chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, Device connection issue
Clinical narrative: Patient received a little of over half; Syringe was defeating while giving the second dose/ The seal broke after pushing the plunger; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received a little of over half) and DEVICE CONNECTION ISSUE (Syringe was defeating while giving the second dose/ The seal broke after pushing the plunger) in an 18-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 27-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced ACCIDENTAL UNDERDOSE (Patient received a little of over half). 27-Apr-2021, the patient experienced DEVICE CONNECTION ISSUE (Syringe was defeating while giving the second dose/ The seal broke after pushing the plunger). At the time of the report, ACCIDENTAL UNDERDOSE (Patient received a little of over half) and DEVICE CONNECTION ISSUE (Syringe was defeating while giving the second dose/ The seal broke after pushing the plunger) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no concomitant medicine Pharmacist calling to report an adverse event. Syringe was defeating while giving the second dose. The seal broke after pushing the plunger. Pharmacist believe patient received a little of over half.  Patient received the vaccine in the right arm in the muscle. Patient received the second dose on 27APR2021 and the lot number is 048B21A. Patient is not taking other medication.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain, Pain in extremity
Clinical narrative: Severe Pain in the neck; Severe Pain in the neck; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Severe Pain in the neck), PAIN IN EXTREMITY (sore arm) and ARTHRALGIA (Severe Pain in the neck) 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 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 19-Apr-2021, the patient experienced NECK PAIN (Severe Pain in the neck) and ARTHRALGIA (Severe Pain in the neck). On 10-Apr-2021, PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, NECK PAIN (Severe Pain in the neck) and ARTHRALGIA (Severe Pain in the neck) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-092524 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-092524:Cross linked case
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chest discomfort, Chest pain, Diarrhoea, Dizziness
Clinical narrative: diarrhea; sore throat; lightheadedness; chest discomfort; Shortness of breath; chest pain; Stomach cramps; This spontaneous case was reported by an other health care professional and describes the occurrence of DYSPNOEA (Shortness of breath), CHEST PAIN (chest pain), ABDOMINAL PAIN UPPER (Stomach cramps), DIARRHOEA (diarrhea) and OROPHARYNGEAL PAIN (sore throat) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Pulmonary arterial hypertension. Concomitant products included TREPROSTINIL SODIUM from 13-Jun-2019 to an unknown date for Secondary pulmonary arterial hypertension, SILDENAFIL CITRATE (SILDENAFIL CRISTERS) for an unknown indication.   On 17-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced DYSPNOEA (Shortness of breath), CHEST PAIN (chest pain) and ABDOMINAL PAIN UPPER (Stomach cramps). On an unknown date, the patient experienced DIARRHOEA (diarrhea), OROPHARYNGEAL PAIN (sore throat), DIZZINESS (lightheadedness) and CHEST DISCOMFORT (chest discomfort). At the time of the report, DYSPNOEA (Shortness of breath), CHEST PAIN (chest pain), ABDOMINAL PAIN UPPER (Stomach cramps), DIARRHOEA (diarrhea), OROPHARYNGEAL PAIN (sore throat), DIZZINESS (lightheadedness) and CHEST DISCOMFORT (chest discomfort) 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.   The treatment information was unknown. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Oropharyngeal pain
Clinical narrative: diarrhea; sore throat; lightheadedness; chest discomfort; Shortness of breath; chest pain; Stomach cramps; This spontaneous case was reported by an other health care professional and describes the occurrence of DYSPNOEA (Shortness of breath), CHEST PAIN (chest pain), ABDOMINAL PAIN UPPER (Stomach cramps), DIARRHOEA (diarrhea) and OROPHARYNGEAL PAIN (sore throat) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Pulmonary arterial hypertension. Concomitant products included TREPROSTINIL SODIUM from 13-Jun-2019 to an unknown date for Secondary pulmonary arterial hypertension, SILDENAFIL CITRATE (SILDENAFIL CRISTERS) for an unknown indication.   On 17-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced DYSPNOEA (Shortness of breath), CHEST PAIN (chest pain) and ABDOMINAL PAIN UPPER (Stomach cramps). On an unknown date, the patient experienced DIARRHOEA (diarrhea), OROPHARYNGEAL PAIN (sore throat), DIZZINESS (lightheadedness) and CHEST DISCOMFORT (chest discomfort). At the time of the report, DYSPNOEA (Shortness of breath), CHEST PAIN (chest pain), ABDOMINAL PAIN UPPER (Stomach cramps), DIARRHOEA (diarrhea), OROPHARYNGEAL PAIN (sore throat), DIZZINESS (lightheadedness) and CHEST DISCOMFORT (chest discomfort) 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.   The treatment information was unknown. Action taken with mRNA-1273 in response to the event was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test
Clinical narrative: Positive for COVID-19 soon after 1st doseCOVID-19; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Positive for COVID-19 soon after 1st doseCOVID-19) 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 COVID-19 (Positive for COVID-19 soon after 1st doseCOVID-19). At the time of the report, COVID-19 (Positive for COVID-19 soon after 1st doseCOVID-19) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: unknown (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information was provided.  Patient is due for the 2nd dose on 30Apr2021 and has been symptom free since 20Apr2021
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Malaise, Somnolence, Vaccination site rash
Clinical narrative: slept much of the afternoon; Extremely tired; had chills through the night; Did not feel well; Rash under the injection site; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Did not feel well), SOMNOLENCE (slept much of the afternoon), VACCINATION SITE RASH (Rash under the injection site), FATIGUE (Extremely tired) and CHILLS (had chills through the night) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 016M204) for COVID-19 vaccination.     Concurrent medical conditions included Iodine allergy and Allergy to plants (Allergy to poison oak).   On 11-Feb-2021 at 9:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021 at 9:15 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE RASH (Rash under the injection site). On 12-Mar-2021, the patient experienced MALAISE (Did not feel well), FATIGUE (Extremely tired) and CHILLS (had chills through the night). On 13-Mar-2021, the patient experienced SOMNOLENCE (slept much of the afternoon). On 14-Mar-2021, MALAISE (Did not feel well), SOMNOLENCE (slept much of the afternoon), VACCINATION SITE RASH (Rash under the injection site), FATIGUE (Extremely tired) and CHILLS (had chills through the night) had resolved.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.  The action taken with mRNA with the events was considered as not applicable.   This case was linked to MOD-2021-018361, MOD-2021-018361 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Aug-2021: Follow-up was received on 11-AUG-2021 and Relevant history added. Site of vaccine administration updated for dose 2. Onset latency updated.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Eosinophil count, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Red rash with no blisters that started under her left breast Red rash that covered 70% of the body; Itchy rash; it burns; This spontaneous case was reported by a health care professional and describes the occurrence of RASH ERYTHEMATOUS (Red rash with no blisters that started under her left breast Red rash that covered 70% of the body), RASH PRURITIC (Itchy rash) and RASH (it burns) in a 68-year-old female patient who received mRNA-1273 (batch nos. 046B21A and 030A21A) for COVID-19 vaccine.     No medical history was provided by the reporter.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Intramuscular) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced RASH ERYTHEMATOUS (Red rash with no blisters that started under her left breast Red rash that covered 70% of the body), RASH PRURITIC (Itchy rash) and RASH (it burns). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency and PREDNISONE at an unspecified dose and frequency. At the time of the report, RASH ERYTHEMATOUS (Red rash with no blisters that started under her left breast Red rash that covered 70% of the body), RASH PRURITIC (Itchy rash) and RASH (it burns) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Eosinophil count: (High) Eosinophil count 150-170; Lab normal count reported as 50. Patient denies eosinophil disease.     For mRNA-1273 (Intramuscular), the reporter did not provide any causality assessments.   Treatment included Benadryl and hydrocortisone cream 2.5% which did not resolve the symptoms. Patient's doctor prescribed prednisone and patient is on second day taking prednisone. Patient reports the rash is fading but the itching and burning are still present. No concomitant medications were reported. Action taken with mRNA-123 is not applicable.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dizziness, Feeding disorder, Feeling abnormal, Headache
Clinical narrative: Feel so bad; Sickness; Symptoms are unbearable; Cannot eat; Progressively getting worse with terrible nausea/ nausea; Terrible headache / severe headache; Feeling sick; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling sick), DIZZINESS (Dizziness), FEELING ABNORMAL (Feel so bad), ILLNESS (Sickness) and CONDITION AGGRAVATED (Symptoms are unbearable) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by reporter.  Concomitant products included SAW PALMETTO [SERENOA REPENS] and COLLAGEN for an unknown indication.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced MALAISE (Feeling sick), DIZZINESS (Dizziness), NAUSEA (Progressively getting worse with terrible nausea/ nausea) and HEADACHE (Terrible headache / severe headache). On an unknown date, the patient experienced FEELING ABNORMAL (Feel so bad), ILLNESS (Sickness), CONDITION AGGRAVATED (Symptoms are unbearable) and FEEDING DISORDER (Cannot eat). At the time of the report, MALAISE (Feeling sick), DIZZINESS (Dizziness), FEELING ABNORMAL (Feel so bad), ILLNESS (Sickness), CONDITION AGGRAVATED (Symptoms are unbearable), FEEDING DISORDER (Cannot eat), NAUSEA (Progressively getting worse with terrible nausea/ nausea) and HEADACHE (Terrible headache / severe headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were provided by reporter.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Malaise, Nausea
Clinical narrative: Feel so bad; Sickness; Symptoms are unbearable; Cannot eat; Progressively getting worse with terrible nausea/ nausea; Terrible headache / severe headache; Feeling sick; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling sick), DIZZINESS (Dizziness), FEELING ABNORMAL (Feel so bad), ILLNESS (Sickness) and CONDITION AGGRAVATED (Symptoms are unbearable) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by reporter.  Concomitant products included SAW PALMETTO [SERENOA REPENS] and COLLAGEN for an unknown indication.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced MALAISE (Feeling sick), DIZZINESS (Dizziness), NAUSEA (Progressively getting worse with terrible nausea/ nausea) and HEADACHE (Terrible headache / severe headache). On an unknown date, the patient experienced FEELING ABNORMAL (Feel so bad), ILLNESS (Sickness), CONDITION AGGRAVATED (Symptoms are unbearable) and FEEDING DISORDER (Cannot eat). At the time of the report, MALAISE (Feeling sick), DIZZINESS (Dizziness), FEELING ABNORMAL (Feel so bad), ILLNESS (Sickness), CONDITION AGGRAVATED (Symptoms are unbearable), FEEDING DISORDER (Cannot eat), NAUSEA (Progressively getting worse with terrible nausea/ nausea) and HEADACHE (Terrible headache / severe headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were provided by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: hives; itching; 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 URTICARIA (hives) and PRURITUS (itching) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (hives) and PRURITUS (itching). At the time of the report, URTICARIA (hives) and PRURITUS (itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment drug was reported.   Reporter did not allow further contact
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Myalgia, Pain in extremity
Clinical narrative: pain on a hand; joint pain; body pain; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain on a hand), ARTHRALGIA (joint pain), MYALGIA (body pain) and HEADACHE (headache) in a 38-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 immunization.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Apr-2021, the patient experienced PAIN IN EXTREMITY (pain on a hand), ARTHRALGIA (joint pain), MYALGIA (body pain) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (pain on a hand), ARTHRALGIA (joint pain), MYALGIA (body pain) and HEADACHE (headache) outcome was unknown.            Treatment information not reported. No concomitant medications reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Erythema, Pruritus, Urticaria
Clinical narrative: Redness and hives and itchiness on face, chest and lips; Redness and hives and itchiness on face, chest and lips; Redness and hives and itchiness on face, chest and lips; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness and hives and itchiness on face, chest and lips), URTICARIA (Redness and hives and itchiness on face, chest and lips), PRURITUS (Redness and hives and itchiness on face, chest and lips) and DIARRHOEA (Diarrhea) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ZILEUTON and HYDROXYZINE for Allergy.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced ERYTHEMA (Redness and hives and itchiness on face, chest and lips), URTICARIA (Redness and hives and itchiness on face, chest and lips), PRURITUS (Redness and hives and itchiness on face, chest and lips) and DIARRHOEA (Diarrhea). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 16-Mar-2021 for Hives, at an unspecified dose and frequency and LOPERAMIDE for Diarrhea, at an unspecified dose and frequency. On 16-Mar-2021, ERYTHEMA (Redness and hives and itchiness on face, chest and lips), URTICARIA (Redness and hives and itchiness on face, chest and lips) and PRURITUS (Redness and hives and itchiness on face, chest and lips) had resolved. On 23-Mar-2021, DIARRHOEA (Diarrhea) had resolved.            No medical history was provided. The patient experienced redness and hives and itchiness on face, chest and lips, right after the dose that she had to take 4 diphenhydramine capsules with 45 minutes of each other on 16-Mar-2021 and loperamide for one week for diarrhea.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia, Renal pain, Vaccination site pain
Clinical narrative: Severe Kidney pain; slight fever; Sore arm at injection site; Headache; This spontaneous case was reported by a consumer and describes the occurrence of RENAL PAIN (Severe Kidney pain), HEADACHE (Headache), PYREXIA (slight fever) and VACCINATION SITE PAIN (Sore arm at injection site) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     Concomitant products included MONTELUKAST, ATORVASTATIN, MELOXICAM, DULOXETINE, CYCLOBENZAPRINE, LORAZEPAM, OMEPRAZOLE, ARIPIPRAZOLE and GABAPENTIN for an unknown indication.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, the patient experienced HEADACHE (Headache). On 30-Apr-2021, the patient experienced RENAL PAIN (Severe Kidney pain), PYREXIA (slight fever) and VACCINATION SITE PAIN (Sore arm at injection site). At the time of the report, RENAL PAIN (Severe Kidney pain), HEADACHE (Headache), PYREXIA (slight fever) and VACCINATION SITE PAIN (Sore arm at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications reported.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Menstrual disorder, Nausea
Clinical narrative: rash at the injection site; rash is red, raised, covered from shoulder down to elbow, warm to touch; period stopped; very tired; lightheaded; slight fever 99.2F; nausea; headache; pain and sore arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (very tired), DIZZINESS (lightheaded), PYREXIA (slight fever 99.2F), NAUSEA (nausea) and HEADACHE (headache) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.  Concomitant products included LEVOTHYROXINE for an unknown indication.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced FATIGUE (very tired), DIZZINESS (lightheaded), PYREXIA (slight fever 99.2F), NAUSEA (nausea), HEADACHE (headache) and VACCINATION SITE PAIN (pain and sore arm at the injection site). On an unknown date, the patient experienced VACCINATION SITE RASH (rash at the injection site), RASH ERYTHEMATOUS (rash is red, raised, covered from shoulder down to elbow, warm to touch) and MENSTRUAL DISORDER (period stopped). The patient was treated with NAPROXEN at an unspecified dose and frequency and TRIAMCINOLONE at an unspecified dose and frequency. At the time of the report, FATIGUE (very tired), DIZZINESS (lightheaded), PYREXIA (slight fever 99.2F), NAUSEA (nausea), HEADACHE (headache), VACCINATION SITE PAIN (pain and sore arm at the injection site), VACCINATION SITE RASH (rash at the injection site), RASH ERYTHEMATOUS (rash is red, raised, covered from shoulder down to elbow, warm to touch) and MENSTRUAL DISORDER (period stopped) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash erythematous, Vaccination site pain, Vaccination site rash
Clinical narrative: rash at the injection site; rash is red, raised, covered from shoulder down to elbow, warm to touch; period stopped; very tired; lightheaded; slight fever 99.2F; nausea; headache; pain and sore arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (very tired), DIZZINESS (lightheaded), PYREXIA (slight fever 99.2F), NAUSEA (nausea) and HEADACHE (headache) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.  Concomitant products included LEVOTHYROXINE for an unknown indication.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced FATIGUE (very tired), DIZZINESS (lightheaded), PYREXIA (slight fever 99.2F), NAUSEA (nausea), HEADACHE (headache) and VACCINATION SITE PAIN (pain and sore arm at the injection site). On an unknown date, the patient experienced VACCINATION SITE RASH (rash at the injection site), RASH ERYTHEMATOUS (rash is red, raised, covered from shoulder down to elbow, warm to touch) and MENSTRUAL DISORDER (period stopped). The patient was treated with NAPROXEN at an unspecified dose and frequency and TRIAMCINOLONE at an unspecified dose and frequency. At the time of the report, FATIGUE (very tired), DIZZINESS (lightheaded), PYREXIA (slight fever 99.2F), NAUSEA (nausea), HEADACHE (headache), VACCINATION SITE PAIN (pain and sore arm at the injection site), VACCINATION SITE RASH (rash at the injection site), RASH ERYTHEMATOUS (rash is red, raised, covered from shoulder down to elbow, warm to touch) and MENSTRUAL DISORDER (period stopped) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Urticaria, Vaccination site erythema, Vaccination site induration
Clinical narrative: Hives; Itching at the injection site; Red at injection site; Itching and swelling at the injection site; Hardness at injection site; Itchy; "COVID arm"; Swollen arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION ("COVID arm"), PERIPHERAL SWELLING (Swollen arm), URTICARIA (Hives), PRURITUS (Itchy) and VACCINATION SITE PRURITUS (Itching at the injection site) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ROSUVASTATIN and HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL HCTZ) for an unknown indication.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced VACCINATION SITE REACTION ("COVID arm"), PERIPHERAL SWELLING (Swollen arm), PRURITUS (Itchy), VACCINATION SITE INDURATION (Hardness at injection site) and VACCINATION SITE SWELLING (Itching and swelling at the injection site). On an unknown date, the patient experienced URTICARIA (Hives), VACCINATION SITE PRURITUS (Itching at the injection site) and VACCINATION SITE ERYTHEMA (Red at injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) from 10-Apr-2021 to 12-Apr-2021 for Adverse event, at a dose of 1 dosage form. On 12-Apr-2021, VACCINATION SITE SWELLING (Itching and swelling at the injection site) had resolved. On 14-Apr-2021, VACCINATION SITE REACTION ("COVID arm"), PERIPHERAL SWELLING (Swollen arm), PRURITUS (Itchy) and VACCINATION SITE INDURATION (Hardness at injection site) had resolved. On 17-Apr-2021, URTICARIA (Hives), VACCINATION SITE PRURITUS (Itching at the injection site) and VACCINATION SITE ERYTHEMA (Red at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Other Treatment for the event included anti-itch cream.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Patient demographics were updated.Concomitant products includeLisinopril/ttz,Rosuvastatin were added.Events Urticaria,Itching at injection site,swelling at injection site,Red at injection site were added
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site reaction, Vaccination site swelling
Clinical narrative: Hives; Itching at the injection site; Red at injection site; Itching and swelling at the injection site; Hardness at injection site; Itchy; "COVID arm"; Swollen arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION ("COVID arm"), PERIPHERAL SWELLING (Swollen arm), URTICARIA (Hives), PRURITUS (Itchy) and VACCINATION SITE PRURITUS (Itching at the injection site) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ROSUVASTATIN and HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL HCTZ) for an unknown indication.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced VACCINATION SITE REACTION ("COVID arm"), PERIPHERAL SWELLING (Swollen arm), PRURITUS (Itchy), VACCINATION SITE INDURATION (Hardness at injection site) and VACCINATION SITE SWELLING (Itching and swelling at the injection site). On an unknown date, the patient experienced URTICARIA (Hives), VACCINATION SITE PRURITUS (Itching at the injection site) and VACCINATION SITE ERYTHEMA (Red at injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) from 10-Apr-2021 to 12-Apr-2021 for Adverse event, at a dose of 1 dosage form. On 12-Apr-2021, VACCINATION SITE SWELLING (Itching and swelling at the injection site) had resolved. On 14-Apr-2021, VACCINATION SITE REACTION ("COVID arm"), PERIPHERAL SWELLING (Swollen arm), PRURITUS (Itchy) and VACCINATION SITE INDURATION (Hardness at injection site) had resolved. On 17-Apr-2021, URTICARIA (Hives), VACCINATION SITE PRURITUS (Itching at the injection site) and VACCINATION SITE ERYTHEMA (Red at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Other Treatment for the event included anti-itch cream.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Patient demographics were updated.Concomitant products includeLisinopril/ttz,Rosuvastatin were added.Events Urticaria,Itching at injection site,swelling at injection site,Red at injection site were added
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: nausea; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea) in a female patient of an unknown age who received mRNA-1273 for COVID-19 vaccination.     No medical history reported.     On an unknown date, the patient received dose of mRNA-1273 (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced NAUSEA (nausea). At the time of the report, NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Intramuscular) was unknown.       No concomitant medication listed.    Reporter did not allow further contact
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Pain, Swelling
Clinical narrative: Pain; Swollen; On right arm she has a 3 inch long and 2 inches wide lymph nodes that is painful and swollen.; On right arm she has a 3 inch long and 2 inches wide lymph nodes that is swollen.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), SWELLING (Swollen), LYMPH NODE PAIN (On right arm she has a 3 inch long and 2 inches wide lymph nodes that is painful and swollen.) and LYMPHADENOPATHY (On right arm she has a 3 inch long and 2 inches wide lymph nodes that is swollen.) in a 56-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch nos. 048B21A and 017B21A) for COVID-19 vaccine.     No medical history was provided by the reporter.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Pain), SWELLING (Swollen), LYMPH NODE PAIN (On right arm she has a 3 inch long and 2 inches wide lymph nodes that is painful and swollen.) and LYMPHADENOPATHY (On right arm she has a 3 inch long and 2 inches wide lymph nodes that is swollen.). At the time of the report, PAIN (Pain), SWELLING (Swollen), LYMPH NODE PAIN (On right arm she has a 3 inch long and 2 inches wide lymph nodes that is painful and swollen.) and LYMPHADENOPATHY (On right arm she has a 3 inch long and 2 inches wide lymph nodes that is swollen.) outcome was unknown.            no concomitant details reported. no treatment details reported.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Dyspnoea, Pharyngeal swelling
Clinical narrative: difficulty breathing; felt her throat swelling; felt uncomfortable; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (difficulty breathing), PHARYNGEAL SWELLING (felt her throat swelling) and DISCOMFORT (felt uncomfortable) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-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 DYSPNOEA (difficulty breathing), PHARYNGEAL SWELLING (felt her throat swelling) and DISCOMFORT (felt uncomfortable). On 02-Apr-2021, DYSPNOEA (difficulty breathing), PHARYNGEAL SWELLING (felt her throat swelling) and DISCOMFORT (felt uncomfortable) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cough, Diarrhoea, Headache, Malaise
Clinical narrative: cough; diarrhea; Feeling very, very weak; affecting throat; nausea; Bad headache; Fever of 103.4F; Feeling not good, feeling really sick; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling not good, feeling really sick), COUGH (cough), DIARRHOEA (diarrhea), ASTHENIA (Feeling very, very weak) and OROPHARYNGEAL DISCOMFORT (affecting throat) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included PANTOPRAZOLE, SERTRALINE, ROSUVASTATIN and LEVOTHYROXINE SODIUM (EUTHYROX) for an unknown indication.    On 23-Apr-2021 at 4:20 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, the patient experienced MALAISE (Feeling not good, feeling really sick). On 29-Apr-2021, the patient experienced COUGH (cough), DIARRHOEA (diarrhea), ASTHENIA (Feeling very, very weak), OROPHARYNGEAL DISCOMFORT (affecting throat), NAUSEA (nausea), HEADACHE (Bad headache) and PYREXIA (Fever of 103.4F). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, MALAISE (Feeling not good, feeling really sick), COUGH (cough), DIARRHOEA (diarrhea), ASTHENIA (Feeling very, very weak), OROPHARYNGEAL DISCOMFORT (affecting throat), NAUSEA (nausea), HEADACHE (Bad headache) and PYREXIA (Fever of 103.4F) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment included  lots of fluids
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Oropharyngeal discomfort, Pyrexia
Clinical narrative: cough; diarrhea; Feeling very, very weak; affecting throat; nausea; Bad headache; Fever of 103.4F; Feeling not good, feeling really sick; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling not good, feeling really sick), COUGH (cough), DIARRHOEA (diarrhea), ASTHENIA (Feeling very, very weak) and OROPHARYNGEAL DISCOMFORT (affecting throat) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included PANTOPRAZOLE, SERTRALINE, ROSUVASTATIN and LEVOTHYROXINE SODIUM (EUTHYROX) for an unknown indication.    On 23-Apr-2021 at 4:20 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, the patient experienced MALAISE (Feeling not good, feeling really sick). On 29-Apr-2021, the patient experienced COUGH (cough), DIARRHOEA (diarrhea), ASTHENIA (Feeling very, very weak), OROPHARYNGEAL DISCOMFORT (affecting throat), NAUSEA (nausea), HEADACHE (Bad headache) and PYREXIA (Fever of 103.4F). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, MALAISE (Feeling not good, feeling really sick), COUGH (cough), DIARRHOEA (diarrhea), ASTHENIA (Feeling very, very weak), OROPHARYNGEAL DISCOMFORT (affecting throat), NAUSEA (nausea), HEADACHE (Bad headache) and PYREXIA (Fever of 103.4F) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment included  lots of fluids
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain
Clinical narrative: Pain in injected arm; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of   in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 062B20A) for an unknown indication.     No Medical History information was reported.   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.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-101947 (Patient Link).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain
Clinical narrative: Sore arm at injection site; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) and INJECTION SITE PAIN (Sore arm at injection site) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included GLIPIZIDE, ATORVASTATIN, LISINOPRIL, AMLODIPINE, BUPROPION, TRAZODONE, FENOFIBRATE, MONTELUKAST and FLUTICASONE for an unknown indication.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, the patient experienced FATIGUE (Fatigue). On 30-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INJECTION SITE PAIN (Sore arm at injection site). At the time of the report, FATIGUE (Fatigue) outcome was unknown and INJECTION SITE PAIN (Sore arm at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient and their husband both received their first dose of vaccine together and their husband had some symptoms as well.  Treatment medication used for the event soreness at the vaccination site included Tylenol.   This case was linked to MOD-2021-100569 (E2B Linked Report).; Sender's Comments:  MOD-2021-100569:Husband's case
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Dizziness, Injection site pain, Lethargy
Clinical narrative: was really dizzy; that was because of my nervousness; lips were tingly; was lethargic the whole week.; pain where I got the shot; chills; week later, I had fever; glandular pain under my arm; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (was really dizzy), NERVOUSNESS (that was because of my nervousness), PARAESTHESIA (lips were tingly), AXILLARY PAIN (glandular pain under my arm) and LETHARGY (was lethargic the whole week.) in a 43-year-old female patient who received mRNA-1273 (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced DIZZINESS (was really dizzy), NERVOUSNESS (that was because of my nervousness), PARAESTHESIA (lips were tingly) and LETHARGY (was lethargic the whole week.). In March 2021, the patient experienced AXILLARY PAIN (glandular pain under my arm), INJECTION SITE PAIN (pain where I got the shot), CHILLS (chills) and PYREXIA (week later, I had fever). At the time of the report, DIZZINESS (was really dizzy), NERVOUSNESS (that was because of my nervousness), PARAESTHESIA (lips were tingly), AXILLARY PAIN (glandular pain under my arm), LETHARGY (was lethargic the whole week.), INJECTION SITE PAIN (pain where I got the shot), CHILLS (chills) and PYREXIA (week later, I had fever) outcome was unknown.        The action taken with mRNA-1273 (Intramuscular) was unknown.   For mRNA-1273 (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided. Treatment information was not  provided.  A week later, patient experienced fever, chills, glandular pain under arm and where the shot was and lethargic the whole week. Allergist recommended not to get the second shot and recommended to get J&J. But then J&J got discontinued. So now, Is it okay to get the second Moderna vaccine since passed the timeframe
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Nervousness, Paraesthesia, Pyrexia
Clinical narrative: was really dizzy; that was because of my nervousness; lips were tingly; was lethargic the whole week.; pain where I got the shot; chills; week later, I had fever; glandular pain under my arm; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (was really dizzy), NERVOUSNESS (that was because of my nervousness), PARAESTHESIA (lips were tingly), AXILLARY PAIN (glandular pain under my arm) and LETHARGY (was lethargic the whole week.) in a 43-year-old female patient who received mRNA-1273 (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced DIZZINESS (was really dizzy), NERVOUSNESS (that was because of my nervousness), PARAESTHESIA (lips were tingly) and LETHARGY (was lethargic the whole week.). In March 2021, the patient experienced AXILLARY PAIN (glandular pain under my arm), INJECTION SITE PAIN (pain where I got the shot), CHILLS (chills) and PYREXIA (week later, I had fever). At the time of the report, DIZZINESS (was really dizzy), NERVOUSNESS (that was because of my nervousness), PARAESTHESIA (lips were tingly), AXILLARY PAIN (glandular pain under my arm), LETHARGY (was lethargic the whole week.), INJECTION SITE PAIN (pain where I got the shot), CHILLS (chills) and PYREXIA (week later, I had fever) outcome was unknown.        The action taken with mRNA-1273 (Intramuscular) was unknown.   For mRNA-1273 (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided. Treatment information was not  provided.  A week later, patient experienced fever, chills, glandular pain under arm and where the shot was and lethargic the whole week. Allergist recommended not to get the second shot and recommended to get J&J. But then J&J got discontinued. So now, Is it okay to get the second Moderna vaccine since passed the timeframe
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Pain, Pyrexia
Clinical narrative: This spontaneous case reported by an other healthcare professional, describes the occurrence of pain (body ache), injection site pain (sore at injection site), fatigue and pyrexia (fever of 100ºF) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# unknown) for COVID-19 immunization. No medical history reported. On Apr 29, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Apr 30, 2021, patient experienced pain (body ache), injection site pain (sore at injection site), fatigue and pyrexia (fever of 100ºF). Patient treated with Tylenol (paracetamol), at an unspecified dose and frequency. At the time of the report, pain (body ache), injection site pain (sore at injection site), fatigue and pyrexia (fever of 100ºF) outcome: unknown. The reporter did not provide any causality assessments or concomitant medications. Action taken with mRNA-1273 in response to the event: not applicable.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysstasia, Feeling abnormal, Hypotension, Nausea
Clinical narrative: Vertigo; Felt extremely dizzy, Light headedness; Severely nauseous; Extreme hypotension with blood pressure of 90-52 mmHg; stand up slowly; Not feeling like her self; This spontaneous case was reported by an other health care professional and describes the occurrence of VERTIGO (Vertigo), DIZZINESS (Felt extremely dizzy, Light headedness), NAUSEA (Severely nauseous), HYPOTENSION (Extreme hypotension with blood pressure of 90-52 mmHg) and DYSSTASIA (stand up slowly) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced VERTIGO (Vertigo), DIZZINESS (Felt extremely dizzy, Light headedness), NAUSEA (Severely nauseous), HYPOTENSION (Extreme hypotension with blood pressure of 90-52 mmHg), DYSSTASIA (stand up slowly) and FEELING ABNORMAL (Not feeling like her self). On 02-Apr-2021, VERTIGO (Vertigo) had resolved. On 06-Apr-2021, DIZZINESS (Felt extremely dizzy, Light headedness), NAUSEA (Severely nauseous), HYPOTENSION (Extreme hypotension with blood pressure of 90-52 mmHg), DYSSTASIA (stand up slowly) and FEELING ABNORMAL (Not feeling like her self) 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.   No concomitant medicines were reported. Treatment information included the Over the counter medicines and anti-nausea medication.