chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Oropharyngeal pain, Rash
Clinical narrative: I had sores they came across my throat; Rashes are becoming sore/ rashes moving up to the chin; Developed rashes; Patient developed a blister on the neck; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of OROPHARYNGEAL PAIN (I had sores they came across my throat), BLISTER (Patient developed a blister on the neck), RASH (Rashes are becoming sore/ rashes moving up to the chin) and RASH (Developed rashes) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced BLISTER (Patient developed a blister on the neck). On 15-Apr-2021, the patient experienced RASH (Developed rashes). On 22-Jun-2021, the patient experienced RASH (Rashes are becoming sore/ rashes moving up to the chin). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (I had sores they came across my throat). The patient was treated with CORTISONE for Rash, at a dose of 1 dosage form and HYDROCORTISONE for Rash, at a dose of 1 dosage form. On 15-Apr-2021, BLISTER (Patient developed a blister on the neck) had resolved. At the time of the report, OROPHARYNGEAL PAIN (I had sores they came across my throat), RASH (Rashes are becoming sore/ rashes moving up to the chin) and RASH (Developed rashes) outcome was unknown.            No information on concomitant medication was provided.  Treatment medication also included moisturizer and other lotions.  Action taken with mRNA-1273 in response to the event was not applicable.         Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Follow up received on 22-JUN-2021. Patient information added, events updated, event outcome updated, treatment medication added.
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: failed to received the 2nd dose on Moderna COVID-19 vaccine within recommended interval; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (failed to received the 2nd dose on Moderna COVID-19 vaccine within recommended interval) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-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 PRODUCT DOSE OMISSION ISSUE (failed to received the 2nd dose on Moderna COVID-19 vaccine within recommended interval). At the time of the report, PRODUCT DOSE OMISSION ISSUE (failed to received the 2nd dose on Moderna COVID-19 vaccine within recommended interval) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided . No treatment medications were provided..   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Follow-up received on 22-jun-2021 contains no newinformation.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling cold, Feeling hot, Laziness
Clinical narrative: Lazy; Left arm was warm to touch from elbow up; Shaky; Had to put on warm sweatshirt and comforters to get warm; Left arm had little bumps from elbow up; Tired; Left arm hurt from elbow up; Nauseated; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of LAZINESS (Lazy), FEELING HOT (Left arm was warm to touch from elbow up), TREMOR (Shaky), FEELING COLD (Had to put on warm sweatshirt and comforters to get warm) and RASH (Left arm had little bumps from elbow up) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer (She had been diagnosed with breast cancer in the past.). Concurrent medical conditions included Allergy NOS and Drug allergy (Had a lot of reactions with medicine.).   On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 an unknown date, the patient experienced LAZINESS (Lazy), FEELING HOT (Left arm was warm to touch from elbow up), TREMOR (Shaky), FEELING COLD (Had to put on warm sweatshirt and comforters to get warm), RASH (Left arm had little bumps from elbow up), FATIGUE (Tired), MYALGIA (Left arm hurt from elbow up), NAUSEA (Nauseated), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, LAZINESS (Lazy), FEELING HOT (Left arm was warm to touch from elbow up), TREMOR (Shaky), FEELING COLD (Had to put on warm sweatshirt and comforters to get warm), RASH (Left arm had little bumps from elbow up), FATIGUE (Tired), MYALGIA (Left arm hurt from elbow up), NAUSEA (Nauseated), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.            No concomitant product use was provided by the reporter.  No treatment medication was provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, Rash, Tremor
Clinical narrative: Lazy; Left arm was warm to touch from elbow up; Shaky; Had to put on warm sweatshirt and comforters to get warm; Left arm had little bumps from elbow up; Tired; Left arm hurt from elbow up; Nauseated; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of LAZINESS (Lazy), FEELING HOT (Left arm was warm to touch from elbow up), TREMOR (Shaky), FEELING COLD (Had to put on warm sweatshirt and comforters to get warm) and RASH (Left arm had little bumps from elbow up) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer (She had been diagnosed with breast cancer in the past.). Concurrent medical conditions included Allergy NOS and Drug allergy (Had a lot of reactions with medicine.).   On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 an unknown date, the patient experienced LAZINESS (Lazy), FEELING HOT (Left arm was warm to touch from elbow up), TREMOR (Shaky), FEELING COLD (Had to put on warm sweatshirt and comforters to get warm), RASH (Left arm had little bumps from elbow up), FATIGUE (Tired), MYALGIA (Left arm hurt from elbow up), NAUSEA (Nauseated), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, LAZINESS (Lazy), FEELING HOT (Left arm was warm to touch from elbow up), TREMOR (Shaky), FEELING COLD (Had to put on warm sweatshirt and comforters to get warm), RASH (Left arm had little bumps from elbow up), FATIGUE (Tired), MYALGIA (Left arm hurt from elbow up), NAUSEA (Nauseated), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.            No concomitant product use was provided by the reporter.  No treatment medication was provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle tightness, Oropharyngeal pain, Swelling, Vaccination site mass, Vaccination site swelling
Clinical narrative: It was swollen at injection site; By next morning, she had swelling on both side of her neck that lasted 3 weeks; She had sore throat that started next morning and is still there; She had tightness on the neck that started next morning and it is still there; She had lump in right arm at injection site on same day; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (She had lump in right arm at injection site on same day), SWELLING (By next morning, she had swelling on both side of her neck that lasted 3 weeks), OROPHARYNGEAL PAIN (She had sore throat that started next morning and is still there), MUSCLE TIGHTNESS (She had tightness on the neck that started next morning and it is still there) and VACCINATION SITE SWELLING (It was swollen at injection site) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022A21A) for COVID-19 vaccination.     No medical history provided by the reporter.  Concomitant products included LISINOPRIL for an unknown indication.    On 16-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-May-2021, the patient experienced VACCINATION SITE MASS (She had lump in right arm at injection site on same day). On 17-May-2021, the patient experienced SWELLING (By next morning, she had swelling on both side of her neck that lasted 3 weeks), OROPHARYNGEAL PAIN (She had sore throat that started next morning and is still there) and MUSCLE TIGHTNESS (She had tightness on the neck that started next morning and it is still there). On an unknown date, the patient experienced VACCINATION SITE SWELLING (It was swollen at injection site). The patient was treated with IBUPROFEN ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. On 08-Jun-2021, SWELLING (By next morning, she had swelling on both side of her neck that lasted 3 weeks) had resolved. At the time of the report, VACCINATION SITE MASS (She had lump in right arm at injection site on same day), OROPHARYNGEAL PAIN (She had sore throat that started next morning and is still there), MUSCLE TIGHTNESS (She had tightness on the neck that started next morning and it is still there) and VACCINATION SITE SWELLING (It was swollen at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Salt water gargle.
Age: 75.0
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: failed to received the 2nd dose on Moderna COVID-19 vaccine within recommended interval; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (failed to received the 2nd dose on Moderna COVID-19 vaccine within recommended interval) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-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 PRODUCT DOSE OMISSION ISSUE (failed to received the 2nd dose on Moderna COVID-19 vaccine within recommended interval). At the time of the report, PRODUCT DOSE OMISSION ISSUE (failed to received the 2nd dose on Moderna COVID-19 vaccine within recommended interval) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Follow up information received contains significant information. Added event.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Feeling abnormal, Headache, Pain in extremity, Pruritus
Clinical narrative: sore bone; congested; itchiness in left and right sides, near the ribs; sore arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (sore bone), FEELING ABNORMAL (congested), PRURITUS (itchiness in left and right sides, near the ribs), PAIN IN EXTREMITY (sore arm) and HEADACHE (headache) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 075C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METFORMIN for an unknown indication.   On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jun-2021, the patient experienced BONE PAIN (sore bone), FEELING ABNORMAL (congested), PRURITUS (itchiness in left and right sides, near the ribs), PAIN IN EXTREMITY (sore arm) and HEADACHE (headache). At the time of the report, BONE PAIN (sore bone), FEELING ABNORMAL (congested), PRURITUS (itchiness in left and right sides, near the ribs), PAIN IN EXTREMITY (sore arm) and HEADACHE (headache) outcome was unknown.            The patient noted she had a temperature, however body temperature value was not provided. She did not take medication to treat the symptoms. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Dysstasia, Fatigue, Headache
Clinical narrative: Very weak; Cannot stand because she feels as if she was going to faint; feels as if she was going to faint, her sight turns black; Fatigued; Could barely sleep; Sore arm/body ache; Fever; Strong headache; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Could barely sleep), ASTHENIA (Very weak), DYSSTASIA (Cannot stand because she feels as if she was going to faint), DIZZINESS (feels as if she was going to faint, her sight turns black) and MYALGIA (Sore arm/body ache) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jun-2021, the patient experienced INSOMNIA (Could barely sleep), PYREXIA (Fever) and HEADACHE (Strong headache). 21-Jun-2021, the patient experienced MYALGIA (Sore arm/body ache). On 22-Jun-2021, the patient experienced ASTHENIA (Very weak), DYSSTASIA (Cannot stand because she feels as if she was going to faint), DIZZINESS (feels as if she was going to faint, her sight turns black) and FATIGUE (Fatigued). On 22-Jun-2021, INSOMNIA (Could barely sleep) and PYREXIA (Fever) had resolved. At the time of the report, ASTHENIA (Very weak), DYSSTASIA (Cannot stand because she feels as if she was going to faint), DIZZINESS (feels as if she was going to faint, her sight turns black) and FATIGUE (Fatigued) outcome was unknown and MYALGIA (Sore arm/body ache) and HEADACHE (Strong headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       In concomitant medications vitamins was reported.  Patient reported that she was told to take aleve and Tylenol as treatment.  At the time of reporting she did not take anything as treatment.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Myalgia, Pyrexia
Clinical narrative: Very weak; Cannot stand because she feels as if she was going to faint; feels as if she was going to faint, her sight turns black; Fatigued; Could barely sleep; Sore arm/body ache; Fever; Strong headache; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Could barely sleep), ASTHENIA (Very weak), DYSSTASIA (Cannot stand because she feels as if she was going to faint), DIZZINESS (feels as if she was going to faint, her sight turns black) and MYALGIA (Sore arm/body ache) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jun-2021, the patient experienced INSOMNIA (Could barely sleep), PYREXIA (Fever) and HEADACHE (Strong headache). 21-Jun-2021, the patient experienced MYALGIA (Sore arm/body ache). On 22-Jun-2021, the patient experienced ASTHENIA (Very weak), DYSSTASIA (Cannot stand because she feels as if she was going to faint), DIZZINESS (feels as if she was going to faint, her sight turns black) and FATIGUE (Fatigued). On 22-Jun-2021, INSOMNIA (Could barely sleep) and PYREXIA (Fever) had resolved. At the time of the report, ASTHENIA (Very weak), DYSSTASIA (Cannot stand because she feels as if she was going to faint), DIZZINESS (feels as if she was going to faint, her sight turns black) and FATIGUE (Fatigued) outcome was unknown and MYALGIA (Sore arm/body ache) and HEADACHE (Strong headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       In concomitant medications vitamins was reported.  Patient reported that she was told to take aleve and Tylenol as treatment.  At the time of reporting she did not take anything as treatment.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Received his first vaccine on 3-12-2021.Patient asked about receiving second Moderna vaccine past 42 days; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Received his first vaccine on 3-12-2021.Patient asked about receiving second Moderna vaccine past 42 days) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-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 (Received his first vaccine on 3-12-2021.Patient asked about receiving second Moderna vaccine past 42 days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Received his first vaccine on 3-12-2021.Patient asked about receiving second Moderna vaccine past 42 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication use was unknown Treatment information was unknown
Sex: U
Vaccine: COVID19
Symptoms: Antibody test, Vaccination complication
Clinical narrative: Only minor side effects if any; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Only minor side effects if any) 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 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-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 VACCINATION COMPLICATION (Only minor side effects if any). At the time of the report, VACCINATION COMPLICATION (Only minor side effects if any) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Antibody test: inconclusive (Inconclusive) unknown.          For mRNA-1273 (COVID 19 Vaccine Moderna)(intramuscular), the reporter did not provide any causality assessment. action taken with mRNA-1273 (COVID 19 Vaccine Moderna)(intramuscular),was unknown No concomitant medication details was reported. No treatment medication details was reported. patient had a infusion in Nov, 2020
Sex: U
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: I have been  itching all over for 3 days now; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (I have been  itching all over for 3 days now) 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 PRURITUS (I have been  itching all over for 3 days now). At the time of the report, PRURITUS (I have been  itching all over for 3 days now) 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.  Patient experienced itching 2 week's after the shot.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Headache, Pain in extremity, Rhinorrhoea
Clinical narrative: soreness of the left arm; headache; coughing; nasal drip; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness of the left arm), HEADACHE (headache), COUGH (coughing) and RHINORRHOEA (nasal drip) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008021A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jun-2021, the patient experienced PAIN IN EXTREMITY (soreness of the left arm), HEADACHE (headache), COUGH (coughing) and RHINORRHOEA (nasal drip). At the time of the report, PAIN IN EXTREMITY (soreness of the left arm), HEADACHE (headache), COUGH (coughing) and RHINORRHOEA (nasal drip) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication were provided. No concomitants were provided.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Vaccination complication
Clinical narrative: Her daughter was quite sick from 2nd dose of moderna vaccine; She had symptoms for 3 to 5 days.; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Her daughter was quite sick from 2nd dose of moderna vaccine) and VACCINATION COMPLICATION (She had symptoms for 3 to 5 days.) 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 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 ILLNESS (Her daughter was quite sick from 2nd dose of moderna vaccine) and VACCINATION COMPLICATION (She had symptoms for 3 to 5 days.). At the time of the report, ILLNESS (Her daughter was quite sick from 2nd dose of moderna vaccine) and VACCINATION COMPLICATION (She had symptoms for 3 to 5 days.) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: UTI; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (UTI) 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 URINARY TRACT INFECTION (UTI). At the time of the report, URINARY TRACT INFECTION (UTI) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: dose from vial that was opened on 18June2021 was administered on 21June2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose from vial that was opened on 18June2021 was administered on 21June2021) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. #039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jun-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 EXPIRED PRODUCT ADMINISTERED (dose from vial that was opened on 18June2021 was administered on 21June2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose from vial that was opened on 18June2021 was administered on 21June2021) 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 and treatment information were reported by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever after Second Shot/ Body temperature very high after Second Shot; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever after Second Shot/ Body temperature very high 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 21-Jun-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 21-Jun-2021, the patient experienced PYREXIA (Fever after Second Shot/ Body temperature very high after Second Shot). At the time of the report, PYREXIA (Fever after Second Shot/ Body temperature very high after Second Shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jun-2021, Body temperature: unknown (High) Unknown.         Concomitant product use was not provided. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was  not applicable.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Upper respiratory tract infection
Clinical narrative: Upper respiratory bug; Sickness; This spontaneous case was reported by a consumer and describes the occurrence of UPPER RESPIRATORY TRACT INFECTION (Upper respiratory bug) and ILLNESS (Sickness) in a 68-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 UPPER RESPIRATORY TRACT INFECTION (Upper respiratory bug) and ILLNESS (Sickness). At the time of the report, UPPER RESPIRATORY TRACT INFECTION (Upper respiratory bug) and ILLNESS (Sickness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient was administered dose from a vial that was punctured 21 hours earlier/This was patient's 1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient was administered dose from a vial that was punctured 21 hours earlier/This was patient's 1st dose) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient was administered dose from a vial that was punctured 21 hours earlier/This was patient's 1st dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient was administered dose from a vial that was punctured 21 hours earlier/This was patient's 1st dose) 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.   Treatment medications were not mentioned. No concomitant medications were provided. Any other reactions to the vaccine were not reported
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Product dose omission issue, Rash
Clinical narrative: Got shingles for 6 weeks; Missed second dose in allowed time window/ The daughter was advised by her doctor to not received the second dose of the vaccine and has not received it at the time of the call; Rash all over body; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Got shingles for 6 weeks), PRODUCT DOSE OMISSION ISSUE (Missed second dose in allowed time window/ The daughter was advised by her doctor to not received the second dose of the vaccine and has not received it at the time of the call) and RASH (Rash all over body) in a 59-year-old female 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 HERPES ZOSTER (Got shingles for 6 weeks), PRODUCT DOSE OMISSION ISSUE (Missed second dose in allowed time window/ The daughter was advised by her doctor to not received the second dose of the vaccine and has not received it at the time of the call) and RASH (Rash all over body). The patient was treated with DOCUSATE SODIUM (LAXADINE [DOCUSATE SODIUM]) for Adverse event, at a dose of 1 dosage form. At the time of the report, HERPES ZOSTER (Got shingles for 6 weeks) and PRODUCT DOSE OMISSION ISSUE (Missed second dose in allowed time window/ The daughter was advised by her doctor to not received the second dose of the vaccine and has not received it at the time of the call) had resolved and RASH (Rash all over body) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient took concomitant medication which were not specified by reporter.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 12-Aug-2021: Follow-up received contain an adverse event such as shingles and its outcome  to recovered/ resolved.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dyspnoea, Myalgia, Nausea
Clinical narrative: a little breathing difficulty; body aches; nausea; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea), MYALGIA (body aches) and DYSPNOEA (a little breathing difficulty) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (virus) in July 2020.   On an unknown date, the patient received 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 NAUSEA (nausea), MYALGIA (body aches) and DYSPNOEA (a little breathing difficulty). At the time of the report, NAUSEA (nausea), MYALGIA (body aches) and DYSPNOEA (a little breathing difficulty) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (Inconclusive) 102 degree temp.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications reported
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort
Clinical narrative: Upper abdominal fullness/heaviness/upset stomach; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Upper abdominal fullness/heaviness/upset stomach) 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 ABDOMINAL DISCOMFORT (Upper abdominal fullness/heaviness/upset stomach). At the time of the report, ABDOMINAL DISCOMFORT (Upper abdominal fullness/heaviness/upset stomach) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: I received my second Vaccine on June 2 and I'm now experiencing flulike symptoms.; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (I received my second Vaccine on June 2 and I'm now experiencing flulike symptoms.) 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 INFLUENZA LIKE ILLNESS (I received my second Vaccine on June 2 and I'm now experiencing flulike symptoms.). At the time of the report, INFLUENZA LIKE ILLNESS (I received my second Vaccine on June 2 and I'm now experiencing flulike symptoms.) outcome was unknown.            Concomitant product details was not reported.  Treatment details was not reported .
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Constipation
Clinical narrative: stomach ache; constipation; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach ache) and CONSTIPATION (constipation) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (stomach ache) and CONSTIPATION (constipation). At the time of the report, ABDOMINAL PAIN UPPER (stomach ache) and CONSTIPATION (constipation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Depression, Diarrhoea, Dizziness, Headache, Vomiting
Clinical narrative: depression; diarrhea; dizzy; headache; vomit; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSION (depression), DIARRHOEA (diarrhea), DIZZINESS (dizzy), HEADACHE (headache) and VOMITING (vomit) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder. Concomitant products included ATENOLOL, LEVOTHYROXINE, CLOZAPINE and BUPROPION HYDROCHLORIDE (WELLBUTRIN) for an unknown indication.    On 08-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jun-2021, the patient experienced DEPRESSION (depression), DIARRHOEA (diarrhea), DIZZINESS (dizzy), HEADACHE (headache) and VOMITING (vomit). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN MIGRAINE) at an unspecified dose and frequency. On 10-Jun-2021, VOMITING (vomit) had resolved. At the time of the report, DEPRESSION (depression), DIARRHOEA (diarrhea), DIZZINESS (dizzy) and HEADACHE (headache) 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.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow up was received No new information
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, Product dose omission issue
Clinical narrative: Back spasms; Got the first dose of the Moderna vaccine around mid April and second dose has not been administered yet.; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Back spasms) and PRODUCT DOSE OMISSION ISSUE (Got the first dose of the Moderna vaccine around mid April and second dose has not been administered yet.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for Anxiety.    In April 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 MUSCLE SPASMS (Back spasms) and PRODUCT DOSE OMISSION ISSUE (Got the first dose of the Moderna vaccine around mid April and second dose has not been administered yet.). The patient was treated with PREDNISONE at a dose of UNK dosage form, qd. At the time of the report, MUSCLE SPASMS (Back spasms) and PRODUCT DOSE OMISSION ISSUE (Got the first dose of the Moderna vaccine around mid April and second dose has not been administered yet.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported No treatment drugs were reported
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Myalgia, Product dose omission issue
Clinical narrative: This spontaneous case reported by a healthcare professional, describes the occurrence of dizziness, product dose omission issue (patient planned not to take second dose), fatigue and myalgia (muscle pain) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On May 27, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced dizziness, product dose omission issue (patient planned not to take second dose), fatigue and myalgia (muscle pain). At the time of the report, dizziness, product dose omission issue (patient planned not to take second dose), fatigue and myalgia (muscle pain) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product administration error
Clinical narrative: Patient accidentally given Pfizer vaccine as second dose; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Patient accidentally given Pfizer vaccine as second dose) in a male patient of an unknown age 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.    The patient's past medical history included Hepatitis C (Desires treatment). Concurrent medical conditions included Drug allergy, Hypertension, Depression, Arthritis since 2013 and Anxiety. Concomitant products included BUPROPION from 24-May-2021 to an unknown date for Depression and Anxiety, HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL/HCTZ) from 24-May-2021 to an unknown date for Hypertension.   On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jun-2021, the patient received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. On 22-Jun-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Patient accidentally given Pfizer vaccine as second dose). On 22-Jun-2021, PRODUCT ADMINISTRATION ERROR (Patient accidentally given Pfizer vaccine as second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered PRODUCT ADMINISTRATION ERROR (Patient accidentally given Pfizer vaccine as second dose) to be not related.    Treatment information was unknown.  Patient had second covid vaccine given as Pfizer with first covid vaccine given as Moderna.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Medical history and concomitant drugs were added. Patient demographics updated. Start date of Moderna vaccine updated. Reporter causality was updated.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Product dose omission issue, SARS-CoV-2 test
Clinical narrative: SICK; PATIENT RECEIVING THE SECOND DOSE OF THE VACCINE MORE THAN 36 DAYS AFTER THE FIRST DOSE; This spontaneous case was reported by a pharmacist and describes the occurrence of ILLNESS (SICK) and PRODUCT DOSE OMISSION ISSUE (PATIENT RECEIVING THE SECOND DOSE OF THE VACCINE MORE THAN 36 DAYS AFTER THE FIRST DOSE) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concomitant products included FUROSEMIDE (LASIX [FUROSEMIDE]) and DILTIAZEM (CARDIZEM [DILTIAZEM]) for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (SICK) and PRODUCT DOSE OMISSION ISSUE (PATIENT RECEIVING THE SECOND DOSE OF THE VACCINE MORE THAN 36 DAYS AFTER THE FIRST DOSE). At the time of the report, ILLNESS (SICK) and PRODUCT DOSE OMISSION ISSUE (PATIENT RECEIVING THE SECOND DOSE OF THE VACCINE MORE THAN 36 DAYS AFTER THE FIRST DOSE) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) positive.     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.   Treatment details was not reported .
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Broke out in a full body rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Broke out in a full body rash) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026D1A and 027B21H) for COVID-19 vaccination.     No Medical History information was reported.   On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jun-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 RASH (Broke out in a full body rash). At the time of the report, RASH (Broke out in a full body rash) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment medications included antihistamine and a nasal spray. Action taken with mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Follow up received: No new information.
Sex: U
Vaccine: COVID19
Symptoms: Cough, Inappropriate schedule of product administration, Nasal congestion
Clinical narrative: cough; congestion; potentially receiving the second dose of the vaccine more than 36 days after the first dose; This spontaneous case was reported by a patient and describes the occurrence of COUGH (cough), NASAL CONGESTION (congestion) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (potentially receiving the second dose of the vaccine more than 36 days after the first dose) 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), NASAL CONGESTION (congestion) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (potentially receiving the second dose of the vaccine more than 36 days after the first dose). At the time of the report, COUGH (cough) and NASAL CONGESTION (congestion) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (potentially receiving the second dose of the vaccine more than 36 days after the first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was mentioned. No treatment medication was mentioned.
Sex: U
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Swelling of limbs; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling of limbs) 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 PERIPHERAL SWELLING (Swelling of limbs). At the time of the report, PERIPHERAL SWELLING (Swelling of limbs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment medication was not provided.