.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 29L20A) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (2 days later, developed rash on the abdomen, both arms) and INJECTION SITE ERYTHEMA (redness at the injection site.). At the time of the report, RASH (2 days later, developed rash on the abdomen, both arms) and INJECTION SITE ERYTHEMA (redness at the injection site.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported. Action taken with mRNA-1273 in response to the event was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: itching at the injection site; redness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (itching at the injection site) and INJECTION SITE ERYTHEMA (redness at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) 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 INJECTION SITE PRURITUS (itching at the injection site) and INJECTION SITE ERYTHEMA (redness at the injection site). At the time of the report, INJECTION SITE PRURITUS (itching at the injection site) and INJECTION SITE ERYTHEMA (redness at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.    Reporter did not allow further contact
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Rash, Vaccination site swelling
Clinical narrative: Injection site swelling; Rash across chest, both shoulders, back and abdomen; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Injection site swelling), RASH (Rash across chest, both shoulders, back and abdomen) and FATIGUE (Tiredness) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021 at 1:30 PM, the patient experienced FATIGUE (Tiredness). On an unknown date, the patient experienced VACCINATION SITE SWELLING (Injection site swelling) and RASH (Rash across chest, both shoulders, back and abdomen). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 29-Jan-2021 at 2:00 PM, FATIGUE (Tiredness) had resolved. At the time of the report, VACCINATION SITE SWELLING (Injection site swelling) and RASH (Rash across chest, both shoulders, back and abdomen) 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.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Gingival discolouration
Clinical narrative: Brown gums since yesterday; This spontaneous case was reported by a consumer and describes the occurrence of GINGIVAL DISCOLOURATION (Brown gums since yesterday) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced GINGIVAL DISCOLOURATION (Brown gums since yesterday). At the time of the report, GINGIVAL DISCOLOURATION (Brown gums since yesterday) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Persisting itches; Persisting redness; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Persisting itches) and INJECTION SITE ERYTHEMA (Persisting redness ) in a 74-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 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced INJECTION SITE PRURITUS (Persisting itches) and INJECTION SITE ERYTHEMA (Persisting redness ). At the time of the report, INJECTION SITE PRURITUS (Persisting itches) and INJECTION SITE ERYTHEMA (Persisting redness ) 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.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site pain, Vaccination site rash
Clinical narrative: rash on the top of her arm; rash goes under her armpit as well; arm sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm sore), VACCINATION SITE RASH (rash on the top of her arm) and RASH (rash goes under her armpit as well) in a 69-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 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE PAIN (arm sore). On 28-Jan-2021, the patient experienced VACCINATION SITE RASH (rash on the top of her arm) and RASH (rash goes under her armpit as well). The patient was treated with DIPHENHYDRAMINE ongoing from 03-Feb-2021 at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (arm sore), VACCINATION SITE RASH (rash on the top of her arm) and RASH (rash goes under her armpit as well) 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 relevant concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: No new information was updated.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Hot flush, Nausea, Vaccination complication
Clinical narrative: Still battles with heat flashes and Nausea; Heat flashes all over the body; Heart Rate went up right away post vaccination; Nausea following heat flashes; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Heart Rate went up right away post vaccination), HOT FLUSH (Heat flashes all over the body), VACCINATION COMPLICATION (Still battles with heat flashes and Nausea) and NAUSEA (Nausea following heat flashes) in a 48-year-old male 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 14-Jan-2020, the patient experienced NAUSEA (Nausea following heat flashes). On 07-Jan-2021, the patient experienced VACCINATION COMPLICATION (Heart Rate went up right away post vaccination). On 14-Jan-2021, the patient experienced HOT FLUSH (Heat flashes all over the body). On 02-Feb-2021, the patient experienced VACCINATION COMPLICATION (Still battles with heat flashes and Nausea). On 07-Jan-2021, VACCINATION COMPLICATION (Heart Rate went up right away post vaccination) had resolved. At the time of the report, HOT FLUSH (Heat flashes all over the body), VACCINATION COMPLICATION (Still battles with heat flashes and Nausea) and NAUSEA (Nausea following heat flashes) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Lymphadenopathy, Vaccination site swelling
Clinical narrative: Flu like symptoms; Swollen lymph nodes left neck; Swollen left arm (Site of Injection); This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), LYMPHADENOPATHY (Swollen lymph nodes left neck) and VACCINATION SITE SWELLING (Swollen left arm (Site of Injection)) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20a) for COVID-19 vaccination.     The patient's past medical history included SARS-CoV-2 infection in April 2019 and Flu like symptoms from 30-Dec-2020 to 07-Jan-2021. Concurrent medical conditions included Hypertension since 2010 and Swollen lymph nodes since 30-Dec-2020. Concomitant products included LOSARTAN for Hypertension, VITAMIN D [VITAMIN D NOS], VITAMIN C [ASCORBIC ACID] and ZINC for Vitamin supplementation.    On 03-Dec-2020 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), LYMPHADENOPATHY (Swollen lymph nodes left neck) and VACCINATION SITE SWELLING (Swollen left arm (Site of Injection)). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) and VACCINATION SITE SWELLING (Swollen left arm (Site of Injection)) had resolved and LYMPHADENOPATHY (Swollen lymph nodes left neck) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.  The swollen lymph nodes were reported to be in th left neck and left arm (injection site).   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Follow up was received on 22-APR-2021. Patient demographics- Date of Birth, age, weight, height and race, medical history information, vaccination dose details, vaccine facility information, concomitant medications and all reported events were added.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, SARS-CoV-2 test
Clinical narrative: positive test for Covid, not experiencing any symptoms; This spontaneous case was reported by a consumer and describes the occurrence of ASYMPTOMATIC COVID-19 (positive test for Covid, not experiencing any symptoms) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced ASYMPTOMATIC COVID-19 (positive test for Covid, not experiencing any symptoms). At the time of the report, ASYMPTOMATIC COVID-19 (positive test for Covid, not experiencing any symptoms) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jan-2021, SARS-CoV-2 test: positive (Positive) Tested positive for Covid-19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported  No treatment medication reported
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Had some reaction; A spontaneous report was received from a Healthcare Professional concerning a  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events had some reactions.  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: UNKNOWN) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date had some reactions.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events, had some reactions was not reported.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: broke out into hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (broke out into hives) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028220A) for COVID-19 vaccination.     No Medical History information was reported.    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 URTICARIA (broke out into hives). The patient was treated with FLUOCINONIDE at an unspecified dose and frequency. At the time of the report, URTICARIA (broke out into hives) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   Reporter did not allow further contact
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Infusion site bruising, Injection site rash, Skin reaction, Vaccination site pruritus
Clinical narrative: delayed type of reaction; arm was red, itchy, and bumpy.; more like a rash; bruised and red; This spontaneous case was reported by a consumer and describes the occurrence of INFUSION SITE BRUISING (bruised and red), SKIN REACTION (delayed type of reaction), VACCINATION SITE PRURITUS (arm was red, itchy, and bumpy.) and INJECTION SITE RASH (more like a rash) in an 83-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 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced INFUSION SITE BRUISING (bruised and red). On 30-Jan-2021, the patient experienced SKIN REACTION (delayed type of reaction), VACCINATION SITE PRURITUS (arm was red, itchy, and bumpy.) and INJECTION SITE RASH (more like a rash). At the time of the report, INFUSION SITE BRUISING (bruised and red), SKIN REACTION (delayed type of reaction), VACCINATION SITE PRURITUS (arm was red, itchy, and bumpy.) and INJECTION SITE RASH (more like a rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medication use was not provided by the reporter she applied Benadryl cream on the rash and it faded  significanty.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Pruritus
Clinical narrative: Soreness; Itchiniess; Redness raised area on left arm; This spontaneous case was reported by a consumer and describes the occurrence of   in a female patient of an unknown age 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 (No relevant medical history).    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.; 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: U
Vaccine: COVID19
Symptoms: Allergy to vaccine
Clinical narrative: allergy to vaccine; A spontaneous report was received from a Healthcare Professional concerning a  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events covid arm.  The patient's medical history was not provided.   No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Detail Batch Number) intramuscularly for prophylaxis of COVID-19 infection.  It was reported that the patient has covid arm following first vaccine.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events, covid arm was not reported.; Reporter's Comments: Based on the current available information which includes a temporal association between the use of the product and onset of the event, a causal relationship cannot be excluded. Covid arm is consistent with the product safety profile.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Feeling cold, Feeling hot, Headache
Clinical narrative: Fever; Sweating; nose running; sneezing; hot; cold; felt bad; headache; Had chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt bad), CHILLS (Had chills), HEADACHE (headache), PYREXIA (Fever) and HYPERHIDROSIS (Sweating) in a 73-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 26-Jan-2021, the patient experienced CHILLS (Had chills). On 27-Jan-2021, the patient experienced FEELING ABNORMAL (felt bad) and HEADACHE (headache). On 30-Jan-2021, the patient experienced PYREXIA (Fever), HYPERHIDROSIS (Sweating), RHINORRHOEA (nose running), SNEEZING (sneezing), FEELING HOT (hot) and FEELING COLD (cold). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (felt bad), CHILLS (Had chills), HEADACHE (headache), PYREXIA (Fever), HYPERHIDROSIS (Sweating), RHINORRHOEA (nose running), SNEEZING (sneezing), FEELING HOT (hot) and FEELING COLD (cold) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Medical History information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Pyrexia, Rhinorrhoea, Sneezing
Clinical narrative: Fever; Sweating; nose running; sneezing; hot; cold; felt bad; headache; Had chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt bad), CHILLS (Had chills), HEADACHE (headache), PYREXIA (Fever) and HYPERHIDROSIS (Sweating) in a 73-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 26-Jan-2021, the patient experienced CHILLS (Had chills). On 27-Jan-2021, the patient experienced FEELING ABNORMAL (felt bad) and HEADACHE (headache). On 30-Jan-2021, the patient experienced PYREXIA (Fever), HYPERHIDROSIS (Sweating), RHINORRHOEA (nose running), SNEEZING (sneezing), FEELING HOT (hot) and FEELING COLD (cold). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (felt bad), CHILLS (Had chills), HEADACHE (headache), PYREXIA (Fever), HYPERHIDROSIS (Sweating), RHINORRHOEA (nose running), SNEEZING (sneezing), FEELING HOT (hot) and FEELING COLD (cold) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Medical History information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site erythema, Myalgia
Clinical narrative: Body Aches; chills; injection site red; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body Aches), CHILLS (chills) and INJECTION SITE ERYTHEMA (injection site red) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced MYALGIA (Body Aches), CHILLS (chills) and INJECTION SITE ERYTHEMA (injection site red). At the time of the report, MYALGIA (Body Aches), CHILLS (chills) and INJECTION SITE ERYTHEMA (injection site red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.; 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: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site rash
Clinical narrative: very large red area, about 2&1/2" x 2&1/2" in size; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (very large red area, about 2&1/2" x 2&1/2" in size) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Not available) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE RASH (very large red area, about 2&1/2" x 2&1/2" in size). At the time of the report, INJECTION SITE RASH (very large red area, about 2&1/2" x 2&1/2" in size) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: This case concerns a 23-year-old male, with medical history of sulfa allergy, who experienced a NS expected event of injection site rash.  Event onset occurred the same day as the first dose of mRNA-1273. Treatment not reported. Event outcome 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: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Pruritus, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Black and blue mark at the injection site; Itching at the injection site; Redness at the injection site; Itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), INJECTION SITE BRUISING (Black and blue mark at the injection site), VACCINATION SITE PRURITUS (Itching at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site) in a 75-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 (No medical history provided).    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced PRURITUS (Itching). On an unknown date, the patient experienced INJECTION SITE BRUISING (Black and blue mark at the injection site), VACCINATION SITE PRURITUS (Itching at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site). On 22-Jan-2021, PRURITUS (Itching) had resolved. At the time of the report, INJECTION SITE BRUISING (Black and blue mark at the injection site), VACCINATION SITE PRURITUS (Itching at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) 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 event, a causal relationship cannot be excluded.