chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: low grade fever broke off after 24 hrs of having the second shot; severe pain at injection site; chills; muscle pain; joint pain; tiredness; Severe pain at injection site; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (Severe pain at injection site), VACCINATION SITE PAIN (severe pain at injection site), CHILLS (chills), MYALGIA (muscle pain) and ARTHRALGIA (joint pain) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Jan-2021, the patient experienced VACCINATION SITE PAIN (Severe pain at injection site). On 02-Feb-2021, the patient experienced VACCINATION SITE PAIN (severe pain at injection site), CHILLS (chills), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and FATIGUE (tiredness). On 03-Feb-2021, the patient experienced PYREXIA (low grade fever broke off after 24 hrs of having the second shot). On 02-Feb-2021, CHILLS (chills) outcome was unknown. At the time of the report, VACCINATION SITE PAIN (Severe pain at injection site) had resolved and VACCINATION SITE PAIN (severe pain at injection site), MYALGIA (muscle pain), ARTHRALGIA (joint pain), FATIGUE (tiredness) and PYREXIA (low grade fever broke off after 24 hrs of having the second shot) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: low grade fever broke off after 24 hrs of having the second shot; severe pain at injection site; chills; muscle pain; joint pain; tiredness; Severe pain at injection site; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (Severe pain at injection site), VACCINATION SITE PAIN (severe pain at injection site), CHILLS (chills), MYALGIA (muscle pain) and ARTHRALGIA (joint pain) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Jan-2021, the patient experienced VACCINATION SITE PAIN (Severe pain at injection site). On 02-Feb-2021, the patient experienced VACCINATION SITE PAIN (severe pain at injection site), CHILLS (chills), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and FATIGUE (tiredness). On 03-Feb-2021, the patient experienced PYREXIA (low grade fever broke off after 24 hrs of having the second shot). On 02-Feb-2021, CHILLS (chills) outcome was unknown. At the time of the report, VACCINATION SITE PAIN (Severe pain at injection site) had resolved and VACCINATION SITE PAIN (severe pain at injection site), MYALGIA (muscle pain), ARTHRALGIA (joint pain), FATIGUE (tiredness) and PYREXIA (low grade fever broke off after 24 hrs of having the second shot) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: sorenes in the left arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (sorenes in the left arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) 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 21-Jan-2021, the patient experienced INJECTION SITE PAIN (sorenes in the left arm). On 22-Jan-2021, INJECTION SITE PAIN (sorenes in the left arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: low grade fever broke off after 24 hrs of having the second shot; Muscle pain; Joint pain; chills; tiredness; severe pain at injection site; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (severe pain at injection site), PYREXIA (low grade fever broke off after 24 hrs of having the second shot), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and CHILLS (chills) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE PAIN (severe pain at injection site), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), CHILLS (chills) and FATIGUE (tiredness). On 03-Feb-2021, the patient experienced PYREXIA (low grade fever broke off after 24 hrs of having the second shot). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of UNK dosage form. At the time of the report, VACCINATION SITE PAIN (severe pain at injection site) had resolved and PYREXIA (low grade fever broke off after 24 hrs of having the second shot), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), CHILLS (chills) and FATIGUE (tiredness) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: low grade fever broke off after 24 hrs of having the second shot; Muscle pain; Joint pain; chills; tiredness; severe pain at injection site; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (severe pain at injection site), PYREXIA (low grade fever broke off after 24 hrs of having the second shot), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and CHILLS (chills) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE PAIN (severe pain at injection site), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), CHILLS (chills) and FATIGUE (tiredness). On 03-Feb-2021, the patient experienced PYREXIA (low grade fever broke off after 24 hrs of having the second shot). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of UNK dosage form. At the time of the report, VACCINATION SITE PAIN (severe pain at injection site) had resolved and PYREXIA (low grade fever broke off after 24 hrs of having the second shot), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), CHILLS (chills) and FATIGUE (tiredness) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea
Clinical narrative: Nausea; headache; chills; A spontaneous report was received from a consumer concerning a 29 years of age, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced nausea, headache and chills.  The patient's medical history was not provided. Concomitant medications, motion sickness medication are were reported.   On 08, Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown)  unknown for prophylaxis of COVID-19 infection.   On 08, Feb 2021, prior to receiving mRNA-1273, from unknown date, the patient experienced nausea, headache and chills.   No treatment were provided. No laboratory details were provided. Action taken with mRNA-1273 in response to the events was not reported.   The events,  nausea, headache and chills were considered as unknown.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Covid like symptoms; A spontaneous report was received from a consumer concerning a 73-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced covid like symptoms and tested positive for covid.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 19 Jan 2021, 13 days prior to the onset of the event covid like symptoms, the patient received their first of two planned doses of mRNA-1273 (032L20A) in the left arm for prophylaxis of COVID-19 infection.  On 31 Jan 2021, the patient experienced covid like symptoms.  On 01 Feb 2021, the patient tested positive for covid.  Treatment for the event included Tylenol.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the covid like symptoms and tested positive for covid was not recovered (ongoing).; Reporter's Comments: This case concerns a 73-year-old female who experienced a nonserious unexpected event of COVID-19.  The event occurred 13 days after the first dose of mRNA-1273. Treatment included Tylenol. Event ongoing. 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.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pyrexia
Clinical narrative: malaise; high temperature; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (malaise) and PYREXIA (high temperature) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID -19.     Concurrent medical conditions included No adverse drug reaction (No reported adverse drug reaction).    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (malaise) and PYREXIA (high temperature). At the time of the report, MALAISE (malaise) and PYREXIA (high temperature) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided  No treatment medications were provided..    Reporter did not allow further contact
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced HEADACHE (Headache). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided.  Treatment information included ibuprofen.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Nausea; vomiting; fever temperature of 102F; A spontaneous report was received from a nurse concerning a, female patient who experienced [EVENT nausea, vomiting and fever.   The patient's medical history was not provided.    Concomitant product use was not provided by the reporter.   Consumer got the first shot of moderna vaccine on 21Jan2021 and developed nausea and vomiting, and fever temperature of 102F.  Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the events was not reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Parosmia
Clinical narrative: Metallic taste in mouth (like mouth full of pennies); She smells her person; A Spontaneous report (United States) was received from  a consumer, concerning a 67 years old, female consumer who was administered by Moderna's COVID-19 vaccine and was reported adverse event by the patient.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 22 JAN 2021, patient took her 1st dose of the Moderna vaccine. About three days after the shot, she had metallic taste in her mouth like mouth full of pennies. She also stated that "she smells her person". Everything smells and tastes metallic.  Patient's next shot is scheduled for 19FEB2021. What should she do? Should she take the 2nd shot? was asked by the patient.  No treatment information was reported.  The outcome of the adverse event occurred due to administered vaccine  was considered to be unknown.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Unexpected therapeutic outcome; A spontaneous report was received from a consumer concerning a 81 year old , female patient .  The patient's medical history included backache in her kidneys for 2 weeks.  Products known to have been used by the patient, within two weeks prior to the event, included medications for Thyroid and water pills to make you urinate.     The patient received her planned dose of mRNA-1273 (Batch number:unknown) on 02-feb-2021 intramuscularly for prophylaxis of COVID-19 infection. .She also reported that her back pain in kidney went away after the administration of covid-19 vaccine.     The outcome of the event(s) was reported as resolved.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site rash, Vaccination site warmth
Clinical narrative: It's warm to touch; Just noticed around the injection site on her right arm, there's is a red area; Little rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (It's warm to touch), VACCINATION SITE ERYTHEMA (Just noticed around the injection site on her right arm, there's is a red area) and VACCINATION SITE RASH (Little rash) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021 at 3:00 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE WARMTH (It's warm to touch), VACCINATION SITE ERYTHEMA (Just noticed around the injection site on her right arm, there's is a red area) and VACCINATION SITE RASH (Little rash). At the time of the report, VACCINATION SITE WARMTH (It's warm to touch), VACCINATION SITE ERYTHEMA (Just noticed around the injection site on her right arm, there's is a red area) and VACCINATION SITE RASH (Little rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.    Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Somnolence, Taste disorder
Clinical narrative: Experience taste of vitamin B 12 in her mouth; dizzy; Sleepy; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (Experience taste of vitamin B 12 in her mouth), DIZZINESS (dizzy) and SOMNOLENCE (Sleepy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TASTE DISORDER (Experience taste of vitamin B 12 in her mouth), DIZZINESS (dizzy) and SOMNOLENCE (Sleepy). At the time of the report, TASTE DISORDER (Experience taste of vitamin B 12 in her mouth), DIZZINESS (dizzy) and SOMNOLENCE (Sleepy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was 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 cannot be excluded.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dyspnoea, Heart rate increased, Insomnia, Muscle twitching
Clinical narrative: muscle twitching; Insomnia; rapid heartbeat; Short of breath; Anxiety; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TWITCHING (muscle twitching), INSOMNIA (Insomnia), HEART RATE INCREASED (rapid heartbeat), DYSPNOEA (Short of breath) and ANXIETY (Anxiety) in a 31-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 09-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 11-Jan-2021, the patient experienced MUSCLE TWITCHING (muscle twitching), INSOMNIA (Insomnia), HEART RATE INCREASED (rapid heartbeat), DYSPNOEA (Short of breath) and ANXIETY (Anxiety). At the time of the report, MUSCLE TWITCHING (muscle twitching), INSOMNIA (Insomnia), HEART RATE INCREASED (rapid heartbeat), DYSPNOEA (Short of breath) and ANXIETY (Anxiety) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment details included that the patient was prescribed with sleeping and anxiety medication.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Abnormal faeces, Chest pain, Decreased appetite, Dyspnoea
Clinical narrative: Couldn't breath; SHARP CHEST PAIN (like cid reflex); ITCHING; STOMACH PAIN; Rapid stool pain; Couldn't eat too much; FATIGUE; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (Couldn't breath), CHEST PAIN (SHARP CHEST PAIN (like cid reflex)), PRURITUS (ITCHING), ABDOMINAL PAIN UPPER (STOMACH PAIN) and FATIGUE (FATIGUE) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Acid reflux (esophageal) (medical history of acid reflux, start/stop date, ongoing not provided).    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced DYSPNOEA (Couldn't breath), CHEST PAIN (SHARP CHEST PAIN (like cid reflex)), PRURITUS (ITCHING), ABDOMINAL PAIN UPPER (STOMACH PAIN), FATIGUE (FATIGUE), ABNORMAL FAECES (Rapid stool pain) and DECREASED APPETITE (Couldn't eat too much). On 31-Jan-2021, DYSPNOEA (Couldn't breath), CHEST PAIN (SHARP CHEST PAIN (like cid reflex)), PRURITUS (ITCHING), ABDOMINAL PAIN UPPER (STOMACH PAIN), FATIGUE (FATIGUE), ABNORMAL FAECES (Rapid stool pain) and DECREASED APPETITE (Couldn't eat too much) 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.   Reporter did not allow further contact
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pruritus
Clinical narrative: Couldn't breath; SHARP CHEST PAIN (like cid reflex); ITCHING; STOMACH PAIN; Rapid stool pain; Couldn't eat too much; FATIGUE; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (Couldn't breath), CHEST PAIN (SHARP CHEST PAIN (like cid reflex)), PRURITUS (ITCHING), ABDOMINAL PAIN UPPER (STOMACH PAIN) and FATIGUE (FATIGUE) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Acid reflux (esophageal) (medical history of acid reflux, start/stop date, ongoing not provided).    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced DYSPNOEA (Couldn't breath), CHEST PAIN (SHARP CHEST PAIN (like cid reflex)), PRURITUS (ITCHING), ABDOMINAL PAIN UPPER (STOMACH PAIN), FATIGUE (FATIGUE), ABNORMAL FAECES (Rapid stool pain) and DECREASED APPETITE (Couldn't eat too much). On 31-Jan-2021, DYSPNOEA (Couldn't breath), CHEST PAIN (SHARP CHEST PAIN (like cid reflex)), PRURITUS (ITCHING), ABDOMINAL PAIN UPPER (STOMACH PAIN), FATIGUE (FATIGUE), ABNORMAL FAECES (Rapid stool pain) and DECREASED APPETITE (Couldn't eat too much) 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.   Reporter did not allow further contact
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: high fever; muscle aches; chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PYREXIA (high fever), MYALGIA (muscle aches) and CHILLS (chills) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 39180) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 02-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced HEADACHE (Headache). On an unknown date, the patient experienced PYREXIA (high fever), MYALGIA (muscle aches) and CHILLS (chills). At the time of the report, HEADACHE (Headache), PYREXIA (high fever), MYALGIA (muscle aches) and CHILLS (chills) outcome was unknown. Not Provided          No concomitant medications were reported.  No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.; Sender's Comments: Based on the current available information which includes a strong temporal association between the use of the product and the start date of the reported events, a causal relationship with the event cannot be excluded. The reported events are consistent with the known safety profile of the vaccine.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Pruritus
Clinical narrative: arm turned red like a rash; sore arm; itching; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (arm turned red like a rash), BACK PAIN (sore) and PRURITUS (itching) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 27-Mar-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose.  On an unknown date, the patient experienced ERYTHEMA (arm turned red like a rash), BACK PAIN (sore) and PRURITUS (itching). At the time of the report, ERYTHEMA (arm turned red like a rash), BACK PAIN (sore) and PRURITUS (itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing
Clinical narrative: Hot and cold flashes; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Hot and cold flashes) in a 77-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 reported).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced FLUSHING (Hot and cold flashes). At the time of the report, FLUSHING (Hot and cold flashes) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain developed on the upper arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain developed on the upper arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided.).    On 03-Feb-2021 at 12:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE PAIN (pain developed on the upper arm). At the time of the report, VACCINATION SITE PAIN (pain developed on the upper arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to INC.-MOD-2021-064212 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. INC.-MOD-2021-064212:Linked with first dose case
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: 2 inch itchy circle around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (2 inch itchy circle around the injection site) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (2 inch itchy circle around the injection site). At the time of the report, VACCINATION SITE PRURITUS (2 inch itchy circle around the injection site) 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.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Additional information received captured no new information.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pain, Pruritus, Somnolence
Clinical narrative: ITCHING; hard; feeling of warmth; redness; pain; A spontaneous report was received from a other health professional concerning a  36-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events Pruritus, Somnolence, Feeling hot, Erythema and pain.   The patient's medical history was not provided. No relevant concomitant medications were reported.    On 22-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch:029L20A) intramuscularly in the Anatomical location unspecified for prophylaxis of COVID-19 infection.  On 01-FEB-2021, The patient experienced the itching, hard, warm, red and painful.  Laboratory details were not provided.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   On 01-FEB-2021 the outcome of the events itching, hard, warm, red and painful is unknown.  The reporter assessed the events itching, hard, warm, red and painful related to the study drug is 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.. Further information has been requested.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Fatigue, Neck pain
Clinical narrative: Tired; Dizzy,  lightheaded; Shortness of breath; Neck pain mostly on the right side; A spontaneous report was received from a consumer concerning a 72-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced tired, dizzy, lightheaded, neck pain mostly on the right side and had shortness of breath.  The patient's medical history, consumer included cold. Concomitant medications reported included Mucinex (guaifenesin) and some cold medications.  On 03 Feb 2021, prior to the onset of the events tired, dizzy, lightheaded, neck pain mostly on the right side and had shortness of breath, the patient received their first of two planned doses of mRNA-1273 (007M20A) in the left upper part of the arm for prophylaxis of COVID-19 infection.  On an unknown date, after starting treatment with mRNA-1273, the patient experienced tired, dizzy, lightheaded, neck pain mostly on the right side and had shortness of breath.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of events tired, dizzy, lightheaded, neck pain mostly on the right side and had shortness of breath was resolved (feeling better).; Reporter's Comments: This case concerns a 72-year-old male, with history of nasopharyngitis on cold medications, who experienced NS unexpected events of dyspnea, dizziness, neck pain and NS expected event of fatigue.  The events occurred with unknown latency after the first dose of mRNA-1273. Treatment not reported. Event outcomes reported as resolved. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Nausea, Pyrexia, Tremor
Clinical narrative: fever; Back ache; body tremors; nausea; moderate chills; A spontaneous report was received from a consumer concerning a 76 year old female patients who received   Moderna's  Covid 19 vaccine(mRNA1273) experienced moderate chills,. nausea, body tremors, back ache and fever.  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included certain unspecified diabetes and arthritis medications.    The patient received first of two planned dose of mRNA-1273 (Batch No-unknown) intramuscularly  in right arm on 22-JAN-2021  for prophylaxis of Covid 19 infection.  On 29-JAN-2021 ,the patient started to experience moderate chills, nausea, body tremors, and a back ache. The patient went to an urgent care clinic where she was told she had a fever. The patient was not tested for Covid. The treatment for the event include Tylenol and two injections(unknown by reporter).  Action taken with mRNA-1273 in response to the event(s) was not provided/unknown.  The outcome of the events, moderate chills, nausea, body tremors, and a back ache and  fever were unknown/not provided by reporter.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: he had his arm very painful at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (he had his arm very painful at the injection site) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ALLOPURINOL, ATORVASTATIN, ENALAPRIL, GLIBENCLAMIDE, SITAGLIPTIN, LEVOTHYROXINE, FUROSEMIDE, METFORMIN, TAMSULOSIN, Rivaroxaban, FINASTERIDE, DILTIAZEM and INSULIN GLARGINE for an unknown indication.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Jan-2021, the patient experienced VACCINATION SITE PAIN (he had his arm very painful at the injection site). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of dosage form. On 07-Jan-2021, VACCINATION SITE PAIN (he had his arm very painful at the injection site) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-016351 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Apr-2021: phone call and left VM On 01-Apr-2021: Contact info added
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Ataxia, Thinking abnormal, Tremor
Clinical narrative: Shaking; Spastic shake; Thinking abnormal; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaking), ATAXIA (Spastic shake) and THINKING ABNORMAL (Thinking abnormal) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     No Medical History information was reported. Concomitant products included ALLOPURINOL, ATORVASTATIN, ENALAPRIL, GLIBENCLAMIDE, SITAGLIPTIN, LEVOTHYROXINE, FUROSEMIDE, METFORMIN, TAMSULOSIN, RIVAROXABAN, FINASTERIDE, DILTIAZEM and INSULIN GLARGINE for an unknown indication. On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced TREMOR (Shaking), ATAXIA (Spastic shake) and THINKING ABNORMAL (Thinking abnormal). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of UNK dosage form. On 03-Feb-2021, TREMOR (Shaking), ATAXIA (Spastic shake) and THINKING ABNORMAL (Thinking abnormal) had resolved. Not Provided. This case was linked to MOD-2021-016347 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 01-Apr-2021: Follow up received on 01-Apr-2021 contains non significant information.; Reporter's Comments: This case concerns a 68-year-old male who experienced nonserious unexpected events of tremor, ataxia, and feeling abnormal. The events occurred 2 days after the second of mRNA-1273. Treatment included acetaminophen. Event outcome resolved. 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. Further information has been requested.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; A spontaneous report was received from a consumer concerning a 57-years-old male patient , who received  Moderna's COVID-19 vaccine(mRNA-1273)  and experienced event headache .  The patient's medical history  was not provided  . No relevant concomitant medications were provided .  On 02 Feb 2021, prior to the onset of events , the patient received their first of two planned doses  of  mRNA-1273(Lot/batch: unknown) through intramuscular route of administration for prophylaxis of COVID-19 infection.  On 03 Feb 2021 , patient experienced event headache .   No lab reports  were provided. Treatment information provided were not provided .  Action taken with mRNA-1273  in response to the events was not reported .   At the time of the report , outcome of the event headache was unknown .
Age: 97.0
Sex: M
Vaccine: COVID19
Symptoms: Balanoposthitis, Scrotal swelling, Swelling
Clinical narrative: Penis swelling; Scrotum swelling; Groin swelling; A spontaneous report was received from a  Consumer  concerning a  97 Years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events as penis and scrotum  swollen and groin swelling.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 28-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot: 011L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, The patient experienced the events list (verbatims) as penis and scrotum  swollen and groin swelling.   Laboratory details not provided.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   On date, the outcome of the event(s) (when there are multiple events, list out which events are being referenced here) was <resolved, resolved with sequelae (include sequelae not provided)>.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; A spontaneous report was received from a Consumer concerning a 57 years old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Headache.  The patient's medical history was not provided. Relevant concomitant medications were not reported.   On 02 FEB 2021, prior to the onset of the events, the patient received their first dose of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 03 FEB 2021, the patient experienced Headache.  No Laboratory details were provided. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was unknown.  On 03 FEB 2021, the outcome of the event Headache was considered as unknown.  Unknown outcomes: At the time of this report, the outcome of the event's Headache was considered as unknown.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasticity, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Tightness in left arm; Swelling in the injection arm; Rednessin the injection arm; This spontaneous case was reported by a patient and describes the occurrence of INJECTION SITE SWELLING (Swelling), INJECTION SITE ERYTHEMA (Redness) and MUSCLE SPASTICITY (Tightness) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033L204) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no relevant medical history reported).    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021, the patient experienced INJECTION SITE SWELLING (Swelling), INJECTION SITE ERYTHEMA (Redness) and MUSCLE SPASTICITY (Tightness). At the time of the report, INJECTION SITE SWELLING (Swelling), INJECTION SITE ERYTHEMA (Redness) and MUSCLE SPASTICITY (Tightness) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication, Vaccination site reaction
Clinical narrative: My arm has a bump where the shot was about 2 inches across and a ring around it, in total 3; swelling in my throat; red arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (My arm has a bump where the shot was about 2 inches across and a ring around it, in total 3), VACCINATION COMPLICATION (swelling in my throat) and VACCINATION COMPLICATION (red arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (My arm has a bump where the shot was about 2 inches across and a ring around it, in total 3), VACCINATION COMPLICATION (swelling in my throat) and VACCINATION COMPLICATION (red arm). At the time of the report, VACCINATION SITE REACTION (My arm has a bump where the shot was about 2 inches across and a ring around it, in total 3), VACCINATION COMPLICATION (swelling in my throat) and VACCINATION COMPLICATION (red arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Upon in internal review on 21 May 2021, the age was corrected to unknown age.  No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness, Vaccination site pain
Clinical narrative: Under arm tenderness; Pain at injection (L); This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Under arm tenderness) and VACCINATION SITE PAIN (Pain at injection (L)) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20R0A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection (L)). On 21-Jan-2021, the patient experienced TENDERNESS (Under arm tenderness). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK UNK, bid and IBUPROFEN at a dose of UNK, bid. On 20-Jan-2021, VACCINATION SITE PAIN (Pain at injection (L)) had resolved. At the time of the report, TENDERNESS (Under arm tenderness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment for the event included paracetamol and ibuprofen.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Follow Up received as email address for the reporter is updated.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure measurement, Dizziness, Heart rate, Palpitations
Clinical narrative: Light headedness; dizziness; Fast heart rate; Weakness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headedness; dizziness), PALPITATIONS (Fast heart rate) and ASTHENIA (Weakness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     The patient's past medical history included Hypertension, Migraine and Headache. Concomitant products included NORTRIPTYLINE for an unknown indication.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Light headedness; dizziness), PALPITATIONS (Fast heart rate) and ASTHENIA (Weakness). At the time of the report, DIZZINESS (Light headedness; dizziness), PALPITATIONS (Fast heart rate) and ASTHENIA (Weakness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 165/101 (Inconclusive) 165/101. On an unknown date, Heart rate: fast (High) fast.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not reported.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache
Clinical narrative: Small headache; Diarrhea for approximately 15 minutes both nights; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea for approximately 15 minutes both nights) and HEADACHE (Small headache) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 25-Jan-2021, the patient experienced DIARRHOEA (Diarrhea for approximately 15 minutes both nights). On 27-Jan-2021, the patient experienced HEADACHE (Small headache). The patient was treated with PARACETAMOL (TYLENOL) on 27-Jan-2021 for Headache, at a dose of UNK dosage form. On 26-Jan-2021, DIARRHOEA (Diarrhea for approximately 15 minutes both nights) had resolved. At the time of the report, HEADACHE (Small headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Rash pruritic
Clinical narrative: red itch burning rash on her chest and neck; red itch burning rash on her chest and neck; red itch burning rash on her chest and neck; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red itch burning rash on her chest and neck), RASH PRURITIC (red itch burning rash on her chest and neck) and BURNING SENSATION (red itch burning rash on her chest and neck) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced ERYTHEMA (red itch burning rash on her chest and neck), RASH PRURITIC (red itch burning rash on her chest and neck) and BURNING SENSATION (red itch burning rash on her chest and neck). At the time of the report, ERYTHEMA (red itch burning rash on her chest and neck), RASH PRURITIC (red itch burning rash on her chest and neck) and BURNING SENSATION (red itch burning rash on her chest and neck) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. Treatment included- a cream for the dermatologist.