chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Musculoskeletal stiffness, Myalgia, Pain, Pain in extremity
Clinical narrative: stiffness; poor bladder control; sore muscles; Excruciating pain; difficulty with mobility; Sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Excruciating pain), PAIN IN EXTREMITY (Sore left arm), MOBILITY DECREASED (difficulty with mobility), MUSCULOSKELETAL STIFFNESS (stiffness) and URINARY INCONTINENCE (poor bladder control) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A31A and 038821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore left arm). On 06-May-2021, the patient experienced PAIN (Excruciating pain) and MOBILITY DECREASED (difficulty with mobility). On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (stiffness), URINARY INCONTINENCE (poor bladder control) and MYALGIA (sore muscles). On 10-May-2021, PAIN (Excruciating pain) and MOBILITY DECREASED (difficulty with mobility) outcome was unknown. At the time of the report, PAIN IN EXTREMITY (Sore left arm), MUSCULOSKELETAL STIFFNESS (stiffness), URINARY INCONTINENCE (poor bladder control) and MYALGIA (sore muscles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant drugs. Treatment was taken but not mentioned the drug.   This case was linked to-MOD-2021-117973 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes:  Sender's Comments:  MOD-2021-117973:Second Dose Case
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary incontinence
Clinical narrative: stiffness; poor bladder control; sore muscles; Excruciating pain; difficulty with mobility; Sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Excruciating pain), PAIN IN EXTREMITY (Sore left arm), MOBILITY DECREASED (difficulty with mobility), MUSCULOSKELETAL STIFFNESS (stiffness) and URINARY INCONTINENCE (poor bladder control) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A31A and 038821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore left arm). On 06-May-2021, the patient experienced PAIN (Excruciating pain) and MOBILITY DECREASED (difficulty with mobility). On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (stiffness), URINARY INCONTINENCE (poor bladder control) and MYALGIA (sore muscles). On 10-May-2021, PAIN (Excruciating pain) and MOBILITY DECREASED (difficulty with mobility) outcome was unknown. At the time of the report, PAIN IN EXTREMITY (Sore left arm), MUSCULOSKELETAL STIFFNESS (stiffness), URINARY INCONTINENCE (poor bladder control) and MYALGIA (sore muscles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant drugs. Treatment was taken but not mentioned the drug.   This case was linked to-MOD-2021-117973 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes:  Sender's Comments:  MOD-2021-117973:Second Dose Case
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose after 42 days; This spontaneous case was reported by a patient family member or friend and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose after 42 days) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No medical history reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose after 42 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose after 42 days) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant medications have not been reported.  The patient will return to the country on 24-May-2021. His friend was inquiring about further actions.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Hasn't gotten the second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Hasn't gotten the second dose) in a female 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 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Hasn't gotten the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Hasn't gotten the second dose) 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.   Concomitant medications have not been specified. The patient travelled out of state and has not received the second dose yet. Treatment information was not given.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Attached document contains no new information.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure diastolic, Body temperature, Fatigue, Feeling cold, Heart rate
Clinical narrative: left arm was infected; left upper arm was swollen; left upper arm was quite warm; left upper arm was red; left upper arm was tender; really really tired, like couch-potato tired".; temperature of 102 degrees Fahrenheit; really really cold; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (left upper arm was quite warm), VACCINATION SITE INFECTION (left arm was infected), FEELING COLD (really really cold), VACCINATION SITE SWELLING (left upper arm was swollen) and PYREXIA (temperature of 102 degrees Fahrenheit) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure and Cholesterol. Concomitant products included NIFEDIPINE for Blood pressure, METOPROLOL SUCCINATE for Blood pressure management, ROSUVASTATIN CALCIUM for Cholesterosis.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced FEELING COLD (really really cold) and PYREXIA (temperature of 102 degrees Fahrenheit). On 20-Mar-2021, the patient experienced FATIGUE (really really tired, like couch-potato tired".). On 22-Mar-2021, the patient experienced VACCINATION SITE WARMTH (left upper arm was quite warm), VACCINATION SITE SWELLING (left upper arm was swollen), VACCINATION SITE ERYTHEMA (left upper arm was red) and VACCINATION SITE PAIN (left upper arm was tender). On an unknown date, the patient experienced VACCINATION SITE INFECTION (left arm was infected). The patient was treated with CEPHALEXIN [CEFALEXIN] at a dose of 250 milligram three times a day. On 19-Mar-2021, FEELING COLD (really really cold) had resolved. On 21-Mar-2021, FATIGUE (really really tired, like couch-potato tired".) had resolved. At the time of the report, VACCINATION SITE WARMTH (left upper arm was quite warm), VACCINATION SITE INFECTION (left arm was infected), VACCINATION SITE SWELLING (left upper arm was swollen), PYREXIA (temperature of 102 degrees Fahrenheit), VACCINATION SITE ERYTHEMA (left upper arm was red) and VACCINATION SITE PAIN (left upper arm was tender) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Mar-2021, Body temperature: 102 (abnormal) 102 degrees  Fahrenheit. On 19-Apr-2021, Blood pressure diastolic: 80-90 (High) 80's and 90's. On 19-Apr-2021, Heart rate: high (High) high.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       Patient states she think she had COVID-19 back in Mar 2019 but her doctor told the immunity won't last that long, patient states she was not going to receive the second dose of Moderna Covid-19 vaccine as she doesn't want problems with her blood pressure again.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site infection, Vaccination site pain, Vaccination site swelling
Clinical narrative: left arm was infected; left upper arm was swollen; left upper arm was quite warm; left upper arm was red; left upper arm was tender; really really tired, like couch-potato tired".; temperature of 102 degrees Fahrenheit; really really cold; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (left upper arm was quite warm), VACCINATION SITE INFECTION (left arm was infected), FEELING COLD (really really cold), VACCINATION SITE SWELLING (left upper arm was swollen) and PYREXIA (temperature of 102 degrees Fahrenheit) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure and Cholesterol. Concomitant products included NIFEDIPINE for Blood pressure, METOPROLOL SUCCINATE for Blood pressure management, ROSUVASTATIN CALCIUM for Cholesterosis.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced FEELING COLD (really really cold) and PYREXIA (temperature of 102 degrees Fahrenheit). On 20-Mar-2021, the patient experienced FATIGUE (really really tired, like couch-potato tired".). On 22-Mar-2021, the patient experienced VACCINATION SITE WARMTH (left upper arm was quite warm), VACCINATION SITE SWELLING (left upper arm was swollen), VACCINATION SITE ERYTHEMA (left upper arm was red) and VACCINATION SITE PAIN (left upper arm was tender). On an unknown date, the patient experienced VACCINATION SITE INFECTION (left arm was infected). The patient was treated with CEPHALEXIN [CEFALEXIN] at a dose of 250 milligram three times a day. On 19-Mar-2021, FEELING COLD (really really cold) had resolved. On 21-Mar-2021, FATIGUE (really really tired, like couch-potato tired".) had resolved. At the time of the report, VACCINATION SITE WARMTH (left upper arm was quite warm), VACCINATION SITE INFECTION (left arm was infected), VACCINATION SITE SWELLING (left upper arm was swollen), PYREXIA (temperature of 102 degrees Fahrenheit), VACCINATION SITE ERYTHEMA (left upper arm was red) and VACCINATION SITE PAIN (left upper arm was tender) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Mar-2021, Body temperature: 102 (abnormal) 102 degrees  Fahrenheit. On 19-Apr-2021, Blood pressure diastolic: 80-90 (High) 80's and 90's. On 19-Apr-2021, Heart rate: high (High) high.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       Patient states she think she had COVID-19 back in Mar 2019 but her doctor told the immunity won't last that long, patient states she was not going to receive the second dose of Moderna Covid-19 vaccine as she doesn't want problems with her blood pressure again.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: left arm was infected; left upper arm was swollen; left upper arm was quite warm; left upper arm was red; left upper arm was tender; really really tired, like couch-potato tired".; temperature of 102 degrees Fahrenheit; really really cold; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (left upper arm was quite warm), VACCINATION SITE INFECTION (left arm was infected), FEELING COLD (really really cold), VACCINATION SITE SWELLING (left upper arm was swollen) and PYREXIA (temperature of 102 degrees Fahrenheit) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure and Cholesterol. Concomitant products included NIFEDIPINE for Blood pressure, METOPROLOL SUCCINATE for Blood pressure management, ROSUVASTATIN CALCIUM for Cholesterosis.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced FEELING COLD (really really cold) and PYREXIA (temperature of 102 degrees Fahrenheit). On 20-Mar-2021, the patient experienced FATIGUE (really really tired, like couch-potato tired".). On 22-Mar-2021, the patient experienced VACCINATION SITE WARMTH (left upper arm was quite warm), VACCINATION SITE SWELLING (left upper arm was swollen), VACCINATION SITE ERYTHEMA (left upper arm was red) and VACCINATION SITE PAIN (left upper arm was tender). On an unknown date, the patient experienced VACCINATION SITE INFECTION (left arm was infected). The patient was treated with CEPHALEXIN [CEFALEXIN] at a dose of 250 milligram three times a day. On 19-Mar-2021, FEELING COLD (really really cold) had resolved. On 21-Mar-2021, FATIGUE (really really tired, like couch-potato tired".) had resolved. At the time of the report, VACCINATION SITE WARMTH (left upper arm was quite warm), VACCINATION SITE INFECTION (left arm was infected), VACCINATION SITE SWELLING (left upper arm was swollen), PYREXIA (temperature of 102 degrees Fahrenheit), VACCINATION SITE ERYTHEMA (left upper arm was red) and VACCINATION SITE PAIN (left upper arm was tender) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Mar-2021, Body temperature: 102 (abnormal) 102 degrees  Fahrenheit. On 19-Apr-2021, Blood pressure diastolic: 80-90 (High) 80's and 90's. On 19-Apr-2021, Heart rate: high (High) high.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       Patient states she think she had COVID-19 back in Mar 2019 but her doctor told the immunity won't last that long, patient states she was not going to receive the second dose of Moderna Covid-19 vaccine as she doesn't want problems with her blood pressure again.
Sex: M
Vaccine: COVID19
Symptoms: Fall
Clinical narrative: Fell several times; This spontaneous case was reported by a consumer and describes the occurrence of FALL (Fell several times) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 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 FALL (Fell several times). At the time of the report, FALL (Fell several times) outcome was unknown. Not Provided          No treatment was reported. No concomitant medication was reported.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.    This case was linked to US-MODERNATX, INC.-MOD-2021-117899 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-117899:Himself
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Headache
Clinical narrative: headaches; This spontaneous case was reported by a non-health professional and describes the occurrence of HEADACHE (headaches) in a 73-year-old female patient who received mRNA-1273 (batch no. 036B12A) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus.    On 05-May-2021, the patient received first dose of mRNA-1273 (unknown route) 1 dosage form. On 05-May-2021, the patient experienced HEADACHE (headaches). At the time of the report, HEADACHE (headaches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-May-2021, Blood glucose: 40 (Low) in the middle of the night ,sugar is going down to the 40's and 300 (High) in the morning it jumps up to over 300. On 11-May-2021, Blood glucose: 215 (High) This morning it was 215 and patient had not eaten anything.     The action taken with mRNA-1273 (Unknown) was unknown.       no concomitant medication. No treatment provided by the reporter. Patient sugar has been fluctuating like crazy
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccine received more than 6 hours after first vial puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine received more than 6 hours after first vial puncture) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 08-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 08-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine received more than 6 hours after first vial puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine received more than 6 hours after first vial puncture) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Malaise, Myalgia, Nausea, Pain
Clinical narrative: feeling sick; weak; sore; achy all over; nauseated; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling sick), ASTHENIA (weak), PAIN (sore), MYALGIA (achy all over) and NAUSEA (nauseated) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, the patient experienced MALAISE (feeling sick), ASTHENIA (weak), PAIN (sore), MYALGIA (achy all over) and NAUSEA (nauseated). At the time of the report, MALAISE (feeling sick), ASTHENIA (weak), PAIN (sore), MYALGIA (achy all over) and NAUSEA (nauseated) outcome was unknown.            No concomitant medication were reported. No treatment information was reported. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Dyspnoea, Feeling abnormal, Feeling cold
Clinical narrative: chills; head is pounding every day; throwed up couple of times; fever; cough; difficulty to breath; runny nose; feeling cold; muscle pain,body is hurting; throat soreness; "I am having a felling like I am going to die."; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), HEADACHE (head is pounding every day), VOMITING (throwed up couple of times), PYREXIA (fever) and COUGH (cough) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A and 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-May-2021, the patient experienced CHILLS (chills), HEADACHE (head is pounding every day), VOMITING (throwed up couple of times), PYREXIA (fever), COUGH (cough), DYSPNOEA (difficulty to breath), RHINORRHOEA (runny nose), FEELING COLD (feeling cold), MYALGIA (muscle pain,body is hurting), OROPHARYNGEAL PAIN (throat soreness) and FEELING ABNORMAL ("I am having a felling like I am going to die."). At the time of the report, CHILLS (chills), HEADACHE (head is pounding every day), VOMITING (throwed up couple of times), PYREXIA (fever), COUGH (cough), DYSPNOEA (difficulty to breath), RHINORRHOEA (runny nose), FEELING COLD (feeling cold), MYALGIA (muscle pain,body is hurting), OROPHARYNGEAL PAIN (throat soreness) and FEELING ABNORMAL ("I am having a felling like I am going to die.") outcome was unknown.            No treatment information was provided.  No concomitant medication was provided.   This case was linked to MOD-2021-117942 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Oropharyngeal pain, Pyrexia, Rhinorrhoea
Clinical narrative: chills; head is pounding every day; throwed up couple of times; fever; cough; difficulty to breath; runny nose; feeling cold; muscle pain,body is hurting; throat soreness; "I am having a felling like I am going to die."; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), HEADACHE (head is pounding every day), VOMITING (throwed up couple of times), PYREXIA (fever) and COUGH (cough) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A and 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-May-2021, the patient experienced CHILLS (chills), HEADACHE (head is pounding every day), VOMITING (throwed up couple of times), PYREXIA (fever), COUGH (cough), DYSPNOEA (difficulty to breath), RHINORRHOEA (runny nose), FEELING COLD (feeling cold), MYALGIA (muscle pain,body is hurting), OROPHARYNGEAL PAIN (throat soreness) and FEELING ABNORMAL ("I am having a felling like I am going to die."). At the time of the report, CHILLS (chills), HEADACHE (head is pounding every day), VOMITING (throwed up couple of times), PYREXIA (fever), COUGH (cough), DYSPNOEA (difficulty to breath), RHINORRHOEA (runny nose), FEELING COLD (feeling cold), MYALGIA (muscle pain,body is hurting), OROPHARYNGEAL PAIN (throat soreness) and FEELING ABNORMAL ("I am having a felling like I am going to die.") outcome was unknown.            No treatment information was provided.  No concomitant medication was provided.   This case was linked to MOD-2021-117942 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: chills; head is pounding every day; throwed up couple of times; fever; cough; difficulty to breath; runny nose; feeling cold; muscle pain,body is hurting; throat soreness; "I am having a felling like I am going to die."; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), HEADACHE (head is pounding every day), VOMITING (throwed up couple of times), PYREXIA (fever) and COUGH (cough) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A and 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-May-2021, the patient experienced CHILLS (chills), HEADACHE (head is pounding every day), VOMITING (throwed up couple of times), PYREXIA (fever), COUGH (cough), DYSPNOEA (difficulty to breath), RHINORRHOEA (runny nose), FEELING COLD (feeling cold), MYALGIA (muscle pain,body is hurting), OROPHARYNGEAL PAIN (throat soreness) and FEELING ABNORMAL ("I am having a felling like I am going to die."). At the time of the report, CHILLS (chills), HEADACHE (head is pounding every day), VOMITING (throwed up couple of times), PYREXIA (fever), COUGH (cough), DYSPNOEA (difficulty to breath), RHINORRHOEA (runny nose), FEELING COLD (feeling cold), MYALGIA (muscle pain,body is hurting), OROPHARYNGEAL PAIN (throat soreness) and FEELING ABNORMAL ("I am having a felling like I am going to die.") outcome was unknown.            No treatment information was provided.  No concomitant medication was provided.   This case was linked to MOD-2021-117942 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pain, Vaccination site pain
Clinical narrative: severe pain; inability to use their right arm, lack of arm function lasted until 36 hours; some tenderness of the right arm injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (severe pain), MOBILITY DECREASED (inability to use their right arm, lack of arm function lasted until 36 hours) and VACCINATION SITE PAIN (some tenderness of the right arm injection site) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A31A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced PAIN (severe pain). 19-Apr-2021, the patient experienced MOBILITY DECREASED (inability to use their right arm, lack of arm function lasted until 36 hours) and VACCINATION SITE PAIN (some tenderness of the right arm injection site). On 20-Apr-2021, MOBILITY DECREASED (inability to use their right arm, lack of arm function lasted until 36 hours) was resolving. At the time of the report, PAIN (severe pain) and VACCINATION SITE PAIN (some tenderness of the right arm injection site) outcome was unknown.            The action taken was not applicable after second dose of mRNA-1273.  Patient reported motion in both arms is slowly recovering.   No concomitant medications or treatments were reported.   This case was linked to INC.-MOD-2021-117959 (E2B Linked Report).; Sender's Comments: INC.-MOD-2021-117959:First Dose Case
Age: 39.0
Sex: U
Vaccine: COVID19
Symptoms: Eye swelling
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EYE SWELLING (Swelling left eye) in a 39-year-old patient of an unknown gender who received mRNA-1273 (batch no. 016c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 10-May-2021, the patient received dose of mRNA-1273 (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced EYE SWELLING (Swelling left eye). At the time of the report, EYE SWELLING (Swelling left eye) outcome was unknown.        The action taken with mRNA-1273 (Intramuscular) was unknown.   For mRNA-1273 (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold, Headache, Inappropriate schedule of product administration, Pain
Clinical narrative: She is scheduled to take the 2nd dose on 13MAY2021; Really cold; Shaking; Aching; Really bad headache; Really really tired; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Really cold), TREMOR (Shaking), PAIN (Aching), HEADACHE (Really bad headache) and FATIGUE (Really really tired) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) 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 07-Apr-2021, the patient experienced FEELING COLD (Really cold), TREMOR (Shaking), PAIN (Aching), HEADACHE (Really bad headache) and FATIGUE (Really really tired). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She is scheduled to take the 2nd dose on 13MAY2021). At the time of the report, FEELING COLD (Really cold), TREMOR (Shaking), PAIN (Aching), HEADACHE (Really bad headache), FATIGUE (Really really tired) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She is scheduled to take the 2nd dose on 13MAY2021) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient might have taken ibuprofen as treatment but it did not help. No concomitant medications were reported.  Reportedly, the patient had experienced the events about 12 hours after getting the vaccination.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: She is scheduled to take the 2nd dose on 13MAY2021; Really cold; Shaking; Aching; Really bad headache; Really really tired; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Really cold), TREMOR (Shaking), PAIN (Aching), HEADACHE (Really bad headache) and FATIGUE (Really really tired) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) 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 07-Apr-2021, the patient experienced FEELING COLD (Really cold), TREMOR (Shaking), PAIN (Aching), HEADACHE (Really bad headache) and FATIGUE (Really really tired). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She is scheduled to take the 2nd dose on 13MAY2021). At the time of the report, FEELING COLD (Really cold), TREMOR (Shaking), PAIN (Aching), HEADACHE (Really bad headache), FATIGUE (Really really tired) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She is scheduled to take the 2nd dose on 13MAY2021) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient might have taken ibuprofen as treatment but it did not help. No concomitant medications were reported.  Reportedly, the patient had experienced the events about 12 hours after getting the vaccination.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: Appears much of the dose leaked down patient's arm; Undetermined amount of 2nd Moderna Vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Appears much of the dose leaked down patient's arm) and DEVICE CONNECTION ISSUE (Undetermined amount of 2nd Moderna Vaccine) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 038B21A) 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) (Intramuscular) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced UNDERDOSE (Appears much of the dose leaked down patient's arm) and DEVICE CONNECTION ISSUE (Undetermined amount of 2nd Moderna Vaccine). On 11-May-2021, UNDERDOSE (Appears much of the dose leaked down patient's arm) and DEVICE CONNECTION ISSUE (Undetermined amount of 2nd Moderna Vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment was reported. No concomitant medication was reported.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dyspnoea, Fatigue, Pain, Vaccination site pain
Clinical narrative: sore arm; balance was off; fatigued; right side started to hurt /pain with bending over / Pain with getting up from toilet; Short of breath; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), PAIN (right side started to hurt /pain with bending over / Pain with getting up from toilet), DYSPNOEA (Short of breath), BALANCE DISORDER (balance was off) and FATIGUE (fatigued) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.     The patient's past medical history included Valley fever (diagnosed prior to receiving the vaccine).    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, the patient experienced PAIN (right side started to hurt /pain with bending over / Pain with getting up from toilet) and DYSPNOEA (Short of breath). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), BALANCE DISORDER (balance was off) and FATIGUE (fatigued). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (sore arm), PAIN (right side started to hurt /pain with bending over / Pain with getting up from toilet), DYSPNOEA (Short of breath), BALANCE DISORDER (balance was off) and FATIGUE (fatigued) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported by reporter.  It was reported that the patient had been diagnosed with "Valley Fever" prior to receiving the vaccine. She was put on a medication (not specified) which made her feel fatigued and like her balance was off. Her fatigue and balance both worsened since she received the vaccine.  Upon follow up, patient stated she was doing fine.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: TCR received, outcome of events/patient history/narrative updated; declined follow-up.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Headache, Pyrexia, Vomiting
Clinical narrative: having trouble walking however he feels that his legs will get better as the day goes; fever; headache; threw up this morning; This spontaneous case was reported by a patient and describes the occurrence of GAIT DISTURBANCE (having trouble walking however he feels that his legs will get better as the day goes), VOMITING (threw up this morning), PYREXIA (fever) and HEADACHE (headache) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.     Concurrent medical conditions included Borderline diabetes. Concomitant products included METFORMIN for Borderline diabetes.    On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced VOMITING (threw up this morning). On an unknown date, the patient experienced GAIT DISTURBANCE (having trouble walking however he feels that his legs will get better as the day goes), PYREXIA (fever) and HEADACHE (headache). At the time of the report, GAIT DISTURBANCE (having trouble walking however he feels that his legs will get better as the day goes), VOMITING (threw up this morning), PYREXIA (fever) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication not reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Mild aches at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Mild aches at injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced VACCINATION SITE PAIN (Mild aches at injection site). At the time of the report, VACCINATION SITE PAIN (Mild aches at injection site) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication were provided Treatment medication was not provided.   This case was linked to MOD-2021-117995 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Fever; aches; This spontaneous case was reported by a physician and describes the occurrence of PYREXIA (Fever) and MYALGIA (aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever) and MYALGIA (aches). At the time of the report, PYREXIA (Fever) and MYALGIA (aches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant and treatment details were not provided.  no signs of allergic reaction after receiving the first dose but took a laxative containing polyethylene glycol sometime after receiving the 1st dose, she had a reaction consisting of aches and fever and Medical Doctor states to  believes the reaction was due to the about of polyethylene glycol in the laxative the patient took.  polyethylene glycol allergy is contraindication to receive 2nd dose
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse event following immunisation, COVID-19, Chills, Fatigue, Full blood count
Clinical narrative: late reaction to the vaccine; deep sweating; very strong muscle pain; chills; tiredness; vomiting; headache; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT FOLLOWING IMMUNISATION, HYPERHIDROSIS, (deep sweating), MYALGIA (very strong muscle pain), CHILLS (chills) and FATIGUE (tiredness) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. not provided) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], PENTOXIFYLLINE (TRENTAL) and HYDROCHLOROTHIAZIDE, IRBESARTAN (IRBESARTAN AND HYDROCHLOROTHIAZIDE) for an unknown indication.   On 21-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 07-May-2021, the patient experienced ADVERSE EVENT FOLLOWING IMMUNISATION (late reaction to the vaccine), HYPERHIDROSIS (deep sweating), MYALGIA (very strong muscle pain), CHILLS (chills), FATIGUE (tiredness), VOMITING (vomiting) and HEADACHE (headache). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ADVERSE EVENT FOLLOWING IMMUNISATION (rate reaction to the vaccine), HYPERHIDROSIS (deep sweating), MYALGIA (very strong muscle pain), CHILLS (chills), FATIGUE (tiredness), VOMITING (vomiting) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: normal (normal) normal. On an unknown date, Full blood count: normal (normal) normal.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication include vintiasen 360.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Myalgia, Vomiting
Clinical narrative: late reaction to the vaccine; deep sweating; very strong muscle pain; chills; tiredness; vomiting; headache; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT FOLLOWING IMMUNISATION, HYPERHIDROSIS, (deep sweating), MYALGIA (very strong muscle pain), CHILLS (chills) and FATIGUE (tiredness) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. not provided) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], PENTOXIFYLLINE (TRENTAL) and HYDROCHLOROTHIAZIDE, IRBESARTAN (IRBESARTAN AND HYDROCHLOROTHIAZIDE) for an unknown indication.   On 21-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 07-May-2021, the patient experienced ADVERSE EVENT FOLLOWING IMMUNISATION (late reaction to the vaccine), HYPERHIDROSIS (deep sweating), MYALGIA (very strong muscle pain), CHILLS (chills), FATIGUE (tiredness), VOMITING (vomiting) and HEADACHE (headache). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ADVERSE EVENT FOLLOWING IMMUNISATION (rate reaction to the vaccine), HYPERHIDROSIS (deep sweating), MYALGIA (very strong muscle pain), CHILLS (chills), FATIGUE (tiredness), VOMITING (vomiting) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: normal (normal) normal. On an unknown date, Full blood count: normal (normal) normal.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication include vintiasen 360.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Ear pain, Inappropriate schedule of product administration, Tinnitus
Clinical narrative: throbbing in right ear; He was due for his second dose today on11-MAY-2021 but rescheduled it for next week; tinnitus increased / throbbing in his right ear; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (tinnitus increased / throbbing in his right ear), EAR PAIN (throbbing in right ear) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (He was due for his second dose today on11-MAY-2021 but rescheduled it for next week) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     The patient's past medical history included Tinnitus.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced TINNITUS (tinnitus increased / throbbing in his right ear). On an unknown date, the patient experienced EAR PAIN (throbbing in right ear) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (He was due for his second dose today on11-MAY-2021 but rescheduled it for next week). At the time of the report, TINNITUS (tinnitus increased / throbbing in his right ear) had not resolved, EAR PAIN (throbbing in right ear) had resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (He was due for his second dose today on11-MAY-2021 but rescheduled it for next week) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was worried about getting the second shot because the ringing was difficult to manage.The patient had consulted with his doctor who told him there was no treatment for tinnitus. No concomitant medications were reported. No treatment provided.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Product dose omission issue
Clinical narrative: 63 days since first shot without having second shot; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (63 days since first shot without having second shot) and PAIN IN EXTREMITY (sore arm ) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (63 days since first shot without having second shot) and PAIN IN EXTREMITY (sore arm ). At the time of the report, PRODUCT DOSE OMISSION ISSUE (63 days since first shot without having second shot) had resolved and PAIN IN EXTREMITY (sore arm ) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment was reported.   This case was linked to MOD21-089185, MOD-2021-118041 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  MOD21-089185:Case for husband MOD-2021-118041:husband case
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Pharmacist caModerna vaccine more than 6 hours after first vial puncture; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacist caModerna vaccine more than 6 hours after first vial puncture) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacist caModerna vaccine more than 6 hours after first vial puncture). On 08-May-2021, EXPIRED PRODUCT ADMINISTERED (Pharmacist caModerna vaccine more than 6 hours after first vial puncture) 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.   Treatment information not reported. No concomitant medications reported.