chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Myalgia
Clinical narrative: Soreness in breast area; Myalgia; This spontaneous case was reported by a consumer and describes the occurrence of BREAST PAIN (Soreness in breast area) and MYALGIA (Myalgia) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BREAST PAIN (Soreness in breast area) and MYALGIA (Myalgia). At the time of the report, BREAST PAIN (Soreness in breast area) and MYALGIA (Myalgia) outcome was unknown.            No concomitant medications were provided by the reporter. No treatment details were provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature increased, Bone pain, Headache
Clinical narrative: Fever; Bone pain; still have some pain in head; This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE INCREASED (Fever), BONE PAIN (Bone pain) and HEADACHE (still have some pain in head) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced BODY TEMPERATURE INCREASED (Fever), BONE PAIN (Bone pain) and HEADACHE (still have some pain in head). At the time of the report, BODY TEMPERATURE INCREASED (Fever) and BONE PAIN (Bone pain) outcome was unknown and HEADACHE (still have some pain in head) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       This case was linked to MOD-2021-216289 (Patient Link).   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: involuntary tremors of upper and lower extremities post his 2nd dose of Moderna Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (involuntary tremors of upper and lower extremities post his 2nd dose of Moderna Vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TREMOR (involuntary tremors of upper and lower extremities post his 2nd dose of Moderna Vaccine). At the time of the report, TREMOR (involuntary tremors of upper and lower extremities post his 2nd dose of Moderna Vaccine) outcome was unknown.            No concomitant medication were provided No treatment medication were provided
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Candida infection, Dehydration, Feeling abnormal, Palpitations, Rash
Clinical narrative: feeling worse; dehydration; palpitation; candida; rash; kidney issue; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feeling worse), DEHYDRATION (dehydration), PALPITATIONS (palpitation), CANDIDA INFECTION (candida) and RASH (rash) in a 79-year-old male 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (feeling worse), DEHYDRATION (dehydration), PALPITATIONS (palpitation), CANDIDA INFECTION (candida), RASH (rash) and RENAL DISORDER (kidney issue). At the time of the report, FEELING ABNORMAL (feeling worse), DEHYDRATION (dehydration), PALPITATIONS (palpitation), CANDIDA INFECTION (candida), RASH (rash) and RENAL DISORDER (kidney issue) outcome was unknown.            No
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Renal disorder
Clinical narrative: feeling worse; dehydration; palpitation; candida; rash; kidney issue; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feeling worse), DEHYDRATION (dehydration), PALPITATIONS (palpitation), CANDIDA INFECTION (candida) and RASH (rash) in a 79-year-old male 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (feeling worse), DEHYDRATION (dehydration), PALPITATIONS (palpitation), CANDIDA INFECTION (candida), RASH (rash) and RENAL DISORDER (kidney issue). At the time of the report, FEELING ABNORMAL (feeling worse), DEHYDRATION (dehydration), PALPITATIONS (palpitation), CANDIDA INFECTION (candida), RASH (rash) and RENAL DISORDER (kidney issue) outcome was unknown.            No
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: pretty severe arm pain; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pretty severe arm pain) and FATIGUE (fatigue) 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 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-May-2021, the patient experienced VACCINATION SITE PAIN (pretty severe arm pain) and FATIGUE (fatigue). On 24-May-2021, VACCINATION SITE PAIN (pretty severe arm pain) and FATIGUE (fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided. List of concomitant medication were not given.   This case was linked to MOD-2021-260056 (Patient Link).
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Expired product administered, Headache, Vaccination site pain
Clinical narrative: Headache; Chills; arm soreness; The dose was given on the 34th day after the vial was thawed; This spontaneous case was reported by a health care professional and describes the occurrence of HEADACHE (Headache), CHILLS (Chills), VACCINATION SITE PAIN (arm soreness) and EXPIRED PRODUCT ADMINISTERED (The dose was given on the 34th day after the vial was thawed) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The dose was given on the 34th day after the vial was thawed). On an unknown date, the patient experienced HEADACHE (Headache), CHILLS (Chills) and VACCINATION SITE PAIN (arm soreness). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache), CHILLS (Chills) and VACCINATION SITE PAIN (arm soreness) outcome was unknown and EXPIRED PRODUCT ADMINISTERED (The dose was given on the 34th day after the vial was thawed) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant product were reported  On 19-JUL-2021 updated query given as event. on 19-JUL-2021 updated query has resolved   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow up received on 19-JUL-2021 and does not contain any new information On 07-Aug-2021: Non-significant follow-up received on 07-AUG-2021.contact information updated ,Patient demographic was added.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache
Clinical narrative: chills; exhaustion; headache; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (chills), FATIGUE (exhaustion) and HEADACHE (headache) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009021a and 054c21a) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHILLS (chills), FATIGUE (exhaustion) and HEADACHE (headache). At the time of the report, CHILLS (chills) and HEADACHE (headache) outcome was unknown and FATIGUE (exhaustion) had not resolved.            No Concomitant and  treatment medications were provided.    This case was linked to MOD-2021-261508 (Patient Link).
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nasopharyngitis, Oropharyngeal pain, Pain, Rhinorrhoea
Clinical narrative: cold-like symptoms; runny nose; Body aches; sore throat; soreness in the right arm; This spontaneous case was reported by a patient and describes the occurrence of NASOPHARYNGITIS (cold-like symptoms), RHINORRHOEA (runny nose), PAIN (Body aches), OROPHARYNGEAL PAIN (sore throat) and MYALGIA (soreness in the right arm) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 078C21A and 041B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Jun-2021, the patient experienced MYALGIA (soreness in the right arm). On 18-Jul-2021, the patient experienced NASOPHARYNGITIS (cold-like symptoms), RHINORRHOEA (runny nose), PAIN (Body aches) and OROPHARYNGEAL PAIN (sore throat). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, NASOPHARYNGITIS (cold-like symptoms), RHINORRHOEA (runny nose), PAIN (Body aches), OROPHARYNGEAL PAIN (sore throat) and MYALGIA (soreness in the right arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   This case was linked to MOD-2021-261598 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody, Antinuclear antibody increased, Asthenia, Blood pressure increased, Blood pressure measurement
Clinical narrative: could not even walk; really sick for about 3 months; Short of breath; both their legs swelled up; really bad cough; extremely weak; getting worse and worse; caused their blood pressure to elevate; elevated ANA; first dose of the Moderna vaccine on 15Feb2021 and no second dose yet; gets tired easy/ can barely walk a mile; This spontaneous case was reported by a consumer and describes the occurrence of GAIT INABILITY (could not even walk), ILLNESS (really sick for about 3 months), DYSPNOEA (Short of breath), PERIPHERAL SWELLING (both their legs swelled up) and COUGH (really bad cough) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ALBUTEROL [SALBUTAMOL] for Seasonal asthma, COLECALCIFEROL (VITAMIN D3) and VITAMIN B12 NOS for an unknown indication.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GAIT INABILITY (could not even walk), ILLNESS (really sick for about 3 months), DYSPNOEA (Short of breath), PERIPHERAL SWELLING (both their legs swelled up), COUGH (really bad cough), ASTHENIA (extremely weak), CONDITION AGGRAVATED (getting worse and worse), BLOOD PRESSURE INCREASED (caused their blood pressure to elevate), ANTINUCLEAR ANTIBODY INCREASED (elevated ANA), PRODUCT DOSE OMISSION ISSUE (first dose of the Moderna vaccine on 15Feb2021 and no second dose yet) and FATIGUE (gets tired easy/ can barely walk a mile). The patient was treated with AMOXICILLIN at a dose of 1 dosage form and PREDNISONE at a dose of 1 dosage form. At the time of the report, GAIT INABILITY (could not even walk), ILLNESS (really sick for about 3 months), DYSPNOEA (Short of breath), PERIPHERAL SWELLING (both their legs swelled up), COUGH (really bad cough), ASTHENIA (extremely weak), CONDITION AGGRAVATED (getting worse and worse), BLOOD PRESSURE INCREASED (caused their blood pressure to elevate), ANTINUCLEAR ANTIBODY INCREASED (elevated ANA), PRODUCT DOSE OMISSION ISSUE (first dose of the Moderna vaccine on 15Feb2021 and no second dose yet) and FATIGUE (gets tired easy/ can barely walk a mile) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antinuclear antibody: elevated (High) elevated. On an unknown date, Blood pressure measurement: high (High) increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product include high blood pressure medication. Pulmonary doctor prescribed an inhaler to use twice a day. Pulmonary doctor referred the patient to a rheumatologist.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Cough, Dyspnoea, Fatigue, Gait inability
Clinical narrative: could not even walk; really sick for about 3 months; Short of breath; both their legs swelled up; really bad cough; extremely weak; getting worse and worse; caused their blood pressure to elevate; elevated ANA; first dose of the Moderna vaccine on 15Feb2021 and no second dose yet; gets tired easy/ can barely walk a mile; This spontaneous case was reported by a consumer and describes the occurrence of GAIT INABILITY (could not even walk), ILLNESS (really sick for about 3 months), DYSPNOEA (Short of breath), PERIPHERAL SWELLING (both their legs swelled up) and COUGH (really bad cough) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ALBUTEROL [SALBUTAMOL] for Seasonal asthma, COLECALCIFEROL (VITAMIN D3) and VITAMIN B12 NOS for an unknown indication.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GAIT INABILITY (could not even walk), ILLNESS (really sick for about 3 months), DYSPNOEA (Short of breath), PERIPHERAL SWELLING (both their legs swelled up), COUGH (really bad cough), ASTHENIA (extremely weak), CONDITION AGGRAVATED (getting worse and worse), BLOOD PRESSURE INCREASED (caused their blood pressure to elevate), ANTINUCLEAR ANTIBODY INCREASED (elevated ANA), PRODUCT DOSE OMISSION ISSUE (first dose of the Moderna vaccine on 15Feb2021 and no second dose yet) and FATIGUE (gets tired easy/ can barely walk a mile). The patient was treated with AMOXICILLIN at a dose of 1 dosage form and PREDNISONE at a dose of 1 dosage form. At the time of the report, GAIT INABILITY (could not even walk), ILLNESS (really sick for about 3 months), DYSPNOEA (Short of breath), PERIPHERAL SWELLING (both their legs swelled up), COUGH (really bad cough), ASTHENIA (extremely weak), CONDITION AGGRAVATED (getting worse and worse), BLOOD PRESSURE INCREASED (caused their blood pressure to elevate), ANTINUCLEAR ANTIBODY INCREASED (elevated ANA), PRODUCT DOSE OMISSION ISSUE (first dose of the Moderna vaccine on 15Feb2021 and no second dose yet) and FATIGUE (gets tired easy/ can barely walk a mile) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antinuclear antibody: elevated (High) elevated. On an unknown date, Blood pressure measurement: high (High) increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product include high blood pressure medication. Pulmonary doctor prescribed an inhaler to use twice a day. Pulmonary doctor referred the patient to a rheumatologist.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Peripheral swelling, Product dose omission issue
Clinical narrative: could not even walk; really sick for about 3 months; Short of breath; both their legs swelled up; really bad cough; extremely weak; getting worse and worse; caused their blood pressure to elevate; elevated ANA; first dose of the Moderna vaccine on 15Feb2021 and no second dose yet; gets tired easy/ can barely walk a mile; This spontaneous case was reported by a consumer and describes the occurrence of GAIT INABILITY (could not even walk), ILLNESS (really sick for about 3 months), DYSPNOEA (Short of breath), PERIPHERAL SWELLING (both their legs swelled up) and COUGH (really bad cough) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ALBUTEROL [SALBUTAMOL] for Seasonal asthma, COLECALCIFEROL (VITAMIN D3) and VITAMIN B12 NOS for an unknown indication.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GAIT INABILITY (could not even walk), ILLNESS (really sick for about 3 months), DYSPNOEA (Short of breath), PERIPHERAL SWELLING (both their legs swelled up), COUGH (really bad cough), ASTHENIA (extremely weak), CONDITION AGGRAVATED (getting worse and worse), BLOOD PRESSURE INCREASED (caused their blood pressure to elevate), ANTINUCLEAR ANTIBODY INCREASED (elevated ANA), PRODUCT DOSE OMISSION ISSUE (first dose of the Moderna vaccine on 15Feb2021 and no second dose yet) and FATIGUE (gets tired easy/ can barely walk a mile). The patient was treated with AMOXICILLIN at a dose of 1 dosage form and PREDNISONE at a dose of 1 dosage form. At the time of the report, GAIT INABILITY (could not even walk), ILLNESS (really sick for about 3 months), DYSPNOEA (Short of breath), PERIPHERAL SWELLING (both their legs swelled up), COUGH (really bad cough), ASTHENIA (extremely weak), CONDITION AGGRAVATED (getting worse and worse), BLOOD PRESSURE INCREASED (caused their blood pressure to elevate), ANTINUCLEAR ANTIBODY INCREASED (elevated ANA), PRODUCT DOSE OMISSION ISSUE (first dose of the Moderna vaccine on 15Feb2021 and no second dose yet) and FATIGUE (gets tired easy/ can barely walk a mile) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antinuclear antibody: elevated (High) elevated. On an unknown date, Blood pressure measurement: high (High) increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product include high blood pressure medication. Pulmonary doctor prescribed an inhaler to use twice a day. Pulmonary doctor referred the patient to a rheumatologist.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Urticaria
Clinical narrative: Hives (on right arm); Redness (on left arm); This spontaneous case was reported by a patient family member or friend and describes the occurrence of URTICARIA (Hives (on right arm)) and ERYTHEMA (Redness (on left arm)) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jul-2021, the patient experienced URTICARIA (Hives (on right arm)) and ERYTHEMA (Redness (on left arm)). At the time of the report, URTICARIA (Hives (on right arm)) and ERYTHEMA (Redness (on left arm)) 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.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Erythema, Heart rate, Rash
Clinical narrative: another red area next to the injection site; Red area on arm at injection site; rash on neck, chest and arms,; This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (another red area next to the injection site), RASH (rash on neck, chest and arms,) and VACCINATION SITE ERYTHEMA (Red area on arm at injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 022M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergy to Sulfa drug). Concomitant products included LOVASTATIN for Cholesterol.   On 23-Feb-2021 at 8:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021 at 8:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (rash on neck, chest and arms,). On an unknown date, the patient experienced ERYTHEMA (another red area next to the injection site) and VACCINATION SITE ERYTHEMA (Red area on arm at injection site). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) on 22-Apr-2021 at a dose of 1 dosage form once a day; CETIRIZINE HYDROCHLORIDE (ZYRTEK) on 22-Apr-2021 at a dose of 1 dosage form once a day; MONTELUKAST SODIUM (SINGULAIR) on 22-Apr-2021 at a dose of 1 dosage form once a day and PREDNISONE from 27-Mar-2021 to 12-May-2021 at an unspecified dose and frequency. At the time of the report, ERYTHEMA (another red area next to the injection site), RASH (rash on neck, chest and arms,) and VACCINATION SITE ERYTHEMA (Red area on arm at injection site) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Mar-2021, Blood pressure measurement: 175-98 mmHg. On 27-Mar-2021, Body temperature: 97.8 degree Fahrenheit. On 27-Mar-2021, Heart rate: 86 beats per minute.         On 22-Apr-2021 lab test, Mast cell tryptase  was done. Other treatment medication include Benedryl.   This case was linked to MOD-2021-263012 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: another red area next to the injection site; Red area on arm at injection site; rash on neck, chest and arms,; This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (another red area next to the injection site), RASH (rash on neck, chest and arms,) and VACCINATION SITE ERYTHEMA (Red area on arm at injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 022M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergy to Sulfa drug). Concomitant products included LOVASTATIN for Cholesterol.   On 23-Feb-2021 at 8:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021 at 8:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (rash on neck, chest and arms,). On an unknown date, the patient experienced ERYTHEMA (another red area next to the injection site) and VACCINATION SITE ERYTHEMA (Red area on arm at injection site). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) on 22-Apr-2021 at a dose of 1 dosage form once a day; CETIRIZINE HYDROCHLORIDE (ZYRTEK) on 22-Apr-2021 at a dose of 1 dosage form once a day; MONTELUKAST SODIUM (SINGULAIR) on 22-Apr-2021 at a dose of 1 dosage form once a day and PREDNISONE from 27-Mar-2021 to 12-May-2021 at an unspecified dose and frequency. At the time of the report, ERYTHEMA (another red area next to the injection site), RASH (rash on neck, chest and arms,) and VACCINATION SITE ERYTHEMA (Red area on arm at injection site) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Mar-2021, Blood pressure measurement: 175-98 mmHg. On 27-Mar-2021, Body temperature: 97.8 degree Fahrenheit. On 27-Mar-2021, Heart rate: 86 beats per minute.         On 22-Apr-2021 lab test, Mast cell tryptase  was done. Other treatment medication include Benedryl.   This case was linked to MOD-2021-263012 (Patient Link).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Bone pain, Bone scan, Chills
Clinical narrative: Headache; Bodyaches; Nausea; Vomiting; Osteoporosis; Bone Pain; Joint Pain; Fever; Chills; This spontaneous case was reported by a patient and describes the occurrence of OSTEOPOROSIS (Osteoporosis), BONE PAIN (Bone Pain), ARTHRALGIA (Joint Pain), PYREXIA (Fever) and CHILLS (Chills) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure increased (Controlled by medications) since 2008, High cholesterol (Controlled by medications) since 2008 and Acid reflux (esophageal) (controlled by medcations) since 2008. Concomitant products included FLUOXETINE HCL, PANTOPRAZOLE, ATORVASTATIN, METOPROLOL and VALACYCLOVIR [VALACICLOVIR] for an unknown indication.   On 03-Mar-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 03-Mar-2021, the patient experienced OSTEOPOROSIS (Osteoporosis), BONE PAIN (Bone Pain), ARTHRALGIA (Joint Pain), PYREXIA (Fever) and CHILLS (Chills). On an unknown date, the patient experienced HEADACHE (Headache), MYALGIA (Bodyaches), NAUSEA (Nausea) and VOMITING (Vomiting). The patient was treated with ZOLEDRONIC ACID (RECLAST) for Osteoporosis, at an unspecified dose and frequency. On 03-Jun-2021, BONE PAIN (Bone Pain) had resolved. At the time of the report, OSTEOPOROSIS (Osteoporosis), ARTHRALGIA (Joint Pain), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache), MYALGIA (Bodyaches), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal normal. On an unknown date, Bone scan: abnormal (abnormal) Significant osteoporosis.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Osteoporosis, Pyrexia
Clinical narrative: Headache; Bodyaches; Nausea; Vomiting; Osteoporosis; Bone Pain; Joint Pain; Fever; Chills; This spontaneous case was reported by a patient and describes the occurrence of OSTEOPOROSIS (Osteoporosis), BONE PAIN (Bone Pain), ARTHRALGIA (Joint Pain), PYREXIA (Fever) and CHILLS (Chills) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure increased (Controlled by medications) since 2008, High cholesterol (Controlled by medications) since 2008 and Acid reflux (esophageal) (controlled by medcations) since 2008. Concomitant products included FLUOXETINE HCL, PANTOPRAZOLE, ATORVASTATIN, METOPROLOL and VALACYCLOVIR [VALACICLOVIR] for an unknown indication.   On 03-Mar-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 03-Mar-2021, the patient experienced OSTEOPOROSIS (Osteoporosis), BONE PAIN (Bone Pain), ARTHRALGIA (Joint Pain), PYREXIA (Fever) and CHILLS (Chills). On an unknown date, the patient experienced HEADACHE (Headache), MYALGIA (Bodyaches), NAUSEA (Nausea) and VOMITING (Vomiting). The patient was treated with ZOLEDRONIC ACID (RECLAST) for Osteoporosis, at an unspecified dose and frequency. On 03-Jun-2021, BONE PAIN (Bone Pain) had resolved. At the time of the report, OSTEOPOROSIS (Osteoporosis), ARTHRALGIA (Joint Pain), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache), MYALGIA (Bodyaches), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal normal. On an unknown date, Bone scan: abnormal (abnormal) Significant osteoporosis.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Headache; Bodyaches; Nausea; Vomiting; Osteoporosis; Bone Pain; Joint Pain; Fever; Chills; This spontaneous case was reported by a patient and describes the occurrence of OSTEOPOROSIS (Osteoporosis), BONE PAIN (Bone Pain), ARTHRALGIA (Joint Pain), PYREXIA (Fever) and CHILLS (Chills) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure increased (Controlled by medications) since 2008, High cholesterol (Controlled by medications) since 2008 and Acid reflux (esophageal) (controlled by medcations) since 2008. Concomitant products included FLUOXETINE HCL, PANTOPRAZOLE, ATORVASTATIN, METOPROLOL and VALACYCLOVIR [VALACICLOVIR] for an unknown indication.   On 03-Mar-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 03-Mar-2021, the patient experienced OSTEOPOROSIS (Osteoporosis), BONE PAIN (Bone Pain), ARTHRALGIA (Joint Pain), PYREXIA (Fever) and CHILLS (Chills). On an unknown date, the patient experienced HEADACHE (Headache), MYALGIA (Bodyaches), NAUSEA (Nausea) and VOMITING (Vomiting). The patient was treated with ZOLEDRONIC ACID (RECLAST) for Osteoporosis, at an unspecified dose and frequency. On 03-Jun-2021, BONE PAIN (Bone Pain) had resolved. At the time of the report, OSTEOPOROSIS (Osteoporosis), ARTHRALGIA (Joint Pain), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache), MYALGIA (Bodyaches), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal normal. On an unknown date, Bone scan: abnormal (abnormal) Significant osteoporosis.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: suppose to receive the 2nd dose on 17May2021 but did not; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (suppose to receive the 2nd dose on 17May2021 but did not) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (suppose to receive the 2nd dose on 17May2021 but did not). At the time of the report, PRODUCT DOSE OMISSION ISSUE (suppose to receive the 2nd dose on 17May2021 but did not) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The reporter stated that patient takes daily medications but the caller does not know the names of the medications.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis, Eye inflammation, Rosacea
Clinical narrative: Bacterial rosacea; broke out" on the left arm, her scalp; broke out on the left arm, her scalp, and eye.; This spontaneous case was reported by a consumer and describes the occurrence of ROSACEA (Bacterial rosacea), DERMATITIS (broke out" on the left arm, her scalp) and EYE INFLAMMATION (broke out on the left arm, her scalp, and eye.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043L204 and 013A21A) for COVID-19 vaccination.     The patient's past medical history included Rosacea since an unknown date and COPD. Concurrent medical conditions included Arthritis. Concomitant products included GABAPENTIN and DULOXETINE HYDROCHLORIDE (CYMBALTA) for an unknown indication.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ROSACEA (Bacterial rosacea), DERMATITIS (broke out" on the left arm, her scalp) and EYE INFLAMMATION (broke out on the left arm, her scalp, and eye.). At the time of the report, ROSACEA (Bacterial rosacea), DERMATITIS (broke out" on the left arm, her scalp) and EYE INFLAMMATION (broke out on the left arm, her scalp, and eye.) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment medication reported.   This case was linked to MOD-2021-265424 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: 1st shot 6 weeks today but have not had a chance to go get my 2nd; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (1st shot 6 weeks today but have not had a chance to go get my 2nd) 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 PRODUCT DOSE OMISSION ISSUE (1st shot 6 weeks today but have not had a chance to go get my 2nd). At the time of the report, PRODUCT DOSE OMISSION ISSUE (1st shot 6 weeks today but have not had a chance to go get my 2nd) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: First dose was 5/22/21; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (First dose was 5/22/21) 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 22-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (First dose was 5/22/21). At the time of the report, PRODUCT DOSE OMISSION ISSUE (First dose was 5/22/21) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment medication was reported.   Reporter did not allow further contact
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Nerve injury, Pruritus, Rash, Rash morbilliform
Clinical narrative: Looks like measles rash on his trunk below his abdominal/ Looks like measles rash on his shoulders/ Looks like measles rash on everywhere/ Measles like rash on his scalp/ Pin head bumps/ Rash around his ears; Very very itchy scalp; Doctor wonders if it is affecting his nerve; Rash around his ears; itchy scalp; This spontaneous case was reported by a consumer and describes the occurrence of RASH MORBILLIFORM (Looks like measles rash on his trunk below his abdominal/ Looks like measles rash on his shoulders/ Looks like measles rash on everywhere/ Measles like rash on his scalp/ Pin head bumps/ Rash around his ears), PRURITUS (Very very itchy scalp), NERVE INJURY (Doctor wonders if it is affecting his nerve), RASH (Rash around his ears) and PRURITUS in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH MORBILLIFORM (Looks like measles rash on his trunk below his abdominal/ Looks like measles rash on his shoulders/ Looks like measles rash on everywhere/ Measles like rash on his scalp/ Pin head bumps/ Rash around his ears), PRURITUS (Very very itchy scalp), NERVE INJURY (Doctor wonders if it is affecting his nerve), RASH (Rash around his ears) and PRURITUS. The patient was treated with FLUOCINONIDE (FLUOCINONIDE F) at a dose of 5 %; CLOBETASOL PROPIONATE (CLOBETASOL PROPIONATE E) at a dose of 5 %; HYDROXYZINE HCL at a dose of 10 mg; LORATADINE (CLARITINE S) at an unspecified dose and frequency; CLOBETASOL for Itchy scalp, at a dose of 5 %; TRIAMCINOLONE ACETONIDE at a dose of 10 mg and PREDNISONE at a dose of 20 mg. At the time of the report, RASH MORBILLIFORM (Looks like measles rash on his trunk below his abdominal/ Looks like measles rash on his shoulders/ Looks like measles rash on everywhere/ Measles like rash on his scalp/ Pin head bumps/ Rash around his ears), PRURITUS (Very very itchy scalp), NERVE INJURY (Doctor wonders if it is affecting his nerve), RASH (Rash around his ears) and PRURITUS outcome was unknown.            Concomitant medications were not provided.   This case was linked to MOD-2021-265811 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pain
Clinical narrative: feeling achy; Sore arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (feeling achy) 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. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jul-2021, the patient experienced MYALGIA (feeling achy) and VACCINATION SITE PAIN (Sore arm at injection site). At the time of the report, MYALGIA (feeling achy) and VACCINATION SITE PAIN (Sore arm at injection site) outcome was unknown.            No concomitant medications reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Malaise, Myalgia
Clinical narrative: not feeling well since I had this shot; severe joint pain; severe muscle pain; severe fatigue; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Jul-2021 and was forwarded to Moderna on 26-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling well since I had this shot), ARTHRALGIA (severe joint pain), MYALGIA (severe muscle pain) and FATIGUE (severe fatigue) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (not feeling well since I had this shot), ARTHRALGIA (severe joint pain), MYALGIA (severe muscle pain) and FATIGUE (severe fatigue). At the time of the report, MALAISE (not feeling well since I had this shot), ARTHRALGIA (severe joint pain), MYALGIA (severe muscle pain) and FATIGUE (severe fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Bowel movement irregularity, Dizziness, Eating disorder, Fatigue, Feeling abnormal
Clinical narrative: Arm was very sore; fatigued; nauseous; lightheaded; vomiting; hard to eat; bowel movement is slow; doesn't feel like themselves; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (Arm was very sore), FATIGUE (fatigued), NAUSEA (nauseous), DIZZINESS (lightheaded) and VOMITING (vomiting) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (Arm was very sore), FATIGUE (fatigued), NAUSEA (nauseous), DIZZINESS (lightheaded), VOMITING (vomiting), EATING DISORDER (hard to eat), BOWEL MOVEMENT IRREGULARITY (bowel movement is slow) and FEELING ABNORMAL (doesn't feel like themselves). At the time of the report, MYALGIA (Arm was very sore), FATIGUE (fatigued), NAUSEA (nauseous), DIZZINESS (lightheaded), VOMITING (vomiting), EATING DISORDER (hard to eat), BOWEL MOVEMENT IRREGULARITY (bowel movement is slow) and FEELING ABNORMAL (doesn't feel like themselves) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drug details were reported. No treatment details were reported.   Reporter did not allow further contact
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Vomiting
Clinical narrative: Arm was very sore; fatigued; nauseous; lightheaded; vomiting; hard to eat; bowel movement is slow; doesn't feel like themselves; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (Arm was very sore), FATIGUE (fatigued), NAUSEA (nauseous), DIZZINESS (lightheaded) and VOMITING (vomiting) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (Arm was very sore), FATIGUE (fatigued), NAUSEA (nauseous), DIZZINESS (lightheaded), VOMITING (vomiting), EATING DISORDER (hard to eat), BOWEL MOVEMENT IRREGULARITY (bowel movement is slow) and FEELING ABNORMAL (doesn't feel like themselves). At the time of the report, MYALGIA (Arm was very sore), FATIGUE (fatigued), NAUSEA (nauseous), DIZZINESS (lightheaded), VOMITING (vomiting), EATING DISORDER (hard to eat), BOWEL MOVEMENT IRREGULARITY (bowel movement is slow) and FEELING ABNORMAL (doesn't feel like themselves) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drug details were reported. No treatment details were reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Headache, Injection site pruritus, Throat tightness
Clinical narrative: dizzy; throat started to close; the site of injection is itchy; The way that headaches goes, I never had something like that. I had to put myself in the dark, no noise, no nothing; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), THROAT TIGHTNESS (throat started to close), INJECTION SITE PRURITUS (the site of injection is itchy) and HEADACHE (The way that headaches goes, I never had something like that. I had to put myself in the dark, no noise, no nothing) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Brain tumor and Seizures.    On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jul-2021, the patient experienced DIZZINESS (dizzy), THROAT TIGHTNESS (throat started to close), INJECTION SITE PRURITUS (the site of injection is itchy) and HEADACHE (The way that headaches goes, I never had something like that. I had to put myself in the dark, no noise, no nothing). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, DIZZINESS (dizzy), THROAT TIGHTNESS (throat started to close), INJECTION SITE PRURITUS (the site of injection is itchy) and HEADACHE (The way that headaches goes, I never had something like that. I had to put myself in the dark, no noise, no nothing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient states that she was Allergic patient. The Concomitant medication included medication for seizures    Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Missed second dose; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed second dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Not Provided) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact