chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Is swelling normal after vaccine?; 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 VACCINATION SITE SWELLING (Is swelling normal after 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (Is swelling normal after vaccine?). At the time of the report, VACCINATION SITE SWELLING (Is swelling normal after vaccine?) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow-up information received on 25-MAY-2021, contains no new information.
Sex: U
Vaccine: COVID19
Symptoms: Cough, Nasal congestion
Clinical narrative: cough; nasal congestion; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of COUGH (cough) and NASAL CONGESTION (nasal congestion) 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 COUGH (cough) and NASAL CONGESTION (nasal congestion). At the time of the report, COUGH (cough) and NASAL CONGESTION (nasal congestion) outcome was unknown. Not Provided      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.   No concomitant medications reported. No treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Fatigue; sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) and VACCINATION SITE PAIN (sore left arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced FATIGUE (Fatigue) and VACCINATION SITE PAIN (sore left arm). On 24-Apr-2021, FATIGUE (Fatigue) and VACCINATION SITE PAIN (sore left arm) had 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.   No concomitant medications were provided. No treatment details were provided.   This case was linked to MOD-2021-169299 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: chills; 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 CHILLS (chills) 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 CHILLS (chills). At the time of the report, CHILLS (chills) outcome was unknown.            No concomitant medications were reported No treatment drugs were reported
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Headache, Illness, Influenza like illness, Productive cough
Clinical narrative: rash; low grade fever; headache; flu-like symptoms; really sick; coughing; phlegm; wheezing; severe respiratory issue; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), ILLNESS (really sick), COUGH (coughing), PRODUCTIVE COUGH (phlegm) and WHEEZING (wheezing) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure and Heart disorder.    On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), ILLNESS (really sick), COUGH (coughing), PRODUCTIVE COUGH (phlegm), WHEEZING (wheezing) and RESPIRATORY DISORDER (severe respiratory issue). On 13-May-2021, the patient experienced RASH (rash), PYREXIA (low grade fever) and HEADACHE (headache). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), ILLNESS (really sick), COUGH (coughing), PRODUCTIVE COUGH (phlegm), WHEEZING (wheezing), RESPIRATORY DISORDER (severe respiratory issue), RASH (rash), PYREXIA (low grade fever) and HEADACHE (headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications include blood pressure medications and heart medication  Treatment includes Tea and emergency
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Respiratory disorder, Wheezing
Clinical narrative: rash; low grade fever; headache; flu-like symptoms; really sick; coughing; phlegm; wheezing; severe respiratory issue; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), ILLNESS (really sick), COUGH (coughing), PRODUCTIVE COUGH (phlegm) and WHEEZING (wheezing) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure and Heart disorder.    On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), ILLNESS (really sick), COUGH (coughing), PRODUCTIVE COUGH (phlegm), WHEEZING (wheezing) and RESPIRATORY DISORDER (severe respiratory issue). On 13-May-2021, the patient experienced RASH (rash), PYREXIA (low grade fever) and HEADACHE (headache). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), ILLNESS (really sick), COUGH (coughing), PRODUCTIVE COUGH (phlegm), WHEEZING (wheezing), RESPIRATORY DISORDER (severe respiratory issue), RASH (rash), PYREXIA (low grade fever) and HEADACHE (headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications include blood pressure medications and heart medication  Treatment includes Tea and emergency
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: round red raised area(silver dollar sized)below the injection site; started itching; sore skin; This spontaneous case was reported by a pharmacist and describes the occurrence of ERYTHEMA (round red raised area(silver dollar sized)below the injection site), PRURITUS (started itching) and PAIN OF SKIN (sore skin) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 041C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN OF SKIN (sore skin). On 25-May-2021, the patient experienced ERYTHEMA (round red raised area(silver dollar sized)below the injection site) and PRURITUS (started itching). At the time of the report, ERYTHEMA (round red raised area(silver dollar sized)below the injection site), PRURITUS (started itching) and PAIN OF SKIN (sore skin) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitants were reported. No treatment was reported.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: have been wakung up dizxy then after brwakfast it go away; 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 DIZZINESS (have been wakung up dizxy then after brwakfast it go away) 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 DIZZINESS (have been wakung up dizxy then after brwakfast it go away). At the time of the report, DIZZINESS (have been wakung up dizxy then after brwakfast it go away) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported No treatment drugs were reported    Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow-up information received on 26-MAY-2021, contains no new information.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Body pain; 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 MYALGIA (Body pain) 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 MYALGIA (Body pain). At the time of the report, MYALGIA (Body pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported  No treatment drugs were reported     Reporter did not allow further contact
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Product dose omission issue
Clinical narrative: some adverse events; Missed vaccine appointment; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (some adverse events) and PRODUCT DOSE OMISSION ISSUE (Missed vaccine appointment) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (some adverse events) and PRODUCT DOSE OMISSION ISSUE (Missed vaccine appointment). At the time of the report, ADVERSE EVENT (some adverse events) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Missed vaccine appointment) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment drugs were reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Additional event reported (some adverse events).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Malaise, Nausea, Pyrexia
Clinical narrative: Felt sick on Saturday; Chills; Nausea; Vomiting; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt sick on Saturday), CHILLS (Chills), NAUSEA (Nausea), VOMITING (Vomiting) and PYREXIA (Fever) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-May-2021, the patient experienced MALAISE (Felt sick on Saturday), CHILLS (Chills), NAUSEA (Nausea), VOMITING (Vomiting) and PYREXIA (Fever). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, MALAISE (Felt sick on Saturday), CHILLS (Chills), NAUSEA (Nausea), VOMITING (Vomiting) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-May-2021, Body temperature: 102 (High) high.         No concomitant medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up received on 25-Jun-2021 contains NNI; Reporter's Comments: N/A; Sender's Comments: N/A
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Felt sick on Saturday; Chills; Nausea; Vomiting; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt sick on Saturday), CHILLS (Chills), NAUSEA (Nausea), VOMITING (Vomiting) and PYREXIA (Fever) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-May-2021, the patient experienced MALAISE (Felt sick on Saturday), CHILLS (Chills), NAUSEA (Nausea), VOMITING (Vomiting) and PYREXIA (Fever). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, MALAISE (Felt sick on Saturday), CHILLS (Chills), NAUSEA (Nausea), VOMITING (Vomiting) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-May-2021, Body temperature: 102 (High) high.         No concomitant medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up received on 25-Jun-2021 contains NNI; Reporter's Comments: N/A; Sender's Comments: N/A
Sex: U
Vaccine: COVID19
Symptoms: Skin discolouration
Clinical narrative: arm is black; 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 SKIN DISCOLORATION (arm is black) 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 SKIN DISCOLORATION (arm is black). At the time of the report, SKIN DISCOLORATION (arm is black) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported  No treatment drugs were reported     Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: No specific follow-up information recorded.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Nasal congestion, Vaccination site pain
Clinical narrative: numbness from inject site to down to her wrist/ numbness is always present/ numbness feels tight/ numbness as feels heavy; stuffiness comes and goes/ stuffy nose only in her left nostril; pain/pain when lifting or moving her left arm/pain comes and goes; This spontaneous case was reported by a health care professional and describes the occurrence of HYPOAESTHESIA (numbness from inject site to down to her wrist/ numbness is always present/ numbness feels tight/ numbness as feels heavy), NASAL CONGESTION (stuffiness comes and goes/ stuffy nose only in her left nostril) and VACCINATION SITE PAIN (pain/pain when lifting or moving her left arm/pain comes and goes) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038b21a) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (chronic) and Sinus disorder NOS.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced HYPOAESTHESIA (numbness from inject site to down to her wrist/ numbness is always present/ numbness feels tight/ numbness as feels heavy), NASAL CONGESTION (stuffiness comes and goes/ stuffy nose only in her left nostril) and VACCINATION SITE PAIN (pain/pain when lifting or moving her left arm/pain comes and goes). At the time of the report, HYPOAESTHESIA (numbness from inject site to down to her wrist/ numbness is always present/ numbness feels tight/ numbness as feels heavy), NASAL CONGESTION (stuffiness comes and goes/ stuffy nose only in her left nostril) and VACCINATION SITE PAIN (pain/pain when lifting or moving her left arm/pain comes and goes) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment drugs were reported
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: 102 degree fever; 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 PYREXIA (102 degree fever) 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 degree fever). At the time of the report, PYREXIA (102 degree fever) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 degree (High) 102 degree.         The action taken with mRNA-1273(Moderna COVID-19 vaccine) was not applicable  No concomitant medications were reported  No treatment drugs were reported     Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: pain; 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 PAIN (pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     No Medical History information was reported.    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 PAIN (pain). At the time of the report, PAIN (pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non-Significant follow up
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second shot will be past day 35; 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second shot will be past day 35) 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 07-Apr-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second shot will be past day 35). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second shot will be past day 35) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported No treatment drugs were reported   Reporter did not allow further contact
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Nasal discomfort, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: nasal dripping; burning in her nose; Drug ineffective; Covid 19 Infection positive after completing 2 doses; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid 19 Infection positive after completing 2 doses), RHINORRHEA (nasal dripping), NASAL DISCOMFORT (burning in her nose) and DRUG INEFFECTIVE (Drug ineffective) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 011M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-May-2021, the patient experienced COVID-19 (Covid 19 Infection positive after completing 2 doses). On an unknown date, the patient experienced RHINORRHEA (nasal dripping), NASAL DISCOMFORT (burning in her nose) and DRUG INEFFECTIVE (Drug ineffective). At the time of the report, COVID-19 (Covid 19 Infection positive after completing 2 doses), RHINORRHEA (nasal dripping) and NASAL DISCOMFORT (burning in her nose) outcome was unknown and DRUG INEFFECTIVE (Drug ineffective) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-May-2021, SARS-CoV-2 test: positive (Positive) positive.         No concomitant medication were provided  Treatment medication was not provided  Action taken with mRNA-1273 Moderna vaccine was Not applicable   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up received on 25-MAY-2021: Included No new information
Sex: U
Vaccine: COVID19
Symptoms: Burning sensation, Feeling hot
Clinical narrative: burning sensation in my torso area; hot sensations moving from my abdomen to my chest, from my neck, nose and lips and sometimes in my head; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (burning sensation in my torso area) and FEELING HOT (hot sensations moving from my abdomen to my chest, from my neck, nose and lips and sometimes in my head) 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 BURNING SENSATION (burning sensation in my torso area) and FEELING HOT (hot sensations moving from my abdomen to my chest, from my neck, nose and lips and sometimes in my head). At the time of the report, BURNING SENSATION (burning sensation in my torso area) and FEELING HOT (hot sensations moving from my abdomen to my chest, from my neck, nose and lips and sometimes in my head) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Dyspnoea, Fatigue, Feeling abnormal, Myalgia
Clinical narrative: loss of taste; not feeling like himself; shortness of breath; muscle pain; fatigue/ tired; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (loss of taste), FEELING ABNORMAL (not feeling like himself), DYSPNOEA (shortness of breath), MYALGIA (muscle pain) and FATIGUE (fatigue/ tired) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 0291CZ01A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2021, the patient experienced AGEUSIA (loss of taste), FEELING ABNORMAL (not feeling like himself), DYSPNOEA (shortness of breath), MYALGIA (muscle pain) and FATIGUE (fatigue/ tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, AGEUSIA (loss of taste), FEELING ABNORMAL (not feeling like himself), DYSPNOEA (shortness of breath), MYALGIA (muscle pain) and FATIGUE (fatigue/ tired) outcome was unknown.            Concomitant medication include medicine for high blood pressure, and prostate.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up received on 25-MAY-2021. contain non-significant information.NNI
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received an expired vaccine as 2nd dose; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine as 2nd dose) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-May-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 EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine as 2nd dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine as 2nd dose) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No relevant concomitant medications reported.  No treatment information was provided.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable     Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non significant follow up
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products, Product administration error
Clinical narrative: Patient got the Pfizer vaccine and today she got moderna vaccine as second dose; Patient got the Pfizer vaccine as first dose /today she got moderna vaccine as second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Patient got the Pfizer vaccine and today she got moderna vaccine as second dose) and INTERCHANGE OF VACCINE PRODUCTS (Patient got the Pfizer vaccine as first dose /today she got moderna vaccine as second dose) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 25-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 25-May-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Patient got the Pfizer vaccine and today she got moderna vaccine as second dose) and INTERCHANGE OF VACCINE PRODUCTS (Patient got the Pfizer vaccine as first dose /today she got moderna vaccine as second dose). On 25-May-2021, PRODUCT ADMINISTRATION ERROR (Patient got the Pfizer vaccine and today she got moderna vaccine as second dose) and INTERCHANGE OF VACCINE PRODUCTS (Patient got the Pfizer vaccine as first dose /today she got moderna vaccine as second dose) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided  Action taken with mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow-up information on received on 25 MAY 2021 and does not contain any new information.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Thyroiditis
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of thyroiditis (inflamed thyroid) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 031M20A and 001B21A) for COVID-19 immunization. No medical history reported. On Feb 13, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 14, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced thyroiditis (inflamed thyroid). At the time of the report, thyroiditis (inflamed thyroid) outcome: unknown/not provided. No concomitant medication reported. The treatment information: unknown. Action taken with mRNA-1273 in response to the event: not applicable. Most recent follow-up information incorporated: On May 25, 2021: Non-significant follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Vaccination site pain
Clinical narrative: sore left injection site arm; fatigue; shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), VACCINATION SITE PAIN (sore left injection site arm) and FATIGUE (fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033321A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-May-2021, the patient experienced DYSPNOEA (shortness of breath). On an unknown date, the patient experienced VACCINATION SITE PAIN (sore left injection site arm) and FATIGUE (fatigue). On 23-May-2021, DYSPNOEA (shortness of breath) had resolved. At the time of the report, VACCINATION SITE PAIN (sore left injection site arm) and FATIGUE (fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Product administration error, Vaccination site movement impairment, Vaccination site pain
Clinical narrative: This spontaneous case reported by a pharmacist, describes the occurrence of product administration error (2nd dose shot given too high on the top of the shoulder), vaccination site movement impairment (shoulder motion limitation) and vaccination site pain (severe pain) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 009C21A and 041C21A) for COVID-19 immunization. No medical history reported. On Apr 23, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), intramuscular; 1 dosage form. On May 23, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On May 23, 2021, patient experienced product administration error (2nd dose shot given too high on the top of the shoulder), vaccination site movement impairment (shoulder motion limitation) and vaccination site pain (severe pain). At the time of the report, product administration error (2nd dose shot given too high on the top of the shoulder), vaccination site movement impairment (shoulder motion limitation) and vaccination site pain (severe pain) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. This case linked to MOD21-097288 (patient link).
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Before the vaccine his lungs were full of fluid after the vaccine his lungs were clear; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Before the vaccine his lungs were full of fluid after the vaccine his lungs were clear) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 030M21A) for COVID-19 vaccination.     Concomitant products included TEMAZEPAM, HYDROXYZINE PAMOATE, ROSUVASTATIN CALCIUM (CRESTOR) and LISINOPRIL for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Before the vaccine his lungs were full of fluid after the vaccine his lungs were clear). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Before the vaccine his lungs were full of fluid after the vaccine his lungs were clear) outcome was unknown.            Treatment information was not provided. The patient reported that no drug treated the fluid that got filled in his lungs but after the administration of vaccine it got clear.  The fluid accumulation in the lungs never happened since vaccine administration.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Follow up document received on 12 Jul 2021. The narrative and contact details were updated. On 03-Aug-2021: Follow-up contains No New Information.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue
Clinical narrative: contracted covid; could not get the second dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (contracted covid) and PRODUCT DOSE OMISSION ISSUE (could not get the second 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 01-Apr-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 COVID-19 (contracted covid) and PRODUCT DOSE OMISSION ISSUE (could not get the second dose). At the time of the report, COVID-19 (contracted covid) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (could not get the second dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment was reported.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: I get rash my face; 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 RASH (I get rash my face) 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) UNK dosage form. On an unknown date, the patient experienced RASH (I get rash my face). At the time of the report, RASH (I get rash my face) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitants included.  No treatment included.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: non signi folloup
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 male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No medical history was provided. No concomitant medication provided.   Reporter did not allow further contact
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient received the 1st dose 56 days ago; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient received the 1st dose 56 days ago) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient received the 1st dose 56 days ago). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient received the 1st dose 56 days ago) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were provided No Treatment information provided    Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: NS follow up append
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Somnolence
Clinical narrative: Bad headache; Drowsiness; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Bad headache), SOMNOLENCE (Drowsiness) and FATIGUE (Fatigue) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 22B21A and 002C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-May-2021, the patient experienced HEADACHE (Bad headache), SOMNOLENCE (Drowsiness) and FATIGUE (Fatigue). The patient was treated with LORATADINE, PSEUDOEPHEDRINE SULFATE (CLARITIN-D) ongoing since an unknown date at a dose of unk dosage form. At the time of the report, HEADACHE (Bad headache), SOMNOLENCE (Drowsiness) and FATIGUE (Fatigue) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant product use was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up was received on 25 may 2021 Non significant follow up has no new information
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: mild headache; 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 HEADACHE (mild headache) 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 23-May-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 HEADACHE (mild headache). At the time of the report, HEADACHE (mild headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant Medications were provided by the reporter. No Treatment History was provided by the reporter.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non significant follow up is added
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Cold chills; 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 CHILLS (Cold chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (Cold chills). At the time of the report, CHILLS (Cold chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was unknown by the reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: NNI
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: heat; redness; Swelling of vaccine site; 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 VACCINATION SITE WARMTH (heat), ERYTHEMA (redness) and VACCINATION SITE SWELLING (Swelling of vaccine site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided.     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 VACCINATION SITE WARMTH (heat), ERYTHEMA (redness) and VACCINATION SITE SWELLING (Swelling of vaccine site). At the time of the report, VACCINATION SITE WARMTH (heat), ERYTHEMA (redness) and VACCINATION SITE SWELLING (Swelling of vaccine site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication given. No treatment information provided.; Reporter's Comments: N/A; Sender's Comments: N/A
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Blood alkaline phosphatase, Body temperature, C-reactive protein, Erythema
Clinical narrative: Anemia; ringing in ear; left arm redness; pain at injection site; fever 102-101.7 range; headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ANAEMIA (Anemia), TINNITUS (ringing in ear), ERYTHEMA (left arm redness), INJECTION SITE PAIN (pain at injection site) and PYREXIA (fever 102-101.7 range) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cancer (she had a cancer diagnosis and is in remission.).    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ANAEMIA (Anemia), TINNITUS (ringing in ear), ERYTHEMA (left arm redness), INJECTION SITE PAIN (pain at injection site), PYREXIA (fever 102-101.7 range), HEADACHE (headache) and FATIGUE (fatigue). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, ANAEMIA (Anemia), TINNITUS (ringing in ear), ERYTHEMA (left arm redness), INJECTION SITE PAIN (pain at injection site), PYREXIA (fever 102-101.7 range), HEADACHE (headache) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2021, Full blood count: (normal) conducted baseline CBC prior to the vaccine and blood was normal. On an unknown date, Blood alkaline phosphatase: (abnormal) blood test done with several markers outside the range of normal. On an unknown date, Body temperature: 102 (High) Fever 102-101.7 range. On an unknown date, C-reactive protein: (abnormal) blood test done with several markers outside the range of normal. On an unknown date, Red blood cell sedimentation rate: (High) elevated sedimentation rates.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided. No treatment information is provided.  Patient stated that he consulted three HCP. Patient stated that his 2nd dose was taken on 11-May-2021 with Lot #002C21A.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow-up information received on 25-May-2021 contains non-significant information. NNI