chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Cough, Fatigue, Headache
Clinical narrative: Sluggish; rash around the left arm; Headaches; muscle pains; chills; nausea; low-grade fever (reached 102 F); Fatigue/tired; "very sick" for two days; Dry cough; very sore left arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION ("very sick" for two days), COUGH (Dry cough), PAIN IN EXTREMITY (very sore left arm), SLUGGISHNESS (Sluggish) and RASH (rash around the left arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high, Hypercholesterolaemia, Depression and COPD. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular). On 10-Feb-2021, the patient experienced VACCINATION COMPLICATION ("very sick" for two days), COUGH (Dry cough), PAIN IN EXTREMITY (very sore left arm), RASH (rash around the left arm), HEADACHE (Headaches), MYALGIA (muscle pains), CHILLS (chills), NAUSEA (nausea), PYREXIA (low-grade fever (reached 102 F)) and FATIGUE (Fatigue/tired). On 12-Feb-2021, the patient experienced SLUGGISHNESS (Sluggish). On 12-Feb-2021, VACCINATION COMPLICATION ("very sick" for two days), COUGH (Dry cough), MYALGIA (muscle pains), CHILLS (chills), NAUSEA (nausea) and PYREXIA (low-grade fever (reached 102 F)) had resolved. On 13-Feb-2021, PAIN IN EXTREMITY (very sore left arm) and RASH (rash around the left arm) had resolved. At the time of the report, SLUGGISHNESS (Sluggish) outcome was unknown and HEADACHE (Headaches) and FATIGUE (Fatigue/tired) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Body temperature: 102 f High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient takes medications to treat current medical conditions but did not provide the names of them all. Patient uses an inhaler (unspecified) to treat COPD.  The patient did not use any medications for treatment of the events.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain in extremity, Pyrexia, Rash
Clinical narrative: Sluggish; rash around the left arm; Headaches; muscle pains; chills; nausea; low-grade fever (reached 102 F); Fatigue/tired; "very sick" for two days; Dry cough; very sore left arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION ("very sick" for two days), COUGH (Dry cough), PAIN IN EXTREMITY (very sore left arm), SLUGGISHNESS (Sluggish) and RASH (rash around the left arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high, Hypercholesterolaemia, Depression and COPD. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular). On 10-Feb-2021, the patient experienced VACCINATION COMPLICATION ("very sick" for two days), COUGH (Dry cough), PAIN IN EXTREMITY (very sore left arm), RASH (rash around the left arm), HEADACHE (Headaches), MYALGIA (muscle pains), CHILLS (chills), NAUSEA (nausea), PYREXIA (low-grade fever (reached 102 F)) and FATIGUE (Fatigue/tired). On 12-Feb-2021, the patient experienced SLUGGISHNESS (Sluggish). On 12-Feb-2021, VACCINATION COMPLICATION ("very sick" for two days), COUGH (Dry cough), MYALGIA (muscle pains), CHILLS (chills), NAUSEA (nausea) and PYREXIA (low-grade fever (reached 102 F)) had resolved. On 13-Feb-2021, PAIN IN EXTREMITY (very sore left arm) and RASH (rash around the left arm) had resolved. At the time of the report, SLUGGISHNESS (Sluggish) outcome was unknown and HEADACHE (Headaches) and FATIGUE (Fatigue/tired) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Body temperature: 102 f High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient takes medications to treat current medical conditions but did not provide the names of them all. Patient uses an inhaler (unspecified) to treat COPD.  The patient did not use any medications for treatment of the events.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Sluggishness, Vaccination complication
Clinical narrative: Sluggish; rash around the left arm; Headaches; muscle pains; chills; nausea; low-grade fever (reached 102 F); Fatigue/tired; "very sick" for two days; Dry cough; very sore left arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION ("very sick" for two days), COUGH (Dry cough), PAIN IN EXTREMITY (very sore left arm), SLUGGISHNESS (Sluggish) and RASH (rash around the left arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high, Hypercholesterolaemia, Depression and COPD. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular). On 10-Feb-2021, the patient experienced VACCINATION COMPLICATION ("very sick" for two days), COUGH (Dry cough), PAIN IN EXTREMITY (very sore left arm), RASH (rash around the left arm), HEADACHE (Headaches), MYALGIA (muscle pains), CHILLS (chills), NAUSEA (nausea), PYREXIA (low-grade fever (reached 102 F)) and FATIGUE (Fatigue/tired). On 12-Feb-2021, the patient experienced SLUGGISHNESS (Sluggish). On 12-Feb-2021, VACCINATION COMPLICATION ("very sick" for two days), COUGH (Dry cough), MYALGIA (muscle pains), CHILLS (chills), NAUSEA (nausea) and PYREXIA (low-grade fever (reached 102 F)) had resolved. On 13-Feb-2021, PAIN IN EXTREMITY (very sore left arm) and RASH (rash around the left arm) had resolved. At the time of the report, SLUGGISHNESS (Sluggish) outcome was unknown and HEADACHE (Headaches) and FATIGUE (Fatigue/tired) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Body temperature: 102 f High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient takes medications to treat current medical conditions but did not provide the names of them all. Patient uses an inhaler (unspecified) to treat COPD.  The patient did not use any medications for treatment of the events.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Chills, Fatigue, Myalgia
Clinical narrative: could hardly move, couldn't get out of bed; injection site soreness; fever that spiked; chills; felt like every muscle in his body was being attacked; A spontaneous report was received from an Other Health Professional on 10-FEB-2021, which refers to a Male aged 78 Years, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccination site pain, pyrexia, chills, myalgia and fatigue.   At the time of the event the patient had Cancer, Dermatomyositis. The following drugs are known to have been taken by the patient prior to the event: Prednisone, Ubiquinol, Lasix, Xarelto, Atorvastatin, Zetia and Niacin.  The patient received the first of the two planned doses of mRNA 1273 on 15-JAN-2021. 24 hours later, the patient experienced injection site soreness, fever that spiked, chills, felt like every muscle in his body was being attacked and could hardly move.  The patient also reported that he received the second dose of Moderna COVID-19 vaccine on 29-JAN-2021 and experienced adverse events.  The events were treated with Tylenol and amoxicillin  Follow-up required.  Action taken with mRNA-1273 in response to the events was not reported.  The event was considered Resolved/Recovered.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: could hardly move, couldn't get out of bed; injection site soreness; fever that spiked; chills; felt like every muscle in his body was being attacked; A spontaneous report was received from an Other Health Professional on 10-FEB-2021, which refers to a Male aged 78 Years, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccination site pain, pyrexia, chills, myalgia and fatigue.   At the time of the event the patient had Cancer, Dermatomyositis. The following drugs are known to have been taken by the patient prior to the event: Prednisone, Ubiquinol, Lasix, Xarelto, Atorvastatin, Zetia and Niacin.  The patient received the first of the two planned doses of mRNA 1273 on 15-JAN-2021. 24 hours later, the patient experienced injection site soreness, fever that spiked, chills, felt like every muscle in his body was being attacked and could hardly move.  The patient also reported that he received the second dose of Moderna COVID-19 vaccine on 29-JAN-2021 and experienced adverse events.  The events were treated with Tylenol and amoxicillin  Follow-up required.  Action taken with mRNA-1273 in response to the events was not reported.  The event was considered Resolved/Recovered.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pruritus, Vaccination site rash, Vaccination site warmth
Clinical narrative: Lump - Near Injection Site; Hot to Touch - Near Injection Site; Itchy Sensation - Near Injection Site; Redness - Near Injection Site; Rash - Near Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Lump - Near Injection Site), VACCINATION SITE WARMTH (Hot to Touch - Near Injection Site), VACCINATION SITE PRURITUS (Itchy Sensation - Near Injection Site), VACCINATION SITE ERYTHEMA (Redness - Near Injection Site) and VACCINATION SITE RASH (Rash - Near Injection Site) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 011J20a) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes mellitus, Blood pressure high, Heart disease, unspecified, Drug allergy (Novocaine) and Iodine allergy (iodine IV).   On 13-Jan-2021 at 2:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021 at 12:10 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE MASS (Lump - Near Injection Site), VACCINATION SITE WARMTH (Hot to Touch - Near Injection Site), VACCINATION SITE PRURITUS (Itchy Sensation - Near Injection Site), VACCINATION SITE ERYTHEMA (Redness - Near Injection Site) and VACCINATION SITE RASH (Rash - Near Injection Site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of UNK dosage form and HYDROCORTISONE ACETATE (CORTIZONE-10 [HYDROCORTISONE ACETATE]) for Adverse event, at a dose of UNK dosage form. On 25-Feb-2021, VACCINATION SITE MASS (Lump - Near Injection Site), VACCINATION SITE WARMTH (Hot to Touch - Near Injection Site), VACCINATION SITE PRURITUS (Itchy Sensation - Near Injection Site), VACCINATION SITE ERYTHEMA (Redness - Near Injection Site) and VACCINATION SITE RASH (Rash - Near Injection Site) had resolved.            Concomitant medications included a Continuous Glucose Monitoring (CGM) device for Diabetes.  It was reported that, delayed reaction, 5 days after vaccine injection. Itching, rash at site of injection from shoulder to elbow. Redness around CGM worn on right arm. Rash faded over the next 8 days.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Added patient demographics, medical history and updated events outcome.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Hot to touch at injection site; Itchiness at injection site; Redness at injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (Hot to touch at injection site), VACCINATION SITE PRURITUS (Itchiness at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J202A) for COVID-19 vaccination.     No medical history was provided. .  Concomitant products included ISOSORBIDE MONONITRATE, PANTOPRAZOLE, LOSARTAN, ACETYLSALICYLIC ACID (BAYER ASPIRIN), METOPROLOL and ATORVASTATIN for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Hot to touch at injection site), VACCINATION SITE PRURITUS (Itchiness at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site). At the time of the report, VACCINATION SITE WARMTH (Hot to touch at injection site), VACCINATION SITE PRURITUS (Itchiness at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenopia, Body temperature, Skin warm
Clinical narrative: felt warm, his temperature was 99F; eyes feel a little heavy; This spontaneous case was reported by a consumer and describes the occurrence of SKIN WARM (felt warm, his temperature was 99F) and ASTHENOPIA (eyes feel a little heavy) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029M20A) for COVID-19 vaccination.     Concomitant products included LOSARTAN and ATORVASTATIN for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced SKIN WARM (felt warm, his temperature was 99F) and ASTHENOPIA (eyes feel a little heavy). At the time of the report, SKIN WARM (felt warm, his temperature was 99F) and ASTHENOPIA (eyes feel a little heavy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Feb-2021, Body temperature: 99f (High) 99F. On an unknown date, Body temperature: 99 and 100 (High) 99 and 100.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details not provided.; Sender's Comments: Based on the current available information which includes a temporal association between the use of the product and the start date of the reported events, a causal relationship with the event cannot be excluded
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Hypersensitivity, Pruritus, Rash, Rash macular
Clinical narrative: Delayed localized allergic reaction; Real itchy; A spot on the arm which was the size of a "lid on the can of vegetables; Red; Rash; This spontaneous case was reported by a patient and describes the occurrence of HYPERSENSITIVITY (Delayed localized allergic reaction), PRURITUS (Real itchy), RASH MACULAR (A spot on the arm which was the size of a "lid on the can of vegetables), ERYTHEMA (Red) and RASH (Rash) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced RASH (Rash). On 13-Feb-2021, the patient experienced HYPERSENSITIVITY (Delayed localized allergic reaction), PRURITUS (Real itchy), RASH MACULAR (A spot on the arm which was the size of a "lid on the can of vegetables) and ERYTHEMA (Red). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of UNK dosage form. At the time of the report, HYPERSENSITIVITY (Delayed localized allergic reaction) and PRURITUS (Real itchy) outcome was unknown and RASH MACULAR (A spot on the arm which was the size of a "lid on the can of vegetables), ERYTHEMA (Red) and RASH (Rash) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.   The patient was also prescribed a topical cream, however, she did not use it as her rash went away.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pain in extremity, Pyrexia
Clinical narrative: Sore arm; a low grade fever 99.6°F; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and PYREXIA (a low grade fever 99.6°F) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 004M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and PYREXIA (a low grade fever 99.6°F). At the time of the report, PAIN IN EXTREMITY (Sore arm) and PYREXIA (a low grade fever 99.6°F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Feb-2021, Body temperature: 99.6°f (Inconclusive) Body temperature-99.6.         No concomitant medication information was provided. Patient have not received any treatment medication. Action taken with mRNA-1273 in response to the drug was not applicable.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Feeling hot, Headache, Injected limb mobility decreased
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SWOLLEN TONGUE (Sensation of swollen tongue, nose and throat), PHARYNGEAL SWELLING (Throat swelling), FEELING HOT (body was warm), INJECTED LIMB MOBILITY DECREASED (Could not lift the right arm) and PERIPHERAL COLDNESS (Feet felt frozen for a minute) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced SWOLLEN TONGUE (Sensation of swollen tongue, nose and throat), PHARYNGEAL SWELLING (Throat swelling), FEELING HOT (body was warm), PERIPHERAL COLDNESS (Feet felt frozen for a minute), LIMB DISCOMFORT (Heaviness of arm and neck), TOOTHACHE (Hurting teeth), FEELING ABNORMAL (Heaviness of arm and neck), SENSORY DISTURBANCE (Swish feeling from neck to arm and fingers) and FATIGUE (Fatigue). On 19-Feb-2021, the patient experienced INJECTED LIMB MOBILITY DECREASED (Could not lift the right arm). On 21-Feb-2021, the patient experienced HEADACHE (Mild headache on and off). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 18-Feb-2021, SENSORY DISTURBANCE (Swish feeling from neck to arm and fingers) had resolved. On 19-Feb-2021, SWOLLEN TONGUE (Sensation of swollen tongue, nose and throat) and PHARYNGEAL SWELLING (Throat swelling) had resolved. On 21-Feb-2021, FEELING HOT (body was warm), INJECTED LIMB MOBILITY DECREASED (Could not lift the right arm), PERIPHERAL COLDNESS (Feet felt frozen for a minute), HEADACHE (Mild headache on and off) and FATIGUE (Fatigue) had resolved. At the time of the report, LIMB DISCOMFORT (Heaviness of arm and neck), TOOTHACHE (Hurting teeth) and FEELING ABNORMAL (Heaviness of arm and neck) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided. Most recent FOLLOW-UP information incorporated above includes: On 04-Mar-2021: Follow up receive on 04-mar-2021 contains, vaccine route of administration and  anatomical location changed from left arm to right arm, new additional events are added. Treatment medication Ibuprofen added.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Peripheral coldness, Pharyngeal swelling, Sensory disturbance, Swollen tongue
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SWOLLEN TONGUE (Sensation of swollen tongue, nose and throat), PHARYNGEAL SWELLING (Throat swelling), FEELING HOT (body was warm), INJECTED LIMB MOBILITY DECREASED (Could not lift the right arm) and PERIPHERAL COLDNESS (Feet felt frozen for a minute) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced SWOLLEN TONGUE (Sensation of swollen tongue, nose and throat), PHARYNGEAL SWELLING (Throat swelling), FEELING HOT (body was warm), PERIPHERAL COLDNESS (Feet felt frozen for a minute), LIMB DISCOMFORT (Heaviness of arm and neck), TOOTHACHE (Hurting teeth), FEELING ABNORMAL (Heaviness of arm and neck), SENSORY DISTURBANCE (Swish feeling from neck to arm and fingers) and FATIGUE (Fatigue). On 19-Feb-2021, the patient experienced INJECTED LIMB MOBILITY DECREASED (Could not lift the right arm). On 21-Feb-2021, the patient experienced HEADACHE (Mild headache on and off). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 18-Feb-2021, SENSORY DISTURBANCE (Swish feeling from neck to arm and fingers) had resolved. On 19-Feb-2021, SWOLLEN TONGUE (Sensation of swollen tongue, nose and throat) and PHARYNGEAL SWELLING (Throat swelling) had resolved. On 21-Feb-2021, FEELING HOT (body was warm), INJECTED LIMB MOBILITY DECREASED (Could not lift the right arm), PERIPHERAL COLDNESS (Feet felt frozen for a minute), HEADACHE (Mild headache on and off) and FATIGUE (Fatigue) had resolved. At the time of the report, LIMB DISCOMFORT (Heaviness of arm and neck), TOOTHACHE (Hurting teeth) and FEELING ABNORMAL (Heaviness of arm and neck) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided. Most recent FOLLOW-UP information incorporated above includes: On 04-Mar-2021: Follow up receive on 04-mar-2021 contains, vaccine route of administration and  anatomical location changed from left arm to right arm, new additional events are added. Treatment medication Ibuprofen added.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Toothache
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SWOLLEN TONGUE (Sensation of swollen tongue, nose and throat), PHARYNGEAL SWELLING (Throat swelling), FEELING HOT (body was warm), INJECTED LIMB MOBILITY DECREASED (Could not lift the right arm) and PERIPHERAL COLDNESS (Feet felt frozen for a minute) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced SWOLLEN TONGUE (Sensation of swollen tongue, nose and throat), PHARYNGEAL SWELLING (Throat swelling), FEELING HOT (body was warm), PERIPHERAL COLDNESS (Feet felt frozen for a minute), LIMB DISCOMFORT (Heaviness of arm and neck), TOOTHACHE (Hurting teeth), FEELING ABNORMAL (Heaviness of arm and neck), SENSORY DISTURBANCE (Swish feeling from neck to arm and fingers) and FATIGUE (Fatigue). On 19-Feb-2021, the patient experienced INJECTED LIMB MOBILITY DECREASED (Could not lift the right arm). On 21-Feb-2021, the patient experienced HEADACHE (Mild headache on and off). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 18-Feb-2021, SENSORY DISTURBANCE (Swish feeling from neck to arm and fingers) had resolved. On 19-Feb-2021, SWOLLEN TONGUE (Sensation of swollen tongue, nose and throat) and PHARYNGEAL SWELLING (Throat swelling) had resolved. On 21-Feb-2021, FEELING HOT (body was warm), INJECTED LIMB MOBILITY DECREASED (Could not lift the right arm), PERIPHERAL COLDNESS (Feet felt frozen for a minute), HEADACHE (Mild headache on and off) and FATIGUE (Fatigue) had resolved. At the time of the report, LIMB DISCOMFORT (Heaviness of arm and neck), TOOTHACHE (Hurting teeth) and FEELING ABNORMAL (Heaviness of arm and neck) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided. Most recent FOLLOW-UP information incorporated above includes: On 04-Mar-2021: Follow up receive on 04-mar-2021 contains, vaccine route of administration and  anatomical location changed from left arm to right arm, new additional events are added. Treatment medication Ibuprofen added.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Shortness of breath; This spontaneous case was reported by an other health care professional and describes the occurrence of DYSPNOEA (Shortness of breath) 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 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced DYSPNOEA (Shortness of breath). At the time of the report, DYSPNOEA (Shortness of breath) was resolving.        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.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Tachycardia, Vaccination complication
Clinical narrative: Light headedness; Fast heart beat; Not feeling well; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (Light headedness), TACHYCARDIA (Fast heart beat) and VACCINATION COMPLICATION (Not feeling well) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20H) for COVID-19 vaccination.     No medical history was provided.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 09-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 DIZZINESS (Light headedness), TACHYCARDIA (Fast heart beat) and VACCINATION COMPLICATION (Not feeling well). At the time of the report, DIZZINESS (Light headedness), TACHYCARDIA (Fast heart beat) and VACCINATION COMPLICATION (Not feeling well) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Additional concomitant medications included an unspecified blood thinner.   No treatment information was provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Itchy at the injection site; Red rash at injection site; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE PRURITUS (Itchy at the injection site) and VACCINATION SITE RASH (Red rash at injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history).    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 17-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy at the injection site) and VACCINATION SITE RASH (Red rash at injection site). On 12-Feb-2021, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Itchy at the injection site) and VACCINATION SITE RASH (Red rash at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  The patient suspected she had an allergic reaction. No treatment was reported for the events.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Tenderness
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Tenderness/slight warmness in arm size of a half dollar) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. Concurrent medical conditions included Glaucoma and Blood pressure high. Concomitant products included HYDROCHLOROTHIAZIDE for Blood pressure high, ATORVASTATIN for Cholesterol, DORZOLAMIDE HYDROCHLORIDE, TIMOLOL MALEATE (COSOPT) and BIMATOPROST (LUMIGAN) for Glaucoma. On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  the patient experienced TENDERNESS (Tenderness/slight warmness in arm size of a half dollar). TENDERNESS (Tenderness/slight warmness in arm size of a half dollar) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high (High) High. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided. This case was linked to MOD-2021-254179. Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Follow-up document was received. Patient's demographics, medical history, concomitant medication, adverse event outcome were updated. It contains significant information.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site pain, Pruritus
Clinical narrative: Itchiness; pain at injection site; soreness at injection site; joint pain in left knee; pain in left hip; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness), INJECTION SITE PAIN (pain at injection site), ARTHRALGIA (soreness at injection site), ARTHRALGIA (joint pain in left knee) and ARTHRALGIA (pain in left hip) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Arthritis.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced INJECTION SITE PAIN (pain at injection site), ARTHRALGIA (soreness at injection site), ARTHRALGIA (joint pain in left knee) and ARTHRALGIA (pain in left hip). On 17-Feb-2021, the patient experienced PRURITUS (Itchiness). On 10-Feb-2021, INJECTION SITE PAIN (pain at injection site), ARTHRALGIA (soreness at injection site) and ARTHRALGIA (joint pain in left knee) had resolved. On 17-Feb-2021, PRURITUS (Itchiness) had resolved. At the time of the report, ARTHRALGIA (pain in left hip) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-015787 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Myalgia, Pyrexia
Clinical narrative: Chest discomfort; fever; chills; body ache; This spontaneous case was reported by a physician and describes the occurrence of CHEST DISCOMFORT (Chest discomfort), PYREXIA (fever), CHILLS (chills) and MYALGIA (body ache) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-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 CHEST DISCOMFORT (Chest discomfort), PYREXIA (fever), CHILLS (chills) and MYALGIA (body ache). At the time of the report, CHEST DISCOMFORT (Chest discomfort), PYREXIA (fever), CHILLS (chills) and MYALGIA (body ache) 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.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site pruritus
Clinical narrative: Injection site starting to itch; Getting a little hard; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Injection site starting to itch) and VACCINATION SITE INDURATION (Getting a little hard) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN, CLOPIDOGREL, ERGOCALCIFEROL, GLIPIZIDE, LEVOTHYROXINE, NIFEDIPINE and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site starting to itch) and VACCINATION SITE INDURATION (Getting a little hard). At the time of the report, VACCINATION SITE PRURITUS (Injection site starting to itch) and VACCINATION SITE INDURATION (Getting a little hard) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the itching included topical iodine.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history 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 URTICARIA (Hives). At the time of the report, URTICARIA (Hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment was reported for the events.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Dizziness, Fatigue, Headache
Clinical narrative: Severe chills; Feels nausea; Dizziness; Not able to drink and eat; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), DECREASED APPETITE (Not able to drink and eat), HEADACHE (Headache), FATIGUE (Fatigue) and CHILLS (Severe chills) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M00A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced DIZZINESS (Dizziness), DECREASED APPETITE (Not able to drink and eat), HEADACHE (Headache) and FATIGUE (Fatigue). On an unknown date, the patient experienced CHILLS (Severe chills) and NAUSEA (Feels nausea). At the time of the report, DIZZINESS (Dizziness), DECREASED APPETITE (Not able to drink and eat), HEADACHE (Headache), FATIGUE (Fatigue), CHILLS (Severe chills) and NAUSEA (Feels nausea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment reported    Reporter did not allow further contact
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Severe chills; Feels nausea; Dizziness; Not able to drink and eat; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), DECREASED APPETITE (Not able to drink and eat), HEADACHE (Headache), FATIGUE (Fatigue) and CHILLS (Severe chills) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M00A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced DIZZINESS (Dizziness), DECREASED APPETITE (Not able to drink and eat), HEADACHE (Headache) and FATIGUE (Fatigue). On an unknown date, the patient experienced CHILLS (Severe chills) and NAUSEA (Feels nausea). At the time of the report, DIZZINESS (Dizziness), DECREASED APPETITE (Not able to drink and eat), HEADACHE (Headache), FATIGUE (Fatigue), CHILLS (Severe chills) and NAUSEA (Feels nausea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment reported    Reporter did not allow further contact
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy
Clinical narrative: Under arm pain (lymph node); Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of   in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer. Concomitant products included APIXABAN (ELIQUIS) for Anticoagulant therapy, TORSEMIDE and METOPROLOL SUCCINATE (TOPROL XL) for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient washed with antibacterial soap when the irritation first started, however no additional treatment was reported for the events.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Initial additional; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site urticaria, Pruritus, Rash, Vaccination site warmth
Clinical narrative: warm to the touch; itching; rash on her arm; little hives at the injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (warm to the touch), PRURITUS (itching), RASH (rash on her arm) and INJECTION SITE URTICARIA (little hives at the injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No medical history was provided. .  Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) and HYDROCORTISONE for an unknown indication.    On 12-Feb-2021 at 5:45 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced PRURITUS (itching), RASH (rash on her arm) and INJECTION SITE URTICARIA (little hives at the injection site). On an unknown date, the patient experienced VACCINATION SITE WARMTH (warm to the touch). At the time of the report, VACCINATION SITE WARMTH (warm to the touch), PRURITUS (itching), RASH (rash on her arm) and INJECTION SITE URTICARIA (little hives at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: Headache; arm hurts; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm hurts) and HEADACHE (Headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE PAIN (arm hurts). On 18-Feb-2021, the patient experienced HEADACHE (Headache). At the time of the report, VACCINATION SITE PAIN (arm hurts) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Having pretty bad headaches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Having pretty bad headaches) 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 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Having pretty bad headaches). At the time of the report, HEADACHE (Having pretty bad headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Joint swelling
Clinical narrative: Swollen Left Ankle; Joints hurt; Case reference number MOD-2021-015738 is a clinical trial case report which refers to a 72 Years old Male patient.  The patient experienced Joints hurt which resulted in .  This occurred while participating in Protocol   -   .  The patients relevant medical history included: No adverse event   .  The patients started Moderna COVID-19 Vaccine on  .  Some  1 day  later, the patient developed Joints hurt.'  Relevant laboratory results included   and relevant physical signs .The patient experienced the following serious criteria:   The eventual diagnosis made was Arthralgia .  The patient was treated for the event . The action taken for Moderna COVID-19 Vaccine. The investigator considered the Joints hurt  did not declare related to the study drug/placebo.  In the investigators opinion other possible factors included and the patients age/history or other factors; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Headache; Arm hurts; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurts) and HEADACHE (Headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm hurts). On 18-Feb-2021, the patient experienced HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Arm hurts) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment medications were unknown.