chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pyrexia, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: Malaise; Mild fever; Red rash; Raised rash; Hot rash; Itchy rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red rash), RASH PAPULAR (Raised rash), SKIN WARM (Hot rash), RASH PRURITIC (Itchy rash) and MALAISE (Malaise) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history were reported.     On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced RASH ERYTHEMATOUS (Red rash), RASH PAPULAR (Raised rash), SKIN WARM (Hot rash) and RASH PRURITIC (Itchy rash). On an unknown date, the patient experienced MALAISE (Malaise) and PYREXIA (Mild fever). The patient was treated with HYDROCORTISONE at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, RASH ERYTHEMATOUS (Red rash), RASH PAPULAR (Raised rash), SKIN WARM (Hot rash), RASH PRURITIC (Itchy rash), MALAISE (Malaise) and PYREXIA (Mild fever) had resolved.            No concomitants medication were provided. No lab data has been provided by the reporter.    This case was linked to MOD-2021-270400 (Patient Link). This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red rash), RASH PAPULAR (Raised rash), SKIN WARM (Hot rash), RASH PRURITIC (Itchy rash) and MALAISE (Malaise) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history were reported.     On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced RASH ERYTHEMATOUS (Red rash), RASH PAPULAR (Raised rash), SKIN WARM (Hot rash) and RASH PRURITIC (Itchy rash). On an unknown date, the patient experienced MALAISE (Malaise) and PYREXIA (Mild fever). The patient was treated with HYDROCORTISONE at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, RASH ERYTHEMATOUS (Red rash), RASH PAPULAR (Raised rash), SKIN WARM (Hot rash), RASH PRURITIC (Itchy rash), MALAISE (Malaise) and PYREXIA (Mild fever) had resolved.            No concomitants medication were provided. No lab data has been provided by the reporter.   This case was linked to MOD-2021-270400 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 17-Aug-2021: Non significant FU received - Reporter declined filling out a followup form and stated she called and reported all the information that is necessary
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm
Clinical narrative: Malaise; Mild fever; Red rash; Raised rash; Hot rash; Itchy rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red rash), RASH PAPULAR (Raised rash), SKIN WARM (Hot rash), RASH PRURITIC (Itchy rash) and MALAISE (Malaise) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history were reported.     On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced RASH ERYTHEMATOUS (Red rash), RASH PAPULAR (Raised rash), SKIN WARM (Hot rash) and RASH PRURITIC (Itchy rash). On an unknown date, the patient experienced MALAISE (Malaise) and PYREXIA (Mild fever). The patient was treated with HYDROCORTISONE at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, RASH ERYTHEMATOUS (Red rash), RASH PAPULAR (Raised rash), SKIN WARM (Hot rash), RASH PRURITIC (Itchy rash), MALAISE (Malaise) and PYREXIA (Mild fever) had resolved.            No concomitants medication were provided. No lab data has been provided by the reporter.    This case was linked to MOD-2021-270400 (Patient Link). This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red rash), RASH PAPULAR (Raised rash), SKIN WARM (Hot rash), RASH PRURITIC (Itchy rash) and MALAISE (Malaise) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history were reported.     On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced RASH ERYTHEMATOUS (Red rash), RASH PAPULAR (Raised rash), SKIN WARM (Hot rash) and RASH PRURITIC (Itchy rash). On an unknown date, the patient experienced MALAISE (Malaise) and PYREXIA (Mild fever). The patient was treated with HYDROCORTISONE at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, RASH ERYTHEMATOUS (Red rash), RASH PAPULAR (Raised rash), SKIN WARM (Hot rash), RASH PRURITIC (Itchy rash), MALAISE (Malaise) and PYREXIA (Mild fever) had resolved.            No concomitants medication were provided. No lab data has been provided by the reporter.   This case was linked to MOD-2021-270400 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 17-Aug-2021: Non significant FU received - Reporter declined filling out a followup form and stated she called and reported all the information that is necessary
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: missed dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Declined) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder NOS.    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 (missed dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided.  No treatment information listed.   Reporter did not allow further contact
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Passed 83 days without second days (Never receive the second dose); This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Passed 83 days without second days (Never receive the second dose)) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Passed 83 days without second days (Never receive the second dose)). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Passed 83 days without second days (Never receive the second dose)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: got covid arm now; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (got covid arm now) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In July 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In July 2021, the patient experienced VACCINATION SITE REACTION (got covid arm now). At the time of the report, VACCINATION SITE REACTION (got covid arm now) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.  Treatment information was not provided.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Eye pain, Feeling abnormal, Muscle contractions involuntary, Muscle spasms
Clinical narrative: muscle contractions, muscles were bothering him; right eye has been hurting him; muscle spasms; a fever of 100-101; has been feeling terrible; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (has been feeling terrible), MUSCLE CONTRACTIONS INVOLUNTARY (muscle contractions, muscles were bothering him), EYE PAIN (right eye has been hurting him), MUSCLE SPASMS (muscle spasms) and PYREXIA (a fever of 100-101) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in January 2021.    On 26-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jul-2021, the patient experienced FEELING ABNORMAL (has been feeling terrible) and PYREXIA (a fever of 100-101). On 28-Jul-2021, the patient experienced MUSCLE CONTRACTIONS INVOLUNTARY (muscle contractions, muscles were bothering him), EYE PAIN (right eye has been hurting him) and MUSCLE SPASMS (muscle spasms). At the time of the report, FEELING ABNORMAL (has been feeling terrible), MUSCLE CONTRACTIONS INVOLUNTARY (muscle contractions, muscles were bothering him), EYE PAIN (right eye has been hurting him), MUSCLE SPASMS (muscle spasms) and PYREXIA (a fever of 100-101) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jul-2021, Body temperature: 101-102 (Inconclusive) 101-102.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: muscle contractions, muscles were bothering him; right eye has been hurting him; muscle spasms; a fever of 100-101; has been feeling terrible; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (has been feeling terrible), MUSCLE CONTRACTIONS INVOLUNTARY (muscle contractions, muscles were bothering him), EYE PAIN (right eye has been hurting him), MUSCLE SPASMS (muscle spasms) and PYREXIA (a fever of 100-101) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in January 2021.    On 26-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jul-2021, the patient experienced FEELING ABNORMAL (has been feeling terrible) and PYREXIA (a fever of 100-101). On 28-Jul-2021, the patient experienced MUSCLE CONTRACTIONS INVOLUNTARY (muscle contractions, muscles were bothering him), EYE PAIN (right eye has been hurting him) and MUSCLE SPASMS (muscle spasms). At the time of the report, FEELING ABNORMAL (has been feeling terrible), MUSCLE CONTRACTIONS INVOLUNTARY (muscle contractions, muscles were bothering him), EYE PAIN (right eye has been hurting him), MUSCLE SPASMS (muscle spasms) and PYREXIA (a fever of 100-101) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jul-2021, Body temperature: 101-102 (Inconclusive) 101-102.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Inflammation, Product administration error, Rhinitis allergic
Clinical narrative: chest pressure; trouble breathing/out of breath; strong allergy that's nasal related, and it feels like asthma; inflammation in the airway; he received it 2 days before the deadline; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTRATION ERROR (he received it 2 days before the deadline), CHEST DISCOMFORT (chest pressure), DYSPNOEA (trouble breathing/out of breath), RHINITIS ALLERGIC (strong allergy that's nasal related, and it feels like asthma) and INFLAMMATION (inflammation in the airway) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Asthma and Wisdom teeth removal. Concurrent medical conditions included Injury (medical uses for his previous injury). Concomitant products included CANNABIS SATIVA (MARIJUANA) for Injury.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced PRODUCT ADMINISTRATION ERROR (he received it 2 days before the deadline). On an unknown date, the patient experienced CHEST DISCOMFORT (chest pressure), DYSPNOEA (trouble breathing/out of breath), RHINITIS ALLERGIC (strong allergy that's nasal related, and it feels like asthma) and INFLAMMATION (inflammation in the airway). The patient was treated with ALBUTEROL [SALBUTAMOL] ongoing since an unknown date for Inflammation and Nasal allergy, at an unspecified dose and frequency. At the time of the report, PRODUCT ADMINISTRATION ERROR (he received it 2 days before the deadline) had resolved and CHEST DISCOMFORT (chest pressure), DYSPNOEA (trouble breathing/out of breath), RHINITIS ALLERGIC (strong allergy that's nasal related, and it feels like asthma) and INFLAMMATION (inflammation in the airway) outcome was unknown.            Patient visited doctor for his strong allergy and an electrocardiogram (ECG) was performed on an unspecified date. The doctor told that the patient had some inflammation the airway. The patient was not diagnosed with asthma. The patient was also prescribed an unspecified steroid for a week.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Cough, Fatigue, Illness
Clinical narrative: Her bones are sore; She was very sick /was sick for about 2 weekand; Now she has a deep cough; Tired; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Her bones are sore), ILLNESS (She was very sick /was sick for about 2 weekand), COUGH (Now she has a deep cough) and FATIGUE (Tired) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced BONE PAIN (Her bones are sore), ILLNESS (She was very sick /was sick for about 2 weekand), COUGH (Now she has a deep cough) and FATIGUE (Tired). At the time of the report, BONE PAIN (Her bones are sore), ILLNESS (She was very sick /was sick for about 2 weekand), COUGH (Now she has a deep cough) and FATIGUE (Tired) had not resolved.      Patient is still experiencing symptoms No concomitant medications were provided. No treatment medications were provided   Most recent FOLLOW-UP information incorporated above includes: On 09-Nov-2021: Follow up received contains Non significant information.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Eye pain, Eye swelling, Nausea
Clinical narrative: Eye swelling; Eye pain; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (Eye swelling ), EYE PAIN (Eye pain) and NAUSEA (Nausea ) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-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 28-Jul-2021, the patient experienced EYE SWELLING (Eye swelling ), EYE PAIN (Eye pain) and NAUSEA (Nausea ). At the time of the report, EYE SWELLING (Eye swelling ), EYE PAIN (Eye pain) and NAUSEA (Nausea ) outcome was unknown.            No concomitant medications reported. No treatment medications reported.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: mild, cold-like symptoms; 5 out of 368 employees who have tested positive with breakthrough COVID; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (5 out of 368 employees who have tested positive with breakthrough COVID) and NASOPHARYNGITIS (mild, cold-like symptoms) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jul-2021, the patient experienced COVID-19 (5 out of 368 employees who have tested positive with breakthrough COVID). On an unknown date, the patient experienced NASOPHARYNGITIS (mild, cold-like symptoms). At the time of the report, COVID-19 (5 out of 368 employees who have tested positive with breakthrough COVID) and NASOPHARYNGITIS (mild, cold-like symptoms) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jul-2021, SARS-CoV-2 test: positive (Positive) positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment details were not reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal rigidity, Arthralgia, Back pain, Decreased appetite, Dizziness
Clinical narrative: She was not getting the second dose; dizzy; sharp stabbing pain on the left side of her back; lack of appetite; ankles were a little swollen; heart burn; right side/middle of her stomach felt a little hard; right knee pain; convulsive shaking in her legs/convulsive shaking in her arms; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (convulsive shaking in her legs/convulsive shaking in her arms), DIZZINESS (dizzy), BACK PAIN (sharp stabbing pain on the left side of her back), DECREASED APPETITE (lack of appetite) and JOINT SWELLING (ankles were a little swollen) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included High cholesterol (controlled by diet).    On 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jul-2021, the patient experienced DIZZINESS (dizzy), BACK PAIN (sharp stabbing pain on the left side of her back), DECREASED APPETITE (lack of appetite) and JOINT SWELLING (ankles were a little swollen). In July 2021, the patient experienced TREMOR (convulsive shaking in her legs/convulsive shaking in her arms), DYSPEPSIA (heart burn), ABDOMINAL RIGIDITY (right side/middle of her stomach felt a little hard) and ARTHRALGIA (right knee pain). On an unknown date, the patient experienced INTENTIONAL DOSE OMISSION (She was not getting the second dose). In July 2021, DYSPEPSIA (heart burn) had resolved. On 16-Jul-2021, BACK PAIN (sharp stabbing pain on the left side of her back) had resolved. At the time of the report, TREMOR (convulsive shaking in her legs/convulsive shaking in her arms), DIZZINESS (dizzy) and JOINT SWELLING (ankles were a little swollen) was resolving and DECREASED APPETITE (lack of appetite), INTENTIONAL DOSE OMISSION (She was not getting the second dose), ABDOMINAL RIGIDITY (right side/middle of her stomach felt a little hard) and ARTHRALGIA (right knee pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was provided by the reporter.  Company Comment:Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.  Patient reported that she was going to see her doctor if symptoms do not subside.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: significant Follow up appended; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspepsia, Intentional dose omission, Joint swelling, Tremor
Clinical narrative: She was not getting the second dose; dizzy; sharp stabbing pain on the left side of her back; lack of appetite; ankles were a little swollen; heart burn; right side/middle of her stomach felt a little hard; right knee pain; convulsive shaking in her legs/convulsive shaking in her arms; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (convulsive shaking in her legs/convulsive shaking in her arms), DIZZINESS (dizzy), BACK PAIN (sharp stabbing pain on the left side of her back), DECREASED APPETITE (lack of appetite) and JOINT SWELLING (ankles were a little swollen) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included High cholesterol (controlled by diet).    On 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jul-2021, the patient experienced DIZZINESS (dizzy), BACK PAIN (sharp stabbing pain on the left side of her back), DECREASED APPETITE (lack of appetite) and JOINT SWELLING (ankles were a little swollen). In July 2021, the patient experienced TREMOR (convulsive shaking in her legs/convulsive shaking in her arms), DYSPEPSIA (heart burn), ABDOMINAL RIGIDITY (right side/middle of her stomach felt a little hard) and ARTHRALGIA (right knee pain). On an unknown date, the patient experienced INTENTIONAL DOSE OMISSION (She was not getting the second dose). In July 2021, DYSPEPSIA (heart burn) had resolved. On 16-Jul-2021, BACK PAIN (sharp stabbing pain on the left side of her back) had resolved. At the time of the report, TREMOR (convulsive shaking in her legs/convulsive shaking in her arms), DIZZINESS (dizzy) and JOINT SWELLING (ankles were a little swollen) was resolving and DECREASED APPETITE (lack of appetite), INTENTIONAL DOSE OMISSION (She was not getting the second dose), ABDOMINAL RIGIDITY (right side/middle of her stomach felt a little hard) and ARTHRALGIA (right knee pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was provided by the reporter.  Company Comment:Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.  Patient reported that she was going to see her doctor if symptoms do not subside.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: significant Follow up appended; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Hyperhidrosis, Myalgia, SARS-CoV-2 test
Clinical narrative: Tested positive; Persistent cough; Body ache; Sweating; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive), HYPERHIDROSIS (Sweating), COUGH (Persistent cough) and MYALGIA (Body ache) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jul-2021, the patient experienced HYPERHIDROSIS (Sweating). On 26-Jul-2021, the patient experienced COVID-19 (Tested positive), COUGH (Persistent cough) and MYALGIA (Body ache). The patient was treated with PARACETAMOL (TYLENOL) in July 2021 for Adverse event, at a dose of 1 dosage form. In July 2021, HYPERHIDROSIS (Sweating) and MYALGIA (Body ache) had resolved. At the time of the report, COVID-19 (Tested positive) outcome was unknown and COUGH (Persistent cough) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jul-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: I just got dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (I just got dizzy) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (I just got dizzy). At the time of the report, DIZZINESS (I just got dizzy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication not provided. Treatment medication not provided.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: have a 101, average temperature since taking the vacine two days ago; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (have a 101, average temperature since taking the vacine two days ago) 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 PYREXIA (have a 101, average temperature since taking the vacine two days ago). At the time of the report, PYREXIA (have a 101, average temperature since taking the vacine two days ago) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication was received by the patient  No Treatment was received by the patient.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vitreous floaters
Clinical narrative: Eye floaters on the right eye; This spontaneous case was reported by a consumer and describes the occurrence of VITREOUS FLOATERS (Eye floaters on the right eye) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 28-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jul-2021, the patient experienced VITREOUS FLOATERS (Eye floaters on the right eye). At the time of the report, VITREOUS FLOATERS (Eye floaters on the right eye) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication included high blood pressure medication.  No treatment medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Three months since first dose (in April); 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 PRODUCT DOSE OMISSION ISSUE (Three months since first dose (in April)) 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. In April 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Three months since first dose (in April)). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Three months since first dose (in April)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Diarrhoea, Pain in extremity, Peripheral swelling
Clinical narrative: "Covid arm" or swelling and painful arm; Urinary tract infection; "Covid arm" or swelling and painful arm; Stomach issues; Diarrhea; Weakness; Drowsiness; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach issues), DIARRHOEA (Diarrhea), PERIPHERAL SWELLING ("Covid arm" or swelling and painful arm), URINARY TRACT INFECTION (Urinary tract infection) and PAIN IN EXTREMITY ("Covid arm" or swelling and painful arm) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jul-2021, the patient experienced ASTHENIA (Weakness) and SOMNOLENCE (Drowsiness). On 26-Jul-2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach issues) and DIARRHOEA (Diarrhea). On 29-Jul-2021, the patient experienced PERIPHERAL SWELLING ("Covid arm" or swelling and painful arm), URINARY TRACT INFECTION (Urinary tract infection) and PAIN IN EXTREMITY ("Covid arm" or swelling and painful arm). At the time of the report, ABDOMINAL DISCOMFORT (Stomach issues), DIARRHOEA (Diarrhea), PERIPHERAL SWELLING ("Covid arm" or swelling and painful arm), URINARY TRACT INFECTION (Urinary tract infection) and PAIN IN EXTREMITY ("Covid arm" or swelling and painful arm) had not resolved and ASTHENIA (Weakness) and SOMNOLENCE (Drowsiness) 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.   No relevant concomitant medication was reported. Treatment information was not provided.   No known allergies to medication or food.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Urinary tract infection
Clinical narrative: "Covid arm" or swelling and painful arm; Urinary tract infection; "Covid arm" or swelling and painful arm; Stomach issues; Diarrhea; Weakness; Drowsiness; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach issues), DIARRHOEA (Diarrhea), PERIPHERAL SWELLING ("Covid arm" or swelling and painful arm), URINARY TRACT INFECTION (Urinary tract infection) and PAIN IN EXTREMITY ("Covid arm" or swelling and painful arm) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jul-2021, the patient experienced ASTHENIA (Weakness) and SOMNOLENCE (Drowsiness). On 26-Jul-2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach issues) and DIARRHOEA (Diarrhea). On 29-Jul-2021, the patient experienced PERIPHERAL SWELLING ("Covid arm" or swelling and painful arm), URINARY TRACT INFECTION (Urinary tract infection) and PAIN IN EXTREMITY ("Covid arm" or swelling and painful arm). At the time of the report, ABDOMINAL DISCOMFORT (Stomach issues), DIARRHOEA (Diarrhea), PERIPHERAL SWELLING ("Covid arm" or swelling and painful arm), URINARY TRACT INFECTION (Urinary tract infection) and PAIN IN EXTREMITY ("Covid arm" or swelling and painful arm) had not resolved and ASTHENIA (Weakness) and SOMNOLENCE (Drowsiness) 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.   No relevant concomitant medication was reported. Treatment information was not provided.   No known allergies to medication or food.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient received 1st dose before 99 days; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient received 1st dose before 99 days) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient received 1st dose before 99 days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient received 1st dose before 99 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications provided.  No treatment medications provided.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Missed second shot; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed second shot) 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 PRODUCT DOSE OMISSION ISSUE (Missed second shot). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed second shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment drug details was reported.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Taste metallic; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Taste metallic) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 031B21A) 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 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DYSGEUSIA (Taste metallic). At the time of the report, DYSGEUSIA (Taste metallic) outcome was unknown.            No treatment medication were provided. No concomitant medication were provided. Patient was not sure about the route of administration , but he was thinking it was subcutaneous.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Fatigue, Feeling guilty
Clinical narrative: Got a breakthrough infection with covid; Sore throat; Lethargic; Her loss of taste and smell still has not come back; Her loss of taste and smell still has not come back; it's so scary because she managed to infect 4 people and they had no contact with anyone else, the guilt is incredible; Headache; Extreme tiredness; Patient received the second dose of the vaccine 21 days after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Got a breakthrough infection with covid), OROPHARYNGEAL PAIN (Sore throat), LETHARGY (Lethargic), ANOSMIA (Her loss of taste and smell still has not come back) and AGEUSIA (Her loss of taste and smell still has not come back) in a 55-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 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose of the vaccine 21 days after the first dose). On 07-Jul-2021, the patient experienced COVID-19 (Got a breakthrough infection with covid), OROPHARYNGEAL PAIN (Sore throat), LETHARGY (Lethargic), ANOSMIA (Her loss of taste and smell still has not come back), AGEUSIA (Her loss of taste and smell still has not come back), FEELING GUILTY (it's so scary because she managed to infect 4 people and they had no contact with anyone else, the guilt is incredible), HEADACHE (Headache) and FATIGUE (Extreme tiredness). On 27-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose of the vaccine 21 days after the first dose) had resolved. At the time of the report, COVID-19 (Got a breakthrough infection with covid), OROPHARYNGEAL PAIN (Sore throat), LETHARGY (Lethargic), FEELING GUILTY (it's so scary because she managed to infect 4 people and they had no contact with anyone else, the guilt is incredible), HEADACHE (Headache) and FATIGUE (Extreme tiredness) outcome was unknown and ANOSMIA (Her loss of taste and smell still has not come back) and AGEUSIA (Her loss of taste and smell still has not come back) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) negative for Covid.         Concomitant products were not provided. Patient was not on any medication and had no health conditions Treatment medication were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Follow up received contains no new information
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Inappropriate schedule of product administration, Lethargy, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: Got a breakthrough infection with covid; Sore throat; Lethargic; Her loss of taste and smell still has not come back; Her loss of taste and smell still has not come back; it's so scary because she managed to infect 4 people and they had no contact with anyone else, the guilt is incredible; Headache; Extreme tiredness; Patient received the second dose of the vaccine 21 days after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Got a breakthrough infection with covid), OROPHARYNGEAL PAIN (Sore throat), LETHARGY (Lethargic), ANOSMIA (Her loss of taste and smell still has not come back) and AGEUSIA (Her loss of taste and smell still has not come back) in a 55-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 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose of the vaccine 21 days after the first dose). On 07-Jul-2021, the patient experienced COVID-19 (Got a breakthrough infection with covid), OROPHARYNGEAL PAIN (Sore throat), LETHARGY (Lethargic), ANOSMIA (Her loss of taste and smell still has not come back), AGEUSIA (Her loss of taste and smell still has not come back), FEELING GUILTY (it's so scary because she managed to infect 4 people and they had no contact with anyone else, the guilt is incredible), HEADACHE (Headache) and FATIGUE (Extreme tiredness). On 27-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose of the vaccine 21 days after the first dose) had resolved. At the time of the report, COVID-19 (Got a breakthrough infection with covid), OROPHARYNGEAL PAIN (Sore throat), LETHARGY (Lethargic), FEELING GUILTY (it's so scary because she managed to infect 4 people and they had no contact with anyone else, the guilt is incredible), HEADACHE (Headache) and FATIGUE (Extreme tiredness) outcome was unknown and ANOSMIA (Her loss of taste and smell still has not come back) and AGEUSIA (Her loss of taste and smell still has not come back) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) negative for Covid.         Concomitant products were not provided. Patient was not on any medication and had no health conditions Treatment medication were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Follow up received contains no new information
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: discovered that the vaccine vial used in administration had been first punctured on 28Jul2021 around 6:00pm. This would be outside of the allowed 12 hour window storage and handling guidelines for administration of the vaccine at room temperature; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (discovered that the vaccine vial used in administration had been first punctured on 28Jul2021 around 6:00pm. This would be outside of the allowed 12 hour window storage and handling guidelines for administration of the vaccine at room temperature) 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 29-Jul-2021 at 6:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (discovered that the vaccine vial used in administration had been first punctured on 28Jul2021 around 6:00pm. This would be outside of the allowed 12 hour window storage and handling guidelines for administration of the vaccine at room temperature). At the time of the report, EXPIRED PRODUCT ADMINISTERED (discovered that the vaccine vial used in administration had been first punctured on 28Jul2021 around 6:00pm. This would be outside of the allowed 12 hour window storage and handling guidelines for administration of the vaccine at room temperature) 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 medications were reported.  No treatment details were reported.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired dose; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 28-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose). On 28-Jul-2021, EXPIRED PRODUCT ADMINISTERED (expired dose) 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 drug details were reported. No treatment details were reported.