chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiovascular disorder, Disturbance in attention, Dyspnoea, Feeling abnormal, Headache
Clinical narrative: Today I didn't go to work because I can't go like this, I cant drive to the work.; feeling as if I had my muscles stunted, without force.; started to feel my right hand that it didn't have any force, couldn't lift anything; deconcentrated; patient feels as missing breathing; patient had circulation tense and hard; difficult to make muslces react; headache; nausea; not feeling good and feel each time worse; feel it very tense; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (started to feel my right hand that it didn't have any force, couldn't lift anything), DISTURBANCE IN ATTENTION (deconcentrated), DYSPNOEA (patient feels as missing breathing), CARDIOVASCULAR DISORDER (patient had circulation tense and hard) and MUSCLE DISCOMFORT (difficult to make muslces react) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history were reported.     On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, the patient experienced MUSCULAR WEAKNESS (started to feel my right hand that it didn't have any force, couldn't lift anything), DISTURBANCE IN ATTENTION (deconcentrated), DYSPNOEA (patient feels as missing breathing), CARDIOVASCULAR DISORDER (patient had circulation tense and hard), MUSCLE DISCOMFORT (difficult to make muslces react), HEADACHE (headache), NAUSEA (nausea), FEELING ABNORMAL (not feeling good and feel each time worse) and TENSION (feel it very tense). On an unknown date, the patient experienced FEELING ABNORMAL (Today I didn't go to work because I can't go like this, I cant drive to the work.) and MUSCLE DISCOMFORT (feeling as if I had my muscles stunted, without force.). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MUSCULAR WEAKNESS (started to feel my right hand that it didn't have any force, couldn't lift anything), DISTURBANCE IN ATTENTION (deconcentrated), DYSPNOEA (patient feels as missing breathing), CARDIOVASCULAR DISORDER (patient had circulation tense and hard), MUSCLE DISCOMFORT (difficult to make muslces react), HEADACHE (headache), NAUSEA (nausea), FEELING ABNORMAL (not feeling good and feel each time worse), TENSION (feel it very tense), FEELING ABNORMAL (Today I didn't go to work because I can't go like this, I cant drive to the work.) and MUSCLE DISCOMFORT (feeling as if I had my muscles stunted, without force.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle discomfort, Muscular weakness, Nausea, Tension
Clinical narrative: Today I didn't go to work because I can't go like this, I cant drive to the work.; feeling as if I had my muscles stunted, without force.; started to feel my right hand that it didn't have any force, couldn't lift anything; deconcentrated; patient feels as missing breathing; patient had circulation tense and hard; difficult to make muslces react; headache; nausea; not feeling good and feel each time worse; feel it very tense; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (started to feel my right hand that it didn't have any force, couldn't lift anything), DISTURBANCE IN ATTENTION (deconcentrated), DYSPNOEA (patient feels as missing breathing), CARDIOVASCULAR DISORDER (patient had circulation tense and hard) and MUSCLE DISCOMFORT (difficult to make muslces react) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history were reported.     On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, the patient experienced MUSCULAR WEAKNESS (started to feel my right hand that it didn't have any force, couldn't lift anything), DISTURBANCE IN ATTENTION (deconcentrated), DYSPNOEA (patient feels as missing breathing), CARDIOVASCULAR DISORDER (patient had circulation tense and hard), MUSCLE DISCOMFORT (difficult to make muslces react), HEADACHE (headache), NAUSEA (nausea), FEELING ABNORMAL (not feeling good and feel each time worse) and TENSION (feel it very tense). On an unknown date, the patient experienced FEELING ABNORMAL (Today I didn't go to work because I can't go like this, I cant drive to the work.) and MUSCLE DISCOMFORT (feeling as if I had my muscles stunted, without force.). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MUSCULAR WEAKNESS (started to feel my right hand that it didn't have any force, couldn't lift anything), DISTURBANCE IN ATTENTION (deconcentrated), DYSPNOEA (patient feels as missing breathing), CARDIOVASCULAR DISORDER (patient had circulation tense and hard), MUSCLE DISCOMFORT (difficult to make muslces react), HEADACHE (headache), NAUSEA (nausea), FEELING ABNORMAL (not feeling good and feel each time worse), TENSION (feel it very tense), FEELING ABNORMAL (Today I didn't go to work because I can't go like this, I cant drive to the work.) and MUSCLE DISCOMFORT (feeling as if I had my muscles stunted, without force.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Interchange of vaccine products, Product administration error
Clinical narrative: 1st covid19 vaccine from dose Pfizer/2nd covid19 vaccine from moderna; 1st covid19 vaccine from dose Pfizer/2nd covid19 vaccine from moderna; allergy is in the legs, especially in the right leg/allergy increased after the moderna vaccination; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (1st covid19 vaccine from dose Pfizer/2nd covid19 vaccine from moderna), PRODUCT ADMINISTRATION ERROR (1st covid19 vaccine from dose Pfizer/2nd covid19 vaccine from moderna) and HYPERSENSITIVITY (allergy is in the legs, especially in the right leg/allergy increased after the moderna vaccination) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included to treat cholesterol and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (1st covid19 vaccine from dose Pfizer/2nd covid19 vaccine from moderna), PRODUCT ADMINISTRATION ERROR (1st covid19 vaccine from dose Pfizer/2nd covid19 vaccine from moderna) and HYPERSENSITIVITY (allergy is in the legs, especially in the right leg/allergy increased after the moderna vaccination). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (1st covid19 vaccine from dose Pfizer/2nd covid19 vaccine from moderna), PRODUCT ADMINISTRATION ERROR (1st covid19 vaccine from dose Pfizer/2nd covid19 vaccine from moderna) and HYPERSENSITIVITY (allergy is in the legs, especially in the right leg/allergy increased after the moderna vaccination) 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 treatment medication were reported.
Sex: F
Vaccine: COVID19
Symptoms: Bowel movement irregularity, Myalgia, Pain
Clinical narrative: Pain; Bowel movement changes; Normal aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), BOWEL MOVEMENT IRREGULARITY (Bowel movement changes) and MYALGIA (Normal aches) 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 PAIN (Pain), BOWEL MOVEMENT IRREGULARITY (Bowel movement changes) and MYALGIA (Normal aches). At the time of the report, PAIN (Pain) and MYALGIA (Normal aches) had resolved and BOWEL MOVEMENT IRREGULARITY (Bowel movement changes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  Treatment medication was not provided.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Tachycardia
Clinical narrative: Increased Heart Rate 130BPM; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Increased Heart Rate 130BPM) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Mar-2021, the patient experienced TACHYCARDIA (Increased Heart Rate 130BPM). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 08-Mar-2021, TACHYCARDIA (Increased Heart Rate 130BPM) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Mar-2021, Heart rate: 130 130 bpm.. On 08-Mar-2021, Heart rate: normal.         Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medication were reported.  All tests were reported normal.  The patient doesn't know the name of the second medicine received for treatment
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Hypoaesthesia, Malaise, Myalgia, Paraesthesia
Clinical narrative: Tingling; Pain in the bones; Hands and feet numb; Not feeling well; Pain all over the body; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling), BONE PAIN (Pain in the bones), HYPOAESTHESIA (Hands and feet numb), MALAISE (Not feeling well) and MYALGIA (Pain all over the body) 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 PARAESTHESIA (Tingling), BONE PAIN (Pain in the bones), HYPOAESTHESIA (Hands and feet numb), MALAISE (Not feeling well) and MYALGIA (Pain all over the body). At the time of the report, PARAESTHESIA (Tingling), BONE PAIN (Pain in the bones), HYPOAESTHESIA (Hands and feet numb), MALAISE (Not feeling well) and MYALGIA (Pain all over the body) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication were reported.  No treatment medication were reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Swelling
Clinical narrative: pink circular patch on her skin has gotten bigger since her second dose; pink circular patch on her skin has gotten bigger since her second dose; light fever; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (pink circular patch on her skin has gotten bigger since her second dose), RASH (pink circular patch on her skin has gotten bigger since her second dose) and PYREXIA (light fever) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Psoriasis, Granuloma annulare, Patchy rash and Allergic reaction to food. Concomitant products included PARACETAMOL (TYLENOL) for Pain, MAGNESIUM CARBONATE (MAGENSIUM VITAFIT) for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced PYREXIA (light fever). On an unknown date, the patient experienced SWELLING (pink circular patch on her skin has gotten bigger since her second dose) and RASH (pink circular patch on her skin has gotten bigger since her second dose). On 26-Feb-2021, PYREXIA (light fever) had resolved. At the time of the report, SWELLING (pink circular patch on her skin has gotten bigger since her second dose) and RASH (pink circular patch on her skin has gotten bigger since her second dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) 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 05-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the event was not applicable.  No Concomitant medication were reported.  No treatment medication were reported.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: Body aches; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches) and HEADACHE (Headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Body aches) and HEADACHE (Headache). At the time of the report, MYALGIA (Body aches) and HEADACHE (Headache) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No Concomitant medication were reported.  No treatment medication were reported.   This case was linked to MOD21-087488, US-MODERNATX, INC.-MOD-2021-109680 (E2B Linked Report).; Sender's Comments:  MOD21-087488:crosslink-wife US-MODERNATX, INC.-MOD-2021-109680:
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site reaction
Clinical narrative: Covid arm; Covid rash; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE REACTION (Covid arm) and RASH (Covid rash) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced VACCINATION SITE REACTION (Covid arm) and RASH (Covid rash). At the time of the report, VACCINATION SITE REACTION (Covid arm) and RASH (Covid rash) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment Unknown whether treatment was given
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered) 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 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication details were provided.  No concomitant medication details were provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: NNI
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Intentional product use issue
Clinical narrative: The patient is sick; considering administering second dose after 42 days; This spontaneous case was reported by a health care professional and describes the occurrence of ILLNESS (The patient is sick) and INTENTIONAL PRODUCT USE ISSUE (considering administering second dose after 42 days) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LISINOPRIL and AMLODIPINE for Blood pressure high and Heart disorder, ATORVASTATIN for Cholesterol blood excessive, ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (The patient is sick) and INTENTIONAL PRODUCT USE ISSUE (considering administering second dose after 42 days). At the time of the report, ILLNESS (The patient is sick) outcome was unknown and INTENTIONAL PRODUCT USE ISSUE (considering administering second dose after 42 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication also include Floraxatine.  No treatment information provided.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot, Hot flush, Pyrexia
Clinical narrative: so hot; hot flashes; Tiredness; High temperature; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (so hot), HOT FLUSH (hot flashes), FATIGUE (Tiredness) and PYREXIA (High temperature) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019021A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ROSUVASTATIN, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and METOPROLOL for an unknown indication.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced FEELING HOT (so hot), HOT FLUSH (hot flashes), FATIGUE (Tiredness) and PYREXIA (High temperature). At the time of the report, FEELING HOT (so hot), HOT FLUSH (hot flashes), FATIGUE (Tiredness) and PYREXIA (High temperature) 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 medication were reported.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Pyrexia, Vaccination site joint pain
Clinical narrative: Soreness after 2nd dose where vaccine was administered; Dizziness; Dizziness worst with 2nd dose; Chills; Fever of 100 F; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE JOINT PAIN (Soreness after 2nd dose where vaccine was administered), DIZZINESS (Dizziness), DIZZINESS (Dizziness worst with 2nd dose), CHILLS (Chills) and PYREXIA (Fever of 100 F) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included Vertigo. Concomitant products included CLONAZEPAM, PRAVASTATIN, IRBESARTAN and PANTOPRAZOLE for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE JOINT PAIN (Soreness after 2nd dose where vaccine was administered), DIZZINESS (Dizziness), DIZZINESS (Dizziness worst with 2nd dose), CHILLS (Chills) and PYREXIA (Fever of 100 F). The patient was treated with MECLIZINE HCL at a dose of 25 milligram. At the time of the report, VACCINATION SITE JOINT PAIN (Soreness after 2nd dose where vaccine was administered), DIZZINESS (Dizziness), DIZZINESS (Dizziness worst with 2nd dose), CHILLS (Chills) and PYREXIA (Fever of 100 F) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-109845 (Patient Link).
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: little bit of a fever, around 99.9; chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (little bit of a fever, around 99.9) and CHILLS (chills) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 036B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced PYREXIA (little bit of a fever, around 99.9) and CHILLS (chills). At the time of the report, PYREXIA (little bit of a fever, around 99.9) and CHILLS (chills) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.9 (Inconclusive) 99.9.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Age: 56.0
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 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced URTICARIA (Hives). At the time of the report, URTICARIA (Hives) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication were reported.  No treatment medication were reported.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Product dose omission issue
Clinical narrative: ill; can patient receive 2nd dose beyond the 42 days; This spontaneous case was reported by a nurse and describes the occurrence of ILLNESS (ill) and PRODUCT DOSE OMISSION ISSUE (can patient receive 2nd dose beyond the 42 days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-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 ILLNESS (ill) and PRODUCT DOSE OMISSION ISSUE (can patient receive 2nd dose beyond the 42 days). At the time of the report, ILLNESS (ill) and PRODUCT DOSE OMISSION ISSUE (can patient receive 2nd dose beyond the 42 days) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable. No Relevant concomitant medications was reported. Treatment information was not provided.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Ocular discomfort, Peripheral swelling, Product dose omission issue, Visual impairment
Clinical narrative: "right hand looked like it had a pillow on top of it" \  "fingers are puffy and it is hard to write"; puffy; "my vision seems to be messed up"; Patient did not get the second dose of the Moderna vaccine and doesn't plan to get it; "I am having a real bad time with my eyes"; This spontaneous case was reported by a nurse and describes the occurrence of PERIPHERAL SWELLING ("right hand looked like it had a pillow on top of it" \  "fingers are puffy and it is hard to write"), OCULAR DISCOMFORT ("I am having a real bad time with my eyes"), PERIPHERAL SWELLING (puffy), VISUAL IMPAIRMENT ("my vision seems to be messed up") and PRODUCT DOSE OMISSION ISSUE (Patient did not get the second dose of the Moderna vaccine and doesn't plan to get it) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced OCULAR DISCOMFORT ("I am having a real bad time with my eyes"), VISUAL IMPAIRMENT ("my vision seems to be messed up") and PRODUCT DOSE OMISSION ISSUE (Patient did not get the second dose of the Moderna vaccine and doesn't plan to get it). On an unknown date, the patient experienced PERIPHERAL SWELLING ("right hand looked like it had a pillow on top of it" \  "fingers are puffy and it is hard to write") and PERIPHERAL SWELLING (puffy). At the time of the report, PERIPHERAL SWELLING ("right hand looked like it had a pillow on top of it" \  "fingers are puffy and it is hard to write"), OCULAR DISCOMFORT ("I am having a real bad time with my eyes"), PERIPHERAL SWELLING (puffy), VISUAL IMPAIRMENT ("my vision seems to be messed up") and PRODUCT DOSE OMISSION ISSUE (Patient did not get the second dose of the Moderna vaccine and doesn't plan to get it) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient takes other medications but did not provide the names of the medications but stated she takes 3 for her heart, 1 for asthma,1 for bipolar, and 1 for pain.
Sex: U
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Vaccination complication
Clinical narrative: had side effects; had to take off work; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (had side effects) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (had to take off work) 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 VACCINATION COMPLICATION (had side effects) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (had to take off work). At the time of the report, VACCINATION COMPLICATION (had side effects) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (had to take off work) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use was unknown Treatment information was unknown   This case was linked to US-MODERNATX, INC.-MOD-2021-060935, US-MODERNATX, INC.-MOD-2021-060922 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-060935:Reporter 2 Dose case US-MODERNATX, INC.-MOD-2021-060922:Reporter 1 Dose case
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Did not receive second dose of Moderna COVID-19 vaccine after receiving first dose on) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0Z3MZOA) for COVID-19 vaccination. No Medical History information was reported. On 05-Mar-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 (Did not receive second dose of Moderna COVID-19 vaccine after receiving first dose on). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Did not receive second dose of Moderna COVID-19 vaccine after receiving first dose on) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication reported No treatment information was provided. Upon in internal review on 04-Aug-2021, the age was corrected to 66 years
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: left arm  flet sore and  heavy; light headaches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left arm  flet sore and  heavy) and HEADACHE (light headaches) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 038K20A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine and Headache. Concomitant products included PARACETAMOL (TYLENOL) for Headache, BLACK COHOSH [CIMICIFUGA RACEMOSA] for Hot flushes, ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN MIGRAINE) for Migraine, VITAMIN D [VITAMIN D NOS] and PANTOPRAZOLE for an unknown indication.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 07-Jan-2021, the patient experienced PAIN IN EXTREMITY (left arm  flet sore and  heavy) and HEADACHE (light headaches). At the time of the report, PAIN IN EXTREMITY (left arm  flet sore and  heavy) and HEADACHE (light headaches) outcome was unknown.            Treatment medications include Tylenol and Consulted Gynecologist for hot flushes, prescribed with: Black Cohosh 540mg capsule once a day. Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Follow up received on 7-jun-2021 had- No New Information.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling hot, Flushing
Clinical narrative: felt flushed; warm inside but no fever (T-98 something F); chills; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (felt flushed), FEELING HOT (warm inside but no fever (T-98 something F)), CHILLS (chills) and FATIGUE (tiredness) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced FLUSHING (felt flushed), FEELING HOT (warm inside but no fever (T-98 something F)), CHILLS (chills) and FATIGUE (tiredness). On 30-Apr-2021, FLUSHING (felt flushed), FEELING HOT (warm inside but no fever (T-98 something F)) and CHILLS (chills) had resolved. At the time of the report, FATIGUE (tiredness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-109489 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-109489:
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received first dose from a vial that was punctured on 3MAY2021) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.  No Medical History information was reported. On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received first dose from a vial that was punctured on 3MAY2021). On 06-May-2021, EXPIRED PRODUCT ADMINISTERED (patient received first dose from a vial that was punctured on 3MAY2021) had resolved. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. This case was linked to US-MODERNATX, INC.-MOD-2021-109454 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow-up information  received on  13 May 2021 contains information regarding  they miss reported this as a Moderna Vaccine administration but it was actually J&J.; Sender's Comments: US-MODERNATX, INC.-MOD-2021-109454:
Sex: F
Vaccine: COVID19
Symptoms: Conjunctival hyperaemia
Clinical narrative: bloody eye; This spontaneous case was reported by a consumer and describes the occurrence of CONJUNCTIVAL HYPERAEMIA (bloody eye) 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 05-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced CONJUNCTIVAL HYPERAEMIA (bloody eye). At the time of the report, CONJUNCTIVAL HYPERAEMIA (bloody eye) outcome was unknown.            No concomitant medications were reported. No treatment information was provided.  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.; 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: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Pruritus, Rash, Urticaria
Clinical narrative: Hives; Itchy; Full body rashes; Missed 2nd dose, recommended interval; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (Itchy), URTICARIA (Hives), PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose, recommended interval) and RASH (Full body rashes) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) 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 23-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose, recommended interval). On 09-Apr-2021, the patient experienced PRURITUS (Itchy) and RASH (Full body rashes). On 27-Apr-2021, the patient experienced URTICARIA (Hives). At the time of the report, PRURITUS (Itchy), URTICARIA (Hives), PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose, recommended interval) and RASH (Full body rashes) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. The patient was treated with antibiotics and prednisone.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Fatigue, Headache, Nausea
Clinical narrative: Cough; Fever; Fatigue; Headache; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), PYREXIA (Fever), FATIGUE (Fatigue), HEADACHE (Headache) and CHILLS (Chills) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, the patient experienced COUGH (Cough), PYREXIA (Fever), FATIGUE (Fatigue), HEADACHE (Headache), CHILLS (Chills) and NAUSEA (Nausea). At the time of the report, COUGH (Cough), PYREXIA (Fever), FATIGUE (Fatigue), HEADACHE (Headache), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment information was not provided.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Cough; Fever; Fatigue; Headache; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), PYREXIA (Fever), FATIGUE (Fatigue), HEADACHE (Headache) and CHILLS (Chills) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, the patient experienced COUGH (Cough), PYREXIA (Fever), FATIGUE (Fatigue), HEADACHE (Headache), CHILLS (Chills) and NAUSEA (Nausea). At the time of the report, COUGH (Cough), PYREXIA (Fever), FATIGUE (Fatigue), HEADACHE (Headache), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment information was not provided.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Vaccination site pain
Clinical narrative: Vaccination site pain; bruising of the arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) and CONTUSION (bruising of the arm) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included RIVAROXABAN (XARELTO), CARVEDILOL, DILTIAZEM and ESTRADIOL, NORETHISTERONE ACETATE (ACTIVELLA) for an unknown indication.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Vaccination site pain) and CONTUSION (bruising of the arm). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) and CONTUSION (bruising of the arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral
Clinical narrative: feeling numbness in roof of mouth; feeling numbness in lips; feeling numbness in tounge; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (feeling numbness in roof of mouth), HYPOAESTHESIA ORAL (feeling numbness in lips) and HYPOAESTHESIA ORAL (feeling numbness in tounge) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced HYPOAESTHESIA ORAL (feeling numbness in roof of mouth), HYPOAESTHESIA ORAL (feeling numbness in lips) and HYPOAESTHESIA ORAL (feeling numbness in tounge). At the time of the report, HYPOAESTHESIA ORAL (feeling numbness in roof of mouth), HYPOAESTHESIA ORAL (feeling numbness in lips) and HYPOAESTHESIA ORAL (feeling numbness in tounge) outcome was unknown.            Concomitant medications were not provided.   This case was linked to MOD-2021-047443 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Vaccination site pain; Slight fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) and PYREXIA (Slight fever) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included Granuloma annulare. Concomitant products included CORTISONE for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain) and PYREXIA (Slight fever). On 12-Feb-2021, PYREXIA (Slight fever) had resolved. On 14-Feb-2021, VACCINATION SITE PAIN (Vaccination site pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were also include oral antihistamines. Treatment details include self administration of topical cortisone and oral antihistamines. Patient prefers phone or physical mail contact, as she does not have an email address. Patient consents to follow-up with safety.Patient agreeable to speaking to her physician.   This case was linked to MOD-2021-109686 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Contusion, Fatigue, Headache, Hot flush
Clinical narrative: More headache; On the left arm between the elbow and shoulder a very blue with circle bruise was noted; hot flushes; chills; very high fever around 103F; fatigue; cold/a little bit chilly; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold/a little bit chilly), HOT FLUSH (hot flushes), CHILLS (chills), FATIGUE (fatigue) and HEADACHE (More headache) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included PARACETAMOL (TYLENOL 8 HOUR) for Headache, ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN MIGRAINE) for Migraine, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), CIMICIFUGA RACEMOSA ROOT, GLYCINE MAX EXTRACT (BLACK COHOSH & SOY ISOFLAVONES) and PANTOPRAZOLE for an unknown indication.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced NASOPHARYNGITIS (cold/a little bit chilly) and FATIGUE (fatigue). On 03-Feb-2021, the patient experienced CHILLS (chills) and PYREXIA (very high fever around 103F). On 16-Feb-2021, the patient experienced HOT FLUSH (hot flushes). On 04-May-2021, the patient experienced HEADACHE (More headache) and CONTUSION (On the left arm between the elbow and shoulder a very blue with circle bruise was noted). At the time of the report, NASOPHARYNGITIS (cold/a little bit chilly), HOT FLUSH (hot flushes), CHILLS (chills), FATIGUE (fatigue), HEADACHE (More headache), PYREXIA (very high fever around 103F) and CONTUSION (On the left arm between the elbow and shoulder a very blue with circle bruise was noted) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details were :Took Tylenol for fever, icepack for headache and consulted Gynecologist for hot flushes and was prescribed with Black cohosh 540 mg capsule once a day   This case was linked to US-MODERNATX, INC.-MOD-2021-109635 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-109635:Original Case : MOD-2021-109635