chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Malaise
Clinical narrative: feeling sick; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and MALAISE (feeling sick) 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.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jul-2021, the patient experienced MALAISE (feeling sick) (seriousness criteria death and hospitalization). On an unknown date, the patient experienced COVID-19 (COVID-19) (seriousness criterion death). The patient died on 05-Aug-2021. The reported cause of death was Covid-19. It is unknown if an autopsy was performed.  Concomitant product use was not provided by the reporter. Treatment medication was not provided by the reporter.  Patient started feeling sick on 13 Jul 2021 and was hospitalized a few days later. Patient was passed away on 05 Aug 2021 with a cause of Death of COVID-19.  Very limited information regarding this event/s has been provided at this time.  Further information has been requested. The causality for the event Covid-19 will be considered as "Not Applicable".; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested. The causality for the event Covid-19 will be considered as "Not Applicable"; Reported Cause(s) of Death: COVID-19
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Allergy test, Balance disorder, Lethargy, Vitamin D, Vitamin D decreased
Clinical narrative: Through May I continued to feel lethargic. / I was still feeling lethargic; was still feeling lethargic and off balance; Vitamin D level was checked and is low; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Through May I continued to feel lethargic. / I was still feeling lethargic), BALANCE DISORDER (was still feeling lethargic and off balance) and VITAMIN D DECREASED (Vitamin D level was checked and is low) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0481321A and 019B21A) for COVID-19 vaccination. No medical history was provided by the reporter.  Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication. On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-May-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 LETHARGY (Through May I continued to feel lethargic. I was still feeling lethargic) (seriousness criterion medically significant), BALANCE DISORDER (was still feeling lethargic and off balance) (seriousness criterion medically significant) and VITAMIN D DECREASED (Vitamin D level was checked and is low) (seriousness criterion medically significant). The patient was treated with COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) from 09-Jun-2021 to July 2021 at an unspecified dose and frequency and CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) from 09-Jun-2021 to July 2021 at an unspecified dose and frequency. At the time of the report, LETHARGY (Through May I continued to feel lethargic. I was still feeling lethargic) had not resolved and BALANCE DISORDER (was still feeling lethargic and off balance) and VITAMIN D DECREASED (Vitamin D level was checked and is low) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, Allergy test: not provided not provided. In May 2021, Vitamin D: decreased (Low) Decreased. No treatment medication details was provided. Other lab tests include Vitamin B test on ??-MAY-2021 and results are not provided. Company Comment: 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. Further information has been requested. This case was linked to MOD-2021-286509 (Patient Link). Reporter did not allow further contact; 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. Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: More than 35 days after the first dose without receiving the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 35 days after the first dose without receiving the second 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.    In March 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 PRODUCT DOSE OMISSION ISSUE (More than 35 days after the first dose without receiving the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 35 days after the first dose without receiving the second dose) 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 by the reporter.    Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: Back pain; This spontaneous case was reported by a patient and describes the occurrence of BACK PAIN (Back pain) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (Back pain). At the time of the report, BACK PAIN (Back pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were  provided. No Treatment information was  provided.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Hypersensitivity, Inappropriate schedule of product administration, Pruritus, Rash
Clinical narrative: Patient delayed receipt of second dose of Moderna COVID-19 vaccine past 35 days; She experienced a delayed allergic reaction; Patient developed shortness of breath; wheezing; full body rash; hives; itching; hives; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient delayed receipt of second dose of Moderna COVID-19 vaccine past 35 days), HYPERSENSITIVITY (She experienced a delayed allergic reaction), DYSPNOEA (Patient developed shortness of breath), WHEEZING (wheezing) and RASH (full body rash) in a female patient of an unknown age 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 Allergy.    On 02-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient delayed receipt of second dose of Moderna COVID-19 vaccine past 35 days), HYPERSENSITIVITY (She experienced a delayed allergic reaction), DYSPNOEA (Patient developed shortness of breath), WHEEZING (wheezing), RASH (full body rash), the first episode of URTICARIA (hives), PRURITUS (itching) and the second episode of URTICARIA (hives). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient delayed receipt of second dose of Moderna COVID-19 vaccine past 35 days) had resolved and HYPERSENSITIVITY (She experienced a delayed allergic reaction), DYSPNOEA (Patient developed shortness of breath), WHEEZING (wheezing), RASH (full body rash), PRURITUS (itching) and the last episode of URTICARIA (hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported. No treatment information was provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Wheezing
Clinical narrative: Patient delayed receipt of second dose of Moderna COVID-19 vaccine past 35 days; She experienced a delayed allergic reaction; Patient developed shortness of breath; wheezing; full body rash; hives; itching; hives; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient delayed receipt of second dose of Moderna COVID-19 vaccine past 35 days), HYPERSENSITIVITY (She experienced a delayed allergic reaction), DYSPNOEA (Patient developed shortness of breath), WHEEZING (wheezing) and RASH (full body rash) in a female patient of an unknown age 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 Allergy.    On 02-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient delayed receipt of second dose of Moderna COVID-19 vaccine past 35 days), HYPERSENSITIVITY (She experienced a delayed allergic reaction), DYSPNOEA (Patient developed shortness of breath), WHEEZING (wheezing), RASH (full body rash), the first episode of URTICARIA (hives), PRURITUS (itching) and the second episode of URTICARIA (hives). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient delayed receipt of second dose of Moderna COVID-19 vaccine past 35 days) had resolved and HYPERSENSITIVITY (She experienced a delayed allergic reaction), DYSPNOEA (Patient developed shortness of breath), WHEEZING (wheezing), RASH (full body rash), PRURITUS (itching) and the last episode of URTICARIA (hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported. No treatment information was provided by the reporter.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Eye irritation, Fatigue, Feeling abnormal, Headache, Lethargy
Clinical narrative: Lethargic; Injection site is hot; Could not get off the couch all day; There is big Knot on left side shoulder when she rubbed her arm; Eyes burning type like feeling; Fatigue; Slight headache; Feeling feverish; Achy; Bump or lump; Red; This spontaneous case was reported by an other health care professional and describes the occurrence of LETHARGY (Lethargic), VACCINATION SITE WARMTH (Injection site is hot), FEELING ABNORMAL (Could not get off the couch all day), SWELLING (There is big Knot on left side shoulder when she rubbed her arm) and EYE IRRITATION (Eyes burning type like feeling) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure. Concomitant products included OLMESARTAN, HIDROCLOROTIAZIDA and ACETYLSALICYLIC ACID (BAYER ASPIRIN) for Blood pressure.    On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LETHARGY (Lethargic), VACCINATION SITE WARMTH (Injection site is hot), FEELING ABNORMAL (Could not get off the couch all day), SWELLING (There is big Knot on left side shoulder when she rubbed her arm), EYE IRRITATION (Eyes burning type like feeling), FATIGUE (Fatigue), HEADACHE (Slight headache), PYREXIA (Feeling feverish), MYALGIA (Achy), VACCINATION SITE SWELLING (Bump or lump) and VACCINATION SITE ERYTHEMA (Red). At the time of the report, LETHARGY (Lethargic), VACCINATION SITE WARMTH (Injection site is hot), FEELING ABNORMAL (Could not get off the couch all day), SWELLING (There is big Knot on left side shoulder when she rubbed her arm), EYE IRRITATION (Eyes burning type like feeling), FATIGUE (Fatigue), HEADACHE (Slight headache), PYREXIA (Feeling feverish), MYALGIA (Achy), VACCINATION SITE SWELLING (Bump or lump) and VACCINATION SITE ERYTHEMA (Red) 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 treatment information was provided by the reporter.   This case was linked to MOD-2021-286515 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Swelling, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Lethargic; Injection site is hot; Could not get off the couch all day; There is big Knot on left side shoulder when she rubbed her arm; Eyes burning type like feeling; Fatigue; Slight headache; Feeling feverish; Achy; Bump or lump; Red; This spontaneous case was reported by an other health care professional and describes the occurrence of LETHARGY (Lethargic), VACCINATION SITE WARMTH (Injection site is hot), FEELING ABNORMAL (Could not get off the couch all day), SWELLING (There is big Knot on left side shoulder when she rubbed her arm) and EYE IRRITATION (Eyes burning type like feeling) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure. Concomitant products included OLMESARTAN, HIDROCLOROTIAZIDA and ACETYLSALICYLIC ACID (BAYER ASPIRIN) for Blood pressure.    On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LETHARGY (Lethargic), VACCINATION SITE WARMTH (Injection site is hot), FEELING ABNORMAL (Could not get off the couch all day), SWELLING (There is big Knot on left side shoulder when she rubbed her arm), EYE IRRITATION (Eyes burning type like feeling), FATIGUE (Fatigue), HEADACHE (Slight headache), PYREXIA (Feeling feverish), MYALGIA (Achy), VACCINATION SITE SWELLING (Bump or lump) and VACCINATION SITE ERYTHEMA (Red). At the time of the report, LETHARGY (Lethargic), VACCINATION SITE WARMTH (Injection site is hot), FEELING ABNORMAL (Could not get off the couch all day), SWELLING (There is big Knot on left side shoulder when she rubbed her arm), EYE IRRITATION (Eyes burning type like feeling), FATIGUE (Fatigue), HEADACHE (Slight headache), PYREXIA (Feeling feverish), MYALGIA (Achy), VACCINATION SITE SWELLING (Bump or lump) and VACCINATION SITE ERYTHEMA (Red) 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 treatment information was provided by the reporter.   This case was linked to MOD-2021-286515 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Lethargic; Injection site is hot; Could not get off the couch all day; There is big Knot on left side shoulder when she rubbed her arm; Eyes burning type like feeling; Fatigue; Slight headache; Feeling feverish; Achy; Bump or lump; Red; This spontaneous case was reported by an other health care professional and describes the occurrence of LETHARGY (Lethargic), VACCINATION SITE WARMTH (Injection site is hot), FEELING ABNORMAL (Could not get off the couch all day), SWELLING (There is big Knot on left side shoulder when she rubbed her arm) and EYE IRRITATION (Eyes burning type like feeling) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure. Concomitant products included OLMESARTAN, HIDROCLOROTIAZIDA and ACETYLSALICYLIC ACID (BAYER ASPIRIN) for Blood pressure.    On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LETHARGY (Lethargic), VACCINATION SITE WARMTH (Injection site is hot), FEELING ABNORMAL (Could not get off the couch all day), SWELLING (There is big Knot on left side shoulder when she rubbed her arm), EYE IRRITATION (Eyes burning type like feeling), FATIGUE (Fatigue), HEADACHE (Slight headache), PYREXIA (Feeling feverish), MYALGIA (Achy), VACCINATION SITE SWELLING (Bump or lump) and VACCINATION SITE ERYTHEMA (Red). At the time of the report, LETHARGY (Lethargic), VACCINATION SITE WARMTH (Injection site is hot), FEELING ABNORMAL (Could not get off the couch all day), SWELLING (There is big Knot on left side shoulder when she rubbed her arm), EYE IRRITATION (Eyes burning type like feeling), FATIGUE (Fatigue), HEADACHE (Slight headache), PYREXIA (Feeling feverish), MYALGIA (Achy), VACCINATION SITE SWELLING (Bump or lump) and VACCINATION SITE ERYTHEMA (Red) 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 treatment information was provided by the reporter.   This case was linked to MOD-2021-286515 (Patient Link).
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: Rash is only itchy in the area of his back; This then spread to his left back, around to his stomach area, and to his left leg; he first noticed a dark red, slightly raised rash on his right arm; Slightly raised rash on his right arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (he first noticed a dark red, slightly raised rash on his right arm), RASH PAPULAR (Slightly raised rash on his right arm), RASH PRURITIC (Rash is only itchy in the area of his back) and RASH (This then spread to his left back, around to his stomach area, and to his left leg) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 032M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jun-2021, the patient experienced RASH ERYTHEMATOUS (he first noticed a dark red, slightly raised rash on his right arm) and RASH PAPULAR (Slightly raised rash on his right arm). On an unknown date, the patient experienced RASH PRURITIC (Rash is only itchy in the area of his back) and RASH (This then spread to his left back, around to his stomach area, and to his left leg). The patient was treated with METHYLPREDNISOLONE (MEDROL [METHYLPREDNISOLONE]) for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, RASH ERYTHEMATOUS (he first noticed a dark red, slightly raised rash on his right arm), RASH PAPULAR (Slightly raised rash on his right arm), RASH PRURITIC (Rash is only itchy in the area of his back) and RASH (This then spread to his left back, around to his stomach area, and to his left leg) had not resolved.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: 6 days after receiving 2nd dose, patient was for positive covid; This spontaneous case was reported by an other health care professional and describes the occurrence of SARS-COV-2 TEST POSITIVE (6 days after receiving 2nd dose, patient was for positive covid) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SARS-COV-2 TEST POSITIVE (6 days after receiving 2nd dose, patient was for positive covid). At the time of the report, SARS-COV-2 TEST POSITIVE (6 days after receiving 2nd dose, patient was for positive covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Apr-2021, SARS-CoV-2 test: positive (Positive) patient was for positive COVID..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drugs was provided. No treatment drugs was provided by the reporter.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity, Vaccination site pain
Clinical narrative: Dead arm; soreness at vaccination site; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Dead arm), VACCINATION SITE PAIN (soreness at vaccination site) and PAIN IN EXTREMITY (sore arm) 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 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jul-2021, the patient experienced HYPOAESTHESIA (Dead arm), VACCINATION SITE PAIN (soreness at vaccination site) and PAIN IN EXTREMITY (sore arm). The patient was treated with ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (Dead arm), VACCINATION SITE PAIN (soreness at vaccination site) and PAIN IN EXTREMITY (sore arm) outcome was unknown.            No concomitant medications were reported by the reporter.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Loss of consciousness
Clinical narrative: Collapsed; Shortness of breath; This spontaneous case was reported by a patient and describes the occurrence of LOSS OF CONSCIOUSNESS (Collapsed) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Asthma (very mild asthma before.) and Anaphylaxis (Reportedly experienced anaphylaxis with certain drugs in the past. ). Concurrent medical conditions included Sulfonamide allergy, Bee sting hypersensitivity, Fruit allergy (Grapefruit) and Reaction to preservatives (preservatives like sodium nitrate or msg.).    On 19-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Aug-2021, the patient experienced DYSPNOEA (Shortness of breath). On 08-Aug-2021, the patient experienced LOSS OF CONSCIOUSNESS (Collapsed) (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (Collapsed) and DYSPNOEA (Shortness of breath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported by the reporter.  No treatment information was provided by the reporter. Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Chills, Erythema, Fatigue, Hyperhidrosis
Clinical narrative: Iching,I made it except for the itchy arm; a couple little bumps; Redness; Body had no energy whatsoever; Profuse night sweats first night and second night; Cold chills then burning up,Hands felt like they were on fire; slept almost 24 hour; Arm is red and itches tender to touch; Was extremely tired,exhausted; Cold chills then burning up; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Iching,I made it except for the itchy arm), SWELLING (a couple little bumps), ERYTHEMA (Redness), ASTHENIA (Body had no energy whatsoever) and HYPERHIDROSIS (Profuse night sweats first night and second night) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Bilateral pneumonia (Hospitalized for 6 days), Epilepsy (had epilepsy due to brain infection), Central nervous system infection NOS (Brain infection) and Neurosurgery (had 3 brain surgeries). Concurrent medical conditions included Drug allergy (multiple allergic to drugs). Concomitant products included HEPARIN for an unknown indication.   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 PRURITUS (Iching,I made it except for the itchy arm), SWELLING (a couple little bumps), ERYTHEMA (Redness), ASTHENIA (Body had no energy whatsoever), HYPERHIDROSIS (Profuse night sweats first night and second night), SKIN BURNING SENSATION (Cold chills then burning up,Hands felt like they were on fire), SOMNOLENCE (slept almost 24 hour), TENDERNESS (Arm is red and itches tender to touch), FATIGUE (Was extremely tired,exhausted) and CHILLS (Cold chills then burning up). The patient was treated with ALOE VERA ongoing since an unknown date for Itching, at an unspecified dose and frequency. At the time of the report, PRURITUS (Iching,I made it except for the itchy arm), SWELLING (a couple little bumps), ERYTHEMA (Redness), ASTHENIA (Body had no energy whatsoever), HYPERHIDROSIS (Profuse night sweats first night and second night), SKIN BURNING SENSATION (Cold chills then burning up,Hands felt like they were on fire), SOMNOLENCE (slept almost 24 hour), TENDERNESS (Arm is red and itches tender to touch), FATIGUE (Was extremely tired,exhausted) and CHILLS (Cold chills then burning up) outcome was unknown.            .
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Skin burning sensation, Somnolence, Swelling, Tenderness
Clinical narrative: Iching,I made it except for the itchy arm; a couple little bumps; Redness; Body had no energy whatsoever; Profuse night sweats first night and second night; Cold chills then burning up,Hands felt like they were on fire; slept almost 24 hour; Arm is red and itches tender to touch; Was extremely tired,exhausted; Cold chills then burning up; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Iching,I made it except for the itchy arm), SWELLING (a couple little bumps), ERYTHEMA (Redness), ASTHENIA (Body had no energy whatsoever) and HYPERHIDROSIS (Profuse night sweats first night and second night) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Bilateral pneumonia (Hospitalized for 6 days), Epilepsy (had epilepsy due to brain infection), Central nervous system infection NOS (Brain infection) and Neurosurgery (had 3 brain surgeries). Concurrent medical conditions included Drug allergy (multiple allergic to drugs). Concomitant products included HEPARIN for an unknown indication.   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 PRURITUS (Iching,I made it except for the itchy arm), SWELLING (a couple little bumps), ERYTHEMA (Redness), ASTHENIA (Body had no energy whatsoever), HYPERHIDROSIS (Profuse night sweats first night and second night), SKIN BURNING SENSATION (Cold chills then burning up,Hands felt like they were on fire), SOMNOLENCE (slept almost 24 hour), TENDERNESS (Arm is red and itches tender to touch), FATIGUE (Was extremely tired,exhausted) and CHILLS (Cold chills then burning up). The patient was treated with ALOE VERA ongoing since an unknown date for Itching, at an unspecified dose and frequency. At the time of the report, PRURITUS (Iching,I made it except for the itchy arm), SWELLING (a couple little bumps), ERYTHEMA (Redness), ASTHENIA (Body had no energy whatsoever), HYPERHIDROSIS (Profuse night sweats first night and second night), SKIN BURNING SENSATION (Cold chills then burning up,Hands felt like they were on fire), SOMNOLENCE (slept almost 24 hour), TENDERNESS (Arm is red and itches tender to touch), FATIGUE (Was extremely tired,exhausted) and CHILLS (Cold chills then burning up) outcome was unknown.            .
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Interchange of vaccine products
Clinical narrative: Moderna vaccine in February and did not get the second dose until 15Jul2021; first dose of the Pfizer covid-19 vaccine by injection in February /On 15JUL2021 they received a dose of the Moderna Covid19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna vaccine in February and did not get the second dose until 15Jul2021) and INTERCHANGE OF VACCINE PRODUCTS (first dose of the Pfizer covid-19 vaccine by injection in February /On 15JUL2021 they received a dose of the Moderna Covid19 vaccine) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033A21A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 15-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna vaccine in February and did not get the second dose until 15Jul2021) and INTERCHANGE OF VACCINE PRODUCTS (first dose of the Pfizer covid-19 vaccine by injection in February /On 15JUL2021 they received a dose of the Moderna Covid19 vaccine). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna vaccine in February and did not get the second dose until 15Jul2021) had resolved and INTERCHANGE OF VACCINE PRODUCTS (first dose of the Pfizer covid-19 vaccine by injection in February /On 15JUL2021 they received a dose of the Moderna Covid19 vaccine) outcome was unknown.        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 drugs were reported No treatment drugs were reported.  Patient received the first dose of the Moderna vaccine in February and did not get the second dose until 15Jul2021 lot # 033A21A.  Patient did not have the dose information or exact date the first dose was given.   Most recent FOLLOW-UP information incorporated above includes: On 13-Aug-2021: Significant follow-up received. Newevent added
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Body temperature, Chest pain, Chills, Dyspnoea
Clinical narrative: She had chest pain; She felt like she was filling up with fluids; She felt like she had pneumonia; She has been suffering from memory loss right after the fever issues; She had body aches; She had trouble breathing; She felt like she wanted to sleep; She was sweating and shivering at the same time; She had body racking chills within 24 hours of receiving 2nd dose; After 2nd dose, she had 102 fever that started within 24 hours and lasted for 5 days.; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (She had trouble breathing), SOMNOLENCE (She felt like she wanted to sleep), HYPERHIDROSIS (She was sweating and shivering at the same time), CHEST PAIN (She had chest pain) and FLUID OVERLOAD (She felt like she was filling up with fluids) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included GABAPENTIN, METOPROLOL, LOSARTAN, FLUOXETINE and ATORVASTATIN for an unknown indication.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced HYPERHIDROSIS (She was sweating and shivering at the same time), CHILLS (She had body racking chills within 24 hours of receiving 2nd dose) and PYREXIA (After 2nd dose, she had 102 fever that started within 24 hours and lasted for 5 days.). On an unknown date, the patient experienced DYSPNOEA (She had trouble breathing), SOMNOLENCE (She felt like she wanted to sleep), CHEST PAIN (She had chest pain), FLUID OVERLOAD (She felt like she was filling up with fluids), PLEURAL DISORDER (She felt like she had pneumonia), AMNESIA (She has been suffering from memory loss right after the fever issues) and MYALGIA (She had body aches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and PREDNISONE at an unspecified dose and frequency. On 03-May-2021, PYREXIA (After 2nd dose, she had 102 fever that started within 24 hours and lasted for 5 days.) outcome was unknown. At the time of the report, DYSPNOEA (She had trouble breathing), SOMNOLENCE (She felt like she wanted to sleep), HYPERHIDROSIS (She was sweating and shivering at the same time), CHEST PAIN (She had chest pain), FLUID OVERLOAD (She felt like she was filling up with fluids), PLEURAL DISORDER (She felt like she had pneumonia), AMNESIA (She has been suffering from memory loss right after the fever issues), MYALGIA (She had body aches) and CHILLS (She had body racking chills within 24 hours of receiving 2nd dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Apr-2021, Body temperature: 102 (High) body temperature.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Fluid overload, Hyperhidrosis, Myalgia, Pleural disorder, Pyrexia
Clinical narrative: She had chest pain; She felt like she was filling up with fluids; She felt like she had pneumonia; She has been suffering from memory loss right after the fever issues; She had body aches; She had trouble breathing; She felt like she wanted to sleep; She was sweating and shivering at the same time; She had body racking chills within 24 hours of receiving 2nd dose; After 2nd dose, she had 102 fever that started within 24 hours and lasted for 5 days.; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (She had trouble breathing), SOMNOLENCE (She felt like she wanted to sleep), HYPERHIDROSIS (She was sweating and shivering at the same time), CHEST PAIN (She had chest pain) and FLUID OVERLOAD (She felt like she was filling up with fluids) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included GABAPENTIN, METOPROLOL, LOSARTAN, FLUOXETINE and ATORVASTATIN for an unknown indication.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced HYPERHIDROSIS (She was sweating and shivering at the same time), CHILLS (She had body racking chills within 24 hours of receiving 2nd dose) and PYREXIA (After 2nd dose, she had 102 fever that started within 24 hours and lasted for 5 days.). On an unknown date, the patient experienced DYSPNOEA (She had trouble breathing), SOMNOLENCE (She felt like she wanted to sleep), CHEST PAIN (She had chest pain), FLUID OVERLOAD (She felt like she was filling up with fluids), PLEURAL DISORDER (She felt like she had pneumonia), AMNESIA (She has been suffering from memory loss right after the fever issues) and MYALGIA (She had body aches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and PREDNISONE at an unspecified dose and frequency. On 03-May-2021, PYREXIA (After 2nd dose, she had 102 fever that started within 24 hours and lasted for 5 days.) outcome was unknown. At the time of the report, DYSPNOEA (She had trouble breathing), SOMNOLENCE (She felt like she wanted to sleep), HYPERHIDROSIS (She was sweating and shivering at the same time), CHEST PAIN (She had chest pain), FLUID OVERLOAD (She felt like she was filling up with fluids), PLEURAL DISORDER (She felt like she had pneumonia), AMNESIA (She has been suffering from memory loss right after the fever issues), MYALGIA (She had body aches) and CHILLS (She had body racking chills within 24 hours of receiving 2nd dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Apr-2021, Body temperature: 102 (High) body temperature.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: She had chest pain; She felt like she was filling up with fluids; She felt like she had pneumonia; She has been suffering from memory loss right after the fever issues; She had body aches; She had trouble breathing; She felt like she wanted to sleep; She was sweating and shivering at the same time; She had body racking chills within 24 hours of receiving 2nd dose; After 2nd dose, she had 102 fever that started within 24 hours and lasted for 5 days.; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (She had trouble breathing), SOMNOLENCE (She felt like she wanted to sleep), HYPERHIDROSIS (She was sweating and shivering at the same time), CHEST PAIN (She had chest pain) and FLUID OVERLOAD (She felt like she was filling up with fluids) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included GABAPENTIN, METOPROLOL, LOSARTAN, FLUOXETINE and ATORVASTATIN for an unknown indication.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced HYPERHIDROSIS (She was sweating and shivering at the same time), CHILLS (She had body racking chills within 24 hours of receiving 2nd dose) and PYREXIA (After 2nd dose, she had 102 fever that started within 24 hours and lasted for 5 days.). On an unknown date, the patient experienced DYSPNOEA (She had trouble breathing), SOMNOLENCE (She felt like she wanted to sleep), CHEST PAIN (She had chest pain), FLUID OVERLOAD (She felt like she was filling up with fluids), PLEURAL DISORDER (She felt like she had pneumonia), AMNESIA (She has been suffering from memory loss right after the fever issues) and MYALGIA (She had body aches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and PREDNISONE at an unspecified dose and frequency. On 03-May-2021, PYREXIA (After 2nd dose, she had 102 fever that started within 24 hours and lasted for 5 days.) outcome was unknown. At the time of the report, DYSPNOEA (She had trouble breathing), SOMNOLENCE (She felt like she wanted to sleep), HYPERHIDROSIS (She was sweating and shivering at the same time), CHEST PAIN (She had chest pain), FLUID OVERLOAD (She felt like she was filling up with fluids), PLEURAL DISORDER (She felt like she had pneumonia), AMNESIA (She has been suffering from memory loss right after the fever issues), MYALGIA (She had body aches) and CHILLS (She had body racking chills within 24 hours of receiving 2nd dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Apr-2021, Body temperature: 102 (High) body temperature.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Thrombosis
Clinical narrative: She did not take the second dose yet; Blood clot in one my legs; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clot in one my legs) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020. Concomitant products included RIVAROXABAN (XARELTO) for an unknown indication.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, the patient experienced THROMBOSIS (Blood clot in one my legs) (seriousness criterion medically significant). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (She did not take the second dose yet). At the time of the report, THROMBOSIS (Blood clot in one my legs) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (She did not take the second dose yet) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not provided.  Patient had a blood clot in one of her legs in May-2021. She had to take blood thinners.  Company Comment - 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.  The patient has been on Xarelto and most likely have a condition that is prone to develop thrombosis even before vaccination. Unlikely, that the events are related to the vaccine. Further information is expected.; 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.  The patient has been on Xarelto and most likely have a condition that is prone to develop thrombosis even before vaccination. Unlikely, that the events are related to the vaccine. Further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Illness
Clinical narrative: started getting dizzy; I have been so sick; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (started getting dizzy) and ILLNESS (I have been so sick) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (started getting dizzy) and ILLNESS (I have been so sick). At the time of the report, DIZZINESS (started getting dizzy) and ILLNESS (I have been so sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Treatment information was not provided.  They kept telling her it was something else.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Muscle pain I got about 3 days after my second dose still persist three months later; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle pain I got about 3 days after my second dose still persist three months later) 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 MYALGIA (Muscle pain I got about 3 days after my second dose still persist three months later). At the time of the report, MYALGIA (Muscle pain I got about 3 days after my second dose still persist three months later) outcome was unknown.            No Concomitant Medications details were provided. No Treatment Medications details were provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Tested positive for covid-19 after first dose of the vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for covid-19 after first dose of the vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for covid-19 after first dose of the vaccine). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for covid-19 after first dose of the vaccine) 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) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided   Reporter did not allow further contact