chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: couldn't eat; Vomited; Very weak/felt so weak; Chills; Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (couldn't eat), ASTHENIA (Very weak/felt so weak), CHILLS (Chills), NAUSEA (Nausea) and HEADACHE (Headache) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Autoimmune disorder NOS (two autoimmune diseases, one in eye). Concomitant products included METHOTREXATE for an unknown indication.   On 15-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced ASTHENIA (Very weak/felt so weak), CHILLS (Chills), NAUSEA (Nausea) and HEADACHE (Headache). On 21-Feb-2021, the patient experienced DECREASED APPETITE (couldn't eat) and VOMITING (Vomited). On 17-Feb-2021, HEADACHE (Headache) had resolved. On 21-Feb-2021, VOMITING (Vomited) had resolved. At the time of the report, DECREASED APPETITE (couldn't eat), ASTHENIA (Very weak/felt so weak), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown.            No treatment information provided   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow up information received on 29-jun-2021 contains email address updated
Sex: F
Vaccine: COVID19
Symptoms: Ocular discomfort
Clinical narrative: things going on with their eyes, same side as injection; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR DISCOMFORT (things going on with their eyes, same side as injection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OCULAR DISCOMFORT (things going on with their eyes, same side as injection). At the time of the report, OCULAR DISCOMFORT (things going on with their eyes, same side as injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications provided.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: a large redness on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (a large redness on the injection site) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal and Colitis.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (a large redness on the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (a large redness on the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medications included blood pressure medications and colitis medication
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling
Clinical narrative: upper arm is swollen; upper arm is a little pink; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (upper arm is swollen) and ERYTHEMA (upper arm is a little pink) in an 87-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.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (upper arm is swollen) and ERYTHEMA (upper arm is a little pink). At the time of the report, PERIPHERAL SWELLING (upper arm is swollen) and ERYTHEMA (upper arm is a little pink) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: chills; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (fever) and HEADACHE (headache) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024A20A and 042L20A) for COVID-19 vaccination.     The patient's past medical history included Cancer and Liver transplant.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Feb-2021, the patient experienced CHILLS (chills), PYREXIA (fever) and HEADACHE (headache). On 23-Feb-2021, CHILLS (chills), PYREXIA (fever) and HEADACHE (headache) had resolved.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Muscle spasms
Clinical narrative: severe muscle spasm; Chills everyday for one month; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (severe muscle spasm) and CHILLS (Chills everyday for one month) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02520A) for COVID-19 vaccination.     The patient's past medical history included No adverse event .  Concomitant products included TOFACITINIB CITRATE (XELJANZ) 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 an unknown date, the patient experienced MUSCLE SPASMS (severe muscle spasm) and CHILLS (Chills everyday for one month). At the time of the report, MUSCLE SPASMS (severe muscle spasm) and CHILLS (Chills everyday for one month) outcome was unknown.        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 these events, a causal relationship cannot be excluded.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Rash at the site of shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash at the site of shot) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041120A and 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Diabetes.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced VACCINATION SITE RASH (Rash at the site of shot). On 27-Feb-2021, VACCINATION SITE RASH (Rash at the site of shot) had resolved.            No concomitant medications were reported   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: On 03-May-2021: Reporter details updated, dose details updated, event details updated and medical history added.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Gait inability, Headache, Injection site pain
Clinical narrative: m injection site was a little tender; charlie horse in upper right thigh/charlie horse in part of inner leg; chest started tightening up a little bit; chest pain; could hardly walk; nagging headache; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (m injection site was a little tender), MUSCLE SPASMS (charlie horse in upper right thigh/charlie horse in part of inner leg), CHEST DISCOMFORT (chest started tightening up a little bit), CHEST PAIN (chest pain) and GAIT INABILITY (could hardly walk) 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.     No medical history was provided by the reporter. .  Concomitant products included HYDRALAZINE, AMLODIPINE, ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) and UBIDECARENONE (COQ) for an unknown indication.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced MUSCLE SPASMS (charlie horse in upper right thigh/charlie horse in part of inner leg), CHEST DISCOMFORT (chest started tightening up a little bit), CHEST PAIN (chest pain), GAIT INABILITY (could hardly walk) and HEADACHE (nagging headache). On an unknown date, the patient experienced INJECTION SITE PAIN (m injection site was a little tender). On 07-Feb-2021, MUSCLE SPASMS (charlie horse in upper right thigh/charlie horse in part of inner leg), CHEST DISCOMFORT (chest started tightening up a little bit), CHEST PAIN (chest pain), GAIT INABILITY (could hardly walk) and HEADACHE (nagging headache) had resolved. At the time of the report, INJECTION SITE PAIN (m injection site was a little tender) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: m injection site was a little tender; charlie horse in upper right thigh/charlie horse in part of inner leg; chest started tightening up a little bit; chest pain; could hardly walk; nagging headache; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (m injection site was a little tender), MUSCLE SPASMS (charlie horse in upper right thigh/charlie horse in part of inner leg), CHEST DISCOMFORT (chest started tightening up a little bit), CHEST PAIN (chest pain) and GAIT INABILITY (could hardly walk) 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.     No medical history was provided by the reporter. .  Concomitant products included HYDRALAZINE, AMLODIPINE, ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) and UBIDECARENONE (COQ) for an unknown indication.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced MUSCLE SPASMS (charlie horse in upper right thigh/charlie horse in part of inner leg), CHEST DISCOMFORT (chest started tightening up a little bit), CHEST PAIN (chest pain), GAIT INABILITY (could hardly walk) and HEADACHE (nagging headache). On an unknown date, the patient experienced INJECTION SITE PAIN (m injection site was a little tender). On 07-Feb-2021, MUSCLE SPASMS (charlie horse in upper right thigh/charlie horse in part of inner leg), CHEST DISCOMFORT (chest started tightening up a little bit), CHEST PAIN (chest pain), GAIT INABILITY (could hardly walk) and HEADACHE (nagging headache) had resolved. At the time of the report, INJECTION SITE PAIN (m injection site was a little tender) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Pyrexia
Clinical narrative: woke up feeling hot; had a fever of 99.8 F; A spontaneous report was received from a consumer concerning, a 70-year-old female patient, who received Moderna (mRNA-1273) vaccine and woke up feeling hot and had a fever of 99.8 F.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 27 Jan 2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 043L20A) in the left arm for prophylaxis of COVID-19 infection.  On 27 Jan 2021 at 10:30 PM, the patient went to bed and slept until 3 AM and woke up feeling hot. The patient had a fever of 99.8 F. The patient went back to sleep and when woke up the fever was gone. The patient stayed up for 2 hours and then slept until 2 PM. The reporter stated that the patient had the best sleep they had in a long time.   Treatment information was not provided by the reporter.    Action taken with mRNA-1273 in response to the event(s) was Not Applicable.  On 28 Jan 2021, the outcome of the events, woke up feeling hot and had a fever of 99.8 F were considered resolved.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site induration
Clinical narrative: Had a 20 inches red induration; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE INDURATION (Had a 20 inches red induration) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE INDURATION (Had a 20 inches red induration). At the time of the report, VACCINATION SITE INDURATION (Had a 20 inches red induration) 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. No treatment information was provided.   This case was linked to MOD-2021-021564, MOD-2021-010050 (Patient Link).
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pain, Palpitations, Pyrexia
Clinical narrative: Heart Racing at Night; Body Aches; Fever - Temperature of 101.0F; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PALPITATIONS (Heart Racing at Night), PAIN (Body Aches), PYREXIA (Fever - Temperature of 101.0F) and FATIGUE (Fatigue) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) 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) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced PALPITATIONS (Heart Racing at Night), PAIN (Body Aches), PYREXIA (Fever - Temperature of 101.0F) and FATIGUE (Fatigue). At the time of the report, PALPITATIONS (Heart Racing at Night), PAIN (Body Aches), PYREXIA (Fever - Temperature of 101.0F) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 101.0f (Inconclusive) 101.0F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided No treatment 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 these events, a causal relationship cannot be excluded.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in jaw
Clinical narrative: jaw pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN JAW (jaw pain) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concomitant products included COLECALCIFEROL (VIT D [COLECALCIFEROL]) and CYANOCOBALAMIN (VIT B 12) for an unknown indication.   On 12-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Jan-2021, the patient experienced PAIN IN JAW (jaw pain). At the time of the report, PAIN IN JAW (jaw pain) had not resolved.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Cough, Head discomfort, Musculoskeletal chest pain, Nasal congestion
Clinical narrative: Chest congestion; Coughing; Runny nose; Sore ribs; Stopped up nose; head congestion; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (head congestion), CHEST DISCOMFORT (Chest congestion), COUGH (Coughing), RHINORRHOEA (Runny nose) and MUSCULOSKELETAL CHEST PAIN (Sore ribs) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced HEAD DISCOMFORT (head congestion). On an unknown date, the patient experienced CHEST DISCOMFORT (Chest congestion), COUGH (Coughing), RHINORRHOEA (Runny nose), MUSCULOSKELETAL CHEST PAIN (Sore ribs) and NASAL CONGESTION (Stopped up nose). At the time of the report, HEAD DISCOMFORT (head congestion) had resolved and CHEST DISCOMFORT (Chest congestion), COUGH (Coughing), RHINORRHOEA (Runny nose), MUSCULOSKELETAL CHEST PAIN (Sore ribs) and NASAL CONGESTION (Stopped up nose) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided; 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: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: Chest congestion; Coughing; Runny nose; Sore ribs; Stopped up nose; head congestion; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (head congestion), CHEST DISCOMFORT (Chest congestion), COUGH (Coughing), RHINORRHOEA (Runny nose) and MUSCULOSKELETAL CHEST PAIN (Sore ribs) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced HEAD DISCOMFORT (head congestion). On an unknown date, the patient experienced CHEST DISCOMFORT (Chest congestion), COUGH (Coughing), RHINORRHOEA (Runny nose), MUSCULOSKELETAL CHEST PAIN (Sore ribs) and NASAL CONGESTION (Stopped up nose). At the time of the report, HEAD DISCOMFORT (head congestion) had resolved and CHEST DISCOMFORT (Chest congestion), COUGH (Coughing), RHINORRHOEA (Runny nose), MUSCULOSKELETAL CHEST PAIN (Sore ribs) and NASAL CONGESTION (Stopped up nose) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided; 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: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Musculoskeletal chest pain, Nasal congestion, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Coughing; Runny nose; Stopped up nose; Sore ribs; Chest congestion; Head congestion; A spontaneous report  was received from a consumer concerning a 72-years-old, female patient who experienced chest congestion, head congestion/stopped up nose , coughing, runny nose, and sore ribs.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 08 Feb 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (lot number: 013M20A) intramuscularly for prophylaxis of COVID-19 infection.   On 17 Feb 2021, the patient reported head congestion that resolved on unknown date. She also reported chest congestion, coughing, runny nose, stopped up nose and sore ribs.  Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events,  chest congestion, head congestion/stopped up nose, coughing, runny nose, and sore ribs, was not reported.; 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: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Adverse reactions; A spontaneous report was received from a pharmacist concerning unspecified patients, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced adverse reactions.   The patient's medical history, was not provided by the reporter. Concomitant medications were not reported.   On an unknown date, prior to the onset of the events, the patient received their planned dose of mRNA-1273 (Lot number: unknown) via an unknown route for prophylaxis of COVID-19 infection.   On an unknown date the patients experienced adverse reactions.  Treatment for the events were not reported.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, adverse reactions were unknown
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site rash, Vaccination site warmth
Clinical narrative: warm to touch at the injection site, it is not painful.; has a little rash around the injection site; little red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm to touch at the injection site, it is not painful.), VACCINATION SITE RASH (has a little rash around the injection site) and VACCINATION SITE ERYTHEMA (little red) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced VACCINATION SITE WARMTH (warm to touch at the injection site, it is not painful.), VACCINATION SITE RASH (has a little rash around the injection site) and VACCINATION SITE ERYTHEMA (little red). At the time of the report, VACCINATION SITE WARMTH (warm to touch at the injection site, it is not painful.), VACCINATION SITE RASH (has a little rash around the injection site) and VACCINATION SITE ERYTHEMA (little red) 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; Sender'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.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles due to the vaccination; A spontaneous report was received from a consumer concerning a  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  shingles due to the vaccination/herpes zoster.  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 second of two planned doses of mRNA-1273 (lot/batch: UNKNOWN) via unknown route for prophylaxis of COVID-19 infection.On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: UNKNOWN) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced shingles due to the vaccination/herpes zoster..  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 shingles due to the vaccination/herpes zoster. due to the vaccination was unknown.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cough, Myalgia, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: tested positive for covid; cough; muscle pain; Fever; very week; This spontaneous report was reported by an other health care professional and describes the occurrence of MYALGIA (muscle pain), ASTHENIA (very weak), COVID-19 (tested positive for covid), COUGH (cough) and PYREXIA (Fever) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient had no medical history     On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYALGIA (muscle pain), ASTHENIA (very weak), COUGH (cough) and PYREXIA (Fever). On 19-Jan-2021, the patient experienced COVID-19 (tested positive for COVID). At the time of the report, MYALGIA (muscle pain), ASTHENIA (very weak), COVID-19 (tested positive for COVID) and COUGH (cough) outcome was unknown.  The outcome for the patient being tested with COVID-19 is unlikely because of the vaccine.      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.   Reporter did not allow further contact
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache
Clinical narrative: Diarrhea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and HEADACHE (Headache) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced DIARRHOEA (Diarrhea) and HEADACHE (Headache). At the time of the report, DIARRHOEA (Diarrhea) and HEADACHE (Headache) 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; Sender'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: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Back pain, Dysgeusia, Fatigue
Clinical narrative: Metalic taste in mouth; paresthesia both legs; shooting pain down my back; felt like legs were shrink wrapped; under skin numbness; left arm sore; tired all over; pins and needles down both legs; A spontaneous report was received from a 68-years-old female patient concerning herself who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events left arm sore, tired all over, legs felt frozen, under skin numbness, felt like legs were shrink wrapped, shooting pain down back, pins and needles down both legs, paresthesia both legs and metallic taste in mouth.  The patient's medical history was provided as auto immune connective tissue disease. No relevant concomitant medications were reported.  On 23 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 012L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 25 J an 2021, the patient experienced events legs were (felt like they were) frozen, feeling numbness under the skin. On 26 Jan 2021 and it felt like they were shrink wrapped.  On 27 Jan 2021 felt shooting pain down back, it lasted about five hours.  On an unknown date, the patient had pins and needles down both legs, that have continued since it started.  On 19 Feb 2021 the patient had metallic taste in my mouth.   No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On 27 Jan 2021, the event shooting pain down back was considered recovered.  The outcome of events, left arm sore, tired all over, legs felt frozen, under skin numbness, felt like legs were shrink wrapped, pins and needles down both legs, paresthesia both legs and metallic taste in mouth was unknown.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: Metalic taste in mouth; paresthesia both legs; shooting pain down my back; felt like legs were shrink wrapped; under skin numbness; left arm sore; tired all over; pins and needles down both legs; A spontaneous report was received from a 68-years-old female patient concerning herself who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events left arm sore, tired all over, legs felt frozen, under skin numbness, felt like legs were shrink wrapped, shooting pain down back, pins and needles down both legs, paresthesia both legs and metallic taste in mouth.  The patient's medical history was provided as auto immune connective tissue disease. No relevant concomitant medications were reported.  On 23 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 012L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 25 J an 2021, the patient experienced events legs were (felt like they were) frozen, feeling numbness under the skin. On 26 Jan 2021 and it felt like they were shrink wrapped.  On 27 Jan 2021 felt shooting pain down back, it lasted about five hours.  On an unknown date, the patient had pins and needles down both legs, that have continued since it started.  On 19 Feb 2021 the patient had metallic taste in my mouth.   No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On 27 Jan 2021, the event shooting pain down back was considered recovered.  The outcome of events, left arm sore, tired all over, legs felt frozen, under skin numbness, felt like legs were shrink wrapped, pins and needles down both legs, paresthesia both legs and metallic taste in mouth was unknown.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Herpes zoster, Pyrexia, Sticky skin
Clinical narrative: felt icky; headache and feverish; headache and feverish; shingles; A spontaneous report was received from a consumer concerning a 59-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events  shingles/herpes zoster, headache and feverish, felt icky/sticky skin.  The patient's medical history was not provided. Concomitant medications reported were aspirin, vitamin D for drug use for unknown indication.  On 22 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 029L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 19 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 024M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 20 Feb 2021, the patient experienced the event,  shingles. On 21 Feb 2021, the patient experienced the events,  headache and feverish, felt icky.  Treatment details included Valacyclovir..  The patient received both scheduled doses of mRNA 1273 before the events, therefore Action taken with mRNA-1273 in response to the events was not applicable. The outcome of events, shingles, headache and feverish, felt icky was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia
Clinical narrative: body aches; Rigors; A spontaneous report (United States) was received from a physician concerning a female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Body aches and rigors.  The patient's medical history, was not provided by the reporter. Concomitant medications reported included Ibuprofen.  On 13 Jan 2021, the patient received their planned dose of mRNA-1273  for prophylaxis of COVID-19 infection.   Since 21 Jan 2021she was taking ibuprofen at that time. When she stopped the ibuprofen she's had been experiencing  body aches and rigors..The physician worked it up and there's no infection  Treatment for the events not reported. Action taken with mRNA-1273 in response to the events was not reported.  Outcome of the events was  also not reported.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: redness and swelling at the injection site; redness and swelling at the injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Jan-2021 and was forwarded to Moderna on 29-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (redness and swelling at the injection site) and VACCINATION SITE SWELLING (redness and swelling at the injection site) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness and swelling at the injection site) and VACCINATION SITE SWELLING (redness and swelling at the injection site). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, VACCINATION SITE ERYTHEMA (redness and swelling at the injection site) and VACCINATION SITE SWELLING (redness and swelling at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       She has treated with cold compress and Ibuprofen.No concomitant medications are provided.The outcome of the patient is  recovered.   Reporter did not allow further contact
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis, SARS-CoV-2 antibody test, Suspected COVID-19
Clinical narrative: COVID-19; Catching cold; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (COVID-19) and NASOPHARYNGITIS (Catching cold) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced SUSPECTED COVID-19 (COVID-19) and NASOPHARYNGITIS (Catching cold). At the time of the report, SUSPECTED COVID-19 (COVID-19) and NASOPHARYNGITIS (Catching cold) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Feb-2021, SARS-CoV-2 antibody test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment: got infusion in hospital.before he left, he was told he tested negative for COVID-19   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Follow-up received on 15-06-2021: Lab data  was added,
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Rash erythematous
Clinical narrative: Burning sensation around the waist area on the lower left side; Weird sensation like its sun burn to touch; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Feb-2021 and was forwarded to Moderna on 22-Feb-2021.    This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Feb-2021 and was forwarded to Moderna on 22-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning sensation around the waist area on the lower left side) and RASH ERYTHEMATOUS (Weird sensation like its sun burn to touch) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No prior medical history was reported.).    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced BURNING SENSATION (Burning sensation around the waist area on the lower left side) and RASH ERYTHEMATOUS (Weird sensation like its sun burn to touch). At the time of the report, BURNING SENSATION (Burning sensation around the waist area on the lower left side) and RASH ERYTHEMATOUS (Weird sensation like its sun burn to touch) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.50% of body covered in a rash - His arms, thighs, back and going up his neck
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Rash, Vaccination site erythema, Vaccination site swelling
Clinical narrative: swollen at injection site; very uncomfortable; inflamed at injection site; 50% of body covered in a rash - His arms, thighs, back and going up his neck; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Feb-2021 and was forwarded to Moderna on 24-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swollen at injection site), DISCOMFORT (very uncomfortable), VACCINATION SITE ERYTHEMA (inflamed at injection site) and RASH (50% of body covered in a rash - His arms, thighs, back and going up his neck) 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 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced VACCINATION SITE SWELLING (swollen at injection site), DISCOMFORT (very uncomfortable), VACCINATION SITE ERYTHEMA (inflamed at injection site) and RASH (50% of body covered in a rash - His arms, thighs, back and going up his neck). At the time of the report, VACCINATION SITE SWELLING (swollen at injection site), DISCOMFORT (very uncomfortable), VACCINATION SITE ERYTHEMA (inflamed at injection site) and RASH (50% of body covered in a rash - His arms, thighs, back and going up his neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Headache, Induration, Musculoskeletal stiffness, Tremor
Clinical narrative: local redness; hard knot/plum size lump; vertigo; right arm tremor/shaking right hand; right side CV stiffening; headache; This spontaneous case was reported by a consumer and describes the occurrence of   in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included Asthma, Aortic Valve Replacement, Cancer, Congenital heart disease NOS, Ventricular tachycardia and Pacemaker Insertion.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        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.   Further testing (nuclear test)
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: local redness; hard knot/plum size lump; vertigo; right arm tremor/shaking right hand; right side CV stiffening; headache; This spontaneous case was reported by a consumer and describes the occurrence of   in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included Asthma, Aortic Valve Replacement, Cancer, Congenital heart disease NOS, Ventricular tachycardia and Pacemaker Insertion.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        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.   Further testing (nuclear test)
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Positive COVID Test after vaccination; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Positive COVID Test after vaccination) 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 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced COVID-19 (Positive COVID Test after vaccination). At the time of the report, COVID-19 (Positive COVID Test after vaccination) 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.   Cross Linked with Case MOD21-032138 and MOD21-036065. Patient received antibody treatment for the infection and have since recovered. No relevant concomitant 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 event, a causal relationship Unlikely.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Pain in extremity
Clinical narrative: arm pain; headaches; joint pains; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain), HEADACHE (headaches) and ARTHRALGIA (joint pains) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm pain), HEADACHE (headaches) and ARTHRALGIA (joint pains). At the time of the report, PAIN IN EXTREMITY (arm pain), HEADACHE (headaches) and ARTHRALGIA (joint pains) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information for the events was reported.   This case was linked to MOD21-035030, MOD-2021-021841 (Patient Link).   Reporter did not allow further contact
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warmth at the injection site), VACCINATION SITE PRURITUS (itchiness at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (warmth at the injection site), VACCINATION SITE PRURITUS (itchiness at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site). At the time of the report, VACCINATION SITE WARMTH (warmth at the injection site), VACCINATION SITE PRURITUS (itchiness at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.   No treatment information for the events was reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow up received on 15 Jul 2021 contains non significant information
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Peripheral swelling, Pruritus, Skin irritation
Clinical narrative: COVID arm; More irritated; More red; More painful; More warm to touch; Swollen arm; Itchy; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE REACTION (COVID arm), SKIN IRRITATION (More irritated), ERYTHEMA (More red), PAIN (More painful) and VACCINATION SITE WARMTH (More warm to touch) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LOSARTAN and ATORVASTATIN for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced VACCINATION SITE REACTION (COVID arm), SKIN IRRITATION (More irritated), ERYTHEMA (More red), PAIN (More painful), VACCINATION SITE WARMTH (More warm to touch), PERIPHERAL SWELLING (Swollen arm) and PRURITUS (Itchy). At the time of the report, VACCINATION SITE REACTION (COVID arm), SKIN IRRITATION (More irritated), ERYTHEMA (More red), PAIN (More painful), VACCINATION SITE WARMTH (More warm to touch), PERIPHERAL SWELLING (Swollen arm) and PRURITUS (Itchy) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable.  Treatment information was not provided by the reporter.   This case was linked to MOD-2021-022335.