chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Product contamination physical
Clinical narrative: Received Vaccine from a vial having black particles in it; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT CONTAMINATION PHYSICAL (Received Vaccine from a vial having black particles in it) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  .     On 13-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced PRODUCT CONTAMINATION PHYSICAL (Received Vaccine from a vial having black particles in it). At the time of the report, PRODUCT CONTAMINATION PHYSICAL (Received Vaccine from a vial having black particles in it) 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.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site mass, Vaccination site pain, Vaccination site pruritus, Vaccination site reaction
Clinical narrative: injection site reaction the size of a half-dollar that was itchy warm  and swollen; Bump that was size of half-dollar; Injection site warm; Injection site itchy; Extremely exhausted; Injection site swollen; Only slightly tender; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (injection site reaction the size of a half-dollar that was itchy warm  and swollen), VACCINATION SITE MASS (Bump that was size of half-dollar), VACCINATION SITE WARMTH (Injection site warm), VACCINATION SITE PRURITUS (Injection site itchy) and FATIGUE (Extremely exhausted) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), DEXLANSOPRAZOLE (DEXILANT), DULOXETINE HYDROCHLORIDE (CYMBALTA), ALPRAZOLAM (XANAX), UBROGEPANT (UBRELVY), SALBUTAMOL SULFATE (PROVENTIL [SALBUTAMOL SULFATE]) and LORATADINE for an unknown indication.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced VACCINATION SITE REACTION (injection site reaction the size of a half-dollar that was itchy warm  and swollen), VACCINATION SITE MASS (Bump that was size of half-dollar), VACCINATION SITE WARMTH (Injection site warm), VACCINATION SITE PRURITUS (Injection site itchy), FATIGUE (Extremely exhausted) and VACCINATION SITE SWELLING (Injection site swollen). In April 2021, the patient experienced VACCINATION SITE PAIN (Only slightly tender). On 09-Apr-2021, FATIGUE (Extremely exhausted) had resolved. On 12-Apr-2021, VACCINATION SITE REACTION (injection site reaction the size of a half-dollar that was itchy warm  and swollen), VACCINATION SITE MASS (Bump that was size of half-dollar), VACCINATION SITE WARMTH (Injection site warm), VACCINATION SITE PRURITUS (Injection site itchy) and VACCINATION SITE SWELLING (Injection site swollen) had resolved. At the time of the report, VACCINATION SITE PAIN (Only slightly tender) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included application of ice to the area.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: injection site reaction the size of a half-dollar that was itchy warm  and swollen; Bump that was size of half-dollar; Injection site warm; Injection site itchy; Extremely exhausted; Injection site swollen; Only slightly tender; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (injection site reaction the size of a half-dollar that was itchy warm  and swollen), VACCINATION SITE MASS (Bump that was size of half-dollar), VACCINATION SITE WARMTH (Injection site warm), VACCINATION SITE PRURITUS (Injection site itchy) and FATIGUE (Extremely exhausted) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), DEXLANSOPRAZOLE (DEXILANT), DULOXETINE HYDROCHLORIDE (CYMBALTA), ALPRAZOLAM (XANAX), UBROGEPANT (UBRELVY), SALBUTAMOL SULFATE (PROVENTIL [SALBUTAMOL SULFATE]) and LORATADINE for an unknown indication.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced VACCINATION SITE REACTION (injection site reaction the size of a half-dollar that was itchy warm  and swollen), VACCINATION SITE MASS (Bump that was size of half-dollar), VACCINATION SITE WARMTH (Injection site warm), VACCINATION SITE PRURITUS (Injection site itchy), FATIGUE (Extremely exhausted) and VACCINATION SITE SWELLING (Injection site swollen). In April 2021, the patient experienced VACCINATION SITE PAIN (Only slightly tender). On 09-Apr-2021, FATIGUE (Extremely exhausted) had resolved. On 12-Apr-2021, VACCINATION SITE REACTION (injection site reaction the size of a half-dollar that was itchy warm  and swollen), VACCINATION SITE MASS (Bump that was size of half-dollar), VACCINATION SITE WARMTH (Injection site warm), VACCINATION SITE PRURITUS (Injection site itchy) and VACCINATION SITE SWELLING (Injection site swollen) had resolved. At the time of the report, VACCINATION SITE PAIN (Only slightly tender) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included application of ice to the area.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache, Pain in extremity, Vaccination site reaction
Clinical narrative: so weak and slept so much; my whole arm ached; "COVID arm"; my feet even ache; headaches that were horrible; fatigue was wicked; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (so weak and slept so much), PAIN IN EXTREMITY (my whole arm ached), VACCINATION SITE REACTION ("COVID arm"), PAIN IN EXTREMITY (my feet even ache) and HEADACHE (headaches that were horrible) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B214) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (so weak and slept so much), PAIN IN EXTREMITY (my whole arm ached), VACCINATION SITE REACTION ("COVID arm"), PAIN IN EXTREMITY (my feet even ache), HEADACHE (headaches that were horrible) and FATIGUE (fatigue was wicked). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 2 tablets a day and IBUPROFEN at a dose of 2 ibuprofen at night. At the time of the report, ASTHENIA (so weak and slept so much), PAIN IN EXTREMITY (my whole arm ached), VACCINATION SITE REACTION ("COVID arm"), PAIN IN EXTREMITY (my feet even ache), HEADACHE (headaches that were horrible) and FATIGUE (fatigue was wicked) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-075858, US-MODERNATX, INC.-MOD-2021-075839 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-075839:Cross linked case US-MODERNATX, INC.-MOD-2021-075858:Cross linked case
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm). At the time of the report, PAIN IN EXTREMITY (Pain in arm) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided.   No treatment information was provided.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: Fatigued all day.; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigued all day.) and PYREXIA (Low grade fever) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 10-Feb-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-Feb-2021, the patient experienced FATIGUE (Fatigued all day.) and PYREXIA (Low grade fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FATIGUE (Fatigued all day.) and PYREXIA (Low grade fever) outcome was unknown.            Concomitant medications included unspecified blood pressure and heart medications. Action taken with mRNA-1273 in response to the events is not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Insomnia, Pain
Clinical narrative: Discomfort; Pain; sleeplessness; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (Discomfort), PAIN (Pain) and INSOMNIA (sleeplessness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DISCOMFORT (Discomfort), PAIN (Pain) and INSOMNIA (sleeplessness). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, DISCOMFORT (Discomfort), PAIN (Pain) and INSOMNIA (sleeplessness) outcome was unknown. Not Provided          No concomitant medications were provided by the reporter.  The patient experienced same  symptoms after second shot was noted.   This case was linked to MOD-2021-075172 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Depressed mood, Feeling abnormal, Swelling
Clinical narrative: Vaccine Knocked her down; swollen up like a football; she thought she is going to die; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSED MOOD (Vaccine Knocked her down), SWELLING (swollen up like a football) and FEELING ABNORMAL (she thought she is going to die) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 06-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced FEELING ABNORMAL (she thought she is going to die). On an unknown date, the patient experienced DEPRESSED MOOD (Vaccine Knocked her down) and SWELLING (swollen up like a football). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. On 06-Apr-2021, FEELING ABNORMAL (she thought she is going to die) had resolved. At the time of the report, DEPRESSED MOOD (Vaccine Knocked her down) and SWELLING (swollen up like a football) had resolved.            No concomitant medications were reported.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Entire body is extremely itchy; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Entire body is extremely itchy) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRURITUS (Entire body is extremely itchy). At the time of the report, PRURITUS (Entire body is extremely itchy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.  The patient stated that the itching started about 1-2 hours after vaccination. The patient did not use anything to treat her symptoms.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood glucose, Fatigue
Clinical narrative: Sore shoulder; Feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Sore shoulder) and FATIGUE (Feeling tired) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes mellitus.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Sore shoulder) and FATIGUE (Feeling tired). At the time of the report, ARTHRALGIA (Sore shoulder) and FATIGUE (Feeling tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Blood glucose: high High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Patient was diabetic, and her blood sugar had been really kind of high and not at all stable as they usually were. It started a day or two after the first injection.  The patient did not receive any treatment
Sex: M
Vaccine: COVID19
Symptoms: Arthritis, Bedridden, Blood uric acid increased, Gout, Pain
Clinical narrative: Flareup; pain; gout; elevated uric acid levels; it has been a week and he is still bed ridden; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain), GOUT (gout), BLOOD URIC ACID INCREASED (elevated uric acid levels), BEDRIDDEN (it has been a week and he is still bed ridden) and ARTHRITIS (Flareup) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 07-Apr-2021, the patient experienced PAIN (pain), GOUT (gout), BLOOD URIC ACID INCREASED (elevated uric acid levels) and BEDRIDDEN (it has been a week and he is still bed ridden). On an unknown date, the patient experienced ARTHRITIS (Flareup). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; IBUPROFEN at an unspecified dose and frequency and INDOMETACIN (INDOMETHACIN COX) at an unspecified dose and frequency. At the time of the report, PAIN (pain), GOUT (gout), BLOOD URIC ACID INCREASED (elevated uric acid levels) and ARTHRITIS (Flareup) outcome was unknown and BEDRIDDEN (it has been a week and he is still bed ridden) had not resolved. Not Provided       Patient had no medical issues before with no concomitant medications. Consent received to be contacted by safety.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: several patients received their second dose but still tested positive for COVID-19 afterwards; 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 SARS-COV-2 TEST POSITIVE (several patients received their second dose but still tested positive for COVID-19 afterwards) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     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 SARS-COV-2 TEST POSITIVE (several patients received their second dose but still tested positive for COVID-19 afterwards). At the time of the report, SARS-COV-2 TEST POSITIVE (several patients received their second dose but still tested positive for COVID-19 afterwards) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-075168 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain in her right arm from shoulder to elbow; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (pain in her right arm from shoulder to elbow) 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 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 09-Apr-2021, the patient experienced PAIN IN EXTREMITY (pain in her right arm from shoulder to elbow). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (pain in her right arm from shoulder to elbow) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: After receiving the second dose, immediately the patient didn't feel right; By the time she got to her car, her upper lip started to go numb; About 20 minutes after vaccine her cheeks were numb; Took about 12 hours before she could feel her lip again; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (After receiving the second dose, immediately the patient didn't feel right), HYPOAESTHESIA (By the time she got to her car, her upper lip started to go numb), HYPOAESTHESIA (About 20 minutes after vaccine her cheeks were numb) and HYPOAESTHESIA ORAL (Took about 12 hours before she could feel her lip again) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 038A21A) 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 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced FEELING ABNORMAL (After receiving the second dose, immediately the patient didn't feel right), HYPOAESTHESIA (By the time she got to her car, her upper lip started to go numb), HYPOAESTHESIA (About 20 minutes after vaccine her cheeks were numb) and HYPOAESTHESIA ORAL (Took about 12 hours before she could feel her lip again). At the time of the report, FEELING ABNORMAL (After receiving the second dose, immediately the patient didn't feel right), HYPOAESTHESIA (By the time she got to her car, her upper lip started to go numb), HYPOAESTHESIA (About 20 minutes after vaccine her cheeks were numb) and HYPOAESTHESIA ORAL (Took about 12 hours before she could feel her lip again) outcome was unknown. Not Provided          No concomitants were reported. No treatment was reported. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration
Clinical narrative: Arm was black and blue; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (Arm was black and blue) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included LOSARTAN, ATORVASTATIN, METOPROLOL, METFORMIN and LEVOTHYROXINE.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, the patient experienced SKIN DISCOLOURATION (Arm was black and blue). At the time of the report, SKIN DISCOLOURATION (Arm was black and blue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: rash on his chest, back, and neck,; rash itches like crazy; it is spreading down to his waist and right arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on his chest, back, and neck,), PRURITUS (rash itches like crazy) and RASH (it is spreading down to his waist and right arm) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included METFORMIN, GABAPENTIN, GLIPIZIDE and INSULIN for an unknown indication.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced RASH (rash on his chest, back, and neck,), PRURITUS (rash itches like crazy) and RASH (it is spreading down to his waist and right arm). At the time of the report, RASH (rash on his chest, back, and neck,), PRURITUS (rash itches like crazy) and RASH (it is spreading down to his waist and right arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure measurement, Vaccination site pain
Clinical narrative: pain at injection site left arm; pain from hip to back of ankles left side; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at injection site left arm) and ARTHRALGIA (pain from hip to back of ankles left side) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced VACCINATION SITE PAIN (pain at injection site left arm) and ARTHRALGIA (pain from hip to back of ankles left side). At the time of the report, VACCINATION SITE PAIN (pain at injection site left arm) and ARTHRALGIA (pain from hip to back of ankles left side) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, Blood pressure measurement: (High) High blood pressure 152/92.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at injection site left arm), BLOOD PRESSURE INCREASED (high blood pressure 152/92) and ARTHRALGIA (pain from hip to back of ankles left side) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced VACCINATION SITE PAIN (pain at injection site left arm), BLOOD PRESSURE INCREASED (high blood pressure 152/92) and ARTHRALGIA (pain from hip to back of ankles left side). At the time of the report, VACCINATION SITE PAIN (pain at injection site left arm), BLOOD PRESSURE INCREASED (high blood pressure 152/92) and ARTHRALGIA (pain from hip to back of ankles left side) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Diarrhoea, Fatigue, Pyrexia
Clinical narrative: weak; diarrhea; tired; vomited; chills; low grade fever of 101; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weak), DIARRHOEA (diarrhea), CHILLS (chills), PYREXIA (low grade fever of 101) and VOMITING (vomited) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced CHILLS (chills) and PYREXIA (low grade fever of 101). On 08-Apr-2021, the patient experienced VOMITING (vomited). On 09-Apr-2021, the patient experienced ASTHENIA (weak), DIARRHOEA (diarrhea) and FATIGUE (tired). On 12-Apr-2021, DIARRHOEA (diarrhea) had resolved. At the time of the report, ASTHENIA (weak), CHILLS (chills), PYREXIA (low grade fever of 101), VOMITING (vomited) and FATIGUE (tired) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information included water and gingerale for 2 days.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Non significant followup. contact information updated.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: weak; diarrhea; tired; vomited; chills; low grade fever of 101; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weak), DIARRHOEA (diarrhea), CHILLS (chills), PYREXIA (low grade fever of 101) and VOMITING (vomited) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced CHILLS (chills) and PYREXIA (low grade fever of 101). On 08-Apr-2021, the patient experienced VOMITING (vomited). On 09-Apr-2021, the patient experienced ASTHENIA (weak), DIARRHOEA (diarrhea) and FATIGUE (tired). On 12-Apr-2021, DIARRHOEA (diarrhea) had resolved. At the time of the report, ASTHENIA (weak), CHILLS (chills), PYREXIA (low grade fever of 101), VOMITING (vomited) and FATIGUE (tired) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information included water and gingerale for 2 days.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Non significant followup. contact information updated.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, the patient experienced URTICARIA (hives). At the time of the report, URTICARIA (hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication use was provided by the reporter.  The patient reported treatment of hives was with steroids on unknown start date.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: Fever; Headache; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (Body ache) in a 61-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 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (Body ache). On 14-Feb-2021, PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (Body ache) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication use was provided by the reporter. No treatment of events was reported.   This case was linked to MOD-2021-009108 (E2B Linked Report).; Sender's Comments:  MOD-2021-009108:First dose
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Herpes zoster, Rash
Clinical narrative: shingles; Pain in the abdomen; Rash; This spontaneous case was reported by a nurse and describes the occurrence of HERPES ZOSTER (shingles), ABDOMINAL PAIN UPPER (Pain in the abdomen) and RASH (Rash) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced HERPES ZOSTER (shingles), ABDOMINAL PAIN UPPER (Pain in the abdomen) and RASH (Rash). At the time of the report, HERPES ZOSTER (shingles), ABDOMINAL PAIN UPPER (Pain in the abdomen) and RASH (Rash) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication use was provided by the reporter.  The patient reported treatment of shingles was with acyclovir since an unknown start date.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested Positive for COVID-19 Disease; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested Positive for COVID-19 Disease) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced COVID-19 (Tested Positive for COVID-19 Disease). At the time of the report, COVID-19 (Tested Positive for COVID-19 Disease) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Mar-2021, SARS-CoV-2 test: positive positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.   No treatment information was provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: arm was sore a little bit; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm was sore a little bit) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION SITE PAIN (arm was sore a little bit). At the time of the report, VACCINATION SITE PAIN (arm was sore a little bit) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-075278 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: women are having reactions with vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (women are having reactions with vaccine) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced ADVERSE REACTION (women are having reactions with vaccine). At the time of the report, ADVERSE REACTION (women are having reactions with vaccine) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable. No concomitant medication use was provided by the reporter. No treatment of events was reported.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Bone pain, Diarrhoea, Gait disturbance, Headache
Clinical narrative: Diarrhea; So sick; Bone aching; Can't walk hardly; Throwing up; 100 degree fever; Headache worse than migraine; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), ILLNESS (So sick), BONE PAIN (Bone aching), GAIT DISTURBANCE (Can't walk hardly) and VOMITING (Throwing up) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea), ILLNESS (So sick), BONE PAIN (Bone aching), GAIT DISTURBANCE (Can't walk hardly), VOMITING (Throwing up), PYREXIA (100 degree fever) and HEADACHE (Headache worse than migraine). At the time of the report, DIARRHOEA (Diarrhea), ILLNESS (So sick), BONE PAIN (Bone aching), GAIT DISTURBANCE (Can't walk hardly), VOMITING (Throwing up), PYREXIA (100 degree fever) and HEADACHE (Headache worse than migraine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 (abnormal) 100 degree fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication use was provided by the reporter.  No treatment of events was reported.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Pyrexia, Vomiting
Clinical narrative: Diarrhea; So sick; Bone aching; Can't walk hardly; Throwing up; 100 degree fever; Headache worse than migraine; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), ILLNESS (So sick), BONE PAIN (Bone aching), GAIT DISTURBANCE (Can't walk hardly) and VOMITING (Throwing up) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea), ILLNESS (So sick), BONE PAIN (Bone aching), GAIT DISTURBANCE (Can't walk hardly), VOMITING (Throwing up), PYREXIA (100 degree fever) and HEADACHE (Headache worse than migraine). At the time of the report, DIARRHOEA (Diarrhea), ILLNESS (So sick), BONE PAIN (Bone aching), GAIT DISTURBANCE (Can't walk hardly), VOMITING (Throwing up), PYREXIA (100 degree fever) and HEADACHE (Headache worse than migraine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 (abnormal) 100 degree fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication use was provided by the reporter.  No treatment of events was reported.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: Redness on face, both ears, both eyelids and neck; Itchy over redness; This spontaneous case was reported by an other health care professional and describes the occurrence of ERYTHEMA (Redness on face, both ears, both eyelids and neck) and PRURITUS (Itchy over redness) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced ERYTHEMA (Redness on face, both ears, both eyelids and neck) and PRURITUS (Itchy over redness). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, ERYTHEMA (Redness on face, both ears, both eyelids and neck) and PRURITUS (Itchy over redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The Medical Assistant at a physician office reported that a patient received Moderna vaccine on 07-Apr-2021 and 2 hours post receiving their vaccine dose the patient experienced redness on face, both ears, both eyelids and neck and it was itchy over redness.   Reportedly, the patient took Benadryl for that.  No Concomitant product use was reported.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Hot flush
Clinical narrative: metallic taste in the mouth; hot flashes; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (metallic taste in the mouth) and HOT FLUSH (hot flashes) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced DYSGEUSIA (metallic taste in the mouth) and HOT FLUSH (hot flashes). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, DYSGEUSIA (metallic taste in the mouth) and HOT FLUSH (hot flashes) outcome was unknown. Details not provided.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypoaesthesia oral, Malaise, Paraesthesia oral, Tachycardia
Clinical narrative: numbness in lip; tingling in lip; dizziness; fast heart beat; she felt off; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (numbness in lip), PARAESTHESIA ORAL (tingling in lip), DIZZINESS (dizziness), TACHYCARDIA (fast heart beat) and MALAISE (she felt off) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01M20A) for COVID-19 vaccination.     The patient's past medical history included Autoimmune disorder NOS.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced HYPOAESTHESIA ORAL (numbness in lip), PARAESTHESIA ORAL (tingling in lip), DIZZINESS (dizziness), TACHYCARDIA (fast heart beat) and MALAISE (she felt off). At the time of the report, HYPOAESTHESIA ORAL (numbness in lip), PARAESTHESIA ORAL (tingling in lip), DIZZINESS (dizziness), TACHYCARDIA (fast heart beat) and MALAISE (she felt off) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication use was provided by the reporter. Treatment information not provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A214) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced DIZZINESS (dizzy). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIZZINESS (dizzy) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported concomitant medication use of female hormones and cholesterol medication both for unknown indications since unknown start dates.     This case was linked to US-MODERNATX, INC.-MOD-2021-075286 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-075286:CROSSLINKED WITH DOSE 2
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Gait disturbance, Peripheral swelling
Clinical narrative: red lines going from his hand up to elbowon right arm; palm and wrist swelled up can hardly move; issues in knees and difficulty in walking ,had to walk very slow; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE, PERIPHERAL SWELLING and ERYTHEMA (red lines going from his hand up to elbow on right arm) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 029L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL, WARFARIN, WARFARIN, VITAMINS, and MINERALS for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Apr-2021, the patient experienced GAIT DISTURBANCE. On 12-Apr-2021, the patient experienced PERIPHERAL SWELLING (palm and wrist swelled up can hardly move). On 13-Apr-2021, the patient experienced ERYTHEMA (red lines going from his hand up to elbow on right arm). At the time of the report, GAIT DISTURBANCE and PERIPHERAL SWELLING (palm and wrist swelled up can hardly move) outcome was unknown and ERYTHEMA (red lines going from his hand up to elbow on right arm) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medication use was provided by the reporter.  The patient denied consent for further follow-up.  No treatment of events was reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Fatigue, Myalgia
Clinical narrative: not much appetite; not much energy; tired...not much energy; achy; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (not much appetite), ASTHENIA (not much energy), FATIGUE (tired...not much energy) and MYALGIA (achy) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Apr-2021, the patient experienced DECREASED APPETITE (not much appetite), ASTHENIA (not much energy), FATIGUE (tired...not much energy) and MYALGIA (achy). The patient was treated with PARACETAMOL (TYLENOL) on 11-Apr-2021 at an unspecified dose and frequency. At the time of the report, DECREASED APPETITE (not much appetite) had resolved and ASTHENIA (not much energy), FATIGUE (tired..not much energy) and MYALGIA (achy) outcome was unknown.            No concomitant medication use was provided by the reporter. The patient drank fluids, slept, taken it easy and started exercising arm  to help alleviate symptoms. The action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-075265 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: pre-drawn syringe stored in refrigartor for more than 12hrs; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (pre-drawn syringe stored in refrigartor for more than 12hrs) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (pre-drawn syringe stored in refrigartor for more than 12hrs). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (pre-drawn syringe stored in refrigartor for more than 12hrs) 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 medication use was provided by the reporter.  The reporter stated that the patient did not have any symptoms after the first dose.  No treatment of events was reported.