chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: injection site be red swollen and itchy; injection site be red swollen and itchy; injection site be red swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (injection site be red swollen and itchy), VACCINATION SITE PRURITUS (injection site be red swollen and itchy) and VACCINATION SITE ERYTHEMA (injection site be red swollen) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (injection site be red swollen and itchy), VACCINATION SITE PRURITUS (injection site be red swollen and itchy) and VACCINATION SITE ERYTHEMA (injection site be red swollen). At the time of the report, VACCINATION SITE SWELLING (injection site be red swollen and itchy), VACCINATION SITE PRURITUS (injection site be red swollen and itchy) and VACCINATION SITE ERYTHEMA (injection site be red swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not reported.  Treatment medications was not reported.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test
Clinical narrative: Covid positive after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid positive after vaccination) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid positive after vaccination). At the time of the report, COVID-19 (Covid positive after vaccination) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: positive (Positive) Tested Positive and contracted covid19 after receiving the vaccine..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Tested positive for covid after being vaccinated; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for covid after being vaccinated) 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for covid after being vaccinated). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for covid after being vaccinated) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive Positive.         The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable  No concomitant medications reported. No treatment reported.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dyspnoea, Fatigue, Headache, Hypertension
Clinical narrative: blood pressure high; Felt like couldn´t breathe sometimes; arm sore for 3 days; Fever 107; headaches; felt tired; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (blood pressure high), DYSPNOEA (Felt like couldn´t breathe sometimes), PAIN IN EXTREMITY (arm sore for 3 days), PYREXIA (Fever 107) and HEADACHE (headaches) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in February 2021 and Asthma.    On 11-Aug-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 HYPERTENSION (blood pressure high), DYSPNOEA (Felt like couldn´t breathe sometimes), PAIN IN EXTREMITY (arm sore for 3 days), PYREXIA (Fever 107), HEADACHE (headaches) and FATIGUE (felt tired). At the time of the report, HYPERTENSION (blood pressure high), DYSPNOEA (Felt like couldn´t breathe sometimes), PAIN IN EXTREMITY (arm sore for 3 days), PYREXIA (Fever 107), HEADACHE (headaches) and FATIGUE (felt tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 107 (High) Fever of 107. On an unknown date, Platelet count: low (Low) Low platelet.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.                   No treatment medication was reported.  The patient was afraid of blood clots from what she had heard.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Platelet count, Pyrexia
Clinical narrative: blood pressure high; Felt like couldn´t breathe sometimes; arm sore for 3 days; Fever 107; headaches; felt tired; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (blood pressure high), DYSPNOEA (Felt like couldn´t breathe sometimes), PAIN IN EXTREMITY (arm sore for 3 days), PYREXIA (Fever 107) and HEADACHE (headaches) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in February 2021 and Asthma.    On 11-Aug-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 HYPERTENSION (blood pressure high), DYSPNOEA (Felt like couldn´t breathe sometimes), PAIN IN EXTREMITY (arm sore for 3 days), PYREXIA (Fever 107), HEADACHE (headaches) and FATIGUE (felt tired). At the time of the report, HYPERTENSION (blood pressure high), DYSPNOEA (Felt like couldn´t breathe sometimes), PAIN IN EXTREMITY (arm sore for 3 days), PYREXIA (Fever 107), HEADACHE (headaches) and FATIGUE (felt tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 107 (High) Fever of 107. On an unknown date, Platelet count: low (Low) Low platelet.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.                   No treatment medication was reported.  The patient was afraid of blood clots from what she had heard.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Product dose omission issue, Rash
Clinical narrative: She had a full body rash from head to toe that lasted for 3 days.; The lymph nodes on all over her body became enlarged.; Her lymph nodes in neck were swollen after receiving 1st dose.; did not get second dose; This spontaneous case was reported by a consumer and describes the occurrence of RASH (She had a full body rash from head to toe that lasted for 3 days.), LYMPHADENOPATHY (The lymph nodes on all over her body became enlarged.), LYMPHADENOPATHY (Her lymph nodes in neck were swollen after receiving 1st dose.) and PRODUCT DOSE OMISSION ISSUE (did not get second dose) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026M21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in October 2020. Concomitant products included PROPRANOLOL for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced LYMPHADENOPATHY (Her lymph nodes in neck were swollen after receiving 1st dose.). On 21-Mar-2021, the patient experienced LYMPHADENOPATHY (The lymph nodes on all over her body became enlarged.). On 01-Apr-2021, the patient experienced RASH (She had a full body rash from head to toe that lasted for 3 days.). In 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (did not get second dose). The patient was treated with PREDNISONE from March 2021 to March 2021 at an unspecified dose and frequency. On 04-Apr-2021, RASH (She had a full body rash from head to toe that lasted for 3 days.) had resolved. In 2021, PRODUCT DOSE OMISSION ISSUE (did not get second dose) had resolved. At the time of the report, LYMPHADENOPATHY (The lymph nodes on all over her body became enlarged.) and LYMPHADENOPATHY (Her lymph nodes in neck were swollen after receiving 1st dose.) was resolving.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Added Historical condition, event, updated reporter details and narrative was updated accordingly.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Reactions; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Reactions) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Reactions). At the time of the report, VACCINATION COMPLICATION (Reactions) 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.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: 102 temp after second shot; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (102 temp after second shot) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (102 temp after second shot). At the time of the report, PYREXIA (102 temp after second shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) 102.         Reportedly, the patient declined for follow-up.  Concomitant product use was not provided.  Treatment product information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: COVID-19 positive after booster vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (COVID-19 positive after booster vaccine) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (COVID-19 positive after booster vaccine). At the time of the report, SARS-COV-2 TEST POSITIVE (COVID-19 positive after booster vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive Positive.         The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable  No concomitant medications reported. No treatment reported
Sex: U
Vaccine: COVID19
Symptoms: Cough, Influenza like illness, Oropharyngeal pain, Pyrexia, Rhinorrhoea
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), PYREXIA (Fever), COUGH (Cough), OROPHARYNGEAL PAIN (Sore throat) and RHINORRHOEA (Runny nose) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), PYREXIA (Fever), COUGH (Cough), OROPHARYNGEAL PAIN (Sore throat) and RHINORRHOEA (Runny nose). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), PYREXIA (Fever), COUGH (Cough), OROPHARYNGEAL PAIN (Sore throat) and RHINORRHOEA (Runny nose) outcome was unknown.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication was not provided Treatment information was not reported
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Rash, Rash erythematous
Clinical narrative: almost looks like a little blister on the fingers; little red dots on arm and legs; breaking out in a rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (breaking out in a rash), BLISTER (almost looks like a little blister on the fingers) and RASH ERYTHEMATOUS (little red dots on arm and legs) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     Concurrent medical conditions included Crohn's disease. Concomitant products included METHOTREXATE and FOLIC ACID for Crohn's disease.   On 04-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Sep-2021, the patient experienced RASH (breaking out in a rash). On an unknown date, the patient experienced BLISTER (almost looks like a little blister on the fingers) and RASH ERYTHEMATOUS (little red dots on arm and legs). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date for Rash, at an unspecified dose and frequency. At the time of the report, RASH (breaking out in a rash), BLISTER (almost looks like a little blister on the fingers) and RASH ERYTHEMATOUS (little red dots on arm and legs) outcome was unknown.            Symptoms: It was reported that after receiving second dose of vaccine the patient started experiencing rash on his fingers and hands, looked like blisters, he experienced rash on his right arm.
Sex: F
Vaccine: COVID19
Symptoms: Incomplete course of vaccination
Clinical narrative: >than 35 days since first dose; This spontaneous case was reported by a consumer and describes the occurrence of INCOMPLETE COURSE OF VACCINATION (>than 35 days since first dose) 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 INCOMPLETE COURSE OF VACCINATION (>than 35 days since first dose). At the time of the report, INCOMPLETE COURSE OF VACCINATION (>than 35 days since first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported by reporter Treatment information was not provided by reporter
Sex: F
Vaccine: COVID19
Symptoms: Chills, Influenza like illness
Clinical narrative: flu-like symptoms; chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms) and CHILLS (chills). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product was provided by the reporter. No treatment medication was provided.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Have a Fever running all last night snd today of 100-101; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Have a Fever running all last night snd today of 100-101) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Have a Fever running all last night snd today of 100-101). At the time of the report, PYREXIA (Have a Fever running all last night snd today of 100-101) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Insomnia, Mobility decreased
Clinical narrative: Sat all day/didn't do anything /"I was like cement; Didn't fall asleep; Just exhausted; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (Sat all day/didn't do anything /"I was like cement), INSOMNIA (Didn't fall asleep) and FATIGUE (Just exhausted) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A, 025B21A and 022C21A) for COVID-19 vaccination.     Concurrent medical conditions included Dermatomyositis and Immunocompromised. Concomitant products included MYCOPHENOLATE MOFETIL HYDROCHLORIDE (CELLCEPT [MYCOPHENOLATE MOFETIL HYDROCHLORIDE]) for Dermatomyositis.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced MOBILITY DECREASED (Sat all day/didn't do anything /"I was like cement), INSOMNIA (Didn't fall asleep) and FATIGUE (Just exhausted). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 31-Mar-2021, MOBILITY DECREASED (Sat all day/didn't do anything /"I was like cement), INSOMNIA (Didn't fall asleep) and FATIGUE (Just exhausted) had resolved.            This case was linked to MOD-2021-310516, MOD-2021-310465 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Consumer answered "Yes" to having side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Consumer answered "Yes" to having side effects) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Consumer answered "Yes" to having side effects). At the time of the report, VACCINATION COMPLICATION (Consumer answered "Yes" to having side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased
Clinical narrative: Pressure rise; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (Pressure rise) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Throat cancer.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Sep-2021, the patient experienced BLOOD PRESSURE INCREASED (Pressure rise). At the time of the report, BLOOD PRESSURE INCREASED (Pressure rise) outcome was unknown.            Patient reported that he was taking several undisclosed medication for high blood pressure, blood thinner.  Treatment information was not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph nodes underneath my arm; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swollen lymph nodes underneath my arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 LYMPHADENOPATHY (swollen lymph nodes underneath my arm). At the time of the report, LYMPHADENOPATHY (swollen lymph nodes underneath my arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided. No treatment medication were provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Pain in extremity, Pyrexia, Somnolence
Clinical narrative: Was not good at all; Fell asleep for 3 hours; Chills/was freezing; Severe fever/had a temperature; Arm hurt/My arm is still tender/legs hurt so bad; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt/My arm is still tender/legs hurt so bad), FEELING ABNORMAL (Was not good at all), SOMNOLENCE (Fell asleep for 3 hours), CHILLS (Chills/was freezing) and PYREXIA (Severe fever/had a temperature) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A, 025B21A and 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Dermatomyositis and Immunocompromised. Concomitant products included MYCOPHENOLATE MOFETIL (CELLCEPT [MYCOPHENOLATE MOFETIL]) for Dermatomyositis.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Sep-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt/My arm is still tender/legs hurt so bad). On 02-Sep-2021, the patient experienced FEELING ABNORMAL (Was not good at all), SOMNOLENCE (Fell asleep for 3 hours), CHILLS (Chills/was freezing) and PYREXIA (Severe fever/had a temperature). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 02-Sep-2021, FEELING ABNORMAL (Was not good at all), SOMNOLENCE (Fell asleep for 3 hours), CHILLS (Chills/was freezing) and PYREXIA (Severe fever/had a temperature) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm hurt/My arm is still tender/legs hurt so bad) outcome was unknown.            This case was linked to MOD-2021-310491, MOD-2021-310465 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate, Heart rate increased
Clinical narrative: rapid heart beat; shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (rapid heart beat) and DYSPNOEA (shortness of breath) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (rapid heart beat) and DYSPNOEA (shortness of breath). At the time of the report, HEART RATE INCREASED (rapid heart beat) and DYSPNOEA (shortness of breath) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: high (High) high.         No concomitant medication were provided by the reporter  No treatment medication were provided by the reporter   Reporter did not allow further contact
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Left arm injection site is warm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Left arm injection site is warm) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Sep-2021, the patient experienced VACCINATION SITE WARMTH (Left arm injection site is warm). At the time of the report, VACCINATION SITE WARMTH (Left arm injection site is warm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Cough, Fatigue, Vaccination site erythema
Clinical narrative: coughing; Redness of the injection site; chills; fatigue; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of COUGH (coughing), VACCINATION SITE ERYTHEMA (Redness of the injection site), CHILLS (chills) and FATIGUE (fatigue) 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 03-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (coughing), VACCINATION SITE ERYTHEMA (Redness of the injection site), CHILLS (chills) and FATIGUE (fatigue). At the time of the report, COUGH (coughing), VACCINATION SITE ERYTHEMA (Redness of the injection site), CHILLS (chills) and FATIGUE (fatigue) outcome was unknown.            No concomitant medication details were provided. No treatment information was mentioned.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Head discomfort, Lymphadenopathy, Myalgia, Neck pain
Clinical narrative: Lymph node swelling on both sides of her neck; Really bad muscle aches; sore at the top of her neck/sore around spinal cord area on her neck; The pain went to the base of her skull around the spinal cord; burning sensation; Her head felt heavy; The pain went to the back of her neck; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Lymph node swelling on both sides of her neck), MYALGIA (Really bad muscle aches), NECK PAIN (sore at the top of her neck/sore around spinal cord area on her neck), SPINAL PAIN (The pain went to the base of her skull around the spinal cord) and BURNING SENSATION (burning sensation) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Aug-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 LYMPHADENOPATHY (Lymph node swelling on both sides of her neck), MYALGIA (Really bad muscle aches), NECK PAIN (sore at the top of her neck/sore around spinal cord area on her neck), SPINAL PAIN (The pain went to the base of her skull around the spinal cord), BURNING SENSATION (burning sensation), HEAD DISCOMFORT (Her head felt heavy) and NECK PAIN (The pain went to the back of her neck). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, LYMPHADENOPATHY (Lymph node swelling on both sides of her neck), MYALGIA (Really bad muscle aches), SPINAL PAIN (The pain went to the base of her skull around the spinal cord), BURNING SENSATION (burning sensation), HEAD DISCOMFORT (Her head felt heavy) and NECK PAIN (The pain went to the back of her neck) outcome was unknown and NECK PAIN (sore at the top of her neck/sore around spinal cord area on her neck) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had taken  6 days of steroids and antibiotics for head and neck effects No concomitant medications were provided
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Spinal pain
Clinical narrative: Lymph node swelling on both sides of her neck; Really bad muscle aches; sore at the top of her neck/sore around spinal cord area on her neck; The pain went to the base of her skull around the spinal cord; burning sensation; Her head felt heavy; The pain went to the back of her neck; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Lymph node swelling on both sides of her neck), MYALGIA (Really bad muscle aches), NECK PAIN (sore at the top of her neck/sore around spinal cord area on her neck), SPINAL PAIN (The pain went to the base of her skull around the spinal cord) and BURNING SENSATION (burning sensation) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Aug-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 LYMPHADENOPATHY (Lymph node swelling on both sides of her neck), MYALGIA (Really bad muscle aches), NECK PAIN (sore at the top of her neck/sore around spinal cord area on her neck), SPINAL PAIN (The pain went to the base of her skull around the spinal cord), BURNING SENSATION (burning sensation), HEAD DISCOMFORT (Her head felt heavy) and NECK PAIN (The pain went to the back of her neck). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, LYMPHADENOPATHY (Lymph node swelling on both sides of her neck), MYALGIA (Really bad muscle aches), SPINAL PAIN (The pain went to the base of her skull around the spinal cord), BURNING SENSATION (burning sensation), HEAD DISCOMFORT (Her head felt heavy) and NECK PAIN (The pain went to the back of her neck) outcome was unknown and NECK PAIN (sore at the top of her neck/sore around spinal cord area on her neck) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had taken  6 days of steroids and antibiotics for head and neck effects No concomitant medications were provided
Sex: U
Vaccine: COVID19
Symptoms: Adverse reaction, Body temperature, Pyrexia
Clinical narrative: my third booster shot Problems with third booster shot; 100 degree fever; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (my third booster shot Problems with third booster shot) and PYREXIA (100 degree fever) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (my third booster shot Problems with third booster shot) and PYREXIA (100 degree fever). At the time of the report, ADVERSE REACTION (my third booster shot Problems with third booster shot) and PYREXIA (100 degree fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 100 (High) having a 100 degree temperature one day after my third booster shot.         No concomitant medications were provided. No treatment medications were reported.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: joint pain in my left hip/aggravated joint pain that lasted around 2-3 days; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (joint pain in my left hip/aggravated joint pain that lasted around 2-3 days) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 041B21A) for COVID-19 vaccination.     The patient's past medical history included Hip replacement. Family history included Arthritis.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (joint pain in my left hip/aggravated joint pain that lasted around 2-3 days). At the time of the report, ARTHRALGIA (joint pain in my left hip/aggravated joint pain that lasted around 2-3 days) outcome was unknown.            No Concomitant informations were reported. No treatment informations were reported.   This case was linked to MOD-2021-310636 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Illness
Clinical narrative: Extremely ill; Difficulty breathing; This spontaneous case was reported by a nurse and describes the occurrence of ILLNESS (Extremely ill) and DYSPNOEA (Difficulty breathing) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Extremely ill) and DYSPNOEA (Difficulty breathing). At the time of the report, ILLNESS (Extremely ill) and DYSPNOEA (Difficulty breathing) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported No treatment Drug was reported.  Company Comment: Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Redness; itching; swelling on the injections side; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness), PRURITUS (itching) and SWELLING (swelling on the injections side) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Sep-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) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Redness), PRURITUS (itching) and SWELLING (swelling on the injections side). At the time of the report, ERYTHEMA (Redness), PRURITUS (itching) and SWELLING (swelling on the injections side) had not resolved.            No concomitant medications were reported. No treatment information was provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Body temperature, Chest pain, Feeling abnormal
Clinical narrative: Not being able to smell; Not being able to taste; Chest hurt when she breathed in deep; Felt horrible; Body aches; The injection site was very swollen; The injection site was red; Vomiting; Headache in her eyes; Ran a fever of 103.5 F/ Now fever is about 100 F; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (Not being able to smell), AGEUSIA (Not being able to taste), CHEST PAIN (Chest hurt when she breathed in deep), FEELING ABNORMAL (Felt horrible) and PAIN (Body aches) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in February 2021.    On 04-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Sep-2021, the patient experienced ANOSMIA (Not being able to smell), AGEUSIA (Not being able to taste), CHEST PAIN (Chest hurt when she breathed in deep), FEELING ABNORMAL (Felt horrible), PAIN (Body aches), VACCINATION SITE SWELLING (The injection site was very swollen), VACCINATION SITE ERYTHEMA (The injection site was red), VOMITING (Vomiting), HEADACHE (Headache in her eyes) and PYREXIA (Ran a fever of 103.5 F/ Now fever is about 100 F). The patient was treated with IBUPROFEN for Adverse event, at a dose of UNK UNK, q4h and PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK, q4h. At the time of the report, ANOSMIA (Not being able to smell), AGEUSIA (Not being able to taste), CHEST PAIN (Chest hurt when she breathed in deep), FEELING ABNORMAL (Felt horrible), PAIN (Body aches), VACCINATION SITE SWELLING (The injection site was very swollen), VACCINATION SITE ERYTHEMA (The injection site was red), VOMITING (Vomiting) and HEADACHE (Headache in her eyes) outcome was unknown and PYREXIA (Ran a fever of 103.5 F/ Now fever is about 100 F) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103.5 (High) Fever at 103.5 F and 100 (High) Fever at 100 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medication was not reported.  The patient's boss was positive for COVID and the patient wanted to know if loss of taste or smell is a side effect of the vaccine. The patient experienced same event when had COVID in February and the patient was planning for test.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Not being able to smell; Not being able to taste; Chest hurt when she breathed in deep; Felt horrible; Body aches; The injection site was very swollen; The injection site was red; Vomiting; Headache in her eyes; Ran a fever of 103.5 F/ Now fever is about 100 F; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (Not being able to smell), AGEUSIA (Not being able to taste), CHEST PAIN (Chest hurt when she breathed in deep), FEELING ABNORMAL (Felt horrible) and PAIN (Body aches) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in February 2021.    On 04-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Sep-2021, the patient experienced ANOSMIA (Not being able to smell), AGEUSIA (Not being able to taste), CHEST PAIN (Chest hurt when she breathed in deep), FEELING ABNORMAL (Felt horrible), PAIN (Body aches), VACCINATION SITE SWELLING (The injection site was very swollen), VACCINATION SITE ERYTHEMA (The injection site was red), VOMITING (Vomiting), HEADACHE (Headache in her eyes) and PYREXIA (Ran a fever of 103.5 F/ Now fever is about 100 F). The patient was treated with IBUPROFEN for Adverse event, at a dose of UNK UNK, q4h and PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK, q4h. At the time of the report, ANOSMIA (Not being able to smell), AGEUSIA (Not being able to taste), CHEST PAIN (Chest hurt when she breathed in deep), FEELING ABNORMAL (Felt horrible), PAIN (Body aches), VACCINATION SITE SWELLING (The injection site was very swollen), VACCINATION SITE ERYTHEMA (The injection site was red), VOMITING (Vomiting) and HEADACHE (Headache in her eyes) outcome was unknown and PYREXIA (Ran a fever of 103.5 F/ Now fever is about 100 F) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103.5 (High) Fever at 103.5 F and 100 (High) Fever at 100 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medication was not reported.  The patient's boss was positive for COVID and the patient wanted to know if loss of taste or smell is a side effect of the vaccine. The patient experienced same event when had COVID in February and the patient was planning for test.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Not being able to smell; Not being able to taste; Chest hurt when she breathed in deep; Felt horrible; Body aches; The injection site was very swollen; The injection site was red; Vomiting; Headache in her eyes; Ran a fever of 103.5 F/ Now fever is about 100 F; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (Not being able to smell), AGEUSIA (Not being able to taste), CHEST PAIN (Chest hurt when she breathed in deep), FEELING ABNORMAL (Felt horrible) and PAIN (Body aches) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in February 2021.    On 04-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Sep-2021, the patient experienced ANOSMIA (Not being able to smell), AGEUSIA (Not being able to taste), CHEST PAIN (Chest hurt when she breathed in deep), FEELING ABNORMAL (Felt horrible), PAIN (Body aches), VACCINATION SITE SWELLING (The injection site was very swollen), VACCINATION SITE ERYTHEMA (The injection site was red), VOMITING (Vomiting), HEADACHE (Headache in her eyes) and PYREXIA (Ran a fever of 103.5 F/ Now fever is about 100 F). The patient was treated with IBUPROFEN for Adverse event, at a dose of UNK UNK, q4h and PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK, q4h. At the time of the report, ANOSMIA (Not being able to smell), AGEUSIA (Not being able to taste), CHEST PAIN (Chest hurt when she breathed in deep), FEELING ABNORMAL (Felt horrible), PAIN (Body aches), VACCINATION SITE SWELLING (The injection site was very swollen), VACCINATION SITE ERYTHEMA (The injection site was red), VOMITING (Vomiting) and HEADACHE (Headache in her eyes) outcome was unknown and PYREXIA (Ran a fever of 103.5 F/ Now fever is about 100 F) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103.5 (High) Fever at 103.5 F and 100 (High) Fever at 100 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medication was not reported.  The patient's boss was positive for COVID and the patient wanted to know if loss of taste or smell is a side effect of the vaccine. The patient experienced same event when had COVID in February and the patient was planning for test.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Suspected COVID-19
Clinical narrative: Exposed to COVID19 and presenting symptoms; Child was part of Moderna's clinical trial; This spontaneous case was reported by a health care professional and describes the occurrence of SUSPECTED COVID-19 (Exposed to COVID19 and presenting symptoms) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Child was part of Moderna's clinical trial) in a 10-year-old male patient 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 SUSPECTED COVID-19 (Exposed to COVID19 and presenting symptoms) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Child was part of Moderna's clinical trial). At the time of the report, SUSPECTED COVID-19 (Exposed to COVID19 and presenting symptoms) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Child was part of Moderna's clinical trial) 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.   Concomitant medications were not reported. Treatment medications were not reported.